This is page 19 of 19. Use http://codebase.md/genomoncology/biomcp?lines=true&page={x} to view the full context.
# Directory Structure
```
├── .github
│ ├── actions
│ │ └── setup-python-env
│ │ └── action.yml
│ ├── dependabot.yml
│ └── workflows
│ ├── ci.yml
│ ├── deploy-docs.yml
│ ├── main.yml.disabled
│ ├── on-release-main.yml
│ └── validate-codecov-config.yml
├── .gitignore
├── .pre-commit-config.yaml
├── BIOMCP_DATA_FLOW.md
├── CHANGELOG.md
├── CNAME
├── codecov.yaml
├── docker-compose.yml
├── Dockerfile
├── docs
│ ├── apis
│ │ ├── error-codes.md
│ │ ├── overview.md
│ │ └── python-sdk.md
│ ├── assets
│ │ ├── biomcp-cursor-locations.png
│ │ ├── favicon.ico
│ │ ├── icon.png
│ │ ├── logo.png
│ │ ├── mcp_architecture.txt
│ │ └── remote-connection
│ │ ├── 00_connectors.png
│ │ ├── 01_add_custom_connector.png
│ │ ├── 02_connector_enabled.png
│ │ ├── 03_connect_to_biomcp.png
│ │ ├── 04_select_google_oauth.png
│ │ └── 05_success_connect.png
│ ├── backend-services-reference
│ │ ├── 01-overview.md
│ │ ├── 02-biothings-suite.md
│ │ ├── 03-cbioportal.md
│ │ ├── 04-clinicaltrials-gov.md
│ │ ├── 05-nci-cts-api.md
│ │ ├── 06-pubtator3.md
│ │ └── 07-alphagenome.md
│ ├── blog
│ │ ├── ai-assisted-clinical-trial-search-analysis.md
│ │ ├── images
│ │ │ ├── deep-researcher-video.png
│ │ │ ├── researcher-announce.png
│ │ │ ├── researcher-drop-down.png
│ │ │ ├── researcher-prompt.png
│ │ │ ├── trial-search-assistant.png
│ │ │ └── what_is_biomcp_thumbnail.png
│ │ └── researcher-persona-resource.md
│ ├── changelog.md
│ ├── CNAME
│ ├── concepts
│ │ ├── 01-what-is-biomcp.md
│ │ ├── 02-the-deep-researcher-persona.md
│ │ └── 03-sequential-thinking-with-the-think-tool.md
│ ├── developer-guides
│ │ ├── 01-server-deployment.md
│ │ ├── 02-contributing-and-testing.md
│ │ ├── 03-third-party-endpoints.md
│ │ ├── 04-transport-protocol.md
│ │ ├── 05-error-handling.md
│ │ ├── 06-http-client-and-caching.md
│ │ ├── 07-performance-optimizations.md
│ │ └── generate_endpoints.py
│ ├── faq-condensed.md
│ ├── FDA_SECURITY.md
│ ├── genomoncology.md
│ ├── getting-started
│ │ ├── 01-quickstart-cli.md
│ │ ├── 02-claude-desktop-integration.md
│ │ └── 03-authentication-and-api-keys.md
│ ├── how-to-guides
│ │ ├── 01-find-articles-and-cbioportal-data.md
│ │ ├── 02-find-trials-with-nci-and-biothings.md
│ │ ├── 03-get-comprehensive-variant-annotations.md
│ │ ├── 04-predict-variant-effects-with-alphagenome.md
│ │ ├── 05-logging-and-monitoring-with-bigquery.md
│ │ └── 06-search-nci-organizations-and-interventions.md
│ ├── index.md
│ ├── policies.md
│ ├── reference
│ │ ├── architecture-diagrams.md
│ │ ├── quick-architecture.md
│ │ ├── quick-reference.md
│ │ └── visual-architecture.md
│ ├── robots.txt
│ ├── stylesheets
│ │ ├── announcement.css
│ │ └── extra.css
│ ├── troubleshooting.md
│ ├── tutorials
│ │ ├── biothings-prompts.md
│ │ ├── claude-code-biomcp-alphagenome.md
│ │ ├── nci-prompts.md
│ │ ├── openfda-integration.md
│ │ ├── openfda-prompts.md
│ │ ├── pydantic-ai-integration.md
│ │ └── remote-connection.md
│ ├── user-guides
│ │ ├── 01-command-line-interface.md
│ │ ├── 02-mcp-tools-reference.md
│ │ └── 03-integrating-with-ides-and-clients.md
│ └── workflows
│ └── all-workflows.md
├── example_scripts
│ ├── mcp_integration.py
│ └── python_sdk.py
├── glama.json
├── LICENSE
├── lzyank.toml
├── Makefile
├── mkdocs.yml
├── package-lock.json
├── package.json
├── pyproject.toml
├── README.md
├── scripts
│ ├── check_docs_in_mkdocs.py
│ ├── check_http_imports.py
│ └── generate_endpoints_doc.py
├── smithery.yaml
├── src
│ └── biomcp
│ ├── __init__.py
│ ├── __main__.py
│ ├── articles
│ │ ├── __init__.py
│ │ ├── autocomplete.py
│ │ ├── fetch.py
│ │ ├── preprints.py
│ │ ├── search_optimized.py
│ │ ├── search.py
│ │ └── unified.py
│ ├── biomarkers
│ │ ├── __init__.py
│ │ └── search.py
│ ├── cbioportal_helper.py
│ ├── circuit_breaker.py
│ ├── cli
│ │ ├── __init__.py
│ │ ├── articles.py
│ │ ├── biomarkers.py
│ │ ├── diseases.py
│ │ ├── health.py
│ │ ├── interventions.py
│ │ ├── main.py
│ │ ├── openfda.py
│ │ ├── organizations.py
│ │ ├── server.py
│ │ ├── trials.py
│ │ └── variants.py
│ ├── connection_pool.py
│ ├── constants.py
│ ├── core.py
│ ├── diseases
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ └── search.py
│ ├── domain_handlers.py
│ ├── drugs
│ │ ├── __init__.py
│ │ └── getter.py
│ ├── exceptions.py
│ ├── genes
│ │ ├── __init__.py
│ │ └── getter.py
│ ├── http_client_simple.py
│ ├── http_client.py
│ ├── individual_tools.py
│ ├── integrations
│ │ ├── __init__.py
│ │ ├── biothings_client.py
│ │ └── cts_api.py
│ ├── interventions
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ └── search.py
│ ├── logging_filter.py
│ ├── metrics_handler.py
│ ├── metrics.py
│ ├── openfda
│ │ ├── __init__.py
│ │ ├── adverse_events_helpers.py
│ │ ├── adverse_events.py
│ │ ├── cache.py
│ │ ├── constants.py
│ │ ├── device_events_helpers.py
│ │ ├── device_events.py
│ │ ├── drug_approvals.py
│ │ ├── drug_labels_helpers.py
│ │ ├── drug_labels.py
│ │ ├── drug_recalls_helpers.py
│ │ ├── drug_recalls.py
│ │ ├── drug_shortages_detail_helpers.py
│ │ ├── drug_shortages_helpers.py
│ │ ├── drug_shortages.py
│ │ ├── exceptions.py
│ │ ├── input_validation.py
│ │ ├── rate_limiter.py
│ │ ├── utils.py
│ │ └── validation.py
│ ├── organizations
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ └── search.py
│ ├── parameter_parser.py
│ ├── prefetch.py
│ ├── query_parser.py
│ ├── query_router.py
│ ├── rate_limiter.py
│ ├── render.py
│ ├── request_batcher.py
│ ├── resources
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ ├── instructions.md
│ │ └── researcher.md
│ ├── retry.py
│ ├── router_handlers.py
│ ├── router.py
│ ├── shared_context.py
│ ├── thinking
│ │ ├── __init__.py
│ │ ├── sequential.py
│ │ └── session.py
│ ├── thinking_tool.py
│ ├── thinking_tracker.py
│ ├── trials
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ ├── nci_getter.py
│ │ ├── nci_search.py
│ │ └── search.py
│ ├── utils
│ │ ├── __init__.py
│ │ ├── cancer_types_api.py
│ │ ├── cbio_http_adapter.py
│ │ ├── endpoint_registry.py
│ │ ├── gene_validator.py
│ │ ├── metrics.py
│ │ ├── mutation_filter.py
│ │ ├── query_utils.py
│ │ ├── rate_limiter.py
│ │ └── request_cache.py
│ ├── variants
│ │ ├── __init__.py
│ │ ├── alphagenome.py
│ │ ├── cancer_types.py
│ │ ├── cbio_external_client.py
│ │ ├── cbioportal_mutations.py
│ │ ├── cbioportal_search_helpers.py
│ │ ├── cbioportal_search.py
│ │ ├── constants.py
│ │ ├── external.py
│ │ ├── filters.py
│ │ ├── getter.py
│ │ ├── links.py
│ │ └── search.py
│ └── workers
│ ├── __init__.py
│ ├── worker_entry_stytch.js
│ ├── worker_entry.js
│ └── worker.py
├── tests
│ ├── bdd
│ │ ├── cli_help
│ │ │ ├── help.feature
│ │ │ └── test_help.py
│ │ ├── conftest.py
│ │ ├── features
│ │ │ └── alphagenome_integration.feature
│ │ ├── fetch_articles
│ │ │ ├── fetch.feature
│ │ │ └── test_fetch.py
│ │ ├── get_trials
│ │ │ ├── get.feature
│ │ │ └── test_get.py
│ │ ├── get_variants
│ │ │ ├── get.feature
│ │ │ └── test_get.py
│ │ ├── search_articles
│ │ │ ├── autocomplete.feature
│ │ │ ├── search.feature
│ │ │ ├── test_autocomplete.py
│ │ │ └── test_search.py
│ │ ├── search_trials
│ │ │ ├── search.feature
│ │ │ └── test_search.py
│ │ ├── search_variants
│ │ │ ├── search.feature
│ │ │ └── test_search.py
│ │ └── steps
│ │ └── test_alphagenome_steps.py
│ ├── config
│ │ └── test_smithery_config.py
│ ├── conftest.py
│ ├── data
│ │ ├── ct_gov
│ │ │ ├── clinical_trials_api_v2.yaml
│ │ │ ├── trials_NCT04280705.json
│ │ │ └── trials_NCT04280705.txt
│ │ ├── myvariant
│ │ │ ├── myvariant_api.yaml
│ │ │ ├── myvariant_field_descriptions.csv
│ │ │ ├── variants_full_braf_v600e.json
│ │ │ ├── variants_full_braf_v600e.txt
│ │ │ └── variants_part_braf_v600_multiple.json
│ │ ├── openfda
│ │ │ ├── drugsfda_detail.json
│ │ │ ├── drugsfda_search.json
│ │ │ ├── enforcement_detail.json
│ │ │ └── enforcement_search.json
│ │ └── pubtator
│ │ ├── pubtator_autocomplete.json
│ │ └── pubtator3_paper.txt
│ ├── integration
│ │ ├── test_openfda_integration.py
│ │ ├── test_preprints_integration.py
│ │ ├── test_simple.py
│ │ └── test_variants_integration.py
│ ├── tdd
│ │ ├── articles
│ │ │ ├── test_autocomplete.py
│ │ │ ├── test_cbioportal_integration.py
│ │ │ ├── test_fetch.py
│ │ │ ├── test_preprints.py
│ │ │ ├── test_search.py
│ │ │ └── test_unified.py
│ │ ├── conftest.py
│ │ ├── drugs
│ │ │ ├── __init__.py
│ │ │ └── test_drug_getter.py
│ │ ├── openfda
│ │ │ ├── __init__.py
│ │ │ ├── test_adverse_events.py
│ │ │ ├── test_device_events.py
│ │ │ ├── test_drug_approvals.py
│ │ │ ├── test_drug_labels.py
│ │ │ ├── test_drug_recalls.py
│ │ │ ├── test_drug_shortages.py
│ │ │ └── test_security.py
│ │ ├── test_biothings_integration_real.py
│ │ ├── test_biothings_integration.py
│ │ ├── test_circuit_breaker.py
│ │ ├── test_concurrent_requests.py
│ │ ├── test_connection_pool.py
│ │ ├── test_domain_handlers.py
│ │ ├── test_drug_approvals.py
│ │ ├── test_drug_recalls.py
│ │ ├── test_drug_shortages.py
│ │ ├── test_endpoint_documentation.py
│ │ ├── test_error_scenarios.py
│ │ ├── test_europe_pmc_fetch.py
│ │ ├── test_mcp_integration.py
│ │ ├── test_mcp_tools.py
│ │ ├── test_metrics.py
│ │ ├── test_nci_integration.py
│ │ ├── test_nci_mcp_tools.py
│ │ ├── test_network_policies.py
│ │ ├── test_offline_mode.py
│ │ ├── test_openfda_unified.py
│ │ ├── test_pten_r173_search.py
│ │ ├── test_render.py
│ │ ├── test_request_batcher.py.disabled
│ │ ├── test_retry.py
│ │ ├── test_router.py
│ │ ├── test_shared_context.py.disabled
│ │ ├── test_unified_biothings.py
│ │ ├── thinking
│ │ │ ├── __init__.py
│ │ │ └── test_sequential.py
│ │ ├── trials
│ │ │ ├── test_backward_compatibility.py
│ │ │ ├── test_getter.py
│ │ │ └── test_search.py
│ │ ├── utils
│ │ │ ├── test_gene_validator.py
│ │ │ ├── test_mutation_filter.py
│ │ │ ├── test_rate_limiter.py
│ │ │ └── test_request_cache.py
│ │ ├── variants
│ │ │ ├── constants.py
│ │ │ ├── test_alphagenome_api_key.py
│ │ │ ├── test_alphagenome_comprehensive.py
│ │ │ ├── test_alphagenome.py
│ │ │ ├── test_cbioportal_mutations.py
│ │ │ ├── test_cbioportal_search.py
│ │ │ ├── test_external_integration.py
│ │ │ ├── test_external.py
│ │ │ ├── test_extract_gene_aa_change.py
│ │ │ ├── test_filters.py
│ │ │ ├── test_getter.py
│ │ │ ├── test_links.py
│ │ │ └── test_search.py
│ │ └── workers
│ │ └── test_worker_sanitization.js
│ └── test_pydantic_ai_integration.py
├── THIRD_PARTY_ENDPOINTS.md
├── tox.ini
├── uv.lock
└── wrangler.toml
```
# Files
--------------------------------------------------------------------------------
/tests/data/ct_gov/trials_NCT04280705.json:
--------------------------------------------------------------------------------
```json
1 | {
2 | "studies": [
3 | {
4 | "protocolSection": {
5 | "identificationModule": {
6 | "nctId": "NCT04280705",
7 | "orgStudyIdInfo": {
8 | "id": "20-0006"
9 | },
10 | "organization": {
11 | "fullName": "National Institute of Allergy and Infectious Diseases (NIAID)",
12 | "class": "NIH"
13 | },
14 | "briefTitle": "Adaptive COVID-19 Treatment Trial (ACTT)",
15 | "officialTitle": "A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults"
16 | },
17 | "statusModule": {
18 | "statusVerifiedDate": "2020-04",
19 | "overallStatus": "COMPLETED",
20 | "expandedAccessInfo": {
21 | "hasExpandedAccess": false
22 | },
23 | "startDateStruct": {
24 | "date": "2020-02-21",
25 | "type": "ACTUAL"
26 | },
27 | "primaryCompletionDateStruct": {
28 | "date": "2020-05-21",
29 | "type": "ACTUAL"
30 | },
31 | "completionDateStruct": {
32 | "date": "2020-05-21",
33 | "type": "ACTUAL"
34 | },
35 | "studyFirstSubmitDate": "2020-02-20",
36 | "studyFirstSubmitQcDate": "2020-02-20",
37 | "studyFirstPostDateStruct": {
38 | "date": "2020-02-21",
39 | "type": "ACTUAL"
40 | },
41 | "resultsFirstSubmitDate": "2020-09-16",
42 | "resultsFirstSubmitQcDate": "2020-09-22",
43 | "resultsFirstPostDateStruct": {
44 | "date": "2020-09-25",
45 | "type": "ACTUAL"
46 | },
47 | "lastUpdateSubmitDate": "2022-03-09",
48 | "lastUpdatePostDateStruct": {
49 | "date": "2022-03-14",
50 | "type": "ACTUAL"
51 | }
52 | },
53 | "sponsorCollaboratorsModule": {
54 | "responsibleParty": {
55 | "type": "SPONSOR"
56 | },
57 | "leadSponsor": {
58 | "name": "National Institute of Allergy and Infectious Diseases (NIAID)",
59 | "class": "NIH"
60 | }
61 | },
62 | "oversightModule": {
63 | "isFdaRegulatedDrug": true,
64 | "isFdaRegulatedDevice": false,
65 | "isUsExport": false
66 | },
67 | "descriptionModule": {
68 | "briefSummary": "This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.",
69 | "detailedDescription": "This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms.\n\nThe initial sample size is projected to be 572 subjects to achieve 400 subjects with a \"recovered\" status (per the primary objective). The primary analysis will be based on those subjects enrolled in order to 400 recoveries. An additional analysis of the moderate severity subgroup (those with baseline status of \"Hospitalized, requiring supplemental oxygen\" or \"Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care\") is also of public health importance. Hence, enrollment will be permitted until the date of April 20, 2020 to ensure 400 recoveries and provide additional data about this important subgroup. With recent enrollment rates, the total sample size may be 600 to over 800.\n\nSubjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29 as an outpatient. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and OP swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, Day 15 and 29 visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and may also be conducted by phone.\n\nAll subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized).\n\nThe primary outcome is time to recovery by Day 29. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. As little is known about the clinical course of COVID-19, a pilot study will be used for a blinded sample size reassessment.\n\nContacts:\n\n20-0006 Central Contact\n\nTelephone: 1 (301) 7617948\n\nEmail: [email protected]"
70 | },
71 | "conditionsModule": {
72 | "conditions": ["COVID-19"],
73 | "keywords": [
74 | "Adaptive",
75 | "COVID-19",
76 | "Efficacy",
77 | "Multicenter",
78 | "novel coronavirus",
79 | "Safety",
80 | "ACTT"
81 | ]
82 | },
83 | "designModule": {
84 | "studyType": "INTERVENTIONAL",
85 | "phases": ["PHASE3"],
86 | "designInfo": {
87 | "allocation": "RANDOMIZED",
88 | "interventionModel": "PARALLEL",
89 | "primaryPurpose": "TREATMENT",
90 | "maskingInfo": {
91 | "masking": "DOUBLE",
92 | "whoMasked": ["PARTICIPANT", "INVESTIGATOR"]
93 | }
94 | },
95 | "enrollmentInfo": {
96 | "count": 1062,
97 | "type": "ACTUAL"
98 | }
99 | },
100 | "armsInterventionsModule": {
101 | "armGroups": [
102 | {
103 | "label": "Placebo",
104 | "type": "PLACEBO_COMPARATOR",
105 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. n=286.",
106 | "interventionNames": ["Other: Placebo"]
107 | },
108 | {
109 | "label": "Remdesivir",
110 | "type": "EXPERIMENTAL",
111 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. n=286.",
112 | "interventionNames": ["Drug: Remdesivir"]
113 | }
114 | ],
115 | "interventions": [
116 | {
117 | "type": "OTHER",
118 | "name": "Placebo",
119 | "description": "The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies.",
120 | "armGroupLabels": ["Placebo"]
121 | },
122 | {
123 | "type": "DRUG",
124 | "name": "Remdesivir",
125 | "description": "Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.",
126 | "armGroupLabels": ["Remdesivir"]
127 | }
128 | ]
129 | },
130 | "outcomesModule": {
131 | "primaryOutcomes": [
132 | {
133 | "measure": "Time to Recovery",
134 | "description": "Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.",
135 | "timeFrame": "Day 1 through Day 29"
136 | },
137 | {
138 | "measure": "Time to Recovery by Race",
139 | "description": "Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.",
140 | "timeFrame": "Day 1 through Day 29"
141 | },
142 | {
143 | "measure": "Time to Recovery by Ethnicity",
144 | "description": "Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.",
145 | "timeFrame": "Day 1 through Day 29"
146 | },
147 | {
148 | "measure": "Time to Recovery by Sex",
149 | "description": "Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.",
150 | "timeFrame": "Day 1 through Day 29"
151 | }
152 | ],
153 | "secondaryOutcomes": [
154 | {
155 | "measure": "Change From Baseline in Alanine Transaminase (ALT)",
156 | "description": "Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
157 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
158 | },
159 | {
160 | "measure": "Change From Baseline in Aspartate Transaminase (AST)",
161 | "description": "Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
162 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
163 | },
164 | {
165 | "measure": "Change From Baseline in Creatinine",
166 | "description": "Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
167 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
168 | },
169 | {
170 | "measure": "Change From Baseline in Glucose",
171 | "description": "Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
172 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
173 | },
174 | {
175 | "measure": "Change From Baseline in Hemoglobin",
176 | "description": "Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
177 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
178 | },
179 | {
180 | "measure": "Change From Baseline in Platelets",
181 | "description": "Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
182 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
183 | },
184 | {
185 | "measure": "Change From Baseline in Prothrombin Time (PT)",
186 | "description": "Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
187 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
188 | },
189 | {
190 | "measure": "Change From Baseline in Total Bilirubin",
191 | "description": "Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
192 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
193 | },
194 | {
195 | "measure": "Change From Baseline in White Blood Cell Count (WBC)",
196 | "description": "Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
197 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
198 | },
199 | {
200 | "measure": "Change From Baseline in Neutrophils",
201 | "description": "Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
202 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
203 | },
204 | {
205 | "measure": "Change From Baseline in Lymphocytes",
206 | "description": "Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
207 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
208 | },
209 | {
210 | "measure": "Change From Baseline in Monocytes",
211 | "description": "Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
212 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
213 | },
214 | {
215 | "measure": "Change From Baseline in Basophils",
216 | "description": "Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
217 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
218 | },
219 | {
220 | "measure": "Change From Baseline in Eosinophils",
221 | "description": "Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
222 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
223 | },
224 | {
225 | "measure": "Change in National Early Warning Score (NEWS) From Baseline",
226 | "description": "The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.",
227 | "timeFrame": "Days 1, 3, 5, 8, 11, 15, 22, and 29"
228 | },
229 | {
230 | "measure": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1",
231 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
232 | "timeFrame": "Day 1"
233 | },
234 | {
235 | "measure": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3",
236 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
237 | "timeFrame": "Day 3"
238 | },
239 | {
240 | "measure": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5",
241 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
242 | "timeFrame": "Day 5"
243 | },
244 | {
245 | "measure": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8",
246 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
247 | "timeFrame": "Day 8"
248 | },
249 | {
250 | "measure": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11",
251 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
252 | "timeFrame": "Day 11"
253 | },
254 | {
255 | "measure": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15",
256 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
257 | "timeFrame": "Day 15"
258 | },
259 | {
260 | "measure": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22",
261 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
262 | "timeFrame": "Day 22"
263 | },
264 | {
265 | "measure": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29",
266 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
267 | "timeFrame": "Day 29"
268 | },
269 | {
270 | "measure": "Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)",
271 | "description": "Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.",
272 | "timeFrame": "Day 1 through Day 29"
273 | },
274 | {
275 | "measure": "Percentage of Participants Reporting Serious Adverse Events (SAEs)",
276 | "description": "An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.",
277 | "timeFrame": "Day 1 through Day 29"
278 | },
279 | {
280 | "measure": "Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics",
281 | "description": "Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.",
282 | "timeFrame": "Day 1 through Day 10"
283 | },
284 | {
285 | "measure": "Duration of Hospitalization",
286 | "description": "Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.",
287 | "timeFrame": "Day 1 through Day 29"
288 | },
289 | {
290 | "measure": "Duration of New Non-invasive Ventilation or High Flow Oxygen Use",
291 | "description": "Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die",
292 | "timeFrame": "Day 1 through Day 29"
293 | },
294 | {
295 | "measure": "Duration of New Oxygen Use",
296 | "description": "Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die\n\n.",
297 | "timeFrame": "Day 1 through Day 29"
298 | },
299 | {
300 | "measure": "Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use",
301 | "description": "Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die",
302 | "timeFrame": "Day 1 through Day 29"
303 | },
304 | {
305 | "measure": "Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use",
306 | "description": "New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.",
307 | "timeFrame": "Day 1 through Day 29"
308 | },
309 | {
310 | "measure": "Percentage of Participants Requiring New Oxygen Use",
311 | "description": "The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline",
312 | "timeFrame": "Day 1 through Day 29"
313 | },
314 | {
315 | "measure": "Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use",
316 | "description": "The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline",
317 | "timeFrame": "Day 1 through Day 29"
318 | },
319 | {
320 | "measure": "Mean Change in the Ordinal Scale",
321 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.",
322 | "timeFrame": "Day 1, 3, 5, 8, 11, 15, 22, and 29"
323 | },
324 | {
325 | "measure": "14-day Participant Mortality",
326 | "description": "The mortality rate was determined as the proportion of participants who died by study Day 15.",
327 | "timeFrame": "Day 1 through Day 15"
328 | },
329 | {
330 | "measure": "29-day Participant Mortality",
331 | "description": "The mortality rate was determined as the proportion of participants who died by study Day 29.",
332 | "timeFrame": "Day 1 through Day 29"
333 | },
334 | {
335 | "measure": "Time to an Improvement by at Least One Category Using an Ordinal Scale",
336 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant",
337 | "timeFrame": "Day 1 through Day 29"
338 | },
339 | {
340 | "measure": "Time to an Improvement of at Least Two Categories Using an Ordinal Scale",
341 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant",
342 | "timeFrame": "Day 1 through Day 29"
343 | },
344 | {
345 | "measure": "Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First",
346 | "description": "The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.",
347 | "timeFrame": "Day 1 through Day 29"
348 | }
349 | ]
350 | },
351 | "eligibilityModule": {
352 | "eligibilityCriteria": "Inclusion Criteria:\n\n1. Admitted to a hospital with symptoms suggestive of COVID-19 infection.\n2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.\n3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.\n4. Male or non-pregnant female adult \\> / = 18 years of age at time of enrollment.\n5. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following:\n\n 1. PCR positive in sample collected \\< 72 hours prior to randomization; OR\n\n Exclusion Criteria:\n 2. PCR positive in sample collected \\>/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking \\>24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.\n6. Illness of any duration, and at least one of the following:\n\n 1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR\n 2. SpO2 \\< / = 94% on room air, OR\n 3. Requiring supplemental oxygen, OR\n 4. Requiring mechanical ventilation.\n7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.\n8. Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.\n\nExclusion Criteria:\n\n1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \\> 5 times the upper limit of normal.\n2. Estimated glomerular filtration rate (eGFR) \\< 30 ml/min (including patients receiving hemodialysis or hemofiltration).\n3. Pregnancy or breast feeding.\n4. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.\n5. Allergy to any study medication.",
353 | "healthyVolunteers": false,
354 | "sex": "ALL",
355 | "minimumAge": "18 Years",
356 | "maximumAge": "99 Years",
357 | "stdAges": ["ADULT", "OLDER_ADULT"]
358 | },
359 | "contactsLocationsModule": {
360 | "locations": [
361 | {
362 | "facility": "University of Alabama at Birmingham School of Medicine - Infectious Disease",
363 | "city": "Birmingham",
364 | "state": "Alabama",
365 | "zip": "35233",
366 | "country": "United States",
367 | "geoPoint": {
368 | "lat": 33.52066,
369 | "lon": -86.80249
370 | }
371 | },
372 | {
373 | "facility": "University of California San Diego Health - Jacobs Medical Center",
374 | "city": "La Jolla",
375 | "state": "California",
376 | "zip": "29037",
377 | "country": "United States",
378 | "geoPoint": {
379 | "lat": 32.84727,
380 | "lon": -117.2742
381 | }
382 | },
383 | {
384 | "facility": "University of California Los Angeles Medical Center - Westwood Clinic",
385 | "city": "Los Angeles",
386 | "state": "California",
387 | "zip": "90095",
388 | "country": "United States",
389 | "geoPoint": {
390 | "lat": 34.05223,
391 | "lon": -118.24368
392 | }
393 | },
394 | {
395 | "facility": "University of California Irvine Medical Center - Infectious Disease",
396 | "city": "Orange",
397 | "state": "California",
398 | "zip": "92868-3298",
399 | "country": "United States",
400 | "geoPoint": {
401 | "lat": 33.78779,
402 | "lon": -117.85311
403 | }
404 | },
405 | {
406 | "facility": "VA Palo Alto Health Care System - Infectious Diseases",
407 | "city": "Palo Alto",
408 | "state": "California",
409 | "zip": "94304-1207",
410 | "country": "United States",
411 | "geoPoint": {
412 | "lat": 37.44188,
413 | "lon": -122.14302
414 | }
415 | },
416 | {
417 | "facility": "University of California Davis Medical Center - Internal Medicine - Infectious Disease",
418 | "city": "Sacramento",
419 | "state": "California",
420 | "zip": "95817-1460",
421 | "country": "United States",
422 | "geoPoint": {
423 | "lat": 38.58157,
424 | "lon": -121.4944
425 | }
426 | },
427 | {
428 | "facility": "Naval Medical Center San Diego - Infectious Disease Clinic",
429 | "city": "San Diego",
430 | "state": "California",
431 | "zip": "92314",
432 | "country": "United States",
433 | "geoPoint": {
434 | "lat": 32.71533,
435 | "lon": -117.15726
436 | }
437 | },
438 | {
439 | "facility": "University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine",
440 | "city": "San Francisco",
441 | "state": "California",
442 | "zip": "94110-2859",
443 | "country": "United States",
444 | "geoPoint": {
445 | "lat": 37.77493,
446 | "lon": -122.41942
447 | }
448 | },
449 | {
450 | "facility": "Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases",
451 | "city": "Stanford",
452 | "state": "California",
453 | "zip": "94305-2200",
454 | "country": "United States",
455 | "geoPoint": {
456 | "lat": 37.42411,
457 | "lon": -122.16608
458 | }
459 | },
460 | {
461 | "facility": "Cedars Sinai Medical Center",
462 | "city": "West Hollywood",
463 | "state": "California",
464 | "zip": "90048-1804",
465 | "country": "United States",
466 | "geoPoint": {
467 | "lat": 34.09001,
468 | "lon": -118.36174
469 | }
470 | },
471 | {
472 | "facility": "Denver Health Division of Hospital Medicine - Main Campus",
473 | "city": "Denver",
474 | "state": "Colorado",
475 | "zip": "80204",
476 | "country": "United States",
477 | "geoPoint": {
478 | "lat": 39.73915,
479 | "lon": -104.9847
480 | }
481 | },
482 | {
483 | "facility": "Emory Vaccine Center - The Hope Clinic",
484 | "city": "Decatur",
485 | "state": "Georgia",
486 | "zip": "30030-1705",
487 | "country": "United States",
488 | "geoPoint": {
489 | "lat": 33.77483,
490 | "lon": -84.29631
491 | }
492 | },
493 | {
494 | "facility": "Northwestern Hospital - Infectious Disease",
495 | "city": "Chicago",
496 | "state": "Illinois",
497 | "zip": "60611-2908",
498 | "country": "United States",
499 | "geoPoint": {
500 | "lat": 41.85003,
501 | "lon": -87.65005
502 | }
503 | },
504 | {
505 | "facility": "University of Illinois at Chicago College of Medicine - Division of Infectious Diseases",
506 | "city": "Chicago",
507 | "state": "Illinois",
508 | "zip": "60612",
509 | "country": "United States",
510 | "geoPoint": {
511 | "lat": 41.85003,
512 | "lon": -87.65005
513 | }
514 | },
515 | {
516 | "facility": "Southeast Louisiana Veterans Health Care System - Section of Infectious Diseases",
517 | "city": "New Orleans",
518 | "state": "Louisiana",
519 | "zip": "70119",
520 | "country": "United States",
521 | "geoPoint": {
522 | "lat": 29.95465,
523 | "lon": -90.07507
524 | }
525 | },
526 | {
527 | "facility": "University of Maryland School of Medicine - Center for Vaccine Development - Baltimore",
528 | "city": "Baltimore",
529 | "state": "Maryland",
530 | "zip": "21201-1509",
531 | "country": "United States",
532 | "geoPoint": {
533 | "lat": 39.29038,
534 | "lon": -76.61219
535 | }
536 | },
537 | {
538 | "facility": "Johns Hopkins Hospital - Medicine - Infectious Diseases",
539 | "city": "Baltimore",
540 | "state": "Maryland",
541 | "zip": "21287-0005",
542 | "country": "United States",
543 | "geoPoint": {
544 | "lat": 39.29038,
545 | "lon": -76.61219
546 | }
547 | },
548 | {
549 | "facility": "Walter Reed National Military Medical Center",
550 | "city": "Bethesda",
551 | "state": "Maryland",
552 | "zip": "20889",
553 | "country": "United States",
554 | "geoPoint": {
555 | "lat": 38.98067,
556 | "lon": -77.10026
557 | }
558 | },
559 | {
560 | "facility": "National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section",
561 | "city": "Bethesda",
562 | "state": "Maryland",
563 | "zip": "20892-1504",
564 | "country": "United States",
565 | "geoPoint": {
566 | "lat": 38.98067,
567 | "lon": -77.10026
568 | }
569 | },
570 | {
571 | "facility": "Massachusetts General Hospital - Infectious Diseases",
572 | "city": "Boston",
573 | "state": "Massachusetts",
574 | "zip": "02114-2621",
575 | "country": "United States",
576 | "geoPoint": {
577 | "lat": 42.35843,
578 | "lon": -71.05977
579 | }
580 | },
581 | {
582 | "facility": "University of Massachusetts Medical School - Infectious Diseases and Immunology",
583 | "city": "Worcester",
584 | "state": "Massachusetts",
585 | "zip": "01655-0002",
586 | "country": "United States",
587 | "geoPoint": {
588 | "lat": 42.26259,
589 | "lon": -71.80229
590 | }
591 | },
592 | {
593 | "facility": "University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine",
594 | "city": "Minneapolis",
595 | "state": "Minnesota",
596 | "zip": "55455-0341",
597 | "country": "United States",
598 | "geoPoint": {
599 | "lat": 44.97997,
600 | "lon": -93.26384
601 | }
602 | },
603 | {
604 | "facility": "Saint Louis University - Center for Vaccine Development",
605 | "city": "Saint Louis",
606 | "state": "Missouri",
607 | "zip": "63104-1015",
608 | "country": "United States",
609 | "geoPoint": {
610 | "lat": 38.62727,
611 | "lon": -90.19789
612 | }
613 | },
614 | {
615 | "facility": "University of Nebraska Medical Center - Infectious Diseases",
616 | "city": "Omaha",
617 | "state": "Nebraska",
618 | "zip": "68105",
619 | "country": "United States",
620 | "geoPoint": {
621 | "lat": 41.25626,
622 | "lon": -95.94043
623 | }
624 | },
625 | {
626 | "facility": "Montefiore Medical Center - Infectious Diseases",
627 | "city": "Bronx",
628 | "state": "New York",
629 | "zip": "10467-2401",
630 | "country": "United States",
631 | "geoPoint": {
632 | "lat": 40.84985,
633 | "lon": -73.86641
634 | }
635 | },
636 | {
637 | "facility": "New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology",
638 | "city": "New York",
639 | "state": "New York",
640 | "zip": "10016-6402",
641 | "country": "United States",
642 | "geoPoint": {
643 | "lat": 40.71427,
644 | "lon": -74.00597
645 | }
646 | },
647 | {
648 | "facility": "University of Rochester Medical Center - Vaccine Research Unit",
649 | "city": "Rochester",
650 | "state": "New York",
651 | "zip": "14642-0001",
652 | "country": "United States",
653 | "geoPoint": {
654 | "lat": 43.15478,
655 | "lon": -77.61556
656 | }
657 | },
658 | {
659 | "facility": "Duke Human Vaccine Institute - Duke Vaccine and Trials Unit",
660 | "city": "Durham",
661 | "state": "North Carolina",
662 | "zip": "27704",
663 | "country": "United States",
664 | "geoPoint": {
665 | "lat": 35.99403,
666 | "lon": -78.89862
667 | }
668 | },
669 | {
670 | "facility": "Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases",
671 | "city": "Hershey",
672 | "state": "Pennsylvania",
673 | "zip": "17033",
674 | "country": "United States",
675 | "geoPoint": {
676 | "lat": 40.28592,
677 | "lon": -76.65025
678 | }
679 | },
680 | {
681 | "facility": "Hospital of the University of Pennsylvania - Infectious Diseases",
682 | "city": "Philadelphia",
683 | "state": "Pennsylvania",
684 | "zip": "19104-4238",
685 | "country": "United States",
686 | "geoPoint": {
687 | "lat": 39.95233,
688 | "lon": -75.16379
689 | }
690 | },
691 | {
692 | "facility": "Vanderbilt University Medical Center - Infectious Diseases",
693 | "city": "Nashville",
694 | "state": "Tennessee",
695 | "zip": "37232-0011",
696 | "country": "United States",
697 | "geoPoint": {
698 | "lat": 36.16589,
699 | "lon": -86.78444
700 | }
701 | },
702 | {
703 | "facility": "Brooke Army Medical Center",
704 | "city": "Fort Sam Houston",
705 | "state": "Texas",
706 | "zip": "78234",
707 | "country": "United States",
708 | "geoPoint": {
709 | "lat": 29.45746,
710 | "lon": -98.4472
711 | }
712 | },
713 | {
714 | "facility": "University of Texas Medical Branch - Division of Infectious Disease",
715 | "city": "Galveston",
716 | "state": "Texas",
717 | "zip": "77555-0435",
718 | "country": "United States",
719 | "geoPoint": {
720 | "lat": 29.30135,
721 | "lon": -94.7977
722 | }
723 | },
724 | {
725 | "facility": "Baylor College of Medicine - Molecular Virology and Microbiology",
726 | "city": "Houston",
727 | "state": "Texas",
728 | "zip": "77030-3411",
729 | "country": "United States",
730 | "geoPoint": {
731 | "lat": 29.76328,
732 | "lon": -95.36327
733 | }
734 | },
735 | {
736 | "facility": "University of Texas Health Science Center at San Antonio - Infectious Diseases",
737 | "city": "San Antonio",
738 | "state": "Texas",
739 | "zip": "78229-3901",
740 | "country": "United States",
741 | "geoPoint": {
742 | "lat": 29.42412,
743 | "lon": -98.49363
744 | }
745 | },
746 | {
747 | "facility": "University of Virginia - Acute Care Surgery",
748 | "city": "Charlottesville",
749 | "state": "Virginia",
750 | "zip": "22908-0816",
751 | "country": "United States",
752 | "geoPoint": {
753 | "lat": 38.02931,
754 | "lon": -78.47668
755 | }
756 | },
757 | {
758 | "facility": "Naval Medical Center Portsmouth - Infectious Disease Division",
759 | "city": "Portsmouth",
760 | "state": "Virginia",
761 | "zip": "23708",
762 | "country": "United States",
763 | "geoPoint": {
764 | "lat": 36.83543,
765 | "lon": -76.29827
766 | }
767 | },
768 | {
769 | "facility": "EvergreenHealth Infectious Disease Service",
770 | "city": "Kirkland",
771 | "state": "Washington",
772 | "zip": "98034",
773 | "country": "United States",
774 | "geoPoint": {
775 | "lat": 47.68149,
776 | "lon": -122.20874
777 | }
778 | },
779 | {
780 | "facility": "The University of Washington - Virology Research Clinic",
781 | "city": "Seattle",
782 | "state": "Washington",
783 | "zip": "98104",
784 | "country": "United States",
785 | "geoPoint": {
786 | "lat": 47.60621,
787 | "lon": -122.33207
788 | }
789 | },
790 | {
791 | "facility": "Providence Sacred Heart Medical Center",
792 | "city": "Spokane",
793 | "state": "Washington",
794 | "zip": "99204",
795 | "country": "United States",
796 | "geoPoint": {
797 | "lat": 47.65966,
798 | "lon": -117.42908
799 | }
800 | },
801 | {
802 | "facility": "Madigan Army Medical Center - Infectious Disease Clinic",
803 | "city": "Tacoma",
804 | "state": "Washington",
805 | "zip": "98431",
806 | "country": "United States",
807 | "geoPoint": {
808 | "lat": 47.25288,
809 | "lon": -122.44429
810 | }
811 | },
812 | {
813 | "facility": "University of Copenhagen - Centre of Excellence for Health, Immunity and Infections (CHIP) - Department of Infectious Diseases",
814 | "city": "Copenhagen",
815 | "zip": "2100",
816 | "country": "Denmark",
817 | "geoPoint": {
818 | "lat": 55.67594,
819 | "lon": 12.56553
820 | }
821 | },
822 | {
823 | "facility": "Universitatsklinikum Bonn, Medizinische Klinik I - Bereich Infektiologie/HIV der Medizinischen Klinik",
824 | "city": "Bonn",
825 | "state": "Nordrhein-Westfalen",
826 | "zip": "53127",
827 | "country": "Germany",
828 | "geoPoint": {
829 | "lat": 50.73438,
830 | "lon": 7.09549
831 | }
832 | },
833 | {
834 | "facility": "Universitatsklinikum Koeln Klinik I fur Innere Medizin Klinisches Studienzentrum fur Infektiologie I",
835 | "city": "Cologne",
836 | "zip": "50937",
837 | "country": "Germany",
838 | "geoPoint": {
839 | "lat": 50.93333,
840 | "lon": 6.95
841 | }
842 | },
843 | {
844 | "facility": "Universitätsklinikum Frankfurt -Medizinische Klinik II - Infektiologie",
845 | "city": "Frankfurt",
846 | "zip": "60590",
847 | "country": "Germany",
848 | "geoPoint": {
849 | "lat": 50.11552,
850 | "lon": 8.68417
851 | }
852 | },
853 | {
854 | "facility": "AHEPA University Hospital - 1st Department of Internal Medicine",
855 | "city": "Thessaloniki",
856 | "state": "Central Macedonia",
857 | "zip": "P.O. 54636",
858 | "country": "Greece",
859 | "geoPoint": {
860 | "lat": 40.64361,
861 | "lon": 22.93086
862 | }
863 | },
864 | {
865 | "facility": "Medical School of Athens University - Evangelismos Hospital - Department of Critical Care and Pulmonary Services",
866 | "city": "Athens",
867 | "zip": "GR-10675",
868 | "country": "Greece",
869 | "geoPoint": {
870 | "lat": 37.97945,
871 | "lon": 23.71622
872 | }
873 | },
874 | {
875 | "facility": "National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center",
876 | "city": "Tokyo",
877 | "zip": "162-8655",
878 | "country": "Japan",
879 | "geoPoint": {
880 | "lat": 35.6895,
881 | "lon": 139.69171
882 | }
883 | },
884 | {
885 | "facility": "Seoul National University Bundang Hospital - Division of Infectious Diseases",
886 | "city": "Bundang-gu Seongnam-si",
887 | "state": "Gyeonggi-do",
888 | "zip": "13620",
889 | "country": "Korea, Republic of"
890 | },
891 | {
892 | "facility": "Seoul National University Hospital",
893 | "city": "Seoul",
894 | "state": "Jongno-gu",
895 | "zip": "03080",
896 | "country": "Korea, Republic of",
897 | "geoPoint": {
898 | "lat": 37.566,
899 | "lon": 126.9784
900 | }
901 | },
902 | {
903 | "facility": "Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán - Departamento de Infectologia",
904 | "city": "Mexico City",
905 | "zip": "14080",
906 | "country": "Mexico",
907 | "geoPoint": {
908 | "lat": 19.42847,
909 | "lon": -99.12766
910 | }
911 | },
912 | {
913 | "facility": "Instituto Nacional de Enfermedades Respiratorias (INER) - Ismael Cosío Villegas",
914 | "city": "Mexico City",
915 | "zip": "14080",
916 | "country": "Mexico",
917 | "geoPoint": {
918 | "lat": 19.42847,
919 | "lon": -99.12766
920 | }
921 | },
922 | {
923 | "facility": "National Centre for Infectious Diseases",
924 | "city": "Singapore",
925 | "zip": "308442",
926 | "country": "Singapore",
927 | "geoPoint": {
928 | "lat": 1.28967,
929 | "lon": 103.85007
930 | }
931 | },
932 | {
933 | "facility": "Hospital Clinic Barcelona, Servicio de Salud Internacional",
934 | "city": "Barcelona",
935 | "state": "Cataluña",
936 | "zip": "08036",
937 | "country": "Spain",
938 | "geoPoint": {
939 | "lat": 41.38879,
940 | "lon": 2.15899
941 | }
942 | },
943 | {
944 | "facility": "Hospital Germans Trias i Pujol - Servei Malalties Infeccioses",
945 | "city": "Barcelona",
946 | "state": "Cataluña",
947 | "zip": "08916",
948 | "country": "Spain",
949 | "geoPoint": {
950 | "lat": 41.38879,
951 | "lon": 2.15899
952 | }
953 | },
954 | {
955 | "facility": "Royal Sussex County Hospital - Department of Intensive Care Medicine",
956 | "city": "East Sussex",
957 | "state": "Brighton",
958 | "zip": "BN2 5BE",
959 | "country": "United Kingdom"
960 | },
961 | {
962 | "facility": "Saint Thomas' Hospital - Directorate of Infection",
963 | "city": "London",
964 | "state": "London, City Of",
965 | "zip": "SE1 7EH",
966 | "country": "United Kingdom",
967 | "geoPoint": {
968 | "lat": 51.50853,
969 | "lon": -0.12574
970 | }
971 | },
972 | {
973 | "facility": "Royal Victoria Infirmary - Department of Infectious Diseases",
974 | "city": "Level 6, Ward 19",
975 | "state": "Newcastle Upon Tyne",
976 | "zip": "NE1 4LP",
977 | "country": "United Kingdom"
978 | },
979 | {
980 | "facility": "St. James's University Hospital - Infectious Diseases",
981 | "city": "Leeds",
982 | "state": "West Yorkshire",
983 | "zip": "LS9 7TK",
984 | "country": "United Kingdom",
985 | "geoPoint": {
986 | "lat": 53.79648,
987 | "lon": -1.54785
988 | }
989 | },
990 | {
991 | "facility": "John Radcliffe Hospital",
992 | "city": "Headington, Oxford",
993 | "zip": "OX3 9DU",
994 | "country": "United Kingdom"
995 | }
996 | ]
997 | },
998 | "referencesModule": {
999 | "references": [
1000 | {
1001 | "pmid": "34473343",
1002 | "type": "DERIVED",
1003 | "citation": "Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2."
1004 | },
1005 | {
1006 | "pmid": "34350582",
1007 | "type": "DERIVED",
1008 | "citation": "Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962."
1009 | },
1010 | {
1011 | "pmid": "33240091",
1012 | "type": "DERIVED",
1013 | "citation": "Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020."
1014 | },
1015 | {
1016 | "pmid": "32969710",
1017 | "type": "DERIVED",
1018 | "citation": "Maleszewski JJ, Young PM, Ackerman MJ, Halushka MK. Urgent Need for Studies of the Late Effects of SARS-CoV-2 on the Cardiovascular System. Circulation. 2021 Mar 30;143(13):1271-1273. doi: 10.1161/CIRCULATIONAHA.120.051362. Epub 2020 Sep 24. No abstract available."
1019 | },
1020 | {
1021 | "pmid": "32445440",
1022 | "type": "DERIVED",
1023 | "citation": "Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8."
1024 | }
1025 | ]
1026 | }
1027 | },
1028 | "resultsSection": {
1029 | "participantFlowModule": {
1030 | "recruitmentDetails": "Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 21FEB2020 and 20APR2020.",
1031 | "groups": [
1032 | {
1033 | "id": "FG000",
1034 | "title": "Placebo",
1035 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.\n\nPlacebo: The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies."
1036 | },
1037 | {
1038 | "id": "FG001",
1039 | "title": "Remdesivir",
1040 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.\n\nRemdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide."
1041 | }
1042 | ],
1043 | "periods": [
1044 | {
1045 | "title": "Overall Study",
1046 | "milestones": [
1047 | {
1048 | "type": "STARTED",
1049 | "achievements": [
1050 | {
1051 | "groupId": "FG000",
1052 | "numSubjects": "521"
1053 | },
1054 | {
1055 | "groupId": "FG001",
1056 | "numSubjects": "541"
1057 | }
1058 | ]
1059 | },
1060 | {
1061 | "type": "Received Treatment",
1062 | "achievements": [
1063 | {
1064 | "groupId": "FG000",
1065 | "numSubjects": "517"
1066 | },
1067 | {
1068 | "groupId": "FG001",
1069 | "numSubjects": "531"
1070 | }
1071 | ]
1072 | },
1073 | {
1074 | "type": "COMPLETED",
1075 | "achievements": [
1076 | {
1077 | "groupId": "FG000",
1078 | "numSubjects": "508"
1079 | },
1080 | {
1081 | "groupId": "FG001",
1082 | "numSubjects": "517"
1083 | }
1084 | ]
1085 | },
1086 | {
1087 | "type": "NOT COMPLETED",
1088 | "achievements": [
1089 | {
1090 | "groupId": "FG000",
1091 | "numSubjects": "13"
1092 | },
1093 | {
1094 | "groupId": "FG001",
1095 | "numSubjects": "24"
1096 | }
1097 | ]
1098 | }
1099 | ],
1100 | "dropWithdraws": [
1101 | {
1102 | "type": "Enrolled but not treated",
1103 | "reasons": [
1104 | {
1105 | "groupId": "FG000",
1106 | "numSubjects": "4"
1107 | },
1108 | {
1109 | "groupId": "FG001",
1110 | "numSubjects": "10"
1111 | }
1112 | ]
1113 | },
1114 | {
1115 | "type": "Physician Decision",
1116 | "reasons": [
1117 | {
1118 | "groupId": "FG000",
1119 | "numSubjects": "1"
1120 | },
1121 | {
1122 | "groupId": "FG001",
1123 | "numSubjects": "0"
1124 | }
1125 | ]
1126 | },
1127 | {
1128 | "type": "Withdrawal by Subject",
1129 | "reasons": [
1130 | {
1131 | "groupId": "FG000",
1132 | "numSubjects": "7"
1133 | },
1134 | {
1135 | "groupId": "FG001",
1136 | "numSubjects": "9"
1137 | }
1138 | ]
1139 | },
1140 | {
1141 | "type": "Adverse Event",
1142 | "reasons": [
1143 | {
1144 | "groupId": "FG000",
1145 | "numSubjects": "0"
1146 | },
1147 | {
1148 | "groupId": "FG001",
1149 | "numSubjects": "4"
1150 | }
1151 | ]
1152 | },
1153 | {
1154 | "type": "Transferred to another hospital",
1155 | "reasons": [
1156 | {
1157 | "groupId": "FG000",
1158 | "numSubjects": "1"
1159 | },
1160 | {
1161 | "groupId": "FG001",
1162 | "numSubjects": "1"
1163 | }
1164 | ]
1165 | }
1166 | ]
1167 | }
1168 | ]
1169 | },
1170 | "baselineCharacteristicsModule": {
1171 | "groups": [
1172 | {
1173 | "id": "BG000",
1174 | "title": "Placebo",
1175 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
1176 | },
1177 | {
1178 | "id": "BG001",
1179 | "title": "Remdesivir",
1180 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
1181 | },
1182 | {
1183 | "id": "BG002",
1184 | "title": "Total",
1185 | "description": "Total of all reporting groups"
1186 | }
1187 | ],
1188 | "denoms": [
1189 | {
1190 | "units": "Participants",
1191 | "counts": [
1192 | {
1193 | "groupId": "BG000",
1194 | "value": "521"
1195 | },
1196 | {
1197 | "groupId": "BG001",
1198 | "value": "541"
1199 | },
1200 | {
1201 | "groupId": "BG002",
1202 | "value": "1062"
1203 | }
1204 | ]
1205 | }
1206 | ],
1207 | "measures": [
1208 | {
1209 | "title": "Age, Categorical",
1210 | "paramType": "COUNT_OF_PARTICIPANTS",
1211 | "unitOfMeasure": "Participants",
1212 | "classes": [
1213 | {
1214 | "categories": [
1215 | {
1216 | "title": "<=18 years",
1217 | "measurements": [
1218 | {
1219 | "groupId": "BG000",
1220 | "value": "0"
1221 | },
1222 | {
1223 | "groupId": "BG001",
1224 | "value": "0"
1225 | },
1226 | {
1227 | "groupId": "BG002",
1228 | "value": "0"
1229 | }
1230 | ]
1231 | },
1232 | {
1233 | "title": "Between 18 and 65 years",
1234 | "measurements": [
1235 | {
1236 | "groupId": "BG000",
1237 | "value": "324"
1238 | },
1239 | {
1240 | "groupId": "BG001",
1241 | "value": "354"
1242 | },
1243 | {
1244 | "groupId": "BG002",
1245 | "value": "678"
1246 | }
1247 | ]
1248 | },
1249 | {
1250 | "title": ">=65 years",
1251 | "measurements": [
1252 | {
1253 | "groupId": "BG000",
1254 | "value": "197"
1255 | },
1256 | {
1257 | "groupId": "BG001",
1258 | "value": "187"
1259 | },
1260 | {
1261 | "groupId": "BG002",
1262 | "value": "384"
1263 | }
1264 | ]
1265 | }
1266 | ]
1267 | }
1268 | ]
1269 | },
1270 | {
1271 | "title": "Age, Continuous",
1272 | "paramType": "MEAN",
1273 | "dispersionType": "STANDARD_DEVIATION",
1274 | "unitOfMeasure": "years",
1275 | "classes": [
1276 | {
1277 | "categories": [
1278 | {
1279 | "measurements": [
1280 | {
1281 | "groupId": "BG000",
1282 | "value": "59.2",
1283 | "spread": "15.4"
1284 | },
1285 | {
1286 | "groupId": "BG001",
1287 | "value": "58.6",
1288 | "spread": "14.6"
1289 | },
1290 | {
1291 | "groupId": "BG002",
1292 | "value": "58.9",
1293 | "spread": "15.0"
1294 | }
1295 | ]
1296 | }
1297 | ]
1298 | }
1299 | ]
1300 | },
1301 | {
1302 | "title": "Sex: Female, Male",
1303 | "paramType": "COUNT_OF_PARTICIPANTS",
1304 | "unitOfMeasure": "Participants",
1305 | "classes": [
1306 | {
1307 | "categories": [
1308 | {
1309 | "title": "Female",
1310 | "measurements": [
1311 | {
1312 | "groupId": "BG000",
1313 | "value": "189"
1314 | },
1315 | {
1316 | "groupId": "BG001",
1317 | "value": "189"
1318 | },
1319 | {
1320 | "groupId": "BG002",
1321 | "value": "378"
1322 | }
1323 | ]
1324 | },
1325 | {
1326 | "title": "Male",
1327 | "measurements": [
1328 | {
1329 | "groupId": "BG000",
1330 | "value": "332"
1331 | },
1332 | {
1333 | "groupId": "BG001",
1334 | "value": "352"
1335 | },
1336 | {
1337 | "groupId": "BG002",
1338 | "value": "684"
1339 | }
1340 | ]
1341 | }
1342 | ]
1343 | }
1344 | ]
1345 | },
1346 | {
1347 | "title": "Ethnicity (NIH/OMB)",
1348 | "paramType": "COUNT_OF_PARTICIPANTS",
1349 | "unitOfMeasure": "Participants",
1350 | "classes": [
1351 | {
1352 | "categories": [
1353 | {
1354 | "title": "Hispanic or Latino",
1355 | "measurements": [
1356 | {
1357 | "groupId": "BG000",
1358 | "value": "116"
1359 | },
1360 | {
1361 | "groupId": "BG001",
1362 | "value": "134"
1363 | },
1364 | {
1365 | "groupId": "BG002",
1366 | "value": "250"
1367 | }
1368 | ]
1369 | },
1370 | {
1371 | "title": "Not Hispanic or Latino",
1372 | "measurements": [
1373 | {
1374 | "groupId": "BG000",
1375 | "value": "373"
1376 | },
1377 | {
1378 | "groupId": "BG001",
1379 | "value": "382"
1380 | },
1381 | {
1382 | "groupId": "BG002",
1383 | "value": "755"
1384 | }
1385 | ]
1386 | },
1387 | {
1388 | "title": "Unknown or Not Reported",
1389 | "measurements": [
1390 | {
1391 | "groupId": "BG000",
1392 | "value": "32"
1393 | },
1394 | {
1395 | "groupId": "BG001",
1396 | "value": "25"
1397 | },
1398 | {
1399 | "groupId": "BG002",
1400 | "value": "57"
1401 | }
1402 | ]
1403 | }
1404 | ]
1405 | }
1406 | ]
1407 | },
1408 | {
1409 | "title": "Race (NIH/OMB)",
1410 | "paramType": "COUNT_OF_PARTICIPANTS",
1411 | "unitOfMeasure": "Participants",
1412 | "classes": [
1413 | {
1414 | "categories": [
1415 | {
1416 | "title": "American Indian or Alaska Native",
1417 | "measurements": [
1418 | {
1419 | "groupId": "BG000",
1420 | "value": "3"
1421 | },
1422 | {
1423 | "groupId": "BG001",
1424 | "value": "4"
1425 | },
1426 | {
1427 | "groupId": "BG002",
1428 | "value": "7"
1429 | }
1430 | ]
1431 | },
1432 | {
1433 | "title": "Asian",
1434 | "measurements": [
1435 | {
1436 | "groupId": "BG000",
1437 | "value": "56"
1438 | },
1439 | {
1440 | "groupId": "BG001",
1441 | "value": "79"
1442 | },
1443 | {
1444 | "groupId": "BG002",
1445 | "value": "135"
1446 | }
1447 | ]
1448 | },
1449 | {
1450 | "title": "Native Hawaiian or Other Pacific Islander",
1451 | "measurements": [
1452 | {
1453 | "groupId": "BG000",
1454 | "value": "2"
1455 | },
1456 | {
1457 | "groupId": "BG001",
1458 | "value": "2"
1459 | },
1460 | {
1461 | "groupId": "BG002",
1462 | "value": "4"
1463 | }
1464 | ]
1465 | },
1466 | {
1467 | "title": "Black or African American",
1468 | "measurements": [
1469 | {
1470 | "groupId": "BG000",
1471 | "value": "117"
1472 | },
1473 | {
1474 | "groupId": "BG001",
1475 | "value": "109"
1476 | },
1477 | {
1478 | "groupId": "BG002",
1479 | "value": "226"
1480 | }
1481 | ]
1482 | },
1483 | {
1484 | "title": "White",
1485 | "measurements": [
1486 | {
1487 | "groupId": "BG000",
1488 | "value": "287"
1489 | },
1490 | {
1491 | "groupId": "BG001",
1492 | "value": "279"
1493 | },
1494 | {
1495 | "groupId": "BG002",
1496 | "value": "566"
1497 | }
1498 | ]
1499 | },
1500 | {
1501 | "title": "More than one race",
1502 | "measurements": [
1503 | {
1504 | "groupId": "BG000",
1505 | "value": "1"
1506 | },
1507 | {
1508 | "groupId": "BG001",
1509 | "value": "2"
1510 | },
1511 | {
1512 | "groupId": "BG002",
1513 | "value": "3"
1514 | }
1515 | ]
1516 | },
1517 | {
1518 | "title": "Unknown or Not Reported",
1519 | "measurements": [
1520 | {
1521 | "groupId": "BG000",
1522 | "value": "55"
1523 | },
1524 | {
1525 | "groupId": "BG001",
1526 | "value": "66"
1527 | },
1528 | {
1529 | "groupId": "BG002",
1530 | "value": "121"
1531 | }
1532 | ]
1533 | }
1534 | ]
1535 | }
1536 | ]
1537 | },
1538 | {
1539 | "title": "Region of Enrollment",
1540 | "paramType": "NUMBER",
1541 | "unitOfMeasure": "participants",
1542 | "classes": [
1543 | {
1544 | "title": "Greece",
1545 | "categories": [
1546 | {
1547 | "measurements": [
1548 | {
1549 | "groupId": "BG000",
1550 | "value": "19"
1551 | },
1552 | {
1553 | "groupId": "BG001",
1554 | "value": "14"
1555 | },
1556 | {
1557 | "groupId": "BG002",
1558 | "value": "33"
1559 | }
1560 | ]
1561 | }
1562 | ]
1563 | },
1564 | {
1565 | "title": "South Korea",
1566 | "categories": [
1567 | {
1568 | "measurements": [
1569 | {
1570 | "groupId": "BG000",
1571 | "value": "12"
1572 | },
1573 | {
1574 | "groupId": "BG001",
1575 | "value": "9"
1576 | },
1577 | {
1578 | "groupId": "BG002",
1579 | "value": "21"
1580 | }
1581 | ]
1582 | }
1583 | ]
1584 | },
1585 | {
1586 | "title": "Singapore",
1587 | "categories": [
1588 | {
1589 | "measurements": [
1590 | {
1591 | "groupId": "BG000",
1592 | "value": "7"
1593 | },
1594 | {
1595 | "groupId": "BG001",
1596 | "value": "9"
1597 | },
1598 | {
1599 | "groupId": "BG002",
1600 | "value": "16"
1601 | }
1602 | ]
1603 | }
1604 | ]
1605 | },
1606 | {
1607 | "title": "United States",
1608 | "categories": [
1609 | {
1610 | "measurements": [
1611 | {
1612 | "groupId": "BG000",
1613 | "value": "410"
1614 | },
1615 | {
1616 | "groupId": "BG001",
1617 | "value": "427"
1618 | },
1619 | {
1620 | "groupId": "BG002",
1621 | "value": "837"
1622 | }
1623 | ]
1624 | }
1625 | ]
1626 | },
1627 | {
1628 | "title": "Japan",
1629 | "categories": [
1630 | {
1631 | "measurements": [
1632 | {
1633 | "groupId": "BG000",
1634 | "value": "7"
1635 | },
1636 | {
1637 | "groupId": "BG001",
1638 | "value": "8"
1639 | },
1640 | {
1641 | "groupId": "BG002",
1642 | "value": "15"
1643 | }
1644 | ]
1645 | }
1646 | ]
1647 | },
1648 | {
1649 | "title": "Denmark",
1650 | "categories": [
1651 | {
1652 | "measurements": [
1653 | {
1654 | "groupId": "BG000",
1655 | "value": "21"
1656 | },
1657 | {
1658 | "groupId": "BG001",
1659 | "value": "22"
1660 | },
1661 | {
1662 | "groupId": "BG002",
1663 | "value": "43"
1664 | }
1665 | ]
1666 | }
1667 | ]
1668 | },
1669 | {
1670 | "title": "Mexico",
1671 | "categories": [
1672 | {
1673 | "measurements": [
1674 | {
1675 | "groupId": "BG000",
1676 | "value": "6"
1677 | },
1678 | {
1679 | "groupId": "BG001",
1680 | "value": "4"
1681 | },
1682 | {
1683 | "groupId": "BG002",
1684 | "value": "10"
1685 | }
1686 | ]
1687 | }
1688 | ]
1689 | },
1690 | {
1691 | "title": "United Kingdom",
1692 | "categories": [
1693 | {
1694 | "measurements": [
1695 | {
1696 | "groupId": "BG000",
1697 | "value": "21"
1698 | },
1699 | {
1700 | "groupId": "BG001",
1701 | "value": "25"
1702 | },
1703 | {
1704 | "groupId": "BG002",
1705 | "value": "46"
1706 | }
1707 | ]
1708 | }
1709 | ]
1710 | },
1711 | {
1712 | "title": "Germany",
1713 | "categories": [
1714 | {
1715 | "measurements": [
1716 | {
1717 | "groupId": "BG000",
1718 | "value": "6"
1719 | },
1720 | {
1721 | "groupId": "BG001",
1722 | "value": "7"
1723 | },
1724 | {
1725 | "groupId": "BG002",
1726 | "value": "13"
1727 | }
1728 | ]
1729 | }
1730 | ]
1731 | },
1732 | {
1733 | "title": "Spain",
1734 | "categories": [
1735 | {
1736 | "measurements": [
1737 | {
1738 | "groupId": "BG000",
1739 | "value": "12"
1740 | },
1741 | {
1742 | "groupId": "BG001",
1743 | "value": "16"
1744 | },
1745 | {
1746 | "groupId": "BG002",
1747 | "value": "28"
1748 | }
1749 | ]
1750 | }
1751 | ]
1752 | }
1753 | ]
1754 | },
1755 | {
1756 | "title": "Disease severity",
1757 | "description": "Mild-moderate disease: SpO2 \\> 94% and respiratory rate \\< 24 breaths/min without supplemental oxygen.\n\nSevere disease: requiring mechanical ventilation, requiring oxygen, a SpO2 = 94% on room air, or tachypnea (respiratory rate = 24 breaths/min).",
1758 | "paramType": "COUNT_OF_PARTICIPANTS",
1759 | "unitOfMeasure": "Participants",
1760 | "classes": [
1761 | {
1762 | "title": "Mild-to-moderate disease severity",
1763 | "categories": [
1764 | {
1765 | "measurements": [
1766 | {
1767 | "groupId": "BG000",
1768 | "value": "50"
1769 | },
1770 | {
1771 | "groupId": "BG001",
1772 | "value": "55"
1773 | },
1774 | {
1775 | "groupId": "BG002",
1776 | "value": "105"
1777 | }
1778 | ]
1779 | }
1780 | ]
1781 | },
1782 | {
1783 | "title": "Severe disease severity",
1784 | "categories": [
1785 | {
1786 | "measurements": [
1787 | {
1788 | "groupId": "BG000",
1789 | "value": "471"
1790 | },
1791 | {
1792 | "groupId": "BG001",
1793 | "value": "486"
1794 | },
1795 | {
1796 | "groupId": "BG002",
1797 | "value": "957"
1798 | }
1799 | ]
1800 | }
1801 | ]
1802 | }
1803 | ]
1804 | }
1805 | ]
1806 | },
1807 | "outcomeMeasuresModule": {
1808 | "outcomeMeasures": [
1809 | {
1810 | "type": "PRIMARY",
1811 | "title": "Time to Recovery",
1812 | "description": "Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.",
1813 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
1814 | "reportingStatus": "POSTED",
1815 | "paramType": "MEDIAN",
1816 | "dispersionType": "95% Confidence Interval",
1817 | "unitOfMeasure": "Days",
1818 | "timeFrame": "Day 1 through Day 29",
1819 | "groups": [
1820 | {
1821 | "id": "OG000",
1822 | "title": "Placebo",
1823 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
1824 | },
1825 | {
1826 | "id": "OG001",
1827 | "title": "Remdesivir",
1828 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
1829 | }
1830 | ],
1831 | "denoms": [
1832 | {
1833 | "units": "Participants",
1834 | "counts": [
1835 | {
1836 | "groupId": "OG000",
1837 | "value": "521"
1838 | },
1839 | {
1840 | "groupId": "OG001",
1841 | "value": "541"
1842 | }
1843 | ]
1844 | }
1845 | ],
1846 | "classes": [
1847 | {
1848 | "categories": [
1849 | {
1850 | "measurements": [
1851 | {
1852 | "groupId": "OG000",
1853 | "value": "15",
1854 | "lowerLimit": "13",
1855 | "upperLimit": "18"
1856 | },
1857 | {
1858 | "groupId": "OG001",
1859 | "value": "10",
1860 | "lowerLimit": "9",
1861 | "upperLimit": "11"
1862 | }
1863 | ]
1864 | }
1865 | ]
1866 | }
1867 | ],
1868 | "analyses": [
1869 | {
1870 | "groupIds": ["OG000", "OG001"],
1871 | "nonInferiorityType": "SUPERIORITY",
1872 | "pValue": "<0.001",
1873 | "statisticalMethod": "Log Rank",
1874 | "paramType": "Cox Proportional Hazard",
1875 | "paramValue": "1.29",
1876 | "ciPctValue": "95",
1877 | "ciNumSides": "TWO_SIDED",
1878 | "ciLowerLimit": "1.12",
1879 | "ciUpperLimit": "1.49"
1880 | }
1881 | ]
1882 | },
1883 | {
1884 | "type": "SECONDARY",
1885 | "title": "Change From Baseline in Alanine Transaminase (ALT)",
1886 | "description": "Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
1887 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
1888 | "reportingStatus": "POSTED",
1889 | "paramType": "MEAN",
1890 | "dispersionType": "Standard Deviation",
1891 | "unitOfMeasure": "Units/Liter (U/L)",
1892 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
1893 | "groups": [
1894 | {
1895 | "id": "OG000",
1896 | "title": "Placebo",
1897 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
1898 | },
1899 | {
1900 | "id": "OG001",
1901 | "title": "Remdesivir",
1902 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
1903 | }
1904 | ],
1905 | "denoms": [
1906 | {
1907 | "units": "Participants",
1908 | "counts": [
1909 | {
1910 | "groupId": "OG000",
1911 | "value": "463"
1912 | },
1913 | {
1914 | "groupId": "OG001",
1915 | "value": "465"
1916 | }
1917 | ]
1918 | }
1919 | ],
1920 | "classes": [
1921 | {
1922 | "title": "Day 3",
1923 | "denoms": [
1924 | {
1925 | "units": "Participants",
1926 | "counts": [
1927 | {
1928 | "groupId": "OG000",
1929 | "value": "463"
1930 | },
1931 | {
1932 | "groupId": "OG001",
1933 | "value": "465"
1934 | }
1935 | ]
1936 | }
1937 | ],
1938 | "categories": [
1939 | {
1940 | "measurements": [
1941 | {
1942 | "groupId": "OG000",
1943 | "value": "14.3",
1944 | "spread": "88"
1945 | },
1946 | {
1947 | "groupId": "OG001",
1948 | "value": "2.9",
1949 | "spread": "31.5"
1950 | }
1951 | ]
1952 | }
1953 | ]
1954 | },
1955 | {
1956 | "title": "Day 5",
1957 | "denoms": [
1958 | {
1959 | "units": "Participants",
1960 | "counts": [
1961 | {
1962 | "groupId": "OG000",
1963 | "value": "403"
1964 | },
1965 | {
1966 | "groupId": "OG001",
1967 | "value": "398"
1968 | }
1969 | ]
1970 | }
1971 | ],
1972 | "categories": [
1973 | {
1974 | "measurements": [
1975 | {
1976 | "groupId": "OG000",
1977 | "value": "23.1",
1978 | "spread": "70.6"
1979 | },
1980 | {
1981 | "groupId": "OG001",
1982 | "value": "10.8",
1983 | "spread": "55.8"
1984 | }
1985 | ]
1986 | }
1987 | ]
1988 | },
1989 | {
1990 | "title": "Day 8",
1991 | "denoms": [
1992 | {
1993 | "units": "Participants",
1994 | "counts": [
1995 | {
1996 | "groupId": "OG000",
1997 | "value": "327"
1998 | },
1999 | {
2000 | "groupId": "OG001",
2001 | "value": "296"
2002 | }
2003 | ]
2004 | }
2005 | ],
2006 | "categories": [
2007 | {
2008 | "measurements": [
2009 | {
2010 | "groupId": "OG000",
2011 | "value": "24.2",
2012 | "spread": "79.7"
2013 | },
2014 | {
2015 | "groupId": "OG001",
2016 | "value": "8.9",
2017 | "spread": "54.2"
2018 | }
2019 | ]
2020 | }
2021 | ]
2022 | },
2023 | {
2024 | "title": "Day 11",
2025 | "denoms": [
2026 | {
2027 | "units": "Participants",
2028 | "counts": [
2029 | {
2030 | "groupId": "OG000",
2031 | "value": "257"
2032 | },
2033 | {
2034 | "groupId": "OG001",
2035 | "value": "227"
2036 | }
2037 | ]
2038 | }
2039 | ],
2040 | "categories": [
2041 | {
2042 | "measurements": [
2043 | {
2044 | "groupId": "OG000",
2045 | "value": "27.7",
2046 | "spread": "89.8"
2047 | },
2048 | {
2049 | "groupId": "OG001",
2050 | "value": "3.4",
2051 | "spread": "48.4"
2052 | }
2053 | ]
2054 | }
2055 | ]
2056 | },
2057 | {
2058 | "title": "Day 15",
2059 | "denoms": [
2060 | {
2061 | "units": "Participants",
2062 | "counts": [
2063 | {
2064 | "groupId": "OG000",
2065 | "value": "242"
2066 | },
2067 | {
2068 | "groupId": "OG001",
2069 | "value": "257"
2070 | }
2071 | ]
2072 | }
2073 | ],
2074 | "categories": [
2075 | {
2076 | "measurements": [
2077 | {
2078 | "groupId": "OG000",
2079 | "value": "28.1",
2080 | "spread": "110.1"
2081 | },
2082 | {
2083 | "groupId": "OG001",
2084 | "value": "1.7",
2085 | "spread": "47.4"
2086 | }
2087 | ]
2088 | }
2089 | ]
2090 | },
2091 | {
2092 | "title": "Day 29",
2093 | "denoms": [
2094 | {
2095 | "units": "Participants",
2096 | "counts": [
2097 | {
2098 | "groupId": "OG000",
2099 | "value": "180"
2100 | },
2101 | {
2102 | "groupId": "OG001",
2103 | "value": "220"
2104 | }
2105 | ]
2106 | }
2107 | ],
2108 | "categories": [
2109 | {
2110 | "measurements": [
2111 | {
2112 | "groupId": "OG000",
2113 | "value": "-3.9",
2114 | "spread": "62.2"
2115 | },
2116 | {
2117 | "groupId": "OG001",
2118 | "value": "-6.8",
2119 | "spread": "43.7"
2120 | }
2121 | ]
2122 | }
2123 | ]
2124 | }
2125 | ]
2126 | },
2127 | {
2128 | "type": "SECONDARY",
2129 | "title": "Change From Baseline in Aspartate Transaminase (AST)",
2130 | "description": "Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
2131 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
2132 | "reportingStatus": "POSTED",
2133 | "paramType": "MEAN",
2134 | "dispersionType": "Standard Deviation",
2135 | "unitOfMeasure": "Units/Liter (U/L)",
2136 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
2137 | "groups": [
2138 | {
2139 | "id": "OG000",
2140 | "title": "Placebo",
2141 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
2142 | },
2143 | {
2144 | "id": "OG001",
2145 | "title": "Remdesivir",
2146 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
2147 | }
2148 | ],
2149 | "denoms": [
2150 | {
2151 | "units": "Participants",
2152 | "counts": [
2153 | {
2154 | "groupId": "OG000",
2155 | "value": "438"
2156 | },
2157 | {
2158 | "groupId": "OG001",
2159 | "value": "445"
2160 | }
2161 | ]
2162 | }
2163 | ],
2164 | "classes": [
2165 | {
2166 | "title": "Day 3",
2167 | "denoms": [
2168 | {
2169 | "units": "Participants",
2170 | "counts": [
2171 | {
2172 | "groupId": "OG000",
2173 | "value": "438"
2174 | },
2175 | {
2176 | "groupId": "OG001",
2177 | "value": "445"
2178 | }
2179 | ]
2180 | }
2181 | ],
2182 | "categories": [
2183 | {
2184 | "measurements": [
2185 | {
2186 | "groupId": "OG000",
2187 | "value": "13.7",
2188 | "spread": "90.7"
2189 | },
2190 | {
2191 | "groupId": "OG001",
2192 | "value": "-2.0",
2193 | "spread": "29.1"
2194 | }
2195 | ]
2196 | }
2197 | ]
2198 | },
2199 | {
2200 | "title": "Day 5",
2201 | "denoms": [
2202 | {
2203 | "units": "Participants",
2204 | "counts": [
2205 | {
2206 | "groupId": "OG000",
2207 | "value": "384"
2208 | },
2209 | {
2210 | "groupId": "OG001",
2211 | "value": "380"
2212 | }
2213 | ]
2214 | }
2215 | ],
2216 | "categories": [
2217 | {
2218 | "measurements": [
2219 | {
2220 | "groupId": "OG000",
2221 | "value": "12.8",
2222 | "spread": "66.2"
2223 | },
2224 | {
2225 | "groupId": "OG001",
2226 | "value": "6.0",
2227 | "spread": "58.9"
2228 | }
2229 | ]
2230 | }
2231 | ]
2232 | },
2233 | {
2234 | "title": "Day 8",
2235 | "denoms": [
2236 | {
2237 | "units": "Participants",
2238 | "counts": [
2239 | {
2240 | "groupId": "OG000",
2241 | "value": "315"
2242 | },
2243 | {
2244 | "groupId": "OG001",
2245 | "value": "285"
2246 | }
2247 | ]
2248 | }
2249 | ],
2250 | "categories": [
2251 | {
2252 | "measurements": [
2253 | {
2254 | "groupId": "OG000",
2255 | "value": "13.1",
2256 | "spread": "114.6"
2257 | },
2258 | {
2259 | "groupId": "OG001",
2260 | "value": "1.1",
2261 | "spread": "55.9"
2262 | }
2263 | ]
2264 | }
2265 | ]
2266 | },
2267 | {
2268 | "title": "Day 11",
2269 | "denoms": [
2270 | {
2271 | "units": "Participants",
2272 | "counts": [
2273 | {
2274 | "groupId": "OG000",
2275 | "value": "247"
2276 | },
2277 | {
2278 | "groupId": "OG001",
2279 | "value": "219"
2280 | }
2281 | ]
2282 | }
2283 | ],
2284 | "categories": [
2285 | {
2286 | "measurements": [
2287 | {
2288 | "groupId": "OG000",
2289 | "value": "11.5",
2290 | "spread": "78.8"
2291 | },
2292 | {
2293 | "groupId": "OG001",
2294 | "value": "-0.3",
2295 | "spread": "51.7"
2296 | }
2297 | ]
2298 | }
2299 | ]
2300 | },
2301 | {
2302 | "title": "Day 15",
2303 | "denoms": [
2304 | {
2305 | "units": "Participants",
2306 | "counts": [
2307 | {
2308 | "groupId": "OG000",
2309 | "value": "236"
2310 | },
2311 | {
2312 | "groupId": "OG001",
2313 | "value": "248"
2314 | }
2315 | ]
2316 | }
2317 | ],
2318 | "categories": [
2319 | {
2320 | "measurements": [
2321 | {
2322 | "groupId": "OG000",
2323 | "value": "4.2",
2324 | "spread": "73.0"
2325 | },
2326 | {
2327 | "groupId": "OG001",
2328 | "value": "-2.3",
2329 | "spread": "60.4"
2330 | }
2331 | ]
2332 | }
2333 | ]
2334 | },
2335 | {
2336 | "title": "Day 29",
2337 | "denoms": [
2338 | {
2339 | "units": "Participants",
2340 | "counts": [
2341 | {
2342 | "groupId": "OG000",
2343 | "value": "170"
2344 | },
2345 | {
2346 | "groupId": "OG001",
2347 | "value": "208"
2348 | }
2349 | ]
2350 | }
2351 | ],
2352 | "categories": [
2353 | {
2354 | "measurements": [
2355 | {
2356 | "groupId": "OG000",
2357 | "value": "-18.4",
2358 | "spread": "47.2"
2359 | },
2360 | {
2361 | "groupId": "OG001",
2362 | "value": "-14.0",
2363 | "spread": "52.2"
2364 | }
2365 | ]
2366 | }
2367 | ]
2368 | }
2369 | ]
2370 | },
2371 | {
2372 | "type": "SECONDARY",
2373 | "title": "Change From Baseline in Creatinine",
2374 | "description": "Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
2375 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
2376 | "reportingStatus": "POSTED",
2377 | "paramType": "MEAN",
2378 | "dispersionType": "Standard Deviation",
2379 | "unitOfMeasure": "milligrams/deciliter (mg/dL)",
2380 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
2381 | "groups": [
2382 | {
2383 | "id": "OG000",
2384 | "title": "Placebo",
2385 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
2386 | },
2387 | {
2388 | "id": "OG001",
2389 | "title": "Remdesivir",
2390 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
2391 | }
2392 | ],
2393 | "denoms": [
2394 | {
2395 | "units": "Participants",
2396 | "counts": [
2397 | {
2398 | "groupId": "OG000",
2399 | "value": "475"
2400 | },
2401 | {
2402 | "groupId": "OG001",
2403 | "value": "482"
2404 | }
2405 | ]
2406 | }
2407 | ],
2408 | "classes": [
2409 | {
2410 | "title": "Day 3",
2411 | "denoms": [
2412 | {
2413 | "units": "Participants",
2414 | "counts": [
2415 | {
2416 | "groupId": "OG000",
2417 | "value": "475"
2418 | },
2419 | {
2420 | "groupId": "OG001",
2421 | "value": "482"
2422 | }
2423 | ]
2424 | }
2425 | ],
2426 | "categories": [
2427 | {
2428 | "measurements": [
2429 | {
2430 | "groupId": "OG000",
2431 | "value": "0.037",
2432 | "spread": "0.517"
2433 | },
2434 | {
2435 | "groupId": "OG001",
2436 | "value": "0.038",
2437 | "spread": "0.569"
2438 | }
2439 | ]
2440 | }
2441 | ]
2442 | },
2443 | {
2444 | "title": "Day 5",
2445 | "denoms": [
2446 | {
2447 | "units": "Participants",
2448 | "counts": [
2449 | {
2450 | "groupId": "OG000",
2451 | "value": "418"
2452 | },
2453 | {
2454 | "groupId": "OG001",
2455 | "value": "411"
2456 | }
2457 | ]
2458 | }
2459 | ],
2460 | "categories": [
2461 | {
2462 | "measurements": [
2463 | {
2464 | "groupId": "OG000",
2465 | "value": "-0.695",
2466 | "spread": "17.552"
2467 | },
2468 | {
2469 | "groupId": "OG001",
2470 | "value": "0.075",
2471 | "spread": "0.762"
2472 | }
2473 | ]
2474 | }
2475 | ]
2476 | },
2477 | {
2478 | "title": "Day 8",
2479 | "denoms": [
2480 | {
2481 | "units": "Participants",
2482 | "counts": [
2483 | {
2484 | "groupId": "OG000",
2485 | "value": "335"
2486 | },
2487 | {
2488 | "groupId": "OG001",
2489 | "value": "309"
2490 | }
2491 | ]
2492 | }
2493 | ],
2494 | "categories": [
2495 | {
2496 | "measurements": [
2497 | {
2498 | "groupId": "OG000",
2499 | "value": "-0.882",
2500 | "spread": "19.637"
2501 | },
2502 | {
2503 | "groupId": "OG001",
2504 | "value": "0.158",
2505 | "spread": "0.951"
2506 | }
2507 | ]
2508 | }
2509 | ]
2510 | },
2511 | {
2512 | "title": "Day 11",
2513 | "denoms": [
2514 | {
2515 | "units": "Participants",
2516 | "counts": [
2517 | {
2518 | "groupId": "OG000",
2519 | "value": "269"
2520 | },
2521 | {
2522 | "groupId": "OG001",
2523 | "value": "234"
2524 | }
2525 | ]
2526 | }
2527 | ],
2528 | "categories": [
2529 | {
2530 | "measurements": [
2531 | {
2532 | "groupId": "OG000",
2533 | "value": "1.173",
2534 | "spread": "15.440"
2535 | },
2536 | {
2537 | "groupId": "OG001",
2538 | "value": "0.236",
2539 | "spread": "1.057"
2540 | }
2541 | ]
2542 | }
2543 | ]
2544 | },
2545 | {
2546 | "title": "Day 15",
2547 | "denoms": [
2548 | {
2549 | "units": "Participants",
2550 | "counts": [
2551 | {
2552 | "groupId": "OG000",
2553 | "value": "249"
2554 | },
2555 | {
2556 | "groupId": "OG001",
2557 | "value": "262"
2558 | }
2559 | ]
2560 | }
2561 | ],
2562 | "categories": [
2563 | {
2564 | "measurements": [
2565 | {
2566 | "groupId": "OG000",
2567 | "value": "-1.239",
2568 | "spread": "22.755"
2569 | },
2570 | {
2571 | "groupId": "OG001",
2572 | "value": "0.319",
2573 | "spread": "2.147"
2574 | }
2575 | ]
2576 | }
2577 | ]
2578 | },
2579 | {
2580 | "title": "Day 29",
2581 | "denoms": [
2582 | {
2583 | "units": "Participants",
2584 | "counts": [
2585 | {
2586 | "groupId": "OG000",
2587 | "value": "189"
2588 | },
2589 | {
2590 | "groupId": "OG001",
2591 | "value": "229"
2592 | }
2593 | ]
2594 | }
2595 | ],
2596 | "categories": [
2597 | {
2598 | "measurements": [
2599 | {
2600 | "groupId": "OG000",
2601 | "value": "-1.863",
2602 | "spread": "26.093"
2603 | },
2604 | {
2605 | "groupId": "OG001",
2606 | "value": "0.075",
2607 | "spread": "0.644"
2608 | }
2609 | ]
2610 | }
2611 | ]
2612 | }
2613 | ]
2614 | },
2615 | {
2616 | "type": "SECONDARY",
2617 | "title": "Change From Baseline in Glucose",
2618 | "description": "Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
2619 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
2620 | "reportingStatus": "POSTED",
2621 | "paramType": "MEAN",
2622 | "dispersionType": "Standard Deviation",
2623 | "unitOfMeasure": "mg/dL",
2624 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
2625 | "groups": [
2626 | {
2627 | "id": "OG000",
2628 | "title": "Placebo",
2629 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
2630 | },
2631 | {
2632 | "id": "OG001",
2633 | "title": "Remdesivir",
2634 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
2635 | }
2636 | ],
2637 | "denoms": [
2638 | {
2639 | "units": "Participants",
2640 | "counts": [
2641 | {
2642 | "groupId": "OG000",
2643 | "value": "456"
2644 | },
2645 | {
2646 | "groupId": "OG001",
2647 | "value": "459"
2648 | }
2649 | ]
2650 | }
2651 | ],
2652 | "classes": [
2653 | {
2654 | "title": "Day 3",
2655 | "denoms": [
2656 | {
2657 | "units": "Participants",
2658 | "counts": [
2659 | {
2660 | "groupId": "OG000",
2661 | "value": "456"
2662 | },
2663 | {
2664 | "groupId": "OG001",
2665 | "value": "459"
2666 | }
2667 | ]
2668 | }
2669 | ],
2670 | "categories": [
2671 | {
2672 | "measurements": [
2673 | {
2674 | "groupId": "OG000",
2675 | "value": "-0.2",
2676 | "spread": "53.4"
2677 | },
2678 | {
2679 | "groupId": "OG001",
2680 | "value": "-3.0",
2681 | "spread": "49.4"
2682 | }
2683 | ]
2684 | }
2685 | ]
2686 | },
2687 | {
2688 | "title": "Day 5",
2689 | "denoms": [
2690 | {
2691 | "units": "Participants",
2692 | "counts": [
2693 | {
2694 | "groupId": "OG000",
2695 | "value": "407"
2696 | },
2697 | {
2698 | "groupId": "OG001",
2699 | "value": "395"
2700 | }
2701 | ]
2702 | }
2703 | ],
2704 | "categories": [
2705 | {
2706 | "measurements": [
2707 | {
2708 | "groupId": "OG000",
2709 | "value": "6.3",
2710 | "spread": "60.2"
2711 | },
2712 | {
2713 | "groupId": "OG001",
2714 | "value": "2.1",
2715 | "spread": "63.8"
2716 | }
2717 | ]
2718 | }
2719 | ]
2720 | },
2721 | {
2722 | "title": "Day 8",
2723 | "denoms": [
2724 | {
2725 | "units": "Participants",
2726 | "counts": [
2727 | {
2728 | "groupId": "OG000",
2729 | "value": "323"
2730 | },
2731 | {
2732 | "groupId": "OG001",
2733 | "value": "301"
2734 | }
2735 | ]
2736 | }
2737 | ],
2738 | "categories": [
2739 | {
2740 | "measurements": [
2741 | {
2742 | "groupId": "OG000",
2743 | "value": "2.2",
2744 | "spread": "73.3"
2745 | },
2746 | {
2747 | "groupId": "OG001",
2748 | "value": "3.2",
2749 | "spread": "68.0"
2750 | }
2751 | ]
2752 | }
2753 | ]
2754 | },
2755 | {
2756 | "title": "Day 11",
2757 | "denoms": [
2758 | {
2759 | "units": "Participants",
2760 | "counts": [
2761 | {
2762 | "groupId": "OG000",
2763 | "value": "260"
2764 | },
2765 | {
2766 | "groupId": "OG001",
2767 | "value": "228"
2768 | }
2769 | ]
2770 | }
2771 | ],
2772 | "categories": [
2773 | {
2774 | "measurements": [
2775 | {
2776 | "groupId": "OG000",
2777 | "value": "1.0",
2778 | "spread": "70.1"
2779 | },
2780 | {
2781 | "groupId": "OG001",
2782 | "value": "-0.1",
2783 | "spread": "77.4"
2784 | }
2785 | ]
2786 | }
2787 | ]
2788 | },
2789 | {
2790 | "title": "Day 15",
2791 | "denoms": [
2792 | {
2793 | "units": "Participants",
2794 | "counts": [
2795 | {
2796 | "groupId": "OG000",
2797 | "value": "241"
2798 | },
2799 | {
2800 | "groupId": "OG001",
2801 | "value": "250"
2802 | }
2803 | ]
2804 | }
2805 | ],
2806 | "categories": [
2807 | {
2808 | "measurements": [
2809 | {
2810 | "groupId": "OG000",
2811 | "value": "-2.8",
2812 | "spread": "64.4"
2813 | },
2814 | {
2815 | "groupId": "OG001",
2816 | "value": "-2.9",
2817 | "spread": "75.4"
2818 | }
2819 | ]
2820 | }
2821 | ]
2822 | },
2823 | {
2824 | "title": "Day 29",
2825 | "denoms": [
2826 | {
2827 | "units": "Participants",
2828 | "counts": [
2829 | {
2830 | "groupId": "OG000",
2831 | "value": "180"
2832 | },
2833 | {
2834 | "groupId": "OG001",
2835 | "value": "219"
2836 | }
2837 | ]
2838 | }
2839 | ],
2840 | "categories": [
2841 | {
2842 | "measurements": [
2843 | {
2844 | "groupId": "OG000",
2845 | "value": "-13.5",
2846 | "spread": "96.8"
2847 | },
2848 | {
2849 | "groupId": "OG001",
2850 | "value": "-11.7",
2851 | "spread": "75.4"
2852 | }
2853 | ]
2854 | }
2855 | ]
2856 | }
2857 | ]
2858 | },
2859 | {
2860 | "type": "SECONDARY",
2861 | "title": "Change From Baseline in Hemoglobin",
2862 | "description": "Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
2863 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
2864 | "reportingStatus": "POSTED",
2865 | "paramType": "MEAN",
2866 | "dispersionType": "Standard Deviation",
2867 | "unitOfMeasure": "grams/deciliter (g/dL)",
2868 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
2869 | "groups": [
2870 | {
2871 | "id": "OG000",
2872 | "title": "Placebo",
2873 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
2874 | },
2875 | {
2876 | "id": "OG001",
2877 | "title": "Remdesivir",
2878 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
2879 | }
2880 | ],
2881 | "denoms": [
2882 | {
2883 | "units": "Participants",
2884 | "counts": [
2885 | {
2886 | "groupId": "OG000",
2887 | "value": "475"
2888 | },
2889 | {
2890 | "groupId": "OG001",
2891 | "value": "475"
2892 | }
2893 | ]
2894 | }
2895 | ],
2896 | "classes": [
2897 | {
2898 | "title": "Day 3",
2899 | "denoms": [
2900 | {
2901 | "units": "Participants",
2902 | "counts": [
2903 | {
2904 | "groupId": "OG000",
2905 | "value": "475"
2906 | },
2907 | {
2908 | "groupId": "OG001",
2909 | "value": "475"
2910 | }
2911 | ]
2912 | }
2913 | ],
2914 | "categories": [
2915 | {
2916 | "measurements": [
2917 | {
2918 | "groupId": "OG000",
2919 | "value": "-0.52",
2920 | "spread": "1.10"
2921 | },
2922 | {
2923 | "groupId": "OG001",
2924 | "value": "-0.69",
2925 | "spread": "5.36"
2926 | }
2927 | ]
2928 | }
2929 | ]
2930 | },
2931 | {
2932 | "title": "Day 5",
2933 | "denoms": [
2934 | {
2935 | "units": "Participants",
2936 | "counts": [
2937 | {
2938 | "groupId": "OG000",
2939 | "value": "420"
2940 | },
2941 | {
2942 | "groupId": "OG001",
2943 | "value": "406"
2944 | }
2945 | ]
2946 | }
2947 | ],
2948 | "categories": [
2949 | {
2950 | "measurements": [
2951 | {
2952 | "groupId": "OG000",
2953 | "value": "-0.83",
2954 | "spread": "1.22"
2955 | },
2956 | {
2957 | "groupId": "OG001",
2958 | "value": "-0.99",
2959 | "spread": "5.83"
2960 | }
2961 | ]
2962 | }
2963 | ]
2964 | },
2965 | {
2966 | "title": "Day 8",
2967 | "denoms": [
2968 | {
2969 | "units": "Participants",
2970 | "counts": [
2971 | {
2972 | "groupId": "OG000",
2973 | "value": "334"
2974 | },
2975 | {
2976 | "groupId": "OG001",
2977 | "value": "310"
2978 | }
2979 | ]
2980 | }
2981 | ],
2982 | "categories": [
2983 | {
2984 | "measurements": [
2985 | {
2986 | "groupId": "OG000",
2987 | "value": "-1.22",
2988 | "spread": "1.42"
2989 | },
2990 | {
2991 | "groupId": "OG001",
2992 | "value": "-0.49",
2993 | "spread": "6.54"
2994 | }
2995 | ]
2996 | }
2997 | ]
2998 | },
2999 | {
3000 | "title": "Day 11",
3001 | "denoms": [
3002 | {
3003 | "units": "Participants",
3004 | "counts": [
3005 | {
3006 | "groupId": "OG000",
3007 | "value": "269"
3008 | },
3009 | {
3010 | "groupId": "OG001",
3011 | "value": "230"
3012 | }
3013 | ]
3014 | }
3015 | ],
3016 | "categories": [
3017 | {
3018 | "measurements": [
3019 | {
3020 | "groupId": "OG000",
3021 | "value": "-1.66",
3022 | "spread": "1.67"
3023 | },
3024 | {
3025 | "groupId": "OG001",
3026 | "value": "-1.29",
3027 | "spread": "1.93"
3028 | }
3029 | ]
3030 | }
3031 | ]
3032 | },
3033 | {
3034 | "title": "Day 15",
3035 | "denoms": [
3036 | {
3037 | "units": "Participants",
3038 | "counts": [
3039 | {
3040 | "groupId": "OG000",
3041 | "value": "253"
3042 | },
3043 | {
3044 | "groupId": "OG001",
3045 | "value": "260"
3046 | }
3047 | ]
3048 | }
3049 | ],
3050 | "categories": [
3051 | {
3052 | "measurements": [
3053 | {
3054 | "groupId": "OG000",
3055 | "value": "-1.51",
3056 | "spread": "2.02"
3057 | },
3058 | {
3059 | "groupId": "OG001",
3060 | "value": "-1.02",
3061 | "spread": "3.04"
3062 | }
3063 | ]
3064 | }
3065 | ]
3066 | },
3067 | {
3068 | "title": "Day 29",
3069 | "denoms": [
3070 | {
3071 | "units": "Participants",
3072 | "counts": [
3073 | {
3074 | "groupId": "OG000",
3075 | "value": "189"
3076 | },
3077 | {
3078 | "groupId": "OG001",
3079 | "value": "227"
3080 | }
3081 | ]
3082 | }
3083 | ],
3084 | "categories": [
3085 | {
3086 | "measurements": [
3087 | {
3088 | "groupId": "OG000",
3089 | "value": "-1.02",
3090 | "spread": "2.38"
3091 | },
3092 | {
3093 | "groupId": "OG001",
3094 | "value": "-1.21",
3095 | "spread": "7.91"
3096 | }
3097 | ]
3098 | }
3099 | ]
3100 | }
3101 | ]
3102 | },
3103 | {
3104 | "type": "SECONDARY",
3105 | "title": "Change From Baseline in Platelets",
3106 | "description": "Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
3107 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
3108 | "reportingStatus": "POSTED",
3109 | "paramType": "MEAN",
3110 | "dispersionType": "Standard Deviation",
3111 | "unitOfMeasure": "10^9 cells/liter",
3112 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
3113 | "groups": [
3114 | {
3115 | "id": "OG000",
3116 | "title": "Placebo",
3117 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
3118 | },
3119 | {
3120 | "id": "OG001",
3121 | "title": "Remdesivir",
3122 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
3123 | }
3124 | ],
3125 | "denoms": [
3126 | {
3127 | "units": "Participants",
3128 | "counts": [
3129 | {
3130 | "groupId": "OG000",
3131 | "value": "471"
3132 | },
3133 | {
3134 | "groupId": "OG001",
3135 | "value": "474"
3136 | }
3137 | ]
3138 | }
3139 | ],
3140 | "classes": [
3141 | {
3142 | "title": "Day 3",
3143 | "denoms": [
3144 | {
3145 | "units": "Participants",
3146 | "counts": [
3147 | {
3148 | "groupId": "OG000",
3149 | "value": "471"
3150 | },
3151 | {
3152 | "groupId": "OG001",
3153 | "value": "474"
3154 | }
3155 | ]
3156 | }
3157 | ],
3158 | "categories": [
3159 | {
3160 | "measurements": [
3161 | {
3162 | "groupId": "OG000",
3163 | "value": "39.3",
3164 | "spread": "60.0"
3165 | },
3166 | {
3167 | "groupId": "OG001",
3168 | "value": "46.0",
3169 | "spread": "62.6"
3170 | }
3171 | ]
3172 | }
3173 | ]
3174 | },
3175 | {
3176 | "title": "Day 5",
3177 | "denoms": [
3178 | {
3179 | "units": "Participants",
3180 | "counts": [
3181 | {
3182 | "groupId": "OG000",
3183 | "value": "419"
3184 | },
3185 | {
3186 | "groupId": "OG001",
3187 | "value": "403"
3188 | }
3189 | ]
3190 | }
3191 | ],
3192 | "categories": [
3193 | {
3194 | "measurements": [
3195 | {
3196 | "groupId": "OG000",
3197 | "value": "76.5",
3198 | "spread": "100.5"
3199 | },
3200 | {
3201 | "groupId": "OG001",
3202 | "value": "90.1",
3203 | "spread": "99.9"
3204 | }
3205 | ]
3206 | }
3207 | ]
3208 | },
3209 | {
3210 | "title": "Day 8",
3211 | "denoms": [
3212 | {
3213 | "units": "Participants",
3214 | "counts": [
3215 | {
3216 | "groupId": "OG000",
3217 | "value": "332"
3218 | },
3219 | {
3220 | "groupId": "OG001",
3221 | "value": "308"
3222 | }
3223 | ]
3224 | }
3225 | ],
3226 | "categories": [
3227 | {
3228 | "measurements": [
3229 | {
3230 | "groupId": "OG000",
3231 | "value": "111.8",
3232 | "spread": "137.4"
3233 | },
3234 | {
3235 | "groupId": "OG001",
3236 | "value": "130.8",
3237 | "spread": "128.1"
3238 | }
3239 | ]
3240 | }
3241 | ]
3242 | },
3243 | {
3244 | "title": "Day 11",
3245 | "denoms": [
3246 | {
3247 | "units": "Participants",
3248 | "counts": [
3249 | {
3250 | "groupId": "OG000",
3251 | "value": "269"
3252 | },
3253 | {
3254 | "groupId": "OG001",
3255 | "value": "229"
3256 | }
3257 | ]
3258 | }
3259 | ],
3260 | "categories": [
3261 | {
3262 | "measurements": [
3263 | {
3264 | "groupId": "OG000",
3265 | "value": "109.3",
3266 | "spread": "149.3"
3267 | },
3268 | {
3269 | "groupId": "OG001",
3270 | "value": "101.0",
3271 | "spread": "145.0"
3272 | }
3273 | ]
3274 | }
3275 | ]
3276 | },
3277 | {
3278 | "title": "Day 15",
3279 | "denoms": [
3280 | {
3281 | "units": "Participants",
3282 | "counts": [
3283 | {
3284 | "groupId": "OG000",
3285 | "value": "252"
3286 | },
3287 | {
3288 | "groupId": "OG001",
3289 | "value": "258"
3290 | }
3291 | ]
3292 | }
3293 | ],
3294 | "categories": [
3295 | {
3296 | "measurements": [
3297 | {
3298 | "groupId": "OG000",
3299 | "value": "96.5",
3300 | "spread": "154.2"
3301 | },
3302 | {
3303 | "groupId": "OG001",
3304 | "value": "71.1",
3305 | "spread": "133.3"
3306 | }
3307 | ]
3308 | }
3309 | ]
3310 | },
3311 | {
3312 | "title": "Day 29",
3313 | "denoms": [
3314 | {
3315 | "units": "Participants",
3316 | "counts": [
3317 | {
3318 | "groupId": "OG000",
3319 | "value": "189"
3320 | },
3321 | {
3322 | "groupId": "OG001",
3323 | "value": "224"
3324 | }
3325 | ]
3326 | }
3327 | ],
3328 | "categories": [
3329 | {
3330 | "measurements": [
3331 | {
3332 | "groupId": "OG000",
3333 | "value": "32.7",
3334 | "spread": "124.2"
3335 | },
3336 | {
3337 | "groupId": "OG001",
3338 | "value": "39.6",
3339 | "spread": "107.4"
3340 | }
3341 | ]
3342 | }
3343 | ]
3344 | }
3345 | ]
3346 | },
3347 | {
3348 | "type": "SECONDARY",
3349 | "title": "Change From Baseline in Prothrombin Time (PT)",
3350 | "description": "Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
3351 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
3352 | "reportingStatus": "POSTED",
3353 | "paramType": "MEAN",
3354 | "dispersionType": "Standard Deviation",
3355 | "unitOfMeasure": "seconds",
3356 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
3357 | "groups": [
3358 | {
3359 | "id": "OG000",
3360 | "title": "Placebo",
3361 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
3362 | },
3363 | {
3364 | "id": "OG001",
3365 | "title": "Remdesivir",
3366 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
3367 | }
3368 | ],
3369 | "denoms": [
3370 | {
3371 | "units": "Participants",
3372 | "counts": [
3373 | {
3374 | "groupId": "OG000",
3375 | "value": "339"
3376 | },
3377 | {
3378 | "groupId": "OG001",
3379 | "value": "352"
3380 | }
3381 | ]
3382 | }
3383 | ],
3384 | "classes": [
3385 | {
3386 | "title": "Day 3",
3387 | "denoms": [
3388 | {
3389 | "units": "Participants",
3390 | "counts": [
3391 | {
3392 | "groupId": "OG000",
3393 | "value": "339"
3394 | },
3395 | {
3396 | "groupId": "OG001",
3397 | "value": "352"
3398 | }
3399 | ]
3400 | }
3401 | ],
3402 | "categories": [
3403 | {
3404 | "measurements": [
3405 | {
3406 | "groupId": "OG000",
3407 | "value": "-0.18",
3408 | "spread": "4.28"
3409 | },
3410 | {
3411 | "groupId": "OG001",
3412 | "value": "0.44",
3413 | "spread": "5.22"
3414 | }
3415 | ]
3416 | }
3417 | ]
3418 | },
3419 | {
3420 | "title": "Day 5",
3421 | "denoms": [
3422 | {
3423 | "units": "Participants",
3424 | "counts": [
3425 | {
3426 | "groupId": "OG000",
3427 | "value": "296"
3428 | },
3429 | {
3430 | "groupId": "OG001",
3431 | "value": "306"
3432 | }
3433 | ]
3434 | }
3435 | ],
3436 | "categories": [
3437 | {
3438 | "measurements": [
3439 | {
3440 | "groupId": "OG000",
3441 | "value": "-0.30",
3442 | "spread": "4.72"
3443 | },
3444 | {
3445 | "groupId": "OG001",
3446 | "value": "1.15",
3447 | "spread": "5.72"
3448 | }
3449 | ]
3450 | }
3451 | ]
3452 | },
3453 | {
3454 | "title": "Day 8",
3455 | "denoms": [
3456 | {
3457 | "units": "Participants",
3458 | "counts": [
3459 | {
3460 | "groupId": "OG000",
3461 | "value": "246"
3462 | },
3463 | {
3464 | "groupId": "OG001",
3465 | "value": "234"
3466 | }
3467 | ]
3468 | }
3469 | ],
3470 | "categories": [
3471 | {
3472 | "measurements": [
3473 | {
3474 | "groupId": "OG000",
3475 | "value": "0.01",
3476 | "spread": "2.59"
3477 | },
3478 | {
3479 | "groupId": "OG001",
3480 | "value": "1.43",
3481 | "spread": "3.89"
3482 | }
3483 | ]
3484 | }
3485 | ]
3486 | },
3487 | {
3488 | "title": "Day 11",
3489 | "denoms": [
3490 | {
3491 | "units": "Participants",
3492 | "counts": [
3493 | {
3494 | "groupId": "OG000",
3495 | "value": "199"
3496 | },
3497 | {
3498 | "groupId": "OG001",
3499 | "value": "182"
3500 | }
3501 | ]
3502 | }
3503 | ],
3504 | "categories": [
3505 | {
3506 | "measurements": [
3507 | {
3508 | "groupId": "OG000",
3509 | "value": "0.86",
3510 | "spread": "7.85"
3511 | },
3512 | {
3513 | "groupId": "OG001",
3514 | "value": "1.88",
3515 | "spread": "5.68"
3516 | }
3517 | ]
3518 | }
3519 | ]
3520 | },
3521 | {
3522 | "title": "Day 15",
3523 | "denoms": [
3524 | {
3525 | "units": "Participants",
3526 | "counts": [
3527 | {
3528 | "groupId": "OG000",
3529 | "value": "176"
3530 | },
3531 | {
3532 | "groupId": "OG001",
3533 | "value": "193"
3534 | }
3535 | ]
3536 | }
3537 | ],
3538 | "categories": [
3539 | {
3540 | "measurements": [
3541 | {
3542 | "groupId": "OG000",
3543 | "value": "0.34",
3544 | "spread": "4.33"
3545 | },
3546 | {
3547 | "groupId": "OG001",
3548 | "value": "-0.03",
3549 | "spread": "4.25"
3550 | }
3551 | ]
3552 | }
3553 | ]
3554 | },
3555 | {
3556 | "title": "Day 29",
3557 | "denoms": [
3558 | {
3559 | "units": "Participants",
3560 | "counts": [
3561 | {
3562 | "groupId": "OG000",
3563 | "value": "134"
3564 | },
3565 | {
3566 | "groupId": "OG001",
3567 | "value": "163"
3568 | }
3569 | ]
3570 | }
3571 | ],
3572 | "categories": [
3573 | {
3574 | "measurements": [
3575 | {
3576 | "groupId": "OG000",
3577 | "value": "-0.28",
3578 | "spread": "3.20"
3579 | },
3580 | {
3581 | "groupId": "OG001",
3582 | "value": "-0.63",
3583 | "spread": "3.37"
3584 | }
3585 | ]
3586 | }
3587 | ]
3588 | }
3589 | ]
3590 | },
3591 | {
3592 | "type": "SECONDARY",
3593 | "title": "Change From Baseline in Total Bilirubin",
3594 | "description": "Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
3595 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
3596 | "reportingStatus": "POSTED",
3597 | "paramType": "MEAN",
3598 | "dispersionType": "Standard Deviation",
3599 | "unitOfMeasure": "mg/dL",
3600 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
3601 | "groups": [
3602 | {
3603 | "id": "OG000",
3604 | "title": "Placebo",
3605 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
3606 | },
3607 | {
3608 | "id": "OG001",
3609 | "title": "Remdesivir",
3610 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
3611 | }
3612 | ],
3613 | "denoms": [
3614 | {
3615 | "units": "Participants",
3616 | "counts": [
3617 | {
3618 | "groupId": "OG000",
3619 | "value": "451"
3620 | },
3621 | {
3622 | "groupId": "OG001",
3623 | "value": "456"
3624 | }
3625 | ]
3626 | }
3627 | ],
3628 | "classes": [
3629 | {
3630 | "title": "Day 3",
3631 | "denoms": [
3632 | {
3633 | "units": "Participants",
3634 | "counts": [
3635 | {
3636 | "groupId": "OG000",
3637 | "value": "451"
3638 | },
3639 | {
3640 | "groupId": "OG001",
3641 | "value": "456"
3642 | }
3643 | ]
3644 | }
3645 | ],
3646 | "categories": [
3647 | {
3648 | "measurements": [
3649 | {
3650 | "groupId": "OG000",
3651 | "value": "0.08",
3652 | "spread": "1.25"
3653 | },
3654 | {
3655 | "groupId": "OG001",
3656 | "value": "-0.04",
3657 | "spread": "0.75"
3658 | }
3659 | ]
3660 | }
3661 | ]
3662 | },
3663 | {
3664 | "title": "Day 5",
3665 | "denoms": [
3666 | {
3667 | "units": "Participants",
3668 | "counts": [
3669 | {
3670 | "groupId": "OG000",
3671 | "value": "394"
3672 | },
3673 | {
3674 | "groupId": "OG001",
3675 | "value": "389"
3676 | }
3677 | ]
3678 | }
3679 | ],
3680 | "categories": [
3681 | {
3682 | "measurements": [
3683 | {
3684 | "groupId": "OG000",
3685 | "value": "0.58",
3686 | "spread": "4.13"
3687 | },
3688 | {
3689 | "groupId": "OG001",
3690 | "value": "-0.03",
3691 | "spread": "1.03"
3692 | }
3693 | ]
3694 | }
3695 | ]
3696 | },
3697 | {
3698 | "title": "Day 8",
3699 | "denoms": [
3700 | {
3701 | "units": "Participants",
3702 | "counts": [
3703 | {
3704 | "groupId": "OG000",
3705 | "value": "315"
3706 | },
3707 | {
3708 | "groupId": "OG001",
3709 | "value": "288"
3710 | }
3711 | ]
3712 | }
3713 | ],
3714 | "categories": [
3715 | {
3716 | "measurements": [
3717 | {
3718 | "groupId": "OG000",
3719 | "value": "0.22",
3720 | "spread": "2.56"
3721 | },
3722 | {
3723 | "groupId": "OG001",
3724 | "value": "0.01",
3725 | "spread": "1.38"
3726 | }
3727 | ]
3728 | }
3729 | ]
3730 | },
3731 | {
3732 | "title": "Day 11",
3733 | "denoms": [
3734 | {
3735 | "units": "Participants",
3736 | "counts": [
3737 | {
3738 | "groupId": "OG000",
3739 | "value": "247"
3740 | },
3741 | {
3742 | "groupId": "OG001",
3743 | "value": "220"
3744 | }
3745 | ]
3746 | }
3747 | ],
3748 | "categories": [
3749 | {
3750 | "measurements": [
3751 | {
3752 | "groupId": "OG000",
3753 | "value": "0.23",
3754 | "spread": "2.79"
3755 | },
3756 | {
3757 | "groupId": "OG001",
3758 | "value": "0.07",
3759 | "spread": "1.48"
3760 | }
3761 | ]
3762 | }
3763 | ]
3764 | },
3765 | {
3766 | "title": "Day 15",
3767 | "denoms": [
3768 | {
3769 | "units": "Participants",
3770 | "counts": [
3771 | {
3772 | "groupId": "OG000",
3773 | "value": "237"
3774 | },
3775 | {
3776 | "groupId": "OG001",
3777 | "value": "254"
3778 | }
3779 | ]
3780 | }
3781 | ],
3782 | "categories": [
3783 | {
3784 | "measurements": [
3785 | {
3786 | "groupId": "OG000",
3787 | "value": "0.00",
3788 | "spread": "1.80"
3789 | },
3790 | {
3791 | "groupId": "OG001",
3792 | "value": "0.09",
3793 | "spread": "1.54"
3794 | }
3795 | ]
3796 | }
3797 | ]
3798 | },
3799 | {
3800 | "title": "Day 29",
3801 | "denoms": [
3802 | {
3803 | "units": "Participants",
3804 | "counts": [
3805 | {
3806 | "groupId": "OG000",
3807 | "value": "178"
3808 | },
3809 | {
3810 | "groupId": "OG001",
3811 | "value": "216"
3812 | }
3813 | ]
3814 | }
3815 | ],
3816 | "categories": [
3817 | {
3818 | "measurements": [
3819 | {
3820 | "groupId": "OG000",
3821 | "value": "-0.17",
3822 | "spread": "1.65"
3823 | },
3824 | {
3825 | "groupId": "OG001",
3826 | "value": "-0.12",
3827 | "spread": "1.77"
3828 | }
3829 | ]
3830 | }
3831 | ]
3832 | }
3833 | ]
3834 | },
3835 | {
3836 | "type": "SECONDARY",
3837 | "title": "Change From Baseline in White Blood Cell Count (WBC)",
3838 | "description": "Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
3839 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
3840 | "reportingStatus": "POSTED",
3841 | "paramType": "MEAN",
3842 | "dispersionType": "Standard Deviation",
3843 | "unitOfMeasure": "10^9 cells/liter",
3844 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
3845 | "groups": [
3846 | {
3847 | "id": "OG000",
3848 | "title": "Placebo",
3849 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
3850 | },
3851 | {
3852 | "id": "OG001",
3853 | "title": "Remdesivir",
3854 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
3855 | }
3856 | ],
3857 | "denoms": [
3858 | {
3859 | "units": "Participants",
3860 | "counts": [
3861 | {
3862 | "groupId": "OG000",
3863 | "value": "474"
3864 | },
3865 | {
3866 | "groupId": "OG001",
3867 | "value": "475"
3868 | }
3869 | ]
3870 | }
3871 | ],
3872 | "classes": [
3873 | {
3874 | "title": "Day 3",
3875 | "denoms": [
3876 | {
3877 | "units": "Participants",
3878 | "counts": [
3879 | {
3880 | "groupId": "OG000",
3881 | "value": "474"
3882 | },
3883 | {
3884 | "groupId": "OG001",
3885 | "value": "475"
3886 | }
3887 | ]
3888 | }
3889 | ],
3890 | "categories": [
3891 | {
3892 | "measurements": [
3893 | {
3894 | "groupId": "OG000",
3895 | "value": "18.691",
3896 | "spread": "424.837"
3897 | },
3898 | {
3899 | "groupId": "OG001",
3900 | "value": "-18.970",
3901 | "spread": "301.944"
3902 | }
3903 | ]
3904 | }
3905 | ]
3906 | },
3907 | {
3908 | "title": "Day 5",
3909 | "denoms": [
3910 | {
3911 | "units": "Participants",
3912 | "counts": [
3913 | {
3914 | "groupId": "OG000",
3915 | "value": "419"
3916 | },
3917 | {
3918 | "groupId": "OG001",
3919 | "value": "405"
3920 | }
3921 | ]
3922 | }
3923 | ],
3924 | "categories": [
3925 | {
3926 | "measurements": [
3927 | {
3928 | "groupId": "OG000",
3929 | "value": "9.886",
3930 | "spread": "566.175"
3931 | },
3932 | {
3933 | "groupId": "OG001",
3934 | "value": "-28.209",
3935 | "spread": "412.615"
3936 | }
3937 | ]
3938 | }
3939 | ]
3940 | },
3941 | {
3942 | "title": "Day 8",
3943 | "denoms": [
3944 | {
3945 | "units": "Participants",
3946 | "counts": [
3947 | {
3948 | "groupId": "OG000",
3949 | "value": "333"
3950 | },
3951 | {
3952 | "groupId": "OG001",
3953 | "value": "310"
3954 | }
3955 | ]
3956 | }
3957 | ],
3958 | "categories": [
3959 | {
3960 | "measurements": [
3961 | {
3962 | "groupId": "OG000",
3963 | "value": "27.223",
3964 | "spread": "479.095"
3965 | },
3966 | {
3967 | "groupId": "OG001",
3968 | "value": "-45.997",
3969 | "spread": "602.461"
3970 | }
3971 | ]
3972 | }
3973 | ]
3974 | },
3975 | {
3976 | "title": "Day 11",
3977 | "denoms": [
3978 | {
3979 | "units": "Participants",
3980 | "counts": [
3981 | {
3982 | "groupId": "OG000",
3983 | "value": "268"
3984 | },
3985 | {
3986 | "groupId": "OG001",
3987 | "value": "230"
3988 | }
3989 | ]
3990 | }
3991 | ],
3992 | "categories": [
3993 | {
3994 | "measurements": [
3995 | {
3996 | "groupId": "OG000",
3997 | "value": "1.967",
3998 | "spread": "16.042"
3999 | },
4000 | {
4001 | "groupId": "OG001",
4002 | "value": "-34.702",
4003 | "spread": "574.065"
4004 | }
4005 | ]
4006 | }
4007 | ]
4008 | },
4009 | {
4010 | "title": "Day 15",
4011 | "denoms": [
4012 | {
4013 | "units": "Participants",
4014 | "counts": [
4015 | {
4016 | "groupId": "OG000",
4017 | "value": "252"
4018 | },
4019 | {
4020 | "groupId": "OG001",
4021 | "value": "260"
4022 | }
4023 | ]
4024 | }
4025 | ],
4026 | "categories": [
4027 | {
4028 | "measurements": [
4029 | {
4030 | "groupId": "OG000",
4031 | "value": "56.311",
4032 | "spread": "620.551"
4033 | },
4034 | {
4035 | "groupId": "OG001",
4036 | "value": "-70.884",
4037 | "spread": "600.011"
4038 | }
4039 | ]
4040 | }
4041 | ]
4042 | },
4043 | {
4044 | "title": "Day 29",
4045 | "denoms": [
4046 | {
4047 | "units": "Participants",
4048 | "counts": [
4049 | {
4050 | "groupId": "OG000",
4051 | "value": "189"
4052 | },
4053 | {
4054 | "groupId": "OG001",
4055 | "value": "226"
4056 | }
4057 | ]
4058 | }
4059 | ],
4060 | "categories": [
4061 | {
4062 | "measurements": [
4063 | {
4064 | "groupId": "OG000",
4065 | "value": "-0.898",
4066 | "spread": "17.801"
4067 | },
4068 | {
4069 | "groupId": "OG001",
4070 | "value": "0.251",
4071 | "spread": "3.987"
4072 | }
4073 | ]
4074 | }
4075 | ]
4076 | }
4077 | ]
4078 | },
4079 | {
4080 | "type": "SECONDARY",
4081 | "title": "Change From Baseline in Neutrophils",
4082 | "description": "Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
4083 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
4084 | "reportingStatus": "POSTED",
4085 | "paramType": "MEAN",
4086 | "dispersionType": "Standard Deviation",
4087 | "unitOfMeasure": "10^9 cells/liter",
4088 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
4089 | "groups": [
4090 | {
4091 | "id": "OG000",
4092 | "title": "Placebo",
4093 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
4094 | },
4095 | {
4096 | "id": "OG001",
4097 | "title": "Remdesivir",
4098 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
4099 | }
4100 | ],
4101 | "denoms": [
4102 | {
4103 | "units": "Participants",
4104 | "counts": [
4105 | {
4106 | "groupId": "OG000",
4107 | "value": "463"
4108 | },
4109 | {
4110 | "groupId": "OG001",
4111 | "value": "459"
4112 | }
4113 | ]
4114 | }
4115 | ],
4116 | "classes": [
4117 | {
4118 | "title": "Day 3",
4119 | "denoms": [
4120 | {
4121 | "units": "Participants",
4122 | "counts": [
4123 | {
4124 | "groupId": "OG000",
4125 | "value": "463"
4126 | },
4127 | {
4128 | "groupId": "OG001",
4129 | "value": "459"
4130 | }
4131 | ]
4132 | }
4133 | ],
4134 | "categories": [
4135 | {
4136 | "measurements": [
4137 | {
4138 | "groupId": "OG000",
4139 | "value": "9.429",
4140 | "spread": "260.345"
4141 | },
4142 | {
4143 | "groupId": "OG001",
4144 | "value": "-8.093",
4145 | "spread": "135.068"
4146 | }
4147 | ]
4148 | }
4149 | ]
4150 | },
4151 | {
4152 | "title": "Day 5",
4153 | "denoms": [
4154 | {
4155 | "units": "Participants",
4156 | "counts": [
4157 | {
4158 | "groupId": "OG000",
4159 | "value": "406"
4160 | },
4161 | {
4162 | "groupId": "OG001",
4163 | "value": "389"
4164 | }
4165 | ]
4166 | }
4167 | ],
4168 | "categories": [
4169 | {
4170 | "measurements": [
4171 | {
4172 | "groupId": "OG000",
4173 | "value": "4.177",
4174 | "spread": "362.782"
4175 | },
4176 | {
4177 | "groupId": "OG001",
4178 | "value": "-15.067",
4179 | "spread": "216.532"
4180 | }
4181 | ]
4182 | }
4183 | ]
4184 | },
4185 | {
4186 | "title": "Day 8",
4187 | "denoms": [
4188 | {
4189 | "units": "Participants",
4190 | "counts": [
4191 | {
4192 | "groupId": "OG000",
4193 | "value": "317"
4194 | },
4195 | {
4196 | "groupId": "OG001",
4197 | "value": "298"
4198 | }
4199 | ]
4200 | }
4201 | ],
4202 | "categories": [
4203 | {
4204 | "measurements": [
4205 | {
4206 | "groupId": "OG000",
4207 | "value": "17.916",
4208 | "spread": "305.321"
4209 | },
4210 | {
4211 | "groupId": "OG001",
4212 | "value": "-28.179",
4213 | "spread": "365.099"
4214 | }
4215 | ]
4216 | }
4217 | ]
4218 | },
4219 | {
4220 | "title": "Day 11",
4221 | "denoms": [
4222 | {
4223 | "units": "Participants",
4224 | "counts": [
4225 | {
4226 | "groupId": "OG000",
4227 | "value": "257"
4228 | },
4229 | {
4230 | "groupId": "OG001",
4231 | "value": "220"
4232 | }
4233 | ]
4234 | }
4235 | ],
4236 | "categories": [
4237 | {
4238 | "measurements": [
4239 | {
4240 | "groupId": "OG000",
4241 | "value": "3.010",
4242 | "spread": "27.502"
4243 | },
4244 | {
4245 | "groupId": "OG001",
4246 | "value": "-21.773",
4247 | "spread": "354.025"
4248 | }
4249 | ]
4250 | }
4251 | ]
4252 | },
4253 | {
4254 | "title": "Day 15",
4255 | "denoms": [
4256 | {
4257 | "units": "Participants",
4258 | "counts": [
4259 | {
4260 | "groupId": "OG000",
4261 | "value": "241"
4262 | },
4263 | {
4264 | "groupId": "OG001",
4265 | "value": "253"
4266 | }
4267 | ]
4268 | }
4269 | ],
4270 | "categories": [
4271 | {
4272 | "measurements": [
4273 | {
4274 | "groupId": "OG000",
4275 | "value": "36.024",
4276 | "spread": "389.093"
4277 | },
4278 | {
4279 | "groupId": "OG001",
4280 | "value": "-39.988",
4281 | "spread": "333.088"
4282 | }
4283 | ]
4284 | }
4285 | ]
4286 | },
4287 | {
4288 | "title": "Day 29",
4289 | "denoms": [
4290 | {
4291 | "units": "Participants",
4292 | "counts": [
4293 | {
4294 | "groupId": "OG000",
4295 | "value": "177"
4296 | },
4297 | {
4298 | "groupId": "OG001",
4299 | "value": "218"
4300 | }
4301 | ]
4302 | }
4303 | ],
4304 | "categories": [
4305 | {
4306 | "measurements": [
4307 | {
4308 | "groupId": "OG000",
4309 | "value": "-1.269",
4310 | "spread": "7.160"
4311 | },
4312 | {
4313 | "groupId": "OG001",
4314 | "value": "-0.840",
4315 | "spread": "3.666"
4316 | }
4317 | ]
4318 | }
4319 | ]
4320 | }
4321 | ]
4322 | },
4323 | {
4324 | "type": "SECONDARY",
4325 | "title": "Change From Baseline in Lymphocytes",
4326 | "description": "Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
4327 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
4328 | "reportingStatus": "POSTED",
4329 | "paramType": "MEAN",
4330 | "dispersionType": "Standard Deviation",
4331 | "unitOfMeasure": "10^9 cells/liter",
4332 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
4333 | "groups": [
4334 | {
4335 | "id": "OG000",
4336 | "title": "Placebo",
4337 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
4338 | },
4339 | {
4340 | "id": "OG001",
4341 | "title": "Remdesivir",
4342 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
4343 | }
4344 | ],
4345 | "denoms": [
4346 | {
4347 | "units": "Participants",
4348 | "counts": [
4349 | {
4350 | "groupId": "OG000",
4351 | "value": "463"
4352 | },
4353 | {
4354 | "groupId": "OG001",
4355 | "value": "459"
4356 | }
4357 | ]
4358 | }
4359 | ],
4360 | "classes": [
4361 | {
4362 | "title": "Day 3",
4363 | "denoms": [
4364 | {
4365 | "units": "Participants",
4366 | "counts": [
4367 | {
4368 | "groupId": "OG000",
4369 | "value": "463"
4370 | },
4371 | {
4372 | "groupId": "OG001",
4373 | "value": "459"
4374 | }
4375 | ]
4376 | }
4377 | ],
4378 | "categories": [
4379 | {
4380 | "measurements": [
4381 | {
4382 | "groupId": "OG000",
4383 | "value": "5.883",
4384 | "spread": "118.740"
4385 | },
4386 | {
4387 | "groupId": "OG001",
4388 | "value": "-7.847",
4389 | "spread": "131.548"
4390 | }
4391 | ]
4392 | }
4393 | ]
4394 | },
4395 | {
4396 | "title": "Day 5",
4397 | "denoms": [
4398 | {
4399 | "units": "Participants",
4400 | "counts": [
4401 | {
4402 | "groupId": "OG000",
4403 | "value": "406"
4404 | },
4405 | {
4406 | "groupId": "OG001",
4407 | "value": "389"
4408 | }
4409 | ]
4410 | }
4411 | ],
4412 | "categories": [
4413 | {
4414 | "measurements": [
4415 | {
4416 | "groupId": "OG000",
4417 | "value": "4.064",
4418 | "spread": "141.580"
4419 | },
4420 | {
4421 | "groupId": "OG001",
4422 | "value": "-11.723",
4423 | "spread": "167.428"
4424 | }
4425 | ]
4426 | }
4427 | ]
4428 | },
4429 | {
4430 | "title": "Day 8",
4431 | "denoms": [
4432 | {
4433 | "units": "Participants",
4434 | "counts": [
4435 | {
4436 | "groupId": "OG000",
4437 | "value": "317"
4438 | },
4439 | {
4440 | "groupId": "OG001",
4441 | "value": "299"
4442 | }
4443 | ]
4444 | }
4445 | ],
4446 | "categories": [
4447 | {
4448 | "measurements": [
4449 | {
4450 | "groupId": "OG000",
4451 | "value": "8.006",
4452 | "spread": "137.149"
4453 | },
4454 | {
4455 | "groupId": "OG001",
4456 | "value": "-15.455",
4457 | "spread": "194.111"
4458 | }
4459 | ]
4460 | }
4461 | ]
4462 | },
4463 | {
4464 | "title": "Day 11",
4465 | "denoms": [
4466 | {
4467 | "units": "Participants",
4468 | "counts": [
4469 | {
4470 | "groupId": "OG000",
4471 | "value": "257"
4472 | },
4473 | {
4474 | "groupId": "OG001",
4475 | "value": "220"
4476 | }
4477 | ]
4478 | }
4479 | ],
4480 | "categories": [
4481 | {
4482 | "measurements": [
4483 | {
4484 | "groupId": "OG000",
4485 | "value": "0.393",
4486 | "spread": "1.371"
4487 | },
4488 | {
4489 | "groupId": "OG001",
4490 | "value": "-12.016",
4491 | "spread": "183.060"
4492 | }
4493 | ]
4494 | }
4495 | ]
4496 | },
4497 | {
4498 | "title": "Day 15",
4499 | "denoms": [
4500 | {
4501 | "units": "Participants",
4502 | "counts": [
4503 | {
4504 | "groupId": "OG000",
4505 | "value": "241"
4506 | },
4507 | {
4508 | "groupId": "OG001",
4509 | "value": "253"
4510 | }
4511 | ]
4512 | }
4513 | ],
4514 | "categories": [
4515 | {
4516 | "measurements": [
4517 | {
4518 | "groupId": "OG000",
4519 | "value": "14.793",
4520 | "spread": "159.583"
4521 | },
4522 | {
4523 | "groupId": "OG001",
4524 | "value": "-23.836",
4525 | "spread": "218.653"
4526 | }
4527 | ]
4528 | }
4529 | ]
4530 | },
4531 | {
4532 | "title": "Day 29",
4533 | "denoms": [
4534 | {
4535 | "units": "Participants",
4536 | "counts": [
4537 | {
4538 | "groupId": "OG000",
4539 | "value": "177"
4540 | },
4541 | {
4542 | "groupId": "OG001",
4543 | "value": "218"
4544 | }
4545 | ]
4546 | }
4547 | ],
4548 | "categories": [
4549 | {
4550 | "measurements": [
4551 | {
4552 | "groupId": "OG000",
4553 | "value": "0.668",
4554 | "spread": "1.406"
4555 | },
4556 | {
4557 | "groupId": "OG001",
4558 | "value": "0.743",
4559 | "spread": "0.664"
4560 | }
4561 | ]
4562 | }
4563 | ]
4564 | }
4565 | ]
4566 | },
4567 | {
4568 | "type": "SECONDARY",
4569 | "title": "Change From Baseline in Monocytes",
4570 | "description": "Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
4571 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
4572 | "reportingStatus": "POSTED",
4573 | "paramType": "MEAN",
4574 | "dispersionType": "Standard Deviation",
4575 | "unitOfMeasure": "10^9 cells/liter",
4576 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
4577 | "groups": [
4578 | {
4579 | "id": "OG000",
4580 | "title": "Placebo",
4581 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
4582 | },
4583 | {
4584 | "id": "OG001",
4585 | "title": "Remdesivir",
4586 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
4587 | }
4588 | ],
4589 | "denoms": [
4590 | {
4591 | "units": "Participants",
4592 | "counts": [
4593 | {
4594 | "groupId": "OG000",
4595 | "value": "463"
4596 | },
4597 | {
4598 | "groupId": "OG001",
4599 | "value": "458"
4600 | }
4601 | ]
4602 | }
4603 | ],
4604 | "classes": [
4605 | {
4606 | "title": "Day 3",
4607 | "denoms": [
4608 | {
4609 | "units": "Participants",
4610 | "counts": [
4611 | {
4612 | "groupId": "OG000",
4613 | "value": "463"
4614 | },
4615 | {
4616 | "groupId": "OG001",
4617 | "value": "458"
4618 | }
4619 | ]
4620 | }
4621 | ],
4622 | "categories": [
4623 | {
4624 | "measurements": [
4625 | {
4626 | "groupId": "OG000",
4627 | "value": "2.448",
4628 | "spread": "41.304"
4629 | },
4630 | {
4631 | "groupId": "OG001",
4632 | "value": "-2.940",
4633 | "spread": "46.752"
4634 | }
4635 | ]
4636 | }
4637 | ]
4638 | },
4639 | {
4640 | "title": "Day 5",
4641 | "denoms": [
4642 | {
4643 | "units": "Participants",
4644 | "counts": [
4645 | {
4646 | "groupId": "OG000",
4647 | "value": "406"
4648 | },
4649 | {
4650 | "groupId": "OG001",
4651 | "value": "388"
4652 | }
4653 | ]
4654 | }
4655 | ],
4656 | "categories": [
4657 | {
4658 | "measurements": [
4659 | {
4660 | "groupId": "OG000",
4661 | "value": "1.498",
4662 | "spread": "57.686"
4663 | },
4664 | {
4665 | "groupId": "OG001",
4666 | "value": "-2.628",
4667 | "spread": "39.329"
4668 | }
4669 | ]
4670 | }
4671 | ]
4672 | },
4673 | {
4674 | "title": "Day 8",
4675 | "denoms": [
4676 | {
4677 | "units": "Participants",
4678 | "counts": [
4679 | {
4680 | "groupId": "OG000",
4681 | "value": "316"
4682 | },
4683 | {
4684 | "groupId": "OG001",
4685 | "value": "299"
4686 | }
4687 | ]
4688 | }
4689 | ],
4690 | "categories": [
4691 | {
4692 | "measurements": [
4693 | {
4694 | "groupId": "OG000",
4695 | "value": "2.324",
4696 | "spread": "36.626"
4697 | },
4698 | {
4699 | "groupId": "OG001",
4700 | "value": "-3.645",
4701 | "spread": "48.636"
4702 | }
4703 | ]
4704 | }
4705 | ]
4706 | },
4707 | {
4708 | "title": "Day 11",
4709 | "denoms": [
4710 | {
4711 | "units": "Participants",
4712 | "counts": [
4713 | {
4714 | "groupId": "OG000",
4715 | "value": "257"
4716 | },
4717 | {
4718 | "groupId": "OG001",
4719 | "value": "220"
4720 | }
4721 | ]
4722 | }
4723 | ],
4724 | "categories": [
4725 | {
4726 | "measurements": [
4727 | {
4728 | "groupId": "OG000",
4729 | "value": "0.383",
4730 | "spread": "0.744"
4731 | },
4732 | {
4733 | "groupId": "OG001",
4734 | "value": "-2.539",
4735 | "spread": "43.454"
4736 | }
4737 | ]
4738 | }
4739 | ]
4740 | },
4741 | {
4742 | "title": "Day 15",
4743 | "denoms": [
4744 | {
4745 | "units": "Participants",
4746 | "counts": [
4747 | {
4748 | "groupId": "OG000",
4749 | "value": "241"
4750 | },
4751 | {
4752 | "groupId": "OG001",
4753 | "value": "253"
4754 | }
4755 | ]
4756 | }
4757 | ],
4758 | "categories": [
4759 | {
4760 | "measurements": [
4761 | {
4762 | "groupId": "OG000",
4763 | "value": "6.475",
4764 | "spread": "69.019"
4765 | },
4766 | {
4767 | "groupId": "OG001",
4768 | "value": "-8.738",
4769 | "spread": "74.365"
4770 | }
4771 | ]
4772 | }
4773 | ]
4774 | },
4775 | {
4776 | "title": "Day 29",
4777 | "denoms": [
4778 | {
4779 | "units": "Participants",
4780 | "counts": [
4781 | {
4782 | "groupId": "OG000",
4783 | "value": "177"
4784 | },
4785 | {
4786 | "groupId": "OG001",
4787 | "value": "218"
4788 | }
4789 | ]
4790 | }
4791 | ],
4792 | "categories": [
4793 | {
4794 | "measurements": [
4795 | {
4796 | "groupId": "OG000",
4797 | "value": "0.125",
4798 | "spread": "0.485"
4799 | },
4800 | {
4801 | "groupId": "OG001",
4802 | "value": "0.117",
4803 | "spread": "0.340"
4804 | }
4805 | ]
4806 | }
4807 | ]
4808 | }
4809 | ]
4810 | },
4811 | {
4812 | "type": "SECONDARY",
4813 | "title": "Change From Baseline in Basophils",
4814 | "description": "Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
4815 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
4816 | "reportingStatus": "POSTED",
4817 | "paramType": "MEAN",
4818 | "dispersionType": "Standard Deviation",
4819 | "unitOfMeasure": "10^9 cells/liter",
4820 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
4821 | "groups": [
4822 | {
4823 | "id": "OG000",
4824 | "title": "Placebo",
4825 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
4826 | },
4827 | {
4828 | "id": "OG001",
4829 | "title": "Remdesivir",
4830 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
4831 | }
4832 | ],
4833 | "denoms": [
4834 | {
4835 | "units": "Participants",
4836 | "counts": [
4837 | {
4838 | "groupId": "OG000",
4839 | "value": "455"
4840 | },
4841 | {
4842 | "groupId": "OG001",
4843 | "value": "452"
4844 | }
4845 | ]
4846 | }
4847 | ],
4848 | "classes": [
4849 | {
4850 | "title": "Day 3",
4851 | "denoms": [
4852 | {
4853 | "units": "Participants",
4854 | "counts": [
4855 | {
4856 | "groupId": "OG000",
4857 | "value": "455"
4858 | },
4859 | {
4860 | "groupId": "OG001",
4861 | "value": "452"
4862 | }
4863 | ]
4864 | }
4865 | ],
4866 | "categories": [
4867 | {
4868 | "measurements": [
4869 | {
4870 | "groupId": "OG000",
4871 | "value": "0.020",
4872 | "spread": "0.257"
4873 | },
4874 | {
4875 | "groupId": "OG001",
4876 | "value": "0.005",
4877 | "spread": "0.043"
4878 | }
4879 | ]
4880 | }
4881 | ]
4882 | },
4883 | {
4884 | "title": "Day 5",
4885 | "denoms": [
4886 | {
4887 | "units": "Participants",
4888 | "counts": [
4889 | {
4890 | "groupId": "OG000",
4891 | "value": "394"
4892 | },
4893 | {
4894 | "groupId": "OG001",
4895 | "value": "380"
4896 | }
4897 | ]
4898 | }
4899 | ],
4900 | "categories": [
4901 | {
4902 | "measurements": [
4903 | {
4904 | "groupId": "OG000",
4905 | "value": "0.038",
4906 | "spread": "0.501"
4907 | },
4908 | {
4909 | "groupId": "OG001",
4910 | "value": "0.005",
4911 | "spread": "0.370"
4912 | }
4913 | ]
4914 | }
4915 | ]
4916 | },
4917 | {
4918 | "title": "Day 8",
4919 | "denoms": [
4920 | {
4921 | "units": "Participants",
4922 | "counts": [
4923 | {
4924 | "groupId": "OG000",
4925 | "value": "309"
4926 | },
4927 | {
4928 | "groupId": "OG001",
4929 | "value": "293"
4930 | }
4931 | ]
4932 | }
4933 | ],
4934 | "categories": [
4935 | {
4936 | "measurements": [
4937 | {
4938 | "groupId": "OG000",
4939 | "value": "0.196",
4940 | "spread": "3.132"
4941 | },
4942 | {
4943 | "groupId": "OG001",
4944 | "value": "0.005",
4945 | "spread": "0.368"
4946 | }
4947 | ]
4948 | }
4949 | ]
4950 | },
4951 | {
4952 | "title": "Day 11",
4953 | "denoms": [
4954 | {
4955 | "units": "Participants",
4956 | "counts": [
4957 | {
4958 | "groupId": "OG000",
4959 | "value": "253"
4960 | },
4961 | {
4962 | "groupId": "OG001",
4963 | "value": "218"
4964 | }
4965 | ]
4966 | }
4967 | ],
4968 | "categories": [
4969 | {
4970 | "measurements": [
4971 | {
4972 | "groupId": "OG000",
4973 | "value": "0.024",
4974 | "spread": "0.042"
4975 | },
4976 | {
4977 | "groupId": "OG001",
4978 | "value": "0.028",
4979 | "spread": "0.053"
4980 | }
4981 | ]
4982 | }
4983 | ]
4984 | },
4985 | {
4986 | "title": "Day 15",
4987 | "denoms": [
4988 | {
4989 | "units": "Participants",
4990 | "counts": [
4991 | {
4992 | "groupId": "OG000",
4993 | "value": "235"
4994 | },
4995 | {
4996 | "groupId": "OG001",
4997 | "value": "248"
4998 | }
4999 | ]
5000 | }
5001 | ],
5002 | "categories": [
5003 | {
5004 | "measurements": [
5005 | {
5006 | "groupId": "OG000",
5007 | "value": "0.158",
5008 | "spread": "1.913"
5009 | },
5010 | {
5011 | "groupId": "OG001",
5012 | "value": "-0.058",
5013 | "spread": "1.028"
5014 | }
5015 | ]
5016 | }
5017 | ]
5018 | },
5019 | {
5020 | "title": "Day 29",
5021 | "denoms": [
5022 | {
5023 | "units": "Participants",
5024 | "counts": [
5025 | {
5026 | "groupId": "OG000",
5027 | "value": "176"
5028 | },
5029 | {
5030 | "groupId": "OG001",
5031 | "value": "216"
5032 | }
5033 | ]
5034 | }
5035 | ],
5036 | "categories": [
5037 | {
5038 | "measurements": [
5039 | {
5040 | "groupId": "OG000",
5041 | "value": "0.040",
5042 | "spread": "0.073"
5043 | },
5044 | {
5045 | "groupId": "OG001",
5046 | "value": "0.029",
5047 | "spread": "0.054"
5048 | }
5049 | ]
5050 | }
5051 | ]
5052 | }
5053 | ]
5054 | },
5055 | {
5056 | "type": "SECONDARY",
5057 | "title": "Change From Baseline in Eosinophils",
5058 | "description": "Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.",
5059 | "populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
5060 | "reportingStatus": "POSTED",
5061 | "paramType": "MEAN",
5062 | "dispersionType": "Standard Deviation",
5063 | "unitOfMeasure": "10^9 cells/liter",
5064 | "timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29",
5065 | "groups": [
5066 | {
5067 | "id": "OG000",
5068 | "title": "Placebo",
5069 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
5070 | },
5071 | {
5072 | "id": "OG001",
5073 | "title": "Remdesivir",
5074 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
5075 | }
5076 | ],
5077 | "denoms": [
5078 | {
5079 | "units": "Participants",
5080 | "counts": [
5081 | {
5082 | "groupId": "OG000",
5083 | "value": "456"
5084 | },
5085 | {
5086 | "groupId": "OG001",
5087 | "value": "455"
5088 | }
5089 | ]
5090 | }
5091 | ],
5092 | "classes": [
5093 | {
5094 | "title": "Day 3",
5095 | "denoms": [
5096 | {
5097 | "units": "Participants",
5098 | "counts": [
5099 | {
5100 | "groupId": "OG000",
5101 | "value": "456"
5102 | },
5103 | {
5104 | "groupId": "OG001",
5105 | "value": "455"
5106 | }
5107 | ]
5108 | }
5109 | ],
5110 | "categories": [
5111 | {
5112 | "measurements": [
5113 | {
5114 | "groupId": "OG000",
5115 | "value": "0.634",
5116 | "spread": "10.614"
5117 | },
5118 | {
5119 | "groupId": "OG001",
5120 | "value": "0.016",
5121 | "spread": "0.727"
5122 | }
5123 | ]
5124 | }
5125 | ]
5126 | },
5127 | {
5128 | "title": "Day 5",
5129 | "denoms": [
5130 | {
5131 | "units": "Participants",
5132 | "counts": [
5133 | {
5134 | "groupId": "OG000",
5135 | "value": "397"
5136 | },
5137 | {
5138 | "groupId": "OG001",
5139 | "value": "387"
5140 | }
5141 | ]
5142 | }
5143 | ],
5144 | "categories": [
5145 | {
5146 | "measurements": [
5147 | {
5148 | "groupId": "OG000",
5149 | "value": "0.666",
5150 | "spread": "11.977"
5151 | },
5152 | {
5153 | "groupId": "OG001",
5154 | "value": "-0.066",
5155 | "spread": "2.807"
5156 | }
5157 | ]
5158 | }
5159 | ]
5160 | },
5161 | {
5162 | "title": "Day 8",
5163 | "denoms": [
5164 | {
5165 | "units": "Participants",
5166 | "counts": [
5167 | {
5168 | "groupId": "OG000",
5169 | "value": "311"
5170 | },
5171 | {
5172 | "groupId": "OG001",
5173 | "value": "293"
5174 | }
5175 | ]
5176 | }
5177 | ],
5178 | "categories": [
5179 | {
5180 | "measurements": [
5181 | {
5182 | "groupId": "OG000",
5183 | "value": "0.596",
5184 | "spread": "8.875"
5185 | },
5186 | {
5187 | "groupId": "OG001",
5188 | "value": "-0.221",
5189 | "spread": "4.108"
5190 | }
5191 | ]
5192 | }
5193 | ]
5194 | },
5195 | {
5196 | "title": "Day 11",
5197 | "denoms": [
5198 | {
5199 | "units": "Participants",
5200 | "counts": [
5201 | {
5202 | "groupId": "OG000",
5203 | "value": "254"
5204 | },
5205 | {
5206 | "groupId": "OG001",
5207 | "value": "218"
5208 | }
5209 | ]
5210 | }
5211 | ],
5212 | "categories": [
5213 | {
5214 | "measurements": [
5215 | {
5216 | "groupId": "OG000",
5217 | "value": "0.093",
5218 | "spread": "0.190"
5219 | },
5220 | {
5221 | "groupId": "OG001",
5222 | "value": "-0.088",
5223 | "spread": "2.973"
5224 | }
5225 | ]
5226 | }
5227 | ]
5228 | },
5229 | {
5230 | "title": "Day 15",
5231 | "denoms": [
5232 | {
5233 | "units": "Participants",
5234 | "counts": [
5235 | {
5236 | "groupId": "OG000",
5237 | "value": "237"
5238 | },
5239 | {
5240 | "groupId": "OG001",
5241 | "value": "251"
5242 | }
5243 | ]
5244 | }
5245 | ],
5246 | "categories": [
5247 | {
5248 | "measurements": [
5249 | {
5250 | "groupId": "OG000",
5251 | "value": "1.992",
5252 | "spread": "20.365"
5253 | },
5254 | {
5255 | "groupId": "OG001",
5256 | "value": "-0.420",
5257 | "spread": "5.378"
5258 | }
5259 | ]
5260 | }
5261 | ]
5262 | },
5263 | {
5264 | "title": "Day 29",
5265 | "denoms": [
5266 | {
5267 | "units": "Participants",
5268 | "counts": [
5269 | {
5270 | "groupId": "OG000",
5271 | "value": "176"
5272 | },
5273 | {
5274 | "groupId": "OG001",
5275 | "value": "217"
5276 | }
5277 | ]
5278 | }
5279 | ],
5280 | "categories": [
5281 | {
5282 | "measurements": [
5283 | {
5284 | "groupId": "OG000",
5285 | "value": "0.241",
5286 | "spread": "0.324"
5287 | },
5288 | {
5289 | "groupId": "OG001",
5290 | "value": "0.211",
5291 | "spread": "0.267"
5292 | }
5293 | ]
5294 | }
5295 | ]
5296 | }
5297 | ]
5298 | },
5299 | {
5300 | "type": "SECONDARY",
5301 | "title": "Change in National Early Warning Score (NEWS) From Baseline",
5302 | "description": "The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.",
5303 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint.",
5304 | "reportingStatus": "POSTED",
5305 | "paramType": "MEAN",
5306 | "dispersionType": "Standard Deviation",
5307 | "unitOfMeasure": "units on a scale",
5308 | "timeFrame": "Days 1, 3, 5, 8, 11, 15, 22, and 29",
5309 | "groups": [
5310 | {
5311 | "id": "OG000",
5312 | "title": "Placebo",
5313 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
5314 | },
5315 | {
5316 | "id": "OG001",
5317 | "title": "Remdesivir",
5318 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
5319 | }
5320 | ],
5321 | "denoms": [
5322 | {
5323 | "units": "Participants",
5324 | "counts": [
5325 | {
5326 | "groupId": "OG000",
5327 | "value": "499"
5328 | },
5329 | {
5330 | "groupId": "OG001",
5331 | "value": "502"
5332 | }
5333 | ]
5334 | }
5335 | ],
5336 | "classes": [
5337 | {
5338 | "title": "Day 3",
5339 | "denoms": [
5340 | {
5341 | "units": "Participants",
5342 | "counts": [
5343 | {
5344 | "groupId": "OG000",
5345 | "value": "499"
5346 | },
5347 | {
5348 | "groupId": "OG001",
5349 | "value": "502"
5350 | }
5351 | ]
5352 | }
5353 | ],
5354 | "categories": [
5355 | {
5356 | "measurements": [
5357 | {
5358 | "groupId": "OG000",
5359 | "value": "0.1",
5360 | "spread": "2.8"
5361 | },
5362 | {
5363 | "groupId": "OG001",
5364 | "value": "-0.3",
5365 | "spread": "2.6"
5366 | }
5367 | ]
5368 | }
5369 | ]
5370 | },
5371 | {
5372 | "title": "Day 5",
5373 | "denoms": [
5374 | {
5375 | "units": "Participants",
5376 | "counts": [
5377 | {
5378 | "groupId": "OG000",
5379 | "value": "447"
5380 | },
5381 | {
5382 | "groupId": "OG001",
5383 | "value": "438"
5384 | }
5385 | ]
5386 | }
5387 | ],
5388 | "categories": [
5389 | {
5390 | "measurements": [
5391 | {
5392 | "groupId": "OG000",
5393 | "value": "0.3",
5394 | "spread": "3.3"
5395 | },
5396 | {
5397 | "groupId": "OG001",
5398 | "value": "-0.4",
5399 | "spread": "2.9"
5400 | }
5401 | ]
5402 | }
5403 | ]
5404 | },
5405 | {
5406 | "title": "Day 8",
5407 | "denoms": [
5408 | {
5409 | "units": "Participants",
5410 | "counts": [
5411 | {
5412 | "groupId": "OG000",
5413 | "value": "348"
5414 | },
5415 | {
5416 | "groupId": "OG001",
5417 | "value": "321"
5418 | }
5419 | ]
5420 | }
5421 | ],
5422 | "categories": [
5423 | {
5424 | "measurements": [
5425 | {
5426 | "groupId": "OG000",
5427 | "value": "-0.3",
5428 | "spread": "3.8"
5429 | },
5430 | {
5431 | "groupId": "OG001",
5432 | "value": "-0.5",
5433 | "spread": "3.2"
5434 | }
5435 | ]
5436 | }
5437 | ]
5438 | },
5439 | {
5440 | "title": "Day 11",
5441 | "denoms": [
5442 | {
5443 | "units": "Participants",
5444 | "counts": [
5445 | {
5446 | "groupId": "OG000",
5447 | "value": "291"
5448 | },
5449 | {
5450 | "groupId": "OG001",
5451 | "value": "254"
5452 | }
5453 | ]
5454 | }
5455 | ],
5456 | "categories": [
5457 | {
5458 | "measurements": [
5459 | {
5460 | "groupId": "OG000",
5461 | "value": "-0.3",
5462 | "spread": "4.1"
5463 | },
5464 | {
5465 | "groupId": "OG001",
5466 | "value": "-0.5",
5467 | "spread": "3.5"
5468 | }
5469 | ]
5470 | }
5471 | ]
5472 | },
5473 | {
5474 | "title": "Day 15",
5475 | "denoms": [
5476 | {
5477 | "units": "Participants",
5478 | "counts": [
5479 | {
5480 | "groupId": "OG000",
5481 | "value": "290"
5482 | },
5483 | {
5484 | "groupId": "OG001",
5485 | "value": "301"
5486 | }
5487 | ]
5488 | }
5489 | ],
5490 | "categories": [
5491 | {
5492 | "measurements": [
5493 | {
5494 | "groupId": "OG000",
5495 | "value": "-1.4",
5496 | "spread": "4.2"
5497 | },
5498 | {
5499 | "groupId": "OG001",
5500 | "value": "-1.7",
5501 | "spread": "3.6"
5502 | }
5503 | ]
5504 | }
5505 | ]
5506 | },
5507 | {
5508 | "title": "Day 22",
5509 | "denoms": [
5510 | {
5511 | "units": "Participants",
5512 | "counts": [
5513 | {
5514 | "groupId": "OG000",
5515 | "value": "151"
5516 | },
5517 | {
5518 | "groupId": "OG001",
5519 | "value": "120"
5520 | }
5521 | ]
5522 | }
5523 | ],
5524 | "categories": [
5525 | {
5526 | "measurements": [
5527 | {
5528 | "groupId": "OG000",
5529 | "value": "-1.4",
5530 | "spread": "4.0"
5531 | },
5532 | {
5533 | "groupId": "OG001",
5534 | "value": "-1.7",
5535 | "spread": "4.1"
5536 | }
5537 | ]
5538 | }
5539 | ]
5540 | },
5541 | {
5542 | "title": "Day 29",
5543 | "denoms": [
5544 | {
5545 | "units": "Participants",
5546 | "counts": [
5547 | {
5548 | "groupId": "OG000",
5549 | "value": "221"
5550 | },
5551 | {
5552 | "groupId": "OG001",
5553 | "value": "251"
5554 | }
5555 | ]
5556 | }
5557 | ],
5558 | "categories": [
5559 | {
5560 | "measurements": [
5561 | {
5562 | "groupId": "OG000",
5563 | "value": "-3.2",
5564 | "spread": "4.0"
5565 | },
5566 | {
5567 | "groupId": "OG001",
5568 | "value": "-3.3",
5569 | "spread": "3.2"
5570 | }
5571 | ]
5572 | }
5573 | ]
5574 | }
5575 | ]
5576 | },
5577 | {
5578 | "type": "SECONDARY",
5579 | "title": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1",
5580 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
5581 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
5582 | "reportingStatus": "POSTED",
5583 | "paramType": "NUMBER",
5584 | "dispersionType": "95% Confidence Interval",
5585 | "unitOfMeasure": "percentage of participants",
5586 | "timeFrame": "Day 1",
5587 | "groups": [
5588 | {
5589 | "id": "OG000",
5590 | "title": "Placebo",
5591 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
5592 | },
5593 | {
5594 | "id": "OG001",
5595 | "title": "Remdesivir",
5596 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
5597 | }
5598 | ],
5599 | "denoms": [
5600 | {
5601 | "units": "Participants",
5602 | "counts": [
5603 | {
5604 | "groupId": "OG000",
5605 | "value": "521"
5606 | },
5607 | {
5608 | "groupId": "OG001",
5609 | "value": "541"
5610 | }
5611 | ]
5612 | }
5613 | ],
5614 | "classes": [
5615 | {
5616 | "title": "Death at or before study Visit",
5617 | "categories": [
5618 | {
5619 | "measurements": [
5620 | {
5621 | "groupId": "OG000",
5622 | "value": "0",
5623 | "lowerLimit": "0",
5624 | "upperLimit": "1"
5625 | },
5626 | {
5627 | "groupId": "OG001",
5628 | "value": "0",
5629 | "lowerLimit": "0",
5630 | "upperLimit": "1"
5631 | }
5632 | ]
5633 | }
5634 | ]
5635 | },
5636 | {
5637 | "title": "Hospitalized, on invasive mech. vent. or ECMO",
5638 | "categories": [
5639 | {
5640 | "measurements": [
5641 | {
5642 | "groupId": "OG000",
5643 | "value": "30",
5644 | "lowerLimit": "26",
5645 | "upperLimit": "34"
5646 | },
5647 | {
5648 | "groupId": "OG001",
5649 | "value": "24",
5650 | "lowerLimit": "21",
5651 | "upperLimit": "28"
5652 | }
5653 | ]
5654 | }
5655 | ]
5656 | },
5657 | {
5658 | "title": "Hospitalized, on non-invasive vent./high flow O2",
5659 | "categories": [
5660 | {
5661 | "measurements": [
5662 | {
5663 | "groupId": "OG000",
5664 | "value": "19",
5665 | "lowerLimit": "16",
5666 | "upperLimit": "22"
5667 | },
5668 | {
5669 | "groupId": "OG001",
5670 | "value": "18",
5671 | "lowerLimit": "15",
5672 | "upperLimit": "21"
5673 | }
5674 | ]
5675 | }
5676 | ]
5677 | },
5678 | {
5679 | "title": "Hospitalized, requiring supplemental oxygen",
5680 | "categories": [
5681 | {
5682 | "measurements": [
5683 | {
5684 | "groupId": "OG000",
5685 | "value": "39",
5686 | "lowerLimit": "35",
5687 | "upperLimit": "43"
5688 | },
5689 | {
5690 | "groupId": "OG001",
5691 | "value": "43",
5692 | "lowerLimit": "39",
5693 | "upperLimit": "47"
5694 | }
5695 | ]
5696 | }
5697 | ]
5698 | },
5699 | {
5700 | "title": "Hospitalized, not on O2, requiring ongoing care",
5701 | "categories": [
5702 | {
5703 | "measurements": [
5704 | {
5705 | "groupId": "OG000",
5706 | "value": "12",
5707 | "lowerLimit": "10",
5708 | "upperLimit": "15"
5709 | },
5710 | {
5711 | "groupId": "OG001",
5712 | "value": "14",
5713 | "lowerLimit": "11",
5714 | "upperLimit": "17"
5715 | }
5716 | ]
5717 | }
5718 | ]
5719 | },
5720 | {
5721 | "title": "Hospitalized, not requiring O2, no longer req care",
5722 | "categories": [
5723 | {
5724 | "measurements": [
5725 | {
5726 | "groupId": "OG000",
5727 | "value": "0",
5728 | "lowerLimit": "0",
5729 | "upperLimit": "1"
5730 | },
5731 | {
5732 | "groupId": "OG001",
5733 | "value": "0",
5734 | "lowerLimit": "0",
5735 | "upperLimit": "1"
5736 | }
5737 | ]
5738 | }
5739 | ]
5740 | },
5741 | {
5742 | "title": "Not hospitalized, limit on activities/req home O2",
5743 | "categories": [
5744 | {
5745 | "measurements": [
5746 | {
5747 | "groupId": "OG000",
5748 | "value": "0",
5749 | "lowerLimit": "0",
5750 | "upperLimit": "1"
5751 | },
5752 | {
5753 | "groupId": "OG001",
5754 | "value": "0",
5755 | "lowerLimit": "0",
5756 | "upperLimit": "1"
5757 | }
5758 | ]
5759 | }
5760 | ]
5761 | },
5762 | {
5763 | "title": "Not hospitalized, no limitations on activities",
5764 | "categories": [
5765 | {
5766 | "measurements": [
5767 | {
5768 | "groupId": "OG000",
5769 | "value": "0",
5770 | "lowerLimit": "0",
5771 | "upperLimit": "1"
5772 | },
5773 | {
5774 | "groupId": "OG001",
5775 | "value": "0",
5776 | "lowerLimit": "0",
5777 | "upperLimit": "1"
5778 | }
5779 | ]
5780 | }
5781 | ]
5782 | },
5783 | {
5784 | "title": "No clinical status score reported - Hospitalized",
5785 | "categories": [
5786 | {
5787 | "measurements": [
5788 | {
5789 | "groupId": "OG000",
5790 | "value": "0",
5791 | "lowerLimit": "0",
5792 | "upperLimit": "1"
5793 | },
5794 | {
5795 | "groupId": "OG001",
5796 | "value": "1",
5797 | "lowerLimit": "0",
5798 | "upperLimit": "2"
5799 | }
5800 | ]
5801 | }
5802 | ]
5803 | },
5804 | {
5805 | "title": "No clinical status score reported - Discharged",
5806 | "categories": [
5807 | {
5808 | "measurements": [
5809 | {
5810 | "groupId": "OG000",
5811 | "value": "0",
5812 | "lowerLimit": "0",
5813 | "upperLimit": "1"
5814 | },
5815 | {
5816 | "groupId": "OG001",
5817 | "value": "0",
5818 | "lowerLimit": "0",
5819 | "upperLimit": "1"
5820 | }
5821 | ]
5822 | }
5823 | ]
5824 | },
5825 | {
5826 | "title": "No clinical status score reported - Discontinued",
5827 | "categories": [
5828 | {
5829 | "measurements": [
5830 | {
5831 | "groupId": "OG000",
5832 | "value": "1",
5833 | "lowerLimit": "0",
5834 | "upperLimit": "2"
5835 | },
5836 | {
5837 | "groupId": "OG001",
5838 | "value": "1",
5839 | "lowerLimit": "0",
5840 | "upperLimit": "2"
5841 | }
5842 | ]
5843 | }
5844 | ]
5845 | }
5846 | ]
5847 | },
5848 | {
5849 | "type": "SECONDARY",
5850 | "title": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3",
5851 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
5852 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
5853 | "reportingStatus": "POSTED",
5854 | "paramType": "NUMBER",
5855 | "dispersionType": "95% Confidence Interval",
5856 | "unitOfMeasure": "percentage of participants",
5857 | "timeFrame": "Day 3",
5858 | "groups": [
5859 | {
5860 | "id": "OG000",
5861 | "title": "Placebo",
5862 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
5863 | },
5864 | {
5865 | "id": "OG001",
5866 | "title": "Remdesivir",
5867 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
5868 | }
5869 | ],
5870 | "denoms": [
5871 | {
5872 | "units": "Participants",
5873 | "counts": [
5874 | {
5875 | "groupId": "OG000",
5876 | "value": "521"
5877 | },
5878 | {
5879 | "groupId": "OG001",
5880 | "value": "541"
5881 | }
5882 | ]
5883 | }
5884 | ],
5885 | "classes": [
5886 | {
5887 | "title": "Death at or before study Visit",
5888 | "categories": [
5889 | {
5890 | "measurements": [
5891 | {
5892 | "groupId": "OG000",
5893 | "value": "1",
5894 | "lowerLimit": "1",
5895 | "upperLimit": "3"
5896 | },
5897 | {
5898 | "groupId": "OG001",
5899 | "value": "1",
5900 | "lowerLimit": "0",
5901 | "upperLimit": "2"
5902 | }
5903 | ]
5904 | }
5905 | ]
5906 | },
5907 | {
5908 | "title": "Hospitalized, on invasive mech. vent. or ECMO",
5909 | "categories": [
5910 | {
5911 | "measurements": [
5912 | {
5913 | "groupId": "OG000",
5914 | "value": "36",
5915 | "lowerLimit": "32",
5916 | "upperLimit": "40"
5917 | },
5918 | {
5919 | "groupId": "OG001",
5920 | "value": "28",
5921 | "lowerLimit": "25",
5922 | "upperLimit": "32"
5923 | }
5924 | ]
5925 | }
5926 | ]
5927 | },
5928 | {
5929 | "title": "Hospitalized, on non-invasive vent./high flow O2",
5930 | "categories": [
5931 | {
5932 | "measurements": [
5933 | {
5934 | "groupId": "OG000",
5935 | "value": "17",
5936 | "lowerLimit": "14",
5937 | "upperLimit": "21"
5938 | },
5939 | {
5940 | "groupId": "OG001",
5941 | "value": "16",
5942 | "lowerLimit": "13",
5943 | "upperLimit": "19"
5944 | }
5945 | ]
5946 | }
5947 | ]
5948 | },
5949 | {
5950 | "title": "Hospitalized, requiring supplemental oxygen",
5951 | "categories": [
5952 | {
5953 | "measurements": [
5954 | {
5955 | "groupId": "OG000",
5956 | "value": "32",
5957 | "lowerLimit": "29",
5958 | "upperLimit": "37"
5959 | },
5960 | {
5961 | "groupId": "OG001",
5962 | "value": "37",
5963 | "lowerLimit": "33",
5964 | "upperLimit": "41"
5965 | }
5966 | ]
5967 | }
5968 | ]
5969 | },
5970 | {
5971 | "title": "Hospitalized, not on O2, requiring ongoing care",
5972 | "categories": [
5973 | {
5974 | "measurements": [
5975 | {
5976 | "groupId": "OG000",
5977 | "value": "12",
5978 | "lowerLimit": "9",
5979 | "upperLimit": "15"
5980 | },
5981 | {
5982 | "groupId": "OG001",
5983 | "value": "13",
5984 | "lowerLimit": "10",
5985 | "upperLimit": "16"
5986 | }
5987 | ]
5988 | }
5989 | ]
5990 | },
5991 | {
5992 | "title": "Hospitalized, not requiring O2, no longer req care",
5993 | "categories": [
5994 | {
5995 | "measurements": [
5996 | {
5997 | "groupId": "OG000",
5998 | "value": "0.4",
5999 | "lowerLimit": "0",
6000 | "upperLimit": "1"
6001 | },
6002 | {
6003 | "groupId": "OG001",
6004 | "value": "0.2",
6005 | "lowerLimit": "0",
6006 | "upperLimit": "1"
6007 | }
6008 | ]
6009 | }
6010 | ]
6011 | },
6012 | {
6013 | "title": "Not hospitalized, limit on activities/req home O2",
6014 | "categories": [
6015 | {
6016 | "measurements": [
6017 | {
6018 | "groupId": "OG000",
6019 | "value": "0",
6020 | "lowerLimit": "0",
6021 | "upperLimit": "1"
6022 | },
6023 | {
6024 | "groupId": "OG001",
6025 | "value": "0",
6026 | "lowerLimit": "0",
6027 | "upperLimit": "1"
6028 | }
6029 | ]
6030 | }
6031 | ]
6032 | },
6033 | {
6034 | "title": "Not hospitalized, no limitations on activities",
6035 | "categories": [
6036 | {
6037 | "measurements": [
6038 | {
6039 | "groupId": "OG000",
6040 | "value": "0",
6041 | "lowerLimit": "0",
6042 | "upperLimit": "1"
6043 | },
6044 | {
6045 | "groupId": "OG001",
6046 | "value": "0.4",
6047 | "lowerLimit": "0",
6048 | "upperLimit": "1"
6049 | }
6050 | ]
6051 | }
6052 | ]
6053 | },
6054 | {
6055 | "title": "No clinical status score reported - Hospitalized",
6056 | "categories": [
6057 | {
6058 | "measurements": [
6059 | {
6060 | "groupId": "OG000",
6061 | "value": "0",
6062 | "lowerLimit": "0",
6063 | "upperLimit": "1"
6064 | },
6065 | {
6066 | "groupId": "OG001",
6067 | "value": "0",
6068 | "lowerLimit": "0",
6069 | "upperLimit": "1"
6070 | }
6071 | ]
6072 | }
6073 | ]
6074 | },
6075 | {
6076 | "title": "No clinical status score reported - Discharged",
6077 | "categories": [
6078 | {
6079 | "measurements": [
6080 | {
6081 | "groupId": "OG000",
6082 | "value": "0.2",
6083 | "lowerLimit": "0",
6084 | "upperLimit": "1"
6085 | },
6086 | {
6087 | "groupId": "OG001",
6088 | "value": "2",
6089 | "lowerLimit": "1",
6090 | "upperLimit": "4"
6091 | }
6092 | ]
6093 | }
6094 | ]
6095 | },
6096 | {
6097 | "title": "No clinical status score reported - Discontinued",
6098 | "categories": [
6099 | {
6100 | "measurements": [
6101 | {
6102 | "groupId": "OG000",
6103 | "value": "1",
6104 | "lowerLimit": "0",
6105 | "upperLimit": "2"
6106 | },
6107 | {
6108 | "groupId": "OG001",
6109 | "value": "2",
6110 | "lowerLimit": "1",
6111 | "upperLimit": "4"
6112 | }
6113 | ]
6114 | }
6115 | ]
6116 | }
6117 | ]
6118 | },
6119 | {
6120 | "type": "SECONDARY",
6121 | "title": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5",
6122 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
6123 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
6124 | "reportingStatus": "POSTED",
6125 | "paramType": "NUMBER",
6126 | "dispersionType": "95% Confidence Interval",
6127 | "unitOfMeasure": "percentage of participants",
6128 | "timeFrame": "Day 5",
6129 | "groups": [
6130 | {
6131 | "id": "OG000",
6132 | "title": "Placebo",
6133 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
6134 | },
6135 | {
6136 | "id": "OG001",
6137 | "title": "Remdesivir",
6138 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
6139 | }
6140 | ],
6141 | "denoms": [
6142 | {
6143 | "units": "Participants",
6144 | "counts": [
6145 | {
6146 | "groupId": "OG000",
6147 | "value": "521"
6148 | },
6149 | {
6150 | "groupId": "OG001",
6151 | "value": "541"
6152 | }
6153 | ]
6154 | }
6155 | ],
6156 | "classes": [
6157 | {
6158 | "title": "Death at or before study Visit",
6159 | "categories": [
6160 | {
6161 | "measurements": [
6162 | {
6163 | "groupId": "OG000",
6164 | "value": "2",
6165 | "lowerLimit": "1",
6166 | "upperLimit": "4"
6167 | },
6168 | {
6169 | "groupId": "OG001",
6170 | "value": "2",
6171 | "lowerLimit": "1",
6172 | "upperLimit": "4"
6173 | }
6174 | ]
6175 | }
6176 | ]
6177 | },
6178 | {
6179 | "title": "Hospitalized, on invasive mech. vent. or ECMO",
6180 | "categories": [
6181 | {
6182 | "measurements": [
6183 | {
6184 | "groupId": "OG000",
6185 | "value": "37",
6186 | "lowerLimit": "33",
6187 | "upperLimit": "41"
6188 | },
6189 | {
6190 | "groupId": "OG001",
6191 | "value": "28",
6192 | "lowerLimit": "24",
6193 | "upperLimit": "32"
6194 | }
6195 | ]
6196 | }
6197 | ]
6198 | },
6199 | {
6200 | "title": "Hospitalized, on non-invasive vent./high flow O2",
6201 | "categories": [
6202 | {
6203 | "measurements": [
6204 | {
6205 | "groupId": "OG000",
6206 | "value": "14",
6207 | "lowerLimit": "12",
6208 | "upperLimit": "18"
6209 | },
6210 | {
6211 | "groupId": "OG001",
6212 | "value": "12",
6213 | "lowerLimit": "9",
6214 | "upperLimit": "15"
6215 | }
6216 | ]
6217 | }
6218 | ]
6219 | },
6220 | {
6221 | "title": "Hospitalized, requiring supplemental oxygen",
6222 | "categories": [
6223 | {
6224 | "measurements": [
6225 | {
6226 | "groupId": "OG000",
6227 | "value": "26",
6228 | "lowerLimit": "23",
6229 | "upperLimit": "30"
6230 | },
6231 | {
6232 | "groupId": "OG001",
6233 | "value": "28",
6234 | "lowerLimit": "24",
6235 | "upperLimit": "31"
6236 | }
6237 | ]
6238 | }
6239 | ]
6240 | },
6241 | {
6242 | "title": "Hospitalized, not on O2, requiring ongoing care",
6243 | "categories": [
6244 | {
6245 | "measurements": [
6246 | {
6247 | "groupId": "OG000",
6248 | "value": "11",
6249 | "lowerLimit": "8",
6250 | "upperLimit": "13"
6251 | },
6252 | {
6253 | "groupId": "OG001",
6254 | "value": "15",
6255 | "lowerLimit": "12",
6256 | "upperLimit": "18"
6257 | }
6258 | ]
6259 | }
6260 | ]
6261 | },
6262 | {
6263 | "title": "Hospitalized, not requiring O2, no longer req care",
6264 | "categories": [
6265 | {
6266 | "measurements": [
6267 | {
6268 | "groupId": "OG000",
6269 | "value": "1",
6270 | "lowerLimit": "0",
6271 | "upperLimit": "2"
6272 | },
6273 | {
6274 | "groupId": "OG001",
6275 | "value": "1",
6276 | "lowerLimit": "0",
6277 | "upperLimit": "2"
6278 | }
6279 | ]
6280 | }
6281 | ]
6282 | },
6283 | {
6284 | "title": "Not hospitalized, limit on activities/req home O2",
6285 | "categories": [
6286 | {
6287 | "measurements": [
6288 | {
6289 | "groupId": "OG000",
6290 | "value": "0",
6291 | "lowerLimit": "0",
6292 | "upperLimit": "1"
6293 | },
6294 | {
6295 | "groupId": "OG001",
6296 | "value": "0.2",
6297 | "lowerLimit": "0",
6298 | "upperLimit": "1"
6299 | }
6300 | ]
6301 | }
6302 | ]
6303 | },
6304 | {
6305 | "title": "Not hospitalized, no limitations on activities",
6306 | "categories": [
6307 | {
6308 | "measurements": [
6309 | {
6310 | "groupId": "OG000",
6311 | "value": "0.2",
6312 | "lowerLimit": "0",
6313 | "upperLimit": "1"
6314 | },
6315 | {
6316 | "groupId": "OG001",
6317 | "value": "0",
6318 | "lowerLimit": "0",
6319 | "upperLimit": "1"
6320 | }
6321 | ]
6322 | }
6323 | ]
6324 | },
6325 | {
6326 | "title": "No clinical status score reported - Hospitalized",
6327 | "categories": [
6328 | {
6329 | "measurements": [
6330 | {
6331 | "groupId": "OG000",
6332 | "value": "0",
6333 | "lowerLimit": "0",
6334 | "upperLimit": "1"
6335 | },
6336 | {
6337 | "groupId": "OG001",
6338 | "value": "0",
6339 | "lowerLimit": "0",
6340 | "upperLimit": "1"
6341 | }
6342 | ]
6343 | }
6344 | ]
6345 | },
6346 | {
6347 | "title": "No clinical status score reported - Discharged",
6348 | "categories": [
6349 | {
6350 | "measurements": [
6351 | {
6352 | "groupId": "OG000",
6353 | "value": "7",
6354 | "lowerLimit": "5",
6355 | "upperLimit": "9"
6356 | },
6357 | {
6358 | "groupId": "OG001",
6359 | "value": "12",
6360 | "lowerLimit": "9",
6361 | "upperLimit": "15"
6362 | }
6363 | ]
6364 | }
6365 | ]
6366 | },
6367 | {
6368 | "title": "No clinical status score reported - Discontinued",
6369 | "categories": [
6370 | {
6371 | "measurements": [
6372 | {
6373 | "groupId": "OG000",
6374 | "value": "2",
6375 | "lowerLimit": "1",
6376 | "upperLimit": "3"
6377 | },
6378 | {
6379 | "groupId": "OG001",
6380 | "value": "3",
6381 | "lowerLimit": "2",
6382 | "upperLimit": "5"
6383 | }
6384 | ]
6385 | }
6386 | ]
6387 | }
6388 | ]
6389 | },
6390 | {
6391 | "type": "SECONDARY",
6392 | "title": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8",
6393 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
6394 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
6395 | "reportingStatus": "POSTED",
6396 | "paramType": "NUMBER",
6397 | "dispersionType": "95% Confidence Interval",
6398 | "unitOfMeasure": "percentage of participants",
6399 | "timeFrame": "Day 8",
6400 | "groups": [
6401 | {
6402 | "id": "OG000",
6403 | "title": "Placebo",
6404 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
6405 | },
6406 | {
6407 | "id": "OG001",
6408 | "title": "Remdesivir",
6409 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
6410 | }
6411 | ],
6412 | "denoms": [
6413 | {
6414 | "units": "Participants",
6415 | "counts": [
6416 | {
6417 | "groupId": "OG000",
6418 | "value": "521"
6419 | },
6420 | {
6421 | "groupId": "OG001",
6422 | "value": "541"
6423 | }
6424 | ]
6425 | }
6426 | ],
6427 | "classes": [
6428 | {
6429 | "title": "Death at or before study Visit",
6430 | "categories": [
6431 | {
6432 | "measurements": [
6433 | {
6434 | "groupId": "OG000",
6435 | "value": "7",
6436 | "lowerLimit": "5",
6437 | "upperLimit": "9"
6438 | },
6439 | {
6440 | "groupId": "OG001",
6441 | "value": "3",
6442 | "lowerLimit": "2",
6443 | "upperLimit": "5"
6444 | }
6445 | ]
6446 | }
6447 | ]
6448 | },
6449 | {
6450 | "title": "Hospitalized, on invasive mech. vent. or ECMO",
6451 | "categories": [
6452 | {
6453 | "measurements": [
6454 | {
6455 | "groupId": "OG000",
6456 | "value": "33",
6457 | "lowerLimit": "29",
6458 | "upperLimit": "37"
6459 | },
6460 | {
6461 | "groupId": "OG001",
6462 | "value": "24",
6463 | "lowerLimit": "21",
6464 | "upperLimit": "28"
6465 | }
6466 | ]
6467 | }
6468 | ]
6469 | },
6470 | {
6471 | "title": "Hospitalized, on non-invasive vent./high flow O2",
6472 | "categories": [
6473 | {
6474 | "measurements": [
6475 | {
6476 | "groupId": "OG000",
6477 | "value": "9",
6478 | "lowerLimit": "7",
6479 | "upperLimit": "12"
6480 | },
6481 | {
6482 | "groupId": "OG001",
6483 | "value": "9",
6484 | "lowerLimit": "7",
6485 | "upperLimit": "12"
6486 | }
6487 | ]
6488 | }
6489 | ]
6490 | },
6491 | {
6492 | "title": "Hospitalized, requiring supplemental oxygen",
6493 | "categories": [
6494 | {
6495 | "measurements": [
6496 | {
6497 | "groupId": "OG000",
6498 | "value": "15",
6499 | "lowerLimit": "13",
6500 | "upperLimit": "19"
6501 | },
6502 | {
6503 | "groupId": "OG001",
6504 | "value": "17",
6505 | "lowerLimit": "14",
6506 | "upperLimit": "21"
6507 | }
6508 | ]
6509 | }
6510 | ]
6511 | },
6512 | {
6513 | "title": "Hospitalized, not on O2, requiring ongoing care",
6514 | "categories": [
6515 | {
6516 | "measurements": [
6517 | {
6518 | "groupId": "OG000",
6519 | "value": "10",
6520 | "lowerLimit": "8",
6521 | "upperLimit": "13"
6522 | },
6523 | {
6524 | "groupId": "OG001",
6525 | "value": "11",
6526 | "lowerLimit": "9",
6527 | "upperLimit": "14"
6528 | }
6529 | ]
6530 | }
6531 | ]
6532 | },
6533 | {
6534 | "title": "Hospitalized, not requiring O2, no longer req care",
6535 | "categories": [
6536 | {
6537 | "measurements": [
6538 | {
6539 | "groupId": "OG000",
6540 | "value": "1",
6541 | "lowerLimit": "1",
6542 | "upperLimit": "3"
6543 | },
6544 | {
6545 | "groupId": "OG001",
6546 | "value": "1",
6547 | "lowerLimit": "1",
6548 | "upperLimit": "3"
6549 | }
6550 | ]
6551 | }
6552 | ]
6553 | },
6554 | {
6555 | "title": "Not hospitalized, limit on activities/req home O2",
6556 | "categories": [
6557 | {
6558 | "measurements": [
6559 | {
6560 | "groupId": "OG000",
6561 | "value": "0",
6562 | "lowerLimit": "0",
6563 | "upperLimit": "1"
6564 | },
6565 | {
6566 | "groupId": "OG001",
6567 | "value": "0.2",
6568 | "lowerLimit": "0",
6569 | "upperLimit": "1"
6570 | }
6571 | ]
6572 | }
6573 | ]
6574 | },
6575 | {
6576 | "title": "Not hospitalized, no limitations on activities",
6577 | "categories": [
6578 | {
6579 | "measurements": [
6580 | {
6581 | "groupId": "OG000",
6582 | "value": "0.2",
6583 | "lowerLimit": "0",
6584 | "upperLimit": "1"
6585 | },
6586 | {
6587 | "groupId": "OG001",
6588 | "value": "0",
6589 | "lowerLimit": "0",
6590 | "upperLimit": "1"
6591 | }
6592 | ]
6593 | }
6594 | ]
6595 | },
6596 | {
6597 | "title": "No clinical status score reported - Hospitalized",
6598 | "categories": [
6599 | {
6600 | "measurements": [
6601 | {
6602 | "groupId": "OG000",
6603 | "value": "0",
6604 | "lowerLimit": "0",
6605 | "upperLimit": "1"
6606 | },
6607 | {
6608 | "groupId": "OG001",
6609 | "value": "0.4",
6610 | "lowerLimit": "0",
6611 | "upperLimit": "1"
6612 | }
6613 | ]
6614 | }
6615 | ]
6616 | },
6617 | {
6618 | "title": "No clinical status score reported - Discharged",
6619 | "categories": [
6620 | {
6621 | "measurements": [
6622 | {
6623 | "groupId": "OG000",
6624 | "value": "22",
6625 | "lowerLimit": "19",
6626 | "upperLimit": "26"
6627 | },
6628 | {
6629 | "groupId": "OG001",
6630 | "value": "30",
6631 | "lowerLimit": "27",
6632 | "upperLimit": "34"
6633 | }
6634 | ]
6635 | }
6636 | ]
6637 | },
6638 | {
6639 | "title": "No clinical status score reported - Discontinued",
6640 | "categories": [
6641 | {
6642 | "measurements": [
6643 | {
6644 | "groupId": "OG000",
6645 | "value": "2",
6646 | "lowerLimit": "1",
6647 | "upperLimit": "3"
6648 | },
6649 | {
6650 | "groupId": "OG001",
6651 | "value": "4",
6652 | "lowerLimit": "2",
6653 | "upperLimit": "5"
6654 | }
6655 | ]
6656 | }
6657 | ]
6658 | }
6659 | ]
6660 | },
6661 | {
6662 | "type": "SECONDARY",
6663 | "title": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11",
6664 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
6665 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
6666 | "reportingStatus": "POSTED",
6667 | "paramType": "NUMBER",
6668 | "dispersionType": "95% Confidence Interval",
6669 | "unitOfMeasure": "percentage of participants",
6670 | "timeFrame": "Day 11",
6671 | "groups": [
6672 | {
6673 | "id": "OG000",
6674 | "title": "Placebo",
6675 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
6676 | },
6677 | {
6678 | "id": "OG001",
6679 | "title": "Remdesivir",
6680 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
6681 | }
6682 | ],
6683 | "denoms": [
6684 | {
6685 | "units": "Participants",
6686 | "counts": [
6687 | {
6688 | "groupId": "OG000",
6689 | "value": "521"
6690 | },
6691 | {
6692 | "groupId": "OG001",
6693 | "value": "541"
6694 | }
6695 | ]
6696 | }
6697 | ],
6698 | "classes": [
6699 | {
6700 | "title": "Death at or before study Visit",
6701 | "categories": [
6702 | {
6703 | "measurements": [
6704 | {
6705 | "groupId": "OG000",
6706 | "value": "8",
6707 | "lowerLimit": "6",
6708 | "upperLimit": "11"
6709 | },
6710 | {
6711 | "groupId": "OG001",
6712 | "value": "4",
6713 | "lowerLimit": "3",
6714 | "upperLimit": "6"
6715 | }
6716 | ]
6717 | }
6718 | ]
6719 | },
6720 | {
6721 | "title": "Hospitalized, on invasive mech. vent. or ECMO",
6722 | "categories": [
6723 | {
6724 | "measurements": [
6725 | {
6726 | "groupId": "OG000",
6727 | "value": "28",
6728 | "lowerLimit": "25",
6729 | "upperLimit": "32"
6730 | },
6731 | {
6732 | "groupId": "OG001",
6733 | "value": "22",
6734 | "lowerLimit": "19",
6735 | "upperLimit": "26"
6736 | }
6737 | ]
6738 | }
6739 | ]
6740 | },
6741 | {
6742 | "title": "Hospitalized, on non-invasive vent./high flow O2",
6743 | "categories": [
6744 | {
6745 | "measurements": [
6746 | {
6747 | "groupId": "OG000",
6748 | "value": "7",
6749 | "lowerLimit": "5",
6750 | "upperLimit": "10"
6751 | },
6752 | {
6753 | "groupId": "OG001",
6754 | "value": "6",
6755 | "lowerLimit": "4",
6756 | "upperLimit": "8"
6757 | }
6758 | ]
6759 | }
6760 | ]
6761 | },
6762 | {
6763 | "title": "Hospitalized, requiring supplemental oxygen",
6764 | "categories": [
6765 | {
6766 | "measurements": [
6767 | {
6768 | "groupId": "OG000",
6769 | "value": "13",
6770 | "lowerLimit": "10",
6771 | "upperLimit": "16"
6772 | },
6773 | {
6774 | "groupId": "OG001",
6775 | "value": "11",
6776 | "lowerLimit": "9",
6777 | "upperLimit": "14"
6778 | }
6779 | ]
6780 | }
6781 | ]
6782 | },
6783 | {
6784 | "title": "Hospitalized, not on O2, requiring ongoing care",
6785 | "categories": [
6786 | {
6787 | "measurements": [
6788 | {
6789 | "groupId": "OG000",
6790 | "value": "6",
6791 | "lowerLimit": "5",
6792 | "upperLimit": "9"
6793 | },
6794 | {
6795 | "groupId": "OG001",
6796 | "value": "7",
6797 | "lowerLimit": "5",
6798 | "upperLimit": "9"
6799 | }
6800 | ]
6801 | }
6802 | ]
6803 | },
6804 | {
6805 | "title": "Hospitalized, not requiring O2, no longer req care",
6806 | "categories": [
6807 | {
6808 | "measurements": [
6809 | {
6810 | "groupId": "OG000",
6811 | "value": "2",
6812 | "lowerLimit": "1",
6813 | "upperLimit": "4"
6814 | },
6815 | {
6816 | "groupId": "OG001",
6817 | "value": "2",
6818 | "lowerLimit": "1",
6819 | "upperLimit": "4"
6820 | }
6821 | ]
6822 | }
6823 | ]
6824 | },
6825 | {
6826 | "title": "Not hospitalized, limit on activities/req home O2",
6827 | "categories": [
6828 | {
6829 | "measurements": [
6830 | {
6831 | "groupId": "OG000",
6832 | "value": "0.4",
6833 | "lowerLimit": "0",
6834 | "upperLimit": "1"
6835 | },
6836 | {
6837 | "groupId": "OG001",
6838 | "value": "0.4",
6839 | "lowerLimit": "0",
6840 | "upperLimit": "1"
6841 | }
6842 | ]
6843 | }
6844 | ]
6845 | },
6846 | {
6847 | "title": "Not hospitalized, no limitations on activities",
6848 | "categories": [
6849 | {
6850 | "measurements": [
6851 | {
6852 | "groupId": "OG000",
6853 | "value": "0.2",
6854 | "lowerLimit": "0",
6855 | "upperLimit": "1"
6856 | },
6857 | {
6858 | "groupId": "OG001",
6859 | "value": "0",
6860 | "lowerLimit": "0",
6861 | "upperLimit": "1"
6862 | }
6863 | ]
6864 | }
6865 | ]
6866 | },
6867 | {
6868 | "title": "No clinical status score reported - Hospitalized",
6869 | "categories": [
6870 | {
6871 | "measurements": [
6872 | {
6873 | "groupId": "OG000",
6874 | "value": "0",
6875 | "lowerLimit": "0",
6876 | "upperLimit": "1"
6877 | },
6878 | {
6879 | "groupId": "OG001",
6880 | "value": "0",
6881 | "lowerLimit": "0",
6882 | "upperLimit": "1"
6883 | }
6884 | ]
6885 | }
6886 | ]
6887 | },
6888 | {
6889 | "title": "No clinical status score reported - Discharged",
6890 | "categories": [
6891 | {
6892 | "measurements": [
6893 | {
6894 | "groupId": "OG000",
6895 | "value": "33",
6896 | "lowerLimit": "29",
6897 | "upperLimit": "37"
6898 | },
6899 | {
6900 | "groupId": "OG001",
6901 | "value": "44",
6902 | "lowerLimit": "40",
6903 | "upperLimit": "48"
6904 | }
6905 | ]
6906 | }
6907 | ]
6908 | },
6909 | {
6910 | "title": "No clinical status score reported - Discontinued",
6911 | "categories": [
6912 | {
6913 | "measurements": [
6914 | {
6915 | "groupId": "OG000",
6916 | "value": "2",
6917 | "lowerLimit": "1",
6918 | "upperLimit": "4"
6919 | },
6920 | {
6921 | "groupId": "OG001",
6922 | "value": "4",
6923 | "lowerLimit": "3",
6924 | "upperLimit": "6"
6925 | }
6926 | ]
6927 | }
6928 | ]
6929 | }
6930 | ]
6931 | },
6932 | {
6933 | "type": "SECONDARY",
6934 | "title": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15",
6935 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
6936 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
6937 | "reportingStatus": "POSTED",
6938 | "paramType": "NUMBER",
6939 | "dispersionType": "95% Confidence Interval",
6940 | "unitOfMeasure": "percentage of participants",
6941 | "timeFrame": "Day 15",
6942 | "groups": [
6943 | {
6944 | "id": "OG000",
6945 | "title": "Placebo",
6946 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
6947 | },
6948 | {
6949 | "id": "OG001",
6950 | "title": "Remdesivir",
6951 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
6952 | }
6953 | ],
6954 | "denoms": [
6955 | {
6956 | "units": "Participants",
6957 | "counts": [
6958 | {
6959 | "groupId": "OG000",
6960 | "value": "521"
6961 | },
6962 | {
6963 | "groupId": "OG001",
6964 | "value": "541"
6965 | }
6966 | ]
6967 | }
6968 | ],
6969 | "classes": [
6970 | {
6971 | "title": "Death at or before study Visit",
6972 | "categories": [
6973 | {
6974 | "measurements": [
6975 | {
6976 | "groupId": "OG000",
6977 | "value": "11",
6978 | "lowerLimit": "9",
6979 | "upperLimit": "14"
6980 | },
6981 | {
6982 | "groupId": "OG001",
6983 | "value": "6",
6984 | "lowerLimit": "5",
6985 | "upperLimit": "9"
6986 | }
6987 | ]
6988 | }
6989 | ]
6990 | },
6991 | {
6992 | "title": "Hospitalized, on invasive mech. vent. or ECMO",
6993 | "categories": [
6994 | {
6995 | "measurements": [
6996 | {
6997 | "groupId": "OG000",
6998 | "value": "22",
6999 | "lowerLimit": "19",
7000 | "upperLimit": "26"
7001 | },
7002 | {
7003 | "groupId": "OG001",
7004 | "value": "15",
7005 | "lowerLimit": "13",
7006 | "upperLimit": "19"
7007 | }
7008 | ]
7009 | }
7010 | ]
7011 | },
7012 | {
7013 | "title": "Hospitalized, on non-invasive vent./high flow O2",
7014 | "categories": [
7015 | {
7016 | "measurements": [
7017 | {
7018 | "groupId": "OG000",
7019 | "value": "4",
7020 | "lowerLimit": "3",
7021 | "upperLimit": "6"
7022 | },
7023 | {
7024 | "groupId": "OG001",
7025 | "value": "4",
7026 | "lowerLimit": "3",
7027 | "upperLimit": "6"
7028 | }
7029 | ]
7030 | }
7031 | ]
7032 | },
7033 | {
7034 | "title": "Hospitalized, requiring supplemental oxygen",
7035 | "categories": [
7036 | {
7037 | "measurements": [
7038 | {
7039 | "groupId": "OG000",
7040 | "value": "11",
7041 | "lowerLimit": "9",
7042 | "upperLimit": "14"
7043 | },
7044 | {
7045 | "groupId": "OG001",
7046 | "value": "10",
7047 | "lowerLimit": "8",
7048 | "upperLimit": "13"
7049 | }
7050 | ]
7051 | }
7052 | ]
7053 | },
7054 | {
7055 | "title": "Hospitalized, not on O2, requiring ongoing care",
7056 | "categories": [
7057 | {
7058 | "measurements": [
7059 | {
7060 | "groupId": "OG000",
7061 | "value": "6",
7062 | "lowerLimit": "5",
7063 | "upperLimit": "9"
7064 | },
7065 | {
7066 | "groupId": "OG001",
7067 | "value": "7",
7068 | "lowerLimit": "5",
7069 | "upperLimit": "9"
7070 | }
7071 | ]
7072 | }
7073 | ]
7074 | },
7075 | {
7076 | "title": "Hospitalized, not requiring O2, no longer req care",
7077 | "categories": [
7078 | {
7079 | "measurements": [
7080 | {
7081 | "groupId": "OG000",
7082 | "value": "2",
7083 | "lowerLimit": "1",
7084 | "upperLimit": "3"
7085 | },
7086 | {
7087 | "groupId": "OG001",
7088 | "value": "3",
7089 | "lowerLimit": "2",
7090 | "upperLimit": "4"
7091 | }
7092 | ]
7093 | }
7094 | ]
7095 | },
7096 | {
7097 | "title": "Not hospitalized, limit on activities/req home O2",
7098 | "categories": [
7099 | {
7100 | "measurements": [
7101 | {
7102 | "groupId": "OG000",
7103 | "value": "17",
7104 | "lowerLimit": "14",
7105 | "upperLimit": "21"
7106 | },
7107 | {
7108 | "groupId": "OG001",
7109 | "value": "19",
7110 | "lowerLimit": "16",
7111 | "upperLimit": "22"
7112 | }
7113 | ]
7114 | }
7115 | ]
7116 | },
7117 | {
7118 | "title": "Not hospitalized, no limitations on activities",
7119 | "categories": [
7120 | {
7121 | "measurements": [
7122 | {
7123 | "groupId": "OG000",
7124 | "value": "22",
7125 | "lowerLimit": "19",
7126 | "upperLimit": "26"
7127 | },
7128 | {
7129 | "groupId": "OG001",
7130 | "value": "29",
7131 | "lowerLimit": "25",
7132 | "upperLimit": "33"
7133 | }
7134 | ]
7135 | }
7136 | ]
7137 | },
7138 | {
7139 | "title": "No clinical status score reported - Hospitalized",
7140 | "categories": [
7141 | {
7142 | "measurements": [
7143 | {
7144 | "groupId": "OG000",
7145 | "value": "0",
7146 | "lowerLimit": "0",
7147 | "upperLimit": "1"
7148 | },
7149 | {
7150 | "groupId": "OG001",
7151 | "value": "0",
7152 | "lowerLimit": "0",
7153 | "upperLimit": "1"
7154 | }
7155 | ]
7156 | }
7157 | ]
7158 | },
7159 | {
7160 | "title": "No clinical status score reported - Discharged",
7161 | "categories": [
7162 | {
7163 | "measurements": [
7164 | {
7165 | "groupId": "OG000",
7166 | "value": "2",
7167 | "lowerLimit": "1",
7168 | "upperLimit": "3"
7169 | },
7170 | {
7171 | "groupId": "OG001",
7172 | "value": "2",
7173 | "lowerLimit": "1",
7174 | "upperLimit": "4"
7175 | }
7176 | ]
7177 | }
7178 | ]
7179 | },
7180 | {
7181 | "title": "No clinical status score reported - Discontinued",
7182 | "categories": [
7183 | {
7184 | "measurements": [
7185 | {
7186 | "groupId": "OG000",
7187 | "value": "3",
7188 | "lowerLimit": "2",
7189 | "upperLimit": "4"
7190 | },
7191 | {
7192 | "groupId": "OG001",
7193 | "value": "5",
7194 | "lowerLimit": "3",
7195 | "upperLimit": "7"
7196 | }
7197 | ]
7198 | }
7199 | ]
7200 | }
7201 | ]
7202 | },
7203 | {
7204 | "type": "SECONDARY",
7205 | "title": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22",
7206 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
7207 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
7208 | "reportingStatus": "POSTED",
7209 | "paramType": "NUMBER",
7210 | "dispersionType": "95% Confidence Interval",
7211 | "unitOfMeasure": "percentage of participants",
7212 | "timeFrame": "Day 22",
7213 | "groups": [
7214 | {
7215 | "id": "OG000",
7216 | "title": "Placebo",
7217 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
7218 | },
7219 | {
7220 | "id": "OG001",
7221 | "title": "Remdesivir",
7222 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
7223 | }
7224 | ],
7225 | "denoms": [
7226 | {
7227 | "units": "Participants",
7228 | "counts": [
7229 | {
7230 | "groupId": "OG000",
7231 | "value": "521"
7232 | },
7233 | {
7234 | "groupId": "OG001",
7235 | "value": "541"
7236 | }
7237 | ]
7238 | }
7239 | ],
7240 | "classes": [
7241 | {
7242 | "title": "Death at or before study Visit",
7243 | "categories": [
7244 | {
7245 | "measurements": [
7246 | {
7247 | "groupId": "OG000",
7248 | "value": "13",
7249 | "lowerLimit": "10",
7250 | "upperLimit": "16"
7251 | },
7252 | {
7253 | "groupId": "OG001",
7254 | "value": "9",
7255 | "lowerLimit": "7",
7256 | "upperLimit": "12"
7257 | }
7258 | ]
7259 | }
7260 | ]
7261 | },
7262 | {
7263 | "title": "Hospitalized, on invasive mech. vent. or ECMO",
7264 | "categories": [
7265 | {
7266 | "measurements": [
7267 | {
7268 | "groupId": "OG000",
7269 | "value": "14",
7270 | "lowerLimit": "12",
7271 | "upperLimit": "18"
7272 | },
7273 | {
7274 | "groupId": "OG001",
7275 | "value": "9",
7276 | "lowerLimit": "7",
7277 | "upperLimit": "12"
7278 | }
7279 | ]
7280 | }
7281 | ]
7282 | },
7283 | {
7284 | "title": "Hospitalized, on non-invasive vent./high flow O2",
7285 | "categories": [
7286 | {
7287 | "measurements": [
7288 | {
7289 | "groupId": "OG000",
7290 | "value": "2",
7291 | "lowerLimit": "1",
7292 | "upperLimit": "4"
7293 | },
7294 | {
7295 | "groupId": "OG001",
7296 | "value": "2",
7297 | "lowerLimit": "1",
7298 | "upperLimit": "4"
7299 | }
7300 | ]
7301 | }
7302 | ]
7303 | },
7304 | {
7305 | "title": "Hospitalized, requiring supplemental oxygen",
7306 | "categories": [
7307 | {
7308 | "measurements": [
7309 | {
7310 | "groupId": "OG000",
7311 | "value": "8",
7312 | "lowerLimit": "6",
7313 | "upperLimit": "11"
7314 | },
7315 | {
7316 | "groupId": "OG001",
7317 | "value": "5",
7318 | "lowerLimit": "4",
7319 | "upperLimit": "8"
7320 | }
7321 | ]
7322 | }
7323 | ]
7324 | },
7325 | {
7326 | "title": "Hospitalized, not on O2, requiring ongoing care",
7327 | "categories": [
7328 | {
7329 | "measurements": [
7330 | {
7331 | "groupId": "OG000",
7332 | "value": "5",
7333 | "lowerLimit": "4",
7334 | "upperLimit": "8"
7335 | },
7336 | {
7337 | "groupId": "OG001",
7338 | "value": "6",
7339 | "lowerLimit": "4",
7340 | "upperLimit": "8"
7341 | }
7342 | ]
7343 | }
7344 | ]
7345 | },
7346 | {
7347 | "title": "Hospitalized, not requiring O2, no longer req care",
7348 | "categories": [
7349 | {
7350 | "measurements": [
7351 | {
7352 | "groupId": "OG000",
7353 | "value": "1",
7354 | "lowerLimit": "0",
7355 | "upperLimit": "2"
7356 | },
7357 | {
7358 | "groupId": "OG001",
7359 | "value": "1",
7360 | "lowerLimit": "1",
7361 | "upperLimit": "3"
7362 | }
7363 | ]
7364 | }
7365 | ]
7366 | },
7367 | {
7368 | "title": "Not hospitalized, limit on activities/req home O2",
7369 | "categories": [
7370 | {
7371 | "measurements": [
7372 | {
7373 | "groupId": "OG000",
7374 | "value": "18",
7375 | "lowerLimit": "15",
7376 | "upperLimit": "22"
7377 | },
7378 | {
7379 | "groupId": "OG001",
7380 | "value": "19",
7381 | "lowerLimit": "16",
7382 | "upperLimit": "23"
7383 | }
7384 | ]
7385 | }
7386 | ]
7387 | },
7388 | {
7389 | "title": "Not hospitalized, no limitations on activities",
7390 | "categories": [
7391 | {
7392 | "measurements": [
7393 | {
7394 | "groupId": "OG000",
7395 | "value": "32",
7396 | "lowerLimit": "29",
7397 | "upperLimit": "37"
7398 | },
7399 | {
7400 | "groupId": "OG001",
7401 | "value": "39",
7402 | "lowerLimit": "35",
7403 | "upperLimit": "43"
7404 | }
7405 | ]
7406 | }
7407 | ]
7408 | },
7409 | {
7410 | "title": "No clinical status score reported - Hospitalized",
7411 | "categories": [
7412 | {
7413 | "measurements": [
7414 | {
7415 | "groupId": "OG000",
7416 | "value": "0",
7417 | "lowerLimit": "0",
7418 | "upperLimit": "1"
7419 | },
7420 | {
7421 | "groupId": "OG001",
7422 | "value": "0",
7423 | "lowerLimit": "0",
7424 | "upperLimit": "1"
7425 | }
7426 | ]
7427 | }
7428 | ]
7429 | },
7430 | {
7431 | "title": "No clinical status score reported - Discharged",
7432 | "categories": [
7433 | {
7434 | "measurements": [
7435 | {
7436 | "groupId": "OG000",
7437 | "value": "2",
7438 | "lowerLimit": "1",
7439 | "upperLimit": "4"
7440 | },
7441 | {
7442 | "groupId": "OG001",
7443 | "value": "3",
7444 | "lowerLimit": "2",
7445 | "upperLimit": "5"
7446 | }
7447 | ]
7448 | }
7449 | ]
7450 | },
7451 | {
7452 | "title": "No clinical status score reported - Discontinued",
7453 | "categories": [
7454 | {
7455 | "measurements": [
7456 | {
7457 | "groupId": "OG000",
7458 | "value": "4",
7459 | "lowerLimit": "2",
7460 | "upperLimit": "6"
7461 | },
7462 | {
7463 | "groupId": "OG001",
7464 | "value": "6",
7465 | "lowerLimit": "4",
7466 | "upperLimit": "8"
7467 | }
7468 | ]
7469 | }
7470 | ]
7471 | },
7472 | {
7473 | "title": "Completed study without reporting score",
7474 | "categories": [
7475 | {
7476 | "measurements": [
7477 | {
7478 | "groupId": "OG000",
7479 | "value": "0",
7480 | "lowerLimit": "0",
7481 | "upperLimit": "1"
7482 | },
7483 | {
7484 | "groupId": "OG001",
7485 | "value": "0.2",
7486 | "lowerLimit": "0",
7487 | "upperLimit": "1"
7488 | }
7489 | ]
7490 | }
7491 | ]
7492 | }
7493 | ]
7494 | },
7495 | {
7496 | "type": "SECONDARY",
7497 | "title": "Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29",
7498 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.",
7499 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
7500 | "reportingStatus": "POSTED",
7501 | "paramType": "NUMBER",
7502 | "dispersionType": "95% Confidence Interval",
7503 | "unitOfMeasure": "percentage of participants",
7504 | "timeFrame": "Day 29",
7505 | "groups": [
7506 | {
7507 | "id": "OG000",
7508 | "title": "Placebo",
7509 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
7510 | },
7511 | {
7512 | "id": "OG001",
7513 | "title": "Remdesivir",
7514 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
7515 | }
7516 | ],
7517 | "denoms": [
7518 | {
7519 | "units": "Participants",
7520 | "counts": [
7521 | {
7522 | "groupId": "OG000",
7523 | "value": "521"
7524 | },
7525 | {
7526 | "groupId": "OG001",
7527 | "value": "541"
7528 | }
7529 | ]
7530 | }
7531 | ],
7532 | "classes": [
7533 | {
7534 | "title": "Death at or before study Visit",
7535 | "categories": [
7536 | {
7537 | "measurements": [
7538 | {
7539 | "groupId": "OG000",
7540 | "value": "15",
7541 | "lowerLimit": "12",
7542 | "upperLimit": "18"
7543 | },
7544 | {
7545 | "groupId": "OG001",
7546 | "value": "11",
7547 | "lowerLimit": "8",
7548 | "upperLimit": "14"
7549 | }
7550 | ]
7551 | }
7552 | ]
7553 | },
7554 | {
7555 | "title": "Hospitalized, on invasive mech. vent. or ECMO",
7556 | "categories": [
7557 | {
7558 | "measurements": [
7559 | {
7560 | "groupId": "OG000",
7561 | "value": "9",
7562 | "lowerLimit": "7",
7563 | "upperLimit": "11"
7564 | },
7565 | {
7566 | "groupId": "OG001",
7567 | "value": "6",
7568 | "lowerLimit": "4",
7569 | "upperLimit": "8"
7570 | }
7571 | ]
7572 | }
7573 | ]
7574 | },
7575 | {
7576 | "title": "Hospitalized, on non-invasive vent./high flow O2",
7577 | "categories": [
7578 | {
7579 | "measurements": [
7580 | {
7581 | "groupId": "OG000",
7582 | "value": "2",
7583 | "lowerLimit": "1",
7584 | "upperLimit": "3"
7585 | },
7586 | {
7587 | "groupId": "OG001",
7588 | "value": "1",
7589 | "lowerLimit": "0",
7590 | "upperLimit": "2"
7591 | }
7592 | ]
7593 | }
7594 | ]
7595 | },
7596 | {
7597 | "title": "Hospitalized, requiring supplemental oxygen",
7598 | "categories": [
7599 | {
7600 | "measurements": [
7601 | {
7602 | "groupId": "OG000",
7603 | "value": "4",
7604 | "lowerLimit": "3",
7605 | "upperLimit": "6"
7606 | },
7607 | {
7608 | "groupId": "OG001",
7609 | "value": "4",
7610 | "lowerLimit": "3",
7611 | "upperLimit": "6"
7612 | }
7613 | ]
7614 | }
7615 | ]
7616 | },
7617 | {
7618 | "title": "Hospitalized, not on O2, requiring ongoing care",
7619 | "categories": [
7620 | {
7621 | "measurements": [
7622 | {
7623 | "groupId": "OG000",
7624 | "value": "3",
7625 | "lowerLimit": "2",
7626 | "upperLimit": "5"
7627 | },
7628 | {
7629 | "groupId": "OG001",
7630 | "value": "3",
7631 | "lowerLimit": "2",
7632 | "upperLimit": "5"
7633 | }
7634 | ]
7635 | }
7636 | ]
7637 | },
7638 | {
7639 | "title": "Hospitalized, not requiring O2, no longer req care",
7640 | "categories": [
7641 | {
7642 | "measurements": [
7643 | {
7644 | "groupId": "OG000",
7645 | "value": "1",
7646 | "lowerLimit": "0",
7647 | "upperLimit": "2"
7648 | },
7649 | {
7650 | "groupId": "OG001",
7651 | "value": "1",
7652 | "lowerLimit": "0",
7653 | "upperLimit": "2"
7654 | }
7655 | ]
7656 | }
7657 | ]
7658 | },
7659 | {
7660 | "title": "Not hospitalized, limit on activities/req home O2",
7661 | "categories": [
7662 | {
7663 | "measurements": [
7664 | {
7665 | "groupId": "OG000",
7666 | "value": "19",
7667 | "lowerLimit": "16",
7668 | "upperLimit": "23"
7669 | },
7670 | {
7671 | "groupId": "OG001",
7672 | "value": "20",
7673 | "lowerLimit": "17",
7674 | "upperLimit": "23"
7675 | }
7676 | ]
7677 | }
7678 | ]
7679 | },
7680 | {
7681 | "title": "Not hospitalized, no limitations on activities",
7682 | "categories": [
7683 | {
7684 | "measurements": [
7685 | {
7686 | "groupId": "OG000",
7687 | "value": "36",
7688 | "lowerLimit": "32",
7689 | "upperLimit": "41"
7690 | },
7691 | {
7692 | "groupId": "OG001",
7693 | "value": "46",
7694 | "lowerLimit": "42",
7695 | "upperLimit": "50"
7696 | }
7697 | ]
7698 | }
7699 | ]
7700 | },
7701 | {
7702 | "title": "No clinical status score reported - Hospitalized",
7703 | "categories": [
7704 | {
7705 | "measurements": [
7706 | {
7707 | "groupId": "OG000",
7708 | "value": "0.2",
7709 | "lowerLimit": "0",
7710 | "upperLimit": "1"
7711 | },
7712 | {
7713 | "groupId": "OG001",
7714 | "value": "0",
7715 | "lowerLimit": "0",
7716 | "upperLimit": "1"
7717 | }
7718 | ]
7719 | }
7720 | ]
7721 | },
7722 | {
7723 | "title": "No clinical status score reported - Discharged",
7724 | "categories": [
7725 | {
7726 | "measurements": [
7727 | {
7728 | "groupId": "OG000",
7729 | "value": "3",
7730 | "lowerLimit": "2",
7731 | "upperLimit": "5"
7732 | },
7733 | {
7734 | "groupId": "OG001",
7735 | "value": "1",
7736 | "lowerLimit": "1",
7737 | "upperLimit": "3"
7738 | }
7739 | ]
7740 | }
7741 | ]
7742 | },
7743 | {
7744 | "title": "No clinical status score reported - Discontinued",
7745 | "categories": [
7746 | {
7747 | "measurements": [
7748 | {
7749 | "groupId": "OG000",
7750 | "value": "5",
7751 | "lowerLimit": "3",
7752 | "upperLimit": "7"
7753 | },
7754 | {
7755 | "groupId": "OG001",
7756 | "value": "7",
7757 | "lowerLimit": "5",
7758 | "upperLimit": "9"
7759 | }
7760 | ]
7761 | }
7762 | ]
7763 | },
7764 | {
7765 | "title": "Completed study without reporting score",
7766 | "categories": [
7767 | {
7768 | "measurements": [
7769 | {
7770 | "groupId": "OG000",
7771 | "value": "3",
7772 | "lowerLimit": "2",
7773 | "upperLimit": "4"
7774 | },
7775 | {
7776 | "groupId": "OG001",
7777 | "value": "2",
7778 | "lowerLimit": "1",
7779 | "upperLimit": "4"
7780 | }
7781 | ]
7782 | }
7783 | ]
7784 | }
7785 | ]
7786 | },
7787 | {
7788 | "type": "SECONDARY",
7789 | "title": "Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)",
7790 | "description": "Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.",
7791 | "populationDescription": "The safety population includes all participants with available data post baseline, analyzed as treated.",
7792 | "reportingStatus": "POSTED",
7793 | "paramType": "NUMBER",
7794 | "dispersionType": "95% Confidence Interval",
7795 | "unitOfMeasure": "percentage of participants",
7796 | "timeFrame": "Day 1 through Day 29",
7797 | "groups": [
7798 | {
7799 | "id": "OG000",
7800 | "title": "Placebo",
7801 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
7802 | },
7803 | {
7804 | "id": "OG001",
7805 | "title": "Remdesivir",
7806 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
7807 | }
7808 | ],
7809 | "denoms": [
7810 | {
7811 | "units": "Participants",
7812 | "counts": [
7813 | {
7814 | "groupId": "OG000",
7815 | "value": "516"
7816 | },
7817 | {
7818 | "groupId": "OG001",
7819 | "value": "532"
7820 | }
7821 | ]
7822 | }
7823 | ],
7824 | "classes": [
7825 | {
7826 | "categories": [
7827 | {
7828 | "measurements": [
7829 | {
7830 | "groupId": "OG000",
7831 | "value": "57",
7832 | "lowerLimit": "52.8",
7833 | "upperLimit": "61.5"
7834 | },
7835 | {
7836 | "groupId": "OG001",
7837 | "value": "51",
7838 | "lowerLimit": "47.0",
7839 | "upperLimit": "55.6"
7840 | }
7841 | ]
7842 | }
7843 | ]
7844 | }
7845 | ],
7846 | "analyses": [
7847 | {
7848 | "groupIds": ["OG000", "OG001"],
7849 | "nonInferiorityType": "SUPERIORITY",
7850 | "pValue": "0.058",
7851 | "statisticalMethod": "Barnard's Exact Test"
7852 | }
7853 | ]
7854 | },
7855 | {
7856 | "type": "SECONDARY",
7857 | "title": "Percentage of Participants Reporting Serious Adverse Events (SAEs)",
7858 | "description": "An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.",
7859 | "populationDescription": "The safety population includes all participants with available data post baseline, analyzed as treated.",
7860 | "reportingStatus": "POSTED",
7861 | "paramType": "NUMBER",
7862 | "dispersionType": "95% Confidence Interval",
7863 | "unitOfMeasure": "percentage of participants",
7864 | "timeFrame": "Day 1 through Day 29",
7865 | "groups": [
7866 | {
7867 | "id": "OG000",
7868 | "title": "Placebo",
7869 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
7870 | },
7871 | {
7872 | "id": "OG001",
7873 | "title": "Remdesivir",
7874 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
7875 | }
7876 | ],
7877 | "denoms": [
7878 | {
7879 | "units": "Participants",
7880 | "counts": [
7881 | {
7882 | "groupId": "OG000",
7883 | "value": "516"
7884 | },
7885 | {
7886 | "groupId": "OG001",
7887 | "value": "532"
7888 | }
7889 | ]
7890 | }
7891 | ],
7892 | "classes": [
7893 | {
7894 | "categories": [
7895 | {
7896 | "measurements": [
7897 | {
7898 | "groupId": "OG000",
7899 | "value": "32",
7900 | "lowerLimit": "27.7",
7901 | "upperLimit": "35.7"
7902 | },
7903 | {
7904 | "groupId": "OG001",
7905 | "value": "24",
7906 | "lowerLimit": "20.9",
7907 | "upperLimit": "28.3"
7908 | }
7909 | ]
7910 | }
7911 | ]
7912 | }
7913 | ],
7914 | "analyses": [
7915 | {
7916 | "groupIds": ["OG000", "OG001"],
7917 | "nonInferiorityType": "SUPERIORITY",
7918 | "pValue": "0.010",
7919 | "statisticalMethod": "Barnard's Exact Test"
7920 | }
7921 | ]
7922 | },
7923 | {
7924 | "type": "SECONDARY",
7925 | "title": "Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics",
7926 | "description": "Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.",
7927 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
7928 | "reportingStatus": "POSTED",
7929 | "paramType": "NUMBER",
7930 | "dispersionType": "95% Confidence Interval",
7931 | "unitOfMeasure": "percentage of participants",
7932 | "timeFrame": "Day 1 through Day 10",
7933 | "groups": [
7934 | {
7935 | "id": "OG000",
7936 | "title": "Placebo",
7937 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
7938 | },
7939 | {
7940 | "id": "OG001",
7941 | "title": "Remdesivir",
7942 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
7943 | }
7944 | ],
7945 | "denoms": [
7946 | {
7947 | "units": "Participants",
7948 | "counts": [
7949 | {
7950 | "groupId": "OG000",
7951 | "value": "521"
7952 | },
7953 | {
7954 | "groupId": "OG001",
7955 | "value": "541"
7956 | }
7957 | ]
7958 | }
7959 | ],
7960 | "classes": [
7961 | {
7962 | "title": "Discontinued due to discharge",
7963 | "categories": [
7964 | {
7965 | "measurements": [
7966 | {
7967 | "groupId": "OG000",
7968 | "value": "30",
7969 | "lowerLimit": "26",
7970 | "upperLimit": "34"
7971 | },
7972 | {
7973 | "groupId": "OG001",
7974 | "value": "41",
7975 | "lowerLimit": "37",
7976 | "upperLimit": "45"
7977 | }
7978 | ]
7979 | }
7980 | ]
7981 | },
7982 | {
7983 | "title": "Discontinued due to death",
7984 | "categories": [
7985 | {
7986 | "measurements": [
7987 | {
7988 | "groupId": "OG000",
7989 | "value": "4",
7990 | "lowerLimit": "2",
7991 | "upperLimit": "6"
7992 | },
7993 | {
7994 | "groupId": "OG001",
7995 | "value": "3",
7996 | "lowerLimit": "2",
7997 | "upperLimit": "5"
7998 | }
7999 | ]
8000 | }
8001 | ]
8002 | },
8003 | {
8004 | "title": "Any infusions halted or slowed",
8005 | "categories": [
8006 | {
8007 | "measurements": [
8008 | {
8009 | "groupId": "OG000",
8010 | "value": "2",
8011 | "lowerLimit": "1",
8012 | "upperLimit": "4"
8013 | },
8014 | {
8015 | "groupId": "OG001",
8016 | "value": "2",
8017 | "lowerLimit": "1",
8018 | "upperLimit": "4"
8019 | }
8020 | ]
8021 | }
8022 | ]
8023 | },
8024 | {
8025 | "title": "Missed any maintenance dose",
8026 | "categories": [
8027 | {
8028 | "measurements": [
8029 | {
8030 | "groupId": "OG000",
8031 | "value": "21",
8032 | "lowerLimit": "18",
8033 | "upperLimit": "25"
8034 | },
8035 | {
8036 | "groupId": "OG001",
8037 | "value": "16",
8038 | "lowerLimit": "13",
8039 | "upperLimit": "19"
8040 | }
8041 | ]
8042 | }
8043 | ]
8044 | }
8045 | ]
8046 | },
8047 | {
8048 | "type": "SECONDARY",
8049 | "title": "Duration of Hospitalization",
8050 | "description": "Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.",
8051 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
8052 | "reportingStatus": "POSTED",
8053 | "paramType": "MEDIAN",
8054 | "dispersionType": "Inter-Quartile Range",
8055 | "unitOfMeasure": "Days",
8056 | "timeFrame": "Day 1 through Day 29",
8057 | "groups": [
8058 | {
8059 | "id": "OG000",
8060 | "title": "Placebo",
8061 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8062 | },
8063 | {
8064 | "id": "OG001",
8065 | "title": "Remdesivir",
8066 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8067 | }
8068 | ],
8069 | "denoms": [
8070 | {
8071 | "units": "Participants",
8072 | "counts": [
8073 | {
8074 | "groupId": "OG000",
8075 | "value": "521"
8076 | },
8077 | {
8078 | "groupId": "OG001",
8079 | "value": "541"
8080 | }
8081 | ]
8082 | }
8083 | ],
8084 | "classes": [
8085 | {
8086 | "title": "Including imputation for participants who died",
8087 | "denoms": [
8088 | {
8089 | "units": "Participants",
8090 | "counts": [
8091 | {
8092 | "groupId": "OG000",
8093 | "value": "521"
8094 | },
8095 | {
8096 | "groupId": "OG001",
8097 | "value": "541"
8098 | }
8099 | ]
8100 | }
8101 | ],
8102 | "categories": [
8103 | {
8104 | "measurements": [
8105 | {
8106 | "groupId": "OG000",
8107 | "value": "17",
8108 | "lowerLimit": "8",
8109 | "upperLimit": "28"
8110 | },
8111 | {
8112 | "groupId": "OG001",
8113 | "value": "12",
8114 | "lowerLimit": "6",
8115 | "upperLimit": "28"
8116 | }
8117 | ]
8118 | }
8119 | ]
8120 | },
8121 | {
8122 | "title": "Restricted to participants who did not die",
8123 | "denoms": [
8124 | {
8125 | "units": "Participants",
8126 | "counts": [
8127 | {
8128 | "groupId": "OG000",
8129 | "value": "443"
8130 | },
8131 | {
8132 | "groupId": "OG001",
8133 | "value": "480"
8134 | }
8135 | ]
8136 | }
8137 | ],
8138 | "categories": [
8139 | {
8140 | "measurements": [
8141 | {
8142 | "groupId": "OG000",
8143 | "value": "14",
8144 | "lowerLimit": "7",
8145 | "upperLimit": "27"
8146 | },
8147 | {
8148 | "groupId": "OG001",
8149 | "value": "10",
8150 | "lowerLimit": "5",
8151 | "upperLimit": "21"
8152 | }
8153 | ]
8154 | }
8155 | ]
8156 | }
8157 | ]
8158 | },
8159 | {
8160 | "type": "SECONDARY",
8161 | "title": "Duration of New Non-invasive Ventilation or High Flow Oxygen Use",
8162 | "description": "Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die",
8163 | "populationDescription": "The analysis population is restricted to randomized participants who were not on non-invasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.",
8164 | "reportingStatus": "POSTED",
8165 | "paramType": "MEDIAN",
8166 | "dispersionType": "Inter-Quartile Range",
8167 | "unitOfMeasure": "Days",
8168 | "timeFrame": "Day 1 through Day 29",
8169 | "groups": [
8170 | {
8171 | "id": "OG000",
8172 | "title": "Placebo",
8173 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8174 | },
8175 | {
8176 | "id": "OG001",
8177 | "title": "Remdesivir",
8178 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8179 | }
8180 | ],
8181 | "denoms": [
8182 | {
8183 | "units": "Participants",
8184 | "counts": [
8185 | {
8186 | "groupId": "OG000",
8187 | "value": "64"
8188 | },
8189 | {
8190 | "groupId": "OG001",
8191 | "value": "52"
8192 | }
8193 | ]
8194 | }
8195 | ],
8196 | "classes": [
8197 | {
8198 | "title": "Including imputations for participants who died",
8199 | "denoms": [
8200 | {
8201 | "units": "Participants",
8202 | "counts": [
8203 | {
8204 | "groupId": "OG000",
8205 | "value": "64"
8206 | },
8207 | {
8208 | "groupId": "OG001",
8209 | "value": "52"
8210 | }
8211 | ]
8212 | }
8213 | ],
8214 | "categories": [
8215 | {
8216 | "measurements": [
8217 | {
8218 | "groupId": "OG000",
8219 | "value": "4",
8220 | "lowerLimit": "2",
8221 | "upperLimit": "23.5"
8222 | },
8223 | {
8224 | "groupId": "OG001",
8225 | "value": "3",
8226 | "lowerLimit": "1",
8227 | "upperLimit": "10.5"
8228 | }
8229 | ]
8230 | }
8231 | ]
8232 | },
8233 | {
8234 | "title": "Among participants who did not die",
8235 | "denoms": [
8236 | {
8237 | "units": "Participants",
8238 | "counts": [
8239 | {
8240 | "groupId": "OG000",
8241 | "value": "50"
8242 | },
8243 | {
8244 | "groupId": "OG001",
8245 | "value": "43"
8246 | }
8247 | ]
8248 | }
8249 | ],
8250 | "categories": [
8251 | {
8252 | "measurements": [
8253 | {
8254 | "groupId": "OG000",
8255 | "value": "3",
8256 | "lowerLimit": "2",
8257 | "upperLimit": "6"
8258 | },
8259 | {
8260 | "groupId": "OG001",
8261 | "value": "3",
8262 | "lowerLimit": "1",
8263 | "upperLimit": "6"
8264 | }
8265 | ]
8266 | }
8267 | ]
8268 | }
8269 | ]
8270 | },
8271 | {
8272 | "type": "SECONDARY",
8273 | "title": "Duration of New Oxygen Use",
8274 | "description": "Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die\n\n.",
8275 | "populationDescription": "The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.",
8276 | "reportingStatus": "POSTED",
8277 | "paramType": "MEDIAN",
8278 | "dispersionType": "Inter-Quartile Range",
8279 | "unitOfMeasure": "Days",
8280 | "timeFrame": "Day 1 through Day 29",
8281 | "groups": [
8282 | {
8283 | "id": "OG000",
8284 | "title": "Placebo",
8285 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8286 | },
8287 | {
8288 | "id": "OG001",
8289 | "title": "Remdesivir",
8290 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8291 | }
8292 | ],
8293 | "denoms": [
8294 | {
8295 | "units": "Participants",
8296 | "counts": [
8297 | {
8298 | "groupId": "OG000",
8299 | "value": "28"
8300 | },
8301 | {
8302 | "groupId": "OG001",
8303 | "value": "27"
8304 | }
8305 | ]
8306 | }
8307 | ],
8308 | "classes": [
8309 | {
8310 | "title": "Including imputations for participants who died",
8311 | "denoms": [
8312 | {
8313 | "units": "Participants",
8314 | "counts": [
8315 | {
8316 | "groupId": "OG000",
8317 | "value": "28"
8318 | },
8319 | {
8320 | "groupId": "OG001",
8321 | "value": "27"
8322 | }
8323 | ]
8324 | }
8325 | ],
8326 | "categories": [
8327 | {
8328 | "measurements": [
8329 | {
8330 | "groupId": "OG000",
8331 | "value": "5.5",
8332 | "lowerLimit": "1",
8333 | "upperLimit": "15"
8334 | },
8335 | {
8336 | "groupId": "OG001",
8337 | "value": "4",
8338 | "lowerLimit": "2",
8339 | "upperLimit": "12"
8340 | }
8341 | ]
8342 | }
8343 | ]
8344 | },
8345 | {
8346 | "title": "Among participants who did not die",
8347 | "denoms": [
8348 | {
8349 | "units": "Participants",
8350 | "counts": [
8351 | {
8352 | "groupId": "OG000",
8353 | "value": "25"
8354 | },
8355 | {
8356 | "groupId": "OG001",
8357 | "value": "24"
8358 | }
8359 | ]
8360 | }
8361 | ],
8362 | "categories": [
8363 | {
8364 | "measurements": [
8365 | {
8366 | "groupId": "OG000",
8367 | "value": "3",
8368 | "lowerLimit": "1",
8369 | "upperLimit": "13"
8370 | },
8371 | {
8372 | "groupId": "OG001",
8373 | "value": "3.5",
8374 | "lowerLimit": "2",
8375 | "upperLimit": "5.5"
8376 | }
8377 | ]
8378 | }
8379 | ]
8380 | }
8381 | ]
8382 | },
8383 | {
8384 | "type": "SECONDARY",
8385 | "title": "Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use",
8386 | "description": "Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die",
8387 | "populationDescription": "The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.",
8388 | "reportingStatus": "POSTED",
8389 | "paramType": "MEDIAN",
8390 | "dispersionType": "Inter-Quartile Range",
8391 | "unitOfMeasure": "Days",
8392 | "timeFrame": "Day 1 through Day 29",
8393 | "groups": [
8394 | {
8395 | "id": "OG000",
8396 | "title": "Placebo",
8397 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8398 | },
8399 | {
8400 | "id": "OG001",
8401 | "title": "Remdesivir",
8402 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8403 | }
8404 | ],
8405 | "denoms": [
8406 | {
8407 | "units": "Participants",
8408 | "counts": [
8409 | {
8410 | "groupId": "OG000",
8411 | "value": "82"
8412 | },
8413 | {
8414 | "groupId": "OG001",
8415 | "value": "52"
8416 | }
8417 | ]
8418 | }
8419 | ],
8420 | "classes": [
8421 | {
8422 | "title": "Including imputations for participants who died",
8423 | "denoms": [
8424 | {
8425 | "units": "Participants",
8426 | "counts": [
8427 | {
8428 | "groupId": "OG000",
8429 | "value": "82"
8430 | },
8431 | {
8432 | "groupId": "OG001",
8433 | "value": "52"
8434 | }
8435 | ]
8436 | }
8437 | ],
8438 | "categories": [
8439 | {
8440 | "measurements": [
8441 | {
8442 | "groupId": "OG000",
8443 | "value": "23",
8444 | "lowerLimit": "12",
8445 | "upperLimit": "28"
8446 | },
8447 | {
8448 | "groupId": "OG001",
8449 | "value": "21.5",
8450 | "lowerLimit": "9",
8451 | "upperLimit": "28"
8452 | }
8453 | ]
8454 | }
8455 | ]
8456 | },
8457 | {
8458 | "title": "Among participants who did not die",
8459 | "denoms": [
8460 | {
8461 | "units": "Participants",
8462 | "counts": [
8463 | {
8464 | "groupId": "OG000",
8465 | "value": "57"
8466 | },
8467 | {
8468 | "groupId": "OG001",
8469 | "value": "39"
8470 | }
8471 | ]
8472 | }
8473 | ],
8474 | "categories": [
8475 | {
8476 | "measurements": [
8477 | {
8478 | "groupId": "OG000",
8479 | "value": "16",
8480 | "lowerLimit": "9",
8481 | "upperLimit": "24"
8482 | },
8483 | {
8484 | "groupId": "OG001",
8485 | "value": "14",
8486 | "lowerLimit": "5",
8487 | "upperLimit": "26"
8488 | }
8489 | ]
8490 | }
8491 | ]
8492 | }
8493 | ]
8494 | },
8495 | {
8496 | "type": "SECONDARY",
8497 | "title": "Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use",
8498 | "description": "New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.",
8499 | "populationDescription": "The analysis population is restricted to randomized participants who were not on non-invasive or high-flow oxygen at baseline.",
8500 | "reportingStatus": "POSTED",
8501 | "paramType": "NUMBER",
8502 | "dispersionType": "95% Confidence Interval",
8503 | "unitOfMeasure": "percentage of participants",
8504 | "timeFrame": "Day 1 through Day 29",
8505 | "groups": [
8506 | {
8507 | "id": "OG000",
8508 | "title": "Placebo",
8509 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8510 | },
8511 | {
8512 | "id": "OG001",
8513 | "title": "Remdesivir",
8514 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8515 | }
8516 | ],
8517 | "denoms": [
8518 | {
8519 | "units": "Participants",
8520 | "counts": [
8521 | {
8522 | "groupId": "OG000",
8523 | "value": "266"
8524 | },
8525 | {
8526 | "groupId": "OG001",
8527 | "value": "307"
8528 | }
8529 | ]
8530 | }
8531 | ],
8532 | "classes": [
8533 | {
8534 | "categories": [
8535 | {
8536 | "measurements": [
8537 | {
8538 | "groupId": "OG000",
8539 | "value": "24",
8540 | "lowerLimit": "19",
8541 | "upperLimit": "30"
8542 | },
8543 | {
8544 | "groupId": "OG001",
8545 | "value": "17",
8546 | "lowerLimit": "13",
8547 | "upperLimit": "22"
8548 | }
8549 | ]
8550 | }
8551 | ]
8552 | }
8553 | ]
8554 | },
8555 | {
8556 | "type": "SECONDARY",
8557 | "title": "Percentage of Participants Requiring New Oxygen Use",
8558 | "description": "The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline",
8559 | "populationDescription": "The analysis population is restricted to randomized participants not requiring oxygen at baseline.",
8560 | "reportingStatus": "POSTED",
8561 | "paramType": "NUMBER",
8562 | "dispersionType": "95% Confidence Interval",
8563 | "unitOfMeasure": "percentage of participants",
8564 | "timeFrame": "Day 1 through Day 29",
8565 | "groups": [
8566 | {
8567 | "id": "OG000",
8568 | "title": "Placebo",
8569 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8570 | },
8571 | {
8572 | "id": "OG001",
8573 | "title": "Remdesivir",
8574 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8575 | }
8576 | ],
8577 | "denoms": [
8578 | {
8579 | "units": "Participants",
8580 | "counts": [
8581 | {
8582 | "groupId": "OG000",
8583 | "value": "63"
8584 | },
8585 | {
8586 | "groupId": "OG001",
8587 | "value": "75"
8588 | }
8589 | ]
8590 | }
8591 | ],
8592 | "classes": [
8593 | {
8594 | "categories": [
8595 | {
8596 | "measurements": [
8597 | {
8598 | "groupId": "OG000",
8599 | "value": "44",
8600 | "lowerLimit": "33",
8601 | "upperLimit": "57"
8602 | },
8603 | {
8604 | "groupId": "OG001",
8605 | "value": "36",
8606 | "lowerLimit": "26",
8607 | "upperLimit": "47"
8608 | }
8609 | ]
8610 | }
8611 | ]
8612 | }
8613 | ]
8614 | },
8615 | {
8616 | "type": "SECONDARY",
8617 | "title": "Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use",
8618 | "description": "The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline",
8619 | "populationDescription": "The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline.",
8620 | "reportingStatus": "POSTED",
8621 | "paramType": "NUMBER",
8622 | "dispersionType": "95% Confidence Interval",
8623 | "unitOfMeasure": "percentage of participants",
8624 | "timeFrame": "Day 1 through Day 29",
8625 | "groups": [
8626 | {
8627 | "id": "OG000",
8628 | "title": "Placebo",
8629 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8630 | },
8631 | {
8632 | "id": "OG001",
8633 | "title": "Remdesivir",
8634 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8635 | }
8636 | ],
8637 | "denoms": [
8638 | {
8639 | "units": "Participants",
8640 | "counts": [
8641 | {
8642 | "groupId": "OG000",
8643 | "value": "364"
8644 | },
8645 | {
8646 | "groupId": "OG001",
8647 | "value": "402"
8648 | }
8649 | ]
8650 | }
8651 | ],
8652 | "classes": [
8653 | {
8654 | "categories": [
8655 | {
8656 | "measurements": [
8657 | {
8658 | "groupId": "OG000",
8659 | "value": "23",
8660 | "lowerLimit": "19",
8661 | "upperLimit": "27"
8662 | },
8663 | {
8664 | "groupId": "OG001",
8665 | "value": "13",
8666 | "lowerLimit": "10",
8667 | "upperLimit": "17"
8668 | }
8669 | ]
8670 | }
8671 | ]
8672 | }
8673 | ]
8674 | },
8675 | {
8676 | "type": "SECONDARY",
8677 | "title": "Mean Change in the Ordinal Scale",
8678 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.",
8679 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward. Clinical scores of 8 were carried forward from the date of death for participants who died.",
8680 | "reportingStatus": "POSTED",
8681 | "paramType": "MEAN",
8682 | "dispersionType": "Standard Deviation",
8683 | "unitOfMeasure": "units on a scale",
8684 | "timeFrame": "Day 1, 3, 5, 8, 11, 15, 22, and 29",
8685 | "groups": [
8686 | {
8687 | "id": "OG000",
8688 | "title": "Placebo",
8689 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8690 | },
8691 | {
8692 | "id": "OG001",
8693 | "title": "Remdesivir",
8694 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8695 | }
8696 | ],
8697 | "denoms": [
8698 | {
8699 | "units": "Participants",
8700 | "counts": [
8701 | {
8702 | "groupId": "OG000",
8703 | "value": "518"
8704 | },
8705 | {
8706 | "groupId": "OG001",
8707 | "value": "533"
8708 | }
8709 | ]
8710 | }
8711 | ],
8712 | "classes": [
8713 | {
8714 | "title": "Day 3",
8715 | "categories": [
8716 | {
8717 | "measurements": [
8718 | {
8719 | "groupId": "OG000",
8720 | "value": "0.2",
8721 | "spread": "0.6"
8722 | },
8723 | {
8724 | "groupId": "OG001",
8725 | "value": "0.1",
8726 | "spread": "0.6"
8727 | }
8728 | ]
8729 | }
8730 | ]
8731 | },
8732 | {
8733 | "title": "Day 5",
8734 | "categories": [
8735 | {
8736 | "measurements": [
8737 | {
8738 | "groupId": "OG000",
8739 | "value": "0.1",
8740 | "spread": "0.9"
8741 | },
8742 | {
8743 | "groupId": "OG001",
8744 | "value": "0.0",
8745 | "spread": "0.8"
8746 | }
8747 | ]
8748 | }
8749 | ]
8750 | },
8751 | {
8752 | "title": "Day 8",
8753 | "categories": [
8754 | {
8755 | "measurements": [
8756 | {
8757 | "groupId": "OG000",
8758 | "value": "0.0",
8759 | "spread": "0.1"
8760 | },
8761 | {
8762 | "groupId": "OG001",
8763 | "value": "-0.2",
8764 | "spread": "1.0"
8765 | }
8766 | ]
8767 | }
8768 | ]
8769 | },
8770 | {
8771 | "title": "Day 11",
8772 | "categories": [
8773 | {
8774 | "measurements": [
8775 | {
8776 | "groupId": "OG000",
8777 | "value": "-0.1",
8778 | "spread": "1.3"
8779 | },
8780 | {
8781 | "groupId": "OG001",
8782 | "value": "-0.3",
8783 | "spread": "1.1"
8784 | }
8785 | ]
8786 | }
8787 | ]
8788 | },
8789 | {
8790 | "title": "Day 15",
8791 | "categories": [
8792 | {
8793 | "measurements": [
8794 | {
8795 | "groupId": "OG000",
8796 | "value": "-1.4",
8797 | "spread": "2.3"
8798 | },
8799 | {
8800 | "groupId": "OG001",
8801 | "value": "-1.9",
8802 | "spread": "2.1"
8803 | }
8804 | ]
8805 | }
8806 | ]
8807 | },
8808 | {
8809 | "title": "Day 22",
8810 | "categories": [
8811 | {
8812 | "measurements": [
8813 | {
8814 | "groupId": "OG000",
8815 | "value": "-1.9",
8816 | "spread": "2.5"
8817 | },
8818 | {
8819 | "groupId": "OG001",
8820 | "value": "-2.4",
8821 | "spread": "2.2"
8822 | }
8823 | ]
8824 | }
8825 | ]
8826 | },
8827 | {
8828 | "title": "Day 29",
8829 | "categories": [
8830 | {
8831 | "measurements": [
8832 | {
8833 | "groupId": "OG000",
8834 | "value": "-2.3",
8835 | "spread": "2.6"
8836 | },
8837 | {
8838 | "groupId": "OG001",
8839 | "value": "-2.7",
8840 | "spread": "2.3"
8841 | }
8842 | ]
8843 | }
8844 | ]
8845 | }
8846 | ]
8847 | },
8848 | {
8849 | "type": "SECONDARY",
8850 | "title": "14-day Participant Mortality",
8851 | "description": "The mortality rate was determined as the proportion of participants who died by study Day 15.",
8852 | "populationDescription": "The ITT population consists of all participants as randomized.",
8853 | "reportingStatus": "POSTED",
8854 | "paramType": "NUMBER",
8855 | "dispersionType": "95% Confidence Interval",
8856 | "unitOfMeasure": "Proportion of participants",
8857 | "timeFrame": "Day 1 through Day 15",
8858 | "groups": [
8859 | {
8860 | "id": "OG000",
8861 | "title": "Placebo",
8862 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8863 | },
8864 | {
8865 | "id": "OG001",
8866 | "title": "Remdesivir",
8867 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8868 | }
8869 | ],
8870 | "denoms": [
8871 | {
8872 | "units": "Participants",
8873 | "counts": [
8874 | {
8875 | "groupId": "OG000",
8876 | "value": "521"
8877 | },
8878 | {
8879 | "groupId": "OG001",
8880 | "value": "541"
8881 | }
8882 | ]
8883 | }
8884 | ],
8885 | "classes": [
8886 | {
8887 | "categories": [
8888 | {
8889 | "measurements": [
8890 | {
8891 | "groupId": "OG000",
8892 | "value": "0.12",
8893 | "lowerLimit": "0.09",
8894 | "upperLimit": "0.15"
8895 | },
8896 | {
8897 | "groupId": "OG001",
8898 | "value": "0.07",
8899 | "lowerLimit": "0.05",
8900 | "upperLimit": "0.09"
8901 | }
8902 | ]
8903 | }
8904 | ]
8905 | }
8906 | ]
8907 | },
8908 | {
8909 | "type": "SECONDARY",
8910 | "title": "29-day Participant Mortality",
8911 | "description": "The mortality rate was determined as the proportion of participants who died by study Day 29.",
8912 | "populationDescription": "The ITT population includes all participants as randomized",
8913 | "reportingStatus": "POSTED",
8914 | "paramType": "NUMBER",
8915 | "dispersionType": "95% Confidence Interval",
8916 | "unitOfMeasure": "Proportion of participants",
8917 | "timeFrame": "Day 1 through Day 29",
8918 | "groups": [
8919 | {
8920 | "id": "OG000",
8921 | "title": "Placebo",
8922 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8923 | },
8924 | {
8925 | "id": "OG001",
8926 | "title": "Remdesivir",
8927 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8928 | }
8929 | ],
8930 | "denoms": [
8931 | {
8932 | "units": "Participants",
8933 | "counts": [
8934 | {
8935 | "groupId": "OG000",
8936 | "value": "521"
8937 | },
8938 | {
8939 | "groupId": "OG001",
8940 | "value": "541"
8941 | }
8942 | ]
8943 | }
8944 | ],
8945 | "classes": [
8946 | {
8947 | "categories": [
8948 | {
8949 | "measurements": [
8950 | {
8951 | "groupId": "OG000",
8952 | "value": "0.15",
8953 | "lowerLimit": "0.12",
8954 | "upperLimit": "0.19"
8955 | },
8956 | {
8957 | "groupId": "OG001",
8958 | "value": "0.11",
8959 | "lowerLimit": "0.09",
8960 | "upperLimit": "0.15"
8961 | }
8962 | ]
8963 | }
8964 | ]
8965 | }
8966 | ]
8967 | },
8968 | {
8969 | "type": "SECONDARY",
8970 | "title": "Time to an Improvement by at Least One Category Using an Ordinal Scale",
8971 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant",
8972 | "populationDescription": "The ITT population includes all participants as randomized",
8973 | "reportingStatus": "POSTED",
8974 | "paramType": "MEDIAN",
8975 | "dispersionType": "95% Confidence Interval",
8976 | "unitOfMeasure": "Days",
8977 | "timeFrame": "Day 1 through Day 29",
8978 | "groups": [
8979 | {
8980 | "id": "OG000",
8981 | "title": "Placebo",
8982 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
8983 | },
8984 | {
8985 | "id": "OG001",
8986 | "title": "Remdesivir",
8987 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
8988 | }
8989 | ],
8990 | "denoms": [
8991 | {
8992 | "units": "Participants",
8993 | "counts": [
8994 | {
8995 | "groupId": "OG000",
8996 | "value": "521"
8997 | },
8998 | {
8999 | "groupId": "OG001",
9000 | "value": "541"
9001 | }
9002 | ]
9003 | }
9004 | ],
9005 | "classes": [
9006 | {
9007 | "categories": [
9008 | {
9009 | "measurements": [
9010 | {
9011 | "groupId": "OG000",
9012 | "value": "9",
9013 | "lowerLimit": "8",
9014 | "upperLimit": "11"
9015 | },
9016 | {
9017 | "groupId": "OG001",
9018 | "value": "7",
9019 | "lowerLimit": "6",
9020 | "upperLimit": "8"
9021 | }
9022 | ]
9023 | }
9024 | ]
9025 | }
9026 | ],
9027 | "analyses": [
9028 | {
9029 | "groupIds": ["OG000", "OG001"],
9030 | "nonInferiorityType": "SUPERIORITY",
9031 | "pValue": "0.002",
9032 | "statisticalMethod": "Log Rank",
9033 | "paramType": "Cox Proportional Hazard",
9034 | "paramValue": "1.23",
9035 | "ciPctValue": "95",
9036 | "ciNumSides": "TWO_SIDED",
9037 | "ciLowerLimit": "1.08",
9038 | "ciUpperLimit": "1.41"
9039 | }
9040 | ]
9041 | },
9042 | {
9043 | "type": "SECONDARY",
9044 | "title": "Time to an Improvement of at Least Two Categories Using an Ordinal Scale",
9045 | "description": "The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant",
9046 | "populationDescription": "The ITT population includes all participants as randomized",
9047 | "reportingStatus": "POSTED",
9048 | "paramType": "MEDIAN",
9049 | "dispersionType": "95% Confidence Interval",
9050 | "unitOfMeasure": "Days",
9051 | "timeFrame": "Day 1 through Day 29",
9052 | "groups": [
9053 | {
9054 | "id": "OG000",
9055 | "title": "Placebo",
9056 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
9057 | },
9058 | {
9059 | "id": "OG001",
9060 | "title": "Remdesivir",
9061 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
9062 | }
9063 | ],
9064 | "denoms": [
9065 | {
9066 | "units": "Participants",
9067 | "counts": [
9068 | {
9069 | "groupId": "OG000",
9070 | "value": "521"
9071 | },
9072 | {
9073 | "groupId": "OG001",
9074 | "value": "541"
9075 | }
9076 | ]
9077 | }
9078 | ],
9079 | "classes": [
9080 | {
9081 | "categories": [
9082 | {
9083 | "measurements": [
9084 | {
9085 | "groupId": "OG000",
9086 | "value": "14",
9087 | "lowerLimit": "13",
9088 | "upperLimit": "15"
9089 | },
9090 | {
9091 | "groupId": "OG001",
9092 | "value": "11",
9093 | "lowerLimit": "10",
9094 | "upperLimit": "13"
9095 | }
9096 | ]
9097 | }
9098 | ]
9099 | }
9100 | ],
9101 | "analyses": [
9102 | {
9103 | "groupIds": ["OG000", "OG001"],
9104 | "nonInferiorityType": "SUPERIORITY",
9105 | "pValue": "<0.001",
9106 | "statisticalMethod": "Log Rank",
9107 | "paramType": "Cox Proportional Hazard",
9108 | "paramValue": "1.29",
9109 | "ciPctValue": "95",
9110 | "ciNumSides": "TWO_SIDED",
9111 | "ciLowerLimit": "1.12",
9112 | "ciUpperLimit": "1.48"
9113 | }
9114 | ]
9115 | },
9116 | {
9117 | "type": "SECONDARY",
9118 | "title": "Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First",
9119 | "description": "The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.",
9120 | "populationDescription": "The ITT population includes all participants as randomized.",
9121 | "reportingStatus": "POSTED",
9122 | "paramType": "MEDIAN",
9123 | "dispersionType": "95% Confidence Interval",
9124 | "unitOfMeasure": "Days",
9125 | "timeFrame": "Day 1 through Day 29",
9126 | "groups": [
9127 | {
9128 | "id": "OG000",
9129 | "title": "Placebo",
9130 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
9131 | },
9132 | {
9133 | "id": "OG001",
9134 | "title": "Remdesivir",
9135 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
9136 | }
9137 | ],
9138 | "denoms": [
9139 | {
9140 | "units": "Participants",
9141 | "counts": [
9142 | {
9143 | "groupId": "OG000",
9144 | "value": "521"
9145 | },
9146 | {
9147 | "groupId": "OG001",
9148 | "value": "541"
9149 | }
9150 | ]
9151 | }
9152 | ],
9153 | "classes": [
9154 | {
9155 | "categories": [
9156 | {
9157 | "measurements": [
9158 | {
9159 | "groupId": "OG000",
9160 | "value": "12",
9161 | "lowerLimit": "10",
9162 | "upperLimit": "15"
9163 | },
9164 | {
9165 | "groupId": "OG001",
9166 | "value": "8",
9167 | "lowerLimit": "7",
9168 | "upperLimit": "9"
9169 | }
9170 | ]
9171 | }
9172 | ]
9173 | }
9174 | ],
9175 | "analyses": [
9176 | {
9177 | "groupIds": ["OG000", "OG001"],
9178 | "nonInferiorityType": "SUPERIORITY",
9179 | "pValue": "<0.001",
9180 | "statisticalMethod": "Log Rank",
9181 | "paramType": "Cox Proportional Hazard",
9182 | "paramValue": "1.27",
9183 | "ciPctValue": "95",
9184 | "ciNumSides": "TWO_SIDED",
9185 | "ciLowerLimit": "1.10",
9186 | "ciUpperLimit": "1.46"
9187 | }
9188 | ]
9189 | },
9190 | {
9191 | "type": "PRIMARY",
9192 | "title": "Time to Recovery by Race",
9193 | "description": "Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.",
9194 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
9195 | "reportingStatus": "POSTED",
9196 | "paramType": "MEDIAN",
9197 | "dispersionType": "95% Confidence Interval",
9198 | "unitOfMeasure": "Days",
9199 | "timeFrame": "Day 1 through Day 29",
9200 | "groups": [
9201 | {
9202 | "id": "OG000",
9203 | "title": "Placebo",
9204 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
9205 | },
9206 | {
9207 | "id": "OG001",
9208 | "title": "Remdesivir",
9209 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
9210 | }
9211 | ],
9212 | "denoms": [
9213 | {
9214 | "units": "Participants",
9215 | "counts": [
9216 | {
9217 | "groupId": "OG000",
9218 | "value": "521"
9219 | },
9220 | {
9221 | "groupId": "OG001",
9222 | "value": "541"
9223 | }
9224 | ]
9225 | }
9226 | ],
9227 | "classes": [
9228 | {
9229 | "title": "Asian",
9230 | "denoms": [
9231 | {
9232 | "units": "Participants",
9233 | "counts": [
9234 | {
9235 | "groupId": "OG000",
9236 | "value": "56"
9237 | },
9238 | {
9239 | "groupId": "OG001",
9240 | "value": "79"
9241 | }
9242 | ]
9243 | }
9244 | ],
9245 | "categories": [
9246 | {
9247 | "measurements": [
9248 | {
9249 | "groupId": "OG000",
9250 | "value": "12.0",
9251 | "lowerLimit": "9.0",
9252 | "upperLimit": "15.0"
9253 | },
9254 | {
9255 | "groupId": "OG001",
9256 | "value": "11.0",
9257 | "lowerLimit": "9.0",
9258 | "upperLimit": "15.0"
9259 | }
9260 | ]
9261 | }
9262 | ]
9263 | },
9264 | {
9265 | "title": "Black or African American",
9266 | "denoms": [
9267 | {
9268 | "units": "Participants",
9269 | "counts": [
9270 | {
9271 | "groupId": "OG000",
9272 | "value": "117"
9273 | },
9274 | {
9275 | "groupId": "OG001",
9276 | "value": "109"
9277 | }
9278 | ]
9279 | }
9280 | ],
9281 | "categories": [
9282 | {
9283 | "measurements": [
9284 | {
9285 | "groupId": "OG000",
9286 | "value": "15.0",
9287 | "lowerLimit": "10.0",
9288 | "upperLimit": "21.0"
9289 | },
9290 | {
9291 | "groupId": "OG001",
9292 | "value": "10.0",
9293 | "lowerLimit": "7.0",
9294 | "upperLimit": "16.0"
9295 | }
9296 | ]
9297 | }
9298 | ]
9299 | },
9300 | {
9301 | "title": "White",
9302 | "denoms": [
9303 | {
9304 | "units": "Participants",
9305 | "counts": [
9306 | {
9307 | "groupId": "OG000",
9308 | "value": "287"
9309 | },
9310 | {
9311 | "groupId": "OG001",
9312 | "value": "279"
9313 | }
9314 | ]
9315 | }
9316 | ],
9317 | "categories": [
9318 | {
9319 | "measurements": [
9320 | {
9321 | "groupId": "OG000",
9322 | "value": "15.0",
9323 | "lowerLimit": "12.0",
9324 | "upperLimit": "19.0"
9325 | },
9326 | {
9327 | "groupId": "OG001",
9328 | "value": "9.0",
9329 | "lowerLimit": "8.0",
9330 | "upperLimit": "12.0"
9331 | }
9332 | ]
9333 | }
9334 | ]
9335 | },
9336 | {
9337 | "title": "Other",
9338 | "denoms": [
9339 | {
9340 | "units": "Participants",
9341 | "counts": [
9342 | {
9343 | "groupId": "OG000",
9344 | "value": "61"
9345 | },
9346 | {
9347 | "groupId": "OG001",
9348 | "value": "74"
9349 | }
9350 | ]
9351 | }
9352 | ],
9353 | "categories": [
9354 | {
9355 | "measurements": [
9356 | {
9357 | "groupId": "OG000",
9358 | "value": "24.0",
9359 | "lowerLimit": "15.0",
9360 | "upperLimit": "NA",
9361 | "comment": "A large number of participants at the median estimate resulted in little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) was unable to compute an upper confidence limit."
9362 | },
9363 | {
9364 | "groupId": "OG001",
9365 | "value": "9.0",
9366 | "lowerLimit": "6.0",
9367 | "upperLimit": "14.0"
9368 | }
9369 | ]
9370 | }
9371 | ]
9372 | }
9373 | ],
9374 | "analyses": [
9375 | {
9376 | "groupIds": ["OG000", "OG001"],
9377 | "groupDescription": "This analysis is for Asian participants",
9378 | "nonInferiorityType": "SUPERIORITY",
9379 | "paramType": "Cox Proportional Hazard",
9380 | "paramValue": "1.07",
9381 | "ciPctValue": "95",
9382 | "ciNumSides": "TWO_SIDED",
9383 | "ciLowerLimit": "0.73",
9384 | "ciUpperLimit": "1.58"
9385 | },
9386 | {
9387 | "groupIds": ["OG000", "OG001"],
9388 | "groupDescription": "This analysis is for Black or African American participants",
9389 | "nonInferiorityType": "SUPERIORITY",
9390 | "paramType": "Cox Proportional Hazard",
9391 | "paramValue": "1.25",
9392 | "ciPctValue": "95",
9393 | "ciNumSides": "TWO_SIDED",
9394 | "ciLowerLimit": "0.91",
9395 | "ciUpperLimit": "1.72"
9396 | },
9397 | {
9398 | "groupIds": ["OG000", "OG001"],
9399 | "groupDescription": "This analysis is for White participants",
9400 | "nonInferiorityType": "SUPERIORITY",
9401 | "paramType": "Cox Proportional Hazard",
9402 | "paramValue": "1.29",
9403 | "ciPctValue": "95",
9404 | "ciNumSides": "TWO_SIDED",
9405 | "ciLowerLimit": "1.06",
9406 | "ciUpperLimit": "1.57"
9407 | },
9408 | {
9409 | "groupIds": ["OG000", "OG001"],
9410 | "groupDescription": "This analysis is for Race of Other participants",
9411 | "nonInferiorityType": "SUPERIORITY",
9412 | "paramType": "Cox Proportional Hazard",
9413 | "paramValue": "1.68",
9414 | "ciPctValue": "95",
9415 | "ciNumSides": "TWO_SIDED",
9416 | "ciLowerLimit": "1.10",
9417 | "ciUpperLimit": "2.58"
9418 | }
9419 | ]
9420 | },
9421 | {
9422 | "type": "PRIMARY",
9423 | "title": "Time to Recovery by Ethnicity",
9424 | "description": "Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.",
9425 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized and for whom Ethnicity was reported",
9426 | "reportingStatus": "POSTED",
9427 | "paramType": "MEDIAN",
9428 | "dispersionType": "95% Confidence Interval",
9429 | "unitOfMeasure": "Days",
9430 | "timeFrame": "Day 1 through Day 29",
9431 | "groups": [
9432 | {
9433 | "id": "OG000",
9434 | "title": "Placebo",
9435 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
9436 | },
9437 | {
9438 | "id": "OG001",
9439 | "title": "Remdesivir",
9440 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
9441 | }
9442 | ],
9443 | "denoms": [
9444 | {
9445 | "units": "Participants",
9446 | "counts": [
9447 | {
9448 | "groupId": "OG000",
9449 | "value": "489"
9450 | },
9451 | {
9452 | "groupId": "OG001",
9453 | "value": "516"
9454 | }
9455 | ]
9456 | }
9457 | ],
9458 | "classes": [
9459 | {
9460 | "title": "Not Hispanic or Latino",
9461 | "denoms": [
9462 | {
9463 | "units": "Participants",
9464 | "counts": [
9465 | {
9466 | "groupId": "OG000",
9467 | "value": "373"
9468 | },
9469 | {
9470 | "groupId": "OG001",
9471 | "value": "382"
9472 | }
9473 | ]
9474 | }
9475 | ],
9476 | "categories": [
9477 | {
9478 | "measurements": [
9479 | {
9480 | "groupId": "OG000",
9481 | "value": "15.0",
9482 | "lowerLimit": "13.0",
9483 | "upperLimit": "18.0"
9484 | },
9485 | {
9486 | "groupId": "OG001",
9487 | "value": "10.0",
9488 | "lowerLimit": "8.0",
9489 | "upperLimit": "12.0"
9490 | }
9491 | ]
9492 | }
9493 | ]
9494 | },
9495 | {
9496 | "title": "Hispanic or Latino",
9497 | "denoms": [
9498 | {
9499 | "units": "Participants",
9500 | "counts": [
9501 | {
9502 | "groupId": "OG000",
9503 | "value": "116"
9504 | },
9505 | {
9506 | "groupId": "OG001",
9507 | "value": "134"
9508 | }
9509 | ]
9510 | }
9511 | ],
9512 | "categories": [
9513 | {
9514 | "measurements": [
9515 | {
9516 | "groupId": "OG000",
9517 | "value": "12.5",
9518 | "lowerLimit": "9.0",
9519 | "upperLimit": "22.0"
9520 | },
9521 | {
9522 | "groupId": "OG001",
9523 | "value": "10.0",
9524 | "lowerLimit": "7.0",
9525 | "upperLimit": "14.0"
9526 | }
9527 | ]
9528 | }
9529 | ]
9530 | }
9531 | ],
9532 | "analyses": [
9533 | {
9534 | "groupIds": ["OG000", "OG001"],
9535 | "groupDescription": "This analysis is for Not Hispanic or Latino participants",
9536 | "nonInferiorityType": "SUPERIORITY",
9537 | "paramType": "Cox Proportional Hazard",
9538 | "paramValue": "1.31",
9539 | "ciPctValue": "95",
9540 | "ciNumSides": "TWO_SIDED",
9541 | "ciLowerLimit": "1.10",
9542 | "ciUpperLimit": "1.55"
9543 | },
9544 | {
9545 | "groupIds": ["OG000", "OG001"],
9546 | "groupDescription": "This analysis is for Hispanic or Latino participants",
9547 | "nonInferiorityType": "SUPERIORITY",
9548 | "paramType": "Cox Proportional Hazard",
9549 | "paramValue": "1.28",
9550 | "ciPctValue": "95",
9551 | "ciNumSides": "TWO_SIDED",
9552 | "ciLowerLimit": "0.94",
9553 | "ciUpperLimit": "1.73"
9554 | }
9555 | ]
9556 | },
9557 | {
9558 | "type": "PRIMARY",
9559 | "title": "Time to Recovery by Sex",
9560 | "description": "Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.",
9561 | "populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
9562 | "reportingStatus": "POSTED",
9563 | "paramType": "MEDIAN",
9564 | "dispersionType": "95% Confidence Interval",
9565 | "unitOfMeasure": "Days",
9566 | "timeFrame": "Day 1 through Day 29",
9567 | "groups": [
9568 | {
9569 | "id": "OG000",
9570 | "title": "Placebo",
9571 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course."
9572 | },
9573 | {
9574 | "id": "OG001",
9575 | "title": "Remdesivir",
9576 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course."
9577 | }
9578 | ],
9579 | "denoms": [
9580 | {
9581 | "units": "Participants",
9582 | "counts": [
9583 | {
9584 | "groupId": "OG000",
9585 | "value": "521"
9586 | },
9587 | {
9588 | "groupId": "OG001",
9589 | "value": "541"
9590 | }
9591 | ]
9592 | }
9593 | ],
9594 | "classes": [
9595 | {
9596 | "title": "Male",
9597 | "denoms": [
9598 | {
9599 | "units": "Participants",
9600 | "counts": [
9601 | {
9602 | "groupId": "OG000",
9603 | "value": "332"
9604 | },
9605 | {
9606 | "groupId": "OG001",
9607 | "value": "352"
9608 | }
9609 | ]
9610 | }
9611 | ],
9612 | "categories": [
9613 | {
9614 | "measurements": [
9615 | {
9616 | "groupId": "OG000",
9617 | "value": "15.0",
9618 | "lowerLimit": "12.0",
9619 | "upperLimit": "19.0"
9620 | },
9621 | {
9622 | "groupId": "OG001",
9623 | "value": "9.0",
9624 | "lowerLimit": "8.0",
9625 | "upperLimit": "12.0"
9626 | }
9627 | ]
9628 | }
9629 | ]
9630 | },
9631 | {
9632 | "title": "Female",
9633 | "denoms": [
9634 | {
9635 | "units": "Participants",
9636 | "counts": [
9637 | {
9638 | "groupId": "OG000",
9639 | "value": "189"
9640 | },
9641 | {
9642 | "groupId": "OG001",
9643 | "value": "189"
9644 | }
9645 | ]
9646 | }
9647 | ],
9648 | "categories": [
9649 | {
9650 | "measurements": [
9651 | {
9652 | "groupId": "OG000",
9653 | "value": "15.0",
9654 | "lowerLimit": "12.0",
9655 | "upperLimit": "19.0"
9656 | },
9657 | {
9658 | "groupId": "OG001",
9659 | "value": "10.0",
9660 | "lowerLimit": "8.0",
9661 | "upperLimit": "13.0"
9662 | }
9663 | ]
9664 | }
9665 | ]
9666 | }
9667 | ],
9668 | "analyses": [
9669 | {
9670 | "groupIds": ["OG000", "OG001"],
9671 | "groupDescription": "This analysis is for Male participants",
9672 | "nonInferiorityType": "SUPERIORITY",
9673 | "paramType": "Cox Proportional Hazard",
9674 | "paramValue": "1.30",
9675 | "ciPctValue": "95",
9676 | "ciNumSides": "TWO_SIDED",
9677 | "ciLowerLimit": "1.09",
9678 | "ciUpperLimit": "1.56"
9679 | },
9680 | {
9681 | "groupIds": ["OG000", "OG001"],
9682 | "groupDescription": "This analysis is for Female participants",
9683 | "nonInferiorityType": "SUPERIORITY",
9684 | "paramType": "Cox Proportional Hazard",
9685 | "paramValue": "1.31",
9686 | "ciPctValue": "95",
9687 | "ciNumSides": "TWO_SIDED",
9688 | "ciLowerLimit": "1.03",
9689 | "ciUpperLimit": "1.66"
9690 | }
9691 | ]
9692 | }
9693 | ]
9694 | },
9695 | "adverseEventsModule": {
9696 | "frequencyThreshold": "5",
9697 | "timeFrame": "Grade 3 and 4 serious and non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29.",
9698 | "description": "Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. In addition, any Grade 2 or higher, suspected drug-related hypersensitivity reaction was to be reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.",
9699 | "eventGroups": [
9700 | {
9701 | "id": "EG000",
9702 | "title": "Placebo",
9703 | "description": "200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.",
9704 | "deathsNumAffected": 77,
9705 | "deathsNumAtRisk": 521,
9706 | "seriousNumAffected": 163,
9707 | "seriousNumAtRisk": 516,
9708 | "otherNumAffected": 295,
9709 | "otherNumAtRisk": 516
9710 | },
9711 | {
9712 | "id": "EG001",
9713 | "title": "Remdesivir",
9714 | "description": "200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.",
9715 | "deathsNumAffected": 59,
9716 | "deathsNumAtRisk": 541,
9717 | "seriousNumAffected": 131,
9718 | "seriousNumAtRisk": 532,
9719 | "otherNumAffected": 276,
9720 | "otherNumAtRisk": 532
9721 | }
9722 | ],
9723 | "seriousEvents": [
9724 | {
9725 | "term": "Coagulopathy",
9726 | "organSystem": "Blood and lymphatic system disorders",
9727 | "sourceVocabulary": "MedDRA (23.0)",
9728 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9729 | "stats": [
9730 | {
9731 | "groupId": "EG000",
9732 | "numEvents": 0,
9733 | "numAffected": 0,
9734 | "numAtRisk": 516
9735 | },
9736 | {
9737 | "groupId": "EG001",
9738 | "numEvents": 1,
9739 | "numAffected": 1,
9740 | "numAtRisk": 532
9741 | }
9742 | ]
9743 | },
9744 | {
9745 | "term": "Febrile neutropenia",
9746 | "organSystem": "Blood and lymphatic system disorders",
9747 | "sourceVocabulary": "MedDRA (23.0)",
9748 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9749 | "stats": [
9750 | {
9751 | "groupId": "EG000",
9752 | "numEvents": 0,
9753 | "numAffected": 0,
9754 | "numAtRisk": 516
9755 | },
9756 | {
9757 | "groupId": "EG001",
9758 | "numEvents": 1,
9759 | "numAffected": 1,
9760 | "numAtRisk": 532
9761 | }
9762 | ]
9763 | },
9764 | {
9765 | "term": "Anaemia",
9766 | "organSystem": "Blood and lymphatic system disorders",
9767 | "sourceVocabulary": "MedDRA (23.0)",
9768 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9769 | "stats": [
9770 | {
9771 | "groupId": "EG000",
9772 | "numEvents": 1,
9773 | "numAffected": 1,
9774 | "numAtRisk": 516
9775 | },
9776 | {
9777 | "groupId": "EG001",
9778 | "numEvents": 0,
9779 | "numAffected": 0,
9780 | "numAtRisk": 532
9781 | }
9782 | ]
9783 | },
9784 | {
9785 | "term": "Cardiac arrest",
9786 | "organSystem": "Cardiac disorders",
9787 | "sourceVocabulary": "MedDRA (23.0)",
9788 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9789 | "stats": [
9790 | {
9791 | "groupId": "EG000",
9792 | "numEvents": 7,
9793 | "numAffected": 7,
9794 | "numAtRisk": 516
9795 | },
9796 | {
9797 | "groupId": "EG001",
9798 | "numEvents": 10,
9799 | "numAffected": 10,
9800 | "numAtRisk": 532
9801 | }
9802 | ]
9803 | },
9804 | {
9805 | "term": "Atrial fibrillation",
9806 | "organSystem": "Cardiac disorders",
9807 | "sourceVocabulary": "MedDRA (23.0)",
9808 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9809 | "stats": [
9810 | {
9811 | "groupId": "EG000",
9812 | "numEvents": 2,
9813 | "numAffected": 1,
9814 | "numAtRisk": 516
9815 | },
9816 | {
9817 | "groupId": "EG001",
9818 | "numEvents": 6,
9819 | "numAffected": 5,
9820 | "numAtRisk": 532
9821 | }
9822 | ]
9823 | },
9824 | {
9825 | "term": "Cardio-respiratory arrest",
9826 | "organSystem": "Cardiac disorders",
9827 | "sourceVocabulary": "MedDRA (23.0)",
9828 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9829 | "stats": [
9830 | {
9831 | "groupId": "EG000",
9832 | "numEvents": 3,
9833 | "numAffected": 3,
9834 | "numAtRisk": 516
9835 | },
9836 | {
9837 | "groupId": "EG001",
9838 | "numEvents": 1,
9839 | "numAffected": 1,
9840 | "numAtRisk": 532
9841 | }
9842 | ]
9843 | },
9844 | {
9845 | "term": "Myocardial infarction",
9846 | "organSystem": "Cardiac disorders",
9847 | "sourceVocabulary": "MedDRA (23.0)",
9848 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9849 | "stats": [
9850 | {
9851 | "groupId": "EG000",
9852 | "numEvents": 4,
9853 | "numAffected": 4,
9854 | "numAtRisk": 516
9855 | },
9856 | {
9857 | "groupId": "EG001",
9858 | "numEvents": 0,
9859 | "numAffected": 0,
9860 | "numAtRisk": 532
9861 | }
9862 | ]
9863 | },
9864 | {
9865 | "term": "Supraventricular tachycardia",
9866 | "organSystem": "Cardiac disorders",
9867 | "sourceVocabulary": "MedDRA (23.0)",
9868 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9869 | "stats": [
9870 | {
9871 | "groupId": "EG000",
9872 | "numEvents": 3,
9873 | "numAffected": 3,
9874 | "numAtRisk": 516
9875 | },
9876 | {
9877 | "groupId": "EG001",
9878 | "numEvents": 0,
9879 | "numAffected": 0,
9880 | "numAtRisk": 532
9881 | }
9882 | ]
9883 | },
9884 | {
9885 | "term": "Ventricular tachycardia",
9886 | "organSystem": "Cardiac disorders",
9887 | "sourceVocabulary": "MedDRA (23.0)",
9888 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9889 | "stats": [
9890 | {
9891 | "groupId": "EG000",
9892 | "numEvents": 0,
9893 | "numAffected": 0,
9894 | "numAtRisk": 516
9895 | },
9896 | {
9897 | "groupId": "EG001",
9898 | "numEvents": 2,
9899 | "numAffected": 2,
9900 | "numAtRisk": 532
9901 | }
9902 | ]
9903 | },
9904 | {
9905 | "term": "Acute myocardial infarction",
9906 | "organSystem": "Cardiac disorders",
9907 | "sourceVocabulary": "MedDRA (23.0)",
9908 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9909 | "stats": [
9910 | {
9911 | "groupId": "EG000",
9912 | "numEvents": 1,
9913 | "numAffected": 1,
9914 | "numAtRisk": 516
9915 | },
9916 | {
9917 | "groupId": "EG001",
9918 | "numEvents": 1,
9919 | "numAffected": 1,
9920 | "numAtRisk": 532
9921 | }
9922 | ]
9923 | },
9924 | {
9925 | "term": "Cardiac failure",
9926 | "organSystem": "Cardiac disorders",
9927 | "sourceVocabulary": "MedDRA (23.0)",
9928 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9929 | "stats": [
9930 | {
9931 | "groupId": "EG000",
9932 | "numEvents": 1,
9933 | "numAffected": 1,
9934 | "numAtRisk": 516
9935 | },
9936 | {
9937 | "groupId": "EG001",
9938 | "numEvents": 1,
9939 | "numAffected": 1,
9940 | "numAtRisk": 532
9941 | }
9942 | ]
9943 | },
9944 | {
9945 | "term": "Cardiogenic shock",
9946 | "organSystem": "Cardiac disorders",
9947 | "sourceVocabulary": "MedDRA (23.0)",
9948 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9949 | "stats": [
9950 | {
9951 | "groupId": "EG000",
9952 | "numEvents": 2,
9953 | "numAffected": 2,
9954 | "numAtRisk": 516
9955 | },
9956 | {
9957 | "groupId": "EG001",
9958 | "numEvents": 0,
9959 | "numAffected": 0,
9960 | "numAtRisk": 532
9961 | }
9962 | ]
9963 | },
9964 | {
9965 | "term": "Acute coronary syndrome",
9966 | "organSystem": "Cardiac disorders",
9967 | "sourceVocabulary": "MedDRA (23.0)",
9968 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9969 | "stats": [
9970 | {
9971 | "groupId": "EG000",
9972 | "numEvents": 0,
9973 | "numAffected": 0,
9974 | "numAtRisk": 516
9975 | },
9976 | {
9977 | "groupId": "EG001",
9978 | "numEvents": 1,
9979 | "numAffected": 1,
9980 | "numAtRisk": 532
9981 | }
9982 | ]
9983 | },
9984 | {
9985 | "term": "Arrhythmia",
9986 | "organSystem": "Cardiac disorders",
9987 | "sourceVocabulary": "MedDRA (23.0)",
9988 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
9989 | "stats": [
9990 | {
9991 | "groupId": "EG000",
9992 | "numEvents": 0,
9993 | "numAffected": 0,
9994 | "numAtRisk": 516
9995 | },
9996 | {
9997 | "groupId": "EG001",
9998 | "numEvents": 1,
9999 | "numAffected": 1,
10000 | "numAtRisk": 532
10001 | }
10002 | ]
10003 | },
10004 | {
10005 | "term": "Palpitations",
10006 | "organSystem": "Cardiac disorders",
10007 | "sourceVocabulary": "MedDRA (23.0)",
10008 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10009 | "stats": [
10010 | {
10011 | "groupId": "EG000",
10012 | "numEvents": 0,
10013 | "numAffected": 0,
10014 | "numAtRisk": 516
10015 | },
10016 | {
10017 | "groupId": "EG001",
10018 | "numEvents": 1,
10019 | "numAffected": 1,
10020 | "numAtRisk": 532
10021 | }
10022 | ]
10023 | },
10024 | {
10025 | "term": "Pulseless electrical activity",
10026 | "organSystem": "Cardiac disorders",
10027 | "sourceVocabulary": "MedDRA (23.0)",
10028 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10029 | "stats": [
10030 | {
10031 | "groupId": "EG000",
10032 | "numEvents": 0,
10033 | "numAffected": 0,
10034 | "numAtRisk": 516
10035 | },
10036 | {
10037 | "groupId": "EG001",
10038 | "numEvents": 1,
10039 | "numAffected": 1,
10040 | "numAtRisk": 532
10041 | }
10042 | ]
10043 | },
10044 | {
10045 | "term": "Ventricular fibrillation",
10046 | "organSystem": "Cardiac disorders",
10047 | "sourceVocabulary": "MedDRA (23.0)",
10048 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10049 | "stats": [
10050 | {
10051 | "groupId": "EG000",
10052 | "numEvents": 0,
10053 | "numAffected": 0,
10054 | "numAtRisk": 516
10055 | },
10056 | {
10057 | "groupId": "EG001",
10058 | "numEvents": 1,
10059 | "numAffected": 1,
10060 | "numAtRisk": 532
10061 | }
10062 | ]
10063 | },
10064 | {
10065 | "term": "Cardiac tamponade",
10066 | "organSystem": "Cardiac disorders",
10067 | "sourceVocabulary": "MedDRA (23.0)",
10068 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10069 | "stats": [
10070 | {
10071 | "groupId": "EG000",
10072 | "numEvents": 1,
10073 | "numAffected": 1,
10074 | "numAtRisk": 516
10075 | },
10076 | {
10077 | "groupId": "EG001",
10078 | "numEvents": 0,
10079 | "numAffected": 0,
10080 | "numAtRisk": 532
10081 | }
10082 | ]
10083 | },
10084 | {
10085 | "term": "Intestinal ischaemia",
10086 | "organSystem": "Gastrointestinal disorders",
10087 | "sourceVocabulary": "MedDRA (23.0)",
10088 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10089 | "stats": [
10090 | {
10091 | "groupId": "EG000",
10092 | "numEvents": 0,
10093 | "numAffected": 0,
10094 | "numAtRisk": 516
10095 | },
10096 | {
10097 | "groupId": "EG001",
10098 | "numEvents": 3,
10099 | "numAffected": 3,
10100 | "numAtRisk": 532
10101 | }
10102 | ]
10103 | },
10104 | {
10105 | "term": "Diarrhoea",
10106 | "organSystem": "Gastrointestinal disorders",
10107 | "sourceVocabulary": "MedDRA (23.0)",
10108 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10109 | "stats": [
10110 | {
10111 | "groupId": "EG000",
10112 | "numEvents": 0,
10113 | "numAffected": 0,
10114 | "numAtRisk": 516
10115 | },
10116 | {
10117 | "groupId": "EG001",
10118 | "numEvents": 1,
10119 | "numAffected": 1,
10120 | "numAtRisk": 532
10121 | }
10122 | ]
10123 | },
10124 | {
10125 | "term": "Duodenal perforation",
10126 | "organSystem": "Gastrointestinal disorders",
10127 | "sourceVocabulary": "MedDRA (23.0)",
10128 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10129 | "stats": [
10130 | {
10131 | "groupId": "EG000",
10132 | "numEvents": 0,
10133 | "numAffected": 0,
10134 | "numAtRisk": 516
10135 | },
10136 | {
10137 | "groupId": "EG001",
10138 | "numEvents": 1,
10139 | "numAffected": 1,
10140 | "numAtRisk": 532
10141 | }
10142 | ]
10143 | },
10144 | {
10145 | "term": "Gastrointestinal haemorrhage",
10146 | "organSystem": "Gastrointestinal disorders",
10147 | "sourceVocabulary": "MedDRA (23.0)",
10148 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10149 | "stats": [
10150 | {
10151 | "groupId": "EG000",
10152 | "numEvents": 0,
10153 | "numAffected": 0,
10154 | "numAtRisk": 516
10155 | },
10156 | {
10157 | "groupId": "EG001",
10158 | "numEvents": 1,
10159 | "numAffected": 1,
10160 | "numAtRisk": 532
10161 | }
10162 | ]
10163 | },
10164 | {
10165 | "term": "Small intestinal perforation",
10166 | "organSystem": "Gastrointestinal disorders",
10167 | "sourceVocabulary": "MedDRA (23.0)",
10168 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10169 | "stats": [
10170 | {
10171 | "groupId": "EG000",
10172 | "numEvents": 0,
10173 | "numAffected": 0,
10174 | "numAtRisk": 516
10175 | },
10176 | {
10177 | "groupId": "EG001",
10178 | "numEvents": 1,
10179 | "numAffected": 1,
10180 | "numAtRisk": 532
10181 | }
10182 | ]
10183 | },
10184 | {
10185 | "term": "Haematemesis",
10186 | "organSystem": "Gastrointestinal disorders",
10187 | "sourceVocabulary": "MedDRA (23.0)",
10188 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10189 | "stats": [
10190 | {
10191 | "groupId": "EG000",
10192 | "numEvents": 1,
10193 | "numAffected": 1,
10194 | "numAtRisk": 516
10195 | },
10196 | {
10197 | "groupId": "EG001",
10198 | "numEvents": 0,
10199 | "numAffected": 0,
10200 | "numAtRisk": 532
10201 | }
10202 | ]
10203 | },
10204 | {
10205 | "term": "Peptic ulcer haemorrhage",
10206 | "organSystem": "Gastrointestinal disorders",
10207 | "sourceVocabulary": "MedDRA (23.0)",
10208 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10209 | "stats": [
10210 | {
10211 | "groupId": "EG000",
10212 | "numEvents": 1,
10213 | "numAffected": 1,
10214 | "numAtRisk": 516
10215 | },
10216 | {
10217 | "groupId": "EG001",
10218 | "numEvents": 0,
10219 | "numAffected": 0,
10220 | "numAtRisk": 532
10221 | }
10222 | ]
10223 | },
10224 | {
10225 | "term": "Small intestinal obstruction",
10226 | "organSystem": "Gastrointestinal disorders",
10227 | "sourceVocabulary": "MedDRA (23.0)",
10228 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10229 | "stats": [
10230 | {
10231 | "groupId": "EG000",
10232 | "numEvents": 1,
10233 | "numAffected": 1,
10234 | "numAtRisk": 516
10235 | },
10236 | {
10237 | "groupId": "EG001",
10238 | "numEvents": 0,
10239 | "numAffected": 0,
10240 | "numAtRisk": 532
10241 | }
10242 | ]
10243 | },
10244 | {
10245 | "term": "Multiple organ dysfunction syndrome",
10246 | "organSystem": "General disorders",
10247 | "sourceVocabulary": "MedDRA (23.0)",
10248 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10249 | "stats": [
10250 | {
10251 | "groupId": "EG000",
10252 | "numEvents": 3,
10253 | "numAffected": 3,
10254 | "numAtRisk": 516
10255 | },
10256 | {
10257 | "groupId": "EG001",
10258 | "numEvents": 5,
10259 | "numAffected": 5,
10260 | "numAtRisk": 532
10261 | }
10262 | ]
10263 | },
10264 | {
10265 | "term": "Pyrexia",
10266 | "organSystem": "General disorders",
10267 | "sourceVocabulary": "MedDRA (23.0)",
10268 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10269 | "stats": [
10270 | {
10271 | "groupId": "EG000",
10272 | "numEvents": 2,
10273 | "numAffected": 2,
10274 | "numAtRisk": 516
10275 | },
10276 | {
10277 | "groupId": "EG001",
10278 | "numEvents": 1,
10279 | "numAffected": 1,
10280 | "numAtRisk": 532
10281 | }
10282 | ]
10283 | },
10284 | {
10285 | "term": "Chest pain",
10286 | "organSystem": "General disorders",
10287 | "sourceVocabulary": "MedDRA (23.0)",
10288 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10289 | "stats": [
10290 | {
10291 | "groupId": "EG000",
10292 | "numEvents": 0,
10293 | "numAffected": 0,
10294 | "numAtRisk": 516
10295 | },
10296 | {
10297 | "groupId": "EG001",
10298 | "numEvents": 1,
10299 | "numAffected": 1,
10300 | "numAtRisk": 532
10301 | }
10302 | ]
10303 | },
10304 | {
10305 | "term": "Death",
10306 | "organSystem": "General disorders",
10307 | "sourceVocabulary": "MedDRA (23.0)",
10308 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10309 | "stats": [
10310 | {
10311 | "groupId": "EG000",
10312 | "numEvents": 1,
10313 | "numAffected": 1,
10314 | "numAtRisk": 516
10315 | },
10316 | {
10317 | "groupId": "EG001",
10318 | "numEvents": 0,
10319 | "numAffected": 0,
10320 | "numAtRisk": 532
10321 | }
10322 | ]
10323 | },
10324 | {
10325 | "term": "Hepatitis",
10326 | "organSystem": "Hepatobiliary disorders",
10327 | "sourceVocabulary": "MedDRA (23.0)",
10328 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10329 | "stats": [
10330 | {
10331 | "groupId": "EG000",
10332 | "numEvents": 1,
10333 | "numAffected": 1,
10334 | "numAtRisk": 516
10335 | },
10336 | {
10337 | "groupId": "EG001",
10338 | "numEvents": 0,
10339 | "numAffected": 0,
10340 | "numAtRisk": 532
10341 | }
10342 | ]
10343 | },
10344 | {
10345 | "term": "Ischaemic hepatitis",
10346 | "organSystem": "Hepatobiliary disorders",
10347 | "sourceVocabulary": "MedDRA (23.0)",
10348 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10349 | "stats": [
10350 | {
10351 | "groupId": "EG000",
10352 | "numEvents": 1,
10353 | "numAffected": 1,
10354 | "numAtRisk": 516
10355 | },
10356 | {
10357 | "groupId": "EG001",
10358 | "numEvents": 0,
10359 | "numAffected": 0,
10360 | "numAtRisk": 532
10361 | }
10362 | ]
10363 | },
10364 | {
10365 | "term": "Drug hypersensitivity",
10366 | "organSystem": "Immune system disorders",
10367 | "sourceVocabulary": "MedDRA (23.0)",
10368 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10369 | "stats": [
10370 | {
10371 | "groupId": "EG000",
10372 | "numEvents": 1,
10373 | "numAffected": 1,
10374 | "numAtRisk": 516
10375 | },
10376 | {
10377 | "groupId": "EG001",
10378 | "numEvents": 0,
10379 | "numAffected": 0,
10380 | "numAtRisk": 532
10381 | }
10382 | ]
10383 | },
10384 | {
10385 | "term": "Septic shock",
10386 | "organSystem": "Infections and infestations",
10387 | "sourceVocabulary": "MedDRA (23.0)",
10388 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10389 | "stats": [
10390 | {
10391 | "groupId": "EG000",
10392 | "numEvents": 15,
10393 | "numAffected": 15,
10394 | "numAtRisk": 516
10395 | },
10396 | {
10397 | "groupId": "EG001",
10398 | "numEvents": 8,
10399 | "numAffected": 8,
10400 | "numAtRisk": 532
10401 | }
10402 | ]
10403 | },
10404 | {
10405 | "term": "COVID-19",
10406 | "organSystem": "Infections and infestations",
10407 | "sourceVocabulary": "MedDRA (23.0)",
10408 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10409 | "stats": [
10410 | {
10411 | "groupId": "EG000",
10412 | "numEvents": 5,
10413 | "numAffected": 5,
10414 | "numAtRisk": 516
10415 | },
10416 | {
10417 | "groupId": "EG001",
10418 | "numEvents": 2,
10419 | "numAffected": 2,
10420 | "numAtRisk": 532
10421 | }
10422 | ]
10423 | },
10424 | {
10425 | "term": "Bacteraemia",
10426 | "organSystem": "Infections and infestations",
10427 | "sourceVocabulary": "MedDRA (23.0)",
10428 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10429 | "stats": [
10430 | {
10431 | "groupId": "EG000",
10432 | "numEvents": 2,
10433 | "numAffected": 2,
10434 | "numAtRisk": 516
10435 | },
10436 | {
10437 | "groupId": "EG001",
10438 | "numEvents": 1,
10439 | "numAffected": 1,
10440 | "numAtRisk": 532
10441 | }
10442 | ]
10443 | },
10444 | {
10445 | "term": "COVID-19 pneumonia",
10446 | "organSystem": "Infections and infestations",
10447 | "sourceVocabulary": "MedDRA (23.0)",
10448 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10449 | "stats": [
10450 | {
10451 | "groupId": "EG000",
10452 | "numEvents": 2,
10453 | "numAffected": 2,
10454 | "numAtRisk": 516
10455 | },
10456 | {
10457 | "groupId": "EG001",
10458 | "numEvents": 1,
10459 | "numAffected": 1,
10460 | "numAtRisk": 532
10461 | }
10462 | ]
10463 | },
10464 | {
10465 | "term": "Sepsis",
10466 | "organSystem": "Infections and infestations",
10467 | "sourceVocabulary": "MedDRA (23.0)",
10468 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10469 | "stats": [
10470 | {
10471 | "groupId": "EG000",
10472 | "numEvents": 2,
10473 | "numAffected": 2,
10474 | "numAtRisk": 516
10475 | },
10476 | {
10477 | "groupId": "EG001",
10478 | "numEvents": 1,
10479 | "numAffected": 1,
10480 | "numAtRisk": 532
10481 | }
10482 | ]
10483 | },
10484 | {
10485 | "term": "Pneumonia",
10486 | "organSystem": "Infections and infestations",
10487 | "sourceVocabulary": "MedDRA (23.0)",
10488 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10489 | "stats": [
10490 | {
10491 | "groupId": "EG000",
10492 | "numEvents": 2,
10493 | "numAffected": 2,
10494 | "numAtRisk": 516
10495 | },
10496 | {
10497 | "groupId": "EG001",
10498 | "numEvents": 0,
10499 | "numAffected": 0,
10500 | "numAtRisk": 532
10501 | }
10502 | ]
10503 | },
10504 | {
10505 | "term": "Catheter bacteraemia",
10506 | "organSystem": "Infections and infestations",
10507 | "sourceVocabulary": "MedDRA (23.0)",
10508 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10509 | "stats": [
10510 | {
10511 | "groupId": "EG000",
10512 | "numEvents": 0,
10513 | "numAffected": 0,
10514 | "numAtRisk": 516
10515 | },
10516 | {
10517 | "groupId": "EG001",
10518 | "numEvents": 1,
10519 | "numAffected": 1,
10520 | "numAtRisk": 532
10521 | }
10522 | ]
10523 | },
10524 | {
10525 | "term": "Gangrene",
10526 | "organSystem": "Infections and infestations",
10527 | "sourceVocabulary": "MedDRA (23.0)",
10528 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10529 | "stats": [
10530 | {
10531 | "groupId": "EG000",
10532 | "numEvents": 0,
10533 | "numAffected": 0,
10534 | "numAtRisk": 516
10535 | },
10536 | {
10537 | "groupId": "EG001",
10538 | "numEvents": 1,
10539 | "numAffected": 1,
10540 | "numAtRisk": 532
10541 | }
10542 | ]
10543 | },
10544 | {
10545 | "term": "Infectious pleural effusion",
10546 | "organSystem": "Infections and infestations",
10547 | "sourceVocabulary": "MedDRA (23.0)",
10548 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10549 | "stats": [
10550 | {
10551 | "groupId": "EG000",
10552 | "numEvents": 0,
10553 | "numAffected": 0,
10554 | "numAtRisk": 516
10555 | },
10556 | {
10557 | "groupId": "EG001",
10558 | "numEvents": 1,
10559 | "numAffected": 1,
10560 | "numAtRisk": 532
10561 | }
10562 | ]
10563 | },
10564 | {
10565 | "term": "Staphylococcal bacteraemia",
10566 | "organSystem": "Infections and infestations",
10567 | "sourceVocabulary": "MedDRA (23.0)",
10568 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10569 | "stats": [
10570 | {
10571 | "groupId": "EG000",
10572 | "numEvents": 0,
10573 | "numAffected": 0,
10574 | "numAtRisk": 516
10575 | },
10576 | {
10577 | "groupId": "EG001",
10578 | "numEvents": 1,
10579 | "numAffected": 1,
10580 | "numAtRisk": 532
10581 | }
10582 | ]
10583 | },
10584 | {
10585 | "term": "Urinary tract infection",
10586 | "organSystem": "Infections and infestations",
10587 | "sourceVocabulary": "MedDRA (23.0)",
10588 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10589 | "stats": [
10590 | {
10591 | "groupId": "EG000",
10592 | "numEvents": 0,
10593 | "numAffected": 0,
10594 | "numAtRisk": 516
10595 | },
10596 | {
10597 | "groupId": "EG001",
10598 | "numEvents": 1,
10599 | "numAffected": 1,
10600 | "numAtRisk": 532
10601 | }
10602 | ]
10603 | },
10604 | {
10605 | "term": "Bacterial sepsis",
10606 | "organSystem": "Infections and infestations",
10607 | "sourceVocabulary": "MedDRA (23.0)",
10608 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10609 | "stats": [
10610 | {
10611 | "groupId": "EG000",
10612 | "numEvents": 1,
10613 | "numAffected": 1,
10614 | "numAtRisk": 516
10615 | },
10616 | {
10617 | "groupId": "EG001",
10618 | "numEvents": 0,
10619 | "numAffected": 0,
10620 | "numAtRisk": 532
10621 | }
10622 | ]
10623 | },
10624 | {
10625 | "term": "Endocarditis bacterial",
10626 | "organSystem": "Infections and infestations",
10627 | "sourceVocabulary": "MedDRA (23.0)",
10628 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10629 | "stats": [
10630 | {
10631 | "groupId": "EG000",
10632 | "numEvents": 1,
10633 | "numAffected": 1,
10634 | "numAtRisk": 516
10635 | },
10636 | {
10637 | "groupId": "EG001",
10638 | "numEvents": 0,
10639 | "numAffected": 0,
10640 | "numAtRisk": 532
10641 | }
10642 | ]
10643 | },
10644 | {
10645 | "term": "Hip fracture",
10646 | "organSystem": "Injury, poisoning and procedural complications",
10647 | "sourceVocabulary": "MedDRA (23.0)",
10648 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10649 | "stats": [
10650 | {
10651 | "groupId": "EG000",
10652 | "numEvents": 0,
10653 | "numAffected": 0,
10654 | "numAtRisk": 516
10655 | },
10656 | {
10657 | "groupId": "EG001",
10658 | "numEvents": 1,
10659 | "numAffected": 1,
10660 | "numAtRisk": 532
10661 | }
10662 | ]
10663 | },
10664 | {
10665 | "term": "Infusion related reaction",
10666 | "organSystem": "Injury, poisoning and procedural complications",
10667 | "sourceVocabulary": "MedDRA (23.0)",
10668 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10669 | "stats": [
10670 | {
10671 | "groupId": "EG000",
10672 | "numEvents": 0,
10673 | "numAffected": 0,
10674 | "numAtRisk": 516
10675 | },
10676 | {
10677 | "groupId": "EG001",
10678 | "numEvents": 1,
10679 | "numAffected": 1,
10680 | "numAtRisk": 532
10681 | }
10682 | ]
10683 | },
10684 | {
10685 | "term": "Procedural pneumothorax",
10686 | "organSystem": "Injury, poisoning and procedural complications",
10687 | "sourceVocabulary": "MedDRA (23.0)",
10688 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10689 | "stats": [
10690 | {
10691 | "groupId": "EG000",
10692 | "numEvents": 1,
10693 | "numAffected": 1,
10694 | "numAtRisk": 516
10695 | },
10696 | {
10697 | "groupId": "EG001",
10698 | "numEvents": 0,
10699 | "numAffected": 0,
10700 | "numAtRisk": 532
10701 | }
10702 | ]
10703 | },
10704 | {
10705 | "term": "Glomerular filtration rate decreased",
10706 | "organSystem": "Investigations",
10707 | "sourceVocabulary": "MedDRA (23.0)",
10708 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10709 | "stats": [
10710 | {
10711 | "groupId": "EG000",
10712 | "numEvents": 3,
10713 | "numAffected": 2,
10714 | "numAtRisk": 516
10715 | },
10716 | {
10717 | "groupId": "EG001",
10718 | "numEvents": 5,
10719 | "numAffected": 5,
10720 | "numAtRisk": 532
10721 | }
10722 | ]
10723 | },
10724 | {
10725 | "term": "Haemoglobin decreased",
10726 | "organSystem": "Investigations",
10727 | "sourceVocabulary": "MedDRA (23.0)",
10728 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10729 | "stats": [
10730 | {
10731 | "groupId": "EG000",
10732 | "numEvents": 2,
10733 | "numAffected": 2,
10734 | "numAtRisk": 516
10735 | },
10736 | {
10737 | "groupId": "EG001",
10738 | "numEvents": 1,
10739 | "numAffected": 1,
10740 | "numAtRisk": 532
10741 | }
10742 | ]
10743 | },
10744 | {
10745 | "term": "Oxygen saturation decreased",
10746 | "organSystem": "Investigations",
10747 | "sourceVocabulary": "MedDRA (23.0)",
10748 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10749 | "stats": [
10750 | {
10751 | "groupId": "EG000",
10752 | "numEvents": 1,
10753 | "numAffected": 1,
10754 | "numAtRisk": 516
10755 | },
10756 | {
10757 | "groupId": "EG001",
10758 | "numEvents": 1,
10759 | "numAffected": 1,
10760 | "numAtRisk": 532
10761 | }
10762 | ]
10763 | },
10764 | {
10765 | "term": "Blood creatinine increased",
10766 | "organSystem": "Investigations",
10767 | "sourceVocabulary": "MedDRA (23.0)",
10768 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10769 | "stats": [
10770 | {
10771 | "groupId": "EG000",
10772 | "numEvents": 0,
10773 | "numAffected": 0,
10774 | "numAtRisk": 516
10775 | },
10776 | {
10777 | "groupId": "EG001",
10778 | "numEvents": 1,
10779 | "numAffected": 1,
10780 | "numAtRisk": 532
10781 | }
10782 | ]
10783 | },
10784 | {
10785 | "term": "Lymphocyte count decreased",
10786 | "organSystem": "Investigations",
10787 | "sourceVocabulary": "MedDRA (23.0)",
10788 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10789 | "stats": [
10790 | {
10791 | "groupId": "EG000",
10792 | "numEvents": 0,
10793 | "numAffected": 0,
10794 | "numAtRisk": 516
10795 | },
10796 | {
10797 | "groupId": "EG001",
10798 | "numEvents": 1,
10799 | "numAffected": 1,
10800 | "numAtRisk": 532
10801 | }
10802 | ]
10803 | },
10804 | {
10805 | "term": "Acidosis",
10806 | "organSystem": "Metabolism and nutrition disorders",
10807 | "sourceVocabulary": "MedDRA (23.0)",
10808 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10809 | "stats": [
10810 | {
10811 | "groupId": "EG000",
10812 | "numEvents": 1,
10813 | "numAffected": 1,
10814 | "numAtRisk": 516
10815 | },
10816 | {
10817 | "groupId": "EG001",
10818 | "numEvents": 1,
10819 | "numAffected": 1,
10820 | "numAtRisk": 532
10821 | }
10822 | ]
10823 | },
10824 | {
10825 | "term": "Dehydration",
10826 | "organSystem": "Metabolism and nutrition disorders",
10827 | "sourceVocabulary": "MedDRA (23.0)",
10828 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10829 | "stats": [
10830 | {
10831 | "groupId": "EG000",
10832 | "numEvents": 0,
10833 | "numAffected": 0,
10834 | "numAtRisk": 516
10835 | },
10836 | {
10837 | "groupId": "EG001",
10838 | "numEvents": 1,
10839 | "numAffected": 1,
10840 | "numAtRisk": 532
10841 | }
10842 | ]
10843 | },
10844 | {
10845 | "term": "Hypernatraemia",
10846 | "organSystem": "Metabolism and nutrition disorders",
10847 | "sourceVocabulary": "MedDRA (23.0)",
10848 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10849 | "stats": [
10850 | {
10851 | "groupId": "EG000",
10852 | "numEvents": 0,
10853 | "numAffected": 0,
10854 | "numAtRisk": 516
10855 | },
10856 | {
10857 | "groupId": "EG001",
10858 | "numEvents": 1,
10859 | "numAffected": 1,
10860 | "numAtRisk": 532
10861 | }
10862 | ]
10863 | },
10864 | {
10865 | "term": "Hyponatraemia",
10866 | "organSystem": "Metabolism and nutrition disorders",
10867 | "sourceVocabulary": "MedDRA (23.0)",
10868 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10869 | "stats": [
10870 | {
10871 | "groupId": "EG000",
10872 | "numEvents": 0,
10873 | "numAffected": 0,
10874 | "numAtRisk": 516
10875 | },
10876 | {
10877 | "groupId": "EG001",
10878 | "numEvents": 1,
10879 | "numAffected": 1,
10880 | "numAtRisk": 532
10881 | }
10882 | ]
10883 | },
10884 | {
10885 | "term": "Decreased appetite",
10886 | "organSystem": "Metabolism and nutrition disorders",
10887 | "sourceVocabulary": "MedDRA (23.0)",
10888 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10889 | "stats": [
10890 | {
10891 | "groupId": "EG000",
10892 | "numEvents": 1,
10893 | "numAffected": 1,
10894 | "numAtRisk": 516
10895 | },
10896 | {
10897 | "groupId": "EG001",
10898 | "numEvents": 0,
10899 | "numAffected": 0,
10900 | "numAtRisk": 532
10901 | }
10902 | ]
10903 | },
10904 | {
10905 | "term": "Pain in extremity",
10906 | "organSystem": "Musculoskeletal and connective tissue disorders",
10907 | "sourceVocabulary": "MedDRA (23.0)",
10908 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10909 | "stats": [
10910 | {
10911 | "groupId": "EG000",
10912 | "numEvents": 0,
10913 | "numAffected": 0,
10914 | "numAtRisk": 516
10915 | },
10916 | {
10917 | "groupId": "EG001",
10918 | "numEvents": 1,
10919 | "numAffected": 1,
10920 | "numAtRisk": 532
10921 | }
10922 | ]
10923 | },
10924 | {
10925 | "term": "Myalgia",
10926 | "organSystem": "Musculoskeletal and connective tissue disorders",
10927 | "sourceVocabulary": "MedDRA (23.0)",
10928 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10929 | "stats": [
10930 | {
10931 | "groupId": "EG000",
10932 | "numEvents": 1,
10933 | "numAffected": 1,
10934 | "numAtRisk": 516
10935 | },
10936 | {
10937 | "groupId": "EG001",
10938 | "numEvents": 0,
10939 | "numAffected": 0,
10940 | "numAtRisk": 532
10941 | }
10942 | ]
10943 | },
10944 | {
10945 | "term": "Myopathy",
10946 | "organSystem": "Musculoskeletal and connective tissue disorders",
10947 | "sourceVocabulary": "MedDRA (23.0)",
10948 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10949 | "stats": [
10950 | {
10951 | "groupId": "EG000",
10952 | "numEvents": 1,
10953 | "numAffected": 1,
10954 | "numAtRisk": 516
10955 | },
10956 | {
10957 | "groupId": "EG001",
10958 | "numEvents": 0,
10959 | "numAffected": 0,
10960 | "numAtRisk": 532
10961 | }
10962 | ]
10963 | },
10964 | {
10965 | "term": "Cerebrovascular accident",
10966 | "organSystem": "Nervous system disorders",
10967 | "sourceVocabulary": "MedDRA (23.0)",
10968 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10969 | "stats": [
10970 | {
10971 | "groupId": "EG000",
10972 | "numEvents": 1,
10973 | "numAffected": 1,
10974 | "numAtRisk": 516
10975 | },
10976 | {
10977 | "groupId": "EG001",
10978 | "numEvents": 3,
10979 | "numAffected": 3,
10980 | "numAtRisk": 532
10981 | }
10982 | ]
10983 | },
10984 | {
10985 | "term": "Seizure",
10986 | "organSystem": "Nervous system disorders",
10987 | "sourceVocabulary": "MedDRA (23.0)",
10988 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
10989 | "stats": [
10990 | {
10991 | "groupId": "EG000",
10992 | "numEvents": 1,
10993 | "numAffected": 1,
10994 | "numAtRisk": 516
10995 | },
10996 | {
10997 | "groupId": "EG001",
10998 | "numEvents": 2,
10999 | "numAffected": 2,
11000 | "numAtRisk": 532
11001 | }
11002 | ]
11003 | },
11004 | {
11005 | "term": "Cerebellar infarction",
11006 | "organSystem": "Nervous system disorders",
11007 | "sourceVocabulary": "MedDRA (23.0)",
11008 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11009 | "stats": [
11010 | {
11011 | "groupId": "EG000",
11012 | "numEvents": 0,
11013 | "numAffected": 0,
11014 | "numAtRisk": 516
11015 | },
11016 | {
11017 | "groupId": "EG001",
11018 | "numEvents": 1,
11019 | "numAffected": 1,
11020 | "numAtRisk": 532
11021 | }
11022 | ]
11023 | },
11024 | {
11025 | "term": "Cerebral haemorrhage",
11026 | "organSystem": "Nervous system disorders",
11027 | "sourceVocabulary": "MedDRA (23.0)",
11028 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11029 | "stats": [
11030 | {
11031 | "groupId": "EG000",
11032 | "numEvents": 0,
11033 | "numAffected": 0,
11034 | "numAtRisk": 516
11035 | },
11036 | {
11037 | "groupId": "EG001",
11038 | "numEvents": 1,
11039 | "numAffected": 1,
11040 | "numAtRisk": 532
11041 | }
11042 | ]
11043 | },
11044 | {
11045 | "term": "Encephalopathy",
11046 | "organSystem": "Nervous system disorders",
11047 | "sourceVocabulary": "MedDRA (23.0)",
11048 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11049 | "stats": [
11050 | {
11051 | "groupId": "EG000",
11052 | "numEvents": 0,
11053 | "numAffected": 0,
11054 | "numAtRisk": 516
11055 | },
11056 | {
11057 | "groupId": "EG001",
11058 | "numEvents": 1,
11059 | "numAffected": 1,
11060 | "numAtRisk": 532
11061 | }
11062 | ]
11063 | },
11064 | {
11065 | "term": "Subarachnoid haemorrhage",
11066 | "organSystem": "Nervous system disorders",
11067 | "sourceVocabulary": "MedDRA (23.0)",
11068 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11069 | "stats": [
11070 | {
11071 | "groupId": "EG000",
11072 | "numEvents": 0,
11073 | "numAffected": 0,
11074 | "numAtRisk": 516
11075 | },
11076 | {
11077 | "groupId": "EG001",
11078 | "numEvents": 1,
11079 | "numAffected": 1,
11080 | "numAtRisk": 532
11081 | }
11082 | ]
11083 | },
11084 | {
11085 | "term": "Depressed level of consciousness",
11086 | "organSystem": "Nervous system disorders",
11087 | "sourceVocabulary": "MedDRA (23.0)",
11088 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11089 | "stats": [
11090 | {
11091 | "groupId": "EG000",
11092 | "numEvents": 1,
11093 | "numAffected": 1,
11094 | "numAtRisk": 516
11095 | },
11096 | {
11097 | "groupId": "EG001",
11098 | "numEvents": 0,
11099 | "numAffected": 0,
11100 | "numAtRisk": 532
11101 | }
11102 | ]
11103 | },
11104 | {
11105 | "term": "Haemorrhagic transformation stroke",
11106 | "organSystem": "Nervous system disorders",
11107 | "sourceVocabulary": "MedDRA (23.0)",
11108 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11109 | "stats": [
11110 | {
11111 | "groupId": "EG000",
11112 | "numEvents": 1,
11113 | "numAffected": 1,
11114 | "numAtRisk": 516
11115 | },
11116 | {
11117 | "groupId": "EG001",
11118 | "numEvents": 0,
11119 | "numAffected": 0,
11120 | "numAtRisk": 532
11121 | }
11122 | ]
11123 | },
11124 | {
11125 | "term": "Hemiparesis",
11126 | "organSystem": "Nervous system disorders",
11127 | "sourceVocabulary": "MedDRA (23.0)",
11128 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11129 | "stats": [
11130 | {
11131 | "groupId": "EG000",
11132 | "numEvents": 1,
11133 | "numAffected": 1,
11134 | "numAtRisk": 516
11135 | },
11136 | {
11137 | "groupId": "EG001",
11138 | "numEvents": 0,
11139 | "numAffected": 0,
11140 | "numAtRisk": 532
11141 | }
11142 | ]
11143 | },
11144 | {
11145 | "term": "Intensive care unit acquired weakness",
11146 | "organSystem": "Nervous system disorders",
11147 | "sourceVocabulary": "MedDRA (23.0)",
11148 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11149 | "stats": [
11150 | {
11151 | "groupId": "EG000",
11152 | "numEvents": 1,
11153 | "numAffected": 1,
11154 | "numAtRisk": 516
11155 | },
11156 | {
11157 | "groupId": "EG001",
11158 | "numEvents": 0,
11159 | "numAffected": 0,
11160 | "numAtRisk": 532
11161 | }
11162 | ]
11163 | },
11164 | {
11165 | "term": "Ischaemic stroke",
11166 | "organSystem": "Nervous system disorders",
11167 | "sourceVocabulary": "MedDRA (23.0)",
11168 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11169 | "stats": [
11170 | {
11171 | "groupId": "EG000",
11172 | "numEvents": 1,
11173 | "numAffected": 1,
11174 | "numAtRisk": 516
11175 | },
11176 | {
11177 | "groupId": "EG001",
11178 | "numEvents": 0,
11179 | "numAffected": 0,
11180 | "numAtRisk": 532
11181 | }
11182 | ]
11183 | },
11184 | {
11185 | "term": "Mental status changes",
11186 | "organSystem": "Psychiatric disorders",
11187 | "sourceVocabulary": "MedDRA (23.0)",
11188 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11189 | "stats": [
11190 | {
11191 | "groupId": "EG000",
11192 | "numEvents": 0,
11193 | "numAffected": 0,
11194 | "numAtRisk": 516
11195 | },
11196 | {
11197 | "groupId": "EG001",
11198 | "numEvents": 1,
11199 | "numAffected": 1,
11200 | "numAtRisk": 532
11201 | }
11202 | ]
11203 | },
11204 | {
11205 | "term": "Psychotic disorder",
11206 | "organSystem": "Psychiatric disorders",
11207 | "sourceVocabulary": "MedDRA (23.0)",
11208 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11209 | "stats": [
11210 | {
11211 | "groupId": "EG000",
11212 | "numEvents": 1,
11213 | "numAffected": 1,
11214 | "numAtRisk": 516
11215 | },
11216 | {
11217 | "groupId": "EG001",
11218 | "numEvents": 0,
11219 | "numAffected": 0,
11220 | "numAtRisk": 532
11221 | }
11222 | ]
11223 | },
11224 | {
11225 | "term": "Acute kidney injury",
11226 | "organSystem": "Renal and urinary disorders",
11227 | "sourceVocabulary": "MedDRA (23.0)",
11228 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11229 | "stats": [
11230 | {
11231 | "groupId": "EG000",
11232 | "numEvents": 12,
11233 | "numAffected": 12,
11234 | "numAtRisk": 516
11235 | },
11236 | {
11237 | "groupId": "EG001",
11238 | "numEvents": 7,
11239 | "numAffected": 7,
11240 | "numAtRisk": 532
11241 | }
11242 | ]
11243 | },
11244 | {
11245 | "term": "Renal failure",
11246 | "organSystem": "Renal and urinary disorders",
11247 | "sourceVocabulary": "MedDRA (23.0)",
11248 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11249 | "stats": [
11250 | {
11251 | "groupId": "EG000",
11252 | "numEvents": 5,
11253 | "numAffected": 5,
11254 | "numAtRisk": 516
11255 | },
11256 | {
11257 | "groupId": "EG001",
11258 | "numEvents": 2,
11259 | "numAffected": 2,
11260 | "numAtRisk": 532
11261 | }
11262 | ]
11263 | },
11264 | {
11265 | "term": "Renal impairment",
11266 | "organSystem": "Renal and urinary disorders",
11267 | "sourceVocabulary": "MedDRA (23.0)",
11268 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11269 | "stats": [
11270 | {
11271 | "groupId": "EG000",
11272 | "numEvents": 3,
11273 | "numAffected": 3,
11274 | "numAtRisk": 516
11275 | },
11276 | {
11277 | "groupId": "EG001",
11278 | "numEvents": 1,
11279 | "numAffected": 1,
11280 | "numAtRisk": 532
11281 | }
11282 | ]
11283 | },
11284 | {
11285 | "term": "Respiratory failure",
11286 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11287 | "sourceVocabulary": "MedDRA (23.0)",
11288 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11289 | "stats": [
11290 | {
11291 | "groupId": "EG000",
11292 | "numEvents": 59,
11293 | "numAffected": 58,
11294 | "numAtRisk": 516
11295 | },
11296 | {
11297 | "groupId": "EG001",
11298 | "numEvents": 36,
11299 | "numAffected": 35,
11300 | "numAtRisk": 532
11301 | }
11302 | ]
11303 | },
11304 | {
11305 | "term": "Acute respiratory failure",
11306 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11307 | "sourceVocabulary": "MedDRA (23.0)",
11308 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11309 | "stats": [
11310 | {
11311 | "groupId": "EG000",
11312 | "numEvents": 14,
11313 | "numAffected": 14,
11314 | "numAtRisk": 516
11315 | },
11316 | {
11317 | "groupId": "EG001",
11318 | "numEvents": 8,
11319 | "numAffected": 8,
11320 | "numAtRisk": 532
11321 | }
11322 | ]
11323 | },
11324 | {
11325 | "term": "Respiratory distress",
11326 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11327 | "sourceVocabulary": "MedDRA (23.0)",
11328 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11329 | "stats": [
11330 | {
11331 | "groupId": "EG000",
11332 | "numEvents": 11,
11333 | "numAffected": 11,
11334 | "numAtRisk": 516
11335 | },
11336 | {
11337 | "groupId": "EG001",
11338 | "numEvents": 6,
11339 | "numAffected": 6,
11340 | "numAtRisk": 532
11341 | }
11342 | ]
11343 | },
11344 | {
11345 | "term": "Acute respiratory distress syndrome",
11346 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11347 | "sourceVocabulary": "MedDRA (23.0)",
11348 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11349 | "stats": [
11350 | {
11351 | "groupId": "EG000",
11352 | "numEvents": 5,
11353 | "numAffected": 5,
11354 | "numAtRisk": 516
11355 | },
11356 | {
11357 | "groupId": "EG001",
11358 | "numEvents": 7,
11359 | "numAffected": 7,
11360 | "numAtRisk": 532
11361 | }
11362 | ]
11363 | },
11364 | {
11365 | "term": "Pneumothorax",
11366 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11367 | "sourceVocabulary": "MedDRA (23.0)",
11368 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11369 | "stats": [
11370 | {
11371 | "groupId": "EG000",
11372 | "numEvents": 5,
11373 | "numAffected": 5,
11374 | "numAtRisk": 516
11375 | },
11376 | {
11377 | "groupId": "EG001",
11378 | "numEvents": 5,
11379 | "numAffected": 5,
11380 | "numAtRisk": 532
11381 | }
11382 | ]
11383 | },
11384 | {
11385 | "term": "Pulmonary embolism",
11386 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11387 | "sourceVocabulary": "MedDRA (23.0)",
11388 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11389 | "stats": [
11390 | {
11391 | "groupId": "EG000",
11392 | "numEvents": 4,
11393 | "numAffected": 4,
11394 | "numAtRisk": 516
11395 | },
11396 | {
11397 | "groupId": "EG001",
11398 | "numEvents": 5,
11399 | "numAffected": 5,
11400 | "numAtRisk": 532
11401 | }
11402 | ]
11403 | },
11404 | {
11405 | "term": "Hypoxia",
11406 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11407 | "sourceVocabulary": "MedDRA (23.0)",
11408 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11409 | "stats": [
11410 | {
11411 | "groupId": "EG000",
11412 | "numEvents": 4,
11413 | "numAffected": 4,
11414 | "numAtRisk": 516
11415 | },
11416 | {
11417 | "groupId": "EG001",
11418 | "numEvents": 4,
11419 | "numAffected": 4,
11420 | "numAtRisk": 532
11421 | }
11422 | ]
11423 | },
11424 | {
11425 | "term": "Pneumonia aspiration",
11426 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11427 | "sourceVocabulary": "MedDRA (23.0)",
11428 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11429 | "stats": [
11430 | {
11431 | "groupId": "EG000",
11432 | "numEvents": 2,
11433 | "numAffected": 2,
11434 | "numAtRisk": 516
11435 | },
11436 | {
11437 | "groupId": "EG001",
11438 | "numEvents": 4,
11439 | "numAffected": 4,
11440 | "numAtRisk": 532
11441 | }
11442 | ]
11443 | },
11444 | {
11445 | "term": "Dyspnoea",
11446 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11447 | "sourceVocabulary": "MedDRA (23.0)",
11448 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11449 | "stats": [
11450 | {
11451 | "groupId": "EG000",
11452 | "numEvents": 1,
11453 | "numAffected": 1,
11454 | "numAtRisk": 516
11455 | },
11456 | {
11457 | "groupId": "EG001",
11458 | "numEvents": 3,
11459 | "numAffected": 3,
11460 | "numAtRisk": 532
11461 | }
11462 | ]
11463 | },
11464 | {
11465 | "term": "Respiratory disorder",
11466 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11467 | "sourceVocabulary": "MedDRA (23.0)",
11468 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11469 | "stats": [
11470 | {
11471 | "groupId": "EG000",
11472 | "numEvents": 2,
11473 | "numAffected": 2,
11474 | "numAtRisk": 516
11475 | },
11476 | {
11477 | "groupId": "EG001",
11478 | "numEvents": 0,
11479 | "numAffected": 0,
11480 | "numAtRisk": 532
11481 | }
11482 | ]
11483 | },
11484 | {
11485 | "term": "Chronic respiratory failure",
11486 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11487 | "sourceVocabulary": "MedDRA (23.0)",
11488 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11489 | "stats": [
11490 | {
11491 | "groupId": "EG000",
11492 | "numEvents": 0,
11493 | "numAffected": 0,
11494 | "numAtRisk": 516
11495 | },
11496 | {
11497 | "groupId": "EG001",
11498 | "numEvents": 1,
11499 | "numAffected": 1,
11500 | "numAtRisk": 532
11501 | }
11502 | ]
11503 | },
11504 | {
11505 | "term": "Haemoptysis",
11506 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11507 | "sourceVocabulary": "MedDRA (23.0)",
11508 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11509 | "stats": [
11510 | {
11511 | "groupId": "EG000",
11512 | "numEvents": 0,
11513 | "numAffected": 0,
11514 | "numAtRisk": 516
11515 | },
11516 | {
11517 | "groupId": "EG001",
11518 | "numEvents": 1,
11519 | "numAffected": 1,
11520 | "numAtRisk": 532
11521 | }
11522 | ]
11523 | },
11524 | {
11525 | "term": "Pulmonary haemorrhage",
11526 | "organSystem": "Respiratory, thoracic and mediastinal disorders",
11527 | "sourceVocabulary": "MedDRA (23.0)",
11528 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11529 | "stats": [
11530 | {
11531 | "groupId": "EG000",
11532 | "numEvents": 0,
11533 | "numAffected": 0,
11534 | "numAtRisk": 516
11535 | },
11536 | {
11537 | "groupId": "EG001",
11538 | "numEvents": 1,
11539 | "numAffected": 1,
11540 | "numAtRisk": 532
11541 | }
11542 | ]
11543 | },
11544 | {
11545 | "term": "Subcutaneous emphysema",
11546 | "organSystem": "Skin and subcutaneous tissue disorders",
11547 | "sourceVocabulary": "MedDRA (23.0)",
11548 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11549 | "stats": [
11550 | {
11551 | "groupId": "EG000",
11552 | "numEvents": 0,
11553 | "numAffected": 0,
11554 | "numAtRisk": 516
11555 | },
11556 | {
11557 | "groupId": "EG001",
11558 | "numEvents": 1,
11559 | "numAffected": 1,
11560 | "numAtRisk": 532
11561 | }
11562 | ]
11563 | },
11564 | {
11565 | "term": "Endotracheal intubation",
11566 | "organSystem": "Surgical and medical procedures",
11567 | "sourceVocabulary": "MedDRA (23.0)",
11568 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11569 | "stats": [
11570 | {
11571 | "groupId": "EG000",
11572 | "numEvents": 9,
11573 | "numAffected": 9,
11574 | "numAtRisk": 516
11575 | },
11576 | {
11577 | "groupId": "EG001",
11578 | "numEvents": 6,
11579 | "numAffected": 6,
11580 | "numAtRisk": 532
11581 | }
11582 | ]
11583 | },
11584 | {
11585 | "term": "Mechanical ventilation",
11586 | "organSystem": "Surgical and medical procedures",
11587 | "sourceVocabulary": "MedDRA (23.0)",
11588 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11589 | "stats": [
11590 | {
11591 | "groupId": "EG000",
11592 | "numEvents": 3,
11593 | "numAffected": 3,
11594 | "numAtRisk": 516
11595 | },
11596 | {
11597 | "groupId": "EG001",
11598 | "numEvents": 1,
11599 | "numAffected": 1,
11600 | "numAtRisk": 532
11601 | }
11602 | ]
11603 | },
11604 | {
11605 | "term": "Hypotension",
11606 | "organSystem": "Vascular disorders",
11607 | "sourceVocabulary": "MedDRA (23.0)",
11608 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11609 | "stats": [
11610 | {
11611 | "groupId": "EG000",
11612 | "numEvents": 7,
11613 | "numAffected": 7,
11614 | "numAtRisk": 516
11615 | },
11616 | {
11617 | "groupId": "EG001",
11618 | "numEvents": 4,
11619 | "numAffected": 4,
11620 | "numAtRisk": 532
11621 | }
11622 | ]
11623 | },
11624 | {
11625 | "term": "Shock",
11626 | "organSystem": "Vascular disorders",
11627 | "sourceVocabulary": "MedDRA (23.0)",
11628 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11629 | "stats": [
11630 | {
11631 | "groupId": "EG000",
11632 | "numEvents": 4,
11633 | "numAffected": 4,
11634 | "numAtRisk": 516
11635 | },
11636 | {
11637 | "groupId": "EG001",
11638 | "numEvents": 5,
11639 | "numAffected": 5,
11640 | "numAtRisk": 532
11641 | }
11642 | ]
11643 | },
11644 | {
11645 | "term": "Deep vein thrombosis",
11646 | "organSystem": "Vascular disorders",
11647 | "sourceVocabulary": "MedDRA (23.0)",
11648 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11649 | "stats": [
11650 | {
11651 | "groupId": "EG000",
11652 | "numEvents": 1,
11653 | "numAffected": 1,
11654 | "numAtRisk": 516
11655 | },
11656 | {
11657 | "groupId": "EG001",
11658 | "numEvents": 1,
11659 | "numAffected": 1,
11660 | "numAtRisk": 532
11661 | }
11662 | ]
11663 | },
11664 | {
11665 | "term": "Embolism venous",
11666 | "organSystem": "Vascular disorders",
11667 | "sourceVocabulary": "MedDRA (23.0)",
11668 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11669 | "stats": [
11670 | {
11671 | "groupId": "EG000",
11672 | "numEvents": 0,
11673 | "numAffected": 0,
11674 | "numAtRisk": 516
11675 | },
11676 | {
11677 | "groupId": "EG001",
11678 | "numEvents": 1,
11679 | "numAffected": 1,
11680 | "numAtRisk": 532
11681 | }
11682 | ]
11683 | },
11684 | {
11685 | "term": "Peripheral artery occlusion",
11686 | "organSystem": "Vascular disorders",
11687 | "sourceVocabulary": "MedDRA (23.0)",
11688 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11689 | "stats": [
11690 | {
11691 | "groupId": "EG000",
11692 | "numEvents": 0,
11693 | "numAffected": 0,
11694 | "numAtRisk": 516
11695 | },
11696 | {
11697 | "groupId": "EG001",
11698 | "numEvents": 1,
11699 | "numAffected": 1,
11700 | "numAtRisk": 532
11701 | }
11702 | ]
11703 | },
11704 | {
11705 | "term": "Shock haemorrhagic",
11706 | "organSystem": "Vascular disorders",
11707 | "sourceVocabulary": "MedDRA (23.0)",
11708 | "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
11709 | "stats": [
11710 | {
11711 | "groupId": "EG000",
11712 | "numEvents": 0,
11713 | "numAffected": 0,
11714 | "numAtRisk": 516
11715 | },
11716 | {
11717 | "groupId": "EG001",
11718 | "numEvents": 1,
11719 | "numAffected": 1,
11720 | "numAtRisk": 532
11721 | }
11722 | ]
11723 | }
11724 | ],
11725 | "otherEvents": [
11726 | {
11727 | "term": "Glomerular filtration rate decreased",
11728 | "organSystem": "Investigations",
11729 | "sourceVocabulary": "MedDRA (23.0)",
11730 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11731 | "stats": [
11732 | {
11733 | "groupId": "EG000",
11734 | "numEvents": 81,
11735 | "numAffected": 74,
11736 | "numAtRisk": 516
11737 | },
11738 | {
11739 | "groupId": "EG001",
11740 | "numEvents": 59,
11741 | "numAffected": 55,
11742 | "numAtRisk": 532
11743 | }
11744 | ]
11745 | },
11746 | {
11747 | "term": "Haemoglobin decreased",
11748 | "organSystem": "Investigations",
11749 | "sourceVocabulary": "MedDRA (23.0)",
11750 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11751 | "stats": [
11752 | {
11753 | "groupId": "EG000",
11754 | "numEvents": 69,
11755 | "numAffected": 62,
11756 | "numAtRisk": 516
11757 | },
11758 | {
11759 | "groupId": "EG001",
11760 | "numEvents": 51,
11761 | "numAffected": 48,
11762 | "numAtRisk": 532
11763 | }
11764 | ]
11765 | },
11766 | {
11767 | "term": "Lymphocyte count decreased",
11768 | "organSystem": "Investigations",
11769 | "sourceVocabulary": "MedDRA (23.0)",
11770 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11771 | "stats": [
11772 | {
11773 | "groupId": "EG000",
11774 | "numEvents": 63,
11775 | "numAffected": 54,
11776 | "numAtRisk": 516
11777 | },
11778 | {
11779 | "groupId": "EG001",
11780 | "numEvents": 56,
11781 | "numAffected": 44,
11782 | "numAtRisk": 532
11783 | }
11784 | ]
11785 | },
11786 | {
11787 | "term": "Anaemia",
11788 | "organSystem": "Blood and lymphatic system disorders",
11789 | "sourceVocabulary": "MedDRA (23.0)",
11790 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11791 | "stats": [
11792 | {
11793 | "groupId": "EG000",
11794 | "numEvents": 58,
11795 | "numAffected": 52,
11796 | "numAtRisk": 516
11797 | },
11798 | {
11799 | "groupId": "EG001",
11800 | "numEvents": 52,
11801 | "numAffected": 42,
11802 | "numAtRisk": 532
11803 | }
11804 | ]
11805 | },
11806 | {
11807 | "term": "Pyrexia",
11808 | "organSystem": "General disorders",
11809 | "sourceVocabulary": "MedDRA (23.0)",
11810 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11811 | "stats": [
11812 | {
11813 | "groupId": "EG000",
11814 | "numEvents": 37,
11815 | "numAffected": 32,
11816 | "numAtRisk": 516
11817 | },
11818 | {
11819 | "groupId": "EG001",
11820 | "numEvents": 52,
11821 | "numAffected": 38,
11822 | "numAtRisk": 532
11823 | }
11824 | ]
11825 | },
11826 | {
11827 | "term": "Hyperglycaemia",
11828 | "organSystem": "Metabolism and nutrition disorders",
11829 | "sourceVocabulary": "MedDRA (23.0)",
11830 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11831 | "stats": [
11832 | {
11833 | "groupId": "EG000",
11834 | "numEvents": 43,
11835 | "numAffected": 34,
11836 | "numAtRisk": 516
11837 | },
11838 | {
11839 | "groupId": "EG001",
11840 | "numEvents": 36,
11841 | "numAffected": 34,
11842 | "numAtRisk": 532
11843 | }
11844 | ]
11845 | },
11846 | {
11847 | "term": "Blood creatinine increased",
11848 | "organSystem": "Investigations",
11849 | "sourceVocabulary": "MedDRA (23.0)",
11850 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11851 | "stats": [
11852 | {
11853 | "groupId": "EG000",
11854 | "numEvents": 41,
11855 | "numAffected": 36,
11856 | "numAtRisk": 516
11857 | },
11858 | {
11859 | "groupId": "EG001",
11860 | "numEvents": 33,
11861 | "numAffected": 31,
11862 | "numAtRisk": 532
11863 | }
11864 | ]
11865 | },
11866 | {
11867 | "term": "Blood glucose increased",
11868 | "organSystem": "Investigations",
11869 | "sourceVocabulary": "MedDRA (23.0)",
11870 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11871 | "stats": [
11872 | {
11873 | "groupId": "EG000",
11874 | "numEvents": 31,
11875 | "numAffected": 27,
11876 | "numAtRisk": 516
11877 | },
11878 | {
11879 | "groupId": "EG001",
11880 | "numEvents": 45,
11881 | "numAffected": 39,
11882 | "numAtRisk": 532
11883 | }
11884 | ]
11885 | },
11886 | {
11887 | "term": "Aspartate aminotransferase increased",
11888 | "organSystem": "Investigations",
11889 | "sourceVocabulary": "MedDRA (23.0)",
11890 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11891 | "stats": [
11892 | {
11893 | "groupId": "EG000",
11894 | "numEvents": 35,
11895 | "numAffected": 33,
11896 | "numAtRisk": 516
11897 | },
11898 | {
11899 | "groupId": "EG001",
11900 | "numEvents": 19,
11901 | "numAffected": 18,
11902 | "numAtRisk": 532
11903 | }
11904 | ]
11905 | },
11906 | {
11907 | "term": "Lymphopenia",
11908 | "organSystem": "Blood and lymphatic system disorders",
11909 | "sourceVocabulary": "MedDRA (23.0)",
11910 | "assessmentType": "SYSTEMATIC_ASSESSMENT",
11911 | "stats": [
11912 | {
11913 | "groupId": "EG000",
11914 | "numEvents": 34,
11915 | "numAffected": 30,
11916 | "numAtRisk": 516
11917 | },
11918 | {
11919 | "groupId": "EG001",
11920 | "numEvents": 15,
11921 | "numAffected": 13,
11922 | "numAtRisk": 532
11923 | }
11924 | ]
11925 | }
11926 | ]
11927 | },
11928 | "moreInfoModule": {
11929 | "certainAgreement": {
11930 | "piSponsorEmployee": false,
11931 | "restrictionType": "LTE60",
11932 | "restrictiveAgreement": true
11933 | },
11934 | "pointOfContact": {
11935 | "title": "John Beigel, MD",
11936 | "organization": "Organization:NIAID",
11937 | "email": "[email protected]",
11938 | "phone": "3014519881"
11939 | }
11940 | }
11941 | },
11942 | "documentSection": {
11943 | "largeDocumentModule": {
11944 | "largeDocs": [
11945 | {
11946 | "typeAbbrev": "Prot",
11947 | "hasProtocol": true,
11948 | "hasSap": false,
11949 | "hasIcf": false,
11950 | "label": "Study Protocol",
11951 | "date": "2020-04-02",
11952 | "uploadDate": "2020-09-16T16:07",
11953 | "filename": "Prot_001.pdf",
11954 | "size": 846604
11955 | },
11956 | {
11957 | "typeAbbrev": "SAP",
11958 | "hasProtocol": false,
11959 | "hasSap": true,
11960 | "hasIcf": false,
11961 | "label": "Statistical Analysis Plan",
11962 | "date": "2020-05-29",
11963 | "uploadDate": "2020-09-16T16:08",
11964 | "filename": "SAP_002.pdf",
11965 | "size": 2793155
11966 | },
11967 | {
11968 | "typeAbbrev": "ICF",
11969 | "hasProtocol": false,
11970 | "hasSap": false,
11971 | "hasIcf": true,
11972 | "label": "Informed Consent Form",
11973 | "date": "2020-03-04",
11974 | "uploadDate": "2020-07-20T15:36",
11975 | "filename": "ICF_000.pdf",
11976 | "size": 281581
11977 | }
11978 | ]
11979 | }
11980 | },
11981 | "derivedSection": {
11982 | "miscInfoModule": {
11983 | "versionHolder": "2025-03-21"
11984 | },
11985 | "conditionBrowseModule": {
11986 | "meshes": [
11987 | {
11988 | "id": "D000086382",
11989 | "term": "COVID-19"
11990 | }
11991 | ],
11992 | "ancestors": [
11993 | {
11994 | "id": "D011024",
11995 | "term": "Pneumonia, Viral"
11996 | },
11997 | {
11998 | "id": "D011014",
11999 | "term": "Pneumonia"
12000 | },
12001 | {
12002 | "id": "D012141",
12003 | "term": "Respiratory Tract Infections"
12004 | },
12005 | {
12006 | "id": "D007239",
12007 | "term": "Infections"
12008 | },
12009 | {
12010 | "id": "D014777",
12011 | "term": "Virus Diseases"
12012 | },
12013 | {
12014 | "id": "D018352",
12015 | "term": "Coronavirus Infections"
12016 | },
12017 | {
12018 | "id": "D003333",
12019 | "term": "Coronaviridae Infections"
12020 | },
12021 | {
12022 | "id": "D030341",
12023 | "term": "Nidovirales Infections"
12024 | },
12025 | {
12026 | "id": "D012327",
12027 | "term": "RNA Virus Infections"
12028 | },
12029 | {
12030 | "id": "D008171",
12031 | "term": "Lung Diseases"
12032 | },
12033 | {
12034 | "id": "D012140",
12035 | "term": "Respiratory Tract Diseases"
12036 | }
12037 | ],
12038 | "browseLeaves": [
12039 | {
12040 | "id": "M2561",
12041 | "name": "COVID-19",
12042 | "asFound": "COVID-19",
12043 | "relevance": "HIGH"
12044 | },
12045 | {
12046 | "id": "M20490",
12047 | "name": "Coronavirus Infections",
12048 | "relevance": "LOW"
12049 | },
12050 | {
12051 | "id": "M13904",
12052 | "name": "Pneumonia",
12053 | "relevance": "LOW"
12054 | },
12055 | {
12056 | "id": "M13914",
12057 | "name": "Pneumonia, Viral",
12058 | "relevance": "LOW"
12059 | },
12060 | {
12061 | "id": "M10283",
12062 | "name": "Infections",
12063 | "relevance": "LOW"
12064 | },
12065 | {
12066 | "id": "M6368",
12067 | "name": "Communicable Diseases",
12068 | "relevance": "LOW"
12069 | },
12070 | {
12071 | "id": "M14978",
12072 | "name": "Respiratory Tract Infections",
12073 | "relevance": "LOW"
12074 | },
12075 | {
12076 | "id": "M17522",
12077 | "name": "Virus Diseases",
12078 | "relevance": "LOW"
12079 | },
12080 | {
12081 | "id": "M6555",
12082 | "name": "Coronaviridae Infections",
12083 | "relevance": "LOW"
12084 | },
12085 | {
12086 | "id": "M23685",
12087 | "name": "Nidovirales Infections",
12088 | "relevance": "LOW"
12089 | },
12090 | {
12091 | "id": "M15149",
12092 | "name": "RNA Virus Infections",
12093 | "relevance": "LOW"
12094 | },
12095 | {
12096 | "id": "M11168",
12097 | "name": "Lung Diseases",
12098 | "relevance": "LOW"
12099 | },
12100 | {
12101 | "id": "M14977",
12102 | "name": "Respiratory Tract Diseases",
12103 | "relevance": "LOW"
12104 | }
12105 | ],
12106 | "browseBranches": [
12107 | {
12108 | "abbrev": "BC01",
12109 | "name": "Infections"
12110 | },
12111 | {
12112 | "abbrev": "BC08",
12113 | "name": "Respiratory Tract (Lung and Bronchial) Diseases"
12114 | },
12115 | {
12116 | "abbrev": "All",
12117 | "name": "All Conditions"
12118 | },
12119 | {
12120 | "abbrev": "BC23",
12121 | "name": "Symptoms and General Pathology"
12122 | }
12123 | ]
12124 | },
12125 | "interventionBrowseModule": {
12126 | "meshes": [
12127 | {
12128 | "id": "C000606551",
12129 | "term": "Remdesivir"
12130 | }
12131 | ],
12132 | "ancestors": [
12133 | {
12134 | "id": "D000963",
12135 | "term": "Antimetabolites"
12136 | },
12137 | {
12138 | "id": "D045504",
12139 | "term": "Molecular Mechanisms of Pharmacological Action"
12140 | },
12141 | {
12142 | "id": "D000998",
12143 | "term": "Antiviral Agents"
12144 | },
12145 | {
12146 | "id": "D000890",
12147 | "term": "Anti-Infective Agents"
12148 | }
12149 | ],
12150 | "browseLeaves": [
12151 | {
12152 | "id": "M6263",
12153 | "name": "Coal Tar",
12154 | "relevance": "LOW"
12155 | },
12156 | {
12157 | "id": "M341627",
12158 | "name": "Remdesivir",
12159 | "asFound": "Isoniazid",
12160 | "relevance": "HIGH"
12161 | },
12162 | {
12163 | "id": "M341633",
12164 | "name": "GS-441524",
12165 | "relevance": "LOW"
12166 | },
12167 | {
12168 | "id": "M107438",
12169 | "name": "Betadex",
12170 | "relevance": "LOW"
12171 | },
12172 | {
12173 | "id": "M4281",
12174 | "name": "Antimetabolites",
12175 | "relevance": "LOW"
12176 | },
12177 | {
12178 | "id": "M4314",
12179 | "name": "Antiviral Agents",
12180 | "relevance": "LOW"
12181 | },
12182 | {
12183 | "id": "M4214",
12184 | "name": "Anti-Infective Agents",
12185 | "relevance": "LOW"
12186 | }
12187 | ],
12188 | "browseBranches": [
12189 | {
12190 | "abbrev": "Derm",
12191 | "name": "Dermatologic Agents"
12192 | },
12193 | {
12194 | "abbrev": "All",
12195 | "name": "All Drugs and Chemicals"
12196 | },
12197 | {
12198 | "abbrev": "Infe",
12199 | "name": "Anti-Infective Agents"
12200 | }
12201 | ]
12202 | }
12203 | },
12204 | "hasResults": true
12205 | }
12206 | ],
12207 | "nextPageToken": "NF0g5JCEk_IgxQc"
12208 | }
12209 |
```