Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 1:26 AM
Ignite Modification Date: 2025-12-25 @ 11:37 PM
NCT ID: NCT04579393
Description: None
Frequency Threshold: 5
Time Frame: 60 days
Study: NCT04579393
Study Brief: Fostamatinib for Hospitalized Adults With COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fostamatinib With Standard of Care for Treatment of COVID-19 Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. 1 None 5 30 8 30 View
Placebo With Standard of Care for Treatment of COVID-19 Placebo: Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. 3 None 10 29 15 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 5.0 View
Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 5.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Self-Extubation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Post COVID Fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5.0 View