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 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT02901067
Description: None
Frequency Threshold: 5
Time Frame: 30 days following the injury
Study: NCT02901067
Study Brief: STAT-STatin and Aspirin in Trauma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU. Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube. 1 None 0 19 0 19 View
Control Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU. Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube. 0 None 2 18 3 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastro-intestinal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View