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: 2025-12-24 @ 5:16 PM
Ignite Modification Date: 2025-12-25 @ 2:53 PM
NCT ID: NCT04366050
Description: None
Frequency Threshold: 0
Time Frame: 28 Days
Study: NCT04366050
Study Brief: Ramipril for the Treatment of 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
Ramipril 2.5mg Orally Daily Total 2.5 mg Ramipril per day once a day orally for 14 days Intervention: Ramipril Ramipril 2.5 MG Oral Capsule: Include description or ramipril from protocol 1 None 2 79 37 79 View
Placebo Placebo in the form of a capsule, taken orally for 14 days Placebo oral capsule: Placebo 0 None 0 35 19 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiopulmonary Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drenching Sweats SYSTEMATIC_ASSESSMENT General disorders None View
Cough/Shortness of Breath/Pulmonary embolus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Elevated Lab Markers SYSTEMATIC_ASSESSMENT General disorders None View
Cardiovascular Issues SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ear Infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Steroid induced Diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Jittery SYSTEMATIC_ASSESSMENT General disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
Head or Body Pain SYSTEMATIC_ASSESSMENT General disorders None View
Loss of Smell SYSTEMATIC_ASSESSMENT General disorders None View
Rectal Hemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Worsening GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Throat Swelling SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View