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 @ 2:08 PM
Ignite Modification Date: 2025-12-25 @ 12:49 PM
NCT ID: NCT03871595
Description: The treated set included all subjects who received at least one dose of trial medication.
Frequency Threshold: 5
Time Frame: From drug administration until the next drug administration or end of trial, up to 15 days.
Study: NCT03871595
Study Brief: A Study in Healthy Men to Test Whether Food Affects the Amount of BI 894416 in the Blood
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BI 894416 30 mg Fed (T) 3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after a high-fat, high-calorie meal (fed conditions) as test treatment (T). 0 None 0 14 1 14 View
BI 894416 30 mg Fast (R) 3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (fasted conditions) as reference treatment (R). 0 None 0 14 3 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View