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 @ 5:31 PM
Ignite Modification Date: 2025-12-25 @ 3:04 PM
NCT ID: NCT02222168
Description: None
Frequency Threshold: 5
Time Frame: From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
Study: NCT02222168
Study Brief: Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers
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 409306 Fasted Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition. 0 None 0 18 1 18 View
BI 409306 Fed Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition. 0 None 0 18 4 18 View
BI 409306 at Bed-time Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time 0 None 0 18 1 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Bladder discomfort SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.1 View