Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-26 @ 1:17 PM
Ignite Modification Date: 2025-12-26 @ 1:17 PM
NCT ID: NCT03483506
Description: Treated set (TS): All subjects who received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: From first day of study drug administration until 12 days after last drug administration, up to 40 days.
Study: NCT03483506
Study Brief: This Study in Healthy Men Tests How the Body Takes up BI 1467335
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 1467335 All participants were orally administered treatment T1 consisted of 10 milligram (mg) (2x5) film-coated tablets of BI 1467335 once daily for 28 days in the fasted state with about 240 milliliters (ml) of non-sparkling water. In addition subjects also received the two single 10 ml intravenous (iv) infusion comprised 50 microgram (μg) BI 1467335 free base, consisting a mixture of 41.15 μg unlabelled BI 1467335 and 8.85 μg \[C-14\] BI 1467335 on Day 1 and a mixture of 45 μg unlabelled BI 1467335 and 5 μg \[C-14\] BI 1467335 free base on Day 28. The infusion started 1 hour after the intake of the BI 1467335 film-coated tablets on Day 1 and Day 28 and ended 15 minutes later. 0 None 0 12 6 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Medical device site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Listless SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View