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 @ 9:59 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT04257032
Description: Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
Frequency Threshold: 5
Time Frame: From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Study: NCT04257032
Study Brief: A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran 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
Rosuvastatin + BI 1323495 (Part 1, Test 1) In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1). 0 None 0 14 5 14 View
Rosuvastatin (Part 1, Reference 1) In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 1 (R1). 0 None 0 14 4 14 View
Dabigatran (Part 2, Reference 2) In part 2 on study Day 1 of Period 1 or 2 a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 2 (R2). 0 None 0 14 0 14 View
Dabigatran + BI 1323495 (Part 2, Test 2) In part 2 on study Day 1 of Period 1 or 2 a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 2 (T2). 0 None 0 14 1 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View