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 @ 9:38 PM
Ignite Modification Date: 2025-12-25 @ 7:21 PM
NCT ID: NCT04099732
Description: Treated set: All subjects who were entered and treated with at least 1 dose of trial drug.
Frequency Threshold: 5
Time Frame: Adverse events occuring up to 144 hours (h) after first rosuvastatin administration in treatment period 1 of part 1 and adverse events occuring up to 168h after administration of BI 1358894 + Rosuvastatin in treatment period 2 of part 1. Adverse events occuring up to 72h after first dabigatran administration in treatment period 1 of part 2 and adverse events occuring up to 168h after administration of BI 1358894 + dabigatran in treatment period 2.
Study: NCT04099732
Study Brief: A Study in Healthy Men to Test the Influence of BI 1358894 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 (Part 1, Reference 1) In part 1, period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 1 (R1). 0 None 0 14 3 14 View
Rosuvastatin + BI 1358894 (Part 1, Test 1) In part 1, period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 1 (T1). 0 None 0 14 9 14 View
Dabigatran (Part 2, Reference 2) In part 2, period 1 a single oral dose of 1 hard capsule of 150 milligram (mg) dabigatran etexilate was administered with 240 ml of water after a high-fat, high-calorie breakfast as reference 2 (R2). 0 None 0 12 2 12 View
Dabigatran + BI 1355894 (Part 2, Test 2) In part 2, period 2, a single oral dose of 1 hard capsule of 150 mg dabigatran etexilate was coadministered with a single oral dose of 2 film-coated tablets of 100 mg BI 1358894 (200 mg in total) with 240 mL of water after a high-fat, high-calorie breakfast as test 2 (T2). 0 None 0 12 4 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View