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 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:38 PM
NCT ID: NCT03843151
Description: Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
Frequency Threshold: 5
Time Frame: For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Study: NCT03843151
Study Brief: A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 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 1358894 Oral administration of single dose of 10 milligram (mg) (2 tablets of 5 mg) BI 1358894 with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast on Day 1. 0 None 0 16 8 16 View
Itraconazole Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 hours once daily on Days -3 to 1 until the administration of BI 1358894. 0 None 0 16 2 16 View
BI 1358894 + Itraconazole Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 h once daily for 14 days on Days -3 to 11 combined with a single dose of 10 mg BI 1358894 (2 tablets of 5 mg) on Day 1 of Treatment Period 2, 1.5 hours after administration of itraconazole. 0 None 0 16 8 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Feeling of relaxation SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Red blood cell sedimentation rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 22.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Faeces soft SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Puncture site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Food craving SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View