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 @ 9:34 PM
Ignite Modification Date: 2025-12-25 @ 7:18 PM
NCT ID: NCT01787032
Description: None
Frequency Threshold: 5
Time Frame: 15 days of treatment (including two 6-days-wash-out periods between BI 113608 treatments) followed by up to 12 days until the end of study. After study completion there was 30 days Adverse Event (AE) follow up period. 57 days on total.
Study: NCT01787032
Study Brief: Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects
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 113608 + Ketoconazole The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours. None None 0 18 3 18 View
BI 113608 + Voriconazole The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours. None None 0 19 5 19 View
Ketoconazole The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours. None None 0 19 9 19 View
Voriconazole The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours. None None 0 20 12 20 View
BI 113608 The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water. None None 0 18 3 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders 16.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders 16.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 16.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 16.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 16.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 16.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 16.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders 16.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 16.0 View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 16.0 View