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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT02057835
Description: None
Frequency Threshold: 5
Time Frame: From drug administration until 31 days after drug administration, 31 days
Study: NCT02057835
Study Brief: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours. None None 0 16 6 16 View
BI 691751 5mg Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. None None 0 12 6 12 View
BI 691751 10mg Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. None None 0 12 4 12 View
BI 691751 30mg Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. None None 0 12 3 12 View
BI 691751 60mg Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. None None 0 12 7 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 17.0 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders 17.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders 17.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders 17.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 17.0 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations 17.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 17.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 17.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 17.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 17.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 17.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders 17.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Sputum increased SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 17.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 17.0 View