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 @ 3:04 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT02248259
Description: Adverse events were analysed by the treatment being administered at the time of the adverse event.
Frequency Threshold: 5
Time Frame: From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days
Study: NCT02248259
Study Brief: Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Extensive Metabolizers: Itra Participants who were extensive metabolisers receiving only 2 capsules of 100 mg itraconazole (Itra) taken orally twice daily. None None 0 13 3 13 View
Extensive Metabolizers: BI 409306 Participants who were extensive metabolisers receiving only 1 single tablet of 25 mg BI 409306 taken orally. None None 0 12 1 12 View
Extensive Metabolizers: Itra+BI 409306 Participants who were extensive metabolisers receiving 2 capsules of 100 mg itraconazole taken orally twice daily and 1 single tablet of 25 mg BI 409306 taken orally. None None 0 12 3 12 View
Poor Metabolizers: Itra Participants who were poor metabolisers receiving only 2 capsules of 100 mg itraconazole taken orally twice daily. None None 0 12 1 12 View
Poor Metabolizers: BI 409306 Participants who were poor metabolisers receiving only 1 single tablet of 25 mg BI 409306 taken orally. None None 0 12 3 12 View
Poor Metabolizers: Itra+BI 409306 Participants who were poor metabolisers receiving 2 capsules of 100 mg itraconazole taken orally twice daily and 1 single tablet of 25 mg BI 409306 taken orally. None None 0 12 0 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders 17.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders 17.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.1 View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.1 View
Sensation of foreign body SYSTEMATIC_ASSESSMENT General disorders 17.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 17.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 17.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders 17.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 17.1 View