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: 2025-12-25 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:47 PM
NCT ID: NCT04580394
Description: The study analysis did not analyze data by period. AEs were reported for the safety analysis by number and percent for treatment group only.
Frequency Threshold: 3
Time Frame: Adverse Events were monitored for 14 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 8 weeks; End of Study Evaluation, 2 weeks post crossover period).
Study: NCT04580394
Study Brief: Crossover Trial of AD109 in Obstructive Sleep Apnea
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A: AD109 Treatment A: AD109 (Atomoxetine 75 mg + R-oxybutynin 2.5 mg) 0 None 1 56 2 56 View
B: Atomoxetine 75 mg + Placebo Treatment B: Atomoxetine 75 mg + Placebo 0 None 0 54 2 54 View
C: R-oxybutynin 2.5 mg + Placebo Treatment C:R-oxybutynin 2.5 mg + Placebo 0 None 0 54 0 54 View
D:Placebo + Placebo Treatment D: Placebo + Placebo 0 None 0 57 0 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (23.0) View
Cardiac Arrythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (23.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (23.0) View