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 @ 10:40 PM
Ignite Modification Date: 2025-12-25 @ 8:11 PM
NCT ID: NCT02030535
Description: None
Frequency Threshold: 5
Time Frame: Adverse events (AEs) occurring up to the minimum of 21 days after drug stop date or the start of the next treatment period were considered on treatment; Up to 64 days.
Study: NCT02030535
Study Brief: Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers
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 Single test dose of oral inhalation of Placebo via RESPIMAT inhaler. 2 inhalations a.m. dosing. None None 0 53 3 53 View
Tio+Olo FDC Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation via RESPIMAT inhaler. 2 inhalations a.m. dosing. None None 0 52 1 52 View
Tiotropium and Olodaterol FC Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination FC (Tio/Olo free combination) Olodaterol: 5 μg (2.5 μg per actuation) Tiotropium: 5 μg (2.5 μg per actuation) 2 inhalations a.m. dosing. None None 2 52 2 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Prinzmetal angina SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 17.0 View
Cystocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MEDDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 17.0 View