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 @ 11:03 PM
Ignite Modification Date: 2025-12-25 @ 8:33 PM
NCT ID: NCT03663569
Description: Treated set (TS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), and at least one documented administration of Spiolto® Respimat®.
Frequency Threshold: 5
Time Frame: From start of treatment until end of observation or discontinuation of treatment, whichever occurred first, up to 29 weeks.
Study: NCT03663569
Study Brief: A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Spiolto® Respimat® Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks. 7 None 8 4819 0 4819 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Other Events(If Any):