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 @ 8:01 PM
Ignite Modification Date: 2025-12-25 @ 5:34 PM
NCT ID: NCT05127304
Description: As this is a non-interventional study with secondary use of data from commercial and Medicare Advantage Part D (MAPD) beneficiaries, safety monitoring and safety reporting on an individual case level is not applicable. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not collected in the database. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed".
Frequency Threshold: 0
Time Frame: Adverse event information was not applicable for this study.
Study: NCT05127304
Study Brief: A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tiotropium Bromide/Olodaterol (TIO/OLO) Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with TIO/OLO initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the TIO/OLO pharmacy claim that started the ≥30 consecutive days with the medication. 0 None 0 0 0 0 View
Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Chronic Obstructive Pulmonary Disease (COPD) patients with ≥30 consecutive days with FF/UMEC/VI initiated during the patient identification period of 01 June 2015 to 30 November 2019 and ≥40 years of age as of the year of the index date. The index date was the date of the FF/UMEC/VI pharmacy claim that started the ≥30 consecutive days with the medication. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):