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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT02586493
Description: The analysis population used for SAEs and non-serious AEs was Intent-to-Treat population: all participants who were screened and received at least one dose of study treatment (placebo)
Frequency Threshold: 3
Time Frame: Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of Visit 1 until completion of Visit 2 (up to Day 30)
Study: NCT02586493
Study Brief: Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects
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 ELLIPTA Inhaler Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. None None 4 278 0 278 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, 18.1 View
Other Events(If Any):