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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT04821869
Description: All ad verse event descriptions and definitions are per clinicaltrials.gov
Frequency Threshold: 0
Time Frame: Data was collected from consent to post study follow-up over approximately 7 months
Study: NCT04821869
Study Brief: ProAir Digihaler in COPD Disease Management: A Real World Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Digihaler Device User Single arm pilot study assessing the relationship of deterioration in COPD healthcare status (COPD exacerbations and/or worsening in COPD Assessment Test ≥2) to changes in physiologic parameters measured from usage of an albuterol Digihaler inhalation device, including peak inspiratory flow (PIF), extra inhaler puff usage per day and inhalation volume (InV) prior to any heaalthcare deterioration event. 0 None 3 27 16 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COPD Exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COPD Exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Non respiratory adverse events NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View