Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:56 PM
Ignite Modification Date: 2025-12-25 @ 3:19 PM
NCT ID: NCT03513068
Description: All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".
Frequency Threshold: 0
Time Frame: Duration of the study = 12 weeks.
Study: NCT03513068
Study Brief: Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SOC + POC (Portable Oxygen Concentrator) Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC) 0 None 1 54 16 54 View
Standard Of Care (SOC) Standard of care long-term oxygen therapy 1 None 6 54 21 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Other respiratory-related condition NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
COPD Exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COPD Exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other respiratory-related condition NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other NON_SYSTEMATIC_ASSESSMENT General disorders None View