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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:28 AM
NCT ID: NCT02241733
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).
Study: NCT02241733
Study Brief: Sustainability of Pulmonary Rehab Gains
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exercise Patients exercised for 12 weeks and then participated in an adherence program Exercise only: Patients participated in a 12-week exercise program . They also participated in an adherence program. 1 None 16 40 0 40 View
Exercise Plus Breathing Retraining Patients exercised plus received breathing retraining for 12 weeks and then participated in an adherence program Breathing retraining plus exercise: Patients participated in a 12-week exercise program with breathing retraining. They also participated in an adherence program. 2 None 15 40 0 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COPD Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rectal abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Kidney stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
brain aneurysm NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
cellulitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
meningioma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
leukemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):