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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT05238103
Description: Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
Frequency Threshold: 1
Time Frame: From enrollment until end of follow-up at 12 weeks after randomization
Study: NCT05238103
Study Brief: Impact of a Corrie Cardiac Rehabilitation Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation. 0 None 2 101 4 101 View
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals. 0 None 9 101 2 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute decompensated heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation with rapid ventricular response NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ST-elevation myocardial infarction (STEMI) due to bypass graft occlusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stress cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest pain (non-cardiac) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Symptoms during 6 minute walk test NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest pain at home (non-cardiac) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain from wearable device NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Delayed blood sample processing NON_SYSTEMATIC_ASSESSMENT Product Issues None View