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 @ 2:48 PM
Ignite Modification Date: 2025-12-25 @ 1:16 PM
NCT ID: NCT02674659
Description: None
Frequency Threshold: 0
Time Frame: 2 months
Study: NCT02674659
Study Brief: The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only) aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour) 0 None 1 43 2 43 View
Intervention Group Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well) resistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes. aerobic training: aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour) 0 None 1 44 0 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders ADHF View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
wound infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders wound infection View