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 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT03133156
Description: None
Frequency Threshold: 0
Time Frame: 16 weeks
Study: NCT03133156
Study Brief: Exercise Regulation of Human Adipose Tissue
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Moderate Intensity Training-Healthy Lean Eligible subjects will undergo a 10-week moderate intensity exercise program. 0 None 0 35 2 35 View
Moderate Intensity Training-Healthy Overweight/Obese Eligible subjects will undergo a 10-week moderate intensity exercise program. 0 None 0 35 1 35 View
Moderate Intensity Training-Overweight/Obese Type 2 Diabetes Eligible subjects will undergo a 10-week moderate intensity exercise program. 0 None 0 11 1 11 View
High Intensity Training-Healthy Lean Eligible subjects will undergo a 10-week high intensity exercise program 0 None 0 12 1 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ankle Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Cramp NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Parethesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest Discomfort NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lightheadedness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Toe Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View