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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:34 AM
NCT ID: NCT02775760
Description: None
Frequency Threshold: 0
Time Frame: 4 months
Study: NCT02775760
Study Brief: The Entorhinal Cortex and Aerobic Exercise in Aging
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cardiovascular Endurance Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center 0 None 2 17 3 17 View
Strength, Balance, and Flexibility Participants will undergo Strength, balance, and flexibility training. Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center 0 None 1 12 3 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fainting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sciatica pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sudden tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
tachycardia and chest tightness NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hip pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Concussion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Back soreness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View