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 @ 1:08 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT02384993
Description: None
Frequency Threshold: 0
Time Frame: up to 26 weeks
Study: NCT02384993
Study Brief: aeRobic Exercise and Cognitive Health
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enhanced Physical Activity Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists. 0 None 0 12 1 12 View
Usual Physical Activity Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise \& Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program. 0 None 0 12 0 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hip Surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View