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 @ 2:05 AM
Ignite Modification Date: 2025-12-26 @ 12:30 AM
NCT ID: NCT05497960
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 12 weeks.
Study: NCT05497960
Study Brief: Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vivo Intervention Participants participated via Zoom in a virtual exercise class 2 days/week for 45 minutes for 12 weeks. Exercise classes were led by a certified trainer and each class focused on building strength, flexibility, balance, and cognitive skills 0 None 0 22 3 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back pain following a skiing accident SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
COVID infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shoulder pain following exercise SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View