Adverse Events Module

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 @ 7:49 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT04070703
Description: Data reported in this record is consistent with the definitions described at clinicaltrials.gov
Frequency Threshold: 0
Time Frame: Events were observed and documented during the 6-month active intervention period.
Study: NCT04070703
Study Brief: Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Tai Ji Quan Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition 0 None 2 107 10 107 View
Cognitively Enhanced Tai Ji Quan Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition 0 None 3 105 10 105 View
Stretching Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition 0 None 2 106 11 106 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious event SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other events SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View