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 @ 2:38 PM
Ignite Modification Date: 2025-12-25 @ 1:10 PM
NCT ID: NCT04048759
Description: Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT04048759
Study Brief: The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Remote High Remote High: Participants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. 0 None 2 34 7 34 View
Personal Coach Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education. 0 None 1 15 4 15 View
Remote Low Remote Low: Participants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. 0 None 3 32 1 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mitral Valve Regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Appendectomy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Spinal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cholecystectomy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Isthmic Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ankle Injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
COVID-19 Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastritis and gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View