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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT02614092
Description: The definition of AEs and SEs does not differ from the provided definition. AEs and SAEs were collected at each study visit.
Frequency Threshold: 0
Time Frame: AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months
Study: NCT02614092
Study Brief: Water-based Activity to Enhance Recall in Veterans
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Water Based Activity+ Cognitive Training This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks. 0 None 3 31 7 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CVA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac discomfort SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Low Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Knee Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
High Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View