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 @ 5:11 AM
Ignite Modification Date: 2025-12-26 @ 4:16 AM
NCT ID: NCT02567227
Description: Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
Frequency Threshold: 5
Time Frame: 12 months from intervention
Study: NCT02567227
Study Brief: Cognitive Remediation to Improve Mobility in Sedentary Seniors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cognitive Remediation An individualized computerized cognitive remediation program. Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation. 2 None 5 192 49 192 View
Active Control Individualized computer based exposure and interactive health education classes. Active Control: Computer, multimedia and group based health education programs. 2 None 1 191 34 191 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
High blood pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View