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 @ 10:14 PM
Ignite Modification Date: 2025-12-25 @ 7:49 PM
NCT ID: NCT03616535
Description: None
Frequency Threshold: 0
Time Frame: Up to 18 months after enrollment for mortality; up to 12 months after enrollment for hospitalizations; all else up to 6 months.
Study: NCT03616535
Study Brief: Interventions Made to Preserve Cognitive Function
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 Training Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session. Cognitive training: The investigators will provide participants with tablets to play brain games. 6 None 6 31 24 31 View
Exercise Training Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session. ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard." Exercise training: The investigators will provide participants with foot peddlers. 4 None 1 29 21 29 View
Combined Cognitive and Exercise Training Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler). Combined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training. 3 None 4 35 28 35 View
Standard of Care Participants in this arm will receive standard of care 4 None 0 26 12 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization/Prolonged Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypotension SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT General disorders None View
Elevated heart rate SYSTEMATIC_ASSESSMENT Cardiac disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View
other unexpected event SYSTEMATIC_ASSESSMENT General disorders None View