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 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:06 AM
NCT ID: NCT02164318
Description: None
Frequency Threshold: 0
Time Frame: All adverse events that are reported to the study staff by the subject during the intervention phase of the study where the subject is contacted by staff three times per week will be documented."
Study: NCT02164318
Study Brief: Effects of Exercise and Improved Nitric Oxide Bioavailability on Arteriovenous Fistula Maturation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group Standard of care None None 0 4 4 4 View
Combined Handgrip Training /Nitroglycerin Ointment Group Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Handgrip training Nitroglycerin ointment None None 2 3 2 3 View
Handgrip Training Group Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes Handgrip training None None 0 3 2 3 View
Nitroglycerin Ointment Group Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly Nitroglycerin ointment None None 0 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute uremia/dialysis initiation SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stroke/Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Head/arm/shoulder pain/discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness/Nausea SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomitting SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension/Bradycardia/Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View