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 @ 2:42 AM
Ignite Modification Date: 2025-12-26 @ 1:21 AM
NCT ID: NCT01221233
Description: Adverse events were reported by study personnel in accordance with the University of Delaware Institutional Review Board for Human Subjects Research. Adverse event definitions as described in the Common Terminology Criteria for Adverse Events (CTCAE) from the National Institutes of Health are used for reporting.
Frequency Threshold: 0
Time Frame: Baseline, 6 weeks of intervention, and 6-week follow-up.
Study: NCT01221233
Study Brief: Investigation of Trunk Muscle Size and Function in Older Adults With Chronic Low Back Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NMES AND Stabilization Exercises Neuromuscular Electrical Stimulation (NMES) and Lumbar Stabilization Exercises 0 None 0 18 1 18 View
Moist Heat AND Stabilization Exercises Moist Heat and Lumbar Stabilization Exercises 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View