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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:59 PM
NCT ID: NCT02906358
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected for 11 months, the duration of the program.
Study: NCT02906358
Study Brief: Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Clinic-based Pain Self-management Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) Clinic-based pain self-management 0 None 0 53 2 53 View
Community-based Pain Self-management Community-based pain self-management: two, one-hour monthly meetings for first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings) Community-based pain self-management 0 None 3 58 3 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fractured leg NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gout attack NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diabetic foot infection leading to leg amputation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sprained wrist NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View