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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT02113592
Description: The only adverse events monitored were serious adverse events, defined as hospitalizations and deaths, assessed systematically from electronic health record data. Assessments were conducted every 6 months throughout the study and reviewed by an independent monitor. For deaths, chart abstraction determined relatedness.
Frequency Threshold: 0
Time Frame: Participants were monitored for serious adverse events during the one-year period of study participation.
Study: NCT02113592
Study Brief: Pain Program for Active Coping & Training
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 Behavioral Therapy (CBT) Intervention Cognitive behavioral therapy (CBT) intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team of a behavioral health specialist, nurse care manager, physical therapist, and pharmacist, embedded in primary care. 4 None 94 433 0 0 View
Usual Care Patients in this arm receive care as usual and can utilize any pharmacologic and/or nonpharmacologic treatments available to them in their health care system without restriction. 8 None 112 417 0 0 View
Serious Events(If Any):

Serious Events

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