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 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT03743402
Description: None
Frequency Threshold: 0
Time Frame: Data were collected for 12 months, ending at participants' final follow up time point.
Study: NCT03743402
Study Brief: Strategies to Improve Pain and Enjoy Life
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. 0 None 0 74 0 74 View
Pain Self-Management This arm includes patients Patients randomized to Pain self-management training; This intervention will have 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper 4. opioid and non-opioid prescribing guidance for the patient's primary care provider. 0 None 0 79 8 79 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stopped taking prescribed opioids NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased anxiety / anger when reminded of appointment with study staff NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Musculoskeletal pain after PMR NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache after PMR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View