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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:45 PM
NCT ID: NCT00856167
Description: Symptoms were monitored per DSMB to locate possible harms, using a checklist of 24 that might be from herbs, acupuncture, lifestyle changes, recommended self-care, and as new; severity; treatment-related; change since previous. Response protocols were in place. Each DSMB reviewed patterns x intervention. Ppts reported use of emergency rooms or hospital admissions since prior query. Every "yes" required follow-up. All final decisions were by medical directors consensus with PI /DSMB concurrence.
Frequency Threshold: 0
Time Frame: Adverse events were solicited at every regular data collection to six months beyond completion of any treatment; all practitioners had forms to use for any adverse event at a treatment session.
Study: NCT00856167
Study Brief: Traditional Chinese Medicine (TCM) for Temporomandibular Dysfunction (TMD): A Whole Systems Multi-site Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Traditional Chinese Medicine - Period 1 Whole systems traditional Chinese medicine, including herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations Traditional Chinese Medicine: Whole systems traditional Chinese medicine, including individually tailored herbal formulas based on a formulary, acupuncture (based on individual TCM diagnoses), tuna (Chinese massage), lifestyle recommendations 0 None 0 39 1 39 View
Self-care Self-care for TMD developed by Dworkin, LeResche et al. Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification 0 None 0 40 0 40 View
Traditional Chinese Medicine - Period 2 Whole systems traditional Chinese medicine, including herbal formulas, acupuncture, tuna (Chinese massage), lifestyle recommendations Traditional Chinese Medicine: Whole systems traditional Chinese medicine, including individually tailored herbal formulas based on a formulary, acupuncture (based on individual TCM diagnoses), tuna (Chinese massage), lifestyle recommendations 0 None 0 43 0 43 View
Self Care - Period 2 Self-care for TMD developed by Dworkin, LeResche et al. Self-care for TMD: a 5-session 8 hour intervention targeting TMD knowledge, stretching and exercises, stress reduction, lifestyle modification 0 None 0 42 0 42 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View