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 @ 3:16 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT00567892
Description: Subjects who had decrease in THI \> 20 pts were followed for up to 6 months. All subjects were followed thru for 4 weeks post treatment.
Frequency Threshold: 5
Time Frame: Up to 6 months.Minimum of 10 weeks in 2wk treatment, or 14 weeks in 4 week treatment.
Study: NCT00567892
Study Brief: Collaborative Tinnitus Research at Washington University
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
2 Weeks Treatment Treatment (either active rTMS or sham) for two weeks followed by 2 weeks wash-out then treatment (opposite of first assignment)for two weeks None None 0 14 7 14 View
Four Week Treatment Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks None None 0 20 3 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Worsening of Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Neck Stiffness or Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lightheaded feeling NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Worsening of Menopausal Symptoms NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View