Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-26 @ 10:58 AM
Ignite Modification Date: 2025-12-26 @ 10:58 AM
NCT ID: NCT03577106
Description: Participants were monitored throughout the TMS protocol, and asked twice a session to describe any discomfort they experienced, along with rating this discomfort on a scale. Participants were also able to report discomfort at any time during treatment, to which the study team would respond accordingly.
Frequency Threshold: 5
Time Frame: Adverse events were systematically assessed daily for the 2 weeks of TMS treatment for each participant, and non-systematically assessed as needed throughout the entire study, an average of 6 weeks.
Study: NCT03577106
Study Brief: A Pilot fMRI Study of TMS in Late-Life Severe Worry
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transcranial Magnetic Stimulation (TMS) Transcranial magnetic stimulation (TMS): Theta Burst Stimulation (TBS), a form of TMS, will be targeted to the Inferior Parietal Cortex based on neural navigation software. TBS will be delivered for about 5-6 minutes, five days a week for two weeks, for a total of ten sessions. 0 None 1 24 23 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Kidney Stone NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Jaw clenching/Teeth Rattling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tapping Sensation on Scalp/Eye or Cheek Twitch SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neck Muscle Twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Unsteadiness/Dizziness SYSTEMATIC_ASSESSMENT General disorders None View