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 @ 7:16 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT02356003
Description: We have a scale for tolerability and adverse events that we use for all TMS studies.
Frequency Threshold: 0
Time Frame: The three weeks of the intervention and the week following.
Study: NCT02356003
Study Brief: Transcranial Magnetic Stimulation for Children With Tourette's Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Frequency rTMS Eleven children (7-12 years of age) with Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation (5 times a week for three weeks). Low frequency repetitive transcranial magnetic stimulation: Baseline high-resolution anatomical magnetic resonance images will allow individualized neuronavigation (Brainsight 2, Rogue Research, Montreal QC) to co-register the transcranial magnetic stimulation Airfilm coil (Magistim, UK) precisely to the supplementary motor area as defined by functional magnetic resonance imaging. Interventional low frequency repetitive transcranial magnetic stimulation parameters will be: intensity 100% resting motor threshold, frequency 1 Hz, duration = 20 minutes (1200 stimulations). Treatments will occur on each weekday at the same time of day for three weeks (15 total). These are standard parameters for low frequency repetitive transcranial magnetic stimulation and are well tolerated in children. 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):