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 @ 4:20 PM
Ignite Modification Date: 2025-12-25 @ 2:16 PM
NCT ID: NCT03275766
Description: inquiry with open questions
Frequency Threshold: 0
Time Frame: Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial
Study: NCT03275766
Study Brief: Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
preSMA/SMA Inhibitory repetitive transcranial magnetic stimulation (rTMS) of 1 Hz over preSMA/SMA should inhibit overactive premotor cortices SMA inhibitory: 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli 0 None 0 11 1 11 View
Sham TMS sham rTMS with a placebo coil over occipital cortex should have no effect at all (no transcranial magnetic stimulation, only sound) sham TMS: Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session 0 None 0 10 1 10 View
DLPFC Facilitatory repetitive transcranial magnetic stimulation (rTMS) of 15 Hz over left DLPFC usually effective in depression treatment, probably no specific effect on psychomotor slowing DLPFC facilitatory: 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli 0 None 0 12 1 12 View
preSMA/SMA Facilitatory intermittend theta burst stimulation (iTBS) over preSMA/SMA should facilitate neural activity within premotor cortices SMA facilitatory: Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli 0 None 1 11 0 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deterioration of psychiatric disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
mild nausea SYSTEMATIC_ASSESSMENT Nervous system disorders None View
neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
altered visual perception SYSTEMATIC_ASSESSMENT Nervous system disorders None View