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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:34 AM
NCT ID: NCT02355002
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was assessed during clinician assessments every 2 weeks from baseline (week 0) through week 6 (phase I and phase II), and once more at the end of the 3-month follow-up after phase I (for those not continuing to phase II) or after phase II.
Study: NCT02355002
Study Brief: Transcranial Magnetic Stimulation (TMS) in Obsessive Compulsive Disorder (OCD): Mechanisms and Biomarkers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Transcranial Magnetic Stimulation (TMS) Treatment (Phase I) In this arm participants received real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. 0 None 0 15 6 15 View
Sham-TMS Treatment (Phase I) This arm served as the sham/placebo control. In TMS, a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. 0 None 0 11 1 11 View
Open-label Active Transcranial Magnetic Stimulation (TMS) Treatment (Phase II) In this arm subjects received real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Transcranial Magnetic Stimulation: Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. 0 None 0 16 3 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Herniated Disk in Back SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ear Pain/Pressure SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Minor Car Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
OCD Symptom Worsening SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Flu-Like Symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Panic Attack SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sharp Pain in Neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue After TMS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypomanic Episode SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased Depressive Symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea Following MRI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pre-Syncopal Epsiode SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stomach Bug SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View