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: 2025-12-26 @ 10:59 AM
Ignite Modification Date: 2025-12-26 @ 10:59 AM
NCT ID: NCT02611206
Description: None
Frequency Threshold: 0
Time Frame: Baseline to follow-up visit 6, 6 months
Study: NCT02611206
Study Brief: Repetitive Transcranial Magnetic Stimulation for Adolescent Depression: Efficacy, Predictive Biomarkers, and Mechanisms
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open Label rTMS All participants who qualify will undergo 6 weeks of open-label rTMS. Active Repetitive Transcranial Magnetic Stimulation (rTMS): rTMS applies a pulsatile magnetic field to the scalp which painlessly induces electrical currents to the brain. Typically, rTMS is applied to the dorsolateral prefrontal cortex (DLPFC), a brain region that is hypoactive in depression. Whereas standard rTMS stimulates superficial (1cm depth) cortical areas, recent advances in rTMS coil technology support stimulation of deeper (5 cm depth) limbic structures that are also relevant to depression. 0 None 2 14 14 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide intent NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Suicide ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Head and Jaw NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastro-intestinal & genito-Urinary NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervous system NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
skin and subcutaneous tissue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cardiovascular NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View