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 @ 6:36 PM
Ignite Modification Date: 2025-12-25 @ 4:06 PM
NCT ID: NCT04907357
Description: Study specific SAEs are worsening depression, suicidal ideation, suicide attempt, suicide, hypomania/mania, seizure, and device malfunction resulting in injury. Study staff assesses for AEs and SAEs by asking the study participant, AEs and SAEs may also be spontaneously reported to study staff at any visit following consent. A suicide severity rating scale (CHRT) to assess both suicide intent and behavior was administered weekly during the treatment phase and at each follow-up visit.
Frequency Threshold: 5
Time Frame: 16 weeks
Study: NCT04907357
Study Brief: rTMS for Stimulant Use 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
Sham (Placebo) Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period. Sham (Placebo): Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain). 0 None 2 63 29 63 View
rTMS Participants will receive up to 30 rTMS sessions within the 8-week treatment period. rTMS: Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). 1 None 5 66 45 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v27.0 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v27.0 View
Cerebral vascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v27.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v27.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v27.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v27.0 View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v27.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v27.0 View
Headache device related SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v27.0 View
Application site discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA v27.0 View
Medical device site discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA v27.0 View
Medical Device Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v27.0 View
Blepharospasm device related SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v27.0 View
Muscle twitching device related SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v27.0 View
Procedural Headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v27.0 View