Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:28 PM
Ignite Modification Date: 2025-12-25 @ 7:14 PM
NCT ID: NCT01391832
Description: Two participants assigned to receive rTMS and one participant assigned to receive sham rTMS reported headaches and requested termination of the rTMS portion of the therapy.
Frequency Threshold: 0
Time Frame: 10 months
Study: NCT01391832
Study Brief: Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (PTSD)
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 rTMS Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment) Repetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe. Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma. 0 None 0 49 1 49 View
Active rTMS Active Repetitive Transcranial Magnet Stimulation treatment Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex Cognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma. Repetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil was be placed over over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46) and stimulation provided at 1 Hz (1.5-2.0 Tesla strength, 100 - 300 microseconds. 0 None 0 54 2 54 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders Headache MedDRA10.0 View