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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT02687360
Description: None
Frequency Threshold: 5
Time Frame: Participants were followed for 9 weeks.
Study: NCT02687360
Study Brief: Imaging the Effects of rTMS on Chronic Pain
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 rTMS Stimulation This arm will receive high-frequency rTMS pulses directed at the medial prefrontal and anterior cingulate cortices. Active rTMS treatment: In the active treatment, magnetic power output will be delivered to the participants through the coils. 0 None 0 4 2 4 View
Sham rTMS Stimulation The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil and to produce activation of facial muscles similar to the effect of active rTMS without stimulating the brain itself. Sham rTMS treatment: The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself. 0 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View