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 @ 3:27 PM
Ignite Modification Date: 2025-12-25 @ 1:43 PM
NCT ID: NCT02231892
Description: AE collection was broken down by phase of the study (Behavioral vs. MRI), TMS Frequency (1Hz vs 10Hz), and Percentage of Motor Threshold (100%, 110%, Sham). Percentage of Motor Threshold (MT) corresponds with the milestones listed in the participant flow section.
Frequency Threshold: 0
Time Frame: Adverse event (AE) monitoring took place from participant consent to 3 weeks after final TMS session. The actual timeframe varied based on participant schedules and availability. Participants completed a TMS monitoring questionnaire before and after each TMS session, as well as 3 weeks after their final TMS session. Participants also completed a nursing assessment the morning of TMS appointments and had vitals taken at the end of each TMS appointment.
Study: NCT02231892
Study Brief: Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Frequency rTMS - 110% MT - Behavioral Phase Active 1Hz rTMS at 110% of motor threshold during the behavioral phase 0 None 0 7 1 7 View
Low Frequency rTMS - Sham - Behavioral Phase Low Frequency rTMS, sham, during behavioral phase. 0 None 0 8 0 8 View
High Frequency rTMS - 100% MT - Behavioral Phase Active 10Hz rTMS at 100% of motor threshold during the behavioral phase 0 None 0 6 0 6 View
High Frequency rTMS - 110% MT - Behavioral Phase Active 10Hz rTMS at 110% of motor threshold during the behavioral phase 0 None 0 5 0 5 View
High Frequency rTMS - Sham - Behavioral Phase High Frequency rTMS, sham, during behavioral phase. 0 None 0 5 0 5 View
High Frequency rTMS - 100% MT - MRI Phase Active 10Hz rTMS at 100% of motor threshold during the MRI phase of the study. 0 None 0 25 3 25 View
High Frequency rTMS - 110% MT - MRI Phase Active 10Hz rTMS at 110% of motor threshold during the MRI phase of the study. 0 None 0 27 2 27 View
High Frequency rTMS - Sham - MRI Phase High Frequency rTMS, sham, during MRI phase. 0 None 0 26 0 26 View
Low Frequency rTMS - 100% MT - Behavioral Phase Active 1Hz rTMS at 100% of motor threshold during the behavioral phase 0 None 0 7 5 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache and Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypomanic Episode NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Involuntary Movement After TMS SYSTEMATIC_ASSESSMENT Nervous system disorders None View