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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:34 AM
NCT ID: NCT00523302
Description: None
Frequency Threshold: 0
Time Frame: 5 Weeks
Study: NCT00523302
Study Brief: A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia
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 TMS Participants receive 5 Active TMS treatment sessions per week for two weeks. Active stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days. Active TMS: Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days. 0 None 0 10 0 10 View
Sham TMS Participants receive 5 Sham TMS treatment sessions per week for two weeks. Sham stimulation involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week=20,000 pulses per week, x 2 weeks = 40,000 pulses. Time - 1200 sec = 20 minutes/ session, all days. Sham TMS: Sham TMS will use the same stimulation frequency for all active subjects (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines. 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):