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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT00524420
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00524420
Study Brief: Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread 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 rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex None None 0 8 5 8 View
Sham rTMS Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS None None 0 11 5 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
increased fatigue None Musculoskeletal and connective tissue disorders None View
headache None Nervous system disorders None View
insomnia None Nervous system disorders None View
tingling sensation in scalp during stimulation None Injury, poisoning and procedural complications None View
dizziness None Nervous system disorders None View
confusion None Nervous system disorders None View
tiredness after session None Musculoskeletal and connective tissue disorders None View
shakiness None Nervous system disorders None View
anxiety None Psychiatric disorders None View
lightheadedness after session None Injury, poisoning and procedural complications None View
"fuzzy-headed" after TMS None Psychiatric disorders None View
migraine None Nervous system disorders None View
pain in teeth during stimulation None Injury, poisoning and procedural complications None View
drowsiness None Nervous system disorders None View
feeling more "distant, detached" None Psychiatric disorders None View
flat affect None Psychiatric disorders None View
sore throat None Infections and infestations None View
coryza None Infections and infestations None View
cough None Infections and infestations None View
sinus headache None Infections and infestations None View
flu None Infections and infestations None View
viral infection None Infections and infestations None View
tinnitus None Ear and labyrinth disorders None View
sinus congestion None Infections and infestations None View
sinus drainage None Infections and infestations None View
nausea None Gastrointestinal disorders None View
abdominal pain None Gastrointestinal disorders None View
diarrhea None Gastrointestinal disorders None View
sebaceous cyst on thigh None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
heart palpitations None Cardiac disorders None View
dry eyes None Eye disorders None View
pain in thumb None Musculoskeletal and connective tissue disorders None View
pain at the site of stimulation None Injury, poisoning and procedural complications None View
increased muscle aches None Musculoskeletal and connective tissue disorders None View
poor concentration None Psychiatric disorders None View
twitching of eye None Injury, poisoning and procedural complications None View
pain in jaw None Injury, poisoning and procedural complications None View
sinus infection None Infections and infestations None View
dry mouth None General disorders None View
TMJ pain None Injury, poisoning and procedural complications None View
pain in shoulder None Musculoskeletal and connective tissue disorders None View