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 @ 5:10 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT01948050
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01948050
Study Brief: Pilot Study of Transcranial Stimulation (tDCS)to Relieve Neuropathic Pain in Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Real tDCS Stimulation non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days. None None 1 16 10 16 View
Sham tDCS sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days. None None 1 8 5 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Exacerbation of shortness of breath None Respiratory, thoracic and mediastinal disorders None View
Exacerbation of Pain due to rectal cellulitis None Gastrointestinal disorders None View
Transient change in mental status None Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache None General disorders None View
Fatigue None General disorders None View
Interrupted Sleep None General disorders None View
Hypotension None General disorders None View
Dry Mouth None General disorders None View
Numbness None General disorders None View
Tongue tingling None General disorders None View
Cellulitis None Skin and subcutaneous tissue disorders None View
Clear discharge from ear None Ear and labyrinth disorders None View
Urinary tract infection None Renal and urinary disorders None View
Tibial fracture None Musculoskeletal and connective tissue disorders None View
Transient Pain None General disorders None View
Dizziness None General disorders None View
Worsening of Pain None General disorders None View
Memory lapse None Nervous system disorders None View
Flu-like symptoms None Respiratory, thoracic and mediastinal disorders None View