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: 2025-12-26 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT01919112
Description: None
Frequency Threshold: 3
Time Frame: Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).
Study: NCT01919112
Study Brief: Fostering Eating After Stroke With Transcranial Direct Current Stimulation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Dose Anodal tDCS High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises 1 None 1 14 3 14 View
Low Dose Anodal tDCS This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises 1 None 1 13 2 13 View
Sham Stimulation Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises 1 None 2 15 3 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Metabolic disorder SYSTEMATIC_ASSESSMENT Endocrine disorders None View