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 @ 4:54 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT00237718
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT00237718
Study Brief: Provision of Antioxidant Therapy in Hemodialysis (PATH) 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
ALA and Vitamin E 600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months None None 44 160 91 160 View
Placebo placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months None None 52 165 85 165 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
pulmonary NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
GI upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
edema NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hypertension/hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
neurological NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
lesions NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
trauma NON_SYSTEMATIC_ASSESSMENT General disorders None View
electrolyte disorder NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
other NON_SYSTEMATIC_ASSESSMENT General disorders None View
musculoskeletal NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
access related NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
fluid overload NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
diabetes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GI upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
access related NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pulmonary NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View