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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:47 AM
NCT ID: NCT02246660
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02246660
Study Brief: RESveratrol To Improve Outcomes in oldeR pEople With PAD (the RESTORE Trial)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Resveratrol - 500 mg/Day The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative. 0 None 4 23 19 23 View
Resveratrol - 125 mg/Day The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative. 0 None 0 21 18 21 View
Placebo Placebo will be taken orally for 6 months. 1 None 4 22 15 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Allergy to lisinopril SYSTEMATIC_ASSESSMENT Immune system disorders None View
Toe amputation SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urologic procedure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pruritic rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lower extremity revascularization SYSTEMATIC_ASSESSMENT Vascular disorders None View
Elective plastic surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness/headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Foot pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hand cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Walking difficulty SYSTEMATIC_ASSESSMENT General disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Black stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT General disorders None View