Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:27 AM
Ignite Modification Date: 2025-12-26 @ 2:07 AM
NCT ID: NCT00006305
Description: Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT00006305
Study Brief: Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Revascularization and Insulin Providing (IP) Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy None None 230 592 331 592 View
Revascularization and Insulin Sensitizing (IS) Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy None None 210 584 362 584 View
Medical Therapy and Insulin Providing (IP) Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy None None 230 593 344 593 View
Medical Therapy and Insulin Sensitizing (IS) Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy None None 235 599 363 599 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Severe Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bone Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Laser Therapy for Macular Edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Lower Extremity Ulcer SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pitting Edema SYSTEMATIC_ASSESSMENT General disorders None View