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 All Studies All Organizations 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: 2025-12-24 @ 2:11 PM
Ignite Modification Date: 2025-12-24 @ 2:11 PM
NCT ID: NCT01396395
Description: None
Frequency Threshold: 1
Time Frame: From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks ).
Study: NCT01396395
Study Brief: Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Treatment Plus Nicorandil The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors \[ACEIs\] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators). None None 9 197 12 197 View
Standard Treatment The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators. None None 7 205 1 205 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sudden death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 14.1 View
Cardiac sudden death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 14.1 View
Angina NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 14.1 View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 14.1 View
Acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 14.1 View
Unstable angina NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 14.1 View
Sick sinus syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 14.1 View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 14.1 View
Peripheral edema NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 14.1 View
Diabetic foot NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 14.1 View
Diabetes NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 14.1 View
Lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 14.1 View
Multiple myeloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 14.1 View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1 View
Gastroenteritis' NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1 View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1 View
Increased blood pressure NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 14.1 View
Chronic renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 14.1 View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 14.1 View