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: 2025-12-24 @ 1:19 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT00023595
Description: None
Frequency Threshold: 0
Time Frame: No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol.
Study: NCT00023595
Study Brief: Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
H01: Medication + CABG None None None 85 534 0 0 View
H01 & H02: Medication+CABG None None None 9 76 0 0 View
H02: Medication+CABG None None None 31 423 0 0 View
H02: Medication+CABG+SVR None None None 53 501 0 0 View
H01: Medication None None None 84 602 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ABSCESS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
ACUTE CORONARY SYNDROME NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ACUTE HEART FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ACUTE LEFT VENTRICULAR FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ACUTE MYOCARDIAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ACUTE PULMONARY EDEMA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ACUTE PULMONARY OEDEMA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ACUTE RENAL FAILURE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ACUTE RESPIRATORY INSUFFICIENCY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ALS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ANGINA PECTORIS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ANGINAL DISCOMFORT NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ANGIOEDEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ANOXIC ENCEPHALOPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
AORTIC RUPTURE NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
ARRHYTHMIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ARTERIAL EMBOLISM (LIMBS) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
ASCITES NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ASPIRATION PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ASYSTOLIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIAL FIBRILLATION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BACTEREMIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
BOWEL ISCHEMIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
BRAIN TUMOR NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
BRONCHITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
BUN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations None View
CANCER OF LUNG NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
CARDIAC ARREST NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC ARRHYTHMIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC CIRRHOSIS NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
CARDIAC DISORDER NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC FAILURE ACUTE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC FAILURE AGGRAVATED NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC TAMPONADE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC VENTRICULAR THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOGENIC SHOCK NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOPULMONARY INSUFFICIENCY NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOVASCULAR INSUFFICIENCY NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CHRONIC SUBDURAL HAEMATOMA NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
CLAUDICATION NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
CMV INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
COLON CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
CONFUSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
CONGESTIVE CARDIAC FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CONGESTIVE HEART FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CORONARY OCCLUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations None View
CYSTITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
DECOMPENSATED HEART FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
DECOMPENSATION CARDIAC NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
DEVICE LEAD ISSUE NON_SYSTEMATIC_ASSESSMENT General disorders None View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DYSPNEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
EDEMA NON_SYSTEMATIC_ASSESSMENT General disorders None View
EDEMA PULMONARY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
EMBOLIC CEREBRAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
END STAGE CARDIAC FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
EPISTAXIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
GALLSTONES NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
GASTRIC ULCER PERFORATED NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GASTROINTESTINAL NECROSIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GOUT NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HAEMODYNAMIC INSTABILITY NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
HEART FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HEMODYNAMIC INSTABILITY NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
HEMORRHAGE BRAIN NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HEPARIN-INDUCED THROMBOCYTOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
HEPATIC INSUFFICIENCY NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
HEPATOMEGALY NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
HERNIA NON_SYSTEMATIC_ASSESSMENT General disorders None View
HOSPITALIZATION NOS NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
HYPERKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERTHYROIDISM NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
HYPOKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPOVOLEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
IMPLANT SITE INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
INFECTED SKIN ULCER NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
INSUFFICIENCY CARDIAC NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ISCHEMIC CARDIOMYOPATHY NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
JAUNDICE NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
LEFT VENTRICULAR FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LEUKOCYTOSIS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
LOSS OF CONSCIOUSNESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
LOW BLOOD PRESSURE NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
LOW CARDIAC OUTPUT SYNDROME NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
LUNG CANCER METASTATIC NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
MALIGNANT VENTRICULAR ARRHYTHMIAS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
MEDIASTINAL HEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
MEDIASTINITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
MESOTHELIOMA MALIGNANT NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
MITRAL VALVE DISEASE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
MULTI ORGAN FAILURE NON_SYSTEMATIC_ASSESSMENT General disorders None View
MULTIORGAN FAILURE NON_SYSTEMATIC_ASSESSMENT General disorders None View
MULTIPLE ORGAN FAILURE NON_SYSTEMATIC_ASSESSMENT General disorders None View
MYELODYSPLASTIC SYNDROME NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
MYOCARDIAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
MYOPATHY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
NECROSIS SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
NECROTIZING FASCIITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
OTHER CARDIAC NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PAROXYSMAL ATRIAL FIBRILLATION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PERICARDIAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PERIPHERAL VASCULAR DISEASE NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
PLEURAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
POSTOPERATIVE HEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
POSTPERICARDIOTOMY SYNDROME NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PULMONARY ARTERY THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY EDEMA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY EMBOLISM NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY EMBOLUS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY THROMBOEMBOLISM NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULSELESS ELECTRICAL ACTIVITY NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RENAL FAILURE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RENAL INSUFFICIENCY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RESPIRATORY FAILURE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
RESPIRATORY INSUFFICIENCY NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SCLERODERMA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
SEPSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
SEPTIC SHOCK NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
SHORTNESS OF BREATH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SIRS NON_SYSTEMATIC_ASSESSMENT General disorders None View
SKIN TROPHIC ULCER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SQUAMOUS CELL CARCINOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
STERNAL DEHISCENCE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
STROKE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SUPERFICIAL PHLEBOTHROMBOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
SUSTAINED VENTRICULAR TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SVT NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
UNSTABLE ANGINA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
UPPER GASTROINTESTINAL HEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
VENTRICULAR ARRHYTHMIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VENTRICULAR FIBRILLATION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VENTRICULAR TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VERTIGO NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
VOLUME OVERLOAD NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):