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 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
NCT ID:
NCT01213251
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01213251
Study Brief:
Post-Myocardial Infarction Remodeling Prevention Therapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dual Site Pacing | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. | None | None | 24 | 41 | 25 | 41 | View |
| Control | Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management. | None | None | 20 | 45 | 27 | 45 | View |
| Single Site Pacing | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. | None | None | 22 | 40 | 20 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Acute coronary syndrome | None | Cardiac disorders | MedDRA 18.0 | View |
| Acute myocardial infarction | None | Cardiac disorders | MedDRA 18.0 | View |
| Angina pectoris | None | Cardiac disorders | MedDRA 18.0 | View |
| Angina unstable | None | Cardiac disorders | MedDRA 18.0 | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA 18.0 | View |
| Atrial flutter | None | Cardiac disorders | MedDRA 18.0 | View |
| Atrioventricular block complete | None | Cardiac disorders | MedDRA 18.0 | View |
| Atrioventricular block second degree | None | Cardiac disorders | MedDRA 18.0 | View |
| Cardiac aneurysm | None | Cardiac disorders | MedDRA 18.0 | View |
| Cardiac arrest | None | Cardiac disorders | MedDRA 18.0 | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA 18.0 | View |
| Cardiac perforation | None | Cardiac disorders | MedDRA 18.0 | View |
| Cardiorenal syndrome | None | Cardiac disorders | MedDRA 18.0 | View |
| Coronary artery disease | None | Cardiac disorders | MedDRA 18.0 | View |
| Decompensated Heart Failure | None | Cardiac disorders | MedDRA 18.0 | View |
| Dresslers syndrome | None | Cardiac disorders | MedDRA 18.0 | View |
| Ischaemic cardiomyopathy | None | Cardiac disorders | MedDRA 18.0 | View |
| Myocardial infarction | None | Cardiac disorders | MedDRA 18.0 | View |
| Supraventricular tachycardia | None | Cardiac disorders | MedDRA 18.0 | View |
| Ventricular extrasystoles | None | Cardiac disorders | MedDRA 18.0 | View |
| Ventricular fibrillation | None | Cardiac disorders | MedDRA 18.0 | View |
| Ventricular tachycardia | None | Cardiac disorders | MedDRA 18.0 | View |
| Gastrointestinal arteriovenous malformation | None | Congenital, familial and genetic disorders | MedDRA 18.0 | View |
| Colitis ulcerative | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Duodenal ulcer haemorrhage | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Inguinal hernia | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Rectal haemorrhage | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Chest pain | None | General disorders | MedDRA 18.0 | View |
| Device infusion issue | None | General disorders | MedDRA 18.0 | View |
| Device stimulation issue | None | General disorders | MedDRA 18.0 | View |
| Implant site haemorrhage | None | General disorders | MedDRA 18.0 | View |
| Lead dislodgement | None | General disorders | MedDRA 18.0 | View |
| Multi-organ failure | None | General disorders | MedDRA 18.0 | View |
| Non-cardiac chest pain | None | General disorders | MedDRA 18.0 | View |
| Undersensing | None | General disorders | MedDRA 18.0 | View |
| Cholecystitis | None | Hepatobiliary disorders | MedDRA 18.0 | View |
| Appendicitis | None | Infections and infestations | MedDRA 18.0 | View |
| Diverticulitis | None | Infections and infestations | MedDRA 18.0 | View |
| Erysipelas | None | Infections and infestations | MedDRA 18.0 | View |
| Implant site infection | None | Infections and infestations | MedDRA 18.0 | View |
| Incision site infection | None | Infections and infestations | MedDRA 18.0 | View |
| Pneumonia | None | Infections and infestations | MedDRA 18.0 | View |
| Urinary tract infection | None | Infections and infestations | MedDRA 18.0 | View |
| Viral myocarditis | None | Infections and infestations | MedDRA 18.0 | View |
| Accidental overdose | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Coronary artery restenosis | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Lumbar vertebral fracture | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| International normalised ratio increased | None | Investigations | MedDRA 18.0 | View |
| Fluid overload | None | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Malnutrition | None | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Joint effusion | None | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Vertebral foraminal stenosis | None | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Bladder transitional cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Lung adenocarcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Rectal adenoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA 18.0 | View |
| Hypoxic-ischaemic encephalopathy | None | Nervous system disorders | MedDRA 18.0 | View |
| Ischaemic stroke | None | Nervous system disorders | MedDRA 18.0 | View |
| Lumbar radiculopathy | None | Nervous system disorders | MedDRA 18.0 | View |
| Syncope | None | Nervous system disorders | MedDRA 18.0 | View |
| Depression suicidal | None | Psychiatric disorders | MedDRA 18.0 | View |
| Acute kidney injury | None | Renal and urinary disorders | MedDRA 18.0 | View |
| Acute prerenal failure | None | Renal and urinary disorders | MedDRA 18.0 | View |
| Nephrolithiasis | None | Renal and urinary disorders | MedDRA 18.0 | View |
| Renal failure | None | Renal and urinary disorders | MedDRA 18.0 | View |
| Renal impairment | None | Renal and urinary disorders | MedDRA 18.0 | View |
| Acute respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pneumothorax | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pulmonary oedema | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Dermatitis contact | None | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Aortic aneurysm | None | Vascular disorders | MedDRA 18.0 | View |
| Arterial stenosis | None | Vascular disorders | MedDRA 18.0 | View |
| Arterial thrombosis | None | Vascular disorders | MedDRA 18.0 | View |
| Hypotension | None | Vascular disorders | MedDRA 18.0 | View |
| Orthostatic hypotension | None | Vascular disorders | MedDRA 18.0 | View |
| Subclavian steal syndrome | None | Vascular disorders | MedDRA 18.0 | View |
| Thrombosis | None | Vascular disorders | MedDRA 18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina unstable | None | Cardiac disorders | MedDRA 18.0 | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA 18.0 | View |
| Atrioventricular block complete | None | Cardiac disorders | MedDRA 18.0 | View |
| Bradycardia | None | Cardiac disorders | MedDRA 18.0 | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA 18.0 | View |
| Adverse drug reaction | None | General disorders | MedDRA 18.0 | View |
| Oversensing | None | General disorders | MedDRA 18.0 | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Foreign body | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Increased tendency to bruise | None | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Thrombocytopenia | None | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Angina pectoris | None | Cardiac disorders | MedDRA 18.0 | View |
| Cardiomegaly | None | Cardiac disorders | MedDRA 18.0 | View |
| Coronary artery disease | None | Cardiac disorders | MedDRA 18.0 | View |
| Decompensated Heart Failure | None | Cardiac disorders | MedDRA 18.0 | View |
| Intracardiac thrombus | None | Cardiac disorders | MedDRA 18.0 | View |
| Palpitations | None | Cardiac disorders | MedDRA 18.0 | View |
| Sinus bradycardia | None | Cardiac disorders | MedDRA 18.0 | View |
| Ventricular fibrillation | None | Cardiac disorders | MedDRA 18.0 | View |
| Ventricular tachycardia | None | Cardiac disorders | MedDRA 18.0 | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA 18.0 | View |
| Hypogonadism | None | Endocrine disorders | MedDRA 18.0 | View |
| Keratitis | None | Eye disorders | MedDRA 18.0 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Dental discomfort | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Dysphagia | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Large intestine polyp | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 18.0 | View |
| Chest pain | None | General disorders | MedDRA 18.0 | View |
| Device alarm issue | None | General disorders | MedDRA 18.0 | View |
| Device capturing issue | None | General disorders | MedDRA 18.0 | View |
| Device electrical impedance issue | None | General disorders | MedDRA 18.0 | View |
| Device infusion issue | None | General disorders | MedDRA 18.0 | View |
| Device malfunction | None | General disorders | MedDRA 18.0 | View |
| Device occlusion | None | General disorders | MedDRA 18.0 | View |
| Device pacing issue | None | General disorders | MedDRA 18.0 | View |
| Device stimulation issue | None | General disorders | MedDRA 18.0 | View |
| Fatigue | None | General disorders | MedDRA 18.0 | View |
| Implant site bruising | None | General disorders | MedDRA 18.0 | View |
| Implant site oedema | None | General disorders | MedDRA 18.0 | View |
| Implant site pain | None | General disorders | MedDRA 18.0 | View |
| Implant site scar | None | General disorders | MedDRA 18.0 | View |
| Implant site swelling | None | General disorders | MedDRA 18.0 | View |
| Lead dislodgement | None | General disorders | MedDRA 18.0 | View |
| Medical device pain | None | General disorders | MedDRA 18.0 | View |
| Non-cardiac chest pain | None | General disorders | MedDRA 18.0 | View |
| Oedema peripheral | None | General disorders | MedDRA 18.0 | View |
| Peripheral swelling | None | General disorders | MedDRA 18.0 | View |
| Phantom shocks | None | General disorders | MedDRA 18.0 | View |
| Undersensing | None | General disorders | MedDRA 18.0 | View |
| Vessel puncture site haematoma | None | General disorders | MedDRA 18.0 | View |
| Cholelithiasis | None | Hepatobiliary disorders | MedDRA 18.0 | View |
| Drug hypersensitivity | None | Immune system disorders | MedDRA 18.0 | View |
| Acarodermatitis | None | Infections and infestations | MedDRA 18.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA 18.0 | View |
| Diverticulitis | None | Infections and infestations | MedDRA 18.0 | View |
| Echinococciasis | None | Infections and infestations | MedDRA 18.0 | View |
| Gastroenteritis norovirus | None | Infections and infestations | MedDRA 18.0 | View |
| Impetigo | None | Infections and infestations | MedDRA 18.0 | View |
| Implant site infection | None | Infections and infestations | MedDRA 18.0 | View |
| Influenza | None | Infections and infestations | MedDRA 18.0 | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA 18.0 | View |
| Accidental overdose | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Cardiac vein dissection | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Cardiac vein perforation | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Incision site pain | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Laceration | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Ligament sprain | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Traumatic haematoma | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Wound dehiscence | None | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Biopsy skin | None | Investigations | MedDRA 18.0 | View |
| Blood pressure increased | None | Investigations | MedDRA 18.0 | View |
| Blood urine present | None | Investigations | MedDRA 18.0 | View |
| Body temperature increased | None | Investigations | MedDRA 18.0 | View |
| C-reactive protein increased | None | Investigations | MedDRA 18.0 | View |
| Echocardiogram abnormal | None | Investigations | MedDRA 18.0 | View |
| Hepatic enzyme increased | None | Investigations | MedDRA 18.0 | View |
| International normalised ratio increased | None | Investigations | MedDRA 18.0 | View |
| Liver function test abnormal | None | Investigations | MedDRA 18.0 | View |
| Gout | None | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypocalcaemia | None | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypokalaemia | None | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Renal adenoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Cervicobrachial syndrome | None | Nervous system disorders | MedDRA 18.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA 18.0 | View |
| Headache | None | Nervous system disorders | MedDRA 18.0 | View |
| Paraesthesia | None | Nervous system disorders | MedDRA 18.0 | View |
| Sciatica | None | Nervous system disorders | MedDRA 18.0 | View |
| Syncope | None | Nervous system disorders | MedDRA 18.0 | View |
| Acute stress disorder | None | Psychiatric disorders | MedDRA 18.0 | View |
| Stress | None | Psychiatric disorders | MedDRA 18.0 | View |
| Haematuria | None | Renal and urinary disorders | MedDRA 18.0 | View |
| Renal failure | None | Renal and urinary disorders | MedDRA 18.0 | View |
| Benign prostatic hyperplasia | None | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Menopausal symptoms | None | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Asthma | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Dyspnoea exertional | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pulmonary hypertension | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Sinus congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Sleep apnoea syndrome | None | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Dermatitis allergic | None | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Ingrowing nail | None | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Photodermatosis | None | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Hypertension | None | Vascular disorders | MedDRA 18.0 | View |
| Hypotension | None | Vascular disorders | MedDRA 18.0 | View |
| Orthostatic hypotension | None | Vascular disorders | MedDRA 18.0 | View |
| Peripheral arterial occlusive disease | None | Vascular disorders | MedDRA 18.0 | View |
| Peripheral artery thrombosis | None | Vascular disorders | MedDRA 18.0 | View |
| Venous stenosis | None | Vascular disorders | MedDRA 18.0 | View |