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 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
NCT ID:
NCT00478933
Description:
Only Serious Adverse Device Effects and Serious Procedure-related Adverse Events (in France only) had to be reported.
Serious Procedure-related Adverse Events (France only): An SAE that occurs due to any procedure specific to the clinical investigation, including the implantation or modification of the system.
Frequency Threshold:
0
Time Frame:
From 1st enrollment, 25 April 2007, through last follow up, 31 July 2012: ~ 5 yrs
Study:
NCT00478933
Study Brief:
DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ICD Therapy, Blood Sampling | Defibrillator, Dual Chamber ; Implantable: Patient must wear a dual chamber ICD to remain in study. Can be enrolled 10 days prior to implant. Is excluded if device type changes. Blood sampling: Blood sampling for genetic analysis on pre-identified SNPs | None | None | 265 | 1145 | 45 | 1145 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| device stimulation issue | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| arrhythmia supraventricular | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| arteriogram coronary | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| atrial tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| bradyarrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| cardiac ablation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (20.0) | View |
| cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| cardiac failure acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| cardiac failure chronic | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| cardiac tamponade | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| cardiogenic shock | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| device lead issue | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| device malfunction | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (20.0) | View |
| Implant site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Abdominal operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (20.0) | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| aneamia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| aortic aneurysm | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| cardioversion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (20.0) | View |
| cerebellar stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Cervical vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Cholecystitis chronic | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.0) | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| circulatory collapse | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| colon cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| Complication associated with device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| cororary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| deep venous thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| device dislocation | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| Device electrical impedance issue | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| device extrusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| device issue | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| device lead damage | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| device pacing issue | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| dyspnoea exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| gastrointestinal uler haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| gout | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| hospitalisation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (20.0) | View |
| hypertension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| hypertensive nephropathy | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (20.0) | View |
| hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| ill-defined disorder | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| implant site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| implant site infection | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| implant site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| implant site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| implant site ulcer | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| inflammatory marker increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| invertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| iron deficiency anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (20.0) | View |
| ischaemic cardiomayopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| lead dislodgement | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| medical device site abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| Medical device site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| multiple injuries | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| Multiple organ dysfunction syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| opthalmic herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| orthopnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| oversensing | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| Pacemaker generated arrhythmia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| paroxysmal arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Peripheral artery stent insertion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (20.0) | View |
| peripheral artery thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| pocket erosion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| silent myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| small cell lung cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | View |
| stent placement | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (20.0) | View |
| supraventricular extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| therapy non-responder | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| transient global amnesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| traumatic haemothorax | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| undersensing | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| urinary tract infection bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| vena cava thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| ventricular arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| ventricular fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| wound necrosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| acute haemorrhagic ulcerative colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| alcohol poisoning | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| cardiac death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| cardiac failure acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| cardiac tamponade | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| carpal tunnel syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.0) | View |
| device extrusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (20.0) | View |
| Diabetes mellitus inadequate control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| emphysema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| hospitalisation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (20.0) | View |
| hypertensive emergency | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| implant site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| implant site infection | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |
| implant site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| implant site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Medical device site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.0) | View |
| sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| sleep apnoea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | View |
| spinal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| wound secretion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.0) | View |