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 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
NCT ID:
NCT00422669
Description:
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee.
All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
Frequency Threshold:
0
Time Frame:
All adverse events reported before the study termination were included.
Study:
NCT00422669
Study Brief:
Optimize RV Selective Site Pacing Clinical Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Subjects With Implant | All 198 subjects with implant were included in this group. | None | None | 50 | 198 | 12 | 198 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | None | Cardiac disorders | MedDRA (10.1) | View |
| Aortic valve stenosis | None | Cardiac disorders | MedDRA (10.1) | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA (10.1) | View |
| Basal cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | View |
| Benign prostatic hyperplasia | None | Reproductive system and breast disorders | MedDRA (10.1) | View |
| Cardiac arrest | None | Cardiac disorders | MedDRA (10.1) | View |
| Cardiac failure | None | Cardiac disorders | MedDRA (10.1) | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA (10.1) | View |
| Cardiac perforation | None | Cardiac disorders | MedDRA (10.1) | View |
| Cardiac tamponade | None | Cardiac disorders | MedDRA (10.1) | View |
| Cardiac valve disease | None | Cardiac disorders | MedDRA (10.1) | View |
| Cerebrovascular accident | None | Nervous system disorders | MedDRA (10.1) | View |
| Cholecystitis | None | Hepatobiliary disorders | MedDRA (10.1) | View |
| Chronic obstructive pulmonary disease | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Coronary artery disease | None | Cardiac disorders | MedDRA (10.1) | View |
| Coronary artery stenosis | None | Cardiac disorders | MedDRA (10.1) | View |
| Deep vein thrombosis | None | Vascular disorders | MedDRA (10.1) | View |
| Device failure | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Duodenal ulcer | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Ejection fraction decreased | None | Investigations | MedDRA (10.1) | View |
| Failure to capture | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Fluid overload | None | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Gastrointestinal disorder | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Hepatic encephalopathy | None | Nervous system disorders | MedDRA (10.1) | View |
| Hypertension | None | Vascular disorders | MedDRA (10.1) | View |
| Hypoglycemia | None | Metabolism and nutrition disorders | MedDRA (10.1) | View |
| Ileus | None | Gastrointestinal disorders | MedDRA (10.1) | View |
| Implant site haematoma | None | General disorders | MedDRA (10.1) | View |
| Intracardiac thrombus | None | Cardiac disorders | MedDRA (10.1) | View |
| Lead dislodgement | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Loss of consciousness | None | Nervous system disorders | MedDRA (10.1) | View |
| Myocardial infarction | None | Cardiac disorders | MedDRA (10.1) | View |
| Neoplasm malignant | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Pneumonia | None | Infections and infestations | MedDRA (10.1) | View |
| Pneumothorax | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Procedural hypertension | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Pulmonary embolism | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Pulmonary edema | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Rectal cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | View |
| Renal artery stenosis | None | Renal and urinary disorders | MedDRA (10.1) | View |
| Renal failure chronic | None | Renal and urinary disorders | MedDRA (10.1) | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Rheumatoid arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | View |
| Road traffic accident | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Skin laceration | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Staphylococcal sepsis | None | Infections and infestations | MedDRA (10.1) | View |
| Ventricular fibrillation | None | Cardiac disorders | MedDRA (10.1) | View |
| Ventricular tachycardia | None | Cardiac disorders | MedDRA (10.1) | View |
| Viral infection | None | Infections and infestations | MedDRA (10.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pacemaker generated arrhythmia | None | Cardiac disorders | MedDRA (10.1) | View |
| Syncope | None | Nervous system disorders | MedDRA (10.1) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (10.1) | View |
| Lead dislodgement | None | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Non-cardiac chest pain | None | General disorders | MedDRA (10.1) | View |
| Angina pectoris | None | Cardiac disorders | MedDRA (10.1) | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA (10.1) | View |
| Cardiac flutter | None | Cardiac disorders | MedDRA (10.1) | View |
| Chest discomfort | None | General disorders | MedDRA (10.1) | View |
| Herpes zoster | None | Infections and infestations | MedDRA (10.1) | View |
| Abdominal mass | None | Gastrointestinal disorders | MedDRA (10.1) | View |