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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
NCT ID:
NCT02132767
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT02132767
Study Brief:
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Rate Control | Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia. Rate Control Agents: Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin | None | None | 71 | 262 | 29 | 262 | View |
| Rhythm Control | Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach. If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF. | None | None | 73 | 261 | 26 | 261 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Heart Failure | None | Cardiac disorders | None | View |
| Major Infection | None | Infections and infestations | None | View |
| Pericardial Fluid Collection | None | Cardiac disorders | None | View |
| Renal Events | None | Renal and urinary disorders | None | View |
| Anemia | None | General disorders | None | View |
| Hypotension/Syncope | None | Cardiac disorders | None | View |
| Encephalopathy | None | General disorders | None | View |
| Deep Vein Thrombosis | None | Vascular disorders | None | View |
| Bleeding | None | General disorders | None | View |
| Cardiac Arrhythmias | None | Cardiac disorders | None | View |
| Cerebrovascular Thromboembolism | None | Nervous system disorders | None | View |
| Non-Cerebral Thromboembolism | None | Vascular disorders | None | View |
| Pleural Effusion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory Failure | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Coumadin Toxicity | None | Injury, poisoning and procedural complications | None | View |
| Amiodarone Toxicity | None | Injury, poisoning and procedural complications | None | View |
| Abdominal Distress | None | Gastrointestinal disorders | None | View |
| Chest Pain | None | Cardiac disorders | None | View |
| Dysphagia | None | General disorders | None | View |
| Fall Not Related to Syncope | None | Injury, poisoning and procedural complications | None | View |
| Heparin-Induced Thrombocytopenia | None | Injury, poisoning and procedural complications | None | View |
| Hyperkalemia | None | General disorders | None | View |
| Hypoglycemia | None | General disorders | None | View |
| Ischemic Colitis | None | Gastrointestinal disorders | None | View |
| Nosocomial Fever | None | General disorders | None | View |
| Peripheral Arterial Thrombus | None | Vascular disorders | None | View |
| Peripheral Vascular Disease | None | Vascular disorders | None | View |
| Peripheral Neuropathy | None | Nervous system disorders | None | View |
| Pneumothorax | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Psychosis | None | Psychiatric disorders | None | View |
| Pulmonary Embolism | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Right Groin Hematoma | None | Injury, poisoning and procedural complications | None | View |
| Sternal Wound Dehiscence | None | Injury, poisoning and procedural complications | None | View |
| Thrombocytopenia | None | Blood and lymphatic system disorders | None | View |
| Post-Pericardiotomy Syndrome | None | Cardiac disorders | None | View |
| Small Bowel Obstruction | None | Gastrointestinal disorders | None | View |
| Non-Cerebral Thromboembolism | None | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Renal events | None | Renal and urinary disorders | None | View |
| Superficial venous thrombosis | None | Vascular disorders | None | View |
| Thrombophlebitis left limb | None | Vascular disorders | None | View |
| Major infection | None | Infections and infestations | None | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Bleeding | None | General disorders | None | View |
| Cardiac Arrhythmias | None | Cardiac disorders | None | View |