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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
NCT ID:
NCT02359994
Description:
None
Frequency Threshold:
5
Time Frame:
Three (3)-months post-randomization for the first five subjects enrolled and 6-weeks post-randomization for subjects who enrolled thereafter.
Study:
NCT02359994
Study Brief:
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PerClot | Participants received up to two 5 gram bellows during index procedure. | 1 | None | 44 | 161 | 89 | 161 | View |
| Arista | Active Control. Participants received up to two 5 gram bellows during index procedure. | 5 | None | 44 | 163 | 78 | 163 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Hemolysis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Pulseless Electrical Activity | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Cardiogenic Shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Pericardial Tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Ventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Acute Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Complete Heart Block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Aortic Regurgitation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Congestive Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Asystole | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Sick Sinus Syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Atrial Fibrillation With Rapid Ventricular Response | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Ventricular Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Ileal Fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Acute Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Gastric Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Gastrointestinal Fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Perihepatic Fluid Collection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Duodenal Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Edema Limbs | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Implant Site Fluid Collection | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Hepatic Failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.0) | View |
| Biloma | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.0) | View |
| Portal Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.0) | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Abdominal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Pelvic Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Diabetic Foot Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Hematoma Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Biliary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Wound Dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Intraoperative Bleeding | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Arteriovenous Fistula Site Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Gastrointestinal Anastomotic Leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Ureteric Anastomotic Leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Thoracic Spine Compression Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Failure To Thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Electrolyte Abnormality | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Flank Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Hepatocellular Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Gastrointestinal Stromal Tumor | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Intracranial Aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Infarct Cerebral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Mania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Hypoxic Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Respiratory Arrest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Diaphoresis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Thromboembolic Event | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Blood Loss Of (Nos) | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Distributive Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Uncontrolled Hemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Bleeding | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Orthostatic Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |