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 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
NCT ID:
NCT02740335
Description:
None
Frequency Threshold:
2
Time Frame:
45 days after surgery
Study:
NCT02740335
Study Brief:
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Octaplex | Participants to receive 1 Octaplex infusion intravenously Octaplex: OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min). | 5 | None | 13 | 105 | 86 | 105 | View |
| Beriplex P/N (Kcentra) | Participants to receive 1 Kcentra infusion intravenously Beriplex P/N (Kcentra): Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (\~3 units/kg/min), up to a maximum rate of 8.4 mL/min (\~210 units/min). | 1 | None | 6 | 103 | 80 | 103 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina Unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Cardiac Failure Chronic | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| Myocardial Ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| Haemorrhagic Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| Cardiac Failure Acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Gastritis Erosive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Mesenteric Haematoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Gastritis Haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Multiple Organ Dysfunction Syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Orchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Anastomotic Haemmorhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Failure to Anastomose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Joint Dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Subdural Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Postoperative Wound Complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Soft Tissue Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Ovarian Cancer Stage IV | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | View |
| Cerebral Infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Acute Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| Pulmonary Oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| Shock | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| Shock Haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Dyschezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Cardiac AEs | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Catheter Site Related Reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Hyperthermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Procedural Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Postoperative Wound Complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Procedural Vomiting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Suture Related Complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Blood Pressure Increase | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| Body Temperature Increase | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| Musculoskeletal and connective tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Metabolism and nutrition disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| Nervous System Disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| Respiratory, thoracic and mediastinal disorders | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| Vascular Disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |