Adverse Events Module

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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 @ 9:09 PM
Ignite Modification Date: 2025-12-25 @ 7:00 PM
NCT ID: NCT05093504
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected over the study duration, that is, within 30 days post-operation
Study: NCT05093504
Study Brief: Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Standard of care with Sham set-up Sham comparator: Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit 0 None 1 5 2 5 View
DrugSorb-ATR Intervention Standard of care + DrugSorb-ATR system DrugSorb-ATR system: Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit 1 None 2 4 2 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 24.0 View
Cerebral ischaemi SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 24.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 24.0 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 24.0 View
Carotid artery dissection SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 24.0 View
Post procedural hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 24.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 24.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 24.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 24.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 24.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 24.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 24.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 24.0 View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 24.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 24.0 View
Procedural site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 24.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDra 24.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDra 24.0 View
Cortisol decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 24.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDra 24.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 24.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 24.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 24.0 View
Procedural anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 24.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 24.0 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 24.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 24.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 24.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 24.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 24.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 24.0 View
Phlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 24.0 View
Subarachnoid hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 24.0 View