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: 2025-12-25 @ 1:38 AM
Ignite Modification Date: 2025-12-25 @ 11:53 PM
NCT ID: NCT01920594
Description: All Subjects Population was used.
Frequency Threshold: 5
Time Frame: AEs were collected up to Follow-up (Day 45).
Study: NCT01920594
Study Brief: Study of GSK1278863 to Reduce Ischemic Events in Patients Undergoing Thoracic Aortic Aneurysm Repair
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GSK1278863 300 mg Loading + 100 mg QD Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day). 6 None 20 27 20 27 View
Placebo Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day). 2 None 14 28 19 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Chronic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Spinal cord ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Monoplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Neurological decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Aortic aneurysm rupture SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Arterial haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haemodynamic instability SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal artery thrombosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Heparin-induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Postoperative respiratory failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Internal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Postoperative thoracic procedure complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Spinal cord injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Retroperitoneal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Incision site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Ischaemic ulcer SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pulse absent SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Red blood cells CSF positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post lumbar puncture syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vocal cord paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View