Study: NCT00221338

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 350 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 350 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 350 at risk

Adverse event: Unspecified Dysrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Charted as "dysrhythmia" or "arrhythmia"
Frequency: 2 affected / 350 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 350 at risk

Adverse event: Sinus Tachy/Brady
Serious: yes
Organ System: Cardiac disorders
Notes: Sinus tachycardia or bradycardia
Frequency: 4 affected / 350 at risk

Adverse event: Hypoxia/Hypoxemia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 350 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 350 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Partial or complete collapse of part of or the entire lung
Frequency: 1 affected / 350 at risk

Adverse event: Reintubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Requiring new dialysis or acute increase in blood creatinine levels
Frequency: 6 affected / 350 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: As evidenced by positive lab cultures
Frequency: 4 affected / 350 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: Stroke or TIA shown by MRI
Frequency: 2 affected / 350 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 350 at risk

Adverse event: Reoperation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Requiring unscheduled second procedure within same hospital stay
Frequency: 2 affected / 350 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Anterior dislocation of left hip, closed reduction on floor without complication. Occurred twice on POD5 and POD7.
Frequency: 1 affected / 350 at risk

Adverse event: Oxygen Desaturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oxygen desaturation below 95% but higher than 88%, as measured by pulse oximetry.
Frequency: 37 affected / 350 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Median sedation as defined as RASS score -2 (light sedation) or -3 (moderate sedation)
Frequency: 3 affected / 350 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 350 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 350 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 350 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 350 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 350 at risk

Adverse event: Hallucination
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 350 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 347 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 347 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 347 at risk

Adverse event: Unspecified Dysrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Charted as "dysrhythmia" or "arrhythmia"
Frequency: 4 affected / 347 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 347 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 347 at risk

Adverse event: Sinus Tachy/Brady
Serious: yes
Organ System: Cardiac disorders
Notes: Sinus tachycardia or bradycardia
Frequency: 3 affected / 347 at risk

Adverse event: Hypoxia/Hypoxemia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 347 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 347 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Partial or complete collapse of part of or the entire lung
Frequency: 3 affected / 347 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 347 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Requiring new dialysis or acute increase in blood creatinine levels
Frequency: 7 affected / 347 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: As evidenced by positive lab cultures
Frequency: 7 affected / 347 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 347 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 347 at risk

Adverse event: Reoperation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Requiring unscheduled second procedure within same hospital stay
Frequency: 2 affected / 347 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 347 at risk

Adverse event: Oesophageal rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: "Mallory-Weiss tear," nasogastric tube placed for 24 hours and tear resolved, advancing to regular diet.
Frequency: 1 affected / 347 at risk

Adverse event: Oxygen Desaturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oxygen desaturation below 95% but higher than 88%, as measured by pulse oximetry.
Frequency: 56 affected / 347 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Notes: Median sedation as defined as RASS score -2 (light sedation) or -3 (moderate sedation)
Frequency: 6 affected / 347 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 5 affected / 347 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 347 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 347 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 347 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 347 at risk

Adverse event: Hallucination
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 347 at risk