Study: NCT01296347

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hallucination, visual
Serious: yes
Organ System: Eye disorders
Notes: Hallucinations experienced post-operatively, mostly thought to be due to opioids
Frequency: 2 affected / 38 at risk

Adverse event: Agitation postoperative
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient developed renal failure 13 days after starting trial. Renal biopsy showed undetected myeloma.
Frequency: 1 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Patients who felt lightheaded after surgery
Frequency: 5 affected / 38 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Nervous system disorders
Notes: Vivid dreams experienced after surgery
Frequency: 2 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-operative vomiting
Frequency: 8 affected / 38 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 38 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient developed respiratory distress after thoracotomy, re-intubated and ventilated
Frequency: 1 affected / 39 at risk

Adverse event: Lung hypoinflation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Lung collapse following thoracotomy for cancer, unable to oxygenate. Death due to respiratory failure.
Frequency: 1 affected / 39 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Vocal cord paralysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Injury post thoracotomy intubation, causing hoarse voice
Frequency: 1 affected / 39 at risk

Adverse event: Hallucination, visual
Serious: yes
Organ System: Eye disorders
Notes: Hallucinations experienced post-operatively, mostly thought to be due to opioids
Frequency: 2 affected / 39 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Patients who felt lightheaded after surgery
Frequency: 14 affected / 39 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Nervous system disorders
Notes: Vivid dreams experienced after surgery
Frequency: 13 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-operative vomiting
Frequency: 8 affected / 39 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 39 at risk