Study: NCT01206062

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 198 affected / 4678 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 141 affected / 4678 at risk

Adverse event: Other ischaemic heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 170 affected / 4678 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 155 affected / 4678 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 138 affected / 4678 at risk

Adverse event: Ischaemic cerebrovascular conditions
Serious: yes
Organ System: Vascular disorders
Frequency: 109 affected / 4678 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 100 affected / 4678 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 58 affected / 4678 at risk

Adverse event: Myocardial infarcation
Serious: yes
Organ System: Cardiac disorders
Frequency: 70 affected / 4678 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 4678 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 67 affected / 4678 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 58 affected / 4678 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 48 affected / 4678 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 4678 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 51 affected / 4678 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 40 affected / 4678 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 36 affected / 4678 at risk

Adverse event: Spinal fusion surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 4678 at risk

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 4678 at risk

Adverse event: Spinal laminectomy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 4678 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 34 affected / 4678 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 34 affected / 4678 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 32 affected / 4678 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: Occurred in less than 1% of total adverse events
Frequency: 952 affected / 4678 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 48 affected / 4678 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 4678 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 4678 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: General disorders
Frequency: 33 affected / 4678 at risk

Adverse event: Injurious fall
Serious: no
Organ System: General disorders
Frequency: 229 affected / 4678 at risk

Adverse event: Acute kidney injury or acute renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 4678 at risk

Adverse event: Serum sodium < 130 mmol/liter
Serious: no
Organ System: General disorders
Frequency: 180 affected / 4678 at risk

Adverse event: Serum sodium > 150 mmol/liter
Serious: no
Organ System: General disorders
Frequency: 6 affected / 4678 at risk

Adverse event: Serum potassium <3.0 mmol/liter
Serious: no
Organ System: General disorders
Frequency: 114 affected / 4678 at risk

Adverse event: Serum potassium >5.5 mmol/liter
Serious: no
Organ System: General disorders
Frequency: 176 affected / 4678 at risk

Adverse event: Orthostatic hypotension alone
Serious: no
Organ System: Nervous system disorders
Frequency: 777 affected / 4678 at risk

Adverse event: Orthostatic hypotension with dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 4678 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 191 affected / 4683 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 176 affected / 4683 at risk

Adverse event: Other ischaemic heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 182 affected / 4683 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 210 affected / 4683 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 119 affected / 4683 at risk

Adverse event: Ischaemic cerebrovascular conditions
Serious: yes
Organ System: Vascular disorders
Frequency: 121 affected / 4683 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 114 affected / 4683 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 98 affected / 4683 at risk

Adverse event: Myocardial infarcation
Serious: yes
Organ System: Cardiac disorders
Frequency: 106 affected / 4683 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 4683 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 81 affected / 4683 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 69 affected / 4683 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 47 affected / 4683 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 4683 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 41 affected / 4683 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 30 affected / 4683 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 40 affected / 4683 at risk

Adverse event: Spinal fusion surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 4683 at risk

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Cardiac disorders
Frequency: 39 affected / 4683 at risk

Adverse event: Spinal laminectomy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 4683 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 32 affected / 4683 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 25 affected / 4683 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 31 affected / 4683 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: Occurred in less than 1% of total adverse events
Frequency: 951 affected / 4683 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 4683 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 4683 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 4683 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: General disorders
Frequency: 22 affected / 4683 at risk

Adverse event: Injurious fall
Serious: no
Organ System: General disorders
Frequency: 222 affected / 4683 at risk

Adverse event: Acute kidney injury or acute renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 4683 at risk

Adverse event: Serum sodium < 130 mmol/liter
Serious: no
Organ System: General disorders
Frequency: 100 affected / 4683 at risk

Adverse event: Serum potassium <3.0 mmol/liter
Serious: no
Organ System: General disorders
Frequency: 74 affected / 4683 at risk

Adverse event: Serum potassium >5.5 mmol/liter
Serious: no
Organ System: General disorders
Frequency: 171 affected / 4683 at risk

Adverse event: Orthostatic hypotension alone
Serious: no
Organ System: Nervous system disorders
Frequency: 857 affected / 4683 at risk

Adverse event: Orthostatic hypotension with dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 71 affected / 4683 at risk