Study: NCT01528072

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Diabetic Ketoacidosis
Frequency: 1 affected / 139 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Reaction to Tramadol
Frequency: 1 affected / 139 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 139 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 139 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Notes: Clostridium difficile
Frequency: 1 affected / 139 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 139 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 139 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 139 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Other- Iliac artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 139 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 139 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 139 at risk

Adverse event: Other- Adjacent level disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Lumbar
Frequency: 4 affected / 139 at risk

Adverse event: Other- Bilateral knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 139 at risk

Adverse event: Other- Mucinous adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 139 at risk

Adverse event: Other- Postoperative pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Other- Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Lumbar
Frequency: 4 affected / 139 at risk

Adverse event: Other- Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cervical
Frequency: 1 affected / 139 at risk

Adverse event: Other- Total hip arthoroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 139 at risk

Adverse event: Other- Urinary hesitancy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 139 at risk

Adverse event: Other- Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Leg
Frequency: 1 affected / 139 at risk

Adverse event: Pseudomeningocele
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 139 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 139 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 139 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 139 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Cellulitis
Frequency: 1 affected / 139 at risk

Adverse event: Superficial vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 139 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 139 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 139 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Notes: Ischemic bowel
Frequency: 1 affected / 139 at risk

Adverse event: Other- Incision site necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 139 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 139 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 139 at risk

Adverse event: Neurological procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Dural tear
Frequency: 5 affected / 139 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 139 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 139 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Leg
Frequency: 5 affected / 139 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 139 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee
Frequency: 5 affected / 139 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 139 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hip
Frequency: 5 affected / 139 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Ankle
Frequency: 2 affected / 139 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: Leg
Frequency: 5 affected / 139 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: Neck
Frequency: 2 affected / 139 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Leg
Frequency: 4 affected / 139 at risk

Adverse event: Radiculopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 139 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 139 at risk

Adverse event: Other- Adjacent level disease
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 139 at risk

Adverse event: Other- Pain in leg
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 139 at risk

Adverse event: Other- Pain low back
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 139 at risk

Adverse event: Other- pain in back
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 139 at risk