Study: NCT00781365

Adverse event: Knee, hip, or shoulder arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 222 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 222 at risk

Adverse event: Spinal decompression/fusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 222 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 222 at risk

Adverse event: Worsening Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 222 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Secondary to other conditions (renal failure, Chronic Obstructive Pulmonary Disease(COPD ), GI blood loss, anal fissure)
Frequency: 4 affected / 222 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 222 at risk

Adverse event: Fracture treatment
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalizations and surgery related to bone fracture
Frequency: 1 affected / 222 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 222 at risk

Adverse event: Hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 222 at risk

Adverse event: Thyroidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 222 at risk

Adverse event: Pyschiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychiatric hospital admissions: depression, alcohol abuse, psychosis, nonspecific altered mental state
Frequency: 2 affected / 222 at risk

Adverse event: Overdose, toxicity, or withdrawal
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Alcohol and narcotic overdose, toxicity, withdrawal
Frequency: 4 affected / 222 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 222 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 222 at risk

Adverse event: Peri-operative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 222 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 222 at risk

Adverse event: Hemorrhoid surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 222 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 222 at risk

Adverse event: Urinary bladder suspension
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 222 at risk

Adverse event: Ascites
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 222 at risk

Adverse event: Acute abdominal pain
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Secondary to end stage liver disease
Frequency: 1 affected / 222 at risk

Adverse event: Chest pain, non-cardiac, non-specific
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 222 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 222 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 222 at risk

Adverse event: Cerebrovascular accident (stroke)
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 222 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 222 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 222 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 222 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 222 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 222 at risk

Adverse event: Hypotension, dizziness, near syncope
Serious: no
Organ System: Cardiac disorders
Notes: ER or urgent care visit for low blood pressure, near syncope
Frequency: 1 affected / 222 at risk

Adverse event: Breast cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 222 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Vascular disorders
Notes: ER or urgent care visit for high blood pressure
Frequency: 2 affected / 222 at risk

Adverse event: Erythema nodosum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 222 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: New diagnosis
Frequency: 1 affected / 222 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: ER visit for allergic reaction possibly related to antihypertensive drugs
Frequency: 1 affected / 222 at risk

Adverse event: Hypersensitivity vasculitis
Serious: no
Organ System: Vascular disorders
Notes: Secondary to bladder infection treatment
Frequency: 1 affected / 222 at risk

Adverse event: Knee, hip, or shoulder arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 228 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 228 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 228 at risk

Adverse event: Spinal decompression/fusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 222 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 228 at risk

Adverse event: Worsening Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 228 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Secondary to other conditions (renal failure, Chronic Obstructive Pulmonary Disease(COPD ), GI blood loss, anal fissure)
Frequency: 2 affected / 228 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 228 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 228 at risk

Adverse event: Hashimoto's encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 228 at risk

Adverse event: Fracture treatment
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalizations and surgery related to bone fracture
Frequency: 2 affected / 228 at risk

Adverse event: Hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 228 at risk

Adverse event: Pyschiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychiatric hospital admissions: depression, alcohol abuse, psychosis, nonspecific altered mental state
Frequency: 1 affected / 228 at risk

Adverse event: Overdose, toxicity, or withdrawal
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Alcohol and narcotic overdose, toxicity, withdrawal
Frequency: 1 affected / 228 at risk

Adverse event: Prostatectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 228 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 228 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 228 at risk

Adverse event: Chest pain, non-cardiac, non-specific
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 228 at risk

Adverse event: Chest pain, atypical
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac cause not ruled out (history of cardiac disease, hypertensive crisis)
Frequency: 4 affected / 228 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 228 at risk

Adverse event: Cerebrovascular accident (stroke)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 228 at risk

Adverse event: Hypotension with syncope
Serious: yes
Organ System: Vascular disorders
Notes: Hospitalization for hypotension with syncope
Frequency: 3 affected / 228 at risk

Adverse event: Stable angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 228 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 228 at risk

Adverse event: Uretral stent change
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 228 at risk

Adverse event: Hypotension, dizziness, near syncope
Serious: no
Organ System: Cardiac disorders
Notes: ER or urgent care visit for low blood pressure, near syncope
Frequency: 3 affected / 228 at risk

Adverse event: Prostate cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 228 at risk