Study: NCT01753297

Adverse event: Inguinal hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Urethral stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Salivary gland calculus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Bone neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 112 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 112 at risk

Adverse event: Haemangioma of liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Retroperitoneum cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 112 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 112 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 112 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 112 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 112 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 112 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Splenomegaly
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 112 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hepatic cyst
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 112 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 112 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 112 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 112 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 112 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Haemangioma of liver
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 112 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 112 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 105 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Urethral stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 105 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 105 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 105 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 105 at risk

Adverse event: Lymphoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 105 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 105 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 105 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 105 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 105 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 105 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 105 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Heat stroke
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 105 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Movement disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 105 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 105 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 105 at risk

Adverse event: Cholecystitis chronic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 217 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 217 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 217 at risk

Adverse event: Gynaecomastia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 217 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 217 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 217 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 217 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 217 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 217 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 217 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 217 at risk

Adverse event: Gingival ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 217 at risk

Adverse event: Breast hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 217 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 217 at risk