Study: NCT01280656

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 62 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 62 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 62 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 62 at risk

Adverse event: Pain in extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 62 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 62 at risk

Adverse event: Cachexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 62 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 62 at risk

Adverse event: Leucopaenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Neutropaenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 62 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 62 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 62 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: High abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 62 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 62 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 62 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 62 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 62 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 62 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Flu condition
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 62 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 7 affected / 62 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 62 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 312 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 312 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Cryoglobulinaemia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Breast mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 312 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 312 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 312 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 312 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Cell tissue inflammation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 312 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 312 at risk

Adverse event: Vocal cord neoplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 312 at risk

Adverse event: Breast tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 312 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 312 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 312 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 312 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 312 at risk

Adverse event: Pain in extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 312 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 312 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 51 affected / 312 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 312 at risk

Adverse event: Cachexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 312 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 109 affected / 312 at risk

Adverse event: Leucopaenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 312 at risk

Adverse event: Neutropaenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 60 affected / 312 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 312 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 67 affected / 312 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 312 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 312 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 312 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 312 at risk

Adverse event: High abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 312 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 312 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 312 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 312 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 312 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 36 affected / 312 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 312 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 114 affected / 312 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 312 at risk

Adverse event: Flu condition
Serious: no
Organ System: General disorders
Frequency: 25 affected / 312 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 36 affected / 312 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 19 affected / 312 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 65 affected / 312 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 286 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 286 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 286 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 286 at risk

Adverse event: Neutropaenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 286 at risk

Adverse event: Febrile neutropaenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 286 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 286 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 286 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 286 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 286 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 286 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 286 at risk

Adverse event: Pain in extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 286 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 286 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 286 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 52 affected / 286 at risk

Adverse event: Cachexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 286 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 111 affected / 286 at risk

Adverse event: Leucopaenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 286 at risk

Adverse event: Neutropaenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 286 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 286 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 67 affected / 286 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 286 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 286 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 286 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 286 at risk

Adverse event: High abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 286 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 286 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 286 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 286 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 286 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 286 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 286 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 107 affected / 286 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 30 affected / 286 at risk

Adverse event: Flu condition
Serious: no
Organ System: General disorders
Frequency: 50 affected / 286 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 35 affected / 286 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 21 affected / 286 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 66 affected / 286 at risk