Study: NCT00302081

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 230 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 230 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 230 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 230 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 230 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 230 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 230 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 230 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 230 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 230 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Anger
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Depressed mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Nervousness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Persecutory delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 230 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 230 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 230 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 230 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 230 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 230 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 230 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 230 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 230 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 230 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 44 affected / 230 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 230 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 52 affected / 230 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 29 affected / 230 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 26 affected / 230 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 8 affected / 230 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 230 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 87 affected / 230 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 230 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 230 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 230 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 230 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 230 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 230 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 230 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 230 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 230 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 230 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 230 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 230 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 230 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 230 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 230 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 230 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 230 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 230 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 230 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 230 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 230 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 224 at risk

Adverse event: Amaurosis fugax
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 224 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 224 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 224 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 224 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 224 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 224 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 224 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 224 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 224 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 224 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 224 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 224 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 224 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 224 at risk

Adverse event: Pregnancy of partner
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 224 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 224 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 224 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 224 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 224 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 224 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 224 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 224 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 224 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 224 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 62 affected / 224 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 224 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 50 affected / 224 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 21 affected / 224 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 31 affected / 224 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 14 affected / 224 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 224 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 83 affected / 224 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 224 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 224 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 224 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 224 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 224 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 224 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 224 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 224 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 224 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 224 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 224 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 224 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 224 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 224 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 224 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 224 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 224 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 224 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 224 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 224 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 224 at risk

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

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

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

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

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

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 228 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 228 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 228 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 228 at risk

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

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 228 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 228 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 228 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 228 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 228 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 228 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 228 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 228 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 228 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 45 affected / 228 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 16 affected / 228 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 36 affected / 228 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 23 affected / 228 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 17 affected / 228 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 10 affected / 228 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 228 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 101 affected / 228 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 228 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 228 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 228 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 228 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 228 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 228 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 228 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 228 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 228 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 228 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 58 affected / 228 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 228 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 228 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 228 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 228 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 228 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 228 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 228 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 228 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 228 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 228 at risk