Study: NCT01370642

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 98 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 98 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 98 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 98 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 98 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 98 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 98 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 98 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 98 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 98 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 98 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 98 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 98 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 98 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 98 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 98 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 98 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 98 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 98 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 24 affected / 98 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 31 affected / 98 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 79 affected / 98 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 98 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 98 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 98 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 98 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 98 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 98 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 98 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 98 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 98 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 98 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 98 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 98 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 35 affected / 98 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 98 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 50 affected / 98 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 28 affected / 98 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 98 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 98 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 45 affected / 98 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 98 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 98 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 98 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 98 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 98 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 49 affected / 98 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 98 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 98 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 98 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 98 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 98 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 98 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 98 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 98 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 97 at risk

Adverse event: Heat stroke
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 97 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 97 at risk

Adverse event: Chondrocalcinosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 97 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 97 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 97 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 97 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 97 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 97 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 97 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 97 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 97 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 97 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 97 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 97 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 97 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 97 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 97 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 97 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 97 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 97 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 97 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 97 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 97 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 97 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 14 affected / 97 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 97 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 26 affected / 97 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 32 affected / 97 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 69 affected / 97 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 97 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 97 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 97 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 97 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 97 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 97 at risk

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 97 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 97 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 97 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 97 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 97 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 97 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 97 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 97 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 97 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 97 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 97 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 97 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 97 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 46 affected / 97 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 97 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 97 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 97 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 44 affected / 97 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 97 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 97 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 97 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 97 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 97 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 97 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 97 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 97 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 97 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 97 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 97 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 97 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 97 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 97 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 97 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 97 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 97 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: Endolymphatic hydrops
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 98 at risk

Adverse event: Sudden hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 98 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 98 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 98 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 98 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 98 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 98 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 98 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 98 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 98 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 98 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 98 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 98 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 98 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 98 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 98 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 98 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 98 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 98 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 16 affected / 98 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 9 affected / 98 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 28 affected / 98 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 37 affected / 98 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 80 affected / 98 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 98 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 98 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 98 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 98 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 98 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 98 at risk

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 98 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 98 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 98 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 98 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 98 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 98 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 98 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 98 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 98 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 98 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 98 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 98 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 98 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 98 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 45 affected / 98 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 98 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 98 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 98 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 98 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 98 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 98 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 98 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 98 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 98 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 98 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 98 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 98 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 98 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 98 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 98 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 98 at risk