Study: NCT00789581

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 305 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 305 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 305 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 305 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 305 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 305 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 305 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 305 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 305 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 305 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 305 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 305 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 305 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 305 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 305 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 305 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 305 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 305 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 305 at risk

Adverse event: Breast pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 305 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Chest wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 305 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 305 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 305 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Diastolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 305 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 305 at risk

Adverse event: Fanconi syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 305 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 305 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 305 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 305 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 305 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 305 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 305 at risk

Adverse event: Neutropenic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 305 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 305 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 305 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 305 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 305 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 305 at risk

Adverse event: Salpingo-oophorectomy bilateral
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 305 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 227 affected / 305 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 131 affected / 305 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 112 affected / 305 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 89 affected / 305 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 53 affected / 305 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 52 affected / 305 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 26 affected / 305 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 20 affected / 305 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 250 affected / 305 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 81 affected / 305 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 47 affected / 305 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 36 affected / 305 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 47 affected / 305 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 214 affected / 305 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 33 affected / 305 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 28 affected / 305 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 20 affected / 305 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 18 affected / 305 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 120 affected / 305 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 87 affected / 305 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 78 affected / 305 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 55 affected / 305 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 37 affected / 305 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 16 affected / 305 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 106 affected / 305 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 83 affected / 305 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 67 affected / 305 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 47 affected / 305 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 41 affected / 305 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 37 affected / 305 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 16 affected / 305 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 139 affected / 305 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 104 affected / 305 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 69 affected / 305 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 45 affected / 305 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: All participants who had at least one dose of study drug.
Frequency: 34 affected / 305 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: All participants who had at least one dose of study drug.
Frequency: 26 affected / 305 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: All participants who had at least one dose of study drug.
Frequency: 21 affected / 305 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 57 affected / 305 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 42 affected / 305 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 36 affected / 305 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 56 affected / 305 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 28 affected / 305 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 24 affected / 305 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 21 affected / 305 at risk

Adverse event: Appetite decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 19 affected / 305 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 79 affected / 305 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 27 affected / 305 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 33 affected / 305 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 50 affected / 305 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 24 affected / 305 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: All participants who had at least one dose of study drug.
Frequency: 22 affected / 305 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Notes: All participants who had at least one dose of study drug.
Frequency: 21 affected / 305 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 304 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 304 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 304 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 304 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 304 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 304 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 304 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 304 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 304 at risk

Adverse event: Breast cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Device related thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 304 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 304 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 304 at risk

Adverse event: Lung infiltration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 304 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 221 affected / 304 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 122 affected / 304 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 114 affected / 304 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 69 affected / 304 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 51 affected / 304 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 51 affected / 304 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 26 affected / 304 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 22 affected / 304 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 251 affected / 304 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 64 affected / 304 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 50 affected / 304 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 58 affected / 304 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 27 affected / 304 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 208 affected / 304 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 47 affected / 304 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 45 affected / 304 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 19 affected / 304 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 16 affected / 304 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 158 affected / 304 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 88 affected / 304 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 69 affected / 304 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 65 affected / 304 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 41 affected / 304 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 19 affected / 304 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 87 affected / 304 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 46 affected / 304 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 53 affected / 304 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 40 affected / 304 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 33 affected / 304 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 22 affected / 304 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 20 affected / 304 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 145 affected / 304 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 119 affected / 304 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 83 affected / 304 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 36 affected / 304 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: All participants who had at least one dose of study drug.
Frequency: 20 affected / 304 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: All participants who had at least one dose of study drug.
Frequency: 28 affected / 304 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: All participants who had at least one dose of study drug.
Frequency: 33 affected / 304 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 66 affected / 304 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 50 affected / 304 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 35 affected / 304 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 43 affected / 304 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 22 affected / 304 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 28 affected / 304 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 22 affected / 304 at risk

Adverse event: Appetite decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 18 affected / 304 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 84 affected / 304 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 40 affected / 304 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 28 affected / 304 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 53 affected / 304 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: All participants who had at least one dose of study drug.
Frequency: 26 affected / 304 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: All participants who had at least one dose of study drug.
Frequency: 16 affected / 304 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Notes: All participants who had at least one dose of study drug.
Frequency: 13 affected / 304 at risk