Study: NCT00410423

Adverse event: Cough
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 38 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 38 at risk

Adverse event: Achiness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Acute infusion reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 38 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 16 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 38 at risk

Adverse event: Arm pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 38 at risk

Adverse event: Bladder stone
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Blood-tinged mucus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Breast mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Bump on finger
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Change in vision
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 38 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 38 at risk

Adverse event: Chronic rhinsinusitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Clostridium difficile
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 38 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dry, cracked lips
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 38 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 38 at risk

Adverse event: Elbow pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 38 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 38 at risk

Adverse event: Fistula
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Flank pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Fluid retention
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Genitourinary obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Gingival swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 17 affected / 38 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haematuria
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Dysphonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 38 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 38 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 38 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 38 at risk

Adverse event: Incontinence of stool
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Increased alklaline phosphatase
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Increased ALT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Increased AST
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Increased creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Iron overload
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 38 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Liver dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 38 at risk

Adverse event: Muscle cramping
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 27 affected / 38 at risk

Adverse event: Neck pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pain at femoral line site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pain at PICC site
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Pain from bone marrow biopsy
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Pain from mouth sore
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 38 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sinus headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Sinus pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 38 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sore in mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Strong urine odor
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Swelling of parotid gland
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 38 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Thigh pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Tingling in fingertips
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tingling in palms
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Toe pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Glossodynia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tremors
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 38 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 38 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 38 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 38 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Wheezing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tingling in toes
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk