Study: NCT00735696

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 40 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 40 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 40 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 40 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 40 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 40 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 40 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 11 affected / 40 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Temperature intolerance
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 40 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 40 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 40 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 40 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 40 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 40 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 40 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 40 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 40 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 40 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Orthopnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 40 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 40 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 40 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 40 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 40 at risk