Study: NCT01465347

Adverse event: Neutropenia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

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

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 56 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 56 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 56 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 56 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 56 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 56 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 56 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 56 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 56 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 56 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 56 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 7 affected / 56 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 56 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 56 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 56 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 56 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 56 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 56 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 56 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 56 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 56 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 56 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 56 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 56 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 56 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 56 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 56 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 56 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 56 at risk