Study: NCT00751296

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Disseminated Zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: In-situ Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 25 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cytopenias
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Relapse of lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 25 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 25 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 25 at risk

Adverse event: Tumour flare
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Drug related
Frequency: 22 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Drug related
Frequency: 18 affected / 25 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Drug related
Frequency: 15 affected / 25 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Drug related
Frequency: 10 affected / 25 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Drug related
Frequency: 8 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Drug related
Frequency: 8 affected / 25 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Drug related
Frequency: 6 affected / 25 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Drug related
Frequency: 4 affected / 25 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Drug related
Frequency: 3 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Drug related
Frequency: 3 affected / 25 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Drug related
Frequency: 3 affected / 25 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Drug related
Frequency: 3 affected / 25 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Investigations
Notes: Drug related
Frequency: 11 affected / 25 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Notes: Drug related
Frequency: 11 affected / 25 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Notes: Drug related
Frequency: 10 affected / 25 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Notes: Drug related
Frequency: 10 affected / 25 at risk

Adverse event: Elevated AST or ALT
Serious: no
Organ System: Investigations
Notes: Drug related
Frequency: 9 affected / 25 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Notes: Drug related
Frequency: 5 affected / 25 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Notes: Drug related
Frequency: 4 affected / 25 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Drug related
Frequency: 1 affected / 25 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Drug related
Frequency: 4 affected / 25 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Notes: Drug related
Frequency: 18 affected / 25 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Drug related
Frequency: 6 affected / 25 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Notes: Drug related
Frequency: 7 affected / 25 at risk

Adverse event: Upper Respiratory/Sinus infection
Serious: no
Organ System: Infections and infestations
Notes: Drug related
Frequency: 2 affected / 25 at risk