Study: NCT00190983

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Female genital tract fistula
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 27 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 27 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 27 at risk

Adverse event: Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 27 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 27 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Auditory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 27 at risk

Adverse event: Ocular
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 27 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 27 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 27 at risk

Adverse event: Constitutional
Serious: no
Organ System: General disorders
Frequency: 21 affected / 27 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 27 at risk

Adverse event: Hepatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 27 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 27 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 11 affected / 27 at risk

Adverse event: Serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 27 at risk

Adverse event: Neurotoxicity
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 27 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 27 at risk

Adverse event: Dermatologic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 27 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 27 at risk