Study: NCT01276379

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 218 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 218 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 218 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 218 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 218 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 218 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 218 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 218 at risk

Adverse event: Hepatic toxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 218 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 218 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 218 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 218 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 218 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 218 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 53 affected / 218 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 218 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 218 at risk

Adverse event: Ocular alterations non otherwise specified (NOS)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 218 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 218 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 218 at risk

Adverse event: Alergic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 218 at risk

Adverse event: Skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 218 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hand-foot syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 218 at risk

Adverse event: Cardiac disorders NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 218 at risk

Adverse event: Metabolic disorders NOS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 218 at risk

Adverse event: Gastrointestinal disorders NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 218 at risk

Adverse event: General and site reactions NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 218 at risk

Adverse event: Muscolosqueletal disorders NOS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 218 at risk

Adverse event: Ocular disorders NOS
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 218 at risk

Adverse event: Urinary disorders NOS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 218 at risk

Adverse event: Respiratory disorders NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 218 at risk

Adverse event: Vascular disorders NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 218 at risk

Adverse event: Xerosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 218 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 218 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 218 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 218 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 101 affected / 218 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 218 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 218 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 218 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 218 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 218 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 218 at risk

Adverse event: Fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 218 at risk

Adverse event: Infections NOS
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 218 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 218 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 87 affected / 218 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 218 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 218 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 218 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 218 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 218 at risk

Adverse event: Cutaneous reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 134 affected / 218 at risk

Adverse event: Mucosa dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 218 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 218 at risk

Adverse event: Metabolic disorders NOS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 218 at risk

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 218 at risk

Adverse event: Musculoskeletal disorders NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 218 at risk

Adverse event: Ocular disorders NOS
Serious: no
Organ System: Eye disorders
Frequency: 24 affected / 218 at risk

Adverse event: Psychiatric disorders NOS
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 218 at risk

Adverse event: Urinary disorders NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 218 at risk

Adverse event: Respiratory disorders NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 218 at risk

Adverse event: Vascular disorders NOS
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 218 at risk

Adverse event: Trichomegaly
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 11 affected / 218 at risk

Adverse event: Xerosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 218 at risk