Study: NCT01636947

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 242 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 242 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Menopausal symptoms
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 242 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 242 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 242 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 242 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 242 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 242 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 242 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 242 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Enterovesical fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 242 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 242 at risk

Adverse event: Neutropenic colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 242 at risk

Adverse event: Catheter site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 242 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 242 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 242 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 242 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 242 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 242 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 242 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 242 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 242 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 242 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 242 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 248 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 248 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 248 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 248 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 248 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 248 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 248 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 248 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 248 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 248 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 248 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 248 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 248 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 248 at risk

Adverse event: Feeling hot
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 248 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 248 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 248 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 248 at risk

Adverse event: Wound dihiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 248 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 248 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 248 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 248 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 248 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 248 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 248 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 248 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 248 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 248 at risk