Study: NCT01195415

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Duodenal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

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

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

Adverse event: General disorders and administration site conditions - Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hepatobiliary disorders - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

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

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 25 at risk

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

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

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

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

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

Adverse event: Surgical and medical procedures - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 25 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death due to disease progression
Frequency: 1 affected / 25 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 25 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 25 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 25 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 25 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 25 at risk

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

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 25 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 7 affected / 25 at risk

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 25 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hepatobiliary disorders - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 25 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 25 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 25 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 25 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 25 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 25 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 25 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 25 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 25 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 25 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 25 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 25 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 25 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 25 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 25 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 25 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 25 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 25 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 25 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 25 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 25 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 25 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 25 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 25 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 25 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 25 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 25 at risk

Adverse event: Renal and urinary disorders - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 25 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 25 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 25 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 25 at risk