Study: NCT00461708

Adverse event: Haemorrhage, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 115 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 115 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 115 at risk

Adverse event: Gastrointestinal toxicity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 115 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 115 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 115 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Bilirubin (Hyperbilirubinemia)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 115 at risk

Adverse event: Haemorrhage, rectal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Liver
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 115 at risk

Adverse event: Myelosuppression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 115 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 115 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 115 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 115 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Gastrointestinal syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Obstruction, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 115 at risk

Adverse event: Perforation, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Haemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 115 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 115 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 115 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 115 at risk

Adverse event: Peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Upper airway nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Urinary tract nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 115 at risk

Adverse event: CNS Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 115 at risk

Adverse event: Abdomen nos
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 115 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 115 at risk

Adverse event: Obstruction, GU
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 115 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 115 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 115 at risk

Adverse event: Thrombosis/Thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 115 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 115 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 115 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 115 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 115 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 115 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 115 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 62 affected / 115 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 115 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 115 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 89 affected / 115 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 115 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 115 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 115 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 115 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 115 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 115 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 115 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 115 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 115 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 115 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 115 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 115 at risk

Adverse event: Eyelid dysfunction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 115 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 115 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 115 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 115 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 115 at risk

Adverse event: Monocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Proctitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Rhabdomyolysis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Vision - Blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 115 at risk

Adverse event: Allergy /immunology- other
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 115 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 115 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 115 at risk

Adverse event: Granulocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 115 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 115 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 115 at risk

Adverse event: Constitutional symptoms- other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 115 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 115 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Dermatology/skin- other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 115 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 115 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 115 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 115 at risk

Adverse event: Endocrine- other
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 115 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 115 at risk

Adverse event: Gastrointestinal - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 115 at risk

Adverse event: Gastrointestinal toxicity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 115 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 115 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 115 at risk

Adverse event: Obstruction, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 115 at risk

Adverse event: Perforation, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 115 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 115 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Liver dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 115 at risk

Adverse event: Pancreas, exocrine
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 115 at risk

Adverse event: Anal/perianal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Blood
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 115 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Lung (Pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Oral cavity-gums
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 115 at risk

Adverse event: Skin
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 115 at risk

Adverse event: Soft tissue nos
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Upper airway nos
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 115 at risk

Adverse event: Urinary tract nos
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 115 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 115 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 115 at risk

Adverse event: Lymphatics- other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 115 at risk

Adverse event: Albumin, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 115 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 115 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 115 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 4 affected / 115 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 115 at risk

Adverse event: Calcium, serum high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 115 at risk

Adverse event: GGT (Gamma-glutamyl)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 115 at risk

Adverse event: Glucose, serum high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 115 at risk

Adverse event: Glucose, serum low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 115 at risk

Adverse event: Magnesium, serum low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 115 at risk

Adverse event: Metabolic/laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 115 at risk

Adverse event: Potassium, serum high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 115 at risk

Adverse event: Potassium, serum low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 115 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 115 at risk

Adverse event: Personality/behavioral
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 115 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 115 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Abdomen nos
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 78 affected / 115 at risk

Adverse event: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 115 at risk

Adverse event: Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 115 at risk

Adverse event: Chest/thorax nos
Serious: no
Organ System: General disorders
Frequency: 2 affected / 115 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 115 at risk

Adverse event: Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 115 at risk

Adverse event: Kidney
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 115 at risk

Adverse event: Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 115 at risk

Adverse event: Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 115 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 115 at risk

Adverse event: Peritoneum
Serious: no
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 115 at risk

Adverse event: Nasal/ paranasal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Nasal/paranasal reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 115 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 115 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 115 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Pulmonay/upper respiratoy- other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 115 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 115 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 115 at risk

Adverse event: Renal/genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 115 at risk

Adverse event: Testicular oedema
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 115 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 115 at risk

Adverse event: Urine color change
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 115 at risk

Adverse event: Upper airway nos
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 115 at risk

Adverse event: Vein nos
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 115 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 115 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 115 at risk

Adverse event: Thrombosis/thrombus
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 115 at risk

Adverse event: Distension/bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 115 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 115 at risk

Adverse event: Ocular/visual- other
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 115 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 115 at risk

Adverse event: Haemorrhage, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Obstruction, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: CNS Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 38 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 38 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 31 affected / 38 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 38 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 38 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Myelitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 38 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Constitutional symptoms- other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dermatology/skin- other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 38 at risk

Adverse event: Gastrointestinal - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 38 at risk

Adverse event: Obstruction, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Liver dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 38 at risk

Adverse event: Abdomen nos
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Blood
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Lung (Pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Middle ear
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Upper airway nos
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Urinary tract nos
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 38 at risk

Adverse event: Calcium, serum high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: GGT (Gamma-glutamyl)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Glucose, serum high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Glucose, serum low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypercreatinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Magnesium, serum low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Metabolic/laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Potassium, serum high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Extrapyramidal
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Personality/behavioral
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 38 at risk

Adverse event: Abdomen nos
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 38 at risk

Adverse event: Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 38 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 38 at risk

Adverse event: Neck/back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 38 at risk

Adverse event: Skin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 38 at risk

Adverse event: Nasal/ paranasal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nasal/paranasal reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 38 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 38 at risk

Adverse event: Vein injury
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Distension/bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 38 at risk