Study: NCT01039519

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

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

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

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

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

Adverse event: Hepatic pain
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 27 at risk

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

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

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

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

Adverse event: Neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 27 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 27 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 27 at risk

Adverse event: Arrhythmia superventribular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 27 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 27 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 27 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 27 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Retching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 27 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Early satiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Feeling jittery
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Eye infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Labyrinthitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 27 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 27 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 27 at risk

Adverse event: Compression fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 27 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 27 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 27 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 27 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 27 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 27 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 27 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Bladder pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fanconi syndrome acquired
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Polymenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Increased upper airway secretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 27 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Exfoliative rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hair colour changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Onychoclasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 27 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk