Study: NCT00075725

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

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

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 218 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 218 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 218 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 4 affected / 218 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 218 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 218 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 96 affected / 218 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 218 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Anal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 30 affected / 218 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 71 affected / 218 at risk

Adverse event: Anorectal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 218 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 44 affected / 218 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 218 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 218 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 218 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 218 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 218 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 218 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 218 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 218 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 218 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 218 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 218 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 218 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 218 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 218 at risk

Adverse event: Endocrine disorders - Other, specify
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 218 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 218 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 218 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Oesophageal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 218 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 164 affected / 218 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 218 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 218 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 218 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 218 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Frequency: 3 affected / 218 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 218 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 218 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 218 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hepatic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 218 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 218 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 218 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 218 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 218 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 218 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 218 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 218 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 218 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 218 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 218 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 218 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 218 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Immune system disorders - Other, specify
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 218 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 147 affected / 218 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 218 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 3 affected / 218 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 218 at risk

Adverse event: Arthritis infective
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 218 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 218 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 218 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 218 at risk

Adverse event: Malabsorption
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Meningitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Middle ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 218 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 218 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 218 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 218 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 218 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 184 affected / 218 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 218 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 218 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 218 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 218 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 218 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 218 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 218 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 218 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pharyngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 218 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 96 affected / 218 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 218 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 218 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 218 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 218 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 218 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 218 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 218 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 218 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Soft tissue infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Splenic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 218 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 218 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 218 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 218 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 218 at risk

Adverse event: Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 218 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 218 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 218 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 91 affected / 218 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 218 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Glucose tolerance impaired
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 90 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 90 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Soft tissue necrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 90 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 90 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 5 affected / 90 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 90 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 90 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 90 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 33 affected / 90 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 90 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 90 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 90 at risk

Adverse event: Anorectal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 90 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 90 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 90 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 90 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 90 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 90 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 90 at risk

Adverse event: Blood corticotrophin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Bone marrow failure
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 90 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 90 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 90 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 90 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 90 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 90 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 90 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Oesophageal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Facial nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 90 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 52 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 90 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 90 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 90 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Frequency: 2 affected / 90 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 90 at risk

Adverse event: Glossopharyngeal nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 90 at risk

Adverse event: Hepatic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Hepatic pain
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 90 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 90 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 90 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 90 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 90 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 90 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 90 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 90 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 90 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 90 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 90 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 90 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 90 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 90 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 90 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 63 affected / 90 at risk

Adverse event: Injury, poisoning and procedural complications - Other, specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 90 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 90 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 90 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 90 at risk

Adverse event: Malabsorption
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Meningitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Middle ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 90 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 90 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Myelitis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 61 affected / 90 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: IIIrd nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 90 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 90 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 90 at risk

Adverse event: Peripheral nerve infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 90 at risk

Adverse event: Peritonitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 90 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 39 affected / 90 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 90 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 90 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 90 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 90 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 90 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Small intestinal perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Soft tissue infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Splenic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Stevens-Johnson syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 90 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 90 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 90 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 90 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 90 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 41 affected / 90 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 90 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 261 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 261 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 261 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 261 at risk

Adverse event: Blood cholesterol increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 261 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 261 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 261 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 261 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 261 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 261 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Small intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 261 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Investigations - Other, specify
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 261 at risk

Adverse event: Iron overload
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 261 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 261 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 261 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 261 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Vascular disorders - Other, specify
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 261 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 261 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 261 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 261 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 261 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 11 affected / 261 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 261 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 261 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 261 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 122 affected / 261 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 261 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Anal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 261 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 36 affected / 261 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 70 affected / 261 at risk

Adverse event: Anorectal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 43 affected / 261 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 261 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 261 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 261 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 63 affected / 261 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 261 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 261 at risk

Adverse event: Biliary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 261 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 47 affected / 261 at risk

Adverse event: Blood corticotrophin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 261 at risk

Adverse event: Bone marrow failure
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 261 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Capillary leak syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 261 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 261 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 261 at risk

Adverse event: Central nervous system necrosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 261 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 261 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 261 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 261 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 261 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 261 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 261 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 261 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 261 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 261 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Duodenal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Duodenal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 261 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 261 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 261 at risk

Adverse event: Encephalitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 261 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 261 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 261 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 261 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 261 at risk

Adverse event: External ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 261 at risk

Adverse event: Ophthalmoplegia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 261 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 261 at risk

Adverse event: Facial nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 261 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 261 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 141 affected / 261 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 261 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 261 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 261 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 261 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 261 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 261 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 261 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 261 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 261 at risk

Adverse event: Hepatic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 261 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 261 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 84 affected / 261 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 261 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 261 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 261 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 261 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 261 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 261 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 261 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 261 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 261 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 261 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 261 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 46 affected / 261 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 261 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 261 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 261 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 261 at risk

Adverse event: Immune system disorders - Other, specify
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 149 affected / 261 at risk

Adverse event: Infective myositis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 261 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 261 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 261 at risk

Adverse event: Respiratory tract procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 261 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 2 affected / 261 at risk

Adverse event: Iron overload
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 261 at risk

Adverse event: Jejunal perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 39 affected / 261 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 261 at risk

Adverse event: Lymph gland infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 261 at risk

Adverse event: Middle ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 261 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 261 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 261 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 261 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 261 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 261 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 261 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 187 affected / 261 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 261 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 261 at risk

Adverse event: Optic nerve disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 261 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 261 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 261 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 261 at risk

Adverse event: Pancreas infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 261 at risk

Adverse event: Pancreatitis necrotising
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 261 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 261 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 261 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 261 at risk

Adverse event: Pharyngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 261 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 261 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 101 affected / 261 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 261 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 261 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 261 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 261 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 261 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 261 at risk

Adverse event: Rectal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 261 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 261 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 261 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 261 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 261 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 261 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 261 at risk

Adverse event: Soft tissue infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Splenic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 261 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 261 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 261 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk

Adverse event: Trigeminal nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 261 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 261 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 261 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 261 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 261 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 261 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 261 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 261 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 261 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 261 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 261 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 261 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 261 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 261 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 103 affected / 261 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 261 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 206 at risk

Adverse event: Alkalosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 206 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 206 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 206 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 206 at risk

Adverse event: Cystitis noninfective
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 206 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 206 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 206 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hepatic pain
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 206 at risk

Adverse event: Investigations - Other, specify
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 206 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 206 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 206 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 206 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 206 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 206 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 206 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 206 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 206 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 206 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 6 affected / 206 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 206 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 206 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 94 affected / 206 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 206 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Anal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 29 affected / 206 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 68 affected / 206 at risk

Adverse event: Anorectal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 206 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 206 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 206 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 206 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 54 affected / 206 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 206 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 206 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 206 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 206 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 206 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 206 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 206 at risk

Adverse event: Large intestine perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 206 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 206 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 206 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 206 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 206 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 206 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 206 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 206 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 206 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 206 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 206 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 206 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 206 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 206 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 206 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 206 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 134 affected / 206 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 206 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 206 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 206 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 2 affected / 206 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 206 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 206 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 206 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 206 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hepatic pain
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hepatitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 206 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 206 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 206 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 206 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 206 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 206 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 206 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 206 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 206 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 206 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 206 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 206 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 206 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 206 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 206 at risk

Adverse event: Immune system disorders - Other, specify
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 206 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 141 affected / 206 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 206 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 2 affected / 206 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 206 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 206 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 206 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 206 at risk

Adverse event: Middle ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 206 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 206 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 206 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 206 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 206 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 168 affected / 206 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 206 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 206 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 206 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 206 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 206 at risk

Adverse event: Penile infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 206 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 206 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 206 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 78 affected / 206 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 206 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 206 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 206 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 206 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 206 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 206 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 206 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 206 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 206 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 206 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 206 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 206 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 206 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 206 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Spleen disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Stoma site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 206 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 206 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 206 at risk

Adverse event: Trigeminal nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 206 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 206 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 206 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 206 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 206 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 206 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 206 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 206 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 206 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 206 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 206 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 206 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 206 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 92 affected / 206 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 206 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 206 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 214 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Cystitis noninfective
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 214 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 214 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 214 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 214 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 214 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 214 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 214 at risk

Adverse event: Lip infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 214 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 214 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 214 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 214 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 214 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 214 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 4 affected / 214 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 214 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 214 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 214 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 92 affected / 214 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 214 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 214 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 214 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 24 affected / 214 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 63 affected / 214 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 214 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 214 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 214 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 214 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 214 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 214 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 214 at risk

Adverse event: Bone marrow failure
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 214 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 214 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 214 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 214 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 214 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 214 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 214 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 214 at risk

Adverse event: Small intestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Duodenal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 214 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 214 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 214 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 214 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 214 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 214 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 214 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 140 affected / 214 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 214 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 214 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 214 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 214 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 214 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 214 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 214 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 214 at risk

Adverse event: Hepatic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Hepatitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 214 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 214 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 214 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 214 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 214 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 214 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 214 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 214 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 214 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 214 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 214 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 214 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 214 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 214 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 214 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 214 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Immune system disorders - Other, specify
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 146 affected / 214 at risk

Adverse event: Infective myositis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Injury, poisoning and procedural complications - Other, specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 214 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 214 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 2 affected / 214 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 214 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 214 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 214 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 214 at risk

Adverse event: Meningitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Middle ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 214 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 214 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 214 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 214 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 172 affected / 214 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 214 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: IIIrd nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Optic nerve disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 214 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 214 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 214 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 214 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 214 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 214 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 214 at risk

Adverse event: Papilloedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 214 at risk

Adverse event: Penile pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 214 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 214 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 214 at risk

Adverse event: Peripheral nerve infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 214 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Phlebitis infective
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 77 affected / 214 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 214 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 214 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 214 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 214 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 214 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 214 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 214 at risk

Adverse event: Sialoadenitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 214 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 214 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 214 at risk

Adverse event: Sinus disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 214 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 214 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 214 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 214 at risk

Adverse event: Soft tissue infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Splenic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 214 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 214 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 214 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 214 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 214 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 214 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 214 at risk

Adverse event: Vagus nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 214 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 214 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 214 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 214 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 83 affected / 214 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 598 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 598 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 598 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 598 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 598 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 598 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 598 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 598 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 598 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 598 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 598 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 598 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 598 at risk

Adverse event: Hepatitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 598 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 598 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 598 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 598 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 598 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 598 at risk

Adverse event: Investigations - Other, specify
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 598 at risk

Adverse event: Leukoencephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 598 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 598 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 598 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 598 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 598 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 598 at risk

Adverse event: Purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 598 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 598 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 598 at risk

Adverse event: Tracheal inflammation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Trigeminal nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 598 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 598 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 598 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 598 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 18 affected / 598 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 598 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 598 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 598 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 598 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 274 affected / 598 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 598 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 598 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 598 at risk

Adverse event: Anal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 598 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 598 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 97 affected / 598 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 179 affected / 598 at risk

Adverse event: Anorectal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 598 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 598 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 598 at risk

Adverse event: Appendicitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 598 at risk

Adverse event: Arachnoiditis
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 598 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 598 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 598 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 146 affected / 598 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 598 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 598 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 598 at risk

Adverse event: Biliary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 598 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 598 at risk

Adverse event: Blood antidiuretic hormone abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 598 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 104 affected / 598 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 598 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Bone marrow failure
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 598 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 598 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 598 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 598 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 598 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 598 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 598 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 598 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 598 at risk

Adverse event: Large intestine perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 598 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 598 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 598 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 598 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 1 affected / 598 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 73 affected / 598 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 598 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 598 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 598 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 598 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 598 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 598 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 598 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 598 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 598 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 598 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 598 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 598 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 598 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 598 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 598 at risk

Adverse event: Oesophageal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 598 at risk

Adverse event: Oesophageal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 598 at risk

Adverse event: Ophthalmoplegia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 598 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 598 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Facial paresis
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Facial nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 598 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 598 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 278 affected / 598 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 598 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 41 affected / 598 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 598 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 598 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 598 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 5 affected / 598 at risk

Adverse event: Gallbladder obstruction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 598 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 598 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Frequency: 2 affected / 598 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 598 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 598 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Glossopharyngeal nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 598 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 598 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 598 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 81 affected / 598 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 598 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 598 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 598 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 598 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 598 at risk

Adverse event: Hepatic failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 598 at risk

Adverse event: Hepatic infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 598 at risk

Adverse event: Hepatic necrosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hepatic pain
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 598 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 598 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 155 affected / 598 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 598 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 598 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 598 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 598 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 598 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 598 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 598 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 56 affected / 598 at risk

Adverse event: Hypoglossal nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 598 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 98 affected / 598 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 598 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 84 affected / 598 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 598 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 30 affected / 598 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 598 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 598 at risk

Adverse event: Immune system disorders - Other, specify
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 297 affected / 598 at risk

Adverse event: Infective myositis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 598 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 598 at risk

Adverse event: Injury, poisoning and procedural complications - Other, specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 598 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 598 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 598 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 19 affected / 598 at risk

Adverse event: Iron overload
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 598 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 598 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 598 at risk

Adverse event: Lip pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 44 affected / 598 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 598 at risk

Adverse event: Lymph gland infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 598 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 35 affected / 598 at risk

Adverse event: Malabsorption
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 598 at risk

Adverse event: Meningitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 598 at risk

Adverse event: Middle ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 598 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 598 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 134 affected / 598 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 598 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 598 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 598 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 598 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 598 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 598 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 598 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 598 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 598 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 598 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 598 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 437 affected / 598 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 598 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 598 at risk

Adverse event: IIIrd nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Optic nerve disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 598 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 598 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 598 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 598 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 598 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 598 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 598 at risk

Adverse event: Pancreas infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Pancreatic leak
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Pancreatic haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pancreatitis necrotising
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 598 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 598 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 598 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 598 at risk

Adverse event: Peripheral nerve infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 598 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 598 at risk

Adverse event: Pharyngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 598 at risk

Adverse event: Pharyngeal stenosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 598 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 598 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 598 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 249 affected / 598 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 598 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 598 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 598 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Postoperative thoracic procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Psychiatric disorders - Other, specify
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 598 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 598 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 598 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 598 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 598 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 598 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Reproductive system and breast disorders - Other, specify
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 598 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 598 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 598 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 598 at risk

Adverse event: Sialoadenitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 598 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 598 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 598 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 598 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 598 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 598 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 598 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 598 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Soft tissue infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 598 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Splenic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 598 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 598 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 598 at risk

Adverse event: Surgical and medical procedures - Other, specify
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 598 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 598 at risk

Adverse event: Testicular pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 598 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 598 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 598 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Second primary malignancy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 598 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Trigeminal nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 598 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 598 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 598 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 598 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 598 at risk

Adverse event: Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 598 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 598 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Vagus nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 598 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 598 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 598 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 598 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 598 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 213 affected / 598 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 598 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 213 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 213 at risk

Adverse event: Hepatobiliary disorders - Other, specify
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 213 at risk

Adverse event: Ileal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 213 at risk

Adverse event: Investigations - Other, specify
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 213 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 213 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 213 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 213 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 213 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Small intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Vascular disorders - Other, specify
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 213 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 213 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 213 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 213 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 6 affected / 213 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 213 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 213 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 101 affected / 213 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 213 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 213 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 213 at risk

Adverse event: Anal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 24 affected / 213 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 68 affected / 213 at risk

Adverse event: Anorectal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 213 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 213 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 54 affected / 213 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 213 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 213 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 213 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 213 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 213 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 213 at risk

Adverse event: Bronchial obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 213 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 213 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 213 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 213 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 213 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 213 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 213 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 213 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 213 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 213 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 213 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 213 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: External ear inflammation
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 213 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 213 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 213 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 140 affected / 213 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 213 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 213 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 213 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 2 affected / 213 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 213 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Frequency: 1 affected / 213 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 213 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 213 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 213 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 213 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 213 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 213 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 213 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 213 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 213 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 213 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 213 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 213 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 213 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 213 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 213 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 213 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 213 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 213 at risk

Adverse event: Immune system disorders - Other, specify
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 213 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 136 affected / 213 at risk

Adverse event: Infective myositis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 213 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 213 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 213 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 3 affected / 213 at risk

Adverse event: Iron overload
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 213 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 213 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Arthritis infective
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 213 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 213 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 213 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 213 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 213 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 213 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 213 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 213 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 213 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 213 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 168 affected / 213 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 213 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 213 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 213 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 213 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 213 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 213 at risk

Adverse event: Penile pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 213 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 213 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 213 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 213 at risk

Adverse event: Personality change
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 213 at risk

Adverse event: Pharyngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 74 affected / 213 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 213 at risk

Adverse event: Haemothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 213 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 213 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Recall phenomenon
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 213 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 213 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 213 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 213 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 213 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 213 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 213 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 213 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 213 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 213 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 213 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 213 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 213 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 213 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 213 at risk

Adverse event: Urethritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 213 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 213 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 213 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 213 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 213 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 213 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 213 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 213 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 81 affected / 213 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 213 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 601 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 601 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 601 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 601 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 601 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 601 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 601 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 601 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 601 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 601 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 601 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Blood cholesterol increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 601 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 601 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 601 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 601 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 601 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Eye disorders - Other, specify
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 601 at risk

Adverse event: Facial nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 601 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 601 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 601 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 601 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 601 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Investigations - Other, specify
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 601 at risk

Adverse event: Jejunal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 601 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 601 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 601 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 601 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 601 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 601 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 601 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk