Study: NCT00086346

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 389 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Abscess
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 389 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 389 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 389 at risk

Adverse event: Adenoma benign
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Ascites
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 389 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 389 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 389 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 389 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 389 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 389 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Face oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 389 at risk

Adverse event: Influenza
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 389 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 389 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 389 at risk

Adverse event: Medication error
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Neck pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 389 at risk

Adverse event: Overdose
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 389 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 389 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 389 at risk

Adverse event: Septic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 389 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 389 at risk

Adverse event: Congenital arterial malformation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Arterial thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 389 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 389 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 389 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 389 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 389 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 389 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 389 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Mesenteric venous occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 389 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 389 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 389 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 389 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 389 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 389 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 389 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 389 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 389 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 389 at risk

Adverse event: Gastrointestinal carcinoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 389 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 389 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 389 at risk

Adverse event: Hepatic neoplasm
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 389 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 389 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Hepatic steatosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 389 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 389 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Peridontal abcess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Anorectal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 389 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 389 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 389 at risk

Adverse event: Lymphagitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 389 at risk

Adverse event: Alkaline phosphotase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 389 at risk

Adverse event: Blood urea increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 389 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 389 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 389 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 389 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 389 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 389 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 389 at risk

Adverse event: Hyperlipidaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 389 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 389 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 389 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 389 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 389 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 389 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 389 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 389 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 389 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 389 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 389 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Musculoskeletal anomaly
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 389 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 389 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 389 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 389 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Lung infiltration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 389 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 389 at risk

Adverse event: Herpes simplex
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 389 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 389 at risk

Adverse event: Skin hypertrophy
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 389 at risk

Adverse event: Eye haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 389 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 389 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 389 at risk

Adverse event: Retinal disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 389 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 389 at risk

Adverse event: Albuminuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Fallopian tube disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 389 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 389 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 389 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 389 at risk

Adverse event: Nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Nephrosclerosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 389 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 389 at risk

Adverse event: Polyuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 389 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 389 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 389 at risk

Adverse event: Urine abnormality
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Local reaction to procedure
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 389 at risk

Adverse event: Surgery
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Cholangitis sclerosing
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Abnormal faeces
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 389 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 389 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 67 affected / 389 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 79 affected / 389 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 42 affected / 389 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 389 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 22 affected / 389 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 79 affected / 389 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 22 affected / 389 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 84 affected / 389 at risk

Adverse event: Hernia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 389 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 71 affected / 389 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 65 affected / 389 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 389 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 389 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 389 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 136 affected / 389 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 389 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 389 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 389 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 389 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 389 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 103 affected / 389 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 389 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 25 affected / 389 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 94 affected / 389 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 55 affected / 389 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 58 affected / 389 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 389 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 389 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 389 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 110 affected / 389 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 389 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 389 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 159 affected / 389 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 389 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 389 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 389 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 127 affected / 389 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 389 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 389 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 389 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 389 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 389 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 389 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 389 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 389 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 389 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 66 affected / 389 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 389 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 40 affected / 389 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 389 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 52 affected / 389 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 389 at risk

Adverse event: Erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 389 at risk

Adverse event: Pruritus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 50 affected / 389 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 111 affected / 389 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 389 at risk

Adverse event: Skin hypertrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 389 at risk

Adverse event: Albuminuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 389 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 389 at risk

Adverse event: Local reaction to procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 36 affected / 389 at risk

Adverse event: Cellulitis
Serious: no
Organ System: General disorders
Frequency: 20 affected / 389 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 16 affected / 389 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 97 affected / 389 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 389 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 389 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 389 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 389 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 389 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 389 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 389 at risk

Adverse event: Skin cancer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 389 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 210 at risk

Adverse event: Acute abdomen
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 210 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 210 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 210 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 210 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 210 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 210 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 210 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 210 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 210 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Congenital arterial malformation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cardiomegaly
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 210 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 210 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Angiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: Carcinoma of the mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 210 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 210 at risk

Adverse event: Gastrointestinal carcinoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 210 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Hepatic neoplasm
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 210 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Anorectal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 210 at risk

Adverse event: Thyroid disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 210 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 210 at risk

Adverse event: Aplastic anema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 210 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 210 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 210 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 210 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 210 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 210 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 210 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Central nervous system neoplasm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 210 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 210 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 210 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 210 at risk

Adverse event: Breast neoplasm
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Ovarian disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 210 at risk

Adverse event: Prostatic disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 210 at risk

Adverse event: Unintended pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 210 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Urinary tract disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 210 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Local reaction to procedure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 210 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 30 affected / 210 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 32 affected / 210 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 210 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 210 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 210 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 210 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 210 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 7 affected / 210 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 23 affected / 210 at risk

Adverse event: Hernia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 210 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 39 affected / 210 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 40 affected / 210 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 210 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 210 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 210 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 210 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 210 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 210 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 210 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 210 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 210 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 210 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 210 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 210 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 210 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 210 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 210 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 210 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 210 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 210 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 210 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 210 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 210 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 210 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 210 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 210 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 210 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 210 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 210 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 210 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 210 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 210 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 210 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 210 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 210 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 210 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 210 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 210 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 210 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 210 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 210 at risk

Adverse event: Erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 210 at risk

Adverse event: Pruritus
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 210 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 210 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 210 at risk

Adverse event: Skin hypertrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 210 at risk

Adverse event: Albuminuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 210 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 210 at risk

Adverse event: Local reaction to procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 210 at risk

Adverse event: Cellulitis
Serious: no
Organ System: General disorders
Frequency: 7 affected / 210 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 15 affected / 210 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 43 affected / 210 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 210 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 210 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 210 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 210 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 210 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 210 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 210 at risk

Adverse event: Skin cancer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 210 at risk