Study: NCT01258855

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 15 affected / 55 at risk

Adverse event: Lymphocyte count increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: Amylase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 55 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 55 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 55 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: splenic infarct
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 55 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: low carbon dioxide
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: red blood cells decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: white blood cells increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 55 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Atrioventricular block second degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Atrioventricular block second degree
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 55 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 55 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 39 affected / 55 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 55 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 55 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 55 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 55 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 55 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 55 at risk

Adverse event: Anal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Large intestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 55 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 55 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 55 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 55 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Oesophageal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Gastric haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Gastric varices
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Mucositis nose
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 55 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 55 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 55 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 55 at risk

Adverse event: Early satiety
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: gum sensitivity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: mouth sores
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: mouth ulcers
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oedema mucosal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: oral mucosal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: tongue sensitivity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 40 affected / 55 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 55 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 25 affected / 55 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 55 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 39 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 55 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 55 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 55 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 8 affected / 55 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 55 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: edema LUE distal to PICC site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: intra and extrahepatic biliary duct dila
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 55 at risk

Adverse event: seasonal allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Anorectal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 55 at risk

Adverse event: Oral Yeast
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Scrotal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 55 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 55 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Toe infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Tonsilar abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 55 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 55 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Activated partial thromboplastin time pr
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 55 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 33 affected / 55 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 55 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 37 affected / 55 at risk

Adverse event: C Reactive Protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Troponin I increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 55 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Elevated lactate acid dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Elevated lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Elevated neutrophil count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Elevated white blood cells
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 55 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 55 at risk

Adverse event: Increaesd LDH
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Blood lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 55 at risk

Adverse event: LDH serum high
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 55 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 55 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 55 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Neutrphil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 46 affected / 55 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 55 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 55 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 55 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 55 at risk

Adverse event: White Blood Cells Increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 55 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: decreased folic acid
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: decreased phosphorus
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: ele3vated phosphorus
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: elevated b natriuretic peptide
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: elevated lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 9 affected / 55 at risk

Adverse event: elevated platelet count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: elevated white blood cells
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: increased LDH
Serious: no
Organ System: Investigations
Frequency: 8 affected / 55 at risk

Adverse event: increased PT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: increased bilirubin, urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: increased chloride
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: increased eosinophils
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: increased phosphorous
Serious: no
Organ System: Investigations
Frequency: 4 affected / 55 at risk

Adverse event: increased phosphorus
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: increased thyroid stimulating hormone
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: increased white blood cells
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Blood lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: lactate dehydrogenase elevated
Serious: no
Organ System: Investigations
Frequency: 4 affected / 55 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: lymhocyte count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: Oliguria
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 55 at risk

Adverse event: Chills
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Blood testosterone decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 55 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 55 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 55 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 55 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 55 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 55 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 55 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 55 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 55 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 55 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 55 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 55 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 55 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 55 at risk

Adverse event: LDH Serum Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: LDH Serum increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: LDH serum increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 55 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Phosphorus Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 55 at risk

Adverse event: low CO2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: low hemoglobin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: phosphorus increasedf
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 55 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 55 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 55 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: pain at left clavicle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: toe pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 55 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 55 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 55 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 55 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 55 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 55 at risk

Adverse event: Sinus pain
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 55 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 55 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: neurological episode NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 55 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 55 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 55 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 55 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 55 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 55 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 55 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 55 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 55 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 55 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 55 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: decreased urine output
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: low urine output
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 55 at risk

Adverse event: urinary pressure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oedema genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: CO2 Decreased
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 55 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 55 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 55 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 55 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 55 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pharyngeal haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Sinus disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 55 at risk

Adverse event: Tracheal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 55 at risk

Adverse event: dry nostrils
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: dry nostrils from O2 use
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 55 at risk

Adverse event: Erythema: chest and face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dermatitis exfoliative generalised
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Onychomalacia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 55 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 55 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 55 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Skin hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Skin induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: callous, right hand
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: desquamation: hands, chest, foot, legs
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: desquamation: head and neck
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: erythema: thighs, legs, arms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: excoriation, groin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: poison ivy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: ruddy color, whole body
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: scrotal desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: white papules, lip
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: white spot on tonsil
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Xanthelasma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Capillary leak syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 55 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 55 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 55 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 55 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 55 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 29 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 29 at risk

Adverse event: white blood cells increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 29 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 29 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: bigeminy ventricular arrhythemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 29 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 29 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 29 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 29 at risk

Adverse event: mouth sores
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 23 affected / 29 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 21 affected / 29 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 29 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 29 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Lip swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Tongue oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 29 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: only noted as bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Activated partial thromboplastin time pr
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 29 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 29 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 29 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 29 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 29 at risk

Adverse event: Elevated Lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Elevated lactate acid dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 29 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 29 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 29 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 29 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 29 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 29 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 29 at risk

Adverse event: bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 29 at risk

Adverse event: Blood chloride increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: elevated lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 29 at risk

Adverse event: elevated white blood cells
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: increased basophils
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: increased eosinophils
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: lactate dehydrogenase elevated
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Oliguria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 29 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 29 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 29 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 29 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 29 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 29 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 29 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 29 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 29 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 29 at risk

Adverse event: LDH Serum Increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: LDH serum increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 29 at risk

Adverse event: decreased bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: elevated chloride
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 29 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 29 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 29 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: tingling, left foot
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: tingling, middle upper abdomen
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 29 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 29 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 29 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 29 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 29 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 29 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 29 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 29 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dermatitis exfoliative generalised
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 29 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 29 at risk

Adverse event: Skin hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Capillary leak syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 29 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 29 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 29 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 29 at risk