Study: NCT00087490

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 537 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 537 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Diabetic gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 537 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Brain death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Necrosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 537 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Extradural abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Postoperative wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Blood culture positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Body temperature increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Bone disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Osteitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Brain injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 537 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 537 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 537 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 537 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Arterial rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 537 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 537 at risk

Adverse event: Blood loss anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 537 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 537 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 537 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Tricuspid valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 537 at risk

Adverse event: Factor XII deficiency
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 537 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 537 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 537 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 537 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 537 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 537 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Anorectal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 537 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 537 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 537 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 537 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 537 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 537 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hyperchlorhydria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Intestinal prolapse
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Lip dry
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Lip swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 537 at risk

Adverse event: Tongue discolouration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 537 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 537 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 537 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 537 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Infusion site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Infusion site phlebitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 537 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 6 affected / 537 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 537 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 537 at risk

Adverse event: Sensation of foreign body
Serious: no
Organ System: General disorders
Frequency: 1 affected / 537 at risk

Adverse event: Ulcer
Serious: no
Organ System: General disorders
Frequency: 2 affected / 537 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 537 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Abscess neck
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Asymptomatic bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 537 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Enterobacter infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Enterococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Escherichia infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Escherichia sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 537 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 537 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Genital candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Haematoma infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Infected skin ulcer
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Infusion site cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Oral fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Pelvic abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Prostate infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Tinea cruris
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 537 at risk

Adverse event: Tonsillitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Trichomoniasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 537 at risk

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Urinary tract infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 537 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Wound infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Wound infection staphylococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 537 at risk

Adverse event: Anaemia postoperative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Foreign body in eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 537 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 537 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Transfusion reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Wound haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 537 at risk

Adverse event: Wound necrosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 537 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 537 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 537 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 537 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Blood culture positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 537 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 537 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 2 affected / 537 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 537 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 537 at risk

Adverse event: Polymerase chain reaction
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 537 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 537 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 537 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 537 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 537 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 537 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 537 at risk

Adverse event: Hypoproteinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 537 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 537 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 537 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 537 at risk

Adverse event: Coccydynia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 537 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 537 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 537 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 537 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 537 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 537 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 537 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 537 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 537 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 537 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 537 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 537 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 537 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 537 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 537 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 537 at risk

Adverse event: Oliguria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 537 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 537 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 537 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 537 at risk

Adverse event: Urine odour abnormal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 537 at risk

Adverse event: Genital rash
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 537 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 537 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 537 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 537 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 537 at risk

Adverse event: Vaginal disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 537 at risk

Adverse event: Vulval disorder
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 537 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 537 at risk

Adverse event: Bronchial obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 537 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 537 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 537 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 537 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 537 at risk

Adverse event: Oropharyngeal blistering
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 537 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 537 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 537 at risk

Adverse event: Blood blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Cold sweat
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 537 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 537 at risk

Adverse event: Erythema nodosum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 537 at risk

Adverse event: Pruritus allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 537 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 537 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 537 at risk

Adverse event: Stasis dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 537 at risk

Adverse event: Venipuncture
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 537 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 537 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 537 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 537 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 537 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 537 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 537 at risk

Adverse event: Shock haemorrhagic
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 537 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 515 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 515 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 515 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Burn infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Cellulitis gangrenous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Intestinal gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Mediastinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Blood creatine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Blood culture positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Haematocrit decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: White blood cell count increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 515 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 515 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Rash erythematous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Vancomycin infusion reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 515 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Thrombectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 515 at risk

Adverse event: Toe amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 515 at risk

Adverse event: Aortic thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 515 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 515 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 515 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 515 at risk

Adverse event: Hypothrombinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 515 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 515 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 515 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 515 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 515 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 515 at risk

Adverse event: Tachyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 515 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 515 at risk

Adverse event: Motion sickness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 515 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 515 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 515 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 515 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 515 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 515 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 515 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 515 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 515 at risk

Adverse event: Erosive oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Faecalith
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Gastric haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Fistula of small intestine
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Lip swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 515 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Tongue ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 515 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Catheter site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Catheter site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Catheter site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 515 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 515 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Disease progression
Serious: no
Organ System: General disorders
Frequency: 2 affected / 515 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 515 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 14 affected / 515 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 515 at risk

Adverse event: Infusion site phlebitis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 515 at risk

Adverse event: Infusion site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Infusion site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Infusion site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Infusion site thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Infusion site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 515 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 515 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 515 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 515 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Abdominal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Bacterial rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Clostridium difficile colitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Enterobacter infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Enterococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Gangrene
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Hepatitis C
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Infusion site abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Injection site abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Morganella infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 515 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Pseudomonas infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Staphylococcal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 515 at risk

Adverse event: Urinary tract infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 515 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 515 at risk

Adverse event: Anaemia postoperative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 515 at risk

Adverse event: Chest injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 515 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 515 at risk

Adverse event: Gastrointestinal stoma complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Postoperative wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 515 at risk

Adverse event: Skeletal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Wound haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 515 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 515 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 515 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 515 at risk

Adverse event: Blood chloride decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 515 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 515 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 515 at risk

Adverse event: Culture wound positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Drug level above therapeutic
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 515 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 515 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 515 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 515 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 515 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 515 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 515 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 515 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 515 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 515 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 515 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 515 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 515 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 515 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 515 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 515 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 515 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Essential tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 515 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 515 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 515 at risk

Adverse event: Neurological decompensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 515 at risk

Adverse event: Post polio syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 515 at risk

Adverse event: Facial paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 515 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 515 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 515 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 515 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 515 at risk

Adverse event: Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 515 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 515 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 515 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 515 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Leukocyturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Oliguria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 515 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 515 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 515 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 515 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 515 at risk

Adverse event: Scrotal irritation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 515 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 515 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 515 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 515 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 515 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 515 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 515 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 515 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 515 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 515 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 515 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 515 at risk

Adverse event: Pruritus allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 515 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 515 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Vancomycin infusion reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 515 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 515 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 515 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 515 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 515 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 515 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 515 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 515 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 515 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 515 at risk