Study: NCT00665561

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 1316 at risk

Adverse event: Eosinophilia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Splenomegaly
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1316 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1316 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1316 at risk

Adverse event: Cardiac valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1316 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 1316 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Torsade de pointes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Fanconi syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Adrenal mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Autoimmune hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Central vision loss
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Anisocoria
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1316 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Abdominal wall haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Anal skin tags
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Anogenital dysplasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Anorectal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Barrett's oesophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1316 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 1316 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Haemorrhoids thrombosed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Odynophagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Oesophageal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Oesophageal rupture
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pancreatic pseudocyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1316 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Rectal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 1316 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 1316 at risk

Adverse event: Dysplasia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1316 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Physical deconditioning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1316 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Treatment noncompliance
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Ulcer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Biliary dilatation
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Hepatitis toxic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hepatorenal syndrome
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: AIDS related complication
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: AIDS retinopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Acquired immunodeficiency syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Acute hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Anorectal cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1316 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Atypical mycobacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Bacterial diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Brain abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 1316 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: CNS ventriculitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Campylobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1316 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Corneal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Cytomegalovirus chorioretinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Cytomegalovirus colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: End stage AIDS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: External ear cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Eye infection syphilitic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Fungal oesophagitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1316 at risk

Adverse event: Gastroenteritis clostridial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Genital herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Genital herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Giardiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Gonorrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: HIV enteropathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: HIV wasting syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: HIV-associated neurocognitive disorder
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1316 at risk

Adverse event: Helicobacter gastritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Helicobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Hepatitis B reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Herpes pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Herpes virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1316 at risk

Adverse event: Histoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1316 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Latent syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1316 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1316 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Mycobacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Mycobacterium abscessus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Neurosyphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Oesophageal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1316 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Parvovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1316 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Pilonidal disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1316 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 51 affected / 1316 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Pneumonia necrotising
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Progressive multifocal leukoencephalopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Rectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Secondary syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1316 at risk

Adverse event: Septic embolus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1316 at risk

Adverse event: Shigella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1316 at risk

Adverse event: Sinusitis fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1316 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1316 at risk

Adverse event: Syphilis anal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Trichomoniasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 1316 at risk

Adverse event: Urinary tract infection pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1316 at risk

Adverse event: Vulval abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1316 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1316 at risk

Adverse event: Chest injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1316 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1316 at risk

Adverse event: Foreign body in respiratory tract
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Fractured sacrum
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Gastrointestinal stoma necrosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1316 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1316 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1316 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1316 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1316 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Splenic injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1316 at risk

Adverse event: Vascular graft thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1316 at risk

Adverse event: Atypical mycobacterium test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Biopsy lymph gland
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Blood potassium decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Body temperature increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Drug clearance increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Electrocardiogram repolarisation abnormality
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Staphylococcus test
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1316 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1316 at risk

Adverse event: Alcoholic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cachexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1316 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Folate deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Haemochromatosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1316 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Vitamin D deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Arthritis reactive
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Costochondritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Diastasis recti abdominis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Fistula
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Anal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Anal cancer stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Anal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Anaplastic large cell lymphoma T- and null-cell types
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Anogenital warts
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Bladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Burkitt's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1316 at risk

Adverse event: Cervix carcinoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Fibrous histiocytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Gastrointestinal lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 1316 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Malignant neoplasm of unknown primary site
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Neoplasm prostate
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

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

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Pancreatic carcinoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Papillary cystadenoma lymphomatosum
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Plasmablastic lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Prostatic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Rectal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Small cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Squamous cell carcinoma of the oral cavity
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Tongue neoplasm malignant stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Vaginal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Vulval cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1316 at risk

Adverse event: Alcoholic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Amputation stump pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cerebellar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 1316 at risk

Adverse event: Clonic convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cranial nerve palsies multiple
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Diabetic hyperglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Motor dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 1316 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1316 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1316 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1316 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1316 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Borderline personality disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Organic brain syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Substance-induced psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 1316 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 1316 at risk

Adverse event: Renal haematoma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Ureteric stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Ovarian vein thrombosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pelvic adhesions
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Prostatomegaly
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Vaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1316 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1316 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1316 at risk

Adverse event: Pulmonary eosinophilia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pulmonary infarction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Dermal cyst
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Lipodystrophy acquired
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Neurodermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Abscess drainage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1316 at risk

Adverse event: Arterial stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Cardiac resynchronisation therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Colostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Gastric banding reversal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Hip surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Inguinal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Leg amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Renal transplant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Valvuloplasty cardiac
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1316 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Aortic arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Bleeding varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1316 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Jugular vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Lymphoedema
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1316 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Subclavian artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1316 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Vasospasm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1316 at risk

Adverse event: Infected neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1316 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 1316 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 1316 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 1316 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 1316 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 1316 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 1316 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 1316 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 1316 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 1130 at risk

Adverse event: Anaemia macrocytic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Anaemia of chronic disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Heparin-induced thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Lymphocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Methaemoglobinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 1130 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Thrombotic thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 1130 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 1130 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Fanconi syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Sickle cell disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Deafness bilateral
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Tympanic membrane perforation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Orbital cyst
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1130 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Aphthous ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 1130 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Faeces discoloured
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Gastrointestinal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Intestinal mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Irritable bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Proctitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Rectal prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Varices oesophageal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1130 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 1130 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Dysplasia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Multi-organ disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 1130 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Treatment noncompliance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Hepatitis alcoholic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Hepatorenal syndrome
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Jarisch-Herxheimer reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Acquired immunodeficiency syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1130 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Amoebic dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Aspergillus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1130 at risk

Adverse event: Bacterial diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1130 at risk

Adverse event: Burkholderia cepacia complex sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Candida infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 1130 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Cerebral toxoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Cryptococcal fungaemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Cryptococcosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Cryptosporidiosis infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Cytomegalovirus chorioretinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: End stage AIDS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Enterococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: External ear cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Eye infection syphilitic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Folliculitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Fungal oesophagitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Furuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1130 at risk

Adverse event: Gastroenteritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Gastroenteritis cryptosporidial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Genital herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Genital herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: HIV infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: HIV wasting syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: HIV-associated neurocognitive disorder
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Helicobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Herpes zoster disseminated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Histoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Infective exacerbation of bronchiectasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: Joint abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Meningitis cryptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Meningitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Meningitis tuberculous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Microsporidia infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Mycobacterium avium complex infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Mycobacterium fortuitum infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Neurosyphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Oesophageal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1130 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: Oral hairy leukoplakia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Osteomyelitis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Otitis externa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 1130 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 54 affected / 1130 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Pneumonia pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Progressive multifocal leukoencephalopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1130 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1130 at risk

Adverse event: Salmonella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Secondary syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1130 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: Shigella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: Sinusitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1130 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Staphylococcal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1130 at risk

Adverse event: Superinfection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Toxoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Trichomoniasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1130 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Vaginal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1130 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Breast injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1130 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Foreign body in gastrointestinal tract
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1130 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1130 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1130 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Periorbital haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1130 at risk

Adverse event: Radial nerve injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1130 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Traumatic liver injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1130 at risk

Adverse event: Culture stool positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1130 at risk

Adverse event: HIV test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1130 at risk

Adverse event: Haemophilus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1130 at risk

Adverse event: Liver function test increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1130 at risk

Adverse event: Staphylococcus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1130 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1130 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1130 at risk

Adverse event: Cachexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 1130 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Electrolyte depletion
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Hyperlipidaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Pseudarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1130 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Anogenital warts
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1130 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Brain neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1130 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1130 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Diffuse large B-cell lymphoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1130 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1130 at risk

Adverse event: Leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Lipoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1130 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1130 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Malignant melanoma stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Metastases to pleura
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Ovarian adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Ovarian germ cell teratoma benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1130 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1130 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1130 at risk

Adverse event: Squamous cell carcinoma of the oral cavity
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Squamous cell carcinoma of the tongue
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: T-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1130 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1130 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1130 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Encephalitis post varicella
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1130 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1130 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Intraventricular haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Lacunar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Mental impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1130 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1130 at risk

Adverse event: Abortion spontaneous complete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1130 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1130 at risk

Adverse event: Adjustment disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Homicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 1130 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Schizoaffective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 18 affected / 1130 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1130 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Glomerulonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Renal injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Renal vein thrombosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Breast enlargement
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Fallopian tube obstruction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Painful erection
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Perineal rash
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Testicular swelling
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1130 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Obstructive airways disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1130 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 1130 at risk

Adverse event: Stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Hidradenitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Neurodermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Night sweats
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Skin lesion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Abdominal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1130 at risk

Adverse event: Arteriovenous fistula operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1130 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1130 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1130 at risk

Adverse event: Immune tolerance induction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1130 at risk

Adverse event: Medical device removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1130 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 1130 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1130 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Vascular stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1130 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 1130 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1130 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1130 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1130 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 1130 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 1130 at risk