Study: NCT00811954

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 605 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 605 at risk

Adverse event: Methaemoglobinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 605 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 605 at risk

Adverse event: Thrombotic thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 605 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 605 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 605 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 605 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 605 at risk

Adverse event: Thyrotoxic crisis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 605 at risk

Adverse event: Eye disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 605 at risk

Adverse event: Necrotising retinitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 605 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 605 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 605 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 605 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 605 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 605 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 605 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 605 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 605 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 605 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 605 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 605 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 605 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 605 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Hepatitis syphilitic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 605 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Mycobacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 605 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Pneumonia cytomegaloviral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Secondary syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 605 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 605 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 605 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Splenic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 605 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 605 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 605 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 605 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 605 at risk

Adverse event: Blood cholesterol increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 605 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 605 at risk

Adverse event: Chest X-ray abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 605 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 605 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 605 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 605 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 605 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 605 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 605 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 605 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 605 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 605 at risk

Adverse event: Intervertebral disc space narrowing
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 605 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 605 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 605 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 605 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 605 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 605 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 605 at risk

Adverse event: Mucoepidermoid carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 605 at risk

Adverse event: Ocular neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 605 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 605 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 605 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 605 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 605 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 605 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 605 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 605 at risk

Adverse event: Wernicke's encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 605 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 605 at risk

Adverse event: Homicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 605 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 605 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 605 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 605 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 605 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 605 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 605 at risk

Adverse event: Breast enlargement
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 605 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 605 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 605 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 605 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 605 at risk

Adverse event: Coronary arterial stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 605 at risk

Adverse event: Cyst removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 605 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 605 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 605 at risk

Adverse event: Nephrectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 605 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 605 at risk

Adverse event: Spinal laminectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 605 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 605 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 605 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 605 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 605 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 605 at risk

Adverse event: Ocular icterus
Serious: no
Organ System: Eye disorders
Frequency: 40 affected / 605 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 605 at risk

Adverse event: Anogenital dysplasia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 605 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 605 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 605 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 605 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 41 affected / 605 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 37 affected / 605 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 605 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 605 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 68 affected / 605 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 73 affected / 605 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 318 affected / 605 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 212 affected / 605 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 105 affected / 605 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 65 affected / 605 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 115 affected / 605 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 70 affected / 605 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 57 affected / 605 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 184 affected / 605 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 74 affected / 605 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 605 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 605 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 605 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 605 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 49 affected / 605 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 605 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 605 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 605 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 605 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Methaemoglobinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 603 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 603 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 603 at risk

Adverse event: Thyroid disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 603 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 603 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 603 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 603 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 603 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 603 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 603 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 603 at risk

Adverse event: Ulcer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 603 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 603 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 603 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 603 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Immune reconstitution inflammatory syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 603 at risk

Adverse event: Cryptococcosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Eye infection syphilitic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Herpes virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Mycobacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Neurosyphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 603 at risk

Adverse event: Osteomyelitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 603 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Proctitis herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Prostatic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 603 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 603 at risk

Adverse event: Sinusitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Viral myocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 603 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 603 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 603 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 603 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 603 at risk

Adverse event: Laryngeal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 603 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 603 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 603 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 603 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 603 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 603 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 603 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 603 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 603 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 603 at risk

Adverse event: Staphylococcus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 603 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 603 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 603 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 603 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 603 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 603 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 603 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 603 at risk

Adverse event: Anal cancer stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 603 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 603 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 603 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 603 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 603 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 603 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 603 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 603 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 603 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 603 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 603 at risk

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 603 at risk

Adverse event: Homicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 603 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 603 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 603 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 603 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 603 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 603 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 603 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 603 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 603 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 603 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 603 at risk

Adverse event: Mediastinal mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 603 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 603 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 603 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 603 at risk

Adverse event: Ocular icterus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 603 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 603 at risk

Adverse event: Anogenital dysplasia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 603 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 603 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 603 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 603 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 36 affected / 603 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 39 affected / 603 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 603 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 603 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 59 affected / 603 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 77 affected / 603 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 603 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 152 affected / 603 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 73 affected / 603 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 89 affected / 603 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 95 affected / 603 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 67 affected / 603 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 65 affected / 603 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 139 affected / 603 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 85 affected / 603 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 603 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 35 affected / 603 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 603 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 603 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 49 affected / 603 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 603 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 60 affected / 603 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 603 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 603 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Granulomatous lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 601 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 601 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pericardial haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pericarditis constrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 601 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 601 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 601 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Mouth ulceration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 601 at risk

Adverse event: Cyst rupture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 601 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 601 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 601 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 601 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 601 at risk

Adverse event: Congestive hepatopathy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 601 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 601 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 601 at risk

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 601 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 601 at risk

Adverse event: Cytomegalovirus chorioretinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Disseminated cytomegaloviral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 601 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 601 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 601 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Meningitis cryptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Mycobacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 601 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 601 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Tubo-ovarian abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 601 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 601 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Burns third degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 601 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 601 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 601 at risk

Adverse event: Laboratory test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 601 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 601 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 601 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 601 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 601 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 601 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 601 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 601 at risk

Adverse event: Anal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: B-cell lymphoma stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: Glioblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 601 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: Large cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 601 at risk

Adverse event: Carotid artery aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 601 at risk

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 601 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 601 at risk

Adverse event: Anembryonic gestation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 601 at risk

Adverse event: Hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 601 at risk

Adverse event: Alcohol abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 601 at risk

Adverse event: Catatonia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 601 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 601 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 601 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 601 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 601 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 601 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 601 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 9 affected / 601 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 601 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 601 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 601 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 601 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 601 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 601 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 601 at risk

Adverse event: Pemphigoid
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 601 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 601 at risk

Adverse event: Alcohol detoxification
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 601 at risk

Adverse event: Mastectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 601 at risk

Adverse event: Spinal laminectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 601 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 601 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 601 at risk

Adverse event: Anogenital dysplasia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 601 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 601 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 601 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 601 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 35 affected / 601 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 37 affected / 601 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 601 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 601 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 46 affected / 601 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 69 affected / 601 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 601 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 227 affected / 601 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 98 affected / 601 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 82 affected / 601 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 105 affected / 601 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 70 affected / 601 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 55 affected / 601 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 183 affected / 601 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 74 affected / 601 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 601 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 601 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 601 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 601 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 601 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 601 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 53 affected / 601 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 601 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 601 at risk