Study: NCT00508820

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 168 at risk

Adverse event: Aplastic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Myelofibrosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 168 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Splenomegaly
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 168 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 168 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Enterocolitis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 168 at risk

Adverse event: Intestinal infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Mouth haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 168 at risk

Adverse event: Pancreatic pseudocyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Periodontitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 168 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 168 at risk

Adverse event: Therapy non-responder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 168 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 168 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 168 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 168 at risk

Adverse event: Hepatic haemorrhage
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 168 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 168 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Fungal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Herpes virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Infected cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 168 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Tuberculous pleurisy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 168 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 168 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 168 at risk

Adverse event: Incision site haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 168 at risk

Adverse event: Electrocardiogram
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 168 at risk

Adverse event: Platelet count abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 168 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 168 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 168 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 168 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 168 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 168 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 168 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 168 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 168 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 168 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 168 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 168 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 168 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 168 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 168 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 168 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 168 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 168 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 168 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 168 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 168 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 168 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 168 at risk

Adverse event: Respiratory tract haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 168 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 168 at risk

Adverse event: Purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 168 at risk

Adverse event: Skin discolouration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 168 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 168 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 168 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 168 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 168 at risk

Adverse event: Superficial vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 168 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 168 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 168 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 168 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 168 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 168 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 168 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 168 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 168 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 168 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 168 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 168 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 168 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 11 affected / 168 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 50 affected / 168 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 11 affected / 168 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 24 affected / 168 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 168 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 168 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 168 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 168 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 168 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 168 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 168 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 168 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 39 affected / 168 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 168 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 168 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 168 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 168 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 168 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 168 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 168 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 168 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 168 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 168 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 168 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 168 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 168 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 168 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 168 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 168 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 168 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 168 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 168 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 168 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 168 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 168 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 168 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 168 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 168 at risk

Adverse event: Aplasia pure red cell
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Bone marrow disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Myelofibrosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 239 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 239 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 239 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 239 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 239 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 239 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 239 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 239 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 239 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 239 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Gastric perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Mouth haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 239 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 239 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Rectal prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 239 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 239 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 239 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 239 at risk

Adverse event: Hyperpyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 239 at risk

Adverse event: Polyp
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 239 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 239 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 239 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 239 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 239 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 239 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 239 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 239 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 239 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 239 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 239 at risk

Adverse event: Stab wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 239 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 239 at risk

Adverse event: Traumatic haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 239 at risk

Adverse event: Traumatic haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 239 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 239 at risk

Adverse event: Blood smear test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 239 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 239 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 239 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 239 at risk

Adverse event: Juvenile melanoma benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 239 at risk

Adverse event: Metastases to lymph nodes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 239 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 239 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Cerebral venous sinus thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Mononeuropathy multiplex
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Temporal lobe epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 239 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 239 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 239 at risk

Adverse event: Urogenital haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 239 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 239 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 239 at risk

Adverse event: Oropharyngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Pemphigus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 239 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 239 at risk

Adverse event: Purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 239 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 239 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 239 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 239 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 239 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 239 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 239 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 239 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 239 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 239 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 239 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 239 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 239 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 239 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 239 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 239 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 239 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 239 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 239 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 239 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 239 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 239 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 239 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 239 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 23 affected / 239 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 239 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 239 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 239 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 239 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 239 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 239 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 239 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 239 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 239 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 239 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 239 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 239 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 239 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 239 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 239 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 239 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 239 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 61 affected / 239 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 239 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 239 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 239 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 239 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 239 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 239 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 239 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 239 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 239 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 239 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 239 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 239 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 239 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 239 at risk