Study: NCT00104234

Adverse event: Body increased temperature
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Broncopneumopathy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cervical cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Corneal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 38 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hip surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 38 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Inguinal hernia obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Osteotomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Tension headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tracheal stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 38 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 38 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 38 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 38 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 38 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 38 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 38 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 38 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 38 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 38 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Dental caries
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 38 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 38 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 38 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 38 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: Pulmonary hypertention
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Restrictive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Increased bronchial secretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Oropharyngeal swelling
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 38 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 38 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 38 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hyperreflexia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hypoaesthenia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Myelopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Migrane
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 38 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 38 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 38 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hernia pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Athralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 38 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 38 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 38 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hip deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Intervertibral disc disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Joint contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Kyphoscoliosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 38 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 38 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 38 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Prurigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Face oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pityriasis rosea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 38 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 38 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 38 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 38 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 38 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 13 affected / 38 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 38 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 38 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 38 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 38 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 38 at risk

Adverse event: Procedural site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 38 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 38 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 38 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 38 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 38 at risk

Adverse event: Poor venous access
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 38 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hyperaemia
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cardiac valve disease
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 38 at risk

Adverse event: Atrial hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cyanosis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dilatation atrial
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 38 at risk

Adverse event: QRS axis abnormal
Serious: no
Organ System: Investigations
Frequency: 3 affected / 38 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Abnormal behaviour
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 38 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 38 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 38 at risk