Study: NCT00298610

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Possibly related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Related to study drug
Frequency: 16 affected / 30 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Related to study drug
Frequency: 8 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not related to study drug
Frequency: 5 affected / 30 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not related to study drug
Frequency: 4 affected / 30 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Related to study drug
Frequency: 8 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Not related to study drug
Frequency: 9 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Related to study drug
Frequency: 4 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 7 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Notes: Related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Related to study drug
Frequency: 5 affected / 30 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Not related to study drug
Frequency: 5 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Not related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Not related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Viraemia
Serious: no
Organ System: Infections and infestations
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Not related to study drug
Frequency: 8 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study drug
Frequency: 3 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Abdominal pain, upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study drug
Frequency: 3 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to study drug
Frequency: 2 affected / 30 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Stevens-Johnson syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk

Adverse event: Bilirubin decreased
Serious: no
Organ System: Investigations
Notes: Not related to study drug
Frequency: 1 affected / 30 at risk