Study: NCT00626795

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 17 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Penetrating abdominal trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 203 at risk

Adverse event: Shunt occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 203 at risk

Adverse event: Aneamia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 203 at risk

Adverse event: Long QT syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 203 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 203 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 203 at risk

Adverse event: Lip swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 18 affected / 203 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 203 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 203 at risk

Adverse event: Application site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 203 at risk

Adverse event: Condition aggravated
Serious: no
Organ System: General disorders
Frequency: 1 affected / 203 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 203 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 203 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 203 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 203 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 203 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 203 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 203 at risk

Adverse event: Human bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 203 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 203 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 203 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 203 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 203 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 203 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 203 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 203 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 203 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 203 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 203 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 203 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 203 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 203 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 203 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 203 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 203 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Hyperthermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 205 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 205 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 205 at risk

Adverse event: Aneamia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Lymphocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 16 affected / 205 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 205 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 205 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Treatment failure
Serious: no
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 205 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 205 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 205 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 205 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 205 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 205 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 205 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 205 at risk

Adverse event: Ligament disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 205 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 205 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 205 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Pharyngeal erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Pharyngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Tonsillar inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 205 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 205 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 204 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 204 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 204 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 204 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 204 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 204 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 204 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 204 at risk

Adverse event: Soft tissue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 204 at risk

Adverse event: Traumatic haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 204 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 204 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 204 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 204 at risk

Adverse event: Joint contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 204 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 204 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 204 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 204 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 204 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 204 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 204 at risk