Study: NCT01701999

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Injection site anaesthesia*
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Injection site erythema*
Serious: no
Organ System: General disorders
Frequency: 5 affected / 8 at risk

Adverse event: Injection site pain*
Serious: no
Organ System: General disorders
Frequency: 6 affected / 8 at risk

Adverse event: Injection site papule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Injection site pruritus*
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Injection site reaction*
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Injection site swelling*
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Haemaglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Musculoskeletal pain*
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Nausea*
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Chills*
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Injection site erythema*
Serious: no
Organ System: General disorders
Frequency: 19 affected / 37 at risk

Adverse event: Injection site induration*
Serious: no
Organ System: General disorders
Frequency: 3 affected / 37 at risk

Adverse event: Injection site nodule*
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Injection site pain*
Serious: no
Organ System: General disorders
Frequency: 15 affected / 37 at risk

Adverse event: Injection site pruritus*
Serious: no
Organ System: General disorders
Frequency: 9 affected / 37 at risk

Adverse event: Injection site swelling*
Serious: no
Organ System: General disorders
Frequency: 18 affected / 37 at risk

Adverse event: Injection site urticaria*
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Malaise*
Serious: no
Organ System: General disorders
Frequency: 5 affected / 37 at risk

Adverse event: Pain*
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pyrexia*
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Swelling*
Serious: no
Organ System: General disorders
Frequency: 3 affected / 37 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Infusion site haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Injection site swelling*
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Procedural complication*
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 37 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 37 at risk

Adverse event: Aspartate aminotransferase increased*
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Body temperature increased*
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 37 at risk

Adverse event: Haemaglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Haemaglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Protein total decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 37 at risk

Adverse event: Urine ketone body present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Muscle spasms*
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Muscular weakness*
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Musculoskeletal pain*
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Myalgia*
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Sensation of heaviness*
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Headache*
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 37 at risk

Adverse event: Paraesthesia*
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Erythema*
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 37 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Rash erythematous*
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Sunburn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Urticaria*
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk