Study: NCT01390064

Adverse event: Other: Subcutaneous nodule at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 - Anticipated - Definitely related to the study - Definitely related to the study Therapy
Frequency: 2 affected / 3 at risk

Adverse event: Sinus disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 - Unanticipated - Unlikely related to the study - Unlikely related to study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Autoimmune disorder: Increase in ANA
Serious: no
Organ System: Immune system disorders
Notes: Grade 1 - Anticipated - Possibly related to study - definitely related to study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Rash maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 - Unanticipated - Definitely related to they study - Definitely related to study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 - Unanticipated - Definitely related to they study - Possibly related to study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 - Unanticipated - Not related to they study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Other: tender knots at the site of injections
Serious: no
Organ System: General disorders
Notes: Grade 2 - Anticipated - Definitely related to the study - Definitely related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Large intestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2- Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Skin induration: small lumps on abdomen at site of study drug administration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 - Anticipated - Definitely related to the study - Not related to study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2 - Anticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Skin induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 - Unanticipated - Possibly related to they study - Definitely related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Skin induration: abdomen and right upper arm
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2 - Anticipated - Possibly related to the study - Definitely related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Pain of skin: constant soreness at injection sites when the area is touched
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2 - Anticipated - Possibly related to the study - Possibly related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 - Anticipated - Possibly related to the study - Possibly related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: Grade 1 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Other: bitten by unknown insect on the back of left leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 2 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Grade 2 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2 - Unanticipated - Not related to the study - Not related to the study therapy
Frequency: 1 affected / 3 at risk