Study: NCT02680002

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 30 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 14 affected / 70 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 8 affected / 70 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 6 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 70 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 70 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 33 affected / 71 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 14 affected / 71 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 9 affected / 71 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 5 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 71 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 71 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 71 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 71 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Joint dislocation (left hip) determined to be displaced prosthesis.
Frequency: 1 affected / 70 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Left foot.
Frequency: 1 affected / 70 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Left foot.
Frequency: 1 affected / 70 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: Left fifth metatarsal.
Frequency: 1 affected / 70 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 70 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 29 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 12 affected / 70 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 7 affected / 70 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 5 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 70 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 70 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 70 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 33 affected / 71 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 14 affected / 71 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 4 affected / 71 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 3 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 71 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 71 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 71 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 71 at risk

Adverse event: Pseudomeningocele
Serious: yes
Organ System: Surgical and medical procedures
Notes: Pseudomeningocele diagnosed post-operatively following anterior/posterior cervical fusion with plating, and a C5-6 right hemilaminectomy.
Frequency: 1 affected / 70 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 25 affected / 70 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 11 affected / 70 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 4 affected / 70 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 6 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 70 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 70 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 70 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 70 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 70 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Injury resulting from motor vehicle accident.
Frequency: 1 affected / 69 at risk

Adverse event: Gastrointestinal organ contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Injury resulting from motor vehicle accident.
Frequency: 1 affected / 69 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Injury resulting from motor vehicle accident.
Frequency: 1 affected / 69 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Injury resulting from motor vehicle accident.
Frequency: 1 affected / 69 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 69 at risk

Adverse event: Organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 29 affected / 69 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 12 affected / 69 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 8 affected / 69 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 7 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 69 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 69 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 69 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 69 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 69 at risk