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Table 13. Serious Adverse Events Over Part 1 and Part 2

Part 1 Part 2
Treatment Control All Patients All Patients
(270) (280) (550) (347)
Subjects Events Subjects Events Subjects Events Subjects Events
Musculoskeletal and connective tissue 11 14 13 13 24 (4.4%) 27 16 17
disorders (4.1%) (4.6%) (4.6%)
Back pain 0 0 2 2 2 2 1 1
Chest wall pain 1 1 1 1 2 2 0 0
Degenerative joint disease 1 1 1 1 2 2 1 1
Arthritis 1 1 0 0 1 1 1 1
Arthritis single joint 0 0 1 1 1 1 0 0
Back pain aggravated 1 2 0 0 1 2 0 0
Charcot's joint 0 0 1 1 1 1 0 0
Groin pain 0 0 1 1 1 1 0 0
Hemarthrosis involving lower leg 1 1 0 0 1 1 0 0
Lumbar spinal stenosis 0 0 1 1 1 1 0 0
Lupus erythematosus 0 0 1 1 1 1 1 2
Muscle necrosis 1 1 0 0 1 1 0 0
Musculoskeletal chest pain 1 1 0 0 1 1 0 0
Neck pain 1 1 0 0 1 1 1 1
Olecranon bursitis 0 0 1 1 1 1 0 0
Osteoarthritis knee 0 0 1 1 1 1 0 0
Polymyositis 1 1 0 0 1 1 0 0
Pseudogout 0 0 1 1 1 1 0 0
Rheumatoid arthritis 1 1 0 0 1 1 0 0
Rotator cuff tear 1 1 0 0 1 1 1 1
Scleroderma 0 0 1 1 1 1 0 0
Shoulder blade pain 1 1 0 0 1 1 0 0
Spinal column stenosis 1 1 0 0 1 1 0 0
Cervical spondylosis 0 0 0 0 0 0 1 1
Foot pain 0 0 0 0 0 0 1 1
Joint instability 0 0 0 0 0 0 1 1
Knee pain 0 0 0 0 0 0 1 1
Low back pain 0 0 0 0 0 0 1 1
Osteoarthritis knees 0 0 0 0 0 0 1 1
Pain in joint involving lower leg 0 0 0 0 0 0 1 1
Shoulder pain 0 0 0 0 0 0 1 1
Spinal stenosis NOS 0 0 0 0 0 0 1 1
Spondylolisthesis 0 0 0 0 0 0 1 1
Blood and lymphatic system disorders 13 14 10 13 23 (4.2%) 27 14 20
(4.8%) (3.6%) (4.0%)
Anemia 11 12 8 10 19 22 11 12
Thrombocytopenia 1 1 1 1 2 2 1 1
Anemia microcytic 1 1 0 0 1 1 0 0
Leukocytosis 0 0 1 1 1 1 0 0
Neutropenia 0 0 1 1 1 1 0 0
Anemia aggravated 0 0 0 0 0 0 1 1
Hemolysis 0 0 0 0 0 0 1 5
Neutropenic fever 0 0 0 0 0 0 1 1
Investigations 10 10 5 (1.8%) 6 15 (2.7%) 16 3 (0.9%) 4
(3.7%)
Serum creatinine increased 2 2 1 2 3 4 0 0
Transplant evaluation 2 2 0 0 2 2 0 0
Anticoagulation drug level above therapeutic 1 1 0 0 1 1 0 0
Blood culture positive 1 1 0 0 1 1 0 0
Blood glucose fluctuation 0 0 1 1 1 1 0 0
INR 0 0 1 1 1 1 0 0
INR increased 1 1 0 0 1 1 0 0

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