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Page 64 - Abbott
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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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