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Adverse Events Reported from Day 85 Through Month 12 by Body System Code (SOC) and Grade
| Body system (SOC) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total |
|---|---|---|---|---|---|
| Cardiac disorders | 1 | 1 | |||
| Gastrointestinal disorders | 1 | 1 | |||
| Musculoskeletal and connective tissue disorders | 6 | 3 | 4 | 13 | |
| Neoplasms, benign, malignant, and unspecified | 1 | 1 | |||
| Nervous system disorders | 2 | 2 | |||
| Renal and urinary disorders | 1 | 1 | |||
| Respiratory, thoracic, and mediastinal disorders | 1 | 1 | |||
| Skin and subcutaneous tissue disorders | 1 | 1 | |||
| 9 | 8 | 4 | 0 | 21 |
