TABLE 6.
Adverse Events: Summary of All Grade 2 and Higher AEs According to Category Attributable to Sirolimus
| Toxicity Category | Possible | Probable | Definite |
|---|---|---|---|
| Blood/bone marrow, (%) | 17 (28) | 11 (18) | 2 (3) |
| Cardiac general, (%) | 0 | 1 (2) | 0 |
| Constitutional symptoms, (%) | 2 (3) | 2 (3) | 0 |
| Dermatology/skin, (%) | 3 (5) | 2 (3) | 0 |
| Gastrointestina, (%)l | 12 (20) | 18 (30) | 3 (5) |
| Infection, (%) | 9 (15) | 0 | 0 |
| Lymphatics, (%) | 3 (5) | 1 (2) | 0 |
| Metabolic/laboratory, (%) | 5 (8) | 6 (10) | 1 (2) |
| Musculoskeletal/soft tissue, (%) | 1 (2) | 0 | 0 |
| Pain, (%) | 5 (8) | 5 (8) | 1 (2) |
| Pulmonary/upper respiratory, (%) | 0 | 1 (2) | 0 |
Total participants = 60.