Table 3.
Incidence and median duration of dose reduction and interruption events and time to resumption of full study dose
| EVE | EXE | PBO | EXE | |
|---|---|---|---|---|
| Duration of dose reductions/interruptions | ||||
| Number of dose reductions/interruptions (n) | 1065 | 224 | 114 | 65 |
| Median duration (days) (range) | 11 (1–672) | 2 (1–47) | 1 (1–131) | 1 (1–20) |
| Number of dose reductions (n) | 360 | 1 | 9 | 0 |
| Median duration (days) (range) | 29 (1–672) | 7 (7–7) | 20 (2–131) | 0 |
| Number of dose interruptions (n) | 705 | 223 | 105 | 68 |
| Median duration (days) (range) | 7 (1–41) | 2 (1–47) | 1 (1–26) | 1 (1–20) |
| Time to resumption of full drug dose | ||||
| ≤1 week [n (%)] | 219 (47) | 154 (69) | 88 (85) | 59 (87) |
| >1 and ≤2 weeks [n (%)] | 133 (29) | 44 (20) | 9 (9) | 7 (10) |
| >2 and ≤3 weeks [n (%)] | 55 (12) | 14 (6) | 4 (4) | 2 (3) |
| >3 weeks [n (%)] | 56 (12) | 11 (5) | 2 (2) | 0 |
| Median time to resumption of full dosea (days) (range) | 8 (2–333) | 3 (2–48) | 2 (2–27) | 2 (2–21) |
EVE, everolimus; EXE, exemestane; PBO, placebo.
aIn patients who were able to resume study drug.