Table 1.
Patient disposition
| n (%) | Everolimus FAS (N = 120) |
Everolimus pediatric subpopulation (N = 90) |
|---|---|---|
| Patients | ||
| Completed study | 100 (83.3) | 79 (87.8) |
| Discontinued | 20 (16.7) | 11 (12.2) |
| Primary reason for premature discontinuation | ||
| Adverse event(s) | 8 (6.7) a | 4 (4.4) |
| Otherb | 5 (4.2) | 3 (3.3) |
| Subject withdrew consent | 5 (4.2) | 2 (2.2) |
| Administrative problems | 1 (0.8) | 1 (1.1) |
| SEGA progression | 1 (0.8) | 1 (1.1) |
FAS full analysis set, SEGA subependymal giant cell astrocytoma
aIncludes abnormal laboratory values
bIncludes investigator’s decision and mother’s decision