Table 2.
Patient disposition (full analysis set).
| Variable | All patients (N = 3246) | CNS metastasis (n = 51) | Prior chemotherapy (n = 194) | ECOG PS 2 (n = 112) | VM + prior chemotherapy (n = 146) | VM + ECOG PS 2 (n = 77) |
|---|---|---|---|---|---|---|
| Completed Core Phase, n (%) | 1301 (40.1) | 19 (37.3) | 60 (30.9) | 34 (30.4) | 38 (26.0) | 22 (28.6) |
| Median duration of exposure, months | ||||||
| Study treatment | 17.8 | 16.8 | 12.5 | 10.7 | 9.6 | 10.5 |
| Ribociclib | 17.5 | 16.8 | 11.9 | 11.0 | 9.5 | 11.0 |
| Discontinued treatment, n (%) | 1945 (59.9) | 32 (62.7) | 134 (69.1) | 78 (69.6) | 108 (74.0) | 55 (71.4) |
| Reason for discontinuation | ||||||
| Progressive disease | 1109 (34.2) | 18 (35.3) | 96 (49.5) | 40 (35.7) | 79 (54.1) | 28 (36.4) |
| Adverse event | 504 (15.5) | 6 (11.8) | 24 (12.4) | 13 (11.6) | 17 (11.6) | 9 (11.7) |
| Physician decision | 112 (3.5) | 2 (3.9) | 4 (2.1) | 10 (8.9) | 4 (2.7) | 7 (9.1) |
| Death | 46 (1.4) | 1 (2.0) | 2 (1.0) | 7 (6.3) | 2 (1.4) | 6 (7.8) |
| Other | 174 (5.4) | 5 (9.8) | 8 (4.1) | 8 (7.1) | 6 (4.1) | 5 (6.5) |
CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; VM, visceral metastases.