Table 1.
Baseline clinical characteristics in Studies 1199 and 1036
| Characteristic | Study 1199 (N = 230) | Study 1036 (N = 1124) |
|---|---|---|
| Age, median (range), years | 60 (11−83) | 59 (10−92) |
| Male sex, n (%) | 139 (60) | 672 (60) |
| ECOG performance status,a n (%) | ||
| 0 | 87 (38) | 420 (37) |
| 1 | 114 (50) | 521 (46) |
| 2 | 24 (10) | 135 (12) |
| 3 | 3 (1) | 33 (3) |
| 4 | 0 | 5 (<1) |
| Time since original diagnosis, median (range), weeks | 186 (12–773) | 171 (3−1584) |
| Maximum prior imatinib dose,b n (%) | ||
| ≤ 400 mg | 71 (31) | 353 (31) |
| > 400–600 mg | 58 (25) | 212 (19) |
| > 600–800 mg | 99 (43) | 532 (47) |
| > 800 mg | 2 (1) | 24 (2) |
| Outcome with prior imatinib therapy,c n (%) | ||
| PD within 6 months of start | 30 (13) | 153 (14) |
| PD beyond 6 months of start | 181 (79) | 871 (77) |
| Intolerance | 19 (8) | 99 (9) |
| Best response to prior imatinib,d n (%) | ||
| CR | 8 (3) | 56 (5) |
| PR | 82 (36) | 353 (31) |
| Stable disease | 93 (40) | 391 (35) |
| PD | 39 (17) | 288 (26) |
| Not applicable | 7 (3) | 31 (3) |
Study 1199: full analysis population; Study 1036: ITT population
CR complete response, ECOG Eastern Cooperative Oncology Group, ITT intent-to-treat, PD progressive disease, PR partial response
aData missing: Study 1199, n = 2; Study 1036, n = 10
bData missing: Study 1036, n = 3
cData missing: Study 1036, n = 1
dData missing: Study 1199, n = 1; Study 1036, n = 5