Table 2 Incidence of high-grade adverse events (safety population).
Characteristics | All patients (n = 203) | Surveillance (n = 108) | Ropeg-IFN (n = 95) |
|---|---|---|---|
Age at diagnosis (years) | |||
median | 46 | 47 | 45 |
range | 14–83 | 14–83 | 19–74 |
Age at randomization (years; median, range) | 55, 20–88 | 56, 20–88 | 53, 24–78 |
Sex – no. (%) | |||
Female | 68 (33) | 42 (39) | 26 (27) |
Male | 135 (67) | 66 (61) | 69 (73) |
Median time on TKI at baseline (years; median, range) | 7,8 (2,5–19,7) | 7,9 (2,5–19,7) | 7,7 (3–19,1) |
TKI at baseline – no (%) | |||
imatinib | 86 (42) | 44 (41) | 42 (44) |
nilotinib | 64 (32) | 35 (32) | 29 (31) |
dasatinib | 47 (23) | 26 (24) | 21 (22) |
bosutinib | 4 (2) | 2 (2) | 2 (2) |
ponatinib | 1 (1) | 1 (1) | 1 (1) |
prior TKI stops – no (%) | |||
none | 163 (80) | 86 (80) | 77 (81) |
1 or more | 40 (20) | 22 (20) | 18 (19) |
Prognostic high risk at diagnosis | |||
ELTS - no | 128 | ||
high risk – no (%) | 19/15 | 13/19 | 6/10 |
EUTOS - no | 132 | ||
high risk – no (%) | 18/14 | 11/15 | 7/12 |
SOKAL | 128 | ||
high risk – no (%) | 30/23 | 17/25 | 13/22 |
EURO - no | 125 | ||
high risk – no (%) | 16/13 | 7/10 | 9/16 |
