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 |
All data are presented as No. (%) unless otherwise indicated.
COVID coronavirus disease, PNP peripheral neuropathic pain, ropeg-IFN ropeginterferon alfa-2b.
Safety population (patients, who received at least one time study medication).