Characteristics of 245 randomized patients with ET overall and according to the assigned treatment
| . | All (n = 245) . | 100 mg, once daily(n = 86) . | 100 mg, twice daily(n = 79) . | 100 mg, thrice daily(n = 80) . |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Male | 112 (45.7) | 40 (46.5) | 36 (45.6) | 36 (45) |
| Female | 133 (54.3) | 46 (53.5) | 43 (54.4) | 44 (55) |
| Age at diagnosis, y | 53 (42-63) | 52 (41.2-62.8) | 59 (43.5-65.5) | 48.5 (39.8-58) |
| Age at enrollment, y | 60 (51-67) | 59 (50.2-66) | 62 (53-69) | 58 (49.8-66) |
| BMI, kg/m2 | 24.9 (22.7-27.3) | 24.9 (22.7-26.9) | 24.5 (22.5-26) | 25.2 (23-28.7) |
| Leukocytes, ×109/L | 7 (5.6-8.5) | 7.3 (5.6-8.3) | 6.9 (5.4-8.8) | 7.1 (5.8-8.4) |
| Platelet count, ×109/L | 521 (422-641) | 512 (418-629) | 521 (404-622) | 532 (424-660) |
| Hematocrit, % | 41.7 (39.1-44.3) | 41.4 (38.3-44.4) | 42.2 (39.5-44.3) | 41.4 (39.6-43.8) |
| JAK2 genotype, n (%) | ||||
| Wild-type | 99 (40.4) | 38 (44.2) | 31 (39.2) | 30 (37.5) |
| Mutated | 145 (59.2) | 48 (55.8) | 48 (60.8) | 49 (61.25) |
| Not available | 1 (0.4) | 0 (0) | 0 (0) | 1 (1.25) |
| CALR mutation, n (%) | ||||
| Type 1 | 19 (7.8) | 7 (8.1) | 6 (7.7) | 6 (7.5) |
| Type 2 | 16 (6.5) | 5 (5.8) | 6 (7.7) | 5 (6.25) |
| Other | 95 (38.8) | 31 (36.1) | 29 (37.2) | 35 (43.75) |
| Not available | 115 (46.9) | 43 (50) | 38 (47.4) | 34 (42.5) |
| IPSET thrombosis score, n | ||||
| 0 | 34 | 14 | 11 | 9 |
| 1 | 41 | 16 | 9 | 16 |
| 2 | 77 | 23 | 26 | 28 |
| 3 | 45 | 20 | 13 | 12 |
| 4 | 42 | 11 | 19 | 12 |
| 5 | 5 | 2 | 1 | 2 |
| 6 | 1 | 0 | 0 | 1 |
| Microvascular symptoms, n (%) | 25 (10.2) | 10 (11.6) | 9 (11.4) | 6 (7.5) |
| Previous thrombosis, n (%) | ||||
| MPN related* | 10 (4.1) | 3 (3.5) | 2 (2.5) | 5 (6.2) |
| Any thrombosis | 28 (11.4) | 10 (11.6) | 8 (10.1) | 10 (12.5) |
| Cytoreductive therapy, n (%) | ||||
| No | 98 (40) | 41 (47.7) | 28 (35.4) | 29 (36.25) |
| Yes | 147 (60) | 45 (52.3) | 51 (64.6) | 51 (63.75) |
| TXB2 before randomization, ng/mL | 19 (9.3-43.2) | 17.1 (8.3-32.8) | 20 (11.6-56.4) | 23.5 (9.8-47.8) |
| . | All (n = 245) . | 100 mg, once daily(n = 86) . | 100 mg, twice daily(n = 79) . | 100 mg, thrice daily(n = 80) . |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Male | 112 (45.7) | 40 (46.5) | 36 (45.6) | 36 (45) |
| Female | 133 (54.3) | 46 (53.5) | 43 (54.4) | 44 (55) |
| Age at diagnosis, y | 53 (42-63) | 52 (41.2-62.8) | 59 (43.5-65.5) | 48.5 (39.8-58) |
| Age at enrollment, y | 60 (51-67) | 59 (50.2-66) | 62 (53-69) | 58 (49.8-66) |
| BMI, kg/m2 | 24.9 (22.7-27.3) | 24.9 (22.7-26.9) | 24.5 (22.5-26) | 25.2 (23-28.7) |
| Leukocytes, ×109/L | 7 (5.6-8.5) | 7.3 (5.6-8.3) | 6.9 (5.4-8.8) | 7.1 (5.8-8.4) |
| Platelet count, ×109/L | 521 (422-641) | 512 (418-629) | 521 (404-622) | 532 (424-660) |
| Hematocrit, % | 41.7 (39.1-44.3) | 41.4 (38.3-44.4) | 42.2 (39.5-44.3) | 41.4 (39.6-43.8) |
| JAK2 genotype, n (%) | ||||
| Wild-type | 99 (40.4) | 38 (44.2) | 31 (39.2) | 30 (37.5) |
| Mutated | 145 (59.2) | 48 (55.8) | 48 (60.8) | 49 (61.25) |
| Not available | 1 (0.4) | 0 (0) | 0 (0) | 1 (1.25) |
| CALR mutation, n (%) | ||||
| Type 1 | 19 (7.8) | 7 (8.1) | 6 (7.7) | 6 (7.5) |
| Type 2 | 16 (6.5) | 5 (5.8) | 6 (7.7) | 5 (6.25) |
| Other | 95 (38.8) | 31 (36.1) | 29 (37.2) | 35 (43.75) |
| Not available | 115 (46.9) | 43 (50) | 38 (47.4) | 34 (42.5) |
| IPSET thrombosis score, n | ||||
| 0 | 34 | 14 | 11 | 9 |
| 1 | 41 | 16 | 9 | 16 |
| 2 | 77 | 23 | 26 | 28 |
| 3 | 45 | 20 | 13 | 12 |
| 4 | 42 | 11 | 19 | 12 |
| 5 | 5 | 2 | 1 | 2 |
| 6 | 1 | 0 | 0 | 1 |
| Microvascular symptoms, n (%) | 25 (10.2) | 10 (11.6) | 9 (11.4) | 6 (7.5) |
| Previous thrombosis, n (%) | ||||
| MPN related* | 10 (4.1) | 3 (3.5) | 2 (2.5) | 5 (6.2) |
| Any thrombosis | 28 (11.4) | 10 (11.6) | 8 (10.1) | 10 (12.5) |
| Cytoreductive therapy, n (%) | ||||
| No | 98 (40) | 41 (47.7) | 28 (35.4) | 29 (36.25) |
| Yes | 147 (60) | 45 (52.3) | 51 (64.6) | 51 (63.75) |
| TXB2 before randomization, ng/mL | 19 (9.3-43.2) | 17.1 (8.3-32.8) | 20 (11.6-56.4) | 23.5 (9.8-47.8) |
Quantitative values are reported as median (interquartile range), unless otherwise indicated. There were no significant differences between the randomized groups, based on the Kruskal-Wallis test or χ2 test for continuous or discrete variables, respectively.
BMI, body mass index; IPSET, International Prognostic Score of Thrombosis in Essential Thrombocythemia; TX, thromboxane.
Any major thrombosis occurring within 2 years before diagnosis and any time afterward.