Table 1.
Demographics and baseline characteristics (ITT population)
| Demographic variable | Eltrombopag (n = 179) | Placebo (n = 177) | All patients (n = 356) |
|---|---|---|---|
| Age, y | |||
| Mean ± SD | 68.3 ± 12.82 | 69.4 ± 10.58 | 68.8 ± 11.76 |
| Median (range) | 70.0 (24-89) | 70.0 (28-88) | 70.0 (24-89) |
| Age category (y), n (%) | |||
| ≥18-64 | 51 (28) | 49 (28) | 100 (28) |
| ≥65-74 | 64 (36) | 68 (38) | 132 (37) |
| ≥75-84 | 54 (30) | 49 (28) | 103 (29) |
| ≥85 | 10 (6) | 11 (6) | 21 (6) |
| Sex, n (%) | |||
| Male | 110 (61) | 124 (70) | 234 (66) |
| Female | 69 (39) | 53 (30) | 122 (34) |
| Race, n (%) | |||
| White | 146 (82) | 148 (84) | 294 (83) |
| East Asian/Japanese/Southeast Asian | 26 (15) | 23 (13) | 49 (14) |
| Other | 4 (2) | 6 (3) | 10 (3) |
| Missing | 3 (2) | 0 | 3 (<1) |
| IPSS risk score, n (%) | |||
| Int-1 | 64 (36) | 61 (34) | 125 (35) |
| Int-2 | 77 (43) | 83 (47) | 160 (45) |
| High | 38 (21) | 33 (19) | 71 (20) |
| BM blast count (local data), n (%) | |||
| <5% | 57 (32) | 52 (29) | 109 (31) |
| 5%-10% | 49 (28) | 60 (34) | 109 (31) |
| 11%-20% | 59 (33) | 56 (32) | 115 (32) |
| 21%-30%* | 12 (7) | 9 (5) | 21 (6) |
| Platelet count, n (%) | |||
| <10 × 109/L | 10 (6) | 10 (6) | 20 (6) |
| ≥10 to <20 × 109/L | 35 (20) | 30 (17) | 65 (18) |
| ≥20 to <50 × 109/L | 83 (47) | 84 (47) | 167 (47) |
| ≥50 to <100 × 109/L | 49 (28) | 53 (30) | 102 (29) |
| Platelet transfusion dependence, n (%) | |||
| Yes | 29 (16) | 37 (21) | 66 (19) |
| No | 150 (84) | 140 (79) | 290 (81) |
| Karyotype† | |||
| 0 good | 86 (48) | 81 (46) | 167 (47) |
| 0.5 intermediate | 39 (22) | 39 (22) | 78 (22) |
| 1 poor | 54 (30) | 57 (32) | 111 (31) |
FAB, French-American-British; ITT, intent-to-treat; SD, standard deviation; WHO, World Health Organization.
*
Patients with AML by WHO or FAB criteria.
†
0 good = normal karyotype, Y alone, del(5q) alone, or del(20q) alone; 0.5 intermediate = other abnormalities; 1 poor = abnormalities involving chromosome 7 or those with a complex karyotype (≥3 unassociated abnormalities).