Table 1.
Baseline Demographics and Characteristicsa
| No. of Patients (%) | |||
|---|---|---|---|
| Variable | Placebo, N = 83 | Romiplostim, N = 167 | Total, N = 250 |
| Men | 53 (63.9) | 95 (56.9) | 148 (59.2) |
| Caucasians | 79 (95.2) | 156 (93.4) | 235 (94.0) |
| Age: Median [Q1, Q3], y | 69.0 [61.0, 76.0] | 71.0 [62.0, 77.0] | 70.0 [61.0, 77.0] |
| Platelets: Median [Q1, Q3], ×109/L | 17.7 [11.0, 28.7] | 19.7 [13.3, 31.3] | 19.3 [12.5, 30.3] |
| MDS duration: Median [Q1, Q3], y | 0.58 [0.16, 1.86] | 0.39 [0.13, 1.74] | 0.44 [0.13, 1.74] |
| MDS WHO classification at baselineb | |||
| RA | 5 (6) | 6 (3.6) | 11 (4.4) |
| RARS | 0 (0) | 2 (1.2) | 2 (0.8) |
| RAEB-1 | 9 (10.8) | 24 (14.4) | 33 (13.2) |
| RAEB-2 | 0 (0) | 1 (0.6) | 1 (0.4) |
| RCMD | 55 (66.3) | 114 (68.3) | 169 (67.6) |
| RCMD-RS | 2 (2.4) | 4 (2.4) | 6 (2.4) |
| MDS-U | 12 (14.5) | 16 (9.6) | 28 (11.2) |
| Del 5q | 0 (0) | 0 (0) | 0 (0) |
| IPSS status | |||
| Low: Total score of 0 | 23 (27.7) | 40 (24) | 63 (25.2) |
| Intermediate-1: Total score of 0.5 or 1 | 58 (70) | 120 (71.9) | 178 (71.2) |
| Intermediate-2: Total score of 1.5c | 0 (0) | 1 (0.6) | 1 (0.4) |
| Missing | 2 (2.4) | 6 (3.6) | 8 (3.2) |
| IPSS cytopenias | |||
| 1 | 31 (37.3) | 63 (37.7) | 94 (37.6) |
| 2 | 32 (38.6) | 61 (36.5) | 93 (37.2) |
| 3 | 20 (24.1) | 43 (25.7) | 63 (25.2) |
| IPSS cytogenetics | |||
| Good | 63 (75.9) | 131 (78.4) | 194 (77.6) |
| Intermediate | 18 (21.7) | 26 (15.6) | 44 (17.6) |
| Poor | 0 (0) | 4 (2.4) | 4 (1.6) |
| Unknown | 1 (1.2) | 5 (3) | 6 (2.4) |
| Missing | 1 (1.2) | 1 (0.6) | 2 (0.8) |
| Bone marrow myeloblasts, % | |||
| <5 | 74 (89.2) | 143 (85.6) | 217 (86.8) |
| 5-10 | 9 (10.8) | 24 (14.4) | 33 (13.2) |
| Prior MDS therapy | |||
| No | 70 (84.3) | 133 (79.6) | 203 (81.2) |
| Yes | 13 (15.7) | 34 (20.4) | 47 (18.8) |
Abbreviations: Del 5q, myelodysplastic syndrome associated with isolated 5q deletion; IPSS, International Prognostic Scoring System; MDS, myelodysplastic syndrome; MDS-U, myelodysplastic syndrome, unclassified; Q1, Q3, interquartile range; RA, refractory anemia; RAEB-1, refractory anemia with excess blasts-1; RAEB-2, refractory anemia with excess blasts-2; RARS, refractory anemia with ringed sideroblasts; RCMD, refractory cytopenia with multilineage dysplasia; RCMD-RS, refractory cytopenia with multilineage dysplasia and ringed sideroblasts; WHO, World Health Organization.
Unless stated otherwise, data shown are the number of patients (%).
Diagnoses were according to 2001 WHO criteria.
The enrollment of 1 patient who had an IPSS score of 1.5 was a protocol deviation.