Demographic and clinical characteristics
| Characteristic . | Placebo (n = 13) . | Romiplostim . | Total (n = 40) . | |
|---|---|---|---|---|
| 500 μg (n = 13) . | 750 μg (n = 14) . | |||
| Median age, y (range) | 64 (58-86) | 72 (56-86) | 72 (61-81) | 71 (56-86) |
| Sex, n (%) | ||||
| Female | 6 (46) | 3 (23) | 7 (50) | 16 (40) |
| ECOG PS, n (%) | ||||
| 0 | 9 (69) | 6 (46) | 5 (36) | 20 (50) |
| 1 | 4 (31) | 7 (54) | 9 (64) | 20 (50) |
| MDS diagnosis, n (%) | ||||
| RA | 2 (15) | 3 (23) | 0 (0) | 5 (13) |
| RARS | 2 (15) | 1 (8) | 0 (0) | 3 (8) |
| RAEB-1 | 3 (23) | 5 (39) | 2 (14) | 10 (25) |
| RAEB-2 | 0 (0) | 1 (8) | 1 (7) | 2 (5) |
| RCMD | 4 (31) | 2 (15) | 8 (57) | 14 (35) |
| RCMD-RS | 1 (8) | 0 (0) | 0 (0) | 1 (3) |
| MDS-U | 1 (8) | 1 (8) | 0 (0) | 2 (5) |
| MDS with isolated del 5Q | 0 (0) | 0 (0) | 2 (14) | 2 (5) |
| IPSS score, n (%) | ||||
| Low | 1 (8) | 1 (8) | 1 (7) | 3 (8) |
| Intermediate-1 | 5 (38) | 9 (69) | 9 (64) | 23 (58) |
| Intermediate-2 | 7 (54) | 3 (23) | 4 (29) | 14 (35) |
| Median duration of MDS, wk (interquartile range) | 41 (24, 144) | 35 (7, 109) | 47 (5, 86) | 43 (7, 124) |
| Bleeding events in previous year, n (%) | 4 (31) | 4 (31) | 5 (36) | 13 (33) |
| History of transfusions, n (%) | 10 (77) | 9 (69) | 11 (79) | 30 (75) |
| Median baseline ANC, 109/L (range) | 1.9 (0.1-9.0) | 1.1 (0.3-44.8) | 1.1 (0.2-3.7) | 1.2 (0.1-44.8) |
| Medain baseline platelets, < 50 × 109/L (range) | 25 (8-433) | 40 (7-296) | 41 (5-160) | 40 (5-433) |
| Baseline platelets, < 50 × 109/L, n (%) | 8 (62) | 8 (62) | 8 (57) | 24 (60) |
| Characteristic . | Placebo (n = 13) . | Romiplostim . | Total (n = 40) . | |
|---|---|---|---|---|
| 500 μg (n = 13) . | 750 μg (n = 14) . | |||
| Median age, y (range) | 64 (58-86) | 72 (56-86) | 72 (61-81) | 71 (56-86) |
| Sex, n (%) | ||||
| Female | 6 (46) | 3 (23) | 7 (50) | 16 (40) |
| ECOG PS, n (%) | ||||
| 0 | 9 (69) | 6 (46) | 5 (36) | 20 (50) |
| 1 | 4 (31) | 7 (54) | 9 (64) | 20 (50) |
| MDS diagnosis, n (%) | ||||
| RA | 2 (15) | 3 (23) | 0 (0) | 5 (13) |
| RARS | 2 (15) | 1 (8) | 0 (0) | 3 (8) |
| RAEB-1 | 3 (23) | 5 (39) | 2 (14) | 10 (25) |
| RAEB-2 | 0 (0) | 1 (8) | 1 (7) | 2 (5) |
| RCMD | 4 (31) | 2 (15) | 8 (57) | 14 (35) |
| RCMD-RS | 1 (8) | 0 (0) | 0 (0) | 1 (3) |
| MDS-U | 1 (8) | 1 (8) | 0 (0) | 2 (5) |
| MDS with isolated del 5Q | 0 (0) | 0 (0) | 2 (14) | 2 (5) |
| IPSS score, n (%) | ||||
| Low | 1 (8) | 1 (8) | 1 (7) | 3 (8) |
| Intermediate-1 | 5 (38) | 9 (69) | 9 (64) | 23 (58) |
| Intermediate-2 | 7 (54) | 3 (23) | 4 (29) | 14 (35) |
| Median duration of MDS, wk (interquartile range) | 41 (24, 144) | 35 (7, 109) | 47 (5, 86) | 43 (7, 124) |
| Bleeding events in previous year, n (%) | 4 (31) | 4 (31) | 5 (36) | 13 (33) |
| History of transfusions, n (%) | 10 (77) | 9 (69) | 11 (79) | 30 (75) |
| Median baseline ANC, 109/L (range) | 1.9 (0.1-9.0) | 1.1 (0.3-44.8) | 1.1 (0.2-3.7) | 1.2 (0.1-44.8) |
| Medain baseline platelets, < 50 × 109/L (range) | 25 (8-433) | 40 (7-296) | 41 (5-160) | 40 (5-433) |
| Baseline platelets, < 50 × 109/L, n (%) | 8 (62) | 8 (62) | 8 (57) | 24 (60) |
ECOG PS indicates Eastern Cooperative Oncology Group performance status; RA, refractory anemia; RARS, refractory anemia with ringed sideroblasts; RAEB-1, refractory anemia with excess blasts-1; RAEB-2, refractory anemia with excess blasts-2; RCMD, refractory cytopenia with multilineage dysplasia; RCMD-RS, refractory cytopenia with multilineage dysplasia and ringed sideroblasts; and MDS-U, myelodysplastic syndrome, unclassified.