Baseline demographics, n (%) | Placebo | Romiplostim | Total | |
---|---|---|---|---|
500 μg | 750 μg | |||
(N = 12) | (N = 14) | (N = 13) | (N = 39) | |
Sex – Male, n (%) | 8 (67) | 8 (57) | 8 (62) | 24 (62) |
Race – White or Caucasian, n (%) | 11 (92) | 13 (93) | 12 (92) | 36 (92) |
Age (years), median (range) | 79 (39–87) | 75 (49–90) | 65 (49–83) | 74 (39–90) |
Platelets (× 109/L), n (%) | ||||
<50 × 109/L | 5 (42) | 5 (36) | 5 (39) | 15 (39) |
≥50 × 109/L | 6 (50) | 8 (57) | 8 (62) | 22 (56) |
Unknown* | 1 (8) | 1 (7) | 0 (0) | 2 (5) |
IPSS score, n (%) | ||||
0 | 4 (33) | 4 (29) | 6 (46) | 14 (36) |
0.5 | 3 (25) | 6 (43) | 4 (31) | 13 (33) |
1.0 | 3 (25) | 2 (14) | 3 (23) | 8 (21) |
1.5† | 1 (8) | 1 (7) | 0 (0) | 2 (5) |
Unknown* | 1 (8) | 1 (7) | 0 (0) | 2 (5) |
MDS duration (y), median (range) | 2.6 (0–9) | 0.5 (0–6) | 0.5 (0–7) | 0.6 (0–9) |
MDS diagnosis - n (%) | ||||
RA | 1 (8) | 0 (0) | 0 (0) | 1 (3) |
RARS | 2 (17) | 2 (14) | 2 (15) | 6 (15) |
RAEB-1 | 2 (17) | 3 (21) | 3 (23) | 8 (21) |
RCMD | 4 (33) | 4 (29) | 4 (31) | 12 (31) |
RCMD-RS | 0 (0) | 0 (0) | 1 (8) | 1 (3) |
MDS-U | 1 (8) | 1 (7) | 1 (8) | 3 (8) |
MDS associated with isolated del(5q) | 1 (8) | 3 (21) | 2 (15) | 6 (15) |
Unknown* | 1 (8) | 1 (7) | 0 (0) | 2 (5) |
Cytogenetic findings‡ | ||||
Normal/diploid | 8 (67) | 7 (50) | 10 (77) | 25 (64) |
+8 | 1 (8) | 2 (14) | 1 (8) | 4 (10) |
-Y | 2 (17) | 1 (7) | 0 | 3 (8) |
del(5q) | 1 (8) | 3 (21) | 2 (15) | 6 (15) |
del(7q) | 0 | 1 (7) | 0 | 1 (3) |
del(12p) | 1 (8) | 1 (7) | 0 | 2 (5) |
Other | 1 (8) | 0 | 0 | 1 (3) |
Complex (>3 abnormalities) | 0 | 0 | 0 | 0 |
Unknown | 1 (8) | 1 (7) | 0 | 2 (5) |