Patient demographic and baseline characteristics
| Characteristic . | Romiplostim (n = 17) . | Placebo (n = 5) . | Total (n = 22) . |
|---|---|---|---|
| Median age, y (range) | 9 (1-17) | 11 (2-14) | 10 (1-17) |
| Females, no. of patients (%) | 4 (24) | 2 (40) | 6 (27) |
| Race, no. of patients (%) | |||
| White | 9 (53) | 4 (80) | 13 (59) |
| Black | 5 (29) | 0 (0) | 5 (23) |
| Hispanic or Latino | 3 (18) | 0 (0) | 3 (14) |
| Other | 0 (0) | 1 (20) | 1 (5) |
| Median weight, kg (range) | 36 (11-129) | 47 (16-58) | 37 (11-129) |
| Duration of ITP, median years since diagnosis (range) | 2.4 (0.8-14.0) | 4.1 (0.6-8.6) | 2.4 (0.6-14.0) |
| Splenectomy, no. of patients (%) | 6 (35) | 2 (40) | 8 (36) |
| Number of previous ITP treatments, median (range) | 5 (0-9) | 3 (2-8) | 5 (0-9) |
| Previous ITP drug treatment, no. of patients (%) | |||
| No previous treatment | 1 (6) | 0 (0) | 1 (5) |
| 1 or 2 previous agents | 1 (6) | 1 (20) | 2 (9) |
| 3 or 4 previous agents | 5 (29) | 2 (40) | 7 (32) |
| 5 or 6 previous agents | 7 (41) | 1 (20) | 8 (36) |
| > 6 previous agents | 3 (18) | 1 (20) | 4 (18) |
| Median platelet count, × 109/L (range) | 13 (2-27) | 9 (8-29) | 13 (2-29) |
| History of bleeding symptoms, no. of patients (%) | |||
| Epistaxis | |||
| Never | 4 (24) | 1 (20) | 5 (23) |
| Current or recent* | 4 (24) | 1 (20) | 5 (23) |
| Oral bleeding | |||
| Never | 7 (41) | 2 (40) | 9 (41) |
| Current or recent* | 5 (29) | 0 (0) | 5 (23) |
| Intracranial bleeding | |||
| Never | 16 (94) | 5 (100) | 21 (96) |
| Current or recent* | 0 (0) | 0 (0) | 0 (0) |
| Characteristic . | Romiplostim (n = 17) . | Placebo (n = 5) . | Total (n = 22) . |
|---|---|---|---|
| Median age, y (range) | 9 (1-17) | 11 (2-14) | 10 (1-17) |
| Females, no. of patients (%) | 4 (24) | 2 (40) | 6 (27) |
| Race, no. of patients (%) | |||
| White | 9 (53) | 4 (80) | 13 (59) |
| Black | 5 (29) | 0 (0) | 5 (23) |
| Hispanic or Latino | 3 (18) | 0 (0) | 3 (14) |
| Other | 0 (0) | 1 (20) | 1 (5) |
| Median weight, kg (range) | 36 (11-129) | 47 (16-58) | 37 (11-129) |
| Duration of ITP, median years since diagnosis (range) | 2.4 (0.8-14.0) | 4.1 (0.6-8.6) | 2.4 (0.6-14.0) |
| Splenectomy, no. of patients (%) | 6 (35) | 2 (40) | 8 (36) |
| Number of previous ITP treatments, median (range) | 5 (0-9) | 3 (2-8) | 5 (0-9) |
| Previous ITP drug treatment, no. of patients (%) | |||
| No previous treatment | 1 (6) | 0 (0) | 1 (5) |
| 1 or 2 previous agents | 1 (6) | 1 (20) | 2 (9) |
| 3 or 4 previous agents | 5 (29) | 2 (40) | 7 (32) |
| 5 or 6 previous agents | 7 (41) | 1 (20) | 8 (36) |
| > 6 previous agents | 3 (18) | 1 (20) | 4 (18) |
| Median platelet count, × 109/L (range) | 13 (2-27) | 9 (8-29) | 13 (2-29) |
| History of bleeding symptoms, no. of patients (%) | |||
| Epistaxis | |||
| Never | 4 (24) | 1 (20) | 5 (23) |
| Current or recent* | 4 (24) | 1 (20) | 5 (23) |
| Oral bleeding | |||
| Never | 7 (41) | 2 (40) | 9 (41) |
| Current or recent* | 5 (29) | 0 (0) | 5 (23) |
| Intracranial bleeding | |||
| Never | 16 (94) | 5 (100) | 21 (96) |
| Current or recent* | 0 (0) | 0 (0) | 0 (0) |
ITP indicates immune thrombocytopenic purpura.
Data are median (range) or number (%).
Ongoing or occurring within 30 days before enrollment. The number of patients who had bleeding more than 30 days before study entry is not shown.