Safety
| Characteristic . | Placebo (n = 13), n (%) . | Romiplostim . | ||
|---|---|---|---|---|
| 500 μg (n = 13), n (%) . | 750 μg (n = 14), n (%) . | Total (n = 27), n (%) . | ||
| Patients with adverse events | 13 (100) | 13 (100) | 14 (100) | 27 (100) |
| Hematologic adverse events* | ||||
| Anemia | 3 (23) | 1 (8) | 4 (29) | 5 (19) |
| Neutropenia | 4 (31) | 5 (38) | 0 (0) | 5 (19) |
| Febrile neutropenia | 6 (46) | 2 (15) | 1 (7) | 3 (11) |
| Thrombocytopenia | 4 (31) | 1 (8) | 1 (7) | 2 (7) |
| Nonhematologic adverse events* | ||||
| Constipation | 5 (38) | 7 (54) | 7 (50) | 14 (52) |
| Nausea | 7 (54) | 5 (39) | 6 (43) | 11 (41) |
| Diarrhea | 1 (8) | 4 (31) | 6 (43) | 10 (37) |
| Fatigue | 5 (38) | 4 (31) | 3 (21) | 7 (26) |
| Pain in extremity | 1 (8) | 2 (15) | 5 (36) | 7 (26) |
| Dizziness | 1 (8) | 2 (15) | 4 (29) | 6 (22) |
| Hypotension | 1 (8) | 1 (8) | 6 (43) | 7 (26) |
| Dyspnea | 6 (46) | 4 (31) | 2 (14) | 6 (22) |
| Peripheral edema | 4 (31) | 2 (15) | 4 (29) | 6 (22) |
| Contusion | 3 (23) | 4 (31) | 3 (21) | 7 (26) |
| Rash | 2 (15) | 2 (15) | 4 (29) | 6 (22) |
| Anorexia | 0 (0) | 2 (15) | 4 (29) | 6 (22) |
| Patients with serious adverse events | 10 (77) | 6 (46) | 10 (71) | 16 (59) |
| Patients with treatment-related serious adverse events | 2 (15) | 0 (0) | 1 (7) | 2 (7) |
| Myelofibrosis | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Erythema nodosum | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Rash and hypersensitivity | 0 (0) | 0 (0) | 1 (7) | 1 (4) |
| Bleeding events | 7 (54) | 8 (62) | 7 (50) | 15 (56) |
| Grade ≥ 3 bleeding events | 2 (15) | 1 (8) | 0 (0) | 1 (4) |
| Pulmonary hemorrhage | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Hematoma | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Epistaxis | 0 (0) | 1 (8) | 0 (0) | 1 (4) |
| Deaths | 2 (15) | 0 (0) | 0 (0) | 0 (0) |
| Endocarditis | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Fungal pneumonia | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Characteristic . | Placebo (n = 13), n (%) . | Romiplostim . | ||
|---|---|---|---|---|
| 500 μg (n = 13), n (%) . | 750 μg (n = 14), n (%) . | Total (n = 27), n (%) . | ||
| Patients with adverse events | 13 (100) | 13 (100) | 14 (100) | 27 (100) |
| Hematologic adverse events* | ||||
| Anemia | 3 (23) | 1 (8) | 4 (29) | 5 (19) |
| Neutropenia | 4 (31) | 5 (38) | 0 (0) | 5 (19) |
| Febrile neutropenia | 6 (46) | 2 (15) | 1 (7) | 3 (11) |
| Thrombocytopenia | 4 (31) | 1 (8) | 1 (7) | 2 (7) |
| Nonhematologic adverse events* | ||||
| Constipation | 5 (38) | 7 (54) | 7 (50) | 14 (52) |
| Nausea | 7 (54) | 5 (39) | 6 (43) | 11 (41) |
| Diarrhea | 1 (8) | 4 (31) | 6 (43) | 10 (37) |
| Fatigue | 5 (38) | 4 (31) | 3 (21) | 7 (26) |
| Pain in extremity | 1 (8) | 2 (15) | 5 (36) | 7 (26) |
| Dizziness | 1 (8) | 2 (15) | 4 (29) | 6 (22) |
| Hypotension | 1 (8) | 1 (8) | 6 (43) | 7 (26) |
| Dyspnea | 6 (46) | 4 (31) | 2 (14) | 6 (22) |
| Peripheral edema | 4 (31) | 2 (15) | 4 (29) | 6 (22) |
| Contusion | 3 (23) | 4 (31) | 3 (21) | 7 (26) |
| Rash | 2 (15) | 2 (15) | 4 (29) | 6 (22) |
| Anorexia | 0 (0) | 2 (15) | 4 (29) | 6 (22) |
| Patients with serious adverse events | 10 (77) | 6 (46) | 10 (71) | 16 (59) |
| Patients with treatment-related serious adverse events | 2 (15) | 0 (0) | 1 (7) | 2 (7) |
| Myelofibrosis | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Erythema nodosum | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Rash and hypersensitivity | 0 (0) | 0 (0) | 1 (7) | 1 (4) |
| Bleeding events | 7 (54) | 8 (62) | 7 (50) | 15 (56) |
| Grade ≥ 3 bleeding events | 2 (15) | 1 (8) | 0 (0) | 1 (4) |
| Pulmonary hemorrhage | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Hematoma | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Epistaxis | 0 (0) | 1 (8) | 0 (0) | 1 (4) |
| Deaths | 2 (15) | 0 (0) | 0 (0) | 0 (0) |
| Endocarditis | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
| Fungal pneumonia | 1 (8) | 0 (0) | 0 (0) | 0 (0) |
Adverse events reported in ≥ 20% of romiplostim-treated patients or ≥ 30% of placebo-treated patients.