Table 3.
Adverse events.
| Double-blind period |
Open-label period |
|||
|---|---|---|---|---|
| Romiplostim N = 151 |
Placebo N = 51 |
Romiplostim N = 151 |
Placebo-romiplostim N = 50 |
|
| Any TEAEs, n (%) | 125 (82.8) | 42 (82.4) | 143 (94.7) | 40 (80.0) |
| Any drug-related TEAEs, n (%) | 69 (45.7) | 21 (41.2) | 97 (64.2) | 24 (48.0) |
| TEAEs found in ≥10% of cases in either treatment group, n (%) | ||||
| Gingival bleeding | 12 (7.9) | 7 (13.7) | 31 (20.5) | 7 (14.0) |
| Injection site hemorrhage | 2 (1.3) | 6 (11.8) | 0 | 0 |
| Upper respiratory tract infection | 37 (24.5) | 10 (19.6) | 56 (37.1) | 12 (24.0) |
| Petechiae | 17 (11.3) | 6 (11.8) | 30 (19.9) | 8 (16.0) |
| Ecchymosis | 13 (8.6) | 9 (17.6) | 25 (16.6) | 9 (18.0) |
| Subcutaneous bleeding | 0 | 0 | 32 (21.2) | 5 (10.0) |
| Thrombocytopenia | 0 | 0 | 21 (13.9) | 6 (12.0) |
| Arthralgia | 0 | 0 | 25 (16.6) | 2 (4.0) |
| Dizziness | 0 | 0 | 18 (11.9) | 4 (8.0) |
| Epistaxis | 0 | 0 | 17 (11.3) | 2 (4.0) |
| Any SAEs, n (%) | 12 (7.9) | 5 (9.8) | 31 (20.5) | 7 (14.0) |
| Incidence of SAEs (≥2 cases in either treatment group), n (%) | ||||
| Thrombocytopenia | 0 | 0 | 6 (4.0) | 1 (2.0) |
| Platelet counts decreased | 2 (1.3) | 3 (5.9) | 12 (7.9) | 4 (8.0) |
| Cerebral hemorrhage | 2 (1.3) | 0 | 2 (1.3) | 0 |
| Hemorrhage | 1 (0.7) | 0 | 3 (2.0) | 0 |
| Lung infection | 1 (0.7) | 0 | 2 (1.3) | 0 |
| Thromboembolism events | 2 (1.3) | 0 | 0 | 1 (2.0) |
| Death, n (%) | 2 (1.3) | 0 | 2 (1.3) | 0 |
SAE, serious adverse event; TEAE, treatment-emergent adverse event.