n (%) | Placebo | Romiplostim | |
---|---|---|---|
500 μg | 750 μg | ||
(N = 9)* | (N = 14)† | (N = 14)‡ | |
Any adverse event (AE) § | 8 (89) | 14 (100) | 14 (100) |
Grade 3 | 5 (56) | 5 (36) | 8 (57) |
Grade 4 | 1 (11) | 4 (29) | 2 (14) |
Most frequently reported AEs | |||
Fatigue | 1 (11) | 4 (29) | 8 (57) |
Thrombocytopenia | 3 (33) | 7 (50) | 3 (21) |
Diarrhea | 5 (56) | 5 (36) | 5 (36) |
Rash | 2 (22) | 5 (36) | 5 (36) |
Nausea | 0 (0) | 4 (29) | 5 (36) |
IP-related adverse events | 2 (22) | 7 (50) | 5 (36) |
Serious adverse events | 6 (67) | 5 (36) | 4 (29) |
Most frequently reported SAEs | |||
Thrombocytopenia | 0 (0) | 3 (21) | 1 (7) |
Anemia | 0 (0) | 1 (7) | 2 (14) |
Back pain | 0 (0) | 2 (14) | 0 (0) |
Febrile neutropenia | 0 (0) | 1 (7) | 1 (7) |
Hyperkalemia | 0 (0) | 1 (7) | 1 (7) |
IP-related SAE | 1 (11) | 1 (7) | 0 (0) |
Cerebrovascular accident | 1 (11) | 0 (0) | 0 (0) |
Worsening thrombocytopenia¶ | 0 (0) | 1 (7) | 0 (0) |
Deaths | 0 (0) | 0 (0) | 0 (0) |
AE leading to study withdrawal or IP discontinuation | 3 (33) | 2 (14) | 1 (7) |