Summary of adverse events
| Event . | Number (%) of patients . | |
|---|---|---|
| Romiplostim (n = 17) . | Placebo (n = 5) . | |
| Any adverse event | 16 (94) | 5 (100) |
| Serious adverse events* | 1 (6) | 0 |
| Adverse events of CTCAE grade ≥ 3 | 1 (6) | 1 (20) |
| Treatment-related adverse events | 3 (18) | 1 (20) |
| Treatment-related serious adverse events | 0 | 0 |
| Deaths | 0 | 0 |
| Bleeding events | 12 (71) | 2 (40) |
| Neutralizing antibodies to thrombopoietin and romiplostim | 0 | 0 |
| Event . | Number (%) of patients . | |
|---|---|---|
| Romiplostim (n = 17) . | Placebo (n = 5) . | |
| Any adverse event | 16 (94) | 5 (100) |
| Serious adverse events* | 1 (6) | 0 |
| Adverse events of CTCAE grade ≥ 3 | 1 (6) | 1 (20) |
| Treatment-related adverse events | 3 (18) | 1 (20) |
| Treatment-related serious adverse events | 0 | 0 |
| Deaths | 0 | 0 |
| Bleeding events | 12 (71) | 2 (40) |
| Neutralizing antibodies to thrombopoietin and romiplostim | 0 | 0 |
CTCAE indicates Common Terminology Criteria for Adverse Events, version 3.0.39
Serious adverse event includes any event that is fatal, life threatening (places patient at immediate risk of death), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. A patient can be counted in more than one category of severity grade.