Patient incidence of severe thrombocytopenia* and platelet transfusions by azacitidine treatment cycle
| . | Incidence, n/N (%) . | Difference in incidence, % (95% CI) . | |||
|---|---|---|---|---|---|
| Placebo . | Romiplostim 500 μg . | Romiplostim 750 μg . | Romiplostim 500 μg vs placebo . | Romiplostim 750 μg vs placebo . | |
| Severe thrombocytopenia | |||||
| Any cycle | 11/13 (85) | 9/13 (69) | 10/14 (71) | −15.4 (−47.3 to 16.5) | −13.2 (−43.9 to 17.5) |
| Cycle 1 | 11/13 (85) | 9/13 (69) | 9/14 (64) | −15.4 (−47.3 to 16.5) | −20.3 (−52.2 to 11.6) |
| Cycle 2 | 7/11 (64) | 5/10 (50) | 5/13 (38) | −13.6 (−55.7 to 28.5) | −25.1 (−63.9 to 13.7) |
| Cycle 3 | 8/11 (73) | 6/10 (60) | 2/11 (18) | −12.7 (−52.9 to 27.5) | −54.5 (−89.3 to −19.7) |
| Cycle 4 | 5/10 (50) | 4/9 (44) | 3/10 (30) | −5.6 (−50.5 to 39.3) | −20.0 (−62.0 to 22.2 |
| Platelet transfusions | |||||
| Any cycle | 9/13 (69) | 6/13 (46) | 5/14 (36) | −23.1 (−60.0 to 13.9) | −33.5 (−69.0 to 2.0) |
| Cycle 1 | 9/13 (69) | 6/13 (46) | 5/14 (36) | −23.1 (−60.0 to 13.9) | −33.5 (−69.0 to 2.0) |
| Cycle 2 | 6/11 (55) | 4/10 (40) | 3/13 (23) | −14.5 (−56.8 to 27.7) | −31.5 (−68.8 to 5.8) |
| Cycle 3 | 5/11 (46) | 3/10 (30) | 2/11 (18) | −15.5 (−56.4 to 25.4) | −27.3 (−64.5 to 9.9) |
| Cycle 4 | 4/10 (40) | 3/9 (33) | 0/10 (0) | −6.7 (−49.9 to 36.6) | −40.0 (−70.4 to −9.6) |
| . | Incidence, n/N (%) . | Difference in incidence, % (95% CI) . | |||
|---|---|---|---|---|---|
| Placebo . | Romiplostim 500 μg . | Romiplostim 750 μg . | Romiplostim 500 μg vs placebo . | Romiplostim 750 μg vs placebo . | |
| Severe thrombocytopenia | |||||
| Any cycle | 11/13 (85) | 9/13 (69) | 10/14 (71) | −15.4 (−47.3 to 16.5) | −13.2 (−43.9 to 17.5) |
| Cycle 1 | 11/13 (85) | 9/13 (69) | 9/14 (64) | −15.4 (−47.3 to 16.5) | −20.3 (−52.2 to 11.6) |
| Cycle 2 | 7/11 (64) | 5/10 (50) | 5/13 (38) | −13.6 (−55.7 to 28.5) | −25.1 (−63.9 to 13.7) |
| Cycle 3 | 8/11 (73) | 6/10 (60) | 2/11 (18) | −12.7 (−52.9 to 27.5) | −54.5 (−89.3 to −19.7) |
| Cycle 4 | 5/10 (50) | 4/9 (44) | 3/10 (30) | −5.6 (−50.5 to 39.3) | −20.0 (−62.0 to 22.2 |
| Platelet transfusions | |||||
| Any cycle | 9/13 (69) | 6/13 (46) | 5/14 (36) | −23.1 (−60.0 to 13.9) | −33.5 (−69.0 to 2.0) |
| Cycle 1 | 9/13 (69) | 6/13 (46) | 5/14 (36) | −23.1 (−60.0 to 13.9) | −33.5 (−69.0 to 2.0) |
| Cycle 2 | 6/11 (55) | 4/10 (40) | 3/13 (23) | −14.5 (−56.8 to 27.7) | −31.5 (−68.8 to 5.8) |
| Cycle 3 | 5/11 (46) | 3/10 (30) | 2/11 (18) | −15.5 (−56.4 to 25.4) | −27.3 (−64.5 to 9.9) |
| Cycle 4 | 4/10 (40) | 3/9 (33) | 0/10 (0) | −6.7 (−49.9 to 36.6) | −40.0 (−70.4 to −9.6) |
Severe thrombocytopenia: platelet count < 50 × 109/L or receipt of platelet transfusion during the cycle.