Definitions of endpoints in the study
Outcomes . | Definitions . |
---|---|
Primary outcome | |
Overall response | Achieving a platelet count of ≥30 × 109/L confirmed on ≥2 separate occasions (≥7 d apart), at least a doubling of the baseline platelet count without administration of any other ITP-specific treatment, and the absence of bleeding within 1 y following enrollment. |
Secondary outcomes | |
Complete response | Platelet count ≥100 × 109/L measured on 2 occasions at least 7 d apart and the absence of bleeding within 1 y following enrollment. |
Sustained response | Maintenance of a platelet count >30 × 109/L, an absence of bleeding, and no requirement for any other ITP-specific treatment of 6 consecutive mo after achievement of response during 1 y following enrollment. |
Remission | A durable platelet count >30 × 109/L without bleeding up to 12 mo after enrollment. |
Outcomes . | Definitions . |
---|---|
Primary outcome | |
Overall response | Achieving a platelet count of ≥30 × 109/L confirmed on ≥2 separate occasions (≥7 d apart), at least a doubling of the baseline platelet count without administration of any other ITP-specific treatment, and the absence of bleeding within 1 y following enrollment. |
Secondary outcomes | |
Complete response | Platelet count ≥100 × 109/L measured on 2 occasions at least 7 d apart and the absence of bleeding within 1 y following enrollment. |
Sustained response | Maintenance of a platelet count >30 × 109/L, an absence of bleeding, and no requirement for any other ITP-specific treatment of 6 consecutive mo after achievement of response during 1 y following enrollment. |
Remission | A durable platelet count >30 × 109/L without bleeding up to 12 mo after enrollment. |