Table 1.

Definitions of endpoints in the study

OutcomesDefinitions
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. 
OutcomesDefinitions
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. 
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