{"analyses":[{"ciLowerLimit":"8.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"10.1","estimateComment":"Based on the t-distribution","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Mean","paramValue":"9.2"},{"ciLowerLimit":"8.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"10.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.4","estimateComment":"Estimates are based on bootstrap method with 1000 samples with replacement.","groupDescription":"Bootstrap analysis","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Bootstrap mean","paramValue":"9.1"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.4","value":"9.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"}],"units":"Participants"}],"description":"The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10\\^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.","dispersionType":"Standard Error","groups":[{"description":"Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\\^9/L could reinitiate romiplostim for up to 8 weeks.","id":"OG000","title":"Romiplostim"}],"paramType":"MEAN","populationDescription":"Safety Analysis Set includes all participants who received at least 1 dose of romiplostim.","reportingStatus":"POSTED","timeFrame":"12 months","title":"Number of Months With Platelet Response During the 12-Month Treatment Period","type":"PRIMARY","unitOfMeasure":"months"}