{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"63"}]}],"title":"All adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Leading to discontinuation of romiplostim"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Leading to discontinuation from study"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Fatal adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"}]}],"title":"Treatment-related adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Treatment-related serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"TRAE leading to discontinuation of romiplostim"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"TRAE leading to discontinuation from study"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Treatment-related fatal adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"}],"units":"Participants"}],"description":"An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.","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":"NUMBER","populationDescription":"Safety analysis set","reportingStatus":"POSTED","timeFrame":"From first dose date of romiplostim to end of study (up to 24 months).","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}