{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"41"}]}],"title":"Any adverse event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"10"}]}],"title":"Serious adverse events (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"AE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"AE leading to discontinuation from study"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"}]}],"title":"Grade 3 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"Grade 4 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 5 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"11"}]}],"title":"Treatment-related adverse events (TRAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Treatment-related serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"TRAE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"TRAE leading to discontinuation from study"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"TRAE Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"TRAE Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"TRAE Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"42"}],"units":"Participants"}],"description":"A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:\n\n* fatal,\n* life threatening (places the subject at immediate risk of death),\n* requires in-patient hospitalization or prolongation of existing hospitalization,\n* results in persistent or significant disability/incapacity,\n* congenital anomaly/birth defect, and/or\n* other significant medical hazard. Adverse events were graded for severity according to the CTCAE version 3.0 grading scale, where Grade 3 = moderate, Grade 4 = life-threatening and Grade 5 = fatal.\n\nTreatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to study drug. This relationship was determined by a \"yes\" or \"no\" response to the question: \"Is there a reasonable possibility that the event may have been caused by study drug?\"","groups":[{"description":"Participants received weekly subcutaneous placebo for 24 weeks.","id":"OG000","title":"Placebo"},{"description":"Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\\^9/L.","id":"OG001","title":"Romiplostim"}],"paramType":"NUMBER","populationDescription":"Safety analysis set (all participants who received at least one dose of study drug)","reportingStatus":"POSTED","timeFrame":"From the first dose of study drug until 4 weeks after last dose; 28 weeks.","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}