{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"193"}]}],"title":"Any adverse event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"60"}]}],"title":"Serious adverse events (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"AEs leading to discontinuation of romiplostim"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66"}]}],"title":"Adverse event Grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"Adverse event Grade ≥ 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Adverse event Grade ≥ 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"56"}]}],"title":"Treatment-related adverse events (TRAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Treatment-related serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"TRAEs leading to discontinuation of romiplostim"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Treatment-related adverse events Grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Treatment-related adverse events Grade ≥ 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Treatment-related adverse events Grade ≥ 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"203"}],"units":"Participants"}],"description":"An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant, which does not necessarily have a causal relationship with study treatment.\n\nA serious adverse event (SAE) was defined as an AE that met at least 1 of the following criteria:\n\n* fatal\n* life threatening\n* required in-patient hospitalization or prolongation of existing hospitalization\n* resulted in persistent or significant disability/incapacity\n* congenital anomaly/birth defect\n* other medically important serious event Adverse events were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grading scale, where Grade 1 = mild AE; Grade 2 = moderate AE; Grade 3 = severe AE; Grade 4 = life-threatening or disabling; Grade 5 = death related to AE.","groups":[{"description":"Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.","id":"OG000","title":"Romiplostim"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants who received at least 1 dose of romiplostim","reportingStatus":"POSTED","timeFrame":"SAEs were collected from Screening through end-of-study follow-up (up to 38 months). Nonserious AEs were collected from first to last dose of study drug during the treatment period (up to 36 months).","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}