{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"45"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"}]}],"title":"AE grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"AE grade ≥ 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Leading to discontinuation of blinatumomab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Leading to interruption of blinatumomab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Fatal adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"}]}],"title":"Treatment-related adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"}]}],"title":"Treatment-related AE grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Treatment-related AE grade ≥ 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Treatment-related serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"TRAE leading to discontinuation of blinatumomab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"TRAE leading to interruption of blinatumomab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Treatment-related fatal adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"}],"units":"Participants"}],"description":"Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.\n\nGrade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.\n\nGrade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.\n\nGrade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?","groups":[{"description":"Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.\n\nThe initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.","id":"OG000","title":"Blinatumomab"}],"paramType":"NUMBER","populationDescription":"All participants who received an infusion of blinatumomab","reportingStatus":"POSTED","timeFrame":"From the first dose of blinatumomab until 30 days after the last dose, up to the cut-off date of 20 May 2015; the median duration of treatment was 53.8 days.","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}