{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"263"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"256"}]}],"title":"AE grade ≥ 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"231"}]}],"title":"AE grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"133"}]}],"title":"AE grade ≥ 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"165"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"86"}]}],"title":"AEs leading to interruption of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"33"}]}],"title":"AEs leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"55"}]}],"title":"Life-threatening adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"51"}]}],"title":"Fatal adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"214"}]}],"title":"Treatment-related adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"195"}]}],"title":"Treatment-related AE grade ≥ 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"143"}]}],"title":"Treatment-related AE grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"57"}]}],"title":"Treatment-related AE grade ≥ 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"74"}]}],"title":"Serious treatment-related adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"58"}]}],"title":"TRAEs leading to interruption of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"19"}]}],"title":"TRAEs leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"21"}]}],"title":"Treatment-related life-threatening adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"}]}],"title":"Treatment-related fatal adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"267"}],"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 one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.\n\nParticipants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\\*/CRi could continue to receive SOC therapy for an additional 12 months.","id":"OG000","title":"Standard of Care Chemotherapy"},{"description":"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.\n\nParticipants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.\n\nThe initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.","id":"OG001","title":"Blinatumomab"}],"paramType":"NUMBER","populationDescription":"All participants who received protocol-specified therapy analyzed according to the treatment they received.","reportingStatus":"POSTED","timeFrame":"From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}