{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"116"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"73"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"71"}]}],"title":"Adverse events ≥ CTC grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}],"title":"Adverse events ≥ CTC grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Fatal adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"}]}],"title":"AEs leading to discontinuation of blinatumomab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"36"}]}],"title":"AEs leading to interruption of blinatumomab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"112"}]}],"title":"Treatment-related adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"60"}]}],"title":"Treatment-related serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"60"}]}],"title":"Treatment-related adverse events ≥ CTC grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"}]}],"title":"Treatment-related adverse events ≥ CTC grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Treatment-related fatal adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"116"}],"units":"Participants"}],"description":"Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows:\n\nGrade 1 - Mild AE;\n\nGrade 2 - Moderate AE;\n\nGrade 3 - Severe AE;\n\nGrade 4 - Life-threatening or disabling AE;\n\nGrade 5 - Death.\n\nThe investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.\n\nAn AE was considered \"serious\" if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition.","groups":[{"description":"Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.","id":"OG000","title":"Blinatumomab"}],"paramType":"NUMBER","populationDescription":"All participants who received any infusion of blinatumomab.","reportingStatus":"POSTED","timeFrame":"From the first dose of blinatumomab until 30 days after last dose; the median treatment duration was 55 days.","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}