{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"5"}]}],"title":"Any adverse event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"61"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"5"}]}],"title":"Adverse event of at least CTC grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"39"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"}]}],"title":"Serious adverse event (SAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"}]}],"title":"SAE of at least grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"}]}],"title":"AE leading to interruption of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"}]}],"title":"AE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}]}],"title":"Adverse event leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"59"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"5"}]}],"title":"Treatment-related adverse event (TRAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"38"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"5"}]}],"title":"TRAE of at least CTC grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"}]}],"title":"Treatment-related serious adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"}]}],"title":"TRAE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"}]}],"title":"TRAE leading to death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"5"}],"units":"Participants"}],"description":"The severity (or intensity) of adverse events (AEs) was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03 and according to the following:\n\nGrade 1 - Mild adverse event; Grade 2 - Moderate adverse event; Grade 3 - Severe and undesirable adverse event; Grade 4 - Life-threatening or disabling adverse event; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.","groups":[{"description":"Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.","id":"OG000","title":"Phase 1: Blinatumomab 5 µg/m²/Day"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.","id":"OG001","title":"Phase 1: Blinatumomab 15 µg/m²/Day"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.","id":"OG002","title":"Phase 1+2: Blinatumomab 5/15 µg/m²/Day"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.","id":"OG003","title":"Phase 1: Blinatumomab 15/30 µg/m²/Day"},{"description":"Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.","id":"OG004","title":"Phase 1: Blinatumomab 30 µg/m²/Day"}],"paramType":"NUMBER","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 28 days","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}