{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"9"}],"units":"Participants"}],"description":"Number of participants with anti-daratumumab antibodies was reported.","groups":[{"description":"Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (\\<) 2 years, 10 mg: 2 to \\<3 years, 12 mg: 3 to \\<9 years and 15 mg: greater than or equal to (\\>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m\\^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m\\^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months).","id":"OG000","title":"Cohort 1: B-cell ALL (1-17 Years)"},{"description":"Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to \\<2 years, 10 mg: 2 to \\<3 years, 12 mg: 3 to \\<9 years and 15 mg: \\>=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\\^2 IV infusion once on Day 1; vincristine 1.5 mg/m\\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m\\^2 as 2 doses (20 mg/m\\^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m\\^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \\<2 years, 10 mg: 2 to \\<3 years, 12 mg: 3 to \\<9 years and 15 mg: \\>=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\\^2 as IV once on Day 2, cyclophosphamide IV 1 g/m\\^2 once on Day 15; cytarabine 75 mg/m\\^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m\\^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months).","id":"OG001","title":"Cohort 2: T-Cell ALL (1-17 Years)"},{"description":"Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to \\<2 years, 10 mg: 2 to \\<3 years, 12 mg: 3 to \\<9 years and 15 mg: \\>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\\^2 as 2 doses (20 mg/m\\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \\<2 years, 10 mg: 2 to \\<3 years, 12 mg: 3 to \\<9 years and 15 mg:\\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\\^2 as IV once on Day 2, cyclophosphamide 1g/m\\^2 once on Day 15; cytarabine 75 mg/m\\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\\^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months).","id":"OG002","title":"Cohort 2: T-Cell ALL (18-30 Years)"},{"description":"Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to \\<2 years, 10 mg: 2 to \\<3 years, 12 mg: 3 to \\<9 years and 15 mg: \\>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\\^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\\^2 as 2 doses (20 mg/m\\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \\<2 years, 10 mg: 2 to \\<3 years, 12 mg: 3 to \\<9 years and 15 mg:\\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\\^2 as IV once on Day 2, cyclophosphamide 1g/m\\^2 once on Day 15; cytarabine 75 mg/m\\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\\^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months).","id":"OG003","title":"Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The immunogenicity evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and had at least 1 post-infusion sample for detection of anti-daratumumab antibodies.","reportingStatus":"POSTED","timeFrame":"Up to 4 years 4 months","title":"Number of Participants With Anti-daratumumab Antibodies","type":"SECONDARY","unitOfMeasure":"Participants"}