Number of Participants With Anti-daratumumab Antibodies

Cohort 1: B-cell ALL (1-17 Years)

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).

Cohort 2: T-Cell ALL (1-17 Years)

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).

Cohort 2: T-Cell ALL (18-30 Years)

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).

Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)

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).

Analysis denominator · Participants