{"analyses":[{"ciLowerLimit":"0.06","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.29","estimateComment":"Risk difference and 95% CI: adjusted percent ponatinib - adjusted percent imatinib and its 95% CI.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.0021","pValueComment":"P-value is based on CMH chi-square test, with stratification according to randomization strata (age): 18 through \\<45 years, ≥45 through \\<60 years, and ≥60 years.","paramType":"Risk Difference (RD)","paramValue":"0.18","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"78"}],"units":"Participants"}],"description":"MRD-negative CR was achieved when a participant met the criteria for both MRD negativity and CR. MRD-negativity: ≤0.01 % breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with ≥ 10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (\\<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system \\[CNS\\] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) \\> 1000 per microliter (/mcL) (or \\>1.0\\*10\\^9/L). 5. Platelets \\>100,000/mcL (or \\>100\\*10\\^9/L).","groups":[{"description":"Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\\<60 years \\[yrs\\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\\^2 as 2-hour IV infusion (\\<60 yrs) and 250 mg/m\\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\\^2 (\\<60 yrs) and 250 mg/m\\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.","id":"OG000","title":"Cohort A: Ponatinib 30 mg"},{"description":"Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\\^2 every 12 hours as a 2-hour-IV infusion (\\<60 yrs) and 250 mg/m\\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\\^2 (\\<60 yrs) and 250 mg/m\\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.","id":"OG001","title":"Cohort B: Imatinib 600 mg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"ITT population with p190/p210 variant was defined as all participants in the ITT population who were identified by the central laboratory as having baseline breakpoint cluster region-Abelson1 (BCR-ABL1) dominant variants of p190 or p210.","reportingStatus":"POSTED","timeFrame":"From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days)","title":"Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase","type":"PRIMARY","unitOfMeasure":"Participants"}