{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"The relationship between ibrutinib metrics of systemic exposure (AUC) with body size was assessed to determine the impact on AUC which were presented per dose groups (240 mg/m\\^2, 329 mg/m\\^2 and 440 mg/m\\^2) and age groups (1-5, 6-11, 12-17 and \\>18 years). The data could not be analyzed in tabular format for this outcome measure as they correspond to a flat regression line in nonlinear mixed effects modeling.","groups":[{"description":"Participants received ibrutinib based on age group and body surface area (BSA) in combination with chemoimmunotherapy (CIT) (investigator choice of RICE \\[rituximab, ifosfamide, carboplatin, etoposide, and dexamethasone\\]). For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for central nervous system (CNS) prophylaxis in age-appropriate dosing. Ibrutinib suspension or capsule was administered once daily starting Day 1 Cycle 1. The first 2 participants enrolled in each age group (1-5 years, 6-11 years, and 12-17 years) received Ibrutinib at a lower starting dose of 240 milligram per meter square (mg/m\\^2) (not to exceed 420 mg per day) for the first cycle (older children \\[6-17 years\\] were enrolled first before enrolling younger children \\[1-5 years\\]), followed by dose escalation to 329 mg/m\\^2 (not to exceed 560 mg per day) at the start of Cycle 2 based on the safety assessments. The RICE regimen was composed of rituximab 750 mg/m\\^2, ifosfamide 9 grams per meter square (g/m\\^2), carboplatin 635 mg/m\\^2, etoposide 300 mg/m\\^2, and dexamethasone 100 mg/m\\^2. Study treatment continued for 3 cycles (each cycle of 28 or 21 days), unless the participants experienced unacceptable toxicity or disease progression.","id":"OG000","title":"Part 1: Ibrutinib+RICE"},{"description":"Participants received ibrutinib based on age group and BSA in combination with CIT (investigator choice of RVICI \\[rituximab, vincristine, ifosfamide, carboplatin, idarubicin, and dexamethasone\\]). dexamethasone\\]). For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for central nervous system (CNS) prophylaxis in age-appropriate dosing. The first 2 participants enrolled in each age group (1-5 years, 6-11 years, and 12-17 years) received Ibrutinib at a lower starting dose of 240 mg/m2 (not to exceed 420 mg per day) for the first cycle (older children \\[6-17 years\\] were enrolled first before enrolling younger children \\[1-5 years\\]), followed by dose escalation to 329 mg/m2 (not to exceed 560 mg per day) at the start of Cycle 2 based on the safety assessments. The RVICI regimen was composed of rituximab 750 mg/m\\^2, vincristine 1.6 mg/m\\^2, ifosfamide 10 g/m\\^2, carboplatin 800 mg/m\\^2, idarubicin 20 mg/m\\^2, and dexamethasone 100 mg/m\\^2. Study treatment continued for 3 cycles (each cycle of 28 or 21 days), unless the participants experienced unacceptable toxicity or disease progression.","id":"OG001","title":"Part 1: Ibrutinib+RVICI"}],"populationDescription":"PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib.","reportingStatus":"POSTED","timeFrame":"Up to Cycle 3 (each cycle of 28 days)","title":"Part 1: Relationship Between AUC and Body Size","type":"PRIMARY"}