{"denoms":[{"counts":[{"groupId":"OG000","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. This outcome measure was planned to be analyzed for specified arm only.","groups":[{"description":"Participants received ibrutinib based on age group and BSA in combination with CIT (investigator choice of RICE or RVICI) until 3 treatment cycles, transplantation if indicated, or until progressive disease (PD) or unacceptable toxicity. 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. Participants of age groups 1-5 years and 6-11 years received ibrutinib 440 mg/m\\^2, and age group 12-17 years received Ibrutinib 329 mg/m\\^2 (dose selected from Part 1).","id":"OG000","title":"Part 2: Ibrutinib+CIT (RICE or 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 2: Relationship Between AUC and Body Size","type":"SECONDARY"}