{"description":"The safety population consisted of all participants who received at least 1 dose of treatment.","eventGroups":[{"deathsNumAffected":4,"deathsNumAtRisk":11,"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":"EG000","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":10,"seriousNumAtRisk":11,"title":"Part 1: Ibrutinib+RICE"},{"deathsNumAffected":9,"deathsNumAtRisk":10,"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":"EG001","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":9,"seriousNumAtRisk":10,"title":"Part 1: Ibrutinib+RVICI"},{"deathsNumAffected":19,"deathsNumAtRisk":35,"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":"EG002","otherNumAffected":35,"otherNumAtRisk":35,"seriousNumAffected":25,"seriousNumAtRisk":35,"title":"Part 2: Ibrutinib+CIT (RICE or RVICI)"},{"deathsNumAffected":10,"deathsNumAtRisk":15,"description":"Participants received CIT (investigator choice of RICE or RVICI) alone based on age group and BSA until 3 treatment cycles, transplantation if indicated, or until PD or unacceptable toxicity. For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for CNS prophylaxis in age-appropriate dosing. The RICE regimen was composed of rituximab 750 mg/m\\^2, ifosfamide 9 g/m2, carboplatin 635 mg/m\\^2, etoposide 300 mg/m\\^2, and dexamethasone 100 mg/m\\^2. The RVICI regimen was composed of rituximab 750 mg/m\\^2, vincristine 1.6 mg/m\\^2, idarubicin 20 mg/m\\^2, carboplatin 800 mg/m\\^2, ifosfamide 10 g/m\\^2, and dexamethasone 100 mg/m\\^2 (all doses represented as cumulative administered in 1 cycle).","id":"EG003","otherNumAffected":15,"otherNumAtRisk":15,"seriousNumAffected":11,"seriousNumAtRisk":15,"title":"Part 2: Chemoimmunotherapy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":11},{"groupId":"EG001","numAffected":9,"numAtRisk":10},{"groupId":"EG002","numAffected":29,"numAtRisk":35},{"groupId":"EG003","numAffected":14,"numAtRisk":15}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Coagulopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Febrile Bone Marrow Aplasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11},{"groupId":"EG001","numAffected":2,"numAtRisk":10},{"groupId":"EG002","numAffected":6,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Febrile Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Hypofibrinogenaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":10,"numAtRisk":35},{"groupId":"EG003","numAffected":3,"numAtRisk":15}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Lymphopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Macrocytosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":11},{"groupId":"EG001","numAffected":6,"numAtRisk":10},{"groupId":"EG002","numAffected":14,"numAtRisk":35},{"groupId":"EG003","numAffected":4,"numAtRisk":15}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":11},{"groupId":"EG001","numAffected":8,"numAtRisk":10},{"groupId":"EG002","numAffected":19,"numAtRisk":35},{"groupId":"EG003","numAffected":4,"numAtRisk":15}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Pericardial Effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Sinus Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":5,"numAtRisk":35},{"groupId":"EG003","numAffected":2,"numAtRisk":15}],"term":"Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Aplasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Ear Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Vertigo"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Eye Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Eyelid Oedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Eyelid Ptosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Keratitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Pupils Unequal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Vision Blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Xerophthalmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Abdominal Distension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":5,"numAtRisk":10},{"groupId":"EG002","numAffected":12,"numAtRisk":35},{"groupId":"EG003","numAffected":2,"numAtRisk":15}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":6,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Abdominal Pain Upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Anal Erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Anal Inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Anal Ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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Lips"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":35},{"groupId":"EG003","numAffected":1,"numAtRisk":15}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":3,"numAtRisk":10},{"groupId":"EG002","numAffected":8,"numAtRisk":35},{"groupId":"EG003","numAffected":3,"numAtRisk":15}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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Inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Gastrointestinal Motility Disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Gingival Bleeding"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Melaena"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":35},{"groupId":"EG003","numAffected":0,"numAtRisk":15}],"term":"Mouth Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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