{"classes":[{"categories":[{"measurements":[{"comment":"MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2.","groupId":"OG000","value":"NA"},{"comment":"MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2.","groupId":"OG001","value":"NA"},{"comment":"MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2.","groupId":"OG002","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"12"}],"units":"Participants"}],"description":"MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).\n\nNA = not estimable.","groups":[{"description":"Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.","id":"OG000","title":"Bosutinib 400 mg (Part 1)"},{"description":"Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.","id":"OG001","title":"Bosutinib 500 mg (Part 1)"},{"description":"Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.","id":"OG002","title":"Bosutinib 600 mg (Part 1)"}],"paramType":"NUMBER","populationDescription":"Safety population included all participants who received at least 1 dose of study medication","reportingStatus":"POSTED","timeFrame":"Part 1 Baseline up to Day 28","title":"Maximum Tolerated Dose (MTD)","type":"PRIMARY","unitOfMeasure":"mg"}