{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"1373","value":"14.0"},{"groupId":"OG001","lowerLimit":"2","upperLimit":"688","value":"36.0"},{"groupId":"OG002","lowerLimit":"38","upperLimit":"38","value":"38.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"284","value":"19.0"},{"groupId":"OG004","lowerLimit":"6","upperLimit":"271","value":"13.0"},{"groupId":"OG005","lowerLimit":"6","upperLimit":"335","value":"61.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"502","value":"12.5"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"52","value":"4.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"20","value":"7.0"}]}],"title":"Anaemia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"775","value":"29.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"344","value":"15.0"},{"comment":"No events therefore duration not available.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"7","upperLimit":"236","value":"21.5"},{"groupId":"OG004","lowerLimit":"5","upperLimit":"87","value":"8.0"},{"groupId":"OG005","lowerLimit":"4","upperLimit":"42","value":"21.0"},{"groupId":"OG006","lowerLimit":"7","upperLimit":"252","value":"21.5"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"41","value":"7.5"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"5","value":"3.0"}]}],"title":"ALT"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"803","value":"29.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"330","value":"13.5"},{"comment":"No events therefore duration not available.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"14","upperLimit":"22","value":"18.0"},{"groupId":"OG004","lowerLimit":"8","upperLimit":"22","value":"8.5"},{"groupId":"OG005","lowerLimit":"8","upperLimit":"21","value":"15.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"188","value":"14.0"},{"groupId":"OG007","lowerLimit":"2","upperLimit":"2","value":"2.0"},{"groupId":"OG008","lowerLimit":"5","upperLimit":"5","value":"5.0"}]}],"title":"AST"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"2174","value":"1.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"1121","value":"2.0"},{"groupId":"OG002","lowerLimit":"1","upperLimit":"59","value":"2.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"189","value":"2.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"413","value":"2.0"},{"groupId":"OG005","lowerLimit":"1","upperLimit":"289","value":"1.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"910","value":"2.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"211","value":"2.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"500","value":"3.0"}]}],"title":"Diarrhoea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"1428","value":"18.5"},{"groupId":"OG001","lowerLimit":"5","upperLimit":"657","value":"29.0"},{"groupId":"OG002","lowerLimit":"14","upperLimit":"421","value":"79.5"},{"groupId":"OG003","lowerLimit":"7","upperLimit":"842","value":"20.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"907","value":"28.0"},{"groupId":"OG005","lowerLimit":"5","upperLimit":"258","value":"20.0"},{"groupId":"OG006","lowerLimit":"4","upperLimit":"1536","value":"21.0"},{"groupId":"OG007","lowerLimit":"11","upperLimit":"101","value":"58.0"},{"groupId":"OG008","lowerLimit":"4","upperLimit":"25","value":"5.0"}]}],"title":"Effusion"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"1026","value":"10.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"546","value":"9.5"},{"groupId":"OG002","lowerLimit":"1","upperLimit":"46","value":"11.5"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"85","value":"8.0"},{"groupId":"OG004","lowerLimit":"2","upperLimit":"366","value":"9.0"},{"groupId":"OG005","lowerLimit":"1","upperLimit":"183","value":"8.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"281","value":"9.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"78","value":"9.5"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"39","value":"9.0"}]}],"title":"Infection"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"972","value":"2.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"446","value":"4.0"},{"groupId":"OG002","lowerLimit":"1","upperLimit":"7","value":"4.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"168","value":"2.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"713","value":"14.0"},{"groupId":"OG005","lowerLimit":"1","upperLimit":"42","value":"2.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"247","value":"6.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"274","value":"6.5"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"31","value":"9.0"}]}],"title":"Nausea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"506","value":"23.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"337","value":"15.0"},{"groupId":"OG002","lowerLimit":"13","upperLimit":"70","value":"23.0"},{"groupId":"OG003","lowerLimit":"4","upperLimit":"81","value":"14.5"},{"groupId":"OG004","lowerLimit":"3","upperLimit":"504","value":"21.0"},{"groupId":"OG005","lowerLimit":"7","upperLimit":"92","value":"26.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"252","value":"8.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"52","value":"5.0"},{"groupId":"OG008","lowerLimit":"5","upperLimit":"8","value":"6.5"}]}],"title":"Neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"1416","value":"29.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"1807","value":"81.5"},{"groupId":"OG002","lowerLimit":"1","upperLimit":"52","value":"4.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"455","value":"1.0"},{"groupId":"OG004","lowerLimit":"2","upperLimit":"774","value":"12.5"},{"groupId":"OG005","lowerLimit":"3","upperLimit":"316","value":"28.0"},{"groupId":"OG006","lowerLimit":"2","upperLimit":"670","value":"88.5"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"214","value":"11.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"8","value":"5.0"}]}],"title":"Oedema"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"1622","value":"15.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"965","value":"13.0"},{"groupId":"OG002","lowerLimit":"7","upperLimit":"52","value":"17.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"348","value":"12.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"1612","value":"19.0"},{"groupId":"OG005","lowerLimit":"1","upperLimit":"150","value":"12.5"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"428","value":"13.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"218","value":"7.5"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"33","value":"12.0"}]}],"title":"Rash"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"831","value":"27.0"},{"groupId":"OG001","lowerLimit":"7","upperLimit":"903","value":"190.0"},{"groupId":"OG002","lowerLimit":"1167","upperLimit":"1167","value":"1167.0"},{"groupId":"OG003","lowerLimit":"21","upperLimit":"299","value":"162.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"203","value":"11.0"},{"groupId":"OG005","lowerLimit":"29","upperLimit":"84","value":"56.5"},{"groupId":"OG006","lowerLimit":"3","upperLimit":"1403","value":"26.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"27","value":"9.0"},{"groupId":"OG008","lowerLimit":"12","upperLimit":"12","value":"12.0"}]}],"title":"Renal events"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"1762","value":"22.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"1541","value":"15.0"},{"groupId":"OG002","lowerLimit":"14","upperLimit":"120","value":"38.5"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"336","value":"15.0"},{"groupId":"OG004","lowerLimit":"2","upperLimit":"420","value":"15.0"},{"groupId":"OG005","lowerLimit":"6","upperLimit":"350","value":"21.5"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"889","value":"11.5"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"176","value":"5.0"},{"groupId":"OG008","lowerLimit":"3","upperLimit":"43","value":"9.0"}]}],"title":"Thrombocytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"165","value":"1.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"36","value":"1.0"},{"comment":"No events therefore duration not available.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"141","value":"1.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"59","value":"2.0"},{"groupId":"OG005","lowerLimit":"1","upperLimit":"39","value":"7.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"128","value":"1.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"41","value":"1.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"9","value":"1.5"}]}],"title":"Vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"1428","value":"11.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"657","value":"6.0"},{"comment":"No events therefore duration not available.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"842","value":"7.5"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"907","value":"22.0"},{"groupId":"OG005","lowerLimit":"1","upperLimit":"1","value":"1.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"1536","value":"14.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"19","value":"3.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"2","value":"1.5"}]}],"title":"Cardiac events"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"277","value":"3.5"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"59","value":"6.0"},{"comment":"No events therefore duration not available.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"3","upperLimit":"18","value":"10.5"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"266","value":"1.5"},{"groupId":"OG005","lowerLimit":"10","upperLimit":"10","value":"10.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"22","value":"2.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"14","value":"1.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"19","value":"1.0"}]}],"title":"Vascular events"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"1343","value":"16.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"1659","value":"1.0"},{"comment":"No events therefore duration not available.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"7","upperLimit":"7","value":"7.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"418","value":"1.0"},{"comment":"No events therefore duration not available.","groupId":"OG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"204","value":"5.0"},{"comment":"No events therefore duration not available.","groupId":"OG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG008","lowerLimit":"2","upperLimit":"2","value":"2.0"}]}],"title":"Hypertension"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"2174","value":"1.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"1121","value":"2.0"},{"groupId":"OG002","lowerLimit":"1","upperLimit":"59","value":"2.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"189","value":"2.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"713","value":"2.0"},{"groupId":"OG005","lowerLimit":"1","upperLimit":"289","value":"2.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"910","value":"2.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"274","value":"3.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"500","value":"4.0"}]}],"title":"Gastrointestinal events"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"862","value":"10.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"131","value":"16.0"},{"groupId":"OG002","lowerLimit":"23","upperLimit":"23","value":"23.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"11","value":"4.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"190","value":"27.5"},{"groupId":"OG005","lowerLimit":"1","upperLimit":"58","value":"7.5"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"147","value":"6.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"28","value":"4.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"21","value":"3.5"}]}],"title":"Haemorrhage"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6","upperLimit":"38","value":"9.0"},{"groupId":"OG001","lowerLimit":"7","upperLimit":"9","value":"8.0"},{"comment":"No events therefore duration not available.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"28","value":"7.0"},{"groupId":"OG004","lowerLimit":"1","upperLimit":"15","value":"6.0"},{"groupId":"OG005","lowerLimit":"1","upperLimit":"9","value":"5.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"1","value":"1.0"},{"comment":"No events therefore duration not available.","groupId":"OG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"No events therefore duration not available.","groupId":"OG008","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Hypersensitivity"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"803","value":"29.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"344","value":"16.0"},{"groupId":"OG002","lowerLimit":"8","upperLimit":"8","value":"8.0"},{"groupId":"OG003","lowerLimit":"7","upperLimit":"236","value":"25.5"},{"groupId":"OG004","lowerLimit":"5","upperLimit":"136","value":"9.0"},{"groupId":"OG005","lowerLimit":"3","upperLimit":"82","value":"21.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"252","value":"16.0"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"441","value":"8.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"9","value":"5.0"}]}],"title":"Liver"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1","upperLimit":"1762","value":"22.0"},{"groupId":"OG001","lowerLimit":"1","upperLimit":"1541","value":"18.0"},{"groupId":"OG002","lowerLimit":"13","upperLimit":"120","value":"28.0"},{"groupId":"OG003","lowerLimit":"1","upperLimit":"336","value":"15.0"},{"groupId":"OG004","lowerLimit":"2","upperLimit":"504","value":"15.0"},{"groupId":"OG005","lowerLimit":"6","upperLimit":"769","value":"27.0"},{"groupId":"OG006","lowerLimit":"1","upperLimit":"889","value":"11.5"},{"groupId":"OG007","lowerLimit":"1","upperLimit":"376","value":"5.0"},{"groupId":"OG008","lowerLimit":"1","upperLimit":"43","value":"7.0"}]}],"title":"Myelosuppression"}],"denoms":[{"counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"89"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"38"},{"groupId":"OG004","value":"50"},{"groupId":"OG005","value":"26"},{"groupId":"OG006","value":"79"},{"groupId":"OG007","value":"64"},{"groupId":"OG008","value":"24"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. The event did not necessarily have a causal relationship with the treatment. PCI AEs included anemia, alanine aminotranferase (ALT), aspartate aminotransferase (AST), cardiac, diarrhea, edema, effusion, gastrointestinal, hemorrhage, hypersensitivity, hypertension, infection, liver, myelosuppression, nausea, neutropenia, rash, renal, thrombocytopenia, vomiting, and vascular events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates.\n\nNA = not estimable.","dispersionType":"Full Range","groups":[{"description":"Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.","id":"OG000","title":"Bosutinib 500 mg, CP2L-CML IM-R (Part 2)"},{"description":"Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.","id":"OG001","title":"Bosutinib 500 mg, CP2L-CML IM-I (Part 2)"},{"description":"Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.","id":"OG002","title":"Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)"},{"description":"Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.","id":"OG003","title":"Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)"},{"description":"Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.","id":"OG004","title":"Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)"},{"description":"Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.","id":"OG005","title":"Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)"},{"description":"All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.","id":"OG006","title":"AP-CML Total (Part 2)"},{"description":"All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.","id":"OG007","title":"BP-CML Total (Part 2)"},{"description":"Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL","id":"OG008","title":"Bosutinib 500 mg, Ph+ ALL (Part 2)"}],"paramType":"MEDIAN","populationDescription":"Safety population included all participants who receive at least one dose of study medication.","reportingStatus":"POSTED","timeFrame":"Baseline up to follow-up visit (30 days after last dose of study treatment)","title":"Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"days"}