{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"5"}]}],"title":"Serious Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"7"}]}],"title":"Adverse Events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"321"},{"groupId":"OG001","value":"137"},{"groupId":"OG002","value":"49"}],"units":"Participants"}],"description":"Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.","groups":[{"description":"Adult participants PH+ CML-CP ( Chronic Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).","id":"OG000","title":"CML-CP With Prior Imatinib Only"},{"description":"Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).","id":"OG001","title":"CML-AP With Prior Imatinib Only"},{"description":"Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).","id":"OG002","title":"CML-CP"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.","reportingStatus":"POSTED","timeFrame":"From First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)","title":"Number of Participants With Adverse Events and Serious Adverse Events to Evaluate Long Term Safety","type":"SECONDARY","unitOfMeasure":"Participants"}