{"analyses":[{"groupDescription":"Age \\< 65 years The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.\n\nSome of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.\n\nAzacitidine: low range of 7.1 months and high range of 15.6 months.\n\nConventional Care: low range of 4.4 and high range of 12.4 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3973","pValueComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"},{"groupDescription":"Age \\>= 65 years\n\nSome of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.\n\nAzacitidine: low range of 17.1 months and high range of 34.7 months.\n\nConventional Care: low range of 8.8 and high range of 16.4 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"},{"groupDescription":"Age \\>= 75 years. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.\n\nSome of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.\n\nAzacitidine: low range of 1.7 months and high range of 15.0 months.\n\nConventional Care: low range of 4.1 and high range of 7.6 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0707","pValueComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"},{"groupDescription":"Gender: Male\n\nSome of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.\n\nAzacitidine: low range of 17.9 months and high range of 'does not exist'.\n\nConventional Care: low range of 10.8 and high range of 17.2 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0042","pValueComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"},{"groupDescription":"Gender: Female\n\nSome of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.\n\nAzacitidine: low range of 13.0 months and high range of 'does not exist'.\n\nConventional Care: low range of 8.2 and high range of 17.6 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0469","pValueComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"},{"ciPctValue":"95","groupDescription":"FAB: Refractory anemia with excess blasts (RAEB). All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0056","pValueComment":"95% CI ranges are added here.\n\nAzacitidine: low range of 21.1 months and high range of 'does not exist'.\n\nConventional Care: low range of 9.3 and high range of 21.9 months.","statisticalComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.","statisticalMethod":"Log Rank"},{"ciPctValue":"95","groupDescription":"FAB: RAEB in transformation\n\nSome of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.\n\nAzacitidine: low range of 11.7 months and high range of 'does not exist'.\n\nConventional Care: low range of 9.4 and high range of 17.0 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0322","pValueComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"},{"ciPctValue":"95","groupDescription":"WHO: RAEB 1. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.\n\nSome of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.\n\nAzacitidine: low range of 6.6 months and high range of 'does not exist'.\n\nConventional Care: low range of 1.8 and high range of 9.8 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1679","pValueComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"},{"ciPctValue":"95","groupDescription":"WHO: RAEB-2\n\nSome of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.\n\nAzacitidine: low range of 15.9 months and high range of 'does not exist'.\n\nConventional Care: low range of 8.8 and high range of 19.4 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0692","pValueComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"},{"ciPctValue":"95","groupDescription":"WHO: Other\n\nSome of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.\n\nAzacitidine: low range of 15.6 months and high range of 'does not exist'.\n\nConventional Care: low range of 11.1 and high range of 17.5 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0017","pValueComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"},{"ciPctValue":"95","groupDescription":"IPSS: Intermediate 2 All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1030","pValueComment":"95% CI ranges are added here.\n\nAzacitidine: low range of 17.1 months and high range of 'does not exist'.\n\nConventional Care: low range of 8.7 and high range of 24.1 months.","statisticalComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.","statisticalMethod":"Log Rank"},{"ciPctValue":"95","groupDescription":"IPSS: High All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0020","pValueComment":"95% CI ranges are added here.\n\nAzacitidine: low range of 15.0 months and high range of 'does not exist'.\n\nConventional Care: low range of 9.0 and high range of 17.0 months.","statisticalComment":"The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.31"},{"groupId":"OG001","value":"7.87"}]}],"title":"Age <65 years"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24.46"},{"groupId":"OG001","value":"13.87"}]}],"title":"Age >= 65 years"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8.92"},{"groupId":"OG001","value":"6.20"}]}],"title":"Age >= 75 years"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24.46"},{"groupId":"OG001","value":"15.02"}]}],"title":"Gender: Male"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25.11"},{"groupId":"OG001","value":"14.85"}]}],"title":"Gender: Female"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34.66"},{"groupId":"OG001","value":"15.21"}]}],"title":"FAB: Refractory anemia with excess blasts (RAEB)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17.25"},{"groupId":"OG001","value":"15.25"}]}],"title":"FAB: RAEB in transformation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11.54"},{"groupId":"OG001","value":"6.72"}]}],"title":"WHO: RAEB 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21.11"},{"groupId":"OG001","value":"15.02"}]}],"title":"WHO: RAEB 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20.46"},{"groupId":"OG001","value":"15.25"}]}],"title":"WHO: Other (AML, CMMoL-1 and 2, indeterminate)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34.66"},{"groupId":"OG001","value":"16.89"}]}],"title":"IPSS: Intermediate 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19.21"},{"groupId":"OG001","value":"14.52"}]}],"title":"IPSS: High"}],"denoms":[{"counts":[{"groupId":"OG000","value":"179"},{"groupId":"OG001","value":"179"}],"units":"Participants"}],"description":"Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.\n\nSubgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification.","groups":[{"description":"Azacitidine, 75 mg/m\\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.","id":"OG000","title":"Azacitidine"},{"description":"Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)","id":"OG001","title":"Conventional Care"}],"paramType":"NUMBER","populationDescription":"Intent to treat population. Includes participants who died and those who were censored.","reportingStatus":"POSTED","timeFrame":"Day 1 (randomization) to 42 months","title":"Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause","type":"PRIMARY","unitOfMeasure":"months"}