{"analyses":[{"groupDescription":"A mixed effects model of EORTC QLQ-C30 GHS was run with independent variables treatment arm, time, baseline Memorial Sloan-Kettering Cancer Center (MSKCC) recursive partitioning analysis (RPA) class, and baseline neurologic symptoms (none/minor vs. moderate/severe), including the interaction of treatment and time, representing difference in the longitudinal trajectory of the scores between the treatment arms. Prospectively, the interaction effect was of most interest and is reported here,","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.005","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.54","value":"62.78"},{"groupId":"OG001","spread":"26.91","value":"54.90"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"34"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.97","value":"67.67"},{"groupId":"OG001","spread":"20.49","value":"64.58"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"End of cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.70","value":"74.54"},{"groupId":"OG001","spread":"20.48","value":"75.35"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"24"}],"units":"Participants"}],"title":"6 Months Post-Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.88","value":"78.47"},{"groupId":"OG001","spread":"24.73","value":"78.99"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"12 Months Post-Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.46","value":"76.79"},{"groupId":"OG001","spread":"24.27","value":"76.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"20"}],"units":"Participants"}],"title":"18 Months Post-Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.00","value":"70.83"},{"groupId":"OG001","spread":"21.43","value":"83.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"title":"24 Months Post-Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.13","value":"77.08"},{"groupId":"OG001","spread":"17.90","value":"79.63"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"30 Months Post-Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.78","value":"75.00"},{"groupId":"OG001","spread":"13.80","value":"85.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"title":"36 Months Post-Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.52","value":"75.00"},{"groupId":"OG001","spread":"19.95","value":"77.56"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"13"}],"units":"Participants"}],"title":"42 Months Post-Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.97","value":"79.76"},{"groupId":"OG001","spread":"19.64","value":"84.38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"48 Months Post-Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.67","value":"70.24"},{"groupId":"OG001","spread":"10.21","value":"91.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"54 Months Post-Treatment"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.35","value":"80.56"},{"comment":"Standard deviation cannot be computed if there is only one observation, as in this case.","groupId":"OG001","spread":"NA","value":"83.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"60 Months Post-Treatment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"description":"Global Health Status is calculated from two questions on the EORTC QLQ-C30. The question responses range from 1 \"very poor\" to 7 \"excellent\" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Data through five years after end of protocol treatment is included in the analysis, while summary data is provided only through three years due to very few participants after that timepoint.","dispersionType":"Standard Deviation","groups":[{"description":"Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine.","id":"OG000","title":"Chemotherapy"},{"description":"Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine.","id":"OG001","title":"Chemotherapy + Low-Dose WBRT"}],"paramType":"MEAN","populationDescription":"Eligible, consented to quality of life study component, and has GHS score for at least one timepoint.","reportingStatus":"POSTED","timeFrame":"EORTC QLQ-C30 was administered at baseline, after cycle 4 of treatment (4 months), then every six months after end of treatment (7 months) for five years.","title":"Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)","type":"SECONDARY","unitOfMeasure":"score on a scale"}