{"analyses":[{"ciLowerLimit":"1.31","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.73","groupDescription":"Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.","groupIds":["OG000"],"nonInferiorityType":"OTHER","paramType":"Odds Ratio (OR)","paramValue":"4.1","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.5","upperLimit":"31.9","value":"25.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"}],"units":"Participants"}],"title":"At 1 month after diagnosis"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.0","upperLimit":"32.0","value":"24.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"96"}],"units":"Participants"}],"title":"At 3 months post-therapy"}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"}],"units":"Participants"}],"description":"Percentage of patients with elevated Anxiety.","dispersionType":"95% Confidence Interval","groups":[{"description":"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \\< 0.1% OR MRD \\>= 0.1% and \\< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \\>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nvincristine sulfate: Given IV","id":"OG000","title":"Induction Therapy"}],"paramType":"NUMBER","populationDescription":"Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these, 159 patients had data at 1 month after diagnosis and 96 patients had data at 3 months post therapy.","reportingStatus":"POSTED","timeFrame":"At 1 month after diagnosis and 3 months post-therapy.","title":"Optimal Time Point for Advance Health Related Quality of Life Intervention","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}