Question
102 patients with acute myelogenous leukemia (AML) in remission were enrolled in a study of a new antisense oligonucleotide(asODN). The patients were randomly assigned to
102 patients with acute myelogenous leukemia (AML) in remission were enrolled in a study of a new antisense oligonucleotide(asODN). The patients were randomly assigned to receive a 10-day infusion of asODN or no treatment (Control), and the effects were followed for 90 days. We code the indicator variable TRT=1 for active treatment group and TRT=0 for control group. Also, we record the time of remission (X, in months) from diagnosis or prior relapse at study enrollment, an important covariate in predicting relapse. Relapse (Y) is coded as 1 to indicate relapse, death, or major intervention, such as bone marrow transplant before Day 90. We want to investigate whether there is any evidence that administration of asODN is associated with the occurrence of an AML relapse. We analyze the data using SAS's LOGISTIC procedure and observe the results shown in Table below. Based on those findings, answer the following questions.
1) Identify the dependent variable and the independent variables in this study. Also, state the Omnibus Null and Alternative hypotheses.
2) Report the test statistic and P-value that should be used to test the Omnibus Null hypothesis (i.e. "Global Null" per SAS). What is your conclusion about the Omnibus Null hypothesis?
3) Report the odds ratios and 95% confidence intervals for all two independent variables. Based on those confidence intervals, which of the independent variables are significant predictors of decreasing relapse time (Y) and which ones are not significant predictors? Be sure to include the reasoning for your decisions.
4) Report p-values of the two independent variables from the "Analysis of Maximum Likelihood Estimates" table in the SAS output. Based on the P-values, which of the independent variables are significant predictors of relapse (Y) and which ones are not significant predictors? Be sure to include the reasoning for your decisions.
5) In 3-4 sentences (max), discuss what these findings mean from public health perspective.
Table 2