As an exploratory study, the primary aim of the analysis was to present descriptive estimates of the CR rates for both treatment groups. Secondary outcomes including the ORR, the clinical benefit rate, OS, time to response, time to treatment failure, and adverse events were also analyzed. Patients with incomplete medical records were not a part of the analysis.
All data were collected utilizing Research Electronic Data Capture (REDCap®) [16 ]. Patient demographics and outcomes were reported for each treatment group and compared using Fisher’s exact test or two-sample t-tests, as appropriate. Efficacy outcomes (CR rate, ORR, and clinical benefit rate) were compared between groups for patients treated with 28 days of VEN and reached cycle 2, day 1 of azacitidine or decitabine. Differences in response to therapy were also compared by the presence or absence of various genetic aberrations. Kaplan-Meier curves were generated for each treatment group for OS, time to response and time to treatment failure. Patients were censored at the date of their last physician visit.
Safety outcomes were reported for all patients who have received at least one dose of VEN, azacitidine or decitabine including frequencies of toxicities, adverse events, and any dose delays or reductions. These outcomes were compared between treatment groups using Fisher’s exact tests. Duration of neutropenia was compared using the Wilcoxon rank-sum test. As a sensitivity analysis, response to therapy was also analyzed, including patients who did not meet the required minimum therapy but had at least one dose of VEN, azacitidine or decitabine. P-values reported are for descriptive purposes, and given the exploratory nature of the study, strong conclusions should not be inferred from the results of the statistical tests. All analyses were performed using SAS version 9.4 (SAS Institute Inc., Cary, NC).
All data were collected utilizing Research Electronic Data Capture (REDCap®) [16 ]. Patient demographics and outcomes were reported for each treatment group and compared using Fisher’s exact test or two-sample t-tests, as appropriate. Efficacy outcomes (CR rate, ORR, and clinical benefit rate) were compared between groups for patients treated with 28 days of VEN and reached cycle 2, day 1 of azacitidine or decitabine. Differences in response to therapy were also compared by the presence or absence of various genetic aberrations. Kaplan-Meier curves were generated for each treatment group for OS, time to response and time to treatment failure. Patients were censored at the date of their last physician visit.
Safety outcomes were reported for all patients who have received at least one dose of VEN, azacitidine or decitabine including frequencies of toxicities, adverse events, and any dose delays or reductions. These outcomes were compared between treatment groups using Fisher’s exact tests. Duration of neutropenia was compared using the Wilcoxon rank-sum test. As a sensitivity analysis, response to therapy was also analyzed, including patients who did not meet the required minimum therapy but had at least one dose of VEN, azacitidine or decitabine. P-values reported are for descriptive purposes, and given the exploratory nature of the study, strong conclusions should not be inferred from the results of the statistical tests. All analyses were performed using SAS version 9.4 (SAS Institute Inc., Cary, NC).
