Efficacy analysis
tumor
REGRESSION, TUMOR
The primary analysis was based on an intention-to-treat approach and included all subjects randomized at baseline. The primary efficacy outcome was overall survival (OS) in months. This outcome was compared between patients randomized to ChemoID-guided chemotherapy) versus standard of care. OS comparisons were examined using Cox Proportional Hazard Models for Overall Survival with baseline hazards stratified by site and medians were compared between treatment arms. Models examining adjustments for sex, race, age, and tumor stage were constructed, as well as for moderating effects of these variables (subpopulation investigations).Secondary analyses included logistic regression models for Overall and Progression-Free Survival at 4, 6, 9, and 12 months, Cox Proportional Hazard Models for Progression-Free Survival in months, Generalized Linear Models (GLMs) for analyses on objective tumor response (RANO), and Health-Related Quality of Life (HRQOL). Generalized Linear Mixed Models (GLMMs) were used for analyses of changes in any additional repeated outcome measures to incorporate within-person associations and examine distributions of participant-specific declines. Huber-White robust standard errors were used, and multiple variance structures were investigated to examine the sensitivity of primary analyses to the choice of association model. Shared Parameter Models (SPM) were used to examine any potential informative missing data effects.