Analysis of cyto-/chemokine response to three cycles of OT-101 therapy

An ANCOVA model was developed to characterize time evolution of cyto-/chemokine levels following OT-101 treatment. The dependent variable was the standardized log10-transformed values calculated from the mean and standard deviation (SD) of each cyto-/chemokine in each patient. Cyto-/chemokines were treated as a categorical variable, TPs were treated as a continuous variable and each patient was treated as a random factor with a separate variance component (to control for multiple measurements taken from the same individual and to take into account differences in the responses between individuals). This model corrects for the appropriate degrees of freedom (DF) in a model with both fixed (time effect, cytokine effect and time cytokine interaction) and random effects (patient to patient variation). The model consisted of 19 measureable cyto-/chemokines with median expression >1.