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Table 2 Modeling probability of having a higher dose, given previous treatment, outcome history, and baseline score

From: Evaluating dose response from flexible dose clinical trials

Predictors of dose level during visit interval (adjusted for previous dose level) Study A Study B
  odds ratio* (95% CI) p-value odds ratio* (95% CI) p-value
YMRS** (Study A) or PANSS** (Study B) reduction from baseline to the end of previous visit interval 0.88 (0.86, 090) < .0001 0.97 (0.96–0.99) <.0001
Adverse event (AE) indicator (max severity score during previous visit interval) 0.87 (0.74–1.01) .075 1.02 (.78–1.33) ns
Baseline YMRS** (Study A) or PANSS** (Study B) total score 1.14 (1.10, 1.18) < .0001 1.04 (1.02–1.05) <.0001
  1. *Estimated by applying the ordinal logistic regression model with the dependent variable as dose received during the current visit interval and the listed predictors. Previous dose was fit into the model as a categorical variable, with associated coefficients capturing effects of specific dose level versus "reference" dose (results were highly significant as to be expected and are not shown here for the sake of the space).
  2. ** YMRS total scores range from 0–60. PANSS total scores range from 30 to 210.