Abstract

The concept of the GENIE SCORE (GS) has been shown to be an effective data reduction tool for the review of lab data in clinical trials, and a convenient tool for monitoring the most severely involved individuals over the course of a study. As defined in an earlier paper, this score requires: 1. the standardization of each lab value to make it dimensionless and permit it to be combined mathematically, and 2. the computation of the score from a weighted linear combination of the absolute deviations from the reference range for the values of a functionally related group of laboratory parametersThe emphasis in this paper is to explore the effectiveness of the GENIE SCORE as a measure for comparing drug safety in controlled clinical trials. Four studies were analyzed: the first study compared two drugs in the treatment of cryptococcal meningitis in AIDS patients; the second study compared two drugs in the prevention of cryptococcal meningitis in AIDS patients who recently recovered from the disease; the third...

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