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 parameters
The 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 study compared two drugs in the treatment of esophageal candidiasis in AIDS patients; and the fourth study compared two drugs in the treatment of dermal infections in non-AIDS patients
For each analysis, the GENIE SCORE for each patient was computed for five functionally related groups–Hepatic, Renal, Hematologic (RBC and WBC), and Electrolytic–at baseline and “end of therapy.” Then using each patient as his own control, the difference in the GENIE SCORES (from baseline to final) between the treatment drugs, were compared (for each functional group) by a nonparametric test
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