Linifanib a sample size of 1 participants per treatment group was needed to provide 0 power to yield a statistically who received dose of study medication and had signi ant difference between treat-data available from baseline and on-treat-ments if the true underlying effect size within each patient. Analyses of the end points were based on changes from baseline back-transformed from logarithm . The ANOVA model included a term for treatment and baseline value as a covaria with pairs of treatmentspared via t tests derived from the model. Additional covari-at including body mass ind baseline S base-line D antihypertensive therapy at baselin and distance between electrode were tested for increase in precision ment difference divided by error SD from ANOVA) was .
The expected effect size was calculated based on water displacement data from Pedrinelli Trihydroxyethylrutin 6 It was assumed that bioimpedance would be at least as precise as foot volume by water displacement. Standard-ized effect size provided a normalized estimate of a change/difference in mean values between treatment groups divided by the pooled error SD from the ANOVA model and allowed for aparison of effectiveness across pedal edema assessments at the various time points. Coef ient of variation provided a nor-malized estimate to the variability associated with a particular measu and allowed for aparison of vari-ability across pedal edema assessments at the various time points. Sensitivity was calculated as the number of true-posi-of the estimates. A -sided t test using the tives/number of true-positives number of false-nega-Volume 4 Number D.A. Schoeller Table I. Baseline characteristics of the patients in this study of Sorafenib VEGFR-PDGFR inhibitor segmental bioimpedance for measuring amlodip-ine-induced pedal edema. Amlodipine Placebo All Patients Characteristics Demographic A y Mean Range .
White Black 1 3 Clinical Body mass ind mea kg/m Bioimpedance at 0 k mea Water displaceme mea g Ankle circumferen mea mm Hypertensi no. Systolic blood pressu mea mm Hg In patients with hypertension In patients without hypertension Diastolic blood buy Finibax pressu mea mm Hg In patients with hypertension In patients without hypertension No statistically signi ant differences were found between groups. Hypertension was deed as mean blood pressure / 0 for any set of triplicate measures prior to the administration of the st dose of study treatment. tives. A true-positive was deed as a change in pitting RESULTS score and a change in water displacement or a Participant Population change in bioimpedance . A false-negative was deed Forty-seven participants were enrolled across sites as a change in pitting score and a change in water in the United States between July and December . displacement or a change in bioimpedance .
Spec-Twenty-four participants were assigned to receive am-i ity was calculated as the number of true-negatives/ lodipine 0 mg and 3 to placebo. Forty-six partici-number of anatomy true-negatives number of false-positives. A pantspleted the study; participant was discontinued from the study due to an and a change in water displacement or a change in adverse event . Participantscharacteristics bioimpedance . A false-positive was deed as a are shown in Table . there were no meaningful differ-change in pitting score.