9 research outputs found
Analysis of a lattice square design and its use in bioassays.
This dissertation deals with the analysis of an experimental design called the Lattice Square design and its use in estimating the relative potency of test preparations in parallel line bioassays. A Lattice Square is an incomplete two-way design and has the advantage of being able to eliminate two sources of variation simultaneously while keeping the block size from becoming too large. The row and column incidence matrices of the design have many interesting mathematical properties which are derived and described in this dissertation, which contribute to making the analysis more elegant. Under suitable conditions and assumptions, the estimates of treatment effects can be improved upon due to the use of recovery of inter-row and column information. The complete detail of the analysis of such designs are also derived in this dissertation and a numerical illustration of the use of this design in multiple bioassay is provided. Furthermore, this dissertation contains interesting and useful results and information about "BLUPs" (Best Linear Unbiased Predictors) of random row and column effects and "penalized least squares" equations and their advantages in the analysis of incomplete two-way designs.Ph.D.BiostatisticsUniversity of Michigan, Horace H. Rackham School of Graduate Studieshttp://deepblue.lib.umich.edu/bitstream/2027.42/104221/1/9501062.pdfDescription of 9501062.pdf : Restricted to UM users only
DOSE ADJUSTMENT PRACTICES OF PEGINESATIDE VS. EPOETIN IN EMERALD 1 AND 2 PIVOTAL TRIALS
Peginesatide (P) is a synthetic, pegylated, peptide-based ESA approved for treatment of anemia due to chronic kidney disease in adult patients (pts) on dialysis. P demonstrated noninferiority to epoetin (E) in maintenance of Hb levels in hemodialysis (HD) pts in two Phase 3 randomized, active-controlled, open-label trials (EMERALD 1,2). A large dialysis organization (LDO) recently reported an ESA dose adjustment rate of 12.1/pt-year (Bond et al, ISPOR 2012). This post hoc analysis evaluated dosing practices for maintaining Hb with P vs E.
Pooled data from the two trials compared P (1x monthly; N=1066) with E (1-3x wkly; N=542) in HD pts previously on stable doses of E. Hb was measured during screening, at baseline and wkly (evaluation period, wks 29-36) or every 2 wks (all other periods). Dose adjustments were not to be made more frequently than every 4 wks, unless required for safety purposes. Dose adjustments (defined as change >±20% from last dose) were evaluated during the titration (wks 0-28), evaluation, and long-term follow-up (LT, wks 36-52) periods. Dose postponements were defined as >35d for P; for E, they were >4d, 6d, or 9d for TIW, BIW, and QW, respectively.
Across the entire study period, P doses were adjusted ∼3 times less frequently and held ∼8 times less than P (Table).
P (per pt-year)
E (per pt-year)
E/P ratio
Total Dose Adjustments
3.5
10.3
2.9
Dose Increases
1.7
5.3
3.0
Dose Decreases
1.8
5.0
2.8
Dost Postponements
0.6
5.0
8.3
Within each treatment arm, dose adjustment and postponement rates (including corresponding E/P ratios) were similar across titration, evaluation, and LT periods.
E dose adjustment rate was similar to that of real world practice in an LDO. E doses were adjusted and held more frequently than P despite similar protocol specifications for dose alteration and Hb maintenance
Telavancin in the Treatment of Concurrent Staphylococcus aureus Bacteremia: A Retrospective Analysis of ATLAS and ATTAIN Studies
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Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates
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Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: Results of the ADVANCE phase 3 multicenter international trial
Earlier phase 1 and 2 studies have shown that regadenoson has desirable features as a stress agent for myocardial perfusion imaging.
This multicenter, double-blinded phase 3 trial involved 784 patients at 54 sites. Each patient underwent 2 sets of gated single photon emission computed tomography myocardial perfusion imaging studies: an initial qualifying study with adenosine and a subsequent randomized study with either regadenoson (2/3 of patients) or adenosine. Regadenoson was administered as a rapid bolus (<10 seconds) of 400 μg. The primary endpoint was to demonstrate noninferiority by showing that the difference in the strength of agreement in detecting reversible defects, based on blinded reading, between sequential adenosine-regadenoson images and adenosine-adenosine images, lay above a prespecified noninferiority margin. Other prospectively defined safety and tolerability comparisons and supporting analyses were also performed. The average agreement rate based on the median of 3 independent blinded readers was 0.63 ± 0.03 for regadenoson-adenosine and 0.64 ± 0.04 for adenosine-adenosine—a 1% absolute difference with the lower limit of the 95% confidence interval lying above the prespecified noninferiority margin. Side-by-side interpretation of regadenoson and adenosine images provided comparable results for detecting reversible defects. The peak increase in heart rate was greater with regadenoson than adenosine, but the blood pressure nadir was similar. A summed symptom score of flushing, chest pain, and dyspnea was less with regadenoson than adenosine (
P = .013).
This phase 3 trial shows that regadenoson provides diagnostic information comparable to a standard adenosine infusion. There were no serious drug-related side effects, and regadenoson was better tolerated than adenosine