This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 239
Type: Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308975
Title: An Individual-Patient Meta-Analytic Mixed Model with Repeated Measures and Time-Dependent Covariates: An Application to Adverse Event Data
Author(s): Sofia Paul*+ and Stephanie Ann Kovalchik and Jing Hu and Glen Laird
Companies: Novartis Pharmaceuticals Corporation and University of California, Los Angeles and Novartis Pharmaceuticals Corporation and Novartis Pharmaceuticals Corporation
Address: , East Hanover, NJ, 07936,
Keywords: meta-analysis ; mixed model ; repeated measures ; adverse event ; panobinostat ; platelet count
Abstract:

Adverse drug events are often influenced by regimen and patient factors. Studying risk determinants in early clinical development is complicated by small trials and high patient heterogeneity. When outcomes from multiple safety studies are available, meta-analytic methods can improve the reliability of an exploratory risk analysis. We applied hierarchical mixed modeling to perform an individual patient meta-analysis with repeated measures of platelet counts, where low values are of concern, from eight phase I/II trials of oral panobinostat regimens for the treatment of metastatic solid or hematological cancer. In one model all available observations were analyzed, while the second used weekly nadir measurements to reduce within patient heterogeneity. We investigated time-dependent patient and regimen risk factors for low platelet count and contrasted the findings between models.


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