Abstract #302306

This is the preliminary program for the 2003 Joint Statistical Meetings in San Francisco, California. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 2-5, 2003); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

To View the Program:
You may choose to view all activities of the program or just parts of it at any one time. All activities are arranged by date and time.

The views expressed here are those of the individual authors
and not necessarily those of the ASA or its board, officers, or staff.

Back to main JSM 2003 Program page
JSM 2003 Abstract #302306
Activity Number: 473
Type: Contributed
Date/Time: Thursday, August 7, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #302306
Title: Analyzing and Coping with the Data Collected from the CFSAN Adverse Event Reporting System
Author(s): Peng Tu Liu*+ and Debra Street
Companies: Food and Drug Administration and Food and Drug Administration
Address: 5100 Paint Branch Pkwy., College Park, MD, 20740,
Keywords: signal ; data mining ; mutual exclusivity ; odds ratio ; capture-recapture ; retrospective odds
Abstract:

The standard statistical procedures for analyzing a two-way contingency table are not adequate for analyzing the CAERS data due to the "multisymptom" and "multiexposure" confounding that is present. "Mutual-exclusivity" among cells, that is, no two cells having any cases in common, is a prerequisite for making any meaningful testing for the independence assumption. In this article we: 1) examine the sampling scheme and data structure, 2) define the sample unit, sample description space, and sample distribution, 3) estimate the number of exposures by the multi-capture-recapture technique, 4) reconstruct and decompose the table into numerous mini-2x2 contingency tables that do satisfy the "mutually-exclusive" requirement, 5) estimate the conditional odds and retrospective odds for assessing the impact of adverse reaction, and 6) test the significance of the odds ratio and use the corresponding p value for identifying the most problematic products.

  • The address information is for the authors that have a + after their name.
  • Authors who are presenting talks have a * after their name.

Back to the full JSM 2003 program

JSM 2003 For information, contact meetings@amstat.org or phone (703) 684-1221. If you have questions about the Continuing Education program, please contact the Education Department.
Revised March 2003