DOI

10.17077/etd.xh1onr0w

Document Type

Dissertation

Date of Degree

Fall 2015

Access Restrictions

Access restricted until 01/31/2020

Degree Name

PhD (Doctor of Philosophy)

Degree In

Epidemiology

First Advisor

Chrischilles, Elizabeth A.

First Committee Member

Carnahan, Ryan M.

Second Committee Member

Jones, Michael P.

Third Committee Member

Winiecki, Scott K.

Fourth Committee Member

Fireman, Bruce H.

Fifth Committee Member

Torner, James C.

Abstract

The research presented in this dissertation harnesses two secondary data sources, administrative databases of patient-level healthcare data and adverse event (AE) data reported in randomized clinical trials (RCTs), to assess the relationship between intravenous immune globulin (IVIg) and the risk of clinically serious thromboembolic adverse events (TEEs). Since 2013, IVIg products have carried a boxed warning concerning TEE risk, a determination supported by numerous case reports, a large claims-based risk assessment, and laboratory evaluations of the thrombogenecity of IVIg products. Questions remain concerning the magnitude of the risk overall and across subgroups of IVIg users.

Taken together, our results are compatible with the conclusion that the absolute risk of TEE following IVIg use is likely to be low overall. While these results are reassuring, a clinically meaningful elevation in risk cannot be ruled out in certain patient sub-groups, such as older adults and others with a high baseline risk of TEE. A limitation of our research is that differences in TEE risk across products could not be evaluated with sufficient statistical power.

Keywords

Adverse events, Drug safety, Epidemiology, Intravenous immune globulin, Pharmacoepidemiology, Thrombosis

Pages

xiii, 152 pages

Bibliography

Includes bibliographical references (pages 142-152).

Copyright

Copyright © 2015 Eric Michael Ammann

Available for download on Friday, January 31, 2020

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