Date of Degree
Access restricted until 01/31/2020
PhD (Doctor of Philosophy)
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
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.
Adverse events, Drug safety, Epidemiology, Intravenous immune globulin, Pharmacoepidemiology, Thrombosis
xiii, 152 pages
Includes bibliographical references (pages 142-152).
Copyright © 2015 Eric Michael Ammann
Ammann, Eric Michael. "Intraveneous immune globulin and thromboembolic adverse events." PhD (Doctor of Philosophy) thesis, University of Iowa, 2015.