Publications
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Displaying 1 through 11 of 11 publications.
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Mayer SE, Kawai A, Fuller CC, Agan AA, Rao S, Koram N, Calingaert B, Marshall J, Connolly JG, Moyneur E, Jamal-allial A, Brown J, Burk J, Chomistek A, Daniels K, Dea K, DeFor TA, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Johannes CB, Kendrick K, Layton JB, Ma Q, Mai X, Mack M, Pawloski PA, Reynolds JS, Selvan M, Sharma V, Vetter J, McMahill-Walraven CN, Platt R, Gilsenan A. Interim utilization results from a post-approval safety study of Pfizer-BioNTech monovalent COVID-19 vaccine in the United States. Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Danysh HE, Gilsenan A, Kaye JA, Garcia de Albeniz Martinez X, Schmid R, Bartsch J, Calingaert B, Rahman S, Layton JB, Gutierrez L. Validation of algorithms to identify breast cancer and bladder cancer among patients with type 2 diabetes mellitus in United States medicare administrative claims. Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Sweeney C, Gilsenan A, Calingaert B, Moeller C, Schomakers G, Sok A, Holzmann R, Pisa F. Physician awareness of the safe use of cyproterone acetate in Europe: a survey on the effectiveness of additional risk minimization measures. Pharmaceut Med. 2024 Mar;38(2):145-56. doi: 10.1007/s40290-023-00510-x.
Forns J, Dudukina E, Hagg D, Szentkuti P, Gembert K, Plana E, Gilsenan A, Horvath-Puho E, Ehrenstein V, Reutfors J, Rebordosa C. Risk of major cardiovascular and cerebrovascular events in users of lisdexamfetamine and other medications for attention-deficit/hyperactivity disorder in Denmark and Sweden: a population-based cohort study. Neurol Ther. 2022 Dec 1;11(4):1659-76. doi: 10.1007/s40120-022-00396-y
Gilsenan A, Kawai A. Considerations for planning safety surveillance studies of COVID-19 vaccine. Presented at the North American Chapter of the International Society of Pharmacovigilance (NASoP); November 8, 2022.
Kawai AT, Fuller CC, de Luise C, Layton JB, Johannes CB, Brown J, Platt R, Gilsenan AW. Adapting to the dynamic landscape of the COVID-19 pandemic: proposed study design approaches for a postauthorization safety study for Pfizer-BioNTech COVID-19 vaccine in the United States. Presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark.
Gilsenan AW, Sturkenboom MC, de Luise C, Cohet C, Anderson SA, Brown J, Foskett N, Perez-Gutthann S. COVID-19 vaccine safety monitoring: opportunities, challenges and lessons learned for pharmacoepidemiology. Presented at the 2022 ICPE Conference; August 27, 2022. Copenhagen, Denmark.
Gilsenan A, Juhaeri J, Poulos C, Levitan B. Weighting the benefits & risks: the science and methods of benefit-risk assessment in drug development. Presented at the 2022 ICPE Conference; August 25, 2022. Copenhagen, Denmark.
Krege JH, Gilsenan AW, Komacko JL, Kellier-Steele N. Teriparatide and osteosarcoma risk: history, science, elimination of boxed warning, and other label updates. J Bone Miner Res. 2022 Aug 14;6(9):e10665. doi: 10.1002/jbm4.10665
Fuller CC, Kawai AT, Haynes K, Coughlin K, Reynolds JS, Hawrusik R, Horgan C, Calingaert B, Johannes CB, Bradley Layton J, Peterson A, Praet N, Willame C, Yost E, Brannan C, McMahill-Walraven CNN, Guzman M, Jamal-allial A, Nair V, Seals RM, Wang FT, Selvan M, Ma Q, Platt R, Gilsenan AW, Brown J. Capacity for identifying Janssen Ad26.COV2.S COVID-19 vaccination in four US health insurance and state Immunization Information System databases: preparation for a post authorization safety study. Presented at the 2022 ICPE Conference; August 2022. Copenhagen, Denmark.
Perez EA, Dang C, Lee C, Singh J, Wang K, Layton JB, Gilsenan A, Hackshaw MD, Cortes J. Incidence of adverse events with therapies targeting HER2-positive metastatic breast cancer: a literature review. Breast Cancer Res Treat. 2022 Jul;194(1):1-11. doi: 10.1007/s10549-021-06469-0