Publications
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Displaying 1 through 14 of 14 publications.
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Kawai A, Fuller CC, Koram N, Agan A, Brown J, Burk J, Cai B, Daniels K, Fearrington J, Franklin JM, Hague C, Jamal-allial A, Johannes CB, Kempner M, Layton JB, Ma Q, Mai X, Mayer SE, Pawloski PA, Reynolds JS, Seals RM, Selvan M, Smith S, McMahill-Walraven CN, Gilsenan A, Platt R. Monitoring results from a postapproval safety study of Pfizer-BioNTech COVID-19 vaccine in the United States: vaccine utilization and incidence rates of myocarditis/pericarditis. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):182. doi: 10.1002/pds.5687
Mayer SE, Fuller CC, Haynes K, Alam S, Brown JS, Daniels K, Hawrusik R, Horgan C, Jamal-allial A, Johannes CB, Kawai AT, Layton JB, Mai X, Marshall J, McMahill-Walraven CN, Reynolds JS, Seals R, Selvan M, Stemkowski S, Wang FT, Yost E, Gilsenan A, Platt R. Use of Janssen Ad26.COV2.S COVID-19 Vaccine (JCOVDEN) and mRNA COVID-19 vaccines in four large US national insurers. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):186. doi: 10.1002/pds.5687
Sweeney C, Calingaert B, Holzmann R, Moeller C, Schomakers G, Sok A, Pisa F, Gilsenan A. Physician knowledge of safe use of cyproterone acetate monotherapies and meningioma. Poster presented at the 39th ICPE Annual Conference; August 26, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):300. doi: 10.1002/pds.5687
Gilsenan AW, Hammad TA, Juhaeri J, Mansfield C, Levitan BS. Weighting the benefits & risks: the science and methods of benefit-risk assessment in drug development. Presented at the 39th ICPE Annual Conference; August 23, 2023. Halifax, Canada. Previously presented at the 2022 ICPE Conference.
Johannes CB, Beachler DC, Layton JB, Danysh HE, Ziemiecki R, Arana A, Dinh J, Li L, Calingaert B, Pladevall-Vila M, Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A. Post-authorization safety study of hospitalization for acute kidney injury in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting. Drug Saf. 2023 Feb 1;46(2):157-74. doi: 10.1007/s40264-022-01263-3
Danysh HE, Johannes CB, Beachler DC, Layton JB, Ziemiecki R, Arana A, Dinh J, Li L, Calingaert B, Pladevall-Vila M, Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A. Post-authorization safety studies of acute liver injury and severe complications of urinary tract infection in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting. Drug Saf. 2023 Feb 1;46(2):175-93. doi: 10.1007/s40264-022-01262-4
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