Publications
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Displaying 1 through 17 of 17 publications.
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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
Danysh HE, Gilsenan A, Arana A, Pladevall-Vila M, Layton JB, Ziemiecki R, Chen H, Hunt PR, Johannes C. Validation of acute outcomes among patients with type 2 diabetes mellitus in the clinical practice research datalink. Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021.
Layton JB, Ziemiecki R, Danysh HE, Gaber C, Gilsenan A, Johannes CB. Graphical representation of an array of quantitative bias analysis scenarios for differential outcome misclassification. Presented at the Virtual ICPE 2021 Conference; August 23, 2021.
Layton JB, Ziemiecki R, Danysh H, Gilsenan A, Johannes C. Graphical representation of multiple quantitative bias analysis scenarios for unmeasured confounding. Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021.
Johannes C, Layton JB, Beachler DM, Ziemiecki RM, Li L, Danysh HE, Dinh J, Hunt PR, Karlsson C, Chen H, Gilsenan A. Risk of acute kidney injury in real-world use of dapagliflozin. Presented at the 2021 Virtual American Diabetes Association 81st Scientific Session; June 25, 2021.
Johannes C, Layton JB, Beachler DC, Ziemiecki RM, Li L, Danysh HE, Dinh J, Hunt PR, Karlsson C, Chen H, Gilsenan A. Risk of severe complications of urinary tract infection in real-world use of dapagliflozin. Poster presented at the 2021 Virtual American Diabetes Association 81st Scientific Session; June 25, 2021.
Forns J, Dudukina E, Hagg D, Szentkuti EP, Gembert K, Plana E, Gilsenan A, Horvath-Puho E, Reutfors J, Rebordosa C. Cohort study of the incidence of major cardiovascular events in new adult users of lisdexamfetamine and remote adult users of other attention-deficit/hyperactivity disorder treatments. Poster presented at the 2021 8th World Congress on ADHD Virtual Event; May 6, 2021.
Ruigomez A, Plana E, Gilsenan A, Fortuny J, Cainzos-Achirica M, Flynn RWV, MacDonald TM, Garcia-Rodriguez L, Ziemiecki R, Andrews EB. Identification and validation of major cardiovascular events in the United Kingdom data sources included in a multi-database post-authorization safety study of prucalopride. Drug Saf. 2021 May;44(5):541-51. doi: 10.1007/s40264-021-01044-4
Oppenheimer J, Slade DJ, Hahn BA, Zografos L, Gilsenan A, Richardson D, McSorley D, Lima R, Molfino NA, Averell CM. Real-world evidence: patient views on asthma in respiratory specialist clinics in America. Ann Allergy Asthma Immunol. 2021 Apr;126(4):385-93. doi: 10.1016/j.anai.2020.12.015
Arana A, Margulis AV, Varas-Lorenzo C, Bui CL, Gilsenan A, McQuay LJ, Reynolds M, Rebordosa C, Franks B, de Vogel S, Appenteng K, Perez-Gutthann S. Validation of cardiovascular outcomes and risk factors in the Clinical Practice Research Datalink in the United Kingdom. Pharmacoepidemiol Drug Saf. 2021 Feb;30(2):237-47. doi: 10.1002/pds.5150