Publications
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Displaying 1 through 22 of 22 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
Gilsenan A, Midkiff K, Harris D, McQuay L, Hunter S, Kellier-Steele N, Andrews E. Assessing the incidence of osteosarcoma among teriparatide users based on Medicare Part D and US State Cancer Registry Data. Pharmacoepidemiol Drug Saf. 2020 Dec;29(12):1616-26. doi: 10.1002/pds.5103
Gilsenan A, Harris D, Reynolds M, McSorley D, Midkiff K, Jackson L, Muldavin B, Kellier-Steele N, Andrews E. Long-term cancer surveillance: results from the Forteo Patient Registry Surveillance Study. Osteoporos Int. 2020 Nov 5;32(4):645-51. doi: 10.1007/s00198-020-05718-0
Gutierrez L, Danysh HE, Aguado J, Hunt PR, Kaye JA, Garcia-Albeniz X, Gilsenan A. Value of adding secondary read diagnosis codes to identify breast cancer and bladder cancer in the Clinical Practice Research Datalink: a pilot validation study. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Danysh HE, Gilsenan A, Beachler DC, Kaye JA, Garcia-Albeniz X, Schmid R, Hunter S, Hunt PR, Aguado J, Calingaert B, Layton JB, Gutierrez L. Validation of breast cancer and bladder cancer among patients with type 2 diabetes mellitus in Medicare: a pilot study. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Layton JB, Zhou CK, Danysh HE, Bleachler DC, Ziemiecki R, Dinah J, Yin R, Calingaert B, Hunt PR, Gilsenan AW, Johannes CW. Identifying cohorts of patients with type 2 diabetes mellitus initiating dapagliflozin in three data sources. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Dinh J, Danysh HE, Johannes C, Gutierrez L, Schmid R, Arana A, Kaye JA, Pladevall-Vila M, Garcia de Albeniz X, Hunt PR, Gilsenan A, Beachler DC, Ke Zhou C. Description of acute kidney injury and breast cancer outcome validation processes across three databases. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Morrato E, Smith M, Auth D, Gilsenan A. Effective risk management: best practices for designing, implementing, and evaluating risk minimization programs. Presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 2020.
Danysh HE, Layton B, Beachler DC, Arana A, Pladevall-Vila M, Schmid R, Calingaert B, Ziemiecki R, Hunt PR, Gilsenan A, Johannes C. Validation of acute outcomes among patients with type 2 diabetes mellitus in Medicare: a pilot study. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 2020.
Gilsenan A, LaCivita C. Practical considerations for robust evaluation of risk minimization programs: regulatory, industry, service provider insights. Presented at the 2020 DIA Virtual Conference; June 14, 2020. Washington, DC.
Molfino NA, Averell CM, Hahn B, Zografos L, Gilsenan A, Richardson D, McSorley D, Slade DJ. Real world evidence in asthma: pulmonary function and asthma control in respiratory specialty clinics in the US. Poster presented at the 2020 American Thoracic Society (ATS) International Conference; May 20, 2020. Philadelphia, PA.
Molfino NA, Averell CM, Hahn BA, Zografos L, Gilsenan A, Richardson D, McSorley D, Slade DJ. Patients with uncontrolled asthma eligible for a biologic. Poster presented at the 2020 American Thoracic Society (ATS) International Conference; May 20, 2020. Philadelphia, PA.
Averell CM, Hahn B, Zografos L, Gilsenan A, Richardson D, McSorley D, Molfino NA, Slade DJ. Assessment of asthma control in respiratory specialist offices in the US. Poster presented at the 2020 American Thoracic Society (ATS) International Conference; May 17, 2020. Philadelphia, PA.
Gilsenan A, Midkiff K, Harris D, Kellier-Steele N, McSorley D, Andrews EB. Teriparatide did not increase adult osteosarcoma incidence in a 15-year US postmarketing surveillance study. J Bone Miner Res. 2020 Feb;36(2):244-51. doi: 10.1002/jbmr.4188
Rebordosa C, Houben E, Laugesen K, Bothner U, Montonen J, Aguado J, Overbeek JA, Ehrenstein V, Asmar J, Wallace L, Gilsenan AW. No evidence of off-label use of Olodaterol and Indacaterol in Denmark, France, and the Netherlands: a drug utilization study. Sci Rep. 2020 Jan 17;10(1):586. doi: 10.1038/s41598-019-57397-5