Publications
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Gilsenan A, Shakir S, Jokinen J. Pharmacovigilance: beyond signal detection and spontaneous reporting. Presentation to be given at the DIA 2025 Global Annual Meeting; June 16, 2025. Washington, DC.
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.
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
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
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
Gilsenan A, Fortuny J, Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Harding A, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Odsbu E, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Cardiovascular safety of prucalopride in patients with chronic constipation: a multinational population-based cohort study. Drug Saf. 2019 Oct;42(10):1179-90. doi: 10.1007/s40264-019-00835-0
Fortuny J, Gilsenan A, Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Study design and cohort comparability in a study of major cardiovascular events in new users of prucalopride versus polyethylene glycol 3350. Drug Saf. 2019 Oct;47(10):1167-77. doi: 10.1007/s40264-019-00836-z
Auth D, Gilsenan A, Morrato E, Smith M. Effective risk management: best practices for designing, implementing and evaluating risk minimization programs. Presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 24, 2019. Philadelphia, PA. Previously presented at the 34th Annual ICPE Conference.
Zhou CK, Dinh J, Danysh HE, Johannes C, Gutierrez L, Schmid R, Arana A, Kaye JA, Pladevall-Vila M, Garcia-Albeniz X, Gangemi K, Yin R, Ruzafa JC, Gilsenan A, Beachler DC. Validity of claims-based algorithms to identify acute kidney injury, acute liver injury, severe complications of urinary tract infections, breast cancer, and bladder cancer among patients with type 2 diabetes: a pilot study. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):317. doi: 10.1002/pds.4864
Midkiff K, Harris D, Gilsenan A, Kellier-Steele N, McSorley D, Andrews EB. Results of a long-term postmarketing case series of adult osteosarcoma and teriparatide in the United States. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):688. doi: 10.1002/pds.4864
Gilsenan A, Fortuny J, Cainzos-Achirica M, Cantero OF, Flynn RW, Garcia-Rodriguez L, Harding A, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Odsbu I, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Cardiovascular safety of prucalopride for chronic constipation: a multinational population-based cohort study. Presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):33. doi: 10.1002/pds.4864
Gilsenan A, Midkiff K, Harris D, McQuay L, Hunter S, Kellier-Steele N, Andrews E. Assessing the incidence of osteosarcoma among teriparatide users via linkage of data from Medicare Part D and multiple state cancer registries in the United States. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 27, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):683.
Gilsenan AW, Brainsky A, Colilla S. Applying CIRS-BRAT framework in a regulatory setting: updated benefit risk assessment for fibrinogen concentrate in the setting of complex cardiac surgery. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):964. doi: 10.1002/pds.4864
Gilsenan AW, Ritchey ME, Hauber B, Andrews EB. Considerations when applying a structured benefit-risk assessment to drug delivery combination products. Poster presented at the 35th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2019. Philadelphia, PA. [abstract] Pharmacoepidemiol Drug Saf. 2019 Aug 20; 28(S2):952. doi: 10.1002/pds.4864