Publications

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Displaying 1 through 18 of 18 publications.

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

Chirila C, Gilligan TM, Gilsenan A, Price M, Hollis K, Calingaert B, Zografos L, Andrews E. A comparison of factors influencing patient knowledge: results across selected REMS surveys. Poster presented at the 27th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 18, 2011. Chicago, IL.

Gilsenan A, Hollis K, Zografos L, Calingaert B, Andrews E. Examination of respondent bias and patient characteristics in multiple REMS assessment surveys. Poster presented at the 27th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 18, 2011. Chicago, IL.

Gilsenan A, Harris DH, Midkiff K, Wright J, Andrews E. Linking with multiple state cancer registries for safety surveillance study – Is it feasible? Poster presented at the 27th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 18, 2011. Chicago, IL.

Midkiff KD, Harris D, Gilsenan AW, Wu Y, Andrews EB. Drug safety studies using cancer registry data: confluence of elements impacting the interview response rate. Poster presented at the 27th International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 14, 2011. Chicago, IL. [abstract] Pharmacoepidemiol Drug Saf. 2011 Aug 1; 20(Suppl. 1):S231. doi: 10.1002/pds.2206

Midkiff KD, Gilsenan AW, Wu Y, Harris DH, Masica D, Andrews EB. Using cancer registry data to advance the science of drug safety: results from an ongoing postmarketing drug safety surveillance study of adult osteosarcoma. Presented at the North American Association of Central Cancer Registries Annual Conference; June 21, 2011. Lexington, KY.

Mintz ML, Yawn BP, Mannino DM, Donohue JF, Hanania NA, Grellet CA, Gilsenan AW, McLeod LD, Dalal AA, Raphiou IH, Prillaman BA, Crater GD, Cicale MJ, Mapel DW. Prevalence of airway obstruction assessed by lung function questionnaire. Mayo Clin Proc. 2011 May 1;86(5):375-81.

Levitan BS, Andrews EB, Gilsenan A, Ferguson J, Noel RA, Coplan PM, Mussen F. Application of the BRAT framework to case studies: observations and insights. Clin Pharmacol Ther. 2011 Feb 1;89(2):217-24. doi: 10.1038/clpt.2010.280

Andrews EB, Midkiff KD, Gilsenan AW, Harris DH. Collaboration with multiple state cancer registries for a data linkage drug safety surveillance study – yes you can!. Poster presented at the North American Association of Central Cancer Registries Annual Conference; 2011.

Gilsenan AW, Midkiff KD, Harris DH. Opportunities for improving the use of cancer registry data in drug safety studies: factors influencing interview response rate. Presented at the North American Association of Central Cancer Registries Annual Conference; 2011.

Midkiff KD, Gilsenan AW, Harris DH, Wu Y, Masica D, Andrews EB. Exposure to possible osteosarcoma risk factors in a US postmarketing osteosarcoma surveillance study. Poster presented at the Scandinavian Sarcoma Group Annual Meeting; 2011.