Publications

Search our bibliography using the filters on the right-hand side.

Displaying 1 through 19 of 19 publications.

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.

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

Rebordosa C, Houben E, Laugesen K, Asmar J, Montonen JT, Aguado J, Overbeek J, Ehrenstein V, Wallace L, Gilsenan A. Utilization of olodaterol and indacaterol in Europe. 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):1128. doi: 10.1002/pds.4864

Fortuny J, Gilsenan AW, Cainzos-Achirica M, Cantero OF, Flynn RW, Garcia-Rodriguez L, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Cohort study of the relative incidence of major cardiovascular events among patients initiating prucalopride versus a matched comparator cohort in a multinational study: study design and comparability of cohorts. 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):627. doi: 10.1002/pds.4864

Cainzos-Achirica M, Ruigomez A, MacDonald T, Garcia-Rodriguez L, Fortuny J, Flynn RW, Plana E, Ziemiecki R, Andrews EB, Gilsenan A. Validation of major cardiovascular events in a multi-database post-authorization safety study of prucalopride. 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):331. doi: 10.1002/pds.4864

Gilsenan A. Challenges with methods used to synthesize findings from observational studies. Presented at the DIA 2019 Global Annual Meeting; June 24, 2019. San Diego, CA.

Gilsenan A, Midkiff K, Harris D, Kellier-Steele N, Andrews E. Results from a fifteen-year postmarketing drug safety study of adult osteosarcoma and teriparatide in the US. Poster presented at the 2019 NAACCR / IACR Combined Annual Conference; June 11, 2019. Vancouver, Canada.

Harris D, Casso D, Midkiff K, Anderson A, Gilsenan A, Oliveria A, Andrews E, Kellier-Steele N. Methods, results, and lessons learned from two postmarketing drug safety surveillance studies linking state cancer registry data to large pharmacy databases. Presented at the 2019 NAACCR / IACR Combined Annual Conference; June 11, 2019. Vancouver, Canada.

Millar M, Kinney AY, Camp N, Cannon-Albright L, Hashibe M, Penson D, Kirchhoff A, Neklason D, Gilsenan A, Dieck GS, Stroup AM, Edwards SL, Bateman C, Carter ME, Sweeney C. Predictors of response outcomes for research recruitment through a central cancer registry: evidence from 17 population-based studies. Am J Epidemiol. 2019 May 1;188(5):928-39. doi: 10.1093/aje/kwz011