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Publications
MacDonald SC, Rivero-Ferrer E, Bell EJ, Franklin J, Hardy J, Margulis AV, Seals R, Yang R, Seeger J, Straghan E, Asomaning K. A retrospective cohort database study to evaluate the safety of rimegepant exposure during pregnancy. Poster to be given at the 38th Annual Meeting of the Society for Pediatric and Perinatal Epidemiologic Research; June 9, 2025. Boston, MA.
Hellwig K, Magyari M, MacDonald TM, Cesta CE, Wergeland S, Leinonen MK, Ornoy A, Vukusic S, Lauer A, Zhou X, Kawai A, Weinrib R, Arana A, Boumenna T. A multi-country cohort database study to assess pregnancy and infant outcomes after potential maternal or paternal exposure to cladribine tablets in the treatment of multiple sclerosis: the CLEAR study methods and status update1. Ther Adv Neurol Disord. 2025 Jan 27;18:175628642. doi: 10.1177/17562864241310996
Domenech E, Fortuny J, Martinez D, Tormos A, Huang Z, Hill D, Weinstein C, Esslinger S, Krumme A, Mines D, Gisbert J. A post-authorization safety study of golimumab in ulcerative colitis using the Spanish ENEIDA registry (MK8259-042). Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Ahmadizar F, Fortuny J, Royo AC, Plana E, Weinrib R, Garcia Esteban R, Boric K, Yefimenko N, Haugh M, Carreras JJ, Urchueguia-Fornes A, Correcher E, van den Berg JM, Lysen T, Villalobos F, Bissacco CA, Newbern EC, Willame C, Praet N, Sturkenboom MCJM. Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data sources: methods and results of the second study feasibility assessment. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
de Vogel S, Seeger J, Arana A, Margulis AV, McQuay LJ, Perez-Gutthann S, Hallas J, Kristiansen NS, Linder M, Odsbu I, Suehs B, Xu Y, Uribe C, Appenteng K, Robinson NJ. Lessons learned from a multi-data source research collaboration: the mirabegron post-authorization safety study program. Pharmacoepidemiol Drug Saf. 2024 May;33(5):e5799. doi: 10.1002/pds.5799
Ahmadizar F, Fortuny J, Cid-Royo A, Plana E, Weinrib R, Garcia Esteban R, Boric K, Yefimenko N, Carreras JJ, Urcheguia A, Correcher-Martinez E, Mira-Iglesias A, Swart KMA, van den Berg JM, Overbeek JA, Villalonos F, Bissacco CA, Newbern C, Praet N, Willame C, Sturkenboom M. Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data: methods and results of the first study feasibility assessment. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):189-90. doi: 10.1002/pds.5687
Fassett MJ, Reed SD, Rothman KJ, Pisa F, Schoendorf J, Wahdan Y, Peipert JF, Gatz J, Ritchey ME, Armstrong MA, Raine-Bennett T, Postlethwaite D, Getahun D, Shi JM, Xie F, Chiu VY, Im TM, Takhar HS, Wang J, Anthony MS. Risks of uterine perforation and expulsion associated with intrauterine devices. Obstet Gynecol. 2023 Sep 1;142(3):641-51. doi: 10.1097/AOG.0000000000005299
Anthony MS, Zhou X, Schoendorf J, Reed SD, Getahun D, Armstrong MA, Gatz J, Peipert JF, Raine-Bennett T, Fassett MJ, Saltus CW, Ritchey ME, Ichikawa L, Shi JM, Alabaster A, Wahdan Y, Wang J, Xie F, Merchant M, Hunter S, Chiu VY, Postlethwaite D, Rothman KJ, Im TM, Chillemi G, Takhar HS, Asiimwe A, Pisa F. Demographic, reproductive, and medical risk factors for intrauterine device explusion. Obstet Gynecol. 2022 Nov 3;140(6):1017-30. doi: 10.1097/AOG.0000000000005000
Stattin P, Westerberg M, Franck Lissbrant I, Hjalm-Eriksson M, Kjellman A, Ullen A, Vassilev Z, Sandstrom P, Weinrib R, Martinez D, Garcia de Albeniz Martinez X. Real world outcomes in patients with metastatic, castration-resistant prostate cancer treated with radium-223 in routine clinical practice in Sweden. Clin Genitourin Cancer. 2022 Sep 9;S1558-7673(22):00194-X. doi: 10.1016/j.clgc.2022.09.002
Gatz JL, Armstrong MA, Postlethwaite D, Raine-Bennett T, Chillemi G, Alabaster A, Merchant M, Reed SD, Ichikawa L, Getahun D, Fassett MJ, Shi JM, Xie F, Chiu VY, Im TM, Takhar HS, Wang J, Saltus CW, Ritchey ME, Asiimwe A, Pisa F, Schoendorf J, Wahdan Y, Zhou X, Hunter S, Anthony MS, Peipert JF. Association between intrauterine device type and risk of perforation and device expulsion: results from the APEX-IUD study. Am J Obstet Gynecol. 2022 Jul 1;227(1):57.e1-57.. doi: 10.1016/j.ajog.2022.03.062
Reed SD, Zhou X, Ichikawa L, Gatz JL, Peipert JF, Armstrong MA, Raine-Bennett T, Getahun D, Fassett MJ, Postlethwaite DA, Shi JM, Asiimwe A, Pisa F, Schoendorf J, Saltus CW, Anthony MS, APEX-IUD study team. Intrauterine device-related uterine perforation incidence and risk (APEX-IUD): a large multisite cohort study. Lancet. 2022 Jun 4;399(10341):2103-12. doi: 10.1016/S0140-6736(22)00015-0
Getahun D, Fassett MJ, Gatz J, Armstrong MA, Peipert JF, Raine-Bennett T, Reed SD, Zhou X, Schoendorf J, Postlethwaite D, Shi JM, Saltus CW, Wang J, Xie F, Chiu VY, Merchant M, Alabaster A, Ichikawa LE, Hunter S, Im TM, Takhar HS, Ritchey ME, Chillemi G, Pisa F, Asiimwe A, Anthony MS. Association between menorrhagia and risk of intrauterine device-related uterine perforation and device expulsion: results from the APEX-IUD Study. Am J Obstet Gynecol. 2022 Jun;399(10341):2103-12. doi: 10.1016/j.ajog.2022.03.025
Armstrong MA, Raine-Bennett T, Reed SD, Gatz J, Getahun D, Schoendorf J, Postlethwaite D, Fassett MJ, Peipert JF, Saltus CW, Merchant M, Alabaster A, Zhou X, Ichikawa L, Shi JM, Chiu VY, Xie F, Hunter S, Wang J, Ritchey ME, Chillemi G, Im TM, Takhar HS, Pisa F, Asiimwe A, Anthony MS. Association of the timing of postpartum intrauterine device insertion and breastfeeding with risks of intrauterine device expulsion. JAMA Netw Open. 2022 Feb 28;5(2):e2148474. doi: 10.1001/jamanetworkopen.2021.48474
Hellwig K, Magyari M, McDonald T, Gembert K, Wergeland S, Leinonen MK, Aydemir A, Sabido M, Kawai A, Arana A. A multi-country cohort database study to assess pregnancy and infant outcomes in women exposed to cladribine tablets: CLEAR study. Poster presented at the 2021 Digital 37th Conference of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); October 13, 2021.
Fortuny J, von Gersdorff G, Lassalle R, Linder M, Overbeek J, Reinold J, Toft G, Timmer A, Dress J, Blin P, Droz-Perroteau C, Ehrenstein V, Franzoni C, Herings R, Kollhorst B, Moore N, Odsbu I, Perez-Gutthann S, Schink T, Rascher K, Rasouliyan L, Rothman KJ, Saigi-Morgui N, Schaller M, Smits E, Forstner M, Intravenous Iron Consortium, Benichou J, Bircher AJ, Garbe E, Rampton DS, Gutierrez L. Use of intravenous iron and risk of anaphylaxis: a multinational observational post-authorisation safety study in Europe. Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1447-57. doi: 10.1002/pds.5319
Hoffman V, Hallas J, Linder M, Margulis AV, Suehs BT, Arana A, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD. Cardiovascular risk in users of mirabegron relative to users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, real-world data safety study. Presented at the Virtual ICPE 2021 Conference; August 24, 2021. Previously presented at the 2020 Virtual American Heart Association’s Scientific Sessions.
Hoffman V, Hallas J, Linder M, Margulis AV, Suehs BT, Arana A, Phiri K, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD, mirabegron PMR-PASS study group. Cardiovascular risk in users of mirabegron compared with users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, multinational, cohort study. Drug Saf. 2021 Aug;44(8):899-915. doi: 10.1007/s40264-021-01095-7
Anthony MS, Reed SD, Armstrong MA, Getahun D, Gatz JL, Saltus CW, Zhou X, Schoendorf J, Postlethwaite DA, Raine-Bennett T, Fassett MJ, Peipert JF, Ritchey ME, Ichikawa LE, Lynen R, Alabaster AL, Merchant M, Chiu VY, Shi JM, Xie F, Hui SL, Wang J, Hunter S, Bartsch J, Frenz AK, Chillemi G, Im TM, Takhar HS, Asiimwe A. Design of the association of uterine perforation and expulsion of intrauterine device study: a multisite retrospective cohort study. Am J Obstet Gynecol. 2021 Jun;224(6):599.e1. doi: 10.1016/j.ajog.2021.01.003.
Phiri K, Hallas J, Linder M, Margulis A, Suehs B, Arana A, Bahmanyar S, Hoffman V, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Kristiansen NS, Appenteng K, de Vogel S, Seeger J. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder. Curr Med Res Opin. 2021 May;37(5):867-77. doi: 10.1080/03007995.2021.1891035
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
Hoffman V, Hallas J, Linder M, Margulis A, Suehs BT, Arana A, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Xu Y, Kristiansen NS, Appenteng K, de Vogel S, Seeger JD. Cardiovascular risk in users of mirabegron relative to users of antimuscarinic treatments for overactive bladder: findings from a non-interventional, real-world data safety study. Poster presented at the 2020 Virtual American Heart Association’s Scientific Sessions; November 13, 2020.
Reed S, Getahun D, Gatz J, Armstrong M, Raine-Bennett T, Zhou X, Fassett M, Peipert J, Saltus CW, Im T, Alabaster A, Hunter S, Takhar H, Chillemi G, Xie F, Wang J, Chiu V, Frenz A, Shi J, Lynen R, Asiimwe A, Anthony MS. Postpartum timing of IUD insertion is associated with risk of uterine perforation: results from APEX IUD. Poster presented at the Society of Family Planning Virtual 2020 Annual Meeting; October 9, 2020. [abstract] Contraception. 2020 Oct; 102(4):302. doi: 10.1016/j.contraception.2020.07.099
Raine-Bennett TR, Gatz JL, Reed SD, Armstrong MA, Getahun D, Zhou X, Merchant M, Takhar HS, Ichikawa LE, Peipert JF, Saltus CW, Fassett MJ, Chillemi GA, Im TM, Lynen R, Shi JM, Wang J, Xie F, Hunter S, Chiu VY, Asiimwe A, Anthony MS. Postpartum timing of IUD insertion is associated with risk of IUD expulsion: results from APEX IUD. Poster presented at the Society of Family Planning Virtual 2020 Annual Meeting; October 9, 2020. [abstract] Contraception. 2020 Oct; 102(4):295-6.
Reed SD, Armstrong MA, Getahun D, Gatz JL, Raine-Bennett TR, Alabaster AL, Ichikawa L, Saltus CW, Xie F, Zhou X, Fassett MJ, Peipert JF, Merchant M, Chiu VY, Hunter S, Schoendorf J, Shi JM, Chillemi GA, Im TM, Takhar HS, Asiimwe A, Anthony MS. Risk of uterine perforation and expulsion associated with breastfeeding among postpartum women with an intrauterine device insertion: results from APEX IUD. Poster presented at the Society of Family Planning Virtual 2020 Annual Meeting; October 9, 2020. [abstract] Contraception. 2020 Oct; 102(4):297.
Ritchey ME, Gatz J, Merchant M, Fassett M, Reed S, Saltus C, Getahun D, Peipert J, Chillemi G, Bartsch J, Im T, Asiimwe A, Armstrong MA, Anthony M. Risk across postpartum timing of insertion in women with intrauterine devices. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Ritchey ME, Reed S, Alabaster A, Getahun D, Gatz J, Saltus C, Amstrong MA, Xie F, Wang J, Fassett M, Chillemi G, Peipert J, Hunter S, Ichikawa L, Asiimwe A, Anthony M. Are indicators of difficult insertion among women with intrauterine devices associated with uterine perforation and expulsion? Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Gutierrez L, Blin P, Dress J, Droz-Perroteau C, Ehrenstein V, Franzoni C, Kollhorst B, Lassalle R, Linder M, Moore N, Odsbu I, Overbeek J, Perez-Gutthann S, Schink T, Rascher K, Rasouliyan L, Reinold J, Rothman KJ, Saigi-Morgui N, Schaller M, Smits E, Timmer A, Toft G, von Gersdorff G, Intravenous Iron Consortium, Fortuny J. A multinational European study of anaphylaxis among recipients of intravenous iron. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Saltus C, Reed S, Peipert J, Fassett M, Merchant M, Asiimwe A, Ritchey ME, Xie F, Amstrong MA, Gatz N, Ichikawa L, Getahun D, Lynen R, Wang J, Hunter S, Chillemi G, Anthony M. IUD type and indicators of difficult insertion among women with intrauterine devices. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Saltus C, Asiimwe A, Peipert J, Reed S, Getahun D, Alabaster A, Ritchey ME, Ichikawa L, Gatz J, Chiu V, Merchant M, Fassett M, Frenz A-K, Armstrong MA, Wang J, Hunter S, Chillemi G, Anthony M. Assessing outcomes of uterine perforation and IUD expulsion before and after ICD-9-CM to ICD-10-CM transition in women with IUD insertions. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Anthony M, Getahun D, Amstrong MA, Gatz J, Asiimwe A, Saltus C, Reed S, Shi J, Alabaster A, Fassett M, Peipert J, Schoendorf J, Hunter S, Wang J, Chillemi G, Ritchey ME. Breastfeeding, postpartum timing, and indicators of difficult insertion among women with intrauterine devices. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
de Vogel S, Hoffman V, Phiri K, Seeger J, Arana A, Margulis A, McQuay L, Perez-Gutthann S, Hallas J, Sahlertz Kristiansen N, Suehs B, Uribe C, Appenteng K, Robinson NJ. The Mirabegron Post-marketing Requirements (PMRs)/ Non-interventional Post-authorization Safety Study (NI-PASS) Program. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.
Reed SD, Saltus CW, Getahun D, Schoendorf J, Armstrong MA, Peipert JF, Raine-Bennett TR, Ritchey ME, Ichikawa LE, Zhou X, Fassett MJ, Alabaster A, Xie F, Merchant M, Chiu VY, Shi JM, Frenz A-K, Im TM, Takhar HS, Lynen R, Asiimwe A, Anthony MS. Menorrhagia and risk of intrauterine device (IUD) expulsion and uterine perforation: results from the APEX IUD study. Presented at the Virtual 76th Scientific Congress of the American Society for Reproductive Medicine (ASRM); October 17, 2020. [abstract] Fertil Steril. 2020 Sep 1; 114(3 Suppl):e12. doi: 10.1016/j.fertnstert.2020.08.059
Phiri K, Hallas J, Linder M, Margulis A, Suehs B, Arana A, Bahmanyar S, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Sahlertz Kristiansen N, Appenteng K, de Vogel S, Seeger J. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder. Presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 2020.
Phiri K, Hallas J, Linder M, Margulia A, Suehs B, Arana A, Bahmanyar S, Enger C, Horter L, Odsbu I, Olesen M, Perez-Gutthann S, Sahlertz Kristiansen N, Appenteng K, de Vogel S, Seeger J. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder. Poster presented at the American Urological Association 2020 Conference (Conference cancelled); May 2020. Washington, DC. [abstract] J Urol. 2020 Apr; 203(Supplement 4):e910-1. doi: 10.1097/JU.0000000000000931.010
Saltus CW, Gatz J, Ritchey ME, Ichikawa LE, Armstrong MA, Alabster AL, Merchant M, Lynen R, Asiimwe A, Shi JM, Getahun DT, Xie F, Chiu VY, Anthony MS. Study of the association of uterine perforation and IUD expulsion with breastfeeding and postpartum timing at IUD insertion (APEX IUD) - study size estimation to actuality. 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):748. doi: 10.1002/pds.4864
Didden E-M, Andrews EB, Hellwig K, Hernandez-Diaz S, Magyari M, Margulis AV, Rivero-Ferrer E, Bader-Weder S, Wormser D. A novel approach for active surveillance of pregnancy safety in multiple sclerosis. Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):268. doi: 10.1002/pds.4629
Kuiper JG, van Herk-Sukel MPP, Castellsague J, Pottegard A, Berglind IA, Dedman D, Gutierrez L, Calingaert B, Hallas J, Sundstrom A, Gallagher AM, Kaye JA, Pardo C, Rothman KJ, Perez-Gutthann S. Use of topical tacrolimus and topical pimecrolimus in four European countries: a multicentre database cohort study. Drugs Real World Outcomes. 2018 Jun;5(2):109-16. doi: 10.1007/s40801-018-0133-1
Margulis A, Andrews E, Hernandez-Diaz S, Magyari M, Rivero-Ferrer E, Bader-Weder S, Evershed J, Garas M, Wang Q, Wormser D. Design of a multi-source post-marketing study to evaluate pregnancy and infant outcomes in women with multiple sclerosis who were exposed to ocrelizumab during, or within 6 months before, pregnancy. Poster presented at the 2018 American Academy of Neurology Annual Meeting; April 25, 2018. Los Angeles, CA.
Gossec L, Kvien TK, Conaghan PG, Ostergaard M, Canete JD, Gaillez C, Mpofu S, Sherif B, Jugl S. Relationship between improvements in fatigue and signs & symptoms of active psoriatic: arthritis a sub-analysis of a phase 3 study with secukinumab. Poster presented at the 2015 ACR/ARHP Annual Meeting; November 10, 2015. San Francisco, CA. [abstract] Arthritis Rheumatol. 2015 Sep 29; 67(Suppl 10).
Stenehjem DD, Tyczynski JE, Unni SK, Bauer H, Sainski A, Deka R, Shauehamer M, Gutierrez LP, Kaye JA, Telford C, Brixner DI, Biskupiak DI. Evaluation of BRCA mutation (BRCAm) testing patterns, clinical characteristics and overall survival (OS) in breast cancer (BC) patients over a 20-year period. J Clin Oncol. 2015 May 29;33(15_suppl):e12518. doi: 10.1200/jco.2015.33.15_suppl.e12518
Pignone M, Wheeler SB, Hawly S, Lewis C, Crutchfield T, Lich KH, Brown PM, Goyal RK, Gillen E, Laping J. Understanding preferences for CRC screening programs among vulnerable adults in rural North Carolina: a discrete choice experiment. Poster presented at the 35th Annual Meeting of the Society for Medical Decision Making; October 2013. Baltimore, MD.