Publications
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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.
Perrone RD, Garbinsky D, Nunna S, Gandhi HK, Fernandes AW, Burgos G, Olopoenia A, DeCongelio M, Maculaitis MC, Zhou X. Effectiveness of tolvaptan for autosomal dominant polycystic kidney disease in US clinical practice with comparison to historical control data. Kidney Med. 2025 Feb 27;7(5):100988. doi: 10.1016/j.xkme.2025.100988
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
Chebib FT, Dahl N, Zhou X, Garbinsky D, Wang J, Nunna S, Oberdhan D, Fernandes AW. Tolvaptan and autosomal dominant polycystic kidney disease progression in individuals aged 18–35 years: a pooled database analysis. Kidney Med. 2025 Jan;7(1):100935. doi: 10.1016/j.xkme.2024.100935
Gitomer BY, Chonchol M, Zhou X, Garbinsky D, Wang J, Nunna S, Fernandes AW, Oberdhan D. Kidney stone disease and progression risk in autosomal dominant polycystic kidney disease: a post hoc analysis of OVERTURE. Kidney360. 2024 Sep;5(9):1364-6. doi: 10.34067/KID.0000000000000524
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.
Slota C, Norcross L, Comerford E, Sasane M, Zheng Y, Gnanasakthy A. Critical comments by Food and Drug Administration Reviewers on patient-reported outcomes in Food and Drug Administration Regulatory Submissions (2018-2021) [Editor's Choice]. Value Health. 2024 Jun;27(6):755-66. doi: 10.1016/j.jval.2024.02.011
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
Comerford E, Norcross L, Sasane M, Zheng Y, Gnanasakthy A. Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021): a review of criticism and concerns in comments from regulators. Poster presented at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference; April 5, 2024. Orlando, FL. [abstract] J Natl Compr Canc Netw. 2024 Apr 5; 22(2.5). doi: 10.6004/jnccn.2023.7146
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.
Maeda-Chubachi T, McLeod L, Enloe C, Cartwright M, Siegfried E, Hebert AA, Silverberg N. Defining clinically meaningful improvement in molluscum contagiosum. J Am Acad Dermatol. 2024 Feb;90(2):443-5. doi: 10.1016/j.jaad.2023.10.033
Sherif B, Burke M, Besse B, Solomon B, Bazhenova L, Kim DW, Lin JJ, Wolf J, Popat S, Goto K, de Langen AJ, Springfeld C, Reynolds M, Odom D, Yuan Y, Lee A, Blum SI, Thamake S, Ades F, Drilon A. Health-related quality-of-life of patients treated with repotrectinib for neurotrophic tyrosine receptor kinase (NTRK)-positive advanced solid tumors: results From TRIDENT-1. Poster presented at the ISPOR Europe 2023; November 14, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 Supplement):S484. doi: 10.1016/j.jval.2023.09.2619
Yee KS, Chirila C, Davenport E, Mladsi D, Barnett C, Kronenberger WG. A post hoc analysis of Projected Retained Ability Scores (PRAS) for the longitudinal assessment of cognitive functioning in patients with neuronopathic mucopolysaccharidosis II receiving intrathecal idursulfase-IT. Orphanet J Rare Dis. 2023 Nov 2;18(1):343. doi: 10.1186/s13023-023-02957-2
Perrone RD, Nunna S, Gandhi HK, Fernandes AW, Garbinsky D, Zhou X. Kidney function decline in autosomal dominant polycystic kidney disease (ADPKD) patients: assessment of real world effectiveness of tolvaptan. Poster presented at the Kidney Week 2023; November 2, 2023. Philadelphia, PA.
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
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
Garcia-Albeniz X, Stattin P, Westerberg M, Weinrib R, Sandstrom P, Vassilev Z. Design considerations for observational studies of drugs for advanced cancer. Pharmacoepidemiol Drug Saf. 2023 Jul 15;32(7):812-5. doi: 10.1002/pds.5612
Chebib FT, Dahl N, Zhou X, Garbinsky D, Wang J, Nunna S, Oberdhan D, Fernandes AW. Pooled data analysis of the effect of tolvaptan in patients aged 18-35 years with autosomal dominant polycystic kidney disease. Poster presented at the PKD Connect Conference 2023; June 23, 2023. Denver, CO.
Lioudis M, Zhou X, Davenport E, Nunna S, Krasa HB, Oberdhan D, Fernandes AW. Effects of tolvaptan discontinuation in patients with autosomal dominant polycystic kidney disease: a post hoc pooled analysis. BMC Neurol. 2023 Jun 22;24:182. doi: 10.1186/s12882-023-03247-6
Davenport E, Zhou X, Wang J, Nunna S, Oberdhan D, Fernandes A, Mekahli D. Disease burden and disease progression of young adult patients with autosomal dominant polycystic kidney disease (ADPKD). Poster presented at the 51st Annual Meeting of the European Working Group on Psychosocial Aspects of Children; June 8, 2023. Leuven, Belgium. Previously presented at the National Kidney Foundation 2023 Spring Clinical Meeting.
Chebib FT, Zhou X, Garbinsky D, Davenport E, Nunna S, Oberdhan D, Fernandes A. Tolvaptan and kidney function decline in older individuals with autosomal dominant polycystic kidney disease: a pooled analysis of randomized clinical trials and observational studies. Kidney Med. 2023 Jun;5(6):100639. doi: 10.1016/j.xkme.2023.100639
Maeda-Chubachi T, McLeod L, Cartwright M. Meaningful change in children's dermatology life quality index (DLQI) and lesion counts in patients with molluscum contagiosum. Poster presented at the First International Societies for Investigative Dermatology (ISID2023) Meeting; May 10, 2023. Tokyo, Japan. [abstract] J Invest Dermatol. 2023 May; 143(5 Suppl):S105. doi: 10.1016/j.jid.2023.03.622
Davenport E, Zhou X, Wang J, Nunna S, Oberdhan D, Fernandes A, Mekahli D. Disease burden and disease progression of young adult patients with autosomal dominant polycystic kidney disease. Poster presented at the National Kidney Foundation 2023 Spring Clinical Meeting; April 11, 2023. Austin, TX. [abstract] Am J Kidney Dis. 2023 Apr 1; 81(4, Supple 1):S102. doi: 10.1053/j.ajkd.2023.01.349
Bergerot C, Young Rha S, Pal S, Koralewski P, Stroyakovskiy D, Alekseev B, Parnis F, Castellano D, Lyun Lee J, Sunela K, Ciuleanu T, Heng D, Glen H, Wang J, Bennett L, Pan J, O'Hara K, Puente J. Health-related quality of life outcomes with two different starting doses of lenvatinib in combination with everolimus for previously treated renal cell carcinoma. Oncologist. 2023 Jan 18;28(1):59-71. doi: 10.1093/oncolo/oyac142
Forsythe E, Haws RM, Argente J, Beales P, Martos-Moreno GA, Dollfus H, Chirila C, Gnanasakthy A, Buckley BC, Mallya UG, Clement K, Haqq AM. Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results. Orphanet J Rare Dis. 2023 Jan 16;18(1):12. doi: 10.1186/s13023-022-02602-4
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
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
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
Motzer R, Porta C, Alekseev B, Rha SY, Choueiri TK, Mendez-Vidal MJ, Hong SH, Kapoor A, Goh JC, Eto M, Bennett L, Wang J, Pan JJ, Saretsky TL, Perini RF, He CS, Mody K, Cella D. Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study. Lancet Oncol. 2022 Jun;23(6):768-80. doi: 10.1016/S1470-2045(22)00212-1
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
Zhou X, Davenport E, Ouyang J, Hoke ME, Garbinsky D, Agarwal I, Krasa HB, Oberdhan D. Pooled data analysis of the long-term treatment effects of tolvaptan in ADPKD. Kidney Int Rep. 2022 Feb 19;7(5):1037-48. doi: 10.1016/j.ekir.2022.02.009
Kuhnen P, Wabitsch M, von Schnurbein J, Chirila C, Mallya UG, Callahan P, Gnanasakthy A, Poitou C, Krabusch PM, Stewart M, Clement K. Quality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency. Orphanet J Rare Dis. 2022 Feb 5;17(1):38. doi: 10.1186/s13023-022-02186-z
de Sordi D, Kappen S, Otto-Sobotka F, Kulschewski A, Weyland A, Gutierrez L, Fortuny J, Reinold J, Schink T, Timmer A. Validity of hospital ICD-10-GM codes to identify anaphylaxis. Pharmacoepidemiol Drug Saf. 2021 Dec;12:1643-52. doi: 10.1002/pds.5348
Kummar S, Berlin J, Mascarenhas L, van Tilburg CM, Geoerger B, Lassen UN, Schilder RJ, Turpin B, Nanda S, Keating K, Childs BH, Chirila C, Laetsch TW, Hyman DM, Drilon A, Hong DS. Quality of life in adult and pediatric patients with tropomyosin receptor kinase fusion cancer receiving larotrectinib. Curr Probl Cancer. 2021 Dec;45(6):100734. doi: 10.1016/j.currproblcancer.2021.100734
Forsythe E, Haws RM, Argente J, Beales P, Chirila C, Clement K, Dollfus H, Martos-Moreno GA, Gnanasakthy A, Buckley BC, Mallya U, Haqq AM. Quality of life in patients with bardet-biedl syndrome in a setmelanotide phase 3 trial. Poster presented at the 2021 Obesity Week Virtual Conference; November 1, 2021.
Kuhnen P, Wabitsch M, von Schnurbein J, Chirila C, Mallya UG, Callahan P, Gnanasakthy A, Poitou C, Krabusch PM, Stewart M, Clement K. Quality of life in POMC or LEPR deficiency: setmelanotide phase 3 trials. Poster presented at the 2021 Virtual Overcoming Obesity Conference; October 14, 2021.
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.
Xiao H, Blum S, Davenport E, Wang J, Hunter S, Li M, Kondo K. Health care resource utilization of patients with advanced gastric cancer/gastroesophageal junction cancer or esophageal adenocarcinoma: results of nivolumab plus chemotherapy versus chemotherapy from CheckMate 649. Poster presented at the AMCP Nexus 2021; October 18, 2021. [abstract] J Manag Care Pharm. 2021 Oct; 27(10-a):S19.
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
Kupperman BD, Keyloun KR, Campbell JH, Zhou X, Davenport E, Bakri SJ. Decreased vision improvement in DME eyes with longer duration or larger amounts of excess edema: a post-hoc analysis of protocol T. Presented at the 2021 54th Retina Society Annual Scientific Meeting; September 29, 2021. Chicago, IL.
Elimova E, Wyrwicz L, Blum SI, Xiao H, Li M, Kondo K, Davenport E, Wang J, Hunter S, Moehler MH. Health-related quality of life (HRQOL) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC): results of nivolumab plus chemotherapy (NIVO+chemo) versus chemo from CheckMate 649. Poster presented at the 2021 ASCO Quality Care Symposium; September 24, 2021.
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
Smith MR, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Mohamed AF, Odom D, Bartsch J, Snapir A, Sarapohja T, Fizazi K. Darolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the phase III ARAMIS trial. Eur J Cancer. 2021 Jul 14;154:138-46.
Hofheinz RD, Bruix J, Demetri GD, Grothey A, Marian M, Bartsch J, Odom D. Effect of regorafenib in delaying definitive deterioration in health-related quality of life in patients with advanced cancer of three different tumor types. Cancer Manag Res. 2021 Jul 12;13:5523-33. doi: 10.2147/CMAR.S305939