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Sultana J, Crisafulli S, Almas M, Antonazzo IC, Baan E, Bartolini C, Bertuccio MP, Bonifazi F, Capuano A, Didio A, Ehrenstein V, Felisi M, Ferrajolo C, Fontana A, Francisca R, Fourrier-Reglat A, Fortuny J , Gini R, Hyeraci G, Hoeve C, Kontogiorgis C, Isgrò V, Lalagkas P, L'Abbate L, Layton D, Landi A, Narduzzi S, Pereira LR, Poulentzas G, Rafaniello C, Roberto G, Scondotto G, Sportiello L, Toma M, Toussi M, Verhamme K, Volpe E, Trifirò G. Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018 . Pharmacoepidemiol Drug Saf. 2022 Jun;31(6):689-705. doi: 10.1002/pds.5413
Beachler DC, Taylor DH, Anthony MS , Yin R, Li L, Saltus CW , Li Lin, Shaunik A, Walsh KE, Rothman KJ , Johannes CB , Aroda VR, Carr W, Goldberg P, Accardi A, O'Shura JS, Sharma K, Juhaeri J, Lanes S, Wu C. Response to letter to the editor regarding “Development and validation of a predictive model algorithm to identify anaphylaxis in adults with type 2 diabetes in U.S. administrative claims data” . Pharmacoepidemiol Drug Saf. 2022 Jan;31(1):110-1. doi: 10.1002/pds.5376
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
Pajouheshnia R , Thurin NH, Roberto G, Dodd C, Hyeraci G, Bartolini C, Paoletti O, Nordeng H, Wallach-Kildemoes H, Ehrenstein V, Dudukina E, MacDonald T, De Paoli G, Loane M, Demase-Michel C, Beau AB, Droz-Perroteau C, Lassalle R, Swart-Polinder K, Schink T, Cavero-Carbonell C, Barrachina-Bonet L, Gomez-Lumbreras A, Giner-Soriano M, Aragon M, Neville AJ, Armaroli A, Puccini A, Pierini A, Lentile V, Trifiro G, Gatt M, Rissmann A, Leinonen MK, Martikainen V, Jordan S, Georgiou ME, Cunnington M, Sturkenboom M, Gini R. Inception to ConcePTION: a conceptual framework forcharacterizing pharmacoepidemiologic data sources. A study fromthe ConcePTION project . Poster presented at the Virtual ICPE 2021 Conference; August 23, 2021. [abstract] Pharmacoepidemiol Drug Saf. 2021 Aug 24; 30(S1):252. doi: 10.1002/pds.5305
Beachler DC, Taylor DH, Anthony MS , Yin R, Li L, Saltus CW , Li Lin, Shaunik A, Walsh KE, Rothman KJ , Johannes CB , Aroda VR, Carr W, Goldberg P, Accardi A, O'Shura JS, Sharma K, Juhaeri J, Lanes S, Wu C. Development and validation of a predictive model algorithm to identify anaphylaxis in adults with type 2 diabetes in U.S. administrative claims data . Pharmacoepidemiol Drug Saf. 2021 Jul;30(7):918-26. doi: 10.1002/pds.5257
Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X , Park J, Ridolfi A, Lorenzo I, Andre F. Patient-reported outcomes in patients with PIK3CA-mutated hormone receptor-positive, human epidermal growth factor receptor 2–negative advanced breast cancer from SOLAR-1 . J Clin Oncol. 2021 Jun 20;39(18):2005-15. doi: 10.1200/JCO.20.01139
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
Motzer RJ, Porta C, Alekseev B, Rha SY, Choueiri TK, Mendez-Vidal MJ, Hong SH, Kapoor A, Goh JC, Eto M, Wang J , Pan J, Ayele Asfaw A, He CS, Mody K, Cella D. Health-related quality-of-life (HRQoL) analysis from the phase 3 CLEAR trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) or everolimus (EVE) versus sunitinib (SUN) for patients (pts) with advanced renal cell carcinoma (aRCC) . Presented at the 2021 ASCO Conference; June 4, 2021. [abstract] J Clin Oncol. 2021; 39(Suppl 15):4502.
Wyrwicz L, Elimova E, Blum SI, Xiao H, Davenport E , Wang J , Hunter S, Li M, Kondo K, Mohler M. Health-related quality of life (HRQOL) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC): interim results of nivolumab plus chemotherapy (N+C) versus (C) from CheckMate 649 . Poster presented at the 2021 ASCO Conference; June 4, 2021. [abstract] J Clin Oncol. 2021; 39(Suppl 15):4066. doi: 10.1200/JCO.2021.39.15_suppl.4066
Cella D, Hackshaw MD, Vondeling GT, Bennett L , Garbinsky D , Saito K, Sugihara M, Bang YJ, Yamaguchi K, Shitara K. Quality-adjusted time without symptoms or toxicity (Q-TWiST) of trastuzumab deruxtecan (T-DXd) versus chemotherapy in patients with advanced gastric cancer from the DESTINY-Gastric01 trial . Poster presented at the 2021 ASCO Conference; June 4, 2021. [abstract] J Clin Oncol. 2021; 39(Suppl 15):4057. doi: 10.1200/JCO.2021.39.15_suppl.4057
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
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
Gutierrez L , Bezemer ID, Dress J, Ehrenstein V, Forstner M, Franzoni C , Lassalle R, Linder M, Droz-Perroteau C, Odsbu I, Overbeek JA, Perez-Gutthann S , Pisa FE, Rascher K, Rasouliyan L, Reinold J, Rothman KJ , Saigi-Morgui N , Schaller M, Smits E, Timmer A, Toft G, von Gersdorff G, Fortuny J . Challenges in conducting a multinational European study of severe hypersensitivity reactions among recipients of intravenous iron . 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):640. doi: 10.1002/pds.4864
Gutierrez L , Booth H, Dedman D, Crellin E, Kaye JA, Franzoni C , Arana A , Schmitt-Egenolf M, Sundstrom A, Bystrom C. Case validation of cutaneous lymphoma to minimize protopathic bias . 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):645. 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
Plana E , Rivero-Ferrer E , Aguado J , Saigi-Morgui N , Nuevo J, Daoud SZ, Lei A, Perez-Gutthann S , Rebordosa C . Hospitalization for heart failure among patients using aclidinium bromide and other COPD medications: a post-authorisation safety study in the CPRD . 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):1153. doi: 10.1002/pds.4864
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
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
Saigi N , Rebordosa C , Bui C , Aguado J , Plana E , Nuevo J, Daoud SZ, Lei A, Perez-Gutthann S , Rivero-Ferrer E . A validation exercise: identifying hospitalizations for heart failure among patients with COPD in the CPRD . 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):334. doi: 10.1002/pds.4864