Publications

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Displaying 1 through 50 of 382 publications.
Gini R, Pajouheshnia R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Commentary - Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): lessons learnt from the MINERVA project in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5884. doi: 10.1002/pds.5884
Pajouheshnia R, Gini R, Gutierrez L, Swertz MA, Hyde E, Sturkenboom M, Arana A, Franzoni C, Ehrenstein V, Roberto G, Gil M, Macia MA, Schafer W, Haug U, Thurin NH, Lassalle R, Droz-Perroteau C, Zaccagnino S, Busto MP, Middelkoop B, Gembert K, Sanchez-Saez F, Rodriguez-Bernal C, Sanfelix-Gimeno G, Hurtado I, Acosta MB, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Prados-Torres A, Schultze A, Jansen E, Herings R, Kuiper J, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Perez-Gutthann S. Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA): development and pilot of a metadata list and catalogue in Europe. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871
Kawai A, Fuller CC, Koram N, Agan A, Brown J, Burk J, Cai B, Daniels K, Fearrington J, Franklin JM, Hague C, Jamal-allial A, Johannes CB, Kempner M, Layton JB, Ma Q, Mai X, Mayer SE, Pawloski PA, Reynolds JS, Seals RM, Selvan M, Smith S, McMahill-Walraven CN, Gilsenan A, Platt R. Monitoring results from a postapproval safety study of Pfizer-BioNTech COVID-19 vaccine in the United States: vaccine utilization and incidence rates of myocarditis/pericarditis. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):182. doi: 10.1002/pds.5687
Tormos A, Thomsen RW, Tave AK, Madsen M, Beachler DC, Martinez D, Garcia Esteban R, Plana E, Farsani SF, Perez-Gutthann S, Pladevall-Vila M, Rebordosa C. Post-authorisation safety study (PASS) assessing the risk of liver, renal, genitourinary, and diabetic ketoacidosis outcomes among users of empagliflozin versus DPP-4 inhibitors in patients with type 2 diabetes mellitus (T2D). Poster presented at the 39th ICPE Annual Conference; August 27, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):585. doi: 10.1002/pds.5687
Mayer SE, Fuller CC, Haynes K, Alam S, Brown JS, Daniels K, Hawrusik R, Horgan C, Jamal-allial A, Johannes CB, Kawai AT, Layton JB, Mai X, Marshall J, McMahill-Walraven CN, Reynolds JS, Seals R, Selvan M, Stemkowski S, Wang FT, Yost E, Gilsenan A, Platt R. Use of Janssen Ad26.COV2.S COVID-19 Vaccine (JCOVDEN) and mRNA COVID-19 vaccines in four large US national insurers. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):186. doi: 10.1002/pds.5687
Weibel D, De Luise C, Elbers R, van den Bor R, Martin I, Cid-Royo A, Plana E, Garcia de Albeniz Martinez X, Weinrib R, Yefimenko N, Poblador-Plou B, Marconi E, Barbieri E, Stona L, Swart KMA, Roy D, Hyeraci G, Bartolini C, Lupattelli A, Villalobos F, Kendrick K, Garg R, Rubino H, Eijkemans R, Sturkenboom M, Arana A. Utilisation patterns of the COVID-19 mRNA vaccine (Comirnaty®) from the VAC4EU active safety surveillance study in five European countries. Poster presented at the 39th ICPE Annual Conference; August 25, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):173-4. 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
Ogilvie RP, Layton JB, Wong HL, Jiao Y, Parambi RJ, Deng J, Miller M, Song J, Lloyd PC, Weatherby L, Peetluk LS, Bell EJ, Yang G, Amend KL, Kawai A, Lo AC, Matuska K, Wernecke M, Gruber JF, Clarke TC, Forshee RA, Anderson SA, Anthony MS, Chillarige Y, Seeger JD, Shoaibi A. Effectiveness of BNT162b2 COVID-19 vaccine in US children aged 5-17 years. Presented at the 39th ICPE Annual Conference; August 26, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):78. doi: 10.1002/pds.5687
Layton JB, Peetluk LS, Wong H, Jiao Y, Ogilvie RP, Miller M, Glazier-Essalmi A, Parambi RJ, Song J, Garcia de Albeniz Martinez X, Lloyd PC, Lo A, Kawai A, Weatherby L, Bell EJ, Yang G, Amend KL, Gruber JF, Clarke TC, Forshee RA, Anderson SA, Wernecke M, Matuska K, Chillarige Y, Anthony M, Seeger JD, Shoaibi A. Effectiveness of monovalent COVID-19 booster/additional vaccine doses in the United States. Presented at the 39th ICPE Annual Conference; August 27, 2023. Halifax, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2023 Oct 12; 32(S1):608. doi: 10.1002/pds.5687
Wang SV, Pottegard A, Crown W, Arlett P, Ashcroft DM, Benchimol EI, Berger ML, Crane G, Goettsch W, Hua W, Kabadi S, Kern DM, Kurz X, Langan S, Nonaka T, Orsini L, Perez-Gutthann S, Pinheiro S, Pratt N, Schneeweiss S, Toussi M, Williams RJ. HARmonized protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force. Pharmacoepidemiol Drug Saf. 2023 Jan;32(1):44-55. doi: 10.1002/pds.5507
Gini R, Pajouheshnia R, Hall G, Platt R, Setoguchi S, Bazelier M, Kaplan S, Zhou X, Lanes S, Man K, Li L, Burcu M, Roberto G, Dodd C, Duran C, Wientzek-Fleischmann A, Soman K, Lai E, Marinier K, Bennett D, Gardarsdottir H. Data source heterogeneity in multi-data base Pharmacoepidemiologic studies: an ISPE-sponsored scoping review. Poster presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):216. doi: 10.1002/pds.5518
Weibel D, Sturkenboom M, Eijkemans R, van den Bor R, Elbers R, Plana E, Garcia de Albeniz X, Weinrib R, Yefimenko N, Bianchini E, Stona L, Poblador-Plou B, Swart-Polinder K, Bartolini C, Hyeraci RG, Roy D, Lupattelli A, Villalobos F, Barbieri E, Garg RK, Rubino H, De Luise C, Arana A. VAC4EU active safety surveillance study of the BNT162b2 COVID-19 vaccine in five European countries: study design and first results. Poster presented at the 2022 ICPE Conference; August 30, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):627-8. doi: 10.1002/pds.5518
Pajouheshnia R, Gini R, Hyde E, Swertz MA, Sturkenboom M, Margulis AV, Franzoni C, Arana A, Ehrenstein V, Gembert K, Jansen E, Herings RMC, Thurin NH, Locatelli I, Jazbar J, Zerovnik S, Kos M, Smit S, Lind S, Metspalu A, Zaccagnino S, Busto MP, Middelkoop B, Barreiro-De Acosta M, Saez FS, Rodriguez-Bernal C, Sanfelix-Gimeno G, Poblador-Plou B, Carmona-Pirez J, Gimeno-Miguel A, Gil M, Schafer W, Haug U, Simou S, Hedenmalm K, Cochino A, Alcini P, Kurz X, Gutierrez L, Perez-Gutthann S. MINERVA: Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies. Poster presented at the 2022 ICPE Conference; August 28, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):564. doi: 10:1002/pds.5518
Limoncella G, Bartolini CC, Duran C, Girardi A, Hyeraci G, Arnau JR, Llorente A, Soriano LC, Martin-Perez M, Garcia-Poza P, Sanchez-Saez F, Sanfelix-Gimeno G, Nordeng H, Hurley E, Maglanoc LA, Holthuis E, Swart k, Lentile V, Tanaglia M, Brown J, Wing K, Schink T, Pajouheshnia R, Cunnington M, Sturkenboom M, Gini R. Extracting pregnancies from heterogeneous data sources in Europe: a novel algorithm in the conception project. Poster presented at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark. [abstract] Pharmacoepidemiol Drug Saf. 2022 Sep 23; 31(S2):236-7. doi: 10.1002/pds.5518
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