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Weibel D, De Luise C, Cid Royo A, Ryan O, Vaz T, Aguado J, Marsal J, Garcia de Albeniz Martinez X, Weinrib R, Yefimenko N, Pala E, Poblador-Plou B, Gimeno-Miguel A, Santos-Mejias A, Marconi E, Barbieri E, Stona L, Lysen T, Roy D, Hyeraci G, Girardi A, Lupattelli A, Desalegn AA, Villalobos F, Bissacco CA, Kendrick K, Garg R, Rubino H, Sturkenboom MCJM, Arana A. Interim results from the VAC4EU Post-Authorization Safety Study (PASS) among recipients of the Pfizer-BioNTech COVID-19 (Comirnaty®) vaccine in Europe. Poster presented at the 2024 ISPE Annual Meeting; August 27, 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.
Jacobson MH, Sabido M, Afonso AS, Ajao A, Alghamdi EA, Andrade S, Bennett D, Kharat V, Kurzinger ML, Le Noan-Laine M, Molgaard-Nielsen D, Murray G, Rivero-Ferrer E, Lopez-Leon S. Algorithms to identify major congenital malformations in routinely collected healthcare databases: a systematic literature review. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Peetluk LS, Djibo DA, Layton JB, Deng J, Deshazo J, Richey MM, Ogilvie RP, Parambi RJ, Miller M, Song J, Tarazi W, Weatherby LB, Bell EJ, Anthony MS, McMahill-Walraven CN, Yang GW, Seeger JD, Amend KL. Considerations for negative control outcome analyses in vaccine effectiveness studies: post-hoc analyses from an adult vaccine effectiveness study conducted within the FDA BEST initiative. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Broe A, Willis SK, Dareng E, Haviland M, van Gelder MMHJ, Nordeng HME, Wood ME, Sahin L, Margulis AV, Rivero-Ferrer E. Building global consensus on definitions for drug safety studies in pregnancy to improve harmonized evaluation of real-world data. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Layton JB, Peetluk LS, Lloyd PC, Jiao Y, Djibo DA, Deng J, Gruber JF, Ogilvie RP, Parambi R, Miller M, Song J, Weatherby LB, Bell EJ, Lo AC, Hervol JR, Wernecke M, Cho S, Wong H-L, Clarke TC, Bui CL, Stone A, Tarazi W, Deshazo J, Forshee RA, Anderson SA, Seeger JD, Amend KL, MaMahill-Walraven CN, Chillarige Y, Yang GW, Anthony MS, Shoaibi A. Effectiveness over time of a complete primary series of the original, monovalent COVID-19 vaccines among adults aged 18-64 years in the United States. Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Layton JB, Richey M, Lindaas A, Muthuri S, Lloyd PC, Gruber JF, Bui C, McKillop M, Kowarski L, Lyu H, Cheng A, Wan Z, Clarke TC, Kawai AT, Beers J, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS, Shoaibi A. Events on day zero of follow-up: considerations for cohort studies of adverse events after COVID-19 diagnosis. Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Johannes CB, Ziemiecki R, Pladevall-Vila M, Kosvesdy CP, Ebert N, Thomsen RWW, Christiansen CF, Baak B, Cabaninas CR, Kashihara N, Yano Y, Kanegae H, Coleman CI, Okami S, Li u F, Layton JB, Vizcaya D, Oberprieler NG. Use of SGLT2 inhibitors in patients with type 2 diabetes and chronic kidney disease: a multicountry report from the FOUNTAIN platform. Poster presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
Pajouheshnia R, Gini R, Gardarsdottir H, Bennett D, Li L, Gulea C, Wientzek-Fleischmann A, Bazelier M, Burcu M, Dodd C, Duran C, Kaplan S, Lanes S, Marinier K, Roberto G, Soman KV, Platt R, Setoguchi S, Hall G, Zhou X. Describing diversity of real-world data sources: a new framework adapted from the DIVERSE initiative scoping review. Poster presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
Weinrib R, Fortuny J, Martinez D, Kollhorst B, Haug U, Kousholt A, Ehrenstein V, Iversen P, Mortensen J, Bosch D, Kuppen M, Pisa F, Vassiley Z. Drug utilisation of radium-223 under routine clinical practice (DIRECT) in Europe: a post-authorisation safety study. Poster presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
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
Romano (DeMuro) C, Bratlee-Whhitaker E, Hartry A, Mearns E, Taylor J, Taylor G, Callahan L, Monks D, Kremer I, Lappin D, Frangiosa T, Sangodkar S, Herring WL, Gnanasakthy K, Goss D, McLeod L, Edwards T, Poulos C, DiBenedetti D, Paulsen R. Measuring what matters most to people living with Alzheimer's disease and care partners: what matters most quantitative research development. Poster presented at the Alzheimer's Association International Conference (AAIC) 2024; July 31, 2024. Philadelphia, PA.
Cope H, Fischer R, Heslop E, McNiff M, Johnson A, Camino E, Denger B, Armstrong N, Thakrar S, Bateman-House A, Beaverson KL, Woollacott IOC, Phillips D, Fernandez V, Ganot A, Donisa-Dreghici R, Mansfield C, Peay H. Clinician perspectives of gene therapy as a treatment option for Duchenne muscular dystrophy. J Neuromuscular Dis. 2024 Jul 29;11(5):1085-93. doi: 10.3233/JND-240033
Clevenger C, Brubaker M, Jackson WC, Stroud J, Peschin S, Fehnel S, Brown TM, Bratlee-Whitaker E, Bucior I, Patel M, Grossberg G. Study protocol: quantitative evaluation of the Agitation in Alzheimer's screener for caregivers (AASC™), a novel tool for improving recognition of agitation in Alzheimer's dementia. Poster presented at the Alzheimer's Association International Conference (AAIC) 2024; July 28, 2024. Philadelphia, PA.
Kessler AS, Brown TM, Bratleey-Whitaker E, Arca M, Baass A, Baum SJ, Bergeron J, Gauget D, Grijalvo OM, Alexander VJ, Llonch MV, Fehnel S, Tsimikas S. Patient experience with familial chylomicronemia syndrome before and after olezarsen treatment: qualitative interviews with clinical trial participants. Poster presented at the PancreasFest 2024; July 25, 2024. Cincinnati, OH. Previously presented at the National Lipid Association Scientific Sessions 2024.
Connor MJ, Genie M, Dudderidge T, Wu H, Sukumar J, Beresford M, Bianchini D, Goh C, Horan G, Innominato P, Khoo V, Klimowska-Nassar N, Madaan S, Mangar S, McCracken S, Ostler P, Paisey S, Robinson A, Rai B, Sarwar N, Srihari N, Jayaprakash KT, Varughese M, Winkler M, Ahmed HU, Watson V, IP5-MATTER Trial Investigators. Patients' preferences for cytoreductive treatments in newly diagnosed metastatic prostate cancer: the IP5-MATTER study. Eur Urol Oncol. 2024 Jul 6;S2588-9311(24):00158-5. doi: 10.1016/j.euo.2024.06.010
Norman K, Bettger J, Dong C, French A, Lake A, Tchuisseu YP, Repka S, Vasudeva K, Whitaker R. Perspectives of telehealth and the impact on equity in access to health care from community members and healthcare providers: a multimethod analysis. Poster presented at the Academy Health 2024 Annual Research Meeting; June 30, 2024. Baltimore, MD.
Norman K, Barton K, Boucher H, Collyar D, Doemberg S, King H, Lydon E, Miller J, Oakes M, Radar A, Ruffin F, Skalla L, Wang T-W. A systematic review of patient-reported health-related quality of life measurement in patients with acute bacterial skin and skin structure infection. Poster presented at the Academy Health 2024 Annual Research Meeting; June 30, 2024. Baltimore, MD.
Taieb J, Fakih M, Salvatore L, Esaki T, Modest DP, Paez D, Karamouzis MV, Ruiz-Garcia E, Kim TW, Kuboki Y, Meriggi F, Cunningham D, Yeh KH, Cremolini C, Wang J, Tran Q, Chao J, Chen Z, Pietrantonio F. Patient-reported tolerability of sotorasib (soto) and panitumumab (pani) versus trifluridine/tipiracil (T/T) or regorafenib (rego) in patients (pts) with metastatic colorectal cancer (mCRC) in the CodeBreaK 300 study. Poster presented at the ESMO 2024 Gastrointestinal Cancers Annual Congress; June 26, 2024. Munich, Germany.
Morris MJ, de Bono J, Nagarajah J, Sartor O, Wei XX, Nordquist LT, Koshkin VS, Chi KN, Krause BJ, Herrmann K, Rahbar K, Vickers A, Mirante O, Ghouse R, Fizazi K, Tagawa ST. Correlation analyses of radiographic progression-free survival with clinical and health-related quality of life outcomes in metastatic castration-resistant prostate cancer: analysis of the phase 3 VISION trial. Cancer. 2024 Jun 21. doi: 10.1002/cncr.35438
Passamonti F, Parikh RC, Korgaonkar S, Chevli M, Yucel A, Rombi J, Zissler D, Davis KL, Slaff S. Patient characteristics, treatment patterns, and health outcomes in a real-world population of patients with myelofibrosis treated with fedratinib. Poster presented at the European Hematology Association (EHA) 2024 Hybrid Congress; June 13, 2024. Madrid, Spain.
