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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.
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
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.
Gini R, Pajouheshnia R , Gardarsdottir H, Bennett D, Li L, Gulea C, Wientzek-Fleischmann A, Bazelier MT, Burcu M, Dodd C, Duran CE, Kaplan S, Lanes S, Marinier K, Roberto G, Soman K, Zhou X, Platt R, Setoguchi S, Hall GC. Describing diversity of real world data sources in pharmacoepidemiologic studies: the DIVERSE scoping review . Pharmacoepidemiol Drug Saf. 2024 May;33(5):e5787. doi: 10.1002/pds.5787
Kluge F, Brand YE, Mico-Amigo ME, Bertuletti S, D'Ascanio I, Gazit E, Bonci T, Kirk C, Kuderle A, Palmerini L, Paraschiv-Ionescu A, Salis F, Soltani A, Ullrich M, Alcock L, Aminian K, Becker C, Brown P, Buekers J, Carsin AE , Caruso M, Caulfield B, Cereatti A, Chiari L, Echevarria C, Eskofier B, Evers J, Garcia-Aymerich J, Hache T, Hansen C, Hausdorff JM, Hiden H, Hume E, Keogh A, Koch S, Maetzler W, Megaritis D, Niessen M, Perlman O, Schwickert L, Scott K, Sharrack B, Singleton D, Vereijken B, Vogiatzis I, Yarnall A, Rochester L, Mazza C, Del Din S, Mueller A. Real-world gait detection using a wrist-worn inertial sensor: validation study . JMIR Form Res. 2024 May 1;8:e50035. doi: 10.2196/50035
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
Ogilvie RP, Layton JB , Lloyd PC, Jiao Y, Djibo DA, Wong HL, Gruber JF, Parambi R, Deng J, Miller M, Song J, Weatherby LB, Peetluk L, Lo A, Matuska K, Wernecke M, Bui CL , Clarke TC, Cho S, Bell EJ, Yang G, Amend KL, Forshee RA, Anderson SA, McMahill-Walraven CN, Chillarige Y, Anthony MS , Seeger JD , Shoaibi A. Effectiveness of BNT162b2 COVID-19 primary series vaccination in children aged 5–17 years in the United States: a cohort study . BMC Pediatr. 2024 Apr 26;24(1):276. doi: 10.1186/s12887-024-04756-5
Melen E, Faner R, Allinson JP, Bui D, Bush A, Custovic A, Garcia-Aymerich J, Guerra S, Breyer-Kohansal R, Hallberg J, Lahousse L, Martinez FD, Merid SK, Powell P, Pinnock H, Stanojevic S, Vanfleteren LEGW, Wang G, Dharmage SC, Wedzicha J, Agusti Alvar, Abellan A , CADSET Investigators. Lung-function trajectories: relevance and implementation in clinical practice . Lancet. 2024 Apr 13;403(10435):1494-503. doi: 10.1016/S0140-6736(24)00016-3
Dadvand P, Gascon M, Bustamante M, Rivas I, Foraster M , Basagana X, Cosin M, Eixarch E, Ferrer M, Gratacos E, Gomez Herrera L, Jimenez-Arenas P, Julvez J, Morillas A, Nieuwenhuijsen MJ, Persavento C, Pujol J, Querol X, Sanchez Garcia O, Vrijheid M, Llurba E, Gomez-Roig MD, Sunyer J, BiSC Group. Cohort profile: Barcelona life study cohort (BiSC) . Int J Epidemiol. 2024 Apr 11;53(3):dyae063. doi: 10.1093/ije/dyae063
Josa-Cullere A, Basagana X, Koch S, Arbillaga-Etxarri A, Balcells E, Bosch de Basea M, Celorrio N, Foraster M , Rodriguez-Roisin R, Marin A, Peralta GP, Rodriguez-Chiaradia DA, Simonet P, Toran-Monserrat P, Vall-Casas P, Garcia-Aymerich J. Short-term effects of air pollution and weather on physical activity in patients with chronic obstructive pulmonary disease (COPD) . Environ Res. 2024 Apr;247:118195. doi: 10.1016/j.envres.2024.118195.
Hu M, Shoaibi A, Feng Y, Lloyd PC, Wong HL, Smith ER, Amend KL, Kline A, Beachler DC, Gruber JF, Mitra M, Seeger JD , Harris C, Secora A, Obidi J, Wang J, Song J, McMahill-Walraven CN, Reich C, McEvoy R, Do R, Chillarige Y, Clifford R, Cooper DD, Forshee RA, Anderson SA. Safety of ancestral monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 vaccines in US children aged 6 months to 17 years . JAMA Netw Open. 2024 Apr 1;7(4):e248192. doi: 10.1001/jamanetworkopen.2024.8192
Rebordosa C , Thomsen RW, Tave AK, Madsen M, Beachler DC, Martinez D , Garcia-Esteban R , Plana E , Tormos A , Farsani SF, Perez-Gutthann S , Pladevall-Vila M. Liver, renal, genitourinary, and diabetic ketoacidosis risks among new users of empagliflozin versus DPP-4 inhibitors in patients with type 2 diabetes: post-authorisation safety study based on multinational cohorts . Diabetes Obes Metab. 2024 Apr;26(4):1291-304. doi: 10.1111/dom.15429
Anthony MS , Aroda VR, Parlett LE, Djebarri L, Berreghis S, Calingaert B , Beachler DC, Crowe CL, Johannes CB , Juhaeri J, Lanes S, Pan C, Rothman KJ , Saltus CW , Walsh KE. Risk of anaphylaxis among new users of glp-1 receptor agonists: a cohort study . Diabetes Care. 2024 Apr 1;47(4):712-9. doi: 10.2337/dc23-1911
Wesselink AK, Kirwa K, Hystad P, Kaufman JD, Szpiro AA, Willis MD, Savitz DA, Levy JI, Rothman K , Mikkelsen EM, Laursen ASDL, Hatch EE, Wise LA. Ambient air pollution and rate of spontaneous abortion . Environ Res. 2024 Apr 1;246:118067. doi: 10.1016/j.envres.2023.118067
Keens T, Hoffman V , Topuria I, Elder K, Cerf S, Mulder K, Roberts J, Lysinger J, Del Carmen Reyes M, Berdella M, Cairns AM, Jain M, Ganapathy V, Lou Y, Morcos B, Wu C, Sass L, VX19-CFD-003 Study Group. Real-world effectiveness of elexacaftor/tezacaftor/ivacaftor on the burden of illness in adolescents and adults with cystic fibrosis . Heliyon. 2024 Mar 26;10(7):e28508. doi: 10.1016/j.heliyon.2024.e28508
Lloyd PC, Lufkin B, Moll K, Ogilvie RP, McMahill-Walraven CN, Beachler DC, Kelman JA, Shi X, Hobbi S, Amend KL, Djibo DA, Shangguan S, Shoaibi A, Sheng M, Secora A, Zhou CK, Kowarski L, Chillarige Y, Forshee RA, Anderson SA, Muthuri S, Seeger JD , Kline A, Reich C, MaCurdy T, Wong HL. Incidence rates of thrombosis with thrombocytopenia syndrome (TTS) among adults in United States commercial and Medicare claims databases, 2017-2020 . Vaccine. 2024 Mar 19;42(8):2004-10. doi: 10.1016/j.vaccine.2024.02.017.
Joseph MD, Koenig MR, Kuriyama AS, Wang TR, Wesselink AK, Eisenberg ML, Sommer GJ, Rothman KJ , Stuver SO, Wise LA, Hatch EE. A preconception cohort study of sugar-sweetened beverage consumption and semen quality . Andrology. 2024 Mar 7. doi: 10.1111/andr.13615
Koch S, Peralta GP, Carsin AE , Abellan A , Roda C, Torrent M, Iniguez C, Ballester F, Ferrero A, Zabaleta C, Lertxundi A, Guxens M, Vrijheid M, Sunyer J, Casas M, Garcia-Aymerich J. Physical activity and body mass related to catch-up lung function growth in childhood: a population-based accelerated cohort study . Thorax. 2024 Mar 6;79(8):762-9. doi: 10.1136/thorax-2022-219666
Rao S , Forns J , Danysh HE , Calingaert B , Dempsey C, Aquilina T, Pathak S, Anthony MS , Layton JB . Natural history and clinical outcomes in patients with Alzheimer's disease-related psychosis in the United States . Presented at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) 2024; March 5, 2024. Lisbon, Portugal.
Cadman T, Strandberg-Larsen K, Calas L, Christiansen M, Culpin I, Dadvand P, de Castro M, Foraster M , Fossati S, Guxens M, Harris JR, Hillegers M, Jaddoe V, Lee Y, Lepeule J, El Marroun H, Maule M, McEachen R, Moccia C, Nader J, Nieuwenhuijsen M, Nybo Andersen AM, Pearson R, Swertz M, Vafeiadi M, Vrijheid M, Wright J, Lawlor DA, Pedersen M. Urban environment in pregnancy and postpartum depression: an individual participant data meta-analysis of 12 European birth cohorts . Environ Int. 2024 Mar;185:108453. doi: 10.1016/j.envint.2024.108453
Muntner P, Hernandez RK, Kent ST, Browning JE, Gilbertson DT, Hurwitz KE, Jick SS, Lai EC, Lash TL, Monda KL, Rothman KJ , Bradbury BD, Brookhart MA. Staging and clean room: constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data . Pharmacoepidemiol Drug Saf. 2024 Mar;33(3):1-10. doi: 10.1002/pds.5770
Abellan A , Warembourg C, Mensink-Bout SM, Ambros A, de Castro M, Fossati S, Guxens M, Jaddoe VW, Nieuwenhuijsen MJ, Vrijheid M, Santos S, Casas M, Duijts L. Urban environment during pregnancy and lung function, wheezing, and asthma in school-age children. The generation R study . Environ Pollut. 2024 Mar 1;344:123345. doi: 10.1016/j.envpol.2024.123345
Desai RJ, Wang SV, Sreedhara SK, Zabotka L, Khosrow-Khavar F, Nelson JC, Shi X, Toh S, Wyss R, Patorno E, Dutcher S, Li J, Lee H, Ball R, Dal Pan G, Segal JB, Suissa S, Rothman KJ , Greenland S, Hernan MA, Heagerty PJ, Schneeweiss S. Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center . BMJ. 2024 Feb 12;384:e076460. doi: 10.1136/bmj-2023-076460
Bond JC, Coleman CM, Yland JJ, Wesselink AK, Wang T, Willis M, Hatch EE, Rothman KJ , Savitz D, Eisenberg ML, Wise LA. Preconception sleep duration, non-daytime work schedules, and incidence of spontaneous abortion: a prospective cohort study . Hum Reprod. 2024 Feb 1;39(2):413-24. doi: 10.1093/humrep/dead249