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Abtahi S, Pajouheshnia R , Duran CE, Riera-Arnau J, Gamba M, Alsina E, Hoxhaj V, Andersen M, Bartolini C, Kristiansen SB, Brown J, Hallgreen CE, Garcia-Poza P, Gardarsdottir H, Gini R, Girardi A, Holthuis E, Huerta C, Ibanez L, Limoncella G, Martin-Perez M, Paoletti O, Roberto G, Souverein P, Swart KMA, Wing K, Sturkenboom M, Klungel O. Impact of 2018 EU Risk minimisation measures and revised pregnancy prevention programme on utilisation and prescribing trends of medicinal products containing valproate: an interrupted time series study . Drug Saf. 2023 Jul;46(7):689-702. doi: 10.1007/s40264-023-01314-3
Johannes CB , Beachler DC, Layton JB , Danysh HE , Ziemiecki R , Arana A , Dinh J, Li L, Calingaert B , Pladevall-Vila M , Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A . Post-authorization safety study of hospitalization for acute kidney injury in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting . Drug Saf. 2023 Feb 1;46(2):157-74. doi: 10.1007/s40264-022-01263-3
Danysh HE , Johannes CB , Beachler DC, Layton JB , Ziemiecki R , Arana A , Dinh J, Li L, Calingaert B , Pladevall-Vila M , Hunt PR, Chen H, Karlsson C, Johnsson K, Gilsenan A . Post-authorization safety studies of acute liver injury and severe complications of urinary tract infection in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting . Drug Saf. 2023 Feb 1;46(2):175-93. doi: 10.1007/s40264-022-01262-4
Abtahi S, Pajouheshnia R , Duran-Salinas C, Riera-Arnau J, Gamba M, Alsina E, Hallgreen CE, Limoncella G, Bartolini C, Holthuis E, Martin-Perez M, Brown J, Sturkenboom M, Klungel O, Other Lot Consortium Members of the Valproate study. Impact of 2018 EU risk minimisation measures and revised pregnancy prevention programme on utilisation and prescribing trends of valproates . Poster presented at the 21st International Society of Pharmacovigilance (ISoP) Annual Meeting 2022; September 20, 2022. Verona, Italy. [abstract] Drug Saf. 2022 Aug 29; 45:1312-3. doi: 10.1007/s40264-022-01219-7
Abtahi S, Pajouheshnia R , Duran-Salinas C, Riera-Arnau J, Gamba M, Alsina E, Hallgreen CE, Limoncella G, Bartolini C, Martin-Perez M, Brown J, Sturkenboom M, Klungel O, Other Lot4 Consortium Members of the Valproate study1. Impact of the 2018 pregnancy prevention program on the use of oral retinoids in childbearing age females in Europe . Presented at the 21st International Society of Pharmacovigilance (ISoP) Annual Meeting 2022; September 20, 2022. Verona, Italy. [abstract] Drug Saf. 2022 Aug 29; 45:1111-327. doi: 10.1007/s40264-022-01219-7
Beau-Lejdstrom R, Hong LS, Garcia de Albeniz X , Floricel F, Lorenzen J, Bonfitto F, Kalilani L, Loesch C, Luscombe G, Perez-Gutthann S , Mottet I, Foskett N. Incidence of acute renal failure in patients using Levetiracetam versus other antiseizure medications: a voluntary post-authorization safety study . Drug Saf. 2022 Jul;45(7):781-90. doi: 10.1007/s40264-022-01193-0
Ersbøll AK, Sengupta K, Pukkala E, Bolin K, Aas E, Emneus M, Ramey DR, Brady JE, Mines D , Aasbjerg K, Vestergaard C, Gislason G, Born AP, Kjærulff TM. Desloratadine exposure and incidence of seizure: a nordic post-authorization safety study using a new-user cohort study design, 2001-2015 . Drug Saf. 2021 Nov;44(11):1231-42. doi: 10.1007/s40264-021-01106-7
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
Gilsenan A , Fortuny J , Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Harding A , Kollhorst B, Karlsson P, Linner L, MacDonald TM, Odsbu E, Plana E , Ruigomez A, Schink T, Ziemiecki R , Andrews EB. Cardiovascular safety of prucalopride in patients with chronic constipation: a multinational population-based cohort study . Drug Saf. 2019 Oct;42(10):1179-90. doi: 10.1007/s40264-019-00835-0
Fortuny J , Gilsenan A , Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Plana E , Ruigomez A, Schink T, Ziemiecki R , Andrews EB. Study design and cohort comparability in a study of major cardiovascular events in new users of prucalopride versus polyethylene glycol 3350 . Drug Saf. 2019 Oct;47(10):1167-77. doi: 10.1007/s40264-019-00836-z
Yosipovitch G, Reaney M, Mastey V, Eckert L, Nelson L , Clark M , Abbe A, Ardeleanu M, Radin A, Gadkari A. Validation of the peak pruritus numerical rating scale: results from clinical studies of dupilumab in adults with moderate-to-severe atopic dermatitis . Poster presented at the 2017 American Academy of Dermatology Annual Meeting; March 4, 2017. Orlando, FL. [abstract] J Am Acad Dermatol. 2017 Jun; 76(6 Suppl 1):AB278. doi: 10.1016/j.jaad.2017.04.1082
Strober B, Gottlieb AB, Sherif B , Mollon P, Gilloteau I, McLeod L , Fox T, Mordin M , Gnanasakthy A , Papavassilis C, Lebwohl MG. Secukinumab sustains early patient-reported outcome benefits through 1 year: results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept . J Am Acad Dermatol. 2017 Apr;76(4):655-61. doi: 10.1016/j.jaad.2016.11.043
Strober B, Blauvelt A, Zhao Y, Milutinovic M, Mollon P, You R, Sherif B , Williams N, Fox T, Augustin M, Lebwohl M. Secukinumab treatment provides more effective relief from patient-reported psoriasis-related pain, itching, and scaling than ustekinumab . Poster presented at the American Academy of Dermatology 74th Annual Meeting; March 4, 2016. Washington, DC. [abstract] J Am Acad Dermatol. 2016 May; 74(5 (Supplement 1)):AB273. Previously presented at the 24th European Academy of Dermatology and Venereology Congress. doi: 10.1016/j.jaad.2016.02.1054
Korman N, Sofen H, Rich P, Fretzin S, Zhao Y, Herrera V, Mordin M , Williams N, Nyirady J, Tyring S. Secukinumab provides more effective relief from psoriasis impact on personal relationships and influence on clothes worn than etanercept and placebo . Poster presented at the American Academy of Dermatology 74th Annual Meeting; March 4, 2016. Washington, DC. [abstract] J Am Acad Dermatol. 2016 May; 74(5 (Supplement 1)):AB272. doi: 10.1016/j.jaad.2016.02.1049
Tyring S, Sofen H, Fretzin S, Rich P, Zhao Y, Herrera V, Sherif B , Williams N, Nyirady J, Korman N. Secukinumab provides more effective relief from skin-related quality-of-life impact than etanercept in moderate to severe psoriasis . Poster presented at the American Academy of Dermatology 74th Annual Meeting; March 4, 2016. Washington, DC. [abstract] J Am Acad Dermatol. 2016 May; 74(5 (Supplement 1)):AB272. doi: 10.1016/j.jaad.2016.02.1050
Sofen H, Korman N, Rich P, Fretzin S, Zhao Y, Herrera V, Sherif B , McLeod L , Nyirady J, Tyring S. Secukinumab provides more effective relief from skin-related quality-of-life impact than placebo in moderate to severe psoriasis . Poster presented at the American Academy of Dermatology 74th Annual Meeting; March 4, 2016. Washington, DC. [abstract] J Am Acad Dermatol. 2016 May; 74(5 (Supplement 1)):AB272. doi: 10.1016/j.jaad.2016.02.1051
Blauvelt A, Korman N, Mollon P, Zhao Y, Milutinovic M, You R, Sherif B , Williams N, Fox T, Augustin M. Secukinumab treatment provides faster and more effective relief from patient-reported quality-of-life impact than ustekinumab in subjects with moderate to severe plaque psoriasis . Poster presented at the American Academy of Dermatology 74th Annual Meeting; March 4, 2016. Washington, DC. [abstract] J Am Acad Dermatol. 2016 May; 74(5[S1]):AB273. Previously presented at the 24th European Academy of Dermatology and Venereology Congress. doi: 10.1016/j.jaad.2016.02.1053
Kimball AB, Rothman KJ , Kricorian G, Pariser D, Yamauchi PS, Menter A, Teller CF, Aras G, Accortt NA, Hooper M, Rice KC, Gelfand JM. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results . J Am Acad Dermatol. 2015 Jan;72(1):115-22. doi: 10.1016/j.jaad.2014.08.050
Gulmez SE, Larrey D, Pageaux GP, Lignot S, Lassalle R, Jove J, Gatta A, McCormick A, Metselaar HJ, Monteiro E, Thorburn D, Bernal W, Zouboulis-Vafiadis I, de Vries C, Perez-Gutthann S , Sturkenboom M, Benichou J, Montastruc JL, Horsmans Y, Salvo F, Hamoud F, Micon S, Droz-Perroteau C, Blin P, Moore N. Transplantation for acute liver failure in patients exposed to NSAIDs or Paracetamol (acetaminophen): the multinational case-population SALT study . Drug Saf. 2013 Feb 1;36(2):135-44.
Arana A , Allen S, Burkowitz J, Fantoni V, Ghatnekar O, Rico MT, Vanhaverbeke N, Wentworth CE, Brosa M, Arellano FM. Infliximab paediatric Crohn's disease educational plan: a European, cross-sectional, multicentre evaluation . Drug Saf. 2010 Jun;33(6):489-501.