Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR

被引:0
|
作者
Robert Bissonnette
Alice B. Gottlieb
Richard G. Langley
Craig L. Leonardi
Kim A. Papp
David M. Pariser
Jonathan Uy
Kim Parnell Lafferty
Wayne Langholff
Steven Fakharzadeh
Jesse A. Berlin
Emily S. Brouwer
Andrew J. Greenspan
Bruce E. Strober
机构
[1] Innovaderm Research,
[2] Inc.,undefined
[3] Icahn School of Medicine at Mount Sinai,undefined
[4] Dalhousie University,undefined
[5] Saint Louis University Medical School,undefined
[6] K. Papp Clinical Research and Probity Research Inc.,undefined
[7] Eastern Virginia Medical School,undefined
[8] Janssen Scientific Affairs,undefined
[9] LLC,undefined
[10] Janssen Research & Development,undefined
[11] LLC,undefined
[12] Janssen Global Services,undefined
[13] LLC,undefined
[14] Yale University,undefined
[15] Central Connecticut Dermatology Research,undefined
来源
Drug Safety | 2021年 / 44卷
关键词
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
页码:699 / 709
页数:10
相关论文
共 50 条
  • [1] Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR
    Bissonnette, Robert
    Gottlieb, Alice B.
    Langley, Richard G.
    Leonardi, Craig L.
    Papp, Kim A.
    Pariser, David M.
    Uy, Jonathan
    Lafferty, Kim Parnell
    Langholff, Wayne
    Fakharzadeh, Steven
    Berlin, Jesse A.
    Brouwer, Emily S.
    Greenspan, Andrew J.
    Strober, Bruce E.
    DRUG SAFETY, 2021, 44 (06) : 699 - 709
  • [2] Long-Term, Real-World Safety of Adalimumab in Rheumatoid Arthritis
    Harrold, Leslie R.
    Griffith, Jenny
    Litman, Heather J.
    Gershenson, Bernice
    Islam, Syecl
    Barr, Christine J.
    Guo, Dianlin
    Zueger, Patrick
    Fay, Jonathan
    Greenberg, Jeffrey
    ARTHRITIS & RHEUMATOLOGY, 2018, 70
  • [3] Long-term safety of onasemnogene abeparvovec for patients with spinal muscular atrophy: real-world findings from the RESTORE Registry
    Servais, L.
    Alecu, I.
    Lopez-Leon, S.
    Ilic, A.
    Brueckner, A.
    Benguerba, K.
    Reyna, S.
    Dabbous, O.
    Mumneh, N.
    Finkel, R.
    NEUROMUSCULAR DISORDERS, 2024, 43
  • [4] Long-Term Safety and Real-World Effectiveness of Trastuzumab in Breast Cancer
    Mazzotta, Marco
    Krasniqi, Eriseld
    Barchiesi, Giacomo
    Pizzuti, Laura
    Tomao, Federica
    Barba, Maddalena
    Vici, Patrizia
    JOURNAL OF CLINICAL MEDICINE, 2019, 8 (02)
  • [5] Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience
    Levra, Stefano
    Guida, Giuseppe
    Sprio, Andrea Elio
    Crosa, Flavio
    Ghio, Paolo Carlo
    Bertolini, Francesca
    Carriero, Vitina
    Albera, Carlo
    Ricciardolo, Fabio Luigi Massimo
    BIOMEDICINES, 2022, 10 (12)
  • [6] Long-Term Safety Experience with Bendamustine for Injection in a Real-World Setting
    Martin, Peter
    Barr, Paul
    Kahl, Brad S.
    Pathak, Ashutosh
    BLOOD, 2016, 128 (22)
  • [7] Long-term safety experience with bendamustine for injection in a real-world setting
    Martin, Peter
    Barr, Paul M.
    James, Leonard
    Pathak, Ashutosh
    Kahl, Brad
    EXPERT OPINION ON DRUG SAFETY, 2017, 16 (06) : 647 - 650
  • [8] Real-world long-term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry
    Iborra, Marisa
    Beltran, Belen
    Fernandez-Clotet, Agnes
    Iglesias-Flores, Eva
    Navarro, Pablo
    Rivero, Montserrat
    Gutierrez, Ana
    Sierra-Ausin, Monica
    Mesonero, Francisco
    Ferreiro-Iglesias, Rocio
    Hinojosa, Joaquin
    Calvet, Xavier
    Sicilia, Beatriz
    Gonzalez-Munoza, Carlos
    Antolin, Beatriz
    Gonzalez-Vivo, Maria
    Carbajo, Ana Y.
    Garcia-Lopez, Santiago
    Martin-Cardona, Albert
    Suris, Gerard
    Dolores Martin-Arranz, Maria
    de Francisco, Ruth
    Canete, Fiorella
    Domenech, Eugeni
    Nos, Pilar
    ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2020, 52 (06) : 1017 - 1030
  • [9] Real-world long-term effectiveness of ustekinumab in Crohn's disease: Results from the ENEIDA registry
    Iborra Colomino, M. I.
    Beltran, B.
    Fernandez-Clotet, A.
    Iglesias Flores, E.
    Navarro, P.
    Rivero, M.
    Gutierrez, A.
    Sierra-Ausin, M.
    Mesonero, F.
    Ferreiro-Iglesias, R.
    Hinojosa, J.
    Calvet, X.
    Sicilia, B.
    Gonzalez-Munoza, C.
    Antolin, B.
    Gonzalez Vivo, M.
    Carbajo, A. Y.
    Garcia, S.
    Martin-Cardona, A.
    Suris Marin, G.
    Martin-Arranz, M. D.
    De Francisco, R.
    Canete, F.
    Carlos, T.
    Gomollon, F.
    Lorente, R.
    Rodriguez-Lago, I.
    Fores-Bosch, A.
    Bernardos, E.
    Ramos, L.
    Delgado, P.
    Hernandez, A.
    Van Domselaar, M.
    Hervas, D.
    Domenech, E.
    Nos, P.
    JOURNAL OF CROHNS & COLITIS, 2020, 14 : S458 - S460
  • [10] REAL-WORLD LONG-TERM EFFECTIVENESS OF USTEKINUMAB IN CROHN'S DISEASE: RESULTS FROM THE ENEIDA REGISTRY
    Iborra, Marisa
    Beltran, Belen
    Fernandez-Clotet, Agnes
    Flores, Eva Iglesias
    Cortes, Pablo Navarro
    Rivero, Montserrat
    Gutierrez, Ana
    Sierra-Ausin, Monica
    Mesonero, Francisco
    Ferreiro, Rocio
    Hinojosa, Joaquin
    Calvet, Xavier
    Sicilia, Beatriz
    Gonzalez-Munosa, Carlos
    Antolin, Beatriz
    Gonzalez, Maria
    Lopez, Ana Y. Carbajo
    Garcia-Lopez, Santiago
    Cardona, Albert Martin
    Suris, Gerard
    Arranz, Maria Dolores A. Martin
    De Francisco, Ruth M.
    Canete, Fiorella
    Samso, Carlos Taxonera
    Gomollon, Fernando
    Lorente, Rufo
    Rodriguez-Lago, Iago
    Fores-Bosh, Ana
    Bernardos, Esther
    Ramos, Laura
    Delgado-Guillena, Pedro
    Camba, Alejandro Hernandez
    Van Domselaar, Manuel
    Hervas, David
    Domenech, Eugeni
    Nos, Pilar
    GASTROENTEROLOGY, 2020, 158 (06) : S953 - S953