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Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.
Velentgas P, Amato AA, Bohn RL, Chan KA, Cochrane T, Funch DP, Dashevsky I, Duddy AL, Gladowski P, Greenberg SA, Kramer JM, McMahill-Walraven C, Nakasato C, Spettell CM, Syat BL, Wahl PM, Walker AM, Zhang F, Brown JS, Platt R. Velentgas P, et al. Pharmacoepidemiol Drug Saf. 2012 Dec;21(12):1350-8. doi: 10.1002/pds.3321. Epub 2012 Jul 16. Pharmacoepidemiol Drug Saf. 2012. PMID: 22807266
Intussusception risk after rotavirus vaccination in U.S. infants.
Yih WK, Lieu TA, Kulldorff M, Martin D, McMahill-Walraven CN, Platt R, Selvam N, Selvan M, Lee GM, Nguyen M. Yih WK, et al. N Engl J Med. 2014 Feb 6;370(6):503-12. doi: 10.1056/NEJMoa1303164. Epub 2014 Jan 14. N Engl J Med. 2014. PMID: 24422676 Free article.
Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System.
Yih WK, Kulldorff M, Sandhu SK, Zichittella L, Maro JC, Cole DV, Jin R, Kawai AT, Baker MA, Liu C, McMahill-Walraven CN, Selvan MS, Platt R, Nguyen MD, Lee GM. Yih WK, et al. Pharmacoepidemiol Drug Saf. 2016 May;25(5):481-92. doi: 10.1002/pds.3908. Epub 2015 Nov 17. Pharmacoepidemiol Drug Saf. 2016. PMID: 26572776 Free PMC article.
Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.
Chrischilles EA, Gagne JJ, Fireman B, Nelson J, Toh S, Shoaibi A, Reichman ME, Wang S, Nguyen M, Zhang R, Izem R, Goulding MR, Southworth MR, Graham DJ, Fuller C, Katcoff H, Woodworth T, Rogers C, Saliga R, Lin ND, McMahill-Walraven CN, Nair VP, Haynes K, Carnahan RM. Chrischilles EA, et al. Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):263-271. doi: 10.1002/pds.4375. Epub 2018 Jan 10. Pharmacoepidemiol Drug Saf. 2018. PMID: 29318683
FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.
Cocoros NM, Pokorney SD, Haynes K, Garcia C, Al-Khalidi HR, Al-Khatib SM, Archdeacon P, Goldsack JC, Harkins T, Lin ND, Martin D, McCall D, Nair V, Parlett L, Temple R, McMahill-Walraven C, Granger CB, Platt R. Cocoros NM, et al. Clin Trials. 2019 Feb;16(1):90-97. doi: 10.1177/1740774518812776. Epub 2018 Nov 16. Clin Trials. 2019. PMID: 30445835
57 results