참고문헌 (28)

1. Management of Safety Information from Clinical Trials. 2005 Report of Council for International Organizations of Medical Sciences (CIOMS) Working Group VI Management of Safety Information from Clinical Trials. Report of Council for International Organizations of Medical Sciences (CIOMS) Working Group VI. Geneva, Switzerland: World Health Organization; 2005. 

2. Stat Biopharm Res B Crowe 5 3 180 2013 10.1080/19466315.2013.791640 Crowe B, Brueckner A, Beasley C, Kulkarni P. Current practices, challenges, and statistical issues with product safety labeling. Stat Biopharm Res. 2013;5(3):180-193. 

   상세보기

3. Drug Inf J C Chuang-Stein 32 1363 1998 10.1177/00928615980320S132 Chuang-Stein C. Safety analysis in controlled clinical trials. Drug Inf J. 1998;32:1363-1372. 

   상세보기

4. J Biopharm Stat O Siddiqui 19 5 889 2009 10.1080/10543400903105463 Siddiqui O. Statistical methods to analyze adverse events data of randomized clinical trials. J Biopharm Stat. 2009;19(5):889-899. 

   상세보기

5. N Engl J Med DM Black 356 1809 2007 10.1056/NEJMoa067312 Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356:1809-1822. 

   상세보기

6. Stat Med GF Liu 25 1275 2006 10.1002/sim.2335 Liu GF, Wang J, Liu K, Snavely DB. Confidence intervals for an exposure adjusted incidence rate difference with applications to clinical trials. Stat Med. 2006;25:1275-1286. 

   상세보기

7. N Engl J Med RS Bresalier 352 11 1092 2005 10.1056/NEJMoa050493 Bresalier RS, Sandler PS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005;352(11):1092-1102. 

   상세보기

8. Drug Inf J G Rosenkranz 40 79 2006 10.1177/009286150604000110 Rosenkranz G. Analysis of adverse events in the presence of discontinuations. Drug Inf J. 2006;40:79-87. 

   상세보기

9. Biometrics DF Heitjan 49 1099 1993 10.2307/2532251 Heitjan DF. Ignorability and coarsening: some biomedical examples. Biometrics. 1993;49:1099-1109. 

   상세보기

10. Biometrika DY Lin 83 381 1996 10.1093/biomet/83.2.381 Lin DY, Robins JM, Wei LJ. Comparing two failure time distributions in the presence of dependent censoring. Biometrika. 1996;83:381-393. 

    상세보기

11. Biometrika JP Fine 88 907 2001 10.1093/biomet/88.4.907 Fine JP, Jiang H, Chappell R. On semi-competing risks data. Biometrika. 2001;88:907-919. 

    상세보기

12. Controlled Clin Trials H Jiang 24 135 2003 10.1016/S0197-2456(02)00307-0 Jiang H, Chappell R, Fine JP. Estimating the distribution of nonterminal event time in the presence of mortality or informative dropout. Controlled Clin Trials. 2003;24:135-146. 

    상세보기

13. Berkrot B. Biogen reports 10 more Tysabri PML cases, 4 deaths. Reuters, February 18, 2011. Available at: http://www.reuters.com/article/2011/02/18/biogen-tysabri-idUSN1811430320110218. 

14. Xie T, et al. Statistical analysis of safety data in long-term clinical trials. Paper presented at the Joint Statistical Meetings-Biometrics Section; New York City, New York; 2002. 

15. Pharm Stat SS Menjoge 2 191 2003 10.1002/pst.37 Menjoge SS. On estimation of frequency data with censored observations. Pharm Stat. 2003;2:191-197. 

    상세보기

16. WB Nelson 2003 Recurrent Events Analysis for Product Repairs, Disease Recurrences, and Other Applications 10.1137/1.9780898718454 Nelson WB. Recurrent Events Analysis for Product Repairs, Disease Recurrences, and Other Applications. ASA-SIAM Series on Statistics and Applied Probability. Philadelphia, PA: Society for Industrial and Applied Mathematics; 2003. 

    

17. J R Stat Soc B DY Lin 62 4 711 2000 10.1111/1467-9868.00259 Lin DY, Wei LJ, Yang I, Ying Z. Semiparametric regression for the mean and rate functions of recurrent events. J R Stat Soc B. 2000;62(4):711-730. 

    상세보기

18. N Engl J Med A Laupacis 318 26 1728 1988 10.1056/NEJM198806303182605 Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med. 1988;318(26):1728-1733. 

    상세보기

19. J Clin Epidemiol TJ Mayne 59 217 2006 10.1016/j.jclinepi.2005.07.006 Mayne TJ, Whalen E, Vu A. Annualized was found better than absolute risk reduction in the calculation of number needed to treat in chronic conditions. J Clin Epidemiol. 2006;59:217-223. 

    상세보기

20. BMJ DG Altman 317 7168 1309 1998 10.1136/bmj.317.7168.1309 Altman DG. Confidence intervals for the number needed to treat. BMJ. 1998;317(7168):1309-1312. 

    상세보기

21. JD Kalbfleisch 2002 The Statistical Analysis of Failure Time Data 2nd ed 10.1002/9781118032985 Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. 2nd ed. New York, NY: John Wiley; 2002. 

    

22. Biometrika DM Dabrowska 76 763 1989 10.1093/biomet/76.4.763 Dabrowska DM, Doksum KA, Song J. Graphical comparison of cumulative hazards for two populations. Biometrika. 1989;76:763-773. 

    상세보기

23. Biometrika DY Lin 81 73 1994 10.2307/2337051 Lin DY, Fleming T, Wei LJ. Confidence bands for survival curves under the proportional hazards model. Biometrika. 1994;81:73-82. 

    상세보기

24. Scand J Stat MI Parzen 24 309 1997 10.1111/1467-9469.t01-1-00065 Parzen MI, Wei LJ, Ying Z. Simultaneous confidence intervals for the difference of two survival functions. Scand J Stat. 1997;24:309-314. 

    상세보기

25. Epidemiology S Greenland 4 32 1993 10.1097/00001648-199301000-00007 Greenland S. Additive risk versus additive relative risk models. Epidemiology. 1993;4:32-36. 

    상세보기

26. Arch Dis Child AK Akobeng 90 54 2005 10.1136/adc.2004.052233 Akobeng AK. Understanding measures of treatment effect in clinical trials. Arch Dis Child. 2005;90:54-56. 

    상세보기

27. Acta Psychiatr Scand L Citrome 121 94 2010 10.1111/j.1600-0447.2009.01449.x Citrome L. Relative vs. absolute measures of benefit and risk: what’s the difference? Acta Psychiatr Scand. 2010;121:94-102. 

    상세보기

28. Guidance for industry, diabetes mellitus-evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2008.