EnasGG. Making decisions about safety in clinical trials — the case for inferential statistics. Drug Inf J.1991;25: 439–446.
2.
HusterWJ. Clinical trial adverse events: The case for descriptive techniques. Drug lnf J.1991;25: 447–456.
3.
CutlerSJEdererF.Maximum utilization of the life table method in analyzing survival. Journal of Chronic Disease.1958;6: 699–712.
4.
O'NeillRT. Assessment of safety. In: PeaceKE, ed. Biopharmaceutical Statistics for Drug Development. New York: Marcel Dekker, Inc.; 1988: 543–604.
5.
CoxDR. Regression models and life tables (with discussion). Journal of the Royal Statistical Society B.1972;34: 187–220.
6.
EdwardsSEKochGGSollecitoWAPeaceKE. Summarization, analysis and monitoring of adverse events. In: PeaceKE, ed. Statistical Issues in Drug Research and Development. New York: Marcel Dekker, Inc.; 1990: 19–170.
7.
HedgesLOlkinI.Statistical Methods for Meta-analysis. New York: Academic Press; 1985.
8.
DerSimonianRLairdN.Meta–analysis in clinical trials. Controlled Clinical Trials.1986;7: 177–188.
FleissJL. Statistical Methods for Rates and Proportions, 2nd ed.New York: John Wiley & Sons; 1981.
11.
BissetteJCarrGKochGAdamsKFShepsDS. Analysis of (events/time at risk) ratios from two–period crossover studies. Proceedings of the Biopharmaceutical Section. Washington, DC: American Statistical Association; 1986: 104–9.