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Physiologic endpoints for clinical studies for cystic fibrosis
Sanja Stanojevic, Felix Ratjen Journal of Cystic Fibrosis Volume 15, Issue 4, Pages (July 2016) DOI: /j.jcf Copyright © 2016 European Cystic Fibrosis Society. Terms and Conditions
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Fig. 1 Sample size estimates (significance level=0.05, power=80%) based on the observed treatment effect and common standard deviation reported in the studies presented in Table 1. a) absolute change in FEV1 Liters where the average FEV1 in the placebo group was 2L and sample size was estimated for improvements of 20ml, 80ml and 360ml, b) Absolute change in FEV1% predicted where the placebo group has an average FEV1 of 65% predicted and sample size was estimated for a 1%, 5% and 10% absolute improvement and c) Relative change in FEV1 where the placebo group has an average change of 0% and sample size was estimated for a 2, 6, 10 and 15% improvement in FEV1. Journal of Cystic Fibrosis , DOI: ( /j.jcf ) Copyright © 2016 European Cystic Fibrosis Society. Terms and Conditions
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Fig. 2 Sample size estimates (significance level=0.05, power=80%) for LCI, where the placebo group has an average LCI change of 0units, and the sample size is estimated for improvements of 0.75, 1, 1.5 and 2units based on treatment effect that was observed in Table 2. Journal of Cystic Fibrosis , DOI: ( /j.jcf ) Copyright © 2016 European Cystic Fibrosis Society. Terms and Conditions
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