Adjusting the Crossover Effect in Survival Analysis Using a Rank ...

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Overall Survival (NDA, 2005)Overall Survival Probability (%)100908070605040302010Sunitinib (N=207)Placebo (N=105)Hazard Ratio=0.4995% CI (0.29, 0.83)P=0.00700 26 52 78 104 130 156 182 208 234Time (Week)HTMR Network Workshop on Treatment Switching February 20, 2012
Overall Survival (Final, 2008)Overall Survival Probability (%)100908070605040302010Sunitinib (N=243)Median 72.7 weeks95% CI (61.3, 83.0)Placebo (N=118)Median 64.9 weeks95% CI (45.7, 96.0)Hazard Ratio=0.87695% CI (0.679, 1.129)p=0.30600 26 52 78 104 130 156 182 208 234Time (Week)HTMR Network Workshop on Treatment Switching February 20, 2012
Page 1 and 2: Adjusting the Crossover Effect in O
Page 3 and 4: Uniqueness of Oncology TrialsThe de
Page 5 and 6: Overall Survival (OS)• OS is defi
Page 7 and 8: Time to Tumor Progression (TTP)•
Page 9 and 10: OS, TTP, and PFS Challenges• OS c
Page 11 and 12: Sutent ® (sunitinib malate)• Mec
Page 13 and 14: Study Objectives• Primary- TTP (a
Page 15 and 16: Time to Tumor Progression(Interim A
Page 17 and 18: Overall Survival (ASCO, 2006)Overal
Page 19 and 20: What We Know about Placebo Patients
Page 21 and 22: Conventional AnalysesITT (naïve)Co
Page 23 and 24: Impact of Crossover to OS Analysis
Page 25 and 26: Why/When Does Crossover Cause Bias?
Page 27: A Novel Solution to the Crossover I
Page 31 and 32: Overall Survival (Final, 2008)Cross
Page 33 and 34: The End of the Story• The final G
Page 35 and 36: Conclusions• The benefit demonstr

Adjusting the Crossover Effect in Survival Analysis Using a Rank ...

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