A randomized phase II design with a time-to-event endpoint using predictive probability of success of the follow-up phase III study as the criteria for go/no-go decision.

被引:0
|
作者
Chen, B.
Fan, X.
Wang, Y.
Jauffret, S.
Dey, J.
Waltzman, R.
Lopez-Martin, E. M.
Malek, K.
Kreitz, S.
Zuber, E.
机构
[1] Novartis Pharmaceut, E Hanover, NJ USA
[2] Novartis Pharma AG, Basel, Switzerland
[3] Novartis Farmaceut SA, Barcelona, Spain
关键词
D O I
10.1200/jco.2010.28.15_suppl.e18078
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
e18078
引用
收藏
页数:1
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    Singhal, S
    Jagannath, S
    Irwin, DH
    Rajkumar, SV
    Srkalovic, G
    Alsina, M
    Anderson, KC
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    Little, W
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    Davies, M
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