笔记详情
标题
II期研究的最小样本量计算描述（Phase II Study of the Safety and Efficacy of Temsirolimus in East Asian Patients with Advanced Renal Cell Carcinoma）
内容
The study was planned to include ∼80 patients (20 Japanese, 30 Chinese
and 30 Korean). The null hypothesis (uninteresting
CBR) was set at 20% and the alternative
hypothesis (sufficiently promising CBR) was set at 40%. With a sample
size of 80 patients,
there was an ∼97% chance that the 95% CI for the
CBR excluded 20% when the true rate was 40%. The number of patients in
each
country was based on clinical considerations.
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来源
Jpn. J. Clin. Oncol. (2012) 42 (9): 836-844.
类别
领域
Cancer/Oncology
关键词
