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Analysis of the interim results was performed after each stage when patients became fully assessable.
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Because of the interim analysis, the primary analysis of the study was performed at a significance level of 0.0467.
The interim analysis of the study looked at 37 patients who completed 56 days of treatment with the combination of Kalydeco and VX-809, and 11 patients who received a placebo.
5 Even in the interim analysis of the Multicenter Selective Lymphadenectomy Trial I, the false-negative rate is 17.6%.
The interim analysis of the data (first 82 patients) revealed a significant overestimation of mortality risk by the PESI in this subgroup of patients [ 27].
The future of endocrine treatment for breast cancer is currently uncertain since the interim analysis of the Arimidex, tamoxifen, alone or in combination (ATAC) trial [ 2].
However, the interim analysis of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) trial has shown inconclusive results (21).
These results were, however, not confirmed by the interim analysis of the major cardiovascular events occurring in the RECORD trial [ 35].
The interim analysis of the REAL-2 study reported 9% grade 3/4 lethargy for patients treated with ECX (Sumpter et al, 2005).
In the interim analysis of the European compassionate use program, cabazitaxel-related adverse events were manageable in clinical practice in elderly population (≥70 years).
In order to facilitate the interim analysis of the data by the review committee, the randomization algorithm was weighted so that 8 of the first 10 patients receive either the lowest or the highest drug dosage.
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