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Unfortunately, the trial ended prematurely due to interim analysis results that showed that the trial crossed the futility boundary after the 92 PFS events were analyzed.
The interim analysis results (Table 3) show median age was 76 years (70 100 years).
Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous.
Discussion should be started on the inclusion of this minimal set of parameters in design/protocol papers and trial registries[ 154, 155] Reporting of DMC activities, interim analysis results and early termination of pediatric trials is incomplete and heterogeneous.
A total of 203 ICI cases were identified by the end of October 2010; since CRF collection and data management for part of the cases are ongoing, here we report the interim analysis results of 145 proven ICIs.
An international randomised phase III trial of sunitinib (administered in repeated cycles of 50 mg daily for 4 weeks then 2 weeks off) vs IFN- α (administered three times weekly) has recently completed accrual; interim analysis results will be available soon.
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In May 2013, an independent data monitoring committee conducted an interim analysis resulting in an unanimous recommendation to continue the study.
The change in randomization that occurred after the interim analysis resulted in an enrichment of lymph node-positive patients in the group of tamoxifen-treated patients.
Depending on the interim analysis result and prespecified P values, it had to be determined whether there was a premature study termination due to futility (P > 0·500), an early termination due to a significant result (P < 0·0102), or an adjustment of the sample size to reach a statistically significant result (0·0102 ≤ P ≤ 0·500).
The Dendreon Corporation said its Provenge vaccine for prostate cancer might not make the goals set for a late-stage study, according to an interim analysis of results, setting off a 38percentt fall in its share price.
Onyx also disclosed that the drug had failed to improve survival in an interim analysis of results from a clinical trial being conducted to win approval in Europe.
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