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The study was stopped at the interim analysis for futility.
Results: The trial was stopped after the planned interim analysis for achieving efficacy endpoints and owing to safety concerns.
If the interim analysis for IMPACT had shown an unambiguous result, that would have been enough to get Provenge approved, but it didn't meet that high hurdle.
No interim analysis for efficacy was planned.
The randomization was interrupted at an interim analysis for lack of efficacy of the drug.
An interim analysis for efficacy is planned at two months after randomisation of the last patient.
Similar(23)
There was no provision for an interim analysis or for stopping the trial.
The trial is designed as a two-stage study with a planned interim analysis, allowing for early stopping, and a power of 0.90 to reject the null hypothesis.
After completion, patients were followed for an additional 2 years (interim analysis), and later for 5 years during which open-label simvastatin treatment was provided for all patients [ 19, 20].
Without any interim analysis, no adjustment for multiple testing was necessary and the study was analysed after collection of all data.
No interim analysis is planned for this study.
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CEO of Professional Science Editing for Scientists @ prosciediting.com