英語 での Interim analysis の使用例とその 日本語 への翻訳
{-}
-
Colloquial
-
Ecclesiastic
-
Computer
-
Programming
The results of this interim analysis indicate that rVSV-ZEBOV might be highly efficacious and safe in preventing Ebola virus disease and is most likely effective at the population level when delivered during an Ebola virus disease outbreak via a ring vaccination strategy.
This approval is based on two pivotal clinical studies for people with hemophilia A with inhibitors: the results of HAVEN 1 study(NCT02622321) for adolescents and adults, and the interim analysis of HAVEN 2 study(NCT02795767) in children.
This approval is based on the two pivotal studies for hemophilia A with inhibitors: the results of HAVEN1 study(NCT02622321) for adolescents and adults, and the interim analysis of HAVEN2 study(NCT02795767) in children.
The trial closed to enrollment early when an interim analysis revealed a higher frequency of relapse/disease persistence(7 of 9 patients) in children who received the reduced-intensity regimen than in children who received the standard-intensity regimen(1 of 6 patients).
When an interim analysis is planned with the intention of deciding whether or not to terminate a trial, this is usually accomplished by the use of a group sequential design which employs statistical monitoring schemes as guidances(see Section 3.4).
An independent data monitoring committee conducted an interim analysis, the results of which indicated that the pre-determined standard related to the primary endpoint of overall survival was not met, and they therefore recommended that the trial be terminated.
An interim analysis of this study was recently conducted, and the Independent Data Monitoring Committee determined that the pre-defined criteria for lack of efficacy of reldesemtiv had been met; Astellas has notified investigators to halt further enrollment in the trial.
Two different doses of fosravuconazole will be tested(200 mg and 300 mg weekly dose) and an interim analysis when 28 patients per arm reach 3 months will decide which of the two test arms should be continued based on efficacy and safety.
However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial(a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM(a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.
Nineteen poster presentations will be given by Eisai at AES 2018, including reports on the interim analysis results of a Phase III clinical study(Study 311) in pediatric patients aged 4 to less than 12 years as well as a presentation on sustained seizure-free status in the open-label extension phase of a Phase III clinical study(Study 307) in patients 12 years of age and older.
MYSTIC additionally includes several undisclosed interim analyses for OS.
No interim analyses were done.
The results for each dose arm are generally consistent with previous interim analyses.
A planned interim analysis was performed in January 2016.
Safety and tolerability from the STASEY study interim analysis.
The pre-planned interim analysis was triggered by the occurrence of 347 events.
This is an interim analysis, the final analysis should be available in 2014.
At interim analysis, accrual to the study was stopped early because of futility.
There was no statistically significant difference in OS at the first interim analysis for this endpoint.