Sentences with phrase «interim analysis»

Synergen, a biotechnology company based in Boulder, Colorado, stopped the trial involving 700 patients when interim analysis of data showed that the drug, called Antril, was not working.

Patient accrual was stopped ahead of schedule after an unplanned interim analysis found substantially improved survival rates in the arm receiving local therapy, matching similar findings in a parallel trial.

Thus, the claim by Cowtan and Way (2014) that the ERA - interim analysis shows a rapidly increasing cold bias in HadCRUT4 after 1998 does not apply to HadCRUT4v4 over the longer post 1978 period.

The trial, named PREVAIL, was concluded early, after a planned interim analysis, because of overwhelming response to the treatment.

A previous interim analysis of the CHAARTED trial showed a survival benefit with docetaxel added to ADT, but there were a low number of events at that point.

After 12 - month interim analysis, placebo participants will be switched to active treatment (RG7916).

The trial was stopped for futility at the first interim analysis.

The FDA's announcement is based on a five - year interim analysis of data gathered during an ongoing ten - year study.

The Data Monitoring and Ethics Committee met in July 2013 to review the safety of family therapy in a formal interim analysis of the primary endpoint, at which point no concerns were raised, and it was recommended that SHIFT continue to recruit the full sample.

The ERA - Interim analyses of soil moisture are included in the monthly summaries to provide a qualitative picture of major anomalies and to show the consistency with other variables.

An interim analysis of a trial of a vaccine to protect against the deadly ebola virus has been called «highly effective,» the World Health Organization announced today.

Interim analysis of a trial to protect against the deadly disease has been shown to, thus far, be successful.

said they will discontinue a late - stage trial of their experimental lung cancer drug after an interim analysis showed it would not meet the main goal of improving overall survival.

And in a rather brave pronouncement, management said during the company's recent quarterly conference call: «We expect that this interim analysis will determine if we have successfully met our primary endpoint, thus allowing us to halt the trial and file a [Biologics License Application].»

While researchers did not find differences in survival rates, they did find differences in side effects between the treatment arms at this interim analysis.

However, in a current comparative study there was a problem in the interim analysis: The events defined as study outcomes, pyelonephritis and preterm birth, occurred considerably less often than expected.

This interim analysis included 60 patients, with an average age of 68 years.

Healthy adults mounted strong immune responses after receiving an investigational whole inactivated Zika virus vaccine, according to interim analyses of three Phase 1, placebo - controlled, double - blind trials conducted at Beth Israel Deaconess Medical Center (BIDMC), Walter Reed Army Institute of Research (WRAIR), and Saint Louis University School of Medicine.

The U.S. study testing the long - term benefits and risks of hormone replacement therapy (HRT) was halted after an interim analysis found that the drugs — a combination of estrogen and progestin — increased the risk of breast cancer, stroke, and heart disease, and that those risks outweighed reduced risks of colorectal cancer and bone fractures (ScienceNOW, 9 July).

In fact, the trial was terminated early based on the recommendation of an independent data and safety monitoring board because an interim analysis demonstrated efficacy of the intervention with 49 percent of the enrollment target.

The study was stopped early because an interim analysis conducted by the data safety monitoring board demonstrated futility for simvastatin to provide benefit for COPD.

The interim analysis found a median progression - free survival rate of 9.7 months with consolidative radiation therapy followed by chemotherapy, versus 3.5 months for maintenance chemotherapy alone (p = 0.01; Hazard Ratio (HR) = 0.304, 95 % CI 0.113 - 0.815).

In the lower - dose otamixaban group, discontinued by the data monitoring committee for futility based on the interim analysis, the rate of the primary outcome at day 7 was 6.3 percent.

But an interim analysis presented today by Foy and Dabiré at the annual meeting of the American Society of Tropical Medicine and Hygiene suggests that the drug is already having an impact.

The interim analysis found that 39 people had become infected, and 28 cases were linked by genetic tests to their regular partners.

NIAID, which spent $ 73 million on the trial, had planned to fund it for another 4 years, but an interim analysis by an independent monitoring group led the institute to pull the plug early and announce the results.

A recent press release from Auspex Pharmaceuticals reported on an interim analysis from their ongoing ARC - HD trial that switching from tetrabenazine (Xenazine) to SD - 109, resulted in equal control of chorea in Huntington's disease.

For this interim analysis, Hellmann described the 3 - month progression - free and overall survival rates.

NEWARK, Calif., May 31, 2016 (GLOBE NEWSWIRE)-- StemCells, Inc. (NASDAQ: STEM)(the «Company») today announced its decision to terminate the Company's Phase II Pathway Study in spinal cord injury following an in - depth review of data from the study and after obtaining the concurrence of the study's Interim Analysis Data Monitoring Committee (the «IA - DMC»).

Limitations of this study include that it is an open - label study and the results are from a planned interim analysis of 10 of 17 enrolled infants (7 patients with 2 SMN2 copies and 3 with 3 SMN2 copies) who met the treatment duration criterion at the time of the interim analysis.1

A prospective study on the natural history of patients with profound combined immunodeficiency (P - CID): an interim analysis.

On the basis of the results of an interim analysis, the trial was stopped after a median follow - up of 4.8 years.

An interim analysis of data received as of September 2017 showed that:

The study was terminated early following an interim analysis as the evidence was considered conclusive and it was deemed unethical to continue to withhold treatment from the placebo group.

The ERA - Interim analyses of soil moisture are included here to provide a qualitative picture of major anomalies and to show the consistency with other variables.

As a result of this interim analysis, we reduced the P value in our current analysis of the data from.050 to.049, as determined by the sequential design criteria of Fleming et al. 18 After the completion of the study, we also performed an analysis of the subsample, women who were enrolled prior to January 2002, to verify that these results were consistent with the full study sample.

No interim analysis is planned.