Sentences with phrase «one's primary endpoint»

A significant difference emerged at the one - year primary endpoint of all - cause mortality: 14.2 percent for TAVR with CoreValve compared with 19.1 percent for surgical replacement.

«Stroke Care: Randomized penumbra 3 - D trial of next generation stent retriever meets primary endpoints: Data also highlight frontline effectiveness of aspiration using Penumbra System for stroke revascularization.»

• Study achieves primary endpoints; DG031 shown to be well - tolerated and to significantly reduce levels of leukotriene B4 and myeloperoxidase • First ever clinical trial based upon the isolation of a disease gene in a common disease

The composite primary endpoint was defined as the onset of left ‑ sided CHF, cardiac ‑ related death, or euthanasia.

«Our plan moving forward is to analyze primary endpoint data and present updated toxicity results approximately one year from now.»

«We believe regulators and physicians will want primary endpoint success and key 12 - month secondary endpoints, which could be a high bar.»

However, the second primary endpoint, which included those events plus major bleeding, showed a significant reduced risk in patients randomized to receive a catheter via the arm, known as the radial approach, rather than the groin, known as the femoral approach.

The EPIC Study showed that administration of pimobendan resulted in a 15 ‑ month delay in time to primary endpoint compared with dogs receiving placebo.

However, a number of late - stage clinical trials have failed to meet primary endpoints and the fate of MSCs following systemic infusion is largely unknown.

• Study achieves primary endpoints; DG031 shown to be well - tolerated and to significantly reduce levels of leukotriene B4 and myeloperoxidase • First ever clinical trial based upon the isolation of a disease gene in a common disease Reykjavik, ICELAND, October 19,...

«While we are disappointed CheckMate - 026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase III CheckMate - 227 study exploring the potential of the combination of Opdivo plus [our other cancer immunotherapy] Yervoy for PD - L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD - L1 negative patients,» he added.

The primary endpoint of this global, double - blind study is the time to the first occurrence of a composite of primary major adverse cardiovascular events (MACE).

The trial's primary endpoint was progression - free survival, and its secondary goal was overall survival; Keytruda hit both.

Allergan and Paratek Pharmaceuticals are celebrating the success of sarecycline, an experimental acne treatment that met the primary endpoints in a pair of crucial phase 3 clinical trials.

Roche said a phase III IMvigor211 study that evaluated the drug in people with locally advanced or metastatic urothelial cancer whose disease progressed during or after treatment with chemotherapy «did not meet its primary endpoint of overall survival compared to chemotherapy.»

Both trials — which enrolled patients who had not fully responded to conventional disease - modifying drugs or to tumor necrosis factor (TNF) inhibitors — met their primary endpoints, the pharma giant said.

While the company hit its primary endpoints with the trial, patients in the test group experienced a higher...

On February 24th, the New York - based drug giant announced that Prevenar 13, a drug widely used to prevent infection in children, met its primary endpoint in a post-approval study consisting of 85,000 individuals aged 65 and older.

Given that LJPC - 501 achieved the primary endpoint suggested by the FDA, the analysts believe this should suffice for an approval in last - line approval, which means where patients have no other treatment options.

About 69.9 percent of angiotensin II patients achieved the primary endpoint versus 23.4 percent of placebo patients.

The primary endpoint is the response in mean arterial blood, or MAP, at hour three, and among the secondary endpoints was CV Sequential Organ Failure Assessment, or SOFA, score at hour 48.

So I'm willing to go out on a limb here and say that oliceridine will most likely hit the mark in each trial in terms of its primary endpoint.

Now, the first thing to understand about oliceridine's ongoing studies is that the primary endpoint for both trials is the drug's ability to outperform placebo as a pain reliever — a feat it has performed in spades in its mid-stage trials that even led to a breakthrough therapy designation from the FDA last February.

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].»

What: Shares of Alkermes (NASDAQ: ALKS) shed up to 43 % of their value on extraordinary volume in early morning trading today after the company announced that its orally administered drug ALKS - 5461, indicated for major depressive disorder (MDD), failed to meet its primary endpoints in two late - stage studies.

Results The intervention group showed significantly greater improvements over time for the primary endpoint of spiritual well - being as compared to the control group (P =.03, partial η2 =.01).

The NPSC score was chosen as the primary endpoint because it is an accepted, objective, continuous measure of the healthiness of packaged foods.

The primary endpoint was satisfaction with cosmetic outcome.

The primary endpoint was the percentage change in LDL cholesterol at six months for each dose of inclisiran versus placebo.

In the new study, patients receiving angioplasty with the new stents had a 47 percent higher risk of one of the outcomes identified as a primary endpoint in the study: death, heart attack and subsequent procedure to clear blocked arteries, as compared to patients who received bypass.

In the new study, 71 percent of patients treated with a surgical procedure called catheter ablation were free of atrial fibrillation, the study's primary endpoint, after two years of follow - up, while only 34 percent of patients who took the antiarrhythmic drug Amiodarone were free of symptoms at that point.

The primary endpoint of the study was major cardiovascular disease, defined as a combined endpoint of myocardial infarction, stroke or fatal cardiovascular disease.

The primary endpoint of death and non-fatal heart attack at 30 days was no different between the two groups (7 percent in the aspirin group and 7.1 percent in the placebo group); however, major bleeding was significantly higher in aspirin - treated patients than in the placebo group (4.6 percent vs. 3.7 percent).

Over the course of a 12 - week blinded treatment period and an 8 - week follow - up, those patients who had received weekly injections of dupilumab experienced an 87 percent reduction in protocol defined asthma exacerbations, the primary endpoint of the study, vs. weekly placebo injections (odds ratio [95 % CI] = 0.08 [0.021 to 0.28]; p < 0.01).

As reported in 2015, the study met its primary endpoint after a median follow up of 2.3 years, with ipilimumab significantly improving recurrence - free survival.2 The drug was subsequently approved by the US Food and Drug Administration as adjuvant therapy for stage III melanoma.

«The reason KEYNOTE - 024 met its primary endpoint, in contrast with other studies, is probably because the trial only included patients who had PD - L1 expression of at least 50 % and were therefore optimal candidates for treatment with pembrolizumab,» he added.

The primary endpoint was 30 - day net adverse clinical events (NACE), a composite of major adverse cardiac and cerebral events (MACCE; all - cause death, reinfarction, ischemia - driven target vessel revascularization, or stroke) or any bleeding as defined by the Bleeding Academic Research Consortium (BARC) definition.

The primary endpoint of the study was progression - free survival (PFS) and secondary endpoints were overall survival (OS), response rate and safety.

The investigators found that pembrolizumab significantly improved the primary endpoint of progression - free survival by approximately four months compared to chemotherapy (10.3 months versus 6.0 months, hazard ratio [HR] 0.50).

The study experienced very rapid enrollment and at the preplanned independent data and safety monitoring review panel, the study was stopped early only 10 months after the study commenced because it met the primary endpoint of improving progression - free survival (time to cancer relapse).

The primary endpoint was the change from baseline in 24 - hour ambulatory blood pressure after four months.

In 17 out of the 18 completed studies, surrogate measures were still the primary endpoints of the studies.

The primary endpoint of this trial is recurrence of breast cancer in the same breast, known as ipsilateral breast tumor recurrence (IBTR).

The primary endpoint was progression - free survival, assessed by a blinded independent review committee.

The primary endpoint was a reduction in apnea hypopnea index (AHI) at three months compared to baseline with six and 12 month data also collected.