Sentences with phrase «secondary endpoints»

"Secondary endpoints" refers to additional measures or outcomes that are studied in a research study or clinical trial, apart from the primary objective. These secondary endpoints help gather more information and explore other aspects of the intervention or treatment being investigated. Full definition
The analysts were also impressed by LJPC - 501's statistically significant improvement in the key secondary endpoint of CV SOFA score.
There were also significant changes seen in secondary endpoints — body weight fell by 2.32 kg, diastolic blood pressure by 4.9 mm Hg, total cholesterol by 18.48 mg / dl, and heart rate by.27 beats / min.
Secondary endpoints included cough severity, urge to cough, quality of life, and global ratings of change, as measured by patient - reported outcomes.
«We believe regulators and physicians will want primary endpoint success and key 12 - month secondary endpoints, which could be a high bar.»
While the focus of this phase III trial was to assess differences in OS among patients receiving hypofractionated versus conventional RT, researchers also measured several secondary endpoints, including PFS (an indicator that the cancer is still present but has not spread), toxicities, quality of life and cost effectiveness of the treatment.
No differences were shown in the other secondary endpoints, which included the incidence of acute kidney injury, incidence of post-operative atrial fibrillation, quality of life and duration of stay in the intensive therapy unit and in the hospital.
The critical secondary endpoint of the change in retinal ganglion cell macular volume measured from baseline to week 48 demonstrated a statistically significant difference (p = 0.0189) between all GS010 - treated eyes and all sham - treated eyes, with untreated eyes losing 0.038 cubic mm of macular ganglion cell volume while treated eyes preserved their ganglion cell volume -LRB--0.003 cubic mm).
Statistically significant improvements over placebo in secondary endpoints, including severity and urge to cough, as well as quality of life and global ratings of change.
CALM study: secondary endpoints of a phase II study of a novel oncolytic immunotherapeutic agent, coxsackievirus A21, delivered intratumorally in patients with advanced malignant melanoma.
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.
But oliceridine's value proposition actually depends on how well it stacks up against morphine from both a safety and efficacy standpoint, which is the secondary endpoint in each trial.
Today researchers report results of one of the secondary endpoints, which was the change in LDL cholesterol at one year with one or two doses of inclisiran.
Secondary endpoints were total coronary heart disease, defined as fatal or non-fatal myocardial infarction, and total stroke, which included all fatal and non-fatal strokes.
The secondary endpoints were NACE at one year, as well as MACCE and bleeding at 30 days and one year.
The primary endpoint of the study was progression - free survival (PFS) and secondary endpoints were overall survival (OS), response rate and safety.
The secondary endpoint of overall survival was also significantly prolonged, and 80 % of patients on pembrolizumab were alive at six months compared to 72 % on chemotherapy (HR = 0.60).
However, a pre-specified examination of the study's secondary endpoints, which included the rate of heart attacks, revealed that patients who received the methylprednisolone faced a 15 percent greater risk of death or heart attack and a 21 percent greater risk of heart attack alone, a pattern that was consistent across all subgroups.
Secondary endpoints were levels of cardiac enzymes and number of occurrences of ventricular arrhythmia.
Although the primary endpoint was not met, a statistically significant 4 percent improvement was seen in a secondary endpoint, left ventricular ejection fraction — a measure of how much blood is being pumped out of the left ventricle — in patients whose STEMIs involved the front wall of the left ventricle (the heart's main pumping chamber), he said.
The primary endpoint of the study was overall survival and secondary endpoints were the development of HCC and liver cirrhosis.
Nor were there significant differences between the two groups on blood flow from the left ventricle or levels of cardiac enzymes (secondary endpoints).
Significant improvements were also observed in all secondary endpoints.
Secondary endpoints were levels of other markers of atherosclerosis including LDL cholesterol.
However, bivalirudin was associated with significantly lower rates of bleeding complications and death, two of the study's secondary endpoints.
The study is ongoing and patients will continue to be followed to further evaluate the primary and secondary endpoints.
The secondary endpoint of change in thickness of the temporal quadrant and papillomacular bundle of the retinal nerve fiber layer from baseline to week 48 demonstrated a large statistically significant difference (p = 0.0359) between all GS010 - treated eyes and all sham - treated eyes, with untreated eyes showing a loss of 3.4 μm while treated eyes showed a limited loss of 0.6 μm.
With regard to median overall survival (OS), a secondary endpoint, T - VEC had a 4.4 - month advantage over GM - CSF (23.3 months vs 18.9 months [hazard ratio (HR), 0.79 (95 % CI, 0.62 — 1.00); P =.051]-RRB-; this approached but did not achieve statistical significance.
The secondary endpoint was ORR (CR + PR).
Although the full results are not yet published, Elysium Health just issued this press release stating that primary and secondary endpoints were met.
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