Examples of using Pre-specified in English and their translations into Hungarian
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Financial
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Programming
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Official/political
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Computer
Pre-specified interim analysis.
A= estimated time to median factor IX activity above the pre-specified%.
The pre-specified non-inferiority margin was a treatment difference of 20%.
What if companies told people that emailwill only be delivered during just three pre-specified times?
The essence of the game- to capture certain pre-specified control points(they- indicated by specific marks places on the map).
Transfer in Lebanon-land transportation service,which will save on taxis and quickly deliver to a pre-specified destination.
When the alarm is triggered, a pre-specified chain of people or personnel receive alerts, and the appropriate type of assistance is sent to the scene.
Both the time to viral suppression andchange from baseline analyses were pre-specified and adjusted for multiplicity.
Out of the pre-specified subgroup of patients with prior treatment with bortezomib and an immunomodulatory agent(N=193), 76% of patients had received at least two prior regimens.
Improvements in OS and PFS were consistently observed in pre-specified subgroups based on age, sex, race and in most other pre-specified subgroups.
RET mutation status should be assessed according to pre-defined mutational analysis, where type of test andexons to be analyzed are protocol pre-specified.
The pre-specified exchange rate for a foreign exchange contract settling at some agreed future date, based upon the interest rate differential between the two currencies involved.
In studies demonstrating superiority of XGEVA to zoledronic acid,patients were offered open label XGEVA in a pre-specified 2-year extension treatment phase.
In a separate pre-specified subgroup analysis, mean reductions from baseline in HbA1c were generally greater for patients with higher baseline HbA1c values.
Every year the Department for Employment and Learning in Northern Ireland(DEL)funds a number of PhD students to undertake research on pre-specified topics within the School of Psychology.
A pre-specified sensitivity analysis using the negative binomial regression model treatment showed a statistically significant difference of -14.2%(rate ratio: 0.86; 95% CI: 0.74 to 0.99).
In study TDM4370g/BO21977,consistent treatment benefit of trastuzumab emtansine was seen in the majority of pre-specified subgroups evaluated, supporting the robustness of the overall result.
Pre-specified events that occurred with the highest incidence in all three treatment groups involved the category of surgical wound complications, including deep surgical infections and sternal wound healing events.
A“symptom responder” was defined as meeting both the 12-week responder criteria anddemonstrating improvement in pre-specified OIC symptoms and no deterioration in symptoms.
There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke[0.87(95% CI 0.76- 1.00, p= 0.048)].
Pre-specified subgroup analyses of the primary endpoint by baseline CRP(≥ 1 mg/dL vs< 1 mg/dL) demonstrated higher flare rates in placebo+ MTX vs golimumab+ MTX treated subjects among subjects with baseline CRP≥ 1 mg/dL(87% vs 40% p= 0.0068).
Table 3 shows the results of a prospectively plannedcombined analysis of the CDI recurrence rates in pre-specified subgroups of patients at high risk for CDI recurrence across the two Phase 3 Trials.
One patient met the pre-specified criteria for treatment success(> 75% reduction in SEGA volume) and was temporarily taken off trial therapy; however, SEGA re-growth was evident at the next assessment at 4.5 months and treatment was restarted.
The Applicant statedthat no protocol was established before the in vitro comparison but that in house documents with pre-specified criteria were used and that test product batches were subjected to release and stability testing according to protocols from the quality control department.
At the pre-specified interim analysis for overall survival when 540 deaths were observed, treatment with enzalutamide demonstrated a statistically significant improvement in overall survival compared to treatment with placebo with a 29.4% reduction in risk of death[HR= 0.706,(95% CI: 0.596; 0.837), p< 0.0001].
After 6 consecutive monthly injections,patients received treatment only if they met pre-specified retreatment criteria, except for patients in the control group in the GALILEO study who continued to receive sham(control to control) until week 52.
A pre-specified interim meta-analysis was conducted of adjudicated major cardiovascular events in the phase 2 and 3 clinical studies in 9,632 patients with type 2 diabetes, including 4,327 patients(44.9%) with cardiovascular disease or at high risk for cardiovascular disease who are participating in an ongoing cardiovascular study.
Question 1- The Applicant should provide the protocol of the in vitro comparisons of the particle size distributions in dry conditions, humid conditions and with spacer where all the relevant information should have been pre-specified, e. g. objective, sample size required to demonstrate equivalence in the predefined pools of stages within a pre-specified acceptance range, the pre-specified batches and the pre-specified statistical methods.
Pre-specified subgroup analyses of PFS per IRF were performed by patients' best response to pre-ASCT salvage therapy, HL status after frontline therapy, age, gender, baseline weight, baseline ECOG performance status, number of treatments pre-ASCT, geographic region, pre-ASCT PET status, B symptom status after failure of frontline therapy, and pre-ASCT extranodal disease status.
The OS and PFS benefitwas observed consistently, in all relevant pre-specified subgroups, including race, geographic region, age(< 65;≥ 65), sex, ECOG PS, KRAS status, time since diagnosis of first metastasis, number of metastatic sites, and primary tumour site.
