Examples of using Pooled data in English and their translations into Slovak
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Pooled data from the ECHO and THRIVE trials.
The results below are pooled data from the two trials.
Pooled data was analyzed in three different ways.
The pool shall be representative for the portfolio for which the pooled data is used;
Credit institutions are allowed to use pooled data in the estimation of risk parameter values.
Previous studies were limited to asmall number of specific categories of foods or pooled data on products together.
The safety profile is based on pooled data from clinical studies in 425 patients.
Table 19: Treatment outcome in treatment-naïve HCV genotype 1 infected patients(pooled data studies C208 and C216).
Institutions using pooled data according to Articles 175(2) and 175(3) may outsource the following tasks.
Psychiatric Adverse Events Occurring in≥ 1% of Patients from Pooled Data from 18 Clinical Trials.
Adverse drug reactions(ADRs) based upon pooled data are shown by system, organ class and by preferred term are listed below.
Independently reviewed internal data ordata from external sources including pooled data shall be used;
Notwithstanding paragraph 128, credit institutions using pooled data according to paragraphs 57 and 58 may outsource the following tasks.
Based on pooled data from four phase III studies in patients with uterine fibroids treated for 3 months, the following adverse reactions have been reported.
Table 5:Resistance outcome by background NRTI regimen used(pooled data from the ECHO and THRIVE trials in the week 96 resistance analysis).
Pooled data from these studies demonstrated a significant advantage for Bondronat 50 mg p. o. over placebo in the reduction in SREs measured by the SMPR(p=0.041).
Assessment of adverse reactions is based on pooled data from five Phase 3 clinical studies(both controlled and uncontrolled).
Pooled data from these studies demonstrated a significant advantage for ibandronic acid 50 mg p. o. over placebo in the reduction in SREs measured by the SMPR(p=0.041).
Institutions may use external data(including pooled data) or statistical models for quantification provided that the following strong links both exist.
Table 2 Proportion of patients who achieved target serum uric acid levels(< 6 mg/dL)with Zurampic in combination with allopurinol- Pooled data from CLEAR1 and CLEAR2 studies.
One meta-analysis pooled data from 21 neuroimaging studies examining the brains of about 300 experienced meditation practitioners.
Table 4:Virologic outcome in adult subjects in the ECHO and THRIVE trials(pooled data in the week 48(primary) and week 96 analysis; ITT-TLOVR*).
In the pooled data from these two studies the most serious adverse reactions on Gilenya 0.5 mg were infections, macular oedema and transient atrioventricular block at treatment initiation.
Time to event analysis of the adjudicated exacerbation events using pooled data yielded a hazard ratio(HR) of 0.32(95% CI 0.16, 0.65; p=0.0010).
Pooled data from these 18 trials showed a similar incidence rate of individual categories of psychiatric events in patients treated with varenicline compared to patients treated with placebo.
Table 2: ADRs reported in antiretroviral treatment-naïve HIV-1infected adult patients treated with Rilpivirine(pooled data from the week 96 analysis of the Phase III ECHO and THRIVE trials) N=686.
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients(Aranesp 1200, placebo 912).
Table 1: All treatment-emergent adverse drug reactionsreported in patients in phase III studies(pooled data of the phase III studies for the indications wet AMD, CRVO, BRVO, DME and myopic CNV) or during post-marketing surveillance.
The placebo-controlled Phase 2 and Phase 3 Studies(pooled data) included 1,346 HCV-infected patients incidence rates are based on adverse event reporting rates(additionally, see Laboratory abnormalities below).