Examples of using Pooled data in English and their translations into Romanian
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Pooled data from the ECHO and THRIVE trials.
The results below are pooled data from the two trials.
The following adverse reactions were observed during the clinical trials(pooled data*).
The safety profile is based on pooled data from clinical studies in 425 patients.
The pool is representative of the portfolio for which the pooled data is used;
(pooled data from the ECHO and THRIVE trials in the week 96 resistance analysis).
Psychiatric Adverse Events Occurring in≥ 1% of Patients from Pooled Data from 18 Clinical Trials.
Table 1 shows pooled data from the overall treatment period in CLEOPATRA(data cutoff 11 February 2014; median number of cycles of Perjeta was 24);
Table 2: Annual rate of decline in FVC(mL) in trials INPULSIS-1,INPULSIS-2 and their pooled data- treated set.
Assessment of adverse reactions is based on pooled data from five Phase 3 clinical studies(both controlled and uncontrolled).
Table 3: Proportion of FVC responders at 52 weeks in trials INPULSIS-1,INPULSIS-2 and their pooled data- treated set.
Adverse drug reactions(ADRs)based upon pooled data are shown by system, organ class and by preferred term are listed below.
Table 6: All-cause mortality over 52 weeks in trials INPULSIS-1,INPULSIS-2, and their pooled data- treated set.
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).
Institutions may use external data(including pooled data) or statistical models for quantification provided a strong link exists between the following.
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.
In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received Enbrel.
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).
In the pooled data from clinical trials the most commonly reported adverse reactions with naloxegol(≥ 5%) are: abdominal pain, diarrhoea, nausea, headache and flatulence.
Table 4: Frequency of patients with≥ 10% absolute decline of FVC% predicted or death over 52 weeks andtime to progression in trials INPULSIS-1, INPULSIS-2, and their pooled data- treated set.
The project pooled data show that in March(when they started testing) by the end of August, 6628 patients across the country were tested with modern equipment.
Table 4: Virologic outcomes of randomised treatment of studies TMC278-C209 and TMC278-C215(pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with FTC/TDF) at Week 48(primary) and Week 96.
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 1: All treatment-emergent adverse drug reactions reported 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.
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.
Tabulated list of adverse reactions in breast cancer for adjuvant therapy with DOCETAXEL KABI 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive(TAX 316) and node-negative(GEICAM 9805)breast cancer- pooled data.
In pooled data, mean eosinophil counts were 655 µL-1(n=476) and 654 µL-1(n=477) for the placebo and reslizumab treatment groups at baseline and were 514 µL-1(n=405) and 61 µL-1(n=407) at week 52.
Table 5: Frequency of patients with acute IPF exacerbations over 52 weeks and time to first exacerbation analysis based on investigator-reported events in trials INPULSIS-1,INPULSIS-2, and their pooled data- treated set.