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multipla primerjava
1 Prevajalska redakcija
RS
EMEA
Razmerje ogroženosti manj kot 1 pomeni prednost kombinacije docetaksel + cisplatin + fluorouracil * Nekorigirani log- rang test ** Nekorigirani log- rang test, nekorigiran za multiple primerjave *** Test hi- kvadrat, nekorigiran za multiple primerjave NP – ni podatka
A Hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
2 Prevajalska redakcija
RS
EMEA
Učinkovitost kombinacije zdravila Caelyx in bortezomiba pri multiplem mielomu so preučili s primerjavo s samostojno uporabo bortezomiba pri 646 bolnikih.
For multiple myeloma, the effectiveness of the combination of Caelyx and bortezomib was compared with that of bortezomib alone in 646 patients.
3 Prevajalska redakcija
RS
EMEA
Korigirano za multiple primerjave in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
4 Prevajalska redakcija
RS
EMEA
Na podlagi vrednosti Cmax in AUC je bila izpostavitev pri bolnikih z multiplim mielomom rahlo večja kot pri zdravih moških prostovoljcih, ker je razmerje očistka in biološko uporabne frakcije zdravila (CL/ F) pri bolnikih z multiplim mielomom manjše (približno 200 ml/ min v primerjavi s 300 ml/ min) kot pri zdravih prostovoljcih.
14 following single and multiple doses in multiple myeloma patients.Exposure in multiple myeloma patients is slightly higher based on Cmax and AUC values as compared to healthy male volunteers since the clearance/bioavailable fraction of a drug (CL/F) in multiple myeloma patients is lower (approximately 200 ml/min compared to 300 ml/min) than it is in healthy volunteers.
5 Prevajalska redakcija
RS
EMEA
• Bolniki s hitro razvijajočo se hudo recidivno remitentno multiplo sklerozo, ki se kaže z 2 ali več recidivi prizadetosti v enem letu ter z 1 ali več lezijami, vidnimi z gadolinijem na MRS možganov ali znatnim povečanjem površine lezij T2 v primerjavi s predhodno nedavno MRS.
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
6 Prevajalska redakcija
RS
EMEA
V študiji z bolniki z enkratnim demielinizacijskim dogodkom so ugotovili, da je zdravilo Extavia zmanjšalo tveganje za razvoj klinično dokončne multiple skleroze: multipla skleroza se je razvila pri 28 % bolnikov, ki so prejemali zdravilo Extavia, v primerjavi s 45 % tistih, ki so prejemali placebo.
In the study of patients with a single demyelinating event, Extavia was shown to reduce the risk of developing clinically defined MS: 28 % of the patients who received Extavia developed MS, against 45 % of those who received placebo.
7 Prevajalska redakcija
RS
EMEA
Pri bolnikih z multiplim mielomom je kombinacija lenalidomida in deksametazona povezana s povečano incidenco trombocitopenije 3. in 4. stopnje (9, 9 % 3. stopnje in 1, 4 % 4. stopnje pri bolnikih, ki so prejemali lenalidomid/ deksametazon, v primerjavi z 2, 3 % 3. stopnje in 0, 0 % 4. stopnje pri bolnikih, ki so prejemali placebo/ deksametazon; glejte poglavje 4. 8).
The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients; see section 4.8).
8 Prevajalska redakcija
RS
EMEA
Klinične študije Učinkovitost in varnost lenalidomida so ocenili v dveh multicentričnih, randomiziranih, dvojno slepih, s placebom nadzorovanih, paralelnih študijah III. faze (MM- 009 in MM- 010), v katerih so primerjali zdravljenje z lenalidomidom in deksametazonom v primerjavi z zdravljenjem samo z deksametazonom pri bolnikih z multiplim mielomom, ki so se že zdravili.
Clinical trials The efficacy and safety of lenalidomide were evaluated in two Phase III multi-centre, randomised, double-blind, placebo-controlled, parallel-group controlled studies (MM-009 and MM-010) of lenalidomide plus dexamethasone therapy versus dexamethasone alone in previously treated patients
9 Prevajalska redakcija
RS
EMEA
Pri 646 bolnikih je bila opravljena randomizirana, odprta, multicentrična študija III. faze pri vzporednih skupinah za primerjavo varnosti in učinkovitosti kombinirane terapije z zdravilom Caelyx in bortezomibom in monoterapije z bortezomibom pri bolnikih z multiplim mielomom, ki so prejeli najmanj eno predhodno terapijo in pri katerih bolezen ni napredovala med prejemanjem antraciklinske terapije.
A phase III randomized, parallel-group, open-label, multicentre study comparing the safety and efficacy of Caelyx plus bortezomib combination therapy with bortezomib monotherapy in patients with multiple myeloma who have received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy, was conducted in 646 patients.
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multipla primerjava