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the study was unblinded based on the magnitude of clinical benefit observed and patients in the placebo group were offered treatment with zytiga.
Štúdia bola odslepená na základe pozorovaného významného klinického prínosu a pacientom v skupine s placebom bola ponúknutá liečba zytigou.
oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive sclc in patient self reports on an unblinded symptom scale assessment in each of these two studies.
perorálny a intravenózny topotekán bol spojený s podobným zmiernením príznakov u pacientov s recidivujúcim, senzitívnym sclc v hláseniach príznakov zo strany pacientov na odslepenej hodnotiacej škále v oboch týchto štúdiách.
oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive sclc in patient self- reports on an unblinded symptom scale assessment in each of these two studies.
perorálny a intravenózny topotekán bol spojený s podobným zmiernením príznakov u pacientov s recidivujúcim senzitívnym sclc v hláseniach pacientov na nezaslepenej stupnici hodnotenia príznakov v každej zo štúdií.
after the interim analysis of efficacy and safety, at recommendation of the independent dsmb, the study was unblinded and patients on the placebo arm were offered open-label sunitinib treatment.
po predbežnej analýze účinnosti a bezpečnosti na základe odporúčania nezávislej komisie dsmb bola štúdia odslepená a pacientom v ramene s placebom bola ponúknutá liečba sunitinibom v otvorenej fáze štúdie.
one phase 2 study (study 065) and one phase 3 study (study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy. (see table 1) oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive sclc in patient self- reports on an unblinded symptom scale assessment in each of these two studies.
perorálny a intravenózny topotekán bol spojený s podobným zmiernením príznakov u pacientov s recidivujúcim senzitívnym sclc v hláseniach príznakov zo strany pacientov na odslepenej hodnotiacej škále v oboch týchto štúdiách.