FrancophonIA/ELRC3.0 huggingface dataset:
English: The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the pre-specified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Slovenian: Študija je ob vmesni analizi (opravljeni po 82 % načrtovanih dogodkov PFS) dosegla svoj primarni cilj podaljšanja PFS po oceni raziskovalca; rezultati so presegli vnaprej določeno Haybittle-Petovo mejo učinkovitosti (α = 0,00135) ter so dokazali statistično značilno podaljšanje PFS in klinično pomemben terapevtski učinek.
English: Randomisation was stratified by disease setting (locally advanced or metastatic), prior chemotherapy for advanced disease, and measurable disease.
Slovenian: Randomizacija je bila stratificirana po obsegu bolezni (lokalno napredovala ali metastatska), predhodni kemoterapiji za napredovalo bolezen in merljivosti bolezni.
English: The objective response rate for Faslodex 250 mg was 19.2% compared with 16.5% for anastrozole.
Slovenian: Objektivni delež odgovorov je bil za zdravilo Faslodex 250 mg 19,2 % v primerjavi s 16,5 % pri anastrozolu.
English: Faslodex is indicated in patients whose disease had recurred or progressed on an antiestrogen therapy.
Slovenian: Zdravilo Faslodex je indicirano pri bolnikih, katerih bolezen se je ponovila ali napredovala med zdravljenjem z antiestrogeni.
English: Keep the pre-filled syringe in the original package, in order to protect from light.
Slovenian: Napolnjeno injekcijsko brizgo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Faslodex is indicated:
Slovenian: Zdravilo Faslodex je indicirano:
English: The results in the AI subgroup are inconclusive.
Slovenian: Na podlagi rezultatov pri AI podskupini ni možno narediti zaključkov.
English: This 12-month study investigated a range of MAS endpoints and showed a reduction in the frequency of vaginal bleeding and a reduction in the rate of bone age advancement.
Slovenian: Ta 12-mesečna študija, pri kateri so proučevali vrsto ciljev študije v povezavi z MAS, je pokazala manjšo pogostnost vaginalnih krvavitev in počasnejše napredovanje staranja kosti.
English: There was up to about 2.5-fold increase in AUC in women with hepatic impairment compared to healthy subjects.
Slovenian: Pri ženskah z okvaro jeter se je AUC zvišal za približno 2,5-krat v primerjavi z zdravimi ženskami.
English: Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.
Slovenian: Prilagoditev odmerka tako ni potrebna pri bolnicah, ki sočasno uporabljajo fulvestrant in zaviralce ali induktorje CYP 3A4.
English: • Inflammation of the liver (hepatitis)
Slovenian: • vnetje jeter (hepatitis)
English: The descriptions included below are based on the safety analysis set of 228 patients who received at least one (1) dose of fulvestrant and 232 patients who received at least one (1) dose of anastrozole, respectively in the Phase 3 FALCON study.
Slovenian: Spodaj navedeni opisi temeljijo na naboru podatkov za analizo varnosti 228 bolnic, ki so v študiji 3. faze FALCON prejele vsaj en (1) odmerek fulvestranta, in 232 bolnic, ki so prejele vsaj en (1) odmerek anastrozola.