FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is 600 mg (three 200 mg film-coated tablets) of ribociclib once daily for 21 consecutive days followed by 7 days off treatment, resulting in a complete cycle of 28 days.
Slovenian: Priporočeni odmerek je 600 mg (tri 200-miligramske filmsko obložene tablete) ribocikliba enkrat na dan 21 dni zaporedoma, čemur sledi 7 dni brez zdravljenja, tako da celotni ciklus traja 28 dni.
English: Substances that may increase ribociclib plasma concentrations
Slovenian: Snovi, ki lahko zvišajo koncentracijo ribocikliba v plazmi
English: The concomitant use of strong CYP3A4 inducers may therefore lead to decreased exposure and consequently a risk for lack of efficacy.
Slovenian: Sočasna uporaba močnih induktorjev CYP3A4 lahko torej zmanjša izpostavljenost zdravilu, to pa lahko predstavlja tveganje za manjšo učinkovitost zdravila.
English: • Serious infection with increased heart rate, shortness of breath or rapid breathing, fever and chills (these may be signs of sepsis which is an infection in the blood system which may be life threatening).
Slovenian: • resna okužba s pospešenim srčnim utripom, zadihanost ali hitro dihanje, zvišana telesna temperatura in mrazenje (to so lahko znaki sepse, ki je okužba v krvnem obtoku in je lahko življenjsko nevarna).
English: ECGs with QTcF >480 msec
Slovenian: EKG posnetki s trajanjem intervala QTcF > 480 ms
English: If treatment with a strong CYP3A4 inhibitor cannot be avoided, the dose should be reduced to 400 mg once daily (see sections 4.2 and 4.5).
Slovenian: Če se zdravljenju z močnim zaviralcem CYP3A4 ni mogoče izogniti, je treba odmerek zdravila Kisqali zmanjšati na 400 mg enkrat na dan (glejte poglavji 4.2 in 4.5).
English: Eye disorders Lacrimation increased, dry eye
Slovenian: Očesne bolezni močnejše solzenje, suhe oči pogosti
English: Ribociclib and its metabolites are eliminated mainly via faeces, with a small contribution of the renal route.
Slovenian: Ribociklib in njegovi presnovki se izločajo večinoma z blatom, skozi ledvice se izloči le majhen del.
English: ECG should be assessed before initiating treatment.
Slovenian: Pred začetkom zdravljenja je treba posneti EKG.
English: Metabolite LEQ803 was a significant metabolite in excreta and represented approximately 13.9% and 3.74% of the administered dose in faeces and urine, respectively.
Slovenian: V izločkih je bil v pomembni količini prisoten presnovek LEQ803, ki je v blatu predstavljal približno 13,9 %, v urinu pa 3,74 % danega odmerka.
English: Clinical activity (pharmacological and safety) of ribociclib was due primarily to parent drug, with negligible contribution from circulating metabolites.
Slovenian: Klinično aktivnost ribocikliba (s farmakološkega in varnostnega vidika) pripisujejo predvsem matični učinkovini, medtem ko presnovki v krvnem obtoku zanemarljivo malo prispevajo h klinični aktivnosti.
English: Tablet core: microcrystalline cellulose; crospovidone type A; low-substituted hydroxypropylcellulose; magnesium stearate; colloidal anhydrous silica.
Slovenian: Jedro tablete: mikrokristalna celuloza, krospovidon tipa A, nizko substituirana hidroksipropilceluloza, magnezijev stearat, brezvodni koloidni silicijev dioksid.
English: • Medicines used to treat symptoms of benign prostatic hyperplasia such as alfuzosin.
Slovenian: • zdravila, ki jih uporabljamo pri zdravljenju benigne hiperplazije prostate, kot je alfuzosin,
English: • Antiarrhythmics such as amiodarone or quinidine.
Slovenian: • antiaritmiki, kot sta amiodaron in kinidin,
English: The dose of a sensitive CYP3A4 substrate with a narrow therapeutic index, including but not limited to alfentanil, ciclosporin, everolimus, fentanyl, sirolimus and tacrolimus, may need to be reduced as ribociclib can increase their exposure.
Slovenian: Pri občutljivih substratih CYP3A4 z nizkim terapevtskim indeksom, med drugim pri alfentanilu, ciklosporinu, everolimusu, fentanilu, sirolimusu in takrolimusu, je v nekaterih primerih treba zmanjšati njihov odmerek, saj ribociklib lahko poveča izpostavljenost tem snovem.
English: Increases in transaminases were observed.
Slovenian: Opažali so zvišane vrednosti aminotransferaz.
English: Take Kisqali once a day on days 1 to 21 of a 28-day cycle.
Slovenian: Zdravilo Kisqali vzemite enkrat na dan od 1. do 21. dne 28-dnevnega ciklusa.
English: Treatment discontinuation due to neutropenia was low (0.8%) (see sections 4.2 and
Slovenian: Do ukinitve zdravljenja zaradi nevtropenije je prišlo redko (pri 0,8 %) (glejte poglavji 4.2 in 4.4).
English: Kisqali 200 mg film-coated tablets
Slovenian: Kisqali 200 mg filmsko obložene tablete
English: Dose reduction due to adverse events, regardless of causality, occurred in 37.3% of patients receiving Kisqali in the phase III clinical studies regardless of the combination and permanent discontinuation was reported in 7.0% of patients receiving Kisqali and any combination in the phase III clinical studies.
Slovenian: Do zmanjševanja odmerka zaradi neželenih dogodkov, ne glede na vzročno povezanost z zdravilom, je v kliničnih študijah faze III prišlo pri 37,3 % bolnikov, ki so prejemali zdravilo Kisqali ne glede na kombinacijo, o ukinitvi zdravljenja pa so poročali pri 7,0 % bolnikov, ki so v kliničnih študijah faze III prejemali zdravilo Kisqali v kateri koli kombinaciji.
English: Table 11 MONALEESA-7 - Efficacy results (OS)
Slovenian: Preglednica 11 MONALEESA-7 - Rezultati za oceno učinkovitosti (celokupno preživetje, OS)
English: Take Kisqali once a day only on days 1 to 21 of a 28-day cycle.
Slovenian: Zdravilo Kisqali vzemite enkrat na dan samo od 1. do 21. dne 28-dnevnega ciklusa.
English: Drug-food interactions
Slovenian: Medsebojno delovanje zdravila s hrano
English: No dose adjustment is necessary in patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: These findings included reduced/small lung lobes and additional vessel on the aortic arch and diaphragmatic hernia, absent accessory lobe or (partly) fused lung lobes and reduced/small accessory lung lobe (30 and 60 mg/kg), extra/rudimentary thirteenth ribs and misshapen hyoid bone and reduced number of phalanges in the pollex.
Slovenian: Med temi nepravilnostmi so bile tudi zmanjšana velikost/število pljučnih režnjev, razvoj dodatne žile na aortnem loku, diafragmalna hernija, odsotnost pljučnega režnja ali (deloma) zraščeni pljučni režnji in manjša velikost/število pljučnih režnjev ali prisotnost dodatnega pljučnega režnja (30 oziroma 60 mg/kg), prisotnost dodatnega oziroma rudimentarnega trinajstega rebra, nepravilno oblikovana hioidna kost in zmanjšano število falang palca.
English: After initiating treatment, ECG should be repeated at approximately day 14 of the first cycle and at the beginning of the second cycle, then as clinically indicated.
Slovenian: Po začetku zdravljenja je treba EKG ponovno posneti približno 14. dan prvega ciklusa in na začetku drugega ciklusa, nato pa kot je klinično indicirano.
English: The global health status/QoL data showed no relevant difference between the Kisqali plus letrozole arm and the placebo plus letrozole arm.
Slovenian: Podatki o globalnem zdravstvenem stanju oziroma kakovosti življenja niso pokazali pomembnih razlik med skupino bolnic z zdravilom Kisqali in letrozolom in skupino bolnic s placebom in letrozolom.
English: Other side effects include the following listed below.
Slovenian: Drugi možni neželeni učinki vključujejo spodaj naštete učinke.
English: If you stop taking Kisqali
Slovenian: Če ste prenehali jemati zdravilo Kisqali
English: A series of pre-specified subgroup PFS analyses was performed based on prognostic factors and baseline characteristics to investigate the internal consistency of treatment effect.
Slovenian: Na podatkih podskupin bolnic so opravili vrsto vnaprej opredeljenih analiz preživetja brez napredovanja bolezni na osnovi prognostičnih dejavnikov in izhodiščnih karakteristik za oceno interne enotnosti učinka zdravljenja.
English: You should take Kisqali once daily every day at the same time, preferably in the morning.
Slovenian: Zdravilo Kisqali morate jemati enkrat na dan, vsak dan ob istem času, najbolje zjutraj.
English: Thus, ribociclib may interact with medicinal products which are metabolised via CYP3A4, which may lead to increased serum concentrations of CYP3A4 substrates (see section 4.5).
Slovenian: Iz tega razloga lahko pride do interakcij med ribociklibom in zdravili, ki se presnavljajo s CYP3A4, kar lahko zvišuje koncentracije substratov CYP3A4 v serumu (glejte poglavje 4.5).
English: Co-administration of ribociclib with medicinal products that elevate the gastric pH was not evaluated in a clinical study; however, altered ribociclib absorption was not observed in population pharmacokinetic and non-compartmental pharmacokinetic analyses.
Slovenian: Sočasne uporabe ribocikliba z zdravili, ki zvišujejo pH v želodcu, niso ovrednotili v okviru klinične študije, vendar pri populacijski farmakokinetični analizi in nekompartmentalni farmakokinetični analizi niso opažali sprememb v absorpciji ribocikliba.
English: In the phase III clinical studies, hepatobiliary toxicity events occurred in a higher proportion of patients in the Kisqali plus any combination arms compared with the placebo plus any combination arms (23.2% versus 16.5%, respectively), with more grade 3/4 adverse events reported in the patients treated with Kisqali plus any combination (11.4% versus 5.4%, respectively).
Slovenian: V kliničnih študijah faze III je do epizod hepatobiliarne toksičnosti prišlo pri večjem deležu bolnikov, ki so prejemali zdravilo Kisqali v kateri koli kombinaciji, kot v skupini s placebom v kateri koli kombinaciji (23,2 % v primerjavi s 16,5 %), pri čemer je bilo več neželenih učinkov stopnje 3/4 poročanih pri bolnikih, ki so prejemali zdravilo Kisqali in katero koli kombinacijo (11,4 % v primerjavi s 5,4 %).
English: Light greyish violet, unscored, round, curved with bevelled edges (approximate diameter: 11.1 mm), debossed with “RIC” on one side and “NVR” on the other side.
Slovenian: Tableta je svetlo sivkasto vijolična, brez zareze, okrogla, z zaobljenimi robovi (premera približno 11,1 mm), z vtisnjeno oznako “RIC” na eni in “NVR” na drugi strani.
English: • Methadone, used to treat pain or addiction to opioids.
Slovenian: • metadon, ki ga uporabljamo za lajšanje bolečin in pri zdravljenju odvisnosti od opioidov,
English: When tested in a panel of breast cancer cell lines with known ER status, ribociclib demonstrated to be more efficacious in ER+ breast cancer cell lines than in the ER- ones.
Slovenian: Pri testiranju na vrsti celičnih linij raka dojke z znanim statusom estrogenskih receptorjev se je pokazalo, da je ribociklib bolj učinkovit pri celičnih linijah raka dojke s pozitivnim statusom estrogenskih receptorjev (ER+) kot pri tistih z negativnim statusom (ER-).
English: No of events Ribociclib: 83, Placebo: 109
Slovenian: št. dogodkov ribociklib: 83, placebo: 109
English: 63 film-coated tablets.
Slovenian: 63 filmsko obloženih tablet.
English: Each film-coated tablet contains ribociclib succinate equivalent to 200 mg ribociclib.
Slovenian: Ena filmsko obložena tableta vsebuje ribociklibijev sukcinat v količini, ki ustreza 200 mg ribocikliba.
English: Your doctor may ask you to take a lower dose, interrupt your treatment with Kisqali, or stop it permanently.
Slovenian: Zdravnik vam bo morda naročil, da jemljete manjši odmerek, da začasno prekinete jemanje zdravila Kisqali ali pa ga dokončno prenehate jemati.
English: Table 13 MONALEESA-3 - Efficacy results (ORR, CBR) based on investigator assessment
Slovenian: Preglednica 13 MONALEESA-3 - Rezultati za oceno učinkovitosti (ORR, CBR) na osnovi ocene raziskovalcev
English: The effect of renal impairment on the pharmacokinetics of ribociclib was also assessed in a renal impairment study that included 7 healthy subjects with normal renal function (absolute GFR [aGFR] ≥90 ml/min), 7 non-cancer subjects with severe renal impairment (aGFR 15 to <30 ml/min) and 3 noncancer subjects with end-stage renal disease (ESRD) (aGFR <15 ml/min) at a single ribociclib dose of 400 mg.
Slovenian: Vpliv okvare ledvic na farmakokinetiko ribocikliba so ocenjevali tudi v študiji okvare ledvic, v katero je bilo vključenih 7 zdravih oseb z normalno ledvično funkcijo (z absolutno hitrostjo glomerulne filtracije [aGFR] ≥ 90 ml/min), 7 oseb brez raka in s hudo okvaro ledvic (aGFR 15 do < 30 ml/min) in 3 osebe brez raka in s končno ledvično odpovedjo (end-stage renal disease, ESRD) (aGFR < 15 ml/min); vsi preiskovanci so prejeli enkratni odmerek ribocikliba, in sicer 400 mg.
English: Neutropenia No dose adjustment is required
Slovenian: Nevtropenija Prilagajanje odmerka ni potrebno.
English: Anti-arrhythmic medicinal products and other medicinal products that may prolong the QT interval Co-administration of Kisqali with medicinal products with a known potential to prolong the QT interval such as anti-arrhythmic medicinal products (including, but not limited to, amiodarone, disopyramide, procainamide, quinidine and sotalol), and other medicinal products that are known to prolong the QT interval (including, but not limited to, chloroquine, halofantrine, clarithromycin, ciprofloxacin, levofloxacin, azithromycin, haloperidol, methadone, moxifloxacin, bepridil, pimozide and intravenous ondansetron) should be avoided (see section 4.4).
Slovenian: Antiaritmiki in druga zdravila, ki lahko podaljšajo interval QT Izogibati se je treba sočasni uporabi zdravila Kisqali z zdravili, za katera je znano, da lahko podaljšajo interval QT, kot so antiaritmiki (med drugim amiodaron, dizopiramid, prokainamid, kinidin in sotalol), ter druga zdravila, za katera je znano, da podaljšujejo interval QT (med drugim klorokin, halofantrin, klaritromicin, ciprofloksacin, levofloksacin, azitromicin, haloperidol, metadon, moksifloksacin, bepridil, pimozid in intravenski ondansetron) (glejte poglavje 4.4).
English: CI=confidence interval; N=number of patients; NE = Not estimable.
Slovenian: IZ = interval zaupanja; N = število bolnic; NO = vrednosti ni mogoče oceniti a
English: 54.7% of patients receiving ribociclib plus letrozole were estimated to be progression-free at 24 months compared with 35.9% in the placebo plus letrozole arm.
Slovenian: Po ocenah je bilo po 24 mesecih v stanju brez napredovanja bolezni 54,7 % bolnic, ki so prejemale ribociklib in letrozol, v primerjavi s 35,9 % bolnic iz skupine s placebom in letrozolom.
English: • Medicines used to treat low blood pressure or migraine such as ergotamine or dihydroergotamine.
Slovenian: • zdravila za zdravljenje nizkega krvnega tlaka ali migrene, kot sta ergotamin in dihidroergotamin,
English: Kisqali can be administered with or without food (see sections 4.2 and 5.2).
Slovenian: Zdravilo Kisqali je mogoče jemati skupaj s hrano ali brez nje (glejte poglavji 4.2 in 5.2).
English: Dose modification for use of Kisqali with strong CYP3A4 inhibitors Concomitant use of strong CYP3A4 inhibitors should be avoided and an alternative concomitant medicinal product with less potential to inhibit CYP3A4 inhibition should be considered.
Slovenian: Prilagajanje odmerkov pri uporabi zdravila Kisqali skupaj z močnimi zaviralci CYP3A4 Sočasni uporabi močnih zaviralcev CYP3A4 se je treba izogibati in razmisliti o sočasni uporabi drugega zdravila z manjšim potencialom za zaviranje CYP3A4.
English: • Tiredness, itchy yellow skin or yellowing of the whites of your eyes, nausea or vomiting, loss of appetite, pain in the upper right side of the belly (abdomen), dark or brown urine, bleeding or bruising more easily than normal (these may be signs of a liver problem).
Slovenian: • utrujenost, srbeča porumenela koža ali porumenelost oči (beločnice), slabost ali bruhanje, izguba apetita, bolečine v zgornjem desnem delu trebuha, temno ali rjavo obarvan urin ali pojavljanje krvavitev ali podplutb brez očitnega vzroka (to so lahko znaki težav z jetri).
English: No of events Ribociclib: 92, Placebo: 132
Slovenian: št. dogodkov ribociklib: 92, placebo: 132
English: Target organs associated with the pharmacological action of ribociclib in repeat-dose studies include bone marrow (hypocellularity), lymphoid system (lymphoid depletion), intestinal mucosa (atrophy), skin (atrophy), bone (decreased bone formation), kidney (concurrent degeneration and regeneration of tubular epithelial cells) and testes (atrophy).
Slovenian: Med tarčnimi organi, ki so bili v študijah ponavljajočih odmerkov povezani s farmakološkim delovanjem ribocikliba, so bili kostni mozeg (hipocelularnost), limfatični sistem (limfatična deplecija), črevesna sluznica (atrofija), koža (atrofija), kosti (zmanjšana tvorba kostnine), ledvice (sočasna degeneracija in regeneracija tubularnih epitelijskih celic) in testisi (atrofija).
English: Ribociclib was extensively metabolised, with unchanged drug accounting for 17.3% and 12.1% of the dose in faeces and urine, respectively.
Slovenian: Ribociklib se je obsežno presnavljal, tako da je nespremenjena učinkovina v blatu predstavljala le 17,3 %, v urinu pa le 12,1 % danega odmerka.
English: • Some medicines used to treat seizures or fits (anti-epileptics) such as carbamazepine and phenytoin.
Slovenian: • nekatera zdravila za zdravljenje epileptičnih napadov (antiepileptiki), kot sta karbamazepin in fenitoin,
English: There were no such cases reported in Study E2301 (MONALEESA-7).
Slovenian: V študiji E2301 (MONALEESA-7) o takih primerih niso poročali.
English: CI=confidence interval, NE=not estimable, N=number of patients; p-value is obtained from the one-sided log-rank test stratified by lung and/or liver metastases, prior chemotherapy for advanced disease, and endocrine partner per IRT (interactive response technology).
Slovenian: IZ = interval zaupanja, NO = vrednosti ni mogoče oceniti, N = število bolnic a vrednost p na osnovi enostranskega log-rank testa s stratifikacijo glede na prisotnost jetrnih in/ali pljučnih metastaz, predhodno prejemanje kemoterapije zaradi napredovale bolezni in glede na zdravilo v kombinaciji hormonskega zdravljenja na osnovi podatkov, pridobljenih s tehnologijo interaktivnega odzivnika (IRT - Interactive Response Technology)
English: Do not take this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali da je bila že odprta.
English: How much Kisqali to take
Slovenian: Koliko zdravila Kisqali je treba jemati
English: Kisqali was given orally at a dose of 600 mg daily for 21 consecutive days followed by 7 days off treatment in combination with NSAI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen (20 mg) orally once daily for 28 days, and goserelin (3.6 mg) subcutaneously every 28 days, until disease progression or unacceptable toxicity.
Slovenian: Bolnice so zdravilo Kisqali prejemale peroralno v odmerku 600 mg na dan 21 zaporednih dni, čemur je sledilo 7 dni brez zdravljenja in sicer v kombinaciji z nesteroidnim zaviralcem aromataze (letrozol 2,5 mg ali anastrozol 1 mg) ali s tamoksifenom (20 mg) peroralno enkrat na dan 28 dni ter z goserelinom (3,6 mg) subkutano vsake 28 dni do napredovanja bolezni ali nesprejemljive toksičnosti.
English: In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Slovenian: Pri ženskah pred menopavzo ali v perimenopavzi je treba hormonsko zdravljenje uporabljati skupaj z agonistom gonadoliberina (LHRH-luteinizing hormone releasing hormone).
English: 400 mg/day
Slovenian: 400 mg/dan drugo zmanjšanje odmerka
English: No of events Ribociclib: 61, Placebo: 80
Slovenian: št. dogodkov ribociklib: 61, placebo: 80
English: If QTcF prolongation resolves to <481 msec, resume treatment at the next lower dose level.
Slovenian: Če se trajanje intervala QTcF zmanjša na < 481 ms, je treba zdravilo ponovno uvesti z naslednjo nižjo ravnjo odmerjanja.
English: Ribociclib is not a substrate for hepatic uptake transporters OATP1B1, OATP1B3 or OCT-1 in vitro.
Slovenian: Ribociklib in vitro ni substrat jetrnih privzemnih prenašalcev OATP1B1, OATP1B3 in OCT-1.
English: Substances that may decrease ribociclib plasma concentrations
Slovenian: Snovi, ki lahko znižajo koncentracijo ribocikliba v plazmi
English: * Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events) ** Baseline = prior to treatment initiation
Slovenian: * opredelitev stopenj neželenih dogodkov po verziji 4.03 CTCAE (Skupni terminološki kriteriji za neželene dogodke, angl. Common Terminology Criteria for Adverse Events) ** izhodišče = pred začetkom zdravljenja
English: The majority of patients included were Caucasian (57.7%), Asian (29.5%) or Black (2.8%) and nearly all patients (99.0%) had a baseline ECOG performance status of 0 or 1.
Slovenian: Večina vključenih bolnic je bila bele (57,7 %), azijske (29,5 %) ali črne rase (2,8 %) in skoraj vse bolnice (99,0 %) so imele izhodiščno oceno stanja zmogljivosti po lestvici ECOG 0 ali 1.
English: Your doctor may also decide to stop treatment with Kisqali permanently.
Slovenian: Zdravnik se lahko odloči tudi za ukinitev zdravila Kisqali.
English: • Medicines used to treat cardiac disorders such as digoxin
Slovenian: • zdravila za zdravljenje bolezni srca, kot je digoksin,
English: Log-rank test and Cox model are stratified by lung and/or liver metastasis, prior chemotherapy for advanced disease, and endocrine combination partner per IRT
Slovenian: Podatki za log-rank test in Coxov model so stratificirani glede na prisotnost jetrnih in/ali pljučnih metastaz, predhodno prejemanje kemoterapije zaradi napredovale bolezni in glede na zdravilo v kombinaciji hormonskega zdravljenja na osnovi podatkov, pridobljenih z IRT.
English: Hypersensitivity to the active substance or to peanut, soya or any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, arašide, sojo ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: If you get certain side effects your doctor may ask you to take a lower dose, interrupt your treatment with Kisqali, or stop it permanently.
Slovenian: Če pride do določenih neželenih učinkov, vam bo zdravnik morda naročil, da jemljete manjši odmerek zdravila Kisqali, da začasno prekinete jemanje zdravila ali pa ga dokončno prenehate jemati.
English: Efficacy results for overall response rate (ORR) and clinical benefit rate (CBR) per investigator assessment based on RECIST v1.1 are provided in Table 13.
Slovenian: Rezultati za oceno učinkovitosti glede deleža celokupnega odziva (ORR) in deleža klinične (CBR) koristi na osnovi ocene raziskovalcev po kriterijih RECIST v1.1 so prikazani v preglednici 13.
English: The primary endpoint for the study was met at the planned interim analysis conducted after observing 80% of targeted progression-free survival (PFS) events using Response Evaluation Criteria in Solid Tumours (RECIST v1.1), based on the investigator assessment in the full population (all randomised patients), and confirmed by a blinded independent central radiological assessment.
Slovenian: Primarni cilj študije je bil dosežen do načrtovane vmesne analize, ki so jo izvedli po tem, ko so zabeležili 80 % ciljnih dogodkov, to je preživetje brez napredovanja bolezni (PFS-progression-free survival), kjer so uporabili kriterije vrednotenja odziva pri solidnih tumorjih (RECIST v 1.1Response Evaluation Criteria in Solid Tumors) na osnovi ocene raziskovalca v celotni populaciji bolnic (pri vseh randomiziranih bolnicah) in potrditve s slepo neodvisno radiološko oceno centralnih ocenjevalcev.
English: 21 film-coated tablets.
Slovenian: 21 filmsko obloženih tablet.
English: Multipack: 63 (3 packs of 21) film-coated tablets Multipack: 126 (3 packs of 42) film-coated tablets Multipack: 189 (3 packs of 63) film-coated tablets
Slovenian: Skupno pakiranje: 63 (3 pakiranja po 21) filmsko obloženih tablet Skupno pakiranje: 126 (3 pakiranja po 42) filmsko obloženih tablet Skupno pakiranje: 189 (3 pakiranja po 63) filmsko obloženih tablet