FrancophonIA/ELRC3.0 huggingface dataset:
English: This clastogenicity is consistent with genomic instability resulting from the primary pharmacology of talazoparib, indicating the potential for genotoxicity in humans.
Slovenian: Ta klastogenost je skladna z genomsko nestabilnostjo, ki je posledica primarnih farmakoloških lastnosti talazopariba, in kaže na potencial za genotoksičnost pri ljudeh.
English: Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable.
Slovenian: Bolnikom z mutacijami gena BRCA je treba zagotoviti genetsko svetovanje v skladu z lokalnimi predpisi in kot je ustrezno.
English: How much to take The recommended dose is one 1-mg capsule taken by mouth once daily.
Slovenian: Koliko zdravila vzeti Priporočeni odmerek je ena 1 mg kapsula, ki jo zaužijete enkrat na dan.
English: This is because Talzenna can affect the way some other medicines work.
Slovenian: Zdravilo Talzenna lahko namreč vpliva na delovanje nekaterih drugih zdravil.
English: If MDS/AML is confirmed, talazoparib should be discontinued.
Slovenian: Če potrdimo MDS/AML, je treba zdravljenje s talazoparibom prekiniti.
English: It is not known if Talzenna passes into breast milk.
Slovenian: Ni znano, ali zdravilo Talzenna prehaja v materino mleko.
English: Women who can become pregnant and men with partners who are or can become pregnant should use effective contraception.
Slovenian: Ženske v rodni dobi in moški s partnerkami, ki so noseče ali v rodni dobi, morajo uporabljati učinkovito kontracepcijo.
English: Time from initial diagnosis of breast cancer to diagnosis of advanced breast cancer (years) n
Slovenian: Čas od začetne diagnoze raka dojk do diagnoze napredovalega raka dojk (leta)
English: Talazoparib is an inhibitor of PARP enzymes, PARP1, and PARP2.
Slovenian: Talazoparib je zaviralec encimov PARP, in sicer PARP1 in PARP2.
English: Overall, MDS/AML has been reported in 2 out of 584 (0.3%) solid tumour patients treated with talazoparib in clinical studies.
Slovenian: Skupaj so o MDS/AML poročali pri 2 od 584 (0,3 %) bolnikov s čvrstimi tumorji, ki so jih v kliničnih študijah zdravili s talazoparibom.
English: What Talzenna is and how it works
Slovenian: Kaj je zdravilo Talzenna in kako deluje
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle or blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki ali pretisnem omotu poleg oznake ''EXP''.
English: Rarely, low blood cell counts may be a sign of more serious problems with the bone marrow such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
Slovenian: Redko je lahko zmanjšanje števila krvnih celic znak resnejših težav s kostnim mozgom, kot sta mielodisplastični sindrom (MDS) ali akutna mieloična levkemija (AML).
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX60
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX60
English: There are no data from the use of Talzenna in pregnant women.
Slovenian: Podatkov o uporabi zdravila Talzenna pri nosečnicah ni.
English: Your doctor will perform a pregnancy test prior to starting Talzenna.
Slovenian: Zdravnik bo pred začetkom zdravljenja z zdravilom Talzenna opravil test nosečnosti.
English: If co-administration of strong BCRP inhibitors cannot be avoided, patient should be monitored for potential increased adverse reactions.
Slovenian: Če se sočasnemu dajanju močnih zaviralcev BCRP ni mogoče izogniti, je treba bolnika spremljati glede morebitnih številnejših neželenih učinkov.
English: A series of prespecified subgroup PFS analyses was performed based on prognostic factors and baseline characteristics to investigate the internal consistency of treatment effect.
Slovenian: Na osnovi prognostičnih dejavnikov in izhodiščnih lastnosti so opravili vrsto analiz PFS predhodno določenih podskupin za preučitev notranje konsistentnosti učinka zdravljenja.
English: Carcinogenicity studies have not been conducted with talazoparib.
Slovenian: Študij kancerogenosti s talazoparibom niso izvedli.
English: Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in certain cancer cells.
Slovenian: Zdravilo Talzenna deluje tako, da zavira PARP, ki je encim, ki popravlja poškodovano DNK v določenih rakavih celicah.
English: Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments (see section 5.1).
Slovenian: Bolniki so se morali predhodno že zdraviti z antraciklinom in/ali taksanom v okviru (neo)adjuvantnega zdravljenja lokalno napredovale ali metastatske bolezni, razen če bolniki za to zdravljenje niso bili primerni (glejte poglavje 5.1).
English: Insufficient data are available to estimate the impact of severe renal impairment on talazoparib CL/F in this patient population.
Slovenian: Za oceno vpliva hude okvare ledvic na vrednost CL/F talazopariba pri tej populaciji bolnikov ni na voljo dovolj podatkov.
English: Excretion of unchanged talazoparib in urine was the major route of elimination accounting for 55% of the administered dose, while unchanged talazoparib recovered in the faeces accounted for 14%.
Slovenian: Izločanje nespremenjenega talazopariba v urin je bila glavna pot izločanja, ki je predstavljala 55 % danega odmerka, nespremenjeni talazoparib, ki so ga odkrili v blatu, pa je predstavljal 14 %.
English: Concomitant use of strong BCRP inhibitors (including but not limited to curcumin and cyclosporine) should be avoided.
Slovenian: Sočasni uporabi močnih zaviralcev BCRP (med drugim kurkumina in ciklosporina) se je treba izogibati.
English: Consistent with the overall results, a reduction in the risk of disease progression or death in favour of the talazoparib arm was observed in all individual patient subgroups (Figure 2).
Slovenian: Skladno s celokupnimi rezultati so v vseh posameznih podskupinah bolnikov opazili zmanjšanje tveganja za napredovanje bolezni ali smrt v korist skupine, ki je prejemala talazoparib (slika 2).
English: Pharmacokinetics of talazoparib have not been evaluated in patients < 18 years of age.
Slovenian: Farmakokinetike talazopariba pri bolnikih, starih < 18 let, niso ovrednotili.
English: Following oral administration of talazoparib, the median time to Cmax (Tmax) was generally between 1 to 2 hours after dosing.
Slovenian: Po peroralnem dajanju talazopariba je bil mediani čas do Cmax (tmax) na splošno od 1 do 2 uri po odmerjanju.
English: What you need to know before you take Talzenna
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Talzenna
English: It is unknown whether talazoparib is excreted in human breast milk.
Slovenian: Ni znano, ali se talazoparib izloča v materino mleko.
English: Serious problems with the bone marrow
Slovenian: Resne težave s kostnim mozgom
English: The median accumulation ratio of talazoparib following repeated oral administration of 1 mg once daily was in the range of 2.3 to 5.2.
Slovenian: Mediano razmerje kopičenja talazopariba po ponavljajočem se peroralnem dajanju 1 mg enkrat na dan je bilo v razponu od 2,3 do 5,2.
English: If you are allergic to talazoparib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Talzenna - če ste alergični na talazoparib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: If you have taken more Talzenna than your normal dose, contact your doctor or nearest hospital right away.
Slovenian: Če ste vzeli večji odmerek zdravila Talzenna, kot bi smeli Če ste vzeli večji odmerek zdravila Talzenna, kot je vaš običajni odmerek, se takoj obrnite na zdravnika ali najbližjo bolnišnico.
English: Abbreviations: BRCA=breast cancer susceptibility gene; ER=estrogen receptor; HER2=human epidermal growth factor receptor 2; N=number of patients; n=number of patients in category; PgR=progesterone receptor.
Slovenian: Okrajšave: BRCA = gen dovzetnosti za raka dojk (breast cancer susceptibility gene); ER = estrogenski receptor; HER2 = receptor humanega epidermalnega rastnega dejavnika 2 (human epidermal growth factor receptor 2); N = število bolnikov; n = število bolnikov v določeni kategoriji; PgR = progesteronski receptor.
English: Talk to your doctor, pharmacist or nurse before taking Talzenna and during your treatment if you experience signs or symptoms described in this section.
Slovenian: Pred začetkom jemanja zdravila Talzenna in med zdravljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če opazite znake ali simptome, opisane v tem poglavju.
English: Figure 1 shows the Kaplan-Meier curve for the EMBRACA study.
Slovenian: Slika 1 prikazuje Kaplan-Meierjevo krivuljo iz študije EMBRACA.
English: Talazoparib exposure generally increased proportionally with dose across the range of 0.025 mg to 2 mg after daily administration of multiple doses.
Slovenian: Izpostavljenost talazoparibu se na splošno zvečuje sorazmerno z odmerkom v razponu od 0,025 mg do 2 mg po vsakodnevnem dajanju več odmerkov.
English: The Kaplan-Meier curves for PFS is displayed in Figure 1.
Slovenian: KaplanMeierjevi krivulji za PFS sta prikazani na sliki 1.
English: Patients with prior platinum therapy for advanced disease were required to have no evidence of disease progression during platinum therapy.
Slovenian: Bolniki, ki so zaradi napredovale bolezni predhodno prejemali zdravljenje na osnovi platine, med zdravljenjem s platino niso smeli imeti znakov napredovanja bolezni.
English: Potential contributing factors for the development of MDS/AML include previous platinum-containing chemotherapy, other DNA damaging agents or radiotherapy.
Slovenian: Morebitni dejavniki, ki prispevajo k nastanku MDS/AML, vključujejo predhodno zdravljenje s kemoterapijo, ki vsebuje platino, zdravljenje z drugimi zdravili, ki poškodujejo DNK, ali obsevanje.
English: In the event of overdose, treatment with talazoparib should be stopped, and physicians should consider gastric decontamination, follow general supportive measures and treat symptomatically.
Slovenian: V primeru prevelikega odmerjanja je treba zdravljenje s talazoparibom prekiniti, zdravnik pa mora razmisliti o izpiranju želodca, upoštevati splošne podporne ukrepe in bolnika zdraviti simptomatsko.
English: Kaplan-Meier curves of PFS - EMBRACA study
Slovenian: Kaplan-Meierjevi krivulji PFS - študija EMBRACA
English: Talzenna has not been studied in patients with severe renal impairment (CrCl < 30 mL/min) or patients requiring haemodialysis.
Slovenian: Zdravila Talzenna niso preučevali pri bolnikih s hudo okvaro ledvic (CrCl < 30 ml/min) ali bolnikih, ki potrebujejo hemodializo.
English: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method.
Slovenian: Bolnike je treba za zdravljenje raka dojk z zdravilom Talzenna izbrati na podlagi prisotnosti škodljivih ali domnevno škodljivih germinalnih mutacij gena BRCA, ki jih z validirano preskusno metodo določi izkušen laboratorij.
English: Myelodysplastic syndrome/Acute myeloid leukaemia
Slovenian: Mielodisplastični sindrom/akutna mieloična levkemija
English: If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced to 0.75 mg once daily.
Slovenian: Če se sočasnemu dajanju z močnim zaviralcem P-gp ni mogoče izogniti, je treba odmerek zdravila Talzenna zmanjšati na 0,75 mg enkrat na dan.
English: Patient demographic, baseline, and disease characteristics were generally similar between the study treatment arms (see Table 4).
Slovenian: Demografske značilnosti bolnikov, izhodiščne značilnosti in značilnosti bolezni so bile med zdravljenima skupinama na splošno podobne (glejte preglednico 4).
English: For patients with moderate renal impairment (30 mL/min ≤ CrCl < 60 mL/min), the recommended starting dose of Talzenna is 0.75 mg once daily.
Slovenian: Pri bolnikih z zmerno okvaro ledvic (30 ml/min ≤ CrCl < 60 ml/min) je priporočeni začetni odmerek zdravila Talzenna 0,75 mg enkrat na dan.
English: When the strong P-gp inhibitor is discontinued, the Talzenna dose should be increased (after 3‐5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the strong P-gp inhibitor (see section 4.5).
Slovenian: Po prekinitvi zdravljenja z močnim zaviralcem P-gp je treba odmerek zdravila Talzenna povečati (po 3-5 razpolovnih časih zaviralca P-gp) na odmerek, ki ste ga uporabljali pred uvedbo močnega zaviralca P-gp (glejte poglavje 4.5).
English: d. Conducted in ITT with measurable disease population who had an objective response.
Slovenian: Oceno so opravili pri populaciji z namenom zdravljenja (ITT - intent-to-treat), ki je imela merljivo bolezen in pri kateri je prišlo do objektivnega odziva.
English: Table 3 summarises adverse reactions based on pooled dataset listed by system organ class, and frequency category.
Slovenian: V preglednici 3 so povzeti neželeni učinki na podlagi združene zbirke podatkov, navedeni pa so po organskih sistemih in pogostnosti.
English: If such events occur, dose modifications (reduction or interruption) are recommended (see section 4.2).
Slovenian: Če pride do teh pojavov, je priporočljivo prilagajanje odmerka (zmanjšanje odmerka ali prekinitev zdravljenja) (glejte poglavje 4.2).
English: A risk to breast-fed children cannot be excluded and therefore breast-feeding is not recommended during treatment with Talzenna and for at least 1 month after the final dose.
Slovenian: Tveganja za dojene otroke ni mogoče izključiti, zato dojenje med zdravljenjem z zdravilom Talzenna in še vsaj 1 mesec po zadnjem odmerku ni priporočljivo.
English: These toxicity findings are consistent with the pharmacology of talazoparib and its tissue distribution pattern.
Slovenian: Te toksikološke ugotovitve so skladne s farmakologijo talazopariba in vzorcem njegove porazdelitve v tkivih.
English: Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
Slovenian: Bolniki z rakom dojk, pozitivnim na hormonske receptorje (HR - hormone receptors), so se morali predhodno zdraviti z endokrinim zdravljenjem ali pa so morali biti neprimerni za endokrino zdravljenje.
English: Number of patients who received following prior therapies, n (%) Taxane
Slovenian: Število bolnikov, ki so prejeli naslednja predhodna zdravljenja, n (%) taksan antraciklin platina
English: Talzenna hard capsules come in different strengths.
Slovenian: Zdravilo Talzenna trde kapsule je na voljo v različnih jakostih.
English: PARP enzymes are involved in cellular DNA damage response signalling pathways such as DNA repair, gene transcription, and cell death.
Slovenian: Encimi PARP sodelujejo v celičnih signalnih poteh odziva na poškodbe DNK, kot so popravilo DNK, transkripcija genov in celična smrt.
English: Talzenna may only be used in patients with moderate or severe hepatic impairment if the benefit outweighs the potential risk, and the patient should be carefully monitored for hepatic function and adverse events.
Slovenian: Zdravilo Talzenna lahko pri bolnikih z zmerno ali hudo okvaro jeter uporabljamo samo, če korist odtehta morebitno tveganje, bolnika pa je treba skrbno spremljati glede delovanja jeter in neželenih učinkov.
English: Do not use curcumin in food supplements while you are taking Talzenna as it may increase Talzenna's side effects.
Slovenian: Med jemanjem zdravila Talzenna ne uporabljajte kurkumina v prehranskih dopolnilih, saj lahko okrepi neželene učinke zdravila Talzenna.
English: Missing
Slovenian: manjka
English: Complete blood counts should be obtained at baseline and monitored monthly for signs of haematologic toxicity during treatment.
Slovenian: Ob izhodišču je treba pregledati celotno krvno sliko in bolnike med zdravljenjem mesečno spremljati glede znakov hematološke toksičnosti.
English: The most common (≥ 25%) adverse reactions in patients receiving talazoparib in these clinical studies were fatigue (57.1%), anaemia (49.6%), nausea (44.3%), neutropenia (30.2%), thrombocytopenia (29.6%), and headache (26.5%).
Slovenian: Najpogostejši (≥ 25 %) neželeni učinki pri bolnikih, ki so v teh kliničnih študijah prejemali talazoparib, so bili utrujenost (57,1 %), anemija (49,6 %), navzea (44,3 %), nevtropenija (30,2 %), trombocitopenija (29,6 %) in glavobol (26,5 %).
English: In repeat-dose toxicity studies in rats and in dogs, the main findings at subtherapeutic exposures included bone marrow hypocellularity with dose-dependent decrease in haematopoietic cells, depletion of lymphoid tissue in multiple organs and atrophy and/or degenerative changes in testes, epididymis and seminiferous tubules.
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih pri podganah in psih so glavne ugotovitve pri subterapevtskih izpostavljenostih vključevale hipocelularnost kostnega mozga z od odmerka odvisnim zmanjšanjem števila krvotvornih celic, izčrpanjem limfatičnega tkiva v več organih ter atrofijo in/ali degenerativne spremembe na testisih, epididimisu in semenskih cevkah.
English: Based on these results, Talzenna can be administered with or without food (see section 4.2).
Slovenian: Ti rezultati kažejo, da lahko zdravilo Talzenna uporabljamo s hrano ali brez nje (glejte poglavje 4.2).
English: Contraception in women of childbearing potential
Slovenian: Kontracepcija pri ženskah v rodni dobi
English: No dose adjustment is necessary in elderly (≥ 65 years of age) patients (see section 5.2).
Slovenian: Starejši bolniki Pri starejših bolnikih (≥ 65 let) prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: A population PK analysis was conducted using data from 490 patients with cancer to evaluate the impact of age (ranging from 18 to 88 years), sex (53 males and 437 females), and body weight (ranging from 35.7 kg to 162 kg) on the PK of talazoparib.
Slovenian: Populacijsko FK analizo so opravili s podatki 490 bolnikov z rakom za oceno vpliva starosti (v razponu od 18 do 88 let), spola (53 moških in 437 žensk) in telesne mase (razpon od 35,7 kg do 162 kg) na FK talazopariba.
English: Women of childbearing potential should not become pregnant while receiving Talzenna and should not be pregnant at the beginning of treatment.
Slovenian: Ženske v rodni dobi med prejemanjem zdravila Talzenna ne smejo zanositi in ob začetku zdravljenja ne smejo biti noseče.
English: Pregnant women should be advised of the potential risk to the foetus (see section 4.6).
Slovenian: Nosečnice je treba seznaniti z morebitnim tveganjem za plod (glejte poglavje 4.6).
English: Summary of efficacy results - EMBRACA study Talazoparib
Slovenian: Povzetek rezultatov učinkovitosti - študija EMBRACA talazoparib kemoterapija
English: The primary efficacy endpoint was progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by blinded independent central review (BICR).
Slovenian: Primarni opazovani dogodek učinkovitosti je bilo preživetje brez napredovanja bolezni (PFSprogression-free survival), ki so ga ocenjevali s slepim neodvisnim centralnim pregledom (BICRblinded independent central review) v skladu z merili za ocenjevanje odziva pri čvrstih tumorjih (RECIST - response evaluation criteria in solid tumors), različica 1.1.
English: Manufacturer Excella GmbH & Co. KG Nürnberger Strasse 12 90537 Feucht Germany
Slovenian: KG Nürnberger Strasse 12 90537 Feucht Nemčija
English: The effect of talazoparib on cardiac repolarisation was evaluated using time-matched electrocardiograms (ECGs) in assessing the relationship between the change of the QT interval corrected for heart rate (QTc) from baseline and the corresponding plasma talazoparib concentrations in 37 patients with advanced solid tumours.
Slovenian: Učinek talazopariba na repolarizacijo srca so ovrednotili na podlagi časovno usklajenih elektrokardiogramov (EKG) z ocenjevanjem povezave med spremembo intervala QT, korigiranega za srčno frekvenco (QTc), od izhodišča in ustreznimi koncentracijami talazopariba v plazmi pri 37 bolnikih z napredovalimi čvrstimi tumorji.
English: The dose may be lowered to 0.75 mg (taken as three 0.25-mg capsules) once daily, or 0.5 mg (two 0.25-mg capsules) once daily, or 0.25 mg (one 0.25-mg capsule) once daily.
Slovenian: Odmerek vam lahko zmanjša na 0,75 mg (ki ga vzamete v obliki treh 0,25 mg kapsul) enkrat na dan ali 0,5 mg (dve 0,25 mg kapsuli) enkrat na dan ali 0,25 mg (ena 0,25 mg kapsula) enkrat na dan.
English: Abbreviations: BICR=blinded independent central review; CI=confidence interval; CMH=CochranMantel-Haenszel; CR=complete response; IQR=interquartile range; ITT=intent-to-treat; ORR=objective response rate; OS=overall survival; PR=partial response; RECIST 1.1=Response Evaluation Criteria in Solid Tumors version 1.1. a. Hazard ratio was based on stratified Cox regression model with treatment as the only covariate
Slovenian: Okrajšave: BICR = slepi neodvisni centralni pregled (blinded independent central review); IZ = interval zaupanja; CMH = Cochran-Mantel-Haenszel; CR = popolni odziv (complete response); IQR = interkvartilni razpon (interquartile range); ITT = populacija z namenom zdravljenja (intent-to-treat); ORR = objektivni odziv na zdravljenje (objective response rate); OS = celokupno preživetje (overall survival); PR = delni odziv (partial response); RECIST 1.1 = merila za ocenjevanje odziva pri čvrstih tumorjih, različica 1.1 (response evaluation criteria in solid tumors).
English: Also some medicines can affect the way Talzenna works.
Slovenian: Prav tako pa lahko nekatera druga zdravila vplivajo na delovanje zdravila Talzenna.
English: Talazoparib is a substrate for drug transporters P-gp and Breast Cancer Resistance Protein (BCRP) and it is mainly eliminated by renal clearance as unchanged compound.
Slovenian: Talazoparib je substrat prenašalcev zdravil P-gp in beljakovine odpornosti pri raku dojk (BCRPbreast cancer resistance protein) in se večinoma v nespremenjeni obliki izloča skozi ledvice.
English: Male and female contraception
Slovenian: Kontracepcija pri moških in ženskah
English: PARP inhibitors (PARPi) exert cytotoxic effects on cancer cells by 2 mechanisms, inhibition of PARP catalytic activity and by PARP trapping, whereby PARP protein bound to a PARPi does not readily dissociate from a DNA lesion, thus preventing DNA repair, replication, and transcription, thereby resulting in apoptosis and/or cell death.
Slovenian: Zaviralci PARP (PARPi - PARP inhibitors) delujejo citotoksično na rakave celice z 2 mehanizmoma, in sicer z zaviranjem katalitske aktivnosti PARP in ujetjem PARP, pri čemer beljakovina PARP, vezana na PARPi, ne disociira zlahka s poškodbe DNK in tako prepreči popravilo, podvojevanje in prepisovanje DNK, kar povzroči apoptozo in/ali celično smrt.
English: Population pharmacokinetic (PK) analysis has also shown that concomitant use of strong P-gp inhibitors increased talazoparib exposure by 45%, relative to talazoparib given alone.
Slovenian: Populacijska farmakokinetična (FK) analiza je pokazala tudi, da je sočasna uporaba močnih zaviralcev P-gp povečala izpostavljenost talazoparibu za 45 % v primerjavi s talazoparibom, ki so ga dali samostojno.
English: Supportive care with or without blood and/or platelet transfusions and/or administration of colony stimulating factors may be used as appropriate.
Slovenian: Če je to primerno, lahko uvedemo podporno oskrbo s transfuzijo krvi in/ali trombocitov ali brez nje in/ali uporabo kolonije stimulirajočih faktorjev.
English: BRCA mutation status (breast cancer susceptibility gene 1 [BRCA1] positive or breast cancer susceptibility gene 2 [BRCA2] positive) was similar across both treatment arms.
Slovenian: BRCA (pozitivno za gen dovzetnosti za raka dojk 1 [BRCA1 - breast cancer susceptibility gene 1] ali pozitivno za gen dovzetnosti za raka dojk 2 [BRCA2]) je bil podoben pri obeh zdravljenih skupinah.