FrancophonIA/ELRC3.0 huggingface dataset:
English: Direct the stream toward the wall of the vial and not directly on the lyophilized cake.
Croatian: Usmjerite mlaz prema stijenci bočice, a ne izravno u liofilizirani kolačić.
English: The most common gastrointestinal toxicity events were diarrhoea and nausea.
Croatian: Najčešći događaji gastrointestinalne toksičnosti bili su proljev i mučnina.
English: Primary reasons patients were not candidates for HSCT included age (40%), insufficient response to salvage therapy (26%) and prior transplant failure (20%).
Croatian: Primarni razlozi zbog kojih bolesnici nisu bili kandidati za HSCT uključivali su dob (40%), nedostatan odgovor na spasonosnu terapiju (26%) i prethodno neuspješno presađivanje (20%).
English: Polivy should not be administered in the presence of an active severe infection.
Croatian: Polivy se ne smije primjenjivati u prisutnosti aktivne teške infekcije.
English: Give supportive treatment.
Croatian: Primijeniti potporno liječenje.
English: What Polivy is and what it is used for What you need to know before you are given Polivy How Polivy is given
Croatian: Što je Polivy i za što se koristi Što morate znati prije nego počnete primati Polivy Kako se Polivy primjenjuje Moguće nuspojave
English: 80% of patients had refractory disease.
Croatian: Osamdeset posto (80%) bolesnika imalo je refraktornu bolest.
English: It is given into a vein, as a drip over 90 minutes.
Croatian: Daje se u venu, kao drip u trajanju od 90 minuta.
English: What you need to know before you are given Polivy You must not be given Polivy
Croatian: Što morate znati prije nego počnete primati Polivy Ne smijete primiti Polivy
English: Clinical studies of Polivy did not include sufficient numbers of patients aged ≥65 to determine whether they respond differently from younger patients.
Croatian: U klinička ispitivanja lijeka Polivy nije bio uključen dovoljan broj bolesnika u dobi od ≥ 65 godina da bi se utvrdilo odgovaraju li ti bolesnici drugačije od mlađih bolesnika.
English: If you are not sure, talk to your doctor or nurse before you are given Polivy.
Croatian: Ako niste sigurni, obratite se svom liječniku ili medicinskoj sestri prije nego primite Polivy.
English: Among 173 patients treated with Polivy in Study GO29365, 95 (55%) were ≥65 years of age.
Croatian: Od 173 bolesnika liječena lijekom Polivy u ispitivanju GO29365, njih 95 (55%) bilo je u dobi od ≥ 65 godina.
English: A risk for breast-feeding children cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenčad.
English: • unusual sensations
Croatian: • neuobičajeni osjeti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1388/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1388/001
English: • you think you have an infection or have had long-lasting or repeated infections such as herpes (see “Infections” in section 4).
Croatian: • ako mislite da imate infekciju ili ako ste imali dugotrajne ili opetovane infekcije poput herpesa (pogledajte odlomak ‘Infekcije' u dijelu 4.)
English: For the clinical development program of Polivy as a whole, an estimated total of 588 patients have received Polivy.
Croatian: Procjenjuje se da je u sklopu cjelokupnog programa kliničkog razvoja Polivy primilo ukupno 588 bolesnika.
English: Do not breast-feed while receiving Polivy because small amount of Polivy may pass into your breast milk.
Croatian: Nemojte dojiti dok primate Polivy jer se male količine tog lijeka mogu izlučiti u majčino mlijeko.
English: What Polivy is and what it is used for
Croatian: Što je Polivy i za što se koristi
English: Pregnant women should be advised regarding risk to the foetus.
Croatian: Trudnice treba upozoriti na rizik za plod.
English: Women of childbearing potential/Contraception in males and females
Croatian: Žene reproduktivne dobi / kontracepcija u muškaraca i žena
English: In vitro, MMAE is moderately bound (71%-77%) to human plasma proteins.
Croatian: MMAE se in vitro umjereno vezuje (71 - 77%) za proteine u ljudskoj plazmi.
English: • trouble speaking
Croatian: • poteškoće s govorom
English: **6-8 weeks after Day 1 of Cycle 6 or last study treatment *** Stratification by duration of response to prior therapy (≤ 12 months vs > 12 months)
Croatian: **6 - 8 tjedana nakon 1. dana 6. ciklusa ili posljednje doze ispitivane terapije ***Stratifikacija prema trajanju odgovora na prethodnu terapiju (≤ 12 mjeseci naspram > 12 mjeseci)
English: Polivy has not been evaluated in patients with HIV.
Croatian: Polivy se nije ocjenjivao u bolesnika s HIV-om.
English: Due to the limited number of anti-polatuzumab vedotin antibody positive patients, no conclusions can be drawn concerning a potential effect of immunogenicity on efficacy or safety.
Croatian: Zbog ograničenog broja bolesnika pozitivnih na protutijela na polatuzumab vedotin ne mogu se donijeti zaključci o mogućem učinku imunogenosti na djelotvornost ili sigurnost.
English: In another study, two cases of serious hepatic toxicity (hepatocellular injury and hepatic steatosis) were reported and were reversible.
Croatian: U drugom su ispitivanju prijavljena dva slučaja ozbiljne hepatotoksičnosti (hepatocelularno oštećenje i steatoza jetre), koja su bila reverzibilna.
English: Plasma exposures of unconjugated MMAE are < 3% of acMMAE exposures.
Croatian: Plazmatska izloženost nekonjugiranom MMAE-u iznosi < 3% izloženosti acMMAE-u.
English: This is because there is no information about its use in this age group.
Croatian: Naime, nema informacija o njegovoj primjeni u toj dobnoj skupini.
English: Patients should be closely monitored during treatment for signs of bacterial, fungal, or viral infections and seek medical advice if signs and symptoms appear.
Croatian: Bolesnike treba pažljivo nadzirati tijekom liječenja zbog moguće pojave znakova bakterijskih, gljivičnih ili virusnih infekcija i uputiti ih da zatraže medicinski savjet ako se pojave takvi znakovi i simptomi.
English: Your doctor will do blood tests to check your blood cell count.
Croatian: Liječnik će provesti krvne pretrage kako bi provjerio Vašu krvnu sliku.
English: If you miss a dose of Polivy
Croatian: Ako ste propustili dozu lijeka Polivy
English: If a planned dose of Polivy is missed, it should be administered as soon as possible and the schedule of administration should be adjusted to maintain a 21-day interval between doses.
Croatian: Ako bolesnik propusti primiti planiranu dozu lijeka Polivy, treba je primijeniti što je prije moguće, a raspored primjene prilagoditi kako bi se održao 21-dnevni interval između doza.
English: The European Medicines Agency has waived the obligation to submit results of studies with Polivy in all subsets of the paediatric population for the treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Polivy u svim podskupinama pedijatrijske populacije u liječenju novotvorina zrelih B-stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Polivy must be reconstituted and diluted using aseptic technique under the supervision of a healthcare professional.
Croatian: Polivy se mora rekonstituirati i razrijediti primjenom aseptične tehnike pod nadzorom zdravstvenog radnika.
English: Patients were stratified by duration of response to last prior treatment of ≤ 12 months or > 12 months.
Croatian: Bolesnici su bili stratificirani prema trajanju odgovora na posljednje primijenjeno liječenje (≤ 12 mjeseci ili > 12 mjeseci).
English: • if you are allergic to polatuzumab vedotin or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na polatuzumab vedotin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Myelosuppression is a condition in which the production of blood cells is decreased, resulting in fewer red blood cells, white blood cells, and platelets.
Croatian: Mijelosupresija je stanje kod kojega je proizvodnja krvnih stanica smanjena, zbog čega je smanjen i broj crvenih krvnih stanica, bijelih krvnih stanica te krvnih pločica.
English: Polivy can cause IRRs , including severe cases.
Croatian: Polivy može uzrokovati reakcije povezane s infuzijom, uključujući teške slučajeve.
English: No significant difference was observed in the pharmacokinetics of acMMAE and unconjugated MMAE among patients < 65 years of age (n = 187) and patients ≥ 65 years of age (n = 273).
Croatian: Nije primijećena značajna razlika u farmakokinetici acMMAE-a i nekonjugiranog MMAE-a između bolesnika u dobi od < 65 godina (n=187) i onih u dobi od ≥ 65 godina (n=273).
English: Pharmacotherapeutic group: antineoplastic agents; other antineoplastic agents; monoclonal antibodies ATC code: L01XC37
Croatian: Farmakoterapijska skupina: antineoplastici, ostali antineoplastici, monoklonska protutijela ATK oznaka: L01XC37
English: Tell your doctor or nurse straight away if you have any problems with a change in the sensitivity of your skin, especially in your hands or feet, such as:
Croatian: Odmah se obratite svom liječniku ili medicinskoj sestri ako primijetite bilo kakve promjene u osjetljivosti kože, osobito na šakama ili stopalima, kao što su:
English: PML has been reported with Polivy treatment (see section 4.8).
Croatian: Kod liječenja lijekom Polivy prijavljen je PML (vidjeti dio 4.8).
English: • If you have peripheral neuropathy, your doctor may lower your dose to 1.4 mg for each kilogram of your body weight.
Croatian: • Ako imate perifernu neuropatiju, liječnik će Vam možda smanjiti dozu na 1,4 mg po kilogramu tjelesne težine.
English: Interrupt POLIVY infusion and give supportive treatment.
Croatian: Privremeno prekinuti infuziju lijeka Polivy i primijeniti potporno liječenje.
English: Signs and symptoms of infections vary between individuals, tell your doctor or nurse straight away if you develop symptoms of an infection such as:
Croatian: Iako se znakovi i simptomi infekcija razlikuju od osobe do osobe, odmah se obratite svom liječniku ili medicinskoj sestri ako se pojave simptomi infekcije kao što su:
English: Tell your doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment.
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od sljedećih ozbiljnih nuspojava - možda će Vam biti potrebno hitno liječenje.
English: Avoid transportation of the prepared solution for infusion as agitation stress can result in aggregation.
Croatian: Izbjegavajte prevoženje pripremljene otopine za infuziju jer tresenje tijekom prijevoza može dovesti do stvaranja agregata.
English: The initial dose of Polivy should be administered as a 90-minute intravenous infusion.
Croatian: Početnu dozu lijeka Polivy treba primijeniti u obliku 90-minutne intravenske infuzije.
English: • have headaches
Croatian: • ako imate glavobolje
English: This is called tumour lysis syndrome.
Croatian: To se naziva sindromom tumorske lize.
English: Your doctor will check your blood to test your liver function before and regularly during treatment.
Croatian: Liječnik će krvnom pretragom ocijeniti jetrenu funkciju prije liječenja i redovito tijekom liječenja.
English: The levels of MMAE metabolites have not been measured in human plasma.
Croatian: Nisu se određivale razine metabolita MMAE-a u ljudskoj plazmi.
English: Talk to your doctor or nurse before you are given Polivy if any of the following apply to you (or you are not sure):
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite Polivy ako se bilo što od sljedećega odnosi na Vas (ili ako niste sigurni):
English: Elderly No dose adjustment of Polivy is required in patients ≥ 65 years of age (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu lijeka Polivy u bolesnika u dobi od ≥ 65 godina (vidjeti dio 5.2).
English: For the next cycle, infuse Polivy over 90 minutes.
Croatian: U sljedećem ciklusu Polivy treba infundirati tijekom razdoblja od 90 minuta.
English: The population estimate of central volume of distribution for acMMAE was 3.15 L, which approximated plasma volume.
Croatian: Procijenjeni centralni volumen distribucije acMMAE-a na temelju populacijske farmakokinetike iznosio je 3,15 l, što je približno odgovaralo plazmatskom volumenu.
English: Some people may develop unusual levels of some substances (such as potassium and uric acid) in the blood caused by the fast breakdown of cancer cells during treatment.
Croatian: Kod nekih osoba može doći do neuobičajenih razina nekih tvari u krvi (kao što su kalij i mokraćna kiselina) zbog brze razgradnje stanica raka tijekom liječenja.
English: • Keep this medicine out of the sight and reach of children.
Croatian: • Lijek čuvati izvan pogleda i dohvata djece.
English: The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Croatian: Pripadajuća kategorija učestalosti za svaku nuspojavu definirana je na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: What other medicines Polivy is given with
Croatian: S kojim se drugim lijekovima Polivy daje
English: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
English: The total storage plus transportation times of the diluted product should not exceed the storage duration specified in Table 6 (see section 6.3).
Croatian: Ukupno vrijeme čuvanja plus prijevoza razrijeđenog lijeka ne smije premašiti vrijeme čuvanja navedeno u Tablici 6 (vidjeti dio 6.3).
English: • raised liver enzymes
Croatian: • povišene razine jetrenih enzima
English: Among the 80 patients who were randomized to receive Polivy plus BR (n=40) or BR alone (n = 40) the majority were white (71%) and male (66%).
Croatian: Od 80 bolesnika randomiziranih za primanje lijeka Polivy plus BR-a (n=40) ili samo BR-a (n=40), većina su bili bijelci (71%) i muškarci (66%).
English: If the prior infusion was well tolerated, the subsequent dose of Polivy may be administered as a 30-minute infusion and patients should be monitored during the infusion and for at least 30 minutes after completion of the infusion.
Croatian: Ako je bolesnik dobro podnio prethodnu infuziju, sljedeća doza lijeka Polivy može se primijeniti u obliku 30-minutne infuzije, a bolesnika treba nadzirati tijekom infuzije i još najmanje 30 minuta nakon njezina završetka.
English: • you have ever had brain or nerve problems such as: memory problems difficulty moving or sensations in your body such as feeling pins and needles, burning, pain and discomfort even from slight touch eyesight problems
Croatian: • ako ste ikada imali tegoba s mozgom ili živcima, kao što su: poteškoće s pamćenjem poteškoće s kretanjem ili osjetima u tijelu, poput trnaca i bockanja, žarenja, boli i nelagode uzrokovane čak i laganim dodirom tegobe s vidom
English: Polivy powder for concentrate for solution for infusion is a white to slightly greyish-white cake provided in a glass vial.
Croatian: Polivy prašak za koncentrat za otopinu za infuziju je bijeli do sivkasto-bijeli kolačić koji dolazi u staklenoj bočici.
English: For dose modifications for peripheral neuropathy (section 4.4) see Table 1 below.
Croatian: Za prilagodbe doze kod periferne neuropatije (dio 4.4) vidjeti Tablicu 1 u nastavku.
English: Diffuse large B-cell lymphoma is a cancer that develops from B lymphocytes also called B-cells.
Croatian: Difuzni B-velikostanični limfom je rak koji se razvija iz B-limfocita, koji se nazivaju i B-stanicama.
English: MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.
Croatian: MMAE se vezuje za mikrotubule i uništava stanice koje se dijele tako što inhibira staničnu diobu i inducira apoptozu.
English: There have been no studies performed with other routes of administration.
Croatian: Nisu provedena ispitivanja s drugim putovima primjene.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Croatian: Bolesnicima u kojih dođe do predoziranja treba odmah prekinuti primjenu infuzije i pažljivo ih nadzirati.
English: For dose modifications for Infusion-related reactions see Table 3.
Croatian: Za prilagodbe doze kod reakcija povezanih s infuzijom vidjeti Tablicu 3.
English: If you get infusion-related reactions or nerve damage, or if you feel tired, weak or dizzy (see section 4) do not drive, cycle or use tools or machines until the reaction stops.
Croatian: Ako se kod Vas pojavi reakcija povezana s infuzijom, ako dođe do oštećenja živaca ili ako osjećate umor, slabost ili omaglicu (pogledajte dio 4.), nemojte upravljati vozilima, voziti bicikl niti rukovati alatima ili strojevima dok se reakcija ne povuče.
English: The median number of prior therapies was 2 (range: 1-7), with 29% (n = 23) receiving one prior therapy, 25% (n = 20) receiving 2 prior therapies, and 46% (n = 37) receiving 3 or more prior therapies.
Croatian: Medijan broja prethodnih terapija bio je 2 (raspon: 1 - 7), pri čemu je 29% bolesnika (n=23) prethodno primilo jednu terapiju, 25% (n=20) dvije terapije, a njih 46% (n=37) tri ili više terapija.
English: Determine the volume of 20 mg/mL reconstituted solution needed based on the required dose (see below):
Croatian: Odredite potreban volumen rekonstituirane otopine koncentracije 20 mg/ml na temelju željene doze (vidjeti u nastavku):
English: The storage details are as follows
Croatian: Uvjeti čuvanja su sljedeći:
English: This includes run-in phase patients (n=6) and randomized patients (n=39) who received Polivy in combination with bendamustine and rituximab (BR) compared to randomized patients (n=39) who received BR alone.
Croatian: To uključuje bolesnike iz uvodnog razdoblja (n=6) i randomizirane bolesnike (n=39) koji su primali Polivy u kombinaciji s bendamustinom i rituksimabom (BR) u odnosu na randomizirane bolesnike (n=39) koji su primali samo BR.
English: Caution is advised in case of concomitant treatment with CYP3A4 inhibitor.
Croatian: Preporučuje se oprez u slučaju istodobnog liječenja inhibitorom CYP3A4.
English: • have unusual bleeding, bruising under the skin, bleeding longer than usual after your blood has been drawn, or bleeding from your gums.
Croatian: • ako primijetite neuobičajeno krvarenje, modrice ispod kože, krvarenje nakon vađenja krvi koje traje dulje nego inače ili krvarenje iz desni
English: Polivy is not recommended during pregnancy and in women of childbearing potential not using contraception unless the potential benefit for the mother outweighs the potential risk to the foetus.
Croatian: Ne preporučuje se primjena lijeka Polivy tijekom trudnoće kao ni u žena reproduktivne dobi koje ne koriste kontracepciju, osim u slučajevima kada moguća korist za majku nadmašuje mogući rizik za plod.
English: Once attached to B cells, the medicine releases MMAE into the B cells and kills them.
Croatian: Nakon što se veže za B-stanice, lijek u njih otpušta MMAE i uništava ih.
English: The efficacy of Polivy was evaluated in an international, multicentre, open-label study (GO29365) which included a randomized cohort of 80 patients with previously treated DLBCL.
Croatian: Djelotvornost lijeka Polivy ocjenjivala se u međunarodnom, multicentričnom, otvorenom ispitivanju (GO29365), koje je uključivalo randomiziranu kohortu od 80 prethodno liječenih bolesnika s DLBCL-om.
English: METHOD OF ADMINISTRATION For IV use after reconstitution and dilution
Croatian: NAČIN PRIMJENE LIJEKA Za IV primjenu nakon rekonstitucije i razrjeđivanja
English: • unusual bleeding or bruising under the skin
Croatian: • neuobičajeno krvarenje ili potkožne modrice
English: If no infusionrelated reaction occurs, subsequent infusions may be administered over 30 minutes.
Croatian: Ako ne nastupi nijedna reakcija povezana s infuzijom, daljnje infuzije mogu se primjenjivati tijekom razdoblja od 30 minuta.
English: MMAE does not significantly partition into human red blood cells in vitro; the blood to plasma ratio is 0.79 to 0.98.
Croatian: MMAE se ne nakuplja u značajnoj mjeri u ljudskim eritrocitima in vitro; omjer količine u krvi i plazmi iznosi 0,79 - 0,98.
English: Overall, 48% of patients had activated B-cell (ABC) DLBCL and 40% had germinal center B-cell like (GCB) DLBCL.
Croatian: Sveukupno je 48% bolesnika imalo DLBCL aktiviranih B-stanica (engl. activated B-cell, ABC), a njih 40% DLBCL B-stanica germinalnog centra (engl. germinal center B-cell, GCB).
English: Eligible patients were not candidates for autologous haematopoietic stem cell transplant (HSCT) and had relapsed or refractory disease after receiving at least one prior systemic chemotherapy regimen.
Croatian: U ispitivanju su mogli sudjelovati bolesnici koji nisu bili kandidati za autologno presađivanje hematopoetskih matičnih stanica (engl. haematopoietic stem cell transplant, HSCT) i koji su imali relapsnu ili refraktornu bolest nakon primanja najmanje jednog prethodnog sistemskog kemoterapijskog protokola.
English: ADRs leading to treatment regimen discontinuation in >5% of patients were thrombocytopenia (8.9%) and neutropenia (6.7%).
Croatian: Nuspojave koje su dovele do prekida primjene terapijskog režima u > 5% bolesnika bile su trombocitopenija (8,9%) i neutropenija (6,7%).
English: Gently mix the intravenous bag by slowly inverting the bag.
Croatian: Nježno promiješajte sadržaj vrećice za intravensku infuziju polako je okrećući.
English: Infusion-related reactions, allergic or anaphylactic (more severe allergic) reactions can happen.
Croatian: Mogu se javiti reakcije povezane s infuzijom te alergijske ili anafilaktičke (teže alergijske) reakcije.
English: Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease.
Croatian: Rezultati testova imunogenosti uvelike ovise o nekoliko faktora, uključujući osjetljivost i specifičnost testa, metodologiju testiranja, rukovanje uzorcima, vrijeme prikupljanja uzoraka, istodobnu primjenu drugih lijekova i podležeću bolest.
English: Polivy must only be administered under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer patients.
Croatian: Polivy se mora primjenjivati isključivo pod nadzorom zdravstvenog radnika koji ima iskustva s dijagnosticiranjem i liječenjem bolesnika oboljelih od raka.
English: Live or live-attenuated vaccines should not be given concurrently with the treatment.
Croatian: Živa ili živa atenuirana cjepiva ne smiju se davati istodobno s liječenjem ovim lijekom.
English: This mechanism is consistent with the pharmacological effect of MMAE as a microtubule disrupting agent.
Croatian: Taj je mehanizam u skladu s farmakološkim učinkom MMAE-a kao tvari koja narušava funkciju mikrotubula.
English: Due to limited clinical experience in patients treated with 1.8 mg/kg Polivy at a total dose >240 mg, it is recommended not to exceed the dose 240 mg/cycle.
Croatian: Zbog ograničenog kliničkog iskustva u bolesnika liječenih lijekom Polivy u dozi od 1,8 mg/kg koji su primili ukupnu dozu > 240 mg, preporučuje se ne prekoračiti dozu od 240 mg po ciklusu.
English: In the absence of infusion-related symptoms, the rate of infusion may be escalated in increments of 50 mg/hour every 30 minutes.
Croatian: Ako nema simptoma povezanih s infuzijom, brzina infuzije može se povećavati u koracima od 50 mg/h svakih 30 minuta.
English: Polivy is for single-use only.
Croatian: Polivy je namijenjen samo za jednokratnu primjenu.
English: The unadjusted estimate for PFS HR was 0.34.
Croatian: Neprilagođen procijenjeni HR za PFS iznosio je 0,34.