FrancophonIA/ELRC3.0 huggingface dataset:
English: Trastuzumab emtansine has the mechanisms of action of both trastuzumab and DM1:
Croatian: Trastuzumab emtanzin ima mehanizme djelovanja i trastuzumaba i DM1:
English: Kadcyla (trastuzumab emtansine) and Herceptin (trastuzumab) are two very different products with different active substances never to be used interchangeably.
Croatian: Kadcyla (trastuzumab emtanzin) i Herceptin (trastuzumab) su dva vrlo različita lijeka s dvama različitim djelatnim tvarima koje se nikada ne smiju međusobno zamjenjivati.
English: Kadcyla delayed patient-reported time to symptom progression for 7.1 months compared with 4.6 months for the control arm (Hazard Ratio 0.796 (0.667, 0.951); p-value 0.0121).
Croatian: Kadcyla je produljila vrijeme do prijave progresije simptoma od strane bolesnika za 7,1 mjesec u usporedbi sa 4,6 mjeseci u kontrolnoj skupini (omjer hazarda 0,796 (0,667; 0,951); pvrijednost 0,0121).
English: NRH should be considered in all patients with clinical symptoms of portal hypertension and/or cirrhosis-like pattern seen on the computed tomography (CT) scan of the liver but with normal transaminases and no other manifestations of cirrhosis.
Croatian: Treba uzeti u obzir mogućnost NRH-a u svih bolesnika s kliničkim simptomima portalne hipertenzije i/ili onih na čijoj se snimci jetre dobivenoj kompjuteriziranom tomografijom (CT-om) vide uzorci nalik onima kod ciroze, a koji imaju normalne vrijednosti transaminaza i nemaju drugih manifestacija ciroze.
English: No dose relationship was observed in clinical studies.
Croatian: U kliničkim ispitivanjima nije primijećena povezanost s dozom.
English: You should not breast-feed during treatment with Kadcyla.
Croatian: Ne smijete dojiti za vrijeme liječenja lijekom Kadcyla.
English: How much you will be given · You will be given 3.6 mg of Kadcyla for every kilogram of your body weight.
Croatian: • Primit ćete 3,6 mg lijeka Kadcyla na svaki kilogram tjelesne težine.
English: Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) with trastuzumab emtansine should be avoided due to the potential for an increase in DM1 exposure and toxicity.
Croatian: Treba izbjegavati istodobnu primjenu snažnih inhibitora CYP3A4 (npr. ketokonazola, itrakonazola, klaritromicina, atazanavira, indinavira, nefazodona, nelfinavira, ritonavira, sakvinavira, telitromicina i vorikonazola) s trastuzumab emtanzinom zbog moguće povećane izloženosti DM1 i toksičnosti.
English: The co-primary efficacy endpoints of the study were progression-free survival (PFS) as assessed by an independent review committee (IRC) and overall survival (OS) (see Table 7 and Figures 2 to 3).
Croatian: Dva primarna ishoda ispitivanja za djelotvornost bila su preživljenje bez progresije bolesti (eng. progression-free survival, PFS) prema procjeni neovisnog ocjenjivačkog povjerenstva (engl. independent review committee, IRC) te ukupno preživljenje (OS) (vidjeti Tablicu 7 i Slike 2 i 3).
English: Succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Croatian: Sukcinatna kiselina, natrijev hidroksid, saharoza, polisorbat 20.
English: Patients develop multiple nodules in the liver that can change how the liver functions.
Croatian: U jetri bolesnika nastaju brojni čvorići koji mogu promijeniti način na koji jetra funkcionira.
English: No significant difference was observed in the PK of trastuzumab emtansine among patients < 65 years (n = 577), patients between 65-75 years (n = 78) and patients > 75 years (n = 16).
Croatian: Nije primijećena značajna razlika u farmakokinetici trastuzumab emtanzina između bolesnika mlađih od 65 godina (n = 577), bolesnika u dobi između 65 i 75 godina (n = 78) i bolesnika starijih od 75 godina (n = 16).
English: Increased Alanine Transaminase (ALT)
Croatian: Povišene vrijednosti alanin transaminaze (ALT)
English: The decision to administer trastuzumab emtansine in MBC patients with low LVEF must be made only after careful benefit risk assessment and cardiac function should be closely monitored in these patients (see section 4.8).
Croatian: Odluka o primjeni trastuzumab emtanzina u bolesnika s metastatskim rakom dojke i niskim LVEF-om smije se donijeti tek nakon pažljive ocjene koristi i rizika te je u tih bolesnika potrebno pažljivo nadzirati srčanu funkciju (vidjeti dio 4.8).
English: Trastuzumab emtansine (N=740) All Grade % Grade 3 (%) Grade 4 (%)
Croatian: Trastuzumab emtanzin (N=740) svi stupnjevi (%) stupanj 3 (%) stupanj 4 (%)
English: The majority of ADRs reported were of Grade 1 or 2 severity.
Croatian: Većina prijavljenih nuspojava lijeka bila je stupnja težine 1 ili 2.
English: The potential need for dose adjustment in patients with severe renal impairment cannot be determined due to insufficient data and therefore patients with severe renal impairment should be monitored carefully.
Croatian: Moguća potreba za prilagodbom doze u bolesnika s teškim oštećenjem bubrežne funkcije ne može se odrediti jer nema dovoljno podataka pa je bolesnike s teškim oštećenjem bubrežne funkcije potrebno pažljivo nadzirati.
English: · Breathing problems: Kadcyla can cause serious breathing problems such as shortness of breath (either at rest or while performing any type of activity) and cough.
Croatian: • Probleme s disanjem: Kadcyla može izazvati ozbiljne probleme s disanjem poput nedostatka zraka (u mirovanju ili pri izvođenju bilo kakve vrste aktivnosti) i kašlja.
English: Patients (n = 110) received 3.6 mg/kg of trastuzumab emtansine intravenously every 3 weeks until disease progression or unacceptable toxicity.
Croatian: Bolesnici (n = 110) su primali trastuzumab emtanzin u dozi od 3,6 mg/kg intravenski svaka 3 tjedna do progresije bolesti ili do pojave neprihvatljive toksičnosti.
English: Some symptoms could be yellowing of your skin and whites of your eyes (jaundice).
Croatian: Neki od simptoma mogu biti žuta boja kože i bjeloočnica (žutica).
English: Because most of the patients in trastuzumab emtansine clinical studies were females, the effect of gender on the PK of trastuzumab emtansine was not formally evaluated.
Croatian: Budući da je većina bolesnika u kliničkim ispitivanjima trastuzumab emtanzina bila ženskoga spola, učinak spola na farmakokinetiku trastuzumab emtanzina nije formalno ocijenjen.
English: Patients should be observed closely for infusion-related reactions, especially during the first infusion.
Croatian: Bolesnike je potrebno pomno nadzirati zbog moguće pojave reakcija povezanih s infuzijom, osobito tijekom prve infuzije.
English: A cumulative effect of trastuzumab emtansine on transaminases has been observed, and generally recovered when treatment was discontinued.
Croatian: Primijećen je kumulativan učinak trastuzumab emtanzina na transaminaze, koji se obično povlačio nakon prekida liječenja.
English: · Bleeding problems: Kadcyla can lower the number of platelets in your blood.
Croatian: • Problemi s krvarenjem: Kadcyla može sniziti broj trombocita u krvi.
English: Patients were treated with trastuzumab emtansine or trastuzumab for a total of 14 cycles unless there was recurrence of disease, withdrawal of consent, or unacceptable toxicity, whichever occurred first.
Croatian: Bolesnici su primili ukupno 14 ciklusa liječenja trastuzumab emtanzinom ili trastuzumabom, osim u slučajevima kada je došlo do povrata bolesti, povlačenja pristanka ili neprihvatljive toksičnosti, što god je nastupilo prvo.
English: Impairment of fertility and teratogenicity
Croatian: Poremećaj plodnosti i teratogenost
English: You must not be given Kadcyla · if you are allergic to trastuzumab emtansine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na trastuzumab emtanzin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: These reactions were usually mild or moderate and comprised erythema, tenderness, skin irritation, pain, or swelling at the infusion site.
Croatian: Te su reakcije obično bile blage ili umjerene, a uključivale su eritem, osjetljivost na dodir, iritaciju kože, bol ili oticanje na mjestu infuzije.
English: Lonzastrasse CH-3930 Visp Switzerland
Croatian: CH-3930 Visp
English: In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (navesti) u zdravstvenom kartonu bolesnika.
English: Permanently discontinue trastuzumab emtansine in the absence of another likely cause for the elevation of liver enzymes and bilirubin, e.g. liver metastasis or concomitant medication
Croatian: Trajno obustaviti liječenje trastuzumab emtanzinom ako ne postoji nijedan drugi vjerojatan uzrok povišenja vrijednosti jetrenih enzima i bilirubina, npr. jetrena metastaza ili istodobno primijenjeni lijekovi.
English: Description of the key differences between trastuzumab emtansine and trastuzumab in relation to indication, dose, administration and packaging differences.
Croatian: Opis ključnih razlika između trastuzumab emtanzina i trastuzumaba s obzirom na indikaciju, dozu,
English: If you get any of the side effects after your treatment with Kadcyla has stopped, talk to your doctor or nurse and tell them that you have been treated with Kadcyla.
Croatian: Ako primijetite bilo koju nuspojavu nakon završetka liječenja lijekom Kadcyla, obratite se svom liječniku ili medicinskoj sestri i recite im da ste bili liječeni lijekom Kadcyla.
English: The majority of the patients had Grade 1 or 2 events (≥ 50,000/mm3), with the nadir occurring by day 8 and generally improving to Grade 0 or 1 (≥ 75,000/mm3) by the next scheduled dose.
Croatian: U većine bolesnika pojavili su se događaji stupnja 1 ili 2 (≥ 50 000/mm3), pri čemu je najniža vrijednost nastupila do 8. dana te se obično poboljšala do stupnja 0 ili 1 (≥ 75 000/mm3) do sljedeće planirane doze.
English: An updated RMP should be submitted: · At the request of the European Medicines Agency; · Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: The objective response rate (ORR) was 58.0% with trastuzumab plus docetaxel and 64.2% with trastuzumab emtansine.
Croatian: Stopa objektivnog odgovora (ORR) iznosila je 58,0% kod primjene trastuzumaba u kombinaciji s docetakselom te 64,2% kod primjene trastuzumab emtanzina.
English: Patients with baseline elevation of ALT (e.g. due to liver metastases) may be predisposed to liver injury with a higher risk of a Grade 3-5 hepatic event or liver function test increase.
Croatian: Bolesnici kojima su povišene vrijednosti ALT-a na početku liječenja (npr. zbog jetrenih metastaza) mogu imati predispoziciju za oštećenje jetre, uz veći rizik od pojave jetrenog oštećenja stupnja 3-5 ili povišenja vrijednosti testova jetrene funkcije.
English: Patients should receive treatment until disease progression or unmanageable toxicity.
Croatian: Bolesnike je potrebno liječiti do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: The liver is a primary organ for eliminating DM1 and DM1-containing catabolites.
Croatian: Jetra je primarni organ eliminacije DM1 i katabolita koji sadrže DM1.
English: What Kadcyla is used for
Croatian: Za što se koristi Kadcyla
English: It is recommended that platelet counts are monitored prior to each trastuzumab emtansine dose.
Croatian: Preporučuje se kontrolirati broj trombocita prije svake doze trastuzumab emtanzina.
English: At retreatment a dose reduction may be considered according to the dose reduction schedule (see Table 1).
Croatian: Pri ponovnom uvođenju lijeka možda će trebati razmotriti smanjenje doze u skladu s rasporedom smanjivanja doze (vidjeti
English: Patients with thrombocytopenia (≤ 100,000/mm3) and patients on anti-coagulant treatment (e.g. warfarin, heparin, low molecular weight heparins) should be monitored closely while on trastuzumab emtansine treatment.
Croatian: Bolesnike s trombocitopenijom (≤ 100 000/mm3) i bolesnike koji primaju antikoagulantnu terapiju (npr. varfarin, heparin, niskomolekularne heparine) potrebno je pomno nadzirati tijekom liječenja trastuzumab emtanzinom.
English: DM1 was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
Croatian: DM1 se nije pokazao mutagenim u in vitro testu reverzne mutacije bakterija (Amesov test).
English: · Liver problems: Kadcyla can cause inflammation or damage to cells in the liver that can stop the liver from functioning normally.
Croatian: • Problemi s jetrom: Kadcyla može izazvati upalu ili oštećenje stanica jetre, koji mogu onemogućiti normalan rad jetre.
English: Population pharmacokinetic analysis indicates that age does not have a clinically meaningful effect on the pharmacokinetics of trastuzumab emtansine (see sections 5.1 and 5.2).
Croatian: Populacijska farmakokinetička analiza upućuje na to da dob nema klinički značajnog utjecaja na farmakokinetiku trastuzumab emtanzina (vidjeti dijelove 5.1 i 5.2).
English: The median duration of response was not reached with trastuzumab emtansine vs. 9.5 months in the control arm.
Croatian: Medijan trajanja odgovora nije postignut kod primjene trastuzumab emtanzina, a u kontrolnoj je skupini iznosio 9,5 mjeseci.
English: Table 3 shows pooled data from the overall treatment period in the MBC studies (N= 1871; median number of cycles of trastuzumab emtansine was 10) and in KATHERINE (N=740; median number of cycles was 14).
Croatian: U Tablici 3 prikazani su objedinjeni podaci prikupljeni tijekom cjelokupnog razdoblja liječenja u ispitivanjima kod metastatskog raka dojke (N = 1871; medijan broja ciklusa liječenja trastuzumab emtanzinom iznosio je 10) i u ispitivanju KATHERINE (N = 740; medijan broja ciklusa liječenja iznosio je 14).
English: Based on population PK analysis, following intravenous administration, the central volume of distribution of trastuzumab emtansine was (3.13 L) and approximated that of plasma volume.
Croatian: Na temelju populacijske farmakokinetičke analize, centralni volumen distribucije trastuzumab emtanzina nakon intravenske primjene iznosio je (3,13 l) i bio je približno jednak volumenu plazme.
English: The median number of anti-cancer agents that patients had received in any setting was 8.5 (range, 5-19) and in the metastatic setting was 7.0 (range, 3-17), including all agents intended for the treatment of breast cancer.
Croatian: Medijan broja antineoplastičnih lijekova koje su bolesnici sveukupno primali iznosio je 8,5 (raspon 5-19), a za metatstatsku bolest 7,0 (raspon 3-17), uključujući sve lijekove namijenjene liječenju raka dojke.
English: · When prepared as a solution for infusion Kadcyla is stable for up to 24 hours at 2°C to 8°C, and must be discarded thereafter.
Croatian: • Nakon pripreme, otopina lijeka Kadcyla za infuziju stabilna je tijekom najviše 24 sata na temperaturi od 2°C do 8°C, a nakon toga se mora baciti.
English: Patients should be observed closely for hypersensitivity/allergic reactions, which may have the same clinical presentation as an IRR.
Croatian: Bolesnike je potrebno pomno nadzirati zbog moguće pojave reakcija preosjetljivosti/alergijskih reakcija, koje se klinički mogu manifestirati jednako kao i reakcije povezane s infuzijom.
English: What Kadcyla is
Croatian: Što je Kadcyla
English: Infections and infestations Urinary tract infection
Croatian: Infekcije i infestacije infekcije mokraćnih puteva
English: If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test.
Croatian: Ako nije dostupan „in vitro“ dijagnostički medicinski proizvod s oznakom „CE“, HER2 status treba ocijeniti drugim validiranim testom.
English: Pharmacokinetics of trastuzumab emtansine in patients with mild (creatinine clearance CLcr 60 to 89 mL/min, n = 254) or moderate (CLcr 30 to 59 mL/min, n = 53) renal impairment were similar to those in patients with normal renal function (CLcr ³ 90 mL/min, n = 361).
Croatian: Farmakokinetika trastuzumab emtanzina u bolesnika s blagim (klirens kreatinina CLcr 60 do 89 ml/min, n = 254) ili umjerenim (CLcr 30 do 59 ml/min, n = 53) oštećenjem bubrežne funkcije bila je slična onoj u bolesnika s normalnom bubrežnom funkcijom (CLcr ≥ 90 ml/min, n = 361).
English: Patients with elevated transaminases improved to Grade 1 or normal within 30 days of the last dose of trastuzumab emtansine in the majority of the cases (see section 4.8).
Croatian: U bolesnika s povišenim vrijednostima transaminaza stanje se u većini slučajeva poboljšalo do stupnja 1 ili normalnih vrijednosti unutar 30 dana nakon posljednje doze trastuzumab emtanzina (vidjeti dio 4.8).
English: If you miss a Kadcyla treatment
Croatian: Ako propustite liječenje lijekom Kadcyla
English: · Infusion-related reactions or allergic reactions: Kadcyla can cause flushing, shivering fits, fever, trouble breathing, low blood pressure, rapid heartbeat, sudden swelling of your face, tongue, or trouble swallowing during the infusion or after the infusion on the first day of treatment.
Croatian: • Reakcije povezane s infuzijom ili alergijske reakcije: Kadcyla može izazvati navale crvenila, napadaje drhtanja, vrućicu, otežano disanje, nizak krvni tlak, ubrzano kucanje srca, naglo oticanje lica i jezika ili otežano gutanje tijekom infuzije ili nakon infuzije tijekom prvoga dana liječenja.
English: It must be verified that the non-proprietary name is trastuzumab emtansine.
Croatian: Mora se provjeriti da je nezaštićeni naziv lijeka trastuzumab emtanzin.
English: No adjustment to the starting dose is required for patients with mild or moderate hepatic impairment.
Croatian: Nije potrebno prilagođavati početnu dozu u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije.
English: Thrombocytopenia Grade 3 (25,000 to < 50,000/mm3)
Croatian: Trombocitopenija Stupanj 3 (25 000 do < 50 000/mm3)
English: Following trastuzumab emtansine dosing, 5.1% (63/1243) of patients tested positive for anti-trastuzumab emtansine antibodies at one or more post-dose time points.
Croatian: Nakon primjene trastuzumab emtanzina, u 5,1% (63/1243) bolesnika nalaz testa na protutijela na trastuzumab emtanzin bio je pozitivan u jednoj ili više vremenskih točaka nakon primjene doze.
English: An average of 3.5 DM1 molecules are conjugated to each molecule of trastuzumab.
Croatian: Jedna molekula trastuzumaba u prosjeku se konjugira s 3,5 molekula DM1.
English: The significance of reported adverse reactions such as fatigue, headache, dizziness and blurred vision on the ability to drive or use machines is unknown.
Croatian: Nije poznat značaj prijavljenih nuspojava poput umora, glavobolje, omaglice i zamagljenog vida na sposobnost upravljanja vozilima i rada sa strojevima.
English: Platelets help your blood to clot so you might get unexpected bruising or bleeding (such as nose bleeds, bleeding from gums).
Croatian: Trombociti pomažu pri zgrušavanju krvi pa se mogu pojaviti neočekivane modrice ili krvarenje (poput krvarenja iz nosa ili desni).
English: Key to abbreviations (Table6): HR: Hazard Ratio; CI: Confidence Intervals, 1.
Croatian: Objašnjenje kratica (Tablica 6): HR (engl. hazard ratio): omjer hazarda; CI (engl. confidence interval):
English: Patients with dyspnoea at rest due to complications of advanced malignancy, co-morbidities, and receiving concurrent pulmonary radiation therapy may be at increased risk of pulmonary events.
Croatian: U bolesnika s dispnejom u mirovanju zbog komplikacija povezanih s uznapredovalom zloćudnom bolešću, bolesnika s popratnim bolestima i onih koji istodobno primaju radioterapiju pluća može postojati povećan rizik plućnih događaja.
English: General risk factors for a cardiac event and those identified in adjuvant breast cancer studies with trastuzumab therapy include advancing age (> 50 years), low baseline LVEF values (< 55%), low LVEF levels prior to or following the use of paclitaxel in the adjuvant setting, prior or concomitant use of antihypertensive medicinal products, previous therapy with an anthracycline and high BMI (> 25 kg/m2).
Croatian: Općeniti faktori rizika za srčani događaj i faktori utvrđeni u ispitivanjima trastuzumaba u adjuvantnom liječenju raka dojke uključuju veću životnu dob (> 50 godina), niske početne vrijednosti LVEF-a (< 55%), niske vrijednosti LVEF-a prije ili nakon primjene paklitaksela u adjuvantnom liječenju, prethodnu ili istodobnu primjenu antihipertenziva, prethodno liječenje antraciklinima i visok indeks tjelesne mase (> 25 kg/m2).
English: Grade 3-4
Croatian: Stupanj 3 - 4
English: You should tell your doctor immediately if you notice any of the above symptoms.
Croatian: Morate odmah obavijestiti svog liječnika ako primijetite bilo koji od navedenih simptoma.
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Whylen Germany
Croatian: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Whylen Njemačka
English: Signs and symptoms include dyspnoea, cough, fatigue, and pulmonary infiltrates.
Croatian: Znakovi i simptomi uključuju dispneju, kašalj, umor i plućne infiltrate.
English: - Plasma concentrations of DM1 and DM1-containing catabolites (Lys-MCC-DM1 and MCC-DM1) were low and comparable between patients with and without hepatic impairment.
Croatian: - Plazmatske koncentracije DM1 i katabolita koji sadrže DM1(Lys-MCC-DM1 i MCC-DM1) bile su niske i usporedive u bolesnika s oštećenjem i onih bez oštećenja jetrene funkcije.
English: Metastatic Breast Cancer
Croatian: Metastatski rak dojke
English: Trastuzumab emtansine has minor influence on the ability to drive and use machines.
Croatian: Trastuzumab emtanzin malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: In case of overdose, the patient should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Croatian: U slučaju predoziranja bolesnika treba pomno nadzirati zbog moguće pojave znakova ili simptoma nuspojava te uvesti odgovarajuće simptomatsko liječenje.
English: Grade 3 or 4 increased AST and ALT were reported in 4.2% and 2.7% of patients with MBC respectively and usually occurred in the early treatment cycles (1-6).
Croatian: Povišene vrijednosti AST-a odnosno ALT-a stupnja 3 ili 4 prijavljene su u 4,2% odnosno 2,7% bolesnika s metastatskim rakom dojke, a obično su se javljale u ranijim ciklusima liječenja (1-6).
English: Transaminase elevations were generally transient with peak elevation at day 8 after administration of therapy and subsequent recovery to Grade 1 or less prior to the next cycle.
Croatian: Povišenja vrijednosti transaminaza uglavnom su bila prolazna, pri čemu su vršnu vrijednost dosegla 8. dana nakon primjene lijeka, nakon čega su se vratila na stupanj 1 ili niže prije sljedećeg ciklusa.
English: The median PFS was 9.2 months in the trastuzumab plus docetaxel arm and 14.2 months in the trastuzumab emtansine arm (hazard ratio, 0.59; p = 0.035), with a median follow-up of approximately 14 months in both arms.
Croatian: Medijan PFS-a iznosio je 9,2 mjeseca u skupini koja je primala trastuzumab i docetaksel te 14,2 mjeseca u skupini liječenoj trastuzumab emtanzinom (omjer hazarda 0,59; p = 0,035), pri čemu je medijan praćenja u obje skupine iznosio približno 14 mjeseci.