FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate procedures for the preparation of chemotherapeutic medicinal products should be used.
Croatian: Treba primijeniti odgovarajuće postupke za pripremu kemoterapijskih lijekova.
English: In the event of a true hypersensitivity reaction (in which severity of reaction increases with subsequent infusions), trastuzumab emtansine treatment must be permanently discontinued.
Croatian: U slučaju prave reakcije preosjetljivosti (kod koje se težina reakcije povećava sa svakom sljedećom infuzijom), liječenje trastuzumab emtanzinom mora se trajno prekinuti.
English: Patients were randomized (1:1) to receive trastuzumab or trastuzumab emtansine.
Croatian: Bolesnici su bili randomizirani (1:1) za primanje trastuzumaba ili trastuzumab emtanzina.
English: · Unexpected bruising and bleeding (such as nose bleeds).
Croatian: • neočekivane modrice ili krvarenje (poput krvarenja iz nosa)
English: Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: BO27938 (KATHERINE)
Croatian: Ispitivanje BO27938 (KATHERINE)
English: · The first infusion will be given to you over 90 minutes.
Croatian: • Prvu ćete infuziju primati tijekom 90 minuta.
English: In some of the observed cases the patients had thrombocytopenia, or were also receiving anti-coagulant therapy or antiplatelet therapy; in others there were no known additional risk factors.
Croatian: U nekima od tih opaženih slučajeva bolesnici su imali trombocitopeniju ili su također primali antikoagulantnu ili antiagregacijsku terapiju; u drugim slučajevima nije bilo poznatih dodatnih faktora rizika.
English: Only patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 were eligible.
Croatian: Eastern Cooperative Oncology Group) status 0 ili 1.
English: · Male patients or their female partners should also use effective contraception.
Croatian: • Bolesnici muškog spola ili njihove partnerice također moraju koristiti djelotvornu kontracepciju.
English: Glucose (5%) solution should not be used (see section 6.2).
Croatian: Ne smije se koristiti otopina glukoze (5%) (vidjeti dio 6.2).
English: If you forget or miss your Kadcyla appointment, make another appointment as soon as possible.
Croatian: Ako ste zaboravili ili propustili doći na infuziju lijeka Kadcyla, dogovorite novi posjet što je prije moguće.
English: The safety and efficacy in children and adolescents below 18 years of age have not been established as there is no relevant use in the paediatric population for the indication of breast cancer .
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost u djece i adolescenata mlađih od 18 godina nisu ustanovljene jer nema relevantne primjene lijeka u pedijatrijskoj populaciji za indikaciju raka dojke.
English: · medicine for depression called nefazodone
Croatian: • lijek za depresiju koji se zove nefazodon
English: These reactions have been observed more frequently within 24 hours of infusion.
Croatian: Te su reakcije češće primijećene unutar 24 sata nakon infuzije.
English: Also you should not breast-feed for 7 months after your last infusion of Kadcyla.
Croatian: Ne smijete dojiti ni 7 mjeseci nakon posljednje infuzije lijeka Kadcyla.
English: You should not be given Kadcyla if the above applies to you.
Croatian: Ne smijete primiti lijek Kadcyla ako se gore navedeno odnosi na Vas.
English: Glucose (5%) solution should not be used for reconstitution or dilution since it causes aggregation of the protein.
Croatian: Za rekonstituciju ili razrjeđivanje ne smije se koristiti otopina glukoze (5%) jer ona izaziva agregaciju proteina.
English: Patients should be observed during the infusion and for at least 30 minutes after infusion.
Croatian: Bolesnike je potrebno nadzirati za vrijeme infuzije i najmanje 30 minuta nakon infuzije.
English: The subgroup of patients 75 years or above did not demonstrate a benefit for PFS or OS, but was too small (n=25) to draw any definitive conclusions.
Croatian: U podskupini bolesnika u dobi od 75 i više godina nije primijećen koristan učinak na PFS ni OS, ali je ta podskupina bila premala (n=25) da bi se mogli donijeti konačni zaključci.
English: The initial dose should be administered as a 90 minute intravenous infusion.
Croatian: Početna doza primjenjuje se kao 90 minutna intravenska infuzija.
English: · If you experience side effects, your doctor may decide to continue your treatment but lower your dose, delay the next dose or stop the treatment.
Croatian: • Ako se pojave nuspojave, liječnik može odlučiti da nastavite liječenje nižom dozom, odgodite sljedeću dozu ili prekinete s liječenjem.
English: · Your skin and whites of your eyes get yellow (jaundice) - these could be signs of severe liver damage.
Croatian: • žuta boja kože i bjeloočnica (žutica) - to mogu biti znakovi teškog oštećenja jetre
English: Peripheral Neuropathy Grade 3-4
Croatian: Periferna neuropatija Stupanj 3 - 4
English: 2,% [95% CI]
Croatian: Razlika (95% CI)
English: ADRs were reported using NCI-CTCAE for assessment of toxicity.
Croatian: Nuspojave na lijek prijavljivane su koristeći se NCI-CTCAE kriterijima za ocjenu toksičnosti.
English: · The other ingredients are succinic acid, sodium hydroxide (see section 2 under ‘Important information about some of the ingredients of Kadcyla'), sucrose, and polysorbate 20.
Croatian: • Drugi sastojci su sukcinatna kiselina, natrijev hidroksid (pogledajte dio 2. „Važna informacija o nekim sastojcima lijeka Kadcyla“), saharoza i polisorbat 20.
English: · you are receiving treatment with blood thinning medicines (e.g. warfarin, heparin).
Croatian: • ako se liječite lijekovima za razrjeđivanje krvi (npr. varfarinom, heparinom)
English: · If the first infusion is well tolerated, the infusion on your next visit may be given over 30 minutes.
Croatian: • Ako dobro podnesete prvu infuziju, pri sljedećem ćete posjetu infuziju možda primati tijekom 30 minuta.
English: Results from in vitro cytotoxicity assays show that DM1 is 20-200 times more potent than taxanes and vinca alkaloids.
Croatian: Rezultati in vitro testova citotoksičnosti pokazuju da je DM1 20-200 puta potentniji od taksana i vinka alkaloida.
English: However, in most cases during Kadcyla treatment, liver enzyme levels are elevated mildly and temporarily, do not cause any symptoms, and do not affect liver function.
Croatian: Međutim, u većini su slučajeva tijekom liječenja lijekom Kadcyla razine jetrenih enzima povišene blago i privremeno te ne uzrokuju nikakve simptome i ne utječu na jetrenu funkciju.
English: · If you do become pregnant during treatment with Kadcyla, tell your doctor straight away.
Croatian: • Ako ipak zatrudnite za vrijeme liječenja lijekom Kadcyla, odmah o tome obavijestite svog liječnika.
English: · Keep this medicine out of the sight and reach of children.
Croatian: • Lijek čuvajte izvan pogleda i dohvata djece.
English: · Neurological problems: Kadcyla can damage nerves.
Croatian: • Neurološki problemi: Kadcyla može oštetiti živce.
English: Kadcyla is not recommended if you are pregnant because this medicine may cause harm to the unborn baby.
Croatian: Primjena lijeka Kadcyla se ne preporučuje u trudnica jer ovaj lijek može naškoditi nerođenom djetetu.
English: IDFS was defined as the time from the date of randomization to first occurrence of ipsilateral invasive breast tumor recurrence, ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.
Croatian: IDFS se definirao kao vrijeme od datuma randomizacije do prvog nastupa ipsilateralnog recidiva invazivnog tumora dojke, ipsilateralnog lokalnog ili regionalnog recidiva invazivnog raka dojke, recidiva bolesti na udaljenom mjestu, kontralateralnog invazivnog raka dojke ili smrti zbog bilo kojeg uzroka.
English: Transaminase elevations were generally transient.
Croatian: Povišenja vrijednosti transaminaza uglavnom su bila prolazna.
English: · The MCC linker is designed to limit systemic release and increase targeted delivery of DM1, as demonstrated by detection of very low levels of free DM1 in plasma.
Croatian: • MCC poveznica oblikovana je tako da ograničava sistemsko otpuštanje i povećava ciljanu isporuku DM1, što je dokazano detekcijom vrlo niskih razina slobodnog DM1 u plazmi.
English: If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects.
Croatian: Ako se razvije reakcija, oni će usporiti ili prekinuti infuziju, a možda će Vam dati lijek kako bi se poništile nuspojave.
English: Women of childbearing potential should use effective contraception while receiving trastuzumab emtansine and for 7 months following the last dose of trastuzumab emtansine.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja trastuzumab emtanzinom i još 7 mjeseci nakon posljednje doze trastuzumab emtanzina.
English: The median duration of response by IRC was not reached (95% CI, 4.6 months to not estimable).
Croatian: Medijan trajanja odgovora prema ocjeni neovisnog ocjenjivačkog povjerenstva nije postignut (95% CI, 4,6 mjeseci do vrijednosti koja se ne može procijeniti).
English: Requirement for further dose reduction
Croatian: Potreba za daljnjim smanjenjem doze
English: Liver function should be monitored prior to initiation of treatment and each dose.
Croatian: Jetrenu funkciju treba nadzirati prije početka liječenja i prije primjene svake doze.
English: When trastuzumab binds to HER2 it can stop the cancer cells growth and cause them to die.
Croatian: Kada se trastuzumab veže za HER2, može zaustaviti rast tih stanica raka i uzrokovati njihovo odumiranje.
English: The colour of the reconstituted solution should be colourless to pale brown.
Croatian: Boja rekonstituirane otopine mora biti bezbojna do blijedo smeđa.
English: Trastuzumab emtansine (N=490) All Grades (%) Grade 3 (%) Grade 4 (%)
Croatian: Trastuzumab emtanzin (N=490) svi stupnjevi (%) stupanj 3 (%) stupanj 4 (%)
English: Kadcyla (trastuzumab emtansine) is NOT a generic version of Herceptin (trastuzumab) and has different properties, indications and dose.
Croatian: Kadcyla (trastuzumab emtanzin) NIJE generička inačica lijeka Herceptin (trastuzumab) i ima drugačija svojstva, indikacije i dozu.
English: If a pregnant woman is treated with trastuzumab emtansine, close monitoring by a multidisciplinary team is recommended.
Croatian: Ako se trudnica liječi trastuzumab emtanzinom, preporučuje se da je pomno nadzire multidisciplinarni tim.
English: If you develop lung disease your doctor may stop treatment with this medicine.
Croatian: Ako se razvije upala pluća, liječnik će možda prekinuti liječenje ovim lijekom.
English: In addition, exploratory analysis showed that the impact of covariates (i.e., renal function, race and age) on the pharmacokinetics of total trastuzumab and DM1 was limited and was not clinically relevant.
Croatian: Osim toga, eksplorativne su analize pokazale da je utjecaj kovarijanti (tj. bubrežne funkcije, rase i dobi) na farmakokinetiku ukupnog trastuzumaba i DM1 ograničen te da nije klinički značajan.
English: The median age was approximately 49 years (range 23-80 years), 72.8% were White, 8.7% were Asian and 2.7% were Black or African American.
Croatian: Medijan dobi iznosio je približno 49 godina (raspon: 23 - 80 godina), 72,8% bolesnika bili su bijelci, njih 8,7% bili su Azijci, a 2,7% bolesnika bili su crnci ili Afroamerikanci.
English: It is not expected that Kadcyla will affect your ability to drive, cycle, use tools or machines.
Croatian: Nije vjerojatno da bi Kadcyla mogla utjecati na Vašu sposobnost upravljanja automobilom, vožnje bicikla, rukovanja alatima ili rada sa strojevima.
English: Since many medicinal products are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding infants, women should discontinue breast-feeding prior to initiating treatment with trastuzumab emtansine.
Croatian: Budući da se mnogi lijekovi izlučuju u majčino mlijeko i s obzirom na mogućnost teških nuspojava u dojenčadi, žene moraju prekinuti dojenje prije početka liječenja trastuzumab emtanzinom.
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 24 hours at 2°C to 8°C.
Croatian: Dokazana kemijska i fizikalna stabilnost rekonstituirane otopine u primjeni je najdulje 24 sata na temperaturi od 2°C do 8°C.
English: Kadcyla is for intravenous use.
Croatian: Kadcyla je namijenjena za intravensku primjenu.
English: Your doctor or nurse will check to see whether you are having any of these side effects.
Croatian: Vaš liječnik ili medicinska sestra provjeravat će imate li neku od tih nuspojava.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC14
Croatian: Farmakoterapijska skupina: Antineoplastici; ostali antineoplastici; monoklonska protutijela, ATK oznaka: L01XC14
English: All of the patients had received taxanes as part of neoadjuvant chemotherapy.
Croatian: Svi su bolesnici primali taksane u sklopu neoadjuvantne kemoterapije.
English: In most patients, these reactions resolved over the course of several hours to a day after the infusion was terminated.
Croatian: U većine bolesnika te su se reakcije povukle unutar nekoliko sati do jednoga dana po završetku infuzije.
English: In more severe cases, swelling of your face or tongue, trouble swallowing or difficulty breathing may occur.
Croatian: U težim slučajevima može doći do oticanja lica ili jezika, otežanog gutanja ili otežanog disanja.
English: Dose reduction schedule (Starting dose is 3.6 mg/kg)
Croatian: Tablica 1 Raspored smanjenja doze Raspored smanjivanja doze (početna doza je 3,6 mg/kg)
English: This HCP educational pack shall consist of the following:
Croatian: Taj edukacijski paket za zdravstvene radnike mora sadržavati sljedeće:
English: Due to the low incidence of ADA, conclusions cannot be made on the impact of anti- trastuzumab emtansine antibodies on the pharmacokinetics, safety, and efficacy of trastuzumab emtansine.
Croatian: Zbog male incidencije protutijela na lijek ne mogu se donijeti zaključci o utjecaju protutijela na trastuzumab emtanzin na farmakokinetiku, sigurnost i djelotvornost trastuzumab emtanzina.
English: The reconstituted Kadcyla solution should be diluted in polyvinyl chloride (PVC) or latex-free PVC-free polyolefin infusion bags.
Croatian: Rekonstituiranu otopinu lijeka Kadcyla potrebno je razrijediti u infuzijskoj vrećici od polivinilklorida (PVC) ili poliolefinskoj infuzijskoj vrećici bez lateksa i PVC-a.
English: Volume (mL) = Total dose to be administered (body weight (kg) x dose (mg/kg)) 20 (mg/mL, concentration of reconstituted solution)
Croatian: Volumen (ml) = ukupna doza koju treba primijeniti (tjelesna težina (kg) x doza (mg/kg)) 20 (mg/ml, koncentracija rekonstituirane otopine)
English: Figure 3 Kaplan-meier curve of overall survival
Croatian: Slika 3 Kaplan-Meierova krivulja ukupnog preživljenja
English: · DM1 - an anti-cancer substance that becomes active once Kadcyla enters the cancer cell.
Croatian: • DM1 - tvar s antitumorskim djelovanjem koja se aktivira nakon što Kadcyla uđe u stanicu raka.
English: Pharmacokinetic data in patients with severe renal impairment (CLcr 15 to 29 mL/min) are limited (n = 1), therefore no dosage recommendations can be made.
Croatian: Farmakokinetički podaci u bolesnika s teškim oštećenjem bubrežne funkcije (CLcr 15 do 29 ml/min) su ograničeni (n = 1), pa se ne mogu dati preporuke o doziranju.
English: · Heart problems: Kadcyla can weaken the heart muscle.
Croatian: • Problemi sa srcem: Kadcyla može oslabiti srčani mišić.
English: Trastuzumab emtansine dose should not be re-escalated after a dose reduction is made.
Croatian: Doza trastuzumab emtanzina ne smije se ponovno povećavati nakon smanjenja doze.
English: Patients treated with trastuzumab emtansine are at increased risk of developing left ventricular dysfunction.
Croatian: Bolesnici liječeni trastuzumab emtanzinom imaju povećan rizik od razvoja disfunkcije lijeve klijetke.
English: Infusion-related reactions resolved over the course of several hours to a day after the infusion was terminated.
Croatian: Reakcije povezane s infuzijom povukle su se unutar nekoliko sati do jednoga dana nakon završetka infuzije.
English: Dose reductions or discontinuation for increased serum transaminases and total bilirubin are specified in section 4.2.
Croatian: Smanjenja doze ili prekid liječenja zbog povišenih vrijednosti serumskih transaminaza i ukupnog bilirubina navedeni su u dijelu 4.2.
English: Patients should be observed during the infusion and for at least 90 minutes following the initial infusion for fever, chills, or other infusion-related reactions.
Croatian: Bolesnike je potrebno nadzirati za vrijeme infuzije i najmanje 90 minuta nakon prve infuzije zbog moguće pojave vrućice, zimice ili drugih reakcija povezanih s infuzijom.
English: Trastuzumab Emtansine N = 743
Croatian: N = 743
English: What you need to know before you are given Kadcyla
Croatian: Što morate znati prije nego počnete primati lijek Kadcyla
English: Administration of trastuzumab emtansine to pregnant women is not recommended and women should be informed of the possibility of harm to the foetus before they become pregnant.
Croatian: Ne preporučuje se primjena trastuzumab emtanzina u trudnica, a žene je potrebno informirati o mogućim štetnim učincima na plod prije nego što zatrudne.
English: Observed cases may have been confounded by comorbidities and/or concomitant medicinal products with known hepatotoxic potential.
Croatian: Na primijećene su slučajeve možda utjecale popratne bolesti i/ili istodobna primjena lijekova s poznatim hepatotoksičnim potencijalom.
English: A cumulative effect on transaminases has also been observed (the proportion of patients with Grade 1-2 ALT/AST abnormalities increases with successive cycles).
Croatian: Primijećen je i kumulativan učinak na transaminaze (udio bolesnika s odstupanjima vrijednosti ALT-a/AST-a stupnja 1-2 povećava se sa svakim sljedećim ciklusom).
English: There have been no studies performed with other routes of administration.
Croatian: Nisu provedena ispitivanja drugih puteva primjene.
English: A vial of Kadcyla reconstituted with water for injections (not supplied) is stable for 24 hours at 2ºC - 8 ºC after reconstitution and must not be frozen.
Croatian: Bočica lijeka Kadcyla rekonstituiranog s vodom za injekcije (ne isporučuje se s lijekom) stabilna je tijekom 24 sata nakon rekonstitucije na temperaturi od 2ºC - 8ºC i ne smije se zamrzavati.
English: However, the magnitude of effect of these covariates on trastuzumab emtansine exposure suggests that these covariates are unlikely to have any clinically meaningful effect on trastuzumab emtansine exposure.
Croatian: Međutim, veličina učinka navedenih kovarijanti na izloženost trastuzumab emtanzinu pokazuje da te kovarijante vjerojatno neće imati klinički značajan učinak na izloženost trastuzumab emtanzinu.
English: Do not freeze or shake the infusion during storage.
Croatian: Infuzija se za vrijeme čuvanja ne smije zamrzavati niti tresti.
English: As with all therapeutic proteins, there is the potential for an immune response to trastuzumab emtansine.
Croatian: Kao i svi terapijski proteini, trastuzumab emtanzin može izazvati imuni odgovor.
English: The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab emtansine in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja trastuzumab emtanzina u svim podskupinama pedijatrijske populacije za karcinom dojke (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If the prior infusion was well tolerated, subsequent doses of trastuzumab emtansine may be administered as 30 minute infusions.
Croatian: Ako je bolesnik dobro podnio prethodnu infuziju, sljedeće doze trastuzumab emtanzina mogu se primjenjivati kao 30 minutne infuzije.
English: In general, the Grade ≥ 3 hepatic events were not associated with poor clinical outcome; subsequent follow-up values tended to show improvement to ranges allowing the patient to remain on study and continue to receive study treatment at the same or reduced dose.
Croatian: Jetreni događaji stupnja ≥ 3 obično nisu bili povezani s lošim kliničkim ishodom; vrijednosti izmjerene tijekom kasnijeg praćenja često su pokazivale poboljšanje do raspona vrijednosti koje su bolesniku omogućile da nastavi sudjelovati u ispitivanju i primati ispitivani lijek u istoj ili smanjenoj dozi.
English: Upon diagnosis of NRH, trastuzumab emtansine treatment must be permanently discontinued.
Croatian: Nakon što se dijagnosticira NRH, liječenje trastuzumab emtanzinom mora se trajno prekinuti.
English: · Swirl the vial gently until completely dissolved.
Croatian: • Nježno okrećite bočicu dok se prašak potpuno ne otopi.
English: Tumor prognostic characteristics including hormone receptor status (positive: 72.3%, negative: 27.7%), clinical stage at presentation (inoperable: 25.3%, operable: 74.8%) and pathological nodal status after preoperative therapy (node positive: 46.4%, node negative or not evaluated: 53.6%) were similar in the study arms.
Croatian: Prognostičke značajke tumora, uključujući status hormonskih receptora (pozitivan: 72,3%; negativan: 27.7%), klinički stadij pri prvom liječničkom pregledu (neoperabilan: 25,3%; operabilan: 74,8%) te patološki status limfnih čvorova nakon preoperativneterapije (pozitivni: 46,4%; negativni ili neocijenjeni: 53,6%), bile su slične u obje ispitivane skupine.
English: Treatment must be permanently discontinued in the event of a life threatening infusionrelated reaction (see section 4.2).
Croatian: Liječenje se mora trajno prekinuti u slučaju po život opasne reakcije povezane s infuzijom (vidjeti dio 4.2).
English: What Kadcyla is and what it is used for
Croatian: Što je Kadcyla i za što se koristi
English: If concomitant use of strong CYP3A4 inhibitors is unavoidable, consider delaying trastuzumab emtansine treatment until the strong CYP3A4 inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible.
Croatian: Ako je istodobna primjena snažnih inhibitora CYP3A4 neizbježna, treba, kad je to moguće, razmisliti o odgađanju liječenja trastuzumab emtanzinom dok se snažni inhibitori CYP3A4 ne izluče iz cirkulacije (približno 3 poluvremena eliminacije inhibitora).
English: If you are not sure, talk to your doctor or nurse before you are given Kadcyla.
Croatian: Ako niste sigurni, obratite se svom liječniku ili medicinskoj sestri prije nego primite lijek Kadcyla.
English: In the fatal case, the patient incorrectly received trastuzumab emtansine 6 mg/kg and died approximately 3 weeks following the overdose; a causal relationship to trastuzumab emtansine was not established.
Croatian: U slučaju sa smrtnim ishodom bolesnik je greškom primio trastuzumab emtanzin u dozi od 6 mg/kg i umro približno 3 tjedna nakon predoziranja; nije utvrđena uzročna povezanost s trastuzumab emtanzinom.
English: No relationship was observed between trastuzumab emtansine exposure (AUC), trastuzumab emtansine maximum serum concentration (Cmax), total trastuzumab exposure (AUC), or Cmax of DM1 and increases in transaminase.
Croatian: Nije primijećena veza između izloženosti (AUC) trastuzumab emtanzinu, vršne koncentracije trastuzumab emtanzina u serumu (Cmax), ukupne izloženosti (AUC) trastuzumabu ili vrijednosti Cmax DM1 i povišenja vrijednosti transaminaza.
English: Patients with treated brain metastases were eligible for enrollment if they did not require therapy to control symptoms.
Croatian: Bolesnici s liječenim moždanim metastazama mogli su sudjelovati u ispitivanju ako im nije bila potrebna terapija za kontrolu simptoma.
English: Treat at the same dose level
Croatian: Nastaviti liječenje istom dozom.