FrancophonIA/ELRC3.0 huggingface dataset:
English: • diarrhoea, feeling and being sick - these are very common side effects that can become serious if they cause you to become dehydrated, which can lead to kidney failure.
Croatian: • proljev, mučnina i povraćanje - to su vrlo česte nuspojave koje mogu postati ozbiljne ako dovedu do dehidracije, koja može uzrokovati zatajenje bubrega.
English: LENVIMA is a medicine that contains the active substance lenvatinib.
Croatian: LENVIMA je lijek koji sadrži djelatnu tvar lenvatinib.
English: Lenvatinib is rapidly absorbed after oral administration with tmax typically observed from 1 to 4 hours postdose.
Croatian: Lenvatinib se brzo apsorbira nakon peroralne primjene, s tmax obično primijećenim od 1 do 4 sata nakon doze.
English: Dose adjustments and Discontinuation for HCC
Croatian: Prilagodbe doze i prekid liječenja za HCC
English: Increased alanine aminotransferase ‡
Croatian: hipoalbuminemijaj,‡ povišena alanin aminotransferaza‡ povišena aspartat aminotransferaza‡
English: This binding was mainly to albumin with minor binding to α1-acid glycoprotein and γ-globulin.
Croatian: Uglavnom se veže za albumin, a u manjoj mjeri za α1-kiseli glikoprotein i γ-globulin.
English: The daily dose is to be modified, as needed, according to the dose/toxicity management plan.
Croatian: Dnevnu dozu treba prilagoditi, po potrebi, u skladu s planom upravljanja omjerom doze/toksičnosti.
English: The median time to objective responsive was 2.0 (95% CI: 1.9, 3.5) months; however, of the patients who experienced a complete or partial response to lenvatinib, 70.4% were observed to develop the response on or within 30 days of being on the 24-mg dose.
Croatian: Medijan vremena do objektivnog odgovora iznosio je 2,0 (95% CI: 1,9-3,5) mjeseca; međutim, među bolesnicima koji su imali potpuni ili djelomični odgovor na lenvatinib, opaženo je da je njih 70,4% razvilo odgovor 30. dan ili unutar 30 dana od uzimanja doze od 24 mg.
English: Since lenvatinib is mainly eliminated by hepatic metabolism, an increase in exposure in patients with moderate to severe hepatic impairment is expected.
Croatian: Budući da se lenvatinib uglavnom eliminira putem jetrenog metabolizma, očekuje se povećano izlaganje u bolesnika s umjerenim do teškim oštećenjem funkcije jetre.
English: m: Hepatocellular damage and hepatitis includes: drug-induced liver injury, hepatic steatosis, and cholestatic liver injury.
Croatian: m: Hepatocelularno oštećenje i hepatitis uključuju: oštećenje jetre uzrokovano lijekom, steatozu jetre i kolestatsko oštećenje jetre.
English: Therefore, the decision to resume lenvatinib following a major surgical procedure should be based on clinical judgment of adequate wound healing.
Croatian: Stoga, odluku o nastavku davanja lenvatiniba nakon velikih kirurških zahvata treba donositi na temelju kliničke prosudbe primjerenog cijeljenja rane.
English: Most reactions resolved following supportive treatment, without dose interruption or reduction, which occurred in 1.5% and 1.1% of patients, respectively; 1 patient with Grade 4 hypocalcaemia discontinued treatment permanently.
Croatian: Većina se nuspojava povukla nakon potpornog liječenja, bez privremenog prekida primjene ili sniženja doze, što se dogodilo u 1,5% odnosno 1,1% bolesnika; 1 bolesnik s hipokalcemijom 4. stupnja trajno je prekinuo liječenje.
English: There was also a case of acute hepatitis in a patient without liver metastases.
Croatian: Bio je i jedan slučaj akutnog hepatitisa u bolesnika bez jetrenih metastaza.
English: All patients other than those with severe hepatic or renal impairment (see below) should initiate treatment at the recommended 24 mg dose, following which the dose should be further adjusted on the basis of individual tolerability.
Croatian: Svi bolesnici, osim onih s teškim oštećenjem funkcije jetre ili bubrega (vidjeti niže), trebaju započeti liječenje preporučenom dozom od 24 mg, nakon čega dozu treba dodatno prilagoditi na temelju podnošljivosti u pojedinog bolesnika.
English: Following independent review confirmation of disease progression, 109 (83.2%) patients randomised to placebo had crossed over to open-label lenvatinib at the time of the primary efficacy analysis.
Croatian: Nakon što je neovisnim pregledom potvrđena progresija bolesti, 109 (83,2%) bolesnika randomiziranih u skupinu koja je primala placebo prešlo je na otvoreno liječenje lenvatinibom u vrijeme primarne analize djelotvornosti.
English: • If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Croatian: • imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile.
English: Carcinogenicity studies have not been conducted with lenvatinib.
Croatian: Nisu provedena ispitivanja kancerogenosti lenvatiniba.
English: • have a history of abnormal connections (known as a fistula) between different organs in the body or from an organ to the skin
Croatian: • ste imali stvaranje neprirodnih spojeva (poznatih pod nazivom fistula) između različitih organa u tijelu ili između nekog organa i kože
English: • feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy - these may be signs of a stroke, bleeding on your brain, or the effect on your brain of a severe increase in blood pressure.
Croatian: • osjećaj utrnulosti ili slabosti na jednoj strani tijela, jaka glavoblja, napadaj, smetenost, otežan govor, promjene vida ili osjećaj omaglice - to mogu biti znakovi moždanog udara, krvarenja u mozak ili učinka jako povišenog krvnog tlaka na mozak
English: Lenvatinib dose interruption due to hypocalcaemia occurred in one subject (0.2%) and there were no dose reductions or discontinuations.
Croatian: Do privremenog prekida doziranja lenvatiniba zbog hipokalcemije došlo je u jednog ispitanika (0,2%), a nije bilo smanjenja doze ili trajnog prekida liječenja.
English: Lenvatinib was embryotoxic and teratogenic when administered to rats and rabbits (see section 5.3).
Croatian: Lenvatinib je bio embriotoksičan i teratogen kad se primjenjivao u štakora i kunića (vidjeti dio 5.3).
English: • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0: 63%, ECOG PS of
Croatian: • Ocjena općeg stanja prema ECOG (ECOG PS) 0: 63%, ECOG PS 1: 37%
English: Lenvatinib should be used with caution in such patients, given the reduced tolerability of lenvatinib in Asian and elderly patients (see section 4.8, Other special populations).
Croatian: U takvih bolesnika lenvatinib treba primjenjivati s oprezom, s obzirom na smanjenu podnošljivost lenvatiniba u bolesnika azijatskog porijekla i starijih bolesnika (vidjeti dio 4.8, Druge posebne populacije).
English: Patients of age ≥75 years, of Asian race, with comorbidities (such as hypertension, and hepatic or renal impairment), or body weight below 60 kg appear to have reduced tolerability to lenvatinib (see section 4.8, Other special populations).
Croatian: Čini se da bolesnici u dobi od ≥75 godina, azijatske rase, s komorbiditetima (kao što su hipertenzija i oštećenje funkcije jetre ili bubrega) ili tjelesne težine manje od 60 kg slabije podnose lenvatinib (vidjeti dio 4.8, Druge posebne populacije).
English: Lenvatinib is a multikinase inhibitor which has shown mainly antiangiogenic properties in vitro and in vivo, and direct inhibition of tumour growth was also observed in in vitro models.
Croatian: Lenvatinib je inhibitor više kinaza koji pokazuje uglavnom antiangiogena svojstva in vitro i in vivo te izravnu inhibiciju rasta tumora u modelima in vitro.
English: Resolves to Grade 0-1.
Croatian: Povlači se na 0.-1. stupanj.
English: Histologically, 66.1% had a confirmed diagnosis of papillary thyroid cancer and 33.9% had follicular thyroid cancer which included Hürthle cell 14.8% and clear cell 3.8%.
Croatian: Histološki, 66,1% bolesnika imalo je potvrđenu dijagnozu papilarnog raka štitnjače, a 33,9% imalo je folikularni rak štitnjače koji je uključivao Hürthleove stanice u 14,8% i svijetle stanice u 3,8% bolesnika.
English: Thyroid stimulating hormone (TSH) levels should be monitored on a regular basis and thyroid hormone administration should be adjusted to reach appropriate TSH levels, according to the patient's therapeutic target.
Croatian: Razine tireotropina (TSH) treba redovito pratiti i prilagoditi primjenu hormona štitnjače kako bi se postigle odgovarajuće razine TSH-a, sukladno cilju terapije u bolesnika.
English: Similarly, although not studied directly, the MOA for proteinuria is postulated to be mediated by downregulation of VEGFR1 and VEGFR2 in the podocytes of the glomerulus.
Croatian: Slično tome, iako nije izravno ispitan, pretpostavlja se da je mehanizam djelovanja kod proteinurije posredovan smanjenjem broja VEGFR1 i VEGFR2 u podocitima glomerula.
English: The primary efficacy endpoint was Overall Survival (OS).
Croatian: Primarna mjera ishoda bila je ukupno preživljenje (engl.
English: One fatal case of hepatic tumour haemorrhage in a patient with HCC has been reported.
Croatian: Prijavljen je jedan fatalan slučaj krvarenja tumora jetre u bolesnika sa HCC-om.
English: Electrocardiograms should be monitored at baseline and periodically during treatment in all patients with particular attention to those with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, and those taking medicinal products known to prolong the QT interval, including Class Ia and III antiarrhythmics.
Croatian: Potrebno je elektrokardiografski pratiti sve bolesnike na početku liječenja i redovito tijekom liječenja, a posebnu pozornost treba posvetiti onima s kongenitalnim sindromom dugog QT intervala, kongestivnim zatajenjem srca, bradiaritmijama i onima koji uzimaju lijekove za koje se zna da produljuju QT interval, uključujući antiaritmike skupine Ia i III.
English: Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS)
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES) / sindrom reverzibilne posteriorne leukoencefalopatije (RPLS)
English: Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormality judged to be non-life-threatening, in which case they should be managed as severe reaction (e.g., Grade 3).
Croatian: Liječenje treba trajno prekinuti u slučaju životno ugrožavajućih nuspojava (npr. 4. stupnja), uz iznimku laboratorijskih abnormalnosti za koje se prosudi da nisu životno ugrožavajuće i koje se u tom slučaju trebaju zbrinjavati kao teška nuspojava (npr. 3. stupnja).
English: When systolic BP ≤150 mmHg, diastolic BP ≤95 mmHg, and patient has been on a stable dose of antihypertensive therapy for at least 48 hours, resume lenvatinib at a reduced dose (see section 4.2)
Croatian: Kada je sistolički krvni tlak ≤150 mmHg, dijastolički krvni tlak ≤95 mmHg, a bolesnik je na stabilnoj dozi antihipertenzivne terapije najmanje 48 sati, nastavite s primjenom lenvatiniba u sniženoj dozi (vidjeti dio 4.2)
English: INFORMATION IN BRAILLE LENVIMA 4 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU LENVIMA 4 mg
English: In this trial, there was 1 case of fatal intracranial haemorrhage among 16 patients who received lenvatinib and had CNS metastases at baseline.
Croatian: U ovom je ispitivanju zabilježen 1 slučaj intrakranijalnog krvarenja sa smrtnim ishodom među 16 bolesnika koji su primali lenvatinib i imali metastaze u SŽS-u na početku ispitivanja.
English: Randomisation was stratified by geographic region (Europe, North America, and Other), prior VEGF/VEGFR-targeted therapy (patients may have received 0 or 1 prior VEGF/VEGFR-targeted therapy), and age (≤65 years or >65 years).
Croatian: Randomizacija je bila stratificirana po geografskoj regiji (Europa, Sjeverna Amerika i ostali), prethodnoj terapiji usmjerenoj na VEGF/VEGFR (bolesnici su mogli prethodno primiti 0 ili 1 terapiju usmjerenu na VEGF/VEGFR) i dobi (≤65 godina ili >65 godina).
English: Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, the platelet derived growth factor (PDGF) receptor PDGFRα, KIT, and RET.
Croatian: Lenvatinib je inhibitor receptora tirozin kinaze (RTK) koji selektivno inhibira kinaznu aktivnost receptora za vaskularni endotelni čimbenik rasta (VEGF) VEGFR1 (FLT1), VEGFR2 (KDR) i VEGFR3 (FLT4), kao i drugih RTK-ova povezanih s proangiogenim i onkogenim putevima uključujući receptore za fibroblastni čimbenik rasta (FGF) FGFR1, 2, 3 i 4, receptor za trombocitni čimbenik rasta (PDGF) PDGFRα, KIT i RET.
English: • Caregivers should not open the capsules to avoid exposure to the contents of the capsule.
Croatian: • Osobe koje skrbe o Vama ne smiju otvarati kapsule kako bi izbjegle izlaganje sadržaju kapsule.
English: Antihypertensive agents should be started as soon as elevated BP is confirmed.
Croatian: Terapiju antihipertenzivima treba započeti čim se potvrdi povišen krvni tlak.
English: • black, tarry, or bloody stools, or coughing up of blood - these may be signs of bleeding inside your body.
Croatian: • crna, katranasta ili krvava stolica ili iskašljavanje krvi - to mogu biti znakovi krvarenja u tijelu
English: For lenvatinib related toxicities (see Table 3), upon resolution/improvement of an adverse reaction to Grade 0-1 or baseline, treatment should be resumed at a reduced dose of lenvatinib as suggested in Table 1.
Croatian: U slučaju toksičnosti povezanih s lenvatinibom (vidjeti tablicu 3), kad se postigne povlačenje/poboljšanje nuspojave na 0.-1. stupanj ili povratak na početno stanje, liječenje treba nastaviti sniženom dozom lenvatiniba kako je predloženo u tablici 1.
English: Lenvatinib should not be started in patients with fistula to avoid worsening and lenvatinib should be permanently discontinued in patients with oesophageal or tracheobronchial tract involvement and any Grade 4 fistula (see section 4.2); limited information is available on the use of dose interruption or reduction in management of other events, but worsening was observed in some cases and caution should be taken.
Croatian: Primjena lenvatiniba ne smije započeti u bolesnika s fistulom kako bi se izbjeglo pogoršanje, a lenvatinib treba trajno ukinuti u bolesnika s fistulom koja uključuje ezofagealni i traheobronhalni sustav i bilo koju fistulu 4. stupnja (vidjeti dio 4.2); ograničeni su podaci o privremenom prekidu ili sniženju doze kao načinu zbrinjavanja drugih događaja, ali u nekim je slučajevima opaženo pogoršanje pa je potreban oprez.
English: • yellow skin or yellowing of the whites of the eyes (jaundice) or drowsiness, confusion, poor concentration - these may be signs of liver problems.
Croatian: • žutilo kože ili bjeloočnica (žutica) ili omamljenost, smetenost, slaba koncentracija - to mogu biti znakovi problema s jetrom.
English: Hypercholesterolaemia includes hypercholesterolaemia and increased blood cholesterol.
Croatian: Hiperkolesterolemija uključuje hiperkolesterolemiju i povišen kolesterol u krvi.
English: Optimal medical management (i.e. treatment or therapy) for nausea, vomiting, and diarrhoea should be initiated prior to any lenvatinib therapy interruption or dose reduction; gastrointestinal toxicity should be actively treated in order to reduce the risk of development of renal impairment or failure (see section 4.4, Renal failure and impairment).
Croatian: Optimalno medicinsko zbrinjavanje (tj. liječenje ili terapiju) mučnine, povraćanja i proljeva treba započeti prije privremenog prekida terapije lenvatinibom ili sniženja doze; gastrointestinalnu toksičnost treba aktivno liječiti kako bi se smanjio rizik od oštećenja funkcije ili zatajenja bubrega (vidjeti dio 4.4, Zatajenje i oštećenje funkcije bubrega).
English: Lenvatinib has not been studied in patients with severe hepatic imparement (Child-Pugh C) and is not recommended for use in these patients.
Croatian: Lenvatinib nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C) i ne preporučuje se primjena kod takvih bolesnika.
English: Following administration of radiolabelled lenvatinib to 6 patients with solid tumours, approximately two-thirds and one-quarter of the radiolabel were eliminated in the faeces and urine, respectively.
Croatian: Nakon primjene radioaktivno označenog lenvatiniba u 6 bolesnika sa solidnim tumorima, približno je dvije trećine radioaktivno označene tvari bilo eliminirano stolicom, a jedna četvrtina mokraćom.
English: Magnetic resonance imaging is necessary to confirm the diagnosis of PRES.
Croatian: Da bi se potvrdila dijagnoza PRES-a, potrebno je oslikavanje magnetskom rezonancijom.
English: Initiate medical management for nausea, vomiting, or diarrhoea prior to interruption or dose reduction.
Croatian: Započnite liječenje mučnine, povraćanja ili proljeva prije privremenog prekida doziranja ili smanjenja doze.
English: Hepatotoxicity events and haemorrhage events also occurred at a higher incidence in CP score 6 patients compared to CP score 5 patients.
Croatian: Slučajevi hepatotoksičnosti i slučajevi krvarenja također su se javili većom incidencijom u bolesnika sa 6 CP bodova u usporedbi s bolesnicima koji su imali 5 CP bodova.
English: Accidental medication errors resulting in single doses of 40 to 48 mg have occurred in clinical trials.
Croatian: U kliničkim su se ispitivanjima dogodile slučajne medikacijske pogreške kada su primijenjene pojedinačne doze od 40 do 48 mg.
English: Eligible patients with measurable disease according to RECIST 1.1 were randomised 2:1 to receive lenvatinib 24 mg once daily (n=261) or placebo (n=131).
Croatian: Pogodni bolesnici s mjerljivom bolešću prema RECIST 1.1 bili su randomizirani u omjeru 2:1 u skupinu koja je primala lenvatinib 24 mg jedanput na dan (n=261) odnosno skupinu koja je primala placebo (n=131).
English: If you forget to take LENVIMA Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu (dvije doze odjednom) kako biste nadoknadili zaboravljenu dozu.
English: Lenvatinib should be discontinued in the event of persistence of Grade 4 diarrhoea despite medical management.
Croatian: Primjenu lenvatiniba treba trajno prekinuti u slučaju ustrajnog proljeva 4. stupnja unatoč medicinskom zbrinjavanju.
English: NE (22.0, NE)
Croatian: NP (22,0, NP)
English: Percentages (95% CI)
Croatian: Postoci (95% CI)
English: • The other ingredients are calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose, talc.
Croatian: • Drugi sastojci su kalcijev karbonat, manitol, mikrokristalična celuloza, hidroksipropilceluloza, nisko supstituirana hidroksipropilceluloza, talk.
English: In the repeated-dose toxicity studies (up to 39 weeks), lenvatinib caused toxicologic changes in various organs and tissues related to the expected pharmacologic effects of lenvatinib including glomerulopathy, testicular hypocellularity, ovarian follicular atresia, gastrointestinal changes, bone changes, changes to the adrenals (rats and dogs), and arterial (arterial fibrinoid necrosis, medial degeneration, or haemorrhage) lesions in rats, dogs, and cynomolgus monkeys.
Croatian: U ispitivanjima toksičnosti ponovljenih doza (do 39 tjedana) lenvatinib je uzrokovao toksikološke promjene u raznim organima i tkivima povezane s očekivanim farmakološkim učincima lenvatiniba, a one su uključivale glomerulopatiju, testikularnu hipocelularnost, atreziju folikula jajnika, gastrointestinalne promjene, promjene na kostima, promjene u nadbubrežnim žlijezdama (štakori i psi) i arterijske (arterijska fibrinoidna nekroza, degeneracija medije ili krvarenje) lezije u štakora, pasa i makaki majmuna.
English: Continue lenvatinib and increase the dose of the current antihypertensive therapy or initiate additional antihypertensive therapy
Croatian: Nastavite s lenvatinibom i povisite dozu antihipertenzivne terapije koju bolesnik već uzima ili uvedite dodatnu antihipertenzivnu terapiju
English: • underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin)
Croatian: • smanjena aktivnost štitnjače (umor, dobivanje na težini, zatvor, osjećaj hladnoće, suha koža)
English: PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules 60 hard capsules 90 hard capsules METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: OBLIK I SADRŽAJ 30 tvrdih kapsula 60 tvrdih kapsula 90 tvrdih kapsula NAČIN I PUT(EVI) PRIMJENE LIJEKA Kroz usta.
English: A 5-mg dose was evaluated in 6 subjects with severe hepatic impairment (Child-Pugh C).
Croatian: Doza od 5 mg bila je procijenjena u 6 ispitanika s teškim oštećenjem funkcije jetre (Child-Pugh C).
English: These patients also had a higher incidence of renal reactions and a trend towards a higher incidence of liver reactions.
Croatian: Ti su bolesnici također imali višu incidenciju bubrežnih nuspojava i sklonost višoj incidenciji jetrenih nuspojava.
English: Proteinuria led to permanent treatment discontinuation in 0.8% of patients.
Croatian: Proteinurija je dovela do trajnog prekida liječenja u 0,8% bolesnika.
English: Pharmacokinetic parameters of lenvatinib have been studied in healthy adult subjects, adult subjects with hepatic impairment, renal impairment, and solid tumours.
Croatian: Farmakokinetički parametri lenvatiniba ispitani su u zdravih odraslih ispitanika, odraslih ispitanika s oštećenjem funkcije jetre, oštećenjem funkcije bubrega i solidnim tumorima.
English: Blood pressure (BP) should be well controlled prior to treatment with lenvatinib and, if patients are known to be hypertensive, they should be on a stable dose of antihypertensive therapy for at least 1 week prior to treatment with lenvatinib.
Croatian: Prije početka liječenja lenvatinibom, krvni tlak treba biti dobro kontroliran, a bolesnici za koje se zna da imaju hipertenziju trebaju biti na stabilnoj dozi antihipertenzivne terapije najmanje tjedan dana prije početka liječenja lenvatinibom.
English: Limited data are available on use in patients from ethnic origins other than Caucasian or Asian (see also section 4.8, Other special populations).
Croatian: Dostupni su ograničeni podaci o primjeni u bolesnika koji po etničkom porijeklu nisu bijelci ili azijati (vidjeti također dio 4.8 Druge posebne populacije).
English: The objective response rate (complete response [CR] plus partial response [PR]) per independent radiological review was significantly (p<0.0001) higher in the lenvatinib-treated group (64.8%) than in the placebo-treated group (1.5%).
Croatian: Prema neovisnom radiološkom pregledu, stopa objektivnog odgovora (potpuni odgovor plus djelomični odgovor) bila je značajno (p<0,0001) viša u skupini liječenoj lenvatinibom (64,8%) nego u skupini koja je primala placebo (1,5%).
English: • severe pain in the upper left part of the belly (abdomen) which may be associated with fever,
Croatian: • jaki bol u gornjem lijevom dijelu trbuha (abdomena), koji može biti praćen vrućicom, zimicom,
English: Close monitoring of overall safety is recommended in these patients (see sections 4.4 and 5.2).
Croatian: Za te se bolesnike preporučuje pomno praćenje ukupnog sigurnosnog profila (vidjeti dijelove 4.4 i 5.2).
English: The incidence of QTcF interval prolongation of greater than 500ms was
Croatian: Incidencija produljenja QTcF intervala veća od 500 ms bila je 2,4%.
English: Stratified by region (Europe vs. North America vs. Other), age group (≤65 years vs >65 years), and previous VEGF/VEGFR-targeted therapy (0 vs. 1).
Croatian: Stratificirano prema regiji (Europa naspram Sjeverne Amerike naspram ostalih), dobnoj skupini (≤65 godina naspram >65 godina) i prethodnoj terapiji usmjerenoj na VEGF/VEGFR (0 naspram 1).
English: 18.7 (16.4, NE)
Croatian: 18,7 (16,4, NP)
English: Metastases were present in 99% of the patients: lungs in 89.3%, lymph nodes in 51.5%, bone in 38.8%, liver in 18.1%, pleura in 16.3%, and brain in 4.1%.
Croatian: Metastaze su bile prisutne u 99% bolesnika: na plućima u 89,3%, limfnim čvorovima u 51,5%, kostima u 38,8%, jetri u 18,1%, pleuri u 16,3% i mozgu u 4,1%.