FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with a baseline Child Pugh (CP) score of 6 (about 20% patients in the REFLECT study) had a higher incidence of decreased appetite, fatigue, proteinuria, hepatic encephalopathy and hepatic failure compared to patients with a baseline CP score of 5.
Croatian: Bolesnici sa 6 Child Pugh (CP) bodova na početku ispitivanja (oko 20% bolesnika u ispitivanju REFLECT) imali su veću incidenciju smanjenog apetita, umora, proteinurije, hepatičke encefalopatije i zatajenja jetre u usporedbi s bolesnicima koji su imali 5 početnih CP bodova.
English: QT interval prolongation (see section 4.4)
Croatian: Produljenje QT intervala (vidjeti dio 4.4)
English: Management of some adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy.
Croatian: Zbrinjavanje određenih nuspojava može zahtijevati privremeni prekid doziranja, prilagodbu doze ili trajni prekid liječenja lenvatinibom.
English: Hepatic encephalopathy tended to be associated with adverse disease characteristics at baseline or with the use of concomitant medications.
Croatian: Hepatička encefalopatija bila je povezana sa štetnim značajkama bolesti na početku liječenja ili s istodobnom primjenom drugih lijekova.
English: Cardiac failure Prolonged electrocardiogram QT Decreased ejection fraction
Croatian: zatajenje srca produljen QT interval na elektrokardiogramu smanjena ejekcijska frakcija
English: Lenvatinib was non-inferior for OS to sorafenib with HR = 0.92 [95% CI of (0.79, 1.06)] and a median OS of 13.6 months vs 12.3 months (see Table 7 and Figure 2).
Croatian: Overall Survival, OS) Ukupno preživljenje lenvatiniba bilo je neinferiorno sorafenibu sa HR = 0,92 [95% CI od (0,79; 1,06)] i s medijanom ukupnog preživljenja od 13,6 mjeseci u usporedbi sa 12,3 mjeseci (vidjeti Tablicu 7 i Sliku 2).
English: Amongst 1,823 patients treated with lenvatinib monotherapy in clinical trials, there were 5 cases (0.3%) of PRES (0.2% were Grade 3 or 4), all of which resolved after treatment and/or dose interruption, or permanent discontinuation.
Croatian: Među 1823 bolesnika liječenih monoterapijom lenvatiniba u kliničkim ispitivanjima, bilo je 5 slučajeva (0,3%) PRES-a (0,2% bila su 3. ili 4. stupnja), a svi su se povukli nakon liječenja i/ili privremenog prekida doziranja ili trajnog prekida primjene lijeka.
English: The incidence of QT interval prolongation of greater than 500 ms was 2% in the lenvatinib-treated patients compared to no reports in the placebo group.
Croatian: Incidencija produljenja QT intervala na više od 500 ms bila je 2% u bolesnika liječenih lenvatinibom, dok u skupini koja je primala placebo produljenje nije zabilježeno.
English: No formal studies of the effect of lenvatinib on wound healing have been conducted.
Croatian: Nisu provedena nikakva formalna ispitivanja učinka lenvatiniba na cijeljenje rana.
English: (2 capsules of 10 mg and 1 capsule of 4 mg).
Croatian: (2 kapsule od 10 mg i 1 kapsula od 4 mg).
English: Discontinue Do not resume *Grade 4 laboratory abnormalities judged to be non-life-threatening, may be managed as severe reactions (e.g., Grade 3)
Croatian: *Odstupanja u rezultatima laboratorijskih testova 4. stupnja za koje se procijeni da nisu životno ugrožavajuća, mogu se zbrinjavati kao teške reakcije (npr. 3. stupnja)
English: In HCC patients treated with lenvatinib in the REFLECT trial, liver-related adverse reactions including hepatic encephalopathy and hepatic failure (including fatal reactions) were reported at a higher frequency (see Section 4.8) compared to patients treated with sorafenib .
Croatian: U bolesnika sa HCC-om koji su liječeni lenvatinibom u ispitivanju REFLECT, nuspojave povezane s jetrom, uključujući hepatičku encefalopatiju i zatajenje jetre (uključujući fatalne nuspojave) prijavljene su s većom učestalošću (vidjeti dio 4.8) u odnosu na bolesnike koji su liječeni sorafenibom.
English: Bleeding in sites other than the brain (e.g. trachea, intra-abdominal, lung) has also been reported.
Croatian: Također su zabilježena krvarenja na drugim mjestima osim mozga (npr. u dušniku, intraabdominalno, u plućima).
English: Lenvatinib is for oral use.
Croatian: Lenvatinib se primjenjuje peroralno.
English: Efficacy results in DTC patients
Croatian: Tablica 6 Rezultati djelotvornosti u bolesnika s DTC-om
English: • need to have a surgical procedure.
Croatian: • se morate podvrgnuti kirurškom zahvatu.
English: The hepatic failure cases were generally reported in patients with progressive metastatic liver metastases disease.
Croatian: Slučajevi zatajenja jetre uglavnom su bili zabilježeni u bolesnika sa DTC-om s progresivnom bolesti metastaza jetre.
English: Females had a higher incidence of hypertension, fatigue, ECG QT prolongation and alopecia.
Croatian: U žena je bila veća incidencija hipertenzije, umora, produljenja QT intervala na EKG-u i alopecije.
English: HCC patients other than those with moderate and severe hepatic impairment or severe renal impairment should initiate treatment at the recommended starting dose of 8 mg (two 4 mg capsules) for body weight < 60 kg and 12 mg (three 4 mg capsules) for body weight ≥ 60 kg, following which the dose should be further adjusted on the basis of individual tolerability.
Croatian: Svi bolesnici sa HCC-om, osim onih koji imaju umjereno ili teško oštećenje funkcije jetre ili teško oštećenje funkcije bubrega, moraju započeti liječenje preporučenom početnom dozom od 8 mg (dvije kapsule od 4 mg) za tjelesnu težinu <60 kg i 12 mg (tri kapsule od 4 mg) za tjelesnu težinu ≥60 kg, nakon čega dozu treba dodatno prilagoditi na temelju podnošljivosti u pojedinog bolesnika.
English: Although not studied directly with lenvatinib, the mechanism of action (MOA) for hypertension is postulated to be mediated by the inhibition of VEGFR2 in vascular endothelial cells.
Croatian: Iako nije izravno ispitan, pretpostavlja se da je mehanizam djelovanja lenvatiniba kod hipertenzije posredovan inhibicijom VEGFR2 u vaskularnim endotelnim stanicama.
English: The available data do not allow for a dosing recommendation for patients with HCC and severe renal impairment.
Croatian: Dostupni podaci nisu dovoljni za preporuku doziranja u bolesnika sa HCC-om i teškim oštećenjem funkcije bubrega.
English: In patients with severe (Child-Pugh C) hepatic impairment, the recommended starting dose is 14 mg taken once daily.
Croatian: U bolesnika s teškim (Child-Pugh C) oštećenjem funkcije jetre, preporučena početna doza je 14 mg koja se uzima jedanput na dan.
English: Severe (e.g., Grade 3) or intolerable adverse reactions require interruption of lenvatinib until improvement of the reaction to Grade 0-1 or baseline.
Croatian: Teške (npr. 3. stupnja) ili nepodnošljive nuspojave zahtijevaju privremeni prekid primjene lenvatiniba sve do njihovog poboljšanja na 0.-1. stupanj ili povratka na početno stanje.
English: In 452 patients with RAI-refractory DTC, dose reduction and discontinuation were the actions taken for an adverse reaction in 63.1% and 19.5% of patients, respectively.
Croatian: U 452 bolesnika s diferenciranim karcinomom štitnjače refraktornim na RAI, poduzete mjere zbog nuspojave bile su sniženje doze u 63,1% i prestanak primjene u 19,5% bolesnika.
English: After drinking, add the same amount of water or apple juice, swirl and swallow.
Croatian: Nakon što ste ju popili, dodajte ponovno u čašu istu količinu vode ili soka od jabuke, zavrtite kružnim pokretom i popijte.
English: In the lenvatinib arm, median OS was 19.5 months (95% CI: 15.7, 23.0) for subjects who received post-treatment anticancer therapy (43%) and 10.5 months (95% CI: 8.6, 12.2) for those who did not.
Croatian: U skupini na lenvatinibu, medijan OS-a bio je 19,5 mjeseci (95%-tni CI: 15,7; 23,0) za ispitanike koji su primili terapiju protiv raka nakon liječenja (43%) i 10,5 mjeseci (95%-tni CI: 8,6; 12,2) za one koji nisu.
English: Data in HCC patients with moderate hepatic impairment (Child-Pugh B) are very limited and there are currently no data available in HCC patients with severe hepatic impairment (Child-Pugh C).
Croatian: Podaci u bolesnika sa HCC-om s umjerenim oštećenjem funkcije jetre (Child-Pugh B) vrlo su ograničeni i trenutno nema dostupnih podataka u bolesnika sa HCC-om s teškim oštećenjem funkcije jetre (Child-Pugh C).
English: The recommended daily dose of lenvatinib is 8 mg (two 4 mg capsules) once daily for patients with a body weight of < 60 kg and 12 mg (three 4 mg capsules) once daily for patients with a body weight of ≥ 60 kg.
Croatian: Preporučena dnevna doza lenvatiniba je 8 mg (dvije kapsule od 4 mg) jedanput dnevno za bolesnike tjelesne težine <60 kg i 12 mg (tri kapsule od 4 mg) jedanput dnevno u bolesnika tjelesne težine ≥60 kg.
English: It is currently unknown whether lenvatinib may reduce the effectiveness of hormonal contraceptives, and therefore women using oral hormonal contraceptives should add a barrier method (see section
Croatian: Trenutno nije poznato može li lenvatinib smanjiti učinkovitost hormonskih kontraceptiva pa stoga žene koje koriste oralnu hormonsku kontracepciju trebaju dodatno koristiti i mehaničku metodu (vidjeti dio 4.6).
English: Table 3 Adverse reactions requiring dose modification of lenvatinib in DTC and HCC Adverse reaction Severity
Croatian: Tablica 3 Nuspojave koje zahtijevaju promjenu doze lenvatiniba kod DTC-a i HCC-a Nuspojava
English: Excluding laboratory abnormalities judged to be nonlife-threatening, which should be managed as Grade 3.
Croatian: Isključujući laboratorijska odstupanja za koje se smatra da nisu opasna po život, što bi trebalo biti liječeno kao stupanj 3.
English: Dose adjustments and discontinuations for DTC
Croatian: Prilagodba doze i prekid primjene kod DTC-a
English: Gastrointestinal perforation and fistula formation
Croatian: Gastrointestinalna perforacija i stvaranje fistule
English: Non-gastrointestinal fistula includes cases of fistula occurring outside of the stomach and intestines such as tracheal, tracheo-oesophageal, oesophageal, female genital tract fistula, and cutaneous fistula.
Croatian: Fistula koja nije gastrointestinalna uključuje slučajeve fistule koja nastane izvan želuca i crijeva, kao što je trahealna, traheoezofagealna, ezofagealna, fistula ženskog genitalnog sustava i kožna fistula.
English: Grade 3 or greater reactions occurred in 1.9% of lenvatinib-treated patients.
Croatian: Nuspojave 3.stupnja ili većeg javile su se u 1,9% bolesnika liječenih lenvatinibom.
English: Lenvatinib showed minimal or no inhibitory effect on OATP1B3 and MATE2-K. Lenvatinib weakly inhibits MATE1.
Croatian: Pokazalo se da lenvatinib ima minimalan ili uopće nema inhibicijski učinak na OATP1B3 i MATE2-K ili ga uopće nema.
English: Arterial thromboembolisms
Croatian: Arterijska tromboembolija
English: Number of complete responses Number of partial responses Median time to objective response,d months (95% CI) Duration of response,d months, median (95% CI)
Croatian: Broj djelomičnih odgovora Medijan vremena do objektivnog odgovorad, mjeseci (95% CI)
English: • If you have severe liver or kidney problems the recommended dose is 14 mg once a day
Croatian: • Ako imate teške tegobe s jetrom ili bubrezima, preporučena doza je 14 mg jedanput na dan (1
English: The available very limited data are not sufficient to allow for a dosing recommendation for HCC patients with moderate hepatic impairment (Child-Pugh B).
Croatian: Dostupni su vrlo ograničeni podaci, koji nisu dovoljni za preporuku doziranja u bolesnika sa HCC-om s umjerenim oštećenjem funkcije jetre (Child-Pugh B).
English: Patients ≥75 years, of white race or female sex or those with worse baseline hepatic impairment (Child-Pugh A score of 6 compared to score of 5) appear to have reduced tolerability to lenvatinib.
Croatian: Čini se da bolesnici ≥75 godina, bijele rase ili ženskog spola, ili oni s težim oštećenjem funkcije jetre na početku liječenja (Child-Pugh stadij A - 6 bodova u usporedbi sa 5 bodova) slabije podnose lenvatinib.
English: Table 1 Dose modifications from recommended lenvatinib daily dose in DTC patientsa
Croatian: Tablica 1 Prilagodbe doze u odnosu na preporučenu dnevnu dozu lenvatiniba u bolesnika s DTC-oma
English: In 496 patients with HCC, dose modification (interruption or reduction) and discontinuation were the actions taken for an adverse reaction in 62.3% and 20.2% of patients, respectively.
Croatian: U 496 bolesnika sa HCC-om, poduzete mjere zbrinjavanja nuspojava bile su prilagodba doze (privremeni prekid doziranja ili smanjenje doze) u 62,3% bolesnika, i trajni prekid liječenja u 20,2% bolesnika.
English: Cases of fistula formation or enlargement that involve areas of the body other than stomach or intestines were observed in clinical trials and in post-marketing experience (e.g. tracheal, tracheo-oesophageal, oesophageal, cutaneous, female genital tract fistulae).
Croatian: Slučajevi stvaranja fistule ili njenog povećanja na drugim područjima tijela osim želuca ili crijeva opaženi su kliničkim ispitivanjima te nakon stavljanja lijeka u promet (npr. trahealna, traheoezofagealna, ezofagealna, kožna fistula, fistula ženskog genitalnog sustava).
English: What LENVIMA contains
Croatian: Što LENVIMA sadrži
English: In patients with severe renal impairment, the recommended starting dose is 14 mg taken once daily.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega, preporučena početna doza je 14 mg koja se uzima jedanput na dan.
English: There are not sufficient data for HCC patients with Child-Pugh B (moderate hepatic impairment, 3 patients treated with lenvima in the pivotal trial) and no data available in Child Pugh C HCC patients (severe hepatic impairment).
Croatian: Nema dovoljno podataka za bolesnike sa HCC-om i Child-Pugh stadijem B (umjereno oštećenje funkcije jetre, 3 bolesnika liječena lenvatinibom u ključnom ispitivanju), te nema dostupnih podataka u bolesnika sa HCC-om i Child Pugh stadijem C (teško oštećenje jetre).
English: • changes in blood test results for potassium levels (low) and calcium levels (low)
Croatian: • promjene u nalazima krvnih pretraga u razini kalija (snižena) i kalcija (snižena)
English: Thyroid function should be monitored before initiation of, and periodically throughout, treatment with lenvatinib.
Croatian: Funkciju štitnjače treba pratiti prije započinjanja liječenja lenvatinibom te periodički tijekom čitavog liječenja.
English: Patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Croatian: Bolesnici u dobi od ≥75 godina imali su veću vjerojatnost razvoja 3. ili 4. stupnja hipertenzije, proteinurije, smanjenog apetita i dehidracije.
English: Grades are based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Croatian: Terminology Criteria for Adverse Events, CTCAE) Nacionalnog instituta za rak (engl.
English: Myocardial infarction includes myocardial infarction and acute myocardial infarction.
Croatian: Infarkt miokarda uključuje infarkt miokarda i akutni infarkt miokarda.
English: Limited data are available on use in patients aged ≥75 years (see also section 4.8, Other special populations).
Croatian: ≥75 godina (vidjeti također dio 4.8 Druge posebne populacije).
English: Gastrointestinal perforation and fistula formation (see section 4.4)
Croatian: Gastrointestinalna perforacija i stvaranje fistule (vidjeti dio 4.4)
English: In the sorafenib arm, median OS was 17.0 months (95% CI: 14.2, 18.8) for subjects who received posttreatment anticancer therapy (51%) and 7.9 months (95% CI: 6.6, 9.7) for those who did not.
Croatian: U skupini na sorafenibu, medijan OS-a bio je 17,0 mjeseci (95%-tni CI: 14,2; 18,8) za ispitanike koji su primili terapiju protiv raka nakon liječenja (51%) i 7,9 mjeseci (95%-tni CI: 6,6; 9,7) za one koji nisu.
English: Resolves to <480 ms or baseline
Croatian: Povlači se na <480 ms ili na početno stanje.
English: The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (44.0%), diarrhoea (38.1%), decreased appetite (34.9%), fatigue (30.6%), and decreased weight
Croatian: Najčešće zabilježene nuspojave (pojavile su se u ≥30% bolesnika) su hipertenzija (44,0%), proljev (38,1%), smanjen apetit (34,9%), umor (30,6%) i smanjena tjelesna težina (30,4%).
English: Patients who had received 1 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
Croatian: Bolesnici koji su prethodno primili 1 terapiju usmjerenu na VEGF/VEGFR (%) Broj progresija ili smrti Medijan PFS u mjesecima (95% CI)
English: The median duration of treatment was 5.7 months (Q1: 2.9, Q3: 11.1) in the lenvatinib arm and 3.7 months (Q1: 1.8, Q3: 7.4) in the sorafenib arm.
Croatian: Medijan trajanja liječenja iznosio je 5,7 mjeseci (Q1: 2,9; Q3: 11,1) u skupini na lenvatinibu i 3,7 mjeseci (Q1: 1,8; Q3: 7,4) u skupini na sorafenibu.
English: The median OS had not been reached for either the lenvatinib group or the placebo crossover group.
Croatian: Medijan ukupnog preživljenja nije postignut niti u skupini liječenoj lenvatinibom niti u skupini koja je prešla s placeba na lenvatinib.
English: Limited data are available for patients of ethnic origin other than Caucasian or Asian, and in patients aged ≥75 years.
Croatian: Za bolesnike koji po etničkom porijeklu nisu bijelci ili azijati, i za bolesnike u dobi
English: Hepatic failure events were observed in male patients only.
Croatian: Slučajevi zatajenja jetre zabilježeni su samo u muških bolesnika.
English: In the placebo group 0.8% of patients developed renal failure or impairment (0.8% were Grade ≥ 3).
Croatian: U skupini koja je primala placebo, zatajenje ili oštećenje funkcije bubrega razvilo je 0,8% bolesnika (0,8% bilo je ≥3. stupnja).
English: The capsule shell contains hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Croatian: Ovojnica kapsule sadrži hipromelozu, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172).
English: Table 4 Recommended management of hypertension
Croatian: Tablica 4 Preporučeno liječenje hipertenzije Razina krvnog tlaka
English: Grade 3 reactions occurred in 10.7% of lenvatinib-treated patients and none in placebotreated patients.
Croatian: Nuspojave 3. stupnja nastale su u 10,7% bolesnika liječenih lenvatinibom i nijednog bolesnika koji je primao placebo.
English: The majority of cases had an outcome of recovered or resolved following dose interruption or reduction, which occurred in 16.9% and 10.7% of patients, respectively.
Croatian: Ishod je u većini slučajeva bio oporavak ili povlačenje nuspojava nakon privremenog prekida primjene ili sniženja doze, što se dogodilo u 16,9% odnosno 10,7% bolesnika.
English: The pharmacokinetics of lenvatinib following a single 10-mg dose were evaluated in 6 subjects each with mild and moderate hepatic impairment (Child-Pugh A and Child-Pugh B, respectively).
Croatian: Farmakokinetika lenvatiniba nakon jedne doze od 10 mg bila je procijenjena u 6 ispitanika koji su imali blago odnosno umjereno oštećenje funkcije jetre (Child-Pugh A odnosno Child-Pugh B).
English: In the pivotal Phase 3 SELECT trial (see section 5.1), 88% of all patients had a baseline TSH level less than or equal to 0.5 mU/L.
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1) 88% svih bolesnika imalo je na početku razinu TSH manju ili jednaku 0,5 mU/l.
English: The European Medicines Agency (EMA) has deferred the obligation to submit the results of a study with lenvatinib in one or more subsets of the paediatric population in the treatment of radioiodinerefractory differentiated thyroid cancer and has has waived the obligation to submit the results of studies with lenvatinib in one or more subsets of the paediatric population in the treatment of hepatocellular carcinoma (HCC).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lenvatiniba u jednoj ili više podskupina pedijatrijske populacije u liječenju diferenciranog raka štitnjače refraktornog na
English: Lenvatinib should be withheld in the event of development of QT interval prolongation greater than 500 ms. Lenvatinib should be resumed at a reduced dose when QTc prolongation is resolved to < 480 ms or baseline.
Croatian: Lenvatinib treba nastaviti primjenjivati u sniženoj dozi kada se produljenje QTc intervala smanji na <480 ms ili na početnu vrijednost.
English: Lenvatinib exposure, based on dose-adjusted AUC0-t and AUC0-inf data, was 119%, 107%, and 180% of normal for subjects with mild, moderate, and severe hepatic impairment, respectively.
Croatian: Izloženost lenvatinibu, temeljena na podacima za AUC0-t i AUC0-inf prilagođenima dozi, u ispitanika s blagim, umjerenim i teškim oštećenjem funkcije jetre bila je 119%, 107% odnosno 180% normalne izloženosti.
English: The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (68.6%), diarrhoea (62.8%), decreased appetite (51.5%), decreased weight (49.1%), fatigue (45.8%), nausea (44.5%), proteinuria 36.9%), stomatitis (35.8%), vomiting (34.5%), dysphonia (34.1%), headache (34.1%), and palmar-plantar erythrodysaesthesia syndrome (PPE) (32.7%).
Croatian: Najčešće zabilježene nuspojave (pojavile su se u ≥30% bolesnika) su hipertenzija (68,6%), proljev (62,8%), smanjeni apetit (51,5%), smanjena tjelesna težina (49,1%), umor (45,8%), mučnina (44,5%), proteinurija (36,9%), stomatitis (35,8%), povraćanje (34,5), disfonija (34,1%), glavobolja (34,1%) i sindrom palmarno-plantarne eritrodizestezije (PPE) (32,7%).
English: Grade 4
Croatian: 4. stupnja
English: Four (1.5%) subjects treated with lenvatinib attained a CR and 165 subjects (63.2%) had a PR, while no subjects treated with placebo had a CR and 2 (1.5%) subjects had a PR.
Croatian: Četiri (1,5%) ispitanika liječena lenvatinibom postigla su potpuni odgovor, a 165 ispitanika (63,2%) imalo je djelomični odgovor, dok niti jedan od ispitanika liječenih placebom nije imao potpuni odgovor, a 2 (1,5%) ispitanika imala su djelomični odgovor.
English: Capsule shell Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Croatian: Ovojnica kapsule hipromeloza titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: In the Phase 3 REFLECT trial (see section 5.1), 89.6% of patients had a baseline TSH level of less than the upper limit of normal.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), 89,6% bolesnika imalo je razinu TSH-a na početku ispitivanja nižu od gornje granice normale.
English: Interrupt until resolved to Grade 0-1 or baselined
Croatian: Privremeni prekid doziranja do povlačenja na stupanj 0-1 ili na početne vrijednostid
English: Progression-Free Survival (PFS)a Number of progressions or deaths (%) Median PFS in months (95% CI)
Croatian: Preživljenje bez progresije bolesti (PFS)a Broj progresija ili smrti (%) Medijan PFS u mjesecima (95% CI)
English: • changes in blood test results for kidney function and kidney failure
Croatian: • promjene u rezultatima krvnih pretraga za funkciju bubrega i zatajenje bubrega
English: Patients who had received 0 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
Croatian: Bolesnici koji su prethodno primili 0 terapija usmjerenih na VEGF/VEGFR (%) Broj progresija ili smrti Medijan PFS u mjesecima (95% CI)
English: It has been determined that plasma protein binding in plasma from hepatically impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed.
Croatian: Utvrđeno je da je vezanje za proteine plazme u ispitanika s oštećenjem funkcije jetre slično odgovarajućim podudarnim zdravim ispitanicima te nije uočena ovisnost o koncentraciji.
English: Liverrelated reactions led to dose interruptions and reductions in 4.6% and 2.7% of patients, respectively, and to permanent discontinuation in 0.4%.
Croatian: Nuspojave povezane s jetrom dovele su do privremenog prekida primjene ili sniženja doze u 4,6% odnosno 2,7% bolesnika, a do trajnog prestanka liječenja u 0,4% bolesnika.
English: Radioiodine-refractory differentiated thyroid cancer
Croatian: Diferencirani rak štitnjače refraktoran na radioaktivni jod