natgillin/translations-raw huggingface dataset:
Administration of lenvatinib during organogenesis resulted in embryolethality and teratogenicity in rats (foetal external and skeletal anomalies) at exposures below the clinical exposure (based on AUC) at the maximum tolerated human dose, and rabbits (foetal external, visceral or skeletal anomalies) based on body surface area; mg/m2 at the maximum tolerated human dose. 
Dajanje lenvatiniba med organogenezo je povzročilo smrtnost zarodkov in teratogenost pri podganah (fetalne zunanje in skeletne anomalije) pri izpostavljenostih, manjših od klinične izpostavljenosti (na podlagi AUC) pri največjem toleriranem odmerku za človeka, in kuncih (fetalne zunanje, visceralne ali skeletne anomalije) na podlagi velikosti telesne površine; mg/m2 pri največjem toleriranem odmerku za človeka.
may be restarted once adequate wound healing is established. 
Zdravilo LENVIMA se lahko ponovno uvede, ko je ugotovljeno ustrezno celjenje ran
Patients with worse hepatic impairment and/or greater liver tumour burden at baseline had a higher risk of developing hepatic encephalopathy and hepatic failure. 
Bolniki s hujšo jetrno okvaro in/ali večjim bremenom tumorja jeter v izhodišču so imeli večje tveganje za razvoj jetrne encefalopatije in odpovedi jeter.
Table 5 Adverse reactions reported in patients treated with lenvatinib System Organ 
Preglednica 5 Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z lenvatinibom Organski sistem (terminologija
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. 
Pri toksičnostih, povezanih z lenvatinibom (glejte preglednico 3), naj se po tistem, ko neželeni učinek izzveni ali se izboljša na stopnjo 0-1 ali v izhodišče, zdravljenje spet začne z zmanjšanim odmerkom lenvatiniba v skladu s preglednico 1.
Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS) (see section 4.4) 
Sindrom posteriorne reverzibilne encefalopatije (PRES) / sindrom reverzibilne posteriorne levkoencefalopatije (RPLS)(glejte poglavje 4.4)
Cardiac failure Prolonged electrocardiogram QT Decreased ejection fraction 
popuščanje srca podaljšanje intervala QT v elektrokardiogramu zmanjšanje iztisne frakcije
Proteinuria led to permanent treatment discontinuation in 0.8% of patients. 
Proteinurija je povzročila trajno ukinitev zdravljenja pri 0,8 % bolnikov.
• feeling bloated or having excess wind 
• občutek napihnjenosti ali vetrovi,
Special populations Elderly population 
Posebne skupine bolnikov Starejša populacija
Lenvatinib and its metabolites are excreted in rat milk. 
Lenvatinib in njegovi presnovki se izločajo v mleko podgan.
Non-Gastrointestinal fistula 
ne-gastrointestinalna fistulao
Some reports of fistula and pneumothorax occurred in association with tumour regression or necrosis. 
O nekaterih primerih fistul in pnevmotoraksa so poročali v povezavi z regresijo tumorja ali nekrozo.
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. 
Zdi se, da bolniki, stari ≥ 75 let, ki pripadajo beli rasi ali so ženskega spola ali bolniki s slabšo okvaro jeter v izhodišču (rezultat Child-Pugh A 6 v primerjavi z rezultatom 5), slabše prenašajo lenvatinib.
• have a history of abnormal connections (known as a fistula) between different organs in the body or from an organ to the skin 
• ste v preteklosti imeli nenormalne povezave (ki jim rečemo fistula) med različnimi organi v telesu ali med organom in kožo;
Myocardial infarction includes myocardial infarction and acute myocardial infarction. 
Miokardni infarkt vključuje miokardni infarkt in akutni miokardni infarkt.
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%. 
Metastaze so bile prisotne pri 99 % bolnikov: v pljučih pri 89,3 %, v bezgavkah pri 51,5 %, v kosteh pri 38,8 %, v jetrih pri 18,1 %, v plevri pri 16,3 % in v možganih pri 4,1 %.
Elevation of TSH above the upper limit of normal was observed post baseline in 69.6% of lenvatinib-treated patients. 
Zvišanje ravni TSH nad zgornjo mejo normalnega razpona so po izhodišču ugotovili pri 69,6 % bolnikov, zdravljenih z lenvatinibom.
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. 
Bolniki z izhodiščno oceno Child Pugh (CP) 6 (približno 20 % bolnikov v študiji REFLECT) so imeli večjo incidenco zmanjšanega apetita, utrujenosti, proteinurije, jetrne encefalopatije in jetrne odpovedi v primerjavi z bolniki z izhodiščno oceno CP 5.
Lenvatinib is for oral use. 
Lenvatinib je namenjen za peroralno uporabo.
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. 
Štirje (1,5 %) preiskovanci, zdravljeni z lenvatinibom, so dosegli CR in 165 preiskovancev (63,2 %) je imelo PR, medtem ko nobeden od preiskovancev, ki so prejemali placebo, ni imel CR, 2 preiskovanca (1,5 %) pa sta imela PR.
Proteinuria led to permanent treatment discontinuation in 0.6% of patients. 
Proteinurija je povzročila trajno ukinitev zdravljenja pri 0,6 % bolnikov.
Lenvatinib showed minimal or no inhibitory activities toward P-gp-mediated and breast cancer resistance protein (BCRP)-mediated transport activities. 
Lenvatinib je pokazal minimalno ali nikakršno inhibicijsko aktivnost proti prenašalskim aktivnostim, ki jih posredujeta P-gp in protein odpornosti pri raku dojke (BCRP - breast cancer resistance protein).
• need to have a surgical procedure. 
• boste morali prestati kirurški poseg.
Prior surgery and radiotherapy may be contributing risk factors. 
Predhodna operacija in zdravljenje z obsevanjem sta lahko dejavnika tveganja, ki prispevata k nastanku fistul.
In DTC, liver-related adverse reactions most commonly reported in patients treated with lenvatinib included increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and blood bilirubin. 
Z jetri povezani neželeni učinki, o katerih so najpogosteje poročali pri bolnikih z DTC, zdravljenih z lenvatinibom, vključujejo zvišanje alanin-aminotransferaze (ALT), aspartat-aminotransferaze (AST) in bilirubina v krvi.
A single 32-mg dose of lenvatinib did not prolong the QT/QTc interval based on results from a thorough QT study in healthy volunteers; however, QT/QTc interval prolongation has been reported at a higher incidence in patients treated with lenvatinib than in patients treated with placebo (see sections 4.4 and 4.8). 
Enkraten 32-miligramski odmerek lenvatiniba sodeč po rezultatih temeljite študije intervala QT pri zdravih prostovoljcih ni podaljšal intervala QT/QTc; so pa o večji incidenci podaljšanja intervala QT/QTc poročali pri bolnikih, zdravljenih z lenvatinibom, kot pri bolnikih, ki so prejemali placebo (glejte poglavji 4.4 in 4.8).
Hypercholesterolaemia includes hypercholesterolaemia and increased blood cholesterol. 
Hiperholesterolemija vključuje hiperholesterolemijo in zvišan holesterol v krvi.
The main metabolic pathways in humans were identified as oxidation by aldehyde oxidase, demethylation via CYP3A4, glutathione conjugation with elimination of the O-aryl group (chlorophenyl moiety), and combinations of these pathways followed by further biotransformations (e.g., glucuronidation, hydrolysis of the glutathione moiety, degradation of the cysteine moiety, and intramolecular rearrangement of the cysteinylglycine and cysteine conjugates with subsequent dimerisation). 
Ugotovili so, da so poglavitne presnovne poti pri ljudeh oksidacija z aldehidno oksidazo, demetilacija s CYP3A4, konjugacija z glutationom z odstranitvijo O-arilne skupine (klorofenilni del molekule) in kombinacije teh presnovnih poti, ki jim sledijo nadaljnje biotransformacije (npr. glukuronidacija, hidroliza glutationskega dela molekule, razgradnja cisteinskega dela molekule in intramolekulska prerazporeditev cisteinilglicinskih in cisteinskih konjugatov s poznejšo dimerizacijo).
Adjusted Doseb (<60 kg BW) 
Prilagojen odmerekb (< 60 kg TM)
Thyroid function should be monitored before initiation of, and periodically throughout, treatment with lenvatinib. 
Funkcijo ščitnice je treba spremljati pred začetkom, nato pa v rednih presledkih ves čas zdravljenja z lenvatinibom.
Limited data are available for patients of ethnic origin other than Caucasian or Asian, and in patients aged ≥75 years. 
Za bolnike, ki niso bele ali azijske rase, in za bolnike, stare 75 let ali več, je na voljo malo podatkov.
Hepatic failure (including fatal events in 12 patients) occurred in 3.6% of patients (all were ≥ Grade 3). 
Jetrna odpoved (vključno z 12 smrtnimi izidi) je nastopila pri 3,6 % bolnikov (vsi so bili stopnje ≥ 3).
One occurred in a patient with no liver metastases. 
En primer je nastopil pri bolniku brez metastaz v jetrih.
Discontinue 
prekinite
Radioiodine-refractory differentiated thyroid cancer 
Proti radioaktivnemu jodu odporni diferencirani rak ščitnice
Patients with low body weight (<60 kg) had a higher incidence of PPE, proteinuria, of Grade 3 or 4 hypocalcaemia and hyponatraemia, and a trend towards a higher incidence of Grade 3 or 4 decreased appetite. 
Bolniki z majhno telesno maso (< 60 kg) so imeli večjo incidenco PPE, proteinurije, hipokalciemije in hiponatriemije stopnje 3 ali 4 in nagnjenost k večji incidenci zmanjšanega apetita stopnje 3 ali 4.
Neutropenia includes neutropenia and decreased neutrophil count decreased. 
Nevtropenija vključuje nevtropenijo in zmanjšano število nevtrofilcev.
Hepatic encephalopathy (including fatal events in 4 patients) occurred in 8.4% of patients (5.5% were ≥ Grade 3). 
Jetrna encefalopatija (vključno s 4 smrtnimi izidi) je nastopila pri 8,4 % bolnikov (5,5 % jih je bilo stopnje ≥ 3).
Management of some adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy. 
Zaradi obvladovanja nekaterih neželenih učinkov utegnejo biti potrebne prekinitev odmerjanja, prilagoditev odmerka ali ukinitev zdravljenja z lenvatinibom.
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. 
Med 1823 bolniki, zdravljenimi z lenvatinibom v monoterapiji v kliničnih preskušanjih, je bilo 5 primerov (0,3 %) PRES (0,2 % jih je bilo stopnje 3 ali 4), od katerih so vsi okrevali po zdravljenju in/ali prekinitvi odmerjanja ali trajni ukinitvi.
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. 
Ne-gastrointestinalna fistula vključuje primere fistule, ki nastane zunaj želodca in črevesa, kot so trahealna, traheo-ezofagealna, ezofagealna fistula, fistula ženskih spolovil in kožna fistula.
Lenvatinib has not been studied in patients with severe hepatic imparement (Child-Pugh C) and is not recommended for use in these patients. 
Lenvatiniba niso preučevali pri bolnikih s hudo jetrno okvaro (Child-Pugh C), zato uporaba pri teh bolnikih ni priporočljiva.
Amongst 1,823 patients treated with lenvatinib monotherapy in clinical studies, there were 10 cases (0.5%) of arterial thromboembolisms (5 cases of myocardial infarction and 5 cases of cerebrovascular accident) with a fatal outcome. 
Med 1823 bolniki, zdravljenimi z lenvatinibom v monoterapiji v kliničnih preskušanjih, je bilo 10 primerov (0,5 %) arterijskih trombembolij (5 primerov miokardnega infarkta in 5 primerov cerebrovaskularnega insulta) s smrtnim izidom.
Since lenvatinib is mainly eliminated by hepatic metabolism, an increase in exposure in patients with moderate to severe hepatic impairment is expected. 
Ker se lenvatinib pretežno izloča s presnovo v jetrih, se pri bolnikih z zmerno do hudo jetrno okvaro pričakuje večja izpostavljenost.
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). 
Zdi se, da starejši bolniki, stari ≥ 75 let, ki pripadajo azijski rasi in imajo sočasne druge bolezni (na primer hipertenzijo in okvaro jeter ali ledvic) ali telesno maso, ki je manjša od 60 kg, slabše prenašajo lenvatinib (glejte poglavje 4.8, Druge posebne skupine bolnikov).
• you are breast-feeding (see the section below on Contraception, pregnancy and breast-feeding). 
• če dojite (glejte poglavje Kontracepcija, nosečnost in dojenje v nadaljevanju).
Limited data are available on use in patients aged ≥75 years (see also section 4.8, Other special populations). 
O uporabi pri bolnikih, starih 75 let ali več, je na voljo malo podatkov (glejte tudi poglavje 4.8, Druge posebne skupine bolnikov).
No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment. 
Prilagoditev začetnega odmerka na podlagi ledvične funkcije pri bolnikih z blago ali zmerno okvaro ledvic ni potrebna.
The suspension is to be swallowed. 
Suspenzijo spijemo.
• underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin) 
• premalo aktivna ščitnica (utrujenost, pridobivanje telesne mase, zaprtje, občutek mraza, suha koža),
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eisai GmbH 
Imetnik dovoljenja za promet z zdravilom Eisai GmbH
No formal studies of the effect of lenvatinib on wound healing have been conducted. 
Formalnih študij o učinku lenvatiniba na celjenje ran niso izvedli.
The median time to first onset was 11.9 weeks. 
Mediani čas do nastopa je bil 11,9 tednov.
Hepatic encephalopathyl,‡,† 
jetrna encefalopatijal,‡,†
Accidental medication errors resulting in single doses of 40 to 48 mg have occurred in clinical trials. 
V kliničnih preskušanjih je prišlo do nehotenih napak pri dajanju zdravila, ki so imele za posledico enkratne odmerke od 40 mg do 48 mg.
Avoid driving or using machines if you feel dizzy or tired. 
Če ste omotični ali utrujeni, ne vozite in ne uporabljajte strojev.
A 5-mg dose was evaluated in 6 subjects with severe hepatic impairment (Child-Pugh C). 
Petmiligramski odmerek so ovrednotili pri 6 preiskovancih s hudo okvaro jeter (Child-Pugh C).
Lenvatinib displays minimimal accumulation at steady state. 
Lenvatinib kaže v stanju dinamičnega ravnovesja minimalno kopičenje.
The median time to onset was 6.1 weeks. 
Mediani čas do nastopa je bil 6,1 tedna.
The median time to onset of hepatotoxocity adverse reactions was 6.4 weeks. 
Mediani čas do nastopa s hepatotoksičnostjo povezanih neželenih učinkov je bil 6,4 tednov.
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. 
Izpostavljenost lenvatinibu na podlagi za odmerek popravljenih podatkov AUC0-t in AUC0-inf je bila 119 %, 107 % oziroma 180 % normalne vrednosti pri preiskovancih z blago, zmerno oziroma hudo okvaro jeter.
In the placebo group 0.8% of patients developed renal failure or impairment (0.8% were Grade ≥ 3). 
V skupini s placebom se je odpoved ali okvara ledvic razvila pri 0,8 % bolnikov (0,8 % jih je bilo stopnje ≥ 3).
Lenvima 10 mg hard capsules EU/1/15/1002/002 
Lenvima 10 mg trde kapsule EU/1/15/1002/002
EU/1/15/1002/002 (Pack size of 30 hard capsules) EU/1/15/1002/005 (Pack size of 60 hard capsules) EU/1/15/1002/006 (Pack size of 90 hard capsules) 
EU/1/15/1002/002 (pakiranje 30 trdih kapsul) EU/1/15/1002/005 (pakiranje 60 trdih kapsul) EU/1/15/1002/006 (pakiranje 90 trdih kapsul)
The recommended daily dose of lenvatinib is 24 mg (two 10 mg capsules and one 4 mg capsule) once daily. 
Priporočeni dnevni odmerek lenvatiniba je 24 mg (dve 10 mg kapsuli in ena 4 mg kapsula) enkrat na dan.
18th September 2019 
DATUM ZADNJE REVIZIJE BESEDILA 18. september 2019
Efficacy Results from the REFLECT study in HCC Efficacy parameter 
Table 7: Rezultati učinkovitosti v študiji REFLECT pri bolnikih s HCC
In vitro, the lenvatinib blood-to-plasma concentration ratio ranged from 0.589 to 0.608 (0.110 μg/mL, mesylate). 
Razmerje koncentracij lenvatiniba v krvi in plazmi in vitro je bilo v mejah od 0,589 do 0,608 (0,1-10 μg/ml, mesilat).
Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS) 
Sindrom posteriorne reverzibilne encefalopatije (Posterior reversible encephalopathy syndrome ali PRES) / Sindrom reverzibilne posteriorne levkoencefalopatije (Reversible posterior leucoencephalopathy syndrome ali RPLS)
Females had a higher incidence of hypertension, fatigue, ECG QT prolongation and alopecia. 
Pri ženskah so bile pogostejše hipertenzija, utrujenost, podaljšanje intervala QT na EKG in alopecija.
Lenvatinib was embryotoxic and teratogenic when administered to rats and rabbits (see section 5.3). 
Lenvatinib je bil toksičen za zarodke in teratogen, ko so ga dajali podganam in kuncem (glejte poglavje 5.3).
Efficacy results in DTC patients 
Preglednica 6 Rezultati učinkovitosti pri bolnikih z DTC
It is currently unknown if lenvatinib increases the risk of thromboembolic events when combined with oral contraceptives. 
Trenutno ni znano, ali lenvatinib v kombinaciji s peroralnimi kontraceptivi zvečuje tveganje trombemboličnih dogodkov.
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. 
Čeprav mehanizma hipertenzijskega delovanja niso proučevali neposredno z lenvatinibom, predpostavljajo, da gre za inhibicijoVEGFR2 v vaskularnih endotelijskih celicah.
After drinking, the same amount of water or apple juice (one tablespoon) must be added to the glass and swirled a few times. 
Potem v kozarec dodamo enako količino vode ali jabolčnega soka (ena žlica) in tekočino nekaj časa vrtinčimo.
Amongst 1,166 patients treated with lenvatinib, there were 3 cases (0.3%) of hepatic failure, all with a fatal outcome. 
Med 1166 bolniki, zdravljenimi z lenvatinibom, so bili 3 primeri (0,3 %) odpovedi jeter, vsi s smrtnim izidom.
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. 
Pri 452 bolnikih z DTC, odpornim proti RAI, sta bila ukrepa, ki so ju uporabili pri neželenih učinkih, zmanjšanje odmerka oziroma ukinitev zdravila pri 63,1 % oziroma 19,5 % bolnikov.
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). 
Stratificirano po regijah (Evropa proti Severni Ameriki proti drugim regijam), starostnih skupinah (≤ 65 let proti > 65 let) in predhodnem zdravljenju, usmerjenem v VEGF/VEGFR (0 proti 1).
Hepatotoxicity events and haemorrhage events also occurred at a higher incidence in CP score 6 patients compared to CP score 5 patients. 
S hepatotoksičnostjo povezani neželeni učinki in krvavitve so se z večjo incidenco pojavljali pri bolnikih z oceno CP 6 v primerjavi z bolniki z oceno CP 5.
The median time to onset was 6.7 weeks. 
Mediani čas do nastopa je bil 6,7 tedna.
Subjects with end-stage renal disease were not studied. 
Preiskovancev z boleznijo ledvic v končnem stadiju niso proučevali.
There is limited clinical experience regarding the timing of reinitiation of lenvatinib following a major surgical procedure. 
Klinične izkušnje o času ponovne uvedbe lenvatiniba po večjem kirurškem posegu so omejene.
Lenvatinib and its metabolites are excreted in rat milk (see section 5.3). 
Lenvatinib in njegovi presnovki se izločajo v mleko podgan (glejte poglavje 5.3).
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. 
Trenutno ni znano, ali lenvatinib lahko zmanjša učinkovitost hormonskih kontracepcijskih sredstev, zato naj ženske, ki uporabljajo peroralna hormonska kontracepcijska sredstva, dodatno uporabijo še pregradno metodo kontracepcije.
Median was estimated with the Kaplan-Meier method and the 95% confidence interval was constructed with a generalised Brookmeyer and Crowley method. 
Mediana je bila ocenjena s Kaplan-Meierjevo metodo; 95-odstotni IZ je bil sestavljen s posplošeno Brookmeyer-Crowleyevo metodo.
Some cases of bleeding have occurred secondarily to tumour shrinkage and fistula formation, e.g. tracheo-oesophageal fistulae. 
Nekateri primeri krvavitev so se pojavili sekundarno zaradi zmanjšanja tumorske mase in nastanka fistule, npr. traheo-ezofagealnih fistul.
One fatal case of hepatic tumour haemorrhage in a patient with HCC has been reported. 
Poročali so o enem primeru krvavitve jetrnega tumorja s smrtnim izidom pri bolniku s HCC.
• Uncommon (≥1/1,000 to <1/100) 
(≥ 1/1.000 do < 1/100)
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. 
Pri 496 bolnikih s HCC je bil odmerek spremenjen (prekinitev ali zmanjšanje) pri 62,3 %, zdravljenje pa ukinjeno pri 20,2 % bolnikov.
Lenvima 4mg hard capsules EU/1/15/1002/001 
Lenvima 4 mg trde kapsule EU/1/15/1002/001
Gastrointestinal perforation and fistula formation 
Gastrointestinalna perforacija in nastanek fistule
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). 
Lenvatinib se mora pri takih bolnikih uporabljati previdno, saj bolniki, ki pripadajo azijski rasi, in starejši bolniki lenvatinib slabše prenašajo (glejte poglavje 4.8 Druge posebne skupine bolnikov).
Hepatotoxicity reactions of ≥ Grade 3 occurred in 26.1% of lenvatinib-treated patients. 
S hepatotoksičnostjo povezani neželeni učinki stopnje ≥ 3 so nastopili pri 26,1 % bolnikov, zdravljenih z lenvatinibom.
Hyperbilirubinaeamia includes: hyperbilirubinaemia, increased blood bilirubin, jaundice and increased bilirubin conjugated. 
Hiperbilirubinemija vključuje: hiperbilirubinemijo, zvišano raven bilirubina v krvi, zlatenico in zvišano raven konjugiranega bilirubina.
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. 
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) je imelo 88 % vseh bolnikov izhodiščno raven TSH nižjo kot 0,5 mE/l ali enako 0,5 mE/l.
Discontinue Do not resume *Grade 4 laboratory abnormalities judged to be non-life-threatening, may be managed as severe reactions (e.g., Grade 3) 
Zdravljenja ne začnite znova *Laboratorijske nenormalnosti stopnje 4, za katere sodimo, da niso življenjsko nevarne, lahko obravnavamo kot resne neželene učinke (npr. stopnje 3).
The incidence of QTcF interval prolongation of greater than 500ms was 
Pojavnost podaljšanja intervala QT, večjega od 500 ms, je bila 2,4 %.
These patients also had a higher incidence of renal reactions and a trend towards a higher incidence of liver reactions. 
Ti bolniki so imeli tudi večjo incidenco neželenih učinkov na ledvice in so bili nagnjeni k večji incidenci neželenih učinkov na jetra.
Females had a higher incidence of hypertension (including Grade 3 or 4 hypertension), proteinuria, and PPE, while males had a higher incidence of decreased ejection fraction and gastrointestinal perforation and fistula formation. 
Pri ženskah so bile pogostejše hipertenzija (vključno s hipertenzijo stopnje 3 ali 4), proteinurija in PPE, moški pa so imeli večje incidenco zmanjšane iztisne frakcije, gastrointestinalnih perforacij in nastanka fistul.