natgillin/translations-raw huggingface dataset:
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
Your doctor will discuss the results of these tests with you and decide whether you can be given LENVIMA. 
Zdravnik se bo pogovoril z vami o rezultatih teh preiskav in se odločil, ali vam lahko da zdravilo LENVIMA.
Persistent and Intolerable Grade 2 or Grade 3 Toxicitiesa Adverse Reaction Modification 
Vztrajne in nevzdržne toksičnosti stopnje 2 ali 3a Neželeni učinek Prilagoditev
Differentiated Thyroid Cancer (DTC) 
Diferencirani karcinom ščitnice (DTC)
Patients were eligible to participate if they had a liver function status of Child-Pugh class A and Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1. 
Bolniki so lahko sodelovali, če so imeli status jetrne funkcije razreda A po lestvici Child-Pugh in stanje zmogljivosti po lestvici ECOG PS (Eastern Cooperative Oncology Group Performance Status) 0 ali 1.
• Do not take LENVIMA if you are planning to become pregnant during your treatment. 
• Ne jemljite zdravila LENVIMA, če načrtujete zanositev med zdravljenjem.
• Demographic and baseline disease characteristics were similar between the lenvatinib and the sorafenib groups and are shown below for all 954 randomised patients: 
• Demografske značilnosti in bolezni v izhodišču so bile podobne med skupinama, ki sta prejemali lenvatinib, in skupino, ki je prejemala sorafenib, in so prikazane v nadaljevanju za vseh 954 randomiziranih bolnikov:
Number of capsules 
Število kapsul
• Underlying cirrhosis (by independent imaging review): 75% 
• osnovna ciroza (z neodvisnim pregledom slike): 75 %,
When necessary, manage hypertension as recommended in Table 4. 
Po potrebi zdravite hipertenzijo po priporočilih v preglednici 4.
Lenvatinib should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus. 
Lenvatinib naj se med nosečnostjo ne uporablja, če to ni nujno potrebno in le po skrbni presoji nujnosti zdravljenja za mater in tveganja za plod.
Alternatively, the lenvatinib capsules may be added without breaking or crushing them to a tablespoon of water or apple juice in a small glass to produce a suspension. 
Druga možnost je, da kapsule lenvatiniba dodamo, ne da bi jih prelomili ali zdrobili, v jedilno žlico vode ali jabolčnega soka v majhnem kozarcu, da nastane suspenzija.
Further dose reductions should be considered on an individual patient basis as limited data are available for doses below 10 mg. 
Nadaljnja zmanjševanja odmerka se presojajo za vsakega bolnika posebej, ker je za odmerke, manjše od 10 mg, na voljo malo podatkov.
The daily dose is to be modified as needed according to the dose/toxicity management plan. 
Dnevni odmerek naj se spreminja po potrebi v skladu z načrtom za obvladovanje odmerka/toksičnosti.
The percentage of the dose of lenvatinib excreted in urine was low in all cohorts (<2.16% across treatment cohorts). 
Odstotni delež v urinu izločenega odmerka lenvatiniba je bil v vseh kohortah majhen (< 2,16 % v zdravljenih kohortah).
The Efron method was used for ties. 
Za izenačenja je bila uporabljena metoda Efron.
• Swallow the capsules whole with water or dissolved. 
• Kapsule pogoltnite cele z vodo ali raztopljene.
Reports of fistulae that involve areas of the body other than stomach or intestines were observed across various indications. 
Poročila o fistulah, ki so zajele druge telesne dele, ne želodca ali črevesja, so opazili pri različnih indikacijah.
Based on AUC(0 - inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively. 
Na podlagi AUC(0-inf) je lenvatinib predstavljal 60 % oziroma 64 % celotne radioaktivnosti v plazmi oziroma krvi.
The safety profile of lenvatinib is based on data from 452 DTC patients and 496 HCC patients; allowing characterisation only of common adverse drug reactions in DTC and HCC patients. 
Varnostni profil lenvatiniba temelji na podatkih 452 bolnikov z DTC in 496 bolnikov s HCC, kar omogoča samo opis pogostih neželenih učinkov zdravila pri bolnikih z DTC in HCC.
The adverse reactions presented in this section are based on safety data of both DTC and HCC patients (see section 5.1). 
Neželeni učinki, predstavljeni v tem poglavju, temeljijo na podatkih o varnosti pri bolnikih z DTC in bolnikih z HCC (glejte poglavje 5.1).
HR was estimated from the Cox proportional hazard model with treatment as independent variable and stratified by IxRS stratification factors. 
Vrednost HR je bila ocenjena s Coxovim modelom proporcionalnih tveganj z zdravljenjem kot neodvisno spremenljivko in stratifikacijo po faktorjih stratifikacije IxRS.
Pancreatitis includes: pancreatitis and acute pancreatitis. 
Pankreatitis vključuje: pankreatitis in akutni pankreatitis.
• increase in lipase and amylase (enzymes involved in digestion) 
• zvišanje lipaze in amilaze (encimov, ki sta vpletena v prebavo).
The following side effects may happen with this medicine. 
Pri tem zdravilu se lahko pojavijo naslednji neželeni učinki.
• Absence of macroscopic portal vein invasion (MPVI): 79% 
• odsotnost makroskopske invazije portalne vene (MPVI - macroscopic portal vein invasion):
• If it is 12 hours or more until your next dose: take the missed dose as soon as you remember. 
• Če do naslednjega odmerka manjka 12 ur ali več: vzemite pozabljeni odmerek, takoj ko se spomnite nanj.
Talk to your doctor if you experience any new or unsual symptoms such as coughing when swallowing. 
Posvetujte se z zdravnikom, če imate kakšne nove ali nenavadne simptome, na primer kašljanje med požiranjem.
In plasma samples collected up to 24 hours after administration, lenvatinib constituted 97% of the radioactivity in plasma radiochromatograms while the M2 metabolite accounted for an additional 2.5%. 
V vzorcih plazme, odvzetih do 24 ur po dajanju zdravila, je lenvatinib predstavljal 97 % radioaktivnosti v radiokromatogramih plazme, presnovek M2 pa je predstavljal še dodatna 2,5 %.
Patients with HCC should be monitored for worsening liver function including hepatic encephalopathy. 
Bolnike s HCC je treba spremljati glede poslabšanja delovanja jeter, vključno z jetrno encefalopatijo.
If patients have severe renal impairment, the initial dose of lenvatinib should be adjusted (see sections 4.2 and 5.2). 
Če imajo bolniki hudo okvaro ledvic, je treba prilagoditi začetni odmerek lenvatiniba (glejte poglavji 4.2 in 5.2).
Patients with body weight <60 kg 
Bolniki s telesno maso < 60 kg
These proteins can be present in high amounts in cancer cells, and by blocking their action LENVIMA may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs. 
Te beljakovine so lahko prisotne v velikih količinah v rakastih celicah, z zaviranjem njihovega delovanja pa zdravilo LENVIMA lahko upočasni hitrost razmnoževanja rakavih celic in rast tumorja in pomaga prekiniti preskrbo s krvjo, ki jo rak potrebuje.
There are no data on the use of lenvatinib in pregnant women. 
Podatkov o uporabi lenvatiniba pri nosečnicah ni na voljo.
The additional liquid must be swallowed. 
Dodatno tekočino moramo spiti.
Reactions were reported at various time points during treatment ranging from two weeks to greater than 1 year from initiation of lenvatinib, with median latency of about 3 months. 
O reakcijah so poročali ob različnih časovnih točkah med zdravljenjem, od dveh tednov do več kot enega leta po uvedbi lenvatiniba, mediana latenca je bila okrog 3 mesece.
>500 ms 
> 500 ms prekinite
These findings indicate that lenvatinib has a teratogenic potential, likely related to the pharmacologic activity of lenvatinib as an antiangiogenic agent. 
Te ugotovitve kažejo, da ima lenvatinib teratogen potencial, ki je verjetno povezan s farmakološko aktivnostjo lenvatiniba kot antiangiogenega sredstva.
The highest doses of lenvatinib studied clinically were 32 mg and 40 mg per day. 
Največja odmerka lenvatiniba, ki so ju klinično proučevali, sta bila 32 mg in 40 mg na dan.
No adjustment of starting dose is required on the basis of race (see section 5.2). 
Na podlagi rase prilagoditev začetnega odmerka ni potrebna (glejte poglavje 5.2).
Effect of lenvatinib on other medicinal products 
Učinek lenvatiniba na druga zdravila
The majority of patients had an ECOG performance status of 0; 42.1% had a status of 1; 3.9% had a status above 1. 
Večina bolnikov je imela stanje zmogljivosti 0 po ECOG; 42,1 % jih je imelo stanje 1; 3,9 % je imelo stanje, večje od 1.
• heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs 
• težave s srcem ali krvni strdki v pljučih (oteženo dihanje, bolečina v prsih) ali drugih organih,
These cases were associated with adverse reactions consistent with the known safety profile of lenvatinib (i.e., renal and cardiac failure), or were without adverse reactions. 
Ti primeri so bili povezani z neželenimi učinki, ki so se ujemali z znanim varnostnim profilom lenvatiniba (t. j. odpoved ledvic in popuščanje srca), ali pa so bili brez neželenih učinkov.
The main efficacy outcome measure was progression-free survival (PFS) as determined by blinded independent radiologic review using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. 
Glavno merilo izida učinkovitosti je bilo preživetje brez napredovanja bolezni (progression-free survival ali PFS), ugotovljeno s slepim neodvisnim radiološkim pregledom z uporabo meril za ocenjevanje odziva pri čvrstih tumorjih (Response Evaluation Criteria in Solid Tumours ali RECIST) 1.1.
It is used on its own to treat progressive or advanced thyroid cancer in adults when radioactive iodine treatment has not helped to stop the disease. 
Uporablja se za samostojno zdravljenje napredujočega ali napredovalega raka ščitnice pri odraslih, če zdravljenje z radioaktivnim jodom ni pomagalo zaustaviti bolezni.
Target lesions previously treated with radiotherapy or locoregional therapy had to show radiographic evidence of disease progression. 
Za ciljne lezije, predhodno zdravljene z radioterapijo ali lokoregionalno terapijo, je bilo treba radiografsko potrditi napredovanje bolezni.
Consequently, in vivo, inducers and inhibitors of CYP 3A4 had a minimal effect on lenvatinib exposure (see section 4.5). 
Zato so in vivo spodbujevalci in zaviralci CYP 3A4 imeli minimalen učinek na izpostavljenost lenvatinibu (glejte poglavje 4.5).
Noninferiority margin for hazard ratio (HR: lenvatinib vs sorafenib = 1.08). 
Meja neinferiornosti za razmerje ogroženosti (HR: lenvatinib proti sorafenibu = 1,08).
Magnetic resonance imaging is necessary to confirm the diagnosis of PRES. 
Za potrditev diagnoze PRES je potrebno slikanje z magnetno resonanco.
Kaplan-Meier Curve of Overall Survival - HCC 
Slika 2 Kaplan-Meierjeva krivulja celotnega preživetja - HCC
Over this range, the median accumulation index (Rac) ranged from 0.96 (20 mg) to 1.54 (6.4 mg). 
V tem območju je mediani indeks kopičenja (Rac) segal od 0,96 (20 mg) do 1,54 (6,4 mg).
• The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30,60 or 90 hard capsules. 
• Kapsule so na voljo v pretisnih omotih iz poliamida/aluminija/PVC, prekritih z aluminijevo folijo za predrtje, v kartonskih škatlah s po 30, 60 ali 90 trdimi kapsulami.
For those patients already on antihypertensive medication, the dose of the current agent may be increased, if appropriate, or one or more agents of a different class of antihypertensive should be added. 
Pri tistih bolnikih, ki že jemljejo antihipertenzivno zdravilo, je treba zvečati odmerek tega zdravila, če je to primerno, ali dodati eno ali več zdravil iz druge skupine antihipertenzivov.
You may need to have additional treatment with other medicines, to take a lower dose of LENVIMA, or to take extra care due to an increased risk of side effects. 
Mogoče se boste morali dodatno zdraviti z drugimi zdravili, jemati manjši odmerek zdravila LENVIMA ali pa biti zaradi zvečanega tveganja neželenih učinkov še posebej pazljivi.
Antihypertensive agents should be started as soon as elevated BP is confirmed. 
Antihipertenzivna zdravila je treba začeti dajati, takoj ko je zvišan KT potrjen.
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. 
Krvni tlak (KT) naj bo pred zdravljenjem z lenvatinibom dobro nadzorovan in, če je za bolnike znano, da so hipertenzivni, naj bodo vsaj 1 teden pred zdravljenjem z lenvatinibom na stabilnem odmerku antihipertenzivne terapije.
A statistically significant prolongation in PFS was demonstrated in lenvatinib-treated patients compared with those receiving placebo (p<0.0001) (see figure 1). 
Statistično značilno podaljšanje PFS so dokazali pri bolnikih, zdravljenih z lenvatinibom, v primerjavi s tistimi, ki so prejemali placebo (p < 0,0001) (glejte sliko 1).
When administered with food to healthy subjects, peak plasma concentrations are delayed by 2 hours. 
Kadar ga dajemo zdravim preiskovancem z obrokom hrane, se najvišje plazemske koncentracije zakasnijo za 2 uri.
For the following transporters, OAT1, OAT3, OATP1B1, OCT1, OCT2, and BSEP, clinically relevant inhibition was excluded based on a cutoff of IC50> 50  Cmax,unbound. 
Za prenašalce OAT1, OAT3, OATP1B1, OCT1, OCT2 in BSEP so klinično pomembno inhibicijo izključili na podlagi meje IC50 > 50  Cmax,nevezan.
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. 
Raven tirotropnega hormona (thyroid stimulating hormone ali TSH) je treba redno spremljati in prilagoditi dajanje ščitničnega hormona tako, da bo TSH dosegel ustrezno raven v skladu z bolnikovim terapevtskim ciljem.
Your doctor can give you medicine to reduce these side effects. 
Zdravnik vam bo lahko dal zdravilo, ki bo zmanjšalo te neželene učinke.
Second occurrence (same reaction or new reaction) 
Drugi pojav (enak učinek ali nov učinek)
The primary efficacy endpoint was Overall Survival (OS). 
Primarni opazovani dogodek je bilo celotno preživetje (OS - overall survival).
This binding was mainly to albumin with minor binding to α1-acid glycoprotein and γ-globulin. 
Ta vezava je bila v glavnem na albumine z manjšo vezavo na α1-kisli glikoprotein in γ-globulin.
• changes in urine tests for protein (high) and urinary infections (increased frequency in urination and pain in passing urine) 
• spremembe urinskih preiskav beljakovin (zvišane) in okužbe sečil (pogostnejše uriniranje in bolečine pri uriniranju),
Blood pressure should be well controlled prior to treatment with lenvatinib, and should be regularly monitored during treatment (see section 4.4). 
Krvni tlak mora biti pred zdravljenjem z lenvatinibom dobro nadzorovan, med zdravljenjem pa ga je treba redno spremljati (glejte poglavje 4.4).
Not Known (the following side effects have been reported since the marketing of LENVIMA but the frequency for them to occur is not known) 
Neznana pogostnost (o naslednjih neželenih učinkih so poročali, odkar je prišlo zdravilo LENVIMA na trg, vendar pogostnost, s katero se pojavljajo, ni znana):
The choice of antihypertensive treatment should be individualised to the patient's clinical circumstances and follow standard medical practice. 
Izbiro antihipertenzivnega zdravljenja je treba pri vsakem bolniku prilagoditi njegovim kliničnim okoliščinam in ravnati v skladu s standardno medicinsko prakso.
In both treatment arms in the REFLECT study, median OS was approximately 9 months longer in subjects who received post-treatment anticancer therapy than in those who did not. 
V obeh terapevtskih skupinah v študiji REFLECT je bilo mediano OS približno 9 mesecev daljše pri osebah, ki so po zdravljenju prejele onkološko terapijo, kot pri tistih, ki je niso.
In human liver cytosol, lenvatinib did not inhibit aldehyde oxidase activity. 
V citosolu človeških jeter lenvatinib ni zaviral aktivnosti aldehidne oksidaze.
• have had recent surgery or radiotherapy 
• ste pred nedavnim imeli operacijo ali zdravljenje z obsevanjem;
No specific studies with lenvatinib have been conducted in animals to evaluate the effect on fertility. 
Z lenvatinibom niso opravili specifičnih študij na živalih za oceno učinka na plodnost.
Grades are based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). 
Stopnje temeljijo na Skupnih terminoloških merilih za neželene učinke (Common Terminology Criteria for Adverse Events oziroma CTCAE) Nacionalnega inštituta za raka (National Cancer Institute oziroma NCI).
Hypothyroidism should be treated according to standard medical practice to maintain euthyroid state. 
Hipotiroidizem je treba zdraviti v skladu s standardno medicinsko prakso, da se vzdržuje evtiroidno stanje.
A clinical drug-drug interaction (DDI) study in cancer patients showed that plasma concentrations of midazolam (a sensitive CYP3A and Pgp substrate) were not altered in the presence of lenvatinib. 
Klinična študija o medsebojnem delovanju zdravil (DDI - drug-drug interaction) pri bolnikih z rakom je pokazala, da se plazemske koncentracije midazolama (občutljivega substrata CYP3A in Pgp) v prisotnosti lenvatiniba ne spremenijo.
Before taking LENVIMA, your doctor may carry out some tests, for example to check your blood pressure and your liver or kidney function and to see if you have low levels of salt and high levels of thyroid stimulating hormone in your blood. 
Pred začetkom jemanja zdravila LENVIMA vam lahko zdravnik naredi nekatere preiskave, lahko vam na primer kontrolira krvni tlak in delovanje jeter ali ledvic in se prepriča, ali imate nizko raven soli in visoko raven tirotropnega hormona v krvi.
Third occurrence (same reaction or new reaction) 
Tretji pojav (enak učinek ali nov učinek)
• If you could become pregnant, use highly effective contraception while taking this medicine, and for at least one month after you finish treatment. 
• Če je možno, da bi lahko zanosili, morate med jemanjem tega zdravila in vsaj še en mesec po končanem zdravljenju uporabljati učinkovito kontracepcijo.
Tell your doctor straight away if you notice any of the side effects above. 
Nemudoma povejte zdravniku, če opazite kakega od zgoraj navedenih neželenih učinkov.
≥ 2 g / 24 hours 
≥ 2 g/24 ur prekinite
Approximately half of the events of hepatic failure and one third of the events of the hepatic encephalopathy were reported in patients with disease progression. 
Približno polovico dogodkov odpovedi jeter in eno tretjino dogodkov jetrne encefalopatije so zabeležili pri bolnikih z napredovanjem bolezni.
Includes all haemorrhage terms. 
Vključuje vse izraze za krvavitev.
LENVIMA blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them to grow. 
Zdravilo LENVIMA zavira delovanje beljakovin, ki se imenujejo receptorji tirozin-kinaze (RTK), ki so vpletene v razvoj novih krvnih žil, ki preskrbujejo celice s kisikom in hranilnimi snovmi in jim pomagajo rasti.
4.7 Effects on ability to drive and use machines Lenvatinib has a minor influence on the ability to drive and use machines, due to undesirable effects such as fatigue and dizziness. 
Lenvatinib ima blag vpliv na sposobnost vožnje in upravljanja s stroji, in to zaradi neželenih učinkov, kot sta utrujenost in omotica.
In addition, lenvatinib had selective, direct antiproliferative activity in hepatocellular cell lines dependent on activated FGFR signalling, which is attributed to the inhibition of FGFR signalling by lenvatinib. 
Poleg tega ima lenvatinib selektivno, neposredno antiproliferativno aktivnost v hepatocelularnih celičnih linijah, odvisno od aktivirane signalizacije FGFR, kar je posledica zaviranja signalizacije FGFR z lenvatinibom.
Plasma concentrations decline bi-exponentially following Cmax. 
Koncentracije v plazmi se po Cmax zmanjšujejo bieksponencialno.
Of the 392 patients randomised, 76.3% were naïve to prior VEGF/VEGFR-targeted therapies, 49.0% were female, 49.7% were European, and the median age was 63 years. 
Od 392 randomiziranih bolnikov jih 76,3 % nikoli prej ni prejemalo zdravljenja, usmerjenega v VEGF/VEGFR, 49,0 % jih je bilo ženskega spola, 49,7 % je bilo Evropejcev, mediana starost pa je bila 63 let.
For haematologic toxicity, dosing can restart when resolved to Grade 2; proteinuria, resume when resolves to less than 2g/24 hours e. 
Pri hematološki toksičnosti se lahko odmerjanje ponovno začne, če se izboljša na stopnjo 2; pri proteinuriji odmerjanje nadaljujte, ko se izboljša na manj kot 2 g/24 ur.
In post-marketing surveillance, serious and fatal carotid artery haemorrhages were seen more frequently in patients with anaplastic thyroid carcinoma (ATC) than in DTC or other tumour types. 
Pri nadzoru po prihodu zdravila na trg so ugotavljali resne in smrtne krvavitve karotidnih arterij pogosteje pri bolnikih z anaplastičnim tireoidnim karcinomom (ATC) kot pri DTC ali drugih vrstah tumorjev.
The majority of Grade 3 to 4 adverse reactions occurred during the first 6 months of treatment except for diarrhoea, which occurred throughout treatment, and weight loss, which tended to be cumulative over time. 
Večina neželenih učinkov stopnje 3 do 4 se je pojavila v prvih 6 mesecih zdravljenja, razen driske, ki se je pojavljala ves čas zdravljenja, in hujšanja, ki je sčasoma postajalo čedalje izrazitejše.
Lenvatinib dose should be interrupted or dose adjusted as necessary depending on severity, presence of ECG changes, and persistence of hypocalcaemia. 
Po potrebi je treba prekiniti odmerjanje lenvatiniba ali odmerek prilagoditi, odvisno od resnosti, prisotnosti sprememb EKG in trdovratnosti hipokalciemije.
Electrolyte disturbances such as hypokalaemia, hypocalcaemia, or hypomagnesaemia increase the risk of QT prolongation; therefore, electrolyte abnormalities should be monitored and corrected in all patients before starting treatment. 
Motnje elektrolitov, na primer hipokaliemija, hipokalciemija ali hipomagneziemija, zvečujejo tveganje podaljšanja intervala QT, zato moramo spremljati in popraviti motnje elektrolitov pri vseh bolnikih, preden začnemo z zdravljenjem.
The SELECT study was a multicentre, randomised, double-blind, placebo-controlled trial that was conducted in 392 patients with radioiodine-refractory differentiated thyroid cancer with independent, centrally reviewed, radiographic evidence of disease progression within 12 months (+1 month window) prior to enrolment. 
Študija SELECT je bila multicentrično, randomizirano, dvojno slepo, s placebom kontrolirano preskušanje, opravljeno pri 392 bolnikih z diferenciranim rakom ščitnice, odpornim proti radioaktivnemu jodu, z neodvisno ugotovljenimi, centralno pregledovanimi radiografskimi znaki napredovanja bolezni v 12 mesecih (+ 1-mesečno okno) pred vključitvijo.
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). 
Primerni bolniki z merljivo boleznijo po RECIST 1.1 so bili randomizirani v razmerju 2:1 na prejemanje lenvatiniba 24 mg enkrat na dan (n=261) ali placeba (n=131).
• bleeding (most commonly nose bleeds, but also other types of bleeding such as blood in the urine, bruising, bleeding from the gums or gut wall) 
• krvavitve (najpogosteje krvavitve iz nosu, lahko pa tudi druge vrste krvavitev, na primer kri v urinu, modrice, krvavitve iz dlesni ali črevesne stene),
Hepatic encephalopathy also occurred more frequently in patients aged 75 years and older. 
Jetrna encefalopatija se je pogosteje pojavila pri bolnikih, starih 75 let ali več.