natgillin/translations-raw huggingface dataset:
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. 
Vsi bolniki s HCC razen tistih, ki imajo zmerno in hudo okvaro jeter ali hudo okvaro ledvic, naj začnejo z zdravljenjem s priporočenim odmerkom 8 mg (dve 4 mg kapsuli) za bolnike s telesno maso < 60 kg oz. 12 mg (tri 4 mg kapsule) za bolnike s telesno maso ≥ 60 kg, nato pa naj se odmerek nadalje prilagaja na podlagi prenašanja vsakega bolnika posebej.
In those patients with a normal TSH at baseline, elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of lenvatinib-treated patients as compared with 14% of placebo-treated patients. 
Pri tistih bolnikih, ki so imeli v izhodišču normalen TSH, so opazili zvišanje ravni TSH nad 0,5 mE/l po izhodišču pri 57 % bolnikov, zdravljenih z lenvatinibom, in pri 14 % bolnikov, ki so prejemali placebo.
Impairment of thyroid stimulating hormone suppression/ Thyroid dysfunction 
Okvara supresije tirotropnega hormona / disfunkcija ščitnice
• have liver or kidney problems 
• imate težave z jetri ali ledvicami;
Increased blood alkaline phosphatase Hepatic function abnormal Increased gammaglutamyltransferase Cholecystitis 
zvišana alkalna fosfataza v krvi abnormalna funkcija jeter zvišana gamaglutamiltransferaza holecistitis hepatocelularna poškodba/hepatitism
Discontinue lenvatinib and institute appropriate medical management. 
Ukinite lenvatinib in začnite z ustreznim zdravljenjem.
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. 
Priporočeni dnevni odmerek lenvatiniba je 8 mg (dve 4 mg kapsuli) enkrat na dan za bolnike s telesno maso < 60 kg in 12 mg (tri 4 mg kapsule) enkrat na dan za bolnike s telesno maso ≥ 60 kg.
No differences between lenvatinib- and placebo-treated patients were observed in the incidences of serious reactions (3.4% vs. 3.8%), reactions leading to premature discontinuation (1.1% vs. 1.5%), or reactions leading to dose interruption (3.4% vs. 3.8%) or reduction (0.4% vs. 0). 
Nobenih razlik med bolniki, zdravljenimi z lenvatinibom, in bolniki, ki so prejemali placebo, niso opazili glede incidenc resnih neželenih učinkov (3,4 % v primerjavi s 3,8 %), tistih, ki so povzročili prezgodnjo ukinitev zdravila (1,1 % v primerjavi z 1,5 %), ali neželenih učinkov, ki so povzročili prekinitev (3,4 % v primerjavi s 3,8 %) ali zmanjšanje odmerka (0,4 % v primerjavi z 0).
Across clinical studies in which 1327 patients received lenvatinib monotherapy in indications other than HCC, hepatic failure (including fatal events) was reported in 4 patients (0.3%), liver injury in 2 patients (0.2%), acute hepatitis in 2 patients (0.2%), and hepatocellular injury in 1 patient (0.1%). 
V več študijah so med 1327 bolniki, zdravljenimi z lenvatinibom zaradi indikacij, ki niso bile HCC, poročali o jetrni odpovedi (vključno s smrtnimi izidi) pri 4 bolnikih (0,3 %), jetrni poškodbi pri 2 bolnikih (0,2 %), akutnem hepatitisu pri 2 bolnikih (0,2 %) in hepatocelularni poškodbi pri 1 bolniku
Bleeding in sites other than the brain (e.g. trachea, intra-abdominal, lung) has also been reported. 
Poročali so tudi o krvavitvah drugje, ne v možganih (npr. v traheji, intraabdominalno, v pljučih).
Serious tumour related bleeds, including fatal haemorrhagic events have occurred in clinical trials and have been reported in post-marketing experience (see section 4.8, Description of selected adverse reactions). 
V kliničnih preskušanjih so se pojavile resne krvavitve, povezane s tumorjem, vključno s smrtnimi hemoragičnimi dogodki, o njih so poročali tudi v izkušnjah po prihodu zdravila na trg (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
(2 capsules of 10 mg and 1 capsule of 4 mg). 
(2 kapsuli po 10 mg in 1 kapsula s 4 mg).
Table 1 Dose modifications from recommended lenvatinib daily dose in DTC patientsa 
Preglednica 1 Spremembe odmerka od priporočenega dnevnega odmerka lenvatiniba pri bolnikih z DTCa
Hypoalbuminaemia includes hypoalbuminaemia and decreased blood albumin. 
Hipoalbuminemija vključuje hipoalbuminemijo in znižano raven albumina v krvi.
Lenvatinib is mainly eliminated via the liver and exposure might be increased in these patient populations. 
Ker se lenvatinib pretežno izloča s presnovo v jetrih, se pri teh bolnikih lahko poveč izpostavljenost.
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). 
lenvatinib sorafenib diferenciranega raka ščitnice in je odstopila od zahteve za predložitev rezultatov študij z lenvatinibom v eni ali več podskupin pediatrične populacije pri zdravljenju hepatocelularnega karcinoma (HCC).
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. 
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) je imelo 89,6 % bolnikov izhodiščno raven TSH nižjo od zgornje meje normalnega razpona.
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). 
Lenvatinib je bil neinferioren sorafenibu glede OS, z razmerjem ogroženosti (HR - hazard ratio) = 0,92 [95-odstotni IZ (0,79; 1,06)] in mediano OS 13,6 mesecev v primerjav z 12,3 meseca (glejte preglednico 7 in sliko 2).
Patients in the placebo arm could opt to receive lenvatinib treatment at the time of confirmed disease progression. 
Bolniki v kraku s placebom so se lahko ob času potrjenega napredovanja bolezni odločili, da bodo prejemali zdravljenje z lenvatinibom.
The pharmacokinetics of lenvatinib following a single 24-mg dose were evaluated in 6 subjects each with mild, moderate, and severe renal impairment, and compared with 8 healthy, demographically matched subjects. 
Farmakokinetiko lenvatiniba po enkratnem 24-miligramskem odmerku so ovrednotili pri 6 preiskovancih z blago, 6 preiskovancih z zmerno in 6 preiskovancih s hudo okvaro jeter in rezultate primerjali z 8 zdravimi, demografsko podobnimi preiskovanci.
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. 
Ugotovilo se je, da je v plazmi preiskovancev z okvaro jeter vezava na plazemske beljakovine podobna vezavi pri ustreznih zdravih preiskovancih, odvisnost od koncentracije pa ni bila opažena.
Grade 3 or greater reactions occurred in 1.9% of lenvatinib-treated patients. 
Neželeni učinek stopnje 3 ali višje se je pojavil pri 1,9 % bolnikov, zdravljenih z lenvatinibom.
• The other ingredients are calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose, talc. 
• Druge sestavine zdravila so kalcijev karbonat, manitol, mikrokristalna celuloza, hidroksipropilceluloza, hipromeloza, smukec.
There is no specific antidote for overdose with lenvatinib. 
Za prevelik odmerek lenvatiniba ni specifičnega antidota.
No adjustment of starting dose is required on the basis of hepatic function in patients with mild (ChildPugh A) or moderate (Child-Pugh B) hepatic impairment. 
Prilagoditev začetnega odmerka na podlagi jetrne funkcije pri bolnikih z blago (Child-Pugh A) ali zmerno (Child-Pugh B) okvaro jeter ni potrebna.
Arterial thromboembolisms 
Arterijske trombembolije
For previously normotensive subjects, monotherapy with one of the classes of antihypertensives should be started when elevated BP is observed. 
Pri predhodno normotenzivnih osebah je treba takrat, ko opazimo zvišan KT, začeti z monoterapijo z eno od skupin antihipertenzivnih zdravil.
It has been determined that plasma protein binding in plasma from renally impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed. 
Ugotovilo se je, da je v plazmi preiskovancev z okvaro ledvic vezava na plazemske beljakovine podobna vezavi pri ustreznih zdravih preiskovancih, odvisnost od koncentracije pa ni bila opažena.
The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhoea, fatigue, stomatitis, proteinuria, headache, and aggravation of PPE. 
Najpogosteje opaženi neželeni učinki zdravila pri teh odmerkih so bili hipertenzija, navzea, driska, utrujenost, stomatitis, proteinurija, glavobol in poslabšanje PPE.
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 
Najpogostejši neželeni učinki (pojavljajo se pri ≥ 30 % bolnikov) so hipertenzija (44,0 %), driska (38,1 %), zmanjšan apetit (34,9 %), utrujenost (30,6 %) in hujšanje (30,4 %).
• changes in blood test results for potassium levels (low) and calcium levels (low) 
• spremembe rezultatov krvnih preiskav kalija (znižan) in kalcija (znižan),
Hazard ratio (95% CI)b, e P-value b, e 
razmerje tveganja (95 % IZ)b, e vrednost P b, e
Table 2 Dose modifications from recommended lenvatinib daily dose in HCC patients Starting Dose 
Preglednica 2 Spremembe odmerka od priporočenega dnevnega odmerka lenvatiniba pri bolnikih s HCC
Hepatic encephalopathy includes: hepatic encephalopathy, coma hepatic, metabolic encephalopathy and encephalopathy. 
Jetrna encefalopatija vključuje: jetrno encefalopatijo, hepatično komo, presnovno encefalopatijo in encefalopatijo.
• changes in blood test results for kidney function and kidney failure 
• spremembe rezultatov krvnih preiskav delovanja ledvic in odpoved ledvic,
Talk to your doctor before taking LENVIMA if you: 
Pred začetkom jemanja zdravila LENVIMA se posvetujte z zdravnikom, če:
Renal failure and impairment 
Ledvična odpoved in okvara
Renal failure cases includes: acute prerenal failure, renal failure, renal failure acute, acute kidney injury and renal tubular necrosis. 
Primeri odpovedi ledvic vključujejo: akutno prerenalno odpoved, odpoved ledvic, akutno odpoved ledvic, akutno poškodbo ledvic in ledvično tubulno nekrozo.
Lenvatinib dose interruption due to hypocalcaemia occurred in one subject (0.2%) and there were no dose reductions or discontinuations. 
Hipokalciemija je pri 1 bolniku (0,2 %) povzročila prekinitev odmerjanja, primerov zmanjšanja odmerka ali trajne ukinitve pa ni bilo.
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). 
Podatkov pri bolnikih s HCC z zmerno jetrno okvaro (Child-Pugh B) je zelo malo, podatkov pri bolnikih s HCC s hudo jetrno okvaro (Child-Pugh C) pa trenutno ni.
Patients should be monitored for clinical symptoms or signs of cardiac decompensation, as dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2). 
Bolnike je treba spremljati glede kliničnih simptomov ali znakov dekompenzacije srca, ker bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
No significant drug-drug interaction is therefore expected between lenvatinib and other CYP3A4/Pgp substrates. 
Zato med lenvatinibom in drugimi substrati CYP3A/Pgp ni pričakovati pomembnega medsebojnega delovanja.
If you take more LENVIMA than you should, talk to a doctor or pharmacist straight away. 
Če ste vzeli večji odmerek zdravila LENVIMA, kot bi smeli Če vzamete več zdravila LENVIMA, kot bi smeli, se nemudoma posvetujte z zdravnikom ali s farmacevtom.
LENVIMA is not recommended for use in children and adolescents. 
Pri otrocih in mladostnikih uporaba zdravila LENVIMA ni priporočljiva.
• redness, soreness and swelling of the skin on the hands and feet (hand-foot syndrome) 
• rdečina, občutljivost in otekanje kože dlani in stopal (sindrom roka-noga),
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. 
Podobno predpostavljajo, da mehanizem delovanja za proteinurijo izhaja iz zmanjšanja koncentracij VEGFR1 in VEGFR2 v podocitih glomerula.
Gastrointestinal and abdominal pain includes: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, epigastric discomfort, and gastrointestinal pain. 
Gastrointestinalna in abdominalna bolečina vključuje: neugodje v trebuhu, bolečino v trebuhu, bolečino v spodnjem delu trebuha, bolečino v zgornjem delu trebuha, občutljivost trebuha, epigastrično neugodje in gastrointestinalno bolečino.
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. 
Mediana trajanja zdravljenja je bila 5,3 meseca (1. kvartil: 2,9; 3. kvartil: 11,1) v kraku z lenvatinibom in 3,7 meseca (1. kvartil: 1,8; 3. kvartil: 7,4) v kraku s sorafenibom.
How to take LENVIMA 
Kako jemati zdravilo LENVIMA
In total, 954 patients were randomised 1:1 to receive either lenvatinib (12 mg [baseline body weight ≥60 kg] or 8 mg [baseline body weight <60 kg]) given orally once daily or sorafenib 400 mg given orally twice daily. 
Skupno je bilo 954 bolnikov randomiziranih v razmerju 1:1 na prejemanje lenvatiniba (12 mg [izhodiščna telesna masa ≥ 60 kg] ali 8 mg [izhodiščna telesna masa < 60 kg]), ki so ga prejemali peroralno enkrat na dan, ali 400 mg sorafeniba, ki so prejemali peroralno dvakrat na dan.
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). 
Podatkov pri bolnikih s HCC s Child-Pugh B (zmerna jetrna okvara, 3 bolniki, zdravljeni z zdravilom Lenvima v ključnem preskušanju) je premalo, podatkov pri bolnikih s HCC s Child-Pugh C (huda jetrna okvara) pa ni na voljo.
After drinking, add the same amount of water or apple juice, swirl and swallow. 
Potem v kozarec dodajte enako količino vode ali jabolčnega soka, tekočino vrtinčite in spijte.
In patients, the median apparent volume of distribution (Vz/F) of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg. 
Pri bolnikih je mediani navidezni porazdelitveni volumen (Vz/F) prvega odmerka segal od 50,5 l do 92 l in je bil na splošno skladen v skupinah odmerkov od 3,2 mg do 32 mg. Analogni mediani navidezni porazdelitveni volumen v stanju dinamičnega ravnovesja (Vz/Fss) je bil tudi na splošno skladen in je segal od 43,2 l do 121 l.
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. 
Med zdravljenjem z lenvatinibom je mediano OS znašalo 19,5 mesecev (95-odstotni IZ: 15,7; 23,0) za bolnike, ki so po zdravljenju prejeli onkološko terapijo (43 %), in 10,5 mesecev (95-odstotni IZ: 8,6; 12,2) pri tistih, ki je niso.
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 
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 (glejte poglavje 4.6).
QT interval prolongation (see section 4.4) 
Podaljšanje intervala QT (glejte poglavje 4.4)
Renal failure and impairment (see section 4.4) 
Ledvična odpoved in okvara (glejte poglavje 4.4)
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 . 
Pri bolnikih s HCC, zdravljenih z lenvatinibom v preskušanju REFLECT, so poročali o večji pogostnosti neželenih učinkov, povezanih z jetri, vključno z jetrno encefalopatijo in odpovedjo jeter (vključno z učinki s smrtnim izidom) (glejte poglavje 4.8) v primerjavi z bolniki, zdravljenimi s sorafenibom.
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%). 
Neželeni učinki, o katerih najpogosteje poročajo (pojavljajo se pri ≥ 30 % bolnikov), so hipertenzija (68,6 %), driska (62,8 %), zmanjšan apetit (51,5 %), hujšanje (49,1 %), utrujenost (45,8 %), navzea (44,5 %), proteinurija (36,9 %), stomatitis (35,8 %), bruhanje (34,5 %), disfonija (34,1 %), glavobol (34,1 %) in sindrom palmarno-plantarne eritrodizestezije (PPE) (32,7 %).
Women of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with lenvatinib and for at least one month after finishing treatment. 
Ženske v rodni dobi naj med zdravljenjem z lenvatinibom in še vsaj en mesec po končanem zdravljenju ne zanosijo in naj uporabljajo zelo učinkovito kontracepcijo.
The median time to onset in lenvatinib-treated patients was 16 days. 
Mediani čas do nastopa pri bolnikih, zdravljenih z lenvatinibom, je bil 16 dni.
Gastrointestinal perforation and fistula formation (see section 4.4) 
Gastrointestinalna perforacija in nastanek fistule (glejte poglavje 4.4)
Patients who had received 0 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI) 
Bolniki, ki so prejeli 0 predhodnih zdravljenj, usmerjenih v VEGF/VEGFR (%) število napredovanj ali smrti mediano PFS v mesecih (95 % IZ)
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). 
zdravljenje ali terapijo) navzee, bruhanja in driske; toksičnost za prebavila je treba zdraviti aktivno, da se zmanjša tveganje razvoja ledvične okvare ali odpovedi (glejte poglavje 4.4, Ledvična odpoved in okvara).
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). 
Farmakokinetiko lenvatiniba po enkratnem 10-miligramskem odmerku so ovrednotili pri 6 preiskovancih z blago in 6 preiskovancih z zmerno okvaro jeter (Child-Pugh A oziroma Child-Pugh B).
• Prior treatments: hepatectomy (28%), radiotherapy (11%), loco-regional therapies including transarterial (chemo)embolisation (52%), radiofrequency ablation (21%) and percutaneous ethanol injection (4%) 
• predhodne terapije: hepatektomija (28 %), radioterapija (11 %), lokoregionalna terapija,
Lenvatinib may adversely affect the wound healing process as for other agents of the same class. 
Lenvatinib, tako kot druga zdravila iste skupine, lahko neugodno vpliva na proces celjenja ran.
Hazard ratio (99% CI)b,c P-valueb 
razmerje tveganja (99 % IZ)b,c vrednost Pb
Close monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2). 
Pri bolnikih z blago ali zmerno jetrno okvaro je priporočljivo natančno spremljanje celotne varnosti (glejte tudi poglavji 4.2 in 5.2).
Non-Gastrointestinal fistulae (see section 4.4) 
Ne-gastrointestinalne fistule (glejte poglavje 4.4)
Renal failure cases n, † 
primeri odpovedi ledvicn,†
≥60 kg BW 12 mg (three 4 mg capsules orally once daily) 
≥ 60 kg TM 12 mg (tri 4 mg kapsule peroralno enkrat na dan)
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) 
razmerje tveganja (95 % IZ)b,c Objektivna odzivnosta število objektivnih odzivov (%) (95 % IZ) vrednost Pb število popolnih odzivov število delnih odzivov mediani čas do objektivnega odziva,d meseci (95 %
In the Phase 3 REFLECT trial (see section 5.1), QT/QTc interval prolongation was reported in 6.9% of lenvatinib-treated patients. 
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o podaljšanju intervala QT/QTc pri 6,9 % bolnikov, zdravljenih z lenvatinibom.
Limited data are available on use in patients from ethnic origins other than Caucasian or Asian (see also section 4.8, Other special populations). 
O uporabi pri bolnikih, ki ne pripadajo beli ali azijski rasi, je na voljo malo podatkov (glejte tudi poglavje 4.8, Druge posebne skupine bolnikov).
However, testicular and ovarian toxicity has been observed in rats, dogs, and monkeys (see section 5.3). 
Vendar so pri podganah, psih in opicah opazili toksičnost za moda in jajčnike (glejte poglavje 5.3).
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1002/001 (Pack size of 30 hard capsules) EU/1/15/1002/003 (Pack size of 60 hard capsules) EU/1/15/1002/004 (Pack size of 90 hard capsules) 13. 
EU/1/15/1002/001 (pakiranje 30 trdih kapsul) EU/1/15/1002/003 (pakiranje 60 trdih kapsul) EU/1/15/1002/004 (pakiranje 90 trdih kapsul)
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. 
V kraku s sorafenibom je mediano OS znašalo 17,0 mesecev (95-odstotni IZ: 14,2; 18,8) pri osebah, ki so po zdravljenju prejele onkološko terapijo (51 %) in 7,9 mesecev (95-odstotni IZ: 6,6; 9,7) pri tistih, ki ga niso.
• inflammation of the gallbladder 
• vnetje žolčnika,
QT/QTc interval prolongation has been reported at a higher incidence in patients treated with lenvatinib than in patients treated with placebo (see section 4.8, Description of selected adverse reactions). 
O podaljšanju intervala QT/QTc so pogosteje poročali pri bolnikih, zdravljenih z lenvatinibom, kot pri bolnikih, ki so prejemali placebo (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
Elevated transaminase levels asociated with signs of hepatotoxicity, were also observed in rats, dogs and monkeys. 
Pri podganah, psih in opicah so opazili tudi zvišane ravni transaminaz, povezane z znaki hepatotoksičnosti.
Liverrelated reactions led to dose interruptions and reductions in 4.6% and 2.7% of patients, respectively, and to permanent discontinuation in 0.4%. 
Z jetri povezani neželeni učinki so povzročili prekinitev oziroma zmanjšanje odmerjanja pri 4,6 % oziroma 2,7 % bolnikov, trajno ukinitev pa pri 0,4 %.
The median duration of objective response was 7.3 (95% CI 5.6, 7.4) months in the lenvatinib arm and 6.2 (95% CI 3.7, 11.2) months in the sorafenib arm. 
Mediano trajanje objektivnega odziva v kraku z lenvatinibom je bilo 7,3 (95-odstotni IZ 5,6; 7,4) mesecev, v kraku s sorafenibom pa 6,2 (95-odstotni IZ 3,7; 11,2) mesecev.
Hypomagnesaemia includes hypomagnesaemia and decreased blood magnesium. 
Hipomagneziemija vključuje hipomagneziemijo in znižan magnezij v krvi.
Reactions of Grade 3 or higher (including 1 reaction of Grade 4) occurred in 44.4% of lenvatinib-treated patients compared with 3.8% of placebo-treated patients. 
Neželeni učinek stopnje 3 ali višje stopnje (vključno z 1 primerom stopnje 4) se je pojavil pri 44,4 % bolnikov, zdravljenih z lenvatinibom, in pri 3,8 % bolnikov, ki so prejemali placebo.