natgillin/translations-raw huggingface dataset:
A haemorrhage event led to dose interruption or reduction in 3.2% and 0.8% patients respectively and to treatment discontinuation in 1.7% of patients. 
Dogodek s krvavitvijo je pri bolnikih povzročili prekinitev oziroma zmanjšanje odmerjanja pri 3,2 % oziroma 0,8 % bolnikov, trajno ukinitev pa pri 1,7 %.
• Common 
• pogosti
Patients with baseline renal impairment had a higher incidence of fatigue, hypothyroidism, dehydration, diarrhoea, decreased appetite, proteinuria and hepatic encephalopathy. 
Bolniki z izhodiščno okvaro ledvic so imeli večjo incidenco utrujenosti, hipotiroidizma, dehidracije, driske, zmanjšanega apetita, proteinurije in jetrne encefalopatije.
Patients with baseline hepatic impairment had a higher incidence of hypertension and PPE, and a higher incidence of Grade 3 or 4 hypertension, asthenia, fatigue, and hypocalcaemia compared with patients with normal hepatic function. 
Bolniki z izhodiščno okvaro jeter so imeli večjo incidenco hipertenzije in PPE in večjo incidenco hipertenzije, astenije, utrujenosti in hipokalciemije stopnje 3 ali 4 kot bolniki z normalno funkcijo jeter.
Grade 3 reactions occurred in 3.4%, Grade 4 reactions in 0.2% and 7 patients (1.5%) had a grade 5 reaction including cerebral haemorrhage, upper gastrointestinal haemorrhage, intestinal haemorrhage and tumour haemorrhage. 
Neželeni učinki stopnje 3 so se pojaviji pri 3,4 %, stopnje 4 pri 0,2 %, 7 bolnikov (1,5 %) pa je imelo reakcijo stopnje 5, vključno z možgansko krvavitvijo, krvavitvijo iz zgornjih prebavil, krvavitvijo iz črevesja in krvavitvijo iz tumorja.
20 mg orally once daily Two 10mg capsules 
20 mg peroralno enkrat na dan dve 10 mg kapsuli
The capsule shell contains hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172). 
Ovojnica kapsule vsebuje hipromelozo, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
Severe (e.g., Grade 3) or intolerable adverse reactions require interruption of lenvatinib until improvement of the reaction to Grade 0-1 or baseline. 
Ob hudih neželenih učinkih (npr. stopnje 3) ali neželenih učinkih, ki jih bolnik ne more prenašati, je potrebna prekinitev odmerjanja lenvatiniba do izboljšanja neželenega učinka na stopnjo 0-1 ali na izhodiščno stanje.
• Do not breast-feed if you are taking LENVIMA. 
• Ne dojite, če jemljete zdravilo LENVIMA.
Cases of nephrotic syndrome have been reported in patients using lenvatinib. 
Pri bolnikih, ki so uporabljali lenvatinib, so poročali o primerih nefrotičnega sindroma.
In the pivotal Phase 3 SELECT trial (see section 5.1), hypertension (including hypertension, hypertensive crisis, increased diastolic blood pressure , and increased blood pressure) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group. 
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o hipertenziji (vključno s hipertenzijo, hipertenzivno krizo, zvišanim diastoličnim krvnim tlakom in zvišanim krvnim tlakom) pri 72,8 % bolnikov, zdravljenih z lenvatinibom, in pri 16,0 % bolnikov, ki so prejemali placebo.
Patients with baseline hypertension had a higher incidence of Grade 3 or 4 hypertension, proteinuria, diarrhoea, and dehydration, and experienced more serious cases of dehydration, hypotension, pulmonary embolism, malignant pleural effusion, atrial fibrillation, and GI symptoms (abdominal pain, diarrhoea, vomiting). 
Bolniki z izhodiščno hipertenzijo so imeli večjo incidenco hipertenzije, proteinurije, driske in dehidracije stopnje 3 ali 4, med njimi je bilo tudi več resnih primerov dehidracije, hipotenzije, pljučne embolije, malignega plevralnega izliva, atrijske fibrilacije in gastrointestinalnih simptomov (bolečina v trebuhu, driska, bruhanje).
Adverse reactions that most commonly led to dose reductions (in ≥5% of patients) were hypertension, proteinuria, diarrhoea, fatigue, PPE, decreased weight, and decreased appetite. 
Neželeni učinki, ki so najpogosteje povzročili zmanjšanje odmerka (pri ≥ 5 % bolnikov), so bili hipertenzija, proteinurija, driska, utrujenost, PPE, hujšanje in zmanjšan apetit.
How LENVIMA works 
Kako zdravilo LENVIMA deluje
Cardiac dysfunction (see section 4.4) 
Disfunkcija srca (glejte poglavje 4.4)
Grade 3 reactions occurred in 10.7% of lenvatinib-treated patients and none in placebotreated patients. 
Neželeni učinek stopnje 3 se je pojavil pri 10,7 % bolnikov, zdravljenih z lenvatinibom, in pri nobenem od bolnikov, ki so prejemali placebo.
In the Phase 3 REFLECT trial (see section 5.1), cardiac dysfunction (including congestive cardiac failure, cardiogenic shock, and cardiopulmonary failure) was reported in 0.6% of patients (0.4% were Grade ≥ 3) in the lenvatinib-treated group. 
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o srčni disfunkciji (vključno s kongestivnim srčnim popuščanjem, kardiogenim šokom in kardiopulmonalno odpovedjo) pri 0,6 % bolnikov (0,4 % jih je bilo stopnje ≥ 3) v skupini, zdravljeni z lenvatinibom.
Grade 3 (despite optimal antihypertensive therapy) 
Ukrepanje Zmanjšajte odmerek in spet začnite zdravljenje z lenvatinibom hipertenzija stopnja 3 (kljub optimalnemu antihipertenzivnemu zdravljenju)
• severe pain in the upper left part of the belly (abdomen) which may be associated with fever, 
• močna bolečina v zgornjem levem delu trebuha (abdomna), ki je lahko povezana z zvišano telesno temperaturo, mrzlico, navzeo in bruhanjem (infarkt vranice),
• Not known 
• neznana pogostnost
Increased alanine aminotransferase ‡ 
hipoalbuminemija j, ‡ zvišana alaninaminotransferaza ‡ zvišana aspartataminotransferaza ‡
In the Phase 3 REFLECT trial (see section 5.1), the most commonly reported hepatotoxicity adverse reactions were increased blood bilirubin (14.9%), increased aspartate aminotransferase (13.7%), increased alanine aminotransferase (11.1%), hypoalbuminaemia (9.2%), hepatic encephalopathy (8.0%), increased gamma-glutamyltransferase (7.8%) and increased blood alkaline phosphatase (6.7%). 
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so bili neželeni učinki, povezani s hepatotoksičnostjo, o katerih so najpogosteje poročali, zvišanje bilirubina v krvi (14,9 %), zvišanje aspartat-aminotransferaze (13,7 %), zvišanje alanin-aminotransferaze (11,1 %), hipoalbuminemija (9,2 %), jetrna encefalopatija (8,0 %), zvišanje gama-glutamiltransferaze (7,8 %) in zvišanje alkalne fosfataze v krvi (6,7 %).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA KARTONASTA ŠKATLA
Gastrointestinal perforation or fistulae have been reported in patients treated with lenvatinib (see section 4.8). 
Pri bolnikih, zdravljenih z lenvatinibom, so poročali o gastrointestinalni perforaciji ali fistulah (glejte poglavje 4.8).
The most important serious adverse reactions were renal failure and impairment (2.4%), arterial thromboembolisms (3.9%), cardiac failure (0.7%), intracranial tumour haemorrhage (0.7%), PRES / RPLS (0.2%), hepatic failure (0.2%), and arterial thromboembolisms (cerebrovascular accident (1.1%), transient ischaemic attack (0.7%), and myocardial infarction (0.9%). 
Najpomembnejši resni neželeni učinki so bili odpoved in okvara ledvic (2,4 %), arterijska trombembolija (3,9 %), popuščanje srca (0,7 %), krvavitev v znotrajlobanjski tumor (0,7 %), PRES/RPLS (0,2 %), odpoved jeter (0,2 %) in arterijske trombembolije (cerebrovaskularni insult (1,1 %), tranzitorna ishemična ataka (0,7 %) in miokardni infarkt (0,9 %)).
Resolves to <480 ms or baseline 
Izboljša se na < 480 ms ali v izhodišče driska stopnja 3
Patients of age ≥75 years were more likely to experience hypertension, proteinuria, decreased appetite, asthenia, dehydration, dizziness, malaise, peripheral oedema, pruritus and hepatic encephalopathy. 
Pri bolnikih, starih ≥ 75 let, so bile verjetnejše hipertenzija, proteinurija, zmanjšan apetit, astenija, dehidracija, omotica, splošno slabo počutje, periferni edem, pruritus in jetrna encefalopatija.
Asian patients had a higher incidence than Caucasian patients of proteinuria, decreased neutrophil count, decreased platelet count, decreased white blood count and PPE syndrome, while Caucasian patients had a higher incidence of fatigue, hepatic encephalopathy, acute kidney injury, anxiety, asthenia, nausea, thrombocytopenia and vomiting. 
Bolniki azijske rase so imeli večjo incidenco proteinurije, zmanjšanja števila nevtrofilcev, zmanjšanja števila trombocitov, zmanjšanja števila levkocitov in sindroma PPE kot bolniki bele rase, medtem ko so imeli bolniki bele rase večjo incidenco utrujenosti, jetrne encefalopatije, akutne poškodbe ledvic, tesnobe, astenije, siljenja na bruhanje, trombocitopenije in bruhanja.
In the pivotal Phase 3 SELECT trial (see section 5.1), the most commonly reported liver-related adverse reactions were hypoalbuminaemia (9.6% lenvatinib vs. 1.5% placebo) and elevations of liver enzyme levels, including increases in alanine aminotransferase (7.7% lenvatinib vs. 0 placebo), aspartate aminotransferase (6.9% lenvatinib vs. 1.5% placebo), and blood bilirubin (1.9% lenvatinib vs. 0 placebo). 
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so bili neželeni učinki, povezani z jetri, o katerih so najpogosteje poročali, hipoalbuminemija (9,6 % pri lenvatinibu in 1,5 % pri placebu) in zvišanja ravni jetrnih encimov, vključno z zvišanjem alanin-aminotransferaze (7,7 % pri lenvatinibu in 0 pri placebu), aspartat-aminotransferaze (6,9 % pri lenvatinibu in 1,5 % pri placebu) in bilirubina v krvi (1,9 % pri lenvatinibu in 0 pri placebu).
In the pivotal Phase 3 SELECT trial (see section 5.1), 5.0% of patients developed renal failure and 1.9% developed renal impairment (3.1% of patients had a Grade ≥ 3 event of renal failure or impairment). 
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) se je pri 5,0 % bolnikov razvila odpoved ledvic, pri 1,9 % pa okvara ledvic (3,1 % bolnikov je imelo dogodek odpovedi ali okvare ledvic stopnje ≥ 3).
Hypertension and proteinuria tend to occur early during lenvatinib treatment (see sections 4.4 and 4.8, Description of selected adverse reactions). 
Hipertenzija in proteinurija se navadno pojavita kmalu po začetku zdravljenja z lenvatinibom (glejte poglavji 4.4 in 4.8, Opis izbranih neželenih učinkov).
The most important serious adverse reactions were hepatic failure (2.8%), hepatic encephalopathy (4.6%), oesophageal varices haemorrhage (1.4%), cerebral haemorrhage (0.6%), arterial thromboembolic events (2.0%) including myocardial infarction (0.8%), cerebral infarction (0.4%) and cerebrovascular accident (0.4%) and renal failure/impairment events (1.4%). 
Najpomembnejši resni neželeni učinki so bili jetrna odpoved (2,8 %), jetrna encefalopatija (4,6 %), krvavitev iz ezofagealnih varic (1,4 %), možganska krvavitev (0,6 %), arterijski tromboembolični dogodki (2,0 %), vključno z miokardnim infarktom (0,8 %), cerebralni infarkt (0,4 %) in cerebrovaskularni insult (0,4 %) ter dogodki ledvične odpovedi/okvare (1,4 %).
Resolves to less than 2 g / 24 hours. 
Izboljša se na manj kot 2 g/24 ur nefrotični sindrom ------
In the Phase 3 REFLECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group. 
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) je bil en dogodek PRES (stopnje 2) v skupini, zdravljeni z lenvatinibom.
Cardiac dysfunction Grade 3 
Zdravljenja ne začnite znova disfunkcija srca stopnja 3
Excluding laboratory abnormalities judged to be nonlife-threatening, which should be managed as Grade 3. 
Razen pri nepravilnostih laboratorijskih vrednosti, za katere sodimo, da niso življenjsko nevarne, ki jih lahko obravnavamo kot resne neželene učinke stopnje 3.
The printing ink contains shellac, black iron oxide (E172), potassium hydroxide, propylene glycol. 
Tiskarsko črnilo vsebuje šelak, črni železov oksid (E172), kalijev hidroksid, propilenglikol.
Adverse reactions that most commonly led to discontinuation of lenvatinib were hepatic encephalopathy, fatigue, increased blood bilirubin, proteinuria and hepatic failure. 
Neželeni učinki, ki so najpogosteje privedli do ukinitve zdravljenja z lenvatinibom, so bila jetrna encefalopatija, utrujenost, povečan bilirubin v krvi, proteinurija in jetrna odpoved.
Progression-Free Survival (PFS)a Number of progressions or deaths (%) Median PFS in months (95% CI) 
Preživetje brez napredovanja bolezni (PFS)a število napredovanj ali smrti (%) mediano PFS v mesecih (95 % IZ)
Asian patients had a higher incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, thrombocytopenia, and increased blood thyroid stimulating hormone. 
Bolniki azijske rase so imeli večjo incidenco perifernih edemov, hipertenzije, utrujenosti, PPE, proteinurije, trombocitopenije in zvišanega tirotropnega hormona v krvi kot bolniki bele rase.
One subject (0.2%) discontinued lenvatinib due to hypertension. 
Pri 1 bolniku (0,2 %) je hipertenzija povzročila trajno ukinitev zdravljenja z lenvatinibom.
In the pivotal Phase 3 SELECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group and no reports in the placebo group. 
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) je bil en dogodek PRES (stopnje 2) v skupini, zdravljeni z lenvatinibom, v skupini s placebom pa niso poročali o nobenem primeru.
<60 kg BW 8 mg (two 4 mg capsules orally once daily) 
< 60 kg TM 8 mg (dve 4 mg kapsuli peroralno enkrat na dan)
Capsule shell Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172) 
Ovojnica kapsule hipromeloza, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
Liver cancer 
Rak ščitnice
Patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration. 
Pri bolnikih, starih ≥ 75 let, so bile verjetnejše hipertenzija, proteinurija, zmanjšan apetit in dehidracija stopnje 3 ali 4.
Management of adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy (see section 4.4). 
Zaradi obvladovanja neželenih učinkov utegnejo biti potrebne prekinitev odmerjanja, prilagoditev odmerka ali ukinitev zdravljenja z lenvatinibom (glejte poglavje 4.4).
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). 
V kliničnih preskušanjih in izkušnjah po prihodu zdravila na trg so opazili primere nastanka ali zvečanja fistul, ki so zajeli druge dele telesa, ne želodca ali črevesja (npr. trahealne, traheo-ezofagealne, ezofagealne, kožne fistule in fistule ženskih spolovil).
Liver-related reactions of Grade 3 or higher (including 1 Grade 5 case of hepatic failure) occurred in 5.4% of lenvatinib-treated patients compared with 0.8% in placebo-treated patients. 
Z jetri povezani neželeni učinki stopnje 3 ali višje stopnje (vključno z 1 primerom odpovedi jeter stopnje 5) so nastopili pri 5,4 % bolnikov, zdravljenih z lenvatinibom, in pri 0,8 % bolnikov, ki so prejemali placebo.
In the pivotal Phase 3 SELECT trial (see section 5.1), QT/QTc interval prolongation was reported in 8.8% of lenvatinib-treated patients and 1.5% of patients in the placebo group. 
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o podaljšanju intervala QT/QTc pri 8,8 % bolnikov, zdravljenih z lenvatinibom, in pri 1,5 % bolnikov v skupini s placebom.
Grade 4 (despite medical management) 
Izboljša se na stopnjo 0-1 ali v izhodišče stopnja 4 (kljub medicinski obravnavi)
Hypothyroidism Increased blood thyroid stimulating hormone ‡ 
Bolezni endokrinega sistema hipotiroidizem zvišan tirotropni hormon v krvi‡
If urine dipstick proteinuria ≥2+ is detected, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2). 
Če z urinskim testnim lističem odkrijemo proteinurijo ≥ 2+, bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
In the Phase 3 -REFLECT trial (see section 5.1), hypertension (including hypertension, increased blood pressure, increased diastolic blood pressure and orthostatic hypertension) was reported in 44.5% of lenvatinib-treated patients and Grade 3 hypertension occurred in 23.5%. 
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o hipertenziji (vključno s hipertenzijo, zvišanim krvnim tlakom, zvišanim diastoličnim krvnim tlakom in ortostatsko hipertenzijo) pri 44,5 % bolnikov, zdravljenih z lenvatinibom.
LENVIMA 
Driska
Lenvatinib should be discontinued following an arterial thrombotic event. 
Po arterijskem trombotičnem dogodku je treba lenvatinib ukiniti.
Reactions that occurred at an incidence of ≥ 0.75% above placebo were: epistaxis (11.9%), haematuria (6.5%), contusion (4.6%), gingival bleeding (2.3%), haematochezia (2.3%), rectal haemorrhage (1.5%), haematoma (1.1%), haemorrhoidal haemorrhage (1.1%), laryngeal haemorrhage (1.1%), petechiae (1.1%), and intracranial tumour haemorrhage (0.8%). 
Neželeni učinki, ki so se pojavili z incidenco, za ≥ 0,75 % večjo kot pri placebu, so bili: epistaksa (11,9 %), hematurija (6,5 %), kontuzija (4,6 %), gingivalna krvavitev (2,3 %), hematohezija (2,3 %), rektalna krvavitev (1,5 %), hematom (1,1 %), krvavitev iz hemoroidov (1,1 %), laringealna krvavitev (1,1 %), petehije (1,1 %) in krvavitev v znotrajlobanjski tumor (0,8 %).
In the Phase 3 REFLECT trial (see section 5.1), haemorrhage was reported in 24.6% of patients and 5.0% were Grade ≥ 3. 
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o krvavitvah pri 24,6 %, in 5,0 % jih je bilo stopnje ≥ 3.
The available data do not allow for a dosing recommendation for patients with HCC and severe renal impairment. 
Razpoložljivi podatki pri bolnikih s HCC in hudo okvaro ledvic ne zadostujejo za priporočilo glede odmerjanja.
Adverse reactions that most commonly led to dose modifications (in ≥5% of patients) were decreased appetite, diarrhoea, proteinuria, hypertension, fatigue, PPE and decreased platelet count. 
Neželeni učinki, ki so najpogosteje privedli do sprememb odmerka (pri ≥ 5 % bolnikov), so bili zmanjšan apetit, driska, proteinurija, hipertenzija, utrujenost, PPE in zmanjšano število trombocitov.
LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules lenvatinib 
LENVIMA 4 mg trde kapsule LENVIMA 10 mg trde kapsule lenvatinib
Hazard ratioa, b (95% CI) 
Razmerje ogroženostia, b (95-odstotni IZ)
Patients with baseline renal impairment had a higher incidence of Grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, oedema peripheral, thrombocytopenia, dehydration, prolonged QT, hypothyroidism, hyponatraemia, increased blood thyroid stimulating hormone, pneumonia compared with subjects with normal renal function. 
Bolniki z izhodiščno okvaro ledvic so imeli večjo incidenco hipertenzije, proteinurije, utrujenosti, stomatitisa, perifernih edemov, trombocitopenije, dehidracije, podaljšanega intervala QT, hipotiroidizma, hiponatriemije, zvišanega tirotropnega hormona v krvi in pljučnice stopnje 3 ali 4 v primerjavi s preiskovanci z normalno funkcijo ledvic.
Across clinical studies in which 1,327 patients received lenvatinib monotherapy in indications other than HCC, Grade ≥ 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.2%) had a Grade 4 haemorrhage and 8 patients (0.6%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial haemorrhage, intracranial tumour haemorrhage, haematemesis, melaena, haemoptysis and tumour haemorrhage. 
Med 1166 bolniki, zdravljenimi z lenvatinibom v monoterapiji za druge indikacije kot HCC, so poročali o krvavitvi stopnje ≥ 3 ali višje stopnje pri 2 % bolnikov, 3 bolniki (0,2 %) so imeli krvavitve stopnje 4, 8 bolnikov (0,6 %) pa je imelo neželeni učinek stopnje 5, vključno z arterijsko krvavitvijo, hemoragično možgansko kapjo, znotrajlobansko krvavitvijo, krvavitvijo v znotrajlobanski tumor, hematemezo, meleno, hemoptizo in krvavitvijo v tumor.
In the Phase 3 REFLECT trial (see section 5.1), diarrhoea was reported in 38.7% of patients treated with lenvatinib (4.2% were Grade ≥ 3). 
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o driski pri 38,7 % bolnikov, zdravljenih z lenvatinibom (4,2 % jih je bilo stopnje ≥ 3).
The majority of cases recovered following dose interruption or reduction, which occurred in 3.6% and 3.4% of patients respectively. 
V večini primerov je prišlo do okrevanja po prekinitvi ali zmanjšanju odmerjanja, kar se je zgodilo pri 3,6 % oziroma 3,4 % bolnikov.
Adverse reactions that most commonly led to discontinuation of lenvatinib were proteinuria, asthenia, hypertension, cerebrovascular accident, diarrhoea, and pulmonary embolism. 
Neželeni učinki, ki so najpogosteje povzročili ukinitev lenvatiniba, so bili proteinurija, astenija, hipertenzija, cerebrovaskularni insult, driska in pljučna embolija.
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. 
V večini primerov je prišlo do ozdravitve ali okrevanja po prekinitvi ali zmanjšanju odmerka, kar se je zgodilo pri 16,9 % oziroma 10,7 % bolnikov.
In the pivotal Phase 3 SELECT trial (see section 5.1), decreased ejection fraction/cardiac failure was reported in 6.5% of patients (1.5% were Grade ≥ 3) in the lenvatinib treated group, and 2.3% in the placebo group (none were Grade ≥ 3). 
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o zmanjšani iztisni frakciji/popuščanju srca pri 6,5 % bolnikov (1,5 % jih je bilo stopnje ≥ 3) v skupini, zdravljeni z lenvatinibom, in pri 2,3 % v skupini s placebom (nobeden ni bil stopnje ≥ 3).
24 mg orally once daily Two 10 mg capsules plus one 4 mg capsule 
24 mg peroralno enkrat na dan dve 10 mg kapsuli in ena 4 mg kapsula
The majority of cases recovered following dose interruption or reduction, which occurred in 6.9% and 2.5% of patients respectively. 
V večini primerov je prišlo do okrevanja po prekinitvi ali zmanjšanju odmerka, kar se je zgodilo pri 6,9 % oziroma 2,5 % bolnikov.
• feeling sick and being sick, constipation, diarrhoea, abdominal pain, indigestion 
• slabost in bruhanje, zaprtje, driska, bolečina v trebuhu, prebavne motnje,
Table 3 Adverse reactions requiring dose modification of lenvatinib in DTC and HCC Adverse reaction Severity 
Preglednica 3 Neželeni učinki pri DTC in HCC, pri katerih je potrebna sprememba odmerka lenvatiniba Neželeni učinek Resnost
In the Phase 3 REFLECT trial (see section 5.1), events of gastrointestinal perforation or fistula were reported in 1.9% of lenvatinib-treated patients. 
V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o dogodkih gastrointestinalne perforacije ali fistule pri 1,9 % bolnikov, zdravljenih z lenvatinibom.
Quartiles are estimated by the Kaplan-Meier method, and the 95% CIs are estimated with a generalized Brookmeyer and Crowley method f. 
e Kvartili so ocenjeni s Kaplan-Meierjevo metodo; 95-odstotni IZ so bili ocenjeni s posplošeno
Interrupt until resolved to Grade 0-1 or baselined 
prekinite, dokler se ne izboljša na stopnjo 0-1 ali izhodiščed
Haemorrhage terms that occurred in 5 or more subjects with DTC were: epistaxis, haemoptysis, haematuria, contusion, haematochezia, gingival bleeding, petechial, pulmonary haemorrhage, rectal haemorrhage, blood urine present, haematoma and vaginal haemorrhage. 
Izrazi za krvavitev, ki so se pojavili pri 5 ali več preiskovancih z DTC, so bili: epistaksa, hemoptiza, hematurija, kontuzija, hematohezija, krvavitev iz dlesni, petehije, krvavitev v pljučih, rektalna krvavitev, prisotnost krvi v urinu, hematom in vaginalna krvavitev.
4 mg (one 4 mg capsule) orally every other day 
4 mg (ena 4 mg kapsula) peroralno vsak drugi dan
In the pivotal Phase 3 SELECT trial (see section 5.1), diarrhoea was reported in 67.4% of patients in the lenvatinib-treated group (9.2% were Grade ≥ 3) and in 16.8% of patients in the placebo group (none were Grade ≥ 3). 
V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o driski pri 67,4 % bolnikov v skupini, zdravljeni z lenvatinibom (9,2 % jih je bilo stopnje ≥ 3), in pri 16,8 % bolnikov v skupini s placebom (nobeden ni bil stopnje ≥ 3).