FrancophonIA/ELRC3.0 huggingface dataset:
English: There are not sufficient data for HCC patients with Child-Pugh B (moderate hepatic impairment, 3 patients treated with lenvima in the pivotal trial) and no data available in Child Pugh C HCC patients (severe hepatic impairment).
Slovenian: 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.
English: After drinking, add the same amount of water or apple juice, swirl and swallow.
Slovenian: Potem v kozarec dodajte enako količino vode ali jabolčnega soka, tekočino vrtinčite in spijte.
English: 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.
Slovenian: 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.
English: In the lenvatinib arm, median OS was 19.5 months (95% CI: 15.7, 23.0) for subjects who received post-treatment anticancer therapy (43%) and 10.5 months (95% CI: 8.6, 12.2) for those who did not.
Slovenian: 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.
English: It is currently unknown whether lenvatinib may reduce the effectiveness of hormonal contraceptives, and therefore women using oral hormonal contraceptives should add a barrier method (see section
Slovenian: 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).
English: QT interval prolongation (see section 4.4)
Slovenian: Podaljšanje intervala QT (glejte poglavje 4.4)
English: Renal failure and impairment (see section 4.4)
Slovenian: Ledvična odpoved in okvara (glejte poglavje 4.4)
English: In HCC patients treated with lenvatinib in the REFLECT trial, liver-related adverse reactions including hepatic encephalopathy and hepatic failure (including fatal reactions) were reported at a higher frequency (see Section 4.8) compared to patients treated with sorafenib .
Slovenian: 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.
English: The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (68.6%), diarrhoea (62.8%), decreased appetite (51.5%), decreased weight (49.1%), fatigue (45.8%), nausea (44.5%), proteinuria 36.9%), stomatitis (35.8%), vomiting (34.5%), dysphonia (34.1%), headache (34.1%), and palmar-plantar erythrodysaesthesia syndrome (PPE) (32.7%).
Slovenian: 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 %).
English: 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.
Slovenian: 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.
English: The median time to onset in lenvatinib-treated patients was 16 days.
Slovenian: Mediani čas do nastopa pri bolnikih, zdravljenih z lenvatinibom, je bil 16 dni.
English: Gastrointestinal perforation and fistula formation (see section 4.4)
Slovenian: Gastrointestinalna perforacija in nastanek fistule (glejte poglavje 4.4)
English: Patients who had received 0 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
Slovenian: Bolniki, ki so prejeli 0 predhodnih zdravljenj, usmerjenih v VEGF/VEGFR (%) število napredovanj ali smrti mediano PFS v mesecih (95 % IZ)
English: 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).
Slovenian: 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).
English: The pharmacokinetics of lenvatinib following a single 10-mg dose were evaluated in 6 subjects each with mild and moderate hepatic impairment (Child-Pugh A and Child-Pugh B, respectively).
Slovenian: 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).
English: • Prior treatments: hepatectomy (28%), radiotherapy (11%), loco-regional therapies including transarterial (chemo)embolisation (52%), radiofrequency ablation (21%) and percutaneous ethanol injection (4%)
Slovenian: • predhodne terapije: hepatektomija (28 %), radioterapija (11 %), lokoregionalna terapija,
English: Lenvatinib may adversely affect the wound healing process as for other agents of the same class.
Slovenian: Lenvatinib, tako kot druga zdravila iste skupine, lahko neugodno vpliva na proces celjenja ran.
English: Hazard ratio (99% CI)b,c P-valueb
Slovenian: razmerje tveganja (99 % IZ)b,c vrednost Pb
English: Close monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
Slovenian: Pri bolnikih z blago ali zmerno jetrno okvaro je priporočljivo natančno spremljanje celotne varnosti (glejte tudi poglavji 4.2 in 5.2).
English: Non-Gastrointestinal fistulae (see section 4.4)
Slovenian: Ne-gastrointestinalne fistule (glejte poglavje 4.4)
English: Renal failure cases n, †
Slovenian: primeri odpovedi ledvicn,†
English: ≥60 kg BW 12 mg (three 4 mg capsules orally once daily)
Slovenian: ≥ 60 kg TM 12 mg (tri 4 mg kapsule peroralno enkrat na dan)
English: Number of complete responses Number of partial responses Median time to objective response,d months (95% CI) Duration of response,d months, median (95% CI)
Slovenian: 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 %
English: In the Phase 3 REFLECT trial (see section 5.1), QT/QTc interval prolongation was reported in 6.9% of lenvatinib-treated patients.
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o podaljšanju intervala QT/QTc pri 6,9 % bolnikov, zdravljenih z lenvatinibom.
English: Limited data are available on use in patients from ethnic origins other than Caucasian or Asian (see also section 4.8, Other special populations).
Slovenian: 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).
English: However, testicular and ovarian toxicity has been observed in rats, dogs, and monkeys (see section 5.3).
Slovenian: Vendar so pri podganah, psih in opicah opazili toksičnost za moda in jajčnike (glejte poglavje 5.3).
English: 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.
Slovenian: 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)
English: In the sorafenib arm, median OS was 17.0 months (95% CI: 14.2, 18.8) for subjects who received posttreatment anticancer therapy (51%) and 7.9 months (95% CI: 6.6, 9.7) for those who did not.
Slovenian: 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.
English: • inflammation of the gallbladder
Slovenian: • vnetje žolčnika,
English: 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).
Slovenian: 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).
English: Elevated transaminase levels asociated with signs of hepatotoxicity, were also observed in rats, dogs and monkeys.
Slovenian: Pri podganah, psih in opicah so opazili tudi zvišane ravni transaminaz, povezane z znaki hepatotoksičnosti.
English: Liverrelated reactions led to dose interruptions and reductions in 4.6% and 2.7% of patients, respectively, and to permanent discontinuation in 0.4%.
Slovenian: Z jetri povezani neželeni učinki so povzročili prekinitev oziroma zmanjšanje odmerjanja pri 4,6 % oziroma 2,7 % bolnikov, trajno ukinitev pa pri 0,4 %.
English: 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.
Slovenian: 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.
English: Hypomagnesaemia includes hypomagnesaemia and decreased blood magnesium.
Slovenian: Hipomagneziemija vključuje hipomagneziemijo in znižan magnezij v krvi.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Dogodek s krvavitvijo je pri bolnikih povzročili prekinitev oziroma zmanjšanje odmerjanja pri 3,2 % oziroma 0,8 % bolnikov, trajno ukinitev pa pri 1,7 %.
English: • Common
Slovenian: • pogosti
English: Patients with baseline renal impairment had a higher incidence of fatigue, hypothyroidism, dehydration, diarrhoea, decreased appetite, proteinuria and hepatic encephalopathy.
Slovenian: Bolniki z izhodiščno okvaro ledvic so imeli večjo incidenco utrujenosti, hipotiroidizma, dehidracije, driske, zmanjšanega apetita, proteinurije in jetrne encefalopatije.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 20 mg orally once daily Two 10mg capsules
Slovenian: 20 mg peroralno enkrat na dan dve 10 mg kapsuli
English: The capsule shell contains hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Slovenian: Ovojnica kapsule vsebuje hipromelozo, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
English: Severe (e.g., Grade 3) or intolerable adverse reactions require interruption of lenvatinib until improvement of the reaction to Grade 0-1 or baseline.
Slovenian: 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.
English: • Do not breast-feed if you are taking LENVIMA.
Slovenian: • Ne dojite, če jemljete zdravilo LENVIMA.
English: Cases of nephrotic syndrome have been reported in patients using lenvatinib.
Slovenian: Pri bolnikih, ki so uporabljali lenvatinib, so poročali o primerih nefrotičnega sindroma.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Adverse reactions that most commonly led to dose reductions (in ≥5% of patients) were hypertension, proteinuria, diarrhoea, fatigue, PPE, decreased weight, and decreased appetite.
Slovenian: Neželeni učinki, ki so najpogosteje povzročili zmanjšanje odmerka (pri ≥ 5 % bolnikov), so bili hipertenzija, proteinurija, driska, utrujenost, PPE, hujšanje in zmanjšan apetit.
English: How LENVIMA works
Slovenian: Kako zdravilo LENVIMA deluje
English: Cardiac dysfunction (see section 4.4)
Slovenian: Disfunkcija srca (glejte poglavje 4.4)
English: Grade 3 reactions occurred in 10.7% of lenvatinib-treated patients and none in placebotreated patients.
Slovenian: Neželeni učinek stopnje 3 se je pojavil pri 10,7 % bolnikov, zdravljenih z lenvatinibom, in pri nobenem od bolnikov, ki so prejemali placebo.
English: 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.
Slovenian: 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.
English: Grade 3 (despite optimal antihypertensive therapy)
Slovenian: Ukrepanje Zmanjšajte odmerek in spet začnite zdravljenje z lenvatinibom hipertenzija stopnja 3 (kljub optimalnemu antihipertenzivnemu zdravljenju)
English: • severe pain in the upper left part of the belly (abdomen) which may be associated with fever,
Slovenian: • močna bolečina v zgornjem levem delu trebuha (abdomna), ki je lahko povezana z zvišano telesno temperaturo, mrzlico, navzeo in bruhanjem (infarkt vranice),
English: • Not known
Slovenian: • neznana pogostnost
English: Increased alanine aminotransferase ‡
Slovenian: hipoalbuminemija j, ‡ zvišana alaninaminotransferaza ‡ zvišana aspartataminotransferaza ‡
English: 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%).
Slovenian: 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 %).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA KARTONASTA ŠKATLA
English: Gastrointestinal perforation or fistulae have been reported in patients treated with lenvatinib (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z lenvatinibom, so poročali o gastrointestinalni perforaciji ali fistulah (glejte poglavje 4.8).
English: 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%).
Slovenian: 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 %)).
English: Resolves to <480 ms or baseline
Slovenian: Izboljša se na < 480 ms ali v izhodišče driska stopnja 3
English: Patients of age ≥75 years were more likely to experience hypertension, proteinuria, decreased appetite, asthenia, dehydration, dizziness, malaise, peripheral oedema, pruritus and hepatic encephalopathy.
Slovenian: Pri bolnikih, starih ≥ 75 let, so bile verjetnejše hipertenzija, proteinurija, zmanjšan apetit, astenija, dehidracija, omotica, splošno slabo počutje, periferni edem, pruritus in jetrna encefalopatija.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Hypertension and proteinuria tend to occur early during lenvatinib treatment (see sections 4.4 and 4.8, Description of selected adverse reactions).
Slovenian: Hipertenzija in proteinurija se navadno pojavita kmalu po začetku zdravljenja z lenvatinibom (glejte poglavji 4.4 in 4.8, Opis izbranih neželenih učinkov).
English: 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%).
Slovenian: 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 %).
English: Resolves to less than 2 g / 24 hours.
Slovenian: Izboljša se na manj kot 2 g/24 ur nefrotični sindrom ------
English: In the Phase 3 REFLECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group.
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) je bil en dogodek PRES (stopnje 2) v skupini, zdravljeni z lenvatinibom.
English: Cardiac dysfunction Grade 3
Slovenian: Zdravljenja ne začnite znova disfunkcija srca stopnja 3
English: Excluding laboratory abnormalities judged to be nonlife-threatening, which should be managed as Grade 3.
Slovenian: Razen pri nepravilnostih laboratorijskih vrednosti, za katere sodimo, da niso življenjsko nevarne, ki jih lahko obravnavamo kot resne neželene učinke stopnje 3.
English: The printing ink contains shellac, black iron oxide (E172), potassium hydroxide, propylene glycol.
Slovenian: Tiskarsko črnilo vsebuje šelak, črni železov oksid (E172), kalijev hidroksid, propilenglikol.
English: Adverse reactions that most commonly led to discontinuation of lenvatinib were hepatic encephalopathy, fatigue, increased blood bilirubin, proteinuria and hepatic failure.
Slovenian: Neželeni učinki, ki so najpogosteje privedli do ukinitve zdravljenja z lenvatinibom, so bila jetrna encefalopatija, utrujenost, povečan bilirubin v krvi, proteinurija in jetrna odpoved.
English: Progression-Free Survival (PFS)a Number of progressions or deaths (%) Median PFS in months (95% CI)
Slovenian: Preživetje brez napredovanja bolezni (PFS)a število napredovanj ali smrti (%) mediano PFS v mesecih (95 % IZ)
English: Asian patients had a higher incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, thrombocytopenia, and increased blood thyroid stimulating hormone.
Slovenian: Bolniki azijske rase so imeli večjo incidenco perifernih edemov, hipertenzije, utrujenosti, PPE, proteinurije, trombocitopenije in zvišanega tirotropnega hormona v krvi kot bolniki bele rase.