FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Lenvatinib ima blag vpliv na sposobnost vožnje in upravljanja s stroji, in to zaradi neželenih učinkov, kot sta utrujenost in omotica.
English: 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.
Slovenian: 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.
English: Plasma concentrations decline bi-exponentially following Cmax.
Slovenian: Koncentracije v plazmi se po Cmax zmanjšujejo bieksponencialno.
English: 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.
Slovenian: 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.
English: For haematologic toxicity, dosing can restart when resolved to Grade 2; proteinuria, resume when resolves to less than 2g/24 hours e.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Lenvatinib dose should be interrupted or dose adjusted as necessary depending on severity, presence of ECG changes, and persistence of hypocalcaemia.
Slovenian: Po potrebi je treba prekiniti odmerjanje lenvatiniba ali odmerek prilagoditi, odvisno od resnosti, prisotnosti sprememb EKG in trdovratnosti hipokalciemije.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: • 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)
Slovenian: • krvavitve (najpogosteje krvavitve iz nosu, lahko pa tudi druge vrste krvavitev, na primer kri v urinu, modrice, krvavitve iz dlesni ali črevesne stene),
English: Hepatic encephalopathy also occurred more frequently in patients aged 75 years and older.
Slovenian: Jetrna encefalopatija se je pogosteje pojavila pri bolnikih, starih 75 let ali več.
English: In vitro binding of lenvatinib to human plasma proteins is high and ranged from 98% to 99% (0.3 - 30 μg/mL, mesylate).
Slovenian: Vezava lenvatiniba na beljakovine humane plazme in vitro je velika, v razponu od 98 % do 99 % (0,3-30 μg/ml, mesilat).
English: Lenvatinib exhibited good oral bioavailability in dogs (70.4%) and monkeys (78.4%).
Slovenian: Lenvatinib je pokazal dobro peroralno biološko uporabnost pri psih (70,4 %) in opicah
English: • severe pain in your belly (abdomen) - this may be due to a hole in the wall of your gut or a fistula (a hole in your gut which links through a tube-like passage to another part of your body or skin).
Slovenian: • močna bolečina v trebuhu (abdomnu) - ta lahko nastane zaradi luknje v steni črevesa ali fistule (luknja v črevesu, ki je po cevastem prehodu povezana z drugim delom vašega telesa ali kožo);
English: Dose adjustments and Discontinuation for HCC
Slovenian: Prilagajanje odmerka in ukinitev pri HCC
English: Appropriate measures should be taken to control blood pressure (see section 4.4, Hypertension).
Slovenian: Uvesti je treba primerne ukrepe za obvladanje krvnega tlaka (glejte poglavje 4.4 Hipertenzija).
English: The primary risk factor identified was dehydration and/or hypovolemia due to gastrointestinal toxicity.
Slovenian: Ugotovili so, da je bil primarni dejavnik tveganja dehidracija in/ali hipovolemija zaradi toksičnosti za prebavila.
English: The hepatic failure cases were generally reported in patients with progressive metastatic liver metastases disease.
Slovenian: O primerih odpovedi jeter so na splošno poročali pri bolnikih s progresivno metastatsko jetrno boleznijo.
English: Polyamide/Aluminium/PVC/Aluminium blisters containing 10 capsules.
Slovenian: Pretisni omoti iz poliamida/aluminija/PVC/aluminija, ki vsebujejo po 10 kapsul.
English: Adverse reactions observed in clinical trials in DTC and HCC and reported from post-marketing use of lenvatinib are listed in Table 5.
Slovenian: Neželeni učinki, ki so jih ugotovili v kliničnih preskušanjih pri DTC in HCC ter o katerih so poročali pri uporabi lenvatiniba v obdobju trženja, so navedeni v preglednici 5.
English: Haematologic toxicity or proteinuria-no dose adjustment required for first occurrence.
Slovenian: Hematološka toksičnost ali proteinurija: pri prvem pojavu prilagajanje odmerka ni potrebno.
English: Manufacturer Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.
Slovenian: Proizvajalec Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, Velika Britanija.
English: • Caregivers should not open the capsules to avoid exposure to the contents of the capsule.
Slovenian: • Skrbniki bolnikov naj ne odpirajo kapsul, da ne bodo prišli v stik z vsebino kapsule.
English: Patients with end-stage renal disease were not studied, therefore the use of lenvatinib in these patients is not recommended.
Slovenian: Bolnikov z boleznijo ledvic v končnem stadiju niso proučevali, zato uporaba lenvatiniba pri teh bolnikih ni priporočljiva.
English: The positive effect on PFS was seen across the subgroups of age (above or below 65 years), sex, race, histological subtype, geographic region, and those who received 0 or 1 prior VEGF/VEGFR-targeted therapies.
Slovenian: Pozitivni učinek na PFS je bil viden v podskupinah po starosti (več ali manj kot 65 let), spolu, rasi, histološki podvrsti, zemljepisni regiji in tistih, ki so prejeli 0 ali 1 predhodna zdravljenja, usmerjena v VEGF/VEGFR.
English: Mild to severe hypertension may be present.
Slovenian: Lahko je prisotna blaga do huda hipertenzija.
English: Reduce dose in succession based on the previous dose level (12 mg, 8 mg, 4 mg or 4 mg every other day).
Slovenian: Odmerek zmanjšajte v korakih glede na predhodni odmerek (12 mg, 8 mg, 4 mg ali 4 mg vsak drugi dan).
English: Symptoms and Management
Slovenian: Simptomi in zdravljenje
English: The overall survival analysis was confounded by the fact that placebo-treated subjects with confirmed disease progression had the option to cross over to open-label lenvatinib.
Slovenian: Analizo celotnega preživetja je otežilo dejstvo, da so preiskovanci s potrjenim napredovanjem bolezni, ki so prejemali placebo, imeli možnost izbire prehoda na odprti lenvatinib.
English: In vitro transporter studies
Slovenian: Študije prenašalcev in vitro
English: LENVIMA can also be used on its own to treat liver cancer (hepatocellular carcinoma) in adults who have not previously been treated with another anticancer medicine that travels through the bloodstream.
Slovenian: Zdravilo LENVIMA se lahko uporablja tudi za samostojno zdravljenje raka jeter (hepatocelularnega karcinoma) pri odraslih, ki še niso bili zdravljeni z drugim zdravilom proti raku, ki potuje po krvnem obtoku.
English: A risk to newborns or infants cannot be excluded and, therefore, lenvatinib is contraindicated during breast-feeding (see section 4.3).
Slovenian: Tveganja za novorojenčke ali dojenčke ni mogoče izključiti, zato je lenvatinib med dojenjem kontraindiciran (glejte poglavje 4.3).
English: In 1.1% of patients, hypertension led to permanent treatment discontinuation.
Slovenian: Pri 1,1 % bolnikov je hipertenzija povzročila trajno ukinitev zdravljenja.
English: P-value is for the superiority test of lenvatinib versus sorafenib.
Slovenian: d Vrednost p velja za preskus superiornosti lenvatiniba v primerjavi s sorafenibom.
English: Lenvatinib is a multikinase inhibitor which has shown mainly antiangiogenic properties in vitro and in vivo, and direct inhibition of tumour growth was also observed in in vitro models.
Slovenian: Lenvatinib je multikinazni inhibitor, ki je in vitro in in vivo pokazal predvsem antiangiogene lastnosti, v modelih in vitro pa so opazili tudi neposredno inhibicijo rasti tumorjev.
English: • Absence of MPVI, extra-hepatic tumour spread (EHS) or both: 30%
Slovenian: • odsotnost MPVI, razširjenost tumorja izven jeter (EHS - extra-hepatic tumour spread) ali oboje:
English: Hepatic encephalopathy occurred at more than twice the incidence in patients aged ≥75 years (17.2%) than in those <75 years (7.1%).
Slovenian: Jetrna encefalopatija se je pojavila več kot dvakrat pogosteje pri bolnikih, starih ≥ 75 let (17,2 %), kot pri bolnikih, starih < 75 let (7,1 %).
English: Lenvatinib should be discontinued in the event of persistence of Grade 4 diarrhoea despite medical management.
Slovenian: Lenvatinib je treba ukiniti v primeru driske stopnje 4, ki vztraja kljub medicinski obravnavi.
English: • anal fistula (a small channel that forms between the anus and the surrounding skin)
Slovenian: • analna fistula (majhen kanal, ki nastane med zadnjikom in okolno kožo),
English: There have also been reports of overdose with lenvatinib involving single administrations of 6 to 10 times the recommended daily dose.
Slovenian: Poročali so tudi o prevelikem odmerjanju lenvatiniba, kjer so bili enkratni odmerki 6-krat do 10-krat večji od priporočenega dnevnega odmerka.
English: Lenvatinib showed minimal or no inhibitory effect on OATP1B3 and MATE2-K. Lenvatinib weakly inhibits MATE1.
Slovenian: Lenvatinib je pokazal minimalen ali nikakršen inhibicijski učinek na OATP1B3 in MATE2-K. Lenvatinib šibko inhibira MATE1.
English: Close monitoring of overall safety is recommended in these patients (see sections 4.4 and 5.2).
Slovenian: Pri teh bolnikih je priporočljivo natančno spremljanje celotne varnosti (glejte poglavji 4.4 in 5.2).
English: Lenvatinib should be withheld in the event of development of QT interval prolongation greater than 500 ms. Lenvatinib should be resumed at a reduced dose when QTc prolongation is resolved to < 480 ms or baseline.
Slovenian: Dajanje lenvatiniba je treba prekiniti, če se razvije podaljšanje intervala QT, ki presega 500 ms. Lenvatinib je treba spet začeti dajati v zmanjšanem odmerku, ko se podaljšanje intervala QTc vrne na < 480 ms ali izhodiščno vrednost.
English: Electrolytes (magnesium, potassium and calcium) should be monitored periodically during treatment.
Slovenian: Med zdravljenjem je treba v rednih časovnih presledkih spremljati elektrolite (magnezij, kalij in kalcij).
English: Blood calcium levels should be monitored at least monthly and calcium should be replaced as necessary during lenvatinib treatment.
Slovenian: Raven kalcija v krvi je treba spremljati vsaj enkrat na mesec in med zdravljenjem z lenvatinibom kalcij po potrebi nadomeščati.
English: LENVIMA treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies.
Slovenian: Zdravljenje z zdravilom LENVIMA mora uvesti in nadzorovati zdravnik z izkušnjami pri uporabi zdravil proti raku.
English: • other types of fistulae (an abnormal connection between different organs in the body or between the skin and an underlying structure such as throat and windpipe).
Slovenian: • druge vrste fistul (fistula je nenormalna povezava med različnimi telesnimi organi ali med kožo in spodaj ležečo strukturo, na primer žrelom in sapnikom).
English: • If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Slovenian: • imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
English: Prompt medical management of diarrhoea should be instituted in order to prevent dehydration.
Slovenian: Začeti moramo takojšnjo medicinsko obravnavo driske, da preprečimo dehidracijo.
English: Systolic BP ≥140 mmHg up to <160 mmHg or diastolic BP ≥90 mmHg up to <100 mmHg
Slovenian: Priporočeno ukrepanje sistolični KT ≥ 140 mmHg do < 160 mmHg ali diastolični KT ≥ 90 mmHg do < 100 mmHg
English: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal antihypertensive therapy
Slovenian: sistolični KT ≥ 160 mmHg ali diastolični KT ≥ 100 mmHg kljub optimalni antihipertenzivni terapiji
English: M2' and M3', the major metabolites in human faeces, were formed from M2 and lenvatinib, respectively, by aldehyde oxidase.
Slovenian: M2' in M3', poglavitna presnovka v človeškem blatu, sta nastala iz M2 oziroma lenvatiniba z aldehidno oksidazo.
English: The clinical efficacy and safety of lenvatinib have been evaluated in an international, multicenter, open-label, randomised phase 3 study (REFLECT) in patients with unresectable hepatocellular carcinoma (HCC).
Slovenian: Klinična učinkovitost in varnost lenvatiniba sta bili ocenjeni v mednarodni multicentrični odprti randomizirani študiji 3. faze (REFLECT) pri bolnikih z neoperabilnim hepatocelularnim karcinomom (HCC).
English: Therefore, the decision to resume lenvatinib following a major surgical procedure should be based on clinical judgment of adequate wound healing.
Slovenian: Odločitev za nadaljevanje zdravljenja z lenvatinibom po večjem kirurškem posegu mora zato temeljiti na klinični presoji, ali se rane primerno celijo.
English: Percentages (95% CI)
Slovenian: Odstotki (95-odstotni IZ)
English: Cases of fatal intracranial haemorrhage have been reported in some patients with or without brain metastases.
Slovenian: O primerih smrtnih znotrajlobanjskih krvavitev so poročali pri nekaterih bolnikih z zasevki v možganih ali brez njih.
English: • The active substance is lenvatinib.
Slovenian: • Učinkovina je lenvatinib.
English: • If you have severe liver or kidney problems the recommended dose is 14 mg once a day
Slovenian: • Če imate izrazite težave z jetri ali ledvicami, je priporočeni odmerek 14 mg enkrat na dan
English: PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules 60 hard capsules 90 hard capsules METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 trdih kapsul 60 trdih kapsul 90 trdih kapsul POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba.
English: In addition, pneumothorax has been reported with and without clear evidence of a bronchopleural fistula.
Slovenian: Poleg tega so poročali o pnevmotoraksu, z jasnimi dokazi bronhoplevralne fistule in brez njih.
English: Details for monitoring, dose adjustment and discontinuation are provided in Table 2.
Slovenian: Podrobni podatki za spremljanje, prilagoditev odmerka in ukinitev zdravljenja so v preglednici 2.
English: Resolves to Grade 0-1.
Slovenian: Izboljša se na stopnjo 0-1
English: To dissolve them, pour a tablespoon of water or apple juice into a small glass and put the capsules into the liquid without breaking or crushing them.
Slovenian: Za raztapljanje nalijte jedilno žlico vode ali jabolčnega soka v majhen kozarec ter kapsule dodajte v tekočino, ne da bi jih prelomili ali zdrobili.
English: The median half-life was comparable in subjects with mild, moderate, and severe hepatic impairment as well as those with normal hepatic function and ranged from 26 hours to 31 hours.
Slovenian: Mediana razpolovna doba je bila primerljiva pri preiskovancih z blago, zmerno in hudo okvaro jeter, pa tudi pri tistih z normalno funkcijo jeter, in je bila v razponu od 26 ur do 31 ur.
English: • diarrhoea, feeling and being sick - these are very common side effects that can become serious if they cause you to become dehydrated, which can lead to kidney failure.
Slovenian: • driska, slabost in bruhanje - to so zelo pogosti neželeni učinki, ki lahko postanejo resni, če zaradi njih postanete dehidrirani, kar lahko povzroči odpoved ledvic.
English: • low levels of platelets in the blood which may lead to bruising and difficulty in wound healing
Slovenian: • nizka koncentracija krvnih ploščic v krvi, ki lahko povzroči modrice in oteženo celjenje ran.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE29
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), inhibitorji proteinske kinaze, oznaka ATC: L01XE29.
English: • black, tarry, or bloody stools, or coughing up of blood - these may be signs of bleeding inside your body.
Slovenian: • črno, katranasto ali krvavo blato ali izkašljevanje krvi - to so lahko znaki krvavitve znotraj telesa;
English: Electrocardiograms should be monitored at baseline and periodically during treatment in all patients with particular attention to those with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, and those taking medicinal products known to prolong the QT interval, including Class Ia and III antiarrhythmics.
Slovenian: Elektrokardiograme je treba spremljati v izhodišču in v rednih presledkih ves čas zdravljenja pri vseh bolnikih, posebno pa moramo biti pozorni na tiste s prirojenim sindromom dolgega intervala QT, kongestivnim popuščanjem srca, z bradiaritmijami in pri tistih, ki jemljejo zdravila, za katera je znano, da podaljšujejo interval QT, vključno z antiaritmiki skupin Ia in III.
English: The degree of tumour invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.
Slovenian: Treba je oceniti stopnjo tumorske invazije/infiltracije večjih krvnih žil (npr. karotidnih arterij) zaradi možnega tveganja resne krvavitve, povezane z zmanjšanjem tumorske mase/nekrozo tumorja po zdravljenju z lenvatinibom.
English: • are a woman able to become pregnant (see the section below on Contraception, pregnancy and breast-feeding)
Slovenian: • ste ženska, ki bi lahko zanosila (glejte poglavje Kontracepcija, nosečnost in dojenje v nadaljevanju);
English: • The recommended dose of LENVIMA is usually 24 mg once a day
Slovenian: • Priporočeni odmerek zdravila LENVIMA je navadno 24 mg enkrat na dan
English: Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule.
Slovenian: Skrbniki bolnikov naj ne odpirajo kapsul, da se bodo izognili večkratnemu izpostavljanju vsebini kapsul.
English: People get LENVIMA when their liver cancer has spread or cannot be taken out by surgery.
Slovenian: Bolniki prejmejo zdravilo LENVIMA, če se je rak jeter razširil ali ga s kirurškim posegom ni mogoče odstraniti.
English: Drink the mixture.
Slovenian: Suspenzijo spijte.
English: Leave for at least 10 minutes then stir for at least 3 minutes to dissolve the capsule shells.
Slovenian: Pustite jih v tekočini vsaj 10 minut, nato mešajte vsaj 3 minute, da se ovojnica kapsule raztopi.
English: What you need to know before you take LENVIMA
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo LENVIMA
English: It is not known whether lenvatinib is excreted in human milk.
Slovenian: Ni znano, ali se lenvatinib izloča v materino mleko.
English: Do not take LENVIMA if:
Slovenian: Ne jemljite zdravila LENVIMA:
English: In patients with solid tumours administered single and multiple doses of lenvatinib once daily, exposure to lenvatinib (Cmax and AUC) increased in direct proportion to the administered dose over the range of 3.2 to 32 mg once-daily.
Slovenian: Pri bolnikih s čvrstimi tumorji, ki so prejeli enkratne in večkratne odmerke lenvatiniba enkrat na dan, se je izpostavljenost lenvatinibu (Cmax in AUC) zvečala neposredno sorazmerno danemu odmerku v območju od 3,2 do 32 mg enkrat na dan.
English: Estimated using the Kaplan-Meier method; the 95% CI was constructed with a generalised Brookmeyer and Crowley method in patients with a best overall response of complete response or partial response.
Slovenian: Ocenjeno s Kaplan-Meierjevo metodo; 95-odstotni IZ je bil sestavljen s posplošeno Brookmeyer-Crowleyevo metodo pri bolnikih z najboljšim celotnim odzivom v obliki popolnega odziva ali delnega odziva.
English: The median time to onset was 26 days.
Slovenian: Mediani čas do nastopa je bil 26 dni.
English: Hypertension includes: hypertension, hypertensive crisis, increased diastolic blood pressure , , orthostatic hypertension, and increased blood pressure.
Slovenian: Hipertenzija vključuje: hipertenzijo, hipertenzivno krizo, zvišanje diastoličnega krvnega tlaka, ortostatsko hipertenzijo in zvišanje krvnega tlaka.
English: Table 4 Recommended management of hypertension
Slovenian: Preglednica 4 Priporočila za zdravljenje hipertenzije
English: Mild to moderate adverse reactions (e.g., Grade 1 or 2) generally do not warrant interruption of lenvatinib, unless intolerable to the patient despite optimal management.
Slovenian: Blagi do zmerni neželeni učinki (npr. stopnje 1 ali 2) na splošno ne upravičijo prekinitve odmerjanja lenvatiniba, razen če jih bolnik ne more prenašati kljub optimalni obravnavi.
English: There was no statistically significant difference in overall survival between the treatment groups at the time of the primary efficacy analysis (HR=0.73; 95% CI: 0.50, 1.07, p=0.1032).
Slovenian: Ni bilo statistično značilne razlike v celotnem preživetju med skupinama z različnima zdravljenjema v času analize primarne učinkovitosti (HR (hazard ratio; razmerje tveganja)=0,73; 95 % IZ: 0,50; 1,07, p=0,1032).