FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: Lenvatinib var non-inferior i forhold til sorafenib, hvad angår OS, med HR = 0,92 (95 % CI 0,79-;, 1,06) og en median OS på 13,6 måneder vs 12,3 måneder (se Tabel 7 og Figur 2).
English: • chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, feeling very tired - these may be signs of a heart problem, a blood clot in your lung or a leak of air from your lung into your chest so your lung cannot inflate.
Danish: • brystsmerter eller trykken for brystet, smerter i dine arme, ryggen, halsen eller kæben, stakåndethed, hurtig eller uregelmæssig puls, hoste, blåfarvning af læber eller fingre, udpræget træthed - dette kan være tegn på et hjerteproblem, en blodprop i lungen eller udsivning af luft fra din lunge og ud i brystet, således at der ikke kan komme luft i lungen.
English: Baseline hypertension
Danish: Hypertension ved baseline
English: Vomiting Nausea Oral inflammationg Oral painh
Danish: Opkastning Kvalme Oral inflammationg Orale smerterh
English: If you take more LENVIMA than you should
Danish: Hvis du har taget for meget LENVIMA
English: Dose adjustments and Discontinuation for HCC
Danish: Dosisjusteringer og seponering ved HCC
English: • mini-stroke
Danish: • mini-slagtilfælde
English: The hepatic failure cases were generally reported in patients with progressive metastatic liver metastases disease.
Danish: Tilfældene med leversvigt blev generelt rapporteret hos patienter med progressive levermetastaser.
English: 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.
Danish: Median varighed af behandling var 5,7 måneder (Q1: 2,9; Q3: 11,1) i lenvatinib-armen og 3,7 måneder (Q1: 1,8; Q3: 7,4) i sorafenib-armen.
English: Refer also to section 4.8, Other special populations.
Danish: 4.8, Andre specielle populationer).
English: When systolic BP ≤150 mmHg, diastolic BP ≤95 mmHg, and patient has been on a stable dose of antihypertensive therapy for at least 48 hours, resume lenvatinib at a reduced dose (see section 4.2)
Danish: Når systolisk blodtryk ≤ 150 mmHg, diastolisk blodtryk ≤ 95 mmHg, og patienten har været på en stabil dosis af antihypertensiv behandling i mindst 48 timer, skal lenvatinib genoptages med en reduceret dosis (se pkt.
English: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal antihypertensive therapy
Danish: Systolisk blodtryk ≥ 160 mmHg eller diastolisk blodtryk ≥ 100 mmHg, trods optimal antihypertensiv behandling
English: 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.
Danish: I alt blev 954 patienter randomiseret 1:1 til at få enten levantinib (12 mg [baseline kropsvægt ≥ 60 kg] eller 8 mg [baseline kropsvægt < 60 kg]) givet oralt en gang dagligt eller sorafenib 400 mg givet oralt to gange dagligt
English: What you need to know before you take LENVIMA
Danish: Det skal du vide, før du begynder at tage LENVIMA
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).
Danish: • svære mavesmerter - dette kan skyldes et hul i tarmvæggen eller en fistel (et hul i tarmen, der via en rørformet kanal er forbundet med en anden del af kroppen eller huden).
English: • Common
Danish: • Almindelig
English: Symptoms and Management
Danish: Symptomer og behandling
English: • changes in blood test results for liver function
Danish: • blodprøver viser ændringer i leverfunktionen
English: The incidence of QT interval prolongation of greater than 500 ms was 2% in the lenvatinib-treated patients compared to no reports in the placebo group.
Danish: Forekomsten af en forlængelse af QT-intervallet over 500 ms var 2 % hos de lenvatinibbehandlede patienter sammenlignet med ingen rapporter i gruppen, der fik placebo.
English: Thyroid function should be monitored before initiation of, and periodically throughout, treatment with lenvatinib.
Danish: Tyreoideafunktionen bør overvåges før behandlingen med lenvatinib indledes og periodisk i løbet af hele behandlingen.
English: • have a history of abnormal connections (known as a fistula) between different organs in the body or from an organ to the skin
Danish: • tidligere har haft unormale forbindelser (der kaldes fistler) mellem forskellige kropsorganer eller fra et organ til huden.
English: Absolute bioavailability has not been determined in humans; however, data from a mass-balance study suggest that it is in the order of 85%.
Danish: Data fra et masse-balance-studie tyder imidlertid på, at den er i størrelsesordenen 85 %.
English: There is no specific antidote for overdose with lenvatinib.
Danish: Der er ingen kendt antidot mod en overdosis af lenvatinib.
English: Table 2 Dose modifications from recommended lenvatinib daily dose in HCC patients Starting Dose
Danish: Table 2 Dosismodifikationer fra anbefalet daglig dosis af lenvatinib hos HCC patienter Startdosis
English: Lenvatinib and its metabolites are excreted in rat milk.
Danish: Lenvatinib og dets metabolitter udskilles i rottemælk.
English: P-valueb
Danish: P-værdib
English: Number of objective responders (%) (95% CI)
Danish: Antal objektivt responderende personer (%) (95 % CI)
English: Gastrointestinal toxicity should be actively managed in order to reduce the risk of development of renal impairment or renal failure.
Danish: Mave-tarm-toksicitet bør behandles aktivt for at reducere risikoen for udvikling af nedsat nyrefunktion eller nyresvigt.
English: 4.5 Interaction with other medicinal products and other forms of interaction Effect of other medicinal products on lenvatinib
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Administration of lenvatinib during organogenesis resulted in embryolethality and teratogenicity in rats (foetal external and skeletal anomalies) at exposures below the clinical exposure (based on AUC) at the maximum tolerated human dose, and rabbits (foetal external, visceral or skeletal anomalies) based on body surface area; mg/m2 at the maximum tolerated human dose.
Danish: Administration af lenvatinib i løbet af organogenesen førte til embryoletalitet og teratogenicitet hos rotter (føtale eksterne anomalier og skeleletanomalier) ved eksponeringer under den kliniske eksponering (baseret på AUC) ved den maksimalt tolererede humane dosis og hos kaniner (føtale eksterne, viscerale anomalier eller skeletanomalier) ved eksponeringer under den kliniske eksponering (baseret på legemsoverfladearealet, mg/m2) ved den maksimalt tolererede humane dosis.
English: The median time to first onset was 11.9 weeks.
Danish: Mediantiden til første indtræden var 11,9 uger.
English: Stratified by region (Europe vs. North America vs. Other), age group (≤65 years vs >65 years), and previous VEGF/VEGFR-targeted therapy (0 vs. 1).
Danish: Stratificeret efter region (Europa versus Nordamerika versus andet), aldersgruppe (≤ 65 år versus > 65 år) samt tidligere VEGF/VEGFR-målrettet behandling (0 versus 1).
English: Subjects with end-stage renal disease were not studied.
Danish: Personer med nyresygdom i slutstadiet blev ikke undersøgt.
English: Patients were excluded who had prior systemic anticancer therapy for advanced/unresectable HCC or any prior anti-VEGF therapy.
Danish: Patienter blev ekskluderet, hvis de tidligere havde fået systemisk anticancer-behandling for fremskreden/ikkeresektabelt HCC eller tidligere havde fået anti-VEGF behandling.
English: Discontinue lenvatinib and institute appropriate medical management.
Danish: Seponer lenvatinib, og påbegynd passende medicinsk behandling.
English: If you forget to take LENVIMA Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Danish: Hvis du har glemt at tage LENVIMA Du må ikke tage en dobbeltdosis (to doser på samme tid) som erstatning for den glemte dosis.
English: Hypercholesterolaemia includes hypercholesterolaemia and increased blood cholesterol.
Danish: Hyperkolesterolæmi omfatter hyperkolesterolæmi og et forhøjet niveau af kolesterol i blodet.
English: • dry, sore, or inflamed mouth, odd taste sensation
Danish: • tør, øm eller betændt mund, smagsforstyrrelser
English: Discontinue Do not resume
Danish: Må ikke genstartes
English: 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.
Danish: Lenvatinibs farmakokinetik efter en enkelt dosis på 24 mg blev evalueret hos 6 personer med let, moderat og svært nedsat nyrefunktion og sammenlignet med 8 raske, demografisk matchede personer.
English: • The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30,60 or 90 hard capsules.
Danish: • De leveres i blister af polyamid/aluminium/PVC i pakninger med 30, 60 eller 90 hårde kapsler med et lag af aluminiumsfolie, hvorigennem kapslerne kan trykkes ud.
English: Patients with a baseline Child Pugh (CP) score of 6 (about 20% patients in the REFLECT study) had a higher incidence of decreased appetite, fatigue, proteinuria, hepatic encephalopathy and hepatic failure compared to patients with a baseline CP score of 5.
Danish: Patienter med baseline Child-Pugh (CP) score på 6 (omtrent 20 % af patienterne i REFLECT-studiet) havde en højere forekomst af nedsat appetit, træthed, proteinuri, hepatisk encefalopati og leversvigt sammenlignet med patienter med en baseline CP score på 5.
English: Dizziness Headache Dysgeusia
Danish: Svimmelhed Hovedpine Dysgeusi
English: Patients with ≥50% liver occupation, clear invasion into the bile duct or a main branch of the portal vein (Vp4) on imaging were also excluded.
Danish: Patienter blev også ekskluderet, hvis de havde ≥ 50 % okkupation af leveren, tydelig invasion i galdegangen eller i en hovedgren af portalvenen (Vp4) ved billeddiagnostik.
English: Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS)
Danish: Posteriort reversibelt encefalopatisyndrom (PRES)/reversibelt posteriort leukoencefalopatisyndrom (RPLS)
English: One occurred in a patient with no liver metastases.
Danish: Et tilfælde forekom hos en patient uden levermetastaser.
English: Hepatotoxicity reactions of ≥ Grade 3 occurred in 26.1% of lenvatinib-treated patients.
Danish: Reaktioner med hepatotoksicitet af ≥ grad 3 forekom hos 26,1 % af patienternebehandlet med lenvatinib.
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).
Danish: Der er ikke tilstrækkelige data for HCC-patienter med Child-Pugh B (moderat nedsat leverfunktion; 3 patienter behandlet med lenvima i det pivotale studie), og ingen tilgængelige data for Child-Pugh C HCC patienter (svært nedsat leverfunktion).
English: Pharmacokinetic parameters of lenvatinib have been studied in healthy adult subjects, adult subjects with hepatic impairment, renal impairment, and solid tumours.
Danish: Farmakokinetiske parametre for lenvatinib er blevet undersøgt hos raske vokse personer, voksne personer med nedsat leverfunktion, nedsat nyrefunktion og faste tumorer.
English: 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).
Danish: Der blev ikke observeret nogen forskelle mellem lenvatinib- og placebobehandlede patienter, hvad angår forekomsten af alvorlige reaktioner (3,4 % versus 3,8 %), reaktioner, der førte til for tidlig seponering (1,1 % versus 1,5 %), eller reaktioner, der førte til dosisafbrydelse (3,4 % versus 3,8 %) ellerreduktion (0,4 % versus 0).
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.
Danish: Median varigheden af objektivt respons var 7,3 (95 % CI 5,6; 7,4) måneder i lenvatinib-armen og 6,2 (95 % CI 3,7; 11,2) måneder i sorafenib-armen.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Hepatocellular damage/hepatitis m
Danish: Hepatocellulær skade/hepatitisi
English: Limited data are available on use in patients aged ≥75 years (see also section 4.8, Other special populations).
Danish: Der foreligger kun begrænsede data for anvendelsen hos patienter i alderen ≥ 75 år (se også pkt.
English: The recommended daily dose of lenvatinib is 24 mg (two 10 mg capsules and one 4 mg capsule) once daily.
Danish: Den anbefalede daglige dosis af lenvatinib er 24 mg (to 10 mg kapsler og en 4 mg kapsel) én gang dagligt.
English: Patients with low body weight (<60 kg) had a higher incidence of PPE, proteinuria, of Grade 3 or 4 hypocalcaemia and hyponatraemia, and a trend towards a higher incidence of Grade 3 or 4 decreased appetite.
Danish: Patienter med lav legemsvægt (< 60 kg) havde en større forekomst af PPE, proteinuri, grad 3 eller 4 hypocalcæmi og hyponatriæmi og en tendens til en større forekomst af grad 3 eller 4 nedsat appetit.
English: A 5-mg dose was evaluated in 6 subjects with severe hepatic impairment (Child-Pugh C).
Danish: En 5 mg dosis blev evalueret hos 6 personer med svært nedsat leverfunktion (Child-Pugh C).
English: Overall Survival Number of deaths (%) Median OS in months (95% CI)
Danish: Samlet overlevelse Antal dødsfald (%) Median OS i måneder (95 % CI)
English: Dose adjustments and discontinuations for DTC
Danish: Dosisjusteringer og seponering ved DTC
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.
Danish: Kvinder i den fertile alder skal undgå at blive gravide og anvende meget sikker kontraception, mens de er i behandling med lenvatinib og i mindst en måned efter behandlingsophør.
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.
Danish: Det er aktuelt ukendt, om lenvatinib kan reducere virkningen af hormonal kontraception, og derfor skal kvinder, der anvender oral hormonal kontraception, tilføje en barrieremetode.
English: BP should be monitored after 1 week of treatment with lenvatinib, then every 2 weeks for the first 2 months, and monthly thereafter.
Danish: Blodtrykket bør overvåges efter 1 uges behandling med lenvatinib, og derefter hver 2. uge i løbet af de første 2 måneders behandling, og derefter månedligt.
English: The incidence of QTcF interval prolongation of greater than 500ms was
Danish: Forekomsten af en forlængelse af QTcF-intervallet over 500 ms var 2,4 %.
English: 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.
Danish: Det er blevet fastslået, at plasmaproteinbinding i plasma fra personer med nedsat leverfunktion lignede de respektive matchede raske personer, og der blev ikke observeret nogen koncentrationsafhængighed.
English: m: Hepatocellular damage and hepatitis includes: drug-induced liver injury, hepatic steatosis, and cholestatic liver injury.
Danish: m: Hepatocellulær skade og hepatitis omfatter: lægemiddelinduceret leverskade, leversteatose og kolestatisk leverskade.
English: Proteinuria led to permanent treatment discontinuation in 0.8% of patients.
Danish: Proteinuri førte til permanent behandlingsseponering hos 0,8 % af patienterne.
English: Hyperbilirubinaeamia includes: hyperbilirubinaemia, increased blood bilirubin, jaundice and increased bilirubin conjugated.
Danish: Hyperbilirubinæmi omfatter: hyperbilirubinæmi, forhøjet bilirubin i blodet, gulsot og forhøjet konjugeret bilirubin.
English: Thrombocytopeniaa Leukopeniaa Neutropeniaa
Danish: Trombocytopenia Leukopenia Neutropenia
English: 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%).
Danish: På tværs af de kliniske studier, i hvilke 1327 patienter modtog lenvatinib monoterapi for andre indikationer end HCC, blev leversvigt (inklusive letale hændelser) rapporteret hos 4 patienter (0,3 %), leverskade hos 2 patienter (0,2 %), akut hepatitis hos 2 patienter (0,2 %) og hepatocellulær skade hos 1 patient (0,1 %).
English: The main metabolic pathways in humans were identified as oxidation by aldehyde oxidase, demethylation via CYP3A4, glutathione conjugation with elimination of the O-aryl group (chlorophenyl moiety), and combinations of these pathways followed by further biotransformations (e.g., glucuronidation, hydrolysis of the glutathione moiety, degradation of the cysteine moiety, and intramolecular rearrangement of the cysteinylglycine and cysteine conjugates with subsequent dimerisation).
Danish: De primære metaboliske veje hos mennesker blev identificeret som oxidation ved hjælp af aldehydoxidase, demethylering via CYP3A4, glutathionkonjugering med elimination af O-arylgruppen (chlorphenyl-delen) og kombinationer af disse metabolismeveje, efterfulgt af videre biotransformationer (f.eks. glukuronidation, hydrolyse af glutathion-delen,
English: EU/1/15/1002/002 (Pack size of 30 hard capsules) EU/1/15/1002/005 (Pack size of 60 hard capsules) EU/1/15/1002/006 (Pack size of 90 hard capsules)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1002/002 (pakningsstørrelse på 30 hårde kapsler) EU/1/15/1002/005 (pakningsstørrelse på 60 hårde kapsler) EU/1/15/1002/006 (pakningsstørrelse på 90 hårde kapsler) 13.
English: However, testicular and ovarian toxicity has been observed in rats, dogs, and monkeys (see section 5.3).
Danish: Der er imidlertid blevet observeret testikeltoksicitet og ovarietoksicitet hos rotter, hunde og aber (se pkt.
English: In DTC, liver-related adverse reactions most commonly reported in patients treated with lenvatinib included increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and blood bilirubin.
Danish: Ved DTC omfattede de mest almindeligt rapporterede leverrelaterede bivirkninger hos patienter i behandling med lenvatinib forhøjelser i niveauet af alaninaminotransferase (ALAT), aspartataminotransferase (ASAT) og bilirubin i blodet.
English: • you are breast-feeding (see the section below on Contraception, pregnancy and breast-feeding).
Danish: • hvis du ammer (se punktet nedenfor om Prævention, graviditet og amning).
English: 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.
Danish: Det er blevet fastslået, at plasmaproteinbinding i plasma fra personer med nedsat nyrefunktion lignede de respektive matchede raske personer, og der blev ikke observeret nogen koncentrationsafhængighed.
English: • black, tarry, or bloody stools, or coughing up of blood - these may be signs of bleeding inside your body.
Danish: • sort, tjærefarvet eller blodig afføring eller ophostning af blod - det kan være tegn på en indre blødning.
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.
Danish: En hændelse med blødning medførte dosisafbrydelse eller dosisreduktion hos henholdsvis 3,2 % og 0,8 % af patienterne og til seponering af behandlingen hos 1,7 % af patienterne.
English: Hepatocellular Carcinoma
Danish: Hepatocellulært carcinom
English: Increased blood alkaline phosphatase Hepatic function abnormal Increased gammaglutamyltransferase Cholecystitis
Danish: Forhøjet niveau af basisk fosfatase i blodet Unormal leverfunktion Forhøjet niveau af gammaglutamyltransferase Kolecystitis
English: Metastases were present in 99% of the patients: lungs in 89.3%, lymph nodes in 51.5%, bone in 38.8%, liver in 18.1%, pleura in 16.3%, and brain in 4.1%.
Danish: Der var metastaser til stede hos 99 % af patienterne: i lungerne hos 89,3 %, i lymfeknuderne hos 51,5 %, i knoglerne hos 38,8 %, i leveren hos 18,1 %, i pleura hos 16,3 % og i hjernen hos 4,1 %.
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
Danish: Det er aktuelt ukendt, om lenvatinib kan reducere virkningen af hormonal kontraception, og derfor skal kvinder, der anvender oral hormonal antikonception, tilføje en barrieremetode (se pkt.
English: Grade 3 reactions occurred in 10.7% of lenvatinib-treated patients and none in placebotreated patients.
Danish: Grad 3 reaktioner forekom hos 10,7 % af de lenvatinibbehandlede patienter, og ikke hos nogen af de placebobehandlede patienter.
English: In patients with severe (Child-Pugh C) hepatic impairment, the recommended starting dose is 14 mg taken once daily.
Danish: Hos patienter med svært (Child-Pugh C) nedsat leverfunktion er den anbefalede startdosis 14 mg én gang dagligt.
English: 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.
Danish: Der kræves ingen justering af startdosis på basis af leverfunktionen hos patienter med let (Child-Pugh A) eller moderat (Child-Pugh B) nedsat leverfunktion.
English: In the patient populations enrolled in the HCC study no dose adjustments were required on the basis of hepatic function in those patients who had mild hepatic impairment (Child-Pugh A).
Danish: Hos patientpopulationer, der var indskrevet i HCC-studiet, var dosisjustering ikke nødvendig på basis af leverfunktion hos de patienter, som havde let nedsat leverfunktion (Child-Pugh A).
English: Amongst 1,823 patients treated with lenvatinib monotherapy in clinical studies, there were 10 cases (0.5%) of arterial thromboembolisms (5 cases of myocardial infarction and 5 cases of cerebrovascular accident) with a fatal outcome.
Danish: Blandt 1.823 patienter behandlet med lenvatinib monoterapi i kliniske studier var der 10 tilfælde (0,45 %) af arteriel tromboemboli (5 tilfælde af myokardieinfarkt og 5 tilfælde af cerebrovaskulært anfald) med dødelig udgang.
English: • low levels of platelets in the blood which may lead to bruising and difficulty in wound healing
Danish: • lavt antal blodplader, hvilket kan føre til blå mærker og problemer med sårheling
English: Proteinuria led to permanent treatment discontinuation in 0.6% of patients.
Danish: Proteinuri medførte permanent afbrydelse af behandlingen hos 0,6% af patienterne.
English: Response rate (complete or partial response)
Danish: Antal fuldstændigt respons Antal delvist respons
English: Patients ≥75 years, of white race or female sex or those with worse baseline hepatic impairment (Child-Pugh A score of 6 compared to score of 5) appear to have reduced tolerability to lenvatinib.
Danish: Patienter ≥ 75 år, hvide, kvinder eller dem med den alvorligste nedsatte leverfunktion (Child-Pugh A 6 point i forhold til 5 point) ved baseline lader til at have reduceret tolerabilitet for lenvatinib.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION LENVIMA 4 mg hard capsules
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING LENVIMA 4 mg hårde kapsler