natgillin/translations-raw huggingface dataset:
Lenvatinib dose should be interrupted or dose adjusted as necessary depending on severity, presence of ECG changes, and persistence of hypocalcaemia.
Odmerjanje lenvatiniba je treba prekiniti ali odmerek prilagoditi po potrebi, odvisno od resnosti, prisotnosti sprememb EKG in trdovratnosti hipokalciemije.
These proteins can be present in high amounts in cancer cells, and by blocking their action Kisplyx may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs.
Te beljakovine so lahko prisotne v velikih količinah v rakastih celicah, z zaviranjem njihovega delovanja pa zdravilo Kisplyx lahko upočasni hitrost razmnoževanja rakavih celic in rast tumorja in pomaga prekiniti preskrbo s krvjo, ki jo rak potrebuje.
Tumour assessment was based on RECIST 1.1 criteria.
Ocenjevanje tumorja je temeljilo na merilih RECIST 1.1.
• are a woman able to become pregnant (see the section “Contraception, pregnancy and breast-feeding”
• ste ženska, ki bi lahko zanosila (glejte poglavje »Kontracepcija, nosečnost in dojenje« v nadaljevanju);
Not all pack sizes may be marketed .
Na trgu morda ni vseh navedenih pakiranj.
The additional liquid must be swallowed.
Nato mora spiti dodatno tekočino.
Body weight below 60 kg
Telesna masa, manjša od 60 kg
Blood pressure (BP) should be well controlled prior to treatment with lenvatinib and, if patients are known to be hypertensive, they should be on a stable dose of antihypertensive therapy for at least 1 week prior to treatment with lenvatinib.
Krvni tlak (KT) naj bo pred zdravljenjem z lenvatinibom dobro nadzorovan in če je za bolnike znano, da so hipertenzivni, naj bodo vsaj 1 teden pred zdravljenjem z lenvatinibom na stabilnem odmerku antihipertenzivne terapije.
Kisplyx treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies.
Zdravljenje z zdravilom Kisplyx mora uvesti in nadzorovati zdravnik z izkušnjami pri uporabi zdravil proti raku.
Periodic monitoring of ECG and electrolytes (magnesium, potassium and calcium) should be considered during treatment.
Med zdravljenjem moramo razmisliti o spremljanju EKG in elektrolitov (magnezij, kalij in kalcij) v rednih časovnih presledkih.
cData cut-off date = 31 Jul 2015
cDatum zaključka zbiranja podatkov = 31. julij 2015.
Grade 4*
stopnja 4*
A total of 62 patients received the combination of lenvatinib and everolimus at the recommended dose.
Skupaj 62 bolnikov je prejemalo kombinacijo lenvatiniba in everolimusa v priporočenem odmerku.
Figure 1: Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment)
Slika 1: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (raziskovalčeva ocena)
Alanine aminotransferase increased‡
zvišana alaninaminotransferaza‡
The analogous median apparent volume of distribution at steady-state (Vz/Fss) was also generally consistent and ranged from 43.2 L to 121 L.
navidezni porazdelitveni volumen v stanju ravnovesja (Vz/Fss) je bil tudi na splošno skladen in je segal od 43,2 l do 121 l.
Do not take Kisplyx if:
Ne jemljite zdravila Kisplyx:
Hypertension includes: hypertension, hypertensive crisis, increased blood pressure diastolic, and increased blood pressure.
Hipertenzija vključuje: hipertenzijo, hipertenzivno krizo, zvišanje diastoličnega krvnega tlaka in zvišanje krvnega tlaka.
bStratified hazard ratio is based on a stratified Cox regression model including treatment as a covariate factor and haemoglobin and corrected serum calcium as strata.
bStratificirano razmerje tveganja temelji na Coxovem stratificiranem regresijskem modelu, ki je vključil obravnavo kot kovariatni faktor ter hemoglobin in popravljeni serumski kalcij kot strata.
Kisplyx 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.
Zdravilo Kisplyx zavira delovanje beljakovin, imenovanih receptorji tirozin-kinaze (RTK), ki so vpletene v razvoj novih krvnih žil, ki preskrbujejo celice s kisikom in hranilnimi snovmi in jim pomagajo rasti.
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.
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.
The final dose level in the combination arm was 18 mg for 29% of patients, 14 mg for 31% of patients, 10 mg for 23% of patients, 8 mg for 16% of patients and 4 mg for 2% of patients.
Končna raven odmerka v skupini s kombinacijo zdravil je bila 18 mg pri 29 % bolnikov, 14 mg pri 31 % bolnikov, 10 mg pri 23 % bolnikov, 8 mg pri 16 % bolnikov in 4 mg pri 2 % bolnikov.
Over this range, the median accumulation index (Rac) ranged from 0.96 (20 mg) to 1.54 (6.4 mg).
V tem območju je indeks medianega kopičenja (Rac) segal od 0,96 (20 mg) do 1,54 (6,4 mg).
Patients were required, among others, to have histological confirmation of predominant clear cell RCC, radiographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1), one prior VEGF-targeted therapy and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Bolniki so med drugim morali imeti histološko potrditev RCC s prevladujočimi svetlimi celicami, rentgenski dokaz napredovanja bolezni po merilih za ocenjevanje odziva pri čvrstih tumorjih, verzija 1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1RECIST 1.1), eno predhodno zdravljenje, usmerjeno v VEGF, in status zmogljivosti (Performance Status - PS) Eastern Cooperative Oncology Group (ECOG) 0 ali 1.
Kisplyx is a medicine that contains the active substance lenvatinib.
Kisplyx je zdravilo, ki vsebuje zdravilno učinkovino lenvatinib.
Kisplyx may be restarted once adequate wound healing is established.
Zdravilo Kisplyx se lahko ponovno uvede, ko je ugotovljeno ustrezno celjenje ran;
Hepatocellular damage/hepatitisi
holecistitis hepatocelularna poškodba/hepatitisi
• Caregivers should not open capsules to avoid exposure to the contents of the capsule.
• Skrbniki bolnikov naj ne odpirajo kapsul, da ne bodo prišli v stik z vsebino kapsule.
• other types of fistulae (an abnormal connection between different organs in the body or from the skin to an underlying structure such as throat and windpipe).
• druge vrste fistul (fistula je nenormalna povezava med različnimi telesnimi organi ali od kože do spodaj ležeče strukture, na primer žrela in sapnika).
What Kisplyx is and what it is used for What you need to know before you take Kisplyx How to take Kisplyx
Kaj je zdravilo Kisplyx in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Kisplyx Kako jemati zdravilo Kisplyx Možni neželeni učinki
Contraception, pregnancy and breast-feeding
Kontracepcija, nosečnost in dojenje
If you are not sure talk to your doctor before taking Kisplyx.
Če ste negotovi, se posvetujte z zdravnikom, preden začnete jemati zdravilo Kisplyx.
Resolves to Grade 0-1.
Izboljša se na stopnjo 0-1.
• black, tarry, or bloody stools, or coughing up of blood - these may be signs of bleeding inside your body.
• črno, smolasto ali krvavo blato ali izkašljevanje krvi - to so lahko znaki krvavitve znotraj telesa;
It is used in combination with everolimus to treat patients with advanced kidney cancer (advanced renal cell carcinoma) where other treatments (so-called “VEGF-targeted therapy”) have not helped stop the disease.
Uporablja se skupaj z everolimusom za zdravljenje bolnikov z napredovalim ledvičnim rakom (napredovali karcinom ledvičnih celic), če drugi načini zdravljenja (tako imenovana »terapija, usmerjena v VEGF«) niso pomagali zaustaviti bolezni.
• Your doctor may reduce your dose if you experience side effects.
• Zdravnik vam lahko zmanjša odmerek, če se pri vas pojavijo neželeni učinki.
Your doctor may consider stopping Kisplyx if you will be undergoing a major surgical procedure as Kisplyx may affect wound healing.
Zdravnik bo morda razmislil o prekinitvi zdravljenja z zdravilom Kisplyx, če boste imeli večji kirurški poseg, saj zdravilo Kisplyx lahko vpliva na celjenje ran.
Mild to moderate adverse reactions (e.g., Grade 1 or 2) generally do not warrant interruption of the combination, unless intolerable to the patient despite optimal management.
Blagi do zmerni neželeni učinki (npr. stopnje 1 ali 2) na splošno ne upravičijo prekinitve odmerjanja kombinacije zdravil, razen če jih bolnik ne more prenašati kljub optimalni obravnavi.
• Swallow the capsules whole with water or dissolved.
• Kapsule pogoltnite cele z vodo ali raztopljene v njej.
Based on a population pharmacokinetic analysis of patients receiving up to 24 mg lenvatinib once daily, age, sex, weight, and race (Japanese vs. other, Caucasian vs. other) had no significant effects on clearance (see section 4.2).
Na podlagi populacijske farmakokinetične analize bolnikov, ki so prejemali do 24 mg lenvatiniba enkrat na dan, starost, spol, telesna masa in rasa (Japonci v primerjavi z drugimi, belci v primerjavi z drugimi) niso pomembno vplivali na očistek (glejte poglavje 4.2).
Tumour assessments were evaluated according to RECIST 1.1.
Ocenjevanje tumorjev so vrednotili po RECIST 1.1.
Blood pressure (BP) level
Raven krvnega tlaka (KT)
Carcinogenicity studies have not been conducted with lenvatinib.
Študij kancerogenosti z lenvatinibom niso opravili.
Alternatively, the lenvatinib capsules may be added without breaking or crushing them to a tablespoon of water or apple juice in a small glass to produce a suspension.
Druga možnost je, da bolnik doda kapsule lenvatiniba, ne da bi jih odprl ali zdrobil, jedilni žlici vode ali sadnega soka v majhnem kozarcu, da bo nastala suspenzija.
Paediatric population See section 4.2 for information on paediatric use.
Pediatrična populacija Za podatke o pediatrični uporabi glejte poglavje 4.2.
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.
Raztopite jih tako, da nalijete jedilno žlico vode ali jabolčnega soka v majhen kozarec in date kapsule v tekočino, ne da bi jih odprli ali zdrobili.
• low levels of platelets in the blood which may lead to bruising and difficulty in wound healing
• nizka raven krvnih ploščic v krvi, kar lahko povzroči modrice in oteženo celjenje ran.
Tabulated list of adverse reactions for RCC and DTC studies Similar adverse reactions were observed in clinical trials in RCC and DTC.
Seznam neželenih učinkov v študijah RCC in DTC V kliničnih preskušanjih pri RCC in DTC so ugotovili podobne neželene učinke.
Kisplyx is not recommended for use in children and adolescents.
Pri otrocih in mladostnikih uporaba zdravila Kisplyx ni priporočljiva.
A multicentre, randomised, open-label, trial was conducted to determine the safety and efficacy of lenvatinib administered alone or in combination with everolimus in subjects with unresectable advanced or metastatic RCC.
Opravili so multicentrično, randomizirano, odprto preskušanje, da bi ugotovili varnost in učinkovitost lenvatiniba, danega bodisi samega bodisi v kombinaciji z everolimusom pri preiskovancih z neresektabilnim napredovalim ali metastatskim RCC.
Diarrhoea resulted in discontinuation in one patient.
Driska je povzročila ukinitev zdravljenja pri enem bolniku.
Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormalities judged to be non-life-threatening, in which case they should be managed as severe reactions (e.g., Grade 3).
Zdravljenje je treba prekiniti v primeru življenjsko nevarnih neželenih učinkov (npr. stopnje 4), z izjemo laboratorijskih nenormalnosti, za katere sodimo, da niso življenjsko nevarne; v tem primeru jih obravnavajte kot hude neželene učinke (npr. stopnje 3).
Caution should be taken in patients receiving agents acting on the renin-angiotensin aldosterone system given a potentially higher risk for acute renal failure with the combination treatment.
Pri bolnikih, ki jemljejo zdravila, ki delujejo na renin-angiotenzin-aldosteronski sistem, je potrebna previdnost zaradi možnega večjega tveganja akutne odpovedi ledvic pri kombiniranem zdravljenju.
All events of hypothyroidism in the lenvatinib plus everolimus-treated group were of Grade 1 or 2.
Vsi dogodki hipotiroidizma v skupini, zdravljeni z lenvatinibom in everolimusom, so bili stopnje 1 ali 2.
• Use highly effective contraception while taking this medicine, and for at least one month after you finish treatment.
• Med jemanjem tega zdravila in vsaj še en mesec po končanem zdravljenju morate uporabljati učinkovito kontracepcijo.
• If you become pregnant while being treated with Kisplyx, tell your doctor immediately.
• Če med zdravljenjem z zdravilom Kisplyx zanosite, to takoj povejte zdravniku.
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.
Treba je upoštevati 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.
Based on the results of a post-hoc exploratory analysis in a limited number of patients per subgroup, the positive effect on PFS was seen regardless of which prior VEGF-targeted therapy was used: sunitinib (Hazard ratio [HR] = 0.356 [95% CI: 0.188, 0.674] or other therapies (HR = 0.350 [95% CI: 0.148, 0.828]).
Na podlagi rezultatov post-hoc eksploratorne analize pri manjšem številu bolnikov na podskupino je bil pozitivni učinek na PFS viden ne glede na to, katero predhodno zdravljenje, usmerjeno v VEGF, so uporabljali: sunitinib (razmerje tveganja [HR] = 0,356 [95 % IZ: 0,188, 0,674] ali druge terapije (HR = 0,350 [95 % IZ: 0,148, 0,828]).
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.
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 razponu od 3,2 do 32 mg enkrat na dan.
Table 5 Efficacy results in renal cell carcinoma lenvatinib 18 mg + everolimus 5 mg (N=51)
Preglednica 5 Rezultati učinkovitosti pri karcinomu ledvičnih celic lenvatinib 18 mg + everolimus 5 mg (N = 51)
Adverse reactions observed in clinical trials and reported from post-marketing use of lenvatinib are listed in Table 4..
Neželeni učinki, ki so jih ugotovili v kliničnih preskušanjih ter o katerih so poročali pri uporabi lenvatiniba v obdobju trženja, so navedeni v preglednici 4.
In 1.1% of patients, hypertension led to permanent treatment discontinuation.
Pri 1,1 % bolnikov so zaradi hipertenzije trajno ukinili zdravljenje.
Patients were stratified by haemoglobin level (≤13 g/dL vs. >13 g/dL for males and ≤11.5 g/dL vs >11.5 g/dL for females) and corrected serum calcium (≥10 mg/dL vs. <10 mg/dL).
Bolnike so stratificirali po koncentraciji hemoglobina (≤ 13 g/dl proti > 13 g/dl za moške in ≤ 11,5 g/dl proti > 11,5 g/dl za ženske) in popravljenem serumskem kalciju (≥ 10 mg/dl proti < 10 mg/dl).
The incidence of serious haemorrhage was 4.8% (cerebral haemorrhage, gastric haemorrhage and haemarthrosis).
Incidenca resnih krvavitev je bila 4,8 % (možganska krvavitev, želodčna krvavitev in hemartroza).
BP should be monitored after 1 week of treatment with lenvatinib, then every 2 weeks for the first 2 months, and monthly thereafter.
KT je treba preveriti po 1 tednu zdravljenja z lenvatinibom, nato prva 2 meseca vsaka 2 tedna in zatem enkrat na mesec.
Liver function tests should be monitored before initiation of treatment, then every 2 weeks for the first 2 months and monthly thereafter during treatment.
Teste funkcije jeter je treba opraviti pred začetkom zdravljenja, med zdravljenjem pa prva 2 meseca vsaka 2 tedna in nato enkrat na mesec.
The following information is derived from the clinical experience on single agent lenvatinib in patients with differentiated thyroid cancer (DTC; see Lenvima SmPC).
Naslednji podatki izvirajo iz kliničnih izkušenj z lenvatinibom kot edinim zdravilom pri bolnikih z diferenciranim rakom ščitnice (differentiated thyroid cancer - DTC; glejte SmPC za zdravilo Lenvima).
Most reactions resolved following supportive treatment, without dose interruption or reduction, which occurred in 1.5% and 1.1% of patients, respectively; 1 patient with Grade 4 hypocalcaemia discontinued treatment permanently.
Večina učinkov je izzvenela po podpornem zdravljenju brez prekinitve ali zmanjšanja odmerjanja, kar se je zgodilo pri 1,5 % oziroma 1,1 % bolnikov; pri 1 bolniku s hipokalcemijo stopnje 4 so zdravljenje trajno ukinili.
Following administration of radiolabelled lenvatinib to 6 patients with solid tumours, approximately two-thirds and one-fourth of the radiolabel were eliminated in the faeces and urine, respectively.
Po dajanju radioaktivno označenega lenvatiniba 6 bolnikom s čvrstimi tumorji se je približno dve tretjini oziroma ena četrtina radioaktivnega označevalca odstranila iz telesa z blatom oziroma urinom.
Table 2 Dose modifications from recommended lenvatinib daily dose a
Preglednica 2 Spremembe odmerka od priporočenega dnevnega odmerka lenvatiniba a
The hepatic failure cases were generally reported in patients with progressive liver metastases.
O primerih odpovedi jeter so na splošno poročali pri bolnikih s progresivnimi metastazami v jetrih.
*Grade 4 laboratory abnormalities judged to be non-life-threatening, may be managed as severe reactions (e.g., Grade 3)
*Laboratorijske nenormalnosti stopnje 4, za katere sodimo, da niso življenjsko nevarne, lahko obravnavamo kot hude neželene učinke (npr. stopnje 3).
Lenvatinib shows minimal or no inhibitory activities toward P-gp mediated and BCRP mediated transport activities.
Lenvatinib kaže minimalno ali sploh nikakršne inhibicijske aktivnosti proti transportnim dejavnostim, posredovanim s P-gp in BCRP.
Lenvatinib should not be started in patients with fistulae to avoid worsening and lenvatinib should be permanently discontinued in patients with oesophageal or tracheobronchial tract involvement and any Grade 4 fistula (see section 4.2); limited information is available on the use of dose interruption or reduction in management of other events, but worsening was observed in some cases and caution should be taken.
Lenvatiniba ne smemo začeti dajati bolnikom s fistulo, da se izognemo poslabšanju, trajno pa ga moramo ukiniti pri bolnikih s prizadetostjo ezofagealnega ali traheobronhialnega trakta in kakršno koli fistulo stopnje 4 (glejte poglavje 4.2); o uporabi prekinitve ali zmanjšanja odmerjanja za zdravljenje drugih dogodkov je na voljo malo podatkov, vendar so v nekaterih primerih opazili poslabšanje, zato je potrebna previdnost.
The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhea, fatigue, stomatitis, proteinuria, headache, and aggravation of PPE.
Najpogosteje opaženi neželeni učinki zdravila pri teh odmerkih so bili hipertenzija, navzea, driska, utrujenost, stomatitis, proteinurija, glavobol in poslabšanje PPE.
Proteinuria led to permanent treatment discontinuation in 4.8% of patients.
Proteinurija je povzročila trajno ukinitev zdravljenja pri 4,8 % bolnikov.
Hepatocellular damage and hepatitis includes: drug-induced liver injury, hepatic steatosis, and cholestatic liver injury.
Hepatocelularna poškodba in hepatitis vključujeta: z zdravili povzročeno poškodbo jeter, steatozo jeter in holestatično poškodbo jeter.
Kisplyx is indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
Zdravilo Kisplyx je v kombinaciji z everolimusom indicirano za zdravljenje odraslih bolnikov z napredovalim karcinomom ledvičnih celic (renal cell carcinoma - RCC) po enem predhodnem zdravljenju, usmerjenem v rastni faktor vaskularnega endotelija (vascular endothelial growth factor - VEGF).
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; however, gastrointestinal toxicity should be actively treated in order to reduce the risk of development of renal impairment or renal failure (see section 4.4 Renal failure and impairment).
Najboljšo medicinsko obravnavo (tj. zdravljenje ali terapijo) navzee, bruhanja in driske je treba uvesti pred kakršno koli prekinitvijo zdravljenja z lenvatinibom ali zmanjšanjem njegovega odmerka; vendar pa je treba toksičnost za prebavila zdraviti aktivno, da se zmanjša tveganje za razvoj okvare ledvic ali odpovedi ledvic (glejte poglavje 4.4 Odpoved ledvic in okvara ledvic).
The toxicity of lenvatinib was more prominent in younger rats (dosing initiated on PND7) compared with those with dosing initiated on PND21 and mortality and some toxicities were observed earlier in the juvenile rats at 10 mg/kg compared with adult rats administered the same dose level.
Toksičnost lenvatiniba je bila izrazitejša pri mlajših podganah (odmerjanje se je začelo na PND7) kot pri tistih, pri katerih se je odmerjanje začelo na PND21, poleg tega so smrtnost in nekatere toksičnosti prej opazili pri mladičih podgan pri odmerku 10 mg/kg v primerjavi z odraslimi podganami, ki so prejemale enako raven odmerkov.
For toxicities thought to be related to everolimus, treatment should be interrupted, reduced to alternate day dosing, or discontinued (see the everolimus SmPC for advice on specific adverse reactions).
Pri toksičnostih, za katere mislimo, da so povezane z everolimusom, je treba zdravljenje prekiniti, zmanjšati odmerek na odmerjanje vsak drugi dan ali zdravljenje ukiniti (glejte SmPC everolimusa za nasvet o specifičnih neželenih učinkih).
The capsules must be left in the liquid for at least 10 minutes and stirred for at least 3 minutes to dissolve the capsule shells.
Kapsule naj pusti v tekočini vsaj 10 minut in jih meša vsaj 3 minute, da se bodo ovojnice kapsul raztopile.
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.
Večina primerov je imela izid okrevanja ali ozdravitve po prekinitvi ali zmanjšanju, ki sta se pojavila pri 16,9 % oziroma 10,7 % bolnikov.
Leave for at least 10 minutes then stir for at least 3 minutes to dissolve the capsule shells.
Kapsule pustite v tekočini vsaj 10 minut, nato tekočino vsaj 3 minute mešajte, da se bodo ovojnice kapsul raztopile.
The Phase 1b portion included 11 patients who received the combination of 18 mg of lenvatinib plus 5 mg of everolimus.
V delu faze 1b je bilo vključenih 11 bolnikov, ki so prejemali kombinacijo 18 mg lenvatiniba in 5 mg everolimusa.
CI = confidence interval, NE = not estimable aPoint estimates are based on Kaplan-Meier method and 95% CIs are based on the Greenwood formula using log-log transformation.
aTočkovne ocene temeljijo na Kaplan-Meierjevi metodi, 95 % IZ-ji pa na Greenwoodovi formuli z uporabo transformacije log-log.
• feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy - these may be signs of a stroke, bleeding in your brain, or the effect on your brain of a severe increase in blood pressure.
• občutek odrevenelosti ali šibkosti na eni strani telesa, močan glavobol, napad krčev, zmedenost, otežen govor, spremembe vida ali občutek omotice - to so lahko znaki možganske kapi, krvavitve v možganih ali učinki močno zvišanega krvnega tlaka na vaše možgane;