natgillin/translations-raw huggingface dataset:
Evidence from a Phase 1/2 study of oral sunitinib conducted in 6 paediatric patients with GIST aged 13 years to 16 years who received sunitinib on Schedule 4/2, at doses ranging between 15 mg/m daily and 30 mg/m daily, and available published data (20 paediatric or young adult patients with GIST) indicated that sunitinib treatment resulted in disease stabilization in 18 of 26 (69.2%) patients, either after imatinib failure or intolerance (16 patients with stable disease out of 21), or de novo/after surgery (2 patients with stable disease out of 5).
faze s peroralnim sunitinibom, ki je potekala pri 6 pediatričnih bolnikih z GIST, starih od 13 let do 16 let, ki so prejemali sunitinib po shemi 4/2 v odmerkih v razponu med 15 mg/m na dan in 30 mg/m na dan, ter razpoložljivi objavljeni podatki (pri 20 pediatričnih ali mlajših odraslih bolnikih z GIST) so pokazali, da je zdravljenje s sunitinibom stabiliziralo bolezen pri 18 od 26 (69,2 %) bolnikov, bodisi po neuspešnem zdravljenju z imatinibom ali neprenašanju imatiniba (16 bolnikov s stabilno boleznijo od 21 bolnikov) ali pri bolezni de novo/po kirurškem posegu (2 bolnika s stabilno boleznijo od 5 bolnikov).
In this study, 312 patients were randomised (2:1) to receive either 50 mg sunitinib or placebo, orally once daily on Schedule 4/2 until disease progression or withdrawal from the study for another reason (207 patients received sunitinib and 105 patients received placebo).
V tej študiji so312 bolnikov randomizirali (2:1) na peroralno uporabo 50 mg sunitiniba ali placeba enkrat na dan po shemi 4/2; bolnike so spremljali do napredovanja bolezni ali do umika iz študije zaradi kakšnega drugega razloga (sunitinib je prejemalo 207 bolnikov in placebo 105 bolnikov).
Cases of hepatic failure, some with a fatal outcome, were observed in < 1% of solid tumour patients treated with sunitinib.
Primere odpovedi delovanja jeter, nekatere s smrtnim izidom, so opažali pri < 1 % bolnikov s čvrstimi tumorji, ki so se zdravili s sunitinibom.
In this study the objective response rate was 36.5% (95% CI: 24.7%, 49.6%) and the median TTP was 37.7 weeks (95% CI: 24.0, 46.4).
V tej študiji je objektivni odziv na zdravljenje znašal 36,5 % (95 % IZ: 24,7 %; 49,6 %) in mediani TTP 37,7 tedna (95 % IZ: 24,0; 46,4).
Cases of serious pancreatic events, some with fatal outcome, have been reported.
Opisali so primere resnih pankreatičnih pojavov, včasih s smrtnim izidom.
Furthermore, based on an integrated population PK analysis of pooled data from the 3 paediatric studies (2 paediatric solid tumour studies and 1 paediatric GIST study; ages: 6 years to 11 years and 12 years to 17 years), baseline body surface area (BSA) was a significant covariate on apparent clearance of sunitinib and its active metabolite.
Nadalje je bila na podlagi celovite populacijske FK analize združenih podatkov iz 3 pediatričnih študij (2 študij pri pediatričnih bolnikih s čvrstimi tumorji in 1 študije pri pediatričnih bolnikih z GIST; starost od 6 let do 11 let in od 12 let do 17 let) izhodiščna telesna površina (BSA - body surface area) pomembna sospremenljivka navideznega očistka sunitiniba in njegovega aktivnega presnovka.
• Infections.
• okužbe
Treatment-related venous thromboembolic events were reported in approximately 1.0% of patients with solid tumours who received sunitinib on clinical trials, including GIST and RCC.
Z zdravljenjem povezane venske trombembolične dogodke so zabeležili pri približno 1,0 % bolnikov s čvrstimi tumorji, ki so prejemali sunitinib v kliničnih preskušanjih, vključno z GIST in RCC.
In clinical studies of sunitinib and from postmarketing surveillance, seizures have been reported.
V kliničnih študijah s sunitinibom in med nadzorom v obdobju trženja zdravila so poročali o konvulzijah.
Prolonged treatment with sunitinib did not appear to be associated with new types of TRAEs.
Podaljšano zdravljenje s sunitinibom ni bilo povezano z novimi vrstami z zdravljenjem povezanih neželenih učinkov.
Sutent may affect the way your wounds heal.
Zdravilo Sutent lahko vpliva na celjenje vaših ran.
You should not breast-feed during treatment with Sutent.
Med zdravljenjem z zdravilom Sutent ne smete dojiti.
Using comprehensive serial ECG assessments at times corresponding to either therapeutic or greater than therapeutic exposures, none of the patients in the evaluable or intent-to-treat (ITT) populations were observed to develop QTc interval prolongation considered as “severe” (i.e. equal to or greater than Grade 3 by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0).
Med tem ovrednotenjem pri nobenem bolniku v ocenljivi populaciji ali populaciji z-namenom-zdravljenja (ITT - Intent-To-Treat) niso opazili podaljšanja intervala QTc, ki bi veljalo za ''hudo'' (tj. enako ali večje od stopnje 3 po merilih za poenoteno terminologijo neželenih dogodkov [CTCAE - Common Terminology Criteria for Adverse Events], različica 3.0).
Temporary suspension of sunitinib is recommended; following resolution, treatment may be resumed at the discretion of the treating physician (see section 4.8).
Priporočljiva je začasna prekinitev uporabe sunitiniba; po izboljšanju stanja je mogoče zdravljenje po presoji lečečega zdravnika znova uvesti (glejte poglavje 4.8).
CYP3A4 inhibitors/inducers
Zaviralci/induktorji CYP3A4
If you might get pregnant, you should use a reliable method of contraception during treatment with Sutent.
Če lahko zanosite, morate med zdravljenjem z zdravilom Sutent uporabljati učinkovito kontracepcijo.
Administration of sunitinib with potent CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations.
Uporaba sunitiniba z močnimi zaviralci CYP3A4 (npr. z ritonavirjem, itrakonazolom, eritromicinom, klaritromicinom, sokom grenivke) lahko zviša koncentracijo sunitiniba.
• Burning or painful sensation in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestine.
• pekoč ali boleč občutek v jeziku, vnetje sluznice prebavnega trakta, prekomerna količina plinov v želodcu ali črevesu
• Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue, muscle pain, muscle spasms.
• mišično-skeletna bolečina (bolečina v mišicah in kosteh), šibkost mišic, utrujenost mišic,
Patients with seizures and signs/symptoms consistent with posterior reversible leukoencephalopathy syndrome (RPLS), such as hypertension, headache, decreased alertness, altered mental functioning and visual loss, including cortical blindness, should be controlled with medical management including control of hypertension.
Bolniki s konvulzijami in znaki oz. simptomi, ki se skladajo s sindromom reverzibilne posteriorne levkoencefalopatije (RPLS - reversible posterior leukoencephalopathy syndrome), npr. hipertenzijo, glavobolom, zmanjšano pozornostjo, duševnimi motnjami in prizadetostjo vida (vključno s kortikalno slepoto), potrebujejo medicinski nadzor, ki naj obsega tudi obvladovanje hipertenzije.
Poly(chlorotrifluoroethylene)/PVC transparent perforated unit dose blister with aluminium foil coated with heat seal lacquer containing 28 x 1 hard capsules.
Prozorni perforirani enoodmerni pretisni omot iz poliklorotrifluoretilena/PVC z aluminijsko folijo, prekrito z lakom za toplotno lepljenje, ki vsebuje 28 x 1 trdih kapsul.
For GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability.
Pri GIST in MRCC je odmerek mogoče prilagajati v korakih po 12,5 mg, upoštevaje varnost in prenašanje pri posameznem bolniku.
• Haemorrhoids, pain in the rectum, gingival bleeding, difficulty in swallowing or inability to swallow.
• hemoroidi, bolečina v rektumu, krvavitev dlesni, težave pri požiranju ali nezmožnost požiranja
A total of 29 patients in the sunitinib arm and 24 in the placebo arm had received no prior systemic treatment; among these patients, the hazard ratio for PFS was 0.365 (95% CI: 0.156, 0.857), p=0.0156.
Skupno 29 bolnikov v skupini, ki je prejemala sunitinib, in 24 bolnikov v skupini, ki je prejemala placebo, ni bilo deležnih nobenega predhodnega sistemskega zdravljenja; med temi bolniki je razmerje ogroženosti za PFS znašalo 0,365 (95 % IZ: 0,156, 0,857), p = 0,0156.
The safety profile of sunitinib has been derived from a Phase 1 dose-escalation study, a Phase 2 open-label study, a Phase 1/2 single-arm study and from publications as described below.
Varnostni profil sunitiniba so pridobili iz študije s povečevanjem odmerka 1. faze, odprte študije 2. faze, študije z eno skupino 1./2.
The most common adverse drug reactions were gastrointestinal (GI) toxicity, neutropenia, fatigue, and ALT elevation.
Najpogostejši neželeni učinki zdravila so bili gastrointestinalna toksičnost, nevtropenija, utrujenost in zvišanje ravni ALT.
Fatal events other than those listed in section 4.4 above or in section 4.8 below that were considered possibly related to sunitinib included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, adrenal insufficiency, pneumothorax, shock, and sudden death.
Med dogodki s smrtnim izidom (razen naštetih v poglavju 4.4 zgoraj ali v poglavju 4.8 spodaj), ki so jih ocenili kot morda povezane s sunitinibom, so bili: odpoved več organov, diseminirana intravaskularna koagulacija, peritonealna krvavitev, adrenalna insuficienca, pnevmotoraks, šok in nenadna smrt.
The median PFS was 11.4 months for the sunitinib arm compared to 5.5 months for the placebo arm [hazard ratio: 0.418 (95% CI: 0.263, 0.662), p-value=0.0001]; similar results were observed when derived tumour response assessments based upon application of RECIST to investigator tumour measurements were used to determine disease progression, as shown in Table 4.
Mediana vrednost PFS je znašala 11,4 meseca pri skupini, ki je prejemala sunitinib, v primerjavi s 5,5 meseci pri skupini, ki je prejemala placebo [razmerje ogroženosti: 0,418 (95 % IZ: 0,263, 0,662), vrednost p = 0,0001]; podobne rezultate so opažali, kadar so bila za določitev napredovanja bolezni uporabljena izpeljana ocenjevanja odziva tumorja, izvedena po merilih RECIST pri meritvah tumorja s strani raziskovalcev, kot je prikazano v Preglednici 4.
At the time of the prespecified interim analysis, the median TTP on sunitinib was 28.9 weeks (95% CI: 21.3, 34.1) as assessed by the investigator and 27.3 weeks (95% CI: 16.0, 32.1) as assessed by the independent review and was statistically significantly longer than the TTP on placebo of 5.1 weeks (95% CI: 4.4, 10.1) as assessed by the investigator and 6.4 weeks (95% CI: 4.4, 10.0) as assessed by the independent review.
Pri vnaprej določeni vmesni analizi je mediani TTP s sunitinibom znašal 28,9 tedna (95 % IZ: 21,3-34,1), kot ga je ocenil raziskovalec, in 27,3 tedna (95 % IZ = 16,0-32,1), kot je bil ocenjen pri neodvisnem pregledu, in je bil statistično pomembno daljši kot TTP s placebom pri 5,1 tedna (95 % IZ: 4,4-10,1), kot ga je ocenil raziskovalec, in 6,4 tedna (95 % IZ = 4,4-10,0), kot je bil ocenjen pri neodvisnem pregledu.
Number of subjects at risk
Razmerje ogroženosti
Patients who develop thyroid dysfunction should be treated as per standard medical practice.
Bolnike, pri katerih se pojavi moteno delovanje ščitnice, je treba zdraviti v skladu z običajno medicinsko prakso.
The most frequent adverse drug reactions were diarrhoea, nausea, WBC count decreased, neutropenia, and headache in 3 (50.0%) patients each, primarily Grade 1 or 2 in severity.
Najpogostejši neželeni učinki zdravila so bili diareja, navzea, zmanjšanje števila belih krvnih celic, nevtropenija in glavobol, pri čemer se je vsak pojavil pri 3 (50,0 %) bolnikih, po resnosti pa so bili predvsem 1. ali 2. stopnje.
Therapy with Sutent should be initiated by a physician experienced in the administration of anticancer agents.
Zdravljenje z zdravilom Sutent mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih bolezni.
Cases of pulmonary embolism were observed in approximately 3.1% of patients with GIST and in approximately 1.2% of patients with MRCC, who received sunitinib in Phase 3 studies.
Primere pljučne embolije so opazili pri približno 3,1 % bolnikov z GIST in približno 1,2 % bolnikov z MRCC, ki so prejemali sunitinib v študijah 3. faze.
Patients should be advised that depigmentation of the hair or skin may occur during treatment with sunitinib.
Bolnikom je treba svetovati, da lahko med zdravljenjem s sunitinibom pride do depigmentacije las in dlak ali kože.
At approximately twice therapeutic concentrations, the maximum QTcF interval change from baseline was 15.4 msec (90% CI: 22.4 msec).
Pri približno dvakratni terapevtski koncentraciji je bila največja sprememba intervala QTcF od izhodišča 15,4 milisekunde (90 % IZ, 22,4 milisekunde).
It may be taken with or without food.
Bolnik lahko zdravilo vzame s hrano ali brez nje.
Hepatic dysfunction has been reported and may include Liver Function Test abnormalities, hepatitis, or liver failure (see section 4.4).
Poročali so o nepravilnem delovanju jeter, kar lahko vključuje nenormalnosti v rezultatih testov jetrne funkcije, hepatitis ali odpoved jeter (glejte poglavje 4.4).
Notify your doctor as soon as possible if you experience any signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger and loss of consciousness).
Obvestite zdravnika takoj, ko je mogoče, če se vam pojavijo znaki in simptomi nizke ravni sladkorja v krvi (utrujenost, razbijanje srca, potenje, občutek lakote in izguba zavesti).
Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles.
Obvestite zdravnika, če se počutite zelo utrujeni, imate kratko sapo ali otekle noge in gležnje.
reductions in gravid uterine weights and number of live foetuses were due to increases in the number of resorptions, increases in postimplantation loss and complete litter loss in 4 of 6 pregnant females at plasma exposure levels 3 times the systemic exposure in humans.
Pri kuncih sta bila zmanjšanje gravidne uterine mase in števila živih plodov posledica večjega števila resorpcij, večje poimplantacijske izgube in popolne izgube legla pri 4 od 6 brejih samic, in sicer pri plazemski izpostavljenosti, ki je bila 3-krat večja od sistemske izpostavljenosti pri ljudeh.
Risk factors associated with ATE, in addition to the underlying malignant disease and age  65 years, included hypertension, diabetes mellitus, and prior thromboembolic disease.
Med dejavniki tveganja, ki so povezani z ATE, so bili poleg osnovne maligne bolezni in starosti  65 let, prisotni hipertenzija, sladkorna bolezen in predhodna trombembolična bolezen.
In addition, 24% of sunitinib patients had received somatostatin analogues compared with 22% of placebo patients.
Poleg tega je 24 % s sunitinibom zdravljenih bolnikov prejemalo analoge somatostatina, v primerjavi z 22 % bolnikov iz skupine s placebom.
During sunitinib treatment, routine monitoring of thyroid function should be performed every 3 months.
Bolnike je treba med zdravljenjem s sunitinibom vsake 3 mesece rutinsko spremljati glede delovanja ščitnice.
Medicinal products that may increase sunitinib plasma concentrations Effect of CYP3A4 inhibitors
Zdravila, ki lahko zvečajo koncentracijo sunitiniba v plazmi Učinek zaviralcev CYP3A4
Treatment-related venous thromboembolic events were reported in patients who received sunitinib including deep venous thrombosis and pulmonary embolism (see section 4.8).
Pri bolnikih, ki so prejemali sunitinib, so zabeležili z zdravljenjem povezane venske trombembolične dogodke, vključno z globoko vensko trombozo in pljučno embolijo (glejte poglavje 4.8).
If angioedema due to hypersensitivity occurs, sunitinib treatment should be interrupted and standard medical care provided (see section 4.8).
Če se zaradi preobčutljivosti pojavi angioedem, je treba zdravljenje s sunitinibom prekiniti in uvesti standardno zdravniško oskrbo (glejte poglavje 4.8).
Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Pri uporabi sunitiniba so poročali o hudih izpuščajih na koži (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem), ki se najprej pojavijo kot rdečkaste pike, podobne tarči, ali okrogle lise, ki imajo na trupu v sredini pogosto še mehurje.
Moxifloxacin (400 mg) used as a positive control showed a 5.6 msec maximum mean QTcF interval change from baseline.
Med uporabo moksifloksacina (400 mg) kot pozitivne kontrole so ugotovili največjo povprečno spremembo intervala QTcF od izhodišča 5,6 milisekunde.
Immune system disorders Hypersensitivity reactions, including angioedema, have been reported (see section 4.4).
Bolezni imunskega sistema Poročali so o preobčutljivostnih reakcijah, vključno z angioedemom (glejte poglavje 4.4).
Baseline laboratory measurement of thyroid function is recommended in all patients.
Izhodiščne meritve delovanja ščitnice je priporočljivo opraviti pri vseh bolnikih.
Additional effects observed in other studies included: QTc interval prolongation, LVEF reduction and testicular tubular atrophy, increased mesangial cells in kidney, haemorrhage in gastrointestinal tract and oral mucosa, and hypertrophy of anterior pituitary cells.
Med dodatnimi učinki, opaženimi v drugih študijah, so bili: podaljšanje intervala QTc, zmanjšanje LVEF in atrofija tubulov v modih, zvečanje mezangijskega matriksa v ledvicah, krvavitve iz prebavil in ustne sluznice ter hipertrofija celic v sprednjem delu hipofize.
Population PK analyses of a pooled dataset from adult patients with GIST and solid tumours and paediatric patients with solid tumours were completed.
Izvedli so populacijske FK analize združenih zbirk podatkov, pridobljenih pri odraslih bolnikih z GIST in čvrstimi tumorji ter pediatričnih bolnikih s čvrstimi tumorji.
For pNET, dose modification in 12.5 mg steps may be applied based on individual safety and tolerability.
Pri pNET je odmerek mogoče prilagajati v korakih po 12,5 mg, upoštevaje varnost in prenašanje pri posameznem bolniku.
If signs or symptoms of hepatic failure are present, sunitinib should be discontinued and appropriate supportive care should be provided (see section 4.8).
Če se pojavijo znaki ali simptomi odpovedi jeter, je treba uporabo sunitiniba prekiniti in zagotoviti ustrezno podporno oskrbo (glejte poglavje 4.8).
Sutent was not studied in subjects with severe (Child-Pugh Class C) hepatic impairment.
Zdravila Sutent niso raziskali pri bolnikih s hudo jetrno okvaro (razred C po Child-Pughu).
Efficacy is based on time-to-tumour progression (TTP) and an increase in survival in GIST, on progression-free survival (PFS) and objective response rates (ORR) for treatment-naïve and cytokine-refractory MRCC respectively, and on PFS for pNET.
Učinkovitost temelji na času do napredovanja tumorja in podaljšanju preživetja pri GIST, na preživetju brez napredovanja bolezni (PFS - progression-free survival) pri še nezdravljenem MRCC, na objektivnem odzivu (ORR - objective response rates) na zdravljenje pri MRCC, odpornemu proti citokinom in na PFS pri pNET.
Patients should be screened for hypertension and controlled as appropriate.
Pri bolnikih je treba opraviti presejanje za hipertenzijo in jo ustrezno urediti.
In patients receiving sunitinib for treatment-naïve MRCC, 39% had bleeding events vs 11% of patients receiving interferon- (IFN-α).
Med bolniki, ki so prejemali sunitinib za še nezdravljen MRCC, je imelo pojave krvavitev 39 % bolnikov, med bolniki, ki so prejemali interferon- (IFN-), pa 11 %.
If symptoms of pancreatitis are present, patients should have sunitinib discontinued and be provided with appropriate supportive care.
Če se pri bolnikih pojavijo simptomi pankreatitisa, je treba zdravljenje s sunitinibom prekiniti in jim nuditi ustrezno podporno oskrbo.
No effects on male or female fertility were observed in reproductive toxicity studies.
Pri samcih in samicah v študijah vpliva na sposobnost razmnoževanja niso opazili učinkov na plodnost.
Sunitinib treatment in rats during organogenesis resulted in developmental effects at  5 mg/kg/day consisting of increased incidence of foetal skeletal malformations, predominantly characterised as retarded ossification of thoracic/lumbar vertebrae and occurred at plasma exposure levels 5.5 times the systemic exposure in humans.
Pri podganah je zdravljenje s sunitinibom med organogenezo, pri odmerkih  5 mg/kg/dan, povzročilo učinke na razvoj, ki so vključevali večjo incidenco skeletnih malformacij pri plodu, ki so se kazale predvsem kot zapoznelo zakostenevanje prsnih in ledvenih vretenc, pojavile pa so se pri plazemski izpostavljenosti, ki je bila 5,5-krat večja od sistemske izpostavljenosti pri ljudeh.
The EMA has waived the obligation to submit the results of the studies with Sutent in all subsets of the paediatric population for the treatment of gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma, and phaeochromocytoma) (see section 4.2).
EMA za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Sutent za vse podskupine pediatrične populacije pri gastroenteropankreatičnih nevroendokrinih tumorjih (z izjemo nevroblastoma, nevroganglioblastoma, feokromocitoma) (glejte poglavje 4.2).
In addition, patients should be observed closely for signs and symptoms of thyroid dysfunction during treatment, and patients who develop any signs and/or symptoms suggestive of thyroid dysfunction should have laboratory testing of thyroid function performed as clinically indicated.
Dodatno je treba bolnike med zdravljenjem skrbno spremljati glede znakov in simptomov motenega delovanja ščitnice, in pri bolnikih, pri katerih se pojavijo znaki ali simptomi, ki nakazujejo na moteno delovanje ščitnice, laboratorijsko preveriti delovanje ščitnice, kot je klinično indicirano.
Baseline was reset at cross-over and efficacy analyses were based on investigators assessment.
Izhodišče je bilo ponastavljeno ob prehodu s placeba na zdravilo, analizi učinkovitosti temeljita na oceni raziskovalcev.
Bleeding events, excluding epistaxis, were reported in 21.7% of patients receiving sunitinib in the Phase 3 pNET study compared to 9.85% of patients receiving placebo (see section 4.4)
Krvavitve, z izjemo epistakse, so se pojavljale pri 21,7 % bolnikov, ki so sunitinib prejemali v študiji 3. faze pri pNET, v primerjavi z 9,85 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
The most common (≥10%) treatment-related adverse events were neutrophil count decreased (6 [20.7%] patients) and haemorrhage intracranial (3[10.3%] patients).
Najpogostejša (≥ 10 %) z zdravljenjem povezana neželena učinka sta bila zmanjšanje števila nevtrofilcev (6 [20,7 %] bolnikov) in intrakranialna krvavitev (3 [10,3 %] bolniki).
In vitro, binding of sunitinib and its primary active metabolite to human plasma protein was 95% and 90%, respectively, with no apparent concentration dependence.
V preskusih in vitro je bila vezava sunitiniba na beljakovine v človeški plazmi 95 %, vezava njegovega primarnega aktivnega presnovka pa 90 %; vezavi nista bili odvisni od koncentracije.
Progression-free survival [median, months (95% CI)] by derived tumour response assessment based upon application of RECIST to investigator tumour assessments
Preživetje brez napredovanja bolezni [mediana, meseci (95 % IZ)] po izpeljani oceni odziva tumorja na temelju uporabe meril RECIST pri ocenah tumorjev s strani raziskovalcev
Treatment-naïve mRCC summary of efficacy endpoints (ITT population)
Preglednica 3 - Povzetek opazovanih dogodkov učinkovitosti pri še nezdravljenem MRCC (populacija ITT)
A higher incidence rate of hypoglycaemia events was reported in patients with pNET in comparison to MRCC and GIST.
Pri bolnikih s pNET so v primerjavi z bolniki z MRCC in GIST poročali o večji incidenci hipoglikemije.
If indicated, elimination of unabsorbed active substance may be achieved by emesis or gastric lavage.
Izločanje neabsorbirane učinkovine je mogoče doseči z emezo ali izpiranjem želodca, če je to indicirano.