FrancophonIA/ELRC3.0 huggingface dataset:
English: * International normalized ratio BSC = Best Supportive Care
Slovenian: * Mednarodno umerjeno razmerje (INR - international normalized ratio) najboljša podporna oskrba (BSC - Best Supportive Care)
English: Patients with unstable angina or new onset angina (within 3 months of starting Stivarga therapy), recent myocardial infarction (within 6 months of starting Stivarga therapy) and those with cardiac failure New York Heart Association (NYHA) Classification 2 or higher were excluded from the clinical studies.
Slovenian: Bolniki z nestabilno angino pektoris ali na novo nastalo angino pektoris (v treh mesecih po začetku zdravljenja z zdravilom Stivarga), nedavno prebolelim miokardnim infarktom (v šestih mesecih po začetku zdravljenja z zdravilom Stivarga) in tisti s srčnim popuščanjem 2. stopnje ali več po funkcijski razvrstitvi Newyorškega društva za srce (NYHA - New York Heart Association) so bili izključeni iz kliničnih študij.
English: No studies on the effects of Stivarga on the ability to drive or use machines have been performed.
Slovenian: Študij o vplivu zdravila Stivarga na sposobnost vožnje ali upravljanja strojev niso izvedli.
English: Recommended measures and dose modification
Slovenian: Priporočeni ukrepi in spremembe odmerka
English: Pharmacokinetic data indicate that regorafenib may be given concomitantly with substrates of CYP2C8, CYP2C9, CYP3A4, and CYP2C19 without a clinically meaningful drug interaction (see also section 4.4).
Slovenian: Farmakokinetični podatki kažejo, da se lahko regorafenib sočasno uporablja s substrati CYP2C8, CYP2C9, CYP3A4 in CYP2C19 brez klinično pomembnih interakcij med zdravili (glejte tudi poglavje 4.4).
English: The in vitro inhibitory potency towards CYP3A4 (Ki value of 11.1 micromolar) and CYP2C19 (Ki value of 16.4 micromolar) was less pronounced.
Slovenian: Učinkovitost zaviranja in vitro proti CYP3A4 (vrednost Ki 11,1 mikromolarna) in CYP2C19 (vrednost Ki 16,4 mikromolarna) je bila manj izrazita.
English: Metabolites M-2 and M-5 are weak substrates of P-gp.
Slovenian: Presnovka M-2 in M-5 sta šibka substrata P-gp.
English: Strong inducers of CYP3A4 should be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 should be considered.
Slovenian: Uporabi močnih induktorjev CYP3A4 se je treba izogibati ali za sočasno uporabo izbrati drugo zdravilo, ki ne inducira ali blago inducira CYP3A4.
English: The safety profile of regorafenib in these studies was consistent with the safety results of a phase III B study conducted in 2872 patients with metastatic colorectal cancer whose disease had progressed after treatment with standard therapies.
Slovenian: Varnostni profil regorafeniba v teh študijah je bil v skladu z izsledki glede varnosti v III. fazi študije B pri 2872 bolnikih z metastatskim kolorektalnim rakom, pri katerih je bolezen napredovala po zdravljenju s standarnimi oblikami zdravljenj.
English: M-5 may be reduced to M-4 in the gastrointestinal tract by microbial flora, allowing reabsorption of M-4 (enterohepatic circulation).
Slovenian: M-5 lahko mikrobna flora v prebavilih reducira v M-4, kar omogoča ponovno absorpcijo M-4 (enterohepatični obtok).
English: Patients receiving regorafenib who experienced disease progression and for whom in the investigator's opinion, treatment with regorafenib was providing clinical benefit, were offered the opportunity to continue open-label regorafenib.
Slovenian: Bolniki, ki so prejemali regorafenib, pri katerih je bolezen napredovala in katerim je, po oceni raziskovalca, zdravljenje z regorafenibom klinično koristilo, je bila ponujena možnost, da nadaljujejo zdravljenje z regorafenibom.
English: In preclinical studies regorafenib has demonstrated potent antitumour activity in a broad spectrum of tumour models including colorectal, gastrointestinal stromal and hepatocellular tumour models which is likely mediated by its anti-angiogenic and anti-proliferative effects.
Slovenian: V predkliničnih študijah je regorafenib pokazal močno protitumorno delovanje pri širokem spektru tumorskih modelov, vključno z modelom kolorektalnega, gastrointestinalnega stromalnega in hepatocelularnega tumorja,verjetno zaradi antiangiogenih in antiproliferativnih učinkov.
English: It is recommended to perform liver function tests (ALT, AST and bilirubin) before initiation of treatment with Stivarga and monitor closely (at least every two weeks) during the first 2 months of treatment.
Slovenian: Pred uvedbo zdravljenja z zdravilom Stivarga je priporočljivo opraviti preiskave delovanja jeter (ALT, AST in bilirubin) ter v prvih dveh mesecih zdravljenja skrbno nadzorovati delovanje jeter (vsaj vsaka dva tedna).
English: There is limited data on regorafenib in the black patient population.
Slovenian: Na voljo je malo podatkov za populacijo bolnikov črne rase.
English: Bayer Hungária Kft. Tel.:+36-14 87-41 00
Slovenian: Magyarország Bayer Hungária Kft. Tel.:+36-14 87-41 00
English: Stivarga 40 mg tablets are available in packs containing one bottle or three bottles.
Slovenian: Zdravilo Stivarga 40 mg je na voljo v pakiranju, ki vsebuje 1 ali 3 plastenke.
English: >3 times ULN (Grade 2 or higher) with concurrent bilirubin >2 times ULN
Slovenian: > 3-kratnik ULN (stopnja 2 ali več) s sočasnimi vrednostmi bilirubina > 2-kratnik ULN
English: UGT1A1 and UGT1A9 substrates
Slovenian: Substrata UGT1A1 in UGT1A9
English: In case of vomiting after regorafenib administration, the patient should not take additional tablets.
Slovenian: Če bolnik po zaužitju regorafeniba bruha, ne sme vzeti dodatnih tablet.
English: The median secondary PFS (as measured by the investigator's assessment) were 5.0 and 4.5 months, respectively.
Slovenian: Mediani sekundarnega preživetja brez napredovana bolezni (izmerjenega po oceni raziskovalca) sta bili 5,0 oziroma 4,5 mesecev.
English: - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall)
Slovenian: - če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
English: Cardiac electrophysiology/QT prolongation
Slovenian: Elektrofiziologija srca/podaljšanje QT intervala
English: Stivarga should be prescribed by physicians experienced in the administration of anticancer therapy.
Slovenian: Zdravilo Stivarga mora predpisati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: However, a potential of regorafenib to adversely affect male and female reproduction has to be considered based on morphological changes in the testes, ovaries, and the uterus observed after repeated dosing in rats and dogs at exposures below the anticipated human exposure (based on AUC comparison).
Slovenian: Vendar pa je treba upoštevati, da lahko regorafenib škodljivo vpliva na plodnost pri moških in ženskah zaradi morfoloških sprememb mod, jajčnikov in maternice, ki so jih opazili po ponavljajočem odmerjanju pri podganah in psih pri izpostavljenosti, ki je bila manjša od pričakovane izpostavljenosti pri ljudeh (glede na primerjavo AUC).
English: The overall safety profile of Stivarga is based on data from more than 4,800 treated patients in clinical trials including placebo-controlled phase III data for 636 patients with metastatic colorectal cancer (CRC), 132 patients with gastrointestinal stromal tumours (GIST) and 374 patients with hepatocellular carcinoma (HCC).
Slovenian: Splošni varnostni profil zdravila Stivarga temelji na podatkih zbranih pri več kot 4.800 zdravljenih bolnikih v kliničnih preskušanjih, vključno s podatki iz s placebom nadzorovane III. faze študije pri 636 bolnikih z metastatskim kolorektalnim rakom, 132 bolnikih z gastrointestinalnimi stromalnimi tumorji (GIST) in 374 bolnikih z rakom jetrnih celic (HCC).
English: Prior to and during treatment with Stivarga, your doctor will do blood tests to monitor your liver function.
Slovenian: Pred in med zdravljenjem z zdravilom Stivarga bo zdravnik opravil krvne preiskave za spremljanje delovanja vaših jeter.
English: In patients developing PRES, discontinuation of Stivarga, along with control of hypertension and supportive medical management of other symptoms is recommended.
Slovenian: Pri bolnikih, pri katerih se razvije PRES, se priporoča prenehanje zdravljenja z zdravilom Stivarga in hkrati nadzor hipertenzije ter podporno simptomatsko zdravljenje drugih simptomov.
English: Stivarga 40 mg tablets are light pink and oval, marked with “BAYER” on one side and “40” on the other side.
Slovenian: Zdravilo Stivarga 40 mg so svetlo rožnate ovalne tablete, z oznako "BAYER" na eni in "40" na drugi strani.
English: Since only limited data are available for patients with moderate hepatic impairment (Child Pugh B), no dose recommendation can be provided.
Slovenian: Ker je za bolnike z zmerno okvaro jeter (Child-Pugh B) na voljo le malo podatkov, priporočil za odmerjanje ni na voljo.
English: - if you get severe stomach and bowel problems (gastrointestinal perforation or fistula), your doctor should decide to discontinue treatment with Stivarga.
Slovenian: - če imate želodčne ali črevesne težave (gastrointestinalna perforacija ali fistula), se bo zdravnik odločil za prekinitev zdravljenja z zdravilom Stivarga.
English: Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium (see section 4.4).
Slovenian: En dnevni odmerek 160 mg vsebuje 2,427 mmol (ali 55,8 mg) natrija (glejte poglavje 4.4).
English: If a dose is missed, then it should be taken on the same day as soon as the patient remembers.
Slovenian: Če bolnik pozabi vzeti odmerek, ga mora vzeti še isti dan, takoj ko se spomni.
English: Inhibitors of CYP3A4 and UGT1A9/inducers of CYP3A4
Slovenian: Zaviralci CYP3A4 in UGT1A9/induktorji CYP3A4
English: If patients experience symptoms affecting their ability to concentrate and react during treatment with Stivarga, it is recommended that they do not drive or use machines until the effect subsides.
Slovenian: Če bolnik med zdravljenjem z zdravilom Stivarga občuti simptome, ki vplivajo na njegovo zbranost in odzivnost je priporočljivo, da ne vozi in ne upravlja strojev, dokler učinki ne izzvenijo.
English: Pregnancy, breast-feeding and fertility Tell your doctor if you think you are pregnant, may be pregnant or plan on becoming pregnant as Stivarga should not be used during pregnancy unless clearly necessary.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, saj zdravila Stivarga med nosečnostjo ne smete uporabljati, če ni nujno potrebno.
English: After repeated dosing to mice, rats and dogs, adverse effects were observed in a number of organs, primarily in the kidneys, liver, digestive tract, thyroid gland, lympho-/haematopoietic system, endocrine system, reproductive system and skin.
Slovenian: Po ponavljajočem odmerjanju mišim, podganam in psom so neželene učinke opazili na številnih organih, predvsem na ledvicah, jetrih, prebavilih, ščitnici, limfopoetskem/hematopoetskem sistemu, endokrinem sistemu, reproduktivnem sistemu in koži.
English: When re-starting treatment, decrease dose by 40 mg (one tablet).
Slovenian: Pri ponovni uvedbi zdravljenja je treba odmerek zmanjšati za 40 mg (ena tableta).
English: Inhibitors of P-glycoprotein and BCRP/Inducers of P-glycoprotein and BCRP In vitro studies indicate that the active metabolites M-2 and M-5 are substrates for P-glycoprotein and BCRP.
Slovenian: Zaviralci glikoproteina P in BCRP / induktorji glikoproteina P in BCRP Študije in vitro kažejo, da sta aktivna presnovka M-2 in M-5 substrata glikoproteina P in BCRP.
English: The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy.
Slovenian: Priporočeni odmerek regorafeniba je 160 mg (4 tablete po 40 mg) enkrat na dan 3 tedne, ki jim sledi 1 teden brez zdravljenja.
English: Regorafenib is a uridine diphosphate glucuronosyl transferase (UGT) 1A1 inhibitor (see section 4.5).
Slovenian: Regorafenib je zaviralec uridindifosfat-glukuroniltransferaze (UGT) 1A1 (glejte poglavje 4.5).
English: In the event of severe bleeding necessitating urgent medical intervention, permanent discontinuation of Stivarga should be considered.
Slovenian: V primeru hude krvavitve, zaradi katere je potrebna nujna medicinska pomoč, je treba razmisliti o trajnem prenehanju zdravljenja z zdravilom Stivarga.
English: The maximum daily dose is 160 mg.
Slovenian: Največji dnevni odmerek je 160 mg.
English: The primary efficacy endpoint was Overall Survival (OS).
Slovenian: Primarni cilj učinkovitosti je bilo celokupno preživetje (OS - Overall Survival).
English: Subgroup analyses for OS and PFS according to age (<65; ≥65), gender, ECOG PS, primary site of disease, time from first diagnosis of metastatic disease, prior anticancer treatment, prior treatment lines for metastatic disease, and KRAS mutation status showed a treatment effect favouring the regorafenib regimen over the placebo regimen.
Slovenian: Analize podskupin glede celokupnega preživetja in preživetja brez napredovanja bolezni glede na starost (< 65 let; ≥ 65 let), spol, ECOG PS, primarno mesto bolezni, čas od prve diagnoze metastatske bolezni, predhodno protitumorno zdravljenje, predhodne linije zdravljenja metastatske bolezni in status mutacije gena KRAS so pokazale terapevtski učinek v korist zdravljenja z regorafenibom v primerjavi s prejemanjem placeba.
English: What Stivarga looks like and contents of the pack
Slovenian: Izgled zdravila Stivarga in vsebina pakiranja
English: The clinical significance of this neomycin interaction is unknown, but may result in a decreased efficacy of regorafenib.
Slovenian: Klinični pomen te interakcije z neomicinom ni znan, vendar je posledično lahko zmanjšana učinkovitost regorafeniba.
English: PFS**
Slovenian: ND**
English: Alterations of teeth and bones and adverse effects in the reproductive system were more pronounced in young and growing animals as well as in juvenile rats and indicate a potential risk for children and adolescents.
Slovenian: Pri mladih, rastočih in juvenilnih podganah so bile bolj izražene spremembe na zobeh in kosteh ter neželeni učinki na reproduktivni sistem, kar kaže na možno tveganje pri otrocih in mladostnikih.
English: България Байер България ЕООД
Slovenian: Байер България ЕООД Тел.
English: For recommended measures and dose modifications in case of worsening of liver function tests considered related to treatment with Stivarga see Table 2 (see also section 4.4).
Slovenian: Za priporočene ukrepe in spremembe odmerkov v primeru poslabšanja izvidov preiskav delovanja jeter, za katere se meni, da so posledica zdravljenja z zdravilom Stivarga, glejte preglednico 2 (glejte tudi poglavje 4.4).
English: There are no data for patients with Child-Pugh C (severe) hepatic impairment.
Slovenian: Na voljo ni podatkov za bolnike s Child-Pugh C (hudo) okvaro jeter.
English: The overall incidence of hand-foot skin reaction (74.8%, CRC, 88.2%, GIST and 67.1%, HCC) was higher in Stivarga-treated Asian patients, compared to other ethnicities.
Slovenian: Celokupna incidenca kožnih reakcij na dlaneh in podplatih (74,8 % (CRC) , 88,2 % (GIST) in 67,1 % (HCC)) je bila večja pri bolnikih azijske rase, ki so bili zdravljeni z zdravilom Stivarga, v primerjavi z drugimi etničnimi skupinami bolnikov.
English: It is unknown whether regorafenib or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se regorafenib ali njegovi presnovki izločajo v materino mleko.
English: A clinical probe substrate study was performed to evaluate the effect of 14 days of dosing with 160 mg regorafenib on the pharmacokinetics of probe substrates of CYP2C8 (rosiglitazone) CYP2C9 (S-warfarin), CYP 2C19 (omeprazole) and CYP3A4 (midazolam).
Slovenian: Izvedena je bila klinična študija preskušanega substrata za oceno učinka 14-dnevne uporabe 160 mg regorafeniba na farmakokinetiko preskušanih substratov CYP2C8 (rosiglitazon), CYP2C9 (S-varfarin), CYP2C19 (omeprazol) in CYP3A4 (midazolam).
English: Of these events, 35.6% in the Stivarga arm and 54.5% in the placebo arm have been reported as not recovered/not resolved.
Slovenian: Za 35,6 % teh dogodkov v skupini bolnikov, zdravljenih z zdravilom Stivarga, in 54,5 % v skupini bolnikov, ki so prejemali placebo, so poročali, da bolniki niso okrevali/učinki niso izzveneli.
English: - The other ingredients are: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone (K-25) and silica colloidal anhydrous, iron oxide red (E172), iron oxide yellow (E172), lecithin (derived from soya), macrogol 3350, polyvinyl alcohol (partially hydrolysed), talc and titanium dioxide (E171) (see also section ‘Important information about some of the ingredients of Stivarga').
Slovenian: - Druge sestavine zdravila so: mikrokristalna celuloza, premrežen natrijev karmelozat, magnezijev stearat, povidon (K-25) in brezvodni koloidni silicijev dioksid, rdeči železov oksid (E 172), rumeni železov oksid (E 172), lecitin (pridobljen iz soje), makrogol 3350, delno hidroliziran polivinilalkohol, smukec in titanov dioksid (E 171) (glejte tudi poglavje »Pomembne informacije o nekaterih sestavinah zdravila Stivarga«).
English: For recommended dose modifications and measures in case of hand-foot skin reaction (HFSR)/palmar-plantar erythrodysesthesia syndrome see Table 1.
Slovenian: Glede priporočenih sprememb odmerkov in ukrepov v primeru kožnih reakcij na dlaneh in podplatih / sindroma palmarno-plantarne eritrodisestezije glejte preglednico 1.
English: In case of vomiting after regorafenib administration, you should not take additional tablets and you should inform your doctor.
Slovenian: Če po zaužitju regorafeniba bruhate, ne smete vzeti dodatnih tablet ampak morate obvestiti zdravnika.
English: The incidence of Grade 3 hypertension was 8.7% (CRC), 28.0% (GIST) and 15.2% (HCC).
Slovenian: Incidenca hipertenzije stopnje 3 je bila 8,7 % (CRC), 28,0 % (GIST) in 15,2 % (HCC).
English: The main circulating metabolites of regorafenib in human plasma are M-2 (N-oxide) and M-5 (N-oxide and N-desmethyl), which are pharmacologically active and have similar concentrations as regorafenib at steady state.
Slovenian: Glavna presnovka regorafeniba v humani plazmi sta M-2 (N-oksid) in M-5 (N-oksid in N-dezmetil), ki sta farmakološko aktivna in imata podobne koncentracije kot regorafenib v stanju dinamičnega ravnovesja.
English: Stivarga is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) as Stivarga has not been studied in this population and exposure might be increased in these patients.
Slovenian: Zdravila Stivarga se ne priporoča za uporabo pri bolnikih s hudo okvaro jeter (ChildPugh C), ker zdravila Stivarga niso preučevali pri tej populaciji in je lahko izpostavljenost pri teh bolnikih povečana.
English: Across all clinical trials, cardiac disorder events (all grades) have been more often (13.7% vs. 6.5%) reported in Stivarga-treated patients aged 75 years or older (N=410), compared to Stivarga-treated patients below 75 years (N=4108).
Slovenian: V vseh kliničnih preskušanjih so o motnjah delovanja srca (vseh stopenj) pogosteje (13,7 % v primerjavi z 6,5 %) poročali pri bolnikih, zdravljenih z zdravilom Stivarga, starih 75 let ali več (N = 410) v primerjavi z bolniki, zdravljenimi z zdravilom Stivarga, mlajših od 75 let (N = 4.108).
English: • Aetiology included Hepatitis B (38%), Hepatitis C (21%), Non-Alcoholic Steato Hepatitis
Slovenian: • glede na etiologijo so bili vključeni bolniki s hepatitisom B (38 %), hepatitisom C (21 %),
English: - reduction in the number of white blood cells (leucopenia) - decreased activity of the thyroid gland (hypothyroidism) - low levels of potassium, phosphate, calcium, sodium or magnesium in your blood
Slovenian: - zmanjšano število belih krvnih celic (levkopenija) - zmanjšano delovanje ščitnice (hipotiroidizem) - majhne vrednosti kalija, fosfatov, kalcija, natrija ali magnezija v vaši krvi (hipokaliemija,
English: Administration of regorafenib with a 5-day break prior to administration of irinotecan resulted in an increase of approximately 44% in AUC of SN-38, a substrate of UGT1A1 and an active metabolite of irinotecan.
Slovenian: Uporaba regorafeniba s 5-dnevnim premorom pred uporabo irinotekana je povzročila približno 44-odstotno povečanje AUC SN-38, ki je substrat UGT1A1 in aktivni presnovek irinotekana.
English: Occurrence Recommended dose modification and measures
Slovenian: Priporočena sprememba odmerka in ukrepi
English: It is a medicine used to treat cancer by slowing down the growth and spread of cancer cells and cutting off the blood supply that keeps cancer cells growing.
Slovenian: Zdravilo Stivarga vsebuje učinkovino regorafenib in se uporablja za zdravljenje raka, saj upočasni rast in razširjanje rakavih celic ter prekine oskrbo s krvjo, ki je potrebna za rast rakavih celic.
English: Systemic exposure of regorafenib at steady-state increases dose proportionally up to 60 mg and less than proportionally at doses greater than 60 mg. Accumulation of regorafenib at steady state results in about a 2-fold increase in plasma concentrations, which is consistent with the elimination half-life and dosing frequency.
Slovenian: Sistemska izpostavljenost regorafenibu v stanju dinamičnega ravnovesja narašča sorazmerno z odmerkom do 60 mg in manj kot sorazmerno pri odmerkih večjih od 60 mg. Kopičenje regorafeniba v stanju dinamičnega ravnovesja povzroči približno 2-kratno povečanje plazemskih koncentracij, kar je v skladu z razpolovnim časom izločanja in pogostnostjo odmerjanja.
English: The safety and efficacy of regorafenib in patients below 18 years of age in the indication gastrointestinal stromal tumours (GIST) have not been established.
Slovenian: Varnost in učinkovitost regorafeniba pri bolnikih, starih do 18 let, za indikacijo gastrointestinalnih stromalnih tumorjev (GIST), nista bili dokazani.
English: Women of childbearing potential and men should ensure effective contraception during treatment and up to 8 weeks after completion of therapy.
Slovenian: Ženske v rodni dobi in moški morajo med zdravljenjem in še 8 tednov po končanem zdravljenju uporabljati učinkovito kontracepcijsko metodo.
English: As medicinal products with anti-angiogenic properties may suppress or interfere with wound healing, temporary interruption of Stivarga is recommended for precautionary reasons in patients undergoing major surgical procedures.
Slovenian: Ker lahko zdravila z antiangiogenimi lastnostmi zavirajo ali ovirajo celjenje ran, se kot previdnostni ukrep pri bolnikih, pri katerih je načrtovan velik kirurški poseg, priporoča začasna prekinitev zdravljenja z zdravilom Stivarga.
English: Table 5: Efficacy results from the CORRECT study Efficacy parameter
Slovenian: Preglednica 5: Rezultati študije CORRECT glede učinkovitosti
English: This medicine contains 1.68 mg of lecithin (derived from soya) per daily dose (4 tablets).
Slovenian: To zdravilo vsebuje 1,68 mg lecitina (pridobljenega iz soje) na dnevni odmerek (4 tablete).
English: PS ≥2 was reported during Stivarga treatment in 11.4% of patients.
Slovenian: Med zdravljenjem z zdravilom Stivarga so pri 11,4 % bolnikov poročali o PS ≥ 2.
English: It is recommended to monitor biochemical and metabolic parameters during Stivarga treatment and to institute appropriate replacement therapy according to standard clinical practice if required.
Slovenian: Med zdravljenjem z zdravilom Stivarga se priporoča spremljanje biokemičnih kazalcev in kazalcev presnove ter uvedba ustreznega nadomestnega zdravljenja v skladu s standardno klinično prakso, če je potrebno.
English: The response rate (complete response or partial response) was 1% and 0.4% for Stivarga and placebo treated patients, respectively (p=0.188432, 1-sided).
Slovenian: Stopnja odziva na zdravljenje (popolni ali delni odziv) je bila 1 % pri bolnikih, zdravljenih z zdravilom Stivarga oziroma 0,4 % pri bolnikih, ki so prejemali placebo (p = 0,188432, 1-stransko).