FrancophonIA/ELRC3.0 huggingface dataset:
English: In the placebo-controlled phase III trials, the overall incidence of haemorrhage was 18.2% in patients treated with Stivarga and 9.5% in patients receiving placebo.
Slovenian: V s placebom nadzorovanih preskušanjih III. faze je bila celokupna incidenca hemoragij 18,2 % pri bolnikih, zdravljenih z zdravilom Stivarga in 9,5 % pri bolnikih, ki so prejemali placebo.
English: Cardiac ischaemia and infarction
Slovenian: Ishemija srca in srčni infarkt
English: Treatment with Stivarga may also lead to a higher risk of fungal infections of the mucous membrane, skin or the body.
Slovenian: Zdravljenje z zdravilom Stivarga lahko poveča tveganje za glivične okužbe sluznic, kože ali telesa.
English: In the placebo-controlled phase III trials, the overall incidence of hand-foot skin reaction was higher in patients treated with Stivarga, compared to patients receiving placebo (all grades: 51.4% vs. 6.5% CRC, 66.7% vs. 15.2% GIST and 51.6% vs.7.3% HCC).
Slovenian: V s placebom nadzorovanih preskušanjih III. faze je bila celokupna incidenca kožnih reakcij na dlaneh in podplatih večja pri bolnikih, zdravljenih z zdravilom Stivarga, v primerjavi z bolniki, ki so prejemali placebo (vse stopnje: 51,4 % oziroma 6,5 % (CRC), 66,7 % oziroma 15,2 % (GIST) in 51,6 % oziroma 7,3 % (HCC)).
English: Results from animal studies indicate that regorafenib can impair male and female fertility (see section 5.3).
Slovenian: Rezultati študij na živalih kažejo, da lahko regorafenib škodljivo vpliva na plodnost pri moških in ženskah (glejte poglavje 5.3).
English: Placebo plus BSC (n= 66)
Slovenian: placebo (N=66)
English: Most cases of hand-foot skin reaction in patients treated with Stivarga appeared during the first cycle of treatment and were mild to moderate in severity (Grades 1 and 2: 34.3%%, CRC, 44.7%, GIST and 39.3%, HCC).
Slovenian: večini primerov so se kožne reakcije na dlaneh in podplatih pri bolnikih, zdravljenih z zdravilom Stivarga, pojavile v prvem ciklu zdravljenja in so bile blage do zmerne (stopnje 1 in 2: 34,3 % (CRC), 44,7 % (GIST) oziroma 39,3 % (HCC)).
English: 1st occurrence
Slovenian: 1. pojav
English: Blood and lymphatic system disorders Haemoglobin decreased
Slovenian: Bolezni krvi in limfatičnega sistema zmanjšana vrednost hemoglobina trombocitopenija nevtropenija limfopenija
English: Disease-specific precautions - Hepatocellular carcinoma (HCC) In the pivotal placebo-controlled phase III study, patients received prior therapy with sorafenib.
Slovenian: Previdnosti ukrepi, povezani z boleznijo - rak jetrnih celic V ključni, s placebom nadzorovani študiji III. faze so bili bolniki predhodno zdravljeni s sorafenibom.
English: Concentration of free triiodothyronine (FT3) post baseline below lower limit of normal (<LLN) was reported in 29.2% of patients treated with Stivarga and in 20.4% of patients receiving placebo.
Slovenian: Koncentracija prostega trijodtironina (FT3) je bila glede na izhodiščno vrednost manjša od spodnje normalne vrednosti (< LLN) pri 29,2 % bolnikov, zdravljenih z zdravilom Stivarga, in pri 20,4 % bolnikov, ki so prejemali placebo.
English: Secondary endpoints were Progression-Free Survival (PFS), Time To Progression (TTP), Objective Tumour Response Rate (ORR) and Disease Control Rate (DCR).
Slovenian: Sekundarni cilji učinkovitosti so bili preživetje brez napredovanja bolezni (PFS - Progression Free Survival), čas do napredovanja bolezni (TTP - Time To Progression), objektivna stopnja tumorskega odziva (ORR
English: In total, 760 patients were randomised 2:1 to receive 160 mg regorafenib (4 tablets Stivarga each containing 40 mg regorafenib) orally once daily (N=505) plus Best Supportive Care (BSC or matching placebo (N=255) plus BSC for 3 weeks on therapy followed by 1 week off therapy.
Slovenian: Skupaj je bilo 760 bolnikov randomiziranih 2:1 v skupino, ki je prejemala 160 mg regorafeniba (4 tablete zdravila Stivarga; ena tableta vsebuje 40 mg regorafeniba) peroralno enkrat na dan (N = 505) in najboljšo podporno oskrbo (BSC) ali ustrezen placebo (N = 255) in najboljšo podporno oskrbo 3 tedne zdravljenja, ki jim je sledil 1 teden brez zdravljenja.
English: Get medical help immediately if you get the following symptoms: - yellowish discolouration of the skin and the whites of the eyes - dark urine - confusion and/or disorientation.
Slovenian: Takoj poiščite medicinsko pomoč, če opazite naslednje simptome: - porumenelost kože in beločnic, - temen seč, - zmedenost in/ali dezorientacija.
English: Method of administration Stivarga is for oral use.
Slovenian: Način uporabe Zdravilo Stivarga je za peroralno uporabo.
English: Most cases of bleeding events in patients treated with Stivarga were mild to moderate in severity (Grades 1 and 2: 15.2%), most notably epistaxis (6.1%).
Slovenian: Večina krvavitev je bila pri bolnikih, zdravljenih z zdravilom Stivarga, blagih do zmernih (stopnje 1 in 2: 15,2 %), najpogosteje epistaksa (6,1 %).
English: Management of HFSR may include the use of keratolytic creams (e.g. urea-, salicylic acid-, or alpha hydroxyl acid-based creams applied sparingly only on affected areas) and moisturizing creams (applied liberally) for symptomatic relief.
Slovenian: Pri oskrbi kožnih reakcij na dlaneh in podplatih se lahko uporabi keratolitične kreme (npr. kreme na osnovi sečnine, salicilne kisline ali alfa-hidroksilne kisline, nanesenih v tankem sloju samo na prizadete predele), in vlažilnih krem (nanesenih v poljubnih količinah) za lajšanje simptomov.
English: Gastrointestinal stromal tumours (GIST)
Slovenian: Gastrointestinalni stromalni tumorji (GIST)
English: Stivarga 40 mg film-coated tablets regorafenib
Slovenian: Stivarga 40 mg filmsko obložene tablete regorafenib
English: Hazard ratio* (95% CI)
Slovenian: Mediana (95 % IZ)
English: In the placebo-controlled phase III trials, tests on thyroid stimulating hormone (TSH) showed post baseline >ULN in 34.6% of patients treated with Stivarga and in 17.2% of patients receiving placebo.
Slovenian: V s placebom nadzorovanih preskušanjih III. faze so preiskave glede vrednosti tiroideo stimulirajočega hormona (TSH) pokazale > ULN glede na izhodiščne vrednosti pri 34,6 % bolnikov, zdravljenih z zdravilom Stivarga, in 17,2 % bolnikov, ki so prejemali placebo.
English: Stivarga has been associated with an increased incidence of arterial hypertension (see section 4.8).
Slovenian: Zdravilo Stivarga je povezano s povečano incidenco arterijske hipertenzije (glejte poglavje 4.8).
English: Figure 5: Kaplan-Meier curve of PFS (mRECIST)
Slovenian: Slika 5: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (mRECIST)
English: 2nd occurrence
Slovenian: 2. pojav
English: Once the bottle is opened the medicine is to be discarded after 7 weeks.
Slovenian: Zdravilo je treba zavreči 7 tednov po prvem odprtju plastenke.
English: Posterior reversible encephalopathy syndrome (PRES)
Slovenian: Bolezni živčevja glavobol tremor periferna nevropatija sindrom posteriorne reverzibilne encefalopatije (PRES)
English: One case of Grade 4 hypertension was reported in the GIST trial.
Slovenian: V preskušanju pri bolnikih z GIST so poročali o enem primeru hipertenzije stopnje 4.
English: In clinical trials, a higher incidence of HFSR was observed in Asian (in particular Japanese) patients treated with Stivarga, compared with Caucasians (see section 4.2).
Slovenian: V kliničnih preskušanjih so opazili večjo incidenco HFSR pri bolnikih azijske rase (predvsem Japoncih), zdravljenih z zdravilom Stivarga, v primerjavi z belci (glejte poglavje 4.2).
English: 3rd occurrence
Slovenian: 3. pojav
English: Close monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter se priporoča skrbno spremljanje splošne varnosti (glejte tudi poglavji 4.2 in 5.2).
English: Tell your doctor if you are breast-feeding or planning to breast-feed.
Slovenian: Obvestite zdravnika, če dojite ali nameravate dojiti.
English: This includes medicines obtained without a prescription or even over-the-counter medicines, such as vitamins, dietary supplements or herbal medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta ali v prosti prodaji, kot so npr. vitamini, prehranska dopolnila ali zdravila rastlinskega izvora.
English: Increase in amylase Increase in lipase Abnormal International normalised ratio
Slovenian: Preiskave izguba telesne mase povečane vrednosti amilaze povečane vrednosti lipaze nenormalna vrednost INR (mednarodno umerjeno razmerje)
English: Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11
Slovenian: Tél/Tel: +32-(0)2-535 63 11
English: The most serious adverse drug reactions in patients receiving Stivarga are severe liver injury, haemorrhage, gastrointestinal perforation and infection.
Slovenian: Najbolj resni neželeni učinki pri bolnikih, ki prejemajo zdravilo Stivarga, so hude okvare jeter, krvavitve, perforacija v prebavilih in okužba.
English: - if you have any liver problems including Gilbert's syndrome with signs such as: yellowish discolouration of the skin and the whites of the eyes, dark urine and confusion and/or disorientation.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Stivarga - če imate težave z jetri, vključno z Gilbertovim sindromom z znaki kot so: porumenelost kože ali beločnic, temen seč in zmedenost in/ali dezorientacija.
English: In vitro data indicate that regorafenib is metabolized by cytochrome CYP3A4 and uridine diphosphate glucuronosyl transferase UGT1A9.
Slovenian: Podatki in vitro kažejo, da se regorafenib presnavlja s citokromom CYP3A4 in uridindifosfat-glukuroniltransferazo UGT1A9.
English: The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (GRID) in patients with gastrointestinal stromal tumours (GIST) previously treated with 2 tyrosine kinase inhibitors (imatinib and sunitinib).
Slovenian: Klinično učinkovitost in varnost zdravila Stivarga so ovrednotili v mednarodnem, multicentričnem, randomiziranem, dvojno slepem, s placebom nadzorovanem kliničnem preskušanju III. faze (GRID) pri bolnikih z gastrointestinalnimi stromalnimi tumorji (GIST), ki so jih predhodno zdravili z dvema zaviralcema tirozin kinaze (imatinibom in sunitinibom).
English: Dose interruptions and/or dose reductions may be required based on individual safety and tolerability.
Slovenian: Glede na varnost in prenašanje zdravila bo morda treba odmerjanje pri posameznih bolnikih prekinjati in/ali zmanjševati odmerke.
English: Table 4a: Treatment emergent liver enzyme test abnormalities reported in placebo-controlled phase III trial in Asian patients with metastatic CRC (CONCUR)
Slovenian: Preglednica 4a: Odstopanja v izvidih laboratorijskih preiskav, ki so se pojavila med zdravljenjem, in o katerih so poročali v s placebom nadzorovanem preskušanju III. faze pri bolnikih z metastatskim kolorektalnim rakom (CONCUR)
English: Administration of ketoconazole (400 mg for 18 days), a strong CYP3A4 inhibitor, with a single dose of regorafenib (160 mg on day 5) resulted in an increase in mean exposure (AUC) of regorafenib of approximately 33%, and a decrease in mean exposure of the active metabolites, M-2 (N-oxide) and
Slovenian: Uporaba ketokonazola (400 mg, 18 dni), močnega zaviralca CYP3A4, z enkratnim odmerkom regorafeniba (160 mg peti dan), je povzročila povečanje povprečne izpostavljenosti (AUC) regorafenibu za približno 33 % in zmanjšanje povprečne izpostavljenosti aktivnima presnovkoma, M-2 (N-oksid) in M-5 (N-oksid in N-desmetil), za približno 90 %.
English: The mean daily regorafenib dose received was 147 mg.
Slovenian: Povprečni dnevni odmerek regorafeniba je bil 147 mg.
English: Available clinical data and physiology-based pharmacokinetic modelling indicate similar steady-state exposure of regorafenib and its metabolites M-2 and M-5 in patients with mild or moderate renal impairment, compared to patients with normal renal function.
Slovenian: Podatki, ki so na voljo, in farmakokinetično modeliranje na osnovi fiziologije kažejo podobno izpostavljenost regorafenibu in njegovima presnovkoma M-2 in M-5 v stanju dinamičnega ravnovesja pri bolnikih z blago ali zmerno okvaro ledvic kot pri bolnikih z normalnim delovanjem ledvic.
English: Treatment with Stivarga may lead to a higher risk of liver problems.
Slovenian: Zdravljenje z zdravilom Stivarga lahko poveča tveganje za težave z jetri.
English: The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (CORRECT) in patients with metastatic colorectal cancer who have progressed after failure of standard therapy.
Slovenian: Klinično učinkovitost in varnost zdravila Stivarga so ovrednotili v mednarodnem, multicentričnem, randomiziranem, dvojno slepem, s placebom nadzorovanem kliničnem preskušanju III. faze (CORRECT) pri bolnikih z metastatskim kolorektalnim rakom, ki je po neuspešnem standardnem zdravljenju napredoval.
English: Blood counts and coagulation parameters should be monitored in patients with conditions predisposing to bleeding, and in those treated with anticoagulants (e.g. warfarin and phenprocoumon) or other concomitant medicinal products that increase the risk of bleeding.
Slovenian: Pri bolnikih, ki so nagnjeni h krvavitvam, in tistih, ki se zdravijo z antikoagulanti (npr. varfarin in fenprokumon) ali drugimi sočasno uporabljenimi zdravili, ki povečajo tveganje za krvavitve, je treba spremljati število krvnih celic in kazalce koagulacije.
English: Severe liver function test abnormalities (Grade 3 to 4) and hepatic dysfunction with clinical manifestations (including fatal outcomes) have been reported in a small proportion of patients (see section 4.8).
Slovenian: Pri majhnem deležu bolnikov so poročali o hudih odstopanjih v izvidih preiskav delovanja jeter (stopnje 3 do 4) in motenem delovanju jeter s kliničnimi znaki (vključno s smrtnimi izidi) (glejte poglavje 4.8).
English: Patients receiving placebo who experienced disease progression were offered open-label regorafenib (cross-over option).
Slovenian: Bolnikom, ki so prejemali placebo, in pri katerih je bolezen napredovala, so ponudili možnost prehoda na zdravljenje z regorafenibom.
English: Concentration of free thyroxin (FT4) post baseline <LLN was reported in 8.1% of patients treated with Stivarga and 5.6% of patients receiving placebo.
Slovenian: O koncentracijah prostega tiroksina (FT4), manjših od spodnje normalne vrednosti (< LLN) glede na izhodiščne vrednosti, so poročali pri 8,1 % bolnikov, zdravljenih z zdravilom Stivarga, in pri 5,6 % bolnikov, ki so prejemali placebo.
English: - shortness of breath - burning/pain when urinating - unusual vaginal discharge or irritation - redness, swelling and/or pain in any part of the body.
Slovenian: - hudo vnetje grla - kratka sapa - pekoča bolečina/bolečina pri uriniranju - neobičajen izcedek iz nožnice ali draženje - rdečina, otekanje in/ali bolečina v katerem koli delu telesa To so lahko znaki okužbe.
English: Taking too much Stivarga may make some side effects more likely or more severe, especially: - skin reactions (rash, blisters, redness, pain, swelling, itching or peeling of your skin) - voice changes or hoarseness (dysphonia) - frequent or loose bowel movements (diarrhoea) - mouth sores (mucosal inflammation)
Slovenian: Pri prevelikem odmerjanju zdravila Stivarga so nekateri neželeni učinki bolj verjetni ali se pojavijo v hujši obliki, predvsem: - kožne reakcije (izpuščaj, mehurji, rdečina, bolečina, oteklina, srbenje ali luščenje kože), - spremenjen glas ali hripavost (disfonija),
English: Limited data in patients with moderate hepatic impairment (Child-Pugh B) indicate similar exposure, compared to patients with normal hepatic function after a single 100 mg dose of regorafenib.
Slovenian: Omejeni podatki po uporabi enkratnega odmerka 100 mg regorafeniba pri bolnikih z zmerno okvaro jeter (Child-Pugh B) kažejo podobno izpostavljenost kot pri bolnikih z normalnim delovanjem jeter.
English: The median treatment duration and daily dose, as well as the rate of dose modification and dose reduction were similar to those observed in patients with a reported
Slovenian: Mediana trajanja zdravljenja in dnevni odmerek ter stopnja prilagoditve odmerka in zmanjšanja odmerka so bili podobni kot pri bolnikih, ki so prejemali placebo in pri katerih je bil PS ≥ 2 (8,3 %).
English: - if you are allergic to regorafenib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Stivarga Ne jemljite zdravila Stivarga - če ste alergični na regorafenib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Regorafenib is metabolized primarily in the liver by oxidative metabolism mediated by CYP3A4, as well as by glucuronidation mediated by UGT1A9.
Slovenian: Regorafenib se primarno presnavlja v jetrih z oksidacijo preko CYP3A4 ter z glukuronidacijo preko UGT1A9.
English: In total, 199 patients with GIST were randomised 2:1 to receive either 160 mg regorafenib plus Best Supportive Care (BSC) (N=133) orally once daily or matching placebo plus BSC (N=66) for 3 weeks on therapy followed by 1 week off therapy.
Slovenian: Skupaj je bilo 199 bolnikov z GIST randomiziranih 2:1 v skupino, ki je prejemala 160 mg regorafeniba peroralno enkrat na dan in najboljšo podporno oskrbo (BSC; N = 133) ali ustrezen placebo (N = 66) in najboljšo podporno oskrbo, 3 tedne zdravljenja, ki jim je sledil 1 teden brez zdravljenja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Stivarga in all subsets of the paediatric population in the treatment of adenocarcinoma of the colon and rectum (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Stivarga za vse podskupine pediatrične populacije za zdravljenje adenokarcinoma debelega črevesa in danke (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Very common side effects (may affect more than 1 in 10 users)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: Gastrointestinal perforation (including fatal outcome) and fistulae have been reported in patients treated with Stivarga (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Stivarga, so poročali o gastrointestinalnih perforacijah (vključno s smrtnimi izidi) in fistulah (glejte poglavje 4.8).
English: No dose adjustment is required in patients with mild hepatic impairment.
Slovenian: Pri bolnikih z blago okvaro jeter odmerka ni treba prilagajati.
English: PFS was significantly longer in patients receiving Stivarga plus BSC (hazard ratio: 0.494, p<0.000001, see Table 5).
Slovenian: Preživetje brez napredovanja bolezni je bilo pomembno daljše pri bolnikih, ki so prejemali zdravilo Stivarga in najboljšo podporno oskrbo (razmerje ogroženosti: 0,494; p < 0,000001, glejte preglednico 5).
English: Tell your doctor immediately if you have taken more than your prescribed dose.
Slovenian: Če ste vzeli večji odmerek zdravila Stivarga, kot bi smeli Takoj obvestite zdravnika, če ste vzeli odmerek, večji od predpisanega.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Stivarga in all subsets of the paediatric population in the treatment of hepatocellular carcinoma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Stivarga za vse podskupine pediatrične populacije za zdravljenje raka jetrnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Get medical help immediately, if you get the following symptoms: passing blood in the stools or passing black stools, passing blood in the urine, stomach pain, coughing/vomiting up blood.
Slovenian: Takoj poiščite medicinsko pomoč, če se vam pojavijo naslednji simptomi: kri v blatu ali črno blato, kri v seču, bolečine v trebuhu, izkašljevanje/bruhanje krvi.
English: Breast-feeding must be discontinued during treatment with Stivarga.
Slovenian: Med zdravljenjem z zdravilom Stivarga je treba prenehati z dojenjem.
English: In total, 573 patients with HCC were randomised 2:1 to receive either 160 mg regorafenib orally once daily (n=379) plus Best Supportive Care (BSC) or matching placebo (n=194) plus BSC for 3 weeks on therapy followed by 1 week off therapy.
Slovenian: Skupaj je bilo 573 bolnikov z rakom jetrnih celic randomiziranih 2:1 v skupino, ki je prejemala peroralno 160 mg regorafeniba enkrat na dan (N = 379) in najboljšo podporno oskrbo (BSC) ali ustrezen placebo (N = 194) in najboljšo podporno oskrbo 3 tedne, nato pa je sledil 1 teden brez zdravljenja.
English: Film coat
Slovenian: Filmska obloga:
English: Stivarga has been associated with an increased incidence of myocardial ischaemia and infarction (see section 4.8).
Slovenian: Zdravilo Stivarga je povezano z večjo incidenco miokardne ishemije in infarkta (glejte poglavje 4.8).
English: Table 1: Recommended dose modifications and measures for HFSR Skin toxicity grade
Slovenian: Preglednica 1: Priporočene spremembe odmerkov in ukrepi v primeru kožnih reakcij na dlaneh in podplatih
English: Discontinuation of Stivarga is recommended in patients developing gastrointestinal perforation or fistula.
Slovenian: Pri bolnikih, pri katerih je prišlo do gastrointestinalne perforacije ali fistule, se priporoča prenehanje zdravljenja z zdravilom Stivarga.
English: No QTc prolonging effects were observed after administration of 160 mg regorafenib at steady state in a dedicated QT study in male and female cancer patients.
Slovenian: Po uporabi 160 mg regorafeniba v stanju dinamičnega ravnovesja v klinični študiji za preučevanje QT intervala pri bolnikih in bolnicah z rakom niso opazili podaljšanja QTc intervala.
English: Interrupt therapy until toxicity resolves to Grade 0-1.
Slovenian: Zdravljenje je treba prekiniti, dokler ni stopnja toksičnosti ponovno med 0 in 1.
English: Posology adjustments
Slovenian: Prilagajanje odmerkov
English: Infections and infestations
Slovenian: Infekcijske in parazitske bolezni okužbe*
English: Monitor transaminases weekly until return to <3 times ULN or baseline.
Slovenian: Vrednosti transaminaz je treba spremljati vsak teden, dokler se vrednosti transaminaz ne vrnejo na < 3-kratnik ULN ali na izhodiščne vrednosti.
English: Treatment with Stivarga may lead to a higher risk of severe liver problems.
Slovenian: Zdravljenje z zdravilom Stivarga lahko poveča tveganje za hudo okvaro jeter.
English: Hyperbilirubinaemia Increase in transaminases
Slovenian: Hiperbilirubinemija povečane vrednosti transaminaz huda okvara jeter*#
English: PFS was also significantly longer in patients receiving Stivarga plus BSC (hazard ratio: 0.311, p<0.000001), median PFS 3.2 months with Stivarga vs. 1.7 months with placebo.
Slovenian: Preživetje brez napredovanja bolezni je bilo pomembno daljše pri bolnikih, ki so prejemali zdravilo Stivarga in najboljšo podporno oskrbo (razmerje ogroženosti: 0,311; p < 0,000001), mediana preživetja brez napredovanja bolezni 3,2 meseca z zdravilom Stivarga v primerjavi z 1,7 meseci pri bolnikih, ki so prejemali placebo.
English: Screening for and subsequent treatment of oesophageal varices in patients with liver cirrhosis should be performed as per standard of care before starting treatment with Stivarga.
Slovenian: Kot standardni postopek je treba pri bolnikih s cirozo jeter pred začetkom zdravljenja z zdravilom Stivarga izvesti preiskave za odkrivanje varic požiralnika in ter jih nato zdraviti.
English: Stivarga plus BSC (n= 374)
Slovenian: Stivarga (N = 379)
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalneg a prostora disfonija
English: Stivarga has been associated with an increased incidence of infection events, some of which were fatal (see section 4.8).
Slovenian: Zdravilo Stivarga je bilo povezano s povečano pogostnostjo okužb, od katerih so bile nekatere smrtne (glejte poglavje 4.8).