FrancophonIA/ELRC3.0 huggingface dataset:
English: NA Best Supportive Care Hazard ratio < 1 favours Stivarga ** based on investigator's assessment of tumour response by modified RECIST Response rate (complete or partial response), DCR (complete response, partial response and stable disease maintained for 6 weeks)
Croatian: Stopa odgovora (potpuni ili djelomični odgovor), stopa kontrole bolesti (potpuni odgovor, djelomični odgovor i stabilna bolest održana 6 tjedana)
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
Croatian: Primjena ketokonazola (400 mg tijekom 18 dana), jakog inhibitora CYP3A4, i jedne doze regorafeniba (160 mg petog dana) rezultirala je povećanjem srednje vrijednosti izloženosti (AUC) regorafeniba za približno 33% i smanjenjem srednje vrijednosti izloženosti djelatnim metabolitima, M-2 (N-oksid) i M-5 (N-oksid i N-dezmetil) za približno 90%.
English: Table 3: Adverse drug reactions (ADRs) reported in clinical trials in patients treated with Stivarga
Croatian: Tablica 3: Nuspojave zabilježene u kliničkim ispitivanjima u bolesnika liječenih lijekom Stivarga
English: This medicine contains 55.8 mg sodium (main component of cooking/table salt) in each daily dose (4 tablets).
Croatian: Važne informacije o nekim sastojcima lijeka Stivarga Ovaj lijek sadrži 55,8 mg natrija (glavni sastojak kuhinjske soli) u jednoj dnevnoj dozi (4 tablete).
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).
Croatian: Većina slučajeva kožne reakcije na šakama i stopalima u bolesnika liječenih lijekom Stivarga pojavila se tijekom prvog ciklusa liječenja i bila je blage do umjerene težine (1. i 2. stupanj: u 34,3% bolesnika s CRC-om, 44,7% bolesnika s GIST-om i 39,3% bolesnika s HCC-om).
English: - if you experience skin problems Stivarga can cause redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
Croatian: Stivarga može prouzročiti crvenilo, bol, oticanje ili mjehure na dlanovima i tabanima.
English: Gastrointestinal stromal tumours (GIST)
Croatian: Gastrointestinalni stromalni tumori (GIST)
English: 5.0 months
Croatian: 5,0 mjeseci
English: Figure 5: Kaplan-Meier curve of PFS (mRECIST)
Croatian: Slika 5: Kaplan-Meierova krivulja preživljenja bez progresije bolesti (mRECIST)
English: Stivarga has been associated with an increased incidence of myocardial ischaemia and infarction (see section 4.8).
Croatian: Primjena lijeka Stivarga povezuje se s povećanom incidencijom ishemije i infarkta miokarda (vidjeti dio 4.8).
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.
Croatian: Preživljenje bez progresije bolesti također je bilo značajno dulje u bolesnika koji su primali lijek Stivarga uz najbolju standardnu njegu (omjer hazarda: 0,311, p<0,000001), s medijanom preživljenja bez progresije bolesti od 3,2 mjeseca uz lijek Stivarga naspram 1,7 mjeseci uz placebo.
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.
Croatian: Odmah potražite liječničku pomoć ako razvijete sljedeće simptome: žućkastu boju kože i bjeloočnica tamnu boju mokraće smetenost i/ili dezorijentaciju
English: TSH post baseline >4 times ULN was reported in 6.5% of patients treated with Stivarga and in 1.3% of patients receiving placebo.
Croatian: TSH nakon početnih vrijednosti > 4 puta od GGN bio je prijavljen u 6,5% bolesnika liječenih lijekom Stivarga i 1,3% bolesnika koji su primali placebo.
English: Monitor liver function weekly until resolution or return to baseline.
Croatian: Pratite jetrene funkcije svakog tjedna do nestanka promjena ili povratka na početne vrijednosti.
English: Rare side effects (may affect up to 1 in 1,000 users)
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 korisnika)
English: Headache Tremor Peripheral neuropathy
Croatian: Poremećaji živčanog sustava glavobolja tremor periferna neuropatija sindrom posteriorne reverzibilne encefalopatije
English: How to store Stivarga
Croatian: Kako čuvati lijek Stivarga
English: Stivarga plus BSC (n= 374)
Croatian: Stivarga uz najbolju potpornunjegu (n= 374)
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.
Croatian: Ukupno je 199 bolesnika s GIST-om bilo randomizirano u omjeru 2:1 da prima 160 mg regorafeniba uz najbolju potpornu njegu (N=133) peroralno jedanput na dan ili odgovarajući placebo uz najbolju potpornu njegu (N=66) tijekom 3 tjedna terapije, a zatim je slijedio 1 tjedan bez terapije.
English: Stivarga has been associated with an increased incidence of infection events, some of which were fatal (see section 4.8).
Croatian: Lijek Stivarga se povezuje s povišenom incidencijom za nastanak infekcija, od kojih su neke bile sa smrtnim ishodom (vidjeti dio 4.8).
English: In clinical trials, a higher incidence of severe liver function test abnormalities and hepatic dysfunction was observed in Asian (in particular Japanese) patients treated with Stivarga, compared with Caucasians (see section 4.2).
Croatian: U kliničkim ispitivanjima opažena je viša incidencija teških poremećaja rezultata testova jetrene funkcije i poremećaja funkcije jetre u bolesnika azijskog podrijetla (osobito Japanaca) liječenih lijekom Stivarga u usporedbi s bijelcima (vidjeti dio 4.2).
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.
Croatian: U bolesnika sa stanjima koja povećavaju sklonost krvarenju, kao i u onih koji se liječe antikoagulansima (primjerice, varfarinom i fenprokumonom) ili istodobno uzimaju lijekove koji povećavaju rizik od krvarenja, moraju se pratiti krvna slika i parametri koagulacije.
English: Icepharma hf. Sími: +354 540 80 00
Croatian: Sími: +354 540 80 00
English: Stivarga plus BSC (n= 132)
Croatian: Stivarga (N=133)
English: weakness or pain (peripheral neuropathy) - taste disorders - dry mouth - heartburn (gastro-oesophageal reflux) - infection or irritation of the stomach and intestines (gastroenteritis) - hair loss (alopecia) - dry skin - rash with flaking or peeling of skin (exfoliative rash) - a sudden, involuntary contraction of a muscle (muscle spasms) - protein in the urine (proteinuria) - high levels of certain enzymes involved in digestion (increase in amylase and lipase) - abnormal blood clotting condition (abnormal International Normalized Ratio).
Croatian: infekcija ili iritacija želuca i crijeva (gastroenteritis) gubitak kose (alopecija) suha koža osip s listanjem i ljuštenjem kože (eksfolijativni osip) iznenadne, nevoljne kontrakcije mišića (mišićni spazmi) bjelančevine u mokraći (proteinurija)
English: Hypokalaemia Hypophosphatemia Hypocalcaemia Hyponatraemia Hypomagnesaemia Hyperuricaemia Dehydration
Croatian: Nepoznato metabolizma i prehrane i uzimanje hrane hipofosfatemija hipokalcemija hiponatremija hipomagnezemija hiperuricemija dehidracija
English: Treatment with Stivarga may lead to a higher risk of liver problems.
Croatian: Liječenje lijekom Stivarga može povećati rizik od problema s jetrom.
English: PFS was significantly longer in patients receiving Stivarga plus BSC (hazard ratio: 0.494, p<0.000001, see Table 5).
Croatian: Preživljenje bez progresije bolesti bilo je značajno dulje u bolesnika koji su primali lijek Stivarga uz najbolju potpornu njegu (omjer hazarda: 0,494, p<0,000001, vidjeti tablicu 5).
English: Thrombocytopenia Anaemia
Croatian: Trombo citopenija anemija leukopenija
English: Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya) (see section 4.4).
Croatian: Svaka dnevna doza od 160 mg sadrži 1,68 mg lecitina (dobivenog iz soje).
English: Regorafenib plus BSC resulted in significantly longer PFS, compared to placebo plus BSC with a hazard ratio of 0.268 [95% CI 0.185, 0.388] and a median PFS of 4.8 months vs. 0.9 months (p < 0.000001).
Croatian: Regorafenib uz najbolju potpornu njegu doveo je do značajno duljeg PFS u usporedbi s placebom uz najbolju potpornu njegu, uz omjer hazarda od 0,268 [95% CI 0,185; 0,388] i medijan PFS od 4,8 mjeseci naspram 0,9 mjeseci (p < 0,000001).
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.
Croatian: Klinička djelotvornost i sigurnost lijeka Stivarga procijenjene su u međunarodnom, multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (CORRECT) u bolesnika s metastatskim CRC-om koji je napredovao nakon neuspjeha standardne terapije.
English: Titanium dioxide (E171)
Croatian: poli(vinilni alkohol), djelomično hidroliziran talk titanijev dioksid (E171) 6.2 Inkompatibilnosti
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva mišićni spazmi
English: Stivarga should be prescribed by physicians experienced in the administration of anticancer therapy.
Croatian: Lijek Stivarga mora propisivati liječnik iskusan u primjeni citotoksičnih lijekova.
English: Wound healing complications
Croatian: Komplikacije s cijeljenjem rana
English: Thrombocytopenia Neutropenia Lymphopenia Metabolism and nutrition disorders Hypocalcaemia Hypokalemia Hypophosphatemia
Croatian: Neutropenija Limfopenija Poremećaji metabolizma i prehrane Hipokalcemija Hipokalemija Hipofosfatemija Poremećaji jetre i žući
English: The most serious adverse drug reactions in patients receiving Stivarga are severe liver injury, haemorrhage, gastrointestinal perforation and infection.
Croatian: Najozbiljnije nuspojave u bolesnika koji su primali lijek Stivarga su teško oštećenje jetre, krvarenje, perforacija u probavnom sustavu i infekcija.
English: The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (RESORCE) in patients with hepatocellular carcinoma who have been previously treated with sorafenib.
Croatian: Klinička djelotvornost i sigurnost lijeka Stivarga procijenjene su u međunarodnom, multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (RESORCE) u bolesnika s hepatocelularnim karcinomom koji su prethodno liječeni sorafenibom.
English: Bayer d. o. o. Tel.: +386-(0)1-58 14 400
Croatian: Tel.: +386-(0)1-58 14 400
English: TTP was significantly longer in patients receiving regorafenib plus BSC than in patients receiving placebo plus BSC with a hazard ratio of 0.248 [95% CI 0.170, 0.364], and median TTP of 5.4 months vs. 0.9 months (p<0.000001) (see Table 6).
Croatian: Vrijeme do progresije bolesti (TTP) bilo je značajno dulje u bolesnika koji su primali regorafenib uz najbolju potpornu njegu nego u bolesnika koji su primali placebo uz najbolju potpornu njegu, uz omjer hazarda od 0,248 [95% CI 0,170; 0,364] i medijan TTP od 5,4 mjeseci naspram 0,9 mjeseci (p < 0,000001) (vidjeti tablicu 6).
English: The incidence of Grade 3 hand-foot skin reaction in Asians was 20.5% (CRC), 23.5% (GIST) and 13.5% (HCC) (see sections 4.2 and 4.4).
Croatian: Incidencija kožne reakcije na šakama i stopalima 3.stupnja u bolesnika azijskog podrijetla bila je 20,5% (CRC), 23,5% (GIST) i 13,5 %
English: The mean daily regorafenib dose received was 147 mg.
Croatian: Prosječna dnevna doza regorafeniba koju su ispitanici primili iznosila je 147 mg.
English: Patients were eligible to participate in the study if they experienced radiological disease progression during treatment with sorafenib and if they had a liver function status of Child-Pugh class A. Patients who permanently discontinued sorafenib therapy due to sorafenib-related toxicity or who tolerated less than 400 mg sorafenib once daily prior to withdrawal were excluded from the study.
Croatian: Bolesnici koji su trajno prestali s terapijom sorafenibom zbog toksičnosti povezane sa sorafenibom ili koji su podnosili manje od 400 mg sorafeniba jednom na dan prije prekida liječenja, isključeni su iz ispitivanja.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Sredstvo za sušenje čuvati u bočici.
English: The mean daily regorafenib dose received was 144 mg.
Croatian: Prosječna dnevna doza regorafeniba koju su ispitanici primili bila je 144 mg.
English: - if you recently had, or are going to have, a surgical procedure Stivarga might affect the way your wounds heal and treatment may need to be stopped until your wound have healed.
Croatian: Stivarga može utjecati na cijeljenje rana pa će možda trebati prekinuti liječenje dok Vam rana ne zacijeli.
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.
Croatian: Ukupno je randomizirano 573 bolesnika s HCC-om u omjeru 2:1 u skupinu koja je primala ili 160 mg regorafeniba jednom dnevno kroz usta (n=379) uz najbolju potpornu njegu ili u skupinu koja je primala placebo na isti način (n=194) uz najbolju potpornu njegu tijekom 3 tjedna, nakon kojih je slijedio 1 tjedan bez terapije.
English: § BSC Supportive Care * Hazard ratio < 1 favours Stivarga ** based on investigator's assessment of tumour response
Croatian: Omjer hazarda < 1 govori u prilog lijeka Stivarga ** na temelju ispitivačeve procjene odgovora tumora prema modificiranim RECIST kriterijima
English: The relative risk of disease progression or death was reduced by approximately 73.2% in regorafenib-treated patients, compared to placebo treated patients (see Table 6, Figure 2).The increase in PFS was consistent independent of age, sex, geographic region, prior lines of treatment, ECOG PS.
Croatian: Relativni rizik od progresije bolesti ili smrti bio je smanjen za približno 73,2% u bolesnika liječenih regorafenibom u usporedbi s bolesnicima koji su primali placebo (vidjeti tablicu 6, sliku 2).
English: Method of administration Stivarga is for oral use.
Croatian: Način primjene Stivarga je namijenjena za peroralnu primjenu.
English: Abnormalities of liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin) have been frequently observed in patients treated with Stivarga.
Croatian: U bolesnika liječenih lijekom Stivarga često su bili opaženi poremećaji rezultata testova jetrene funkcije (alanin aminotransferaze [ALT], aspartat aminotransferaze [AST] i bilirubina).
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja disfonija
English: Bayer plc Tel: +44 (0) 118 206 3000
Croatian: Tel: +44 (0)1 118 206 3000
English: Table 1: Recommended dose modifications and measures for HFSR Skin toxicity grade
Croatian: Tablica 1: Preporučene prilagodbe doze i mjere u slučaju sindroma palmarno-plantarne eritrodizestezije
English: - metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies.
Croatian: ili se ne smatraju kandidatima za liječenje, dostupnim terapijama.
English: Stivarga 40 mg film-coated tablets.
Croatian: NAZIV LIJEKA Stivarga 40 mg filmom obložene tablete
English: The mean daily regorafenib dose received was 140 mg.
Croatian: Srednja vrijednost primljene dnevne doze regorafeniba iznosila je 140 mg.
English: The addition of Stivarga to BSC resulted in a statistically significant improvement in OS compared to placebo plus BSC with a hazard ratio of 0.624 [95% CI 0.498, 0.782], p=0.000017 stratified log rank test, and a median OS of 10.6 months vs. 7.8 months (see Table 7 and Figure 4).
Croatian: Dodavanje lijeka Stivarga najboljoj potpornoj njezi rezultiralo je statistički značajnim poboljšanjem u ukupnom preživljenju, u usporedbi s placebom s najboljom potpornom njegom, uz omjer hazarda od 0,624 [95% CI 0,498; 0,782], p=0,000017 iz stratificiranog log rang testa, i medijan ukupnog preživljenja od 10,6 mjeseci naspram 7,8 mjeseci (vidjeti tablicu 7 i sliku 4).
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.
Croatian: Nakupljanje regorafeniba u stanju dinamičke ravnoteže rezultira u približno dvostrukom povećanju koncentracija u plazmi, što je sukladno poluvremenu eliminacije i učestalosti doziranja.
English: Severe liver injury*#
Croatian: Stopa kontrole bolesti**#
English: Stivarga plus BSC (n= 500)
Croatian: Stivarga (N=505)
English: The addition of Stivarga to BSC resulted in a significantly longer survival, compared to placebo plus BSC with a hazard ratio of 0.550 (p = 0.000159 stratified log rank test) and a median OS of 8.8 months vs. 6.3 months [95% CI 0.395, 0.765].
Croatian: Rezultat dodavanja lijeka Stivarga najboljoj potpornoj njezi bio je značajno dulje preživljenje u usporedbi s placebom uz najbolju potpornu njegu, uz omjer hazarda od 0,550 (p = 0,000159 stratificirani log-rank test) i medijan ukupnog preživljenja od 8,8 mjeseci naspram 6,3 mjeseca [95% CI 0,395, 0,765].
English: Treatment with Stivarga may lead to a higher risk of severe liver problems.
Croatian: Problemi s jetrom Liječenje lijekom Stivarga može povećati rizik od teških problema s jetrom.
English: (NASH, 7%)
Croatian: Alcoholic Steato Hepatitis, NASH, 7%)
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).
Croatian: U bolesnika s blagim i umjerenim oštećenjem funkcije jetre preporučuje se pažljivo pratiti ukupnu sigurnost (vidjeti također dijelove 4.2 i 4.5).
English: The addition of Stivarga to BSC resulted in significantly longer survival, compared to placebo plus BSC with a p value of 0.005178 from stratified log rank test, a hazard ratio of 0.774 [95% CI 0.636, 0.942] ) and a median OS of 6.4 months vs. 5.0 months (see Table 5 and Figure 1).
Croatian: Dodavanje lijeka Stivarga najboljoj potpornoj njezi rezultiralo je značajno duljim preživljenjem, u usporedbi s placebom s najboljom potpornom njegom uz p-vrijednost od 0,005178 iz stratificiranog log rang testa, uz omjer hazarda (engl. hazard ratio, HR) od 0,774 [95% CI 0,636; 0,942] i medijan ukupnog preživljenja od 6,4 mjeseci nasuprot 5,0 mjeseci (vidjeti tablicu 5 i sliku 1).
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.
Croatian: Odmah potražite liječničku pomoć ako razvijete sljedeće simptome: pojavu krvi u stolici ili crnu boju stolice, pojavu krvi u mokraći, bol u trbuhu, kašalj/povraćanje krvi.
English: - if you are allergic to regorafenib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete uzimati lijek Stivarga Nemojte uzimati lijek Stivarga ako ste alergični na regorafenib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
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).
Croatian: U kliničkim ispitivanjima opažena je viša incidencija kožne reakcije na šakama i stopalima u bolesnika azijskog podrijetla (osobito Japanaca) liječenih lijekom Stivarga u usporedbi s bijelcima (vidjeti dio 4.2).
English: Common side effects (may affect up to 1 in 10 users)
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 korisnika)
English: TTP
Croatian: Tlf.
English: >20 times ULN (Grade 4)
Croatian: > 20 puta GGN
English: Posology adjustments
Croatian: Prilagodba doze
English: Uncommon side effects (may affect up to 1 in 100 users)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 korisnika)
English: A higher incidence of hand foot skin reaction (HFSR)/palmar-plantar erythrodysesthesia syndrome, severe liver function test abnormalities and hepatic dysfunction was observed in Asian (in particular Japanese) patients treated with Stivarga compared with Caucasians.
Croatian: U bolesnika azijskog podrijetla (osobito Japanaca) liječenih lijekom Stivarga opažena je viša incidencija kožne reakcije na šakama i stopalima / sindroma palmarnoplantarne eritrodizestezije, teških poremećaja rezultata testova jetrene funkcije i poremećaja funkcije jetre u usporedbi s bijelcima.
English: Gastrointestinal perforation (including fatal outcome) and fistulae have been reported in patients treated with Stivarga (see section 4.8).
Croatian: U bolesnika liječenih lijekom Stivarga zabilježene su perforacija (uključujući i onu sa smrtnim ishodom) i fistule u probavnom sustavu (vidjeti dio 4.8).
English: Haemorrhage* Hypertension
Croatian: Omjer hazarda*
English: No dosage adjustment is necessary if you have a mildly, moderately or severely impaired kidney function.
Croatian: Ako imate blago, umjereno ili teško oštećenu funkciju bubrega, nije potrebna prilagodba doze.
English: (hypokalaemia, hypophosphatemia, hypocalcaemia, hyponatraemia and hypomagnesaemia) - high level of uric acid in the blood (hyperuricaemia) - loss of body fluids (dehydration) - headache - shaking (tremor) - disorder of the nerves which can cause a change in sensation, such as numbness, tingling,
Croatian: visoka razina mokraćne kiseline u krvi (hiperuricemija) gubitak tjelesnih tekućina (dehidracija) glavobolja nevoljno drhtanje (tremor) poremećaj živaca koji može uzrokovati promjene osjeta kao što su utrnulost, trnci, slabost ili bol (periferna neuropatija)
English: Stivarga is indicated as monotherapy for the treatment of adult patients with
Croatian: Stivarga je indicirana kao monoterapija za liječenje odraslih bolesnika: - s metastatskim kolorektalnim karcinomom (engl. colorectal cancer, CRC) koji su prethodno liječeni,
English: Mild, indirect (unconjugated) hyperbilirubinaemia may occur in patients with Gilbert's syndrome.
Croatian: U bolesnika s Gilbertovim sindromom može se razviti blaga, indirektna (nekonjugirana) hiperbilirubinemija.
English: Secondary endpoints were Progression-Free Survival (PFS), Objective Tumour Response Rate (ORR) and Disease Control Rate (DCR).
Croatian: Progression-Free Survival, PFS), stopa objektivnog odgovora tumora (engl.
English: Hyperbilirubinaemia Increase in transaminases
Croatian: Poremećaji jetre i žuči hiperbilirubinemija povišene transaminaze teško oštećenje jetre*#
English: Placebo plus BSC§ (N=194)
Croatian: Placebo uz najbolju potpornu njegu (N=194)
English: Re-occurrence
Croatian: Pojavljivanje
English: Discontinuation of Stivarga is recommended in patients developing gastrointestinal perforation or fistula.
Croatian: U bolesnika u kojih nastane perforacija ili fistula u probavnom sustavu preporučuje se prekid primjene lijeka Stivarga.