FrancophonIA/ELRC3.0 huggingface dataset:
English: • 1,680 mg administered intravenously every four weeks.
Croatian: • 1680 mg primijenjeno intravenski svaka četiri tjedna
English: Immune-Related Endocrinopathies (Type 1 Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Adrenal Insufficiency and Hypophysitis) Immune-Related Neuropathies (Guillain-Barre Syndrome, Myasthenic Syndrome / Myasthenia Gravis) Immune-Related Meningoencephalitis Immune-Related Myocarditis Immune-Related Nephritis Immune-Related Myositis Infusion-Related Reactions
Croatian: - imunološki uzrokovanom hepatitisu - imunološki uzrokovanom pneumonitisu - imunološki uzrokovanom kolitisu - imunološki uzrokovanom pankreatitisu - imunološki uzrokovanim endokrinopatijama (šećerna bolest tipa 1, hipotireoza, hipertireoza, insuficijencija nadbubrežne žlijezde i hipofizitis) - imunološki uzrokovanim neuropatijama (Guillain-Barréov sindrom, mijastenički sindrom / miastenija gravis) - imunološki uzrokovanom meningoencefalitisu - imunološki uzrokovanom miokarditisu - imunološki uzrokovanom nefritisu - imunološki uzrokovanom miozitisu
English: Includes reports of cytokine release syndrome, hypersensitivity, anaphylaxis.
Croatian: Uključuje prijavljene slučajeve sindroma oslobađanja citokina, preosjetljivosti, anafilaksije.
English: Treatment with atezolizumab should be permanently discontinued for Grade 4, or any grade of recurrent pancreatitis.
Croatian: Liječenje atezolizumabom mora se trajno prekinuti u slučaju pankreatitisa 4. stupnja ili rekurentnog pankreatitisa bilo kojeg stupnja.
English: A phase II, multi-centre, international, two-cohort, single-arm clinical trial, IMvigor210, was conducted in patients with locally advanced or metastatic UC (also known as urothelial bladder cancer).
Croatian: Multicentrično, međunarodno, neusporedno kliničko ispitivanje faze II s dvije kohorte (IMvigor210) provedeno je u bolesnika s lokalno uznapredovalim ili metastatskim UK-om (koji se još naziva i urotelnim rakom mokraćnog mjehura).
English: For Cohort 2, median DOR was not reached in any PD-L1 expression subgroup or in all comers, however was reached in patients with PD-L1 expression < 1% (13.3 months; 95% CI 4.2, NE).
Croatian: U Kohorti 2 medijan trajanja odgovora nije dosegnut ni u jednoj od podskupina prema ekspresiji PD-L1 niti u populaciji svih uključenih bolesnika, ali je dosegnut u bolesnika s ekspresijom PD-L1 < 1% (13,3 mjeseca;
English: Figure 5: Kaplan-Meier Curve for Overall Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
Croatian: Slika 5: Kaplan-Meierova krivulja ukupnog preživljenja u bolesnika s ekspresijom PD-L1 ≥ 1% (IMpassion130)
English: The co-primary efficacy endpoints included investigator-assessed progression free survival (PFS) in the ITT population and in patients with PD-L1 expression ≥ 1% per RECIST v1.1 as well as overall survival (OS) in the ITT population and in patients with PD-L1 expression ≥ 1%.
Croatian: Dvije primarne mjere ishoda za djelotvornost uključivale su preživljenje bez progresije bolesti (engl. progression-free survival, PFS) u populaciji predviđenoj za liječenje (engl. intent-to-treat, ITT) i u bolesnika s ekspresijom PD-L1 ≥ 1% prema ocjeni ispitivača na temelju verzije 1.1 RECIST kriterija te ukupno preživljenje (engl. overall survival, OS) u ITT populaciji i u bolesnika s ekspresijom PD-L1 ≥ 1%.
English: The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by intravenous infusion every three weeks.
Croatian: Nakon faze uvodnog liječenja slijedi faza održavanja bez kemoterapije, tijekom koje se primjenjuje Tecentriq u dozi od 1200 mg intravenskom infuzijom svaka tri tjedna.
English: Nab-paclitaxel and carboplatin are administered until completion of 4-6 cycles, or progressive disease or unacceptable toxicity whichever occurs first
Croatian: Nab-paklitaksel i karboplatin primjenjuju se dok se ne dovrši 4 - 6 ciklusa liječenja, ili do progresije bolesti ili pojave neprihvatljive toksičnosti, što god nastupi prije
English: For Grade 2 diarrhoea or colitis, if symptoms persist > 5 days or recur, treatment with 1 to 2 mg/kg/day prednisone or equivalent should be started.
Croatian: U slučaju proljeva ili kolitisa 2. stupnja, ako simptomi potraju > 5 dana ili se ponovno pojave, treba uvesti 1 - 2 mg/kg/dan prednizona ili ekvivalenta.
English: Please also refer to the full prescribing information for the combination products (see also section 5.1).
Croatian: Pročitajte i cjelovite informacije o lijekovima primijenjenima u kombiniranoj terapiji (vidjeti i dio 5.1).
English: Tlf: +47 - 22 78 90 00
Croatian: Roche Norge AS Tlf: +47 - 22 78 90 00
English: Common syncope
Croatian: Često sinkopa
English: After dilution, one mL of solution should contain approximately 6.0 mg of Tecentriq (1680 mg/278 mL).
Croatian: Nakon razrjeđivanja, jedan ml otopine trebao bi sadržavati približno 6,0 mg lijeka Tecentriq (1680 mg/278 ml).
English: • Stop your treatment with Tecentriq.
Croatian: • prekinuti liječenje lijekom Tecentriq
English: Tumour assessments were conducted every 9 weeks for the first 54 weeks, and every 12 weeks thereafter.
Croatian: Procjene tumorskog odgovora provodile su se svakih 9 tjedana tijekom prva 54 tjedna, a zatim svakih 12 tjedana.
English: Post-authorisation efficacy study (PAES): In order to evaluate the efficacy of atezolizumab monotherapy versus atezolizumab plus carboplatin/gemcitabine versus placebo plus cisplatin/gemcitabine in patients with locally advanced or metastatic urothelial cancer who are platinum -ineligible and -eligible patients, the MAH should submit the final CSR of study IMvigor130.
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Radi ocjene djelotvornosti monoterapije atezolizumabom u odnosu na atezolizumab plus karboplatin/gemcitabin i u odnosu na placebo plus cisplatin/gemcitabin u bolesnika s lokalno uznapredovalim ili metastatskim urotelnim karcinomom koji nisu pogodni za liječenje platinom i onih koji jesu pogodni za liječenje platinom, nositelj odobrenja mora dostaviti završno izvješće o kliničkom ispitivanju za ispitivanje IMvigor130.
English: Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):
Croatian: Tecentriq je u monoterapiji indiciran za liječenje lokalno uznapredovalog ili metastatskog urotelnog karcinoma (UK) u odraslih bolesnika:
English: and PFS by PD-L1 expression are summarised in Figures 7 and 9, respectively.
Croatian: Eksploracijski rezultati za OS i PFS prema ekspresiji PD-L1 prikazani su na Slici 7 odnosno Slici 9.
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Event Version 4.0 (NCI-CTCAE v.4.
Croatian: Napomena: Stupnjevi toksičnosti u skladu su s verzijom 4.0 Zajedničkih terminoloških kriterija za nuspojave
English: The median time to onset was 15 days (range: 0 day to 12.5 months).
Croatian: Medijan vremena do nastupa iznosio je 15 dana (raspon od 0 dana do 12,5 mjeseci).
English: If symptoms improve to ≤ Grade 1, taper corticosteroids as clinically indicated.
Croatian: Ako se simptomi poboljšaju do ≤ 1. stupnja, dozu kortikosteroida treba postupno smanjivati sukladno kliničkoj indikaciji.
English: Guillain-Barré syndrome and demyelinating polyneuropathy occurred in 0.2% (5/3,178) of patients who received atezolizumab monotherapy.
Croatian: Guillain-Barréov sindrom i demijelinizirajuća polineuropatija javili su se u 0,2% (5/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: ǂ Stratified by chemotherapy (vinflunine vs. taxane), status on IC (< 5% vs. ≥ 5%), number of prognostic risk factors (0 vs. 1-3), and liver metastases (yes vs. no).
Croatian: ǂ Stratifikacija prema kemoterapiji (vinflunin ili taksan), statusu ekspresije PD-L1 na imunosnim stanicama koje infiltriraju tumor (< 5% ili ≥ 5%), broju prognostičkih faktora rizika (0 ili 1 - 3) i jetrenim metastazama (da ili ne).
English: The recommended dose of Tecentriq is 1,200 mg administered intravenously every three weeks.
Croatian: Preporučena doza lijeka Tecentriq je 1200 mg primijenjena intravenski svaka tri tjedna.
English: In Cohort 2, the co-primary efficacy endpoints were confirmed ORR as assessed by an IRF using RECIST v1.1 and investigator-assessed ORR according to Modified RECIST (mRECIST) criteria.
Croatian: Primarne mjere ishoda za djelotvornost u Kohorti 2 bile su potvrđen ORR prema ocjeni neovisnog ocjenjivačkog povjerenstva na temelju verzije 1.1 RECIST kriterija te ORR prema ocjeni ispitivača na temelju modificiranih RECIST kriterija (mRECIST).
English: The median age was 63 years (range: 31 to 90), and 60% of patients were male.
Croatian: Medijan dobi iznosio je 63 godine (raspon: 31 - 90), a 60% bolesnika bili su muškarci.
English: It is unknown whether atezolizumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se atezolizumab u majčino mlijeko.
English: Data for patients ≥75 years of age are too limited to draw conclusions on this population.
Croatian: Podaci za bolesnike u dobi od ≥ 75 godina previše su ograničeni da bi se mogli donijeti zaključci o toj populaciji.
English: z Includes reports of proteinuria, protein urine present, haemoglobinurea, nephrotic syndrome.
Croatian: z Uključuje prijavljene slučajeve proteinurije, prisutnosti proteina u mokraći, hemoglobinurije, nefrotskog sindroma.
English: Immune-related neuropathies
Croatian: Imunološki uzrokovane neuropatije
English: NE (14.1, NE)
Croatian: NP (14,1; NP)
English: 22.9 months), the median OS for both arms was unchanged relative to the primary OS interim analysis.
Croatian: U eksploracijskoj završnoj analizi OS-a uz dulje trajanje praćenja (medijan: 22,9 mjeseci) medijan OS-a u obje je skupine ostao nepromijenjen u odnosu na primarnu interim analizu OS-a.
English: Investigator-assessed PFS (RECIST v1.1) **
Croatian: PFS prema ocjeni ispitivača (RECIST v1.1)**
English: No reproductive or teratogenicity studies in animals have been conducted with atezolizumab.
Croatian: Nisu provedena ispitivanja reproduktivnih ili teratogenih učinaka atezolizumaba na životinjama.
English: Treatment with atezolizumab should be permanently discontinued for Grade 4 hypophysitis.
Croatian: Liječenje atezolizumabom mora se trajno prekinuti u slučaju hipofizitisa 4. stupnja.
English: The median time to onset was 5.2 months (range: 5.1 to 5.3 months).
Croatian: Medijan vremena do nastupa iznosio je 5,2 mjeseca (raspon od 5,1 do 5,3 mjeseca).
English: The median time to onset was 5.4 months (range: 0.7 to 11.0 months).
Croatian: Medijan vremena do nastupa iznosio je 5,4 mjeseca (raspon od 0,7 do 11,0 mjeseci).
English: The infusions must not be administered as an intravenous push or bolus.
Croatian: Infuzije se ne smiju primijeniti kao brza ili bolusna intravenska injekcija.
English: • inflammation of the liver (hepatitis): symptoms may include yellowing of skin or eyes, nausea, vomiting, bleeding or bruising, dark urine, and stomach pain
Croatian: • upalu jetre (hepatitis): simptomi mogu uključivati žutu boju kože ili očiju, mučninu, povraćanje, krvarenje ili nastanak modrica, tamnu mokraću i bol u trbuhu
English: However, patients with EGFR mutations did not show improved OS with atezolizumab compared to docetaxel (HR of 1.24, 95% CI: 0.71, 2.18; median OS of 10.5 vs. 16.2 months for atezolizumab and docetaxel, respectively).
Croatian: Međutim, u bolesnika s EGFR mutacijama nije primijećeno poboljšanje OS-a uz atezolizumab u odnosu na docetaksel (HR: 1,24; 95% CI: 0,71 - 2,18; medijan OS-a: 10,5 mjeseci uz atezolizumab naspram 16,2 mjeseca uz docetaksel).
English: Table 5: Intravenous treatment regimens (IMpower150) Treatment regimen
Croatian: Tablica 5: Intravenski terapijski protokoli (IMpower150)
English: Treatment with atezolizumab should be withheld if Grade 2 event (ALT or AST > 3 to 5 x ULN or blood bilirubin > 1.5 to 3 x ULN) persists for more than 5 to 7 days, and 1 to 2 mg/kg/day of prednisone or equivalent should be started.
Croatian: Ako događaj 2. stupnja (ALT ili AST > 3 - 5 x GGN ili bilirubin u krvi > 1,5 - 3 x GGN) potraje dulje od 5 - 7 dana, treba odgoditi primjenu atezolizumaba i uvesti 1 - 2 mg/kg/dan prednizona ili ekvivalenta.
English: The median time to onset was 5.5 months (range: 3 days to 19 months).
Croatian: Medijan vremena do nastupa iznosio je 5,5 mjeseci (raspon od 3 dana do 19 mjeseci).
English: Immune-related meningoencephalitis
Croatian: Imunološki uzrokovan meningoencefalitis
English: For TNBC, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity (see section 5.1).
Croatian: Kod trostruko negativnog raka dojke preporučuje se liječiti bolesnike lijekom Tecentriq do progresije bolesti ili pojave toksičnosti koja se ne može zbrinuti (vidjeti dio 5.1).
English: Grade 2
Croatian: 2. stupnja
English: q Includes reports of pneumonitis, lung infiltration, bronchiolitis, interstitial lung disease, radiation pneumonitis.
Croatian: Uključuje prijavljene slučajeve pneumonitisa, plućnih infiltrata, bronhiolitisa, intersticijske bolesti pluća, radijacijskog pneumonitisa.
English: Co-primary endpoints OS analysis*
Croatian: Ko-primarne mjere ishoda Analiza OS-a*
English: Guillain-Barré syndrome led to discontinuation of atezolizumab in 1 patient (< 0.1%).
Croatian: Guillain-Barréov sindrom doveo je do prekida liječenja atezolizumabom u 1 (< 0,1%) bolesnika.
English: Figure 4: Kaplan-Meier Curve for Progression Free Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
Croatian: Slika 4: Kaplan-Meierova krivulja preživljenja bez progresije bolesti u bolesnika s ekspresijom PD-L1 ≥ 1% (IMpassion130)
English: Pancreatitis, including amylase increased and lipase increased, occurred in 0.6% (18/3,178) of patients who received atezolizumab monotherapy.
Croatian: Pankreatitis, uključujući povišene vrijednosti amilaze i lipaze, javio se u 0,6% (18/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: Common influenza like illness, chills a
Croatian: Često bolest nalik gripi, zimica a
English: • overactive thyroid gland (hyperthyroidism)
Croatian: • prekomjerno aktivna štitnjača (hipertireoza)
English: Table 5: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Croatian: Tablica 5: Sažetak rezultata za djelotvornost u populaciji za primarnu analizu (svi uključeni bolesnici)* (OAK)
English: After dilution, one mL of solution should contain approximately 3.2 mg of Tecentriq (840 mg/264 mL).
Croatian: Nakon razrjeđivanja, jedan ml otopine trebao bi sadržavati približno 3,2 mg lijeka Tecentriq (840 mg/264 ml).
English: • The active substance is atezolizumab.
Croatian: • Djelatna tvar je atezolizumab.
English: IMvigor210 (GO29293): Single-arm trial in previously untreated urothelial carcinoma patients who are ineligible for cisplatin therapy and in urothelial carcinoma patients previously treated with chemotherapy
Croatian: IMvigor210 (GO29293): Neusporedno ispitivanje u prethodno neliječenih bolesnika s urotelnim karcinomom koji nisu pogodni za liječenje cisplatinom te u bolesnika s urotelnim karcinomom prethodno liječenih kemoterapijom
English: • inflammation of the heart muscle (myocarditis): symptoms may include shortness of breath, decreased exercise tolerance, feeling tired, chest pain, swelling of the ankles or legs, irregular heartbeat, and fainting
Croatian: • upalu srčanog mišića (miokarditis): simptomi mogu uključivati nedostatak zraka, slabije podnošenje fizičkog napora, umor, bol u prsnom košu, oticanje gležnjeva ili nogu, nepravilne otkucaje srca i nesvjesticu
English: Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
Croatian: Tecentriq je u kombinaciji s bevacizumabom, paklitakselom i karboplatinom indiciran za prvu liniju liječenja odraslih bolesnika s metastatskim neplanocelularnim rakom pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC).
English: Cardiac disorders Rare myocarditisp Vascular disorders Common hypotension
Croatian: Rijetko mijastenički sindromo Srčani poremećaji Rijetko miokarditisp Krvožilni poremećaji Često hipotenzija
English: No overall differences in efficacy were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Croatian: Sveukupno nisu opažene razlike u djelotvornosti lijeka između bolesnika u dobi od ≥ 65 godina i mlađih bolesnika koji su primali atezolizumab u monoterapiji.
English: The release of Tecentriq in the environment should be minimised.
Croatian: Odlaganje lijeka Tecentriq u okoliš treba svesti na najmanju moguću mjeru.
English: Once the infusion is prepared it should be administered immediately.
Croatian: Infuziju treba primijeniti odmah nakon pripreme.
English: First-line treatment of non-small cell lung cancer
Croatian: Prva linija liječenja raka pluća nemalih stanica
English: Treatment with atezolizumab must be permanently discontinued for Grade 4 (life threatening; urgent intervention indicated) diarrhoea or colitis.
Croatian: Liječenje atezolizumabom mora se trajno prekinuti u slučaju proljeva ili kolitisa 4. stupnja (opasnog po život, za koji je indicirana hitna intervencija).
English: Treatment with atezolizumab should be permanently discontinued for Grade 4 or grade 3 recurrent myositis, or when unable to reduce the corticosteroid dose to the equivalent of ≤ 10 mg prednisone per day within 12 weeks after onset.
Croatian: Liječenje atezolizumabom mora se trajno prekinuti u slučaju miozitisa 4. stupnja ili rekurentnog miozitisa 3. stupnja te kada se doza kortikosteroida ne može smanjiti na dozu ekvivalentnu onoj od ≤ 10 mg prednizona na dan unutar 12 tjedana od nastupa miozitisa.
English: Baseline ECOG performance status was 0 (45.6%) or 1 (54.4%).
Croatian: Početni funkcionalni ECOG status iznosio je 0 (45,6%) ili 1 (54,4%).
English: Treatment may be resumed when symptoms are controlled by thyroid replacement therapy and TSH levels are decreasing
Croatian: Liječenje se može nastaviti kada se simptomi stave pod kontrolu nadomjesnom terapijom hormonima štitnjače, a vrijednosti TSH-a počnu padati
English: Tell your doctor straight away if you notice any of the side effects below or if they get worse.
Croatian: Odmah obavijestite svog liječnika ako se pojavi ili pogorša bilo koja od nuspojava navedenih u nastavku.
English: Comparisons with respect to OS between the treatment arm and control arm within the IC2/3, IC1/2/3, and ITT (Intention-to-treat, i.e. all comers) populations were tested using a hierarchical fixed-sequence procedure based on a stratified log-rank test at two-sided level of 5% as follows: step 1) IC2/3 population; step 2) IC1/2/3 population; step 3) all comers population.
Croatian: Response Evaluation Criteria In Solid Tumors, RECIST), bile su stopa objektivnog odgovora (engl. objective response rate, ORR), preživljenje bez progresije bolesti (engl. progression-free survival, PFS) i trajanje odgovora (engl. duration of response, DOR) Usporedbe OS-a između liječene i kontrolne skupine unutar populacije s najvišim stupnjem ekspresije PD-L1 (populacija IC2/3), populacije s bilo kojim stupnjem ekspresije PD-L1 (populacija IC1/2/3) te populacije predviđene za liječenje (engl. intent-to-treat, ITT; svi uključeni bolesnici) testirale su se hijerarhijskim postupkom s fiksnim redoslijedom utemeljenim na stratificiranom log-rang testu pri dvostranoj razini od 5% kako slijedi: 1. korak: populacija IC2/3; 2. korak: populacija IC1/2/3; 3. korak: populacija svih uključenih bolesnika.
English: Patients with ES-SCLC were treated with atezolizumab until disease progression.
Croatian: Bolesnici s prošrenim stadijem SCLC-a primali su atezolizumab do progresije bolesti.
English: A phase II, multi-centre, international, randomised, open-label, controlled study, POPLAR, was conducted in patients with locally advanced or metastatic NSCLC who progressed during or following a platinum-containing regimen, regardless of PD-L1 expression.
Croatian: Provedeno je multicentrično, međunarodno, randomizirano, otvoreno, kontrolirano ispitivanje faze II (POPLAR) u bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om koji su doživjeli progresiju tijekom ili nakon liječenja protokolom koji je sadržavao platinu, neovisno o ekspresiji PD-L1.
English: The median time to onset was 4.7 months (range 15 days to 17.2 months).
Croatian: Medijan vremena do nastupa iznosio je 4,7 mjeseci (raspon od 15 dana do 17,2 mjeseca).
English: d Includes reports of neutropenia, neutrophil count decreased, febrile neutropenia, neutropenic sepsis, granulocytopenia.
Croatian: Uključuje prijavljene slučajeve neutropenije, smanjenog broja neutrofila, febrilne neutropenije, neutropenijske s eps e, granulocitopenije.
English: Atezolizumab should be permanently discontinued in patients with Grade 3 or 4 infusion-related reactions.
Croatian: Liječenje atezolizumabom mora se trajno prekinuti u bolesnika s reakcijama na infuziju 3. ili 4. stupnja.
English: The primary efficacy endpoint for Cohort 1 was confirmed objective response rate (ORR) as assessed by an independent review facility (IRF) using RECIST v1.1.
Croatian: Primarna mjera ishoda za djelotvornost u Kohorti 1 bila je potvrđena stopa objektivnog odgovora (ORR) prema ocjeni neovisnog ocjenjivačkog povjerenstva na temelju verzije 1.1 RECIST kriterija.
English: * Exploratory OS final analysis at clinical cut-off 24 January 2019 ** PFS, ORR and DOR analyses at clinical cut-off 24 April 2018 *** For descriptive purposes only ^ Confirmed ORR and DoR are exploratory endpoints
Croatian: **Analize PFS-a, ORR-a i trajanja odgovora u trenutku prekida prikupljanja kliničkih podataka 24. travnja 2018. ***Samo za deskriptivne potrebe.
English: 51% of patients' tumours had PD-L1 expression of ≥ 1% TC or ≥ 1% IC and 49% of patients' tumours had PD-L1 expression of < 1% TC and < 1% IC.
Croatian: Pedeset i jedan posto (51%) bolesnika imalo je ekspresiju PD-L1 ≥ 1% na tumorskim stanicama ili ≥ 1% na imunosnim stanicama koje infiltriraju tumor, dok je 49% bolesnika imalo tumorsku ekspresiju PD-L1 < 1% na tumorskim stanicama i < 1% na imunosnim stanicama koje infiltriraju tumor.
English: Hepatic impairment was defined by the National Cancer Institute (NCI) criteria of hepatic dysfunction (see section 4.2).
Croatian: National Cancer Institute, NCI) (vidjeti dio 4.2).
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Croatian: Bolesnike treba nadzirati zbog moguće pojave kliničkih znakova i simptoma endokrinopatija.
English: Median time to events (months)
Croatian: Broj smrtnih slučajeva (%) Medijan vremena do događaja (mjeseci)
English: Atezolizumab (1,200 mg)a + nab-paclitaxel (100 mg/m2)b,c
Croatian: Atezolizumab (1200 mg)a + nab-paklitaksel (100 mg/m2)b,c
English: Induction (Four 21-Day Cycles)
Croatian: Uvodno liječenje (četiri 21-dnevna ciklusa)
English: For the description of studies with Tecentriq administered every 3 weeks at 1,200 mg, refer to the Tecentriq 1,200 mg concentrate for solution for infusion SmPC.
Croatian: Za opis ispitivanja primjene lijeka Tecentriq u dozi od 1200 mg svaka 3 tjedna vidjeti sažetak opisa svojstava lijeka za Tecentriq 1200 mg koncentrat za otopinu za infuziju.
English: What Tecentriq is
Croatian: Što je Tecentriq
English: Table 10: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Croatian: Tablica 10: Sažetak rezultata za djelotvornost u populaciji za primarnu analizu (svi uključeni bolesnici)* (OAK)
English: The median age was 64 years (range: 33 to 85), and 61% of patients were male.
Croatian: Medijan dobi iznosio je 64 godine (raspon: 33 - 85), a 61% bolesnika bili su muškarci.
English: Patients with locally advanced or metastatic UC who are ineligible for cisplatin therapy were treated with atezolizumab until disease progression.
Croatian: Bolesnici s lokalno uznapredovalim ili metastatskim urotelnim karcinomom koji nisu bili pogodni za liječenje cisplatinom primali su atezolizumab do progresije bolesti.