FrancophonIA/ELRC3.0 huggingface dataset:
English: Atezolizumab spares the PD-L2/PD-1 interaction allowing PD-L2/PD-1 mediated inhibitory signals to persist.
Croatian: Atezolizumab ne utječe na interakciju PD-L2/PD-1 te tako omogućuje da se i dalje prenose inhibicijski signali posredovani kompleksom PD-L2/PD-1.
English: The majority of patients were white (82%).
Croatian: Većina bolesnika bila je bijele rase (82%).
English: A total of 902 patients were enrolled and stratified by presence of liver metastases, prior taxane treatment, and by PD-L1 expression status in tumour-infiltrating immune cells (IC) (PD-L1 stained tumour-infiltrating immune cells [IC] <1% of tumour area vs. ≥ 1% of the tumour area) assessed by the VENTANA PD-L1 (SP142) Assay.
Croatian: U ispitivanje su bila uključena ukupno 902 bolesnika, koja su bila stratificirana prema prisutnosti jetrenih metastaza, prethodnom liječenju taksanima i statusu ekspresije PD-L1 na imunosnim stanicama koje infiltriraju tumor (obojenje imunosnih stanica koje infiltriraju tumor na PD-L1 u < 1% tumorskog područja ili ≥ 1% tumorskog područja) utvrđenom testom VENTANA PD-L1 (SP142).
English: Fifty-nine percent of patients in the nab-paclitaxel and carboplatin arm received any cancer immunotherapy after disease progression, which includes atezolizumab as crossover treatment (41% of all patients), compared to 7.3% of patients in the atezolizumab, nab paclitaxel and carboplatin arm.
Croatian: Pedeset i devet posto (59%) bolesnika u skupini liječenoj nab-paklitakselom i karboplatinom je nakon progresije bolesti primalo neki oblik imunoterapije za rak, što uključuje i bolesnike koji su prešli na liječenje atezolizumabom (41% svih bolesnika), dok je isto zabilježeno u 7,3% bolesnika u skupini koja je primala atezolizumab, nab-paklitaksel i karboplatin.
English: Each vial contains 1,200 mg of atezolizumab (in 20 mL).
Croatian: Jedna bočica sadrži 1200 mg atezolizumaba (u 20 ml).
English: Adverse reactions known to occur with atezolizumab or chemotherapies given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical trials with combination therapy.
Croatian: Tijekom liječenja ovim lijekovima u kombiniranoj terapiji mogu se pojaviti nuspojave koje se javljaju za atezolizumab ili kemoterapiju kada se primjenjuju u monoterapiji, čak i ako te reakcije nisu prijavljene u kliničkim ispitivanjima u kombiniranoj terapiji.
English: Tecentriq is used in combination with anticancer medicine (chemotherapy called nab-paclitaxel): if your doctor tested your cancer and found high levels of a specific protein in your body called program death ligand (PD-L1) when the cancer has spread to other parts of the body and has not been treated with anticancer medicines (chemotherapy) or else when the cancer has come back in the breast after previous treatment.
Croatian: Tecentriq se koristi u kombinaciji s jednim lijekom za liječenje raka (kemoterapijskim lijekom koji se zove nab-paklitaksel): ako je liječnik testirao rak i u Vašem tijelu ustanovio visoke razine specifičnog proteina koji se zove ligand receptora programirane stanične smrti 1 (PD-L1) ako se rak proširio u druge dijelove tijela, a prethodno se nije liječio lijekovima protiv raka (kemoterapijom) ili ako se rak ponovno pojavio u dojci nakon prethodnog liječenja Važno je da pročitate i uputu o lijeku za nab-paklitaksel.
English: ǂStratified by PD-L1 expression in tumour infiltrating immune cells, the number of prior chemotherapy regimens, and histology ** Based on the stratified log-rank test *** Based on Kaplan-Meier estimates
Croatian: ǂStratifikacija prema ekspresiji PD-L1 na imunosnim stanicama koje infiltriraju tumor, broju prethodnih kemoterapijskih protokola i histološkom nalazu **Na temelju stratificiranog log-rang testa ***Na temelju procjene prema Kaplan-Meierovoj metodi
English: Programmed death-ligand 1 (PD-L1) may be expressed on tumour cells and/or tumour-infiltrating immune cells, and can contribute to the inhibition of the antitumour immune response in the tumour microenvironment.
Croatian: Ligand receptora programirane stanične smrti 1 (PD-L1) može se eksprimirati na tumorskim stanicama i/ili imunosnim stanicama koje infiltriraju tumor te može pridonijeti inhibiciji imunog odgovora na tumor u tumorskom mikrookruženju.
English: Stratified hazard ratio
Croatian: Stratificiran omjer hazarda
English: It is used when this cancer has: spread to other parts of the body come back after previous treatment or, if you cannot receive anticancer medicine (a chemotherapy called cisplatin), and your doctor has tested your cancer and found high levels of a specific protein in your body called programmed death-ligand 1 (PD-L1).
Croatian: Tecentriq se koristi kada se taj rak: proširio u druge dijelove tijela vratio nakon prethodnog liječenja ili ako ne možete primati lijek za rak (kemoterapijski lijek koji se zove cisplatin), a liječnik je testirao rak i u Vašem tijelu ustanovio visoke razine specifičnog proteina koji se zove ligand receptora programirane stanične smrti 1 (engl. programmed death ligand 1, PD-L1).
English: Patients who had prior treatment with CD137 agonists or immune checkpoint blockade therapies (anti-PD-1, and anti-PD-L1 therapeutic antibodies) were not eligible.
Croatian: U ispitivanju nisu mogli sudjelovati bolesnici koji su se prethodno liječili agonistima CD137 ili terapijama koje blokiraju kontrolne točke imunosnog sustava (terapijska protutijela na PD-1 i PD-L1).
English: Patients had a median survival follow up time of 18.6 months and showed improved OS and PFS with atezolizumab, nab-paclitaxel and carboplatin as compared to the control.
Croatian: Medijan praćenja preživljenja bolesnika iznosio je 18,6 mjeseci te je zabilježeno produljenje OS-a i PFS-a uz atezolizumab, nab-paklitaksel i karboplatin u odnosu na kontrolnu skupinu.
English: • inflammation or problems of the nerves (neuropathy): symptoms may include muscle weakness and numbness, tingling in hands and feet
Croatian: • upalu živaca ili tegobe sa živcima (neuropatiju): simptomi mogu uključivati slabost i utrnulost mišića, trnce u šakama i stopalima
English: • 840 mg administered intravenously every two weeks, or
Croatian: • 840 mg primijenjeno intravenski svaka dva tjedna ili
English: Atezolizumab is administered as an intravenous infusion.
Croatian: Atezolizumab se primjenjuje u obliku intravenske infuzije.
English: After dilution (see section 6.6), one mL of solution contains approximately 4.4 mg of atezolizumab.
Croatian: Nakon razrjeđivanja (vidjeti dio 6.6) jedan ml otopine sadrži približno 4,4 mg atezolizumaba.
English: or blood bilirubin > 3 x ULN)
Croatian: ili bilirubin u krvi > 3 x GGN)
English: It is a clear, colourless to slightly yellowish liquid.
Croatian: To je bistra, bezbojna do blago žućkasta tekućina.
English: If you notice any of the side effects above or if they get worse, tell your doctor straight away.
Croatian: Ako se pojavi ili pogorša bilo koja od gore navedenih nuspojava, odmah se obratite svom liječniku.
English: In the population pharmacokinetic analysis, there were no clinically important differences in the clearance of atezolizumab between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 × to 1.5 × ULN and any AST, n= 71) and normal hepatic function (bilirubin and AST ≤
Croatian: U populacijskoj farmakokinetičkoj analizi nisu pronađene klinički važne razlike u klirensu atezolizumaba između bolesnika s blagim oštećenjem jetrene funkcije (bilirubin ≤ GGN i AST > GGN ili bilirubin × > 1,0 - 1,5 × GGN i bilo koja vrijednost AST-a, n= 71) i onih s normalnom jetrenom funkcijom (bilirubin i AST ≤ GGN, n= 401).
English: Do not co-administer other medicinal products through the same infusion line.
Croatian: U istoj infuzijskoj liniji ne smiju se istodobno primjenjivati drugi lijekovi.
English: or blood bilirubin > 1.5 to 3 x ULN)
Croatian: ili bilirubin u krvi > 1,5 - 3 x GGN)
English: Grade 3 or 4: (creatinine level > 3.0 x baseline or > 3.0 x ULN)
Croatian: 3. ili 4. stupnja: (razina kreatinina > 3,0 x početne vrijednosti ili > 3,0 x GGN)
English: Cohort 2 included patients who received at least one platinum-based chemotherapy regimen for locally advanced or metastatic UC or had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
Croatian: Kohorta 2 uključivala je bolesnike koji su primili najmanje jedan kemoterapijski protokol temeljen na platini za lokalno uznapredovali ili metastatski UK ili koji su doživjeli progresiju bolesti unutar 12 mjeseci od liječenja neoadjuvantnim ili adjuvantnim kemoterapijskim protokolom koji je sadržavao platinu.
English: In study IMpower150, age ≥ 65 was associated with an increased risk of developing adverse events in patients receiving atezolizumab in combination with bevacizumab, carboplatin and paclitaxel.
Croatian: U ispitivanju IMpower150, dob od ≥ 65 godina bila je povezana s povećanim rizikom od razvoja štetnih događaja u bolesnika koji primaju atezolizumab u kombinaciji s bevacizumabom, karboplatinom i paklitakselom.
English: Induction (Four or Six 21-day cycles)
Croatian: Uvodno liječenje (četiri ili šest 21-dnevnih ciklusa)
English: The OS rate at 12 month was 37% in all comers.
Croatian: Stopa OS-a nakon 12 mjeseci u populaciji svih uključenih bolesnika iznosila je 37%.
English: Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild hepatic impairment.
Croatian: Prema populacijskoj farmakokinetičkoj analizi nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem jetrene funkcije.
English: Post-authorisation efficacy study (PAES): In order to further evaluate the efficacy of atezolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer, the MAH should submit the final OS results of study IMvigor210.
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Radi dodatne ocjene djelotvornosti atezolizumaba u liječenju bolesnika s lokalno uznapredovalim ili metastatskim urotelnim karcinomom, nositelj odobrenja mora dostaviti završne rezultate za OS u ispitivanju IMvigor210.
English: An updated analysis was performed with a median duration of survival follow-up of 17.2 months for Cohort 1 and is summarised in Table 4.
Croatian: Provedena je analiza ažuriranih podataka, uz medijan praćenja preživljenja za Kohortu 1 od 17,2 mjeseca, a rezultati su sažeto prikazani u Tablici
English: In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section
Croatian: U bolesnika s EGFR mutacijama ili ALK-pozitivnim NSCLC-om Tecentriq je u kombinaciji s bevacizumabom, paklitakselom i karboplatinom indiciran samo nakon prethodnog neuspješnog liječenja odgovarajućim ciljanim terapijama (vidjeti dio 5.1).
English: Grade 3 or 4 serum amylase or lipase levels increased (> 2 x ULN) or Grade 2 or 3 pancreatitis
Croatian: Povišenje serumskih vrijednosti amilaze ili lipaze (> 2 x GGN) 3. ili 4. stupnja ili pankreatitis 2. ili 3. stupnja
English: Asymptomatic patients with abnormal thyroid function tests can receive atezolizumab.
Croatian: Asimptomatski bolesnici s odstupanjima u nalazima testova funkcije štitnjače mogu primati atezolizumab.
English: The majority of patients were white (70%).
Croatian: Većina bolesnika bila je bijele rase (70%).
English: A population pharmacokinetic analysis suggests that steady-state is obtained after 6 to 9 weeks after multiple doses.
Croatian: Populacijska farmakokinetička analiza ukazuje na to da se stanje dinamičke ravnoteže postiže nakon 6 - 9 tjedana primjene višekratnih doza.
English: The median duration was 16.8 months (range: 0 day to 16.8 months).
Croatian: Medijan trajanja iznosio je 16,8 mjeseci (raspon od 0 dana do 16,8 mjeseci).
English: Patients were treated until loss of clinical benefit as assessed by the investigator.
Croatian: Bolesnici su se liječili do gubitka kliničke koristi prema ocjeni ispitivača.
English: In study IMpower150, there are no data on the efficacy of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in EGFR+ patients who have progressed previously on erlotinib+bevacizumab.
Croatian: Nema podataka iz ispitivanja IMpower150 o djelotvornosti atezolizumaba u kombinaciji s bevacizumabom, paklitakselom i karboplatinom u EGFR+ bolesnika kojima je bolest uznapredovala tijekom prethodnog liječenja erlotinibom + bevacizumabom.
English: Physicians should carefully consider the combined risks of the four-drug regimen of atezolizumab bevacizumab, paclitaxel, and carboplatin before initiating treatment (see section 4.8).
Croatian: Prije uvođenja terapije liječnici trebaju pažljivo razmotriti kombinirane rizike četverostrukog protokola koji uključuje atezolizumab, bevacizumab, paklitaksel i karboplatin (vidjeti dio 4.8).
English: o Incudes reports of myasthenia gravis.
Croatian: Uključuje prijavljene slučajeve miastenije gravis.
English: Per the pre-specified hierarchical testing order, the IC2/3 population was tested first, with an OS HR of 0.87 (95% CI: 0.63, 1.21; median OS of 11.1 vs. 10.6 months for atezolizumab and chemotherapy respectively).
Croatian: Prema unaprijed specificiranom redoslijedu za hijerarhijsko testiranje, najprije se testirala populacija IC2/3, uz HR za OS od 0,87 (95% CI: 0,63; 1,21; medijan OS-a iznosio je 11,1 mjesec uz atezolizumab naspram 10,6 mjeseci uz kemoterapiju).
English: Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway in murine pregnancy models can lead to immune-related rejection of the developing foetus resulting in foetal death (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da inhibicija puta PD-L1/PD-1 u mišjim modelima skotnosti može dovesti do imunološki uzrokovanog odbacivanja ploda u razvoju i tako dovesti do smrti ploda (vidjeti dio 5.3).
English: Median duration of PFS (months)
Croatian: Medijan trajanja PFS-a (mjeseci)
English: SWITZERLAND
Croatian: ŠVICARSKA
English: Hrvatska Roche d.o.o.
Croatian: Roche d.o.o.
English: In study IMpower150, age ≥ 65 was associated with a diminished effect of atezolizumab in patients receiving atezolizumab in combination with carboplatin and paclitaxel.
Croatian: U ispitivanju IMpower150 dob od ≥ 65 godina bila je povezana sa smanjenim učinkom atezolizumaba u bolesnika koji su primali atezolizumab u kombinaciji s karboplatinom i paklitakselom.
English: Grade 4 or any grade of recurrent pancreatitis
Croatian: 4. stupnja ili rekurentni pankreatitis bilo kojeg stupnja
English: Use of atezolizumab in combination with nab-paclitaxel in metastatic triple negative breast cancer
Croatian: Primjena atezolizumaba u kombinaciji s nab-paklitakselom u liječenju metastatskog trostruko negativnog raka dojke
English: Tumour assessments were performed every 8 weeks (± 1 week) for the first 12 months after Cycle 1, day 1 and every 12 weeks (± 1 week) thereafter.
Croatian: Tumor se ocjenjivao svakih 8 tjedana (± 1 tjedan) tijekom prvih 12 mjeseci nakon 1. dana 1. ciklusa, a zatim svakih 12 tjedana (± 1 tjedan).
English: Reported in studies outside the pooled dataset.
Croatian: Prijavljeno u ispitivanjima koja nisu bila obuhvaćena objedinjenim podacima.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C or 8 hours at ambient temperature (≤ 25 °C), unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja do primjene lijeka odgovornost su korisnika te u pravilu ne bi trebali trajati dulje od 24 sata na temperaturi od 2°C do 8°C ili od 8 sati na sobnoj temperaturi (≤ 25°C), osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičnim uvjetima.
English: Maintenance (21-day cycles)
Croatian: Terapija održavanja (21-dnevni ciklusi)
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,200 mg/20 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 1200 mg/20 ml
English: Patients had to be eligible for taxane monotherapy (i.e. absence of rapid clinical progression, life-threatening visceral metastases, or need for rapid symptom and/or disease control) and were excluded if they had received prior chemotherapy in the neoadjuvant or adjuvant setting within the last 12 months, a history of autoimmune disease; administration of a live, attenuated vaccine within 4 weeks prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomisation; untreated, symptomatic or corticosteroid-dependent brain metastases.
Croatian: Bolesnici su morali biti pogodni za monoterapiju taksanom (tj. nisu smjeli imati brzu kliničku progresiju, po život opasne visceralne metastaze ni potrebu za brzom kontrolom simptoma i/ili bolesti) te nisu mogli biti uključeni ako su unutar prethodnih 12 mjeseci primali kemoterapiju za neoadjuvantno ili adjuvantno liječenje, ako su imali autoimunu bolest u anamnezi, ako su primili živo atenuirano cjepivo unutar 4 tjedna prije randomizacije, ako su primali sistemske imunostimulatore unutar 4 tjedna ili sistemske imunosupresive unutar 2 tjedna prije randomizacije i ako su imali neliječene, simptomatske ili o kortikosteroidima ovisne moždane metastaze.
English: For ≥ Grade 3 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L), atezolizumab should be withheld.
Croatian: U slučaju hiperglikemije ≥ 3. stupnja (glukoza natašte > 250 mg/dl ili 13,9 mmol/l) treba odgoditi primjenu atezolizumaba.
English: No dedicated studies of atezolizumab have been conducted in elderly patients.
Croatian: Nisu provedena specifična ispitivanja atezolizumaba u starijih bolesnika.
English: • a cancer that affects the bladder and the urinary system, called urothelial carcinoma.
Croatian: • rak koji zahvaća mokraćni mjehur i mokraćni sustav, a zove se urotelni karcinom.
English: The pharmacokinetic properties of atezolizumab 840 mg administered every 2 weeks and atezolizumab 1,200 mg administered every 3 weeks are comparable.
Croatian: Farmakokinetička svojstva atezolizumaba u dozi od 840 mg svaka 2 tjedna i atezolizumaba u dozi od 1200 mg svaka 3 tjedna su usporediva.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One 20 mL vial of concentrate contains 1,200 mg atezolizumab*.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica s 20 ml koncentrata sadrži 1200 mg atezolizumaba*.
English: Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).
Croatian: Tecentriq je u kombinaciji s karboplatinom i etopozidom indiciran za prvu liniju liječenja odraslih bolesnika s proširenim stadijem raka pluća malih stanica (engl. extensive-stage small cell lung cancer, ES-SCLC) (vidjeti dio 5.1).
English: p-value1
Croatian: p-vrijednost1,2
English: The median age was 64 years (range: 26 to 90 years) with 10% of patients ≥75 years of age.
Croatian: Medijan dobi iznosio je 64 godine (raspon: 26 - 90 godina), a 10% bolesnika imalo je ≥ 75 godina.
English: The median time to onset was 3.4 months (range 3 days to 24.8 months).
Croatian: Medijan vremena do nastupa iznosio je 3,4 mjeseca (raspon od 3 dana do 24,8 mjeseci).
English: 12-month PFS (%)
Croatian: 12-mjesečni PFS (%)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 mL vial of concentrate contains 840 mg of atezolizumab*.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica s 14 ml koncentrata sadrži 840 mg atezolizumaba*.
English: 6-month PFS (%) 12-month PFS (%)
Croatian: 6-mjesečni PFS (%) 12-mjesečni PFS (%)
English: Patients should be monitored for changes in renal function.
Croatian: Bolesnike treba nadzirati zbog mogućih promjena bubrežne funkcije.
English: Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic, grey flip-off cap containing 14 mL of concentrate for solution for infusion.
Croatian: Staklena bočica (staklo tipa I) s butilnim gumenim čepom i aluminijskim prstenom sa sivom plastičnom flip-off kapicom, koja sadrži14 ml koncentrata za otopinu za infuziju.
English: Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in EGFR+ patients with NSCLC who have progressed on erlotinib+bevacizumab
Croatian: Primjena atezolizumaba u kombinaciji s bevacizumabom, paklitakselom i karboplatinom u EGFR+ bolesnika s NSCLC-om kojima je bolest uznapredovala uz erlotinib + bevacizumab
English: Symptomatic
Croatian: Simptomatska
English: Cohort 1 included previously untreated patients with locally advanced or metastatic UC who were ineligible or unfit for cisplatin-based chemotherapy or had disease progression at least 12 months after treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
Croatian: Kohorta 1 uključivala je prethodno neliječene bolesnike s lokalno uznapredovalim ili metastatskim UK-om koji nisu bili pogodni ili sposobni za kemoterapiju temeljenu na cisplatinu ili koji su doživjeli progresiju bolesti najmanje 12 mjeseci nakon liječenja neoadjuvantnim ili adjuvantnim kemoterapijskim protokolom koji je sadržavao platinu.
English: Treatment may be resumed when symptoms are controlled by antithyroid medicinal product and thyroid function is improving
Croatian: Liječenje se može nastaviti kada se simptomi stave pod kontrolu antitireoidnim lijekom, a funkcija štitnjače se poboljša
English: How Tecentriq works
Croatian: Kako Tecentriq djeluje
English: mg/m2)b,c placebo a
Croatian: (100 mg/m2)b,c placebo
English: • type 1 diabetes
Croatian: • šećerna bolest tipa 1
English: placebo + carboplatin (AUC 5)
Croatian: placebo + karboplatin (AUC 5)
English: • have been given medicines to suppress your immune system
Croatian: • ako ste primili lijekove koji potiskuju imunosni sustav
English: • inflammation of the thyroid, adrenal glands and the pituitary gland (hypothyroidism, hyperthyroidism, adrenal insufficiency or hypophysitis): symptoms may include tiredness, weight loss, weight gain, change in mood, hair loss, constipation, dizziness, headaches, increased thirst, increased urination and changes in vision.
Croatian: • upalu štitnjače, nadbubrežnih žlijezda i hipofize (hipotireoza, hipertireoza, insuficijencija nadbubrežne žlijezde ili hipofizitis): simptomi mogu uključivati umor, gubitak tjelesne težine, porast tjelesne težine, promjene raspoloženja, opadanje kose, zatvor, omaglicu, glavobolje, pojačanu žeđ, učestalije mokrenje i promjene vida
English: Tecentriq in combination therapy
Croatian: Tecentriq u kombiniranoj terapiji
English: Updated PFS results are also presented in Figures 4 and 5.
Croatian: Na Slikama 4 i 5 prikazani su i ažurirani rezultati za PFS.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 840 mg/14 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 840 mg/14 ml
English: Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Croatian: Tecentriq je u kombinaciji s nab-paklitakselom indiciran za liječenje neresektabilnog lokalno uznapredovalog ili metastatskog trostruko negativnog raka dojke u odraslih bolesnika čiji tumori pokazuju razinu ekspresije PD-L1 ≥ 1% i koji prethodno nisu primali kemoterapiju za metastatsku bolest.
English: Per final analysis for PFS, ORR, DOR and first interim analysis for OS at clinical cut off 17th April 2018
Croatian: Prema završnoj analizi PFS-a, ORR-a i trajanja odgovora te prvoj interim analizi OS-a; završni datum prikupljanja kliničkih podataka 17. travnja 2018.
English: An analysis was also performed with a median duration of survival follow-up of 21.1 months for
Croatian: Za Kohortu 2 provedena je i analiza uz medijan praćenja preživljenja od 21,1 mjeseca.