FrancophonIA/ELRC3.0 huggingface dataset:
English: Atezolizumab (n = 425)
Croatian: (n = 425)
English: Patients should be monitored for signs and symptoms of hepatitis.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma hepatitisa.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Croatian: Emil-Barell-Strasse 1 D-79639
English: Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy.
Croatian: Tecentriq je u monoterapiji indiciran za liječenje lokalno uznapredovalog ili metastatskog NSCLC-a u odraslih bolesnika koji su prethodno primali kemoterapiju.
English: OAK (GO28915): Randomised phase III trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
Croatian: OAK (GO28915): Randomizirano ispitivanje faze III u bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om prethodno liječenih kemoterapijom
English: Vinflunine was administered 320 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Croatian: Vinflunin se primjenjivao u dozi od 320 mg/m2 intravenskom infuzijom 1. dana svakog 3-tjednog ciklusa do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: v Includes reports of ascites, autoimmune hepatitis, hepatocellular injury, hepatitis, hepatitis acute, hepatotoxicity, liver disorder, drug-induced liver injury, hepatic failure, hepatic steatosis, hepatic lesion, oesophageal varices haemorrhage, varices oesophageal.
Croatian: Uključuje prijavljene slučajeve ascitesa, autoimunog hepatitisa, hepatocelularnog oštećenja, hepatitisa, akutnog hepatitisa, hepatotoksičnosti, poremećaja jetre, oštećenja jetre uzrokovanog lijekom, zatajenja jetre, hepatičke steatoze, lezije jetre, krvarenja iz varikoziteta jednjaka, varikoziteta jednjaka.
English: In Cohort 1, 119 patients were treated with atezolizumab 1,200 mg by intravenous infusion every
Croatian: U Kohorti 1 119 bolesnika liječeno je atezolizumabom u dozi od 1200 mg koji se primjenjivao intravenskom infuzijom svaka 3 tjedna do progresije bolesti.
English: Patients with NSCLC that had clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging, were excluded from the pivotal clinical study
Croatian: Bolesnici s NSCLC-om koji su imali jasnu infiltraciju tumora u velike torakalne krvne žile ili jasnu kavitaciju plućnih lezija, vidljivo na snimkama dobivenima oslikavanjem, bili su isključeni iz pivotalnog kliničkog ispitivanja IMpower150 nakon što je opaženo nekoliko slučajeva plućnog krvarenja sa smrtnim ishodom, koje je poznat faktor rizika kod liječenja bevacizumabom.
English: Figure 3: Forest plot of overall survival by PD-L1 expression in the primary analysis population (OAK)
Croatian: Slika 3: Grafikon raspona pouzdanosti za ukupno preživljenje prema ekspresiji PD-L1 u populaciji za primarnu analizu (OAK)
English: During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by bevacizumab, paclitaxel, and then carboplatin every three weeks for four or six cycles.
Croatian: Tijekom faze uvodnog liječenja preporučena doza lijeka Tecentriq je 1200 mg intravenskom infuzijom, nakon koje se primjenjuju bevacizumab, paklitaksel i zatim karboplatin svaka tri tjedna tijekom četiri ili šest ciklusa.
English: Guillain-Barré syndrome requiring the use of corticosteroids occurred in < 0.1% (2/3,178) of patients receiving atezolizumab monotherapy.
Croatian: Guillain-Barréov sindrom koji je zahtijevao primjenu kortikosteroida zabilježen je u < 0,1% (2/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: Refer to the full prescribing information for the combination product (see also section 5.1).
Croatian: Vidjeti i cjelovite informacije o lijeku koji će se primjenjivati u kombiniranoj terapiji (vidjeti i dio 5.1).
English: Docetaxel was administered 75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression.
Croatian: Docetaksel se primjenjivao u dozi od 75 mg/m2 intravenskom infuzijom 1. dana svakog 3-tjednog ciklusa do progresije bolesti.
English: Paclitaxel was administered 175 mg/m2 by intravenous infusion over 3 hours on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Croatian: Paklitaksel se primjenjivao u dozi od 175 mg/m2 intravenskom infuzijom u trajanju od 3 sata 1. dana svakog 3-tjednog ciklusa do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: Figure 11 summarises the results of OS in the ITT and PD-L1 subgroups, demonstrating OS benefit with atezolizumab in all subgroups, including those with PD-L1
Croatian: Slika 11 sažeto prikazuje rezultate za OS u ITT populaciji i podskupinama prema ekspresiji PD-L1, pokazujući korisne učinke atezolizumaba na OS u svim podskupinama, uključujući one s ekspresijom PD-L1 < 1% na tumorskim stanicama i imunosnim stanicama koje infiltriraju tumor.
English: Arm A Atezolizumab + nab-paclitaxel + carboplatin
Croatian: Skupina A Atezolizumab + nab-paklitaksel + karboplatin
English: Aseptic handling must be ensured when preparing the infusion.
Croatian: Kod pripreme infuzije mora se osigurati aseptično rukovanje lijekom.
English: How Tecentriq is given
Croatian: Kako se Tecentriq primjenjuje
English: 22 months showed a median OS of 12.6 months in patients treated with atezolizumab, vs. 9.7 months in patients treated with docetaxel (HR of 0.69, 95% CI: 0.52, 0.92).
Croatian: Analiza ažuriranih podataka nakon ukupno 200 zabilježenih smrtnih ishoda i medijana praćenja preživljenja od 22 mjeseca pokazala je da je medijan OS-a u bolesnika liječenih atezolizumabom iznosio 12,6 mjeseci, a u onih koji su primali docetaksel 9,7 mjeseci (HR: 0,69; 95% CI: 0,52 - 0,92).
English: Patients with previously untreated UC and TNBC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1).
Croatian: Bolesnike s prethodno neliječenim urotelnim karcinomom i trostruko negativnim rakom dojke potrebno je odabrati za liječenje na temelju tumorske ekspresije PD-L1 potvrđene validiranim testom (vidjeti dio 5.1).
English: For symptomatic adrenal insufficiency, atezolizumab should be withheld and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Croatian: U slučaju simptomatske insuficijencije nadbubrežne žlijezde treba odgoditi primjenu atezolizumaba i uvesti liječenje intravenskim kortikosteroidima (1 - 2 mg/kg/dan metilprednizolona ili ekvivalenta).
English: The primary analysis was conducted in all patients, excluding those with EGFR mutations or ALK
Croatian: Primarna analiza obuhvatila je sve bolesnike osim onih s EGFR mutacijama ili izmjenama u redoslijedu baza u genu ALK, koji su se definirali kao ITT populacija s tumorom divljeg tipa (n=679).
English: Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in metastatic non-squamous non-small cell lung cancer
Croatian: Primjena atezolizumaba u kombinaciji s bevacizumabom, paklitakselom i karboplatinom kod metastatskog neplanocelularnog raka pluća nemalih stanica
English: Pneumonitis occurred in 2.7% (87/3,178) of patients who received atezolizumab monotherapy.
Croatian: Pneumonitis se javio u 2,7% (87/3178) bolesnika koji su primali atezolizumab u monoterapiji.
English: Patients with locally advanced or metastatic UC who are ineligible for cisplatin therapy and locally advanced unresectable or metastatic TNBC were treated with atezolizumab until disease progression.
Croatian: Bolesnici s lokalno uznapredovalim ili metastatskim urotelnim karcinomom koji nisu bili pogodni za liječenje cisplatinom i bolesnici s neresektabilnim lokalno uznapredovalim ili metastatskim trostruko negativnim rakom dojke primali su atezolizumab do progresije bolesti.
English: Atezolizumab (n = 467)
Croatian: (n = 467)
English: Arm A (Atezolizumab + carboplatin + etoposide)
Croatian: Skupina A (atezolizumab + karboplatin + etopozid)
English: Baseline ECOG performance status was 0 (43%) or 1 (57%).
Croatian: Početni funkcionalni ECOG status iznosio je 0 (43%) ili 1 (57%).
English: • a cancer that affects the lungs, called non-small cell lung cancer.
Croatian: • rak koji zahvaća pluća, a zove se “rak pluća nemalih stanica“.
English: • inflammation of the liver (hepatitis): symptoms may include yellowing of skin or eyes, nausea,
Croatian: • upalu jetre (hepatitis): simptomi mogu uključivati žutu boju kože ili očiju, mučninu, povraćanje,
English: The confirmed ORRs per IRF-RECIST v1.1 were 28.0% (95% CI: 19.5, 37.9) in patients with PD-L1 expression ≥ 5%, 19.3% (95% CI: 14.2, 25.4) in patients with PD-L1 expression ≥ 1%, and 15.8% (95% CI: 11.9, 20.4) in all comers.
Croatian: Potvrđen ORR prema ocjeni neovisnog ocjenjivačkog povjerenstva na temelju verzije 1.1 RECIST kriterija iznosio je 28,0% (95% CI: 19,5; 37,9) u bolesnika s ekspresijom PD-L1 ≥ 5%, 19,3% (95% CI: 14,2; 25,4) u bolesnika s ekspresijom PD-L1 ≥ 1% te 15,8% (95% CI: 11,9; 20,4) u svih uključenih bolesnika.
English: Table 6 - Summary of efficacy in patients with PD-L1 expression ≥1% (IMpassion130) Key efficacy endpoints
Croatian: Tablica 6 - Sažetak podataka o djelotvornosti u bolesnika s ekspresijom PD L1 ≥ 1% (IMpassion130)
English: Treatment with atezolizumab should be withheld for ≥ Grade 3 serum amylase or lipase levels increased (> 2 x ULN), or Grade 2 or 3 pancreatitis, and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Croatian: U slučaju povišenja serumskih vrijednosti amilaze ili lipaze ≥ 3. stupnja (> 2 x GGN) ili pankreatitisa 2. ili 3. stupnja treba odgoditi primjenu atezolizumaba te uvesti liječenje intravenskim kortikosteroidima (1 - 2 mg/kg/dan metilprednizolona ili ekvivalenta).
English: IMpower133 (GO30081): Randomised phase I/III trial in patients with chemotherapy-naïve extensivestage SCLC, in combination with carboplatin and etoposide
Croatian: IMpower133 (GO30081): Randomizirano ispitivanje faze I/III provedeno u bolesnika s proširenim stadijem SCLC-a koji prethodno nisu primali kemoterapiju, u kombinaciji s karboplatinom i etopozidom
English: The median age was 64 years (range 18 to
Croatian: Medijan dobi iznosio je 64 godine (raspon: 18 - 86 godina).
English: Treatment with atezolizumab should be withheld for Grade 2 or 3 diarrhoea (increase of ≥ 4 stools/day over baseline) or colitis (symptomatic).
Croatian: Primjenu atezolizumaba treba odgoditi u slučaju proljeva 2. ili 3. stupnja (povećanje za ≥ 4 stolice/dan u odnosu na početnu vrijednost) ili kolitisa 2. ili 3. stupnja (simptomatskog).
English: Baseline ECOG performance status was 0 (35%) or 1 (65%).
Croatian: Početni funkcionalni ECOG status iznosio je 0 (35%) ili 1 (65%).
English: A phase III, double-blind, two-arm, multi-center, international, randomised, placebo-controlled study, IMpassion130, was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel, in patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease.
Croatian: Dvostruko slijepo, multicentrično, međunarodno, randomizirano, placebom kontrolirano ispitivanje faze III s dvjema skupinama (IMpassion130) provedeno je radi ocjene djelotvornosti i sigurnosti atezolizumaba u kombinaciji s nab-paklitakselom u bolesnika s neresektabilnim lokalno uznapredovalim ili metastatskim trostruko negativnim rakom dojke koji prethodno nisu primali kemoterapiju za metastatsku bolest.
English: Tumour assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, Day 1 and then every 9 weeks thereafter.
Croatian: Ocjene tumorskog odgovora provodile su se svakih 6 tjedana tijekom prvih 48 tjedana nakon 1. dana 1. ciklusa, a zatim svakih 9 tjedana.
English: Once symptoms improve, treatment with 1 to 2 mg/kg/day of prednisone or equivalent should follow.
Croatian: Nakon što se simptomi poboljšaju, treba uvesti liječenje prednizonom ili ekvivalentom u dozi od 1 do 2 mg/kg na dan.
English: Adrenal insufficiency led to discontinuation of atezolizumab in 1 (<0.1%) patient.
Croatian: Insuficijencija nadbubrežne žlijezde dovela je do prekida liječenja atezolizumabom u 1 (< 0,1%) bolesnika.
English: The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq followed by bevacizumab, is administered by intravenous infusion every three weeks.
Croatian: Nakon faze uvodnog liječenja slijedi faza održavanja bez kemoterapije, tijekom koje se primjenjuju Tecentriq u dozi od 1200 mg i zatim bevacizumab, intravenskom infuzijom svaka tri tjedna.
English: IMpassion130 (WO29522): Randomised phase III trial in locally advanced or metastatic TNBC patients previously untreated for metastatic disease
Croatian: IMpassion130 (WO29522): Randomizirano ispitivanje faze III u bolesnika s lokalno uznapredovalim ili metastatskim trostruko negativnim rakom dojke koji prethodno nisu primali kemoterapiju za metastatsku bolest
English: Randomisation was stratified by PD-L1 expression status on IC, by the number of prior chemotherapy regimens and by histology.
Croatian: Randomizacija je bila stratificirana prema statusu ekspresije PD-L1 na imunosnim stanicama koje infiltriraju tumor, broju prethodnih kemoterapijskih protokola i histološkom nalazu.
English: Pancreatitis, including increases in serum amylase and lipase levels, has been observed in clinical trials with atezolizumab (see section 4.8).
Croatian: U kliničkim ispitivanjima atezolizumaba primijećen je pankreatitis, uključujući povišenja serumskih vrijednosti amilaze i lipaze (vidjeti dio 4.8).
English: A phase III, open-label, randomised study, GO29537 (IMpower130), was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel and carboplatin, in chemotherapy-naïve patients with metastatic non-squamous NSCLC.
Croatian: Ispitivanje GO29537 (IMpower130) bilo je otvoreno, randomizirano ispitivanje faze III provedeno radi ocjene djelotvornosti i sigurnosti atezolizumaba u kombinaciji s nab-paklitakselom i karboplatinom u bolesnika s metastatskim neplanocelularnim NSCLC-om koji prethodno nisu primali kemoterapiju.
English: s Includes reports of colitis, autoimmune colitis, colitis ischaemic, colitis microscopic, colitis ulcerative.
Croatian: Uključuje prijavljene slučajeve kolitisa, autoimunog kolitisa, ishemijskog kolitisa, mikroskopskog kolitisa, ulceroznog kolitisa.
English: Tumour assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, then every 9 weeks thereafter.
Croatian: Ocjene tumorskog odgovora provodile su se svakih 6 tjedana tijekom prvih 48 tjedana nakon 1. ciklusa, a zatim svakih 9 tjedana.
English: Physicians should consult the nab-paclitaxel summary of product characteristics (SmPC) for specific precautions and contraindications of this medicine.
Croatian: Za specifične mjere opreza i kontraindikacije kod primjene nab-paklitaksela liječnici trebaju pročitati sažetak opisa svojstava lijeka za taj lijek.
English: Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration.
Croatian: Lijekove za parenteralnu primjenu treba prije primjene vizualno pregledati kako bi se utvrdilo sadrže li čestice i jesu li promijenili boju.
English: Kaplan-Meier curves for OS in the ITT population are presented in Figure 2.
Croatian: Kaplan-Meierova krivulja OS-a u ITT populaciji prikazana je na Slici 2.
English: Figure 9: Forest plot of progression free survival by PD-L1 expression (IMpower130)
Croatian: Slika 9: Grafikon raspona pouzdanosti za preživljenje bez progresije bolesti prema ekspresiji PD-L1 (IMpower130)
English: Tecentriq monotherapy
Croatian: Monoterapija lijekom Tecentriq
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Tecentriq 1200 mg koncentrat za otopinu za infuziju atezolizumab
English: The confirmed ORR per investigator-assessed mRECIST was 29.0% (95% CI: 20.4, 38.9) in patients with PD-L1 expression ≥ 5%, 23.7% (95% CI: 18.1, 30.1) in patients with PD-L1 expression ≥ 1%, and 19.7% (95% CI: 15.4, 24.6) in all comers.
Croatian: Potvrđen ORR prema ocjeni ispitivača na temelju modificiranih RECIST kriterija iznosio je 29,0% (95% CI: 20,4; 38,9) u bolesnika s ekspresijom PD-L1 ≥ 5%, 23,7% (95% CI: 18,1; 30,1) u bolesnika s ekspresijom PD-L1 ≥ 1% te 19,7% (95% CI: 15,4; 24,6) u svih uključenih bolesnika.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 840 mg concentrate for solution for infusion atezolizumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Tecentriq 840 mg koncentrat za otopinu za infuziju atezolizumab
English: Nephritis occurred in < 0.1% (3/3,178) of patients who received atezolizumab.
Croatian: Nefritis se javio u < 0,1% (3/3178) bolesnika koji su primali atezolizumab.
English: Initiation of systemic corticosteroids (at a dose of 1 to 2 mg/kg/day of prednisone or equivalent) should be considered.
Croatian: Treba razmotriti uvođenje liječenja sistemskim kortikosteroidima u dozi od 1 do 2 mg/kg na dan prednizona ili ekvivalenta.
English: Patients with liver metastases did not show improved PFS or OS with atezolizumab, nab-paclitaxel and carboplatin, compared to nab-paclitaxel and carboplatin (HR of 0.93, 95% CI: 0.59, 1.47 for PFS and HR of 1.04,
Croatian: U bolesnika s jetrenim metastazama nije zabilježeno produljenje PFS-a ni OS-a uz atezolizumab, nab-paklitaksel i karboplatin u odnosu na nab-paklitaksel i karboplatin (HR za PFS: 0,93; 95% CI: 0,59; 1,47; HR za OS: 1,04; 95% CI: 0,63; 1,72).
English: No dedicated studies of atezolizumab have been conducted in patients with hepatic impairment.
Croatian: Nisu provedena specifična ispitivanja atezolizumaba u bolesnika s oštećenjem jetrene funkcije.
English: Pancreatitis led to the discontinuation of atezolizumab in 3 (< 0.1%) patients.
Croatian: Pankreatitis je doveo do prekida liječenja atezolizumabom u 3 (< 0,1%) bolesnika.
English: should also have received targeted therapies before receiving Tecentriq (see section 5.1).
Croatian: Bolesnici s EGFR mutacijama ili ALKpozitivnim NSCLC-om trebali su također primati ciljane terapije prije nego što prime Tecentriq (vidjeti dio 5.1).
English: CI = confidence interval; DOR = duration of response; NE = not estimable; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Croatian: CI = interval pouzdanosti; NP = ne može se procijeniti; ORR = stopa objektivnog odgovora; OS = ukupno preživljenje; PFS = preživljenje bez progresije bolesti; RECIST v1.1 = verzija 1.1 Kriterija za ocjenu odgovora kod solidnih tumora
English: A Phase I/III, randomised, multicentre, double-blind, placebo-controlled study, IMpower133, was conducted to evaluate the efficacy and safety of atezolizumab in combination with carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).
Croatian: Ispitivanje IMpower133 bilo je randomizirano, multicentrično, dvostruko slijepo, placebom kontrolirano ispitivanje faze I/III provedeno radi ocjene djelotvornosti i sigurnosti atezolizumaba u kombinaciji s karboplatinom i etopozidom u bolesnika s proširenim stadijem raka pluća malih stanica (ES-SCLC) koji prethodno nisu primali kemoterapiju.
English: paclitaxel and carboplatin.
Croatian: + karboplatin
English: The paclitaxel starting dose for patients of Asian race/ethnicity was 175 mg/m due to higher overall level of haematologic toxicities in patients from Asian countries compared with those from non-Asian countries c
Croatian: a Atezolizumab se primjenjuje do gubitka kliničke koristi prema ocjeni ispitivača b Početna doza paklitaksela za bolesnike azijskog podrijetla/etničke pripadnosti iznosila je 175 mg/m2 zbog više ukupne razine hematoloških toksičnosti u bolesnika iz azijskih zemalja u odnosu na bolesnike iz ostalih zemalja c Paklitaksel i karboplatin primjenjuju se dok se ne dovrši 4 ili 6 ciklusa liječenja, ili do progresije bolesti ili pojave neprihvatljive toksičnosti, što god nastupi prije d.
English: Administration of atezolizumab could cause foetal harm, including embryo-foetal lethality.
Croatian: Primjena atezolizumaba mogla bi naškoditi plodu, uzrokujući smrt zametka/ploda.
English: Roche a/s c/o Icepharma hf
Croatian: Roche a/s c/o Icepharma hf Sími: +354 540 8000
English: The metabolism of atezolizumab has not been directly studied.
Croatian: Nisu provedena izravna ispitivanja metabolizma atezolizumaba.
English: CI = confidence interval; DOR = duration of response; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Croatian: CI = interval pouzdanosti; ORR = stopa objektivnog odgovora; OS = ukupno preživljenje; PFS = preživljenje bez progresije bolesti; RECIST v1.1 = verzija 1.1 Kriterija za ocjenu odgovora kod solidnih tumora.
English: Includes reports of diarrhoea, defaecation urgency, frequent bowel movements, gastrointestinal hypermotility.
Croatian: Uključuje prijavljene slučajeve proljeva, hitne potrebe za pražnjenjem crijeva, učestalog pražnjenja crijeva, prekomjernog gastrointestinalnog motiliteta.
English: Includes reports of urinary tract infection, cystitis, pyelonephritis, escherichia urinary tract infection, urinary tract infection bacterial, kidney infection, pyelonephritis acute, urinary tract infection fungal, urinary tract infection pseudomonal.
Croatian: Uključuje prijavljene slučajeve infekcije mokraćnog sustava, cistitisa, pijelonefritisa, infekcije mokraćnog sustava uzrokovane bakterijom Escherichia coli, bakterijske infekcije mokraćnog sustava, infekcije bubrega, akutnog pijelonefritisa, gljivične infekcije mokraćnog sustava, pseudomonasne infekcije mokraćnog sustava.
English: Tumour specimens were evaluated prospectively for PD-L1 expression on tumour-infiltrating immune cells (IC) and the results were used to define the PD-L1 expression subgroups for the analyses described below.
Croatian: Uzorci tumora prospektivno su se ocjenjivali kako bi se utvrdila ekspresija PD-L1 na imunosnim stanicama koje infiltriraju tumor, a dobiveni rezultati koristili su se za definiranje podskupina prema ekspresiji PD-L1 radi provedbe analiza opisanih u nastavku.
English: Figure 8: Kaplan-Meier curves for progression free survival (IMpower130)
Croatian: Slika 8: Kaplan-Meierove krivulje preživljenja bez progresije bolesti (IMpower130)
English: • inflammation of the pancreas (pancreatitis): symptoms may include abdominal pain, nausea and vomiting
Croatian: • upalu gušterače (pankreatitis): simptomi mogu uključivati bol u trbuhu, mučninu i povraćanje
English: Kaplan-Meier curves for OS in the ITT population are presented in Figure 10.
Croatian: Kaplan-Meierove krivulje OS-a za populaciju predviđenu za liječenje (ITT) prikazane su na Slici 10.
English: 95% CI: 0.63, 1.72 for OS, respectively).
Croatian: 95% CI: 4,2; NP).
English: The median duration was 24 days (range 3 days to 12.0+ months; + denotes a censored value).
Croatian: Medijan trajanja iznosio je 24 dana (raspon od 3 dana do 12,0+ mjeseci; ‘+' označava cenzuriranu vrijednost).
English: Common pneumonitisq, hypoxia, nasal congestion, nasopharyngitis dysphonia
Croatian: Često pneumonitis q, hipoksija, začepljen nos, nazofaringitis disfonija
English: Myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome, which may be life threatening, were observed in patients receiving atezolizumab.
Croatian: U slučaju mijasteničkog sindroma/miastenije gravis ili Guillain-Barréova sindroma bilo kojeg stupnja liječenje atezolizumabom mora se trajno prekinuti.
English: Tecentriq in combination with nab-paclitaxel in 1L mTNBC The recommended dose of Tecentriq is 840 mg administered by intravenous infusion, followed by 100 mg/m2 nab-paclitaxel.
Croatian: Preporučena doza lijeka Tecentriq je 840 mg intravenskom infuzijom, nakon koje se primjenjuje nab-paklitaksel u dozi od 100 mg/m2.