FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks, until disease progression or unacceptable toxicity, or a maximum of 12 months.
Croatian: Preporučena doza lijeka IMFINZI je 10 mg/kg, a primjenjuje se intravenskom infuzijom u trajanju od 60 minuta svaka 2 tjedna do progresije bolesti ili pojave neprihvatljive toksičnosti, ili do maksimalno 12 mjeseci.
English: • you have had an organ transplant;
Croatian: • ako Vam je presađen organ
English: If not used immediately, chemical and physical in-use stability of IMFINZI has been demonstrated for no more than 24 hours at 2°C to 8°C or 12 hours at room temperature up to 25°C from the time of vial puncture to the start of administration.
Croatian: Ako se ne primijeni odmah, kemijska i fizikalna stabilnost lijeka IMFINZI dokazana je tijekom najviše 24 sata na temperaturi od 2°C do 8°C ili tijekom najviše 12 sati na sobnoj temperaturi do 25°C od trenutka probijanja bočice do početka primjene.
English: Nervous System Disorders Myasthenia gravis
Croatian: Poremećaji živčanog sustava mijastenija gravis rijetko
English: IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).
Croatian: IMFINZI je u monoterapiji indiciran za liječenje lokalno uznapredovalog, neresektabilnog raka pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) kod odraslih osoba čiji tumori pokazuju ekspresiju PD-L1 na ≥ 1% tumorskih stanica i kojima bolest nije uznapredovala nakon kemoradioterapije temeljene na platini (vidjeti dio 5.1).
English: Radiation pneumonitis is frequently observed in patients receiving radiation therapy to the lung and the clinical presentation of pneumonitis and radiation pneumonitis is very similar.
Croatian: Kod bolesnika liječenih radioterapijom pluća često se javlja radijacijski pneumonitis, čija je klinička manifestacija vrlo slična kao kod pneumonitisa.
English: The improvements in PFS and OS in favour of patients receiving IMFINZI compared to those receiving placebo were consistently observed in all predefined subgroups analysed, including ethnicity, age, gender, smoking history, EGFR mutation status and histology.
Croatian: Produljenje PFS-a i OS-a kod bolesnika liječenih lijekom IMFINZI u odnosu na one koji su primali placebo dosljedno je opaženo u svim unaprijed definiranim analiziranim podskupinama, uključujući podskupinu prema etničkom podrijetlu, dobi, spolu, pušačkom statusu, statusu mutacije gena EGFR i histologiji.
English: If not used immediately, the total time from vial puncture to start of the administration should not exceed 24 hours at 2 ºC to 8 ºC or 12 hours at room temperature (up to 25 ºC).
Croatian: Ako se ne primijeni odmah, ukupno vrijeme od bušenja bočice do početka primjene ne smije biti dulje od 24 sata ako se lijek čuva na temperaturi od 2ºC do 8ºC odnosno dulje od 12 sati ako se čuva na sobnoj temperaturi (do 25ºC).
English: Durvalumab has no or negligible influence on the ability to drive and use machines.
Croatian: Durvalumab ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The data for the following immune-mediated adverse reactions reflect the combined safety database of 1889 patients which includes the PACIFIC Study and two additional studies (a multi-cohort, open-label clinical trial in patients with advanced solid tumours, and an open-label study in patients with locally advanced or metastatic NSCLC).
Croatian: Podaci za sljedeće imunološki uzrokovane nuspojave odnose se na objedinjene podatke o sigurnosti prikupljene kod 1889 bolesnika uključenih u ispitivanje PACIFIC i dva dodatna ispitivanja (otvoreno kliničko ispitivanje s više kohorta provedeno kod bolesnika s uznapredovalim solidnim tumorima i otvoreno ispitivanje provedeno kod bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om).
English: Post-hoc subgroup analysis by PD-L1 expression
Croatian: Post-hoc analiza podskupina prema ekspresiji PD-L1
English: Patients had completed at least 2 cycles of definitive platinum-based chemotherapy with radiation therapy within 1 to 42 days prior to initiation of the study and had a ECOG performance status of 0 or 1.
Croatian: Bolesnici su prethodno dovršili najmanje dva ciklusa definitivne kemoterapije temeljene na platini u kombinaciji s radioterapijom unutar 1 - 42 dana prije početka ispitivanja te su imali funkcionalni ECOG status 0 ili 1.
English: You should not be given IMFINZI
Croatian: Ne smijete primiti IMFINZI
English: PD-L1 testing for patients with locally advanced NSCLC Patients with locally advanced NSCLC should be evaluated for treatment based on the tumour expression of PD-L1 confirmed by a validated test (section 5.1).
Croatian: Testiranje na PD-L1 za bolesnike s lokalno uznapredovalim NSCLC-om Kod bolesnika s lokalno uznapredovalim NSCLC-om potrebno je procijeniti pogodnost za liječenje na temelju tumorske ekspresije PD-L1 potvrđene validiranim testom (dio 5.1).
English: PK exposure increased more than dose-proportionally (non-linear PK) at doses < 3 mg/kg, and dose proportionally (linear PK) at doses ≥ 3 mg/kg.
Croatian: Farmakokinetička izloženost povećavala se više nego proporcionalno dozi (nelinearna farmakokinetika) pri dozama < 3 mg/kg, dok se pri dozama ≥ 3 mg/kg povećavala proporcionalno dozi (linearna farmakokinetika).
English: Immune-mediated pneumonitis occurred more frequently in patients in the PACIFIC Study who had completed treatment with concurrent chemoradiation within 1 to 42 days prior to initiation of the study (10.7%), than in the other patients in the combined safety database (2.0%).
Croatian: Imunološki uzrokovan pneumonitis češće se javljao kod bolesnika iz ispitivanja PACIFIC koji su dovršili liječenje kemoradioterapijom unutar 1 - 42 dana prije početka ispitivanja (10,7%) nego kod ostalih bolesnika uključenih u bazu objedinjenih podataka o sigurnosti (2,0%).
English: 29.1 (17.7, NR)
Croatian: 29,1 (17,7; ND)
English: If you have any of the following, call or see your doctor straight away.
Croatian: Ako imate bilo što od navedenoga, odmah nazovite ili posjetite svog liječnika.
English: Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation.
Croatian: Selektivna blokada interakcija PD-L1/PD-1 i PD-L1/CD80 pojačava protutumorske imunosne odgovore i aktivaciju T-stanica.
English: IMFINZI is most commonly associated with immune-mediated adverse reactions.
Croatian: IMFINZI se najčešće povezuje s imunološki uzrokovanim nuspojavama.
English: Baseline demographics of the overall study population were as follows: male (70%), age ≥ 65 years (45%), age ≥ 75 years (8%), White (69%), Asian (27%), other (4%), current smoker (16%), past-smoker (75%), never smoker (9%), ECOG Performance Status 0 (49%), ECOG Performance Status 1 (51%).
Croatian: Početne demografske značajke cjelokupne ispitivane populacije bile su sljedeće: muškarci (70%), dob ≥ 65 godina (45%), dob ≥ 75 godina (8%), bijelci (69%), Azijci (27%), ostali (4%), aktivni pušači (16%), bivši pušači (75%), nepušači (9%), funkcionalni ECOG status 0 (49%), funkcionalni ECOG status 1 (51%).
English: The effect of moderate hepatic impairment (bilirubin > 1.5 to 3 x ULN and any AST) or severe hepatic impairment (bilirubin > 3.0 x ULN and any AST) on the pharmacokinetics of durvalumab is unknown; however, as IgG monoclonal antibodies are not primarily cleared via hepatic pathways, a change in hepatic function is not expected to influence durvalumab exposure.
Croatian: Utjecaj umjerenog (bilirubin > 1,5 - 3 × GGN i bilo koja vrijednost AST-a ) ili teškog (bilirubin > 3 × GGN i bilo koja vrijednost AST-a) oštećenja jetrene funkcije na farmakokinetiku durvalumaba nije poznat; međutim, s obzirom na to da se IgG monoklonska protutijela primarno ne izlučuju putem jetre, ne očekuje se da će promjena u jetrenoj funkciji utjecati na izloženost durvalumabu.
English: Placebo Hazard ratio (95% CI):
Croatian: Placebo Omjer hazarda (95% CI):
English: The following immune-related adverse reactions were reported in less than 1% of patients treated with IMFINZI monotherapy in clinical trials (n = 1889): Myasthenia gravis, myocarditis, myositis, polymyositis.
Croatian: Kod manje od 1% bolesnika koji su u kliničkim ispitivanjima primali monoterapiju lijekom IMFINZI (n = 1889) prijavljene su sljedeće imunološki uzrokovane nuspojave: mijastenija gravis, miokarditis, miozitis, polimiozitis.
English: Eight patients experienced hypothyroidism following hyperthyroidism.
Croatian: Kod osam se bolesnika nakon hipertireoze razvila hipotireoza.
English: Initiate treatment with insulin as clinically indicated
Croatian: Uvesti liječenje inzulinom sukladno kliničkoj indikaciji
English: • decreased secretion of hormones produced by the adrenal glands that can cause tiredness
Croatian: • smanjeno lučenje hormona koje proizvode nadbubrežne žlijezde, koje može izazvati umor
English: Throughout the duration of the study to Week 48, there was no clinically meaningful difference between IMFINZI and placebo groups in symptoms, functioning and HRQoL (as assessed by a difference of greater than or equal to 10 points).
Croatian: Do 48. tjedna ispitivanja nije opažena klinički značajna razlika između skupine liječene lijekom IMFINZI i one koja je primala placebo s obzirom na simptome, funkcioniranje i kvalitetu života vezanu uz zdravlje (koja se ocjenjivala na temelju razlike od 10 bodova ili više).
English: How to store IMFINZI
Croatian: Kako čuvati IMFINZI
English: After withhold, IMFINZI can be resumed within 12 weeks if the adverse reactions improved to ≤ Grade 1 and the corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day.
Croatian: IMFINZI se nakon privremenog prekida liječenja može nastaviti primjenjivati unutar 12 tjedana ako se nuspojave poboljšaju do ≤ 1. stupnja, a doza kortikosteroida smanji na ≤ 10 mg prednizona na dan ili ekvivalentno tome.
English: IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.
Croatian: IMFINZI dolazi u jednodoznoj bočici i ne sadrži nikakve konzervanse, pa se za njegovu pripremu mora koristiti aseptička tehnika.
English: Of 451 patients with PD L1 expression available, 67% were TC ≥ 1% [PD-L1 TC 1-24% (32%), PD L1 TC ≥ 25% (35%)] and 33% were TC < 1%.
Croatian: Od 451 bolesnika za kojeg su bili dostupni podaci o ekspresiji PD-L1, njih 67% imalo je ekspresiju na ≥ 1% tumorskih stanica (TC ≥ 1%) [PD-L1 TC 1 - 24% (32%), PD-L1 TC ≥ 25% (35%)], dok je njih 33% imalo ekspresiju na < 1% tumorskih stanica (TC < 1%).
English: Patients were randomised 2:1 to receive 10 mg/kg IMFINZI (n = 476) or 10 mg/kg placebo (n = 237) via intravenous infusion every 2 weeks for up to 12 months or until unacceptable toxicity or confirmed disease progression.
Croatian: Bolesnici su bili randomizirani u omjeru 2:1 za primanje lijeka IMFINZI u dozi od 10 mg/kg (n = 476) ili placeba u dozi od 10 mg/kg (n = 237) intravenskom infuzijom svaka 2 tjedna tijekom najviše 12 mjeseci ili do pojave neprihvatljive toksičnosti ili potvrđene progresije bolesti.
English: In animal reproduction studies, administration of durvalumab to pregnant cynomolgus monkeys from the confirmation of pregnancy through delivery, at exposure levels approximately 18 times higher than those observed at the clinical dose of 10 mg/kg of durvalumab (based on AUC), was associated with placental transfer but not with maternal toxicity or effects on embryofoetal development, pregnancy outcome or postnatal development.
Croatian: U ispitivanjima reprodukcije na životinjama primjena durvalumaba skotnim ženkama makaki majmuna od potvrde skotnosti do okota, uz razine izloženosti približno 18 puta veće od onih opaženih kod primjene kliničke doze durvalumaba od 10 mg/kg (prema AUC-u), bila je povezana s prolaskom lijeka kroz posteljicu, ali ne i toksičnim učincima na majku ni učincima na embriofetalni razvoj, ishod skotnosti ili postnatalni razvoj.
English: Upon improvement to ≤ Grade 1, corticosteroid taper should be initiated and continued over at least 1 month.
Croatian: Nakon poboljšanja do ≤ 1. stupnja, dozu kortikosteroida treba postupno smanjivati tijekom razdoblja od najmanje mjesec dana.
English: • tooth and mouth soft tissue infections
Croatian: • infekcije zuba i mekih tkiva u usnoj šupljini
English: When you get IMFINZI, you can have some serious side effects (see section 2).
Croatian: Tijekom liječenja lijekom IMFINZI mogu se pojaviti neke ozbiljne nuspojave (pogledajte dio 2).
English: Talk to your doctor straight away if you get any of the side effects listed above.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju od navedenih nuspojava.
English: IMFINZI should be permanently discontinued for recurrent Grade 3 or 4 (severe or life-threatening) immune-mediated adverse reactions.
Croatian: Liječenje lijekom IMFINZI treba trajno prekinuti u slučaju rekurentnih imunološki uzrokovanih nuspojava 3. ili 4. stupnja (teške ili po život opasne nuspojave).
English: Due to minor involvement of hepatic processes in the clearance of durvalumab no dose adjustment of IMFINZI is recommended for patients with hepatic impairment as no difference in exposure is expected (see section 5.2).
Croatian: Budući da jetreni procesi nisu u značajnoj mjeri uključeni u klirens durvalumaba, ne preporučuje se prilagođavati dozu lijeka IMFINZI kod bolesnika s oštećenjem jetrene funkcije jer se razlika u izloženosti ne očekuje (vidjeti dio 5.2).
English: Guidelines for management of immune-mediated adverse reactions are described in Table 1 (see section 4.4).
Croatian: Smjernice za zbrinjavanje imunološki uzrokovanih nuspojava opisane su u Tablici 1 (vidjeti dio 4.4).
English: Grade 3 with AST or ALT > 5-≤ 8 x ULN or total bilirubin > 3≤ 5x ULN Grade 3 with AST or ALT > 8 x ULN or total bilirubin > 5 x ULN
Croatian: 3. stupanj, uz AST ili ALT > 5 - ≤ 8 x GGN ili ukupni bilirubin > 3 - ≤ 5 x GGN 3. stupanj, uz AST ili ALT > 8 x GGN ili ukupni bilirubin > 5 x GGN
English: • IMFINZI is single-dose.
Croatian: • IMFINZI je namijenjen za primjenu samo jedne doze.
English: Since the primary elimination pathways of durvalumab are protein catabolism via reticuloendothelial system or target-mediated disposition, no metabolic drug-drug interactions are expected.
Croatian: Budući da se durvalumab prvenstveno eliminira proteinskim katabolizmom putem retikuloendotelnog sustava ili dispozicijom vezivanjem za ciljno mjesto, ne očekuju se metaboličke interakcije s drugim lijekovima.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
Croatian: U slučaju predoziranja potrebno je pažljivo nadzirati bolesnike zbog moguće pojave znakova ili simptoma nuspojava te odmah uvesti odgovarajuće simptomatsko liječenje.
English: The overall incidence of Grade 3 or 4 adverse reactions was 12.8% in the IMFINZI arm vs 9.8% in placebo.
Croatian: Ukupna incidencija nuspojava 3. ili 4. stupnja iznosila je 12,8% u skupini liječenoj lijekom IMFINZI naspram 9,8% u onoj koja je primala placebo.
English: Based on its mechanism of action, durvalumab has the potential to impact maintenance of pregnancy, and in a mouse allogeneic pregnancy model, disruption of PD-L1 signaling was shown to result in an increase in foetal loss.
Croatian: S obzirom na mehanizam djelovanja, durvalumab može utjecati na očuvanje trudnoće, a u mišjim alogenim modelima skotnosti ometanje signalizacije putem PD-L1 dovelo je do povećanog gubitka plodova.
English: • underactive function of pituitary gland (hypopituitarism including diabetes insipidus) that can cause tiredness, an increase in the amount of your urine
Croatian: • smanjena funkcija hipofize (hipopituitarizam, uključujući insipidni dijabetes), koja može uzrokovati umor i povećanu količinu mokraće
English: Data on patients aged 75 years of age or older are limited.
Croatian: Podaci o primjeni kod bolesnika koji imaju 75 godina ili više su ograničeni.
English: PFS at 12 months (%) (95% CI) PFS at 18 months (%) (95% CI) PFS2 Median PFS2
Croatian: PFS nakon 12 mjeseci (%) (95% CI) PFS nakon 18 mjeseci (%) (95% CI)
English: Grade 1 or 2 Interrupt or slow the rate of infusion
Croatian: Privremeno prekinuti infuziju ili smanjiti brzinu njezine primjene
English: Patients should be monitored for signs and symptoms of pneumonitis or radiation pneumonitis.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma pneumonitisa ili radijacijskog pneumonitisa.
English: Compliance was similar between the IMFINZI and placebo treatment groups (83% vs 85.1% overall of evaluable forms completed).
Croatian: Stopa pridržavanja liječenja bila je slična i u skupini liječenoj lijekom IMFINZI i u onoj koja je primala placebo (sveukupno 83% naspram 85,1% prema ispunjenim upitnicima koji su se mogli ocijeniti).
English: The use of systemic corticosteroids or immunosuppressants before starting durvalumab, except physiological dose of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent), is not recommended because of their potential interference with the pharmacodynamic activity and efficacy of durvalumab.
Croatian: Ne preporučuje se primjena sistemskih kortikosteroida ili imunosupresiva prije početka liječenja durvalumabom, osim fizioloških doza sistemskih kortikosteroida (≤ 10 mg prednizona na dan ili ekvivalent), jer ti lijekovi mogu utjecati na farmakodinamičku aktivnost i djelotvornost durvalumaba.
English: • Withdraw the required volume of concentrate from the vial(s) and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection, to prepare a diluted solution with a final concentration ranging from 1 to 15 mg/mL.
Croatian: • Izvucite potrebni volumen koncentrata iz bočice(a) i prenesite ga u vrećicu za intravensku infuziju koja sadrži otopinu natrijeva klorida za injekciju od 9 mg/ml (0,9%) ili otopinu glukoze za injekciju od 50 mg/ml (5%), da biste dobili razrijeđenu otopinu čija se konačna koncentracija kreće u rasponu od 1 do 15 mg/ml.
English: The study demonstrated a statistically significant improvement in PFS in the IMFINZI-treated group compared with the placebo group [hazard ratio (HR) = 0.52 (95% CI: 0.42, 0.65), p < 0.0001].
Croatian: Ispitivanje je pokazalo statistički značajno produljenje PFS-a u skupini liječenoj lijekom IMFINZI u odnosu na onu koja je primala placebo (omjer hazarda [engl. hazard ratio, HR] = 0,52 [95% CI: 0,42; 0,65], p< 0,0001).
English: • abnormal kidney function tests (blood creatinine increased)
Croatian: • odstupanja u nalazima testova za ocjenjivanje funkcije bubrega (povišene razine kreatinina u krvi)
English: • swelling of the legs (oedema peripheral)
Croatian: • oticanje nogu (periferni edem)
English: Grade 3-4 (%)
Croatian: 3. - 4. stupanj (%)
English: 120 mg/2.4 ml 500 mg/10 ml 1 vial
Croatian: 120 mg/2,4 ml 500 mg/10 ml 1 bočica
English: • inflammation of the lungs (pneumonitis)
Croatian: • upala pluća (pneumonitis)
English: By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation and cytokine production.
Croatian: Vezivanjem za svoje receptore, PD-L1 smanjuje aktivnost i proliferaciju citotoksičnih T-stanica te proizvodnju citokina.
English: If you have any of the symptoms listed above, call or see your doctor straight away.
Croatian: Ako imate bilo koji od navedenih simptoma, odmah nazovite ili posjetite svog liječnika.
English: The median time to onset in the IMFINZI-treated group was 53 days (range: 1-341 days) vs. 55.5 days (range: 0-231 days) in the placebo group.
Croatian: Medijan vremena do nastupa u skupini liječenoj lijekom IMFINZI iznosio je 53 dana (raspon: 1 - 341 dan), naspram 55,5 dana (raspon: 0 - 231 dan) u skupini koja je primala placebo.
English: Immune-mediated hypothyroidism and hyperthyroidism (including thyroiditis) should be managed as recommended in section 4.2.
Croatian: Imunološki uzrokovanu hipotireozu i hipertireozu (uključujući tireoiditis) treba liječiti u skladu s preporukama navedenima u dijelu 4.2.
English: ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
Croatian: Zajednički terminološki kriteriji za nuspojave (CTCAE), verzija 4.03. ALT: alanin aminotransferaza; AST: aspartat aminotransferaza; GGN: gornja granica normale.
English: Twenty-six of the 34 patients received medical therapy (thiamazole, carbimazole, propylthiouracil or beta-blocker), 12 patients received thyroxine when hyperthyroidism transitioned to hypothyroidism, 12 patients received systemic corticosteroids and 3 of the 12 patients received high-dose systemic corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Croatian: Dvadeset i šest (26) od 34 bolesnika primalo je farmakoterapiju (tiamazol, karbimazol, propiltiouracil ili beta-blokator), 12 bolesnika primalo je tiroksin nakon što je hipertireoza prešla u hipotireozu, a 12 bolesnika bilo je liječeno sistemskim kortikosteroidima, od kojih je troje primalo visoke doze sistemskih kortikosteroida (najmanje 40 mg prednizona ili ekvivalent na dan).
English: Patients were enrolled regardless of their tumour PD-L1 expression level.
Croatian: Bolesnici su se uključivali u ispitivanje neovisno o razini tumorske ekspresije PD-L1.
English: NR (34.7, NR)
Croatian: ND (34,7; ND)
English: Where available, archival tumour tissue specimens taken prior to chemoradiation therapy were retrospectively tested for PD-L1 expression on tumour cells (TC) using the VENTANA PD-L1 (SP263) IHC assay.
Croatian: Kod bolesnika za koje su bili dostupni arhivski uzorci tumorskog tkiva prikupljeni prije kemoradioterapije retrospektivno je provedeno testiranje ekspresije PD-L1 na tumorskim stanicama (engl. tumour cells, TC) uz pomoć testa VENTANA PD-L1 (SP263) IHC.
English: HR (95% CI) 2-sided p-value OS at 24 months (%)
Croatian: HR (95% CI) dvostrana p-vrijednost OS nakon 24 mjeseca (%)
English: • inflammation of the muscle
Croatian: • upala mišića
English: • Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous (IV) bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or glucose 50 mg/mL (5%) solution for injection.
Croatian: • Izvucite potrebni volumen iz bočice(a) lijeka IMFINZI i prenesite ga u vrećicu za intravensku (i.v.) infuziju koja sadrži otopinu natrijeva klorida za injekciju od 9 mg/ml (0,9%) ili otopinu glukoze za injekciju od 50 mg/ml (5%).
English: The study demonstrated a statistically significant improvement in OS in the IMFINZI-treated group compared with the placebo group [HR = 0.68 (95% CI: 0.53, 0.87), p = 0.00251].
Croatian: Ispitivanje je pokazalo statistički značajno produljenje OS-a u skupini liječenoj lijekom IMFINZI u usporedbi sa skupinom koja je primala placebo [HR = 0,68 (95% CI: 0,53; 0,87), p = 0,00251].
English: Overall the safety profile of durvalumab in PD-L1 TC ≥ 1% subgroup was consistent with the intent to treat population, as was the PD-L1 TC < 1% subgroup.
Croatian: Sveukupno je profil sigurnosti durvalumaba u podskupini s ekspresijom PD-L1 na ≥ 1% tumorskih stanica (PD-L1 TC ≥ 1%) odgovarao onome u populaciji predviđenoj za liječenje, baš kao i onaj u podskupini bolesnika s ekspresijom PD-L1 na < 1% tumorskih stanica (PD-L1 TC < 1%).
English: Upon resolution (Grade 0), corticosteroid taper should be initiated and continued over at least 1 month, after which IMFINZI can be resumed based on clinical judgment.
Croatian: Nakon povlačenja nuspojave (0. stupanj) treba početi postupno smanjivati dozu kortikosteroida i nastaviti je smanjivati tijekom najmanje mjesec dana, nakon čega se liječenje lijekom IMFINZI može nastaviti prema kliničkoj prosudbi.
English: • abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased)
Croatian: • odstupanja u nalazima pretraga za ocjenjivanje funkcije jetre (povišene razine aspartat aminotransferaze, povišene razine alanin aminotransferaze)