FrancophonIA/ELRC3.0 huggingface dataset:
English: The volume of OPDIVO concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the OPDIVO concentrate strength is 10 mg/mL).
Croatian: Volumen koncentrata lijeka OPDIVO za pripremu doze (ml) = ukupna doza u mg, podijeljena s 10 (jačina koncentrata lijeka OPDIVO iznosi 10 mg/ml).
English: However, based on its mechanism of action, foetal exposure to nivolumab may increase the risk of developing immune-related disorders or altering the normal immune response and immune-related disorders have been reported in PD-1 knockout mice.
Croatian: Međutim, s obzirom na mehanizam djelovanja nivolumaba, izloženost ploda ovom lijeku može povećati rizik od razvoja imunološki uzrokovanih poremećaja ili promjene normalnog imunog odgovora, pa su tako u miševa kojima je inaktiviran (engl. knockout) PD-1 prijavljeni imunološki uzrokovani poremećaji.
English: Nivolumab treatment resulted in rapid resolution of B-symptoms in 88.7% (47/53) of the patients, with a median time to resolution of 1.9 months.
Croatian: Liječenje nivolumabom dovelo je do brzog povlačenja B-simptoma u 88,7% (47/53) bolesnika, a medijan vremena do njihova povlačenja iznosio je 1,9 mjeseci.
English: The safety and tolerability of nivolumab were investigated in a phase 1, open-label dose-escalation study in various tumour types, including malignant melanoma.
Croatian: Sigurnost i podnošljivost nivolumaba ocjenjivane su u otvorenom ispitivanju povećanja doze faze 1, u kojem su sudjelovali bolesnici s različitim vrstama tumora, uključujući maligni melanom.
English: If not used immediately, chemical and physical in-use stability of OPDIVO has been demonstrated for 24 hours at 2ºC to 8ºC protected from light and a maximum of 8 hours at 20°C-25°C and room light (this 8-hour period of the total 24 hours should be inclusive of the product administration period).
Croatian: Ako se ne upotrijebi odmah, kemijska i fizička stabilnost lijeka OPDIVO dokazana je tijekom 24 sata ako se čuva na temperaturi od 2°C-8°C zaštićeno od svjetlosti, te tijekom najviše 8 sati na temperaturi od 20°C-25°C i sobnoj svjetlosti (ovo 8-satno razdoblje od ukupnog 24-satnog razdoblja mora uključivati i vrijeme primjene lijeka).
English: Nivolumab monotherapy:
Croatian: Nivolumab u monoterapiji:
English: Treatment with nivolumab may increase the risk of severe GVHD and death in patients who have had prior allogeneic HSCT, mainly in those with prior history of GVHD.
Croatian: Liječenje nivolumabom može povećati rizik od teškog GVHD-a i smrti u bolesnika prethodno podvrgnutih alogenom HSCT-u, prvenstveno onih koji imaju GVHD u anamnezi.
English: Grade 2 or 3 creatinine elevation
Croatian: Povišenje razine kreatinina 2. ili 3. stupnja
English: Comparable to the overall population, median duration of response was increased with nivolumab vs. docetaxel for patients with no PD-L1 expression (18.3 months vs. 5.6 months) and for patients with PD-L1 expression (16.0 months vs. 5.6 months).
Croatian: Slično kao i u cjelokupnoj populaciji, medijan trajanja odgovora povećao se uz nivolumab u odnosu na docetaksel i u bolesnika bez ekspresije PD-L1 (18,3 mjeseca naspram 5,6 mjeseci) i u onih koji su pokazivali ekspresiju PD-L1 (16,0 mjeseci naspram 5,6 mjeseci).
English: Randomisation was stratified by prior cetuximab treatment.
Croatian: Randomizacija je bila stratificirana prema prethodnom liječenju cetuksimabom.
English: For the monotherapy phase, the first dose of nivolumab should be administered; 3 weeks after the last dose of the combination of nivolumab and ipilimumab if using 240 mg every 2 weeks; or 6 weeks after the last dose of the combination of nivolumab and ipilimumab if using 480 mg every 4 weeks.
Croatian: U fazi monoterapije, prvu dozu nivolumaba treba primijeniti: 3 tjedna nakon posljednje doze kombinacije nivolumaba i ipilimumaba ako se primjenjuje doza od 240 mg svaka 2 tjedna; ili 6 tjedana nakon posljednje doze kombinacije nivolumaba i ipilimumaba ako se primjenjuje doza od 480 mg svaka 4 tjedna.
English: Patients were to have ECOG performance status score of 0 or 1.
Croatian: Bolesnici su morali imati funkcionalni ECOG status 0 ili 1.
English: ≥ 1% to < 10%a ≥ 10% to < 50%a ≥ 50%a
Croatian: ≥ 1% i < 10%a ≥ 10% i < 50%a ≥50%a
English: This helps increase their activity against the melanoma, lung, kidney, lymphoid, head and neck or bladder cancer cells.
Croatian: Na taj način pojačava njihovo djelovanje protiv stanica melanoma, raka pluća, raka bubrega, limfoma, raka glave i vrata ili raka mokraćnog mjehura.
English: The median duration of response was not reached (range: 4.4-16.6+ months).
Croatian: Medijan trajanja odgovora nije postignut (raspon: 4,4 - 16,6+ mjeseci).
English: Responses were assessed per RECIST 1.1 for 588/1008 (58.3%) of patients who continued treatment through week 12 and had a follow-up scan at week 12.
Croatian: Odgovori su ocijenjeni prema verziji 1.1. RECIST kriterija za 588/1008 (58,3%) bolesnika koji su nastavili liječenje tijekom 12 tjedana i u kojih je u 12. tjednu provedeno kontrolno oslikavanje.
English: Patients had to have a Karnofsky Performance Score (KPS) ≥ 70%.
Croatian: Karnofsky Performance Score, KPS) od ≥ 70%.
English: Efficacy by BRAF status: Objective responses to nivolumab (according to the definition of the coprimary endpoint) were observed in patients with or without BRAF mutation-positive melanoma.
Croatian: Djelotvornost prema BRAF statusu: Objektivni odgovori na nivolumab (prema definiciji koprimarne mjere ishoda) primijećeni su u bolesnika koji su imali melanom pozitivan ili negativan na mutaciju gena BRAF.
English: While both arms of the study received active therapy, the QoL data should be interpreted in the context of the open-label study design and therefore cautiously taken.
Croatian: Iako su obje ispitivane skupine primale terapiju aktivnim lijekom, podatke o kvaliteti života treba tumačiti u kontekstu otvorenog dizajna ispitivanja i razmatrati ih uz oprez.
English: The PRO data should be interpreted in the context of the open-label study design and therefore taken cautiously.
Croatian: Podatke o ishodima koje prijavljuju bolesnici treba interpretirati u kontekstu otvorenog dizajna ispitivanja i stoga uzimati s oprezom.
English: Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumour responses in metastatic melanoma.
Croatian: Kombinirana inhibicija koju ostvaruju nivolumab (anti-PD-1) i ipilimumab (anti-CTLA-4) dovodi do poboljšanih protutumorskih odgovora kod metastatskog melanoma.
English: Per the AJCC 8th edition, this corresponds to patients with lymph node involvement or metastases.
Croatian: Prema 8. izdanju AJCC klasifikacije, to odgovara bolesnicima s bolešću koja je zahvatila limfne čvorove ili metastazirala.
English: During administration of the second phase of treatment (nivolumab monotherapy) following combination treatment, permanently discontinue treatment if Grade 3 diarrhoea or colitis occurs.
Croatian: Tijekom primjene u drugoj fazi liječenja (monoterapija nivolumabom) nakon kombinirane terapije, trajno prekinuti liječenje ako se jave proljev ili kolitis 3. stupnja.
English: OPDIVO should not be infused concomitantly in the same intravenous line with other medicinal products.
Croatian: OPDIVO se ne smije infundirati istodobno s drugim lijekovima kroz istu intravensku liniju.
English: Nivolumab in combination with ipilimumab (see section 4.2)
Croatian: Nivolumab u kombinaciji s ipilimumabom (vidjeti dio 4.2)
English: or stop your treatment with OPDIVO altogether.
Croatian: ili posve obustaviti liječenje lijekom OPDIVO
English: Nivolumab with ipilimumab was continued beyond progression in 29% of patients.
Croatian: Liječenje nivolumabom u kombinaciji s ipilimumabom nastavilo se nakon progresije u 29% bolesnika.
English: 30th September 2021
Croatian: 30. rujna 2021.
English: dacarbazine (n = 208)
Croatian: dakarbazin (n = 208)
English: Not reached (0+-12.5+)
Croatian: nije postignut (0+ -12.5+)
English: ORRs were higher for the combination of nivolumab and ipilimumab relative to nivolumab monotherapy across tumour PD-L1 expression levels (Table 12) after 28 months of follow-up, with a best overall response of complete response correlating to an improved survival rate.
Croatian: ORR je nakon 28 mjeseci praćenja bio veći uz kombinaciju nivolumaba i ipilimumaba nego uz monoterapiju nivolumabom kod svih razina tumorske ekspresije PD-L1 (Tablica 12), a najbolji ukupni odgovor bio je potpuni odgovor u korelaciji s poboljšanom stopom preživljenja.
English: Not Reached (1.9+, 12.0+)
Croatian: Nije postignut (1,9+; 12,0+)
English: Efficacy assessments included investigator-assessed ORR, retrospectively evaluated by an IRRC, and duration of response.
Croatian: Ocjene djelotvornosti uključivale su ORR prema ocjeni ispitivača, koji je retrospektivno ocijenio i IRRC, te trajanje odgovora.
English: (95.92% CI) p-valueb
Croatian: (95,92% CI) p-vrijednostb
English: Patients with investigator-assessed primary site of oropharyngeal cancer were tested for HPV (determined by p16 immunohistochemistry [IHC]).
Croatian: Bolesnici kojima je prema ocjeni ispitivača primarno sijelo raka bio orofarinks testirani su na HPV (koji se utvrđivao imunohistokemijskim [IHC] testom na p16).
English: CA209214 also randomised 249 favourable risk patients as per IMDC criteria to nivolumab plus ipilimumab (n = 125) or to sunitinib (n = 124).
Croatian: U ispitivanje CA209214 bilo je uključeno i 249 bolesnika s niskim rizikom prema IMDC kriterijima i randomizirano za primanje nivolumaba plus ipilimumaba (n = 125) ili sunitiniba (n = 124).
English: Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion.
Croatian: Vezivanje PD-1 s ligandima PD-L1 i PD-L2, koji su eksprimirani u antigen prezentirajućim stanicama i mogu biti eksprimirani na tumorskim stanicama ili drugim stanicama u mikrookolini tumora, dovodi do inhibicije proliferacije T-stanica i lučenja citokina.
English: CR+PR, confidence interval based on the Clopper and Pearson method
Croatian: Potpuni odgovor + djelomičan odgovor, interval pouzdanosti na prema Clopperovoj i Pearsonovoj metodi
English: The safety of re-initiating nivolumab or nivolumab in combination with ipilimumab therapy in patients previously experiencing immune-related myocarditis is not known.
Croatian: Sigurnost ponovnog uvođenja nivolumaba ili nivolumaba u kombinaciji s ipilimumabom u bolesnika koji su prethodno imali imunološki uzrokovan miokarditis nije poznata.
English: Renal Cell Carcinoma (RCC)
Croatian: Karcinom bubrežnih stanica (RCC)
English: Resolution occurred in 64 patients (45.4%).
Croatian: Nuspojave su se povukle u 64 bolesnika (45,4%).
English: Of patients evaluable for the presence of antiipilimumab antibodies, the incidence of anti-ipilimumab antibodies ranged from 6.3 to 8.4% and neutralising antibodies against ipilimumab ranged from 0 to 0.3%.
Croatian: Među bolesnicima u kojih se mogla odrediti prisutnost protutijela na ipilimumab, incidencija protutijela na ipilimumab kretala se u rasponu od 6,3% do 8,4%, a incidencija neutralizirajućih protutijela na ipilimumab u rasponu od 0% do 0,3%.
English: OPDIVO must be stored in a refrigerator (2°C to 8°C).
Croatian: OPDIVO se mora čuvati u hladnjaku (2°C do 8°C).
English: Overall survival (Months)
Croatian: Ukupno preživljenje (mjeseci)
English: Apparently meaningful symptom improvement (MID = 2 point change in FKSI-DRS score; p < 0.001) and time to improvement (HR = 1.66 (1.33,2.08), p < 0.001) were significantly better for patients on the nivolumab arm.
Croatian: Prividno značajno poboljšanje simptoma (minimalna važna razlika = promjena FKSI-DRS rezultata za 2 boda; p < 0,001) i vrijeme do poboljšanja (HR = 1,66 [1,33; 2,08], p < 0,001) bili su značajno bolji u bolesnika liječenih nivolumabom.
English: Median durations of response were 31.9 months (range: 1.4+-31.9) and 12.8 months (range: 1.3+-13.6+), respectively.
Croatian: Medijan trajanja odgovora iznosio je 31,9 mjeseci (raspon: 1,4+-31,9) odnosno 12,8 mjeseci (raspon: 1,3+13,6+).
English: chemotherapy (n = 47)
Croatian: kemoterapija (n = 47)
English: P-value is derived from a log-rank test stratified by prior cetuximab; the corresponding O'Brien-Fleming efficacy boundary significance level is 0.0227.
Croatian: P-vrijednost dobivena je iz log-rang testa stratificiranog prema prethodnom liječenju cetuksimabom; odgovarajuća razina značajnosti za granicu djelotvornosti prema O'Brien-Flemingovoj metodi iznosi 0,0227.
English: Patients should be monitored for cardiac and pulmonary adverse reactions continuously, as well as for clinical signs, symptoms, and laboratory abnormalities indicative of electrolyte disturbances and dehydration prior to and periodically during treatment.
Croatian: Bolesnike je potrebno kontinuirano nadzirati zbog moguće pojave srčanih i plućnih nuspojava, kao i kliničkih znakova, simptoma i odstupanja u laboratorijskim nalazima koji upućuju na poremećaje elektrolita i dehidraciju, prije i povremeno tijekom liječenja.
English: Overall survivala Events
Croatian: Ukupno preživljenjea Događaji
English: • patients with prior therapy for melanoma (except patients with surgery, adjuvant radiotherapy after neurosurgical resection for lesions of the central nervous system, and prior adjuvant interferon completed ≥ 6 months prior to randomisation),
Croatian: • u bolesnika koji su prethodno primali terapiju za melanom (izuzev bolesnika koji su bili liječeni kirurškim zahvatom, adjuvantnom radioterapijom zbog lezija u središnjem živčanom sustavu nakon neurokirurške resekcije i adjuvantnom terapijom interferonom koja je završila ≥ 6 mjeseci prije randomizacije)
English: The median PFS was 3.7 months (95% CI: 1.9, 9.3).
Croatian: Medijan PFS-a iznosio je 3,7 mjeseci (95% CI: 1,9; 9,3).
English: Grade 3 or 4 elevation in AST, ALT, or total bilirubin
Croatian: Povišenje razina AST-a, ALT-a ili ukupnog bilirubina 3. ili 4. stupnja
English: PD-L1 Expression nivolumab investigator's choice OS by tumour PD-L1 expression Number of events (number of patients)
Croatian: Izbor ispitivača OS prema tumorskoj ekspresiji PD-L1 Broj događaja (broj bolesnika)
English: Very common (may affect more than 1 in 10 people) Decrease in some white blood cells Diarrhoea (watery, loose or soft stools), nausea Skin rash sometimes with blisters, itching Feeling tired or weak
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) sniženje razine nekih vrsta bijelih krvnih stanica proljev (vodenaste, rijetke ili meke stolice), mučnina kožni osip, ponekad s mjehurićima, svrbež osjećaj umora ili slabosti
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, bolesnike treba pažljivo nadzirati zbog moguće pojave znakova ili simptoma nuspojava te odmah uvesti odgovarajuće simptomatsko liječenje.
English: Rapid onset of GVHD has been reported with nivolumab use before and after allogeneic HSCT (see section 4.4).
Croatian: Kod primjene nivolumaba prije i nakon alogenog HSCT-a prijavljen je brz nastup GVHD-a (vidjeti dio 4.4).
English: The study included adult patients with confirmed unresectable Stage III or Stage IV melanoma.
Croatian: U ispitivanje su bili uključeni odrasli bolesnici s potvrđenim neresektabilnim melanomom stadija III ili IV.
English: In this patient population, objective response was reported in 33 patients (31%) with a median duration of response of 22.9 months (95% CI: 17.0, NR).
Croatian: U toj je populaciji bolesnika objektivan odgovor prijavljen u 33 bolesnika (31%), a medijan trajanja odgovora iznosio je 22,9 mjeseci (95% CI: 17,0; nije postignut).
English: No clear cut off for PD-L1 expression can reliably be established when considering the relevant endpoints of tumour response and PFS and OS.
Croatian: Ne može se pouzdano ustanoviti jasna granična vrijednost za ekspresiju PD-L1 kada se razmatraju relevantne mjere ishoda u smislu tumorskog odgovora, PFS-a i OS-a.
English: The number of prior systemic regimen received was 1 for 27% of patients, 2 for 51% of patients, and > 2 for 21% of patients.
Croatian: 27% bolesnika prethodno je primilo 1 režim sistemskog liječenja, 51% bolesnika primilo je 2, a njih 21% primilo je > 2 režima sistemskog liječenja.
English: Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
Croatian: Nivolumab potencira odgovore T-stanica, uključujući protutumorske odgovore, tako što blokira vezivanje PD-1 za ligande PD-L1 i PD-L2.
English: 11.6 (9.10, NE)
Croatian: 11,6 (9,10; NP)
English: A higher proportion of patients experienced death within the first 3 months in the nivolumab arm (59/292, 20.2%) as compared to the docetaxel arm (44/290, 15.2%).
Croatian: Smrt unutar prva 3 mjeseca nastupila je kod većeg udjela bolesnika u skupini liječenoj nivolumabom (59/292, 20,2%) nego onoj koja je primala docetaksel (44/290, 15,2%).
English: Tumour assessments were continued after treatment discontinuation in patients who discontinued treatment for reasons other than progression.
Croatian: Procjene tumora provodile su se i nakon prestanka liječenja u bolesnika koji su prekinuli liječenje zbog nekog drugog razloga osim progresije.
English: Among 131 patients who discontinued the combination due to adverse reaction after 28 months of follow-up, the ORR was 71% (93/131) with 20% (26/131) achieving a complete response and median OS was not reached.
Croatian: Među 131 bolesnikom koji je nakon 28 mjeseci praćenja prekinuo liječenje kombiniranom terapijom zbog nuspojave, ORR je iznosio 71% (93/131), 20% (26/131) bolesnika ostvarilo je potpuni odgovor, a medijan OS-a nije postignut.
English: It includes 243 patients who had ASCT; Cohort A included 63 (26%) patients who were brentuximab vedotin naïve; Cohort B included 80 (33%) patients who had received brentuximab vedotin after ASCT failure; and Cohort C included 100 (41%) patients who had received brentuximab vedotin before and/or after ASCT out of which 33 (14%) patients received brentuximab vedotin only prior to ASCT.
Croatian: Ispitivanje je obuhvatilo 243 bolesnika podvrgnuta ASCT-u; kohorta A uključivala je 63 (26%) bolesnika koji prethodno nisu primali brentuksimab vedotin, kohorta B uključivala je 80 (33%) bolesnika koji su primali brentuksimab vedotin nakon neuspjeha ASCT-a, dok je kohorta C uključivala 100 (41%) bolesnika koji su primali brentuksimab vedotin prije i/ili nakon ASCT-a, od kojih su njih 33 (14%) primala brentuksimab vedotin samo prije ASCT-a.
English: Objective response, n (%); (95% CI) Complete remission (CR), n (%); (95% CI) Partial remission (PR), n (%); (95% CI)
Croatian: Objektivni odgovor, n (%); (95% CI) Potpuna remisija, n (%); (95% CI) Djelomična remisija, n (%); (95% CI)
English: Nivolumab baseline CL in adjuvant melanoma patients was approximately 40% lower and steady state CL approximately 20 % lower relative to advanced melanoma.
Croatian: Početni klirens nivolumaba u adjuvantno liječenih bolesnika s melanomom bio je približno 40% manji, a u stanju dinamičke ravnoteže približno 20% manji nego u bolesnika s uznapredovalim melanomom.
English: Additional safety and descriptive efficacy data are available from study CA209374, an open-label Phase 3b/4 safety study of nivolumab monotherapy (treated with 240 mg every 2 weeks) for the treatment of patients with advanced or metastatic RCC (n = 142), including 44 patients with non-clear cell histology.
Croatian: Dostupni su dodatni podaci o sigurnosti i dodatni deskriptivni podaci o djelotvornosti iz ispitivanja CA209374 - otvorenog ispitivanja sigurnosti faze 3b/4 u kojem se ocjenjivala monoterapija nivolumabom (u dozi od 240 mg svaka 2 tjedna) za liječenje bolesnika s uznapredovalim ili metastatskim RCC-om (n = 142), uključujući 44 bolesnika s nesvjetlostaničnim histološkim tipom bolesti.
English: Median duration of responseg
Croatian: Medijan trajanja odgovorag
English: Common dehydration dehydration
Croatian: Često dehidracija dehidracija
English: Patients should be monitored for signs and symptoms of nephritis or renal dysfunction.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma nefritisa ili disfunkcije bubrega.
English: Grade 3 or 4 myocarditis
Croatian: Miokarditis 3. ili 4. stupnja
English: In the non-squamous NSCLC study (CA209057), the safety profile in patients with baseline renal or hepatic impairment was comparable to that in the overall population.
Croatian: U ispitivanju provedenom kod neplanocelularnog NSCLC-a (CA209057), sigurnosni profil u bolesnika s oštećenjem bubrežne ili jetrene funkcije na početku ispitivanja bio je usporediv s onim primijećenim u cjelokupnoj populaciji.
English: • patients treated with prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways),
Croatian: • u bolesnika koji su prethodno primali terapiju anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 ili anti-CTLA-4 protutijelima (uključujući ipilimumab ili bilo koje drugo protutijelo ili lijek koji ciljano djeluje upravo na putove kostimulacije T-stanica ili njihove kontrolne točke)
English: Treatment of advanced melanoma
Croatian: Liječenje uznapredovalog melanoma
English: Time to resolution ranged from 0.4 to 155.4+ weeks.
Croatian: Vrijeme do njihova povlačenja kretalo se u rasponu od 0,4 do 155,4+ tjedna.
English: Common musculoskeletal paing arthritis, muscle spasms, muscular weakness
Croatian: Često mišićno-koštana bolg artritis, mišićni spazmi, mišićna slabost
English: Nivolumab in combination with ipilimumab:
Croatian: Nivolumab u kombinaciji s ipilimumabom:
English: The 49 patients had a median follow-up from subsequent allogeneic HSCT of 5.6 months (range: 0-19 months).
Croatian: Medijan praćenja tih 49 bolesnika nakon provedbe alogenog HSCT-a iznosio je 5,6 mjeseci (raspon:0-19 mjeseci).
English: The final OS analysis occurred when all patients had a minimum follow-up of 28 months.
Croatian: Završna analiza OS-a provedena je nakon što su svi bolesnici praćeni najmanje 28 mjeseci.
English: In subjects with non-clear cell histology, at a minimum follow-up of approximately 16.7 months ORR and median duration of response were 13.6% and 10.2 months, respectively.
Croatian: U ispitanika s nesvjetlostaničnim histološkim tipom bolesti, nakon minimalnog praćenja u trajanju od približno 16,7 mjeseci ORR je iznosio 13,6%, a medijan trajanja odgovora 10,2 mjeseca.
English: 240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes
Croatian: 240 mg svaka 2 tjedna tijekom 30 minuta ili 480 mg svaka 4 tjedna tijekom 60 minuta
English: OPDIVO may be given in combination with ipilimumab.
Croatian: OPDIVO se može primjenjivati u kombinaciji s ipilimumabom.
English: Results from exploratory multivariate analyses identified patient and tumour characteristics (ECOG performance status, M stage, baseline LDH, BRAF mutation status, PD-L1 status, and gender) which might contribute to the survival outcome.
Croatian: Rezultati eksploracijskih multivarijantnih analiza identificirali su značajke bolesnika i tumora (funkcionalni ECOG status, metastatski stadij, početnu vrijednost LDH, BRAF status, PD-L1 status i spol) koje mogu utjecati na preživljenje.
English: The median duration of time from initial diagnosis to randomisation was 2.6 years in both the nivolumab and everolimus groups.
Croatian: Medijan vremena od početne dijagnoze do randomizacije iznosio je 2,6 godina i u skupini liječenoj nivolumabom i u onoj koja je primala everolimus.
English: Strata adjusted difference.
Croatian: Razlika prilagođena prema stratumima.
English: Efficacy by tumour PD-L1 expression: Objective responses to nivolumab were observed regardless of tumour PD-L1 expression.
Croatian: Djelotvornost prema tumorskoj ekspresiji PD-L1: Objektivni odgovori na nivolumab primijećeni su neovisno o tumorskoj ekspresiji PD-L1.