FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaemiaa,b Neutropenia a,b Thrombocytopeniab,c a 405 patients assessed in human serum albumin-paclitaxel nanoparticles/gemcitabine-treated group b 388 patients assessed in gemcitabine-treated group c 404 patients assessed in human serum albumin-paclitaxel nanoparticles/gemcitabine-treated group
Croatian: Anaemijaa,b Neutropenija a,b Trombocitopenijab,c a 405 bolesnika procijenjeno u skupini liječenoj paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma/gemcitabinom b 388 bolesnika procijenjeno u skupini liječenoj gemcitabinom c 404 bolesnika procijenjeno u skupini liječenoj paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma/gemcitabinom
English: Based on non-compartmental PK analysis, the plasma clearance of paclitaxel with human serum albumin-paclitaxel nanoparticles was larger (43%) than that following a solvent-based paclitaxel injection and its volume of distribution was also higher (53%).
Croatian: Na temelju farmakokinetičke analize bez uključivanja odjeljaka, plazmatski klirens paklitaksela iz paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma bio je veći (43%) nego nakon primjene injekcija paklitaksela baziranog na otapalu, a i njegov volumen distribucije bio je također veći (53%).
English: Pazenir is indicated as monotherapy for breast cancer, in combination with gemcitabine for pancreatic adenocarcinoma, or in combination with carboplatin for non-small cell lung cancer (see section 4.1).
Croatian: Pazenir je indiciran kao monoterapija za rak dojke, u kombinaciji s gemcitabinom za adenokarcinom pankreasa ili u kombinaciji s karboplatinom za rak pluća nemalih stanica (vidjeti dio 4.1).
English: Unopened vials of Pazenir are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light.
Croatian: Neotvorene bočice lijeka Pazenir stabilne su do datuma naznačenog na pakiranju kada se bočica čuva u vanjskom pakiranju radi zaštite od svjetlosti.
English: Some people may feel tired or dizzy after being given Pazenir.
Croatian: Neke osobe mogu osjećati umor ili omaglicu nakon primjene lijeka Pazenir.
English: Gemcitabine Dose
Croatian: Doza gemcitabina
English: This should be taken into consideration if you are on a controlled sodium diet.
Croatian: O tome treba voditi računa ako ste na dijeti s ograničenim unosom natrija.
English: • Abnormal decrease in the number of types of white blood cells (neutrophils, lymphocytes or leukocytes) in the blood
Croatian: • abnormalno smanjenje broja vrsta bijelih krvnih stanica (neutrofila, limfocita ili leukocita)
English: The most common clinically significant adverse reactions associated with the use of human serum albumin-paclitaxel nanoparticles have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders.
Croatian: Najčešće klinički značajne nuspojave povezane s primjenom paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma bile su neutropenija, periferna neuropatija, artralgija/mijalgija i gastrointestinalni poremećaji.
English: Pazenir should not be used in combination with other anticancer agents.
Croatian: Pazenir se ne smije primjenjivati u kombinaciji s drugim antitumorskim lijekovima.
English: Some settling of the reconstituted dispersion may occur.
Croatian: Moguća je pojava laganog taloženja rekonstituirane disperzije.
English: Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Pazenir.
Croatian: Muški bolesnici trebaju zatražiti savjet o pohrani sperme prije početka liječenja zbog mogućnosti ireverzibilne neplodnosti koja može nastati kao posljedica liječenja lijekom Pazenir.
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed for their ability to tolerate Pazenir in combination with gemcitabine with special consideration to performance status, co-morbidities and increased risk of infections (see section 4.2 and 4.8).
Croatian: U bolesnika s adenokarcinomom pankreasa u dobi od 75 i više godina treba pažljivo procijeniti njihovu sposobnost podnošenja lijeka Pazenir u kombinaciji s gemcitabinom, a osobito valja obratiti pozornost na opći status, komorbiditete i povećani rizik od infekcija (vidjeti dijelove 4.2 i 4.8).
English: Of the 431 patients with pancreatic adenocarcinoma who were randomized to receive human serum albumin-paclitaxel nanoparticles in combination with gemcitabine, the majority (93%) were white, 4% were black and 2% were Asian.
Croatian: Od 431 bolesnika s adenokarcinomom pankreasa koji su bili randomizirani da primaju paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s gemcitabinom, većina (93%) je bila bijele rase, 4% je bilo crne rase a 2% su bili Azijati.
English: 2 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Croatian: 2 Pneumonitis je procijenjen koristeći SMQ za intersticijsku bolest pluća (široki raspon).
English: Paclitaxel clearance is primarily determined by CYP2C8 and CYP3A4 mediated metabolism followed by biliary excretion, while gemcitabine is inactivated by cytidine deaminase followed by urinary excretion.
Croatian: Klirens paklitaksela primarno je određen metabolizmom posredovanim CYP2C8 i CYP3A4 nakon čega slijedi bilijarna ekskrecija, dok je gemcitabin deaktiviran citidin deaminazom nakon čega slijedi ekskrecija urinom.
English: • Decreased or lack of reflexes, involuntary movements, pain along a nerve, fainting, dizziness when standing up, shaking, facial nerve paralysis
Croatian: • smanjeni ili odsutni refleksi, nevoljni pokreti, bol uzduž živca, nesvjestica, omaglica prilikom ustajanja, tresavica, paraliza živca na licu
English: resume at next lower dose levela
Croatian: nastaviti sa sljedećom nižom razinom dozea
English: What Pazenir is and what it is used for What Pazenir is
Croatian: Što je Pazenir i za što se koristi Što je Pazenir
English: 75th Percentile Overall
Croatian: 75. percentil sveukupnog preživljenja (mjeseci)
English: For treatment of advanced pancreatic cancer, Pazenir is given on days 1, 8 and 15 of each 28day treatment cycle with gemcitabine being given immediately after the Pazenir.
Croatian: Za liječenje uznapredovalog raka gušterače, Pazenir se daje 1., 8. i 15. dana svakog 28-dnevnog ciklusa, s tim da se gemcitabin daje odmah nakon primjene lijeka Pazenir.
English: This is possibly due to paclitaxel not being trapped in Cremophor EL micelles as with solvent-based paclitaxel.
Croatian: Moguće je da je to zbog toga što paklitaksel nije uhvaćen u micele Cremophor EL, kao što je slučaj s paklitakselom baziranom na otapalu.
English: Population pharmacokinetic analysis for human serum albumin-paclitaxel nanoparticles included patients with ages ranging from 24 to 85 years old and shows that age does not significantly influence the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Croatian: Analiza populacijske farmakokinetike za paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma uključila je bolesnike u dobi od 24 do 85 godina i pokazuje da dob ne utječe značajno na maksimalnu brzinu eliminacije i sistemsku izloženost paklitakselu (AUC i Cmax).
English: Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6α-hydroxypaclitaxel; and to two minor metabolites, 3'-phydroxypaclitaxel and 6α-3'-p-dihydroxypaclitaxel.
Croatian: Na temelju objavljene literature, in vitro ispitivanja s mikrosomomima iz ljudske jetre i rezovima tkiva pokazala su da se paklitaksel primarno metabolizira u 6α-hidroksipaklitaksel te u dva manja metabolita, 3'-p-hidroksipaklitaksel i 6α-3'-p-dihidroksipaklitaksel.
English: Table 10: Results for overall response rate, median time to disease progression, and progression-free survival as assessed by the investigator
Croatian: Tablica 10: Rezultati ukupne stope odgovora, medijana vremena do progresije bolesti te preživljenja bez progresije bolesti prema procjeni ispitivača
English: Discontinue Treatment
Croatian: Prekinuti liječenje
English: GA-2031 Haarlem Netherlands
Croatian: GA-2031 Haarlem Nizozemska
English: Pronounced hair loss ≥50% is expected for the majority of patients who experience alopecia.
Croatian: Za većinu bolesnika kojima se pojavi alopecija, očekuje se izraziti gubitak kose od ≥ 50%.
English: The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2).
Croatian: Paklitaksel se metabolizira djelomično izoenzimima citokroma P450 CYP2C8 i CYP3A4 (vidjeti dio 5.2).
English: There was no statistically significant difference in progression-free survival (by blinded radiologist assessment) and overall survival between the two treatment arms.
Croatian: Između dviju terapijskih skupina nije bilo statistički značajne razlike u preživljenju bez progresije bolesti (prema slijepoj radiološkoj procjeni) i sveukupnog preživljenja.
English: Following intravenous administration of radiolabelled paclitaxel to rats on days 9 to 10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma concentrations.
Croatian: 10. postpartalnog dana, koncentracije radioaktivnosti u mlijeku bile su više nego u plazmi i smanjivale su se usporedno s koncentracijama u plazmi.
English: Peripheral neuropathy evaluated using the SMQ (broad scope).
Croatian: 1 Periferna neuropatija je procijenjena koristeći SMQ (široki raspon).
English: Once the addition is complete, the vial should be allowed to stand for a minimum of 5 minutes to ensure proper wetting of the solid.
Croatian: Nakon završetka dodavanja, bočica treba odstajati najmanje 5 minuta da bi se omogućilo dovoljno natapanje krutine.
English: The European Medicines Agency has waived the obligation to submit the results of studies with human serum albumin-paclitaxel nanoparticles in all subsets of the paediatric population in the treatment of metastatic breast cancer, pancreatic adenocarcinoma and non-small cell lung cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma u svim podskupinama pedijatrijske populacije za liječenje metastatskog raka dojke, adenokarcinoma pankreasa i raka pluća nemalih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Pharmacokinetic/pharmacodynamic modelling using data from 125 patients with advanced solid tumours indicates that patients ≥ 65 years of age may be more susceptible to development of neutropenia within the first treatment cycle.
Croatian: Farmakokinetičko/farmakodinamičko modeliranje na temelju podataka za 125 bolesnika s uznapredovalim solidnim tumorima pokazuje da bi bolesnici u dobi od ≥ 65 godina mogli biti osjetljiviji na razvoj neutropenije unutar prvog ciklusa liječenja.
English: Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure administration of the complete dose.
Croatian: Nakon primjene preporučuje se intravensku liniju isprati 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekciju kako bi se osigurala primjena cijele doze.
English: Table 13: Non-inferiority analyses on progression-free survival and overall survival in randomized non-small cell lung cancer trial (intent-to-treat population)
Croatian: Tablica 13: Analize neinferiornosti za preživljenje bez progresije bolesti i sveukupno preživljenje u randomiziranom ispitivanju bolesnika s rakom pluća nemalih stanica (populacija s namjerom liječenja)
English: Stability of the reconstituted dispersion in the infusion bag
Croatian: Stabilnost rekonstituirane disperzije u vrećici za infuziju
English: Pazenir is supplied as a sterile lyophilised powder for reconstitution before use.
Croatian: Pazenir se isporučuje kao sterilni liofilizirani prašak za rekonstituciju prije uporabe.
English: In this phase III randomized, controlled, open-label trial, adverse reactions resulting in death within 30 days of the last dose of study drug were reported for 4% of patients receiving human serum albumin-paclitaxel nanoparticles in combination with gemcitabine and for 4% of patients receiving gemcitabine monotherapy.
Croatian: U ovom randomiziranom, kontroliranom, otvorenom ispitivanju faze III, nuspojave koje su rezultirale smrću unutar 30 dana od zadnje doze ispitivanog lijeka zabilježene su u 4% bolesnika koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s gemcitabinom i 4% bolesnika koji su primali gemcitabin kao monoterapiju.
English: • Weakness and tiredness, fever
Croatian: • slabost i umor, vrućica
English: The symptoms were usually transient, typically occurred three days after human serum albumin-paclitaxel nanoparticles administration and resolved within a week.
Croatian: Simptomi su obično bili prolazni, i obično su se pojavljivali tri dana nakon primjene paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma te bi se povukli unutar tjedan dana.
English: For patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment, there are insufficient data to permit dosage recommendations (see sections 4.4 and 5.2).
Croatian: Za bolesnike s metastatskim adenokarcinomom pankreasa koji imaju umjereno do teško oštećenje jetrene funkcije nema dovoljno podataka koji bi omogućili preporuke doza (vidjeti dijelove 4.4 i 5.2).
English: Pharmacokinetic/pharmacodynamic modelling using data from 125 patients with advanced solid tumours indicates that patients ≥ 65 years of age may be more susceptible to development of neutropenia within the first treatment cycle, although the plasma paclitaxel exposure is not affected by age.
Croatian: Farmakokinetičko/farmakodinamičko modeliranje na temelju podataka za 125 bolesnika s uznapredovalim solidnim tumorima pokazuje da bi bolesnici u dobi od ≥ 65 godina mogli biti osjetljiviji na razvoj neutropenije unutar prvog ciklusa liječenja, iako dob ne utječe na izloženost paklitakselu u plazmi.
English: Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Pazenir in combination with gemcitabine.
Croatian: Sepsa u stopi od 5% zabilježena je u bolesnika s neutropenijom ili bez nje koji su primali Pazenir u kombinaciji s gemcitabinom.
English: If foaming or clumping occurs, the solution must stand for at least 15 minutes until foam subsides.
Croatian: Ako se pojavi pjena ili nakupine, otopina mora odstajati najmanje 15 minuta dok se pjena ne slegne.
English: If this happens to you, do not drive or use any tools or machines.
Croatian: nemojte voziti ni rukovati alatima ili strojevima.
English: Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4).
Croatian: Pazenir je indiciran u odraslih kao monoterapija za liječenje metastatskog raka dojke kod bolesnika koji nisu reagirali na prvu liniju liječenja za metastatsku bolest, i za koje nije indicirana standardna terapija antraciklinima (vidjeti dio 4.4).
English: Common: Hypotension, hypertension
Croatian: Često: hipotenzija, hipertenzija
English: Women of childbearing potential should use effective contraception during treatment and up to 1 month after receiving treatment with Pazenir.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i do mjesec dana nakon završetka liječenja lijekom Pazenir.
English: Upon diagnosis of cystoid macular oedema, treatment with Pazenir should be discontinued.
Croatian: Kada se postavi dijagnoza cistoidnog makularnog edema, primjenu lijeka Pazenir treba obustaviti.
English: Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting only, 40% in the metastatic setting only, and 19% in both metastatic and adjuvant settings.
Croatian: Četrnaest posto bolesnika nije prethodno primalo kemoterapiju, 27% je primalo samo adjuvantnu kemoterapiju, 40% samo kemoterapiju za metastatsku bolest, a 19% i adjuvantnu kemoterapiju i kemoterapiju za metastatsku bolest.
English: For treatment of non-small cell lung cancer Pazenir is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Pazenir dose has been given.
Croatian: Za liječenje raka nemalih stanica pluća, Pazenir daje se jednom svaki tjedan (tj. 1., 8. i 15. Dana 21-dnevnog ciklusa), s tim da se karboplatin daje jednom svaka tri tjedna (tj. samo 1. dana svakog 21-dnevnog ciklusa) odmah nakon primjene lijeka Pazenir.
English: • medicine used for heartburn or stomach ulcers (e.g. cimetidine)
Croatian: • lijekovi protiv žgaravice ili želučanog vrijeda (npr. cimetidin)
English: Nadir ANC <500/mm3 with neutropenic fever > 38°C
Croatian: Najniža vrijednost ABN < 500/mm3 i neutropenijska vrućica > 38°C
English: Animal studies with human serum albumin-paclitaxel nanoparticles showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Croatian: Ispitivanja paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma na životinjama pokazala su nepovratne, toksične učinke na muške reproduktivne organe na klinički značajnim razinama izloženosti.
English: After first reconstitution, the dispersion should be filled into an infusion bag immediately.
Croatian: Nakon prve rekonstitucije, disperziju treba odmah ubrizgati u vrećicu za infuziju.
English: In a repeat dose study with 12 patients receiving human serum albumin-paclitaxel nanoparticles administered intravenously at 260 mg/m2, intrapatient variability in AUC was 19% (range = 3.21%37.70%).
Croatian: U ispitivanjima ponovljene doze s 12 bolesnika koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma intravenski u dozi od 260 mg/m2, varijabilnost između bolesnika u vrijednosti AUC-a iznosila je 19% (raspon = 3,21% - 37,70%).
English: Pancreatic adenocarcinoma
Croatian: Adenokarcinom pankreasa
English: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Croatian: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm
English: Sensory neuropathy occurs frequently with human serum albumin-paclitaxel nanoparticles, although development of severe symptoms is less common.
Croatian: Senzorna neuropatija često nastaje uz liječenje paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma, iako je razvoj teških simptoma manje čest.
English: People with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) who received paclitaxel attached to the human protein albumin with gemcitabine in a clinical trial lived longer than people who had only received gemcitabine.
Croatian: Osobe s metastatskim rakom gušterače (rak gušterače koji se proširio na druge dijelove tijela), a koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma s gemcitabinom u kliničkom ispitivanju, živjeli su dulje od onih koji su primali samo gemcitabin.
English: Beginning immediately after the end of human serum albumin-paclitaxel nanoparticles administration, carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 only of each 21-day cycle.
Croatian: Počevši odmah nakon završetka primjene paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma, karboplatin je davan intravenski u dozi AUC = 6 mg•min/ml samo 1. dana svakog 21-dnevnog ciklusa.
English: • Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema)
Croatian: • nadražene oči, bolne oči, crvene oči, svrbež očiju, dvoslike, smanjeni vid ili bljeskanje pred očima, zamućen vid zbog oticanja mrežnice (cistoidni makularni edem)
English: • Swelling of mucosal and soft tissues
Croatian: • oticanje sluznica i mekih tkiva
English: The effectiveness and safety of human serum albumin-paclitaxel nanoparticles in patients with central nervous system (CNS) metastases has not been established.
Croatian: Učinkovitost i sigurnost paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma u bolesnika s metastazama u središnjem živčanom sustavu (SŽS) još nisu ustanovljene.
English: After reconstitution, the reconstituted dispersion in the infusion bag should be used immediately.
Croatian: Nakon rekonstitucije, rekonstituiranu disperziju u vrećici za infuziju treba odmah primijeniti.
English: For patients with total bilirubin > 5 x ULN or AST > 10 x ULN, there are insufficient data to permit dosage recommendations regardless of indication (see sections 4.4 and 5.2).
Croatian: Za bolesnike u kojih je ukupni bilirubin > 5 x GGN ili AST > 10 x GGN, nema dovoljno podataka koji bi omogućili preporuke doza bez obzira na indikaciju (vidjeti dijelove 4.4 i 5.2).
English: Using repeated measure analysis, 3 of the 4 subscales (peripheral neuropathy, pain hands/feet, and hearing) favored human serum albuminpaclitaxel nanoparticles and carboplatin (p ≤ 0.002).
Croatian: Prema analizi ponovljenog mjerenja, 3 od 4 podljestvice (periferna neuropatija, bol u šakama/stopalima te sluh) bile su u korist paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma i karboplatina (p ≤ 0,002).
English: Alopecia was observed in >80% of the patients treated with human serum albumin-paclitaxel nanoparticles.
Croatian: Alopecija je opažena u > 80% bolesnika liječenih paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma.
English: Pazenir in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Croatian: Pazenir je indiciran u kombinaciji s gemcitabinom kao prva linija liječenja u odraslih bolesnika s metastatskim adenokarcinomom pankreasa.
English: Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on human serum albuminpaclitaxel nanoparticleswith 10% being Grade 3, and no cases of Grade 4.
Croatian: Periferna neuropatija (uglavnom senzorna neuropatija 1. ili 2. stupnja) opažena je u 68% bolesnika koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma, u 10% bolesnika bila je 3. stupnja, a nije bilo slučajeva neuropatije 4. stupnja.
English: If Pazenir dispersion contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Croatian: Ako disperzija lijeka Pazenir dođe u dodir s kožom, kožu je potrebno odmah temeljito oprati vodom i sapunom.
English: Common: Stomatitis, intestinal obstruction, colitis, dry mouth
Croatian: Često: stomatitis, intestinalna opstrukcija, kolitis, suha usta
English: Pazenir is not recommended in patients that have total bilirubin > 5 x ULN or AST > 10 x ULN.
Croatian: Pazenir se ne preporučuje u bolesnika u kojih je ukupni bilirubin > 5 x GGN ili AST > 10 x GGN.
English: CI = confidence interval, HRA+G/G = hazard ratio of Paclitaxel human serum albumin-paclitaxel nanoparticles+gemcitabine/gemcitabine, pA+G/pG=response rate ratio of human serum albumin-paclitaxel nanoparticles+gemcitabine/gemcitabine a stratified Cox proportional hazard model b stratified log-rank test, stratified by geographic region (North America versus others), KPS (70 to 80 versus 90 to 100), and presence of liver metastasis (yes versus no).
Croatian: = omjer stope odgovora za paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma +gemcitabin/gemcitabin a stratificirani Coxov model proporcionalnog hazarda b stratificirani log-rang test, stratificiran prema zemljopisnoj regiji (Sjeverna Amerika nasuprot ostalih regija), KPS (70 do 80 nasuprot 90 do 100), i prisutnost metastaza jetre („da“ nasuprot „ne“).