FrancophonIA/ELRC3.0 huggingface dataset:
English: Physiologically-based pharmacokinetic (PBPK) simulations predicted a 17% increase in crizotinib steady-state AUC after treatment with the moderate CYP3A inhibitors, diltiazem or verapamil.
Slovenian: S fiziološko zasnovanimi farmakokinetičnimi simulacijami so napovedali 17 % zvečanje AUC krizotiniba v stanju dinamičnega ravnovesja po zdravljenju z zmernimi zaviralci CYP3A4, diltiazemom ali verapamilom, zato je pri sočasni uporabi krizotiniba z zmernimi zaviralci CYP3A4 potrebna previdnost.
English: Following crizotinib 200 mg twice daily dosing, patients with moderate hepatic impairment (N=8) showed higher systemic crizotinib exposure compared to patients with normal hepatic function (N=9) at the same dose level, with geometric mean ratios for AUCdaily and Cmax of 150% and 144%, respectively.
Slovenian: Po jemanju krizotiniba v odmerku 200 mg dvakrat na dan so bolniki z zmerno okvaro jeter (n = 8) dosegli večjo sistemsko izpostavljenost krizotinibu kot bolniki z normalnim delovanjem jeter (n = 9) pri enaki ravni odmerka, z razmerjem geometričnih sredin 150 % za AUCdaily in 144 % za Cmaks.
English: Based on the population pharmacokinetic analysis of data in Studies 1001, 1005 and 1007, age has no effect on crizotinib pharmacokinetics.
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov iz študij 1001, 1005 in 1007 starost nima vpliva na farmakokinetiko krizotiniba.
English: Oedemap (47%) Fatigue (30%)
Slovenian: Splošne težave in spremembe na mestu aplikacije edemp (47 %) utrujenost (30 %)
English: If contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at 250 mg once dailyc upon recovery to Grade ≤1 or to heart rate 60 or above, with frequent monitoring
Slovenian: Če ugotovite vpliv sočasnega zdravila in se njegova uporaba prekine ali odmerek prilagodi, po izboljšanju na stopnjo ≤ 1 ali na srčni utrip 60 ali več nadaljujte z odmerkom 250 mg enkrat na dan c in bolnika pogosto spremljajte.
English: Coadministration of a single 150 mg oral dose of crizotinib in the presence of ketoconazole (200 mg twice daily), a strong CYP3A inhibitor, resulted in increases in crizotinib systemic exposure, with crizotinib area-under-the-plasma-concentration versus time curve from time zero to infinity (AUCinf) and maximum observed plasma concentration (Cmax) values that were approximately 3.2-fold and 1.4-fold, respectively, those seen when crizotinib was administered alone.
Slovenian: Sočasna uporaba enkratnega 150 mg peroralnega odmerka krizotiniba v prisotnosti ketokonazola, močnega zaviralca CYP3A (200 mg dvakrat na dan), je povzročila povečanje sistemske izpostavljenosti krizotinibu, z vrednostmi površine pod krivuljo plazemske koncentracije v odvisnosti od časa, od časa nič do neskončnosti (AUCinf), in največje opažene plazemske koncentracije (Cmaks) za krizotinib, ki so bile za približno 3,2-krat oziroma 1,4-krat večje od tistih, ki so jih beležili ob uporabi krizotiniba samega.
English: Following crizotinib 250 mg twice daily dosing, patients with mild hepatic impairment (N=10) showed similar systemic crizotinib exposure at steady state compared to patients with normal hepatic function (N=8), with geometric mean ratios for area under the plasma concentration-time curve as daily exposure at steady state (AUCdaily) and Cmax of 91.1% and 91.2%, respectively.
Slovenian: Po jemanju krizotiniba v odmerku 250 mg dvakrat na dan so bolniki z blago okvaro jeter (n = 10) dosegli podobno sistemsko izpostavljenost krizotinibu v stanju dinamičnega ravnovesja kot bolniki z normalnim delovanjem jeter (n = 8), z razmerjem geometričnih sredin 91,1 % za površino pod krivuljo plazemske koncentracije v odvisnosti od časa kot dnevno izpostavljenost v stanju dinamičnega ravnovesja (AUCdaily) in 91,2 % za Cmaks.
English: Crizotinib resulted in overall global quality of life benefits with a significantly greater improvement from baseline observed in the crizotinib arm compared to the chemotherapy arm (Cycles 2 to 20; p-value <0.05).
Slovenian: Krizotinib je povzročil koristne učinke na splošno kakovost življenja, z znatno večjim izboljšanjem od začetka študije v skupini s krizotinibom v primerjavi s skupino s kemoterapijo (cikli od 2 do 20; vrednost p < 0,05).
English: Patients randomised to chemotherapy could crossover to receive crizotinib upon RECIST-defined disease progression confirmed by IRR.
Slovenian: Bolniki, naključno razporejeni v skupino s kemoterapijo, so lahko prešli na krizotinib, ko se je napredovanje bolezni glede na merila RECIST potrdilo s pregledom IRR.
English: If contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to Grade ≤1 or to heart rate 60 or above
Slovenian: Če ugotovite vpliv sočasnega zdravila in se njegova uporaba prekine ali odmerek prilagodi, po izboljšanju na stopnjo ≤ 1 ali na srčni utrip 60 ali več nadaljujte s prejšnjim odmerkom.
English: Crizotinib resulted in symptom benefits by significantly prolonging TTD compared to chemotherapy (median 2.1 months versus 0.5 months; HR=0.59; 95% CI: 0.45, 0.77; Hochberg-adjusted log-rank 2-sided p-value =0.0005).
Slovenian: Krizotinib je izboljšal simptome, tako da je pomembno podaljšal TTD v primerjavi s kemoterapijo (mediana 2,1 meseca v primerjavi z 0,5 meseca; HR = 0,59; 95 % IZ: 0,45; 0,77; po Hochbergu prilagojen test logrank, 2-stranska vrednost p = 0,0005).
English: Across studies in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), 50 (3%) patients treated with crizotinib had any grade all-causality ILD, including 18 (1%) patients with Grade 3 or 4, and 8 (<1%) patients with fatal cases.
Slovenian: V študijah pri bolnikih z ALK-pozitivnim ali ROS1-pozitivnim NSCLC (n = 1.722) je imelo 50 (3 %) bolnikov, zdravljenih s krizotinibom, ILD katerekoli stopnje in katerekoli vzročnosti, vključno z 18 (1 %) bolniki z ILD stopnje 3 ali 4 ter 8 (< 1 %) bolniki s smrtnim izidom.
English: Optic atrophy and optic nerve disorder have been reported as potential causes of vision loss (see section 4.4).
Slovenian: Kot morebitna vzroka za izgubo vida sta bili poročani atrofija vidnega živca in motnje vidnega živca (glejte poglavje 4.4).
English: Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with crizotinib.
Slovenian: Pri bolnikih, zdravljenih s krizotinibom, se lahko pojavi huda, življenjsko nevarna ali smrtna intersticijska bolezen pljuč (ILD - interstitial lung disease)/pnevmonitis.
English: There were no findings related to aqueous cell count and anterior chamber aqueous flare assessment.
Slovenian: Povečanega števila celic v prekatni vodici in bleščave v sprednjem prekatu niso ugotovili.
English: If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, resume at reduced dosec upon recovery to Grade ≤1 or to heart rate 60 or above
Slovenian: Če ne ugotovite vpliva sočasnega zdravila ali se njegova uporaba ne prekine oziroma se odmerka ne prilagodi, po izboljšanju na stopnjo ≤ 1 ali na srčni utrip 60 ali več nadaljujte z zmanjšanim odmerkom bradikardija stopnje 4
English: Treatment with crizotinib should be used with caution in patients with hepatic impairment (see Table 2 and sections 4.4, 4.8 and 5.2).
Slovenian: Pri zdravljenju s krizotinibom je pri bolnikih z okvaro jeter potrebna previdnost (glejte Preglednico 2 ter poglavja 4.4, 4.8 in 5.2).
English: In clinical studies of crizotinib in patients with either ALK-positive or ROS1-positive advanced NSCLC, shifts to Grade 3 or 4 decreases in leukocytes and neutrophils were observed at frequencies of 4% and 13%, respectively.
Slovenian: V kliničnih študijah krizotiniba pri bolnikih z ALK-pozitivnim ali ROS1-pozitivnim napredovalim NSCLC so zmanjšanje števila levkocitov in nevtrofilcev do stopnje 3 ali 4 opazili pri 4 % oziroma 13 % bolnikov.
English: INFORMATION IN BRAILLE XALKORI 250 mg
Slovenian: XALKORI 250 mg
English: Coadministration of repeated doses of crizotinib (250 mg twice daily) with repeated doses of rifampicin (600 mg once daily), a strong CYP3A4 inducer, resulted in 84% and 79% decreases in crizotinib steady-state AUCtau and Cmax, respectively, compared to when crizotinib was given alone.
Slovenian: Zdravila, ki lahko zmanjšajo koncentracije krizotiniba v plazmi Sočasna uporaba ponavljajočih odmerkov krizotiniba (250 mg dvakrat na dan) skupaj s ponavljajočimi odmerki rifampicina (600 mg enkrat na dan), močnega induktorja CYP3A4, je povzročila 84 % oziroma 79 % zmanjšanje vrednosti AUCtau oziroma Cmax krizotiniba v stanju dinamičnega ravnovesja v primerjavi z uporabo krizotiniba samega.
English: i. Interstitial lung disease (Acute respiratory distress syndrome, Alveolitis, Interstitial lung disease, Pneumonitis).
Slovenian: 3 (0,2 %) pa je bil izid smrten i. intersticijska bolezen pljuč (sindrom dihalne stiske, alveolitis, intersticijska bolezen pljuč, pnevmonitis)
English: The demographic and disease characteristics of the overall study population were 62% female, median age of 53 years, baseline Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (95%), 51% White and 46% Asian, 4% current smokers, 32% past smokers and 64% never smokers.
Slovenian: Demografske značilnosti in značilnosti bolezni v celotni študijski populaciji so bile naslednje: 62 % ženski spol, mediana starost 53 let, izhodiščno telesno stanje po ECOG (Eastern Cooperative Oncology Group) 0 ali 1 (95 %), 51 % belopolti in 46 % Azijci, 4 % trenutni kadilci, 32 % nekdanji kadilci in 64 % bolniki, ki niso nikoli kadili.
English: However, in vitro studies indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the metabolism of drugs that are substrates for UGT1A4, UGT1A6, or UGT1A9.
Slovenian: Vendar so in vitro študije pokazale, da je malo verjetno, da bi zaradi zavrtja presnavljanja zdravil, ki so substrati za UGT1A4, UGT1A6 ali UGT1A9, pri katerem sodeluje krizotinib, prišlo do kliničnih interakcij zdravilo-zdravilo.
English: Periodic monitoring with imaging and urinalysis should be considered in patients who develop renal cysts.
Slovenian: Pri bolnikih, pri katerih se razvijejo ledvične ciste, je treba razmisliti o rednem spremljanju s slikanjem in preiskavami urina.
English: Grapefruit or grapefruit juice should be avoided during treatment with crizotinib (see sections 4.2 and
Slovenian: Med zdravljenjem s krizotinibom se je treba izogibati grenivki ali grenivkinemu soku (glejte poglavji 4.2 in 4.5).
English: One hundred forty-four (84%) patients in the chemotherapy arm received subsequent crizotinib treatment.
Slovenian: Poznejše zdravljenje s krizotinibom je prejelo 144 (84 %) bolnikov v skupini s kemoterapijo.
English: INFORMATION IN BRAILLE XALKORI 200 mg
Slovenian: XALKORI 200 mg
English: b. For patients who develop neutropenia and leukopenia, see also sections 4.4 and 4.8. c. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events d. In case of recurrence, dosing should be withheld until recovery to Grade ≤2, then dosing should be resumed at 250 mg once daily.
Slovenian: Prekinite zdravljenje, dokler ne pride do izboljšanja na stopnjo ≤ 2, nato z zdravljenjem nadaljujte z naslednjim manjšim odmerkom d,e a) z izjemo limfopenije (razen če je povezana s kliničnimi dogodki, npr. oportunističnimi okužbami) b) za bolnike, pri katerih se razvijeta nevtropenija in levkopenija, glejte tudi poglavji 4.4 in 4.8 c) merila NCI za poenoteno terminologijo neželenih dogodkov (National Cancer Institute Common Terminology Criteria for Adverse Events) d) V primeru ponovitve bolezni zdravljenje prekinite, dokler ne pride do izboljšanja na stopnjo ≤ 2, nato z zdravljenjem nadaljujte z odmerkom 250 mg enkrat na dan.
English: Blood creatinine increase and creatinine clearance decreased were observed in patients in clinical studies with crizotinib.
Slovenian: V kliničnih študijah s krizotinibom so pri bolnikih opazili zvišanje kreatinina v krvi in zmanjšanje očistka kreatinina.
English: Objective Response Rateb [% (95% CI)] Time to Tumour Response [median (range)] weeks Duration of Responsec [median (95% CI)] weeks Progression-Free Survivalc [median (95% CI)] months
Slovenian: Objektivni odziv na zdravljenje [% (95 % IZ)] Čas do odziva tumorja na zdravljenje [mediana (območje)] v tednih Trajanje odziva b [mediana (95 % IZ)] v mesecih
English: Of 171 ALK-positive NSCLC patients treated with crizotinib in randomised Phase 3 Study 1014, 22 (13%) were 65 years or older, and of 109 ALK-positive patients treated with crizotinib who crossed over from chemotherapy arm, 26 (24%) were 65 years or older.
Slovenian: V randomizirani študiji 3. faze, Študiji 1014, je bilo 22 (13 %) bolnikov od 171 bolnikov z ALKpozitivnim NSCLC, zdravljenih s krizotinibom, starih 65 let ali več, v skupini, ki je prešla s kemoterapije, pa je bilo 26 (24 %) bolnikov od 109 bolnikov z ALK-pozitivnim NSCLC, zdravljenih s krizotinibom, starih 65 let in več.
English: Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, there was no clinically meaningful effect of body weight or gender on crizotinib pharmacokinetics.
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov iz študij 1001, 1005 in 1007 telesna masa in spol nimata klinično pomembnega vpliva na farmakokinetiko krizotiniba.
English: Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of 1722 patients treated with crizotinib across clinical trials.
Slovenian: Pri 0,1 % od 1.722 bolnikov, zdravljenih s krizotinibom v kliničnih preskušanjih, je prišlo do hepatotoksičnosti s smrtnim izidom, ki jo je povzročilo zdravilo.
English: There were reports of fatal cases of gastrointestinal perforation during post-marketing use of crizotinib (see section 4.8).
Slovenian: V obdobju trženja krizotiniba so poročali o smrtnih primerih perforacij v prebavilih (glejte poglavje 4.8).
English: There were reports of fatal cases of gastrointestinal perforation during post-marketing use of crizotinib (see section 4.4).
Slovenian: V obdobju trženja krizotiniba so poročali o smrtnih primerih perforacij v prebavilih (glejte poglavje 4.4).
English: Ophthalmological evaluation is recommended if vision disorder persists or worsens in severity (see sections 4.2 and 4.4).
Slovenian: Če motnja vida traja dlje časa ali se poslabša, je priporočljiv oftalmološki pregled (glejte poglavji 4.2 in 4.4).
English: Efficacy results from randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC* Response Parameter
Slovenian: Rezultati učinkovitosti iz randomizirane študije 3. faze, Študije 1007 (celotna populacija za analizo) pri bolnikih s predhodno zdravljenim ALK-pozitivnim napredovalim NSCLC* Parameter odziva krizotinib n = 173
English: • Naloxone, used to treat opiate drug addiction and withdrawal.
Slovenian: • nalokson, ki se uporablja za zdravljenje odvisnosti od opiatov ter odtegnitvenih znakov.
English: Optic atrophy and optic nerve disorder have been reported as potential causes of vision loss.
Slovenian: Kot morebitna vzroka za izgubo vida sta bili poročani atrofija vidnega živca in motnje vidnega živca.
English: Coadministration of repeated doses of crizotinib (250 mg once daily) with repeated doses of itraconazole (200 mg once daily), a strong CYP3A inhibitor, resulted in increases in crizotinib steady-state AUCtau and Cmax, that were approximately 1.6-fold and 1.3-fold, respectively, those seen when crizotinib was administered alone.
Slovenian: Sočasna uporaba ponavljajočih odmerkov krizotiniba (250 mg enkrat na dan) skupaj s ponavljajočimi odmerki itrakonazola (200 mg enkrat na dan), močnega zaviralca CYP3A, je povzročila približno 1,6kratno oziroma 1,3-kratno povečanje vrednosti AUCtau oziroma Cmax krizotiniba v stanju dinamičnega ravnovesja v primerjavi z uporabo krizotiniba samega.
English: The use of single-agent crizotinib in the treatment of ALK-positive advanced NSCLC was investigated in 2 multinational, single-arm studies (Studies 1001 and 1005).
Slovenian: Študiji ALK-pozitivnega napredovalega NSCLC z eno skupino Samostojno uporabo krizotiniba pri zdravljenju ALK-pozitivnega napredovalega NSCLC so raziskovali v 2 mednarodnih študijah z eno skupino bolnikov (Študiji 1001 in 1005).
English: White opaque and pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 200” on the body.
Slovenian: Neprozorna trda kapsula bele in rožnate barve; na pokrovčku je natisnjena oznaka “Pfizer”, na telesu kapsule pa oznaka “CRZ 200”.
English: In studies with crizotinib in patients with either ALK-positive or ROS1-positive advanced NSCLC, all-causality bradycardia was experienced by 219 (13%) of 1722 patients treated with crizotinib.
Slovenian: V študijah krizotiniba pri bolnikih z ALK-pozitivnim ali ROS1-pozitivnim napredovalnim NSCLC je imelo bradikardijo zaradi vseh vzrokov 219 (13 %) od 1.722 bolnikov, zdravljenih s krizotinibom.
English: Efficacy results from randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALK-positive advanced NSCLC* Response Parameter
Slovenian: Faze, Študije 1014 (analiza celotne populacije) pri bolnikih s predhodno nezdravljenim ALK-pozitivnim napredovalim NSCLC* Parameter odziva
English: The demographic and disease characteristics of the overall study population were 56% female, median age of 50 years, baseline ECOG performance status 0 (39%) or 1 (52%), 52% White and 45% Asian, 4% current smokers, 33% past smokers, and 63% never smokers, 93% metastatic, and 93% of patients' tumours were classified as adenocarcinoma histology.
Slovenian: Demografske značilnosti in značilnosti bolezni v celotni študijski populaciji so bile naslednje: 56 % ženski spol, mediana starost 50 let, izhodiščno telesno stanje po ECOG 0 (39 %) ali 1 (52 %), 52 % belopolti in 45 % Azijci, 4 % trenutni kadilci, 33 % nekdanji kadilci, 63 % bolniki, ki niso nikoli kadili, 93 % metastatski primeri in 93 % tumorjev bolnikov, histološko razvrščenih med adenokarcinome.
English: The other ingredients are:
Slovenian: Uporabno do:
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC, QTcF (corrected QT by the Fridericia method) ≥500 msec was recorded in 34 (2.1%) of 1619 patients with at least 1 postbaseline ECG assessment and a maximum increase from baseline in QTcF ≥60 msec was observed in 79 (5.0%) of 1585 patients with a baseline and at least 1 postbaseline ECG assessment.
Slovenian: V študijah pri bolnikih z ALK-pozitivnim ali ROS1-pozitivnim napredovalim NSCLC so QTcF (interval QT s popravkom Fridericia) ≥ 500 ms ugotovili pri 34 (2,1 %) od 1.619 bolnikov z vsaj 1 oceno EKG po izhodišču.
English: A total of 149 ALK-positive advanced NSCLC patients, including 125 patients with previously treated ALK-positive advanced NSCLC, were enrolled into Study 1001 at the time of data cutoff for PFS and ORR analysis.
Slovenian: V Študijo 1001 je bilo na dan zaključka zajema podatkov za analizo PFS in ORR vključenih skupno 149 bolnikov z ALK-pozitivnim napredovalim NSCLC, vključno s 125 bolniki s predhodno zdravljenim ALK-pozitivnim napredovalim NSCLC.
English: Concurrent elevations in ALT and/or AST ≥3 × ULN and total bilirubin ≥2 × ULN without significant elevations of alkaline phosphatase (≤2 × ULN) have been observed in less than 1% patients treated with crizotinib.
Slovenian: Pri manj kot 1 % bolnikov, zdravljenih s krizotinibom, je prišlo do sočasnih povečanj vrednosti ALT in/ali AST na ≥ 3-kratnik ZMN in vrednosti skupnega bilirubina na ≥ 2-kratnik ZMN, ne da bi obenem prišlo do pomembnega povečanja vrednosti alkalne fosfataze (≤ 2-kratnik ZMN).
English: Thirty-eight (70.4%) of the 54 patients experienced an Eye Disorders System Organ Class treatment-emergent allcausality adverse event of which 30 patients had ophthalmic examinations.
Slovenian: Pri osemintridesetih (70,4 %) od teh 54 bolnikov se je pojavil neželeni učinek (zaradi zdravljenja in zaradi vseh vzrokov) iz skupine očesnih bolezni.
English: In a single arm ECG substudy (see section 5.2) using blinded manual ECG measurements 11 (21%) patients had an increase from Baseline in QTcF value ≥30 to <60 msec and 1 (2%) patient had an increase from Baseline in QTcF value of ≥60 msec. No patients had a maximum QTcF ≥480 msec.
Slovenian: V enoskupinski podštudiji EKG (glejte poglavje 5.2) z zaslepljenimi ročnimi meritvami EKG se je vrednost QTcF glede na izhodišče pri enem bolniku (2 %) zvišala za ≥ 60 ms, pri 11 bolnikih (21 %) pa za ≥ 30 ms do < 60 ms.
English: How to take XALKORI
Slovenian: Kako jemati zdravilo XALKORI
English: The starting crizotinib dose for patients with severe hepatic impairment (any AST and total bilirubin >3 × ULN) is recommended to be 250 mg once daily (see section 5.2).
Slovenian: Priporočeni začetni odmerek krizotiniba za bolnike z zmerno okvaro jeter (katerakoli vrednost AST in vrednost celokupnega bilirubina > 1,5-kratnik ZMN ter  3-kratnik ZMN) je 200 mg dvakrat na dan. Priporočeni začetni odmerek krizotiniba za bolnike s hudo okvaro jeter (katerakoli vrednost AST in vrednost celokupnega bilirubina > 3-kratnik ZMN) je 250 mg enkrat na dan (glejte poglavje 5.2).
English: f. ORRs were 29% (95% CI: 21, 39) for pemetrexed (p-value <0.0001 compared with crizotinib) and 7% (95%
Slovenian: e. ocenjeno s Kaplan-Meierjevo metodo f. Delež ORR je bil 29 % (95 % IZ: 21, 39) pri pemetreksedu (vrednost p < 0,0001 v primerjavi s krizotinibom)
English: Close clinical surveillance is recommended when crizotinib is administered with these medicinal products.
Slovenian: Kadar se krizotinib uporablja skupaj s temi zdravili, je priporočljiv skrben klinični nadzor.
English: Patients could continue treatment beyond the time of RECIST-defined disease progression at the discretion of the investigator.
Slovenian: Raziskovalec se je lahko odločil, da bo bolnik nadaljeval predpisano zdravljenje tudi po napredovanju bolezni, opredeljenem z merili RECIST.
English: The demographic and disease characteristics were 57% female, median age of 53 years, baseline ECOG performance status of 0/1 (82%) or 2/3 (18%), 52% White and 44% Asian, 4% current smokers, 30% former smokers, 66% never smokers, 92% metastatic, and 94% of the cancers were classified as adenocarcinoma histology.
Slovenian: Demografske značilnosti in značilnosti bolezni so bile naslednje: 57 % žensk, mediana starost 53 let, izhodiščno stanje zmogljivosti po ECOG 0/1 (82 %) ali 2/3 (18 %), 52 % belcev in 44 % Azijcev, 4 % trenutnih kadilcev, 30 % nekdanjih kadilcev, 66 % bolnikov, ki niso nikoli kadili, metastatska bolezen pri 92 % bolnikov in 94 % tumorjev histološko razvrščenih med adenokarcinome.
English: XALKORI 200 mg hard capsules XALKORI 250 mg hard capsules crizotinib
Slovenian: XALKORI 200 mg trde kapsule XALKORI 250 mg trde kapsule
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 3 or 4 neutropenia was observed in 212 (12%) patients treated with crizotinib.
Slovenian: V študijah pri bolnikih z ALK-pozitivnim ali ROS1-pozitivnim napredovalim NSCLC (n = 1.722) so nevtropenijo stopnje 3 ali 4 opazili pri 212 (12 %) bolnikih, zdravljenih s krizotinibom.
English: Pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 250” on the body.
Slovenian: Neprozorna trda kapsula rožnate barve; na pokrovčku je natisnjena oznaka “Pfizer”, na telesu kapsule pa oznaka “CRZ 250”.
English: The demographic and disease characteristics were 50% female, median age of 51 years, baseline ECOG performance status of 0 (32%) or 1 (55%), 61% White and 30% Asian, less than 1% were current smokers, 27% former smokers, 72% never smokers, 94% metastatic, and 98% of the cancers were classified as adenocarcinoma histology.
Slovenian: Demografske značilnosti in značilnosti bolezni so bile naslednje: 50 % žensk, mediana starost 51 let, izhodiščno stanje zmogljivosti po ECOG 0 (32 %) ali 1 (55 %), 61 % belcev in 30 % Azijcev, manj kot 1 % trenutnih kadilcev, 27 % nekdanjih kadilcev in 72 % bolnikov, ki niso nikoli kadili, metastatska bolezen pri 94 % bolnikov, 98 % tumorjev je bilo histološko razvrščenih med adenokarcinome.