FrancophonIA/ELRC3.0 huggingface dataset:
English: Previously treated ALK-positive advanced NSCLC -randomised Phase 3 Study 1007
Slovenian: Predhodno zdravljeni ALK-pozitivni napredovali NSCLC - randomizirana študija 3. faze, Študija 1007
English: • Atazanavir, ritonavir, cobicistat, used to treat HIV infections/AIDS.
Slovenian: • atazanavir, ritonavir, kobicistat, ki se uporabljajo za zdravljenje okužb z virusom HIV/AIDS-a.
English: • If you have reduced heart rate.
Slovenian: • če imate upočasnjen srčni utrip.
English: Crizotinib treatment should be withheld if ILD/pneumonitis is suspected.
Slovenian: Zdravljenje s krizotinibom je treba prekiniti, če obstaja sum na ILD/pnevmonitis.
English: • If you are allergic to crizotinib or any of the other ingredients of this medicine (listed in Section 6, “What XALKORI contains”).
Slovenian: • če ste alergični na krizotinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6,
English: Withhold if ILD/pneumonitis is suspected, and permanently discontinue if treatment-related ILD/pneumonitis is diagnosedd
Slovenian: Prekinite zdravljenje, če obstaja sum na ILD/pnevmonitis, in ga trajno prekinite, če se potrdi diagnoza ILD/pnevmonitisa, povezanega z zdravljenjem podaljšanje intervala QTc stopnje 3
English: For patients without baseline brain metastases, the median IC-TTP was not reached in either the crizotinib (N=132) or the chemotherapy arms (N=131) (HR=0.69 [95% CI: 0.33, 1.45]; 1-sided p-value=0.1617).
Slovenian: Bolniki brez možganskih metastaz ob izhodišču v skupini s krizotinibom (n = 132) ali kemoterapijo (n = 131) niso dosegli medianega IC-TTP (HR = 0,69 (95 % IZ: 0,33; 1,45), 1-stranska vrednost p = 0,1617).
English: Tell your doctor right away if you have any new or worsening symptoms including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever.
Slovenian: Če se vam pojavijo kakršnikoli novi simptomi ali se simptomi poslabšajo, vključno s težavami pri dihanju ali kratko sapo, kašljem s sluzjo ali brez nje, ali vročino, to nemudoma povejte zdravniku.
English: Based on the Visual Symptom Assessment Questionnaire (VSAQ-ALK), patients treated with crizotinib in Study 1007 and Study 1014 reported a higher incidence of visual disturbances compared to patients treated with chemotherapy.
Slovenian: Assessment Questionnaire), so bolniki, ki so jih v Študijah 1007 in 1014 zdravili s krizotinibom, poročali o večji incidenci motenj vida kot bolniki, zdravljeni s kemoterapijo.
English: The most frequent adverse reactions (≥3%, all-causality frequency) associated with dosing interruptions were neutropenia (11%), elevated transaminases (7%), vomiting (5%), and nausea (4%).
Slovenian: Najpogostejši neželeni učinki (≥ 3 % pogostnost zaradi vseh vzrokov), povezani s prekinitvijo odmerjanja, so bili nevtropenija (11 %), povečane vrednost transaminaz (7 %), bruhanje (5 %) in navzea (4 %).
English: Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, dizziness, hypotension), vision disorder, or fatigue while taking XALKORI (see sections 4.2, 4.4 and 4.8).
Slovenian: Pri vožnji oziroma upravljanju strojev je potrebna previdnost, saj se lahko pri bolnikih med jemanjem zdravila XALKORI pojavijo simptomatska bradikardija (npr. sinkopa, omotica, hipotenzija), motnje vida ali utrujenost (glejte poglavja 4.2, 4.4 in 4.8).
English: Complete blood counts including differential white blood cell counts should be monitored as clinically indicated, with more frequent repeat testing if Grade 3 or 4 abnormalities are observed, or if fever or infection occurs.
Slovenian: Popolno krvno sliko, vključno z belo krvno sliko, je treba spremljati, kot je klinično indicirano, ponovitve teh preverjanj pa morajo biti pogostejše pri nenormalnostih stopnje 3 ali 4, ali če se pojavi povišana telesna temperatura ali okužba.
English: Unchanged crizotinib represented approximately 53% and 2.3% of the administered dose in faeces and urine, respectively.
Slovenian: Delež nespremenjenega krizotiniba je v blatu znašal približno 53 % danega odmerka, v urinu pa 2,3 %.
English: However, there was no observed induction in vivo when crizotinib was coadministered with the CYP3A probe substrate midazolam.
Slovenian: Vendar pa niso opazili nobene indukcije in vivo, kadar je bil krizotinib uporabljen sočasno s substratom za CYP3A4, midazolamom.
English: Efficacy data from ROS1-positive advanced NSCLC patients from Study 1001 are provided in Table 7.
Slovenian: Podatki o učinkovitosti zdravljenja bolnikov z ROS1-pozitivnim napredovalim NSCLC iz Študije 1001 so povzeti v preglednici 7.
English: Seven (0.4%) patients had temporary treatment discontinuation and 2 (0.1%) patients had a dose reduction associated with vision disorder.
Slovenian: Pri sedmih (0,4 %) bolnikih je bilo treba zaradi motnje vida začasno prekiniti zdravljenje, pri dveh (0,1 %) pa zmanjšati odmerek.
English: Crizotinib demonstrated concentration-dependent inhibition of the kinase activity of ALK, ROS1, and c-Met in biochemical assays and inhibited phosphorylation and modulated kinase-dependent phenotypes in cell-based assays.
Slovenian: Krizotinib je v biokemijskih preskušanjih povzročil od koncentracije odvisno zavrtje aktivnosti kinaze ALK, ROS1 in c-Met in zavrtje fosforilacije ter spremenil od kinaze odvisne fenotipe v preskušanjih na celičnih linijah.
English: In patients with new onset of severe visual loss (best corrected visual acuity less than 6/60 in one or both eyes), crizotinib treatment should be discontinued (see section 4.2).
Slovenian: Zdravljenje s krizotinibom je treba prekiniti pri bolnikih, pri katerih se na novo pojavi huda izguba vida (najboljša vidna ostrina s korekcijo manj kot 6/60 na enem ali obeh očesih) (glejte poglavje 4.2).
English: Body Weight and Gender
Slovenian: Telesna masa in spol
English: Findings observed in the male reproductive tract included testicular pachytene spermatocyte degeneration in rats given ≥50 mg/kg/day for 28 days (approximately 1.1-fold human clinical exposure based on AUC).
Slovenian: Ugotovitve, ki so jih opažali na rodilih pri samcih, so vključevale degeneracijo spermatocitov v pahitenski fazi v modih pri podganah, ki so 28 dni prejemale odmerek ≥ 50 mg/kg/dan (približno 1,1-kratnik klinične izpostavljenosti pri ljudeh, na osnovi vrednosti AUC).
English: In clinical studies with crizotinib, events of gastrointestinal perforations were reported.
Slovenian: V kliničnih študijah s krizotinibom so poročali o perforacijah v prebavilih.
English: If QTc increases by greater than or equal to 60 msec from baseline but QTc is <500 msec, crizotinib should be withheld and cardiologist advice should be sought.
Slovenian: Če se interval QTc podaljša za 60 ms ali več v primerjavi z izhodiščno vrednostjo, vendar je QTc < 500 ms, je treba zdravljenje s krizotinibom začasno prekiniti in se posvetovati s kardiologom.
English: Crizotinib significantly prolonged progression-free survival (PFS), the primary objective of the study, compared to chemotherapy as assessed by IRR.
Slovenian: Krizotinib je v primerjavi s kemoterapijo pomembno podaljšal preživetje brez napredovanja bolezni (PFS - Progression-Free Survival), primarni cilj študije, ki se je ocenil s pregledom IRR.
English: All-causality, all grade, vision disorder, most commonly visual impairment, photopsia, vision blurred, and vitreous floaters, was experienced by 1084 (63%) of 1722 patients treated with crizotinib.
Slovenian: Do motenj vida vseh stopenj zaradi vseh vzrokov (najpogosteje poslabšanja vida, fotopsije, zamegljenega vida in motnjav v steklovini) je prišlo pri 1.084 (63 %) od 1.722 bolnikov, zdravljenih s krizotinibom.
English: The absolute bioavailability of crizotinib was determined to be 43% following the administration of a single 250 mg oral dose.
Slovenian: Ugotovili so, da absolutna biološka uporabnost krizotiniba po jemanju enkratnega 250 mg peroralnega odmerka znaša 43 %.
English: The PFS benefit of crizotinib was consistent across subgroups of baseline patient characteristics such as age, gender, race, smoking class, time since diagnosis, ECOG performance status, and presence of brain metastases.
Slovenian: Koristni učinek krizotiniba na PFS je bil konsistenten v vseh podskupinah bolnikov glede na izhodiščne značilnosti, kot so starost, spol, rasa, kadilski status, čas od diagnoze, telesno stanje po ECOG in prisotnost možganskih metastaz.
English: The concomitant use of crizotinib with strong CYP3A4 inhibitors or with strong and moderate CYP3A4 inducers should be avoided (see section 4.5).
Slovenian: Sočasni uporabi krizotiniba skupaj z močnimi zaviralci ali močnimi in zmernimi induktorji CYP3A4 se je treba izogibati (glejte poglavje 4.5).
English: p-valueg Duration of Response Mediane, Months (95% CI)
Slovenian: vrednost p Trajanje odziva Mediana e, meseci (95 % IZ)
English: You should take special care when driving and using machines as patients taking XALKORI may experience visual disturbances, dizziness, and tiredness.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pri upravljanju vozil in strojev morate biti zelo pazljivi, ker se lahko pri bolnikih, ki jemljejo zdravilo XALKORI, pojavijo motnje vida, omotičnost in utrujenost.
English: • Irinotecan, a chemotherapy drug used to treat cancer of the colon and rectum.
Slovenian: • irinotekan, kemoterapija, ki se uporablja za zdravljenje raka debelega črevesa in danke,
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized by CYP2B6 (e.g., bupropion, efavirenz).
Slovenian: Zato lahko krizotinib zveča plazemske koncentracije sočasno uporabljenih zdravil, ki jih presnavlja CYP2B6 (npr. bupropion, efavirenz).
English: Of 154 and 1063 ALK-positive NSCLC patients in single arm studies 1001 and 1005, 22 (14%) and 173 (16%) were 65 years or older, respectively.
Slovenian: Izmed 154 in 1.063 bolnikov z ALK-pozitivnim NSCLC v Študijah 1001 in 1005 z eno skupino bolnikov jih je bilo 22 (14 %) oziroma 173 (16 %) starih 65 let ali več.
English: Dizzinessf (26%) Bradycardiag (13%)
Slovenian: Srčne bolezni omotica f (26 %) bradikardijag (13 %)
English: q. Blood testosterone decreased (Blood testosterone decreased, Hypogonadism, Secondary hypogonadism).
Slovenian: periorbitalni edem) q. zmanjšana koncentracija testosterona v krvi (zmanjšana koncentracija testosterona v krvi, hipogonadizem,
English: In clinical studies, prolonged QT interval was observed with crizotinib.
Slovenian: V kliničnih študijah so pri uporabi krizotiniba opazili podaljšanje intervala QT.
English: Nervous system effects
Slovenian: Vplivi na živčevje
English: In Study 1001, the adjusted geometric mean of plasma Ctrough, ss in mild (N=35) and moderate (N=8) renal impairment patients were 5.1% and 11% higher, respectively, than those in patients with normal renal function.
Slovenian: V Študiji 1001 je bilo prilagojeno geometrično povprečje plazemske Ctrough, ss pri bolnikih z blago (n = 35) in zmerno (n = 8) okvaro ledvic 5,1 % in 11 % večje kot pri bolnikih z normalnim delovanjem ledvic.
English: There was one ALK-positive patient >85 years old out of 154 patients in single-arm Study 1001 (see also section 4.2 and 5.2).
Slovenian: V enoskupinski Študiji 1001 je bil en bolnik z ALK-pozitivnim NSCLC od 154 bolnikov starejši od 85 let (glejte tudi poglavji 4.2 in 5.2).
English: The most frequent adverse reactions (≥3%) associated with dose reductions were elevated transaminases and neutropenia.
Slovenian: Najpogostejša neželena učinka (≥ 3 %), povezana z zmanjšanjem odmerka, sta bila povečana vrednost transaminaz in nevtropenija.
English: N=125a
Slovenian: n = 125
English: Vomiting (51%) Diarrhoea (54%) Nausea (57%) Constipation (43%) Abdominal painj
Slovenian: Bolezni prebavil bruhanje (51 %) diareja (54 %) navzea (57 %) zaprtje (43 %) bolečina v trebuhu ezofagitis k (2 %) dispepsija (8 %)
English: Progression-Free Survival (Based on IRR) Number with event, n (%) Median PFS in months (95% CI)
Slovenian: Preživetje brez napredovanja (na podlagi IRR) Število z dogodkom, n (%) Mediano PFS v mesecih (95 % IZ)
English: Across studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC, median time to onset of increased Grade 1 or 2 transaminases was 23 days.
Slovenian: V študijah krizotiniba pri bolnikih z ALK-pozitivnim ali ROS1-pozitivnim NSCLC je bil mediani čas do pojava povečanja vrednosti transaminaz stopnje 1 ali 2 23 dni.
English: Information is available from 45 response-evaluable patients with previously treated non-adenocarcinoma NSCLC (including 22 patients with SCC) in Study 1005.
Slovenian: Na voljo so podatki za 45 bolnikov s predhodno zdravljenim NSCLC, ki glede na histologijo ni bil adenokarcinom (vključno z 22 bolniki s SCC), pri katerih je bilo v Študiji 1005 odziv na zdravljenje mogoče ovrednotiti.
English: There were no ROS1-positive patients >85 years old in Study 1001.
Slovenian: V Študiji 1001 ni bilo ROS1-pozitivnih bolnikov, starejših od 85 let.
English: The central tendency analysis indicated that the largest mean change from baseline in QTcF was 12.3 msec (95% CI 5.1-19.5 msec, least squares mean [LS] from Analysis of Variance [ANOVA]) and occurred at 6 hours post-dose on Cycle 2 Day 1.
Slovenian: Analiza centralne tendence je pokazala, da je bila največja povprečna sprememba vrednosti QTcF glede na izhodišče 12,3 ms (povprečje najmanjših kvadratov [LS - least squares] iz analize varianc [ANOVA]), do katere je prišlo 6 ur po odmerku 1. dan 2. cikla.
English: • Second dose reduction: XALKORI 250 mg taken orally once daily
Slovenian: • Drugo zmanjšanje odmerka: zdravilo XALKORI 250 mg peroralno enkrat na dan.
English: One hundred seventy-three (173) patients were randomised to crizotinib and 174 patients were randomised to chemotherapy (either pemetrexed or docetaxel).
Slovenian: V skupino s krizotinibom so naključno razporedili 173 bolnikov, v skupino s kemoterapijo pa 174 bolnikov (pemetreksed ali docetaksel).
English: Crizotinib dose adjustment according to Child-Pugh classification has not been studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter prilagajanja odmerka krizotiniba na podlagi klasifikacije Child-Pugh niso preučevali.
English: Discontinue during evaluation of severe vision loss a. NCI Common Terminology Criteria for Adverse Events b. XALKORI must be permanently discontinued in case of further Grade ≥3 recurrence.
Slovenian: Terminology Criteria for Adverse Events) b. Če pride do še ene ponovitve bolezni stopnje ≥ 3, morate zdravljenje z zdravilom XALKORI trajno prekiniti.
English: Withhold until recovery to Grade ≤1 or to heart rate 60 or above
Slovenian: Prekinite zdravljenje, dokler ne pride do izboljšanja na stopnjo ≤ 1 ali na srčni utrip 60 ali več.
English: Crizotinib should be used with caution in patients at risk for gastrointestinal perforation (e.g., history of diverticulitis, metastases to the gastrointestinal tract, concomitant use of medicinal products with a recognized risk of gastrointestinal perforation).
Slovenian: Krizotinib je treba uporabljati previdno pri bolnikih s tveganjem za nastanek perforacije v prebavilih (npr. pri bolnikih z anamnezo divertikulitisa ali metastazami, ki se širijo v prebavila, ter pri sočasni uporabi zdravil, za katera je znano, da lahko povzročijo perforacijo v prebavilih).
English: MARKETING AUTHORISATION NUMBER(S) XALKORI 200 mg hard capsules EU/1/12/793/001
Slovenian: XALKORI 200 mg trde kapsule EU/1/12/793/001
English: Based on the population pharmacokinetic analysis of data from Studies 1001, 1005, and 1007, age has no effect on crizotinib pharmacokinetics (see sections 4.2 and 5.1).
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov iz študij 1001, 1005 in 1007 starost nima vpliva na farmakokinetiko krizotiniba (glejte poglavji 4.2 in 5.1).
English: Crizotinib showed a significantly greater improvement from baseline compared to chemotherapy in alopecia (Cycles 2 to 15; p-value <0.05), cough (Cycles 2 to 20; p-value <0.0001), dyspnoea (Cycles 2 to 20; p-value <0.0001), haemoptysis (Cycles 2 to 20; p-value <0.05), pain in arm or shoulder (Cycles 2 to 20; p-value <0.0001), pain in chest (Cycles 2 to 20; p-value <0.0001), and pain in other parts (Cycles 2 to 20; p-value <0.05).
Slovenian: Krizotinib je povzročil znatno večje izboljšanje od začetka študije pri alopeciji (cikli od 2 do 15; vrednost p < 0,05), kašlju (cikli od 2 do 20; vrednost p < 0,0001), dispneji (cikli od 2 do 20; vrednost p < 0,0001), hemoptizi (cikli od 2 do 20; vrednost p < 0,05), bolečini v roki ali rami (cikli od 2 do 20; vrednost p < 0,0001), bolečini v prsnem košu (cikli od 2 do 20; vrednost p < 0,0001) ter bolečini v drugih delih telesa (cikli od 2 do 20; vrednost p < 0,05) v primerjavi s kemoterapijo.
English: The efficacy and safety of crizotinib for the treatment of patients with ALK-positive metastatic NSCLC, who had received previous systemic treatment for advanced disease, were demonstrated in a global, randomised, open-label Study 1007.
Slovenian: Učinkovitost in varnost krizotiniba pri zdravljenju bolnikov z ALK-pozitivnim metastatskim NSCLC, ki so predhodno prejeli sistematsko zdravljenje napredovale bolezni, so dokazali v globalni, randomizirani, odprti Študiji 1007.
English: OS is based on the data cutoff date of 31 August 2015. a. The median PFS times were 4.2 months (95% CI: 2.8, 5.7) for pemetrexed (HR=0.59; p-value=0.0004 for crizotinib compared with pemetrexed) and 2.6 months (95% CI: 1.6, 4.0) for docetaxel
Slovenian: 2012; OS so določili na dan zaključka zajema podatkov 31. avgusta 2015. a. Mediani čas PFS je bil 4,2 meseca (95 % IZ: 2,8; 5,7) pri pemetreksedu (HR = 0,59, vrednost p = 0,0004 za zdravilo XALKORI v primerjavi s pemetreksedom) in 2,6 meseca (95 % IZ: 1,6; 4,0) pri docetakselu
English: Dose modification is not required in cases of asymptomatic bradycardia.
Slovenian: Pri asimptomatski bradikardiji odmerka ni treba prilagoditi.
English: Number of deaths, n (%) Overall Survivalc [median (95% CI)] months
Slovenian: Število smrti, n (%) Skupno preživetje c (mediana (95 % IZ)), meseci
English: In randomised Phase 3 Study 1007, increases to Grade 3 or 4 ALT or AST elevations were observed in 18% and 9% of patients receiving crizotinib and 5% and <1% of patients receiving chemotherapy.
Slovenian: V randomizirani študiji 3. faze, Študiji 1007, so povečanja vrednosti ALT ali AST do stopnje 3 ali 4 opazili pri 18 % oziroma 9 % bolnikov, ki so prejemali krizotinib, in 5 % oziroma < 1 % bolnikov, ki so prejemali kemoterapijo.
English: Of 172 ALK-positive patients treated with crizotinib in randomised Phase 3 Study 1007, 27 (16%) were 65 years or older.
Slovenian: Izmed 172 bolnikov z ALK-pozitivnim NSCLC, zdravljenih s krizotinibom v randomizirani študiji 3. faze, Študiji 1007, jih je bilo 27 (16 %) starih 65 let ali več.
English: In vitro, crizotinib is not an inhibitor of BSEP at clinically relevant concentrations.
Slovenian: In vitro krizotinib v klinično pomembnih koncentracijah ni zaviralec BSEP.
English: The antitumour efficacy of crizotinib was dose-dependent and demonstrated a correlation with inhibition of ROS1 phosphorylation in vivo.
Slovenian: Protitumorska učinkovitost krizotiniba je bila odvisna od odmerka in povezana z zavrtjem fosforilacije ROS1 in vivo.
English: Objective Response Rate (Based on IRR) Objective Response Rate % (95% CI)
Slovenian: d % (95 % IZ) Delež objektivnega odziva (na podlagi IRR) Delež objektivnega odziva % (95 % IZ)
English: In Study 1014, the median duration of study treatment was 47 weeks for patients in the crizotinib arm (N=171); the median duration of treatment was 23 weeks for patients who crossed over from the chemotherapy arm to receive crizotinib treatment (N=109).
Slovenian: V Študiji 1014 je bilo mediano trajanje preiskovanega zdravljenja pri bolnikih v skupini s krizotinibom (n = 171) 47 tednov, pri bolnikih, ki so prešli iz skupine s kemoterapijo v skupino, ki je prejemala krizotinib (n = 109), pa 23 tednov.
English: • Keep this medicine out of the sight and reach of children.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: Vision disordere (63%)
Slovenian: Očesne bolezni motnje vida e (63 %)
English: The data described below reflect exposure to XALKORI in 1669 patients with ALK-positive advanced NSCLC who participated in 2 randomised Phase 3 studies (Studies 1007 and 1014) and in 2 single-arm studies (Studies 1001 and 1005), and in 53 patients with ROS1-positive advanced NSCLC who participated in single-arm Study 1001, for a total of 1722 patients (see section 5.1).
Slovenian: Spodaj navedeni podatki odražajo izpostavljenost zdravilu XALKORI pri skupno 1.722 bolnikih, od tega pri 1.669 bolnikih z ALK-pozitivnim napredovalim NSCLC, ki so sodelovali v 2 randomiziranih študijah 3. faze (Študiji 1007 in 1014) ter dveh študijah z eno skupino bolnikov (Študiji 1001 in 1005), in pri 53 bolnikih z ROS1-pozitivnim napredovalim NSCLC, ki so sodelovali v Študiji 1001 z eno skupino bolnikov (glejte poglavje 5.1).
English: All upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were <20 msec.
Slovenian: Vse zgornje meje 90-odstotnega intervala zaupanja spremembe povprečja najmanjših kvadratov vrednosti QTcF glede na izhodišče so bile < 20 ms v vseh časovnih točkah 1. dne 2. cikla.
English: Of the 53 ROS1-positive NSCLC patients in single arm Study 1001, 15 (28%) were 65 years or older.
Slovenian: Izmed 53 bolnikov z ROS1-pozitivnim NSCLC v enoskupinski Študiji 1001 jih je bilo 15 (28 %) starih 65 let ali več.
English: • Metformin, used to treat diabetes.
Slovenian: • metformin, ki se uporablja za zdravljenje sladkorne bolezni,
English: XALKORI may cause foetal harm when administered to a pregnant woman.
Slovenian: Zdravilo XALKORI lahko škoduje plodu, če ga jemljejo nosečnice.
English: In Study 1005, the adjusted geometric mean Ctrough, ss of crizotinib in mild (N=191) and moderate (N=65) renal impairment groups were 9.1% and 15% higher, respectively, than those in patients with normal renal function.
Slovenian: V Študiji 1005 je bilo prilagojeno geometrično povprečje Ctrough, ss krizotiniba pri bolnikih z blago (n = 191) in zmerno (n = 65) okvaro ledvic 9,1 % in 15 % večje kot pri bolnikih z normalnim delovanjem ledvic.
English: If dose reduction is necessary for patients treated with crizotinib 250 mg orally twice daily, then the dose of crizotinib should be reduced as below.
Slovenian: Če je potrebno zmanjšanje odmerka pri bolnikih, ki se zdravijo s krizotinibom 250 mg peroralno dvakrat na dan, je treba odmerek krizotiniba zmanjšati, kot je navedeno spodaj.
English: Abbreviations: CI=confidence interval; HR=hazard ratio; IRR=independent radiology review; N/n=number of patients; PFS=progression-free survival; OS=overall survival.
Slovenian: Kratice: IZ = interval zaupanja, HR = razmerje ogroženosti, IRR = neodvisni radiološki pregled, n = število bolnikov, PFS = preživetje brez napredovanja bolezni, OS = skupno preživetje.
English: Most events were mild in severity.
Slovenian: Resnost večine teh dogodkov je bila blaga.
English: In randomised Phase 3 Study 1014, increases to Grade 3 or 4 ALT or AST elevations were observed in 15% and 8% of patients receiving crizotinib versus 2% and 1% of patients receiving chemotherapy.
Slovenian: V randomizirani študiji 3. faze, Študiji 1014, so povečanja vrednosti ALT ali AST do stopnje 3 ali 4 opazili pri 15 % oziroma 8 % bolnikov, ki so prejemali krizotinib, in 2 % oziroma 1 % bolnikov, ki so prejemali kemoterapijo.
English: An ECG substudy using blinded manual ECG measurements was conducted in 52 ALK-positive NSCLC patients who received crizotinib 250 mg twice daily.
Slovenian: Izvedena je bila podštudija EKG z zaslepljenimi ročnimi meritvami EKG pri 52 ALK-pozitivnih bolnikih z nedrobnoceličnim pljučnim rakom, ki so dvakrat dnevno prejeli 250 mg krizotiniba.