FrancophonIA/ELRC3.0 huggingface dataset:
English: Adequate contraceptive methods should be used during therapy, and for at least 90 days after completing therapy (see section 4.5).
Slovenian: Med zdravljenjem in še najmanj 90 dni po zaključku zdravljenja je treba uporabljati ustrezne kontracepcijske metode (glejte poglavje 4.5).
English: Supportive care should include the use of antiemetic medicinal products.
Slovenian: Podporna nega mora vključevati antiemetike.
English: Patients should be informed of the first signs of gastrointestinal perforations and be advised to consult rapidly in case of occurrence.
Slovenian: Bolnike je treba poučiti o prvih znakih perforacije v prebavilih in jim svetovati, naj se ob njihovem pojavu nemudoma posvetujejo z zdravnikom.
English: It is not known whether crizotinib and its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se krizotinib in njegovi presnovki izločajo v mleko pri ljudeh.
English: Patients should be monitored for hepatotoxicity and managed as recommended in sections 4.2 and 4.4.
Slovenian: Bolnike je treba spremljati glede hepatotoksičnosti in obravnavati, kot je priporočeno v poglavjih 4.2 in 4.4.
English: The European Medicines Agency has waived the obligation to submit the results of studies with XALKORI in all subsets of the paediatric population in NSCLC (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom XALKORI za vse podskupine pediatrične populacije pri zdravljenju NSCLC (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Median time to onset of any grade neutropenia was 89 days.
Slovenian: Mediani čas do pojava nevtropenije katerekoli stopnje je bil 89 dni.
English: • Anticholinesterases, used to restore muscle function.
Slovenian: • antiholinesteraze, ki se uporabljajo za ponovno vzpostavitev delovanja mišic,
English: Seventeen (1%) patients required permanent discontinuation from treatment.
Slovenian: Pri 17 (1 %) bolnikih je bilo treba zdravljenje trajno prekiniti.
English: The most common findings concerned slit lamp biomicroscopy (21.1%), fundoscopy (15.8%) and visual acuity (13.2%).
Slovenian: Najpogostejše ugotovitve so bile povezane z biomikroskopijo s špranjsko svetilko (21,1 %), fundoskopijo (15,8 %) in ostrino vida (13,2 %).
English: The safety and efficacy of crizotinib in paediatric patients has not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost krizotiniba pri pediatričnih bolnikih nista bili dokazani.
English: Neutropenia was associated with dose reduction or permanent treatment discontinuation for 3% and <1% of patients, respectively.
Slovenian: Nevtropenija je bila povezana z zmanjšanjem odmerka ali trajno prekinitvijo zdravljenja pri 3 % oziroma < 1 % bolnikov.
English: Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation with Grade ≤1 total bilirubin
Slovenian: povečanje vrednosti alanin aminotransferaze (ALT) ali aspartat aminotransferaze (AST) stopnje 3 ali 4, ob vrednosti skupnega bilirubina stopnje ≤ 1
English: • Do not use any pack that is damaged or shows signs of tampering.
Slovenian: • Ne uporabljajte tega zdravila, če opazite, da je pakiranje poškodovano oziroma kaže znake odpiranja.
English: The adverse reactions listed in Table 3 are presented by system organ class and frequency categories, defined using the following convention: very common (1/10); common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki, našteti v preglednici 3, so razvrščeni po organskih sistemih in naslednjih pogostnostih: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The primary efficacy endpoint in both studies was objective response rate (ORR) according to RECIST.
Slovenian: Primarni, na učinkovitost nanašajoči se opazovani dogodek v obeh študijah je bil objektivni odziv na zdravljenje (ORR - Objective Response Rate) po merilih RECIST.
English: • Alteration in sense of taste.
Slovenian: • sprememba okusa
English: Some lung problems may get worse during treatment with XALKORI, as XALKORI may cause inflammation of the lungs during treatment.
Slovenian: Nekatere težave s pljuči se med zdravljenjem z zdravilom XALKORI lahko poslabšajo, ker zdravilo XALKORI med zdravljenjem lahko povzroči vnetje pljuč.
English: A decision to resume crizotinib should consider the potential benefit to the patient.
Slovenian: Pri odločitvi za ponovno uvedbo zdravljenja s krizotinibom je treba razmisliti o morebitni koristi za bolnika.
English: • Pravastatin, used to reduce cholesterol levels.
Slovenian: • pravastatin, ki se uporablja za zmanjšanje ravni holesterola,
English: Efficacy data from Studies 1001 and 1005 are provided in Table 6.
Slovenian: Podatki o učinkovitosti iz Študij 1001 in 1005 so povzeti v preglednici 6.
English: Carcinogenicity studies with crizotinib have not been performed.
Slovenian: Študije karcinogenosti s krizotinibom niso bile opravljene.
English: • If you have severe kidney disease.
Slovenian: • če imate hudo bolezen ledvic.
English: Adverse reactions reported in crizotinib clinical studies (N=1722) System organ class
Slovenian: Neželeni učinki, o katerih so poročali v kliničnih študijah (n = 1.722) Organski sistem
English: • Hypophosphataemia (low blood phosphate levels that can cause confusion or muscle weakness).
Slovenian: • hipofosfatemija (zmanjšane vrednosti fosfata v krvi, kar lahko povzroči zmedenost ali oslabelost mišic)
English: Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse drug reaction in Table 3.
Slovenian: Izrazi za neželene učinke, ki predstavljajo isti zdravstveni pojem ali stanje, so v preglednici 3 združeni in poročani kot en neželeni učinek zdravila.
English: ROS1-Positive Advanced NSCLC
Slovenian: ROS1-pozitivni napredovali NSCLC
English: If a dose is missed, then it should be taken as soon as the patient remembers unless it is less than 6 hours until the next dose, in which case the patient should not take the missed dose.
Slovenian: Če bolnik pozabi vzeti odmerek, ga mora vzeti takoj, ko se spomni, razen če do naslednjega odmerka manjka manj kot 6 ur.
English: The MAH should ensure that, at launch and thereafter, all Healthcare Professionals who are expected to use and/or prescribe XALKORI are provided with an educational pack.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora ob začetku trženja zdravila ter ves čas trženja zagotoviti, da vsi zdravstveni delavci, ki bodo predvidoma uporabljali in/ali predpisovali zdravilo XALKORI, prejmejo paket z izobraževalnim gradivom.
English: • Mefloquine, used for the prevention of malaria.
Slovenian: • meflokin, ki se uporablja za preprečevanje malarije,
English: Because of the potential harm to the infant, mothers should be advised to avoid breast-feeding while receiving XALKORI (see section 5.3).
Slovenian: Zaradi možnega škodljivega vpliva na otroka je treba materam svetovati, da se med jemanjem zdravila XALKORI dojenju izogibajo (glejte poglavje 5.3).
English: Grade 3 or 4 leukopenia has been commonly (3%) reported (see section 4.8).
Slovenian: O levkopeniji stopnje 3 ali 4 so poročali pogosto (3 %) (glejte poglavje 4.8).
English: • If you are experiencing severe stomach or abdominal pain, fever, chills, shortness of breath, fast heartbeat, partial or complete loss of vision (in one or both eyes) or changes in bowel habits.
Slovenian: • če se pojavijo hude bolečine v želodcu ali trebušni votlini, vročina, mrazenje, kratka sapa, hitro bitje srca, delna ali popolna izguba vida (na enem ali obeh očesih) ali spremembe v odvajanju blata.
English: Small increases of structural chromosomal aberrations at cytotoxic concentrations were seen in human lymphocytes.
Slovenian: Ugotovili so majhna povečanja strukturnih kromosomskih aberacij pri humanih limfocitih pri citotoksičnih koncentracijah.
English: Median time to onset of any grade leukopenia was 85 days.
Slovenian: Mediani čas do pojava levkopenije katerekoli stopnje je bil 85 dni.
English: Dysgeusia was also very commonly reported in these studies, and was primarily Grade 1 in severity.
Slovenian: V teh študijah so zelo pogosto poročali tudi o disgevziji, katere izraženost je bila večinoma stopnje 1.
English: • Swallow the capsules whole and do not crush, dissolve or open the capsules.
Slovenian: • Kapsule pogoltnite cele, ne smete pa jih zdrobiti, raztopiti ali odpreti.
English: Due to the small size of the increases in crizotinib exposure (5%-15%), no starting dose adjustment is recommended for patients with mild or moderate renal impairment.
Slovenian: Zaradi majhnega povečanja izpostavljenosti krizotinibu (5 %-15 %) prilagajanje začetnega odmerka pri bolnikih z blago ali zmerno okvaro ledvic ni priporočeno.
English: The disease characteristics were 94% metastatic, 96% adenocarcinoma histology, and 13% with no prior systemic therapy for metastatic disease.
Slovenian: Značilnosti bolezni so bile naslednje: 94 % metastatski primeri, 96 % histološko razvrščenih med adenokarcinome in 13 % brez predhodnega sistemskega zdravljenja metastatske bolezni.
English: Your doctor may do blood tests and if the results are abnormal, your doctor may decide to reduce the dose of XALKORI.
Slovenian: Zdravnik bo morda opravil preiskave krvi in če bi bili rezultati nenormalni, se lahko odloči zmanjšati odmerek zdravila XALKORI.
English: • Cisapride, used to treat stomach problems.
Slovenian: • cisaprid, ki se uporablja za zdravljenje težav z želodcem,
English: If QTc increases to greater than or equal to 500 msec, cardiologist advice must be immediately sought.
Slovenian: Če se interval QTc poveča na 500 ms ali več, se je treba takoj posvetovati s kardiologom.
English: • Oedema (excess fluid in body tissue, causing swelling of the hands and feet).
Slovenian: • edem (čezmerno kopičenje tekočine v telesnem tkivu, ki povzroča otekanje dlani in stopal)
English: Crizotinib is also an inhibitor of the Hepatocyte Growth Factor Receptor (HGFR, c-Met) RTK, ROS1 (c-ros) and Recepteur d'Origine Nantais (RON) RTK.
Slovenian: Krizotinib je tudi zaviralec receptorjev rastnega dejavnika hepatocitov (HGFR - Hepatocyte Growth Factor Receptor, c-Met) RTK, ROS1 (c-ros) in receptorjev d'Origine Nantais (RON) RTK.
English: XALKORI could harm a breast-fed baby.
Slovenian: Zdravilo XALKORI bi lahko škodovalo dojenemu otroku.
English: • Morphine, used to treat acute and cancer pain.
Slovenian: • morfin, ki se uporablja za zdravljenje akutne bolečine ter bolečine pri raku,
English: • Alfentanil and other short acting opiates such as fentanyl (painkillers used for surgical procedures).
Slovenian: • alfentanil in drugi kratkodelujoči opiati, kot na primer fentanil (sredstva za blaženje bolečin, ki se uporabljajo pri kirurških posegih),
English: Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitor; ATC code: L01XE16.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinske kinaze; oznaka ATC: L01XE16
English: Oral contraceptives If you take XALKORI whilst using oral contraceptives, the oral contraceptives may be ineffective.
Slovenian: Če jemljete zdravilo XALKORI, medtem ko uporabljate peroralne kontraceptive, bi ti lahko bili neučinkoviti.
English: Increases to Grade 3 or 4 ALT or AST elevations were observed in 187 (11%) and 95 (6%) of patients, respectively.
Slovenian: Povečanja vrednosti ALT ali AST do stopnje 3 ali 4 so opazili pri 187 (11 %) oziroma 95 (6 %) bolnikih.
English: g. Based on the stratified Cochran-Mantel-Haenszel test (2-sided).
Slovenian: g. na podlagi stratificiranega Cochran-Mantel-Haenszelovega testa (2-stranskega)
English: Cardiac failureh (1%) Electrocardiogram QT prolonged (4%) Syncope (3%)
Slovenian: srčno popuščanje h (1 %) podaljšan interval QT na elektrokardiogramu (4 %) sinkopa (3 %)
English: For patients who develop QTc prolongation, see sections 4.2, 4.8 and 5.2.
Slovenian: Za bolnike, pri katerih pride do podaljšanja intervala QTc, glejte poglavja 4.2, 4.8 in 5.2.
English: There is insufficient information to characterize the risks of resumption of crizotinib in patients with a severe visual loss.
Slovenian: Za opredelitev tveganja pri ponovni uvedbi zdravljenja s krizotinibom pri bolnikih s hudo izgubo vida ni dovolj podatkov.
English: XALKORI can be prescribed to you for the initial treatment if your disease is at an advanced stage of lung cancer.
Slovenian: Zdravilo XALKORI vam zdravnik lahko predpiše za začetno zdravljenje, če je vaša bolezen pljučni rak v napredovalem stadiju.
English: Electrolyte disturbances, dehydration and bradycardia may further increase the risk of QTc prolongation and thus, periodic monitoring of ECG and electrolyte levels is recommended in patients with GI toxicity (see section 4.4).
Slovenian: Motnje elektrolitov, dehidracija in bradikardija lahko dodatno povečajo tveganje za podaljšanje intervala QT, zato se pri bolnikih z boleznimi prebavil priporoča redno spremljanje EKG in elektrolitov (glejte poglavje 4.4).
English: Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products
Slovenian: Ocenite sočasna zdravila, za katera je znano, da povzročajo bradikardijo, in antihipertenzive.
English: Supportive care for diarrhoea and constipation should include the use of standard antidiarroheal and laxative medicinal products, respectively.
Slovenian: Podporna nega pri diareji in zaprtju mora vključevati uporabo standardnih antidiaroikov oziroma odvajal.
English: Tell your doctor about the missed dose at your next visit.
Slovenian: Ob naslednjem obisku pri zdravniku mu povejte o pozabljenem odmerku zdravila.
English: The MAH shall agree the content and format of the educational material with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora z nacionalnimi pristojnimi organi dogovoriti glede vsebine in oblike izobraževalnega gradiva.
English: All-causality Grade 3 or 4 Electrocardiogram QT prolonged was reported in 27 (1.6%) out of 1722 patients (see sections 4.2, 4.4, 4.5 and 5.2).
Slovenian: O podaljšanju intervala QT stopnje 3 ali 4 na elektrokardiogramu zaradi kateregakoli vzroka so poročali pri 27 (1,6 %) od 1.722 bolnikov (glejte poglavja 4.2, 4.4, 4.5 in 5.2).
English: • If you have been told that you have an abnormality of your heart tracing after an electrocardiogram (ECG) known as prolonged QT interval.
Slovenian: • če so vam povedali, da imate nepravilnost v delovanju srca, imenovano podaljšanje intervala QT, ki so jo zaznali pri spremljanju elektrokardiograma (EKG).
English: There is no antidote for XALKORI.
Slovenian: Antidota za zdravilo XALKORI ni.
English: XALKORI 250 mg hard capsules EU/1/12/793/003
Slovenian: XALKORI 250 mg trde kapsule EU/1/12/793/003
English: In patients with new onset of Grade 4 visual loss, crizotinib treatment should be discontinued and ophthalmological evaluation should be performed.
Slovenian: Pri bolnikih, pri katerih se na novo pojavi izguba vida stopnje 4, je treba prekiniti zdravljenje s krizotinibom in opraviti oftalmološki pregled.
English: Grade 2, 3 Bradycardiad,e Symptomatic, may be severe and medically significant, medical intervention indicated
Slovenian: d,e simptomatska, lahko huda in medicinsko pomembna; indicirana zdravstvena intervencija
English: There was a numerical improvement in overall survival (OS) in the patients treated with crizotinib, although this improvement was not statistically significant.
Slovenian: Pri bolnikih, zdravljenih s krizotinibom, je prišlo do številčnega izboljšanja v skupnem preživetju (OS - Overall Survival), vendar to izboljšanje ni bilo statistično pomembno.
English: In addition, a decrease in heart rate was found to be associated with increasing crizotinib plasma concentration (see section 4.4), with a maximum mean reduction of 17.8 beats per minute (bpm) after 8 hours on Cycle 2 Day 1.
Slovenian: Poleg tega so ugotovili, da je upočasnitev srčnega utripa povezana z naraščajočo koncentracijo krizotiniba v plazmi (glejte poglavje 4.4), pri čemer je bil največji povprečni upad za 17,8 utripov na minuto po 8 urah v 1. dnevu 2. cikla.
English: Crizotinib should be administered with caution in these patients and periodic monitoring of electrocardiograms (ECG), electrolytes and renal function is required.
Slovenian: Pri teh bolnikih je treba krizotinib uporabljati previdno, potrebno pa je tudi redno spremljanje elektrokardiogramov (EKG), elektrolitov in delovanja ledvic.
English: Either ALK-positive or ROS1-positive NSCLC status should be established prior to initiation of crizotinib therapy.
Slovenian: Status ALK-pozitivnega ali ROS1-pozitivnega NSCLC je treba določiti pred začetkom zdravljenja s krizotinibom.
English: Study 1001
Slovenian: Študija 1001
English: No visual disturbances associated with crizotinib appeared to be related to changes in best corrected visual acuity, the vitreous, the retina, or the optic nerve.
Slovenian: Nobena motnja vida, povezana s krizotinibom, ni bila povezana s spremembami v najboljši korigirani ostrini vida, steklovino, mrežnico ali vidnim živcem.
English: • Medicines for high blood pressure called beta-blockers such as atenolol, propranolol, labetolol.
Slovenian: • zdravila za zdravljenje visokega krvnega tlaka, imenovana beta blokatorji, kot so atenolol,
English: The aqueous solubility of crizotinib is pH dependent, with low (acidic) pH resulting in higher solubility.
Slovenian: Topnost krizotiniba v vodnem mediju je odvisna od pH, pri čemer nižji (kisel) pH povzroči večjo topnost.
English: No starting dose adjustment is required (see sections 5.1 and 5.2).
Slovenian: Starejši bolniki Prilagajanje začetnega odmerka ni potrebno (glejte poglavji 5.1 in 5.2).
English: Liver function tests including ALT, AST, and total bilirubin should be monitored once a week during the first 2 months of treatment, then once a month and as clinically indicated, with more frequent repeat testing for Grades 2, 3 or 4 elevations.
Slovenian: Delovanje jeter, vključno z ALT, AST in skupnim bilirubinom, je treba preveriti enkrat na teden v prvih 2 mesecih zdravljenja, potem pa enkrat na mesec in kot je klinično indicirano; ponovitve preverjanj pa morajo biti pogostejše pri povečanjih vrednosti stopnje 2, 3 ali 4.
English: e. Per data cutoff date 30 November 2013.
Slovenian: e. na dan zaključka zajema podatkov 30. novembra 2013
English: • Bupropion, used to treat depression and smoking cessation.
Slovenian: • bupropion, ki se uporablja za zdravljenje depresije ter pri odvajanju od kajenja,
English: The majority of patients on the crizotinib arm in randomised Phase 3 Studies 1007 and 1014 (>50%) reported visual disturbances; which occurred at a frequency of 4 to 7 days each week, lasted up to 1 minute, and had mild or no impact (scores 0 to 3 out of a maximum score of 10) on daily activities as captured by the VSAQ-ALK questionnaire.
Slovenian: Večina bolnikov (> 50 %) v skupini s krizotinibom v randomiziranih študijah 3. faze, Študij 1007 in 1014, je poročala o motnjah vida, ki so se pojavljale s pogostnostjo od 4 do 7 dni na teden, trajale do 1 minute in so imele ničen ali blag vpliv (rezultat 0 do 3 od skupno 10 točk) na vsakdanje dejavnosti, kar so ocenili z vprašalnikom VSAQ-ALK.
English: The primary efficacy endpoint was ORR according to RECIST.
Slovenian: Primarni, na učinkovitost nanašajoči se opazovani dogodek je bil ORR po merilih RECIST.
English: Your doctor may stop XALKORI treatment and refer you to an ophthalmologist.
Slovenian: Zdravnik lahko prekine zdravljenje z zdravilom XALKORI in vas napoti k oftalmologu.
English: What you need to know before you take XALKORI
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo XALKORI
English: Crizotinib is an inhibitor of OCT1 and OCT2 in vitro.
Slovenian: Krizotinib je zaviralec OCT1 in OCT2 in vitro.
English: e. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.
Slovenian: e) Pri bolnikih, ki se zdravijo z odmerkom 250 mg enkrat na dan, ali tistih, pri katerih so odmerek zmanjšali na 250 mg enkrat na dan, zdravljenje med pregledom prekinite.
English: The primary metabolic pathways in humans were oxidation of the piperidine ring to crizotinib lactam and O-dealkylation, with subsequent Phase 2 conjugation of O-dealkylated metabolites.
Slovenian: Najpomembnejši presnovni poti pri ljudeh sta bili oksidacija piperidinske verige do krizotinib laktama in O-dealkilacija, s poznejšo fazo 2 konjugacije O-dealkiliranih presnovkov.
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano MM/LLLL.
English: No specific studies with crizotinib have been conducted in animals to evaluate the effect on fertility; however, crizotinib is considered to have the potential to impair reproductive function and fertility in humans based on findings in repeat-dose toxicity studies in the rat.
Slovenian: Na živalih niso opravili nobenih posebnih študij s krizotinibom za oceno vpliva na plodnost; vendar pa krizotinib velja za snov, ki bi, glede na ugotovitve študij toksičnosti pri ponavljajočih se odmerkih na podganah, lahko neugodno vplivala na sposobnost razmnoževanja in plodnost pri ljudeh.
English: • Increased levels of the enzyme alkaline phosphatase in the blood (an indicator of organ malfunction or injury, particularly liver, pancreas, bone, thyroid gland, or gall bladder).
Slovenian: • povišane ravni encima alkalne fosfataze v krvi (ki kažejo na nepravilno delovanje ali poškodbo organov, predvsem jeter, trebušne slinavke, kosti, ščitnice ali žolčnika)
English: Of the 1084 patients who experienced vision disorder, 95% had events that were mild in severity.
Slovenian: Izmed 1.084 bolnikov, pri katerih se je pojavila motnja vida, je bila pri 95 % resnost teh dogodkov blaga.
English: Of the 30 patients, an ophthalmic abnormality of any type was reported in 14 (36.8%) patients and no ophthalmic finding was seen in 16 (42.1%) patients.
Slovenian: Od teh 30 bolnikov so o očesni motnji katerekoli vrste poročali pri 14 bolnikih (36,8 %), medtem ko pri 16 bolnikih (42,1 %) niso ugotovili nobenih očesnih motenj.
English: • Rifabutin, rifampicin, used to treat tuberculosis.
Slovenian: • rifabutin, rifampicin, ki se uporabljata za zdravljenje tuberkuloze,
English: In vitro studies demonstrated that CYP3A4/5 were the major enzymes involved in the metabolic clearance of crizotinib.
Slovenian: In vitro študije so pokazale, da so bili encimi CYP3A4/5 najpomembnejši encimi, ki so sodelovali pri izločanju krizotiniba iz telesa s presnovo.
English: Caution should be exercised in administering crizotinib in combination with medicinal products that are predominantly metabolised by these enzymes.
Slovenian: Potrebna je previdnost, kadar se krizotinib uporablja skupaj z zdravili, ki se presnavljajo pretežno preko teh encimov.
English: ALK and ROS1 testing
Slovenian: Preverjanje prisotnosti ALK in ROS1
English: Patients with mild (60≤ CLcr <90 mL/min) and moderate (30≤ CLcr <60 mL/min) renal impairment were enrolled in single-arm Studies 1001 and 1005.
Slovenian: Bolniki z blago (60 ≤ očistek kreatinina [CLcr] < 90 mL/min) in zmerno (30 ≤ CLcr < 60 mL/min) okvaro ledvic so bili vključeni v enoskupinski Študiji 1001 in 1005.
English: Efficacy data from randomised Phase 3 Study 1014 are summarised in Table 4, and the Kaplan-Meier curves for PFS and OS are shown in Figure 1 and 2, respectively.
Slovenian: Podatki o učinkovitosti iz randomizirane študije 3. faze, Študije 1014, so povzeti v preglednici 4, Kaplan-Meierjevi krivulji za PFS in OS pa sta prikazani na slikah 1 in 2.