FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on in vitro data, ceritinib competitively inhibits the metabolism of a CYP3A substrate, midazolam, and a CYP2C9 substrate, diclofenac.
Slovenian: Po podatkih in vitro ceritinib kompetitivno zavira metabolizem midazolama, substrata CYP3A, in diklofenaka, substrata CYP2C9.
English: Pharmacotherapeutic group: antineoplasic and immunomodulating agents, ATC code: L01XE28.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe in imunomodulatorji, oznaka ATC: L01XE28.
English: CARTON OF UNIT PACK CONTAINING 40 OR 90 HARD CAPSULES
Slovenian: ŠKATLA POSAMEZNEGA PAKIRANJA, KI VSEBUJE 40 ALI 90 TRDIH KAPSUL
English: Based on in vitro data, ceritinib does not inhibit apical efflux transporter MRP2, hepatic uptake transporters OATP1B1 or OATP1B3, renal organic anion uptake transporters OAT1 and OAT3, or the organic cation uptake transporters OCT1 or OCT2 at clinically relevant concentrations.
Slovenian: Po podatkih in vitro ceritinib v klinično ustreznih koncentracijah ne zavira apikalnega izločevalnega prenašalca MRP2, jetrnih privzemnih prenašalcev OATP1B1 in OATP1B3, ledvičnih privzemnih prenašalcev organskih anionov OAT1 in OAT3 ter privzemnih prenašalcev organskih kationov OCT1 in OCT2.
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blisters containing 10 hard capsules.
Slovenian: Pretisni omoti iz PVC/PCTFE (polivinilklorida/poliklorotrifluoroetilena) - aluminija, ki vsebujejo 10 trdih kapsul.
English: There is no data with concomitant use of H2 blockers or antacids.
Slovenian: O sočasni uporabi antagonistov histaminskih receptorjev H2 ali antacidov ni podatkov.
English: Single arm studies X2101 and A2201
Slovenian: Študiji s po eno študijsko skupino z oznakama X2101 in A2201
English: If dose reduction is required due to an adverse drug reaction (ADR) not listed in Table 1, then this should be achieved by decrements of 150 mg daily.
Slovenian: Če je treba odmerek znižati zaradi neželenega učinka zdravila, ki ni naveden v preglednici 1, naj zniževanje poteka v stopnjah po 150 mg na dan.
English: QTc prolongation has been observed in clinical studies in patients treated with ceritinib (see sections 4.8 and 5.2), which may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death.
Slovenian: Pri bolnikih, ki so v kliničnih študijah prejemali ceritinib, so opažali podaljšanje intervala QTc (glejte poglavji 4.8 in 5.2), kar lahko poveča tveganje za ventrikularne tahiaritmije (npr. torsade de pointes) ali nenadno smrt.
English: The majority of patients had adenocarcinoma (97.0%) and had either never smoked or were former smokers (96.1%).
Slovenian: Večina bolnikov je imela adenokarcinom (97,0 %) in niso nikdar kadili ali pa so bili nekdanji kadilci (96,1 %).
English: Patients receiving ceritinib showed significant improvements over chemotherapy in general Quality of Life and global Health Status measures (LCSS [p<0.001], QLQ-C30, [p<0.001] and EQ-5D-5L index [p<0.001]).
Slovenian: Pri bolnikih, ki so prejemali ceritinib, se je kazalo statistično značilno izboljšanje glede na merila vprašalnika o splošni kakovosti življenja in globalnih merilih zdravstvenega stanja (LCSS [p<0,001], QLQ-C30, [p<0,001] in EQ-5D-5L indeks [p<0,001]).
English: Caution is advised with concomitant use of proton pump inhibitors, as exposure of ceritinib may be reduced.
Slovenian: Pri sočasni uporabi zaviralcev protonske črpalke se priporoča previdnost, saj je lahko izpostavljenost ceritinibu zmanjšana.
English: Packs containing 40, 90 or 150 (3 packs of 50) hard capsules.
Slovenian: Pakiranja, ki vsebujejo 40, 90 ali 150 (3 pakiranja po 50) trdih kapsul.
English: None of these events led to discontinuation of ceritinib treatment.
Slovenian: V nobenem od teh primerov ni bilo treba dokončno ukiniti zdravljenja s ceritinibom.
English: Cases of pancreatitis have been reported in patients treated with ceritinib (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili s ceritinibom, so poročali o primerih pankreatitisa (glejte poglavje 4.8).
English: CYP2A6 and CYP2E1 substrates
Slovenian: Substrati CYP2A6 in CYP2E1
English: In vitro studies suggest that ceritinib is a substrate for P-glycoprotein (P-gp), but not of breast cancer resistance protein (BCRP) or multi-resistance protein 2 (MRP2).
Slovenian: Po podatkih študij in vitro je ceritinib substrat P-glikoproteina (P-gp), ni pa substrat proteina rezistence pri raku dojke (angl. breast cancer resistance protein, BCRP) ali proteina, ki je povezan z rezistenco na več zdravil (angl. multi-resistance protein 2, MRP2).
English: Overall Response Rate (ORR: CR+PR), n (%) (95% CI)
Slovenian: celokupna stopnja odziva (ORR: popolni odziv +delni odziv), n (%) (95-odstotni IZ)
English: The principal toxicity related to ceritinib administration in rats and monkeys was inflammation of the extra-hepatic bile ducts accompanied by increased neutrophil counts in the peripheral blood.
Slovenian: Poglavitni toksični učinek ceritiniba, ki so ga dajali podganam in opicam, je bilo vnetje ekstrahepatičnih žolčnih vodov ob povečani koncentraciji nevtrofilcev v periferni krvi.
English: Co-administration of ceritinib with strong CYP3A/P-gp inducers decreases ceritinib plasma concentrations.
Slovenian: Sočasno odmerjanje ceritiniba z močnimi induktorji CYP3A/P-gp znižuje koncentracijo ceritiniba v plazmi.
English: Patients should be monitored with liver laboratory tests (including ALT, AST and total bilirubin) prior to the start of treatment, every 2 weeks during the first three months of treatment and monthly thereafter.
Slovenian: Pri bolnikih je treba spremljati laboratorijske vrednosti jetrnih testov (vključno z vrednostmi ALT, AST in celokupnega bilirubina) pred začetkom zdravljenja, vsaka 2 tedna v prvih treh mesecih zdravljenja in nato enkrat mesečno.
English: Significant improvements were reported for the majority of lung cancer specific symptoms for Zykadia compared to chemotherapy (four out of six LCSS and 10 out of 12 QLQ-LC13 symptom scores).
Slovenian: Pri uporabi zdravila Zykadia so poročali o statistično značilnem izboljšanju večine značilnih simptomov pljučnega raka v primerjavi s kemoterapijo (pri štirih od šestih po ocenah na lestvici LCSS in 10 od 12 simptomov po vprašalniku QLQ-LC13).
English: A pharmacokinetic analysis suggested that ceritinib causes concentration-dependent increases in QTc (see section 4.4).
Slovenian: Rezultati farmakokinetične analize kažejo, da ceritinib povzroča od koncentracije odvisno podaljšanje intervala QTc (glejte poglavje 4.4).
English: Caution should be exercised when driving or using machines during treatment as patients may experience fatigue or vision disorders.
Slovenian: V času zdravljenja je pri vožnji in upravljanju s stroji potrebna previdnost, saj pri bolnikih lahko pride do utrujenosti in motenj vida.
English: If you cannot eat food while taking Zykadia, talk to your doctor.
Slovenian: Če v obdobju jemanja zdravila Zykadia ne morete uživati hrane, se posvetujte z zdravnikom.
English: The benefits and potential risks of ceritinib should be considered before beginning therapy in patients who have pre-existing bradycardia (heart rate less than 60 beats per minute [bpm]), patients who have a history of or predisposition for QTc prolongation, patients who are taking anti-arrhythmics or other medicinal products that are known to prolong the QT interval and patients with relevant pre-existing cardiac disease and/or electrolyte disturbances.
Slovenian: Pred začetkom zdravljenja je treba pretehtati koristi in potencialna tveganja zdravljenja s ceritinibom pri bolnikih, ki imajo že prisotno bradikardijo (s frekvenco manj kot 60 utripov na minuto), pri bolnikih, ki imajo podaljšanje intervala QTc v anamnezi ali so nagnjeni k podaljšanju intervala QTc, pri bolnikih, ki jemljejo antiaritmike ali druga zdravila, za katera je znano, da podaljšujejo interval QT, in pri bolnikih s pomembno že prisotno boleznijo srca ali neravnovesjem elektrolitov.
English: If you have questions about how long to take Zykadia, talk to your doctor or pharmacist.
Slovenian: Če vas zanima, kako dolgo je treba jemati zdravilo Zykadia, se obrnite na zdravnika ali farmacevta.
English: If adequate glucose control cannot be achieved with optimal medical management, permanently discontinue Zykadia.
Slovenian: Če z optimalnimi zdravstvenimi ukrepi glikemije ni mogoče ustrezno urediti, dokončno ukinite zdravljenje z zdravilom Zykadia.
English: Across seven clinical studies, 168 out of 925 patients (18.2%) treated with Zykadia were aged 65 years or older.
Slovenian: V sedmih kliničnih študijah je bilo med 925 bolniki, ki so prejemali zdravilo Zykadia, 168 (18,2 %) bolnikov starih 65 let ali več.
English: Your doctor should also perform blood tests to check the functioning of your pancreas and the level of sugar in your blood before you start treatment with Zykadia and regularly during treatment.
Slovenian: Poleg tega vas mora zdravnik napotiti na krvne preiskave za preverjanje delovanja trebušne slinavke in določanje ravni sladkorja v krvi, in sicer najprej pred začetkom zdravljenja, nato pa redno med zdravljenjem z zdravilom Zykadia.
English: Dose must be adjusted properly, i.e for patients treated with 450 mg or 300 mg with food, the dose should be increased to 750 mg or 450 mg taken on an empty stomach, respectively (see section 5.2) and for patients treated with 150 mg with food treatment should be discontinued.
Slovenian: Odmerek je treba ustrezno prilagoditi, in sicer je treba bolnikom, ki se zdravijo z odmerkom 450 mg s hrano, odmerek povečati na 750 mg na prazen želodec, bolnikom, ki se zdravijo z odmerkom 300 mg s hrano na odmerek 450 mg na prazen želodec (glejte poglavje 5.2), pri bolnikih, ki se zdravijo z odmerkom 150 mg s hrano pa je treba zdravljenje ukiniti.
English: There are no or limited amount of data from the use of ceritinib in pregnant women.
Slovenian: Podatkov o uporabi ceritiniba pri nosečnicah ni oziroma so omejeni.
English: The effect of hepatic impairment on the single-dose pharmacokinetics of ceritinib (750 mg under fasted conditions) was evaluated in subjects with mild (Child-Pugh class A; N=8), moderate (ChildPugh class B; N=7), or severe (Child-Pugh class C; N=7) hepatic impairment and in 8 healthy subjects with normal hepatic function.
Slovenian: Vpliv okvare jeter na farmakokinetiko enkratnega odmerka ceritiniba (750 mg na tešče) so ovrednotili pri preiskovancih z blago (Child-Pugh razreda A; N = 8), zmerno (Child-Pugh razreda B; N = 7) ali hudo okvaro jeter (Child-Pugh razreda C; N = 7) ter pri 8 zdravih preiskovancih z normalno jetrno funkcijo.
English: Patients who completed 4 cycles of chemotherapy (induction) without progressive disease subsequently received pemetrexed (500 mg/m2) as single-agent maintenance therapy every 21 days.
Slovenian: Bolniki, ki so zaključili 4 cikluse kemoterapije (indukcijsko zdravljenje) brez napredovanja bolezni, so nadaljevali zdravljenje s pemetreksedom kot samostojnim vzdrževalnim zdravljenjem z odmerjanjem 500 mg/m2 vsakih 21 dni.
English: Chemotherapy (N=187)
Slovenian: kemoterapija (N=187)
English: In patients with ALK defects, an abnormal protein is produced that stimulates the growth of the cancer cells.
Slovenian: Pri bolnikih z okvarjenim genom ALK nastaja nenormalen protein, ki spodbuja razmnoževanje rakavih celic.
English: Particular care should be exercised when administering ceritinib to patients with an increased risk of experiencing torsade de pointes during treatment with a QTc-prolonging medicinal product.
Slovenian: Posebna previdnost je potrebna pri dajanju ceritiniba bolnikom, pri katerih se med zdravljenjem s katerim od zdravil, ki podaljšujejo interval QTc, poveča tveganje za razvoj torsade de pointes.
English: 59.5% of patients with brain metastasis at baseline received no prior radiotherapy to the brain.
Slovenian: 59,5 % bolnikov z možganskimi metastazami predhodno ni bilo zdravljenih z obsevanjem možganov.
English: Zykadia blocks the action of this abnormal protein and thus slows down the growth and spread of NSCLC.
Slovenian: Zdravilo Zykadia zavira delovanje tega nenormalnega proteina in tako upočasni rast in širjenje nedrobnoceličnega pljučnega raka.
English: Daily oral dosing of ceritinib results in achievement of steady-state by approximately 15 days and remains stable afterwards, with a geometric mean accumulation ratio of 6.2 after 3 weeks of daily dosing.
Slovenian: Pri vsakodnevnem peroralnem odmerjanju ceritinib doseže stanje dinamičnega ravnovesja po približno 15 dneh in se nato stabilizira, po 3 tednih vsakodnevnega odmerjanja je geometrična srednja vrednost razmerja kopičenja 6,2.
English: General disorders and administration site conditions Fatigue m
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost m zelo pogosti
English: 93.3% had adenocarcinoma and 96.9% had either never been or were former smokers.
Slovenian: 93,3 % bolnikov je imelo adenokarcinom in 96,9 % bolnikov ni nikdar kadilo ali pa so bili nekdanji kadilci.
English: In contrast with single-dose data, pre-dose concentration (Cmin) after repeated daily dosing appeared to increase in a greater than dose-proportional manner.
Slovenian: Za razliko od podatkov pri odmerjanju enkratnega odmerka se je pri večkratnem odmerjanju enkrat dnevno pokazalo, da se najnižja koncentracija pred naslednjim odmerjanjem (Cmin) zviša bolj kot sorazmerno z odmerkom.
English: Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali da je bila že odprta.
English: Pack containing 84 film-coated tablets (4 blisters per pack).
Slovenian: Pakiranje vsebuje 84 filmsko obloženih tablet (4 pretisne omote v enem pakiranju).
English: Food/drink interactions
Slovenian: Medsebojno delovanje s hrano in pijačo
English: There is no reported experience with overdose in humans.
Slovenian: O izkušnjah s prevelikim odmerjanjem pri ljudeh ni poročil.
English: Mixed cell/neutrophilic inflammation of the extra-hepatic ducts extended to the pancreas and/or duodenum at higher doses.
Slovenian: Mešano celično/nevtrofilno vnetje ekstrahepatičnih žolčnih vodov se je pri višjih odmerkih razširilo na trebušno slinavko in/ali dvanajstnik.
English: Zykadia is a cancer medicine that contains the active substance ceritinib.
Slovenian: Zykadia je zdravilo proti raku, ki vsebuje učinkovino ceritinib.
English: The majority of patients were Caucasian (66.3%) or Asian (28.8%).
Slovenian: Bolniki so bili večinoma belci (66,3 %) ali predstavniki rumene rase (28,8 %).
English: In vitro studies demonstrated that CYP3A was the major enzyme involved in the metabolic clearance of ceritinib.
Slovenian: Študije in vitro so pokazale, da je CYP3A najpomembnejši encimski sistem, ki je vpleten v izločanje ceritiniba s presnovo.
English: Acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) can alter the solubility of ceritinib and reduce its bioavailability.
Slovenian: Zdravila za zmanjšanje izločanja oziroma nevtralizacijo kisline (na primer zaviralci protonske črpalke, antagonisti histaminskih receptorjev H2 in antacidi) lahko vplivajo na topnost ceritiniba in zmanjšajo njegovo biološko uporabnost.
English: Film-coating: hypromellose; titanium dioxide (E171); macrogol; talc; indigo carmine aluminium lake (E132).
Slovenian: Filmska obloga: hipromeloza; titanov dioksid (E171); makrogol; smukec; indigo karmin aluminijev lak (E132).
English: 150 (3 packs of 50) hard capsules.
Slovenian: 150 (3 pakiranja po 50) trdih kapsul
English: Study A2201 ceritinib 750 mg
Slovenian: študija X2101 ceritinib 750 mg študija A2201 ceritinib 750 mg
English: OUTER CARTON OF PACK (INCLUDING BLUE BOX) CONTAINING 150 (3 PACKS OF 50) HARD CAPSULES
Slovenian: ZUNANJA ŠKATLA PAKIRANJA (VKLJUČNO S PODATKI V MODREM OKENCU), KI VSEBUJE 150 (3 PAKIRANJA PO 50) TRDIH KAPSUL
English: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation >5 times upper limit of normal (ULN) with concurrent total bilirubin ≤2 times ULN
Slovenian: zvišanje vrednosti alanin-aminotransferaze (ALT) ali aspartat-aminotransferaze (AST) na >5-kratnik zgornje meje normalnih vrednosti (ZMN), če je sočasno vrednost celokupnega bilirubina ≤2-kratniku ZMN
English: Table 6 ALK-positive advanced NSCLC - overview of efficacy results from Studies X2101 and A2201
Slovenian: Preglednica 6 Bolniki z ALK-pozitivnim napredovalim nedrobnoceličnim pljučnim rakom - pregled rezultatov za oceno učinkovitosti iz študij X2101 in A2201
English: Women of childbearing potential should be advised to use a highly effective method of contraception while taking Zykadia and for up to 3 months after discontinuing treatment (see section 4.5).
Slovenian: Ženskam v rodni dobi je treba svetovati, naj v času zdravljenja in še 3 mesece po prekinitvi zdravljenja z zdravilom Zykadia uporabljajo zelo učinkovito kontracepcijsko metodo (glejte poglavje 4.5).
English: These may be signs or symptoms of liver problems.
Slovenian: To so lahko znaki ali simptomi težav z jetri.
English: If it is not possible to avoid concomitant use with strong CYP3A inhibitors (including, but not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole and nefazodone), reduce the ceritinib dose by approximately one third, rounded to the nearest multiple of the 150 mg dosage strength.
Slovenian: Če se ni mogoče izogniti sočasni uporabi z močnimi zaviralci CYP3A (med katerimi so med drugim ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol in nefazodon), znižajte odmerek ceritiniba za približno eno tretjino, tako da bo številčna vrednost zaokrožena na najbližji mnogokratnik odmerne jakosti 150 mg.
English: A total of 376 patients were randomised in a 1:1 ratio (stratified by WHO performance status, prior adjuvant/neoadjuvant chemotherapy and presence/absence of brain metastasis at screening) to receive either ceritinib (750 mg daily, fasted) or chemotherapy (based on investigator's choice - pemetrexed [500 mg/m2] plus cisplatin [75 mg/m2] or carboplatin [AUC 5-6], administered every 21 days).
Slovenian: Skupno so randomizirali 376 bolnikov v razmerju 1:1 (s stratifikacijo glede na status zmogljivosti po SZO, predhodno adjuvantno oziroma neoadjuvanto zdravljenje s kemoterapijo in prisotnost oziroma odsotnost možganskih metastaz v času presejanja) na prejemanje bodisi ceritiniba (750 mg na dan na tešče) ali kemoterapije (po izbiri raziskovalca - pemetreksed [500 mg/m2] s cisplatinom [75 mg/m2] ali karboplatin [AUC 5-6] z odmerjanjem vsakih 21 dni).
English: The population characteristics across the two arms were: mean age 53 years, age less than 65 (79%), female (57%), Caucasian (54%), Asian (33%), never or former smoker (95%), WHO PS 0 or 1 (93%), adenocarcinoma histology (94%), and metastases to the brain (33%).
Slovenian: V populaciji obeh študijskih skupin so zabeležili naslednje karakteristike: povprečna starost 53 let, starost manj kot 65 let (79 %), ženske (57 %), bela rasa (54 %), azijska rasa (33 %), nekadilci oziroma nekdanji kadilci (95 %), status zmogljivosti po SZO (WHO PS) 0 ali 1 (93 %), histološki izvid adenokarcinoma (94 %) in prisotnost možganskih metastaz (33 %).
English: If ceritinib is administered with medicinal products that inhibit P-gp, an increase in ceritinib concentration is likely.
Slovenian: Pri odmerjanju ceritiniba skupaj z zdravili, ki zavirajo P-gp, bo verjetno prišlo do zvišanja koncentracije ceritiniba.
English: 50 hard capsules.
Slovenian: 50 trdih kapsul.
English: Non-adenocarcinoma histology
Slovenian: Druge histološke oblike, ki niso adenokarcinom
English: Patients should not alternate between fasted and fed dosing.
Slovenian: Bolniki ne smejo izmenjevati režima odmerjanja med jemanjem na tešče in s hrano.
English: Ceritinib was demonstrated to be effective against EML4-ALK activity in a NSCLC cell line (H2228), resulting in inhibition of cell proliferation in vitro and regression of tumours in H2228-derived xenografts in mouse and rat.
Slovenian: Dokazali so, da ceritinib učinkovito zavira aktivnost EML4-ALK v celičnih linijah nedrobnoceličnega pljučnega raka (H2228), kar in vitro omogoča zaviranje celične proliferacije in pri miših in podganah povzroči regresijo heterolognih tumorskih presadkov, pridobljenih iz celične linije H2228.
English: Adverse drug reactions (ADRs) described below reflect exposure to Zykadia 750 mg once daily fasted in 925 patients with ALK-positive advanced NSCLC across a pool of seven clinical studies including two randomised, active-controlled, phase 3 studies (studies A2301 and A2303).
Slovenian: Spodaj navedeni neželeni učinki odražajo izpostavljenost zdravilu Zykadia pri odmerjanju 750 mg enkrat na dan na tešče pri 925 bolnikih, ki so imeli ALK-pozitivnega napredovalega nedrobnoceličnega pljučnega raka, po podatkih, združenih iz sedmih kliničnih študij, med katerimi sta dve randomizirani, aktivno kontrolirani študiji faze 3 (študiji A2301 in A2303).
English: After discontinuation of a strong CYP3A inhibitor, resume at the dose that was taken prior to initiating the strong CYP3A inhibitor.
Slovenian: Po ukinitvi močnega zaviralca CYP3A naj bolnik ponovno začne z jemanjem odmerka, ki ga je jemal pred uvedbo močnega zaviralca CYP3A.
English: Ceritinib has been classified in vivo as a weak CYP2C9 inhibitor.
Slovenian: Ceritinib so in vivo uvrstili med šibke zaviralce CYP2C9.
English: No patients required dose reduction or discontinuation of Zykadia due to diarrhoea, nausea or vomiting (see section 4.8).
Slovenian: Pri nobenem od bolnikov ni bilo treba znižati odmerka ali dokončno ukiniti zdravila Zykadia zaradi diareje, navzee ali bruhanja (glejte poglavje 4.8).
English: If a dose is missed, the patient should make up that dose, unless the next dose is due within 12 hours.
Slovenian: Če bolnik pozabi vzeti odmerek, naj to nadomesti tako, da ga vzame kasneje, razen v primeru, da je do naslednjega odmerka manj kot 12 ur.
English: Patients who develop symptomatic bradycardia should be managed as recommended in sections 4.2 and 4.4.
Slovenian: Pri bolnikih, pri katerih se razvije simptomatska bradikardija, je treba ukrepati v skladu s priporočili v poglavjih 4.2 in 4.4.
English: Renal failure (acute renal injury, renal failure)
Slovenian: k odpoved ledvic (akutna poškodba ledvic, odpoved ledvic)
English: Complete Response (CR), Partial Response (PR) confirmed by repeat assessments performed not less than 4 weeks after response criteria were first met Overall response rate determined based on BIRC assessment per RECIST 1.1 Exact binomial 95% confidence interval
Slovenian: IZ: interval zaupanja popolni odziv (complete response, CR) oziroma delni odziv (partial response, PR) potrjen s ponovnim pregledom, ki so ga opravili najmanj 4 tedne po pregledu, pri katerem je bolnik prvič dosegel kriterije, ki opredeljujejo odziv celokupna stopnja odziva po presoji odbora BIRC v skladu s kriteriji RECIST 1.1
English: Vision disorder (vision impairment, vision blurred, photopsia, vitreous floaters, visual acuity reduced, accommodation disorder, presbyopia)
Slovenian: a motnje vida (okvara vida, zamegljen vid, fotopsija, delci v steklovini, zmanjšanje ostrine vida, motnje akomodacije, presbiopija)
English: Interstitial lung disease/Pneumonitis
Slovenian: Intersticijska pljučna bolezen/pnevmonitis
English: OS data was immature with 48 (41.7%) events in the ceritinib arm and 50 (43.1%) events in the chemotherapy arm, corresponding to approximately 50% of the required events for the final OS analysis.
Slovenian: Podatki o OS še niso bili zreli: 48 dogodkov (41,7 %) v skupini s ceritinibom in 50 dogodkov (43,1 %) v skupini s kemoterapijo je predstavljalo približno 50 % dogodkov, ki so potrebni za končno analizo celokupnega preživetja (OS).
English: Zykadia is only given to patients whose disease is due to a defect in a gene called ALK (anaplastic lymphoma kinase).
Slovenian: Zdravilo Zykadia prejemajo samo tisti bolniki, pri katerih do bolezni pride zaradi okvare gena, ki ga imenujemo gen ALK (gen za anaplastično limfomsko kinazo).
English: Zykadia should not be used during breast-feeding.
Slovenian: Zdravila Zykadia ne smete uporabljati v času dojenja.