FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety pharmacology studies indicate that ceritinib is unlikely to interfere with vital functions of the respiratory and central nervous systems.
Slovenian: Študije farmakološke varnosti kažejo, da ni verjetno, da bi ceritinib vplival na vitalne funkcije dihal in centralnega živčevja.
English: QT corrected for heart rate (QTc) >500 msec on at least 2 separate electrocardiograms (ECGs)
Slovenian: trajanje intervala QT s korekcijo glede na srčno frekvenco (QTc) >500 ms na najmanj dveh ločenih elektrokardiogramih (EKG posnetkih)
English: The EQ-5D questionnaire showed a significant overall health status improvement for Zykadia in comparison to the chemotherapy.
Slovenian: Rezultati vprašalnika EQ-5D so pokazali statistično značilno boljše splošno zdravstveno stanje z zdravilom Zykadia v primerjavi s kemoterapijo.
English: Other factors apart from study treatment could have impacted on observed events of hepatic encephalopathy, however, the relation between study treatment and events cannot be fully ruled out.
Slovenian: Na razvoj hepatične encefalopatije, ki so jo opažali, bi lahko poleg študijskega zdravljenja vplivali tudi drugi dejavniki, vendar ni mogoče povsem izključiti povezave med študijskim zdravilom in temi dogodki.
English: Lipase and/or amylase elevations
Slovenian: Zvišanje vrednosti lipaze in/ali amilaze
English: HR=hazard ratio; CI=confidence interval; BIRC=Blinded Independent Review Committee; NE=not estimable a
Slovenian: HR=razmerje ogroženosti (hazard ratio); IZ=interval zaupanja; odbor BIRC=neodvisen odbor za pregled rezultatov slepega zdravljenja (Blinded Independent Review Committee); NE=vrednosti ni mogoče oceniti (not estimable);
English: The majority of cases were manageable with dose interruption and/or dose reduction.
Slovenian: V večini primerov je bilo težave mogoče odpraviti z začasno prekinitvijo zdravljenja in/ali znižanjem odmerka.
English: One hundred fifteen (115) patients were randomised to Zykadia and one hundred sixteen (116) were randomised to chemotherapy (either pemetrexed or docetaxel).
Slovenian: Sto petnajst (115) bolnikov so randomizirali na prejemanje zdravila Zykadia, sto šestnajst (116) pa na prejemanje kemoterapije (bodisi pemetrekseda ali docetaksela).
English: It is unknown whether ceritinib/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se ceritinib/presnovki izločajo v materino mleko.
English: Addition of a thiol group to O-dealkylated ceritinib was also observed.
Slovenian: Opazili so tudi dodatek tiolne skupine na O-dealkiliran ceritinib.
English: The tablets are provided in blisters and are available in a pack containing 84 tablets (4 blisters of 21 tablets).
Slovenian: Tablete so pakirane v pretisnih omotih in so na voljo v pakiranju, ki vsebuje 84 tablet (4 pretisne omote po 21 tablet).
English: Population pharmacokinetic analyses showed that age, gender and race had no clinically meaningful influence on ceritinib exposure.
Slovenian: Po podatkih populacijske farmakokinetične analize starost, spol in rasna pripadnost nimajo klinično pomembnega vpliva na izpostavljenost ceritinibu.
English: Patients were allowed to continue the assigned study treatment beyond initial progression in case of continued clinical benefit as per the investigator's opinion.
Slovenian: Bolnikom so dovolili, da so nadaljevali zdravljenje z dodeljenimi študijskimi zdravili tudi po začetnem napredovanju bolezni, če jim je zdravljenje še naprej klinično koristilo po presoji raziskovalca.
English: If you have any questions contact your doctor right away.
Slovenian: Če imate glede tega kakršnakoli vprašanja, se takoj posvetujte z zdravnikom.
English: The median duration of follow-up was 19.7 months (from randomisation to cut-off date).
Slovenian: Mediano trajanje spremljanja je bilo 19,7 meseca (od randomizacije do presečnega datuma).
English: What you need to know before you take Zykadia
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zykadia
English: Children and adolescents The use of Zykadia in children and adolescents up to 18 years of age is not recommended.
Slovenian: Otroci in mladostniki Uporabe zdravila Zykadia se ne priporoča pri otrocih in mladostnikih, ki so stari manj kot 18 let.
English: Hepatotoxicity events were managed with dose interruptions or reductions in 40.6% of patients.
Slovenian: Primere hepatotoksičnosti so obvladali s prekinitvijo odmerjanja ali znižanjem odmerka pri 40,6 % bolnikov.
English: Seven patients (7.9%) required study drug interruption due to diarrhoea or nausea.
Slovenian: Sedmim bolnikom (7,9 %) je bilo treba zaradi diareje ali navzee začasno prekiniti odmerjanje študijskega zdravila.
English: No patients had diarrhoea, nausea, or vomiting that required dose reduction or discontinuation of study drug.
Slovenian: Pri nobenem od bolnikov ni prišlo do diareje, navzee ali bruhanja, zaradi katerih bi bilo treba znižati odmerek ali dokončno ukiniti študijsko zdravilo.
English: Elderly (≥65 years)
Slovenian: Starejši bolniki (stari 65 let ali več)
English: Number of events, n (%) Median, months d
Slovenian: c število dogodkov, n (%) mediana, meseci d
English: Zykadia should not be used during pregnancy unless the clinical condition of the woman requires treatment with ceritinib.
Slovenian: Zdravila Zykadia ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje s ceritinibom.
English: Caution should be used in patients with severe renal impairment, as there is no experience with ceritinib in this population (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic je potrebna previdnost, saj pri tej populaciji ni izkušenj z uporabo ceritiniba (glejte poglavje 5.2).
English: The median duration of follow-up was 16.5 months (from randomisation to data cut-off date).
Slovenian: Mediano trajanje spremljanja je bilo 16,5 meseca (od randomizacije do presečnega datuma).
English: ADRs are listed according to MedDRA system organ class.
Slovenian: Neželeni učinki so navedeni po organskih sistemih klasifikacije MedDRA.
English: Main biotransformation pathways identified in healthy subjects included mono-oxygenation, O-dealkylation, and N-formylation.
Slovenian: Najpomembnejše poti biotransformacije, ki so jih ugotovili pri zdravih osebah, so bile monooksigenacija, O-dealkilacija in N-formilacija.
English: Lipase or amylase elevation grade ≥3
Slovenian: zvišanje vrednosti lipaze ali amilaze stopnje ≥3
English: Dose adjustment due to adverse reactions
Slovenian: Prilagajanje odmerka zaradi neželenih učinkov
English: Other medicines and Zykadia
Slovenian: Druga zdravila in zdravilo Zykadia
English: In the event of vomiting, diarrhoea, dehydration or impaired renal function, correct electrolytes as clinically indicated.
Slovenian: V primeru bruhanja, diareje, dehidracije ali zmanjšane ledvične funkcije je treba koncentracije elektrolitov korigirati v skladu s kliničnimi indikacijami.
English: Chemotherapy (N=116)
Slovenian: kemoterapija (N=116)
English: The potential for QT interval prolongation of ceritinib was assessed in seven clinical studies with Zykadia.
Slovenian: Potencial ceritiniba za podaljševanje intervala QT so ocenjevali v sedmih kliničnih študijah zdravila Zykadia.
English: If long-term concomitant treatment with a strong CYP3A inhibitor is necessary and the patient tolerates the reduced dose well, the dose may be increased again with careful monitoring for safety, to avoid potential under-treatment.
Slovenian: Če je potrebno dolgotrajno sočasno zdravljenje z močnim zaviralcem CYP3A in bolnik znižan odmerek dobro prenaša, lahko, ob skrbnem spremljanju bolnika glede varnosti, odmerek znova zvišate in se tako izognete morebitnemu nezadostnemu zdravljenju.
English: The maximum allowable dose under fasted condition is 750 mg (see section 5.2).
Slovenian: Največji dovoljeni odmerek pri odmerjanju na tešče je 750 mg (glejte poglavje 5.2).
English: You should also tell your doctor if you are already taking Zykadia and you are prescribed a new medicine that you have not already taken at the same time as Zykadia.
Slovenian: Zdravnika morate obvestiti tudi v primeru, da jemljete zdravilo Zykadia in vam dodatno predpišejo novo zdravilo, ki ga še niste jemali sočasno z zdravilom Zykadia.
English: As these non-clinical effects were mild, variable and inconsistent, the relationship between ceritinib and thyroid gland changes in animals is unclear.
Slovenian: Navedeni neklinični učinki so bili blagi, variabilni in nekonsistentni, zato povezanost ceritiniba s spremembami v ščitnici pri živalih ni povsem jasna.
English: If you have any questions about how Zykadia works or why this medicine has been prescribed for you, ask your doctor or pharmacist.
Slovenian: Če imate kakršnokoli vprašanje o tem, kako zdravilo Zykadia deluje ali zakaj vam je zdravnik predpisal to zdravilo, se obrnite na zdravnika ali farmacevta.
English: A total of 11 metabolites were found circulating in plasma at low levels with mean contribution to the radioactivity AUC of ≤2.3% for each metabolite.
Slovenian: V plazmi so našli še skupno 11 presnovkov v nizkih koncentracijah, pri čemer je povprečen prispevek k celotni AUC radioaktivnosti za vsakega od njih znašal ≤2,3 %.
English: For subsequent dose adjustment and management recommendations for ADRs, please follow table 1 (see section 4.2).
Slovenian: Glede naknadnega prilagajanja odmerka in priporočil za obvladovanje neželenih učinkov prosimo glejte preglednico 1 (glejte poglavje 4.2).
English: One patient (1.1%) experienced grade 3 diarrhoea.
Slovenian: Pri enem bolniku (1,1 %) je prišlo do diareje stopnje 3.
English: Zykadia should be taken with food.
Slovenian: Zdravilo Zykadia je treba jemati skupaj s hrano.
English: A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Zykadia therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman (see section 5.3).
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Zykadia, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater (glejte poglavje 5.3).
English: Event-free probability estimate at 9 months d
Slovenian: ocena verjetnosti za odsotnost dogodkov v 9 mesecih d
English: If vomiting occurs during the course of treatment, the patient should not take an additional dose, but should continue with the next scheduled dose.
Slovenian: Če med zdravljenjem pride do bruhanja, naj bolnik ne vzame dodatnega odmerka, ampak naj nadaljuje z naslednjim odmerkom po razporedu.
English: These may be signs or symptoms of heart problems.
Slovenian: To so lahko znaki ali simptomi težav s srcem.
English: The limited data on the safety and efficacy of ceritinib in patients aged 65 years and older do not suggest that a dose adjustment is required in elderly patients (see section 5.2).
Slovenian: Majhno število podatkov o varnosti in učinkovitosti ceritiniba pri bolnikih, ki so stari 65 let ali več, ne kaže, da bi bilo treba pri starejših bolnikih prilagajati odmerjanje zdravila (glejte poglavje 5.2).
English: Carcinogenicity studies have not been performed with ceritinib.
Slovenian: Študij kancerogenosti s ceritinibom niso izvedli.
English: The PFS benefit was further supported by local investigator assessment, and analysis of overall response rate (ORR) and disease control rate (DCR).
Slovenian: Izboljšanje PFS so potrdili tudi raziskovalci na študijskih centrih ter rezultati analize celokupne stopnje odziva (overall response rate, ORR) in deleža bolnikov z obvladano boleznijo (disease control rate, DCR).
English: A grade 3 event of diarrhoea was reported in one patient (1.1%).
Slovenian: O diareji stopnje 3 so poročali pri enem bolniku (1,1 %).
English: Seventy-three (73) patients received docetaxel and 40 received pemetrexed.
Slovenian: Triinsedemdeset (73) bolnikov je prejemalo docetaksel, 40 pa jih je prejemalo pemetreksed.
English: Based on available data, ceritinib is eliminated primarily via the liver.
Slovenian: Po podatkih, ki so na voljo, se ceritinib izloča predvsem preko jeter.
English: Gastrointestinal events were managed primarily with concomitant medicinal products including anti-emetic/anti-diarrhoeal medicinal products.
Slovenian: Gastrointestinalne težave so večinoma zdravili s sočasnim dajanjem drugih zdravil, med katerimi so bili antiemetiki oziroma antidiaroiki.
English: The capsules are provided in blisters and are available in packs containing 40, 90 or 150 (3 packs of 50) capsules.
Slovenian: Kapsule so pakirane v pretisnih omotih in so na voljo v pakiranjih, ki vsebujejo 40, 90 ali 150 (3 pakiranja po 50) kapsul.
English: The capsules should be swallowed whole with water and should not be chewed or crushed.
Slovenian: Kapsule je treba pogoltniti cele, z vodo, ne sme se jih zgristi ali zdrobiti.
English: For patients who develop a concurrent medical condition and are unable to take Zykadia with food, Zykadia can be taken on an empty stomach as the alternate continued treatment regimen, in which no food should be eaten for at least two hours before and one hour after the dose.
Slovenian: Bolniki, pri katerih se razvije sočasno obolenje in ne morejo jemati zdravila Zykadia s hrano, lahko zdravilo Zykadia jemljejo na prazen želodec kot alternativni stalni režim zdravljenja, pri katerem bolnik ne sme zaužiti hrane najmanj dve uri pred in eno uro po odmerku.
English: Oral absorption was estimated to be ≥25% based on metabolite percentages in the faeces.
Slovenian: Ocenjena absorpcija po peroralnem odmerjanju je ≥25 % na osnovi odstotkov presnovkov v blatu.
English: ECG studies in monkeys after 4- or 13-weeks of dosing with ceritinib have not shown QT prolongation or abnormal ECGs.
Slovenian: V EKG študiji na opicah po 4 oziroma 13 tednih odmerjanja ceritiniba ni prišlo do podaljšanja intervala QT ali do drugih EKG nepravilnosti.
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blister containing 21 film-coated tablets.
Slovenian: Pretisni omot iz PVC/PCTFE (polivinilklorida/poliklorotrifluoroetilena) - aluminija, ki vsebuje 21 filmsko obloženih tablet.
English: You should not eat grapefruit or drink grapefruit juice during treatment.
Slovenian: V času zdravljenja ne smete uživati grenivk ali grenivkinega soka.
English: However, the risk for a clinically relevant decrease in bioavailability of ceritinib is possibly lower with concomitant use of H2 blockers if they are administered 10 hours before or 2 hours after the ceritinib dose, and with antacids if they are administered 2 hours before or 2 hours after the ceritinib dose.
Slovenian: Je pa tveganje za klinično pomembno zmanjšanje biološke razpoložljivosti ceritiniba ob sočasni uporabi antagonistov histaminskih receptorjev H2 verjetno manjše, če se jih vzame 10 ur pred ali 2 uri po odmerku ceritiniba, in v primeru antacidov, če se jih vzame 2 uri pred ali 2 uri po odmerku ceritiniba.
English: Patient reported outcome questionnaires were collected using the EORTC QLQ C30/LC13, LCSS and EQ-5D-5L.
Slovenian: Bolniki so izide poročali s pomočjo vprašalnikov EORTC QLQ C30/LC13, LCSS in EQ-5D-5L.
English: Not all pack sizes may be marketed in your country.
Slovenian: V vaši državi morda ni na voljo vseh navedenih pakiranj.
English: In patients treated with Zykadia 450 mg with food, 10% of patients had an adverse event that required at least one dose reduction and 42% of patients had an adverse event that required at least one dose interruption.
Slovenian: Izmed bolnikov, ki so prejemali zdravilo Zykadia v odmerku 450 mg skupaj s hrano, je pri 10 % prišlo do neželenega dogodka, zaradi katerega je bolnik potreboval najmanj eno znižanje odmerka, pri 42 % bolnikov pa je prišlo do neželenega dogodka, zaradi katerega je bolnik potreboval najmanj eno začasno prekinitev odmerjanja.
English: Talk to your doctor about the birth control methods that may be right for you.
Slovenian: Z zdravnikom se pogovorite, katere kontracepcijske metode bi bile primerne za vas.
English: An in vivo telemetry study in monkeys showed a modest QT prolongation in 1 of 4 animals after receiving the highest dose of ceritinib.
Slovenian: Rezultati in vivo telemetrične študije na opicah so pokazali manjše podaljšanje intervala QT pri 1 od 4 živali po prejemu najvišjega odmerka ceritiniba.
English: The study met its primary objective demonstrating a statistically significant improvement in progression free survival (PFS) by BIRC (see Table 3 and Figure 1).
Slovenian: Študija je dosegla svoj primarni cilj, saj so dokazali statistično značilno izboljšanje preživetja brez napredovanja bolezni (progression free survival, PFS) po presoji odbora BIRC (glejte preglednico 3 in sliko 1).
English: Log rank p-value = <0.001
Slovenian: vrednost p za log-rank =<0,001
English: One hundred and eighty-nine (189) patients were randomised to ceritinib and one hundred eightyseven (187) were randomised to chemotherapy.
Slovenian: Sto devetinosemdeset (189) bolnikov so randomizirali na prejemanje ceritiniba, sto sedeminosemdeset (187) pa na prejemanje kemoterapije.
English: In rats, ceritinib crosses the intact blood brain barrier with a brain-to-blood exposure (AUCinf) ratio of about 15%.
Slovenian: Pri podganah ceritinib prehaja intaktno krvno-možgansko pregrado z razmerjem izpostavljenosti v možganih proti izpostavljenosti v krvi (AUCinf) približno 15 %.
English: Formal non-clinical studies on the potential effects of ceritinib on fertility have not been conducted.
Slovenian: Formalnih predkliničnih študij možnih vplivov ceritiniba na plodnost niso izvedli.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Zykadia in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Zykadia za vse podskupine pediatrične populacije s pljučnim rakom (z drobnoceličnim ali nedrobnoceličnim rakom) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Persistent hyperglycaemia greater than 250 mg/dl despite optimal anti-hyperglycaemic therapy
Slovenian: vztrajna hiperglikemija z vrednostmi glukoze, ki presegajo 250 mg/dl kljub optimalnemu zdravljenju za odpravljanje hiperglikemije
English: Your doctor may need to adjust your treatment or stop Zykadia temporarily or permanently.
Slovenian: Zdravnik bo morda moral prilagoditi odmerjanje zdravila Zykadia ali pa zdravljenje z njim začasno prekiniti ali dokončno ukiniti.
English: The drug-drug interaction study was designed to observe the impact of proton pump inhibitor in the worst scenario, but in clinical use the impact of proton pump inhibitor on ceritinib exposure appears to be less pronounced.
Slovenian: Študija medsebojnega delovanja zdravil je bila oblikovana tako, da pokaže vpliv zaviralcev protonske črpalke v najslabšem možnem primeru, kaže pa, da je v klinični praksi vpliv zaviralcev protonske črpalke na izpostavljenost ceritinibu manj izrazit.
English: The median duration of exposure to Zykadia 750 mg fasted was 44.9 weeks (range: 0.1 to 200.1 weeks).
Slovenian: Mediano trajanje izpostavljenosti zdravilu Zykadia pri odmerjanju 750 mg na tešče je bilo 44,9 tedna (v razponu od 0,1 do 200,1 tedna).
English: If you stop taking Zykadia
Slovenian: Če ste prenehali jemati zdravilo Zykadia
English: The tablets should be swallowed whole with water and should not be chewed or crushed.
Slovenian: Tablete je treba pogoltniti cele, z vodo, ne sme se jih zgristi ali zdrobiti.
English: Early identification and management of ADRs with standard supportive care measures should be considered.
Slovenian: Razmisliti je treba o možnosti zgodnjega odkrivanja in obvladovanja neželenih učinkov z običajnimi ukrepi podpornega zdravljenja.
English: Binding of ceritinib to human plasma proteins in vitro is approximately 97% in a concentration independent manner, from 50 ng/ml to 10,000 ng/ml.
Slovenian: Delež vezave ceritiniba na beljakovine v plazmi in vitro znaša približno 97 % in je neodvisen od koncentracije ceritiniba v razponu od 50 ng/ml do 10.000 ng/ml.
English: Few events required discontinuation of treatment.
Slovenian: V nekaj primerih je bilo treba zdravljenje ukiniti.
English: The risk of hyperglycaemia was higher in patients with diabetes mellitus and/or concurrent steroid use.
Slovenian: Tveganje za hiperglikemijo je bilo večje pri bolnikih, ki so imeli sladkorno bolezen in/ali so sočasno uporabljali steroide.
English: The effectiveness of concomitant administration of oral contraceptives may be reduced.
Slovenian: Pri sočasni uporabi se lahko zmanjša učinkovitost peroralnih kontraceptivov.
English: The absolute bioavailability of ceritinib has not been determined.
Slovenian: Absolutna biološka uporabnost ceritiniba ni ugotovljena.
English: Time-dependent inhibition of CYP3A was also observed.
Slovenian: Opažali so tudi časovno odvisno zaviranje CYP3A.
English: Oral contraceptives If you take Zykadia whilst using oral contraceptives, the oral contraceptives may become ineffective.
Slovenian: Če jemljete zdravilo Zykadia v obdobju, ko uporabljate peroralne kontraceptive, lahko ti postanejo neučinkoviti.
English: A key secondary efficacy endpoint was ORR according to RECIST 1.1 as evaluated by BIRC.
Slovenian: Ključni sekundarni cilj opazovanja za oceno učinkovitosti je bila celokupna stopnja odziva (ORR) v skladu s kriteriji RECIST 1.1 po presoji odbora BIRC.
English: 64.5% of the study population were Caucasian, 29.4% Asian, 0.4% Black and 2.6% other races.
Slovenian: 64,5 % študijske populacije je bilo belcev, 29,4 % je bilo pripadnikov rumene rase, 0,4 % pripadnikov črne rase in 2,6 % pripadnikov drugih ras.
English: Log rank p-value = 0.496
Slovenian: vrednost p za log-rank = 0,496
English: Treatment with ceritinib is not recommended in patients who have congenital long QT syndrome or who are taking medicinal products known to prolong the QTc interval (see sections 4.4 and 4.5).
Slovenian: Zdravljenje s ceritinibom ni priporočeno pri bolnikih s prirojenim sindromom dolgega intervala QT in pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšujejo interval QTc (glejte poglavji 4.4 in 4.5).
English: For patients who develop a concurrent medical condition and are unable to take Zykadia with food please refer to section 4.5.
Slovenian: Za uporabo pri bolnikih, pri katerih se razvije sočasno obolenje in ne morejo jemati zdravila Zykadia s hrano, prosimo glejte poglavje 4.5.
English: Patients should be monitored and managed using standards of care, including anti-diarrhoeals, anti-emetics or fluid replacement, as clinically indicated.
Slovenian: Bolnike je treba spremljati in jih ustrezno zdraviti z običajnimi zdravstvenimi ukrepi, ki vključujejo zdravljenje z antidiaroiki, antiemetiki in nadomeščanje tekočin v skladu s kliničnimi indikacijami.
English: Patient reported outcome questionnaires (Lung cancer symptom scale [LCSS], EORTC-QLQ-C30 [C30], EORTC QLQ-LC13 [LC13] and EQ-5D-5L) were completed by 80% or more of patients in the ceritinib and chemotherapy arms for all questionnaires at most of the time-points during the course of the study.
Slovenian: Vprašalnike za poročanje izidov s strani bolnikov (vprašalnike Lung cancer symptom Scale [LCSS], EORTC-QLQ-C30 [C30], EORTC QLQ-LC13 [LC13] in EQ-5D-5L) je izpolnilo 80 % ali več bolnikov v skupini s ceritinibom in skupini s kemoterapijo, kar velja za vse vprašalnike pri večini terminov izpolnjevanja v poteku študije.
English: The study met its primary objective demonstrating a statistically significant improvement in PFS by BIRC with an estimated 51% risk reduction in the ceritinib arm compared to chemotherapy arm (see Table 4 and Figure 3).
Slovenian: Študija je dosegla svoj primarni cilj, saj so dokazali statistično značilno izboljšanje PFS po presoji odbora BIRC z ocenjenim 51-odstotnim zmanjšanjem tveganja v skupini s ceritinibom v primerjavi s skupino s kemoterapijo (glejte preglednico 4 in sliko 3).