FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study A2303, 133 patients with baseline brain metastasis (66 patients in the Zykadia arm and 67 patients in the chemotherapy arm) were assessed for intracranial response by BIRC neuroradiologist (per modified RECIST 1.1 (i.e. up to 5 lesions in the brain).
Croatian: Ispitivanju A2303, u 133 bolesnika s metastazama na mozgu na početku ispitivanja (66 bolesnika u Zykadia skupini i 67 bolesnika u kemoterapijskoj skupini) BIRC-ov neuroradiolog ocijenio je intrakranijalni odgovor prema modificiranim kriterijima RECIST 1.1 (tj. do 5 lezija na mozgu).
English: Cases of hyperglycaemia (all grades) have been reported in less than 10% of patients treated with ceritinib in clinical studies; grade 3-4 hyperglycaemia was reported in 5.4% of patients.
Croatian: Slučajevi hiperglikemije (svih stupnjeva) prijavljeni su u manje od 10% bolesnika liječenih ceritinibom u kliničkim ispitivanjima; hiperglikemija stupnja 3-4 prijavljena je u 5,4% bolesnika.
English: Printing ink: Shellac (bleached, de-waxed) glaze 45%, iron oxide black (E172), propylene glycol and ammonium hydroxide 28%.
Croatian: Tinta za označavanje: šelak (izbijeljen, bez voska) glazura 45%, crni željezov oksid (E172), propilenglikol i amonijev hidroksid 28%.
English: In contrast, the steady-state AUC (90% CI) and Cmax (90% CI) for the 600 mg with food arm (N=30) increased by 24% (3%, 49%) and 25% (4%, 49%), respectively, compared to the 750 mg fasted arm.
Croatian: Nasuprot tome, AUC u stanju dinamičke ravnoteže (90% CI) za skupinu koja je primala 600 mg uz hranu (N=30) povećan je za 24% (3%, 49%), a Cmax (90% CI) za 25% (4%, 49%), u usporedbi sa skupinom koja je primala 750 mg natašte.
English: Mixed cell/neutrophilic inflammation of the extra-hepatic ducts extended to the pancreas and/or duodenum at higher doses.
Croatian: Miješana/neutrofilna upala ekstrahepatičkih žučnih vodova proširila se na gušteraču i/ili dvanaesnik pri višim dozama.
English: After discontinuation of a strong CYP3A inhibitor, resume at the dose that was taken prior to initiating the strong CYP3A inhibitor.
Croatian: Nakon prekida primjene snažnog CYP3A inhibitora nastavlja se s dozom koja se primjenjivala prije uvođenja snažnog CYP3A inhibitora.
English: Efficacy data from Study A2303 are summarised in Table 4, and the Kaplan-Meier curves for PFS and OS are shown in Figure 3 and 4, respectively.
Croatian: Podaci o djelotvornosti iz Ispitivanja A2303 sažeti su u Tablici 4, a Kaplan-Meierove krivulje za PFS i OS prikazane su na Slici 3, odnosno 4.
English: Patients randomised to the chemotherapy arm could further crossover to receive Zykadia upon RECIST-defined disease progression confirmed by BIRC.
Croatian: Bolesnici randomizirani u skupinu koja prima kemoterapiju mogli su prijeći na Zykadiu nakon što je BIRC potvrdio progresiju bolesti prema definiciji RECIST-a.
English: 40 hard capsules 90 hard capsules
Croatian: 40 tvrdih kapsula 90 tvrdih kapsula
English: Across the seven clinical studies, bradycardia and/or sinus bradycardia (heart rate less than 60 bpm) events (all grade 1) were reported in 2.3% of patients.
Croatian: U sedam kliničkih ispitivanja, događaji (svi stupnja 1) bradikardije i/ili sinusne bradikardije (srčane frekvencije niže od 60 otkucaja u minuti) bili su prijavljeni u 2,3% bolesnika.
English: Patients randomised to the chemotherapy arm could cross-over to receive ceritinib upon RECIST-defined disease progression confirmed by blinded independent review committee (BIRC).
Croatian: Bolesnici randomizirani u skupinu koja prima kemoterapiju mogli su prijeći na ceritinib nakon što je odbor za slijepo neovisno ocjenjivanje (BIRC) potvrdio progresiju bolesti prema definiciji RECIST-a.
English: 50 hard capsules.
Croatian: 50 tvrdih kapsula.
English: Increasing the frequency of international normalised ratio (INR) monitoring may be considered if co-administration with warfarin is unavoidable.
Croatian: Ako je istodobna primjena s varfarinom neizbježna, može se razmotriti povećanje učestalosti praćenja međunarodnog normaliziranog omjera (INR).
English: OS analysis was not adjusted for the effects of cross-over.
Croatian: Analiza OS-a nije bila prilagođena za učinke prijelaza na drugu terapiju.
English: Oesophageal disorder (dyspepsia, gastro-oesophageal reflux disease, dysphagia)
Croatian: Poremećaj jednjaka (dispepsija, gastroezofagealna refluksna bolest, disfagija)
English: Respiratory, thoracic and mediastinal disorders Pneumonitis d
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Pneumonitis d
English: Concomitant use of strong CYP3A inducers should be avoided; this includes, but is not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum).
Croatian: Istodobnu primjenu snažnih CYP3A induktora treba izbjegavati; to uključuje, između ostalih, karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin i gospinu travu (Hypericum perforatum).
English: If you accidentally take too many capsules, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
Croatian: Ako slučajno uzmete previše kapsula, ili ako netko slučajno uzme
English: ADRs with an incidence of ≥10% in patients treated with Zykadia 750 mg fasted were diarrhoea, nausea, vomiting, fatigue, liver laboratory test abnormalities, abdominal pain, decreased appetite, weight decreased, constipation, blood creatinine increased, rash, anaemia and oesophageal disorder.
Croatian: Nuspojave s incidencijom ≥10% u bolesnika liječenih Zykadiom od 750 mg natašte bile su proljev, mučnina, povraćanje, umor, abnormalnosti na laboratorijskim pretragama jetre, bol u abdomenu, smanjeni apetit, smanjena tjelesna težina, konstipacija, povišeni kreatinin u krvi, osip, anemija i poremećaj funkcije jednjaka.
English: - If your next dose is in 12 hours or more, take the missed tablets as soon as you remember.
Croatian: Ako sljedeću dozu morate uzeti za 12 ili više sati, uzmite propuštene tablete čim se sjetite.
English: Avoid concomitant use of strong CYP3A inhibitors during treatment with Zykadia.
Croatian: Potrebno je izbjegavati istodobnu primjenu snažnih CYP3A inhibitora tijekom liječenja Zykadiom.
English: Ceritinib 750 mg fasted (N=40)
Croatian: Ceritinib 750 mg natašte (N=40)
English: Efficacy data from Study A2301 are summarised in Table 3, and the Kaplan-Meier curves for PFS and OS are shown in Figure 1 and Figure 2, respectively.
Croatian: Podaci o djelotvornosti iz ispitivanja A2301 sažeti su u Tablici 3, a Kaplan-Meierove krivulje za PFS i OS prikazane su na Slici 1, odnosno Slici 2.
English: OS analysis was not adjusted for the potentially confounding effects of cross over.
Croatian: Analiza OS-a nije bila prilagođena za potencijalno zbunjujuće učinke prijelaza na drugu terapiju.
English: Recovery of unchanged ceritinib in the faeces accounts for a mean 68% of an oral dose.
Croatian: Količina nepromijenjenog ceritiniba izlučenog u stolici iznosi srednju vrijednost od 68% peroralne doze.
English: How much to take The recommended dose is 450 mg (three capsules) taken once daily with food, although your doctor could modify this recommendation if needed.
Croatian: Preporučena doza je 450 mg (3 kapsule) jedanput na dan uz hranu, no Vaš liječnik može prilagoditi tu preporuku prema potrebi.
English: Withhold Zykadia until recovery to asymptomatic (grade ≤1) bradycardia or to a heart rate of 60 beats per minute (bpm) or above.
Croatian: Privremeno prekinuti primjenu Zykadie do oporavka do asimptomatske (stupanj ≤1) bradikardije ili do srčane frekvencije od 60 otkucaja u minuti ili više.
English: If you accidentally take too many tablets, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
Croatian: Ako slučajno uzmete previše tableta, ili ako netko slučajno uzme
English: How much to take The recommended dose is 450 mg (three tablets) taken once daily with food, although your doctor could modify this recommendation if needed.
Croatian: Preporučena doza je 450 mg (3 tablete) jedanput na dan uz hranu, no Vaš liječnik može prilagoditi tu preporuku prema potrebi.
English: The PFS benefit of ceritinib was consistent by investigator assessment and across various subgroups including age, gender, race, smoking class, ECOG performance status and disease burden.
Croatian: Korist ceritiniba u pogledu PFS-a bila je u skladu s ocjenom ispitivača te prisutna u različitim podskupinama, uključujući podskupine prema dobi, spolu, rasi, pušačkom statusu, funkcionalnom stanju po ECOG-u i opterećenosti bolešću.
English: Hazard Ratio = 1.00 95% CI (0.67;1.49)
Croatian: Omjer hazarda = 1,00 95% CI (0,67;1,49)
English: Capsule shell: gelatin, indigotine (E132) and titanium dioxide (E171).
Croatian: Ovojnica kapsule: želatina, indigotin (E132) i titanijev dioksid (E171).
English: Zykadia dosing
Croatian: Doza Zykadie
English: After discontinuation of a strong CYP3A inhibitor, resume the ceritinib dose that was taken prior to initiating the strong CYP3A inhibitor.
Croatian: Nakon prekida primjene snažnog CYP3A inhibitora nastavlja se s dozom ceritiniba koja se primjenjivala prije uvođenja snažnog CYP3A inhibitora.
English: The geometric mean apparent clearance (CL/F) of ceritinib was lower at steady-state (33.2 litres/hour) after 750 mg daily oral dosing than after a single 750 mg oral dose (88.5 litres/hour), suggesting that ceritinib demonstrates non-linear pharmacokinetics over time.
Croatian: Geometrijska srednja vrijednost prividnog klirensa (CL/F) ceritiniba bila je niža u stanju dinamičke ravnoteže (33,2 litre/sat) nakon peroralne doze od 750 mg dnevno nego nakon jednokratne peroralne doze od 750 mg (88,5 litara/sat), što ukazuje na to da ceritinib pokazuje nelinearnu farmakokinetiku tijekom vremena.
English: Caution should be exercised with concomitant use of P-gp inhibitors and ADRs carefully monitored.
Croatian: Potreban je oprez kod istodobne primjene P-gp inhibitora te pažljivo praćenje nuspojava.
English: Therefore, ceritinib may have the potential to increase plasma concentrations of co-administered medicinal products transported by these proteins.
Croatian: Stoga ceritinib može potencijalno povećati koncentracije u plazmi lijekova koji se istodobno primjenjuju, a transportiraju se putem tih proteina.
English: new or worsening cough with or without mucus, fever, chest pain, trouble breathing or shortness of breath.
Croatian: To mogu biti znakovi ili simptomi problema s jetrom. novi ili pogoršani kašalj sa sluzi ili bez nje, vrućica, bol u prsnom košu, poteškoće s disanjem ili nedostatak zraka.
English: - If your next dose is in 12 hours or more, take the missed capsules as soon as you remember.
Croatian: Ako sljedeću dozu morate uzeti za 12 ili više sati, uzmite propuštene kapsule čim se sjetite.
English: In clinical studies, QT prolongation was observed with ceritinib.
Croatian: U kliničkim ispitivanjima uočeno je produljenje QT intervala uz ceritinib.
English: An accurate and validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1).
Croatian: Za odabir bolesnika s ALK-pozitivnim NSCLC-om nužno je provesti točan i validiran test za ALK (vidjeti dio 5.1).
English: Hazard Ratio = 0.49 95% CI (0.36;0.67)
Croatian: Omjer hazarda = 0,49 95% CI (0,36;0,67)
English: Tell your doctor or pharmacist immediately if you get any of the following signs or symptoms during treatment with Zykadia: tiredness, itchy skin, yellowing of your skin or the whites of your eyes, nausea (feeling sick) or vomiting, decreased appetite, pain on the right side of your abdomen (belly), dark or brown urine, bleeding or bruising more easily than normal.
Croatian: Odmah se obratite svom liječniku ili ljekarniku ako primijetite bilo koji od niže navedenih znakova ili simptoma tijekom liječenja Zykadiom: umor, svrbež kože, žutilo kože ili bjeloočnica, mučnina ili povraćanje, smanjeni apetit, bol na desnoj strani abdomena (trbuha), tamna ili smeđa mokraća, krvarenje ili stvaranje modrica lakše nego što je normalno.
English: There are no or limited amount of data from the use of ceritinib in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni ceritiniba u trudnica ograničeni.
English: All patients were treated with prior crizotinib.
Croatian: Svi su se bolesnici prethodno liječili krizotinibom.
English: The frequency of these selected gastrointestinal ADRs (diarrhoea, nausea and vomiting) is based on patients treated with the recommended dose of ceritinib 450 mg with food (N=89) in the study A2112 (ASCEND-8) (see subsection ‘Gastrointestinal adverse reactions' below)
Croatian: Učestalost odabranih gastrointestinalnih nuspojava (proljev, mučnina i povraćanje) je temeljena na bolesnicima liječenima preporučenom dozom ceritiniba od 450 mg uz hranu (N=89) u ispitivanju A2112 (ASCEND-8) (vidjeti pododjeljak „Gastrointestinalne nuspojave“ ispod)
English: No dose adjustment is necessary in patients with mild or moderate hepatic impairment.
Croatian: Nije potrebno prilagođavanje doze u bolesnika s blagim ili umjerenim oštećenjem jetre.
English: Therefore, ceritinib should be used with caution in patients who have or may develop prolongation of the QT interval, including those patients taking anti-arrhythmic medicinal products such as class I (e.g. quinidine, procainamide, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) anti-arrhythmics or other medicinal products that may lead to QT prolongation such as domperidone, droperidol, chloroquine, halofantrine, clarithromycin, haloperidol, methadone, cisapride and moxifloxacin.
Croatian: Stoga je ceritinib potrebno primjenjivati s oprezom u bolesnika koji imaju ili u kojih može doći do produljenja QT intervala, uključujući one bolesnike koji uzimaju antiaritmike kao što su antiaritmici klase I (npr. kinidin, prokainamid, dizopiramid) ili klase III (npr. amiodaron, sotalol, dofetilid, ibutilid) ili druge lijekove koji mogu dovesti do produljenja QT intervala kao što su domperidon, droperidol, klorokin, halofantrin, klaritromicin, haloperidol, metadon, cisaprid i moksifloksacin.
English: Across the seven clinical studies, any grade ILD/pneumonitis has been reported in 2.1% of patients treated with ceritinib, and grade 3 or 4 events have been reported in 1.2% of patients.
Croatian: U sedam kliničkih ispitivanja, IBP/pneumonitis bilo kojeg stupnja bio je prijavljen u 2,1% bolesnika liječenih ceritinibom, a događaji stupnja 3 ili 4 bili su prijavljeni u 1,2% bolesnika.
English: The median age was 54.0 years (range: 28 to 84 years); 77.1% of patients were younger than 65 years.
Croatian: Medijan dobi bio je 54,0 godine (raspon: 28 do 84 godine); 77,1% bolesnika bilo je mlađe od 65 godina.
English: Medicines which may increase the risk of side effects with Zykadia: medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir).
Croatian: Lijekovi koji mogu povećati rizik od nuspojava sa Zykadiom: lijekovi koji se koriste za liječenje AIDS-a/HIV-a (npr. ritonavir, sakvinavir). lijekovi koji se koriste za liječenje infekcija.
English: The use of Zykadia in the treatment of ALK-positive NSCLC patients previously treated with an ALK inhibitor was investigated in two global, multicentre, open-label, single-arm phase 1/2 studies (Study X2101 and Study A2201).
Croatian: Primjena Zykadie u liječenju bolesnika s ALK-pozitivnim NSCLC-om koji su prethodno bili liječeni ALK inhibitorom ispitivana je u dva globalna, multicentrična, otvorena ispitivanja faze 1/2 s jednom skupinom (Ispitivanje X2101 i Ispitivanje A2201).
English: In Study A2301, 44 patients with measurable brain metastasis at baseline and at least one post-baseline brain radiological assessment (22 patients in the ceritinib arm and 22 patients in the chemotherapy arm) were assessed for intracranial response by BIRC neuro-radiologist per modified RECIST 1.1 (i.e.
Croatian: U ispitivanju A2301, u 44 bolesnika s mjerljivim metastazama na mozgu na početku i najmanje jednom radiološkom pretragom mozga nakon početka ispitivanja (22 bolesnika u ceritinib skupini i 22 bolesnika u kemoterapijskoj skupini) BIRC-ov neuroradiolog ocijenio je intrakranijalni odgovor prema modificiranim kriterijima RECIST 1.1 (tj. do 5 lezija na mozgu).
English: Tumour responses (based on BIRC) Objective response rate (95% CI) Duration of response Number of responders Median, months d
Croatian: Tumorski odgovori (prema BIRC-u) Stopa objektivnog odgovora (95% CI) Trajanje odgovora Broj bolesnika s odgovorom Medijan, mjeseci d
English: Zykadia should be permanently discontinued in patients who develop QTc >500 msec or >60 msec change from baseline and torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia.
Croatian: Primjena Zykadie mora se trajno prekinuti u bolesnika u kojih dođe do QTc-a >500 msek ili do promjene >60 msek u odnosu na početnu vrijednosti te torsade de pointes ili polimorfne ventrikularne tahikardije ili znakova/simptoma ozbiljne aritmije.
English: Hazard Ratio = 0.73 95% CI (0.50, 1.08)
Croatian: Omjer hazarda = 0,73 95% CI (0,50; 1,08)
English: Severe, life-threatening or fatal ILD/pneumonitis have been observed in patients treated with ceritinib in clinical studies.
Croatian: Teški, po život opasni ili smrtonosni IBP/pneumonitis uočeni su u bolesnika liječenih ceritinibom u kliničkim ispitivanjima.
English: Therefore, no dose adjustment is necessary in patients with mild to moderate renal impairment.
Croatian: Stoga nije potrebno prilagođavanje doze u bolesnika s blagim do umjerenim oštećenjem bubrega.
English: Hyperglycaemia (all grades) was reported in 9.4% of patients treated with ceritinib across the seven clinical studies; grade 3 or 4 events were reported in 5.4% of patients.
Croatian: Hiperglikemija (svih stupnjeva) bila je prijavljena u 9,4% bolesnika liječenih ceritinibom u sedam kliničkih ispitivanja; događaji stupnja 3 ili 4 bili su prijavljeni u 5,4% bolesnika.
English: Co-administration of a single 750 mg fasted ceritinib dose with a proton pump inhibitor (esomeprazole) 40 mg daily for 6 days in healthy, fasting subjects decreased ceritinib AUC by 76% and Cmax by 79%.
Croatian: Istodobna primjena jednokratne doze ceritiniba od 750 mg natašte s inhibitorom protonske pumpe (esomeprazolom) u dozi od 40 mg dnevno natašte tijekom 6 dana u zdravih ispitanika smanjila je AUC ceritiniba za 76% i Cmax za 79%.
English: The median age was 51 years (range: 29-80 years); 87.1% of patients were younger than 65 years and 50.0% were female.
Croatian: Medijan dobi bio je 51 godina (raspon: 29-80 godina); 87,1% bolesnika bilo je mlađe od 65 godina, a 50,0% bolesnika bilo je ženskog spola.
English: 16.7 (14.8, NE)
Croatian: 16,7 (14,8; NP)
English: Agents whose plasma concentration may be altered by ceritinib
Croatian: Tvari čiju koncentraciju u plazmi ceritinib može promijeniti
English: In the dose optimisation study A2112 (ASCEND-8) in both previously treated and untreated patients with ALK-positive advanced NSCLC at the recommended dose of ceritinib 450 mg taken with food (N=89), adverse events of diarrhoea, nausea and vomiting were mainly grade 1 (49.4%).
Croatian: U ispitivanju optimizacije doze A2112 (ASCEND-8) u prethodno liječenih i neliječenih bolesnika s ALK-pozitivnim uznapredovalim NSCLC-om pri preporučenoj dozi ceritiniba od 450 mg uzetoj uz hranu (N=89), štetni događaji proljeva, mučnine i povraćanja bili su većinom stupnja 1 (49,4%).
English: What Zykadia is
Croatian: Što je Zykadia
English: QTc prolongation has been observed in patients treated with ceritinib.
Croatian: Produljenje QTc-a uočeno je u bolesnika liječenih ceritinibom.
English: If the concomitant medicinal product can be adjusted or discontinued, Zykadia should be reinitiated with dose reduced by 150 mg on recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, with frequent monitoring (see sections 4.2 and 4.8).
Croatian: Ako se primjena istodobno primijenjenog lijeka može prilagoditi ili prekinuti, treba ponovo započeti primjenu Zykadie dozom smanjenom za 150 mg nakon oporavka do asimptomatske bradikardije ili do srčane frekvencije od 60 otkucaja u minuti ili više, uz učestalo praćenje (vidjeti dijelove 4.2 i 4.8).
English: Hepatotoxicity i
Croatian: Hepatotoksičnost i
English: chest pain or discomfort, changes in your heartbeat (fast or slow), light-headedness, fainting, dizziness, blue discoloration of your lips, shortness of breath, swelling of your lower limbs or skin.
Croatian: To mogu biti simptomi problema s plućima. bol ili nelagoda u prsnom košu, promjene u otkucajima srca (ubrzani ili usporeni), ošamućenost, nesvjestica, omaglica, plave usnice, nedostatak zraka, oticanje donjih udova ili kože.
English: Withhold Zykadia until recovery to baseline or to a QTc ≤480 msec, check and if necessary correct electrolytes, then reinitiate with dose reduced by 150 mg.
Croatian: Privremeno prekinuti primjenu Zykadie do oporavka na početnu vrijednost ili do QTc-a ≤480 msec, provjeriti te po potrebi korigirati elektrolite, zatim ponovno započeti primjenu dozom smanjenom za 150 mg.
English: Particular caution should be exercised when treating patients with severe hepatic impairment, and the dose should be adjusted (see section 4.2).
Croatian: Potreban je poseban oprez kod liječenja bolesnika s teškim oštećenjem jetre te prilagodba doze (vidjeti dio 4.2).
English: Co-administration of a single dose of midazolam (a sensitive CYP3A substrate) following 3 weeks of ceritinib dosing in patients (750 mg daily fasted) increased the midazolam AUCinf (90% CI) by 5.4-fold (4.6, 6.3) compared to midazolam alone.
Croatian: Istodobna primjena jednokratne doze midazolama (osjetljivog CYP3A supstrata) nakon 3 tjedna primjene ceritiniba u bolesnika (750 mg dnevno natašte) povećala je AUCinf (90% CI) midazolama za 5,4-puta (4,6; 6,3) u usporedbi sa samim midazolamom.
English: Patients should be monitored for fasting plasma glucose prior to the start of Zykadia treatment and periodically thereafter as clinically indicated.
Croatian: U bolesnika je potrebno pratiti glukozu u plazmi natašte prije početka liječenja Zykadiom te periodički nakon toga prema kliničkim indikacijama.
English: Zykadia 150 mg hard capsules
Croatian: Zykadia 150 mg tvrde kapsule
English: In a dose optimisation study A2112 (ASCEND-8) in patients comparing Zykadia 450 mg or 600 mg daily with food (approximately 100 to 500 kcalories and 1.5 to 15 grams of fat) to 750 mg daily under fasted conditions (dose and food condition of administration initially authorised), there was no clinically meaningful difference in the systemic steady-state exposure of ceritinib for the 450 mg with food arm (N=36) compared to the 750 mg fasted arm (N=31), with only small increases in steady-state AUC (90% CI) by 4% (-13%, 24%) and Cmax (90% CI) by 3% (-14%, 22%).
Croatian: U ispitivanju optimizacije doze A2112 (ASCEND-8) u bolesnika koje je uspoređivalo Zykadiu 450 mg ili 600 mg dnevno uz hranu (približno 100 do 500 kilokalorija i 1,5 do 15 grama masti) s 750 mg dnevno natašte (doza i uvjeti primjene s hranom prema inicijalnom odobrenju), nije bilo klinički značajne razlike u sistemskoj izloženosti ceritinibu u stanju dinamičke ravnoteže za skupinu koja je primala 450 mg uz hranu (N=36) u usporedbi sa skupinom koja je primala 750 mg natašte (N=31), sa samo malim porastima AUC-a u stanju dinamičke ravnoteže (90% CI) za 4% (-13%, 24%) i Cmax-a (90% CI) za 3% (-14%, 22%).
English: OS rate at 24 months d, % (95% CI)
Croatian: Stopa OS-a nakon 24 mjeseca d, % (95%
English: The incidence and severity of gastrointestinal adverse drug reactions were reduced for patients treated with Zykadia 450 mg with food (diarrhoea 56%, nausea 45%, vomiting 35%; 1.1% reported a grade 3/4 event) compared to 750 mg fasted (diarrhoea 76%, nausea 50%, vomiting 56%; 12% reported a grade 3/4 event).
Croatian: Incidencija i težina gastrointestinalnih nuspojava bila je smanjena u bolesnika liječenih Zykadiom 450 mg uz hranu (proljev 56%, mučnina 45%, povraćanje 35%; 1,1% prijavljenih događaja stupnja 3/4) u usporedbi s 750 mg natašte (proljev 76%, mučnina 50%, povraćanje 56%; 12% prijavljenih događaja stupnja 3/4).