FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: ILD/pulmonite ta' kwalunkwe grad fi 2.1% tal-pazjenti ttrattati b'ceritinib, u ġew irrapportati avvenimenti tal-grad 3 jew 4 f'1.2% tal-pazjenti.
English: Printing ink
Maltese: Linka stampata
English: Metabolism and nutrition disorders Decreased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Tnaqqis fl-aptit
English: Investigations Liver laboratory test abnormalities n
Maltese: Investigazzjonijiet Testijiet fil-laboratorju dwar anormalitajiet fil-fwied n
English: Censoring Times ceritinib 750 mg (n/N = 89/189) Chemotherapy (n/N = 113/187)
Maltese: Żminijiet ta' Ċensura ceritinib 750 mg (n/N = 89/189) Kimoterapija (n/N = 113/187)
English: Figure 3 ASCEND-5 (Study A2303) - Kaplan-Meier plot of progression-free survival as assessed by BIRC
Maltese: Figura 3 ASCEND-5 (Studju A2303) - Plott Kaplan-Meier ta' sopravivenza mingħajr progressjoni kif ivvalutat minn BIRC
English: Event-free probability estimate at 9 months d
Maltese: Stima mingħajr avvenimenti wara 9 xhur d,
English: The safety and efficacy of ceritinib in children and adolescents aged up to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' ceritinib fit-tfal u adolexxenti sa 18-il sena ma ġewx determinati s'issa.
English: Zykadia 150 mg hard capsules ceritinib
Maltese: Zykadia 150 mg kapsuli iebsa ceritinib
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.
Maltese: Għaldaqstant, ceritinib għandu jintuża b'kawtela f'pazjenti li għandhom jew jistgħu jiżviluppaw titwil tal-intervall tal-QT, inkluż dawk ilpazjenti li jieħdu prodotti mediċinali antiarritmiċi tal-klassi I (eż. quinidine, procainamide, disopyramide) jew tal-klassi III (eż. amiodarone, sotalol, dofetilide, ibutilide) jew prodotti mediċinali oħrajn li jistgħu jwasslu għal titwil tal-QT bħalma huma domperidone, droperidol, chloroquine, halofantrine, clarithromycin, haloperidol, methadone, cisapride u moxifloxacin.
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).
Maltese: It-trattament b'ceritinib mhuwiex irrakkomandat f'pazjenti b'sindrome ta' QT konġenitali mtawwal jew li qegħdin jieħdu prodotti mediċinali magħrufa bħala li jtawlu l-intervall tal-QTc (ara sezzjonijiet 4.4 u 4.5).
English: Study A2201 involved 140 patients who had been previously treated with 1-3 lines of cytotoxic chemotherapy followed by treatment with crizotinib, and who had then progressed on crizotinib.
Maltese: Studju A2201 involva 140 pazjent li kienu ġew ittrattati b'1 sa 3 linji ta' kemoterapija ċitotossika segwiti bi trattament bi crizotinib, u li dak iż-żmien kienu għaddew għal crizotinib.
English: Time (Months) Ceritinib 750 mg 115 107 92 83 71 61 52 37 28 23 13 8 2 2 0 0 Chemotherapy 116 109 91 78 66 53 43 39 29 22 17 7 5 2 1 0
Maltese: Ceritinib 750 mg 115 107 92 83 71 61 52 37 28 23 13 Kimoterapija 116 109 91 78 66 53 43 39 29 22 17
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.
Maltese: Id-dejta tal-effikaċja mill-Istudju A2301 hija miġbura fil-qosor fit-Tabella 3, u l-kurvi Kaplan-Meier għall-PFS u l-OS huma murija fil-Figura 1 u l-Figura 2, rispettivament.
English: A pharmacokinetic analysis suggested that ceritinib causes concentration-dependent increases in QTc (see section 4.4).
Maltese: Analiżi farmakokinetika ssuġġeriet li ceritinib jikkawża żieda fil-QTc dipendenti fuq il-konċentrazzjoni (ara sezzjoni 4.4).
English: Kaplan-Meier medians (95% CI) (Months) Ceritinib 750 mg: 5.4 (4.1;6.9) Chemotherapy: 1.6 (1.4;2.8)
Maltese: Medjani Kaplan-Meier (95% CI) (Xhur) Ceritinib 750 mg: 5.4 (4.1;6.9) Kimoterapija:
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.
Maltese: Kien osservat titwil tal-QTc waqt studji kliniċi f'pazjenti ttrattati b'ceritinib (ara sezzjonijiet 4.8 u 5.2), li jista' jwassal għal żieda fir-riskju ta' takiarritmija ventrikulari (eż. torsade de pointes) jew mewta għall-għarrieda.
English: Hepatotoxicity events were managed with dose interruptions or reductions in 40.6% of patients.
Maltese: L-avvenimenti ta' epatotossiċità ġew immaniġġjati b'interruzzjonijiet jew tnaqqis tad-doża f'40.6% tal-pazjenti.
English: The geometric mean AUCinf (unbound AUCinf) of ceritinib was increased by 66% (108%) in subjects with severe hepatic impairment compared to subjects with normal hepatic function (see section 4.2).
Maltese: L-AUCinf medju ġeometriku (AUCinf mhux marbut) ta' ceritinib żdied b'66 % (108 %) f'individwi b'indeboliment tal-fwied sever meta mqabbel ma' individwi b'funzjoni tal-fwied normali (ara sezzjoni 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.
Maltese: L-għoti flimkien ta' doża waħda ta' midazolam (sottostrat sensittiv ta' CYP3A) wara 3 ġimgħat ta' dożi ta' ceritinib f'pazjenti (750 mg kuljum fi stat sajjem) żied l-AUCinf (90% CI) tal-midazolam b'5.4 darbiet (4.6, 6.3 imqabbel mal-midazolam waħdu.
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.
Maltese: Matul is-seba' studji kliniċi, kienu rrapportati avvenimenti ta' bradikardija u/jew bradikardija tas-sinus (rata tat-taħbit tal-qalb ta' inqas minn 60 bpm) (kollha tal-grad 1) f'2.3% tal-pazjenti.
English: Co-administration of ceritinib with substrates primarily metabolised by CYP3A or CYP3A substrates known to have narrow therapeutic indices (e.g. alfuzosin, amiodarone, cisapride, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quetiapine, quinidine, lovastatin, simvastatin, sildenafil, midazolam, triazolam, tacrolimus, alfentanil and sirolimus) should be avoided and alternative medicinal products that are less sensitive to CYP3A4 inhibition should be used if possible.
Maltese: L-għoti flimkien ta' ceritinib ma' sottostrati mmetabolizzati primarjament b'CYP3A jew b'sottostrati ta' CYP3A magħrufa li għandhom indiċijiet terapewtiċi dojoq (eż. alfuzosin, amiodarone, cisapride, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quetiapine, quinidine, lovastatin, simvastatin, sildenafil, midazolam, triazolam, tacrolimus, alfentanil u sirolimus) għandhom ikunu evitati u jekk jista' jkun għandhom jintużaw prodotti mediċinali alternattivi li huma anqas sensittivi għall-inibizzjoni ta' CYP3A4.
English: Censoring Times ceritinib 750 mg (n/N = 48/189) Chemotherapy (n/N = 59/187)
Maltese: Żminijiet ta' Ċensura ceritinib 750 mg (n/N = 48/189) Kimoterapija (n/N = 59/187)
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.
Maltese: Total ta' 11-il metabolit instabu jiċċirkulaw filplażma f'livelli baxxi bil-medja tikkontribwixxi għar-radjuattività ta' AUC ta' ≤2.3% għal kull metabolit.
English: Ceritinib inhibits autophosphorylation of ALK, ALK-mediated phosphorylation of downstream signalling proteins and proliferation of ALK-dependent cancer cells both in vitro and in vivo.
Maltese: Ceritinib jinibixxi lawtofosforilazzjoni tal-ALK, fosforilazzjoni permezz tal-ALK ta' senjalazzjoni 'l isfel ta' proteini u proliferazzjoni taċ-ċelluli kanċeroġeniċi dipendenti fuq l-ALK kemm f'in vitro u in vivo.
English: No signs of mutagenicity or clastogenicity were observed in other in vitro and in vivo genotoxicity studies with ceritinib.
Maltese: Ma kien osservat l-ebda sinjal ta' mutaġeniċità jew klastoġeniċità fi studji ġenotossiċi in vitro u in vivo oħrajn b'ceritinib.
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).
Maltese: L-użu flimkien ta' indutturi qawwija ta' CYP3A għandu jkun evitat; dan jinkludi, imma mhuwiex limitat għal, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin u St.
English: Safety pharmacology studies indicate that ceritinib is unlikely to interfere with vital functions of the respiratory and central nervous systems.
Maltese: Studji farmakoloġiċi dwar is-sigurtà jindikaw li ceritinib ma jidhirx li se jinterferixxi ma' funzjonijiet vitali tas-sistemi nervużi respiratorji u ċentrali.
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.
Maltese: Il-benefiċċju għall-PFS ta' ceritinib kien konsistenti mill-valutazzjoni tal-investigatur u f'diversi sottogruppi inklużi l-età, is-sess, ir-razza, il-klassi ta' tipjip, l-istat ta' prestazzjoni ECOG u l-piż tal-marda.
English: Censoring Times Ceritinib 750 mg (n/N = 83/115) Chemotherapy (n/N = 89/116)
Maltese: Żminijiet ta' Ċensura Ceritinib 750 mg (n/N = 83/115) Kimoterapija (n/N = 89/116)
English: Oral absorption was estimated to be ≥25% based on metabolite percentages in the faeces.
Maltese: L-assorbiment orali kien stmat li kien ta' ≥25% skont ilperċentwali tal-metaboliti fl-ippurgar.
English: Capsule content
Maltese: KAPSULA IEBSA
English: In the dose optimisation study A2112 (ASCEND-8) in both previously treated and untreated patients with ALK-positive advanced NSCLC, the overall safety profile of Zykadia at the recommended dose of 450 mg with food (N=89) was consistent with Zykadia 750 mg fasted (N=90), except for a reduction in gastrointestinal adverse drug reactions, while achieving comparable steady-state exposure (see section 5.1 and subsection ‘Gastrointestinal adverse reactions' below).
Maltese: Fl-istudju A2112 ta' ottimizzazzjoni tad-doża (ASCEND-8) kemm f'pazjenti ttrattati qabel kif ukoll f'dawk mhux ittrattati qabel b'NSCLC avvanzat pożittiv għal ALK, il-profil ġenerali ta' sigurtà ta' Zykadia fid-doża rrakkomandata ta' 450 mg mal-ikel (N=89) kien konsistenti ma' Zykadia 750 mg fi stat sajjem (N=90), ħlief għal tnaqqis fir-reazzjonijiet gastrointestinali avversi għall-mediċina, filwaqt li nkisbet espożizzjoni komparabbli fi stat stabbli (ara sezzjoni 5.1 u s-sottosezzjoni “Reazzjonijiet gastrointestinali avversi” hawn taħt).
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.
Maltese: Zykadia għandu jitwaqqaf għal kollox f'pazjenti li jiżviluppaw bidla fil-QTc ta' >500 msek jew >60 msek mil-linja bażi u torsade de pointes jew takikardja ventrikulari polimorfika jew sinjali/sintomi ta' arritmija serja.
English: Lipase or amylase elevation grade ≥3
Maltese: GĦAMLA KWALITATTIVA
English: Monitoring of the QT interval is indicated in the event of combinations of such medicinal products (see sections 4.2 and
Maltese: Il-monitoraġġ talintervall tal-QT jiġi indikat f'każ ta' kombinazzjonijiet ta' dawn il-prodotti mediċinali (ara sezzjonijiet 4.2 u 4.4).
English: The median PFS in patients with brain metastases was 10.7 months (95% CI: 8.1, 16.4) versus 6.7 months (95% CI: 4.1, 10.6) in the ceritinib and chemotherapy arms, respectively, with HR=0.70 (95% CI: 0.44, 1.12).
Maltese: 7 xhur (95% CI: 8.1, 16.4) meta mqabbla ma' 6.7 xhur (95% CI: 4.1, 10.6) fil-gruppi ta' ceritinib u talkimoterapija, rispettivament, b'HR=0.70 (95% CI: 0.44, 1.12).
English: Hepatotoxicity (drug-induced liver injury, hepatitis cholestatic, hepatocellular injury, hepatotoxicity)
Maltese: Epatotossiċità (ferita fil-fwied minħabba l-mediċina, epatite kolestatika, ferita epatoċellulari, epatotossiċità)
English: Table 6 ALK-positive advanced NSCLC - overview of efficacy results from Studies X2101 and A2201
Maltese: Tabella 6 NSCLC avvanzati u pożittivi għal ALK - ħarsa ġenerali lejn ir-riżultati tal-effikaċja mill-Istudji X2101 u A2201
English: Table 4 ASCEND-5 (Study A2303) - Efficacy results in patients with previously treated ALK-positive metastatic/advanced NSCLC
Maltese: Tabella 4 ASCEND-5 (Studju A2303) - Riżultati tal-effikaċja f'pazjenti b'NSCLC avvanzat/ALK-pożittiv ittrattati qabel
English: The median duration of exposure to Zykadia 750 mg fasted was 44.9 weeks (range: 0.1 to 200.1 weeks).
Maltese: Id-dewmien medju tal-espożizzjoni għal Zykadia 750 mg fi stat sajjem kien ta' 44.9 ġimgħat (firxa: 0.1 sa 200.
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).
Maltese: WHO, kimoterapija adjuvanti/neoadjuvanti u l-preżenza/nuqqas ta' metastażi fil-moħħ waqt eżaminazzjoni) biex jirċievu jew ceritinib (750 mg kuljum, fi stat sajjem) jew kimoterapija (abbażi tal-għażla tal-investigatur - pemetrexed [500 mg/ m2] flimkien ma' cisplatin [75 mg/m2] jew carboplatin
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.
Maltese: Id-dejta tal-effikaċja mill-Istudju A2303 hija miġbura fil-qosor fit-Tabella 4, u l-kurvi Kaplan-Meier għall-PFS u l-OS huma murija fil-Figuri 3 u 4, rispettivament.
English: Each hard capsule contains 150 mg ceritinib.
Maltese: Kull kapsula iebsa fiha 150 mg ceritinib.
English: Ceritinib demonstrates pH-dependent solubility and becomes poorly soluble as pH increases in vitro.
Maltese: Ceritinib juri solubilità dipendenti fuq il-pH u ma tantx jibqa' solubbli hekk kif il-pH jiżdied in vitro.
English: In healthy subjects, co-administration of a single 750 mg fasted ceritinib dose with rifampicin (600 mg daily for 14 days), a strong CYP3A/P-gp inducer, resulted in 70% and 44% decreases in ceritinib AUCinf and Cmax, respectively, compared to when ceritinib was given alone.
Maltese: F'pazjenti b'saħħithom, l-għoti ta' doża waħda ta' 750 mg ceritinib fi stat sajjem ma' rifampicin (600 mg darbtejn kuljum għal 14-il jum), induttur qawwi ta' CYP3A/P-gp, wassal għal tnaqqis ta' 70% u 44% fl-AUCinf u s-Cmax ta' ceritinib, rispettivament, imqabbel ma' meta ceritinib ingħata waħdu.
English: Abdominal pain f
Maltese: Uġigħ fl-addome f
English: Table 2 ADRs in patients treated with Zykadia
Maltese: Tabella 2 ADRs f'pazjenti ttrattati b'Zykadia
English: ceritinib 750 mg 189 155 139 125 116 105 98 76 59 43 32 23 16 11 1 1 1 0 Chemotherapy 187 136 114 82 71 60 53 35 24 16 11 5 3 1 1 0 0 0
Maltese: Żmien (Xhur) ceritinib 750 mg 189 155 139 125 116 105 98 76 59 43 32 23 16 11 1 1 1 0
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]).
Maltese: Il-pazjenti li ngħataw ceritinib urew titjib sinifikanti meta mqabbla ma' dawk fuq il-kimoterapija filkejliet tal-Kwalità ġenerali tal-Ħajja u l-Istat ġenerali tas-Saħħa (LCSS [p<0.001], QLQ-C30, [p<0.001] u EQ-5D-5L indiċi [p<0.
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.
Maltese: Il-medja tat-tneħħija ġeometrika apparenti (CL/F) ta' ceritinib kienet aktar baxxa waqt l-istat wieqaf (33.2 litri/siegħa) wara doża orali ta' 750 mg kuljum wara l-għoti ta' doża orali singola ta' 750 mg (88.5 litri/siegħa), li tissuġġerixxi li ceritinib juri farmakokinetiċi mhux lineari matul il-medda taż-żmien.
English: 64.5% of the study population were Caucasian, 29.4% Asian, 0.4% Black and 2.6% other races.
Maltese: Total ta' 55.8% tal-pazjenti kienu nisa. 64.5% talpopolazzjoni al-istudju kienu Kawkasi, 29.4% Asjatiċi, 0.4% Suwed u 2.6% razez oħra.
English: The median PFS in patients with brain metastases was 4.4 months (95% CI: 3.4, 6.2) versus 1.5 months (95% CI: 1.3, 1.8) in the ceritinib and chemotherapy arms, respectively with HR=0.54 (95% CI: 0.36, 0.80).
Maltese: Il-PFS medjana f'pazjenti b'metastażijiet fil-moħħ kienet ta' 4.4 xhur (95% CI: 3.4, 6.2) meta mqabbla ma' 1.5 xhur (95% CI: 1.3, 1.8) fil-gruppi ta' ceritinib u talkimoterapija , rispettivament b'HR=0.54 (95% CI: 0.36 , 0.80).
English: (72.7%, 95% CI: 49.8, 89.3) as compared to the chemotherapy arm (27.3%, 95% CI: 10.7, 50.2).
Maltese: Ir-rata ta' rispons intrakranjali globali (OIRR) kienet ogħla minn ceritinib (72.7%, 95% CI: 49.8, 89.3) meta mqabbla mal-grupp talkimoterapija (27.3%, 95% CI: 10.7, 50.2).
English: Other medicines and Zykadia
Maltese: Mediċini oħra u Zykadia
English: Eye disorders Vision disorder a
Maltese: Disturbi fl-għajnejn Disturb fil-vista a
English: The median age was 54 years (range: 22 to 81 years); 78.5% of patients were younger than 65 years.
Maltese: L-età medjana kienet ta' 54 sena (medda: 22 sa 81 sena); 78.5% tal-pazjenti kienu iżgħar minn 65 sena.
English: The median age was 54.0 years (range: 28 to 84 years); 77.1% of patients were younger than 65 years.
Maltese: L-età medjana kienet ta' 54.0 sena (medda bejn 28 u 84 sena); 77.1% tal-pazjenti kienu iżgħar minn 65 sena.
English: Abnormal liver function test (hepatic function abnormal, hyperbilirubinaemia)
Maltese: Test anormali tal-funzjoni tal-fwied (funzjoni epatika anormali, iperbilirubinemija)
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).
Maltese: L-istudju ssodisfa l-objettiv primarju tiegħu li juri u titjib statistikament sinifikanti fis-sopravivenza mingħajr progressjoni (PFS) minn BIRC (ara Tabella 3 u Figura 1).
English: Treatment should continue as long as clinical benefit is observed.
Maltese: It-trattament għandu jitkompla sakemm jibqa' jkun hemm benefiċċju kliniku.
English: Zykadia is for oral use.
Maltese: Zykadia huwa għal użu orali.
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.
Maltese: Il-kwestjonarji bl-eżiti rrapportati tal-pazjenti nġabru permezz tal-EORTC QLQ C30/LC13, LCSS u EQ-5D-5L. 75% jew aktar tal-pazjenti fil-gruppi ta' ceritinib u tal-kimoterapija mlew il-kwestjonarju LCSS fil-biċċa l-kbira tal-punti taż-żmien matul l-istudju.
English: Renal impairment l
Maltese: Indeboliment tal-kliewi l
English: In addition, 81 patients (69.8%) in the chemotherapy arm received subsequent Zykadia as first antineoplastic therapy after study treatment discontinuation.
Maltese: Barra minn hekk, 81 pazjent (69.8%) fil-grupp tal-kimoterapija ngħataw Zykadia sussegwenti bħala l-ewwel terapija antineoplastika wara li twaqqaf it-trattament tal-istudju.
English: Based on available data, ceritinib elimination via the kidney is negligible (1.3% of a single oral administered dose).
Maltese: Skont id-dejta disponibbli, l-eliminazzjoni ta' ceritinib mill-kliewi hi negliġibbli (1.3% tad-doża singola mogħtija mill-ħalq).
English: A dedicated pharmacokinetic study under steady-state in patients with hepatic impairment has not been conducted.
Maltese: Ma twettaq ebda studju farmakokinetiku ddedikat fi stat fiss fuq pazjenti b'indeboliment epatiku.
English: The median duration of follow-up was 19.7 months (from randomisation to cut-off date).
Maltese: It-tul medjan tas-segwitu kien ta' 19.7 xhur (mid-data ta' randomizzazzjoni sa dik ta' limitu).
English: Constipation
Maltese: Rimettare
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.
Maltese: Fl-Istudju A2301, 44 pazjent b'metastażi fil-moħħ li tista' titkejjel fil-linja bażi u mill-inqas valutazzjoni radjoloġika waħda tal-moħħ ta' wara l-linja bażi (22 pazjent fil-grupp ta' ceritinib u 22 pazjent fil-grupp tal-kimoterapija) kienu vvalutati għar-rispons intrakranjali minn newroradjologu BIRC skont RECIST 1.1 modifikati ((jiġifieri sa 5 leżjonijiet fil-moħħ).
English: A categorical outlier analysis of ECG data demonstrated new QTc >500 msec in 12 patients (1.3%).
Maltese: Analiżi b'mod kategoriku tal-valuri anormali tad-dejta minn ECG wriet QTc ġdid ta' >500 msek f'12-il pazjent (1.3%).
English: Light blue, round, biconvex film-coated tablet with bevelled edges, without score, debossed with “NVR” on one side and “ZY1” on the other side.
Maltese: Pillola miksija b'rita ċelesti, tonda, bikonvessa bix-xfar imċanfra bl-ittri “NVR” imbuzzati fuq naħa waħda u b'“ZY1” fuq in-naħa l-oħra.
English: Zykadia should be withheld in patients who develop QTc >500 msec on at least two separate ECGs until recovery to baseline or a QTc ≤480 msec, then reinitiated with dose reduced by 150 mg (see sections 4.2, 4.8 and 5.2).
Maltese: Zykadia għandu jitwaqqaf f'pazjenti li jiżviluppaw QTc ta' >500 msek f'mill-inqas żewġ ECGs separati sakemm ma jkunx hemm irkupru għal-linja bażi jew QTc ta' ≤480 msek, u wara jerġa' jinbeda b'150 mg (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: Gastrointestinal toxicity was observed in both species characterised by body weight loss, decreased food consumption, emesis (monkey), diarrhoea and, at high doses, by histopathological lesions including erosion, mucosal inflammation and foamy macrophages in the duodenal crypts and submucosa.
Maltese: Kienet osservata tossiċità gastrointestinali fiż-żewġ speċi kkaratterizzati b'telf ta' piż, tnaqqis fil-konsum tal-ikel, rimettar (xadini), dijarrea u, meta mogħtija dożi għolja, erożjoni minħabba feriti istopatoloġiċi, infjammazzjoni mukożali u makrofaġi bir-ragħwa fil-kripti duodenali u submokużi.
English: Electrocardiogram QT prolonged
Maltese: Titwil tal-QT fl-elettrokardjogramm
English: Abnormal results of blood tests to check liver function (high levels of enzymes called alanine aminotransferase and/or aspartate aminotransferase and/or gamma glutamyltransferase and/or blood alkaline phosphatase, high levels of bilirubin) Abdominal pain
Maltese: Riżultati anormali tat-testijiet tad-demm biex jiċċekkjaw il-funzjoni tal-fwied (livelli għolja ta' enzimi msejħa alanina aminotransferasi u/jew aspartate aminotransferasi u/jew gamma glutamiltransferasi u/jew alkaline phosphatase fid-demm, livelli għolja ta' bilirubin) Uġigħ fl-addome
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).
Maltese: L-istudju laħaq l-għan ewlieni tiegħu li juri titjib statistikament sinifikanti fil-PFS minn BIRC bi tnaqqis stmat fir-riskju ta' 51% fil-grupp ta' ceritinib meta mqabbel mal-grupp tal-kimoterapija (ara Tabella 4 u Figura 3).