FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3 presents adverse reactions reported in 1722 patients with either ALK-positive or ROS1-positive advanced NSCLC who received crizotinib across 2 randomised Phase 3 studies (1007 and 1014) and 2 single-arm clinical studies (1001 and 1005) (see section 5.1).
Maltese: Tabella 3 tippreżenta r-reazzjonijiet avversi rrappurtati f'1,722 pazjenti b'NSCLC avvanzat jew pożittiv għall-ALK jew pożittiv għal ROS1 li rċevew crizotinib f'żewġ studji (1007 u 1014) ta' Fażi 3 u 2 studji kliniċi b'fergħa waħda (1001 u 1005) (ara sezzjoni 5.1).
English: Coadministration of repeated doses of crizotinib (250 mg once daily) with repeated doses of itraconazole (200 mg once daily), a strong CYP3A inhibitor, resulted in increases in crizotinib steady-state AUCtau and Cmax, that were approximately 1.6-fold and 1.3-fold, respectively, those seen when crizotinib was administered alone.
Maltese: L-għoti flimkien ta' dożi ripetuti ta' crizotinib (250 mg darba kuljum) ma' dożi ripetuti ta' itraconazole (200 mg darba kuljum), inibitur qawwi ta' CYP3A, irriżulta f'żidiet fl-AUCtau u fis-Cmax fi stat fiss ta' crizotinib, li kienu madwar 1.6 darbiet u 1.3 darbiet, rispettivament, dawk li dehru meta crizotinib ingħata waħdu.
English: Coadministration of repeated doses of crizotinib (250 mg twice daily) with repeated doses of rifampicin (600 mg once daily), a strong CYP3A4 inducer, resulted in 84% and 79% decreases in crizotinib steady-state AUCtau and Cmax, respectively, compared to when crizotinib was given alone.
Maltese: L-għoti fl-istess ħin ta' dożi ripetuti ta' crizotinib (250 mg darbtejn kuljum) ma' dożi ripetuti ta' rifampiċin (600 mg darba kuljum), induttur qawwi ta' CYP3A4, irriżulta fi tnaqqis ta' 84% u 79% flAUCinf u Cmax ta' crizotinib f'qagħda stabbli, rispettivament, meta mqabbel ma' meta crizotinib ingħata waħdu.
English: Blood alkaline phosphatase increased
Maltese: Anhydrous calcium hydrogen phosphate
English: 500 mg).
Maltese: 5 xhur
English: Fifty-eight of 84 (69%) patients treated with crizotinib and 17 of 119 (14%) patients treated with chemotherapy continued treatment for at least 3 weeks after objective disease progression.
Maltese: Tmienja u ħamsin minn 84 (69%) pazjent ittrattati bi crizotinib u 17 minn 119-il pazjent (14%) ittratti bil-kimoterapija komplew it-trattament għal mill-anqas 3 ġimgħat wara progressjoni oġġettiva tal-marda.
English: Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Maltese: Għandhom jiġu esklużi kawżi potenzjali oħra ta' ILD/pulmonite (ara sezzjonijiet 4.2 u 4.4).
English: A total of 166 patients in the crizotinib arm and 163 patients in the chemotherapy arm had completed the EORTC QLQ-C30 and LC13 questionnaires at baseline and at least 1 postbaseline visit.
Maltese: Total ta' 166 pazjent fil-fergħa ta' crizotinib u 163 pazjenti fil-fergħa tal-kimoterapija, kienu lestew il-kwestjonarji EORTC QLQ-C30 u LC13 fil-linja bażi u millinqas viżta waħda wara l-linja bażi.
English: Following crizotinib 200 mg twice daily dosing, patients with moderate hepatic impairment (N=8) showed higher systemic crizotinib exposure compared to patients with normal hepatic function (N=9) at the same dose level, with geometric mean ratios for AUCdaily and Cmax of 150% and 144%, respectively.
Maltese: Wara dożaġġ ta' crizotinib 200 mg darbtejn kuljum, pazjenti b'indeboliment epatiku moderat (N=8) urew esponiment sistemiku għal crizotinib ogħla meta mqabbel ma' pazjenti b'funzjoni epatika normali (N=9) fl-istess livell ta' doża, bi proporzjonijiet medji ġeometriċi għal AUCkuljum u Cmax ta' 150% u 144%, rispettivament.
English: The data described below reflect exposure to XALKORI in 1669 patients with ALK-positive advanced NSCLC who participated in 2 randomised Phase 3 studies (Studies 1007 and 1014) and in 2 single-arm studies (Studies 1001 and 1005), and in 53 patients with ROS1-positive advanced NSCLC who participated in single-arm Study 1001, for a total of 1722 patients (see section 5.1).
Maltese: Id-dejta deskritta hawn taħt tirrifletti l-espożizzjoni għal XALKORI f'1669 pazjent b'NSCLC avvanzat pożittiv għall-ALK li ħadu sehem f'żewġ studji ta' Fażi 3 (Studji 1007 u 1014) magħmula b'għażla każwali u f'żewġ studji single-arm (Studji 1001 u 1005), u fi 53 pazjent b'NSCLC avvanzat pożittiv għal ROS1 li pparteċipaw fi Studju 1001 ta' fergħa waħda, għal total ta' 1,722 pazjent (ara sezzjoni 5.1).
English: The concomitant use of crizotinib with CYP3A4 substrates with narrow therapeutic indices should be avoided (see section 4.5).
Maltese: Għandu jiġi evitat l-użu konkomitanti ta' crizotinib ma' sustratti ta' CYP3A4 b'indiċi terapewtiċi stretti (ara sezzjoni 4.5).
English: • Increased levels of the enzyme alkaline phosphatase in the blood (an indicator of organ malfunction or injury, particularly liver, pancreas, bone, thyroid gland, or gall bladder).
Maltese: • Żieda fil-livelli tal-enzima alkaline phosphatase fid-demm (indikatur ta' funzjoni ħażina jeferita f'xi organu, b'mod partikolari fil-fwied, frixa, għadam, glandola tat-tirojde, jew bużżieqa tal-marrara).
English: For patients who develop haematologic laboratory abnormalities, see section 4.2.
Maltese: Għall-pazjenti li jiżviluppaw anormalitajiet ematoloġiċi fil-laboratorju, ara sezzjoni 4.2.
English: HDPE bottles with a polypropylene closure containing 60 hard capsules.
Maltese: Fliexken b'għatu tal-polypropylene li fihom 60 kapsula iebsa.
English: 18-Month Survival Probability,d % (95% CI) 48-Month Survival Probability,d % (95% CI) Objective Response Rate (Based on IRR) Objective Response Rate % (95% CI)
Maltese: (95% CI) Probabbiltà ta' Sopravivenza wara 48 Xahar,d % (95%
English: Drug-induced hepatotoxicity (including cases with fatal outcome) has been reported in patients treated with crizotinib across clinical trials (see section 4.8).
Maltese: Kien hemm epatotossiċità indotta mill-mediċina (li jinkludu każijiet b'eżitu fatali) ġew irrapportati f'pazjenti ttrattati bi crizotinib fil-provi kliniċi (ara sezzjoni 4.8).
English: N=125a
Maltese: Studju 1001 N=125a
English: • Moxifloxacine, used to treat bacterial infections.
Maltese: • Moxifloxacine, użat sabiex jitratta infezzjonijiet batteriċi.
English: Geriatric
Maltese: FARMAĊEWTIKU
English: Coadministration with medicinal products that increase gastric pH
Maltese: L-għoti flimkien ma' prodotti mediċinali li jżidu l-pH gastriku
English: • Morphine, used to treat acute and cancer pain.
Maltese: • Morfina, użata għat-trattament tal-uġigħ akut u uġigħ tal-kanċer.
English: Binding of crizotinib to human plasma proteins in vitro is 91% and is independent of medicinal product concentration.
Maltese: It-twaħħil in vitro ta' crizotinib mal-proteini tal-plażma tal-bniedem huwa ta' 91% u huwa indipendenti mill-konċentrazzjoni tal-prodott mediċinali.
English: However, the systemic crizotinib exposure in patients with moderate hepatic impairment at the dose of 200 mg twice daily was comparable to that observed from patients with normal hepatic function at a dose of 250 mg twice daily, with geometric mean ratios for AUCdaily and Cmax of 114% and 109%, respectively.
Maltese: Madankollu, l-esponiment sistemiku għal crizotinib f'pazjenti b'indeboliment epatiku moderat bid-doża ta' 200 mg darbtejn kuljum kien komparabbli ma' dak osservat minn pazjenti b'funzjoni epatika normali b'doża ta' 250 mg darbtejn kuljum, bi proporzjonijiet medji ġeometriċi għal AUCkuljum u Cmax ta' 114% u 109%, rispettivament.
English: Physiologically-based pharmacokinetic (PBPK) simulations predicted a 17% increase in crizotinib steady-state AUC after treatment with the moderate CYP3A inhibitors, diltiazem or verapamil.
Maltese: Simulazzjon farmakokinetiċi bbażati fiżjoloġikament bassru żieda ta' 17% f'AUC ta' crizotinib wara trattament ma' inibituri moderati ta' CYP3A, diltiazem jew verapamil.
English: Efficacy data from randomised Phase 3 Study 1014 are summarised in Table 4, and the Kaplan-Meier curves for PFS and OS are shown in Figure 1 and 2, respectively.
Maltese: Dejta dwar l-effikaċja minn Studju 1014, ta' Fażi 3 magħmul b'għażla każwali, qed jintwerew f'Tabella 4, u l-kurvi ta' Kaplan-Meier għal PFS u OS qed jintwerew f'Figura 1 u 2, rispettivament.
English: The demographic and disease characteristics of the overall study population were 62% female, median age of 53 years, baseline Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (95%), 51% White and 46% Asian, 4% current smokers, 32% past smokers and 64% never smokers.
Maltese: Il-karatteristiċi demografiċi u talmarda tal-popolazzjoni globali tal-istudju kienu 62% nisa, età medjana ta' 53 sena, stat ta' prestazzjoni ta' Grupp tal-Onkoloġija Kooperattiva tal-Lvant (ECOG) fil-linja bażi ta' 0 jew 1 (95%), 51% Bojod u 46% Asjatiċi, 4% persuni li bħalissa jpejpu, 32% persuni li kienu jpejpu qabel u 64% li qatt ma pejpu.
English: In vitro studies demonstrated that CYP3A4/5 were the major enzymes involved in the metabolic clearance of crizotinib.
Maltese: L-istudji in vitro wrew li CYP3A4/5 kienu l-enzimi prinċipali involuti fit-tneħħija metabolika ta' crizotinib.
English: Of the 30 patients, an ophthalmic abnormality of any type was reported in 14 (36.8%) patients and no ophthalmic finding was seen in 16 (42.1%) patients.
Maltese: Mit-30 pazjent, anormalità oftalmika ta' kwalunkwe tip ġiet irrappurtata f'14il pazjent (36.8%) u l-ebda sejba oftalmoloġika ma ġiet osservata f'16-il pazjent (42.1%).
English: Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, the predicted area under the plasma concentration-time curve at steady-state (AUCss) (95% CI) was 23%-37% higher in Asian patients (N=523) than in non-Asian patients (N=691).
Maltese: Fuq il-bażi tal-analiżi farmakokinetika tal-popolazzjoni tad-dejta mill-Istudji 1001, 1005 u 1007, l-erja mbassra taħt il-kurva tal-konċentrazzjoni-żmien tal‑plażma fi stat fiss (AUC ss) (95% CI) kienet 23%37% ogħla f'pazjenti Asjatiċi (N=523) milli f'pazjenti mhux Asjatiċi (N=691).
English: There were reports of fatal cases of gastrointestinal perforation during post-marketing use of crizotinib (see section 4.8).
Maltese: Kien hemm rapporti ta' każijiet fatali ta' perforazzjoni gastrointestinali wara t-tqegħid fis-suq ta' crizotinib (ara sezzjoni 4.8).
English: a. Median PFS times were 6.9 months (95% CI: 6.6, 8.3) for pemetrexed/cisplatin (HR=0.49; p-value <0.0001 for crizotinib compared with pemetrexed/cisplatin) and 7.0 months (95% CI: 5.9, 8.3) for pemetrexed/carboplatin
Maltese: Żminijiet medjani ta' PFS kienu ta' 6.9 xhur (95% CI: 6.6, 8.3) għal pemetrexed/cisplatin (HR=0.49; valur p <0.
English: • If you have been told that you have an abnormality of your heart tracing after an electrocardiogram (ECG) known as prolonged QT interval.
Maltese: • Jekk qalulek li għandek anormalità tat-traċċar tal-qalb tiegħek wara elettrokardjogramma (ECG) magħrufa bħala titwil tal-intervall QT.
English: In addition, a decrease in heart rate was found to be associated with increasing crizotinib plasma concentration (see section 4.4), with a maximum mean reduction of 17.8 beats per minute (bpm) after 8 hours on Cycle 2 Day 1.
Maltese: Flimkien ma' dan, tnaqqis fir-rata tal-qalb instab li kien assoċjat ma' żieda filkonċentrazzjoni ta' crizotinib fil-plażma (ara sezzjoni 4.4), bi tnaqqis medju massimu ta' 17.8 taħbitiet kull minuta wara 8 sigħat f'Ċiklu 2 Jum 1.
English: In randomised Phase 3 Study 1007, increases to Grade 3 or 4 ALT or AST elevations were observed in 18% and 9% of patients receiving crizotinib and 5% and <1% of patients receiving chemotherapy.
Maltese: Fi Studju 1007, ta' Fażi 3 b'għażla każwali, kienu osservati żidiet għal elevazzjonijiet tal-ALT jew AST ta' Grad 3 jew 4 f'18% u 9% tal-pazjenti li kienu qed jirċievu crizotinib, u 5% u <1% tal-pazjenti li kienu qed jirċievu kimoterapija.
English: In ALK-positive NSCLC patients, the frequency of adverse reactions was generally similar for patients <65 years of age and patients 65 years of age with the exception of oedema and constipation, which were reported with greater frequency (≥15% difference) in Study 1014 among patients treated with crizotinib 65 years of age.
Maltese: F'pazjenti b'NSCLC pożittiv għall-ALK, il-frekwenza tar-reazzjonijiet avversi kienet ġeneralment simili għal pazjenti li kellhom 65 sena u pazjenti li kellhom 65 sena bl-eċċezzjoni ta' edima u stitikezza, li ġew irrapportati bi frekwenza akbar (differenza ta' ≥15%) fi Studju 1014, fost pazjenti ttrattati bi crizotinib li kellhom 65 sena.
English: Based on the population pharmacokinetic analysis of data from Studies 1001, 1005, and 1007, age has no effect on crizotinib pharmacokinetics (see sections 4.2 and 5.1).
Maltese: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni ta' dejta minn Studji 1001, 1005, u 1007, l-età m'għandha l-ebda effett fuq il-farmakokinetika ta' crizotinib (ara sezzjonijiet 4.2 u 5.1).
English: Less than 0.5% of patients experienced febrile neutropenia in clinical studies with crizotinib.
Maltese: Anqas minn 0.5% tal-pazjenti esperjenzaw newtropenija bid-deni fi studji kliniċi bi crizotinib.
English: n. Renal cyst (Renal abscess, Renal cyst, Renal cyst haemorrhage, Renal cyst infection).
Maltese: Ċesta renali (Axxess renali, Ċesta fil-kliewi, Emorraġija taċ-ċesti renali, Infezzjoni taċ-ċesti renali).
English: Caution is therefore recommended in case of coadministration of crizotinib with moderate CYP3A inhibitors.
Maltese: Kawtela hija rrakomandata f'każ ta' koamministrazzjoni ta' crizotinib ma' inibituri moderati ta' CYP3A.
English: There were reports of fatal cases of gastrointestinal perforation during post-marketing use of crizotinib (see section 4.4).
Maltese: Kien hemm rapporti ta' każijiet fatali ta' perforazzjonijiet gastrointestinali wara t-tqegħid fis-suq ta' crizotinib (ara sezzjoni 4.4).
English: Crizotinib is extensively metabolized in the liver.
Maltese: Crizotinib jiġi metabolizzat b'mod estensiv fil-fwied.
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized by CYP2B6 (e.g., bupropion, efavirenz).
Maltese: Għalhekk, crizotinib jista' jkollu lpotenzjal li jżid il-konċentrazzjonijiet fil-plażma ta' mediċini mogħtija fl-istess ħin li jiġu metabolizzati minn CYP2B6 (eż, bupropion, efavirenz).
English: Chemotherapy N=171
Maltese: Kimoterapija N=171
English: Progression-Free Survival (Based on IRR) Number with event, n (%) Type of event, n (%) Progressive Disease Death without objective progression Median PFS in months (95% CI)
Maltese: Numru bl-avveniment, n (%) Tip ta' avveniment, n (%) Mard Progressiv
English: Other side effects of XALKORI may include:
Maltese: Effetti sekondarji oħra ta' XALKORI jistgħu jinkludu:
English: Grade 4 Bradycardiad,e,f Life-threatening consequences, urgent intervention indicated
Maltese: Bradikardija ta' Grad 4d,e,f Konsegwenzi ta' periklu għall-ħajja, indikat intervent urġenti
English: There was one ALK-positive patient >85 years old out of 154 patients in single-arm Study 1001 (see also section 4.2 and 5.2).
Maltese: Kien hemm pazjent pożittiv għall-ALK wieħed li kellu >85 sena minn 154 pazjent, fi Studju 1001 li kellu parti waħda (ara wkoll sezzjoni 4.2 u 5.2).
English: The antitumour efficacy of crizotinib was dose-dependent and demonstrated a correlation with inhibition of ROS1 phosphorylation in vivo.
Maltese: L-effikaċja kontra t-tumuri ta' crizotinib kienet dipendenti fuq id-doża u wriet korrelazzjoni mal-inibizzjoni ta' fosforilizzazzjoni ta' ROS1 in vivo.
English: Re-treatment with crizotinib
Maltese: Trattament mill-ġdid bi crizotinib
English: The aqueous solubility of crizotinib is pH dependent, with low (acidic) pH resulting in higher solubility.
Maltese: Is-solubilità ta' crizotinib fl-ilma tiddependi fuq il-pH, b'pH baxx (aċiduż) li jirriżulta f'solubilità ogħla.
English: Chemotherapy N=174
Maltese: Kimoterapija N=174
English: p-valueg Duration of Response Mediane, Months (95% CI)
Maltese: Dewmien tar-Rispons Medjane, Xhur (95% CI)
English: Close clinical surveillance is recommended when crizotinib is administered with these medicinal products.
Maltese: Sorveljanza klinika mill qrib hija rrakkomandata meta crizotinib jiġi amministrat ma' dawn il-prodotti mediċinali.
English: Grade 2, 3 or 4 ALT or AST elevation with concurrent Grade 2, 3 or 4 total bilirubin elevation (in the absence of cholestasis or haemolysis)
Maltese: ALT ta' Grad 2, 3 jew 4 jew żieda tal-AST b'żieda simultanjata' Grad 2, 3 jew 4 filbilirubin totali (fin-nuqqas ta' kolestasi jew emolisi)
English: In addition, the population pharmacokinetic analysis using data from Studies 1001, 1005 and 1007 indicated CLcr did not have a clinically meaningful effect on the pharmacokinetics of crizotinib.
Maltese: Flimkien ma' dan, l-analiżi farmakokinetika tal-popolazzjoni bl-użu ta' dejta minn Studji 1001, 1005 u 1007 indikat li CLcr ma kellux effett klinikament sinifikanti fuq il-farmakokinetika ta' crizotinib.
English: Of 171 ALK-positive NSCLC patients treated with crizotinib in randomised Phase 3 Study 1014, 22 (13%) were 65 years or older, and of 109 ALK-positive patients treated with crizotinib who crossed over from chemotherapy arm, 26 (24%) were 65 years or older.
Maltese: Mill-171 pazjent b'NSCLC pożittiv għall-ALK ittrattati bi crizotinib, fi Studju 1014, ta' Fażi 3 magħmul b'għażla każwali, 22 (13%) kellhom 65 sena jew aktar, u mill-109 pazjenti pożittivi għallALK ittrattati bi crizotinib, li qalbu mill-fergħa tal-kimoterapija, 26 (24%) kellhom 65 sena jew aktar.
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are substrates of OCT1 or OCT2 (e.g., metformin, procainamide).
Maltese: Għalhekk, crizotinib jista' jkollu l-potenzjal li jżid il-konċentrazzjonijiet fil-plażma ta' mediċini mogħtija fl-istess żmien u li huma sustratti ta' OCT1 jew OCT2 (e.ż., metformin, procainamide).
English: For most patients, ROS1-positive NSCLC was identified by FISH.
Maltese: Għall-biċċa l-kbira tal-pazjenti, NSCLC avvanzat pożittiv għal ROS1 kien identifikat minn FISH.
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC, QTcF (corrected QT by the Fridericia method) ≥500 msec was recorded in 34 (2.1%) of 1619 patients with at least 1 postbaseline ECG assessment and a maximum increase from baseline in QTcF ≥60 msec was observed in 79 (5.0%) of 1585 patients with a baseline and at least 1 postbaseline ECG assessment.
Maltese: Fi studji bi crizotinib f'pazjenti b'NSCLC avvanzat jew pożittiv għall-ALK jew pożittiv għal ROS1, QTcF (QT korrett bil-metodu Fridericia) ta' ≥500 msec ġie osservat f'34 (2.1%) minn 1,619-il pazjent b'mill-anqas valutazzjoni tal-ECG waħda ta' wara l-linja bażi u kienet osservata żieda massima filQTcF ta' ≥60 msec mil-linja bażi f'79 (5.0%) minn 1,585 pazjent b'linja bażi u mill-anqas valutazzjoni tal-ECG waħda ta' wara l-linja bażi.
English: p-valuef
Maltese: Treddigħ
English: Coadministration of a single 150 mg oral dose of crizotinib in the presence of ketoconazole (200 mg twice daily), a strong CYP3A inhibitor, resulted in increases in crizotinib systemic exposure, with crizotinib area-under-the-plasma-concentration versus time curve from time zero to infinity (AUCinf) and maximum observed plasma concentration (Cmax) values that were approximately 3.2-fold and 1.4-fold, respectively, those seen when crizotinib was administered alone.
Maltese: L-għoti fl-istess ħin ta' doża orali waħda ta' 150 mg crizotinib fil-preżenza ta' ketokonazole (200 mg darbtejn kuljum), inibitur qawwi ta' CYP3A, irriżulta f'żidiet fl-espożizzjoni sistemika ta' crizotinib, bl-erja taħt il-konċentrazzjoni fil-plażma kontra lkurva tal-ħin mill-ħin żero sal-infinità (AUCinf) ta' crizotinib u l-valuri tal-ogħla konċentrazzjoni ta' plażma osservata (Cmax) li kienu bejn wieħed u ieħor 3.2 darbiet u 1.4 darbiet akbar, rispettivament, minn dawk li dehru meta crizotinib ġie amministrat waħdu.
English: Eleven (21%) patients had an increase from Baseline in QTcF value ≥30 to <60 msec and 1 (2%) patient had an increase from Baseline in QTcF value of ≥60 msec. No patients had a maximum QTcF ≥480 msec.
Maltese: Ħdax (21%)-il pazjent kellhom żieda mil-Linja Bażi fil-valur tal-QTcF ta' ≥ 30 sa < 60 msec u pazjent wieħed (2%) kellu żieda mil-Linja Bażi fil-valur tal-QTcF ta' ≥ 60 msec.
English: However, in vitro studies indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the metabolism of drugs that are substrates for UGT1A4, UGT1A6, or UGT1A9.
Maltese: Għaldaqstant, studji in vitro indikaw li interazzjonijiet kliniċi bejn mediċina u oħra x'aktarx li mhumiex se jseħħu b'riżultat ta' inibizzjoni medjata minn crizotinib tal-metaboliżmu ta' mediċini li huma sustratti għal UGT1A4, UGT1A6 jew UGT1A9.
English: Discontinue during evaluation of severe vision loss a. NCI Common Terminology Criteria for Adverse Events b. XALKORI must be permanently discontinued in case of further Grade ≥3 recurrence.
Maltese: Kriterji tat-Terminoloġija Komuni għall-Avvenimenti Avversi tal-NCI b.
English: ROS1-positive advanced NSCLC efficacy results from Study 1001 Efficacy Parameter
Maltese: Riżultati tal-effikaċja tal-NSCLC avvanzat pożittiv għal ROS1 minn Studju 1001 Parametru tal-Effikaċja
English: The effect of renal function as measured by baseline CLcr on observed crizotinib steady-state trough concentrations (Ctrough, ss) was evaluated.
Maltese: L-effett tal-funzjoni tal-kliewi kif imkejjel mis-CLcr fil-linja bażi fuq il-konċentrazzjonijiet minimi osservati ta' crizotinib fl-istat fiss (Ctrough, ss) ġie evalwat.
English: b. Three patients were not evaluable for response in Study 1001, and 42 patients were not evaluable for response in Study 1005. c. Estimated using the Kaplan-Meier method.
Maltese: Tliet pazjenti ma setgħux jiġu evalwati għal rispons fi Studju 1001, u 42 pazjenti ma setgħux jiġu evalwati għal rispons fi Studju 1005 c.
English: There were no ROS1-positive patients >85 years old in Study 1001.
Maltese: Ma kienx hemm pazjenti pożittivi għal ROS1 li kellhom >85 sena fi Studju 1001.
English: XALKORI 250 mg hard capsules crizotinib
Maltese: XALKORI 250 mg kapsuli iebsin crizotinib
English: q. Blood testosterone decreased (Blood testosterone decreased, Hypogonadism, Secondary hypogonadism).
Maltese: Tnaqqis fit-testosterone fid-demm (Tnaqqis fit-testosterone fid-demm, Ipogonadiżmu, Ipogonadiżmu Sekondarju).
English: • Dizziness.
Maltese: Odealkilati.
English: In clinical studies of crizotinib in patients with either ALK-positive or ROS1-positive advanced NSCLC, shifts to Grade 3 or 4 decreases in leukocytes and neutrophils were observed at frequencies of 4% and 13%, respectively.
Maltese: Fi studji kliniċi ta' crizotinib f'pazjenti b'NSCLC avvanzat jew pożittiv għall-ALK jew pożittiv għal ROS1, kienu osservati bidliet għal tnaqqis ta' Grad 3 jew 4 fil-lewkoċiti u n-newtrofili bi frekwenzi ta' 4% u 13%, rispettivament.
English: Hepatic failure
Maltese: Indeboliment Epatiku
English: Patients could continue crizotinib treatment beyond the time of Response Evaluation Criteria in Solid Tumours (RECIST)-defined disease progression at the discretion of the investigator if the patient was still experiencing clinical benefit.
Maltese: Il-pazjenti setgħu jkomplu t-trattament bi crizotinib wara ż-żmien tal-progressjoni tal-marda definit minn Kriterji ta' Evalwazzjoni tar-Reazzjoni f'Tumuri Solidi (RECIST) fid-diskrezzjoni talinvestigatur jekk il-pazjent kien għadu jkollu benefiċċju kliniku.
English: The PFS benefit of crizotinib was consistent across subgroups of baseline patient characteristics such as age, gender, race, smoking class, time since diagnosis, ECOG performance status, presence of brain metastases and prior EGFR TKI therapy.
Maltese: Il-benefiċċju ta' crizotinib f'termini ta' PFS kien konsistenti fissottogruppi tal-karatteristiċi tal-pazjent fil-linja bażi bħalma huma l-età, is-sess, ir-razza, il-kategorija tat-tipjip, iż-żmien mid-dijanjożi, l-istatus tal-prestazzjoni tal-ECOG, il-preżenza ta' metastesi filmoħħ u terapija preċedenti b'TKI tal-EGFR.