FrancophonIA/ELRC3.0 huggingface dataset:
English: The demographic and disease characteristics of the overall study population were 56% female, median age of 50 years, baseline ECOG performance status 0 (39%) or 1 (52%), 52% White and 45% Asian, 4% current smokers, 33% past smokers, and 63% never smokers, 93% metastatic, and 93% of patients' tumours were classified as adenocarcinoma histology.
Maltese: Il-karatteristiċi demografiċi u tal-marda tal-popolazzjoni globali tal-istudju kienu 56% nisa, età medjana ta' 50 sena, stat ta' prestazzjoni ECOG fil-linja bażi ta' 0 (39%) jew 1 (52%), 52% Bojod u 45% Asjatiċi, 4% persuni li bħalissa jpejpu, 33% persuni li kienu jpejpu qabel u 63% li qatt ma pejpu,. 93% metastatiċi, u 93% tat-tumuri tal-pazjenti ġew ikklassifikati bħala istoloġija adenokarċinoma.
English: In Study 1005, the adjusted geometric mean Ctrough, ss of crizotinib in mild (N=191) and moderate (N=65) renal impairment groups were 9.1% and 15% higher, respectively, than those in patients with normal renal function.
Maltese: Fi Studju 1005, il-medja ġeometrika aġġustata tasCtrough, ss ta' crizotinib fi gruppi b'indeboliment ħafif (N=191) u moderat (N=65) tal-kliewi kienet ta' 9.1% u 15% ogħla, rispettivament, minn dik f'pazjenti b'funzjoni normali tal-kliewi.
English: Patient-reported symptoms and global QOL were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13) at baseline (Day 1 Cycle 1) and Day 1 of each subsequent treatment cycle.
Maltese: Sintomi rrapportati mill-pazjenti u QOL globali nġabru bl-użu tal-EORTC QLQ-C30 u l-modulu talkanċer tal-pulmun (EORTC QLQ-LC13) fil-linja bażi (Jum 1 Ċiklu 1) u Jum 1 ta' kull ċiklu sussegwenti ta' trattament.
English: For patients without baseline brain metastases, the median IC-TTP was not reached in either the crizotinib (N=132) or the chemotherapy arms (N=131) (HR=0.69 [95% CI: 0.33, 1.45]; 1-sided p-value=0.1617).
Maltese: Għal pazjenti mingħajr metastasijiet tal-moħħ fil-linja bażi, il-medjan ta' IC-TTP ma ntlaħaqx la filfergħa ta' crizotinib (N=132) u lanqas fil-fergħa tal-kimoterapija (N=131) (HR=0.69 [95% CI: 0.33, 1.45]; 1-sided valur p=0.1617).
English: Partial responses were observed in 20 of 45 patients with non-adenocarcinoma NSCLC for an ORR of 44%, and 9 of 22 patients with SCC NSCLC for an ORR of 41%, both of which were less than the ORR reported in Study 1005 (54%) for all patients.
Maltese: Rispons parzjali kien osservat f'20 minn 45 pazjent b'NSCLC mhux adenokarċinoma għal ORR ta' 44% u 9 minn 22 pazjent b'SCC b'NSCLC għal ORR ta' 41%, li t-tnejn kienu anqas mill-ORRs irrapurtati fi Studju 1005 (54%) għall-pazjenti kollha.
English: c. Based on the stratified log-rank test (1-sided).
Maltese: Ibbażat fuq it-test stratifikat tal-log-rank (1-sided).
English: Withhold if ILD/pneumonitis is suspected, and permanently discontinue if treatment-related ILD/pneumonitis is diagnosedd
Maltese: Waqqaf jekk ikunu ssuspettati ILD/pulmonite, u waqqaf b'mod permanenti jekk ikunu ddijanjostikati ILD/pulmonite relatati mat-trattamentd
English: • Alfentanil and other short acting opiates such as fentanyl (painkillers used for surgical procedures).
Maltese: • Alfentanil u opjati oħrajn li jaġixxu f'qasir żmien bħal fentanyl (prodotti li jtaffu l-uġigħ użati fi proċeduri kirurġiċi).
English: Across clinical studies (n=1722), 19 (1.1%) patients treated with crizotinib had any grade cardiac failure, 8 (0.5%) patients had Grade 3 or 4, and 3 (0.2%) patients had fatal outcome.
Maltese: Fl-istudji kliniċi kollha (n=1,722), 19-il pazjent (1.1%) ittrattati b'crizotinib kellhom insuffiċjenza tal-qalb ta' kwalunkwe grad, 8 pazjenti (0.5%) kellhom Grad 3 jew 4, u 3 pazjenti (0.2%) kellhom eżitu fatali.
English: Median time to onset of any grade leukopenia was 85 days.
Maltese: Iżżmien medjan sal-bidu ta' lewkopenija ta' kwalunkwe grad kien ta' 85 jum.
English: The geometric mean volume of distribution (Vss) of crizotinib was 1772 L following intravenous administration of a 50 mg dose, indicating extensive distribution into tissues from the plasma.
Maltese: Il-volum ġeometriku medju tad-distribuzzjoni (Vss) ta' crizotinib kien ta' 1772 L wara l-għoti fil-vini ta' doża ta' 50 mg, li jindika distribuzzjoni estensiva fit-tessuti mill-plażma.
English: Interstitial lung disease/pneumonitis
Maltese: Mard interstizjali tal-pulmun/pulmonite
English: INFORMATION IN BRAILLE XALKORI 200 mg
Maltese: XALKORI 200 mg
English: Therefore, the concomitant use of crizotinib with medicinal products known to prolong QT interval or medicinal products able to induce Torsades de pointes (e.g., class IA [quinidine, disopyramide] or class III [e.g., amiodarone, sotalol, dofetilide, ibutilide], methadone, cisapride, moxifloxacine, antipsychotics, etc.) should be carefully considered.
Maltese: Għaldaqstant, l-użu konkomitanti ta' crizotinib ma' prodotti mediċinali magħrufa li jtawlu l-intervall QT jew prodotti mediċinali li kapaċi jinduċu Torsades de pointes (eż., klassi IA [quinidine, disopyramide] jew klassi III [eż.,amiodarone, sotalol, dofetilide, ibutilide], methadone, cisapride, moxifloxacine, antipsikotiċi, etc.) għandu jiġi kkunsidrat bir-reqqa.
English: How to store XALKORI 6.
Maltese: Kif taħżen XALKORI 6.
English: The most frequent adverse reactions (≥3%, all-causality frequency) associated with dose reductions were elevated transaminases (4%) and neutropenia (3%).
Maltese: L-aktar reazzjonijiet avversi frekwenti (≥3%, frekwenza mill-kawżalitajiet kollha) assoċjati ma' tnaqqis tad-doża kienu żieda fit-transaminases (4%) u newtropenija (3%).
English: In vitro studies indicated that crizotinib is an inhibitor of CYP2B6.
Maltese: Studji in vitro indikaw li crizotinib huwa inibitur ta' CYP2B6.
English: Crizotinib should be used with caution in patients at risk for gastrointestinal perforation (e.g., history of diverticulitis, metastases to the gastrointestinal tract, concomitant use of medicinal products with a recognized risk of gastrointestinal perforation).
Maltese: Crizotinib għandu jintuża b'attenzjoni f'pazjenti b'riskju ta' perforazzjoni gastrointestinali (eż. storja ta' divertikulite, metastasi għall-passaġġ gastrointestinali, użu fl-istess ħin ta' prodotti mediċinali b'riskju rikonoxxut ta' perforazzjoni gastrointestinali).
English: Of the 1084 patients who experienced vision disorder, 95% had events that were mild in severity.
Maltese: Mill-1,084 pazjent li esperjenzaw disturb viżiv, 95% kellhom avvenimenti li kienu ħfief fis-severità.
English: Symptoms may be similar to those from lung cancer.
Maltese: Is-sintomi jistgħu jkunu simili għal dawk minn kanċer tal-pulmun.
English: • Metformin, used to treat diabetes.
Maltese: • Metformin, li jintuża għat-trattament tad-dijabete.
English: Neutropenia was associated with dose reduction or permanent treatment discontinuation for 3% and <1% of patients, respectively.
Maltese: In-newtropenija kienet assoċjata ma' tnaqqis fid-doża jew waqfien permanenti tat-trattament għal 3% u <1% tal-pazjenti, rispettivament.
English: Patients with mild (either AST >ULN and total bilirubin ≤ULN or any AST and total bilirubin >ULN but 1.5×ULN), moderate (any AST and total bilirubin >1.5×ULN and 3×ULN), or severe (any AST and total bilirubin >3×ULN) hepatic impairment or normal (AST and total bilirubin ≤ULN) hepatic function, who were matched controls for mild or moderate hepatic impairment, were enrolled in an open-label, non-randomised clinical study (Study 1012), based on NCI classification.
Maltese: Pazjenti b'indeboliment epatiku ħafif (jew AST >ULN u bilirubina totali ≤ULN jew kwalunkwe AST u bilirubina totali >ULN iżda 1.5×ULN), moderat (kwalunkwe AST u bilirubina totali >1.5×ULN u 3×ULN), jew sever (kwalunkwe AST u bilirubina totali >3×ULN) indeboliment epatiku jew b'funzjoni epatika normali (AST u bilirubina totali ≤ULN), li kienu mqabbla ma' kontrolli għal indeboliment epatiku ħafif jew moderat, ġew irreġistrati fi studju kliniku open-label, mhux randomizzat (Studju 1012), abbażi ta' klassifikazzjoni tal- NCI.
English: In rat and dog repeat-dose toxicity studies up to 3-month duration, the primary target organ effects were related to the gastrointestinal (emesis, faecal changes, congestion), haematopoietic (bone marrow hypocellularity), cardiovascular (mixed ion channel blocker, decreased heart rate and blood pressure, increased LVEDP, QRS and PR intervals, and decreased myocardial contractility), or reproductive (testicular pachytene spermatocyte degeneration, single-cell necrosis of ovarian follicles) systems.
Maltese: Fi studji tal-effett tossiku minn doża ripetuta fil-firien u l-klieb li damu sa 3 xhur, l-effetti primarji fuq l-organi fil-mira kienu relatati mas-sistema gastro-intestinali (rimettar, bidliet fl-ippurgar, konġestjoni), ematopojetika (ipoċellolarità tal-mudullun), kardjovaskulari (imblokkatur imħallat talkanali tal-joni, rata tat-taħbit tal-qalb u pressjoni tad-demm baxxi, żieda fl-intervalli ta' LVEDP, QRS u PR, u tnaqqis fil-kontrattilità mijokardijaka), jew riproduttiva (testicular pachytene spermatocyte degeneration, nekrożi ta' ċellola waħda tal-follikoli tal-ovarji).
English: The demographic characteristics were 57% female; median age 55 years; baseline ECOG performance status of 0 or 1 (98%) or 2 (2%), 57% White and 40% Asian; 25% former smokers, and 75% never smokers.
Maltese: Il-karatteristiċi demografiċi kienu 57% nisa, età medjana ta' 55 sena, l-stat tal-prestazzjoni tal-ECOG fil-linja bażi ta' 0 jew 1 (98%) jew 2 (2%), 57% Bojod u 40% Asjatiċi, 25% persuni li kienu jpejpu flimgħoddi, u 75% persuni li qatt ma pejpu.
English: In vitro studies suggest that crizotinib is a substrate for P-glycoprotein (P-gp).
Maltese: L-istudji in vitro jissuġġerixxu li crizotinib huwa sustratt għal P-glycoprotein (P-gp).
English: • Tiredness.
Maltese: • Stitikezza.
English: For patients with previously treated baseline brain metastases, the median intracranial time to progression (IC-TTP) was 15.7 months in the crizotinib arm (N=39) and 12.5 months in the chemotherapy arm (N=40) (HR=0.45 [95% CI: 0.19, 1.07]; 1-sided p-value=0.0315).
Maltese: Għal pazjenti mingħajr metastasijiet tal-moħħ fil-linja bażi li ma rċevewx trattament qabel, il-medjan ta' żmien għal progressjoni (IC-TTP) intrakranjali kien ta' 15.7 xhur fil-fergħa ta' crizotinib (N=39) u 12.5 xhur fil-fergħa tal-kimoterapija (N=40) (HR=0.45 [95% CI: 0.19, 1.07]; 1-sided valur p=0.0315).
English: Following crizotinib 250 mg twice daily dosing, patients with mild hepatic impairment (N=10) showed similar systemic crizotinib exposure at steady state compared to patients with normal hepatic function (N=8), with geometric mean ratios for area under the plasma concentration-time curve as daily exposure at steady state (AUCdaily) and Cmax of 91.1% and 91.2%, respectively.
Maltese: Wara dożaġġ ta' crizotinib 250 mg darbtejn kuljum, pazjenti b'indeboliment epatiku ħafif (N=10) urew esponiment sistemiku għal crizotinib simili fi stat fiss meta mqabbel ma' pazjenti b'funzjoni epatika normali (N=8), bi proporzjonijiet medji ġeometriċi għal erja taħt il-kurva konċentrazzjoniżmien tal-plażma bħala esponiment kuljum fi stat fiss (AUCkuljum) u Cmax ta' 91.1% u 91.2%, rispettivament.
English: The most frequent adverse reactions (≥3%, all-causality frequency) associated with dosing interruptions were neutropenia (11%), elevated transaminases (7%), vomiting (5%), and nausea (4%).
Maltese: L-aktar reazzjonijiet avversi frekwenti (≥3%, frekwenza mill-kawżalitajiet kollha) assoċjati ma' interruzzjonijiet tad-dożaġġ kienu newtropenija (11%), żieda fit-transaminases (7%), rimettar (5%), u dardir (4%).
English: All-causality adverse events associated with permanent treatment discontinuation occurred in 302 (18%) patients of which the most frequent (≥1%) were interstitial lung disease (1%) and elevated transaminases (1%).
Maltese: Avvenimenti avversi mill-kawżalitajiet kollha relatati mal-waqfien permanenti tat-trattament seħħew fi 302 pazjenti (18%) li minnhom, l-iktar frekwenti (≥1%) kienu l-mard interstizjali tal-pulmun (1%) u ż-żieda fittransaminases (1%).
English: It is available in blister packs of 60 hard capsules and in plastic bottles of 60 hard capsules.
Maltese: Huwa disponibbi f'pakketti ta' folji ta' 60 kapsula iebsa u fi fliexken tal-plastik ta' 60 kapsula iebsa.
English: The most serious adverse reactions in 1722 patients with either ALK-positive or ROS1-positive advanced NSCLC were hepatotoxicity, ILD/pneumonitis, neutropenia, and QT interval prolongation (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi serji f'1,722 pazjenti b'NSCLC avvanzat jew pożittiv għall-ALK jew għal ROS1, kienu epatotossiċità, ILD/pulmonite, newtropenija, u titwil tal-intervall QT (ara sezzjoni 4.4).
English: The dose may be increased to 200 mg twice daily based on individual safety and tolerability after at least 4 weeks of treatment (see sections 4.4 and 5.2).
Maltese: Id-doża tista' tiżdied sa 200 mg darbtejn kuljum fuq bażi ta' sigurtà u tolerabilità individwali wara mill-inqas 4 ġimgħat ta' trattament (ara sezzjoni 4.4 u 5.2).
English: XALKORI treatment
Maltese: Trattament b' XALKORI
English: OS is based on the data cutoff date of 31 August 2015. a. The median PFS times were 4.2 months (95% CI: 2.8, 5.7) for pemetrexed (HR=0.59; p-value=0.0004 for crizotinib compared with pemetrexed) and 2.6 months (95% CI: 1.6, 4.0) for docetaxel
Maltese: Iż-żminijet tal-PFS medjana kienu 4.2 xhur (95% CI: 2.8, 5.7) għal pemetrexed (HR=0.59; valur p=0.0004 għal crizotinib meta mqabbel ma' pemetrexed) u 2.6 xhur (95% CI: 1.6, 4.0) għal docetaxel (HR=0.30; valur p <0.
English: • Efavirenz, raltegravir, used to treat HIV infection.
Maltese: • Efavirenz, raltegravir, użati għat-trattament ta' infezzjonijiet bl-HIV.
English: Findings observed in the male reproductive tract included testicular pachytene spermatocyte degeneration in rats given ≥50 mg/kg/day for 28 days (approximately 1.1-fold human clinical exposure based on AUC).
Maltese: Issejbiet osservati fl-apparat riproduttiv tar-raġel kienu jinkludu testicular pachytene spermatocyte degeneration f'firien mogħtija ≥50 mg/kg/jum għal 28 jum (bejn wieħed u ieħor 1.1 darbiet akbar millespożizzjoni klinika tal-bniedem fuq il-bażi tal-AUC).
English: Crizotinib resulted in symptoms benefit by significantly prolonging time to deterioration (median 4.5 months versus 1.4 months) in patients who reported symptoms of pain in chest, dyspnoea, or cough, compared to chemotherapy (HR 0.50; 95% CI: 0.37, 0.66; Hochberg adjusted log-rank p< 0.0001).
Maltese: Crizotinib wassal għal benefiċċju fis-sintomi billi tawwal b'mod sinifikanti ż-żmien sad-deterjorament (żmien medjan ta' 4.5 xhur kontra 1.4 xhur) f'pazjenti li rrapportaw sintomi ta' wġigħ fis-sider, dispneja, jew sogħla , meta mqabbel mal-kimoterapija (HR 0.50; 95% CI: 0.37, 0.66; Log-rank 2-sided aġġustat ta' Hochberg valur p < 0.0001).
English: The median OS at the time of data cutoff was 51.4 months (95% CI: 29.3, NR).
Maltese: L-OS medjana fiż-żmien tal-għeluq tad-dejta kienet ta' 51.4 xhur (95% CI: 29.3, NR).
English: The use of single-agent crizotinib in the treatment of ALK-positive advanced NSCLC was investigated in 2 multinational, single-arm studies (Studies 1001 and 1005).
Maltese: L-użu tas-sustanza unika crizotinib ft-trattament ta' NSCLC avvanzat pożittiv għall-ALK ġie investigat f'2 studji multinazzjonali, bi trattament wieħed (Studji 1001 u 1005).
English: All-causality neuropathy, as defined in Table 3, was experienced by 435 (25%) out of 1722 patients treated with crizotinib.
Maltese: Newropatija ta' kull kawżalità, kif definita f'Tabella 3, kienet esperjenzata minn 435 (25%) minn 1,722 pazjent ittrattati bi crizotinib.
English: The disease characteristics of the overall study population were metastatic disease in 98% of patients, 92% of patients' tumours were classified as adenocarcinoma histology, and 27% of patients had brain metastases.
Maltese: Il-karatteristiċi tal-marda tal-popolazzjoni globali tal-istudju kienu mard metastatiku fi 98% talpazjenti, 92% tat-tumuri tal-pazjenti ġew ikklassifikati bħala istoloġija adenokarċinoma, u 27% talpazjenti kellhom metastasijiet fil-moħħ.
English: For patients who develop QTc prolongation, see sections 4.2, 4.8 and 5.2.
Maltese: Għall-pazjenti li jiżviluppaw titwil tal-QTc, ara sezzjonijiet 4.2, 4.8 u 5
English: The full analysis population included 343 patients with ALK-positive advanced NSCLC as identified by Fluorescence In Situ Hybridization (FISH) prior to randomisation: 172 patients were randomised to crizotinib and 171 patients were randomised to chemotherapy (pemetrexed + carboplatin or cisplatin; up to 6 cycles of treatment).
Maltese: Il-popolazzjoni sħiħa tal-analiżi kienet tinkludi 343 pazjent b'NSCLC avvanzat pożittiv għall-ALK, kif identifikati minn Fluorescence In Situ Hybridization (FISH) qabel l-għażla każwali: 172 pazjent intgħażlu b'mod każwali għal crizotinib u 171 pazjent intgħażlu b'mod każwali għal kimoterapija (pemetrexed + carboplatin jew cisplatin; sa 6 ċikli ta' trattament).
English: All-causality complex renal cysts were experienced by 52 (3%) of 1722 patients treated with crizotinib.
Maltese: Ċesti renali kumplessi f' kull kawżalità, kienu esperjenzati minn 52 (3%) minn 1,722 pazjent ittrattati bi crizotinib.
English: The median DR was 24.7 months (95% CI: 15.2, 45.3).
Maltese: IdDR medjan kien ta' 24.7 xhur (95% CI: 15.
English: The NOAEL for aneugenicity was approximately 1.8-fold human clinical exposure based on AUC.
Maltese: In-NOAEL għallanewġeniċità kien bejn wieħed u ieħor 1.8 darbiet akbar mill-espożizzjoni klinika tal-bniedem fuq ilbażi tal-AUC.
English: In Study 1001, the adjusted geometric mean of plasma Ctrough, ss in mild (N=35) and moderate (N=8) renal impairment patients were 5.1% and 11% higher, respectively, than those in patients with normal renal function.
Maltese: Fi Studju 1001, il-medja ġeometrika aġġustata tas-Ctrough, ss fil-plażma f'pazjenti b'indeboliment ħafif (N=35) u moderat (N=8) tal-kliewi kienet ta' 5.1% u 11% ogħla, rispettivament, minn dik f'pazjenti b'funzjoni normali tal-kliewi.
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized predominantly by UGT1A1 (e.g., raltegravir, irinotecan) or UGT2B7 (e.g., morphine, naloxone).
Maltese: Għalhekk, crizotinib jista' jkollu l-potenzjal li jżid ilkonċentrazzjonijiet fil-plażma ta' mediċini mogħtija fl-istess żmien u li huma ġeneralment metabolizzati minn UGT1A1 (e.ż. raltegravir, irinotecan) jew UGT2B7 (morphine, naloxone).
English: Following single doses of crizotinib, the apparent plasma terminal half-life of crizotinib was 42 hours in patients.
Maltese: Wara dożi waħdanin ta' crizotinib, il-half life terminali apparenti ta' crizotinib fil-plażma kienet ta' 42 siegħa fil-pazjenti.
English: Sixty-five of 89 (73%) patients treated with crizotinib and 11 of 132 (8.3%) patients treated with chemotherapy continued treatment for at least 3 weeks after objective disease progression.
Maltese: Ħamsa u sittin minn 89 (73%) pazjent ittrattati bi crizotinib u 11 minn 132 (8.3%) tal-pazjenti ttrattati bil-kimoterapija, komplew ittrattament għal mill-inqas 3 ġimgħat wara progressjoni oġġettiva tal-marda.
English: Duration of Response Monthsg (95% CI)
Maltese: Tul tar-Rispons Xhurg (95% CI)
English: The systemic crizotinib exposure parameters AUCdaily and Cmax in patients with severe hepatic impairment (N=6) receiving a crizotinib dose of 250 mg once daily were approximately 64.7% and 72.6%, respectively, of those from patients with normal hepatic function receiving a dose of 250 mg twice daily.
Maltese: Il-parametri ta' esponiment sistemiku għal crizotinib AUCkuljum u Cmax f'pazjenti b'indeboliment epatiku sever (N=6) li kienu qed jirċievu doża ta' 250 mg darba kuljum kienu madwar 64.7% u 72.6%, rispettivament, li minnhom pazjenti b'funzjoni epatika normali li kienu qed jirċievu doża ta' 250 mg darbtejn kuljum.
English: In clinical studies, prolonged QT interval was observed with crizotinib.
Maltese: Fi studji kliniċi, ġie osservat intervall QT imtawwal bi crizotinib.
English: f. ORRs were 29% (95% CI: 21, 39) for pemetrexed (p-value <0.0001 compared with crizotinib) and 7% (95%
Maltese: L-ORRs kienu ta' 29% (95% CI: 21, 39) għal pemetrexed (valur p <0.
English: Following the administration of a single 250 mg radiolabeled crizotinib dose to healthy subjects, 63% and 22% of the administered dose was recovered in faeces and urine, respectively.
Maltese: Wara l-amministrazzjoni ta' doża waħda ta' 250 mg crizotinib radiolabeled lil suġġetti b'saħħithom, 63% u 22% tad-doża amministrata ġiet irkuprata fl-ippurgar u l-awrina, rispettivament.
English: In randomised Phase 3 Study 1014, increases to Grade 3 or 4 ALT or AST elevations were observed in 15% and 8% of patients receiving crizotinib versus 2% and 1% of patients receiving chemotherapy.
Maltese: Fi Studju 1014, ta' Fażi 3 b'għażla każwali, żidiet ta' Grad 3 jew 4 fl-ALT jew AST, ġew osservati fi 15% u 8% tal-pazjenti li kienu qed jirċievu crizotinib, kontra 2% u 1% talpazjenti li kienu qed jirċievu kimoterapija.
English: Efficacy data from Study 1007 are summarised in Table 5, and the Kaplan-Meier curves for PFS and OS are shown in Figure 3 and 4, respectively.
Maltese: Id-dejta dwar l-effikaċja mill-Istudju 1007 hija miġbura fil-qosor f'Tabella 5, u l-kurvi ta' KaplanMeier għall-PFS u OS huma murija f'Figuri 3 u 4 rispettivament.
English: Crizotinib showed a significantly greater improvement from baseline compared to chemotherapy in alopecia (Cycles 2 to 15; p-value <0.05), cough (Cycles 2 to 20; p-value <0.0001), dyspnoea (Cycles 2 to 20; p-value <0.0001), haemoptysis (Cycles 2 to 20; p-value <0.05), pain in arm or shoulder (Cycles 2 to 20; p-value <0.0001), pain in chest (Cycles 2 to 20; p-value <0.0001), and pain in other parts (Cycles 2 to 20; p-value <0.05).
Maltese: 0001), l-uġigħ fis-sider (Ċikli 2 sa 20; valur p <0.0001), u l-uġigħ f'partijiet oħra (Ċikli 2 sa 20; valur p <0.05). Crizotinib wassal għal deterjorament sinifikament aktar baxx mil-linja bażi finnewropatija periferali (Ċikli 6 sa 20; valur p <0.05), id-disfaġja (Ċikli 5 sa 11; valur p <0.05) u l-uġigħ fil-ħalq (Ċiklu 2 sa 20; valur p <0.05) meta mqabbel mal-kimoterapija.
English: The starting crizotinib dose for patients with severe hepatic impairment (any AST and total bilirubin >3 × ULN) is recommended to be 250 mg once daily (see section 5.2).
Maltese: Id-doża tal-bidu ta' crizotinib għal pazjenti b'indeboliment epatiku sever (kwalunwke AST u bilirubina totali >3 × ULN) hija rakkomandata li tkun 250 mg darba kuljum (ara sezzjoni 5.2).
English: • Hypophosphataemia (low blood phosphate levels that can cause confusion or muscle weakness).
Maltese: • Ipofosfatimja (livelli baxxi ta' fosfat fid-demm li jistgħu jikkawżaw konfużjoni jew dgħufija fil-muskoli).
English: In a single arm ECG substudy (see section 5.2) using blinded manual ECG measurements 11 (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: F'sottostudju single-arm dwar ECG (ara sezzjoni 5.2) bl-użu ta' kejl manwali blinded tal-ECG 11 (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: A total of 259 (16%) of 1666 patients with at least 1 postbaseline vital sign assessment had a pulse rate <50 bpm.
Maltese: Total ta' 259 (16%) minn 1,666 pazjent b'mill-anqas valutazzjoni tas-sinjali vitali waħda ta' wara l-linja bażi kellhom rata ta' polz ta' <50 bpm.
English: QTc prolongation has been observed in clinical studies in patients treated with crizotinib (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: Ġie osservat titwil tal-QTc fl-istudji kliniċi fuq pazjenti ttrattati bi crizotinib (ara sezzjonijiet 4.8 u 5.2), li jista jwassal għal żieda fir-riskju ta' takiarritmija ventrikulari (e.ż. Torsade de Pointes) jew mewt f'daqqa.
English: Patients with pulmonary symptoms indicative of ILD/pneumonitis should be monitored.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sintomi pulmonari li jindikaw ILD/pulmonite.