FrancophonIA/ELRC3.0 huggingface dataset:
English: This leads to inhibition of cell growth, while showing significantly less activity against EGFR in wild-type cell lines (apparent IC50s from 480 nM to 1.8 μM against phospho-EGFR).
Maltese: Dan iwassal għal inibizzjoni tat-tkabbir taċ-ċelloli, filwaqt li juri attività ferm iktar baxxa kontra EGFR f'linji ta' ċelloli wildtype (IC50s evidenti minn 480 nM sa 1.8 μM kontra phosphoEGFR).
English: This medicine contains < 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
Maltese: Din il-mediċina fiha < 1 mmol sodiun (23 mg) għal kull pillola ta' 40 mg jew 80 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Non-clinical data indicate that osimertinib and its metabolite (AZ5104) inhibit the h-ERG channel, and QTc prolonging effect cannot be excluded.
Maltese: Dejta mhux klinika tindika li osimertinib u l-metabolit tiegħu (AZ5104) jinibixxu l-kanal h-ERG, u leffett ta' titwil tal-QTc ma jistax jiġi eskluż.
English: Unchanged osimertinib accounted for approximately 2% of the elimination with 0.8% in urine and 1.2% in faeces.
Maltese: Osimertinib mhux mibdul jammonta għal madwar 2% tal-eliminazzjoni b'0.8% fl-awrina u 1.2% fl-ippurgar.
English: In a clinical PK study, co-administration of TAGRISSO with rosuvastatin (sensitive BCRP substrate) increased the AUC and Cmax of rosuvastatin by 35% and 72%, respectively.
Maltese: Fi studju kliniku PK, l-għoti flimkien ta' TAGRISSO ma' rosuvastatin (Sottostrat sensittiv ta' BCRP) żid l-AUC u s-Cmax ta' rosuvastatin b'35% u bi 72% , rispettivament.
English: At least 12 components were observed in the pooled urine and faecal samples in humans with 5 components accounting for >1% of the dose of which unchanged osimertinib, AZ5104 and AZ7550, accounted for approximately 1.9, 6.6 and 2.7% of the dose while a cysteinyl adduct (M21) and an unknown metabolite (M25) accounted for 1.5% and 1.9% of the dose, respectively.
Maltese: Tal-inqas 12il komponent kienu osservati fil-kampjuni miġbura tal-awrina u l-ippurgar fi bnedmin b' 5 komponenti li jammontaw għal >1% tad-doża ta' osimertinib mhux mibdula, AZ5104 u AZ7550, ammontaw għal madwar 1.9, 6.6 u 2.7% tad-doża filwaqt li cysteinyl adduct (M21) u metabolit mhux magħruf (M25) ammontaw għal 1.5% u 1.9% tad-doża, rispettivament.
English: Very common (47%) 0.9%
Maltese: Komuni ħafna (47%) 0.9%
English: Of 556 patients, 200 patients had available baseline brain scans.
Maltese: Mill-556 pazjent, 200 pazjent kellhom scans tal-moħħ fil-linja bażi disponibbli.
English: Up to month 9 there were no clinically meaningful differences in patient-reported symptoms between TAGRISSO and EGFR TKI comparator groups (as assessed by a difference of ≥ 10 points).
Maltese: Sa xahar 9 ma kien hemm l-ebda differenza klinikament sinifikanti fis-sintomi rrappurtati mill pazjenti bejn il-gruppi ta' TAGRISSO u tal-komparatur ta' EGFR TKI (kif ivvalutat minn differenzata' ≥10 punti).
English: Interstitial lung disease (ILD)
Maltese: Mard tal-Interstizju tal-Pulmun (ILD)
English: TAGRISSO has not been studied in children or adolescents.
Maltese: TAGRISSO ma ġiex studjat fi tfal jew adolexxenti.
English: The PFS benefit of TAGRISSO compared to EGFR TKI comparator was consistent across all predefined subgroups analysed, including ethnicity, age, gender, smoking history, CNS metastases status at study entry and EGFR mutation type (Exon 19 deletion or L858R).
Maltese: Il-benefiċċju ta' PFS ta' TAGRISSO meta mqabbel mal-komparatur EGFR TKI kien konsistenti fissottogruppi ddefiniti minn qabel analizzati kollha, inkluż l-etniċità, l-età, is-sess, storja ta' tipjip, listatus tal-metastasi ta' CNS mad-dħul fl-istudju u l-mutazzjoni ta' EFGR (tneħħija ta' Exon 19 u L858R).
English: The safety and efficacy of this medicinal product has not been established in patients with end-stage renal disease [creatinine clearance (CLcr) <15 mL/min, calculated by the Cockcroft and Gault equation], or on dialysis.
Maltese: Is-sigurtà u l-effikaċja ta' dan il-prodott mediċinali ma ġewx determinati f'pazjenti b'marda tal-kliewi fi stadju finali [eliminazzjoni tal-kreatinina (CLcr) <15 mL/min, ikkalkolata bl-ekwazzjoni ta' Cockcroft u Gault], jew fuq dijaliżi.
English: • you have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease').
Maltese: • batejt minn inflammazzjonita' pulmuni (kundizzjoni msejħa 'mard tal-interstizju tal-pulmun')
English: • If TAGRISSO is the first protein kinase inhibitor medicine you are receiving, it means that your cancer contains defects in the EGFR gene, for example ‘exon 19 deletions' or ‘exon 21 substitution mutations'.
Maltese: • Jekk TAGRISSO huwa l-ewwel mediċina ta' inibitur ta' protein kinase li qed tirċievi, dan ifisser li l-kanċer tiegħek fih difetti fil-ġene EFGR imsejħa ‘tneħħijiet exon 19' jew ‘mutazzjonijiet ta' sostituzzjoni exon 21'.
English: No arrhythmic events were reported in FLAURA or AURA studies (see section 4.8).
Maltese: FLAURA jew AURA (ara sezzjoni 4.8).
English: The OS analysis was not adjusted for the potentially confounding effects of crossover (94 [67%] patients on the chemotherapy arm received subsequent osimertinib treatment).
Maltese: L-analiżi OS ma ġietx aġġustata għall-effetti potenzjali ta' konfużjoni ta' ‘crossover' (94 [67 %] Pazjenti fuq il-fergħa tal-kimoterapija rċevew kura sussegwenti b'osimertinib).
English: CNS PFS determined by RECIST v1.1by CNS BICR (CNS measurable and non-measurable lesions at baseline by BICR) n=61 for TAGRISSO and n=67 for EGFR TKI comparator; responses are unconfirmed Nominally statistically significant
Maltese: PFS f'CNS iddeterminata permezz ta' RECIST v1.1 permezz ta' CNS BICR (leżjonijiet ta' CNS li jistgħu jitkejlu u li ma jistgħux jitkejlu fil-linja bażi permezz ta' BICR) n=61 għal TAGRISSO u n=67 għall-komparatur EGFR TKI; irrisponsi mhumiex ikkonfermati
English: Includes cases reported within the clustered terms: Dry skin, skin fissures, xerosis, eczema, xeroderma.
Maltese: Tinkludi każijiet irrapportati f'termini miġburin: Ġilda xotta, qsim fil-ġilda, xerożi, ekżema.
English: Patients receiving TAGRISSO 80 mg with low body weight (<50 kg) reported higher frequencies of Grade ≥3 adverse events (52% versus 35%) and QTc prolongation (14% versus 4%) than patients with higher body weight (≥50 kg).
Maltese: Il-pazjenti li rċivew TAGRISSO 80 mg b'piż tal-ġisem baxx (<50 kg) irrappurtaw frekwenzi ogħla ta' avvenimenti avversi ta' Grad ≥3 (52 % kontra 35 %) u titwil tal-QTc (14 % kontra 4%) minn pazjenti b'piż tal-ġisem ogħla (≥50 kg).
English: Efficacy results from AURA3 by investigator assessment
Maltese: Riżultati tal-efffikaċja minn AURA3 minn valutazzjoni tal-investigatur
English: • Modafinil -used for sleep disorders.
Maltese: • Modafinil -użat għad-disturbi tal-irqad.
English: TAGRISSO 40 mg tablets
Maltese: TAGRISSO 40 mg pilloli
English: CNS Progression-free survival
Maltese: Sopravivenza mingħajr progressjoni CNS
English: Second PFS after start of first subsequent therapy (PFS2)
Maltese: It-tieni PFS wara bidu tal-ewwel terapija sussegwenti (PS2)
English: Name and address of the manufacturer responsible for batch release AstraZeneca AB
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott AstraZeneca AB
English: A HR<1 favours TAGRISSO
Maltese: Kif jaħdem TAGRISSO
English: Discuss with your doctor the most appropriate methods of contraception.
Maltese: Iddiskuti mat-tabib tiegħek l-iktar metodi xierqa ta' kontraċezzjoni.
English: In the FLAURA and AURA studies, diarrhoea was reported in 49% of patients of which 39% were Grade 1 events, 8.0% Grade 2 and 1.2% were Grade 3; no Grade 4 or 5 events were reported.
Maltese: Fl-istudji FLAURA u AURA, id-dijarea ġiet irrapportata fi 49% tal-pazjenti li 36.8% kienu episodji ta' Grad 1, 8.0% ta' Grad 2 u 1.2% kienu ta' Grad 3; ma ġie rrapportat ebda episodju ta' Grad 4 jew 5.
English: One event (0.1%) led to discontinuation.
Maltese: Episodju wieħed (0.1%) wassal għal waqfien.
English: TAGRISSO 80 mg tablets
Maltese: TAGRISSO 80 mg pilloli
English: National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Maltese: Kriterji tat-Terminoloġija Komuni għall-Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kanċer, verżjoni 4.0.
English: MedDRA SOC MedDRA term
Maltese: OĦRA, JEKK MEĦTIEĠA
English: The model included patient, treatment, visit, treatment-by-visit interaction, baseline symptom score, and baseline symptom score-by-visit interaction and used an unstructured covariance matrix.
Maltese: Il-mudell inkluda pazjent, kura, vista, interazzjoni kura skont il-vista, punteġġ tas-sintomi fil-linja bażi, u interazzjoni punteġġ tas-sintomi fil-linja bażi skont il-vista u uża matriċi tal-kovarjanza mhux strutturata.
English: Number of patients who had second subsequent treatment or died (%)
Maltese: Numru ta' pazjenti li rċivew it-tieni terapija sussegwenti jew mietu (%)
English: The median duration of follow up for PFS was 12.6 months.
Maltese: Id-dewmien medjan tas-segwitu għal PFS kien ta' 12.6 xhur.
English: Very common (20%) 0.2%
Maltese: Komuni ħafna (20 %) 0.2%
English: Up to month 9, there were no clinically meaningful differences between the TAGRISSO and EGFR TKI comparator groups in functioning or HRQL.
Maltese: Sa xahar 9, ma kien hemm lebda differenza statistikament sinifikanti bejn il-gruppi ta' TAGRISSO u l-komparatur EGFR TKI filfunzjonament jew fl-HRQL.
English: In TAGRISSO clinical trials a limited number of patients were treated with daily doses of up to 240 mg without dose limiting toxicities.
Maltese: Fi studji kliniċi ta' TAGRISSO, numru limitat ta' pazjenti kienu kkurati b'dożi ta' kuljum sa 240 mg mingħajr tossiċitajiet li jillimitaw id-doża.
English: Includes cases reported within the clustered terms: Nail bed disorder, nail bed inflammation, nail bed infection, nail discolouration, nail pigmentation, nail disorder, nail toxicity, nail dystrophy, nail infection, nail ridging, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomalacia, paronychia.
Maltese: Mard tad-dwiefer, disturbi fil-bażi tad-dwiefer, infjammazzjoni fil-bażi tad-dwiefer, infezzjoni fil-bażi tad-dwiefer, tibdil fil-kulur tad-dwiefer, pigmentazzjoni tad-dwiefer,disturb fiddwiefer, tossiċità tad-dwiefer, distrofija tad-dwiefer, infezzjoni tad-dwiefer, ridging tad-dwiefer, onikalġija, onikoklażi, onikoliżi, onikomadeżi, onikomalaċja, paronikja.
English: Case reports of Stevens-Johnson syndrome (SJS) have been reported rarely in association with TAGRISSO treatment.
Maltese: Kien hemm rapporti rari ta' każijiet tas-sindrome ta' Stevens-Johnson (SJS) b'rabta mal-kura b'TAGRISSO.
English: Active substances that may decrease osimertinib plasma concentrations In a clinical pharmacokinetic study in patients, the steady-state AUC of osimertinib was reduced by 78% when co-administered with rifampicin (600 mg daily for 21 days).
Maltese: Sustanzi attivi li jistgħu jnaqqsu l-konċentrazzjonijiet fil-plażma ta' osimertinib Fi studju kliniku farmakokinetiku, l-AUC fi stat fiss ta' osimertinib tnaqqset bi 78% (90% CI 81, 76) meta ngħata ma' rifampicin (600 mg kuljum għal 21 jum).
English: It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M.
Maltese: Huwa inibitur irriversibbli tar-Riċetturi tal-Fattur ta' Tkabbir Epidermali (EGFRs) li kellhom mutazzjonijiet ta' sensitizzazzjoni (EGFRm) u mutazzjoni ta' reżistenza għal TKI T790M.
English: Very common (33%) 0.1%
Maltese: Komuni ħafna (33 %) 0.1%
English: Patients were randomised in a 2:1 (TAGRISSO: platinum-based doublet chemotherapy) ratio to receive TAGRISSO (n=279) or platinum-based doublet chemotherapy (n=140).
Maltese: Il-pazjenti ġew randomizzati fi proporzjon 2:1 (TAGRISSO: kimoterapija doublet ibbażata fuq ilplatinu) biex jirċievu TAGRISSO (n=279) jew kimoterapija doublet ibbażata fuq il-platinu (n=140).
English: CNS Progression-free survival Number of Events (%) Median, Months (95% CI)
Maltese: Sopravivenza mingħajr progressjoni f'CNS Numru ta' Avvenimenti (%) Medjana, Xhur (95% CI)
English: TAGRISSO 40 mg tablets osimertinib
Maltese: TAGRISSO 40 mg pilloli osimertinib
English: Data is cumulative from FLAURA and AURA (AURA3, AURAex, AURA 2 and AURA1) studies; only events for patients receiving at least one dose of TAGRISSO as their randomised treatment are summarised.
Maltese: FLAURA u AURA (AURA3, AURAex, AURA 2 u AURA 1); huma miġburin filqosor biss dawk l-avvenimenti għal pazjenti li qegħdin jirċievu tal-inqas doża waħda ta' TAGRISSO bħala l-kura fortuwita tagħhom.
English: Based on in vitro studies, osimertinib is a substrate of P-gp and BCRP, but is unlikely to result in clinically relevant drug interactions with active substances by osimertinib at the clinical doses.
Maltese: Abbażi ta' studji in vitro , osimertinib huwa sottostrat ta' P-gp u BCRP, iżda mhuwiex probabbli li jirriżulta f'interazzjonijiet klinikament rilevanti ma' mediċini b'sustanzi attivi b'osimertinib f'dożi kliniċi (ara sezzjoni 4.5).
English: Taking the extremes of body weight into consideration, from <43 kg to >88 kg, AZ5104 metabolite ratios ranged from 11.8% to 9.6% while for AZ7550 it ranged from 12.8% to 8.1%, respectively.
Maltese: Jekk jitqiesu l-livell estremi ta' piż tal-ġisem, minn <43 kg sa >88 kg, il-proporzjonijiet tal-metabolit AZ5104 varjaw minn 11.8% sa 9.6% filwaqt li għal AZ7550 varjaw minn 12.8% sa 8.1 %, rispettivament.
English: One event was reported in a post-marketing study, and the frequency has been derived from the FLAURA and AURA studies and the post-marketing study (N=4720).
Maltese: Avveniment wieħed kien irrapportat fi studju wara t-tqegħid fis-suq, u l-frekwenza ġiet derivata mill-istudji FLAURA u AURA u mill-istudju wara t-tqegħid fis-suq (N=4720).
English: Objective response rates by BICR above 50% were observed in all predefined subgroups analysed, including line of therapy, ethnicity, age and region.
Maltese: Rati ta' rispons oġġettivi mill-BICR ta' iktar minn 50% kienu osservati fis-sottogruppi ddefiniti minn qabel kollha li ġew analizzati, inkluż il-linja ta' terapija, l-etniċità, l-età u r-reġjun.
English: Represents the incidence of patients who had a QTcF prolongation >500msec.
Maltese: k Tirrappreżenta l-inċidenza tal-pazjenti li kellhom titwil fl-intervall QTcF>500 msec.
English: TAGRISSO 80 mg tablets osimertinib
Maltese: TAGRISSO 80 mg pilloli osimertinib
English: This medicine contains 0.3 mg sodium per 40 mg tablet and 0.6 mg sodium per 80 mg tablet.
Maltese: Din il-mediċina fiha 0.3 mg sodium għal kull pillola ta' 40 mg u 0.6 mg sodium għal kull pillola ta' 80 mg.
English: Number of responses, Response Rate (95% CI)
Maltese: Numru ta' risponsi, Rata ta' Rispons (95 % CI)
English: Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in AURA3
Maltese: PFS globali mill-valutazzjoni tal-investigatur mill-istatus tal-metastasi ta' CNS maddħul fl-istudju, plott Kaplan-Meier (sett ta' analiżi sħiħa) f'AURA3
English: The QTc interval prolongation potential of TAGRISSO was assessed in 210 patients who received osimertinib 80 mg daily in AURA2.
Maltese: Il-potenzjal ta' titwil fl-intervall QTc ta' TAGRISSO kien ivvalutat f'210 pazjenti li rċevew osimertinib 80 mg darba kuljum f'AURA2.
English: QTc interval prolongation
Maltese: Titwil fl-intervall QTc
English: A BICR assessment of CNS efficacy by RECIST v1.1 in the subgroup of 116/419 (28%) patients identified to have CNS metastases on a baseline brain scan are summarised in Table 6.
Maltese: Valutazzjoni BICR tal-effikaċja ta' CNS minn RECIST v1.1 fis-sottogrupp ta' 116/419 (28 %) pazjenti identifikati li għandhom metastasi CNS fi scan tal-moħħ fil-linja bażi huma miġbura fil-qosor f'Tabella 9.
English: In a population based pharmacokinetic analyses (n=1367), no clinically significant relationships were identified between predicted steady-state exposure (AUCss) and patient's age (range: 25 to 91 years), gender (65% female), ethnicity (including White, Asian, Japanese, Chinese and non-Asian-non-White patients), line of therapy and smoking status (n=34 current smokers, n=419 former smokers).
Maltese: F'analiżijiet farmakokinetiċi bbażati fuq il-popolazzjoni (n=1367), ma ġew identifikati l-ebda relazzjonijiet klinikament sinifikanti bejn l-espożizzjoni fi stat fiss imbassra (AUCss) u l-età talpazjent (medda: 25 sa 91 sena), sess (65 % nisa), etniċità (inkluż pazjenti Bojod, Asjatiċi, Ġappuniżi, Ċiniżi u li la huma bojod u lanqas Asjatiċi), linja ta' terapija u jekk il-pazjent ipejjipx jew le (n=34 li bħalissa jpejpu, n=419 li qabel kienu jpejpu).
English: Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in FLAURA
Maltese: PFS globali mill-valutazzjoni tal-investigatur mill-istatus tal-metastasi ta' CNS maddħul fl-istudju, plott Kaplan-Meier (sett ta' analiżi sħiħa) f'FLAURA
English: Intestinal inhibition of UGT1A1 is possible but the clinical impact is unknown.
Maltese: L-inibizzjoni intestinali ta' UGT1A1 hija possibbli iżda l-impatt kliniku mhuwiex magħruf.
English: Patients with CLcr less than 15 mL/min were not included in the clinical trials.
Maltese: Il-pazjenti b'CLcr ta' inqas minn 15 mL/min ma ġewx inklużi fil-provi kliniċi.
English: CNS metastases efficacy data in Phase 2 studies (AURAex and AURA2) A BICR assessment of CNS efficacy by RECIST v 1.1 was performed in a subgroup of 50 (out of 411) patients identified to have measurable CNS metastases on a baseline brain scan.
Maltese: 2 (AURAex u AURA2) Saret valutazzjoni BICR tal-effikaċja ta' CNS minn RECIST v 1.1 f'sottogrupp ta' 50 (minn 411) pazjent identifikati li kellhom metastasi tas-CNS li setgħet titkejjel bi scan tal-moħħ fil-linja bażi.
English: Includes cases reported within the clustered terms: Keratitis, punctate keratitis, corneal erosion, corneal epithelium defect.
Maltese: Keratite, keratite ‘punctuate', tnawwir korneali, difett fl-epitelju korneali.
English: In the evaluable for response population, 85% (223/262) had documentation of response at the time of the first scan (6 weeks); 94% (247/262) had documentation of response at the time of the second scan (12 weeks).
Maltese: Fil-popolazzjoni evalwabbli għal rispons, 85 % (223/262) kellhom dokumentazzjoni ta' rispons fiżżmien meta sar l-ewwel scan (6 ġimgħat); 94% (247/262) kellhom dokumentazzjoni ta' rispons fiżżmien meta sar it-tieni scan (12-il ġimgħa).
English: Based on population PK analysis, serum albumin was identified as a significant covariate with a <30% change in osimertinib AUCss expected across the albumin range of 29 to 46 g/L respectively (95% to 5% quantiles) when compared to the AUCss for the median baseline albumin of 39 g/L.
Maltese: Abbażi tal-analiżi tal-PK tal-popolazzjoni, serum albumin ġie identifikat bħala kovarjat sinifikanti b'bidla ta' <30% fl-AUC ss ta' osimertinib mistenni fil-medda ta' albumina ta' 29 sa 46 g/L rispettivament (quantiles ta' 95 % sa 5 %) meta mqabbel mal-AUC ss għallmedjan ta' albumina fil-linja bażi ta' 39 g/L.
English: Clinical studies have not been conducted in patients with de novo EGFR T790M mutation-positive NSCLC.
Maltese: Ma twettqux studji kliniċi fil-pazjenti b'NSCLC pożittiva għal mutazzjoni T790M ta' EGFR de novo.
English: This analysis demonstrated a consistent treatment effect (HR 0.28; 95% CI: 0.20, 0.38) with that observed by investigator assessment.
Maltese: Din l-analiżi wriet effett konsistenti tal-kura (HR 0.28; 95 % CI: 0.20, 0.38) meta mqabbel ma' dak osservat mill-valutazzjoni tal-investigatur.
English: CNS progression free and alive at 6 months (%) (95% CI) CNS progression free and alive at 12
Maltese: CNS mingħajr progressjoni u ħajjin wara 6 xhur (%) (95% CI) CNS mingħajr progressjoni u ħajjin wara 12-il xahar (%) (95% CI)
English: Grade 3 or higher adverse reaction Withhold TAGRISSO for up to 3 weeks If Grade 3 or higher adverse reaction improves to Grade 0-2 after withholding of TAGRISSO for up to
Maltese: Jekk reazzjoni avversa ta' Grad 3 jew ogħla titjieb għal Grad 0-2 wara li twaqqaf TAGRISSO għal sa 3 ġimgħat
English: Clinical studies that were conducted excluded patients with AST or ALT >2.5x upper limit of normal (ULN), or if due to underlying malignancy, >5.0x ULN or with total bilirubin >1.5x ULN.
Maltese: L-istudji kliniċi li twettqu eskludew pazjenti b'limitu ta' fuq tan-normal (Upper Limit of Normal, ULN) ta' >2.5x AST jew ALT jew jekk minħabba tumur malinn, >5.0x ULN jew b'bilirubina totali ta' >1.5x ULN.
English: Median PFS2, months (95% CI)
Maltese: PFS2 medjana, xhur (95 % CI)
English: The main metabolic pathway of osimertinib was oxidation and dealkylation.
Maltese: Il-passaġġ metaboliku ewlieni ta' osimertinib kienu l-ossidazzjoni u d-dejalkilazzjoni.
English: Adverse reactions reported in FLAURA and AURA studies
Maltese: Tabella 2: Reazzjonijiet avversi f'studji FlAURA u AURA
English: In FLAURA and AURA3 the median time to onset was 19 days and 22 days, respectively, and the median duration of the Grade 2 events was 19 days and 6 days, respectively.
Maltese: F' FLAURA u AURA3, il-ħin medjan għall-feġġa kien ta' 19 il-jum u 22 jum rispettivament u d-durata medjana tal-episodji ta' Grad 2 kienet ta' 19 il-jum u 6 jiem rispettivament
English: In the FLAURA and AURA studies, the incidence of ILD was 10.4% in patients of Japanese ethnicity, 1.8% in patients of non-Japanese Asian ethnicity and 2.8% in non-Asian patients.
Maltese: Fl-istudji FLAURA u AURA, l-inċidenza ta' ILD kienet ta' 10.4 % fil-pazjenti ta' etniċità Ġappuniża, 1.8 % f'pazjenti ta' etniċità Asjatika mhux Ġappuniża u 2.8 % f'pazjenti mhux Asjatiċi.
English: Following a single oral dose of 20 mg, 67.8% of the dose was recovered in faeces (1.2% as parent) while 14.2% of the administered dose (0.8% as parent) was found in urine by 84 days of sample collection.
Maltese: Wara doża orali waħda ta' 20 mg, 67.8% tad-doża kienet irkuprata fl-ippurgar (1.2% bħala ewlenija) filwaqt li 14.2% tad-doża mogħtija (0.8% bħala ewlenija) instabet fl-awrina sa 84 jum mill-ġbir talkampjun.
English: TAGRISSO as monotherapy is indicated for:
Maltese: TAGRISSO bħala monoterapija huwa indikat għal:
English: The baseline demographic and disease characteristics of the overall study population were: median age 62, ≥75 years old (15%), female (64%), white (32%), Asian (65%), never smoker (68%), WHO performance status 0 or 1 (100%).
Maltese: Il-karatteristiċi demografiċi u tal-marda fil-linja bażi tal-popolazzjoni globali tal-istudju kienu: età medjana ta' 62, ≥75 sena (15 %), nisa (64 %),bojod (32 %), Asjatiċi (65 %), qatt ma pejpu (68 %), status ta' prestazzjoni tal-WHO 0 jew 1 (100 %).
English: Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g. pneumonitis) were reported in 3.9% and were fatal in 0.4% of the 1142 patients who received TAGRISSO in FLAURA and AURA studies.
Maltese: Mard tal-Interstizju tal-Pulmun (ILD) jew reazzjonijiet avversi qishom ta' ILD (eż. pnewmonite) kienu rraportati fi 3.9 % u kienu fatali f'0.4 % tat-1142 pazjent li rċevew TAGRISSO fl-istudji FLAURA u AURA.
English: In the subset of patients without CNS lesions at baseline, there were a lower number of new CNS lesions in the TAGRISSO arm compared to the EGFR TKI comparator arm (7/226 [3.1%] vs. 15/214 [7.0%], respectively).
Maltese: Fis-sottosett ta' pazjenti mingħajr leżjonijiet ta' CNS fil-linja bażi, kien hemm numru aktar baxx ta' leżjonijiet ġodda ta' CNS fil-fergħa ta' TAGRISSO meta mqabbel mal-fergħa tal-komapratur EGFR TKI (7/226 [3.1%] vs. 15/214 [7.0%], rispettivament).
English: • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Maltese: • il-kura tal-ewwel linja ta' pazjenti adulti b'kanċer tal-pulmun b'ċelloli mhux żgħar (non-small-cell lung cancer, NSCLC) lokalment avvanzat jew metastatiku b'attivazzjoni ta' mutazzjonijiet tarriċettur tal-fattur tat- tkabbir eipdermali (epidermal growth factor receptor, EGFR).
English: • TAGRISSO may interfere with how well oral hormonal contraceptives work.
Maltese: • TAGRISSO jista' jinterferixxi ma' kemm jaħdmu tajjeb il-kontraċettivi ormonali orali.