FrancophonIA/ELRC3.0 huggingface dataset:
English: TAGRISSO improved patient-reported lung cancer symptoms compared to chemotherapy by demonstrating a statistically significant difference in mean change from baseline versus chemotherapy during the overall time period from randomisation until 6 months for 5 pre-specified primary PRO symptoms (appetite loss, cough, chest pain, dyspnoea, and fatigue) as shown in Table 7.
Maltese: TAGRISSO tejjeb is-sintomi tal-kanċer tal-pulmun irrappurtati mill-pazjenti meta mqabbla malkimoterapija billi wera differenza statistikament sinifikanti fil-bidla medja mil-linja bażi kontra lkimoterapija matul il-perjodu ta' żmien globali mir-randomizzazzjoni sa 6 xhur għal 5 sintomi PRO primarji speċifikati minn qabel (nuqqas ta' aptit, sogħla, uġigħ fis-sider, dispnea u għeja) kif muri f'Tabella 7.
English: Very common (17%) 0.1%
Maltese: Komuni ħafna (17 %) 0.1%
English: How to store TAGRISSO 6.
Maltese: Kif taħżen TAGRISSO 6.
English: Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g. QTc interval greater than 470 ms) were excluded from these studies (see section 4.8).
Maltese: Il-pazjenti b'anormalitajiet klinikament importanti fir-ritmu u l-konduzzjoni kif imkejjel minn elettrokardjogramma fi stat ta' mistrieħ (Electrocardiogram, ECG) (eż. intervall QTc ta' iktar minn 470 ms) kienu esklużi minn dawn l-istudji (ara sezzjoni 4.8).
English: Based on population PK analysis, there was no relationship between markers of hepatic function (ALT, AST, bilirubin) and osimertinib exposure.
Maltese: Abbażi tal-analiżi PK tal-popolazzjoni, ma kien hemm ebda relazzjoni bejn il-markaturi tal-funzjoni tal-fwied (ALT, AST, bilirubina) u l-espożizzjoni għal osimertinib.
English: CNS Duration of Response
Maltese: Durata tar-Rispons ta' CNS
English: CNS Objective Response Rate and Duration of Response determined by RECIST v1.1 by CNS BICR in the evaluable for response population (CNS measurable lesions at baseline by BICR) n=30 for TAGRISSO and n=16 for Chemotherapy
Maltese: Ir-Rata' Rispons Oġġettiva u d-Durata tar-Rispons CNS huma ddeterminati minn RECIST v1.1 minn CNS BICR fil-popolazzjoni ta' rispons evalwabbli (leżjonijiet CNS li jistgħu jitkejlu fil-linja bażi minn BICR) n=30 għal TAGRISSO u n=16 għall-Kimoterapija
English: Strong CYP3A4 inducers can decrease the exposure of osimertinib.
Maltese: Indutturi qawwija ta' CYP3A4 jistgħu jnaqqsu l-espożizzjoni ta' osimertinib.
English: Osimertinib should be permanently discontinued in patients who develop QTc interval prolongation in combination with any of the following: Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia.
Maltese: Torsade de pointes, takikardija ventrikulari polimorfika, sinjali/sintomi ta' arritmija serja.
English: Baseline characteristics of the overall study population (AURAex and AURA2) were as follows: median age 63 years, 13% of patients were ≥75 years old, female (68%), White (36%), Asian (60%).
Maltese: Il-karatteristiċi fil-linja bażi tal-popolazzjoni globali tal-istudju (AURAex u AURA2) kienu kif ġej: età medjana ta' 63 sena, 13% tal-pazjenti kienu ≥75 sena, nisa (68%), Bojod (36%), Asjatiċi (60%).
English: Based on clinical studies, no dose adjustments are necessary in patients with mild hepatic impairment (Child Pugh A) or moderate hepatic impairment (Child Pugh B).
Maltese: Abbażi ta' studji kliniċi, mhu meħtieġ l-ebda aġġustament fid-doża f'pazjenti b'indeboliment ħafif talfwied (Child Pugh A) jew indeboliment moderat tal-fwied (Child Pugh B).
English: Chemotherapy
Maltese: Pulmonari
English: Uncommon (0.7%)
Maltese: Mhux komuni (0.7 %) 0.1 %
English: Kaplan-Meier curves of Progression-Free Survival as assessed by investigator in AURA3
Maltese: Figura 3. Il-kurvi ta' Kaplan-Meier ta' Sopravivenza Mingħajr Progressjoni mill-investigatur f'AURA3
English: Fifty-nine percent (59%) of patients had extra-thoracic visceral metastasis including 39% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery and/or prior radiotherapy to CNS metastases) and 29% with liver metastases.
Maltese: Disgħa u ħamsin fil-mija (59 %) tal-pazjenti kellhom mestastasi vixxerali estratoraċika inkluż 39 % b'metastasi tas-CNS (identifikata mis-sit tal-leżjoni CNS fil-linja bażi, storja medika, u/jew qabel il-kirurġija u/jew qabel ir-radjoterapija għall-metastasi CNS) u 29 % b'metastasi tal-fwied.
English: Based on patients with response only; DoR defined as the time from the date of first documented response (complete response or partial response) until progression or death event; DCR definedas the proportion of patients with response (complete response or partial response), or stable disease ≥ 6 weeks CNS Progression Free Survival determined by RECIST v1.1 by CNS BICR in the full analysis set population (CNS measurable and non-measurable lesions at baseline by BICR) n=75 for TAGRISSO and n=41 for Chemotherapy
Maltese: Ibbażata fuq pazjenti b'rispons biss; DoR iddefinita bħala l-ħin mid-data tal-ewwel rispons iddokumentat (rispons komplet jew rispons parzjali) sa progressjoni jew avveniment ta' mewt; DCR iddefinita bħala lproporzjon tal-pazjenti b'rispons (rispons komplet jew parzjali), jew marda stabbli ≥ 6 ġimgħat Sopravivenza Mingħajr Progressjoni CNS iddeterminata minn RECIST v1.1 minn CNS BICR fil-grupp ta' popolazzjoni tal-analiżi sħiħa (leżjonijiet tas-CNS li jistgħu jitkejlu u li ma jistgħux jitkejlu fil-linja bażi minn BICR) n=75 għal TAGRISSO u n=41 għall-Kimoterapija HR<1 jiffavorixxi TAGRISSO
English: These patients received TAGRISSO at a dose of 80 mg daily in two randomised Phase 3 studies (FLAURA, first line and AURA3, second line only), two single-arm studies (AURAex and AURA2, second line or greater) and one Phase 1 study (AURA1, first-line or greater) (see section 5.1).
Maltese: Dawn il-pazjenti rċivew TAGRISSO f'doża ta' 80 mg kuljum f' żewġ studji ta' Fażi 3 randomizzat (FLAURA, l-ewwel linja u AURA3tieni linja biss), żewġ studji ta' fergħa waħda (AURAex u AURA2-tieni linja jew akbar) u studju wieħed ta' Fażi 1 (ara sezzjoni 5.1).
English: At baseline, no differences in patient reported symptoms, function or HRQL were observed between TAGRISSO and EGFR TKI comparator (gefitinib or erlotinib) arms.
Maltese: Fil-linja bażi, ma ġiet osservata l-ebda differenza bejn is-sintomi rrappurtati, il-fuznjoni jew l-HRQL bejn il-fergħat ta' TAGRISSO u tal-komparatur EGFR TKI (gefitinib jew erlotinib).
English: Additional efficacy outcome measures included ORR, DoR and overall survival (OS) as assessed by investigator.
Maltese: Il-miżuri addizzjonali tal-eżitu tal-effikaċja inkludew ORR, DoR u sopravivenza globali (OS, overall survival) kif ivvalutati mill-investigatur.
English: Median TFST, months (95% CI)
Maltese: TFST medjan, xhur (95 % CI)
English: Across clinical trials, Left Ventricular Ejection Fraction (LVEF) decreases greater than or equal to 10% and a drop to less than 50% occurred in 3.9% (35/908) of patients treated with TAGRISSO who had baseline and at least one follow-up LVEF assessment.
Maltese: Fil-provi kliniċi, il-Frazzjoni tal-Ħruġ Ventrikolari tax-Xellug (LVEF, Left Ventricular Ejection Fraction) titnaqqas iktar minn jew daqs 10 % u seħħ tnaqqis sa inqas minn 50 % f'3.9 % (35/908) talpazjenti kkurati b'TAGRISSO li kellhom linja bażi u tal-inqas valutazzjoni waħda ta' segwitu talLVEF.
English: Seventy-two percent (72%) of patients were never smokers, 100% of patients had a World Health Organization (WHO) performance status of 0 or 1.
Maltese: Tnejn u sebgħin fil-mija (72%) tal-pazjenti qatt ma kienu pejpu qabel, 100% tal-pazjenti kellhom status ta' prestazzjoni tal-Organizzazzjoni Dinjija tas-Saħħa (WHO) ta' 0 jew 1.
English: Active substances that may increase osimertinib plasma concentrations In vitro studies have demonstrated that the Phase I metabolism of osimertinib is predominantly via CYP3A4 and CYP3A5.
Maltese: Sustanzi attivi li jistgħu jżidu l-konċentrazzjonijiet fil-plażma ta' osimertinib Studji in vitro urew li l-metaboliżmu ta' Fażi I ta' osimertinib prinċipalment isir permezz ta' CYP3A4 u CYP3A5.
English: Do not take TAGRISSO if:
Maltese: TAGRISSO Le:
English: Clinically meaningful improvements in PFS with HRs less than 0.50 in favour of patients receiving TAGRISSO compared to those receiving chemotherapy were consistently observed in all predefined subgroups analysed, including ethnicity, age, gender, smoking history and EGFR mutation (Exon 19 deletion and L858R).
Maltese: Titjib klinikament sinifikanti fil-PFS b'HRs ta' inqas minn 0.50 favur il-pazjenti li kienu qed jirċievu TAGRISSO meta mqabbel ma' dawk li kienu qed jirċievu l-kimoterapija ġew osservati b'mod konsistenti fis-sottogruppi definiti minn qabel analizzati kollha, inkluż, l-etniċità, l-età, is-sess, storja ta' tipjip, u l-mutazzjoni ta' EFGR (tneħħija ta' Exon 19 u L858R)
English: Irrespective of CNS lesion status at study entry, patients in the TAGRISSO arm demonstrated an efficacy benefit over those in the EGFR TKI comparator arm and there were fewer patients with new CNS lesions in the TAGRISSO arm compared to the EGFR TKI comparator arm (TAGRISSO, 11/279 [3.9%] compared to EGFR TKI comparator, 34/277 [12.3%]).
Maltese: Irrispettivament mill-istatus ta' leżjoni ta' CNS mad-dħul fl-istudju, il-pazjenti fil-fergħa ta' TAGRISSO wrew benefiċċju tal-effikaċja fuq dawk fil-fergħa tal-komparatur EGFR TKI u kien hemm inqas pazjenti b'leżjonijiet ġodda ta' CNS fil-fergħa ta' TAGRISSO meta mqabbel mal-fergħa tal-komapratur EGFR TKI (TAGRISSO, 11/279 [3.9%] meta mqabbel mal-komparatur EGFR TKI, 34/277 [12.3%]).
English: Osimertinib did not cause genetic damage in in vitro and in vivo assays.
Maltese: Osimertinib ma kkawżax ħsara ġenetika f'assaġġi in vitro u in vivo.
English: The AUC and Cmax increased dose proportionally over 20 to 240 mg dose range.
Maltese: L-AUC u s-Cmax żdiedu b'mod proporzjonali fil-medda tad-doża ta' 20 sa 240 mg.
English: Treatment should be withheld in patients who develop a QTc interval greater than 500 msec on at least 2 separate ECGs until the QTc interval is less than 481 msec or recovery to baseline if the QTc interval is greater than or equal to 481 msec, then resume TAGRISSO at a reduced dose as described in Table 1.
Maltese: Il-kura għandha titwaqqaf f'pazjenti li jiżviluppaw intervall QTc ta' iktar minn 500 msec f'tal-inqas 2 ECGs separati sakemm l-intervall ta' QTc ikun inqas minn 481 msec jew irkupru sal-linja bażi jekk l-intervall QTc ikun iktar minn jew ugwali għal 481 msec, imbagħad kompli TAGRISSO f'doża mnaqqsa kif deskritt fit-Tabella 1.
English: Very common (31%) 0.3%
Maltese: Komuni ħafna (31 %) 0.3%
English: For patients receiving EGFR TKI comparator, post-progression crossover to open-label TAGRISSO was permitted provided tumour samples tested positive for the T790M mutation.
Maltese: Għal pazjenti li kienu qed jirċievu komparatur EGFR TKI, qlib wara l-progressjoni għal TAGRISSO open-label ġie permess diment li l-kampjuni tat-tumur kienu jittestjaw pożittivi għall-mutazzjoni T790M.
English: TAGRISSO 80 mg tablets Each tablet contains 80 mg osimertinib (as mesylate).
Maltese: TAGRISSO 80 mg pilloli Kull pillola fiha 80 mg osimertinib (bħala mesylate).
English: In repeat dose toxicity studies, an increased incidence of anoestrus, corpora lutea degeneration in the ovaries and epithelial thinning in the uterus and vagina were seen in rats exposed to osimertinib for ≥1 month at clinically relevant plasma concentrations.
Maltese: Fi studji dwar it-tossiċità b'doża ripetuta, żieda fl-inċidenża ta' anoestrus, deġenerazzjoni ta' corpora lutea flovarji u traqqiq epiteljali fl-utru u fil-vaġina kienet osservata fil-firien esposti għal osimertinib għal ≥1 xahar f'konċentrazzjonijiet klinikament rilevanti fil-plażma.
English: A BICR assessment of these scans resulted in a subgroup of 128/556 (23%) patients with CNS metastases and these data are summarised in Table 4.
Maltese: Valutazzjoni BICR ta' dawn l-iscans irriżultat fis-sottogrupp ta' 128/556 (23 %) pazjenti b'metastasi ta' CNS u din id-dejta hija miġbura fil-qosor f'Tabella 6.
English: TAGRISSO 80 mg is supplied as beige, film-coated, oval and biconvex tablets, marked with “AZ” and “80” on one side, and plain on the other.
Maltese: TAGRISSO 80 mg jiġi bħala pilloli ta' kulur kafellatte, miksijin b'rita, ovali u bikonvessi, immarkati b'"AZ" u "80" fuq naħa waħda, u xejn fuq in-naħa l-oħra.
English: Each tablet contains 80 mg osimertinib (as mesylate).
Maltese: Kull pillola fiha 80 mg osimertinib (bħala mesylate).
English: Kaplan-Meier Curves of Progression-Free Survival as assessed by investigator in FLAURA
Maltese: Il-kurvi ta' Kaplan-Meier ta' Sopravivenza Mingħajr Progressjoni kif ivvalutata millinvestigatur f'FLAURA
English: months (%) (95% CI)
Maltese: Stmata (95 %C
English: Odds ratio (95% CI); P-value
Maltese: Proporzjon ta' odds (95 % CI); valur-P
English: Of the 1142 patients in FLAURA and AURA studies treated with TAGRISSO 80 mg, 0.9% of patients (n=10) were found to have a QTc greater than 500 msec, and 3.6% of patients (n=41) had an increase from baseline QTc greater than 60 msec. A pharmacokinetic/pharmacodynamic analysis with TAGRISSO predicted a concentration-dependent increase in QTc interval prolongation.
Maltese: AURA kkurati b'TAGRISSO 80 mg, 0.9 % tal-pazjenti (n=10) instab li għandhom QTc ta' iktar minn 500 msec, u 3.6 % tal-pazjenti (n=41) kellhom żieda mill-QTc fil-linja bażi ta' iktar min 60 msec.
English: A greater proportion of patients treated with TAGRISSO were alive at 12 months and 18 months (89% and 83%, respectively) compared to patients treated with EGFR TKI comparator (83% and 71%, respectively).
Maltese: Proporzjon akbar ta' pazjenti kkurati b'TAGRISSO kienu ħajjin wara 12-il xahar u 18-il xahar (89% u 83%, rispettivament) meta mqabbe; ma' pazjenti kkurati bil-komparatur EGFR TKI (83% u 71%, rispettivament).
English: Analysis of post-progression end-points demonstrated that the PFS benefit was preserved through subsequent lines of therapy.
Maltese: Analiżi ta' end-points ta' wara l-progressjoni wriet li l-benefiċċju tal-PFS inżamm matul il-linji sussegwenti ta' terapija.
English: Key lung cancer symptoms analysis
Maltese: Analiżi tas-sintomi ewlenin tal-kanċer tal-pulmun
English: Randomisation was stratified by ethnicity (Asian and non-Asian).
Maltese: Ir-randomizzazzjoni ġiet stratifikata skont l-etniċità (Asjatiċi u mhux Asjatiċi).
English: Data collected from baseline up to month 9 showed similar improvements in TAGRISSO and EGFR TKI comparator groups for the five pre-specified primary PRO symptoms (cough, dyspnoea, chest pain, fatigue, and appetite loss) with improvement in cough reaching the established clinically relevant cutoff.
Maltese: Dejta miġbura mil-linja bażi sa xahar 9 uriet titjib simili fil-gruppi ta' TAGRISSO u tal-komparatur EGFR TKI għall-ħames stinomi PRO primarji speċifikati minn qabel (sogħla,dispnea, uġigħ fis-sider, għeja u nuqqas ta' aptit) b'titjib fis-sogħla li laħqet il-cut off rilevanti klinikament rilevanti stabbilit.
English: The ORR by BICR in AURAex was 62% (95% CI: 55, 68) and 70% (95% CI: 63, 77) in AURA2.
Maltese: Fil-pazjenti b'rispons ikkonfermat mill-BICR, id-DoR medjana kienet ta' 12.5 xhur (95% CI: 11.1, NE). L-ORR mill-BICR f'AURAex kienet ta' 62 % (95 % CI: 55, 68) u ta' 70 % (95 % CI: 63, 77) f'AURA2.
English: These effects were seen at a maternally tolerated dose of 20 mg/kg where exposure was equivalent to the human exposure at the recommended dose of 80 mg daily (based on total AUC).
Maltese: Dawn l-effetti kienu osservati f'doża ttollerata sew mill-omm ta' 20 mg/kg fejn espożizzjoni kienet ekwivalenti għall-espoiżizzjoni tal-bniedem fiddoża rakkomandata ta' 80 mg kuljum (abbażi tal-AUC totali).
English: Following oral administration of TAGRISSO, peak plasma concentrations of osimertinib were achieved with a median (min-max) tmax of 6 (3-24) hours, with several peaks observed over the first 24 hours in some patients.
Maltese: Wara l-għoti orali ta' TAGRISSO, l-ogħla konċentrazzjonijiet fil-plażma ta' osimertinib intlaħqu b'tmax medjan (minimu-massimu) ta' 6 (3 - 24) sigħat, b'diversi livelli massimi osservati fl-ewwel 24 siegħa f'xi pazjenti.
English: Pulmonary ILD/Pneumonitis
Maltese: ILD/Pnewmonite
English: Dose modification
Maltese: Modifika fid-doża
English: • Rosuvastatin - used to lower cholesterol.
Maltese: • Rosuvastatin -li jintuża biex inaqqas il-kolesterol.
English: Each tablet contains 40 mg osimertinib (as mesylate).
Maltese: Kull pillola fiha 40 mg osimertinib (bħala mesylate).
English: Beige, 9 mm, round, biconvex tablet, debossed with “AZ” and “40” on one side and plain on the reverse.
Maltese: Pillola ta' kulur kafellatte, ta' 9 mm, tonda, bikonvessa, imnaqqxa b'“AZ” u “40” fuq naħa waħda u xejn fuq in-naħa l-oħra
English: Efficacy results from FLAURA by investigator assessment
Maltese: Tabella 3. Riżultati tal-efffikaċja minn FLAURA minn valutazzjoni tal-investigatur
English: Patient-reported symptoms and health-related quality of life (HRQL) were electronically collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Maltese: Is-sintomi rrappurtati mill-pazjenti u l-kwalità tal-ħajja relatata mas-saħħa (HRQL, health-related quality of life) inġabru b'mod elettroniku bl-użu tal-EORTC QLQ-C30 u l-modulu tal-kanċer talpulmun tiegħu (EORTC
English: HR=Hazard Ratio; CI=Confidence Interval, NC=Not Calculable, NS=Not Statistically Significant All efficacy results based on RECIST investigator assessment
Maltese: HR=Propozjon ta' Periklu; CI=intervall ta' kunfidenza; NC=ma jistax jiġi kkalkulat, NS=Mhux Statistikament Sinifikanti
English: Periodic monitoring with electrocardiograms (ECGs) and electrolytes should be considered in patients with congestive heart failure, electrolyte abnormalities, or those who are taking medicinal products that are known to prolong the QTc interval.
Maltese: Għandu jiġi kkunsidrat monitoraġġ perjodiku b'elettrokardjogrammi (ECGs) u elettroliti f'pazjenti b'insuffiċjenza konġestiva tal-qalb, anormalitajiet fl-elettroliti, jew dawk li qegħdin jieħdu prodotti mediċinali li huma magħrufin li jtawlu l-intervall QTc.
English: Caution should be exercised when treating patients with severe and end-stage renal impairment (see section 5.2).
Maltese: Għandha tiġi eżerċitata kawtela meta jiġu kkurati pazjenti b'indeboliment tal-kliewi sever u fi stadju finali (ara sezzjoni 5.2).
English: The primary efficacy outcome measure of these two trials was ORR according to RECIST v1.1 as evaluated by a Blinded Independent Central Review (BICR).
Maltese: Ir-riżultati ta' ORR permezz tar-Reviżjoni Ċentrali Indipendenti Blinded (BICR, Blinded Independent Central Review)
English: Careful assessment of all patients with an acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever) should be performed to exclude ILD.
Maltese: Għandha titwettaq valutazzjoni bir-reqqa tal-pazjenti kollha b'bidu akut u/jew b'aggravar mhux spjegat tas-sintomi pulmonarji (dispnea, sogħla, deni) biex jiġi eskluż ILD.
English: All patients received at least one prior line of therapy.
Maltese: Ilpazjenti kollha rċevew tal-inqas linja ta' terapija preċedenti waħda.
English: Median TSST, months (95% CI)
Maltese: TSST medjan, xhur (95 % CI)
English: • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
Maltese: • il-kura ta' pazjenti adulti b'NSCLC, pożittivi għall-mutazzjoni T790M ta' EGFR lokalment avvanzat jew metastatiku.
English: TAGRISSO 40 mg tablets Each tablet contains 40 mg osimertinib (as mesylate).
Maltese: TAGRISSO 40 mg pilloli Kull pillola fiha 40 mg osimertinib (bħala mesylate).
English: How TAGRISSOworks
Maltese: TAGRIS SO
English: Osimertinib penetrated the intact blood-brain barrier of the cynomolgus monkey (i.v.
Maltese: Osimertinib ippenetra l-barriera ematoenċefalika intatta tax-xadina cynomolgus (dożaġġ i.v.), tal-far u tal-ġurdien (għoti orali).
English: Only robust, reliable and sensitive tests with demonstrated utility for the determination of EGFR mutation status of tumour derived DNA (from a tissue or a plasma sample) should be used.
Maltese: Għandhom jintużaw biss testijiet robusti, affidabbli u sensittivi b'utilità murija biex jiġi ddeterminat listatus tal-mutazzjoni ta' EFGR ta' DNA derivat mit-tumur (minn kampjun ta' tessut jew plażma).
English: Frequency of CTCAE grade 3 or higher
Maltese: Frekwenza tal-grad 3 jew ogħla ta' CTCAE
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA
Maltese: Tqala - Informazzjoni għall-irġiel
English: Dose reduction was required in 0.2% of patients and dose interruption in 1.4%.
Maltese: F'0.2% tal-pazjenti kien meħtieġ tnaqqis fid-doża u f'1.4% kienet meħtieġa interruzzjoni tad-doża.
English: Pre-treated T790M positive NSCLC patients-AURA3
Maltese: Dejta tal-effikaċja tal-metastasi f'CNS fl-istudju AURA3
English: Each 80 mg film-coated tablet contains 80 mg of osimertinib.
Maltese: Kull pillola ta' 80 mg miksija b'rita fiha 80 mg ta' osimertinib. .
English: Gastric pH modifying agents can be concomitantly used with TAGRISSO without any restrictions.
Maltese: Aġenti li jimmodifikaw il-pH gastriku jistgħu jintużaw b'mod konkomitanti ma' TAGRISSO mingħajr ebda restrizzjoni.
English: (Findings based on test results presented as CTCAE grade shifts)
Maltese: (Sejbiet ibbażati fuq riżultati tat-testijiet ippreżentati bħala tibdil fil-gradi ta' CTCAE)
English: Table 4.
Maltese: Tabella4.
English: In a modified embryofoetal development study in the rat, osimertinib caused embryolethality when administered to pregnant rats prior to embryonic implantation.
Maltese: Fi studju modifikat dwar l-iżvilupp embrijofetali fil-firien, osimertinib ikkawża embrijoletalità meta ngħata lil firien tqal qabel impjantazzjoni embrijonika.
English: QTc interval prolongation may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death.
Maltese: Titwil fl-intervall QTc jista' jwassal għal riskju ikbar għal takjarritmiji ventrikulari (eż. torsade de pointes) jew mewt f'daqqa.
English: TAGRISSO contains the active substance osimertinib, which belongs to a group of medicines called protein kinase inhibitors which are used to treat cancer.
Maltese: Tagrisso fih is-sustanza attiva osimertinib, li tagħmel parti minn grupp ta' mediċini msejħa inibituri ta' protein kinase li jintużaw biex jikkuraw il-kanċer.
English: If the patient is unable to swallow the tablet, the tablet may first be dispersed in 50 mL of non-carbonated water.
Maltese: Jekk il-pazjent ma jkunx jista' jibla' l-pillola, il-pillola l-ewwel tista' tinħall f'50 mL ta' ilma mhux karbonizzat.
English: A HR< 1 favours TAGRISSO, an Odds ratio of >1 favours TAGRISSO Based on an interim analysis with 25% maturity a P-value < 0.0015 was required to achieve statistical significance ORR results by Blinded Independent Central Review (BICR) were consistent with those reported via investigator assessment; ORR by BICR assessment was 78% (95% CI:73, 83) on TAGRISSO and 70% (95% CI:65, 76) on EGFR TKI
Maltese: HR< 1 jiffavorixxi TAGRISSO, proporzjon ta' Probabbiltà ta' >1 jiffavorixxi TAGRISSO Abbażi ta' analiżi inizjali b'25 % maturità kien meħtieġ valur-P < 0.0015 biex tinkiseb sinifikanza statistika
English: Adjusted mean and estimated differences obtained from a Mixed Model Repeated Measures (MMRM) analysis.
Maltese: Il-medja aġġustata u d-differenzi stmati huma miksuba mill-analiżi ta' Kejl Ripetut ta' Mudell Imħallat (MMRM, Mixed Model Repeated Measures).
English: 5.3 Preclinical safety data
Maltese: Nominament statistikament sinifikanti
English: Cardiac electrophysiology
Maltese: Tibdil fil-kontrattilità kardijaka