FrancophonIA/ELRC3.0 huggingface dataset:
English: The baseline demographic and disease characteristics of the overall study population were: median age 64 years (range 26-93 years), ≥75 years old (14%), female (63%), White (36%), Asian (62%), never smokers (64%), World Health Organization (WHO) performance status of 0 or 1 (100%), metastatic bone disease (36%), extra-thoracic visceral metastases (35%), CNS metastases (21%, identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases).
Croatian: Početne demografske karakteristike i karakteristike bolesti u cjelokupnoj ispitivanoj populaciji bile su sljedeće: medijan dobi 64 godine (raspon: 26 - 93 godine), dob ≥75 godina (14%), žene (63%), bijelci (36%), Azijci (62%), osobe koje nikad nisu pušile (64%), WHO (World Health Organization) funkcionalni status 0 ili 1 (100%), metastatska koštana bolest (36%), visceralne metastaze izvan toraksa (35%), metastaze u središnjem živčanom sustavu (SŽS) (21%, utvrđene na temelju lezije u SŽS-u na početku ispitivanja, medicinske anamneze i/ili prethodnog kirurškog zahvata i/ili prethodne radioterapije zbog metastaza u SŽS-u).
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.
Croatian: U kliničkom farmakokinetičkom ispitivanju, istodobna primjena lijeka TAGRISSO i rosuvastatina (osjetljiv BCRP supstrat) povećala je vrijednosti AUC i Cmax rosuvastatina za 35% odnosno 72%.
English: Patients with a past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD were excluded from clinical studies (see section 4.8).
Croatian: Bolesnici koji su u anamnezi imali IBP, IBP izazvan liječenjem, pneumonitis uzrokovan zračenjem koji je zahtijevao liječenje steroidima ili bilo kakav dokaz klinički aktivnog IBP-a bili su isključeni iz kliničkih ispitivanja (vidjeti dio 4.8).
English: • Dabigatran - used to prevent blood clots.
Croatian: • Dabigatran - koristi se za liječenje krvnih ugrušaka.
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
Croatian: Preživljenje bez progresije bolesti u SŽS-u prema BICR-u za SŽS na temelju verzije 1.1 RECIST kriterija (mjerljive i nemjerljive lezije u SŽS-u na početku ispitivanja prema BICR-u) n=61 za TAGRISSO i n=67 za usporedni inhibitor tirozin kinaze EGFR-a; odgovori nisu potvrđeni Nominalno statistički značajno
English: Findings in the ovaries seen following 1 month dosing were reversible.
Croatian: Promjene na jajnicima nakon mjesec dana doziranja bile su reverzibilne.
English: The T790M mutation status was also assessed using ctDNA extracted from a plasma sample taken during screening.
Croatian: Status mutacije T790M ocjenjivao se i korištenjem ctDNK dobivene iz uzorka plazme uzetog tijekom probira.
English: 10 FILM-COATED TABLET BLISTERS (PERFORATED) 7 FILM-COATED TABLET BLISTERS (PERFORATED)
Croatian: TABLETA BLISTERI (PERFORIRANI) SA 7 FILMOM OBLOŽENIH
English: The median time to onset of ILD or ILD-like adverse reactions was 85 days (see section 4.4).
Croatian: Medijan vremena do nastupa IBP-a ili nuspojava nalik IBP-u bio je 85 dana (vidjeti dio
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).
Croatian: Korisni učinci na PFS uz TAGRISSO u odnosu na usporedni inhibitor tirozin kinaze EGFR-a dosljedno su opaženi u svim unaprijed definiranim analiziranim podskupinama, uključujući podskupine prema etničkoj pripadnosti, dobi, spolu, pušačkoj anamnezi, statusu metastaza u SŽS-u pri uključivanju u ispitivanje i tipu mutacije EGFR-a (delecija eksona 19 ili L858R).
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.
Croatian: Podaci prikupljeni od početka ispitivanja do 9. mjeseca pokazali su slična poboljšanja u skupini koja je primala TAGRISSO i onoj liječenoj usporednim inhibitorom tirozin kinaze EGFR-a s obzirom na pet unaprijed specificiranih primarnih simptoma ishoda koje su prijavljivali bolesnici (kašalj, dispneju, bol u prsištu, umor i gubitak teka), pri čemu je poboljšanje kašlja dosegnulo utvrđenu klinički značajnu granicu.
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.
Croatian: Pedeset i devet posto (59%) bolesnika imalo je visceralne metastaze izvan toraksa, uključujući 39% bolesnika s metastazama u SŽS-u (utvrđenima na temelju lezije u SŽS-u na početku ispitivanja, medicinske anamneze i/ili prethodnog kirurškog zahvata i/ili prethodne radioterapije zbog metastaza u SŽS-u) i 29% bolesnika s jetrenim metastazama.
English: There are no data available on patients with severe hepatic impairment (see section 4.2).
Croatian: Nema podataka za bolesnike s teškim oštećenjem funkcije jetre (vidjeti dio
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih daljnjih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
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.
Croatian: Od 1142 bolesnika liječena lijekom TAGRISSO u dozi od 80 mg u ispitivanju FLAURA i ispitivanjima iz programa AURA, 0,9% bolesnika (n=10) imalo je QTc interval veći od 500 msek, dok je 3,6% bolesnika (n=41) imalo povećanje QTc intervala u odnosu na početnu vrijednost veće od 60 msek.
English: When possible, the use of osimertinib in patients with congenital long QT syndrome should be avoided.
Croatian: Primjenu osimertiniba u bolesnika s urođenim sindromom dugog QT intervala potrebno je izbjegavati, kada je to moguće.
English: Very common (68%) 1.5%
Croatian: Vrlo često (68%)
English: CNS Disease control rate
Croatian: Stopa kontrole bolesti u SŽS-u
English: Two single-arm, open-label clinical studies, AURAex (Phase 2 Extension cohort, (n=201)) and AURA2 (n=210) were conducted in patients with EGFR T790M mutation-positive lung cancer who have progressed on one or more prior systemic therapies, including an EGFR TKI.
Croatian: Prethodno liječeni bolesnici s NSCLC-om pozitivnim na mutaciju T790M - AURAex i AURA2 Provedena su dva otvorena klinička ispitivanja s jednom skupinom, AURAex (kohortni nastavak faze 2, (n=201)) i AURA2 (n=210) u bolesnika s rakom pluća pozitivnim na T790M mutaciju EGFR-a čija je bolest napredovala tijekom jedne ili više prethodnih sustavnih terapija, koja je uključivala i inhibitore tirozin kinaze EGFR-a.
English: All patients were required to have EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory prior to randomisation.
Croatian: Svi su bolesnici morali imati NSCLC pozitivan na T790M mutaciju EGFR-a, koja se određivala cobas testom za mutacije EGFR-a provedenim u središnjem laboratoriju prije randomizacije.
English: Caution should be exercised when treating patients with severe and end-stage renal impairment (see section 5.2).
Croatian: Potreban je oprez prilikom liječenja bolesnika s teškim oštećenjem funkcije bubrega i završnim stadijem oštećenja funkcije bubrega (vidjeti dio 5.2).
English: EGFR TKI comparator (gefitinib or erlotinib) (N=277)
Croatian: Usporedni inhibitor tirozin kinaze EGFR-a (gefitinib ili erlotinib) (N=277)
English: Gärtunavägen SE-151 85 Södertälje Sweden
Croatian: AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Švedska
English: Number of responses, Response Rate (95% CI)
Croatian: Broj odgovora, stopa odgovora (95% CI)
English: 11.7 (10, NC)
Croatian: 11,7 (10; NI)
English: In a clinical PK study, co-administration of TAGRISSO with simvastatin (sensitive CYP3A4 substrate) decreased the AUC and Cmax of simvastatin by 9% and 23% respectively.
Croatian: U kliničkom farmakokinetičkom ispitivanju, istodobna primjena lijeka TAGRISSO i simvastatina (osjetljiv CYP3A4 supstrat) smanjila je vrijednosti AUC i Cmax simvastatina za 9% odnosno 23%.
English: Clinical studies have not been conducted in patients with de novo EGFR T790M mutation-positive NSCLC.
Croatian: Nisu provedena klinička ispitivanja u bolesnika s de novo NSCLC-om s pozitivnom T790M mutacijom EGFR-a.
English: If ILD is diagnosed, TAGRISSO should be discontinued and appropriate treatment initiated as necessary.
Croatian: Ako se dijagnosticira IBP, primjena lijeka TAGRISSO mora se prekinuti, te prema potrebi započeti odgovarajuće liječenje.
English: Fifty-four percent (54%) of patients had extra-thoracic visceral metastases, including 34% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases) and 23% with liver metastases.
Croatian: Pedeset i četiri posto (54%) bolesnika imalo je visceralne metastaze izvan toraksa, uključujući 34% bolesnika s metastazama u središnjem živčanom sustavu (SŽS) (utvrđenima na temelju lezije u SŽS-u na početku ispitivanja, medicinske anamneze i/ili prethodnog kirurškog zahvata i/ili prethodne radioterapije zbog metastaza u SŽS-u) i 23% bolesnika s jetrenim metastazama.
English: Number of responses (n), Response Rate (95% CI)
Croatian: Broj odgovora (n), stopa odgovora (95% CI)
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake definicije učestalosti, nuspojave su navedene po ozbiljnosti, padajućim redoslijedom.
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.
Croatian: U usporedbi s kemoterapijom, TAGRISSO je poboljšao simptome raka pluća koje su prijavljivali bolesnici - ostvario je statistički značajnu razliku u srednjoj vrijednosti promjene početnog rezultata za 5 unaprijed specificiranih primarnih simptoma ishoda koje su prijavljivali bolesnici (gubitak teka, kašalj, bol u prsištu, dispneja i umor) u odnosu na kemoterapiju tijekom cijelog razdoblja od randomizacije do 6. mjeseca, što je prikazano u Tablici 7.
English: Very common (67%) 7.2%
Croatian: Vrlo često (67%)
English: Kaplan-Meier curves of Progression-Free Survival as assessed by investigator in AURA3
Croatian: Slika 3. Kaplan-Meierove krivulje preživljenja bez progresije bolesti prema ocjeni ispitivača u ispitivanju AURA3
English: CNS Objective Response Rate
Croatian: Stopa objektivnog odgovora u SŽS-u
English: Number of Events (% maturity)
Croatian: Broj događaja (% zrelosti)
English: The primary efficacy outcome was progression-free survival (PFS) as assessed by investigator.
Croatian: Primarna mjera ishoda za djelotvornost bilo je preživljenje bez progresije bolesti (PFS) prema ocjeni ispitivača.
English: Number of Deaths (% maturity)
Croatian: Broj smrtnih slučajeva (% zrelosti)
English: Each 40mg film-coated tablet contains 40mg of osimertinib.
Croatian: Svaka filmom obložena tableta od 40 mg sadrži 40 mg osimertiniba.
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.
Croatian: Bolesnici koji su primali usporedni inhibitor tirozin kinaze EGFR-a mogli su nakon progresije bolesti prijeći na otvorenu primjenu lijeka TAGRISSO uz uvjet da su njihovi uzorci tumora bili pozitivni na mutaciju T790M.
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).
Croatian: U podskupini bolesnika koji na početku ispitivanja nisu imali lezije u SŽS-u, broj novih lezija u SŽS-u bio je manji u skupini koja je primala TAGRISSO nego u skupini koja je primala usporedni inhibitor tirozin kinaze EGFR-a (7/226 [3,1%] naspram 15/214 [7,0%]).
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
Croatian: Ako se nuspojava stupnja 3 ili većeg ublaži do stupnja 0-2 nakon privremenog prekida primjene lijeka TAGRISSO do 3 tjedna
English: Includes cases reported within the clustered terms: Keratitis, punctate keratitis, corneal erosion, corneal epithelium defect.
Croatian: Uključuje slučajeve prijavljene unutar skupnog pojma: keratitis, točkasti keratitis, erozija rožnice, oštećenje epitela rožnice.
English: Each 80 mg film-coated tablet contains 80 mg of osimertinib.
Croatian: Svaka filmom obložena tableta od 80 mg sadrži 80 mg osimertiniba.
English: Patients with CNS metastases not requiring steroids and with stable neurologic status for at least two weeks after completion of the definitive therapy and steroids were eligible to be randomised in the FLAURA study.
Croatian: U ispitivanje FLAURA mogli su biti randomizirani bolesnici s metastazama u SŽS-u kojima nisu bili potrebni steroidi i koji su imali stabilan neurološki status tijekom najmanje dva tjedna nakon završetka primjene definitivne terapije i steroida.
English: Grade 3 or higher adverse reaction that does not improve to Grade 0-2 after withholding for up to 3 weeks
Croatian: Ako se nuspojava stupnja 3 ili većeg ne ublaži na stupanj 0-2 nakon privremenog prekida primjene lijeka TAGRISSO do 3 tjedna
English: Kaplan-Meier Curves of Progression-Free Survival as assessed by investigator in FLAURA
Croatian: Slika 1. Kaplan-Meierove krivulje preživljenja bez progresije bolesti prema ocjeni ispitivača u ispitivanju FLAURA
English: CNS metastases efficacy data in AURA3 study
Croatian: Podaci o djelotvornosti kod metastaza u SŽS-u iz ispitivanja AURA3
English: A pre-specified PFS subgroup analysis based on CNS metastases status at study entry was performed in AURA3 and is shown in Figure 4.
Croatian: U ispitivanju AURA3 provedena je unaprijed specificirana analiza PFS-a u podskupinama prema statusu metastaza u SŽS-u pri uključivanju u ispitivanje, koja je prikazana na Slici 4.
English: Additional efficacy outcome measures included ORR, DoR and overall survival (OS) as assessed by investigator.
Croatian: Dodatne mjere ishoda za djelotvornost uključivale su stopu objektivnog odgovora (engl. objective response rate, ORR), trajanje odgovora i ukupno preživljenje (engl. overall survival, OS) prema ocjeni ispitivača.
English: A consistent pattern in safety and efficacy results was observed in the analysis of AURA Phase 2 studies.
Croatian: U analizi ispitivanja faze 2 iz programa AURA primijećeni su dosljedni rezultati za sigurnost i djelotvornost.
English: Limited data are available in patients with severe renal impairment.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega dostupni su ograničeni podaci.
English: Efficacy results from AURA3 by investigator assessment
Croatian: Tablica 5. Rezultati djelotvornosti iz ispitivanja AURA3 prema ocjeni ispitivača
English: A pharmacokinetic study in patients with renal impairment has not been conducted.
Croatian: Nije provedeno farmakokinetičko ispitivanje u bolesnika s oštećenjem funkcije bubrega.
English: 8.9 (4.3, NC)
Croatian: 8,9 (4,3; NI)
English: Includes cases reported within the clustered terms for rash AEs: Rash, rash generalised, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pustular, rash pruritic, rash vesicular, rash follicular, erythema, folliculitis, acne, dermatitis, dermatitis acneiform, drug eruption, skin erosion.
Croatian: Uključuje slučajeve prijavljene unutar skupnog pojma za nuspojave osipa: osip, generalizirani osip, eritematozni osip, makularni osip, makulopapularni osip, papularni osip, pustularni osip, pruritički osip, vezikularni osip, folikularni osip, eritem, folikulitis, akne, dermatitis, akneiformni dermatitis, erupcija uzrokovana lijekom, erozija kože.
English: Median PFS2, months (95% CI)
Croatian: Medijan PFS2, mjeseci (95% CI)
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.
Croatian: TAGRISSO 80 mg su ovalne, bikonveksne, bež filmom obložene tablete s oznakom “AZ” i “80” na jednoj strani i bez oznake na drugoj strani.
English: This medicine contains < 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
Croatian: Ovaj lijek sadrži < 1 mmol (23 mg) natrija po tableti od 40 mg ili 80 mg, tj. zanemarive količine natrija.
English: Neutrophils decreased
Croatian: Sniženi neutrofili
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.
Croatian: Tablica 6 sažeto prikazuje djelotvornost u SŽS-u prema BICR-u na temelju verzije 1.1 RECIST kriterija u podskupini od 116/419 (28%) bolesnika u kojih su oslikavanjem mozga na početku ispitivanja otkrivene metastaze u SŽS-u.
English: No QTcrelated arrhythmias were reported in the FLAURA or AURA studies (see sections 4.4 and 5.1).
Croatian: Tijekom ispitivanja FLAURA i ispitivanja iz programa AURA nisu prijavljene aritmije povezane s QTc intervalom (vidjeti dijelove 4.4 i 5.1).
English: A pre-specified PFS subgroup based on CNS metastases status (identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases) at study entry was performed in FLAURA and is shown in Figure 2.
Croatian: U ispitivanju FLAURA provedena je unaprijed specificirana analiza PFS-a u podskupinama prema statusu metastaza u SŽS-u pri uključivanju u ispitivanje (utvrđenih na temelju lezije u SŽS-u na početku ispitivanja, medicinske anamneze i/ili prethodnog kirurškog zahvata i/ili prethodne radioterapije zbog metastaza u SŽS-u), a dobiveni rezultati prikazani su na Slici 2.
English: MedDRA SOC MedDRA term
Croatian: Pojam prema MedDRA
English: • If your partner becomes pregnant while you are taking this medicine, tell your doctor straight away.
Croatian: Trudnoća - informacije za muškarce • Ako Vaša partnerica zatrudni dok Vi uzimate ovaj lijek, odmah se obratite svom liječniku.
English: Beige, 7.25 x 14.5 mm, oval, biconvex tablet, debossed with “AZ” and “80” on one side and plain on the reverse.
Croatian: Ovalne, bikonveksne, bež tablete dimenzija 7,25 x 14,5 mm, s utisnutom oznakom “AZ” i “80” na jednoj strani i bez oznake na drugoj strani.
English: Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in FLAURA
Croatian: Slika 2. Ukupni PFS prema ocjeni ispitivača na temelju statusa metastaza u SŽS-u pri uključivanju u ispitivanje FLAURA, Kaplan-Meierova krivulja (svi randomizirani bolesnici)
English: Very common (54%) 1.6%
Croatian: Vrlo često (54%)
English: SWEDEN
Croatian: Švedska
English: The primary efficacy end-point was progression-free survival (PFS) as assessed by investigator.
Croatian: Primarna mjera ishoda za djelotvornost bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS) prema ocjeni ispitivača.
English: Probability of Progression-Free Survival
Croatian: Preživljenje bez progresije bolesti
English: Based on in vitro studies, osimertinib is not an inhibitor of UGT1A1 and UGT2B7 at clinically relevant concentrations hepatically.
Croatian: Na temelju in vitro ispitivanja, pri klinički relevantnim koncentracijama u jetri, osimertinib nije inhibitor UGT1A1 i UGT2B7.
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.
Croatian: U bolesnika s kongestivnim zatajenjem srca, abnormalnostima elektrolita ili onih koji uzimaju lijekove za koje je poznato da produljuju QTc interval potrebno je razmotriti redovito praćenje pretragama elektrokardiograma i elektrolita.
English: At baseline, no differences in patient reported symptoms, function or HRQL were observed between TAGRISSO and EGFR TKI comparator (gefitinib or erlotinib) arms.
Croatian: Na početku ispitivanja nisu opažene razlike u simptomima, funkciji ni kvaliteti života vezanoj uz zdravlje koje su prijavili bolesnici između skupine koja je primala TAGRISSO i one liječene usporednim inhibitorom tirozin kinaze EGFR-a (gefitinibom ili erlotinibom).
English: Adverse reactions reported in FLAURA and AURA studies
Croatian: Tablica 2. Nuspojave prijavljene u ispitivanju FLAURA i ispitivanjima iz programa AURA
English: Efficacy results from FLAURA by investigator assessment are summarised in Table 3, and the Kaplan-Meier curve for PFS is shown in Figure 1.
Croatian: U Tablici 3 sažeto su prikazani rezultati djelotvornosti iz ispitivanja FLAURA prema ocjeni ispitivača, dok je na Slici 1 prikazana Kaplan-Meierova krivulja PFS-a.
English: Pre-treated T790M positive NSCLC patients-AURA3
Croatian: Prethodno liječeni bolesnici s NSCLC-om pozitivnim na mutaciju T790M - AURA3
English: Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in AURA3
Croatian: Slika 4. Ukupni PFS prema ocjeni ispitivača na temelju statusa metastaza u SŽS-u pri uključivanju u ispitivanje AURA3, Kaplan-Meierova krivulja (svi randomizirani bolesnici)
English: TAGRISSO 40 mg tablets
Croatian: TAGRISSO 40 mg tablete
English: CNS metastases efficacy data in FLAURA study
Croatian: Podaci o djelotvornosti kod metastaza u SŽS-u iz ispitivanja FLAURA
English: Permanently discontinue TAGRISSO
Croatian: Trajno prekinite primjenu lijeka TAGRISSO
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).
Croatian: Do 9. mjeseca između skupine koja je primala TAGRISSO i one liječene usporednim inhibitorom tirozin kinaze EGFR-a nisu opažene klinički značajne razlike u simptomima koje su prijavljivali bolesnici (ocijenjene na temelju razlike od ≥ 10 bodova).
English: Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin)
Croatian: Kemoterapija (pemetreksed/cisplatin ili pemetreksed/karboplatin)
English: TAGRISSO 80 mg tablets
Croatian: TAGRISSO 80 mg tablete
English: 13.9 (8.3, NC)
Croatian: 13,9 (8,3; NI)
English: How to store TAGRISSO
Croatian: Kako čuvati TAGRISSO
English: 0.63 (0.45, 0.88); P=0.0068 (NS)
Croatian: 0,63 (0,45; 0,88); P=0,0068 (NZ)
English: Efficacy results from AURA3 by investigator assessment are summarised in Table 5, and the Kaplan-Meier curve for PFS is shown in Figure 3.
Croatian: Tablica 5 sažeto prikazuje rezultate djelotvornosti iz ispitivanja AURA3 prema ocjeni ispitivača, dok je na Slici 3 prikazana Kaplan-Meierova krivulja PFS-a.
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.
Croatian: In vitro ispitivanja su pokazala da se I. faza metabolizma osimertiniba pretežno odvija preko CYP3A4 i CYP3A5.