FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with IDflu, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'IDflu, ara l-fuljett ta' tagħrif.
English: The vaccine contains fragments of influenza (flu) viruses that have been inactivated (treated to prevent them causing infection).
Maltese: Il-vaċċin fih frammenti ta' virusis tal-influwenza li ġew diżattivati (ikkurati sabiex ma jkunux jistgħu jikkawżaw infezzjoni).
English: What measures are being taken to ensure the safe and effective use of IDflu?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' IDflu?
English: Interrupt until Grade 0/1
Maltese: Interrompi sa Grad 0/1
English: See also section 4 “Possible side effects”.
Maltese: Ara wkoll sezzjoni 4 “Effetti sekondarji possibbli”.
English: MedDRA Preferred Term
Maltese: Terminu Preferut MedDRA
English: Grade > 3
Maltese: Grad > 3
English: PVC/PVDC perforated unit dose blister.
Maltese: Folja pperforata tal-PVC/PVDC bid-doża tal-unità.
English: Interactions with BCRP
Maltese: Interazzjonijiet ma' BCRP
English: % of patients improved a, c
Maltese: % ta' pazjenti li tjiebu a,c
English: NCI-CTC Grade
Maltese: Grad NCI-CTC
English: Pack sizes of 7 x 1, 14 x 1 or 28 x 1 film-coated tablets.
Maltese: Daqsijiet ta' pakketti 7 x 1, 14 x 1 jew 28 x 1 pillola miksija b'rita.
English: Phototoxicity An in vitro 3T3 test showed that afatinib may have phototoxicity potential.
Maltese: Fototossiċità Test 3T3 in vitro wera li afatinib jista' jkollu potenzjal ta' fototossiċità.
English: Mutation in EGFR defines a distinct molecular subtype of lung cancer.
Maltese: Mutazzjoni f'EFGR tiddefinixxi sottotip molekulari distint ta' kanċer tal-pulmun.
English: ® 40 mg orally once daily (N=160) or gefitinib 250 mg orally once daily (N=159).
Maltese: ® 40 mg oralment darba kuljum (N=160) jew gefitinib 250 mg oralment darba kuljum (N=159).
English: • Ritonavir, ketoconazole (except in shampoo), itraconazole, erythromycin, nelfinavir, saquinavir - used to treat different kinds of infections.
Maltese: • Ritonavir, ketoconazole (ħlief fix-shampoo), itraconazole, erythromycin, nelfinavir saquinavir li jintużaw biex jikkuraw tipi differenti ta' infezzjonijiet.
English: In vitro data indicated that drug-drug interactions with afatinib due to inhibition of OATB1B1, OATP1B3, OATP2B1, OAT1, OAT3, OCT1, OCT2, and OCT3 transporters are considered unlikely.
Maltese: Interazzjonijiet ma' sistemi tat-trasport tal-assorbiment tal-mediċina Dejta in vitro indikat li interazzjonijiet bejn mediċina u oħra ma' afatinib minħabba l-inibizzjoni ta' trasportaturi ta' OATB1B1, OATP1B3, OATP2B1, OAT1, OAT3, OCT1, OCT2, u OCT3 mhumiex ikkunsidrati li huma probabbli.
English: • Abnormal taste sensations (dysgeusia)
Maltese: • Sensazzjonijiet ta' togħma mhux normali (disġewsija)
English: • Carbamazepine, phenytoin, phenobarbital - used to treat seizures.
Maltese: • Carbamazepine, phenytoin, phenobarbital - li jintużaw biex jikkuraw l-aċċessjonijiet.
English: Stevens-Johnson syndrome Toxic epidermal necrolysis
Maltese: Sindrome ta' Stevens-Johnson Nekroliżi epidermali tossika
English: Other patient characteristics/intrinsic factors found with a significant impact on afatinib exposure were: ECOG performance score, lactate dehydrogenase levels, alkaline phosphatase levels and total protein.
Maltese: Karatteristiċi oħra ta' pazjenti/fatturi intrinsiċi li nstab li kellhom impatt sinifikanti fuq l-esponiment għal afatinib kienu: punteġġ tal-prestazzjoni ECOG, livelli ta' lactate dehydrogenase, livelli ta' alkaline phosphatase u proteina totali.
English: Overall Survival (OS)
Maltese: Sopravivenza Totali (OS)
English: • Cyclosporine A, tacrolimus - medicines that affect your immune system.
Maltese: • Cyclosporine A, tacrolimus - mediċini li jaffettwaw lis-sistema immuni tiegħek.
English: Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous (E551) Crospovidone (type A) Magnesium stearate (E470b)
Maltese: Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous (E551) Crospovidone (tip A) Magnesium stearate (E470b)
English: CR=complete response; PR=partial response
Maltese: CR = rispons komplet; PR = rispons parzjali
English: Objective Response Rate (CR+PR)
Maltese: Rata ta' Rispons Oġġettiv (CR+PR)
English: 55216 Ingelheim am Rhein GERMANY
Maltese: 55216 Ingelheim am Rhein Il-ĠERMANJA
English: Discontinuation due to ADRs diarrhoea and rash/acne was 1.3% and 0% in LUX-Lung 3 and 3.8% and 2.0% in LUX-Lung 8, respectively.
Maltese: Ir-rata ta' twaqqif minħabba l-ADRs dijarea u raxx/akne kienet ta' 1.3% u 0% f'LUX-Lung 3 u 3.8% u 2.0% f'LUX-Lung 8, rispettivament.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 September 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 Settembru 2013
English: Data on Black racial groups was limited.
Maltese: Id-dejta dwar gruppi razzjali Suwed kienet limitata.
English: 3 4 Any Grade
Maltese: 3 4 Kwalunkwe Grad
English: The co-primary endpoints include PFS by independent review and OS.
Maltese: Il-punti ta' tmiem ko-primarji jinkludu PFS b'reviżjoni indipendenti u OS.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE13.
Maltese: Kategorija farmakoterapewtika: mediċini antineoplastiċi, inibituri ta' protein kinase, Kodiċi ATC:
English: • Sulfasalazine, used to treat inflammation/infection.
Maltese: • Sulfasalazine, li jintuża għall-kura ta' infjammazzjoni/infezzjoni.
English: • Rifampicin, an antibiotic used to treat tuberculosis.
Maltese: • Rifampicin, antibijotiku li jintuża biex jikkura t-tuberkolożi.
English: Patients were screened for the presence of 29 different EGFR mutations using a polymerase chain reaction (PCR)-based method (TheraScreen
Maltese: Il-pazjenti ġew eżaminati għall-preżenza ta' 29 mutazzjoni EGFR differenti bl-użu ta' metodu bbażat fuq polymerase chain reaction (PCR) (TheraScreen
English: 7.7 vs. 1.7 HR 0.53; p<0.0001
Maltese: 7.7 kontra 1.7 HR 0.53; p<0.0001
English: Afatinib covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4.
Maltese: Afatinib jeħel b'mod kovalenti ma', u jimblokka b'mod irreversibbli s-sienjalazzjoni mill-homo- u heterodimers kollha ffurmati mill-membri tal-familja ErbB EGFR (ErbB1), HER2 (ErbB2), ErbB3 u ErbB4.
English: for a 95 kg patient (97.5
Maltese: 22% għal pazjent li jiżen 95 kg (97.5
English: Reporting of suspected adverse reactions
Maltese: Avvenimenti avversi relatati mal-ġilda
English: Paronychia
Maltese: Paronikija
English: Use of P-glycoprotein (P-gp) inhibitors
Maltese: Interazzjonijiet ta' P-glikoproteina (P-gp)
English: 4.2 vs. 3.1 HR 0.83; p=0.1882
Maltese: 4.2 kontra 3.1 HR 0.83; p=0.1882
English: Body weight Plasma exposure (AUCτ,ss) was increased by 26% for a 42 kg patient (2.5
Maltese: Piż tal-ġisem L-esponiment fil-plażma (AUCτ,ss) żdied b'26% għal pazjent li jiżen 42 kg (2.5
English: Afatinib is a potent and selective, irreversible ErbB Family Blocker.
Maltese: Afatinib huwa Imblokkatur qawwi u selettiv u irriversibbli tal-Familja ErbB.
English: In contrast, when ritonavir was administered simultaneously or 6 hours after 40 mg GIOTRIF, the relative bioavailability of afatinib was 119% (AUC0-∞) and 104% (Cmax) and 111% (AUC0-∞) and 105% (Cmax), respectively.
Maltese: B'kuntrast ma' dan, meta ritonavir ingħata fl-istess ħin jew 6 sigħat wara 40 mg ta' GIOTRIF, il-bijodisponibiltà relattiva ta' afatinib kienet ta' 119% (AUC0∞) u 104% (Cmax) u 111% (AUC0-∞) u 105% (Cmax), rispettivament.
English: Effects of afatinib on P-gp substrates
Maltese: Effetti ta' afatinib fuq substrati ta' P-gp
English: Effect of UDP-glucuronosyltransferase 1A1 (UGT1A1) inhibition on afatinib In vitro data indicated that drug-drug interactions with afatinib due to inhibition of UGT1A1 are considered unlikely.
Maltese: L-effett ta' inibizzjoni ta' UDP-glucuronosyltransferase 1A1 (UGT1A1) fuq afatinib Dejta in vitro indikat li interazzjonijiet bejn mediċina u oħra ma' afatinib minħabba l-inibizzjoni ta' UGT1A1 huma kkunsidrati li mhumiex probabbli.
English: • Increased levels of the liver enzymes (aspartate aminotransferase and alanine aminotransferase) in blood tests.
Maltese: • Żieda fil-livelli tal-enzimi tal-fwied (aspartate aminotransferase u alanine aminotransferase)
English: Subjects with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment had similar exposure in comparison to healthy volunteers following a single dose of 50 mg GIOTRIF.
Maltese: Individwi b'indeboliment ħafif (Child Pugh A) jew moderat (Child Pugh B) tal-fwied kellhom esponiment simili meta mqabbla ma' voluntiera b'saħħithom wara doża waħda ta' 50 mg ta' GIOTRIF.
English: The PFS hazard ratio for patients with DEL 19 mutations and L858R mutations was 0.76 (95% CI [0.55, 1.06]; p=0.1071), and 0.71 (95% CI [0.47, 1.06]; p=0.0856) respectively for afatinib vs gefitinib.
Maltese: Il-proporzjon ta' periklu PFS għal pazjenti b'mutazzjonijiet DEL 19 u b'mutazzjonijiet L858R kien 0.76 (95% CI [0.55, 1.06]; p=0.1071), u 0.71 (95% CI [0.47, 1.06]; p=0.0856) rispettivament għal afatinib vs gefitinib.
English: Patients (N=319) were randomised (1:1) to receive GIOTRIF
Maltese: Il-pazjenti (N=319) ġew randomizzati (1:1) biex jirċievu GIOTRIF
English: In the pivotal trials Grade 3 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations were observed in 2.4% (LUX-Lung-3) and 1.6% (LUX-Lung 8) of patients with normal baseline liver tests treated with 40 mg/day.
Maltese: Fil-provi ewlenin żidiet ta' grad 3 fil-livelli ta' alanine aminotransferase (ALT) u aspartate aminotransferase (AST) ġew osservati fi 2.4% (LUX-Lung 3) u 1.6% (LUX-Lung 8) tal-pazjenti b'testijiet normali tal-fwied fil-linja bażi kkurati b'40 mg/jum.
English: Film-coating
Maltese: Tnaqqis fil-piż
English: The following terms are used to rank the ADRs by frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: It-termini li ġejjin jintużaw biex jikklassifikaw l-ADRs skont il-frekwenza: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000) sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: 71% vs. 48%; p<0.0001
Maltese: 71% kontra 48%; p<0.0001
English: GIOTRIF 20 mg film-coated tablets Hypromellose (E464) Macrogol 400
Maltese: GIOTRIF 20 mg pilloli miksija b'rita Hypromellose 2910 (E464) Macrogol 400
English: 67% vs. 60%; p=0.2133
Maltese: 67% kontra 60%; p=0.2133
English: Secondary endpoints include ORR and DCR.
Maltese: Il-punti ta' tmiem sekondarji jinkludu ORR u DCR.
English: Limited non-clinical and/or clinical activity was observed in NSCLC tumours with insertion mutations in exon 20.
Maltese: Attività limitata mhux klinika u/jew klinika ġiet osservata f'tumuri NSCLC b'mutazzjonijiet ta' inserzjoni f'exon 20.
English: Table 2: Summary of ADRs per frequency category
Maltese: Tabella 2: Sommarju ta' ADRs skont il-kategorija ta' frekwenza Sistema tal-Ġisem Komuni ħafna Komuni
English: GIOTRIF 20 mg film-coated tablets GIOTRIF 30 mg film-coated tablets GIOTRIF 40 mg film-coated tablets GIOTRIF 50 mg film-coated tablets
Maltese: GIOTRIF 20 mg pilloli miksija b'rita GIOTRIF 30 mg pilloli miksija b'rita GIOTRIF 40 mg pilloli miksija b'rita GIOTRIF 50 mg pilloli miksija b'rita
English: Other patient characteristics/intrinsic factors
Maltese: Karatteristiċi oħra tal-pazjenti/fatturi intrinsiċi
English: Figure 1: Kaplan-Meier curve for PFS by independent review by treatment group in trial LUX-Lung 3 (Overall Population)
Maltese: Figura 1: Kurva ta' Kaplan-Meier għal PFS minn evalwazzjoni indipendenti skont il-grupp ta' kura fi Prova LUX-Lung 3 (Popolazzjoni Globali)
English: • Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
Maltese: • Riċettur ta' Fattur tat-Tkabbir Epidermali (EGFR, Epidermal Growth Factor Receptor) TKI b'kanċer tal-pulmun ta' ċelluli mhux żgħar, lokalment avvanzat jew metastatiku (NSCLC, locally advanced or metastatic non-small cell lung cancer) b'mutazzjoni(jiet) attivanti tal-EGFR;
English: Overall, dose reduction (see section 4.2) led to a lower frequency of common adverse reactions.
Maltese: Globalment, it-tnaqqis fid-doża (ara sezzjoni 4.2) wassal għal frekwenza aktar baxxa ta' reazzjonijiet avversi komuni.
English: In 61 patients treated in the first-line setting, confirmed ORR was 65.6% and DCR was 86.9% according to independent review.
Maltese: Fil-61 pazjent kkurati fl-isfond primarju, ORR ikkonfermat kien ta' 65.6% u DCR kien ta' 86.9% skont l-evalwazzjoni indipendenti.
English: The overall survival hazard ratio in patients < 65 years of age was 0.68 (95% CI 0.55, 0.85) and in patients 65 years of age and older it was 0.95 (95% CI 0.76, 1.19).
Maltese: Il-proporzjon ta' periklu tas-sopravivenza globali f'pazjenti < 65 sena kien ta' 0.68 (95% CI 0.55, 0.85) u f'pazjenti ta' 65 sena u ikbar kien ta' 0.95 (95% CI 0.76, 1.19).
English: GIOTRIF is a medicine which contains the active substance afatinib.
Maltese: GIOTRIF hu mediċina li fiha s-sustanza attiva afatinib.
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553b), polysorbate 80 (E433), indigo carmine (E132) aluminium hydroxide.
Maltese: - Is-sustanzi mhux attiva(i) huma lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone ta' tip A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553b), polysorbate 80 (E433), indigo carmine (E132) aluminium hydroxide.
English: Keratitis
Maltese: Keratite
English: PFS Months (median)
Maltese: PFS Xhur (medjan)
English: 60% vs. 48%; p=0.0427
Maltese: 60% kontra 48%; p=0.0427
English: GIOTRIF (40 mg/day) N=229
Maltese: GIOTRIF (40 mg/jum) N=229
English: What GIOTRIF contains - The active substance is afatinib.
Maltese: X'fih GIOTRIF - Is-sustanza attiva hi afatinib.
English: Alanine aminotransferase increased
Maltese: Żieda f'alanine aminotransferase Żieda f'aspartate aminotransferase
English: Dyspepsia Cheilitis
Maltese: Dożaġġ rakkomandat
English: Table 6: Efficacy results of GIOTRIF vs. pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) (Independent review)
Maltese: Ir-riżultati tal-effikaċja ta' GIOTRIF vs. pemetrexed/cisplatin (LUX-Lung 3) u gemcitabine/cisplatin (LUX-Lung 6) (Evalwazzjoni indipendenti).
English: Available non-clinical toxicology data have shown effects on reproductive organs at higher doses.
Maltese: Dejta tossikoloġika mhux klinika disponibbli wriet effetti fuq l-organi riproduttivi f'dożi ogħla.
English: Any Grade
Maltese: Kwalunkwe Grad
English: Table 11: Symptom outcomes for GIOTRIF vs. erlotinib in trial LUX-Lung 8 (EORTC QLQ-C30 & QLQ-LC13)
Maltese: Tabella 11: Sintomi li rriżultaw għal GIOTRIF kontra erlotinib fil-prova LUX-Lung 8 (EORTC QLQ-C30 &
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Sindrome ta' eritrodisestesija palmar-plantar Disturbi fiddwiefer
English: 10.4 vs. 2.9 HR 0.68; p=0.0129
Maltese: 10.4 kontra 2.9 HR 0.68; p=0.0129
English: Other medicines and GIOTRIF
Maltese: Mediċini oħra u GIOTRIF
English: The primary endpoint was PFS; OS was the key secondary endpoint.
Maltese: Il-punt aħħari primarju kien PFS; OS kienet il-punt aħħari sekondarju primarju.
English: Table 8: Symptom outcomes for GIOTRIF vs. chemotherapy in trials LUX-Lung 3 and LUX-Lung 6 (EORTC QLQ-C30 & QLQ-LC13)
Maltese: Tabella 8: Riżultati tas-sintomi għal GIOTRIF kontra tal-kimoterapija fil-provi LUX-Lung 3 u LUX-Lung 6 (EORTC QLQ-C30 u QLQ-LC13)
English: NSCLC tumours with common activating EGFR mutations (Del 19, L858R) and several less common EGFR mutations in exon 18 (G719X) and exon 21 (L861Q) are particularly sensitive to afatinib treatment in non-clinical and clinical settings.
Maltese: Tumuri NSCLC b'mutazzjonijiet komuni EGFR li jattivaw (Del 19 jew L858R) u diversi mutazzjonijiet EGFR inqas komuni f'exon 18 (G719X) u exon 21 (L861Q) huma partikularment sensittivi għal kura b'afatinib fi sfondi mhux kliniċi u kliniċi.
English: In patients with tumours harbouring either G719X (N=18), L861Q (N=16), or S768I substitution mutation (N=8), the confirmed ORR was 72.2%, 56.3%, 75.0%, respectively, and the median duration of response was 13.2 months, 12.9 months and 26.3 months, respectively.
Maltese: F'pazjenti b'tumuri b'mutazzjoni ta' sostituzzjoni ta' G719X (N=18), L861Q (N=16), jew S768I (N=8), l-ORR ikkonfermata kienet 72.2%, 56.3%, 75.0%, rispettivament, u t-tul medjan tar-rispons kien ta' 13.2 xhur, 12.9 xhur u 26.3 xhur, rispettivament.
English: The updated median OS for first- and second-line was 31.7 months and 23.6 months, respectively.
Maltese: L-OS medjan aġġornat għall-ewwel u t-tieni linja kien ta' 31.7 xhur u 23.6 xhur, rispettivament.
English: Patients were screened for the presence of activating EGFR mutations (Del 19 and/or L858R) using the TheraScreen
Maltese: Il-pazjenti ġew skrinjati għall-preżenza ta' mutazzjonijiet EGFR attivanti (Del 19 u/jew L858R) bl-użu ta' TheraScreen
English: CR=complete response; PR=partial response p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on logistic regression
Maltese: CR=complete response (rispons sħiħ); PR=partial response (rispons parzjali) valur p għal PFS/OS fuq il-bażi ta' test stratifikat ta' log-rank; valur p għal Rata ta' Rispons Objettiva fuq il-bażi ta' rigressjoni loġistika
English: Table 3: Very common ADRs in trial LUX-Lung 3
Maltese: Tabella 3: ADRs komuni ħafna fil-prova LUX-Lung 3
English: 76% vs. 55%; p=0.0003
Maltese: 76% kontra 55%; p=0.0003
English: 65% vs. 50%; p=0.0078
Maltese: 65% kontra 50%; p=0.0078
English: The pharmacokinetics of afatinib have not been studied in subjects with severe (Child Pugh C) hepatic dysfunction (see section 4.4).
Maltese: Il-farmakokinetika ta' afatinib ma ġietx studjata f'individwi b'disfunzjoni severa tal-fwied (Child Pugh Ċ) (ara sezzjoni 4.4).
English: • Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis)
Maltese: • Nfafet jew tqaxxir sever tal-ġilda (li jistgħu jkunu sintomi ta' sindrome ta' Stevens-Johnson u nekroliżi epidermali tossika)
English: The maximum daily dose is 50 mg.
Maltese: Id-doża massima ta' kuljum hi ta' 50 mg.
English: Population pharmacokinetic analysis in special populations A population pharmacokinetic analysis was performed in 927 cancer patients (764 with NSCLC) receiving GIOTRIF monotherapy.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'popolazzjonijiet speċjali Analiżi farmakokinetika tal-popolazzjoni twettqet f'927 pazjent tal-kanċer (764 b'NSCLC) li kienu qed jirċievu GIOTRIF mogħti waħdu.
English: Very common ADRs in GIOTRIF-treated patients occurring in at least 10% of patients in trial LUX-Lung 3 and LUX-Lung 7 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Tables 3 and 4.
Maltese: ADRs komuni ħafna f'pazjenti kkurati b'GIOTRIF li seħħew f'mill-inqas 10% tal-pazjenti fil-prova LUX-Lung 3 u LUX-Lung 7 qed jintwerew fil-qosor skont il-Grad ta' Kriterji Komuni tat-TossiċitàIstitut Nazzjonali tal-Kanċer (NCI-CTC - National Cancer Institute-Common Toxicity Criteria) f'Tabelli 3 u 4.
English: Hazard Ratio (HR) (95%CI) p-value p-value for PFS/OS based on stratified log-rank test
Maltese: Proporzjon ta' Periklu (HR) (95%CI) valur p il-valur p għal PFS/OS ibbażat fuq test tal-log-rank stratifikat
English: Resume with dose reduction by 10 mg decrements a
Maltese: Kompli bi tnaqqis fid-doża f'passi ta' 10 mg a
English: Approximately 2% of the afatinib dose was metabolized by FMO3 and the CYP3A4-dependent N-demethylation was too low to be quantitatively detected.
Maltese: Madwar 2% tad-doża ta' afatinib ġiet metabolizzata minn FMO3 u l-N-demethylation dipendenti fuq CYP3A4 kien baxx wisq biex jiġi osservat b'mod kwantitattiv.
English: Exposure to afatinib moderately increased with lowering of the creatinine clearance (CrCL, calculated according to Cockcroft Gault), i.e. for a patient with a CrCL of 60 mL/min or 30 mL/min exposure (AUCτ,ss) to afatinib increased by 13% and 42%, respectively, and decreased by 6% and 20% for a patient with CrCL of 90 mL/min or 120 mL/min, respectively, compared to a patient with the CrCL of 79 mL/min (median CrCL of patients in the overall patient population analysed).
Maltese: L-esponiment għal afatinib żdied b'mod moderat bi tnaqqis fit-tneħħija tal-krejatinina (CrCL, ikkalkulata skont Cockcroft Gault), i.e. għal pazjent bi CrCL ta' 60 jew esponiment ta' 30 mL/min (AUCτ,ss) għal afatinib żdied bi 13% u 42%, rispettivament, u naqas b'6% u 20% għal pazjent b'CrCL ta' 90 jew 120 mL/min, rispettivament, meta mqabbel ma' pazjent bi CrCL ta' 79 mL/min (CrCL medjana tal-pazjenti fil-popolazzjoni globali ta' pazjenti analizzati).
English: Table 7 shows outcomes in the subgroups of patients with two common EGFR mutations - Del 19 and L858R.
Maltese: It-Tabella 7 turi r-riżultati tas-sottogruppi ta' pazjenti b'żewġ mutazzjonijiet komuni tal-EGFR - Del 19 u L858R.
English: Patients who received at least 4 cycles of platinum-based therapy in the first line setting were subsequently randomized 1:1 to daily GIOTRIF 40 mg or erlotinib 150 mg until progression.
Maltese: Pazjenti li rċevew mill-inqas 4 ċikli ta' terapija bbażata fuq il-platinu fl-ambjent tal-ewwel linja kienu sussegwentement randomizzati 1:1 għal GIOTRIF 40 mg jew erlotinib 150 mg kuljum sal-progressjoni tal-marda.
English: Among 795 patients randomized, the majority were males (84%), white (73%), current or former smokers (95%) with baseline performance status ECOG 1 (67%) and ECOG 0 (33%).
Maltese: Fost is-795 pazjent randomizzati, il-maġġoranza kienu rġiel (84%), bojod (73%), ipejpu jew kienu jpejpu (95%) bi stat ta' prestazzjoni fil-linja bażi ECOG 1 (67%) u ECOG 0 (33%).
English: Afatinib is eliminated with an effective half-life of approximately 37 hours.
Maltese: Afatinib jiġi eliminat b'half-life effettiva ta' madwar 37 siegħa.
English: No significant impact of age (range: 28 years - 87 years) on the pharmacokinetics of afatinib could be observed.
Maltese: Ma seta' jiġi osservat l-ebda impatt sinifikanti tal-età (medda: 28 sena - 87 sena) fuq il-farmakokinetika ta' afatinib.
English: However, systemic exposures achieved in animals were either in a similar range or below the levels observed in patients (see section 5.3).
Maltese: Madankollu, esponimenti sistemiċi miksuba fl-annimali kienu jew f'medda simili jew taħt il-livelli osservati fil-pazjenti (ara sezzjoni 5.3).
English: Median PFS (months), Overall Trial Population 18-months PFS rate 24-months PFS rate
Maltese: PFS medjan (xhur), Popolazzjoni tal-Prova Ġenerali Rata ta' PFS ta' 18-il xahar Rata ta' PFS ta' 24 xahar
English: Afatinib binds to proteins both non-covalently (traditional protein binding) and covalently.
Maltese: Afatinib jeħel mal-proteini kemm b'mod mhux kovalenti (twaħħil tradizzjonali mal-proteini) u b'mod kovalenti.
English: The median PFS was 12.0 months by independent review.
Maltese: Il-PFS medjan kien ta' 12.0-il xahar skont l-evalwazzjoni indipendenti.
English: 65% vs. 47%; p=0.0017
Maltese: 65% kontra 47%; p=0.0017
English: GIOTRIF film-coated tablets are available in packs containing 1, 2 or 4 perforated unit dose blisters.
Maltese: GIOTRIF pilloli miksija b'rita huma disponibbli f'pakketti li jkun fihom 1, 2 jew 4 folji perforati tad-doża tal-unità.