FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with BRAF V600K mutation positive metastatic melanoma (n=16) the response rate was 13% (95% CI: 0.0, 28.7) with a median DoR of 5.3 months (95% CI: 3.7, 6.8).
Maltese: F'pazjenti b'melanoma metastatika pożittiva għall-mutazzjoni BRAF V600K (n=16), ir-rata ta' rispons keient ta' 13 % (95 % CI: 0.0, 28.7) b'DoR li kien ta' 5.3 xhur (95 % CI: 3.7, 6.8).
English: Bleeding from various sites, including intracranial bleeding and fatal bleeding g
Maltese: Fsada minn diversi postijiet, inklużi fsada fil-kranju u fsada fatali g
English: Granulomatous nephritis has been reported (see section 4.8).
Maltese: Ġiet irrappurtata nefrite granulomatuża (ara sezzjoni 4.8).
English: Metabolism and nutrition disorders
Maltese: Disturbi tal-metaboliżmu u tan-nutrizzjoni
English: Based on updated data with an additional 10 months of follow-up compared to the primary analysis (minimum follow-up of 40 months), the RFS benefit was maintained with an estimated HR of 0.49 [95% CI: (0.40, 0.59)] (Figure 4).
Maltese: Abbażi ta' dejta aġġornata b'10 xhur addizzjonali ta' segwitu meta mqabbla mal-analiżi primarja (segwitu minimu ta' 40 xahar), il-benefiċċju RFS inżamm b'HR stmat ta' 0.49 [95 % CI: (0.40, 0.59)] (Figura 4).
English: Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity.
Maltese: Trametinib huwa inibitur allosteriku, riversibbli u selettiv ħafna ta' kinase 1 (MEK1) u attivazzjoni MEK2 regolati b'sinjal ekstraċellulari attivat b'mitoġenu.
English: The combination of dabrafenib with trametinib has shown anti-tumour activity in BRAF V600 mutation positive melanoma cell lines in vitro and delays the emergence of resistance in vivo in BRAF V600 mutation positive melanoma xenografts.
Maltese: Il-kombinazzjoni ta' dabrafenib ma' trametinib uriet attività anti-tumur f'linji ta' ċelloli tal-melanoma pożittiva għall-mutazzjoni BRAF V600 in vitro u ddewwem lemerġenza tar-reżistenza in vivo f'xenografts tal-melanoma pożittiva għall-mutazzjoni BRAF V600.
English: • Inflammation of the lung (pneumonitis)
Maltese: • Infjammazzjoni tal-pulmun (pulmonite)
English: Actinic keratosis Skin lesion Erythema Photosensitivity
Maltese: Fissuri fil-ġilda Fotosensittività
English: Effects of other medicinal products on dabrafenib
Maltese: Effetti ta' prodotti mediċinali oħra fuq dabrafenib
English: Most subjects had LDH ≤ULN (67%), ECOG performance status of 0 (70%), and visceral disease (78%) at Baseline.
Maltese: Il-biċċa l-kbira tal-individwi kellhom LDH ≤ULN (67 %), status tal-prestazzjoni ECOG ta' 0 (70 %) u marda vixxerali (78 %) fil-linja bażi.
English: Cardiovascular effects, including coronary arterial degeneration/necrosis and/or haemorrhage, cardiac atrioventricular valve hypertrophy/haemorrhage and atrial fibrovascular proliferation were seen in dogs (≥2 times clinical exposure based on AUC).
Maltese: Kienu osservati effetti kardjovaskulari, inkluż deġenerazzjoni/nekrożi tal-arterji koronarji u/jew emorraġija, ipertrofija tal-valv atrijuventrikolari tal-qalb/emorraġija u proliferazzjoni fibrovaskulari atrijali fil-klieb (≥ darbtejn l-esponiment kliniku abbażi tal-AUC).
English: Tafinlar 50 mg and 75 mg hard capsules are available in packs containing 28 or 120 capsules.
Maltese: Tafinlar 50 mg u 75 mg pilloli ibsin jiġu f'pakketti ta' 28 jew 120 kapsula.
English: Data as of June 25, 2012
Maltese: Dejta mill25 ta' Ġunju 2012
English: Subsequently, all patient samples were re-tested using the bioMerieux (bMx) THxID BRAF validated assay, which has CE marking.
Maltese: ThxID bioMerieux (bMx), li għandha marka CE.
English: OS analysis (data cut-off: 12-Jan-2015)
Maltese: Analiżi tal-OS (data tal-limitu: 12-Jan-2015)
English: Combination 1
Maltese: F'sena 1
English: Hepatic effects, including hepatocellular necrosis and inflammation, were observed in mice (≥0.6 times clinical exposure).
Maltese: Effetti tal-fwied, inkluż nekrożi u infjammazzjoni epatoċellulari kienu osservati fil-ġrieden (≥ 0.6 drabi l-esponiment kliniku).
English: Tafinlar 75 mg hard capsules are opaque dark pink and imprinted with “GS LHF” and “75 mg”.
Maltese: Tafinlar 75 mg kapsuli ebsin huma ta' lewn roża skur opak u stampat fuqhom ‘GS LHF' u '75 mg'
English: The majority of subjects had a BRAF V600E mutation (85%).
Maltese: Il-maġġoranza tal-individwi kellhom mutazzjoni BRAF V600E (85 %).
English: Cohort B N=16
Maltese: Koħort B N=16
English: • Inflamed, flaky skin (exfoliative dermatitis)
Maltese: • Ġilda infjammata u bil-qxur (dermatite esfoljattiva)
English: Tell your doctor immediately if you get a temperature above 38.5ºC while you are taking this medicine.
Maltese: Kellem lit-tabib tiegħek minnufih jekk ikollok temperatura ta' aktar minn 38.5ºC waqt li tkun qed tieħu l-mediċina tiegħek.
English: Patients should be evaluated for signs and symptoms of infection.
Maltese: Il-pazjenti għandhom jiġu evalwati għal sinjali u sintomi ta' infezzjoni.
English: In the Phase III study BRF115532 (COMBI-AD) in the adjuvant treatment of melanoma, 1% (6/435) of patients receiving dabrafenib in combination with trametinib as compared to 1% (5/432) of patients receiving placebo developed cuSCC.
Maltese: III BRF115532 (COMBI-AD) fit-trattament adjuvanti tal-melanoma, 1 % (6/435) tal-pazjenti li kienu qed jirċievu dabrafenib flimkien ma' trametinib meta mqabbla ma' 1 % (5/432) tal-pazjenti li kienu qed jirċievu plaċebo żviluppat għal cuSCC.
English: Results for the primary analysis of RFS are presented in Table 14.
Maltese: Ir-riżultati tal-analiżi primarja ta' RFS huma ppreżentati f'Tabella 14.
English: Hypophosphataemia
Maltese: Ipofosfatimja
English: In the Phase III study MEK116513 four patients (1%) treated with trametinib in combination with dabrafenib had a QTcB Grade 3 increase (>500 msec).
Maltese: Fl-istudju tal-Fażi III MEK116513, erba' pazjenti (1 %) ikkurati bi trametinib flimkien ma' dabrafenib kellhom żieda tal-QTcB fil-Grad 3 (> 500 msek).
English: OS data from a further post-hoc analysis based on a 18 December 2012 data cut are shown in Figure 3.
Maltese: Id-dejta OS minn analiżi post-hoc oħra datata mit18 ta' Diċembru 2012 'il quddiem huma indikati fil-Figura 3.
English: The majority of subjects had Stage IVM1c disease (67%).
Maltese: Il-maġġoranza tal-individwi kellhom marda flIstadju IVM1c (67 %).
English: BRF113710 (BREAK-2) was a multicentre, single-arm study that enrolled 92 subjects with metastatic melanoma (Stage IV) with confirmed BRAF V600E or V600K mutation-positive melanoma.
Maltese: BRF113710 (BREAK-2) kien studju b'aktar minn ċentru wieħed, b'fergħa waħda, li rreġistra 92 individwu b'melanoma metastatika (Stadju IV) b'melanoma pożittiva kkonfermata għallmutazzjoni V600E jew V600K BRAF.
English: In vitro experiments have demonstrated paradoxical activation of mitogen-activated protein kinase (MAP kinase) signalling in BRAF wild-type cells with RAS mutations when exposed to BRAF inhibitors.
Maltese: Esperimenti in vitro urew attivazzjoni paradossali ta' sinjalazzjoni ta' kinase tal-proteini attivata b'mitoġen (MAP kinase) f'ċelloli tat-tip selvaġġ ta' BRAF b'mutazzjonijiet RAS meta esposti għal inibituri BRAF.
English: • Cohort C: Combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily), 34 patients.
Maltese: Terapija ta' kombinazzjoni (dabrafenib 150 mg darbtejn kuljum u trametinib 2 mg darba kuljum), 34 pazjent.
English: In the Phase II study BRF113928 in patients with advanced NSCLC the incidence and severity of pyrexia were increased slightly when dabrafenib was used in combination with trametinib (48%, 3% Grade 3) as compared to dabrafenib monotherapy (39%, 2% Grade 3).
Maltese: II BRF113928 f'pazjenti b'NSCLC avvanzat l-inċidenza u s-severità ta' deni żdiedu xi ftit meta dabrafenib intuża flimkien ma' trametinib (48%, 3% Grad 3) meta mqabbel ma' monoterapija b'dabrafenib (39%, 2% Grad 3).
English: • warfarin and acenocoumarol, medicines used to thin the blood
Maltese: • warfarin u acenocoumarol, mediċini użati biex iraqqu d-demm
English: Blood alkaline phosphatase increased Gamma-glutamyltransferase increased Blood creatine phosphokinase increased a
Maltese: Żieda fl-alkaline phosphatase fid-demm Żieda fil-gamma-glutamyltransferase Żieda fil-creatine phosphokinase fiddemm a
English: A small decrease in trametinib bioavailability, corresponding to a decrease in AUC of 12%, was estimated when trametinib is administered in combination with dabrafenib, a CYP3A4 inducer, using a population pharmacokinetic analysis.
Maltese: Kien stmat tnaqqis żgħir filbijodisponibbiltà ta' trametinib, li jikkorrespondi għal tnaqqis f'AUC ta' 12 %, meta trametinib jingħata flimkien ma' dabrafenib, induttur CYP3A4, bl-użu ta' analiżi tal-farmakokinetika talpopolazzjoni.
English: • Dabrafenib monotherapy
Maltese: • Monoterapija b'dabrafenib
English: IV plasma clearance is 12 l/hr.
Maltese: IV hija ta' 12 l/siegħa.
English: 1.5 mg once daily
Maltese: 1.5 mg darba kuljum
English: • some immunosuppressants, such as cyclosporin, tacrolimus and sirolimus
Maltese: • xi immunosuppressanti, bħal cyclosporin, tacrolimus u sirolimus
English: Dabrafenib + trametinib Placebo
Maltese: Dabrafenib + trametinib Plaċebo
English: Oedema peripheral Pyrexia
Maltese: Edema periferali
English: The efficacy of dabrafenib in the treatment of adult patients with BRAF V600 mutation positive unresectable or metastatic melanoma has been evaluated in 3 clinical trials (BRF113683 [BREAK-3], BRF113929 [BREAK-MB], and BRF113710 [BREAK-2]) including patients with BRAF V600E and/or V600K mutations.
Maltese: L-effikaċja ta' dabrafenib fil-kura ta' pazjenti adulti b'melanoma li ma tistax titneħħa jew metastatika pożittiva għall-mutazzjoni BRAF V600 ġiet evalwata fi 3 provi kliniċi (BRF113683 [BREAK-3], BRF113929 [BREAK-MB], u BRF113710 [BREAK-2]) inklużi pazjenti bil-mutazzjonijiet BRAF V600E u/jew V600K.
English: Mucosal inflammation Face oedema
Maltese: Vista mċajpra Vista batuta Uveite
English: EU/1/13/865/003 28 capsules EU/1/13/865/004 120 capsules
Maltese: EU/1/13/865/003 28 kapsula EU/1/13/865/004 120 kapsula
English: • some medicines to treat HIV, such as ritonavir, amprenavir, indinavir, darunavir, delavirdine,
Maltese: • xi mediċini għall-kura tal-HIV, bħal ritonavir, amprenavir, indinavir, darunavir, delavirdine,
English: The most common adverse reactions (incidence 15%) reported with dabrafenib were hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, papilloma, alopecia, rash, and vomiting.
Maltese: L-aktar reazzjonijiet avversi komuni (inċidenza ta'  15 %) li seħħew b'mod frekwenti rapportata b'dabrafenib kienu iperkeratożi, uġigħ ta' ras, deni, artralġja, għeja, dardir, papilloma, alopeċja, raxx u rimettar.
English: EU/1/13/865/001 28 capsules EU/1/13/865/002 120 capsules
Maltese: EU/1/13/865/001 28 kapsula EU/1/13/865/002 120 kapsula
English: Dabrafenib is an enzyme inducer and increases the synthesis of drug-metabolising enzymes including CYP3A4, CYP2Cs and CYP2B6 and may increase the synthesis of transporters.
Maltese: Dabrafenib huwa induttur tal-enzimi u jżid is-sintesi ta' enzimi li jimmetabolizzaw il-mediċina inkluż CYP3A4, CYP2Cs u CYP2B6 u jista' jżid is-sintesi ta' trasportaturi.
English: Cases of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with dabrafenib/trametinib combination therapy.
Maltese: Każijiet ta' reazzjonijiet avversi gravi fil-ġilda (SCARs), li jinkludu s-sindrome ta' Stevens-Johnson, u reazzjoni mill-mediċina b'eosinofilija u sintomi sistemiċi (DRESS), li jistgħu jkunu ta' theddida għallħajja jew fatali, kienu rrappurtati matul it-trattament b'terapija mħallta ta' dabrafenib/trametinib.
English: Cutaneous squamous cell carcinoma Seborrhoeic keratosis Acrochordon (skin tags) Basal cell carcinoma
Maltese: Keratosi seborrejika Acrochordon (skin tags) Karċinoma taċ-ċelloli bażali
English: 150 mg twice daily
Maltese: 150 mg darbtejn kuljum2 mg darba kuljum
English: Worst-case QTc prolongation of >60 millisecond (msec) was observed in 3% of dabrafenib-treated subjects (one >500 msec in the integrated safety population).
Maltese: L-agħar każ ta' titwil tal-QTc ta' > 60 millisekonda (msek) kien osservat fi 3 % tal-individwi li kienu qed jirċievu kura b'dabrafenib (Wieħed > 500 msek fil-popolazzjoni ta' sigurtà integrata).
English: The safety of dabrafenib monotherapy is based on the integrated safety population from five clinical trials, BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220, and BRF112680, which included 578 patients with BRAF V600 mutant unresectable or metastatic melanoma treated with dabrafenib 150 mg twice daily.
Maltese: Is-sigurtà tal-monoterapija b'dabrafenib huwa bbażat fuq il-popolazzjoni ta' sigurtà integrata minn ħames provi kliniċi, BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220, u BRF112680, li kienu jinkludu 578 pazjent b'melanoma metastatika jew li ma titneħħiex b'intervent kirurġiku tal-mutazzjoni BRAF V600 ikkurati b'dabrafenib 150 mg darbtejn kuljum.
English: Patients should be routinely monitored for serum creatinine while on therapy.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati regolarment għal kreatinina tas-serum waqt li jkunu qegħdin jingħataw it-terapija.
English: The response was durable with median DoR in the previously treated population reaching 9.8 months (95% CI, 6.9, 16.0) by investigator assessment.
Maltese: Irrispons kien durabbli bid-DoR medjan fil-popolazzjoni kkurata qabel jilħaq id-9.8 xhur (95% CI, 6.9, 16.0) fil-valutazzjoni tal-investigatur.
English: • Localised tissue swelling
Maltese: • Nefħa lokalizzata tat-tessuti
English: The investigator assessed confirmed response rate in patients with BRAF V600E metastatic melanoma (n=76) was 59% (95% CI: 48.2, 70.3) and the median DoR was 5.2 months (95% CI: 3.9, not calculable) based on a median follow-up time of 6.5 months.
Maltese: Ir-rata ta' rispons ikkonfermata u vvalutata mill-investigatur f'pazjenti b'melanoma metastatika BRAF V600E (n=76) kienet ta' 59 % (95 % CI: 48.2, 70.3) u d-DoR kien ta' 5.2 xhur (95 % CI: 3.9, mhux kalkulabbli) ibbażata fuq ħin ta' segwitu medju ta' 6.5 xhur.
English: Administration of ketoconazole (a CYP3A4 inhibitor) 400 mg once daily, with dabrafenib 75 mg twice daily, resulted in a 71% increase in dabrafenib AUC and a 33% increase in dabrafenib Cmax relative to administration of dabrafenib 75 mg twice daily alone.
Maltese: L-għoti ta' ketoconazole (inibitur ta' CYP3A4) 400 mg darba kuljum, ma' dabrafenib 75 mg darbtejn kuljum, irriżulta f'żieda ta' 71 % fl-AUC ta' dabrafenib u f'żieda ta' 33 % fis-Cmax ta' dabrafenib meta mqabbel mal-għoti ta' dabrafenib 75 mg darbtejn kuljum waħdu.
English: Panniculitis
Maltese: Pannikulite
English: Median PFS after cross-over was 4.4 months.
Maltese: Il-PFS medjan wara l-qlib kien ta' 4.4 xhur.
English: Overall response,% (95% CI)
Maltese: Rispons globali, % (95% CI)
English: Interrupt therapy until toxicity is Grade 0 to 1 and reduce by one dose level when resuming therapy.
Maltese: Waqqaf it-terapija sakemm it-tossiċità tkun ta' Grad 0 sa 1 u naqqas b'livell wieħed tad-doża meta terġa' tibda t-terapija.
English: Neither dabrafenib nor its 3 main metabolites were demonstrated to be inhibitors of Pgp in vitro.
Maltese: La dabrafenib u lanqas it-3 metaboliti ewlenin tiegħu ma ntwerew li huma inibituri ta' Pgp in vitro.
English: Table 8 Overall Survival results for Study MEK116513 (COMBI-v)
Maltese: Tabella 8 Ir-riżultati tas-Sopravivenza Globali għall-Istudju MEK116513 (COMBI-v)
English: Part B of study BRF113220 included a cohort of 26 patients that had progressed on a BRAF inhibitor.
Maltese: Il-Parti B tal-istudju BRF113220 kienet tinkludi koorti ta' 26 pazjent li wrew progress fuq inibitur BRAF.
English: Further, the capsules are printed with black ink that contains black iron oxide (E172) shellac and propylene glycol.
Maltese: Barra minn hekk, il-kapsuli huma stampati b'linka sewda li fiha black iron oxide (E172) shellac u propylene glycol.
English: Table 7 Efficacy results for Study MEK115306 (COMBI-d)
Maltese: Tabella 7 Riżultati tal-effikaċja għall-Istudju MEK115306 (COMBI-d)
English: Updated analysis (data cut-off: 12-Jan-2015)
Maltese: Analiżi aġġornata (data tal-limitu: 12-Jan-2015)
English: Hyperkeratosis
Maltese: Iperkeratożi
English: • New melanoma
Maltese: • Melanoma ġdida
English: (7.5, NR) a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (≥59%) of investigator-assessed responses were still ongoing e - ORR difference calculated based on the ORR result not rounded f - Updated analysis was not pre-planned and the p-value was not adjusted for multiple testing NR = Not reached
Maltese: (7.5, NR) a - Sopravivenza mingħajr progressjoni (evalwata mill-investigatur) b - Rata ta' Rispons Globali = Rispons Sħiħ + Rispons Parzjali ċ - Tul tar-rispons d - Fil-ħin tar-rappurtar, il-maġġoranza (≥59 %) tar-reazzjonijiet evalwati mill-investigatur kienu għadhom għaddejjin e - Id-differenza tal-ORR ikkalkulata abbażi tar-riżultat tal-ORR miġjuba sal-eqreb valur f - L-analiżi aġġornata ma kenitx imfassla minn qabel u l-valur-p ma ġiex aġġustat għal ittestjar multiplu NR = Ma ntlaħaqx
English: Of these patients, 559 were treated with the combination for BRAF V600 mutant melanoma in two randomised Phase III clinical trials, MEK115306 (COMBI-d) and MEK116513 (COMBI-v), 435 were treated with the combination in the adjuvant treatment of Stage III BRAF V600 mutant melanoma after complete resection in a randomised Phase III study BRF115532 (COMBI-AD) and 82 were treated with the combination for BRAF V600 mutant NSCLC in a multi-cohort, non-randomised Phase II study BRF113928 (see section 5.1).
Maltese: III, MEK115306 (COMBI-d) u MEK116513 (COMBI-v), 435 kienu ttrattati b'taħlita ta' trattament adjuvanti ta' melanoma fi Stadju III b'mutazzjoni BRAF V600 wara tneħħija sħiħa b'intervent kirurġiku waqt studju randomizzat BRF115532 (COMBI-AD) f'Fażi III u 82 kienu kkurati bil-kombinazzjoni għal NSCLC b'mutazzjoni BRAF V600 fi studju mhux randomizzat, b'diversi gruppi ta' Fażi
English: A supratherapeutic dose of 300 mg dabrafenib twice daily was administered in 32 subjects with BRAF V600 mutation-positive tumours.
Maltese: Ingħatat doża supraterapewtika ta' 300 mg dabrafenib darbtejn kuljum lil 32 suġġett b'tumuri pożittivi għall-mutazzjoni BRAF V600.
English: In vitro evaluation of drug-drug interaction potential
Maltese: Evalwazzjoni in vitro tal-potenzjal ta' interazzjoni b'rabta mal-mediċina
English: In the Phase III study BRF115532 in the adjuvant treatment of melanoma, the incidence and severity of pyrexia were higher in the dabrafenib in combination with trametinib arm (67%; 6% Grade 3/4) as compared to the placebo arm (15%; <1% Grade 3).
Maltese: III BRF115532 fit-trattament adjuvanti tal-melanoma, l-inċidenza u s-severità tad-deni kienu ogħla fil-fergħa ta' dabrafenib flimkien ma' trametinib (67 %; 6 % Grad 3/4) meta mqabbla mal-fergħa tal-plaċebo (15 %; <1 % Grad 3).
English: Dose modifications or interruptions are not recommended for adverse reactions of cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma (see section 4.4).
Maltese: Modifikazzjonijiet jew interruzzjonijiet tad-doża mhumiex rakkomandati għal reazzjonijiet avversi ta' karċinoma taċ-ċelluli skwamużi tal-ġilda (cuSCC) jew ta' melanoma primarja ġdida (ara sezzjoni 4.4).
English: 5-year OS analysis (data cut-off: 08-Oct-2018)
Maltese: Analiżi fuq 5 snin (Data tal-limitu: 08-Ott-2018)
English: Among the total of 93 patients who were enrolled in the combination therapy cohorts B and C, most patients were Caucasian (>90%), and similar female versus male (54% versus 46%), with a median age of 64 years in second line or higher patients and 68 years in the first line patients.
Maltese: Fost it-total ta' 93 pazjent li kienu rreġistrati fil-gruppi B u C ta' terapija ta' kombinazzjoni, il-biċċa lkbira tal-pazjenti kienu Kawkasi (>90%), kien hemm ammont simili ta' nisa u rġiel (54% f'paragun ma' 46%), b'età medjana ta' 64 sena f'pazjenti fuq terapija tat-tieni linja u ogħla u 68 sena fil-pazjenti fuq terapija tal-ewwel linja.
English: As of 25 June 2012 cut-off, thirty five subjects (55.6%) of the 63 randomised to DTIC had crossed over to dabrafenib and 63% of subjects randomised to dabrafenib and 79% of subjects randomised to DTIC had progressed or died.
Maltese: Mid-data tal-25 ta' Ġunju 2012, ħamsa u tletin (55.6 %) mis-63 randomizzati għall-DTIC kienu qelbu għal dabrafenib u 63 % tal-individwi randomizzati għal dabrafenib u 79 % tal-individwi randomizzati għal DTIC avvanzaw fil-marda jew mietu.
English: Arthralgia was reported very commonly in the integrated safety population of dabrafenib monotherapy (25%) and dabrafenib in combination with trametinib (25%) although these were mainly Grade 1 and 2 in severity with Grade 3 occurring uncommonly (<1%) and no Grade 4 occurrences being reported.
Maltese: Artralġja kienet irrapportata b'mod komuni ħafna fil-popolazzjoni ta' sigurtà integrata ta' monoterapija b'dabrafenib (25%) u dabrafenib flimkien ma' trametinib (25 %) għalkemm dawn kienu prinċipalment ta-Grad 1 u 2 ta' severità tal-Grad 3 jseħħ b'mod mhux komuni (< 1 %) u ma ġie rrapportat l-ebda każ tal-Grad 4.
English: The safety of dabrafenib in combination with trametinib has been evaluated in the integrated safety population of 1076 patients with BRAF V600 mutant unresectable or metastatic melanoma, Stage III BRAF V600 mutant melanoma following complete resection (adjuvant treatment) and advanced NSCLC treated with dabrafenib 150 mg twice daily and trametinib 2 mg once daily.
Maltese: Is-sigurtà ta' dabrafenib flimkien ma' trametinib ġiet evalwata fil-popolazzjoni ta' sigurtà integrata ta' 1076 pazjent b'melanoma li jew għandha mutazzjoni BRAF V600 u ma titneħħiex b'intervent krurġiku jew li hija metastatika, melanoma fi Stadju III b'mutazzjoni BRAF V600 wara tneħħija sħiħa b'intervent kirurġiku (trattament adjuvanti) u NSCLC avvanzat ikkurati b'dabrafenib 150 mg darbtejn kuljum u trametinib 2 mg darba kuljum.
English: Sixty percent of patients were male and 99.6% were Caucasian; the median age was 52 years with 21% of patients being ≥65 years, 98.4% had ECOG status of 0 or 1, and 97% of patients had metastatic disease.
Maltese: Sittin filmija tal-pazjenti kienu rġiel u 99.6 % kienu Kawkasi; l-età medja kienet ta' 52 sena b'21 % talpazjenti kellhom aktar minn 65 sena, 98.4 % kellhom status ECOG ta' 0 jew 1, u 97 % tal-pazjenti kellhom marda metastatika.
English: Secondary endpoints include overall survival (OS; key secondary endpoint), freedom from relapse (FFR) and distant metastasis-free survival (DMFS).
Maltese: L-endpoints sekondarji jinkludu s-sopravivenza ġenerali (OS, endpoint sekondarju ewlieni), nuqqas ta' rikaduta (FFR) u sopravivenza ħielsa minn metastażi distanti (DMFS).
English: Prior BRAF inhibitor therapy
Maltese: Terapija b'inibitur preċedenti ta' BRAF
English: Cohort C N=16
Maltese: Koħort Ċ N=16
English: Opaque dark red capsules, approximately 18 mm long, with capsule shell imprinted with “GS TEW” and “50 mg”.
Maltese: Kapsuli opaki ħomor skuri, twal madwar 18 mm, bil-qoxra tal-kapsula stampata b'‘GS TEW' u ‘50 mg'.
English: th
Maltese: WT
English: The efficacy and safety of dabrafenib in combination with trametinib were studied in a Phase III, multicentre, randomised, double-blind, placebo-controlled study in patients with Stage III (Stage IIIA [lymph node metastasis >1 mm], IIIB, or IIIC) cutaneous melanoma with a BRAF V600 E/K mutation, following complete resection.
Maltese: III, multiċentriku, mhux randomizzat, double-blind, ikkontrollat bi plaċebo f'pazjenti b'melanoma fi Stadju III (Stadju IIIA, [metastasi tan-nodi limfatiċi >1 mm], IIIB, jew IIIC) b'mutazzjoni BRAF V600 E/K taħt il-ġilda, wara tneħħija sħiħa b'intervent kirurġiku.