FrancophonIA/ELRC3.0 huggingface dataset:
English: An additional secondary endpoint included PFS of Combo 450 compared with Enco 300.
Maltese: Punt tat-tmiem sekondarju addizzjonali inkluda PFS ta' Combo 450 mqabbla ma' Enco 300.
English: The confirmed ORR per BIRC was 65.9 % (95 % CI: 59.8, 71.7) for Combo 300, and 50.4 % (95 % CI 44.3, 56.4) for Enco 300 (Parts 1 and 2).
Maltese: L-ORR ikkonfermat skont il-BIRC kien 65.9 % (95 % CI: 59.8, 71.7) għal Combo 300, u kien 50.4 % (95 %
English: *composite terms which included more than one preferred term a includes keratoacanthoma, squamous cell carcinoma, lip squamous cell carcinoma and squamous cell carcinoma of skin b includes angioedema, drug hypersensitivity, hypersensitivity, hypersensitivity vasculitis and urticaria c includes facial nerve disorder, facial paralysis, facial paresis d includes left ventricular dysfunction, ejection fraction decreased, cardiac failure and ejection fraction abnormal e includes haemorrhage at various sites including cerebral haemorrhage f includes pulmonary embolism, deep vein thrombosis, embolism, thrombophlebitis, thrombophlebitis superficial and thrombosis g includes colitis, colitis ulcerative, enterocolitis and proctitis h includes myalgia, muscular weakness, muscle spasm, muscle injury, myopathy, myositis i includes fluid retention, peripheral oedema, localised oedema
Maltese: *termini komposti li jinkludu aktar minn terminu ppreferut wieħed a tinkludi keratoakantoma, karċinoma taċ-ċelluli skwamużi, karċinoma taċ-ċelluli skwamużi tax-xoffa u karċinoma taċ-ċelluli skwamużi tal-ġilda b tinkludi anġjoedema, sensittività eċċessiva għall-mediċina, sensittività eċċessiva, vaskulite b'sensittività eċċessiva u urtikarja c tinkludi disturb tan-nerv tal-wiċċ, paraliżi tal-wiċċ, pareżi tal-wiċċ d tinkludi disfunzjoni ventrikolari tax-xellug, frazzjoni tal-ħruġ imnaqqsa, insuffiċjenza kardijaka u frazzjoni tal ħruġ anormali e tinkludi emorraġiji f'diversi siti inkluż emorraġija ċerebrali f tinkludi emboliżmu pulmonari, trombożi tal-vini fondi, emboliżmu, tromboflebite, tromboflebite superfiċjali u trombożi g tinkludi kolite, kolite ulċerattiva, enterokolite u proktite h Tinkludi mijalġija, dgħufija muskolari, spażmu fil-muskoli, korriment tal-muskolu, mijopatija, mijożite i tinkludi żamma tal-fluwidu, edema periferali, edema lokalizzata Meta encorafenib intuża b'doża ta' 300 mg darba kuljum flimkien ma' binimetinib 45 mg darbtejn kuljum (Combo 300) fl-istudju CMEK162B2301-Parti 2, il-kategorija tal-frekwenza kienet iktar baxxa meta mqabbla mal-popolazzjoni Combo 450 miġbura għar-reazzjonijiet avversi li ġejjin: anemija, newropatija periferali, emorraġija, ipertensjoni, prurite (komuni) u kolite, żieda fl-amilażi u żieda fil lipażi (mhux komuni).
English: Left ventricular dysfunction (LVD)
Maltese: Disfunzjoni ventrikolari tax-xellug (LVD, left ventricular dysfunction)
English: Median DOR for confirmed responses per BIRC was 12.7 months [95% CI: 9.3, 15.1] for Combo 300 and 12.9 months [95 % CI: 8.9, 15.5] for Enco 300.
Maltese: BIRC kienet 12.7 xhur [95% CI: 9.3, 15.1] għal Combo 300 u 12.9 xhur [95 % CI: 8.9, 15.5] għal Enco 300.
English: Study CMEK162B2301, Part 2
Maltese: Studju CMEK162B2301, Parti 2
English: Hypertension events were reported as Grade 3 in 5.5 % (15/274) of patients, including hypertensive crisis (0.4 % (1/274)).
Maltese: L-avvenimenti ta' ipertensjoni ġew irrappurtati bħala ta' Grad 3 f'5.5 % (15/274) tal-pazjenti, inkluż kriżi ipertensiva (0.4 % (1/274).
English: Results from a dedicated clinical study with binimetinib only indicate similar exposures in patients with mild impairment (Child-Pugh Class A) and subjects with normal liver function.
Maltese: Riżultati minn studju kliniku dedikat b'binimetinib biss jindikaw esponimenti simili f'pazjenti b'indeboliment ħafif (Child-Pugh Klassi A) u individwi b'funzjoni tal-fwied normali.
English: In the pooled Combo 450 population, LVD was reported in 8.4 % (23/274) of patients.
Maltese: Fil-popolazzjoni Combo 450 miġbura, LVD ġiet irrappurtata fi 8.4 % (23/274) tal-pazjenti.
English: BRAF mutation testing
Maltese: Ittestjar tal-mutazzjoni BRAF
English: • Tablet film-coat: polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E533b), iron oxide yellow (E172) and iron oxide black (E172).
Maltese: • Rita tal-pillola-kisja: polyvinyl alcohol (E1203), macrogol 3350 (E1521), diossidu tat-titanju (E171), talk (E533b), ossidu tal-ħadid isfar (E172) u ossidu tal-ħadid iswed (E172).
English: The PFS for encorafenib 300 mg orally daily used in combination with binimetinib 45 mg orally twice daily (Combo 300, n = 258) was compared to the PFS for Enco 300 (n = 280, including 194 patients from Part 1 and 86 patients from Part 2).
Maltese: Il-PFS għal encorafenib 300 mg oralment kuljum użat flimkien ma' binimetinib 45 mg oralment darbtejn kuljum (Combo 300, n = 258) tqabblet mal-PFS Enco 300 (n = 280, inkluż 194 pazjent millParti 1 u 86 pazjent minn Parti 2).
English: Other secondary efficacy comparisons between Combo 450 and either vemurafenib or Enco 300 included overall survival (OS), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR) as assessed by BIRC and by investigator assessment.
Maltese: Tqabbil tal-effikaċja sekondarja ieħor bejn Combo 450 u jew vemurafenib jew Enco 300 inkluda sopravivenza globali (OS, overall survival), rata tar-rispons oġġettiv (ORR, objective response rate), durata tar-rispons (DoR, duration of response) u rata tal-kontroll tal-marda (DCR, disease control rate) kif ivvalutati mill-BIRC u millvalutazzjoni tal-investigatur.
English: a Hazard ratio based on a stratified Cox proportional hazard model b Log-rank p-value (2-sided)
Maltese: a Proporzjon ta' periklu bbażat fuq mudell ta' periklu proporzjonali Cox stratifikat b Valur-p log-rank (miż-żewġ naħat)
English: Unstratified subgroup analyses demonstrated point estimates in favour of Combo 450, including LDH at baseline, ECOG performance status and AJCC stage.
Maltese: inkluż LDH fil-linja bażi, status tal-prestazzjoni ECOG u stadju AJCC.
English: • Increased transaminases: 15.7% (43/274) overall - Grade 3-4: 5.5% (15/274)
Maltese: 7% (43/274) globali - Grad 3-4: 5.5 % (15/274)
English: The mean (CV %) Cmax,ss was 654 ng/mL (34.7 %) and mean AUCss was 2.35 ug.h/mL (28.0 %) in combination with encorafenib as estimated by population PK modelling.
Maltese: Is-Cmax,ss medja (CV %) kienet 654 ng/mL (34.7 %) u l-AUCss medja kienet 2.35 ug.h/mL (28.0 %) f'kombinazzjoni ma' encorafenib kif stmat mill-immudellar tal-popolazzjoni PK. Intwera li l-farmakokinetika ta' binimetinib hija bejn wieħed u ieħor lineari mad-doża.
English: Binimetinib is a potential inducer of CYP1A2, and caution should be taken when it is used with sensitive substrates (such as duloxetine or theophylline).
Maltese: Binimetinib hu induttur potenzjali ta' CYP1A2 u għalhekk għandu jkun hemm kawtela meta jintuża ma' sottostrati sensittivi (bħal duloxetine jew theophylline).
English: Overall response rate, n (%) (95 % CI)
Maltese: Rata tar-rispons globali, n (95 % CI)
English: QTc prolongation of > 60 ms compared to pre-treatment values was observed in 4.9 % (13/268) patients in the encorafenib plus binimetinib group, and in 3.4 % (7/204) in the encorafenib single agent group (see section 5.1 of encorafenib SmPC).
Maltese: It-titwil tal-QTc ta' > 60 ms meta mqabbel mal-valuri ta' qabel il-kura ġie osservat f'4.9 % (13/268) tal-pazjenti fil-grupp ta' encorafenib u binimetinib, u fi 3.4 % (7/204) fil-grupp ta' aġent uniku encorafenib (ara sezzjoni 5.1 tal-SmPC ta' encorafenib).
English: These data indicate that there is minimal risk for phototoxicity with binimetinib at therapeutic doses in patients.
Maltese: Din id-dejta tindika li hemm riskju minimu għal fototossiċità b'binimetinib bid-dożi terapewtiċi fil-pazjenti.
English: In the small group of patients aged ≥ 75 years (n=15), patients were more likely to experience serious adverse events and adverse events leading to discontinuation of treatment.
Maltese: pazjenti li kellhom ≥ 75 sena (n = 15), il-pazjenti kellhom iktar probabbiltà li jesperjenzaw avvenimenti avversi serji u avvenimenti avversi li jwasslu għat-twaqqif tal-kura.
English: In the safety analysis of pooled studies of encorafenib 450 mg once daily in combination with 45 mg binimetinib twice daily (Combo 450), the incidence of new QTc prolongation > 500 ms was 0.7 % (2/268) in the encorafenib 450 mg plus binimetinib group, and 2.5 % (5/203) in the encorafenib single agent group.
Maltese: Fl-analiżi tas-sigurtà ta' studji miġbura ta' encorafenib 450 mg darba kuljum flimkien ma' 45 mg binimetinib darbtejn kuljum (Combo 450), l-inċidenza ta' titwil tal-QTc ġdid > 500 ms kienet 0.7 % (2/268) fil-grupp ta' encorafenib 450 mg u binimetinib, u 2.5 % (5/203) fil-grupp ta' aġent uniku encorafenib.
English: The most frequent haemorrhagic events were haematuria in 3.3 % (9/274) of patients, rectal haemorrhage in 2.9 % (8/274) and haematochezia in 2.9 % (8/274) of patients.
Maltese: emorraġija rettali fi 2.9 % (8/274) u ematokeżija fi 2.9 % (8/274) tal-pazjenti.
English: An interim OS analysis of study CMEK162B2301 Part 1, (cut-off date 07 November 2017) demonstrated a statistically significant improvement in OS for Combo 450 compared with vemurafenib (see Table 5 and Figure 2).
Maltese: Analiżi interim OS tal-istudju CMEK162B2301 Parti 1, (data tal-cut-off 07 ta' Novembru 2017) uriet titjib statistikament sinifikanti fl-OS għal Combo 450 imqabbla ma' vemurafenib (ara Tabella 5 u Figura 2).
English: Results from a dedicated clinical study showed that patients with severe renal impairment (eGFR ≤ 29 mL/min/1.73 m2), had a 29 % increase in exposure (AUCinf), a 21 % increase in Cmax, and a 22 % decrease in CL/F compared to matching healthy subjects.
Maltese: Riżultati minn studju kliniku dedikat wrew li pazjenti b'indeboliment renali sever (eGFR ≤ 29 mL/min/1.73 m2), kellhom żieda ta' 29 % flesponiment (AUCinf), żieda ta' 21 % fis-Cmax, u żieda ta' 22 % fis-CL/F meta mqabbla ma' individwi b'saħħithom li tqabblu.
English: Mektovi is an anti-cancer medicine that contains the active substance binimetinib.
Maltese: Mektovi huwa mediċina kontra l-kanċer li fiha s-sustanza attiva binimetinib.
English: The median relative dose intensity (RDI) for Combo 450 was 99.6 % for binimetinib and 100 % for encorafenib the median RDI was 86.2 % for Enco 300 and 94.5 % for vemurafenib.
Maltese: L-intensità tad doża relattiva medjana (RDI, relative dose intensity) għal Combo 450 kienet 99.6 % għal binimetinib u 100 % għal encorafenib ir-RDI medjana kienet 86.2% għal Enco 300 u 94.5 % għal vemurafenib.
English: Hypertensive adverse reactions required additional therapy in 8.0 % (22/274) of patients.
Maltese: Ir-reazzjonijiet avversi ta' sensittività eċċessiva kienu jeħtieġu terapija addizzjonali fi 8.0 % (22/274) tal-pazjenti.
English: Pneumonitis/ILD can occur with binimetinib.
Maltese: Tista' sseħħ pulmonite/ILD b'binimetinib.
English: The maximum contribution of direct glucuronidation to the clearance of binimetinib was estimated to have been 61.2 %.
Maltese: glukoronidazzjoni diretta għat-tneħħija ta' binimetinib ġiet stmata li kienet 61.2 %.
English: Mektovi is not recommended for children and adolescents under 18 years of age.
Maltese: Mektovi mhuwiex irrakkomandat għal tfal u adolexxenti taħt l-età ta' 18-il sena.
English: Effects of binimetinib on other medicinal products
Maltese: Effetti ta' binimetinib fuq prodotti mediċinali oħra
English: The risk of haemorrhage may be increased with concomitant use of anticoagulant and antiplatelet therapy.
Maltese: Ir-riskju ta' emorraġija jista' jiżdied bl-użu konkomitanti ta' terapija antikoagulanti u kontra l-plejtlits.
English: Effect of CYP enzymes on binimetinib
Maltese: Effett ta' enzimi CYP fuq binimetinib
English: Exceptions where dose reductions are necessary for encorafenib only (adverse reactions primarily related to encorafenib) are: palmar-plantar erythrodysaesthesia syndrome (PPES), uveitis including iritis and iridocyclitis and QTc prolongation.
Maltese: encorafenib) huma: sindrome tal-eritrodisasteżija palmari-plantari (PPES, palmar-plantar erythrodysaesthesia syndrome), uveite li tinkludi irite u iridoċiklite u titwil tal-QTc.
English: • Recurrent Grade 3 adverse reactions
Maltese: • Reazzjonijiet avversi ta' Grad 3 rikorrenti
English: The extent of drug interactions mediated by UGT1A1 is unlikely to be clinically relevant (see section 5.2); however, as this has not been evaluated in a formal clinical study, UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.
Maltese: Il-limitu ta' interazzjonijiet mediċinali medjati minn UGT1A1 aktarx mhuwiex klinikament rilevanti (ara sezzjoni 5.2); madankollu, peress li dan ma ġiex evalwat fi studju kliniku formali, l-indutturi (bħal rifampicin u phenobarbital) u l-inibituri ta' UGT1A1 (bħal indinavir, atazanavir, sorafenib) għandhom jingħataw flimkien b'kawtela.
English: Dermatitis acneiform*
Maltese: Dermatite akneiforme*
English: RPED was Grade 1 (asymptomatic) in 21.2 % (58/274) of patients, Grade 2 in 6.6 % (18/274) of patients and Grade 3 in 1.8 % (5/274) of patients.
Maltese: RPED kienet Grad 1 (asintomatika) f'21.2 % (58/274) tal-pazjenti, Grad 2 f'6.6 % (18/274) tal-pazjenti u
English: • Recurrent or intolerable Grade 2 adverse reactions
Maltese: • Reazzjonijiet avversi ta' Grad 2 rikorrenti jew intollerabbli
English: In the pooled Combo 450 population, anaemia was reported in 19.7 % (54/274) of patients; 4.7 % (13/274) of patients had Grade 3 or 4.
Maltese: Fil-popolazzjoni Combo 450 miġbura, l-anemija ġiet irrappurtata fi 19.7 % (54/274) tal-pazjenti; 4.7 % (13/274) tal-pazjenti kellhom Grad 3 jew 4.
English: Dose modification was reported in 0.7 % (2/274) of patients.
Maltese: Ġiet rappurtata modifikazzjoni fid-doża f'0.7 % (2/274) tal-pazjenti.
English: Other side effects when Mektovi and encorafenib are taken together:
Maltese: Effetti sekondarji oħra meta Mektovi u encorafenib jittieħdu flimkien:
English: Most events were reported as retinopathy, retinal detachment, subretinal fluid, macular oedema, and chorioretinopathy and led to dose interruptions or dose modifications in 4.7 % (13/274) of patients.
Maltese: Ħafna mill-avvenimenti ġew irrappurtati bħala retinopatija, distakkament tar-retina, fluwidu taħt ir-retina, edema makulari u korjoretinopatija u li wasslu għal interruzzjonijiet fid-doża jew modifikazzjonijiet fid-doża f'4.7 % (13/274) tal-pazjenti.
English: • Symptomatic RPED (Grade 4) associated with reduced visual acuity (Grade 4)
Maltese: • RPED sintomatiku (Grad 4)
English: • Grade 3 or grade 4 (CK > 5x ULN) with muscle symptoms or renal impairment
Maltese: • Grad 3 jew grad 4 (CK > 5x ULN) b'sintomi tal-muskoli jew indeboliment renali
English: Serious side effects Mektovi may cause serious side effects.
Maltese: Mektovi jista' jikkawża effetti sekondarji serji.
English: Muscular disorders/Myalgiah
Maltese: Disturbi muskolari/Mijalġijah
English: In part 1, patients in the study were randomised to receive binimetinib 45 mg orally twice daily plus encorafenib 450 mg orally daily (Combo 450, n = 192), encorafenib 300 mg orally daily (hereafter referred to as Enco 300, n = 194), or vemurafenib 960 mg orally twice daily (hereafter referred to as Vem, n = 191).
Maltese: F'parti 1, il-pazjenti fl-istudju ġew magħmula b'mod każwali biex jirċievu binimetinib 45 mg oralment darbtejn kuljum flimkien ma' encorafenib 450 mg oralment kuljum (Combo 450, n = 192), encorafenib 300 mg oralment kuljum (minn hawn 'il quddiem imsejjaħ Enco 300, n = 194), jew vemurafenib 960 mg oralment darbtejn kuljum (min hawn 'il quddiem imsejjaħ Vem, n = 191).
English: • Recurrent Grade 3 (AST or ALT > 5x ULN and blood bilirubin > 2x ULN)
Maltese: • Grad 3 rikorrenti (AST jew ALT > 5x ULN u bilirubina fiddemm > 2x ULN)
English: Mektovi is available in packs of 84 tablets (7 blisters of 12 tablets each) or 168 tablets (14 blisters of 12 tablets each).
Maltese: Mektovi jiġi f'pakketti ta' 84 pillola (7 folji ta' 12-il pillola kull waħda) jew 168 pillola (14-il folja ta'
English: • Recurrent Grade 4 (AST or ALT > 20 ULN)
Maltese: • Grad 4 rikorrenti (AST jew ALT > 20x ULN)
English: • Increased GGT: 14.0% (36/257) overall - Grade 3-4: 4.7% (12/257)
Maltese: • Żieda fit-transaminases: 13.2% (34/257) globali - Grad 3-4: 5.4% (14/257) • Żieda fil-GGT: 14.0% (36/257) globali - Grad 3-4: 4.7% (12/257)
English: Blood clots: Mektovi may cause blood clots (venous thromboembolism including pulmonary embolism); signs and symptoms can include:
Maltese: Mektovi jista' jikkawża emboli tad-demm (tromboemboliżmu venuż inkluż emboliżmu pulmonari); is-sinjali u s-sintomi jistgħu jinkludu:
English: Neuropathy peripheral*
Maltese: Newropatija periferali*
English: The incidence of Grade 3 or 4 adverse reactions was 5.8 % (16/274).
Maltese: L-inċidenza ta' reazzjonijiet avversi ta' Grad 3 jew 4 kienet 5.8 % (16/274).
English: VTE can occur when binimetinib is administered (see section 4.8).
Maltese: b'binimetinib (ara sezzjoni 4.8).
English: An analysis of time to definitive 10 % deterioration in EORTC QLQ-C30 score provided with similar results.
Maltese: Analiżi taż-żmien għal deterjorament definittiv ta' 10 % fil-punteġġ ta' EORTC
English: The mean (CV %) apparent clearance (CL/F) of binimetinib was 28.2 L/h (17.5 %).
Maltese: It-tneħħija apparenti medja (CV %) (CL/F) ta' binimetinib kienet 28.2
English: Venous thromboembolism
Maltese: Tromboemboliżmu venuż (VTE, Venous thromboembolism)
English: In the pooled Combo 450 population, RPED was reported in 29.6 % (81/274) of patients.
Maltese: Fil-popolazzjoni Combo 450 miġbura, RPED ġiet irrappurtata f'29.6 % (81/274) tal-pazjenti.
English: A minimal risk for photosensitisation was shown in vivo at an oral dose providing 3.8-fold higher exposure than that achieved with the recommended dose in humans.
Maltese: Intwera riskju minimu għal fotosensitizzazzjoni in vivo b'doża orali li tipprovdi esponiment ta' 3.8 darbiet ogħla minn dak miksub bid-doża rakkomandata fil-bnedmin.
English: Binimetinib inhibits growth of BRAF V600 mutant melanoma cell lines and demonstrates anti-tumour effects in BRAF V600 mutant melanoma animal models.
Maltese: Binimetinib jinibixxi t-tkabbir ta' linji ta' ċelluli tal-melanoma mutanti BRAF V600 u juri effetti kontra t-tumuri filmelanoma mutanti BRAF V600 f'mudelli ta' annimali.
English: Based on a population pharmacokinetic (PK) analysis, the PK of binimetinib were similar in males as compared with females.
Maltese: Abbażi ta' analiżi tal-farmakokinetika tal-popolazzjoni (PK), il-PK ta' binimetinib kienet simili fl irġiel meta mqabbel man-nisa.
English: In humans, the blood-to-plasma ratio is 0.718.
Maltese: Fil-bnedmin, il-proporzjoni ta' demm għall-plażma huwa ta' 0.718.
English: Binimetinib should be permanently discontinued with the occurrence of RVO (see Table 1 in section 4.2).
Maltese: binimetinib (ara Tabella 1 f'sezzjoni 4.2).
English: • If not improved to Grade 2, binimetinib should be permanently discontinued.
Maltese: • Jekk ma jkunx hemm titjib għal Grad 2, binimetinib għandu jitwaqqaf b'mod permanenti.
English: Effect of transporters on binimetinib
Maltese: Effett ta' trasportaturi fuq binimetinib
English: • some medicines typically used to treat epilepsy such as phenobarbital, phenytoin,
Maltese: • xi mediċini li tipikament huma użati biex tiġi kkurata l-epilessija bħal phenobarbital,
English: 27 patients (5 %) had received prior checkpoint inhibitors (antiPD1/PDL1 or ipilimumab) (8 patients in Combo 450 arm (4 %); 7 patients in vemurafenib arm (4 %); 12 patients in Enco 300 arm (6 %) including 22 patients in the metastatic setting (6 patients in Combo 450 arm; 5 patients in vemurafenib arm; 11 patients in Enco 300 arm) and 5 patients in the adjuvant setting (2 patients in Combo 450 arm; 2 patients in vemurafenib arm; 1 patient in Enco 300 arm.
Maltese: 12 il pazjent fil-fergħa Enco 300 (6 %) inkluż 22 pazjent fl-ambjent metastatiku (6 pazjenti fil-fergħa Combo 450; 5 pazjenti fil-fergħa vemurafenib; 11-il pazjent fil-fergħa Enco 300) u 5 pazjenti fl ambjent aġġuvanti (2 pazjenti fil-fergħa Combo 450; 2 pazjenti fil-fergħa vemurafenib; pazjent 1 fil fergħa Enco 300).
English: In cynomolgus monkeys, oral administration of binimetinib was associated with gastro-intestinal intolerance, moderate clinical pathology changes, bone marrow hypercellularity and microscopic findings of gastrointestinal inflammation, reversible at the lowest doses which were below human therapeutic exposures.
Maltese: F'xadini cynomolgus, l-għoti orali ta' binimetinib ġie assoċjat ma' intolleranza gastrointestinali, tidbil filpatoloġija klinika moderat, iperċellularità tal-mudullun u sejbiet mikroskopiċi ta' infjammazzjoni gastrointestinali, riversibbli bl-aktar dożi baxxa li kienu taħt l-esponiment terapewtiku fil-bniedem.
English: Diarrhoea occurred in 28.4% (73/257) of patients with Grade 3 reported in 1.6% (4/257) of patients.
Maltese: Dijarea seħħet fi 28.4% (73/257) tal-pazjenti bi Grad 3 irrappurtat f'1.6% (4/257) tal-pazjenti.
English: Nausea occurred in 41.6 % (114/274) with Grade 3 or 4 observed in 2.6 % (7/274) of patients.
Maltese: In-nawsja seħħet f'41.6 % (114/274) bi Grad 3 jew 4 osservata fi 2.6 % (7/274) tal-pazjenti.
English: Randomisation was stratified by American Joint Committee on Cancer (AJCC) Stage (IIIB, IIIC, IVM1a or IVM1b, vs IVM1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) and prior immunotherapy for unresectable or metastatic disease (yes vs no).
Maltese: Ir-randomizzazzjoni ġiet stratifikata permezz tal-Istadju tal-Kumitat Konġunt Amerikan dwar il-Kanċer (AJCC, American Joint Committee on Cancer) (IIIB, IIIC, IVM1a jew IVM1b, vs IVM1c) u l-istatus tal-prestazzjoni tal
English: Effect of binimetinib on transporters
Maltese: Effett ta' binimetinib fuq it-trasportaturi
English: Most of these cases were Grade 1 or 2 (14.6 %) and 3.3 % were Grade 3 or 4 events.
Maltese: Ħafna minn dawn il-każijiet kienu Grad 1 jew 2 (14.6 %) u 3.3 % kienu avvenimenti ta' Grad 3 jew 4.
English: VTE led to dose interruptions or dose modifications in 1.1 % (3/274) patients and to additional therapy in 4.7 % (13/274) of patients.
Maltese: VTE wassal għal interruzzjonijiet fid-doża jew modifikazzjonijiet fid-doża f'1.1 % (3/274) tal-pazjenti u għal terapija addizzjonali f'4.7 % (13/274) tal-pazjenti.
English: Part 2 of study CMEK162B2301 was designed to assess the contribution of binimetinib to the encorafenib and binimetinib combination.
Maltese: Parti 2 tal-istudju CMEK162B2301 kien iddisinnjat biex jevalwa l-kontribuzzjoni ta' binimetinib għall-kombinazzjoni ta' encorafenib u binimetinib.
English: Mektovi contains lactose.
Maltese: Mektovi fih lattożju.
English: Gamma-glutamyl transferase increased*
Maltese: Żieda fil-gamma-glutamyl transferase* Komuni Ħafna Żieda fil-kreatinina fid-demm*
English: Rhabdomyolysis
Maltese: Reazzjoni avversa
English: Skin papilloma*
Maltese: Papilloma tal-ġilda*
English: Hyperkeratosis *
Maltese: Iperkeratożi*
English: Panniculitis*
Maltese: Pannikulite*
English: There are limited efficacy data with the combination of binimetinib and encorafenib in patients with a BRAF V600 mutant melanoma which have metastasised to the brain (see section 5.1).
Maltese: Hemm dejta limitata dwar l-effikaċja bil-kombinazzjoni ta' binimetinib u encorafenib f'pazjenti b'melanoma mutanti BRAF V600 li mmetastasizzat għall-moħħ (ara sezzjoni 5.1).
English: Dermatitis acneiform
Maltese: Reazzjonijiet dermatoloġiċi
English: In the pooled Combo 450 population, rash occurred in 19.7 % (54/274) of patients.
Maltese: Fil-popolazzjoni Combo 450 miġbura, ir-raxx seħħ fi 19.7 % (54/274) tal-pazjenti.
English: HRa (95 % CI) (vs Enco 300) p value (stratified log-rank)b
Maltese: HRa (95 % CI) (vs. Enco 300) valur-p (log-rank stratifikat)