FrancophonIA/ELRC3.0 huggingface dataset:
English: Stopping treatment with Pregabalin Zentiva should also be done gradually, over at least a week.
Maltese: interruzzjoni tal-kura bi Pregabalin Zentiva għandha ssir ukoll gradwalment, fuq mill-inqas ġimgħa.
English: • epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures
Maltese: • epilessija, fejn jintuża bħala ‘żieda' flimkien ma' kura eżistenti f'pazjenti li jbatu minn aċċessjonijiet parzjali (epilessija gravi li tibda f'parti speċifika tal-moħħ) li ma tistax tiġi kkontrollata bil-kura li jkunu qed jieħdu fil-preżent;
English: [Where one-year marketing protection/data exclusivity is accepted, please select the statement(s) as provided below, otherwise provide scientific conclusions and grounds.]
Maltese: [Where one-year marketing protection/data exclusivity is accepted, please select the statement(s) as provided below, otherwise provide scientificconclusions and grounds.]
English: <and>
Maltese: <u>
English: <one-year <marketing protection> <data exclusivity>>
Maltese: <sena waħda ta' <protezzjoni tal-kummerċjalizzazzjoni> <esklussività tad-data> >
English: [Art 74(a)- legal status switch]<Furthermore, the CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 74(a) of Directive 2001/83/EC, and considers that the data submitted in support of the classification of {specify medicinal product name} as ‘medicinal product not subject to medical prescription' were significant as further explained in the European Public Assessment Report.>
Maltese: [Art 74(a)- legal status switch]<Barra minnhekk, is-CHMP rreveda d-data sottomessa mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, billi kkunsidra d-dispożizzjonijiet tal-Artikolu 74(a) tad-Direttiva 2001/83/KE, u kkunsidra li d-data sottomessa b'sostenn għall-klassifikazzjoni ta' {speċifika l-isem tal-prodott mediċinali} bħala ‘prodott mediċinali mhux suġġett għall-preskrizzjoni medika' kienu sinifikanti kif spjegat aktar fit-tul fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.>
English: [Art 10(5)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 10(5) of Directive 2001/83/EC, and considers that <the <pre-clinical tests> <and> <clinical studies> carried out in relation to the new indication were significant as further explained in the European Public Assessment Report.
Maltese: [ Art 10(5)] <Is-CHMP irreveda d-data sottomessa mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, filwaqt li kkunsidra d-dispożizzjonijiet tal-Artikolu 10(5) tad-Direttiva 2001/83/KE, u jqis li <t-testijiet pre-kliniċi> <u> <l-istudji kliniċi> mwettqa b'rabta mal-indikazzjoni l-ġdida kienu sinifikanti, kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: <the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication>.
Maltese: <l-applikant jista' jistabbilixxi fl-applikazzjoni li l-prodott mediċinali, minkejja li huwa simili għall-<prodott mediċinali orfni awtorizzat>, huwa aktar sigur, aktar effettiv jew inkella klinikament superjuri (kif definit fl-Artikolu 3 tar-Regolament tal-Kummissjoni (KE) Nru 847/2000) għall-istess indikazzjoni terapewtika >.
English: <The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal product(s) within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report.
Maltese: <Is-CHMP huwa tal-fehma li <isem il-prodott mediċinali> hu simili għal prodott(i) mediċinali orfni fis-sens tal-Artikolu 3 tar-Regolament tal-Kummissjoni (KE) Nru 847/2000 kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: Grade 4:
Maltese: Grad 4:
English: Study NO25395 (BRIM7)
Maltese: Studju NO25395 (BRIM7)
English: Primary Endpoint a, f
Maltese: Punt Finali Primarju a, f
English: Study GO28141 (coBRIM)
Maltese: Studju GO28141 (coBRIM)
English: Film coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Maltese: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
English: ^ Data cut-off date of 19 September 2014
Maltese: ^ Data meta waqqfet tinġabar id-dejta 19 ta' Settembru 2014
English: Transparent PVC/PVDC blisters containing 21 tablets.
Maltese: Folji trasparenti tal-PVC/PVDC li fihom 21 pillola.
English: 0.70 (95% CI: 0.55, 0.90) (p-value = 0.0050
Maltese: 0.70 (CI ta' 95%: 0.55, 0.90) (valur p = 0.0050 e)
English: Overall Survival (OS)g
Maltese: Globali (OS - Overall Survival)g
English: Rhabdomyolysis***
Maltese: Rabdomijolisi***
English: The absolute bioavailability of cobimetinib was 45.9% (90% CI: 39.7%, 53.1%) in healthy subjects.
Maltese: Il-bijodisponibilità assoluta ta' cobimetinib kienet ta' 45.9% (CI ta' 90%: 39.7%, 53.1%) f'individwi f'saħħithom.
English: One pack size is available: 63 tablets (3 blisters of 21 tablets).
Maltese: Hemm disponibbli daqs tal-pakkett wieħed: 63 pillola (3 folji ta' 21 pillola).
English: All Grades Grades 3-4 All Grades Grades 3-4
Maltese: Kull Grad Gradi 3-4
English: CYP1A2 substrates
Maltese: Sottostrati ta' CYP1A2
English: The difference in ORR was 22.9 % (p-value<0.0001).
Maltese: Id-differenza fl-ORR kienet ta' 22.9 % (valur p < 0.0001).
English: In vitro, cobimetinib is a moderate inhibitor of BCRP (Breast Cancer Resistance Protein).
Maltese: In vitro, cobimetinib huwa inibitur moderat ta' BCRP (Proteina ta' Reżistenza għall-Kanċer tas-SiderBreast Cancer Resistance Protein).
English: · Muscle problems
Maltese: Problemi fil-muskoli
English: Avoid taking Cotellic with grapefruit juice.
Maltese: Evita li tieħu Cotellic mal-meraq tal-grejpfrut.
English: Each film-coated tablet contains 36 mg lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 36 mg lactose monohydrate.
English: Each pack contains 63 tablets.
Maltese: Kull pakkett fih 63 pillola.
English: In Study GO28141, there were 89 patients (18.1%) aged 65-74, 38 patients (7.7%) aged 75-84 and 5 patients (1.0%) aged 85 years and older.
Maltese: Fi Studju GO28141, kien hemm 89 pazjent (18.1%) b'età ta' 65-74, 38 pazjent (7.7%) b'età ta' 75-84 u 5 pazjenti (1.0%) b'età ta' 85 sena u aktar.
English: The mean steady-state Cmax and AUC0-24 were 273 ng/mL and 4340 ng.h/mL respectively.
Maltese: Il-medja fi stat fiss ta' Cmax u l-AUC0-24 kienu ta' 273 ng/mL u 4340 ng.s/mL rispettivament.
English: Cobimetinib is 94.8% bound to human plasma proteins in vitro.
Maltese: Distribuzzjoni Cobimetinib huwa 94.8% marbut mal-proteini tal-plażma tal-bniedem in vitro.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1048/001
Maltese: EU/1/15/1048/001
English: Progression-free survival (PFS) as assessed by the investigator (INV) was the primary endpoint.
Maltese: Sopravivenza mingħajr progressjoni (PFS - Progression-free survival) kif evalwata mill-investigatur (INV - investigator) kienet il-punt finali primarju.
English: CYP3A and CYP2D6 substrates
Maltese: Sottostrati ta' CYP3A u CYP2D6
English: The safety profile of Study NO25395 was consistent with that observed in Study GO28141.
Maltese: Il-profil tas-sigurtà ta' Studju NO25395 kien konsistenti ma' dak osservat fi Studju GO28141.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH
Maltese: Roche Registration GmbH
English: Grade 1 or Grade 2 (tolerable)
Maltese: Grad 1 jew Grad 2 (tollerabbli)
English: (or 40-49%
Maltese: (jew tnaqqis assolut ta' 40-49% u
English: Figure 2: Forest plot for hazard ratios of final overall survival subgroup analyses - Intent to treat population (cut-off date: 28 August 2015)
Maltese: Figura 2: Forest plot għall-proporzjonijiet ta' periklu għall-analiżi finali tas-sopravivenza globali tas-sottogrupp - popolazzjoni b'intenzjoni li tiġi kkurata (data meta waqqfet tinġabar id dejta: 28 ta' Awwissu 2015)
English: Table 4 provides the frequency of measured liver laboratory abnormalities and elevated creatine phosphokinase for all Grades and Grades 3-4.
Maltese: Tabella 4 tipprovdi l-frekwenza ta' anormalitajiet tal-laboratorju tal-fwied imkejla u ta' creatine phosphokinase elevata għall-Gradi kollha u Gradi 3-4.
English: Symptomatic
Maltese: Sintomatiku
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Germany
Maltese: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Il-Ġermanja
English: Objective response rate (ORR) (95% CI) for ORR
Maltese: (ORR - Objective response rate) (CI ta' 95%) għal ORR
English: In vitro, cobimetinib is a potential inducer of CYP1A2 and may therefore reduce the exposure of substrates of this enzyme e.g., theophylline.
Maltese: In vitro, cobimetinib huwa induttur potenzjali ta' CYP1A2 u għalhekk jista' jnaqqas l-esponiment għal sottostrati ta' din l-enzima eż., theophylline.
English: cobicistat, telaprevir, lopinavir, itraconazole, voriconazole, clarithromycin, telithromycin, posaconazole, nefazodone and grapefruit juice.
Maltese: ritonavir, cobicistat, telaprevir, lopinavir, itraconazole, voriconazole, clarithromycin, telithromycin,
English: Consider permanent discontinuation *The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE)
Maltese: (CTC-AE - Common Terminology Criteria for Adverse Events)
English: BCRP substrates
Maltese: Sottostrati ta' BCRP
English: The proportion of patients experiencing adverse events (AE) was similar in the patients aged <65 years and those aged ³65 years.
Maltese: Ilproporzjon ta' pazjenti li kellhom avvenimenti avversi (AE - adverse events) kien simili fil-pazjenti b'età ta' <65 sena u dawk b'età ta' ³65 sena.
English: Figure 1 Kaplan-Meier curves of final overall survival - Intent to treat population (cut-off date: 28 August 2015)
Maltese: Kaplan-Meier tas-sopravivenza globali finali - Popolazzjoni b'intenzjoni li tiġi kkurata (data meta waqqfet tinġabar id-dejta: 28 ta' Awwissu 2015)
English: Difference in ORR % (95% CI)
Maltese: Differenza f'ORR % (CI ta' 95%)d
English: Cotellic contain lactose
Maltese: Cotellic fih lactose
English: Cobimetinib is a reversible, selective, allosteric, oral inhibitor that blocks the mitogen-activated protein kinase (MAPK) pathway by targeting the mitogen-activated extracellular signal-regulated kinase (MEK) 1 and MEK 2 which results in inhibition of phosphorylation of the extracellular signalregulated kinase (ERK) 1 and ERK 2.
Maltese: Cobimetinib huwa inibitur orali riversibbli, selettiv u allosteriku li jimblokka r-rotta ta' protein kinase attivati permezz ta' mitogen (MAPK - mitogen-activated protein kinases) billi jimmira kinase ekstraċellulari rregolat minn sinjali u attivat permezz ta' mitogen (MEK - mitogen-activated extracellular signal regulated kinase) 1 u MEK 2 u dan iwassal għal inibizzjoni tal-fosforilazzjoni ta' kinase ekstraċellulari rregolat minn sinjali (ERK - extracellular signal-related kinase) 1 u ERK 2.
English: In the Phase III study with Cotellic in combination with vemurafenib in patients with unresectable or metastatic melanoma (n=247), 183 patients (74%) were <65 years of age, and 44 patients (18%) were 65-74 years of age, 16 (6%) were 75-84 years of age, and 4 patients (2%) were aged ³85 years.
Maltese: III b'Cotellic flimkien ma' vemurafenib f'pazjenti b'melanoma li ma tistax titneħħa jew metastatika (n=247), 183 pazjent (74%) kellhom età ta' <65 sena, u 44 pazjent (18%) kellhom età ta' 65-74 sena, 16 (6%) kellhom età ta' 75-84 sena, u 4 pazjenti (2%) kellhom età ta' ³85 sena.
English: Liver laboratory abnormalities, specifically increases in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP), have been observed in patients treated with Cotellic plus vemurafenib (see section 4.8).
Maltese: Anormalitajiet tal-laboratorju tal-fwied, speċifikament żidiet f'Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP), kienu osservati f'pazjenti kkurati b'Cotellic flimkien ma' vemurafenib (ara sezzjoni 4.8).
English: The final OS analysis for Study GO28141 was conducted with a data-cut off date of 28 August 2015.
Maltese: L-analiżi finali ta' OS għall-Istudju GO28141 twettqet b'data meta waqqfet tinġabar id-dejta ta' 28 ta' Awwissu 2015.
English: · The other ingredients are: · lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate in the tablet core; and · polyvinyl alcohol, titanium dioxide, macrogol and talc in the film-coating.
Maltese: L-ingredjenti l-oħra huma: · lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, u magnesium stearate fil-qalba tal-pillola; u · polyvinyl alcohol, titanium dioxide, macrogol u talc fil-kisja b'rita.
English: Using Clopper-Pearson method d Using Hauck-Anderson method e
Maltese: Analiżi stratifikata skont ir-reġjun ġeografiku u l-klassifikazzjoni tal-metastasi (stadju tal-marda) ċ Bl-użu tal-metodu Clopper-Pearson d Bl-użu tal-metodu Hauck-Anderson e
English: The apparent volume of distribution was 806 L in cancer patients based on population pharmacokinetic analysis.
Maltese: Il-volum apparenti ta' distribuzzjoni kien ta' 806 L f'pazjenti bil-kaner ibbażat fuq analiżi talfarmakokinetika tal-popolazzjoni.
English: Unchanged medicinal product in faeces and urine accounted for 6.6% and 1.6% of the administered dose, respectively, indicating that cobimetinib is primarily metabolised with minimal renal elimination.
Maltese: Prodott mediċinali mhux mibdul fl-ippurgar u fl-awrina ammonta għal 6.6% u 1.6% tad-doża mogħtija, rispettivament, li jindika li cobimetinib huwa primarjament metabolizzat b'eliminazzjoni minima mill-kliewi.
English: (or 40-49% and < 10% absolute decrease from baseline)
Maltese: (jew tnaqqis assolut ta' 40-49% u < 10% mil linja bażi)
English: Placebo + vemurafenib N=248
Maltese: Plaċebo + vemurafenib n=248
English: Fatigue was observed at similar frequencies in both arms.
Maltese: Għeja kienet osservata fi frekwenzi simili fiż-żewġ gruppi.
English: g The data cut-off date for the final OS analysis is 28 August 2015 and median follow-up was 18.5 months.
Maltese: Id-data meta waqqfet tinġabar id-dejta għall-analiżi finali ta' OS hija 28 ta' Awwissu 2015 u is-segwitu medjan kien ta' 18.5 xhur.
English: Purpose of the medicine itraconazole, clarithromycin, erythromycin, telithromycin, voriconazole, rifampicin, posaconazole, fluconazole, miconazole for some fungal and bacterial infections ritonavir, cobicistat, lopinavir, delavirdine, amprenavir, fosamprenavir for HIV infection telaprevir for hepatitis C
Maltese: Għalxiex tintuża l-mediċina itraconazole, clarithromycin, erythromycin, telithromycin, voriconazole, rifampicin, posaconazole, fluconazole, miconazole għal xi infezzjonijiet ikkawżati minn fungi u batterji ritonavir, cobicistat, lopinavir, delavirdine, amprenavir, fosamprenavir għall-infezzjoni tal-HIV
English: Moderate CYP3A inhibitors include, but are not limited to, amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, delavirdine, amprenavir, fosamprenavir, imatinib.
Maltese: Inibituri moderati ta' CYP3A jinkludu, iżda mhumiex limitati għal, amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil,
English: Cobimetinib has linear pharmacokinetics in the dose range of ~3.5 mg to 100 mg.
Maltese: Cobimetinib għandu farmakokinetika lineari fil-firxa tad-doża ta' ~3.5 mg sa 100 mg.
English: Photosensitivityb, Rash, Rash maculo-papular, Dermatitis acneiform, Hyperkeratosis**
Maltese: Fotosensittivitàb, Raxx, Raxx makulo-papulari, Dermatite akniformi, Iperkeratosi**
English: Maintain Cotellic at a dose of 60 mg once daily (3 tablets)
Maltese: 60 mg darba kuljum (3 pilloli)
English: Liver laboratory abnormalities
Maltese: Anormalitajiet tal-laboratorju
English: A population pharmacokinetic analysis using data from 151 patients with mild renal impairment (creatinine clearance (CRCL) 60 to less than 90 mL/min), 48 patients with moderate renal impairment (CRCL 30 to less than 60 mL/min), and 286 patients with normal renal function (CRCL greater than or equal to 90 mL/min), showed that CRCL had no meaningful influence on exposure of cobimetinib.
Maltese: Analiżi farmakokinetika tal-popolazzjoni bl-użu ta'dejta minn 151 pazjent b'indeboliment tal-kliewi ħafif (tneħħija tal-krejatinina (CRCL - creatinine clearance) ta' 60 sa inqas minn 90 mL/min), 48 pazjenti b'indeboliment tal-kliewi moderat (CRCL 30 sa inqas minn 60 mL/min), u 286 pazjent b'funzjoni tal-kliewi normali (CRCL akbar minn jew ugwali għal 90 mL/min), uriet li CRCL ma kellha l-ebda influwenza sinifikanti fuq l-espożizzjoni għal cobimetinib.
English: Cobimetinib is a substrate of P-gp in vitro.
Maltese: Cobimetinib huwa sottostrat ta' P-gp in vitro.
English: and ≥ 10%
Maltese: ≥ 10% millinja bażi)
English: In patients who were naive to BRAF inhibitor therapy, the median overall survival was 28.5 months (95% CI 23.3-34.6).
Maltese: F'pazjenti li qatt ma rċevew terapija b'inibitur ta' BRAF qabel, is-sopravivenza globali medjana kienet ta' 28.5 xhur (CI ta' 95% 23.3-34.6).
English: Table 4 Liver function and other laboratory tests observed in the Phase III Study GO28141
Maltese: Tabella 4 Testijiet tal-laboratorju tal-funzjoni tal-fwied u oħrajn osservati fl-Istudju ta' Fażi III GO28141
English: A clinical drug-drug interaction (DDI) study in cancer patients showed that plasma concentrations of midazolam (a sensitive CYP3A substrate) and dextromethorphan (a sensitive CYP2D6 substrate) were not altered in the presence of cobimetinib.
Maltese: Studju kliniku dwar interazzjoni bejn mediċina u oħra (DDI - drug-drug interaction) f'pazjenti bilkanċer wera li l-konċentrazzjonijiet fil-plażma ta' midazolam (sottostrat sensittiv ta' CYP3A) u dextromethorphan (sottostrat sensittiv ta' CYP2D6) ma kinux mibdula fil-preżenza ta' cobimetinib.
English: 495 previously untreated patients with unresectable locally advanced or metastatic melanoma were randomised to receive either: · Placebo once daily on Days 1-21 of each 28-day treatment cycle and 960 mg vemurafenib twice daily on Days 1-28, or · Cotellic 60 mg once daily on Days 1-21 of each 28-day treatment cycle and 960 mg vemurafenib twice daily on Days 1-28
Maltese: V600, 495 pazjent li ma kinux ikkurati qabel b'melanoma avanzata lokalment li ma tistax titneħħa jew metastatika kienu randomised biex jirċievu: · Placebo darba kuljum fi Ġranet 1-21 ta' kull ċiklu ta' kura ta' 28 ġurnata u 960 mg vemurafenib darbtejn kuljum fi Ġranet 1-28, jew · Cotellic 60 mg darba kuljum fi Ġranet 1-21 ta' kull ċiklu ta' kura ta' 28 ġurnata u 960 mg vemurafenib darbtejn kuljum fi Ġranet 1-28
English: Patients with rare hereditary problems of galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption should consult with their physician and discuss whether the benefits outweigh the risks on an individual basis.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza konġenitali ta' lactase jew assorbiment ħażin ta' glucose-galactose għandhom jikkonsultaw mat-tabib tagħhom u jiddiskutu jekk il-benefiċċji humiex akbar mir-riskji fuq bażi individwali.
English: Symptomatic regardless of LVEF Permanent discontinuation
Maltese: Sintomatiku irrispettivament millLVEF
English: Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib.
Maltese: Kull pillola miksija b'rita fiha cobimetinib hemifumarate ekwivalenti għal 20 mg cobimetinib.
English: Serous retinopathy (fluid accumulation within the layers of the retina) has been observed in patients treated with MEK-inhibitors, including Cotellic (see section 4.8).
Maltese: Retinopatija seruża (akkumulazzjoni ta' fluwidu fis-saffi tar-retina) kienet osservata f'pazjenti kkurati b'inibituri ta' MEK, inkluż Cotellic (ara sezzjoni 4.8).
English: Following confirmation of a BRAF V600 mutation, using the cobas® 4800 BRAF V600 mutation test,
Maltese: Wara konferma ta' mutazzjoni BRAF V600, bl-użu tat-test cobas® 4800 għall-mutazzjoni BRAF
English: *** Please refer to the paragraph Rhabdomyolysis in the “Description of selected adverse reactions” section.
Maltese: *** Jekk jogħġbok irreferi għall-paragrafu Rabdomijolisi fis-sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula”.
English: Median (months) (95 % CI)
Maltese: Medjan (xhur) (CI ta' 95%)
English: Cotellic + vemurafenib N=247
Maltese: Cobimetinib + vemurafenib n=247
English: In patients who had progressed on BRAF inhibitor therapy, the median overall survival was 8.4 months (95% CI 6.7-11.1).
Maltese: F'pazjenti li kellhom progressjoni fuq terapija b'inibitur ta' BRAF, is-sopravivenza globali medjana kienet 8.4 xhur (CI ta' 95% 6.7-11.
English: Cobimetinib is the predominant moiety in plasma.
Maltese: Cobimetinib huwa l-molekola predominanti fil-plażma.
English: Photosensitivity has been observed with a higher frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm (47% vs 35%).
Maltese: Fotosensittività kienet osservata bi frekwenza ogħla fil-grupp ta' Cotellic flimkien ma' vemurafenib kontra l-grupp tal-plaċebo flimkien ma' vemurafenib (47% kontra 35%).
English: Key baseline characteristics included: 58% of patients were male, median age was 55 years (range 23 to 88 years), 60% had metastatic melanoma stage M1c and the proportion of patients with elevated LDH was 46.3% in the cobimetinib plus vemurafenib arm and 43.0% in the placebo plus vemurafenib arm.
Maltese: Karatteristiċi importanti fil-linja bażi kienu jinkludu: 58% tal-pazjenti kienu rġiel, l-età medjana kienet ta' 55 sena (firxa 23 sa 88 sena), 60% kellhom melanoma metastatika stadju M1c u l-proporzjon ta' pazjenti b'LDH elevat kien ta' 46.3% fil-grupp ta' cobimetinib flimkien ma' vemurafenib u ta' 43.0% fil-grupp tal-plaċebo flimkien ma' vemurafenib.
English: < 10% absolute decrease from baseline
Maltese: < 10% mil-linja bażi
English: Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break).
Maltese: Kull doża tikkonsisti minn tliet pilloli ta' 20 mg (60 mg) u għandha tittieħed darba kuljum għal 21 ġurnata konsekuttiva (Jiem 1 sa 21 - perjodu ta' kura); segwit minn waqfien ta' 7 ijiem (Jiem 22 sa 28 - waqfa mill-kura).
English: Hypertension, Haemorrhage*
Maltese: Pressjoni għolja, Emorraġija*
English: Grade 2 (intolerable) or Grade ≥3 acneiform rash: General dose modification recommendations in Table 1 for Cotellic should be followed.
Maltese: Raxx akniformi ta' Grad 2 (intollerabbli) jew ta' Grad ≥3: Għandhom jiġu segwiti rrakkomandazzjonijiet ġenerali ta' modifikazzjoni fid-doża f'Tabella 1 għal Cotellic.
English: Cobimetinib is a substrate of P-glycoprotein (P-gp).
Maltese: Inibituri ta P-glycoprotein Cobimetinib huwa sottostrat ta' P-glycoprotein (P-gp).
English: Permanent discontinuation
Maltese: Twaqqif permanenti
English: Table 2 Recommended dose modifications for Cotellic in patients with left ventricular ejection fraction (LVEF) decrease from baseline
Maltese: Tabella 2 Modifikazzjonijiet rakkomandati fid-doża ta' Cotellic f'pazjenti b'porzjon imbuttat il barra mill-ventriklu tax-xellug (LVEF - left ventricular ejection fraction) imnaqqas mill-linja bażi
English: Grade 4: Cotellic treatment should be interrupted.
Maltese: Grad 4: It-trattament b'Cotellic għandu jiġi interrott.
English: Key Secondary Endpointsa, f,
Maltese: Punti Finali Sekondarji Ewlenina, f Sopravivenza
English: Grade (CTC-AE)*
Maltese: Tabella 1 Modifikazzjonijiet rakkomandati fid-doża ta' Cotellic Grad (CTC-AE)*
English: Grade 2 (intolerable) or Grade 3/4 1st Appearance
Maltese: Grad 2 (intollerabbli) jew Grad 3/4 L-ewwel Dehra
English: The most common adverse reactions (>20%) observed with a higher frequency in the placebo plus vemurafenib arm were arthralgia, alopecia, and hyperkeratosis.
Maltese: L-aktar reazzjonijiet avversi komuni (>20%) osservati bi frekwenza ogħla fil-grupp ta' plaċebo flimkien ma' vemurafenib kienu artralġja, alopeċja, u iperkeratosi.
English: Dehydration, Hypophosphataemia, Hyponatremia, Hyperglycaemia
Maltese: Deidratazzjoni, Ipofosfatemija, Iponatrimija,