FrancophonIA/ELRC3.0 huggingface dataset:
English: Amylase increased *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 extrasystoles, sinus tachycardia, supraventricular extrasystoles, tachyarrhythmia, tachycardia e includes erythema, generalised erythema, plantar erythema f includes dermatitis exfoliative, skin exfoliation, exfoliative rash g includes myalgia, muscle fatigue, muscle injury, muscle spasm, muscle weakness h includes left ventricular dysfunction, ejection fraction decreased, cardiac failure and ejection fraction abnormal i includes haemorrhage at various sites including cerebral haemorrhage j includes pulmonary embolism, deep vein thrombosis, embolism, thrombophlebitis, thrombophlebitis superficial and thrombosis k includes colitis, colitis ulcerative, enterocolitis and proctitis l includes myalgia, muscular weakness, muscle spasm, muscle injury, myopathy, myositis m includes fluid retention, peripheral oedema, localised oedema
Maltese: Żieda fl-Amilażi *termini komposti li inkludew aktar minn terminu ppreferut wieħed a inklużi keratoakantoma, karċinoma taċ-ċelloli tat-tip skwamuż, karċinoma taċ-ċelloli tat-tip skwamuż tax-xoffa u karċinoma taċ-ċelloli tat-tip skwamuż tal-ġilda b inklużi anġjoedema, sensittività eċċessiva għall-mediċina, sensittività eċċessiva, vaskulite ipersensittiva u urtikarja c inklużi disturb tan-nervituri tal-wiċċ, paraliżi tal-wiċċ, pareżi tal-wiċċ d inklużi extrasistoli, takikardija tas-sinus, extrasistoli supraventrikolari, takiarritmija, takikardija e inklużi eritema, eritema ġeneralizzata, eritema plantari f inklużi dermatite esflojattiva, esflojazzjoni tal-ġilda, raxx esfoljattiv g inklużi mijalġja, għeja fil-muskoli, korriment fil-muskoli, spażmu tal-muskoli, dgħjufija tal-muskoli h tinkludi disfunzjoni ventrikolari tax-xellug, frazzjoni mnaqqsa tat-tfigħ 'il barra, insuffiċjenza kardijaka u frazzjoni anormali tat-tfigħ 'il barra i inkluż emorraġija f'diversi siti inkluża emorraġija ċerebrali j inklużi emboliżmu pulmonari, trombożi tal-vini fondi, emboliżmu, tromboflebite, tromboflebite superfiċjali u trombożi k inklużi kolite, kolite ulċerattiva, enterokolite u proktite l inklużi mijalġja, dgħjufija muskolari, spażmu tal-muskoli, korriment fil-muskoli, mijopatija, mijosite m inklużi ritenzjoni tal-fluwidi, edema periferali, edema lokalizzata
English: Quality of Life (QoL) (cut-off date: 19 May 2016)
Maltese: Il-Kwalità tal-Ħajja (QoL) (data ta' limitu: 19 ta' Mejju 2016)
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE46
Maltese: Kategorija farmakoterapewtika: aġent antineoplastiku, inibitur tal-kinasi tal-proteina, Kodiċi ATC:
English: • Capsule shell: gelatin (E441), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)
Maltese: • Qoxra tal-kapsula: gelatin (E441), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)
English: Supraventricular tachycardiad
Maltese: Takikardija supraventrikolarid
English: An analysis of time to definitive 10% deterioration in EORTC QLQ-C30 score provided with similar results.
Maltese: Analiżi taż-żmien għad-deterjorament definittiv ta' 10 % fil-punteġġ tal-EORTC QLQ-C30 ipprovdiet riżultati simili.
English: • Increased GGT: 14.6% (40/274) overall - Grade 3-4: 8.4% (23/274)
Maltese: • Żieda fi GGT: 14.6% (40/274) b'mod ġenerali - Grad 3-4 : 8.4% (23/274)
English: Arthritis *
Maltese: Artrite*
English: Encorafenib 450 mg in combination with binimetinib (n = 274)
Maltese: Encorafenib 450 mg flimkien ma' binimetinib (n = 274)
English: CI=Confidence interval; CR=Complete Response; DCR=Disease Control Rate (CR+PR+SD+Non-CR/Non-PD; Non-CR/Non-PD applies only to patients without a target lesion who did not achieve CR or have PD); HR=hazard ratio; NE=Not estimable; PFS=progression-free survival; PR=Partial response; SD=stable disease.
Maltese: CR/Non-PD; Non-CR/Non-PD japplikaw biss għal pazjenti mingħajr leżjoni fil-mira li ma kisbux CR jew għandhom PD); HR = proporzjon tal-periklu; NE = Ma jistax jiġi stmat;
English: Haemorrhagic events were observed in 17.9% (49/274) of patients in the pooled Combo 450 population.
Maltese: Avvenimenti emorraġiċi kienu osservati fi 17.9 % (49/274) tal-pazjenti filpopolazzjoni raggruppata Combo 450.
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: IVM1c) tal-American Joint Committee on Cancer (AJCC) u l-istatus talprestazzjoni (0 kontra 1) tal-Eastern Cooperative Oncology Group (ECOG) u l-immunoterapija preċedenti għal marda li ma tistax titneħħa jew metastatika (iva kontra le).
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) PPES was reported in 6.2% (17/274) of patients in the pooled Combo 450 population.
Maltese: Sindrome tal-eritrodisesteżija palmari-plantari (PPES) PPES ġie rrapportat f'6.2% (17/274) tal-pazjenti fil-popolazzjoni raggruppata Combo 450.
English: Examples of moderate CYP3A4 inhibitors include, but are not limited to, amiodarone, erythromycin, fluconazole, diltiazem, amprenavir and imatinib.
Maltese: Eżempji ta' inibituri moderati ta' CYP3A4 jinkludu, iżda mhumiex limitati għal, amiodarone, erythromycin, fluconazole, diltiazem, amprenavir u imatinib.
English: Dose interruption or modification was reported in 3.7% (8/217) and symptomatic treatment including corticosteroids was reported in 5.1% (11/217) of patients.
Maltese: Interruzzjoni tad doża jew modifika tad-doża ġew irrapportati f'3.7% (8/217) u trattament sintomatiku li kien jinkludi kortikosterojdi ġie rrapportat f'5.1% (11/217) tal-pazjenti.
English: The involvement of several uptake transporter families (OCT1, OATP1B1, OATP1B3 and OATPB1) was investigated in vitro using relevant transporter inhibitors.
Maltese: L-involviment ta' diversi familji ta' trasportaturi tat-teħid (OCT1, OATP1B1, OATP1B3 u OATPB1) ġie investigat in vitro bl-użu ta'
English: A similar proportion of patients in each treatment arm received subsequent treatment with checkpoint inhibitors, mainly pembrolizumab, nivolumab and ipilimumab (34.4% Combo 450 arm, 36.1% encorafenib arm, 39.8% vemurafenib arm).
Maltese: Proporzjon simili tal-pazjenti f'kull fergħa tat-trattament irċieva trattament sussegwenti b'inibituri talpunti ta' kontroll, jiġifieri pembrolizumab, nivolumab u ipilimumab (34.4% parti tal-Combo 450, 36.1% parti ta' encorafenib, 39.8% parti ta' vemurafenib).
English: Study CMEK162B2301, Part 1: Kaplan-Meier plot of interim overall survival (cut-off date: 7 November 2017)
Maltese: Studju CMEK162B2301, Parti 1: Plot Kaplan-Meier ta' sopravivenza temporanja globali (data ta' limitu (7 ta' Novembru 2017)
English: EU/1/18/1314/002 42 hard capsules EU/1/18/1314/004 168 hard capsules
Maltese: EU/1/18/1314/002 42 kapsula iebsa EU/1/18/1314/004 168 kapsula iebsa
English: The median age of patients was 56 years (range 20-89), 58% were male, 90% were Caucasian, and 72% of patients had baseline ECOG performance status of 0.
Maltese: L-età medjana tal-pazjenti kienet ta' 56 sena (medda 20 - 89), 58% kienu rġiel, 90% kienu Kawkasi, u 72% tal-pazjenti kellhom status tal-prestazzjoni mil-linja bażi tal-ECOG ta' 0.
English: • QTcF>500 ms and increased by >60 ms from pre-treatment values
Maltese: • QTcF>500 ms u żieda minn >60 ms mill-valuri ta' qabel it-trattament
English: • Increased transaminases: 13.2% (34/257) overall - Grade 3-4: 5.4% (14/257)
Maltese: • Żieda fit-transaminases: 13.2% (34/257) b'mod ġenerali - Grad 3-4: 5.4% (14/257)
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: L-aktar avvenimenti emorraġiċi frekwenti kienu ematurja fi 3.3 % (9/274) tal-pazjenti, emorraġija mir-rektum fi 2.9 % (8/274) u ematokeżja fi 2.9 % (8/274) tal-pazjenti.
English: a Hazard ratio based on a stratified Cox proportional hazard model b Log-rank p-value (2-sided)
Maltese: a Proporzjon tal-periklu bbażat fuq mudell tal-periklu stratifikat proporzjonali Cox b Valur-p tal-log-rank (2 naħat)
English: Encorafenib induced CYP1A2, CYP2B6, CYP2C9 and CYP3A4 in human primary hepatocytes.
Maltese: Encorafenib induċa CYP1A2, CYP2B6, CYP2C9 u CYP3A4 fl-epatoċiti primarji tal-bniedem.
English: • Increased GGT: 14.0% (36/257) overall - Grade 3-4: 4.7% (12/257)
Maltese: • Żieda fi GGT: 14.0% (36/257) b'mod ġenerali - Grad 3-4: 4.7% (12/257)
English: Shellac (E904) Iron oxide black (E172) Propylene glycol (E1520)
Maltese: Iron oxide black (E172) Propylene glycol (E1520)
English: - Keep this leaflet.
Maltese: remettar u prurite.
English: All events were Grade 1-2.
Maltese: L-avvenimenti kollha kienu tal-Grad 1-2.
English: The Functional Assessment of Cancer Therapy-Melanoma (FACT-M), the European Organisation for Research and Treatment of Cancer's core quality of life questionnaire (EORTC QLQ-C30) and the EuroQoL-5 Dimension-5 Level examination (EQ-5D-5L) were used to explore patient-reported outcomes (PRO) measures of health-related Quality of Life, functioning, melanoma symptoms, and treatment-related adverse reactions.
Maltese: Kanċer (EORTC QLQ-C30) u l-eżaminazzjonital-Livell EuroQoL-5 Dimensjoni-5 (EQ-5D-5L) biex jiġi esplorat il-kejl tal-eżiti rrapportati mill-pazjenti (PRO) tal-Kwalità tal-Ħajja relatata mas-saħħa, il funzjonament, is-sintomi tal-melanoma, u reazzjonijiet avversi relatati mat-trattament.
English: • QTcF > 500 ms and change ≤ 60 ms from pre-treatment value
Maltese: • QTcF >500 ms u biddel ≥ 60 ms millvalur ta' qabel ittrattament
English: In urine, 1.8% of the radioactivity was excreted as encorafenib.
Maltese: Fl-awrina, 1.8% tar radjuattività tneħħiet bħala encorafenib.
English: Braftovi 75 mg is available in packs of 42 capsules (7 blisters of 6 capsules each) or 168 capsules (28 blisters of 6 capsules each).
Maltese: Braftovi 75 mg hu disponibbli f'pakketti ta' 42 kapsula (7 folji b'6 kapsuli kull waħda) jew 168 kapsula (28 folja b'6 kapsuli kull waħda).
English: Adverse reactions are listed below by MedDRA body system organ class and the following frequency convention: 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), not known (cannot be estimated from the available data).
Maltese: MedDRA u l-konvenzjoni tal-frekwenza li ġejja: komuni ħafna ( ≤ 1/10), komuni ( ≤ 1/100 sa < 1/10), mhux komuni ( ≤ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Renal dysfunction
Maltese: Disfunzjoni renali
English: Most events were mild-moderate: Grade 1 in 12.4% (27/217) of patients, Grade 2 in 26.7% (58/217) and Grade 3 in 12.4% (27/217) of patients.
Maltese: Grad 1 fi 12.4% (27/217) tal-pazjenti, Grad 2 f'26.7% (58/217) u Grad 3 fi 12.4% (27/217) tal-pazjenti.
English: Braftovi is an anti-cancer medicine that contains the active substance encorafenib.
Maltese: Braftovi hu mediċina kontra l-kanċer li fiha s-sustanza attiva encorafenib.
English: • Printing ink: shellac (E904), iron oxide black (E172), propylene glycol (E1520)
Maltese: • Inka tal-istampar: shellac (E904), iron oxide black (E172), propylene glycol (E1520)
English: Study CMEK162B2301, Part 1
Maltese: Studju CMEK162B2301, Parti 1
English: The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation (see Tables 1 and 2).
Maltese: Il-ġestjoni tar-reazzjonijiet avversi tista' tkun teħtieġ tnaqqis tad-doża, interruzzjoni temporanja jew waqfien tat-trattament (ara t-Tabelli 1 u 2).
English: • Recurrent Grade 4 (AST or ALT > 20 ULN)
Maltese: • Grad 4 rikorrenti (AST jew ALT > 20
English: Hypersensitivityb
Maltese: Sensittività eċċessivab
English: The risk of haemorrhage may be increased with concomitant use of anticoagulant and antiplatelet therapy.
Maltese: Ir-riskju ta' emorraġija jista' jiżdied b'użu konkomitanti ta' terapija antikoagulanti u antipjastri.
English: In the 13-week study, partial reversibility was noted at the highest dose level (60 mg/kg/d).
Maltese: riversibbiltà parzjali ġiet innotata fl-ogħla livell tad-doża (60 mg/kg/d).
English: Agents that are substrates of renal transporters OAT1, OAT3, OCT2 (such as furosemide, penicillin) or agents that are substrates of the hepatic transporters OATP1B1, OATP1B3, OCT1 (such as atorvastatin, bosentan) or substrates of BCRP (such as methotrexate, rosuvastatin) or substrates of P-gp (e.g. posaconazole) may have increased exposure and should be therefore co-administered with caution.
Maltese: L-aġenti li huma substrati tat-trasportaturi renali OAT1, OAT3, OCT2 (bħal furosemide, penicillin) jew l-aġenti li huma substrati tat-trasportaturi epatiċi OATP1B1, OATP1B3, OCT1 (bħal atorvastatin, bosentan) jew substrati tal-BCRP (bħal methotrexate, rosuvastatin) jew substrati ta' P-gp (eż. posaconazole) jista' jkollhom esponiment miżjud u għalhekk għandhom jiġu koamministrati b'attenzjoni.
English: Preliminary Part 2 data, at a cut-off date of 9 November 2016, demonstrated the contribution of binimetinib with an improved median PFS estimate of 12.9 months (95% CI: 10.1, 14.0) for Combo 300 compared to 9.2 months (95% CI: 7.4, 11.0) for Enco 300 (Parts 1 and 2) per independent central review (BIRC).
Maltese: Data preliminari ta' Parti 2 f'data ta' limitu ta' 9 ta' Novembru 2016 uriet l-kontribuzzjoni ta' binimetinib b'stima medja tal-PFS imtejba ta' 12.9-il xahar (95 % CI: 10.1, 14.0) għal Combo 300 meta mqabbla ma' 9.2 xhur (95 % CI: 7.4, 11.0) għal-Enco 300 (Parti 1 u 2) għal kull reviżjoni ċentrali indipendenti (BIRC).
English: Amylase and lipase elevations were reported in 3.3% (9/274) and 5.1% (14/274) of patients, respectively.
Maltese: Elevazzjonijiet tal-amilażi u tal-lipażi kienu irrapportati fi 3.3 % (9/274) u f'5.1 % (14/274) tal-pazjenti, rispettivament.
English: Effects of other medicinal products on encorafenib Encorafenib is primarily metabolised by CYP3A4.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Effetti ta' prodotti mediċinali oħra fuq encorafenib Encorafenib primarjament jiġi metabolizzat minn CYP3A4.
English: Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, the mean (SD) blood-to-plasma concentration ratio is 0.58 (0.02) and the mean (CV%) apparent volume of distribution (Vz/F) of encorafenib is 226 L (32.7%).
Maltese: Wara doża orali waħda ta' 100 mg [14C] encorafenib f'individwi b'saħħithom, il-proporzjon tal-konċentrazzjoni medjan (SD) tad-demm għall-plażma hu ta' 0.58 (0.02) u l-volum apparenti medjan (CV%) taddistribuzzjoni (Vz/F) ta' encorafenib hu ta' 226 L (32.7%).
English: The most common adverse drug reactions (ADRs) (>25%) reported with encorafenib 300 were hyperkeratosis, alopecia, PPES, fatigue, rash, arthralgia, dry skin, nausea, myalgia, headache, vomiting and pruritus.
Maltese: L-aktar reazzjonijiet avversi komuni (ADRs) (> 25 %) irrapportati b'encorafenib 300 kienu iperkeratożi, alopeċja, PPES, għeja, raxx, artralġja, ġilda xotta, nawsja, mijalġija, uġigħ ta' ras,
English: Study CMEK162B2301, Part 2:
Maltese: Studju CMEK162B2301, Parti 1:
English: The proportions of patients experiencing adverse events (AE) and serious adverse events (SAE) were similar in patients aged <65 years and those aged ≥65 years.
Maltese: Il-proporzjonijiet ta' pazjenti li kellhom avvenimenti avversi (AE - adverse events) u avvenimenti avversi serji (SAEserious adverse events) kienu simili f'pazjenti li kellhom < 65 sena u dawk li kellhom ≥ 65 sena.
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 Sections 4.2 and 4.4).
Maltese: It-titwil tal-QTc ta' > 60 msec mqabbla mal-valuri ta' qabel ittrattament ġie osservat f'4.9% (13/268) ta' pazjenti fil-grupp encorafenib flimkien ma' binimetinib, u fi 3.4% (7/204) fil-grupp ta' encorafenib bħala aġent uniku (ara Sezzjonijiet 4.2 u 4.4).
English: The median relative dose intensity (RDI) for Combo 450 was 100% for encorafenib and 99.6% for binimetinib; the median RDI was 86.2% for Enco 300 and 94.5% for vemurafenib.
Maltese: L-intensità relattiva medjana tad-doża (RDI) għal Combo 450 kienet ta' 100% għal encorafenib u ta' 99.6% għal binimetinib; l-RDI medjana kienet ta' 86.2% għal Enco 300 u kienet ta' 94.5% għal vemurafenib.
English: The pharmacokinetics of encorafenib has not been evaluated clinically in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Maltese: Il-farmakokinetika ta' encorafenib ma ġietx evalwata klinikament f'pazjenti b'indeboliment epatiku moderat (Klassi B Child-Pugh) jew sever (Klassi Ċ Child-Pugh).
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 li jintuża flimkien ma' binimetinib 45 mg oralment darbtejn kuljum (Combo 300, n = 258) kien imqabbel mal-PFS għal Enco 300 (n = 280, inklużi 194 pazjent minn Parti 1 u 86 pazjent minn Parti 2).
English: Exceptions where dose modifications are necessary for binimetinib only (adverse reactions primarily related to binimetinib) are: retinal pigment epithelial detachment (RPED), retinal vein occlusion (RVO), interstitial lung disease/pneumonitis, cardiac dysfunction, creatine phosphokinase (CK) elevation and rhabdomyolysis, and venous thromboembolism (VTE).
Maltese: binimetinib) huma: distakkament tal-epitilju pigmentali retinali (retinal pigment epithelial detachment, RPED), okklużjoni tal-vina retinali (retinal vein occlusion, RVO), marda tal-pulmun interstizjali/pulmonite, disfunzjoni kardijaka, elevazzjoni tal-fosfokinasi tal-kreatina (creatine phosphokinase, CK) u rabdomjolisi, u tromboemboliżmu venuż (venous thromboembolism, VTE).
English: In the pooled Combo 450 population, cuSCC including keratoacanthomas was observed in 3.3% (9/274) of patients.
Maltese: Fil-popolazzjoni raggruppata Combo 450, cuSCC li tinkludi keratoakantomi ġiet osservata fi 3.3 % (9/274) tal-pazjenti.
English: EU/1/18/1314/001 28 hard capsules EU/1/18/1314/003 112 hard capsules
Maltese: EU/1/18/1314/001 28 kapsula iebsa EU/1/18/1314/003 112-il kapsula iebsa
English: This is because it could increase Braftovi side effects.
Maltese: Braftovi jista' jikkawża effetti sekondarji serji.
English: The accumulation ratio of approximately 0.5 is likely due to auto-induction of CYP3A4.
Maltese: Il-proporzjon ta' akkumulazzjoni ta' madwar 0.5 aktarx li hu dovut għal awtoinduzzjoni ta' CYP3A4.
English: Braftovi 50 mg hard capsules EU/1/18/1314/001 28 hard capsules EU/1/18/1314/003 112 hard capsules Braftovi 75 mg hard capsules EU/1/18/1314/002 42 hard capsules EU/1/18/1314/004 168 hard capsules
Maltese: Braftovi 50 mg kapsuli iebsin EU/1/18/1314/001 28 kapsula iebsa EU/1/18/1314/003 112-il kapsula iebsa
English: For co-administration with CYP3A4 and UGT1A1 substrates that undergo gut extraction, a minor to moderate interaction is expected.
Maltese: Għall-koamministrazzjoni b'substrati ta' CYP3A4 u ta' UGT1A1 li ssirilhom estrazzjoni tal-musrana, hi mistennija interazzjoni minuri sa moderata.
English: Renal failure events, including acute kidney injury and renal impairment, were reported in 3.3% (9/274) patients treated with encorafenib and binimetinib with Grade 3 or 4 events in 2.2% (6/274) of patients.
Maltese: L-avvenimenti ta' insuffiċjenza renali li jinkludu korriment akut tal-kliewi u indeboliment renali, ġew irrapportati fi 3.3% (9/274) tal pazjenti ttrattati b'encorafenib u b'binimetinib b'avvenimenti tal-Grad 3 jew 4 fi 2.2% (6/274) tal pazjenti.
English: • Recurrent Grade 4 adverse reactions
Maltese: • Reazzjonijiet avversi talGrad 4 rikorrenti
English: • Recurrent or intolerable Grade 2 adverse reactions
Maltese: • Reazzjonijiet avversi talGrad 2 rikorrenti jew intollerabbli
English: In the pooled Combo 450 population, uveitis was reported in 4.4% (12/274) of patients, and was Grade 1 in 0.4% (1/274), Grade 2 in 3.6% (10/274) and Grade 3 in 0.4% (1/274).
Maltese: Fil-popolazzjoni raggruppata Combo 450, l-uveite ġiet irrapportata f'4.4 % (12/274) tal-pazjenti, u kienet tal-Grad 1 f'0.4 % (1/274), tal-Grad 2 fi 3.6 % (10/274) u tal-Grad 3 f'0.4 % (1/274).
English: Most events were mild-moderate: Grade 1 in 2.3% (5/217); Grade 2 in 3.7% (8/217) and Grade 3 in 1.4% (3/217) of patients.
Maltese: Grad 1 f'2.3% (5/217); tal-pazjenti; Grad 2 f'3.7% (8/217) u Grad 3 f'1.4% (3/217) tal-pazjenti.
English: Encorafenib was found to be a substrate of the P-glycoprotein (P-gp) transporters.
Maltese: L-effett tat-trasportaturi fuq encorafenib Instab li encorafenib hu substrat tat-trasportaturi tal-P-glikoproteina (P-gp).
English: Encorafenib should be permanently discontinued (see monitoring in section 4.4).
Maltese: Encorafenib għandu jitwaqqaf b'mod permanenti (ara l-monitoraġġ fissezzjoni 4.4).
English: In the pooled encorafenib 300 population, new primary melanoma events occurred in 4.1% of patients (9 /217) and was reported as Grade 1 in 1.4% (3/217) of patients, Grade 2 in 2.1% (4/217) of patients, Grade 3 in 0.5% (1/217) of patients and Grade 4 in 0.5% (1/217) of patients.
Maltese: Fil-popolazzjoni raggruppata ta' encorafenib 300, l-avvenimenti ta' melanoma primarja ġdida seħħew f'4.1 % tal-pazjenti (9/217) u ġew irrapportati bħala Grad 1 f'1.4 % (3/217) tal-pazjenti, Grad 2 fi 2.1 % (4/217) tal-pazjenti, Grad 3 f'0.5 % (1/217) tal-pazjenti u Grad 4 f'0.5 % (1/217) tal-pazjenti.
English: In vitro, CYP3A4 was predicted to be the major enzyme contributing to total oxidative clearance of encorafenib in human liver microsomes (~83.3%), followed by CYP2C19 and CYP2D6 (~16.0% and 0.71%, respectively).
Maltese: CYP3A4 hu l-enzima ewlenija li tikkontribwixxi għat-tneħħija ossidattiva totali ta' encorafenib fil mikrożomi tal-fwied tal-bniedem (~83.3%), segwit minn CYP2C19 u minn CYP2D6 (~16.0% u 0.71%, rispettivament).
English: In Part 1, patients in the study were randomised to receive encorafenib 450 mg orally daily and binimetinib 45 mg orally twice daily (Combo 450, n = 192), encorafenib 300 mg orally daily (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 ntgħażlu b'mod aleatorju biex jirċievu encorafenib 450 mg oralment kuljum u binimetinib 45 mg oralment darbtejn kuljum (Combo 450, n = 192), encorafenib 300 mg oralment kuljum (Enco 300, n = 194), jew vemurafenib 960 mg oralment darbtejn kuljum (minn hawn 'il quddiem imsejjaħ Vem, n = 191).
English: An additional secondary endpoint included PFS of Combo 450 compared with Enco 300.
Maltese: Punt ta' tmiem sekondarju addizzjonali kien jinkludi PFS tal-Combo 450 meta mqabbla ma' Enco 300.
English: In a population pharmacokinetic analysis, no clear trend in encorafenib CL/F was observed in patients with mild (eGFR 60 to 90 mL/min/1.73 m2) or moderate (eGFR 30 to 59 mL/min/1.73 m2) renal impairment compared with subjects with normal renal function (eGFR ≥90 mL/min/1.73 m2).
Maltese: encorafenib f'pazjenti b'indeboliment renali ħafif (eGFR 60 sa 90 mL/min/1.73 m2) jew moderat (eGFR 30 sa 59 mL/min/1.73 m2) meta mqabbla ma' suġġetti b'funzjoni renali normali (eGFR
English: Capsule content
Maltese: Qoxra tal-kapsula
English: Braftovi 50 mg is available in packs of 28 capsules (7 blisters of 4 capsules each) or 112 capsules (28 blisters of 4 capsules each).
Maltese: Braftovi 50 mg hu disponibbli f'pakketti ta' 28 kapsula (7 folji b'4 kapsuli kull waħda) jew 112il kapsula (28 folja b'4 kapsuli kull waħda).