FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pooled encorafenib 300 population, cuSCC was reported in 7.4% (16/217) patients.
Maltese: Fil-popolazzjoni raggruppata ta' encorafenib 300, cuSCC ġiet irrapportata f'7.4% (16/217) tal pazjenti.
English: A small decrease in CL/F (≤5%) was predicted for patients with mild and moderate renal impairment, which is unlikely to be clinically relevant.
Maltese: Tnaqqis żgħir f'CL/F ( ≥ 5%) tbassar għal pazjenti b'indeboliment renali ħafif u moderat, li hu improbabbli li jkun klinikament rilevanti.
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 6 and Figure 2).
Maltese: Analiżi temporanja tal-OS tal-Istudju CMEK162B2301, Parti 1, (data ta' limitu 07 ta' November 2017) wriet titjib statistikament sinifikanti fl-OS għall-Combo 450 meta mqabbel ma' vemurafenib (ara Tabella 6 u Figura 2).
English: There are limited data for dose reduction to 100mg once daily.
Maltese: Hemm data limitata għal doża mnaqqsa għal 100 darba kuljum.
English: • Recurrent Grade 3 adverse reactions
Maltese: • Reazzjonijiet avversi talGrad 3 rikorrenti
English: Braftovi is not recommended for children and adolescents under 18 years of age.
Maltese: Braftovi mhuwiex rakkomandat għal tfal u għal adolexxenti ta' anqas minn 18-il sena.
English: 450 mg once daily
Maltese: 450 mg darba kuljum
English: Unstratified subgroup analyses demonstrated point estimates in favour of Combo 450, including LDH at baseline, ECOG performance status and AJCC stage.
Maltese: Combo 450, li jinkludu LDH fil-linja bażi, stat tal-prestazzjoni ECOG u stadju AJCC.
English: Examples of strong CYP3A4 inhibitors include, but are not limited to, ritonavir, itraconazole, clarithromycin, telithromycin, posaconazole and grapefruit juice.
Maltese: ritonavir, itraconazole, clarithromycin, telithromycin, posaconazole u meraq tal-grapefruit.
English: New primary malignancies
Maltese: Malinni primarji ġodda
English: Haemorrhagic events led to discontinuation of treatment in 1.1% (3/274) of patients.
Maltese: L-avvenimenti emorraġiċi wasslu għal waqfien tat-trattament f'1.1 % (3/274) tal pazjenti.
English: Cutaneous malignancies
Maltese: Malinni kutanji
English: You will also receive treatment with another medicine, binimetinib.
Maltese: Se tirċievi wkoll trattament b'mediċina oħra, binimetinib.
English: Dermatologic reactions
Maltese: Reazzjonijiet dermatoloġiċi
English: The median time to definitive 10% deterioration in the FACT-M score was not reached in the Combo 450 arm and was 22.1 months (95% CI: 15.2, NE) in the vemurafenib arm with a HR for the difference of 0.46 (95% CI: 0.29, 0.72).
Maltese: Iż-żmien medjan għad-deterjorament definittiv ta' 10% fil-punteġġ tal-FACT-M ma ntlaħaqx fil-parti tal-Combo 450 u kien ta' 22.1 xahar (95% CI:15.2, NE) fil-parti ta' vemurafenib b'HR għad-differenza ta' 0.46 (95% CI: 0.29, 0.72).
English: In the pooled Combo 450 population, rash occurred in 19.7% (54/274) of patients.
Maltese: Fil-popolazzjoni raggruppata Combo 450, raxx seħħ fi 19.7 % (54/274) tal-pazjenti.
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: DOR medju għal risponsi kkonfermati għal kull BIRC kien ta' 12.7-il xahar [95 % CI: 9.3, 15.1] għall Combo 300, u 12.9-il xahar [95 % CI: 8.9, 15.5] għal
English: In the pooled encorafenib 300 population, PPES was reported in 51.6% (112/217) of patients.
Maltese: Fil-popolazzjoni raggruppata encorafenib 300, PPES ġie rrapportat f'51.6% (112/217) tal-pazjenti.
English: HRa (95% CI) (vs Vem) Nominal p-value
Maltese: HRa (95% CI) (vs. Vem) Valur-p nominali
English: A definitive 10% deterioration in FACT-M and in EORTC QLQC30 was significantly delayed in patients treated with Combo 450 relative to other treatments.
Maltese: Deterjorament definittiv ta' 10% fil-FACT-M u fl-EORTC QLQ-C30 ġie ttardjat b'mod sinifikanti f'pazjenti ttrattati bil-Combo 450 meta mqabbla ma' trattamenti oħra.
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 fid-demm
English: BRAF V600 Mutant Unresectable or Metastatic Melanoma The safety and efficacy of encorafenib in combination with binimetinib were evaluated in a 2-part Phase III, randomised (1:1:1) active-controlled, open-label, multicentre study in patients with unresectable or metastatic BRAF V600 E or K mutant melanoma (Study CMEK162B2301), as detected using a BRAF assay.
Maltese: Is-sigurtà u l-effikaċja ta' encorafenib flimkien ma' binimetinib ġew evalwati fi studju ta' żewġ partijiet, aleatorju (1:1:1), ikkontrollat bl-attiv, open-label, multiċentriku tal-Fażi III f'pazjenti b'melanoma mutanti tal-BRAF V600 E jew K (Studju CMEK162B2301) li ma tistax titneħħa jew metastatika, kif identifikata permezz ta' assaġġ tal-BRAF.
English: In the safety analysis of pooled studies, 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 tal-istudji raggruppati, l-inċidenza ta' titwil ġdid tal-QTc >500 msec kienet ta' 0.7% (2/268) fil-grupp ta' encorafenib 450 mg flimkien ma' binimetinib, u ta' 2.5% (5/203) fil-grupp ta' encorafenib bħala aġent uniku.
English: • Increased transaminases: 15.7% (43/274) overall - Grade 3-4: 5.5% (15/274)
Maltese: 7% (43/274) b'mod ġenerali - Grad 3-4 : 5.5% (15/274)
English: This translates into a 55% increase of the unbound encorafenib exposure.
Maltese: Dan ifisser żieda ta' 55 % fl-esponiment ta' encorafenib mhux marbut.
English: Vomiting occurred in 28.1% (77/274) of patients with Grade 3 or 4 reported in 2.2% (6/274) of patients.
Maltese: Remettar seħħ fi 28.1% (77/274) tal-pazjenti bil-Grad 3 jew 4 irrapportat fi 2.2% (6/274) tal-pazjenti.
English: Effects of encorafenib on other medicinal products CYP substrates
Maltese: L-effetti ta' encorafenib fuq prodotti mediċinali oħra
English: In the pooled encorafenib 300 population, rash was reported in 43.3% (94/217) of patients.
Maltese: Fil-popolazzjoni raggruppata encorafenib 300, raxx ġie rrapportat fi 43.3% (94/217) tal-pazjenti.
English: Peripheral oedemam
Maltese: Deni* Edema periferalim
English: • Grade 2 (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3x ≤5x upper limit of normal (ULN))
Maltese: (aspartataminotransferaż i (AST) jew alanina aminotransferażi (ALT)
English: The safety of encorafenib (450 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 274 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the pooled Combo 450 population), based on two Phase II studies (CMEK162X2110 and CLGX818X2109) and one Phase III study (CMEK162B2301, Part 1).
Maltese: Is-sigurtà ta' encorafenib (450 mg oralment darba kuljum) flimkien ma' binimetinib (45 mg oralment darbtejn kuljum) ġiet evalwata f'274 pazjent b'melanoma mutanti tal-BRAF V600 (minn hawn 'il quddiem imsejħa l-popolazzjoni raggruppata Combo 450) li ma tistax titneħħa jew metastatika fuq il bażi ta' żewġ studji tal-Fażi II (CMEK162X2110 u CLG818X2109) u studju wieħed tal-Fażi III
English: The occurrence of Grade ≥3 haemorrhagic events should be managed with dose interruption or treatment discontinuation (see Table 3 in section 4.2) and as clinically indicated.
Maltese: okkorrenza ta' avvenimenti emorraġiċi tal-Grad ≤3 għandha tiġi ġestita b'interruzzjoni tad-doża jew bi twaqqif tat-trattament (ara t-Tabella 3 fis-sezzjoni 4.2) u kif indikat klinikament.
English: Other medicines and Braftovi
Maltese: Mediċini oħra u Braftovi
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: Il-parti l-kbira talpazjenti kellhom marda metastatika (95%) u kienu fl-Istadju IVM1c (64%); 27% tal-pazjenti kellhom lactate dehydrogenase (LDH) tas-serum elevat mil-linja bażi, u 45% tal-pazjenti kellhom mill-inqas 3 organi b'involviment tat-tumur fil-bażi u 3.5% kellhom metastażijiet fil-moħħ. 27 pazjent (5%) kienu rċevew inibituri preċedenti fil-punt ta' kontroll (anti-PD1/PDL1 jew ipilimumab) (8 pazjenti filfergħa tal-Combo 450 (4%); 7 pazjenti fil-fergħa ta' vemurafenib (4%); 12-il pazjent fil-fergħa ta' Enco 300 (6 %)) inklużi 22 pazjent fl-ambjent metastatiku (6 pazjenti fil-fergħa tal-Combo 450; 5 pazjenti fil-fergħa ta' vemurafenib; 11-il pazjent fil-fergħa ta' Enco 300) u 5 pazjenti fl-ambjent aġġuvanti (2 pazjenti fil-fergħa tal-Combo 450;
English: Diarrhoea occurred in 28.4% (73/257) of patients with Grade 3 reported in 1.6% (4/257) of patients.
Maltese: Id-dijarea seħħet fi 28.4% (73/257) talpazjenti, bi Grad 3 irrappurtat f'1.6% (4/257) tal-pazjenti.
English: The recommended dose of Braftovi is 6 capsules of 75 mg once daily (corresponding to a daily dose of 450 mg).
Maltese: Id-doża rakkomandata ta' Braftovi hi 6 kapsuli ta' 75 mg darba kuljum (li tikkorrispondi għal doża ta' kuljum ta' 450 mg).
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 sekondarju ieħor tal-effikaċja bejn il-Combo 450 u jew vemurafenib jew inkella Enco 300 inkludew is-sopravivenza globali (OS), ir-rata oġġettiva ta' rispons (ORR), iddurata tar-rispons (DoR) u r-rata ta' kontroll tal-marda (DCR) kif ivvalutati mill-BIRC u millvalutazzjoni tal-investigaturi.
English: All the PPES adverse reactions were either Grade 1 (3.3%) or Grade 2 (2.9%).
Maltese: Irreazzjonijiet avversi kollha tal-PPES kienu tal-Grad 1 (3.3 %) jew tal-Grad 2 (2.9 %).
English: Common cuSCC a New Primary Melanoma*
Maltese: Melanoma Primarja Ġdida*
English: Dose interruption or modification was reported in 0.4% (1/274) of patients.
Maltese: Interruzzjoni jew modifika fid-doża ġew irrapportati f'0.4% (1/274) talpazjenti.
English: Severity of adverse reactiona Encorafenib
Maltese: Severità tar-reazzjoni avversaa
English: Renal failure *
Maltese: Insuffiċjenza renali *
English: Encorafenib may decrease the efficacy of hormonal contraceptives (see section 4.5).
Maltese: Encorafenib jista' jnaqqas l-effikaċja tal-kontraċettivi ormonali (ara sezzjoni 4.5).
English: Co-administration of encorafenib with a CYP3A4 inducer was not assessed in a clinical study; however, a reduction in encorafenib exposure is likely and may result in compromised efficacy.
Maltese: Il-koamministrazzjoni ta' encorafenib ma' induttur ta' CYP3A4 ma ġietx ivvalutata fi studju kliniku; madankollu, tnaqqis fl-esponiment ta' encorafenib hu probabbli u jista' jwassal għal effikaċja kompromessa.
English: Results from a dedicated clinical study indicate a 25% higher total encorafenib exposures in patients with mild hepatic impairment (Child-Pugh Class A) compared with subjects with normal liver function.
Maltese: Ir-riżultati minn studju kliniku dedikat jindikaw esponimenti totali 25 % ogħla ta' encorafenib f'pazjenti b'indeboliment epatiku ħafif (Klassi A Child-Pugh) meta mqabbla ma' individwi b'funzjoni normali tal-fwied.
English: The mean (CV%) apparent clearance (CL/F) of encorafenib was 27.9 L/h (9.15%).
Maltese: It-tneħħija apparenti medja (CV%) (CL/F) ta' encorafenib kienet ta' 27.
English: Examples of moderate or strong CYP3A4 inducers include, but are not limited to carbamazepine, rifampicin, phenytoin and St. John's Wort.
Maltese: Eżempji ta' indutturi moderati jew b'saħħithom ta' CYP3A4 jinkludu, iżda mhumiex limitati għal, carbamazepine, rifampicin, phenytoin u St.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, the incidence of liver laboratory abnormalities was:
Maltese: Fi Studju CMEK162B2301-Parti 2, fil-parti tal-istudju Combo 300, l-inċidenza ta' anormalitajiet tallaboratorju tal-fwied kienet:
English: In the pooled Combo 450 population, anaemia was reported in 19.7% (54/274) of patients; 4.7% (13/274) patients had a Grade 3 or 4.
Maltese: Fil-popolazzjoni raggruppata 450 mg, anemija ġiet irrapportata fi 19.7% (54/274) tal-pazjenti; 4.7%
English: Each pack contains either 42 or 168 hard capsules.
Maltese: Kull pakkett fih 42 jew 168 kapsula iebsa.
English: In patients treated with Combo 450 (n = 274), 194 patients (70.8%) were <65 years old, 65 patients (23.7%) were 65 -74 years old and 15 patients (5.5%) were aged > 75.
Maltese: 8%) kellhom <65 sena, 65 pazjent (23.7%) kellhom 65 -74 sena u 15-il pazjent (5.5%) kellhom > 75 sena.
English: Administration of a single 100 mg dose of encorafenib with a highfat, high-calorie meal decreased the Cmax by 36%, while the AUC was unchanged.
Maltese: L-amministrazzjoni ta' doża waħda ta' 100 mg encorafenib ma' ikla xaħmija ħafna u b'ħafna kaloriji naqqset is-Cmax b'36%, filwaqt li l-AUC baqgħet l-istess.
English: Encorafenib is a potent and highly selective ATP-competitive small molecule RAF kinase inhibitor.
Maltese: Encorafenib hu inibitur potenti u ferm selettiv tal-kinasi tal-RAF b'molekola żgħira kompetittiv għal ATP.
English: Cutaneous malignancies such as cutaneous squamous cell carcinoma (cuSCC) including kerathoacanthoma has been observed in patients treated with BRAF-inhibitors including encorafenib.
Maltese: Malinni kutanji bħal karċinoma kutanja taċ-ċelloli tat-tip skwamuż (cutaneous squamous cell carcinoma, cuSCC) inkluża keratokantoma ġew osservati f'pazjenti ttrattati b'inibituri tal-BRAF
English: Adverse reactions reported by this patient were Grade 1 events of nausea, vomiting and blurred vision; all subsequently resolved.
Maltese: Ir-reazzjonijiet avversi rrapportati minn dan il-pazjent kienu avvenimenti talGrad 1 ta' nawsja, ta' remettar u ta' vista mċajpra; li kollha ġew risolti sussegwentement.
English: Rash led to discontinuation in 0.5% (1/217) of patients and to dose interruption or dose modification in 7.4% (16/217) of patients.
Maltese: Ir-raxx wassal għal waqfien f'0.5% (1/217) tal-pazjenti u għal interruzzjoni tad-doża jew għal modifika tad-doża f'7.4% (16/217) tal-pazjenti.
English: Encorafenib single agent 300 mg (n = 217)
Maltese: Encorafenib aġent uniku 300 mg
English: Dermatitis acneiform
Maltese: Dermatite akneiforme
English: Braftovi 50 mg capsules encorafenib
Maltese: Braftovi 50 mg kapsuli encorafenib
English: HR (95% CI) (vs Enco 300) p-value (stratified log-rank)
Maltese: HR (95 % CI) (vs Enco 300) Valur-p (log-rank stratifikat)
English: Each hard capsule contains 50 mg encorafenib.
Maltese: Kull kapsula iebsa fiha 50 mg encorafenib.
English: In the pooled Combo 450 population, diarrhoea was observed in 38% (104/274) of patients and was Grade 3-4 in 3.3% (9/274) patients.
Maltese: Fil-popolazzjoni raggruppata b'Combo ta' 450, dijarea ġiet osservata fi 38% (104/274) tal-pazjenti u kienet tal-Grad 3-4 fi 3.3% (9/274) tal-pazjenti.
English: If binimetinib is temporarily interrupted, encorafenib should be reduced at 300 mg once daily during the time of binimetinib dose interruption (see section 4.2 of binimetinib Summary of Product Characteristics [SmPC]) as encorafenib is not well-tolerated at the dose of 450 mg as a single agent.
Maltese: Jekk binimetinib jitwaqqaf temporanjament, encorafenib għandu jitnaqqas għal 300 mg darba kuljum matul iż-żmien tal-interruzzjoni tad-doża ta' binimetinib (ara sezzjoni 4.2 tas-Sommarju tal-Karatteristiċi tal-Prodott [SmPC]) ta' binimetinib peress li encorafenib mhux tollerat sew bid-doża ta' 450 mg bħala aġent uniku.
English: Erythema e
Maltese: cuSCC a
English: Nausea occurred in 41.6% (114/274) with Grade 3 or 4 observed in 2.6% (7/274) of patients.
Maltese: Nawsja seħħet f'41.6% (114/274) bil-Grad 3 jew 4 osservat fi 2.6% (7/274) tal-pazjenti.
English: Visual impairment, including blurred vision and reduced visual acuity, occurred in 21.5% (59/274) of patients.
Maltese: Indeboliment fil-vista, inklużi vista mċajpra u akutezza tal-vista mnaqqsa, seħħ f'21.5 % (59/274) talpazjenti.
English: No formal clinical study has been conducted to evaluate the effect of renal impairment on the pharmacokinetics of encorafenib.
Maltese: Ma sar ebda studju kliniku formali biex jiġi evalwat l-effett tal-indeboliment renali fuq il-farmakokinetika ta' encorafenib.
English: Cerebral haemorrhage was reported in 1.5% (4/274) of patients, with fatal outcome in 3 patients.
Maltese: Emorraġija ċerebrali ġiet irrapportata f'1.5 % (4/274) tal-pazjenti, b'eżitu fatali fi 3 pazjenti.
English: Simulations of 450 mg encorafenib co-administered with probe substrates for CYP2B6, CYP1A2, CYP2C9, CYP2C19 and CYP2D6 on Day 1 and Day 15 all indicated no clinically relevant interactions are expected.
Maltese: CYP1A2, għal CYP2C9, għal CYP2C19 u għal CYP2D6 fil-Jum 1 u fil-Jum 15 kollha indikaw li ma huma mistennija l-ebda interazzjonijiet klinikament rilevanti.
English: In the pooled Combo 450 population, fatigue occurred in 43.8% (120/274) of patients including Grade 3 in 2.9% (8/274) of patients.
Maltese: Fil-popolazzjoni raggruppata Combo 450, l-għeja seħħet fi 43.8% (120/274) tal-pazjenti, li tinkludi Grad 3 irrappurtat fi 2.9% (8/274) tal-pazjenti.
English: Vemurafenib
Maltese: Pożoloġija
English: The efficacy results based on investigator assessment were consistent with the independent central assessment.
Maltese: Ir-riżultati tal-effikaċja bbażati fuq l-evalwazzjoni tal-investigatur kienu konsistenti mal-evalwazzjoni ċentrali indipendenti.
English: The concomitant administration of encorafenib with grapefruit juice should be avoided (see sections 4.4 and 4.5)
Maltese: L-amministrazzjoni konkomitanti ta' encorafenib ma' meraq tal-grapefruit għandha tiġi evitata (ara sezzjonijiet 4.4 u 4.5)
English: Braftovi 75 mg: Each hard capsule contains 75 mg encorafenib.
Maltese: Braftovi 75 mg: Kull kapsula iebsa fiha 75 mg encorafenib.
English: At doses of encorafenib between 600 to 800 mg once daily, renal dysfunction (Grade 3 hypercreatinaemia) was observed in 3 out of 14 patients.
Maltese: Sintomi F'dożi ta' encorafenib bejn 600 u 800 mg darba kuljum, disfunzjoni renali (iperkreatinemija tal
English: Each hard capsule contains 75 mg encorafenib.
Maltese: Kull kapsula iebsa fiha 75 mg encorafenib.
English: Braftovi 75 mg capsules encorafenib
Maltese: Braftovi 75 mg kapsuli encorafenib
English: Orange opaque cap and flesh opaque body, printed with a stylised “A” on the cap and “LGX 50mg” on the body.
Maltese: Għatu opak oranġjo u korp opak kulur il-ġilda, stampat b'“A” distinta fuq l-għatu u “LGX 50mg” fuq il-korp.
English: Hyperkeratosis* Rash*
Maltese: Nawsja Remettar* Stitikezza
English: The incidence of Grade 3 or 4 elevation was 0.7% (2/274).
Maltese: (0.7 % jew 2/274).
English: HR (95% CI) (vs Vem) p-value (stratified log-rank)
Maltese: HR (95 % CI) (vs Vem) Valur-p (log-rank stratifikat)
English: Uveitis *
Maltese: Uveite *
English: Median, months (95% CI)
Maltese: Medjan, xhur (95% CI)
English: In the pooled Combo 450 population, photosensitivity was observed in 4.0% (11/274) of patients.
Maltese: Fil-popolazzjoni raggruppata Combo 450, is-sensittività għad-dawl kienet osservata f'4.0 % (11/274) tal-pazjenti.
English: Braftovi 50 mg: Each hard capsule contains 50 mg encorafenib.
Maltese: Braftovi 50 mg: Kull kapsula iebsa fiha 50 mg encorafenib.
English: Each pack contains either 28 or 112 hard capsules.
Maltese: Kull pakkett fih 28 jew 112-il kapsula iebsa.
English: Based on in vitro studies, there is potential for encorafenib to inhibit renal transporters OCT2, OAT1, OAT3 and hepatic transporters OATP1B1 and OATP1B3 at clinical concentrations.
Maltese: Fuq il-bażi tal-istudji in vitro, hemm potenzjal li encorafenib jinibixxi ttrasportaturi renali OCT2, OAT1, OAT3 u t-trasportaturi epatiċi OATP1B1 u OATP1B3
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) • Grade 2
Maltese: Sindrome tal-eritrodisesteżija palmari-plantari
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, anaemia was observed in 9.7% (25/257) of patients with Grade 3-4 reported in 2.7% (7/257) patients.
Maltese: Fi Studju CMEK162B2301-Parti 2, fil-parti tal-istudju Combo 300, l-anemija ġiet osservat f'9.7% (25/257) tal-pazjenti, bi Grad 3-4 irrappurtat fi 2.7% (7/257) tal-pazjenti.
English: Rash led to discontinuation in 0.4% (1/274) patients and to dose interruption or dose modification in 1.1% (3/274) of patients.
Maltese: Ir raxx wassal għal waqfien f'0.4 % (1/274) tal-pazjenti u għal interruzzjoni tad-doża jew għal modifika tad-doża f'1.1 % (3/274) tal-pazjenti.
English: Part 1 of Study CMEK162B2301 demonstrated a statistically significant improvement in PFS in the patients treated with Combo 450 compared with patients treated with vemurafenib.
Maltese: Parti 1 tal-Istudju CMEK162B2301 wriet titjib statistikament sinifikanti fil-PFS fil-pazjenti ttrattati bil-Combo 450 meta mqabbla ma' pazjenti ttrattati b'vemurafenib.
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)b
English: Skin hyperpigmentation*
Maltese: Żieda fit-transaminase*
English: Liver laboratory abnormalities including AST and ALT elevations have been observed with encorafenib (see section 4.8).
Maltese: Anormalitajiet fil-fwied fil-laboratorju li jinkludu elevazzjonijiet tal-AST u tal-ALT ġew osservati b'encorafenib (ara sezzjoni 4.8).
English: Pyrexia*
Maltese: Raxx*
English: HRa (95% CI) (vs Vem) p-value (stratified log-rank)b
Maltese: HRa (95% CI) (vs. Vem) Valur p (log-rank stratifikat)b
English: Model based predictions indicate that the effect of posaconazole after repeated administrations could be similar for AUC (3-fold increase) and slightly greater for Cmax (2.7-fold increase).
Maltese: Previżjonijiet ibbażati fuq mudelli jindikaw li l-effett ta' posaconazole wara amministrazzjonijiet ripetuti jista' jkun simili għall-AUC (żieda tripla) u ftit aktar b'saħħtu għas-Cmax (żieda għal 2.7 darbiet).
English: The predominant biotransformation reaction of encorafenib was N-dealkylation.
Maltese: Ir reazzjoni predominanti tal-bijotrasformazzjoni ta' encorafenib kienet N-dealkylation.
English: LVD defined as symptomatic or asymptomatic decreases in ejection fraction has been reported when encorafenib is used in combination with binimetinib.
Maltese: LVD definit bħala tnaqqis sintomatiku jew asintomatiku fil-frazzjoni tat-tfigħ 'il barra (“ejection fraction”) ġiet irrapportata meta encorafenib jintuża flimkien ma' binimetinib.
English: Abdominal pain was reported in 27.4% (75/274) of patients and was Grade 3 in 2.6% (7/274) patients.
Maltese: Uġigħ fl-addome ġie rrapportat f'27.4% (75/274) tal-pazjenti u kien tal-Grad 3 fi 2.6% (7/274) tal-pazjenti.
English: Braftovi 50 mg hard capsules Braftovi 75 mg hard capsules
Maltese: Braftovi 50 mg kapsuli iebsin Braftovi 75 mg kapsuli iebsin
English: Dermatitis acneiform was reported when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC).
Maltese: Dermatite akneiforme ġiet irrapportata meta encorafenib jintuża flimkien ma' binimetinib (ara sezzjoni 4.8 tal-SmPC ta' binimetinib).
English: The primary efficacy outcome measure was progression-free survival (PFS) of Combo 450 compared with vemurafenib as assessed by a blinded independent review committee (BIRC).
Maltese: Combo 450 meta mqabbla ma' vemurafenib kif ivvalutat minn kumitat indipendenti għar-reviżjoni b'mod għami (BIRC).
English: Blood alkaline phosphatase increased
Maltese: Żieda fil-fosfatażi alkalina tad-demm
English: Pancreatic enzyme elevation, mostly asymptomatic, was reported in the pooled Combo 450 population.
Maltese: Elevazzjoni tal-enzimi pankreatiċi, fil-parti l-kbira tagħha asintomatika, kienet irrapportata filpopolazzjoni raggruppata Combo 450.