FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3 Adverse reactions reported in the integrated safety population of dabrafenib monotherapy in the studies BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220, and BRF112680 (n=578)
Maltese: Tabella 3 Reazzjonijiet avversi rrapportati fil-popolazzjoni ta' sigurtà integrata ta' monoterapija b'dabrafenib fl-istudji BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220, u BRF112680
English: ORRb % (95% CI) ORR difference (95% CI)
Maltese: ORRb % (95 % CI) Differenza talORR (95 % CI)
English: • medicines to treat fungal infections, such as ketoconazole, itraconazole, voriconazole and posaconazole
Maltese: • mediċini għall-kura ta' infezzjonijiet fungali, bħal ketoconazole, itraconazole, voriconazole u posaconazole
English: Table 14 Investigator-assessed RFS results for Study BRF115532 (COMBI-AD)
Maltese: Tabella 14 Riżultati tal-RFS evalwati mill-investigatur għall-Istudju BRF115532 (COMBI-AD)
English: Following administration of 150 mg twice daily, geometric mean Cmax, AUC(0-) and predose concentration (C) were 1478 ng/ml, 4341 ng*hr/ml and 26 ng/ml, respectively.
Maltese: Wara l-għoti ta' 150 mg darbtejn kuljum, isCmax medju ġejometriku, l-AUC(0-) u l-konċentrazzjoni ta' qabel id-doża (C) kienu 1478 ng/ml, 4341 ng*hr/ml u 26 ng/ml, rispettivament.
English: The observed RFS benefit was consistently demonstrated across subgroups of patients including age, sex and race.
Maltese: Il-benefiċċju osservat ta' RFS intwera b'mod konsistenti fost is-sottogruppi ta' pazjenti inkluż l-età, is-sess u r-razza.
English: New primary melanoma
Maltese: Melanoma primarja ġdida
English: Dabrafenib was phototoxic in an in vitro mouse fibroblast 3T3 Neutral Red Uptake (NRU) assay and in vivo at doses ≥100 mg/kg (>44 times clinical exposure based on Cmax) in an oral phototoxicity study in hairless mice.
Maltese: Dabrafenib kien fototossiku f'assaġġ in vitro tan-Neutral Red Uptake (NRU) tal-fibroblast 3T3 talġurdien u in vivo f'dożi ta' ≥ 100mg/kg (> 44 darba l-espożizzjoni klinika msejsa fuq Cmax) fi studju fototossiku orali fi ġrieden mingħajr pil.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE23
Maltese: Aġenti antineoplastiċi, inibituri tal-proteina kinase, Kodiċi ATC:
English: Frequency (all grades) Adverse reactions
Maltese: Frekwenza (gradi kollha) Reazzjonijiet avversi
English: Dabrafenib is a substrate for the metabolising enzymes CYP2C8 and CYP3A4, while the active metabolites hydroxy-dabrafenib and desmethyl-dabrafenib are CYP3A4 substrates.
Maltese: Dabrafenib huwa substrat għall-enzimi metabolizzanti CYP2C8 u CYP3A4, filwaqt li l-metaboliti attivi hydroxy-dabrafenib u desmethyl-dabrafenib huma substrati ta' CYP3A4.
English: • Dehydration (low levels of water or fluid)
Maltese: • Deidratazzjoni (livelli baxxi ta' ilma jew fluwidi)
English: The increased Cmax of rosuvastatin is unlikely to have clinical relevance.
Maltese: Cmax miżjud ta' rosuvastatin mhux probabbli li jkollu rilevanza klinika.
English: Cohort D N=17
Maltese: Koħort D N=17
English: June 25, 2012
Maltese: 25 ta' Ġunju 2012
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskuloskeletali u tat-tessuti konnettivi
English: Adverse drug reactions are listed below by MedDRA system organ class ranked by frequency using the following 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) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi tal-mediċina huma elenkati hawn taħt skont il-klassi tas-sistema u tal-organi MedDRA u skont il-frekwenza bl-użu tal-konvenzjoni 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Avoid co-administration of dabrafenib with potent inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, or St John's wort (Hypericum perforatum)) of CYP2C8 or CYP3A4.
Maltese: Evita l-għoti flimkien ta' dabrafenib ma' indutturi qawwija (eż. rifampicin, phenytoin, carbamazepine, phenobarbital jew St John' s wort (Hypericum perforatum)) ta' CYP2C8 jew CYP3A4.
English: Thrombocytopenia Leukopenia
Maltese: Tromboċitopenija Lewkopenja
English: Table 5 Kinase inhibitory activity of dabrafenib against RAF kinases
Maltese: Attività inibitorja tal-kinases ta' dabrafenib kontra kinases RAF
English: Table 15 Summary of efficacy in the combination treatment cohorts based on investigator and independent radiology review
Maltese: Tabella 15 Sommarju tal-effikaċja fil-gruppi ta' kura ta' kombinazzjoni bbażat fuq reviżjoni tarradjoloġija tal-investigatur u indipendenti
English: Desmethyl-dabrafenib is metabolised by CYP3A4 to oxidative metabolites.
Maltese: Desmethyl-dabrafenib huwa metabolizzat minn CYP3A4 għal metaboliti ossidattivi.
English: December 19, 2011 DTIC
Maltese: 19 ta' Diċembru 2011
English: Hypophosphataemia has been reported commonly in the integrated safety population of dabrafenib monotherapy (7%) and of dabrafenib in combination with trametinib (4%).
Maltese: Ipofosfatimja kienet irrapportata b'mod komuni fil-popolazzjoni ta' sigurtà integrata ta' monoterapija b'dabrafenib (7 %) u ta' dabrafenib flimkien ma' trametinib (4%).
English: For the primary endpoint of investigator-assessed ORR, the ORR in the first line population was 61.1% (95% CI, 43.5%, 76.9%) and in the previously treated population was 66.7% (95% CI, 52.9%, 78.6%).
Maltese: Għall-endpoint primarju tal-ORR ivvalutat mill-investigatur, l-ORR fil-popolazzjoni tal-ewwel linja kien ta' 61.1% (95% CI, 43.5%, 76.9%) u fil-popolazzjoni kkurata qabel kien ta' 66.7% (95% CI, 52.9%, 78.6%).
English: Tafinlar is a medicine that contains the active substance dabrafenib.
Maltese: Tafinlar huwa mediċina li fiha s-sustanza attiva dabrafenib.
English: Deep vein thrombosis/Pulmonary embolism
Maltese: Trombożi tal-vini fondi/Emboliżmu pulmonari
English: Data as of December 19, 2011
Maltese: Dejta mid19 ta' Diċembru 2011
English: Analysis
Maltese: Analiżi
English: ORR, DoR and PFS were also assessed by an Independent Review Committee (IRC) as a sensitivity analysis.
Maltese: L-ORR, id-DoR u l-PFS kienu vvalutati wkoll minn Kumitat ta' Reviżjoni Indipendenti (Independent Review Committee - IRC) bħala analiżi tas-sensittività.
English: Hypertension Haemorrhage f
Maltese: Pressjoni għolja Emorraġija f
English: There was an increase in AUC of 73% for carboxy-dabrafenib and a decrease in AUC of 30% for desmethyl-dabrafenib.
Maltese: Kien hemm żieda fl-AUC ta' 73% għal carboxy-dabrafenib u tnaqqis fl-AUC ta' 30% għal desmethyl-dabrafenib.
English: Renal failure Nephritis
Maltese: Insuffiċjenza renali Nefrite
English: Dabrafenib + Trametinib Dabrafenib + Placebo
Maltese: Dabrafenib + Trametinib Dabrafenib + Plaċebo
English: Figure 2 Kaplan-Meier overall survival curves for Study MEK116513
Maltese: Kaplan-Meier għall-Istudju MEK116513
English: A decrease of 16% in AUC was noted for carboxy-dabrafenib.
Maltese: Ġie nnotat tnaqqis ta' 16 % fl-AUC għal carboxy-dabrafenib.
English: Dabrafenib terminal half-life after a single oral dose is 8 hours due to absorption-limited elimination after oral administration (flip-flop pharmacokinetics).
Maltese: Il-half-life terminali ta' dabrafenib wara doża orali waħda hija ta' 8 sigħat minħabba eliminazzjoni limitata għal assorbiment wara għoti orali (farmakokinetika flip-flop).
English: A total of 704 subjects were randomised 1:1 to either combination or vemurafenib.
Maltese: Għadd totali ta' 704 individwu ġew randomizzati 1:1 għal kombinazzjoni jew għal vemurafenib.
English: Otherwise, similar toxicities were observed as in comparable monotherapy studies.
Maltese: Altrimenti, ġew osservati tossiċitajiet simili bħal fl-istudji ta' monoterapija komparabbli.
English: Duration of intracranial response, median, months (95% CI) N=29 4.6 (2.8, NR)
Maltese: Dewmien tar-rispons intrakranjali, medjan, xhur (95% CI) N=29 4.6 (2.8, NR)
English: Based on 153 events (60 [14%] in the combination arm and 93 [22%] in the placebo arm) corresponding to a 26% information fraction of the total target of 597 OS events, the estimated hazard ratio for OS was 0.57 (95% CI: 0.42, 0.79; p=0.0006).
Maltese: Skont il-153 episodju (60 [14%] fost il-grupp mogħti t-taħlita u 93 [22%] fost il-grupp mogħti plaċebo) li jikkorrispondu għal 26% tal-frazzjoni ta' informazzjoni tal-mira totali ta' 597 episodju ta' OS, il-proporzjon stmat ta' periklu għal OS kien ta' 0.57 (95% CI: 0.42, 0.79; p=0.0006).
English: In the integrated safety population of dabrafenib in combination with trametinib (n=1076), 265 patients (25%) were ≥65 years of age, 62 patients (6%) were ≥75 years of age.
Maltese: Fil-popolazzjoni ta' sigurtà integrata ta' dabrafenib flimkien ma' trametinib (n = 1076) 265 pazjent (25%) kellhom età ta' ≥ 65 sena; 62 pazjent (6%) kellhom età ta' ≥ 75 sena.
English: Cutaneous squamous cell carcinoma (cu SCC): SCC, SCC of the skin, SCC in situ (Bowen's disease) and keratoacanthoma c
Maltese: SCC, SCC tal-ġilda, SCC in situ (il-marda ta' Bowen) u keratoakantoma c
English: In a clinical drug interaction study, Cmax and AUC of oral midazolam (a CYP3A4 substrate) decreased by 47% and 65%, respectively with co-administration of repeat-dose dabrafenib.
Maltese: Fi studju kliniku dwar l-interazzjoni tal-mediċina, is-Cmax u l-AUC ta' midazolam (substrat ta' CYP3A4) orali naqas b'47 % u b'65 %, rispettivament bl-għoti ta' dożi ripetuti ta' dabrafenib.
English: Cutaneous squamous cell carcinoma (cuSCC)
Maltese: Karċinoma taċ-ċelluli skwamużi tal-ġilda (cuSCC)
English: Dabrafenib binds to human plasma protein and is 99.7% bound.
Maltese: Dabrafenib jeħel mal-proteina fil-plażma tal-bniedem u huwa 99.7 % marbut.
English: Cohort A N=76
Maltese: Koħort A N=76
English: Figure 1 Kaplan-Meier overall survival curves for Study MEK115306 (ITT population)
Maltese: Kaplan-Meier għall-Istudju MEK115306 (popolazzjoni ITT)
English: • Inflammation of the intestines (colitis)
Maltese: • Infjammazzjoni tal-intestini (kolite)
English: Non-cutaneous malignancies were reported in 1% (6/586) of patients in the integrated safety population of dabrafenib monotherapy, and <1% (8/1076) of patients in the integrated safety population of dabrafenib in combination with trametinib.
Maltese: Ġew irrappurtati tumuri malinni mhux tal-ġilda f'1 % (6/586) tal-pazjenti fil-popolazzjoni ta' sigurtà integrata ta' monoterapija b'dabrafenib u <1% (8/1076) talpazjenti fil-popolazzjoni ta' sigurtà integrata ta' dabrafenib flimkien ma' trametinib.
English: Dermatitis acneiform Actinic keratosis
Maltese: Dermatite akneiforme Keratosi aktinika
English: Hard capsule (capsule).
Maltese: GĦAMLA FARMAĊEWTIKA Kapsula iebsa (kapsula).
English: Dabrafenib is a substrate of CYP2C8 and CYP3A4.
Maltese: Dabrafenib huwa substrat ta' CYP2C8 u CYP3A4.
English: There is also a risk of increased formation of active metabolites of these medicinal products.
Maltese: Hemm ukoll riskju ta' żieda fil-formazzjoni talmetaboliti attivi ta' dawn il-prodotti mediċinali.
English: Most subjects had LDH ≤ULN (65%), Eastern Cooperative Oncology Group (ECOG) performance status of 0 (72%), and visceral disease (73%) at baseline.
Maltese: Il-biċċa l-kbira tal-individwi kellhom LDH ≤ULN (65 %), status talprestazzjoni tal-Grupp taal-Onkoloġija Kooperattiva tal-Lvant (Eastern Cooperative Oncology Group - ECOG) ta' 0 (72 %) u marda vixxerali (73 %) fil-linja bażi.
English: Dabrafenib demonstrated suppression of a downstream pharmacodynamic biomarker (phosphorylated ERK) and inhibited cell growth of BRAF V600 mutant melanoma cell lines, in vitro and in animal models.
Maltese: Dabrafenib wera soppressjoni ta' bijomarkatur farmakodinamiku downstream (ERK fosforilat) u tkabbir inibit taċ-ċelloli tal-linji ta' celloli ta' melanoma mutanti BRAF V600, in vitro u f'mudelli ta' annimali.
English: The investigator-assessed confirmed response rate was 15% (95% CI: 4.4, 34.9) and the median PFS was 3.6 months (95% CI: 1.9, 5.2).
Maltese: Ir-rata tar-rispons ikkonfermata vvalutata mill-investigatur kienet ta' 15% (95 % CI: 4.4, 34.9) u l-PFS medja kienet ta' 3.6 xhur (95 % CI: 1.9, 5.2).
English: Use caution if strong inhibitors (e.g. ketoconazole, gemfibrozil, nefazodone, clarithromycin, ritonavir, saquinavir, telithromycin, itraconazole, voriconazole, posaconazole, atazanavir) are co-administered with dabrafenib.
Maltese: Uża l-kawtela jekk inibituri qawwija (eż. ketoconazole, gemfibrozil, nefazodone, clarithromycin, ritonavir, saquinavir, telithromycin, itraconazole, voriconazole, posaconazole, atazanavir) jingħataw flimkien ma' dabrafenib.
English: Table 2 Dose modification schedule based on the grade of any adverse events (AE)
Maltese: Tabella 2 Skeda tal-modifikazzjoni tad-doża abbażi tal-grad ta' xi avvenimenti avversi (AEAdverse Events)
English: • some anti-inflammatory medicines, such as dexamethasone and methylprednisolone
Maltese: • xi mediċini antiinfjammatorji, bħal dexamethasone u methylprednisolone
English: Table 11 Efficacy in previously untreated patients (BREAK-3 Study, 25 June 2012)
Maltese: Tabella 11 Effikaċja f'pazjenti li ma ġewx ikkurati qabel (Studju tal-BREAK-3, 25 ta' Ġunju 2012)
English: In vitro, dabrafenib produced dose-dependent increases in CYP2B6 and CYP3A4.
Maltese: In vitro, dabrafenib ipproduċa żidiet dipendenti fuq id-doża f'CYP2B6 u CYP3A4.
English: Duration of response, median, months (95% CI) N=28 5.1 (3.7, NR)
Maltese: Dewmien tar-rispons intrakranjali, medjan, xhur (95% CI) N=28 5.1 (3.7, NR)
English: Cohort B N=18
Maltese: Koort iB N=18
English: Stevens-Johnson syndrome Drug reaction with eosinophilia and systemic symptoms Dermatitis exfoliative generalised
Maltese: Sindrome ta' Stevens-Johnson Reazzjoni mill-mediċina b'eosinofilija u sintomi sistemiċi
English: The primary endpoint was ORR using the RECIST 1.1 assessed by the investigator.
Maltese: L-endpoint primarju kien l-ORR permezz tar-RECIST 1.1 ivvalutati mill-investigatur.
English: Figure 4 Kaplan-Meier RFS curves for Study BRF115532 (ITT population, updated results)
Maltese: Kaplan-Meier RFS għall-Istudju BRF115532 (popolazzjoni ITT, riżultati aġġornati)
English: • antidepressant medicines such as nefazodone and the herbal medicine St John's wort
Maltese: • mediċini antidepressanti bħal nefazodone u l-mediċina mill-ħxejjex St John's wort (Hypericum perforatum)
English: Dabrafenib + Placebo (n=212)
Maltese: Dabrafenib + Plaċebo (n=212)
English: Administration of rifampin (a CYP3A4/CYP2C8 inducer) 600 mg once daily with dabrafenib 150 mg twice daily resulted in a decrease in repeat dose dabrafenib Cmax (27%) and AUC (34%).
Maltese: L-għoti ta' rifampin (induttur ta' CYP3A4/CYP2C8) 600 mg darba kuljum ma' dabrafenib 150 mg darbtejn kuljum wassal għal tnaqqis fis-Cmax (27%) u l-AUC (34%) ta' doża ripetuta ta' dabrafenib.
English: Compared with younger subjects (<65), more subjects 65 years old had adverse reactions that led to study drug dose reductions (22% versus 12%) or interruptions (39% versus 27%).
Maltese: Meta mqabbla ma' individwi iżgħar fl-età (< 65), kien hemm aktar individwi  65 sena li kellhom reazzjonijiet avversi li wasslu għal tnaqqis fid-doża tal-mediċina tal-istudju (22 % kontra 12 %) jew interruzzjonijiet (39 % kontra 27 %).
English: These pharmacokinetic differences were not considered clinically relevant.
Maltese: Dawn id-differenzi farmakokinetiċi ma tqisux bħala klinikament rilevanti.
English: OS data from a further post-hoc analysis based on the 18 December 2012 data cut demonstrated a 12-month OS rate of 63% and 70% for DTIC and dabrafenib treatments, respectively.
Maltese: Id-dejta OS minn analiżi post-hoc oħra bbażata fuq id-data mit-18 ta' Diċembru 2012 uriet rata ta' OS ta' tnax-il xahar ta' 63 % u 70 % għall-kuri b'DTIC jew dabrafenib, rispettivament.
English: Dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives and an effective alternative method of contraception should be used (see section 4.5).
Maltese: Dabrafenib jista' jnaqqas l-effikaċja ta' kontraċettivi ormonali orali jew kwalunkwe kontraċettivi ormonali sistemiċi u għandu jintuża metodu alternattiv effettiv ta' kontraċezzjoni (ara sezzjoni 4.5).
English: Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and UGTs (glucuronide conjugating enzymes).
Maltese: Enzimi li jistgħu jiġu indotti jinkludu CYP3A filfwied u fl-imsaren, CYP2B6, CYP2C8, CYP2C9, CYP2C19, u UGTs (enzimi li jgħaqqdu lglukuronidi).
English: Descriptions of these effects can be found in sections 2 and 4.
Maltese: Deskrizzjoni ta' dawn l-effetti tista' tinstab f'sezzjonijiet 2 u 4.
English: Abdominal pain g
Maltese: Uġigħ addominali g
English: Possible side effects when Tafinlar and trametinib are taken together
Maltese: Effetti sekondarji possibbli meta Tafinlar u trametinib jittieħdu flimkien
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 08 May 2018
Maltese: Data tal-aħħar tiġdid: 08 Mejju 2018
English: BRAF V600 testing
Maltese: Ittestjar ta' BRAF V600
English: • Blurred vision, eyesight problems, inflammation of the eye (uveitis)
Maltese: • Vista mċajpra, problemi fil-vista, infjammazzjoni tal-għajn (uveite)
English: Although dabrafenib and its metabolites, hydroxy-dabrafenib, carboxy-dabrafenib and desmethyl-dabrafenib, were inhibitors of human organic anion transporter (OAT) 1 and OAT3 in vitro, and dabrafenib and its desmethyl metabolite were found to be inhibitors of organic cation transporter 2 (OCT2) in vitro, the risk of a drug-drug interaction at these transporters is minimal based on clinical exposure of dabrafenib and its metabolites.
Maltese: Għalkemm dabrafenib u l-metaboliti tiegħu, hydroxy-dabrafenib, carboxy-dabrafenib u desmethyldabrafenib, kienu inibituri tat-trasportatur tal-anjon organiku (OAT) 1 u OAT3 tal-bniedem (human organic anion transporter) in vitro, u dabrafenib u l-metabolit desmethyl tiegħu instabu li huma inibituri tat-trasportatur 2 ta' kazzjoni organika (inhibitors of organic cation transporter 2, OCT2) in vitro, ir-riskju ta' interazzjoni bejn mediċina u oħra b'dawn it-trasportaturi huwa minimu abbażi talesponiment kliniku ta' dabrafenib u l-metaboliti tiegħu.
English: Erythema, generalised erythema i Muscle spasms, musculoskeletal stiffness
Maltese: Spażmi tal-muskoli, ebusija muskoloskeletrali
English: Dry mouth Stomatitis
Maltese: Ħalq xott Stomatite
English: The steady-state volume of distribution following intravenous microdose administration is 46 L.
Maltese: Il-volum fi stat fiss ta' distribuzzjoni wara l-għoti ta' mikrodoża ġol-vina huwa ta' 46 L.
English: Other medicines and Tafinlar
Maltese: Mediċini oħra u Tafinlar
English: Co-administration of repeat dosing of trametinib 2 mg once daily and dabrafenib 150 mg twice daily resulted in no clinically meaningful changes in trametinib or dabrafenib Cmax and AUC with increases of 16 and 23%, respectively, in dabrafenib Cmax and AUC.
Maltese: L-għoti flimkien ta' dożi ripetuti ta' trametinib 2 mg darba kuljum u dabrafenib 150 mg darbtejn kuljum ma rriżulta f'ebda bidla klinikament sinjifikanti fi trametinib jew dabrafenib Cmax u AUC b'żidiet ta' 16 u 23 %, rispettivament, f'dabrafenib Cmax u AUC.
English: Headache Dizziness
Maltese: Nażofarinġite
English: Included in these clinical trials were in total 402 subjects with BRAF V600E and 49 subjects with BRAF V600K mutation.
Maltese: F'dawn il-provi kliniċi ħadu sehem total ta' 402 individwu b'BRAF V600E u 49 individwu bilmutazzjoni BRAF V600K.
English: OS analysis data cut-off: 13-Mar-2015)
Maltese: Analiżi tal-OS (data tal-limitu: 13-Mar-2015)
English: No relevant change in AUC was noted for hydroxy-dabrafenib.
Maltese: Ma ġiet innotata l-ebda bidla rilevanti fl-AUC għal hydroxy-dabrafenib.
English: In 1% of patients in clinical trials with dabrafenib monotherapy, serious non-infectious febrile events were identified defined as fever accompanied by severe rigors, dehydration, hypotension and/or acute renal insufficiency of pre-renal origin in subjects with normal baseline renal function (see section 4.8).
Maltese: F'1 % tal-pazjenti fil-provi kliniċi b'monoterapija b'dabrafenib, ġew identifikati avvenimenti serji mhux infettivi ta' deni definiti bħala deni akkumpanjat minn tertir sever, deidratazzjoni, pressjoni baxxa u/jew insuffiċjenza renali akuta ta' oriġini pre-renali f'individwi b'funzjoni renali normali fil-linja bażi (ara sezzjoni 4.8).
English: Primary analysis (data cut-off: 26-Aug-2013)
Maltese: Analiżi primarja (data tallimitu: 26-Aww-2013)
English: The study showed a statistically significant difference for the primary outcome of RFS between treatment arms, with a median RFS of 16.6 months for the placebo arm and not yet reached for the combination arm (HR: 0.47; 95% confidence interval: (0.39, 0.58); p=1.53×10
Maltese: L-istudju wera differenza statistikament sinjifikanti fir-riżultat primarju ta' RFS bejn il-gruppi ta' trattament, b'RFS medju ta' 16.6 xhur għall-grupp ta' plaċebo u għadu ma ntlaħaqx mill-grupp mogħti t-taħlita (HR: 0.47; 95% talintervall ta' kunfidenza: (0.39, 0.58); p=1.53×10
English: d a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (59% of dabrafenib+trametinib and 42% of vemurafenib) of investigator-assessed responses were still ongoing NR = Not reached
Maltese: d a - Sopravivenza Mingħajr Progressjoni (ivvalutata mill-investigatur) b - Rata ta' Rispons Globali = Rispons Sħiħ + Rispons Parzjali ċ - Tul tar-Rispons d - Fil-ħin tar-rappurtar, il-maġġoranza (59% ta' dabrafenib+trametinib u 42% ta' vemurafenib)) tarreazzjonijiet ivvalutati mill-investigatur kienu għadhom għaddejjin NR = Ma ntlaħaqx
English: Table 4 Adverse reactions reported in the integrated safety population of dabrafenib in combination with trametinib in the studies MEK115306, MEK116513
Maltese: Tabella 4 Reazzjonijiet avversi rrapportati fil-popolazzjoni ta' sigurtà integrata ta' dabrafenib flimkien ma' trametinib (n = 641) fl-istudji MEK115306, MEK116513
English: At the pre-specified analysis with a 19 December 2011 data cut, a significant improvement in the primary endpoint of PFS (HR=0.30; 95% Cl 0.18, 0.51; p < 0.0001) was achieved.
Maltese: Fl-analiżi speċifikata minn qabel datata d-19 ta' Diċembru 2011għall-punt ta' ġbir tal-aħħar ta' dejta, intlaħaq titjib sinifikanti fil-punt ta' tmiem primarju tal-PFS (HR = 0.30; 95 % Cl 0.18, 0.51; p < 0.0001).
English: Upon discontinuation of dabrafenib offset of induction is gradual, concentrations of sensitive CYP3A4, CYP2B6, CYP2C8, CYP2C9 and CYP2C19, UDP glucuronosyl transferase (UGT) and transporter substrates (e.g. Pgp or MRP-2) may increase and patients should be monitored for toxicity and dose of these agents may need to be adjusted.
Maltese: Wara lwaqfien ta' dabrafenib l-offset tal-induzzjoni huwa gradwali, il-konċentrazzjonijiet ta' substrati sensittivi ta' CYP3A4, CYP2B6, CYP2C8, CYP2C9 u CYP2C19, UDP glucuronosyl transferase (UGT) u tat-trasportaturi (eż. Pgp jew MRP-2) jistgħu jiżdiedu u l-pazjenti għandhom jiġu mmonitorjati għal tossiċità u d-doża ta' dawn l-aġenti tista' teħtieġ tiġi aġġustata.
English: Table 13 Efficacy data in patients with brain metastases (BREAK-MB Study)
Maltese: Tabella 13: Dejta dwar l-effikaċja f'pazjenti b'metastasi fil-moħħ (Studju BREAK-MB)
English: In the first line population, 68% of patients had not progressed after 9 months.
Maltese: Fil-popolazzjoni tal-ewwel linja, 68% tal-pazjenti ma wrew lebda progressjoni fil-marda wara 9 xhur.
English: Determination of BRAF mutation status
Maltese: Determinazzjoni tal-istatus ta' mutazzjoni ta' BRAF
English: • some antibiotics, such as clarithromycin, doxycyline and telithromycin
Maltese: • xi antibijotiċi, bħal clarithromycin, doxycyline u telithromycin