FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important to take Braftovi for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.
Croatian: Važno je uzimati lijek Braftovi dokle god Vam ga liječnik propisuje.
English: Encorafenib + binimetinib N=192 (Combo 450)
Croatian: Enkorafenib + binimetinib N = 192 (kombinirana terapija 450)
English: • Grade 3
Croatian: • Stupanj 3
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).
Croatian: Produljenje QTc-a od > 60 ms u odnosu na početnu vrijednost primijećeno je u 4,9% (13/268) bolesnika iz skupine koja je liječena enkorafenibom s binimetinibom i u 3,4% (7/204) u skupini liječenoj enkorafenibom kao monoterapijom (vidjeti dijelove 4.2 i 4.4).
English: Encorafenib should be withheld until improved to Grade 0 or 1 and resumed at the same dose if first occurrence, or resumed at a reduced dose if recurrent Grade 3.
Croatian: Treba prekinuti s enkorafenibom dok se ne postigne poboljšanje na stupanj 0 ili 1, a potom nastaviti s istom dozom ako se nuspojava pojavila prvi put ili nastaviti sa smanjenom dozom u slučaju ponovnog nastupa stupnja 3.
English: While binimetinib is a UGT1A1 substrate, it does not undergo gut extraction and therefore no DDI with encorafenib is expected.
Croatian: Iako binimetinib predstavlja supstrat UGT1A1, ne izlučuje se putem crijeva i stoga se ne očekuje farmakodinamička interakcija između lijekova s enkorafenibom.
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).
Croatian: PFS za enkorafenib 300 mg peroralno jednom dnevno u kombinaciji s binimetinibom 45 mg peroralno dvaput dnevno (kombinirana terapija 300, n = 258) uspoređen je s PFS-om za enkorafenib 300 (n = 280, uključujući 194 bolesnika iz dijela 1 i 86 bolesnika iz dijela 2).
English: • Recurrent Grade 3 (AST or ALT > 5x ULN and blood bilirubin > 2x ULN)
Croatian: • Ponovni nastup stupnja 3 (AST ili ALT > 5x GGN i bilirubin u krvi > 2x GGN)
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.
Croatian: Većina događaja je bila blaga do umjerena: Stupanj 1 u 12,4% (27/217) bolesnika; stupanj 2 u 26,7% (58/217) i stupanj 3 u 12,4% (27/217) bolesnika.
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.
Croatian: Učestalost krvarenja stupnja ≥ 3 treba se smanjiti privremenim prekidom ili trajnom obustavom liječenja (vidjeti Tablicu 3 u dijelu 4.2) i kako je klinički indicirano.
English: Vemurafenib N=191 (Vem)
Croatian: Vemurafenib n = 191 (vemurafenib)
English: Encorafenib and binimetinib should be continued without any dose modification.
Croatian: Mora se nastaviti s enkorafenibom i binimetinibom bez daljnje prilagodbe doze lijeka.
English: While encorafenib is a relatively potent reversible inhibitor of UGT1A1, no differences in binimetinib exposure have been observed clinically when binimetinib was co-administered with encorafenib.
Croatian: Iako je enkorafenib relativno potentan reverzibilni inhibitor UGT1A1, nisu klinički zapažene nikakve promjene u izloženosti binimetinibu pri istodobnoj primjeni s enkorafenibom.
English: Based on a population pharmacokinetic analysis, age was found to be a significant covariate on encorafenib volume of distribution, but with high variability.
Croatian: Rezultati populacijske farmakokinetičke analize pokazuju da dob predstavlja značajnu kovarijatu u volumenu distribucije enkorafeniba, ali s velikom varijabilnosti.
English: If concomitant use of a strong CYP3A inhibitor is unavoidable, patients should be carefully monitored for safety.
Croatian: Ako je neizbježna istodobna uporaba snažnih inhibitora CYP3A, bolesnike treba radi sigurnosti pomno nadzirati.
English: An analysis of time to definitive 10% deterioration in EORTC QLQ-C30 score provided with similar results.
Croatian: Analiza vremena do jasnog 10% pogoršanja prema rezultatu EORTC QLQ
English: Duration of response Median, months (95% CI)
Croatian: Trajanje odgovora Medijan, mjeseci (95 % CI)
English: Before starting treatment your doctor will check for the BRAF mutation.
Croatian: Što morate znati prije nego počnete uzimati lijek Braftovi Prije početka liječenja, Vaš liječnik će provjeriti prisustvo BRAF mutacije.
English: In the pooled Combo 450 population, photosensitivity was observed in 4.0% (11/274) of patients.
Croatian: U ukupnoj populaciji kombinirane terapije 450, fotoosjetljivost je zapažena u 4,0% (11/274) bolesnika.
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).
Croatian: Lijek Braftovi 75 mg dostupan je u pakiranjima od 42 kapsule (7 blistera od po 6 kapsule) ili 168
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).
Croatian: (8 bolesnika u skupini kombiniranog liječenja 450 (4%); 7 bolesnika u skupini liječenoj vemurafenibom (4%); 12 bolesnika u skupini liječenoj enkorafenibom 300 (6%)), uključujući i 22 bolesnika u metastatskoj skupini (6 bolesnika u skupini kombinirane terapije 450; 5 bolesnika u skupini liječenoj vemurafenibom; 11 bolesnika u skupini enkorafenib 300) i 5 bolesnika liječenih adjuvantnom kemoterapijom (2 bolesnika iz skupine kombinirane terapije 450; 2 bolesnika iz skupine liječene vemurafenibom; 1 bolesnik iz skupine enkorafenib 300).
English: Encorafenib does not inhibit RAF/MEK/ERK signalling in cells expressing wild-type BRAF.
Croatian: Enkorafenib ne inhibira RAF/MEK/ERK signalni put u stanica koje imaju izraženu ekspresiju divljeg tipa BRAF.
English: Patients with mild to severe hepatic impairment may have increased encorafenib exposure (see section 5.2).
Croatian: U bolesnika s blagim do teškim oštećenjem jetrene funkcije, izloženost enkorafenibu može biti povećana (vidjeti dio 5.2).
English: Encorafenib induced CYP1A2, CYP2B6, CYP2C9 and CYP3A4 in human primary hepatocytes.
Croatian: Enkorafenib inducira CYP1A2, CYP2B6, CYP2C9 i CYP3A4 u ljudskim primarnim hepatocitima.
English: For patients in the Phase III study (CMEK162B2301) who developed cuSCC, the median time to onset of the first event of cuSCC (all grades) was 2.3 months (range 0.3 to 12.0 months).
Croatian: U bolesnika uključenih u kliničko ispitivanje faze III (CMEK162B2301) kod kojih se javio planocelularni karcinom, medijan vremena do prvog pojavljivanja planocelularnog karcinoma (za sve stupnjeve) iznosio je 2,3 mjeseca (u rasponu od 0,3 do 12,0 mjeseci).
English: Basal cell carcinoma* Skin papilloma*
Croatian: planocelularni karcinom kožea bazocelularni karcinom* papilomi kože*
English: If encorafenib is permanently discontinued, then binimetinib should be discontinued.
Croatian: Ako je enkorafenib trajno obustavljen, onda treba obustaviti i binimetinib.
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.
Croatian: Primjena jedne doze od 100 mg enkorafeniba uz obrok s velikim udjelom masti snižava vrijednost Cmax za 36%, dok AUC (površina ispod krivulje plazmatske koncentracije u vremenu) ostaje nepromijenjen.
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).
Croatian: Interim analiza ukupnog preživljenja (OS) ispitivanja CMEK162B2301, dio 1 (krajnji rok 7. studenoga 2017.) pokazala je statistički značajno poboljšanje OS-a u skupini kombinirane terapije 450 u usporedbi sa skupinom liječenom vemurafenibom (vidjeti Tablicu 6 i sliku 2).
English: Effect of encorafenib on CYP substrates
Croatian: Učinak enkorafeniba na CYP supstrate
English: There are no data available in patients with severe renal impairment (see sections 4.2 and 5.2).
Croatian: Nema dostupnih podataka o primjeni u bolesnika s teškim oštećenjem bubrežne funkcije (vidjeti dijelove 4.2 i 5.2).
English: If one of these toxicities occurs, see section 4.2 of binimetinib SmPC for dose modification instructions for binimetinib.
Croatian: Ako nastupi neka od ovih toksičnosti, vidjeti dio 4.2 sažetka opisa svojstava lijeka za binimetinib, upute za prilagodbu doze binimetiniba.
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.
Croatian: Na temelju analize sigurnosti iz objedinjenih ispitivanja, incidencija novih produljenja intervala QTc > 500 ms bila je 0,7% (2/268) u skupini bolesnika liječenih enkorafenibom u dozi od 450 mg s binimetinibom, i 2,5% (5/203) u skupini bolesnika liječenih enkorafenibom kao monoterapijom.
English: Diarrhoea led to dose discontinuation in 0.4% of patients and to dose interruption or dose modification in 4.4% of patients.
Croatian: Proljev je doveo do obustave liječenja u 0,4% bolesnika i privremenog prekida liječenja ili prilagodbe doze u 4,4% bolesnika.
English: Concurrent use of strong CYP3A inhibitors during treatment with encorafenib should be avoided.
Croatian: Treba izbjegavati istodobnu primjenu snažnih inhibitora CYP3A tijekom liječenja enkorafenibom.
English: Effects of other medicinal products on encorafenib.
Croatian: Učinak drugih lijekova na enkorafenib
English: - Liver problems: Braftovi can cause abnormal blood tests related to how your liver works (raised levels of liver enzymes).
Croatian: - Problemi s jetrom: Lijek Braftovi može prouzročiti odstupanja u rezultatima krvnih pretraga u svezi s funkcijom jetre (povećane razine jetrenih enzima).
English: It is recommended that an electrocardiogram (ECG) is assessed before initiation of encorafenib, one month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment.
Croatian: Preporučuje se procjena elektrokardiograma prije početka primjene enkorafeniba, jedan mjesec nakon početka primjene te približno svaka 3 mjeseca ili češće ako je klinički potrebno, tijekom trajanja liječenja.
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.
Croatian: U ukupnoj populaciji enkorafenib 300, novi primarni melanom se pojavio u 4,1% bolesnika (9 /217) i prijavljen je kao stupanj 1 u 1,4% (3/217) bolesnika, stupanj 2 u 2,1% (4/217) bolesnika, stupanj 3 u 0,5% (1/217) bolesnika i stupanj 4 u 0,5% (1/217) bolesnika.
English: When encorafenib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.
Croatian: Kada se enkorafenib primjenjuje istodobno s umjerenim inhibitorima CYP3A, bolesnike treba radi sigurnosti pomno nadzirati.
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.
Croatian: Većina je događaja bila blaga do umjerena: stupanj 1 u 2,3% (5/217), stupanj 2 u 3,7% (8/217) i stupanj 3 u 1,4% (3/217) bolesnika.
English: Overall, results suggest that single agent encorafenib has the potential to cause mild increases in heart rate.
Croatian: Sve u svemu, rezultati ukazuju da enkorafenib kao monoterapija ima potencijal prouzročiti blago povećanje srčane frekvencije.
English: Dose modification
Croatian: Sljedeća prilagodba
English: • First occurrence of Grade 4 (AST or ALT >20 ULN)
Croatian: • Prvi nastup stupnja 4 (AST ili ALT > 20x GGN)
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE
English: • Increased transaminases: 15.7% (43/274) overall - Grade 3-4: 5.5% (15/274)
Croatian: • Povišenje transaminaza: 15,7% (43/274) ukupno - stupanj 3-4: 5,5% (15/274)
English: Gelatin (E441) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172)
Croatian: Želatina (E441) Titanijev dioksid (E171) Željezov oksid, crveni (E172) Željezov oksid, žuti (E172) Željezov oksid, crni (E172)
English: Encorafenib should be permanently discontinued and a follow up with ophthalmologic monitoring should be performed.
Croatian: Treba trajno obustaviti enkorafenib te nastaviti oftalmološko praćenje.
English: There are no clinical data with encorafenib in patients with severe renal impairment.
Croatian: Nema kliničkih podataka o primjeni enkorafeniba u bolesnika s teškim oštećenjem bubrežne funkcije.
English: Transporter substrates
Croatian: Supstrati transportnih proteina
English: Administration of encorafenib should be undertaken with caution at a reduced dose in patients with mild hepatic impairment (see section 4.2).
Croatian: Enkorafenib se mora oprezno davati u smanjenim dozama bolesnicima s blagim oštećenjem funkcije jetre (vidjeti dio 4.2).
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.
Croatian: Medijan trajanja odgovora (DoR) za potvrđene odgovore prema ocjeni BIRC-a iznosio je 12,7 mjeseci (95% CI: 9,3; 15,1) za kombiniranu terapiju 300 i 12,9 mjeseci (95% CI: 8,9; 15,5) za enkorafenib 300.
English: Moderate CYP3A4 inhibitors should be co-administered with caution.
Croatian: Umjereni se inhibitori CYP3A4 trebaju istodobno primjenjivati s oprezom.
English: OS
Croatian: U
English: Dermatologic evaluations should be performed prior to initiation of therapy with encorafenib in combination with binimetinib, every 2 months while on therapy and for up to 6 months following discontinuation of the combination.
Croatian: Prije započinjanja terapije enkorafenibom u kombinaciji s binimetinibom, potrebno je napraviti dermatološki pregled, kao i svaka 2 mjeseca tijekom terapije te u razdoblju do 6 mjeseci nakon prestanka terapije.
English: Examples of moderate CYP3A4 inhibitors include, but are not limited to, amiodarone, erythromycin, fluconazole, diltiazem, amprenavir and imatinib.
Croatian: Primjeri umjerenih inhibitora CYP3A4 uključuju, ali nisu ograničeni na amiodaron, eritromicin, flukonazol, diltiazem,
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.
Croatian: Najčešća krvarenja obuhvaćala su hematuriju u 3,3% (9/274) bolesnika, rektalno krvarenje u 2,9% (8/274) bolesnika i hematoheziju u
English: Creatinine elevation has been commonly reported with encorafenib as single agent or in combination with binimetinib.
Croatian: Povišene vrijednosti kreatinina često su prijavljene kod liječenja enkorafenibom kao monoterapijom ili u kombinaciji s binimetinibom.
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.
Croatian: To dovodi do povećanja izloženosti nevezanom enkorafenibu za Farmakokinetika enkorafeniba nije klinički procijenjena u bolesnika s umjerenim (Child-Pugh stupanj B) ili teškim (Child-Pugh stupanj C) oštećenjem jetrene funkcije.
English: Call your doctor right away if you get these symptoms of eye problems: - blurred vision, loss of vision, or other vision changes (such as coloured dots in your vision) - halo (seeing blurred outline around objects) - eye pain, swellling or redness
Croatian: Odmah nazovite svog liječnika ako imate ove simptome problema s očima: - zamućenje vida, gubitak vida ili druge promjene vida (npr. obojene točkice u vidnom polju) - halo (viđenje nejasnog obrisa oko objekata)
English: • Increased GGT: 14.0% (36/257) overall - Grade 3-4: 4.7% (12/257)
Croatian: • Povišenje GGT: 14,0% (36/257) ukupno - stupanj 3-4: 4,7% (12/257)
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).
Croatian: Sigurnost enkorafeniba (450 mg peroralno jednom dnevno) u kombinaciji s binimetinibom (45 mg peroralno dvaput dnevno) procijenjena je na 274 bolesnika s neoperabilnim ili metastatskim melanomom s pozitivnom mutacijom BRAF V600 (u daljnjem tekstu: ukupna populacija kombinirane terapije 450), na temelju dva ispitivanja faze II (CMEK162X2110 i CLGX818X2109) te jednog ispitivanja faze III (CMEK162B2301, dio 1).
English: The involvement of several uptake transporter families (OCT1, OATP1B1, OATP1B3 and OATPB1) was investigated in vitro using relevant transporter inhibitors.
Croatian: (OCT1, OATP1B1, OATP1B3 i OATPB1) ispitivana je in vitro korištenjem specifičnih inhibitora transportera.
English: Vomiting occurred in 15.2% (39/257) of patients with Grade 3 reported in 0.4% (1/257) of patients.
Croatian: Povraćanje se javilo kod 15,2% (39/257) bolesnika i to stupnja 3 prijavljenog u 0,4% (1/257) bolesnika.
English: Encorafenib should not be used in patients with wild type BRAF malignant melanoma.
Croatian: V600K. Enkorafenib se ne smije primjenjivati u bolesnika koji imaju maligni melanom s divljim tipom BRAF gena.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek Braftovi Lijek čuvajte izvan pogleda i dohvata djece.
English: Before taking encorafenib in combination with binimetinib, patients must have BRAF V600 mutation confirmed by a validated test.
Croatian: Prije primjene enkorafeniba u kombinaciji s binimetinibom, u bolesnika se validiranim testom mora potvrditi da je tumor pozitivan na mutaciju BRAF V600.
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).
Croatian: U dijelu 1, bolesnici su u ispitivanju randomizirani na liječenje enkorafenibom 450 mg peroralno jednom dnevno i binimetinibom 45 mg peroralno dvaput dnevno (kombinirana terapija 450, n = 192), enkorafenibom 300 mg peroralno jednom dnevno (enkorafenib 300, n = 194), ili vemurafenibom
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.
Croatian: U ukupnoj populaciji kombinirane terapije 450, anemija je prijavljena u 19,7% (54/274) bolesnika; 4,7% (13/274) bolesnika je imalo nuspojave stupnja 3 ili 4.
English: In the pooled encorafenib 300 population, photosensitivity was reported in 4.1% (9/217) of patients.
Croatian: U ukupnoj populaciji enkorafeniba 300, fotoosjetljivost je zabilježena u 4,1% (9/217) bolesnika.
English: erythromycin, penicillin) - medicines typically used to treat epilepsy (seizures) (such as phenytoin, carbamazepine) - medicines typically used to treat cancer (such as methotrexate, imatinib) - medicines typically used to treat high cholesterol (such as rosuvastatin, atorvastatin) - an herbal treatment for depression: St. John's wort - some medicines for HIV treatment such as ritonavir, amprenavir, raltegravir, dolutegravir - birth control medicines containing hormones - medicines typically used to treat high blood pressure (such as diltiazem, bosentan, furosemide) - a medicine used to treat an uneven heartbeat: amiodarone.
Croatian: karbamazepin) - lijekovi koji se obično koriste za liječenje raka (kao što su metotreksat, imatinib) - lijekovi kojima se obično liječi visok kolesterol (kao što su rosuvastatin, atorvastatin) - biljni lijekovi protiv depresije: gospina trava - neki lijekovi za liječenje HIV infekcije, kao što su ritonavir, amprenavir, raltegravir,
English: Encorafenib should be maintained.
Croatian: Treba održavati dozu enkorafeniba.
English: Talk to your doctor immediately if you get blurred vision, loss of vision, or other vision changes (e.g. coloured dots in your vision), halo (seeing blurred outline around objects).
Croatian: Odmah obavijestite svog liječnika ako primijetite zamućenje vida, gubitak vida ili druge poremećaje vida (npr. obojene točkice u vidnom polju) ili halo (viđenje nejasnog obrisa oko objekata).
English: Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, radioactivity was eliminated equally in both the faeces and urine (mean of 47.2%).
Croatian: Nakon jedne peroralne doze od 100 mg (14C) enkorafeniba u zdravih ispitanika, eliminacija radioaktivno označene doze lijeka bila je podjednaka putem stolice i putem mokraće (srednja vrijednost od 47,2%).
English: Neuropathy peripheral* Dizziness*
Croatian: periferna neuropatija* omaglica* glavobolja*
English: Fatal gastric ulcer haemorrhage, with multiple organ failure as a concurrent cause of death, occurred in one patient.
Croatian: Krvarenje iz čira na želucu sa smrtnim ishodom uslijed otkazivanja brojnih organa prijavljeno je kod jednog bolesnika.
English: Survival at 24 months (95% CI)
Croatian: Preživljenje 24 mjeseca (95 % CI)
English: Based on a population pharmacokinetic analysis gender was not found to be a significant model covariate on clearance or volume of distribution.
Croatian: Populacijske farmakokinetičke analize pokazale su da spol ne predstavlja značajnu kovarijatu u modelu klirensa ili volumena distribucije enkorafeniba.
English: Figure 1 Study CMEK162B2301, Part 1: Kaplan-Meier plot of progression-free survival by independent central review (cut-off date: 19 May 2016)
Croatian: Slika 1 Ispitivanje CMEK162B2301, dio 1: Kaplan-Meierove krivulje preživljenja bez progresije prema neovisnom središnjem pregledu (krajnji rok: 19. svibnja 2016.)
English: Most events were mild, with Grade 3 or 4 events reported in 0.7% (2/274) of patients.
Croatian: Većina događaja bila je blaga, sa stupnjem 3 ili 4 prijavljenim u 0,7% (2/274) bolesnika.
English: • Capsule shell: gelatin (E441), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)
Croatian: • Ovojnica kapsule: želatina (E441), titanijev dioksid (E171), željezov oksid, crveni (E172), željezov oksid, žuti (E172), željezov oksid, crni (E172)
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.
Croatian: Medijan dobi bolesnika bio je 56 godina (raspon 20 - 89), 58% ispitivane populacije bili su muškarci,
English: If not improved despite supportive therapy within 2 weeks, encorafenib should be withheld until improved to Grade 0 or 1 and treatment should be resumed at same dose level or at a reduced dose.
Croatian: Ako se ne postigne poboljšanje unutar dva tjedna usprkos potpornoj terapiji, treba prekinuti s enkorafenibom dok se ne postigne poboljšanje na stupanj 0 ili 1 te nastaviti liječenje s istom razinom doze ili smanjenom dozom.
English: A decision must be made whether to discontinue breast-feeding or to discontinue encorafenib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Croatian: Uzimajući u obzir korist dojenja za dijete i dobrobit terapije za majku, nužno je donijeti odluku o tome hoće li se prekinuti dojenje ili obustaviti terapiju enkorafenibom.