natgillin/translations-raw huggingface dataset:
• If you do become pregnant while you are taking this medicine, tell your doctor immediately. 
• Če med jemanjem tega zdravila zanosite, morate nemudoma obvestiti zdravnika.
• coloured dots in your vision 
• obarvane pike v vašem vidu
Do not take a double dose to make up for a missed dose. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Results were also consistent across stratification factors for disease stage and BRAF V600 mutation type. 
Rezultati so se ujemali tudi po skupinah glede na stratifikacijske dejavnike stadija bolezni in vrste mutacije BRAF V600.
b This study was designed to support or reject the null hypothesis of OIRR ≤10% (based on historical results) in favour of the alternative hypothesis of OIRR ≥ 30% in BRAF V600E mutation positive subjects. 
b Namen študije je bil podpreti ali zavrniti ničelno hipotezo o OIRR ≤ 10 % (na podlagi preteklih rezultatov) v korist alternativne hipoteze o OIRR ≥ 30 % med preiskovanci z mutacijo BRAF
Elderly No adjustment of the initial dose is required in patients >65 years of age. 
Starejši bolniki Bolnikom, starejšim od 65 let, začetnega odmerka ni treba prilagoditi.
The increased Cmax of rosuvastatin is unlikely to have clinical relevance. 
Povečanje vrednosti Cmax rosuvastatina verjetno ni klinično pomembno.
These checks are to detect if any other cancer, including squamous cell carcinoma, develops inside your body. 
Namen teh preiskav je ugotoviti, ali se vam je v telesu pojavil kakšen drug rak, vključno s ploščatoceličnim karcinomom.
Dabrafenib is a substrate of human P-glycoprotein (Pgp) and human BCRP in vitro. 
Dabrafenib je substrat humanega P-glikoproteina (Pgp) in humanega BCRP in vitro.
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%). 
V primerjavi z mlajšimi bolniki (< 65 let) je imelo več bolnikov, starih  65 let, takšne neželene učinke, ki so povzročili znižanje odmerka preskušanega zdravila (22 % v primerjavi z 12 %) ali prekinitev zdravljenja (39 % v primerjavi s 27 %).
Once the fever is controlled, your doctor may recommend that you start taking Tafinlar again. 
Ko je zvišana telesna temperatura obvladana, lahko zdravnik naroči, da znova začnete jemati zdravilo Tafinlar.
The assay was designed to detect the BRAF V600E and V600K mutations with high sensitivity (down to 5% V600E and V600K sequence in a background of wild-type sequence using DNA extracted from FFPE tissue). 
Test je bil zasnovan za odkrivanje mutacij BRAF V600E in V600K z veliko senzitivnostjo (navzdol do 5 % sekvence V600E in V600K v ozadju sekvence divjega tipa ob uporabi DNA, pridobljene iz tkiva FFPE).
Effects of dabrafenib on substance transport systems 
Vplivi dabrafeniba na transportne sisteme snovi
• floating spots before the eyes 
• plavajoče pike pred očmi
Tell your doctor, pharmacist or nurse if you are taking any of these (or if you are not sure). 
Zdravniku, farmacevtu ali medicinski sestri morate povedati, če jemljete katero od teh zdravil (ali če ste negotovi).
The median duration of follow-up (time from randomisation to last contact or death) was 2.83 years in the dabrafenib and trametinib combination arm and 2.75 years in the placebo arm. 
Mediano trajanje spremljanja (čas od randomizacije do zadnjega kontakta z bolnikom oziroma njegove smrti) je bilo 2,83 let v skupini s kombinacijo dabrafeniba in trametiniba ter 2,75 let v skupini s placebom.
Taking the combination of Tafinlar and trametinib may increase the risk of developing holes in the gut wall. 
Jemanje kombinacije zdravila Tafinlar in trametiniba lahko poveča tveganje za nastanek lukenj v steni črevesa.
Table 5 Kinase inhibitory activity of dabrafenib against RAF kinases 
Preglednica 5 Kinazna inhibitorna aktivnost dabrafeniba proti RAF-kinazam
Red iron oxide (E172) Titanium dioxide (E171) Hypromellose (E464) 
Ovojnica kapsule rdeči železov oksid (E172) titanov dioksid (E171) hipromeloza (E464)
Part B of study BRF113220 included a cohort of 26 patients that had progressed on a BRAF inhibitor. 
Del B študije BRF113220 je vključeval kohorto s 26 bolniki, pri katerih je bolezen napredovala med predhodnim zdravljenjem z zaviralcem BRAF.
Unresectable or metastatic melanoma 
Inoperabilni ali metastatski melanom
Both cancers have a particular change (mutation) in a gene called BRAF at the V600 position. 
Pri obeh navedenih vrstah raka se pojavlja posebna sprememba (mutacija) gena z imenom BRAF na mestu V600.
NR = Not reached, NA = Not applicable 
ND = ni doseženo, NA = ni relevantno
If the fever is severe, your doctor may recommend that you stop taking Tafinlar while they treat the fever with other medicines. 
Če je telesna temperatura močno zvišana, lahko zdravnik naroči, da nehate jemati zdravilo Tafinlar, medtem ko zvišano telesno temperaturo zdravijo z drugimi zdravili.
If patients develop symptoms of pulmonary embolism or deep vein thrombosis such as shortness of breath, chest pain, or arm or leg swelling, they should immediately seek medical care. 
Če se pri bolniku pojavijo znaki pljučne embolije ali globoke venske tromboze, kot so zadihanost, bolečine v prsnem košu ali zatekanje rok ali nog, mora takoj poiskati zdravniško pomoč.
Therefore, transient inhibition of CYP3A4 may be observed during the first few days of treatment. 
Zato se lahko v prvih nekaj dneh zdravljenja pojavi prehodno zavrtje CYP3A4.
Stevens-Johnson syndrome Drug reaction with eosinophilia and systemic symptoms Dermatitis exfoliative generalised 
Stevens-Johnsonov sindrom reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS sindrom) generaliziran eksfoliativni dermatitis
How to take it Swallow the capsules whole with water, one after the other. 
Kapsule zaužijte cele, z vodo, eno za drugo.
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE23 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci protein-kinaze, oznaka ATC: L01XE23
Onset of induction is likely to occur after 3 days of repeat dosing with dabrafenib. 
Pojav indukcije je verjeten po 3 dneh ponavljajočega se odmerjanja dabrafeniba.
Subjects with brain metastases were not included in the trial. 
Bolniki z metastazami v možganih niso bili vključeni v študijo.
The bottles also include a silica gel desiccant in a small cylinder shaped container. 
Plastenke vsebujejo tudi sušilo s silicijevim dioksidom v majhnem vsebniku cilindrične oblike.
Cases were managed with excision and did not require treatment modification (see section 4.4). 
Zdravili so jih z ekscizijo in niso zahtevali prilagoditve zdravljenja (glejte poglavje 4.4).
• after eating, you must wait at least 2 hours before taking Tafinlar. 
• morate po jedi počakati vsaj 2 uri, preden vzamete zdravilo Tafinlar.
Tafinlar is a medicine that contains the active substance dabrafenib. 
Zdravilo Tafinlar je zdravilo, ki vsebuje učinkovino dabrafenib.
Patients on the DTIC arm were allowed to cross over to dabrafenib after independent radiographic confirmation of initial progression. 
Bolniki v kraku z DTIC so po neodvisni radiografski potrditvi uvodnega napredovanja lahko prešli na dabrafenib.
The risk for liver injury after paracetamol administration is suspected to be higher in patients concomitantly treated with enzyme inducers. 
Tveganje za okvaro jeter po uporabi paracetamola je domnevno večje pri bolnikih, ki sočasno prejemajo induktorje encimov.
Complete blood cell counts and blood chemistry should be performed as clinically indicated. 
Opraviti je treba pregled celotne krvne slike in biokemične preiskave krvi, kot je klinično indicirano.
Patients with serious non-infectious febrile events responded well to dose interruption and/or dose reduction and supportive care. 
Bolniki z resnimi neinfekcijskimi febrilnimi pojavi so se dobro odzvali na prekinitev uporabe in/ali znižanje odmerka ter podporno oskrbo.
The potential effect of dabrafenib on QT prolongation was assessed in a dedicated multiple dose QT study. 
Možnost učinkovanja dabrafeniba na podaljšanje QT intervala so ocenjevali v posebni študiji za ovrednotenje QT intervala z več odmerki.
If you forget to take Tafinlar 
Če ste pozabili vzeti zdravilo Tafinlar
Thus, trametinib and dabrafenib inhibit two kinases in this pathway, MEK and RAF, and therefore the combination provides concomitant inhibition of the pathway. 
Trametinib in dabrafenib zavirata dve kinazi na tej poti, MEK in RAF, kombinacija zdravil torej sočasno zavira pot.
Please also read the trametinib package leaflet for details of the side effects you may get with trametinib. 
Preberite tudi navodilo za uporabo za trametinib glede podrobnosti o neželenih učinkih, do katerih lahko pride zaradi trametiniba.
Neither dabrafenib nor its 3 main metabolites were demonstrated to be inhibitors of Pgp in vitro. 
Niti za dabrafenib niti za tri njegove presnovke ni dokazano, da bi bili zaviralci Pgp in vitro.
• If you are a woman who could become pregnant you must use a reliable birth control method while you are taking Tafinlar and for at least 2 weeks after you stop taking it and for at least 16 weeks following the last dose of trametinib when given in combination with Tafinlar. 
• Če ste ženska, ki bi lahko zanosila, morate med jemanjem zdravila Tafinlar in še vsaj 2 tedna po koncu jemanja tega zdravila oziroma še vsaj 16 tednov po zadnjem odmerku trametiniba, če ga uporabljate v kombinaciji z zdravilom Tafinlar, uporabljati zanesljivo kontracepcijsko zaščito.
Dabrafenib terminal half-life after a single oral dose is 8 hours due to absorption-limited elimination after oral administration (flip-flop pharmacokinetics). 
Terminalni razpolovni čas dabrafeniba po enem samem peroralnem odmerku je 8 ur, in sicer zaradi absorpcijsko omejenega odstranjevanja po peroralni uporabi ("flip-flop farmakokinetika").
If possible, show them the Tafinlar pack with this leaflet. 
Če je mogoče, jim pokažite pakiranje zdravila Tafinlar in to navodilo.
Usually, these skin changes remain local and can be removed with surgery and treatment with Tafinlar can be continued without interruption. 
Po navadi ostanejo te spremembe kože lokalizirane in jih je mogoče odstraniti z operacijo ter nadaljevati zdravljenje z zdravilom Tafinlar brez prekinitve.
The primary endpoint was investigator-assessed relapse-free survival (RFS), defined as the time from randomisation to disease recurrence or death from any cause. 
Primarni cilj opazovanja je bilo preživetje brez ponovitve bolezni (relapse-free survival, RFS) po oceni raziskovalca, ki je bilo opredeljeno kot čas od randomizacije do ponovitve bolezni ali smrti iz kateregakoli vzroka.
Cases of new primary melanoma can be managed with excision and do not require treatment modification. 
V primeru novega primarnega melanoma je bolnika mogoče zdraviti z ekscizijo, spremembe v zdravljenju niso potrebne.
Adjuvant treatment of Stage III melanoma 
Adjuvantno zdravljenje melanoma stadija III
Patients should take dabrafenib as monotherapy or in combination with trametinib at least one hour prior to or two hours after a meal due to the effect of food on dabrafenib absorption (see section 5.2). 
Bolniki morajo dabrafenib, bodisi v monoterapiji ali v kombinaciji s trametinibom, vzeti vsaj eno uro pred jedjo ali vsaj dve uri po jedi, ker hrana vpliva na absorpcijo dabrafeniba (glejte poglavje 5.2).
Tell your doctor, pharmacist or nurse immediately if you get a fever (temperature 38.5ºC or above) while you are taking this medicine. 
Zdravniku, farmacevtu ali medicinski sestri morate nemudoma povedati, če med jemanjem tega zdravila dobite zvišano telesno temperaturo (38,5 °C ali več).
Liver monitoring may be continued thereafter as clinically indicated. 
Kontroliranje delovanja jeter se lahko nadaljuje, kot je klinično indicirano.
Subjects were enrolled into Cohort A (subjects with no prior local therapy for brain metastasis) or Cohort B (subjects who received prior local therapy for brain metastasis). 
Bolniki so bili vključeni v kohorto A (bolniki brez predhodnega lokalnega zdravljenja metastaz na možganih) ali v kohorto B (bolniki, ki so pred tem že prejemali lokalno zdravljenje metastaz na možganih).
Rare side effects (may affect up to 1 in 1000 people) • A hole (perforation) in the stomach or intestines 
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov): • predrtje (perforacija) stene želodca ali črevesa
The primary endpoint of the study was overall intracranial response rate (OIRR) in the V600E patient population, as assessed by investigators. 
Primarni opazovani dogodek študije je bil celotni delež intrakranialnega odziva (OIRR - overall intracranial response rate) v populaciji bolnikov z V600E po raziskovalčevi oceni.
• Increase in creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle 
• zvišana vrednost kreatin-kinaze, encima, ki je večinoma prisoten v srcu, možganih in skeletnih mišicah
Dabrafenib 438 405 + Trametinib 
število izpostavljenih tveganju dabrafenib 438 405 + trametinib placebo
Before you take Tafinlar in combination with trametinib your doctor also needs to know if you: 
Preden boste začeli jemati zdravilo Tafinlar v kombinaciji s trametinibom, mora vaš zdravnik vedeti tudi:
Medicinal products that alter the pH of the upper gastrointestinal (GI) tract (e.g. proton pump inhibitors, H2-receptor antagonists, antacids) are not expected to reduce the bioavailability of dabrafenib. 
Ne pričakuje se, da bi zdravila, ki spreminjajo pH zgornjega gastrointestinalnega trakta (npr. zaviralci protonske črpalke, antagonisti histaminskih receptorjev H2, antacidi), zmanjšala biološko uporabnost dabrafeniba.
These results did not meet the pre-specified boundary to claim statistical significance at this first OS interim analysis (HR=0.50; p=0.000019). 
Navedeni rezultati ne dosegajo vnaprej opredeljene omejitve za doseganje statistične značilnosti pri prvi vmesni analizi celokupnega preživetja (razmerje ogroženosti = 0,50; p = 0,000019).
The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 2). 
Videti je, da pride do stabilizacije Kaplan-Meierjeve krivulje za OS pri 3 do 5 letih (glejte sliko 2).
Some medicines may affect how Tafinlar works, or make it more likely that you will have side effects. 
Nekatera zdravila lahko vplivajo na delovanje zdravila Tafinlar ali povečajo verjetnost neželenih učinkov.
• have or have had any gastrointestinal problems such as diverticulitis (inflamed pouches in the colon) or metastases to the gastrointestinal tract. 
• če imate ali ste kdaj imeli težave s prebavili, kot so divertikulitis (vnetje žepkov v debelem črevesu) ali metastaze v prebavnem traktu.
Non-clinical and clinical trials with retrospective bi-directional Sanger sequencing analyses have shown that the test also detects the less common BRAF V600D mutation and V600E/K601E mutation with lower sensitivity. 
Predklinične in klinične študije z retrospektivnimi analizami obojestranskega sekvenciranja po Sangerju so pokazale, da ta test odkrije tudi manj pogosti mutaciji BRAF V600D in mutacijo V600E/K601E z manjšo senzitivnostjo.
HR for recurrence = 0.49 95% CI (0.40, 0.59) 
razmerje ogroženosti za ponovitev = 0,49 95% IZ (0,40; 0,59)
It is recommended that the doses of dabrafenib be taken at similar times every day, leaving an interval of approximately 12 hours between doses. 
Priporočljivo je, da bolnik odmerek dabrafeniba vzame vsak dan ob približno istem času, presledek med odmerkoma pa naj bo približno 12 ur.
The desiccant must be kept inside the bottle and must not be eaten. 
Sušilo mora ostati v plastenki in se ga ne sme zaužiti.
The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 1). 
Videti je, da pride do stabilizacije Kaplan-Meierjeve krivulje za OS pri 3 do 5 letih (glejte sliko 1).
Further, the capsules are printed with black ink that contains black iron oxide (E172) shellac and propylene glycol. 
Poleg tega so oznake na kapsulah natisnjene s črnim črnilom, ki vsebuje črni železov oksid (E172), šelak in propilenglikol.
The other side effects that you may see when you take Tafinlar alone are as follows: 
Drugi neželeni učinki, ki jih lahko opazite, če jemljete samo zdravilo Tafinlar so:
The primary objective for this study was to evaluate the efficacy of dabrafenib compared to DTIC with respect to PFS per investigator assessment. 
Primarni cilj študije je bila ocena učinkovitosti dabrafeniba v primerjavi z DTIC, kar zadeva preživetje brez napredovanja bolezni (PFS) po raziskovalčevi oceni.
Secondary endpoints include overall survival (OS; key secondary endpoint), freedom from relapse (FFR) and distant metastasis-free survival (DMFS). 
Med sekundarnimi cilji opazovanja so bili celokupno preživetje (OS; ključni sekundarni cilj opazovanja), stanje brez ponovitve bolezni (freedom from relapse, FFR) in preživetje brez oddaljenih metastaz (distant metastasis-free survival, DMFS).
This is to look for any new skin cancers. 
Namen tega je, da bi odkril morebitne nove kožne rake.
If you stop taking Tafinlar 
Če ste prenehali jemati zdravilo Tafinlar
The majority of subjects had Stage IV M1c disease (61% overall). 
Pri večini preiskovancev je bil stadij bolezni IV M1c (skupno pri 61 %).
Not all pack sizes may be marketed in your country. 
V vaši državi morda ni na trgu vseh navedenih pakiranj.
Women of childbearing potential must use effective methods of contraception during therapy and for 2 weeks following discontinuation of dabrafenib and 16 weeks following the last dose of trametinib when given in combination with dabrafenib. 
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 2 tedna po prenehanju zdravljenja z dabrafenibom in še 16 tednov po zadnjem odmerku trametiniba, če ga uporabljajo v kombinaciji z dabrafenibom.
Carcinogenicity studies with dabrafenib have not been conducted. 
Študij kancerogenosti z dabrafenibom niso izvedli.
• Increase in blood sugar level 
• zvišana vrednost sladkorja v krvi
Taking Tafinlar or the combination of Tafinlar and trametinib may cause fever, although it is more likely if you are taking the combination treatment (see also section 4). 
Jemanje zdravila Tafinlar ali kombinacije zdravila Tafinlar in trametiniba lahko povzroči zvišanje telesne temperature, pri čemer je verjetnost za to večja pri jemanju navedene kombinacije zdravil (glejte tudi poglavje 4).
However, these transporters have minimal impact on dabrafenib oral bioavailability and elimination and the risk for clinically relevant drug-drug interactions with inhibitors of Pgp or BCRP is low. 
Vendar ta dva prenašalca le minimalno vplivata na biološko uporabnost in izločanje peroralno apliciranega dabrafeniba, tudi tveganje za klinično pomembno medsebojno delovanje z zaviralci Pgp ali BCRP je majhno.
Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity. 
Trametinib je reverzibilen, visoko selektiven, alosterični zaviralec aktivacije in kinazne aktivnosti MEK1 in MEK2 (MEK - mitogeno aktivirana, z zunajceličnim signalom aktivirana kinaza).
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. 
Podatki o celokupnem preživetju iz nadaljnje post hoc analize na podlagi podatkov do presečnega datuma 18. decembra 2012 so pokazali, da je stopnja 12-mesečnega celokupnega preživetja 63 % ob zdravljenju z DTIC in 70 % ob zdravljenju z dabrafenibom.
BRF115532 (COMBI-AD) 
Študija BRF115532 (COMBI-AD)
Do not change your dose or stop Tafinlar or trametinib unless your doctor, nurse or pharmacist tells you to. 
Ne spreminjajte odmerka in ne prekinjajte zdravljenja z zdravilom Tafinlar ali trametinibom, razen če vam tako naroči zdravnik, medicinska sestra ali farmacevt.
The majority of patients had a non-squamous histology. 
Pri večini bolnikov je šlo za neploščatocelični histološki tip raka.
Age greater than 75 years was a significant predictor of carboxy- and desmethyl-dabrafenib plasma concentrations with a 40% greater exposure in subjects ≥75 years of age, relative to subjects <75 years old. 
Starost nad 75 let je bila pomemben napovednik koncentracije karboksi- in dezmetildabrafeniba v plazmi; pri bolnikih v starosti ≥ 75 let je bila izpostavljenost 40 % večja kot pri bolnikih, starih < 75 let.
In a study in dogs in which trametinib and dabrafenib were given in combination for 4 weeks, signs of gastrointestinal toxicity and decreased lymphoid cellularity of the thymus were observed at lower exposures than in dogs given trametinib alone. 
V študiji na psih, ki so jim 4 tedne dajali trametinib in dabrafenib v kombinaciji, so opažali znake gastrointestinalne toksičnosti in zmanjšano število limfatičnih celic v timusu pri izpostavljenostih, ki so bile nižje kot pri psih, ki so jim dajali samo trametinib.
• some medicines that reduce cholesterol levels, such as atorvastatin and simvastatin 
• nekatera zdravila za zniževanje holesterola, npr. atorvastatin in simvastatin
3) The following adverse reaction has occurred in MEK116513 and BRF115532 but not in MEK115306 and BRF113928: rhabdomyolysis (uncommon) 
3. naslednji neželeni učinek se je pojavljal v študijah MEK116513 in BRF115532, ni pa se pojavljal v študijah MEK115306 in BRF113928: rabdomioliza (občasni).
The efficacy of the combination with trametinib was superior when indirectly compared to dabrafenib monotherapy in Cohort A. 
Pri posredni primerjavi je bila učinkovitost kombinacije s trametinibom večja kot pri dabrafenibu v monoterapiji v kohorti A.
The median time to onset of the first occurrence of cuSCC in the combination arm of the adjuvant treatment study was approximately 18 weeks and was 33 weeks in the placebo arm. 
Mediani čas do prvega pojava ploščatoceličnega karcinoma kože je bil v skupini, ki je prejemala kombinirano adjuvantno zdravljenje, približno 18 tednov in v skupini, ki je prejemala placebo, 33 tednov.
The majority of subjects had Stage IVM1c disease (67%). 
Pri večini preiskovancev je bil stadij bolezni IVM1c (67 %).
Grade 1 or Grade 2 (Tolerable) 
1. in 2. stopnja (znosni)
Tell your doctor, pharmacist or nurse if you get any of the signs and symptoms listed. 
Zdravniku, farmacevtu ali medicinski sestri povejte, če se vam pojavi kateri od naštetih znakov in simptomov.
In some cases, people with fever may develop low blood pressure and dizziness. 
V nekaterih primerih se lahko osebam z zvišano telesno temperaturo pojavita nizek krvni tlak in omotica.
Do not make up for missed doses and just take your next dose at your regular time: o If it is less than 6 hours to your next scheduled dose of Tafinlar, which is taken twice daily. 
Izpuščenega odmerka pa ne nadomeščajte in vzemite samo naslednji odmerek po razporedu, če: o je manj kot 6 ur do naslednjega rednega odmerka zdravila Tafinlar, ki ga jemljete dvakrat na dan; o je manj kot 12 ur do naslednjega rednega odmerka trametiniba, ki ga jemljete enkrat na dan.
The most commonly observed BRAF mutation is V600E which accounts for approximately 90% of the BRAF mutations that are seen in melanoma. 
Najpogosteje opažena mutacija BRAF je V600E; ta predstavlja ~90 % mutacij BRAF pri melanomu.
Based on updated data with an additional 10 months of follow-up compared to the primary analysis (minimum follow-up of 40 months), the RFS benefit was maintained with an estimated HR of 0.49 [95% CI: (0.40, 0.59)] (Figure 4). 
Po analizi posodobljenih podatkov z dodatnimi 10 meseci spremljanja glede na primarno analizo (najkrajši čas spremljanja je bil 40 mesecev), se je izboljšanje RFS ohranilo z ocenjenim razmerjem ogroženosti 0,49 [95-odstotni IZ: (0,40; 0,59)] (slika 4).
• Dehydration (low levels of water or fluid) 
• dehidracija (zmanjšana količina vode oziroma tekočin v telesu)
Medicinal products that are strong inhibitors or inducers of CYP2C8 or CYP3A4 are therefore likely to increase or decrease, respectively, dabrafenib concentrations. 
Zato je verjetno, da zdravila, ki močno zavirajo ali inducirajo CYP2C8 ali CYP3A4, povečajo oziroma zmanjšajo koncentracijo dabrafeniba.