natgillin/translations-raw huggingface dataset:
It is important that you keep this Alert Card and show it to your partner or caregivers.
Pomembno je, da to opozorilno kartico shranite in jo pokažete partnerju ali skrbniku.
They may occur if you had this kind of transplant in the past or if you get it in the future.
Lahko se pojavijo v primeru, če ste imeli tako presaditev v preteklosti ali jo boste imeli v prihodnosti.
- It is very important that you do not miss a dose of this medicine.
- Zelo pomembno je, da ne izpustite odmerka tega zdravila.
These complications can be severe and can lead to death.
Ti zapleti so lahko hudi in lahko povzročijo smrt.
- If you are taking, have recently taken or might take any other medicines.
- če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Ker pa je znano, da se protitelesa lahko izločajo v materino mleko, tveganja za novorojence/otroke ne moremo izključiti.
These results should be interpreted in the context of the open-label study design and therefore taken cautiously.
Te rezultate je treba tolmačiti v okviru odprtega načrta študije in jih torej previdno obravnavati.
6 weeks.
3 tedne.
It is available in cartons containing one glass vial.
Na voljo je v škatlah, ki vsebujejo eno stekleno vialo.
Data from these patients are too limited to draw any conclusion on safety or efficacy in this population.
Podatkov pri teh bolnikih je premalo, da bi lahko podali zaključke glede varnosti in učinkovitosti v tej populaciji.
It is important that you also read the package leaflets for these other medicines.
Pomembno je, da preberete tudi navodila za uporabo teh drugih zdravil.
The patient educational material should contain:
Izobraževalno gradivo za bolnike mora vsebovati:
The KEYNOTE-426 trial was not powered to evaluate efficacy of individual subgroups.
Moč preskušanja KEYNOTE-426 ni bila zadostna za ocenjevanje učinkovitosti po posameznih podskupinah.
Patients without disease progression could be treated for up to 24 months.
Bolnike brez napredovanja bolezni so lahko zdravili do 24 mesecev.
All but two patients were white.
Vsi bolniki razen dveh so bili belci.
The following terms represent a group of related events that describe a medical condition rather than a single event.
Naslednji izrazi predstavljajo skupino sorodnih učinkov, ki opisujejo zdravstveno stanje, ne enega posameznega učinka.
The management guidelines for these adverse reactions are described in section 4.4.
Navodila za ukrepanje pri teh neželenih učinkih so opisana v poglavju 4.4.
Allow up to 5 minutes for the bubbles to clear.
Pustite do 5 minut, da izginejo mehurčki.
ATC code: L01XC18
Oznaka ATC: L01XC18
A total of 559 patients were randomised.
Skupno je bilo randomiziranih 559 bolnikov.
Not reached
ni doseženo
A total of 861 patients were randomised.
V celoti je bilo randomiziranih 861 bolnikov.
Hyperthyroidism may be managed symptomatically.
Hipertiroidizem je mogoče obvladovati simptomatsko.
Control:
kontrola:
Common severe skin reactions s,
Pogosti hude kožne reakcije s,
Efficacy results based on an additional seven months of follow-up are summarized in Table 10 and Figure 4.
Rezultati učinkovitosti na podlagi dodatnih sedmih mesecev spremljanja so povzeti v preglednici 10 in na sliki 4.
Children and adolescents KEYTRUDA should not be used in children and adolescents below 18 years of age.
Otroci in mladostniki Zdravila KEYTRUDA se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Standard Treatment:
standardno zdravljenje:
Chemistry and haematology laboratory tests were performed at each cycle.
Biokemične in hematološke laboratorijske preiskave so bile opravljene v vsakem ciklusu.
• To avoid foaming, deliver the water along the walls of the vial and not directly on the lyophilised powder.
• Za preprečitev penjenja vodo dodajte ob steni viale, ne neposredno na liofiliziran prašek.
OS results are reported from the final analysis at a median follow-up of 25 months.
O rezultatih OS so poročali iz končne analize pri medianem času spremljanja 25 mesecev.
The Card reminds patients about key symptoms that need to be reported immediately to the physician/nurse.
Kartica bolnike opomni na ključne simptome, o katerih morajo takoj obvestiti zdravnika/medicinsko sestro.
Number (%
število (%
Frequencies are defined as: 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).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Patient-reported outcomes (PROs) were assessed using EORTC QLQ-C30.
Izidi po navedbi bolnikov (PRO - patient-reported outcome) so bili ocenjeni z uporabo EORTC QLQ-C30.
All but one patient was white.
Vsi bolniki razen enega so bili belci.
The value of biomarkers to predict the efficacy of pembrolizumab should be further explored, specifically:
Pomen biomarkerjev za napoved učinkovitosti pembrolizumaba je treba še naprej raziskovati, točneje:
When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations.
Pri ocenjevanju statusa PD-L1 tumorja je pomembno izbrati dobro validirano in robustno metodologijo, da bi čim bolj zmanjšali možnost lažno negativnih ali lažno pozitivnih določitev.
PFS and ORR results are reported from an interim analysis at a median follow-up of 11 months.
O rezultatih PFS in ORR so poročali iz vmesne analize pri medianem času spremljanja 11 mesecev.
The exposure multiple between the NOAEL and a human dose of 200 mg was 74.
Večkratnik izpostavljenosti med NOAEL in odmerkom 200 mg pri človeku je bil 74.
Your doctor may give you other medicines in order to prevent more severe complications and reduce your symptoms.
Zdravnik vam lahko predpiše druga zdravila, da bi preprečil hujše zaplete in omilil simptome.
Based on Kaplan-Meier estimation
Na podlagi Kaplan-Meierjeve ocene
BRAF mutations were reported in 13% of the study population.
Mutacije BRAF so bile ugotovljene pri 13 % študijske populacije.
These side effects can sometimes become life-threatening and can lead to death.
Ti neželeni učinki lahko včasih postanejo življenjsko nevarni in lahko povzročijo smrt.
The educational programme is aimed at increasing the awareness of patients and/or their caregivers on the signs and symptoms relevant to the early recognition/identification of the potential immunerelated adverse reactions (irARs).
Namen izobraževalnega programa je povečati ozaveščenost bolnikov in/ali njihovih skrbnikov o znakih in simptomih, pomembnih za zgodnje odkrivanje/prepoznavanje možnih imunsko pogojenih neželenih učinkov.
You will also find this information in the Patient Alert Card you have been given by your doctor.
To informacijo boste našli tudi v opozorilni kartici, ki jo boste prejeli pri zdravniku.
These side effects may happen anytime during treatment or even after your treatment has ended.
Ti neželeni učinki se lahko pojavijo kadar koli med zdravljenjem ali celo po koncu zdravljenja.
• Do not co-administer other medicinal products through the same infusion line.
• Tega zdravila po isti infuzijski liniji ne dajajte skupaj z drugimi zdravili.
Immune-related adverse reactions affecting more than one body system can occur simultaneously.
Imunsko pogojeni neželeni učinki, ki prizadenejo več organskih sistemov, se lahko pojavijo hkrati.
• Data on RNA and proteomic serum profiling
• Podatki o profilu RNA in proteomskem serumu
Both studies included patients regardless of PD-L1 expression.
V obe študiji so bili vključeni bolniki ne glede na izraženost PD-L1.
Efficacy results are summarized in Table 18.
Rezultati učinkovitosti so povzeti v preglednici 18.
11.3 (10.8, Not reached)
11,3 (10,8; ni dosežena)
TPS 1 to 49%
TPS 1 do 49 %
Sub-population analyses
Analize podpopulacij
KEYTRUDA will be given to you in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.
Zdravilo KEYTRUDA boste prejeli v bolnišnici ali ambulanti pod nadzorom zdravnika z izkušnjami pri zdravljenju raka.
28.0 (14, not available)
28,0 (14, ni na voljo)
What KEYTRUDA is and what it is used for
Kaj je zdravilo KEYTRUDA in za kaj ga uporabljamo
In 20 subjects with ocular melanoma included in KEYNOTE-001, no objective responses were reported; stable disease was reported in 6 patients.
Med 20 preiskovanci z očesnim melanomom, ki so bili vključeni v študijo KEYNOTE-001, ni bilo objektivnega odgovora; o stabilni bolezni so poročali pri 6 bolnikih.
Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful.
Na podlagi podatkov o varnosti, ki so na voljo za cHL in druge vrste tumorjev, te razlike niso klinično pomembne.
The safety profile in these paediatric patients was generally similar to that seen in adults treated with pembrolizumab.
Varnostni profil je bil pri teh pediatričnih bolnikih na splošno podoben kot pri odraslih, zdravljenih s pembrolizumabom.
Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed.
Opaženi so bili netipični odgovori (tj. prehodno začetno povečanje velikosti tumorja ali majhne nove lezije v prvih nekaj mesecih zdravljenja, čemur je sledilo zmanjšanje tumorja).
Liver enzymes should be monitored before initiation of and periodically throughout treatment.
Jetrne encime je treba spremljati pred začetkom zdravljenja in periodično med zdravljenjem.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
(n=84), or vinflunine 320 mg/m
(n = 84) ali vinflunin 320 mg/m
BRAF mutation status in melanoma
Status mutacije BRAF pri melanomu
The Patient Information Brochure and Patient Alert Card shall contain the following key elements:
Vodnik za bolnike in opozorilna kartica za bolnika morata vsebovati naslednje ključne elemente:
Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria.
Povečanje odmerka aksitiniba na 10 mg dvakrat na dan je bilo dovoljeno z uporabo enakih meril.
• KEYTRUDA is for single use only.
• Zdravilo KEYTRUDA je samo za enkratno uporabo.
These reactions are presented by system organ class and by frequency.
Ti učinki so prikazani po organskih sistemih in pogostnosti.
If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use.
Če so viale in/ali intravenske vrečke shranjene v hladilniku, jih morate pustiti, da pred uporabo dosežejo sobno temperaturo.
The MAH shall ensure that in each Member State where KEYTRUDA is marketed, all healthcare professionals and patients/caregivers who are expected to prescribe and use KEYTRUDA have access to/are provided with the patient educational material.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo KEYTRUDA trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali in uporabljali zdravilo KEYTRUDA, imeli dostop do/prejeli izobraževalno gradivo za bolnike.
Fifty-nine percent of the patients with increased ALT received systemic corticosteroids.
Devetinpetdeset odstotkov bolnikov z zvišano vrednostjo ALT je prejemalo sistemske kortikosteroide.
Table 27 summarises the key efficacy measures for the TPS ≥ 50% population.
Preglednica 27 povzema ključna merila učinkovitosti za TPS ≥ 50 % populacijo.
KEYTRUDA is used in adults to treat:
Zdravilo KEYTRUDA uporabljamo pri odraslih za zdravljenje:
Efficacy and safety data from patients ≥ 75 years are limited.
Podatkov o varnosti in učinkovitosti pri bolnikih, starih ≥ 75 let, je malo.
Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer.
Zdravljenje morajo uvesti in nadzorovati zdravniki specialisti z izkušnjami pri zdravljenju raka.
KEYTRUDA may be given in combination with other anti-cancer medicines.
Zdravilo KEYTRUDA se lahko uporablja v kombinaciji z drugimi zdravili proti raku.
Exclusion criteria were similar to those of KEYNOTE-002.
Merila za nevključitev so bila podobna kot v študiji KEYNOTE-002.
Examples of these may include corticosteroids, such as prednisone.
Primer takšnih zdravil so kortikosteroidi, na primer prednizon.
The safety and efficacy of KEYTRUDA in children below 18 years of age have not yet been established.
Varnost in učinkovitost zdravila KEYTRUDA pri otrocih, starih manj kot 18 let, še nista bili dokazani.
- It is not known if KEYTRUDA passes into your breast milk.
- Ni znano, ali zdravilo KEYTRUDA prehaja v materino mleko.
18.9 (11, not available)
18,9 (11, ni na voljo)
Participants were enrolled across 28 tumour types by primary diagnosis.
Vključeni preiskovanci so imeli kot primarno diagnozo 28 vrst tumorjev.
It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with KEYTRUDA.
Vsebuje tudi opozorilo, da si zabeležijo kontaktne podatke zdravnika in opozorilo drugim zdravnikom, da se bolnik zdravi z zdravilom KEYTRUDA.
The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy.
Pot PD-1/PD-L1 je domnevno povezana z vzdrževanjem tolerance za plod v času nosečnosti.
Consistent with a limited extravascular distribution, the volume of distribution of pembrolizumab at steady state is small (~6.0 L; CV: 20%).
Skladno z majhno zunajžilno porazdelitvijo je volumen porazdelitve pembrolizumaba v stanju dinamičnega ravnovesja majhen (~6,0 l, KV: 20 %).
Pembrolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab.
Pembrolizumaba se med nosečnostjo ne sme uporabljati, razen če klinično stanje ženske zahteva zdravljenje s pembrolizumabom.
Do not store any unused portion of the infusion solution for reuse.
Neporabljenega ostanka raztopine za infundiranje ne shranite za ponovno uporabo.
If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 96 hours at 2°C to 8°C.
Če ni uporabljena takoj, sta kemična in fizikalna stabilnost zdravila KEYTRUDA med uporabo dokazani za 96 ur na temperaturi 2 °C do 8 °C.
As expected for an antibody, pembrolizumab does not bind to plasma proteins in a specific manner.
Kot je pričakovano za protitelo, se pembrolizumab ne veže specifično na beljakovine v plazmi.
In 1 month and 6 month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs; however, many animals in these studies were not sexually mature.
V 1-mesečni in 6-mesečni toksikološki študiji ponavljajočih se odmerkov pri opicah ni bilo opaznih učinkov na spolne organe samcev in samic, vendar številne živali v teh študijah niso bile spolno zrele.
The relationship between body weight and clearance supports the use of either fixed dose or body weight-based dosing to provide adequate and similar control of exposure.
Razmerje med telesno maso in očistkom potrjuje, da tako uporaba fiksnega odmerka kot odmerka glede na telesno maso zagotavljata ustrezno in podobno obvladovanje izpostavljenosti.
Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant-related complications should be made case by case (see section 4.8).
Dokler ne bo na voljo več podatkov, je treba pri vsakem bolniku posebej skrbno pretehtati možne koristi HSCT in možno večje tveganje za pojav zapletov, povezanih s presaditvijo (glejte poglavje 4.8).
Factors associated with early deaths were fast progressive disease on prior platinum therapy and liver metastases.
Dejavnika, povezana z zgodnjimi smrtmi, sta bila hitro napredujoča bolezen med predhodnim zdravljenjem s platino in metastaze v jetrih.
PD-L1 status in melanoma
Status PD-L1 pri melanomu
Immune system disorders Common infusion related reaction infusion related reaction a infusion related reaction
Bolezni imunskega sistema Pogosti z infuzijo povezana reakcija z infuzijo povezana reakcija z infuzijo povezana reakcija
What you need to know before you are given KEYTRUDA
Kaj morate vedeti, preden boste prejeli zdravilo KEYTRUDA
BRAF wild type
divji tip BRAF
Grade 2 with creatinine > 1.5 to ≤ 3 times upper limit of normal (ULN)
2. stopnja s kreatininom > 1,5- do ≤ 3-krat nad zgornjo normalno mejo (ZNM)
Treatment with pembrolizumab may increase the risk of rejection in solid organ transplant recipients.
Zdravljenje s pembrolizumabom lahko poveča tveganje za zavrnitev pri prejemnikih presadkov čvrstih organov.
Table 1: Recommended treatment modifications for KEYTRUDA
Preglednica 1: Priporočene prilagoditve zdravljenja z zdravilom KEYTRUDA
This can affect your ability to drive or to use machines.
To lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
Dose delay or discontinuation (see also section 4.4)
Odložitev odmerka ali ukinitev zdravljenja (glejte tudi poglavje 4.4)
Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded.
Bolnike je treba spremljati glede znakov in simptomov adrenalne insuficience in hipofizitisa (vključno s hipopituitarizmom) in izključiti druge vzroke.
What KEYTRUDA is and what it is used for What you need to know before you are given KEYTRUDA How you are given KEYTRUDA Possible side effects
Kaj je zdravilo KEYTRUDA in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo KEYTRUDA Kako boste prejeli zdravilo KEYTRUDA Možni neželeni učinki
These results indicate a potential risk, based on its mechanism of action, that administration of pembrolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Ti rezultati kažejo na možno tveganje, da bi uporaba pembrolizumaba med nosečnostjo zaradi njegovega mehanizma delovanja lahko povzročila okvaro ploda, vključno z večjimi deleži splavov ali mrtvorojenosti.
Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab.
Ženske v rodni dobi morajo med zdravljenjem s pembrolizumabom in vsaj še 4 mesece po zadnjem odmerku pembrolizumaba uporabljati učinkovito kontracepcijo.
Pembrolizumab may have a minor influence on the ability to drive and use machines.
Pembrolizumab ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib).
Za obe zdravili je treba upoštevati navodila za ukrepanje (glejte poglavje 4.2 in SmPC aksitiniba).
Not reached (0.0+, 45.6+)
ni dosežena (0,0+; 45,6+)
Grades 3 or 4 myocarditis Grades 3 or 4 encephalitis Grades 3 or 4 Guillain-Barré syndrome
miokarditis 3. ali 4. stopnje encefalitis 3. ali 4. stopnje Guillain-Barréjev sindrom 3. ali 4. stopnje
Data from patients ≥ 65 years are too limited to draw conclusions on cHL population (see section 5.1).
Podatkov pri bolnikih, starih ≥ 65 let, je premalo, da bi lahko podali zaključke glede populacije s cHL (glejte poglavje 5.1).
Your doctor will monitor you for signs and symptoms, which may include skin rash, liver inflammation, abdominal pain, or diarrhoea.
Zdravnik vas bo spremljal glede znakov in simptomov, ki lahko vključujejo izpuščaj na koži, vnetje jeter, bolečine v trebuhu ali drisko.
The potential risk of gastrointestinal perforation should be taken into consideration.
Upoštevati je treba morebitno tveganje za perforacije v prebavilih.
These studies enrolled patients who failed ASCT and BV, who were ineligible for ASCT because they were unable to achieve a complete or partial remission to salvage chemotherapy and failed BV, or who failed ASCT and did not receive BV.
Ti študiji sta zajeli bolnike, pri katerih ASCT in BV nista bila uspešna, bolnike, ki niso bili primerni za ASCT, ker niso mogli doseči popolne ali delne remisije z rešilno kemoterapijo in zdravljenje z BV ni bilo uspešno, ali ASCT ni bila uspešna in niso prejeli BV.
• The importance of not attempting to self-treat any symptoms without consulting their healthcare professional first
• Opozorilo, naj bolniki ne poskušajo sami zdraviti katerih koli simptomov, ne da bi se posvetovali z zdravnikom
Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy.
Pet preiskovancev v študiji ni bilo primernih za ASCT zaradi drugih razlogov, ne zaradi neuspeha rešilne kemoterapije.
The European Medicines Agency has deferred the obligation to submit the results of studies with pembrolizumab in one or more subsets of the paediatric population in treatment of Hodgkin lymphoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s pembrolizumabom za eno ali več podskupin pediatrične populacije za zdravljenje Hodgkinovega limfoma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Patients with mild or moderate infusion reaction may continue to receive pembrolizumab with close monitoring; premedication with antipyretic and antihistamine may be considered.
Bolniki z blago ali zmerno z infuzijo povezano reakcijo lahko pembrolizumab še naprej prejemajo pod skrbnim nadzorom; razmisliti je treba o premedikaciji z antipiretikom in antihistaminikom.
Prior to launch of KEYTRUDA in each Member State the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila KEYTRUDA na trg v vsaki posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vseh drugih vidikih programa.
Response was assessed in KN087 and KN013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at week 12.
Odgovor so v KN087 ocenjevali na 12 tednov in v KN013 na 8 tednov; prva načrtovana poizhodiščna ocena je bila v 12. tednu.
Chemotherapy OS by PD-L1 Expression Number of Events (number of patients)*
izraženost PD-L1 pembrolizumab kemoterapija OS glede na izraženost PD-L1 število dogodkov (število bolnikov)*
Table 19 summarises the key efficacy measures for the ITT population at the final analysis.
Preglednica 19 povzema ključna merila učinkovitosti za populacijo ITT pri končni analizi.
Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines.
Predhodno zdravljenje je obsegalo dvojno shemo s platino (100 %); bolniki so prejeli eno (69 %) ali dve ali več (29 %) linij zdravljenja.
There were no Grade 5 hepatic events.
Jetrnih učinkov 5. stopnje ni bilo.
• Aseptically add 2.3 mL of water for injections to yield a 25 mg/mL (pH 5.2-5.8) solution of KEYTRUDA.
• Aseptično dodajte 2,3 ml vode za injekcije, da dobite raztopino zdravila KEYTRUDA 25 mg/ml (pH 5,2-5,8).
cardiac arrhythmia (including atrial fibrillation)
motnja srčnega ritma (vključno z atrijsko fibrilacijo)
Randomisation was stratified by risk categories (favourable versus intermediate versus poor) and geographic region (North America versus Western Europe versus “Rest of the World”).
Randomizacija je bila stratificirana po kategorijah tveganja (ugodna kategorija v primerjavi s srednjo in v primerjavi s slabo) in po geografskem področju (Severna Amerika v primerjavi z Zahodno Evropo v primerjavi s "preostalim svetom").
The same scoring system was used for metastatic melanoma (MEL score).
Sistem točkovanja je enak kot je bil uporabljen pri metastatskem melanomu (ocena po lestvici MEL).