FrancophonIA/ELRC3.0 huggingface dataset:
English: • a kind of skin cancer called melanoma
Slovenian: • vrste kožnega raka, imenovanega melanom,
English: Median (95% CI), months
Slovenian: mediana (95 % IZ), meseci
English: In a subgroup analysis, a reduced survival benefit of pembrolizumab compared to chemotherapy was observed in the small number of patients who were never-smokers; however, due to the small number of patients, no definitive conclusions can be drawn from these data.
Slovenian: V analizi podskupine so pri majhnem številu bolnikov, ki niso nikoli kadili, opazili zmanjšano korist pembrolizumaba za preživetje v primerjavi s kemoterapijo, vendar zaradi majhnega števila bolnikov končni zaključki na podlagi teh podatkov niso mogoči.
English: • IHC staining for PD-L2
Slovenian: • Barvanje po metodi IHC za PD-L2
English: When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first.
Slovenian: Če se zdravilo KEYTRUDA uporablja kot del kombiniranega zdravljenja skupaj z intravensko kemoterapijo, je treba zdravilo KEYTRUDA aplicirati prvo.
English: Warnings and precautions Talk to your doctor or nurse before receiving KEYTRUDA.
Slovenian: Opozorila in previdnostni ukrepi Preden prejmete zdravilo KEYTRUDA, se posvetujte z zdravnikom ali medicinsko sestro.
English: When used in combination with pembrolizumab, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer (see section 5.1).
Slovenian: Če je aksitinib uporabljen v kombinaciji s pembrolizumabom, se lahko razmisli o povečanju odmerka aksitiniba nad začetnih 5 mg v presledkih šest tednov ali več (glejte poglavje 5.1).
English: Assessment of PD-L1 status
Slovenian: Ocena statusa PD-L1
English: Table 17 summarises key efficacy measures for the entire population (TPS  1%) and for the patients with TPS  50%, and Figure 11 shows the Kaplan-Meier curve for OS (TPS  1%), based on a final analysis with median follow up of 42.6 months.
Slovenian: Preglednica 17 povzema ključna merila učinkovitosti za celotno populacijo (TPS  1 %) in za bolnike s TPS  50 %, slika 11 pa prikazuje Kaplan-Meierjevo krivuljo celokupnega preživetja (TPS  1 %) na podlagi končne analize z medianim časom spremljanja 42,6 meseca.
English: Not reached (1.4+, 18.2+)
Slovenian: ni dosežena (1,4+; 18,2+)
English: Feeling tired or weak is a very common side effect of KEYTRUDA.
Slovenian: Utrujenost in šibkost sta zelo pogosta neželena učinka zdravila KEYTRUDA.
English: Randomisation was stratified by tumour PD-L1 expression (TPS < 1% [negative] vs. TPS ≥ 1%), investigator's choice of paclitaxel or nabpaclitaxel, and geographic region (East Asia vs. non-East Asia).
Slovenian: Randomizacija je bila stratificirana glede na izraženost PD-L1 tumorja (TPS < 1 % [negativni] ali TPS ≥ 1 %), raziskovalčevo izbiro paklitaksela ali nab-paklitaksela in geografsko regijo (vzhodna Azija ali ne-vzhodna Azija).
English: The most common tumour types by histology were Hodgkin lymphoma (11.7%), glioblastoma multiforme (9.1%), neuroblastoma (6.5%), osteosarcoma (6.5%) and melanoma (5.2%).
Slovenian: Najpogostejše vrste tumorjev glede na histologijo so bile: Hodgkinov limfom (11,7 %), multiformni glioblastom (9,1 %), nevroblastom (6,5 %), osteosarkom (6,5 %) in melanom (5,2 %).
English: For the adjuvant treatment of melanoma, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year.
Slovenian: Pri adjuvantnem zdravljenju melanoma je treba zdravilo KEYTRUDA uporabljati do ponovitve bolezni, pojava nesprejemljivih toksičnih učinkov oziroma mora zdravljenje trajati do enega leta.
English: A decision should be made whether to discontinue breast-feeding or to discontinue pembrolizumab, taking into account the benefit of breast-feeding for the child and the benefit of pembrolizumab therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja s pembrolizumabom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja s pembrolizumabom za mater.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4).
Slovenian: Vendar pa je kortikosteroide ali druge imunosupresive mogoče uporabiti po uvedbi zdravljenja s pembrolizumabom za zdravljenje imunsko pogojenih neželenih učinkov (glejte poglavje 4.4).
English: BRAF mutations were reported in 20 (39%) patients.
Slovenian: Mutacije BRAF so bile ugotovljene pri 20 (39 %) bolnikih.
English: While the analysis in patients with PD-L1 positive tumours was a co-primary endpoint, pre-defined subgroup analyses were performed in patients whose tumours were PD-L1 negative, BRAF mutation positive or negative.
Slovenian: Medtem ko je bila analiza pri bolnikih s PD-L1 pozitivnimi tumorji sočasni primarni opazovani dogodek, so bile izvedene tudi vnaprej predvidene analize po podskupinah pri bolnikih s PD-L1 negativnimi tumorji ter pozitivno ali negativno mutacijo BRAF.
English: Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab.
Slovenian: Bolniki, pri katerih se je po postopku presaditve razvila GVHD, imajo lahko povečano tveganje za pojav GVHD po zdravljenju s pembrolizumabom.
English: Patients underwent imaging every 12 weeks after the first dose of pembrolizumab for the first two years, then every 6 months from year 3 to 5, and then annually.
Slovenian: Pri bolnikih so slikovne preiskave opravljali vsakih 12 tednov po prvem odmerku pembrolizumaba prvi dve leti, nato pa vsakih 6 mesecev od 3. do 5. leta in nato enkrat na leto.
English: A total of 67 patients in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab at the time of disease progression and 18 additional patients received a checkpoint inhibitor as subsequent therapy.
Slovenian: Skupno 67 bolnikov v skupini s placebom in kemoterapijo je v času napredovanja bolezni prešlo na samostojno zdravljenje s pembrolizumabom, še dodatnih 18 bolnikov pa je pri nadaljnjem zdravljenju prejelo zaviralca kontrolnih točk.
English: Table 22: ORR and OS by PD-L1 Expression
Slovenian: Preglednica 22: ORR in OS glede na izraženost PD-L1
English: Each vial contains an excess fill of 10 mg (0.4 mL) to ensure the recovery of 50 mg of KEYTRUDA per vial.
Slovenian: Vsaka viala vsebuje prekomerno polnitev 10 mg (0,4 ml) za zagotovitev dobljene količine 50 mg zdravila KEYTRUDA na vialo.
English: These medicines may interfere with the effect of KEYTRUDA.
Slovenian: Ta zdravila lahko medsebojno delujejo z zdravilom KEYTRUDA.
English: Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4).
Slovenian: Opomba: Stopnje toksičnosti so navedene v skladu z verzijo 4.0 Terminološko poenotenih meril neželenih učinkov Nacionalnega onkološkega inštituta (NCI-CTCAE v4; “National Cancer Institute Common Terminology Criteria for Adverse Events.
English: Common colitis n, dry mouth colitis n, dry mouth colitis n, dry mouth
Slovenian: Pogosti kolitis n, suha usta kolitis n, suha usta kolitis n, suha usta
English: Among patients who were evaluable for PD-L1 expression (98%), 82% were PD-L1 positive and 18% were PD-L1 negative.
Slovenian: Med bolniki, ki jih je bilo mogoče oceniti glede izraženosti PD-L1 (98 %), je bilo 82 % PD-L1 pozitivnih in 18 % PD-L1 negativnih.
English: Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
Slovenian: Bolniki s pozitivnimi tumorskimi mutacijami EGFR ali ALK so pred prejemom zdravila KEYTRUDA morali prejeti tudi tarčno zdravljenje.
English: Table 29: Efficacy Results in KEYNOTE-426 by IMDC Risk Category
Slovenian: Preglednica 29: Rezultati učinkovitosti v študiji KEYNOTE-426 po kategoriji tveganja IMDC
English: AstraZeneca Pharmaceuticals LP, Frederick Manufacturing Center (FMC) 633 Research Court
Slovenian: AstraZeneca Pharmaceuticals LP, Frederick Manufacturing Center (FMC) 633 Research Court Frederick, Maryland (MD) 21703 ZDA
English: No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was ≥ 200 mg/kg, which produced exposure multiples of 19 and 94 times the exposure in humans at doses of 10 and 2 mg/kg, respectively.
Slovenian: Toksikološko pomembnih ugotovitev ni bilo, koncentracija, pri kateri niso opazili neželenih učinkov (no observed adverse effect level - NOAEL), je bila v obeh študijah ≥ 200 mg/kg, kar je 19-kratnik izpostavljenosti pri človeku ob odmerku 10 mg/kg oziroma 94-kratnik izpostavljenosti pri človeku ob odmerku 2 mg/kg.
English: Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.
Slovenian: Hipotiroidizem je mogoče urejati z nadomestnim zdravljenjem brez prekinitve osnovnega zdravljenja in brez kortikosteroidov.
English: Following administration of pembrolizumab 200 mg every 3 weeks in patients with cHL, the observed median Cmin at steady-state was up to 40% higher than that in other tumour types treated with the same dosage; however, the range of trough concentrations is similar.
Slovenian: Po uporabi pembrolizumaba 200 mg na 3 tedne pri bolnikih s cHL je opažena mediana Cmin v stanju dinamičnega ravnovesja do 40 % višja kot pri drugih vrstah tumorjev, zdravljenih z enakim odmerkom, vendar pa je razpon glede na koncentracije podoben.
English: Pembrolizumab is administered via the intravenous route and therefore is immediately and completely bioavailable.
Slovenian: Absorpcija Pembrolizumab se uporablja intravensko, zato je njegova biološka uporabnost takojšnja in popolna.
English: Complications, including graft-versus-host-disease (GVHD), in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).
Slovenian: Zapleti, vključno z boleznijo presadka proti gostitelju, pri ljudeh s presadkom kostnega mozga (matičnih celic) z uporabo donorskih matičnih celic (alogenska presaditev).
English: NR 21.7 (17.1, NR)
Slovenian: ND 21,7 (17,1; ND)
English: There are no notable differences in median Cmax between cHL and other tumour types.
Slovenian: Glede mediane Cmax med cHL in drugimi vrstami tumorjev ni opaznih razlik.
English: Corticosteroids to treat adrenal insufficiency and other hormone replacement should be administered as clinically indicated, and pembrolizumab should be withheld for adrenal insufficiency or symptomatic hypophysitis until the event is controlled with hormone replacement.
Slovenian: Za zdravljenje adrenalne insuficience je treba uporabiti kortikosteroide in drugo nadomeščanje hormonov, kot je klinično indicirano; uporabo pembrolizumaba je treba v primeru adrenalne insuficience ali simptomatskega hipofizitisa prekiniti, dokler stanje ni urejeno z nadomeščanjem hormonov.
English: However, once you are treated with KEYTRUDA, your doctor may give you corticosteroids to reduce the side-effects that you may have with KEYTRUDA.
Slovenian: Vendar pa vam tekom zdravljenja z zdravilom KEYTRUDA zdravnik lahko predpiše kortikosteroide za zmanjšanje neželenih učinkov, ki bi jih lahko imeli zaradi zdravila KEYTRUDA.
English: If rechallenging with axitinib, dose reduction as per the axitinib SmPC may be considered.
Slovenian: V primeru ponovne uporabe aksitiniba se lahko razmisli o zmanjšanju odmerka v skladu s SmPC aksitiniba.
English: In patients with cHL (n=241) the incidence of hypothyroidism was 14.1% (all Grades) with 0.4% Grade 3.
Slovenian: Pri bolnikih s cHL (n = 241) je bila pojavnost hipotiroidizma 14,1 % (vse stopnje) z 0,4 % 3. stopnje.
English: % with duration ≥ 6 months % with duration ≥ 9 months
Slovenian: % s trajanjem ≥ 6 mesecev % s trajanjem ≥ 9 mesecev
English: People get KEYTRUDA after they have had surgery to remove melanoma to help prevent their cancer from coming back (adjuvant therapy).
Slovenian: Bolniki prejmejo zdravilo KEYTRUDA po kirurški odstranitvi melanoma za preprečevanje ponovitve bolezni (adjuvantno zdravljenje).
English: There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma (see section 5.1).
Slovenian: Podatkov o varnosti in učinkovitosti zdravila KEYTRUDA pri bolnikih z očesnim melanomom je malo (glejte poglavje 5.1).
English: Randomisation to the chemotherapy and the chemotherapy-pembrolizumab arms remains open.
Slovenian: Randomizacija v skupini s kemoterapijo in s kemoterapijo-pembrolizumabom ostaja odprta.
English: Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab.
Slovenian: Pri bolnikih z EGFR aktivirajočo mutacijo ali ALK translokacijo je bolezen napredovala tudi med uporabo odobrenega zdravljenja za primer takšnih mutacij, preden so dobili pembrolizumab.
English: Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Slovenian: Bolnike je treba spremljati glede hiperglikemije ali drugih znakov in simptomov sladkorne bolezni.
English: Patients should be monitored for suspected severe skin reactions and other causes should be excluded.
Slovenian: Bolnike je treba spremljati glede hudih kožnih reakcij in izključiti druge vzroke.
English: Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus.
Slovenian: Znano je, da humani imunoglobulini G4 (IgG4) prehajajo skozi placentno pregrado, in ker je pembrolizumab IgG4, obstaja možnost njegovega prenosa od matere v razvijajoči se plod.
English: Pembrolizumab concentrations with weight-based dosing at 2 mg/kg every 3 weeks in paediatric patients (2 to 17 years) are comparable to those of adults at the same dose.
Slovenian: Koncentracije pembrolizumaba med odmerjanjem na podlagi telesne mase 2 mg/kg vsake 3 tedne so pri pediatričnih bolnikih (starih od 2 do 17 let) primerljive s tistimi pri odraslih med uporabo enakega odmerka.
English: Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either trial.
Slovenian: Bolniki z aktivnim neinfekcijskim pnevmonitisom, opravljeno alogensko presaditvijo v zadnjih 5 letih (ali > 5 let, toda z GVHD), aktivno avtoimunsko boleznijo ali zdravstvenim stanjem, ki je zahtevalo imunosupresijo, niso bili vključeni v nobeno od raziskav.
English: The reconstituted vials and/or diluted intravenous bags may be stored for a cumulative time of up to 96 hours in a refrigerator (2°C - 8°C).
Slovenian: Pripravljene viale in/ali vrečke z razredčeno raztopino za intravensko uporabo so lahko shranjene v hladilniku (2 °C - 8 °C) do skupno 96 ur.
English: Corticosteroids can also be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions.
Slovenian: Kortikosteroide je mogoče uporabiti tudi kot premedikacijo, če je pembrolizumab uporabljen v kombinaciji s kemoterapijo, kot antiemetično profilakso in/ali za ublažitev neželenih učinkov, povezanih s kemoterapijo.
English: Based on the modelling and simulation of dose/exposure relationships for efficacy and safety for pembrolizumab, there are no clinically significant differences in efficacy or safety among the doses of 200 mg every 3 weeks, 2 mg/kg every 3 weeks, and 400 mg every 6 weeks as monotherapy (see section 4.2).
Slovenian: Na podlagi modeliranja in simulacije razmerja odmerek/izpostavljenost za učinkovitost in varnost pembrolizumaba ni klinično pomembnih razlik v učinkovitosti ali varnosti pembrolizumaba pri samostojnem zdravljenju z odmerki 200 mg na 3 tedne, 2 mg/kg na 3 tedne in 400 mg na 6 tednov (glejte poglavje 4.2).
English: Pembrolizumab is catabolised through non-specific pathways; metabolism does not contribute to its clearance.
Slovenian: Katabolizem pembrolizumaba poteka po nespecifičnih poteh; presnova ne pripomore k njegovemu očistku.
English: KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Slovenian: Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za zdravljenje napredovalega (neoperabilnega ali metastatskega) melanoma pri odraslih.
English: Hazard ratio* (98% CI) p-Value (stratified log-rank) RFS at 6 months RFS rate RFS at 12 months RFS rate RFS at 18 months RFS rate
Slovenian: razmerje ogroženosti (HR)* (98 % IZ) vrednost p (stratificirani logrank) RFS po 6 mesecih delež RFS RFS po 12 mesecih delež RFS RFS po 18 mesecih delež RFS
English: Not statistically significant after adjustment for multiplicity Based on patients with a best overall response as confirmed complete or partial response from the final analysis
Slovenian: Ni statistično značilno po prilagoditvi glede multiplikativnosti Na podlagi bolnikov z najboljšim celokupnim odgovorom, potrjenim kot popolni oziroma delni odgovor, v končni analizi
English: Additional biomarkers other than PD-L1 expression status by Immunohistochemistry (IHC) (e.g. PD-L2, RNA signature, etc.) predictive of pembrolizumab efficacy should be investigated together with more information regarding the pattern of expression of PD-L1 obtained in the ongoing NSCLC studies (P001, P010, P024 and P042) and urothelial carcinoma studies (KN045, KN052), HNSCC study (KN040) and resected Stage II melanoma adjuvant study (KN716):
Slovenian: Raziskati je treba dodatne biomarkerje, ki niso PD-L1 po IHC (Immuno Histo Chemistry) statusu izraženosti (npr. PD-L2, RNA genetski podpis itd.), ki napovedujejo učinkovitost pembrolizumaba, skupaj z informacijami v zvezi z vzorcem izražanja PD-L1, ki je bil pridobljen v potekajočih študijah NSCLC (P001, P010, P024 in P042) in študijah urotelijskega raka (KN045, KN052), študiji HNSCC (KN040) in študiji adjuvantnega zdravljenja melanoma v stadiju II, po kirurški odstranitvi (KN716):
English: Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 µm in-line or add-on filter.
Slovenian: Raztopino za infundiranje aplicirajte intravensko v 30 minutah; skozi sterilen, nepirogen, 0,2 do 5 µm linijski ali dodatni filter, ki minimalno veže beljakovine.
English: KEYTRUDA potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment.
Slovenian: Zdravilo KEYTRUDA okrepi odziv T celic, vključno s protitumorskim odzivom, tako, da povzroči blokado vezave PD-1 na PD-L1 in PD-L2, ki sta izražena na antigen prezentirajočih celicah in sta lahko izražena na tumorskih ali drugih celicah v mikrookolju tumorja.
English: Grade ≥ 3 with creatinine > 3 times ULN
Slovenian: ≥ 3. stopnja s kreatininom > 3-krat nad ZNM
English: Subjects whose tumours express PD-L1 CPS < 10 already enrolled into the pembrolizumab monotherapy arm can continue treatment.
Slovenian: Preiskovanci, pri katerih tumorji izražajo PD-L1 s CPS < 10 in so že vključeni v skupino z monoterapijo s pembrolizumabom, lahko nadaljujejo z zdravljenjem.
English: Patients with active infections occurring during treatment with pembrolizumab were managed with appropriate medical therapy.
Slovenian: Bolniki, pri katerih so se aktivne okužbe pojavile med zdravljenjem s pembrolizumabom, so prejemali ustrezno zdravljenje.
English: The most serious adverse reactions were immune-related adverse reactions and severe infusion-related reactions (see section 4.4).
Slovenian: Najresnejši neželeni učinki so bili imunsko pogojeni neželeni učinki in hude z infuzijo povezane reakcije (glejte poglavje 4.4).
English: NR (1.5+, 38.9+)
Slovenian: ND (1,5+; 38,9+)
English: Do not drive or use machines after you have been given KEYTRUDA unless you are sure you are feeling well.
Slovenian: Potem, ko prejmete zdravilo KEYTRUDA, ne upravljajte vozil ali strojev, če niste povsem prepričani, da se dobro počutite.
English: Based on best response of stable disease or better Based on Kaplan-Meier estimates; includes 84 patients with response of 6 months or longer
Slovenian: Na podlagi najboljšega odgovora "stabilna bolezen" ali boljšega Na podlagi Kaplan-Meierjevih ocen; vključuje 84 bolnikov, ki so imeli odgovor 6 mesecev ali več
English: The efficacy of pembrolizumab was investigated in KEYNOTE-087 and KEYNOTE-013, two multicentre, open-label studies for the treatment of 241 patients with cHL.
Slovenian: Učinkovitost pembrolizumaba so raziskali v študijah KEYNOTE-087 in KEYNOTE-013, ki sta bili multicentrični, odprti študiji zdravljenja 241 bolnikov s cHL.
English: Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies.
Slovenian: V primeru imunsko pogojenih endokrinopatij bo morda potrebno dolgotrajno hormonsko nadomestno zdravljenje.
English: Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%).
Slovenian: Značilnosti bolezni so bile: ploščatocelična (18 %) in neploščatocelična (82 %), M1 (99 %) in metastaze v možganih (9 %).
English: Table 29 summarises the efficacy measures by IMDC risk category from the pre-specified interim analysis.
Slovenian: Preglednica 29 povzema ključna merila učinkovitosti po kategoriji tveganja IMDC iz vnaprej določene vmesne analize.
English: Sixty-five percent of patients had M1c stage, 9% had a history of brain metastases, 66% had no and 34% had one prior therapy.
Slovenian: Petinšestdeset odstotkov bolnikov je imelo M1c stadij, 9 % jih je imelo v anamnezi metastaze v možganih, 66 % jih predhodno ni prejemalo zdravljenja, 34 % pa jih je predhodno prejemalo eno zdravljenje.
English: Overall, 20 cHL patients ≥ 65 years were treated with pembrolizumab in studies KEYNOTE-087 and KEYNOTE-013.
Slovenian: Skupno 20 bolnikov s cHL, starih 65 let ali več, je bilo zdravljenih s pembrolizumabom v študijah KEYNOTE-087 in KEYNOTE-013.
English: • a kind of cancer called classical Hodgkin lymphoma
Slovenian: • vrste raka, imenovane klasični Hodgkinov limfom,
English: Pembrolizumab was administered prior to chemotherapy on Day 1.
Slovenian: Pembrolizumab je bil 1. dan uporabljen pred kemoterapijo.
English: Among patients who were evaluable for PD-L1 expression (79%), 69% (n=294) were PD-L1 positive and 31% (n=134) were PD-L1 negative.
Slovenian: Med bolniki, ki jih je bilo mogoče oceniti glede izraženosti PD-L1 (79 %), je bilo 69 % (n = 294) PD-L1 pozitivnih in 31 % (n = 134) PD-L1 negativnih.
English: The prescriber must discuss the risks of KEYTRUDA therapy with the patient.
Slovenian: Predpisovalec zdravila se mora o tveganjih, povezanih z zdravljenjem z zdravilom KEYTRUDA, pogovoriti z bolnikom.
English: You may experience more than one side effect at the same time.
Slovenian: Hkrati se vam lahko pojavi več neželenih učinkov.
English: In the Hodgkin lymphoma population, the ORR was 50.0%, 2 patients (11.1%) had a complete response and 7 patients (38.9%) had a partial response.
Slovenian: V populaciji s Hodgkinovim limfomom je bil ORR 50,0 %, pri 2 bolnikih (11,1 %) je prišlo do popolnega odgovora in pri 7 bolnikih (38,9 %) do delnega odgovora.
English: In this patient population, the median observation time was 7.3 months (range: 1 day to 31 months) and the most frequent adverse reactions with pembrolizumab were fatigue (32%), nausea (20%), and diarrhoea (20%).
Slovenian: V tej populaciji bolnikov je mediani čas opazovanja znašal 7,3 mesece (v razponu od 1 dneva do 31 mesecev), najpogostejši neželeni učinki zdravljenja s pembrolizumabom pa so bili utrujenost (32 %), navzea (20 %) in diareja (20 %).