natgillin/translations-raw huggingface dataset:
Median follow-up time of 10.1 months Median follow-up time of 52.8 months Assessed by blinded independent central review according to the 2007 revised International Working Group (IWG) criteria by PET CT scans Based on patients (n=145) with a response by independent review Based on patients (n=18) with a response by independent review Based on Kaplan-Meier estimation; includes 31 patients with responses of 6 months or longer Based on Kaplan-Meier estimation; includes 9 patients with responses of 6 months or longer Based on Kaplan-Meier estimation; includes 7 patients with responses of 12 months or longer 
Mediani čas spremljanja 10,1 meseca Mediani čas spremljanja 52,8 meseca Ocenjeno s slepim neodvisnim centralnim pregledom na podlagi revidiranih meril IWG iz leta 2007 na podlagi slikanj PET CT Na podlagi bolnikov (n = 145), pri katerih je bil odgovor ugotovljen z neodvisnim pregledom Na podlagi bolnikov (n = 18), pri katerih je bil odgovor ugotovljen z neodvisnim pregledom Na podlagi Kaplan-Meierjeve ocene; vključuje 31 bolnikov z odgovorom 6 mesecev ali več Na podlagi Kaplan-Meierjeve ocene; vključuje 9 bolnikov z odgovorom 6 mesecev ali več Na podlagi Kaplan-Meierjeve ocene; vključuje 7 bolnikov z odgovorom 12 mesecev ali več
If you have any questions about these medicines, ask your doctor. 
Če imate o teh zdravilih kakršna koli vprašanja, se posvetujte z zdravnikom.
KEYTRUDA must not be administered as an intravenous push or bolus injection. 
Zdravila KEYTRUDA se ne sme aplicirati s hitro infuzijo ali z bolusno injekcijo.
Favourable Intermediate Poor 
ugodna srednja slaba
Randomization was stratified by tumour PD-L1 expression (TPS ≥ 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1). 
Randomizacija je bila stratificirana glede na izraženost PD-L1 na tumorju (TPS ≥ 50 % ali < 50 %), stanje HPV (pozitivno ali negativno) in oceno zmogljivosti po ECOG lestvici (0 v prim.
In clinical studies in patients treated with pembrolizumab 2 mg/kg every three weeks, 200 mg every three weeks, or 10 mg/kg every two or three weeks as monotherapy, 36 (1.8%) of 2,034 evaluable patients tested positive for treatment-emergent antibodies to pembrolizumab, of which 9 (0.4%) patients had neutralising antibodies against pembrolizumab. 
V kliničnih študijah pri bolnikih, zdravljenih s pembrolizumabom v odmerku 2 mg/kg na tri tedne, 200 mg na tri tedne ali 10 mg/kg na dva ali tri tedne v obliki samostojnega zdravljenja, je imelo 36 (1,8 %) od 2.034 ocenljivih bolnikov pozitiven izvid testiranja med zdravljenjem nastalih protiteles proti pembrolizumabu, od katerih je 9 (0,4 %) bolnikov imelo nevtralizirajoča protitelesa proti pembrolizumabu.
For Grade 4 haematological toxicity, only in patients with cHL, KEYTRUDA should be withheld until adverse reactions recover to Grades 0-1. 
V primeru hematoloških toksičnih neželenih učinkov 4. stopnje je treba le pri bolnikih s cHL uporabo zdravila KEYTRUDA zadržati, dokler se neželeni učinki ne zmanjšajo na stopnjo 0-1.
Based on Kaplan-Meier estimates; includes 43 patients with responses of 6 months or longer 
Na podlagi Kaplan-Meierjevih ocen; vključuje 43 bolnikov z odgovorom 6 mesecev ali več
Patients with HNSCC or previously untreated urothelial carcinoma should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1). 
Bolnike s HNSCC ali predhodno nezdravljenim urotelijskim rakom je treba za zdravljenje izbrati na podlagi izraženosti PD-L1, potrjene z validirano preiskavo (glejte poglavje 5.1).
Disease characteristics were squamous (21%) and non-squamous (70%); M1 (91%); stable brain metastases (15%) and the incidence of mutations was EGFR (8%) or ALK (1%). 
Značilnosti bolezni so bile: ploščatocelični (21 %) in neploščatocelični (70 %), M1 (91 %), stabilne metastaze v možganih (15 %) in incidenca mutacij EGFR (8 %) oz. ALK (1 %).
The trial demonstrated a statistically significant improvement in RFS for patients randomised to the pembrolizumab arm compared with placebo at the pre-specified interim analysis. 
Preskušanje je pokazalo statistično pomembno izboljšanje RFS pri bolnikih, randomiziranih v skupino s pembrolizumabom, v primerjavi s placebom, pri vnaprej določeni vmesni analizi.
The study demonstrated statistically significant improvements in OS and ORR for patients randomised to pembrolizumab as compared to chemotherapy. 
Študija je dokazala statistično značilno izboljšanje OS in ORR pri bolnikih, randomiziranih na pembrolizumab, v primerjavi z bolniki, randomiziranimi na kemoterapijo.
For subjects with relapsed or refractory classical Hodgkin lymphoma, clinical data for the use of pembrolizumab in patients ineligible to ASCT due to reasons other than failure to salvage chemotherapy are limited (see section 5.1). 
Pri preiskovancih s ponovljenim ali neodzivnim klasičnim Hodgkinovim limfomom je malo kliničnih podatkov o uporabi pembrolizumaba pri bolnikih, ki za ASCT niso primerni zaradi drugih razlogov kot je neuspeh rešilne (»salvage«) kemoterapije (glejte poglavje 5.1).
The Kaplan-Meier curves for OS and PFS based on an additional four months of follow up are shown in Figures 16 and 17. 
Kaplan-Meierjevi krivulji celokupnega preživetja (OS) in preživetja brez napredovanja bolezni (PFS), ki temeljita na dodatnih štirih mesecih spremljanja, sta prikazani na slikah 16 in 17.
What KEYTRUDA looks like and contents of the pack KEYTRUDA is a white to off-white lyophilised powder. 
Izgled zdravila KEYTRUDA in vsebina pakiranja Zdravilo KEYTRUDA je bel ali skoraj bel liofiliziran prašek.
Table 12 summarizes key efficacy measures for the entire intent to treat (ITT) population. 
Preglednica 12 povzema ključna merila učinkovitosti za celotno populacijo z-namenom-zdravljenja (ITT - intent to treat).
Not reached (22, NA) 
ni doseženo (22, NP)
Patients received pembrolizumab 200 mg every 3 weeks (n=210; KEYNOTE-087) or 10 mg/kg every 2 weeks (n=31; KEYNOTE-013) until unacceptable toxicity or documented disease progression. 
Bolniki so prejemali 200 mg pembrolizumaba na 3 tedne (n = 210; KEYNOTE-087) ali 10 mg/kg na 2 tedna (n = 31, KEYNOTE-013) do pojava nesprejemljivih toksičnih učinkov ali dokumentiranega napredovanja bolezni.
Physicians should consider the delayed onset of pembrolizumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease. 
Zdravniki morajo pred uvedbo zdravljenja s pembrolizumabom pri bolnikih z neugodnimi prognostičnimi dejavniki in/ali agresivnim potekom bolezni upoštevati zapozneli začetek delovanja pembrolizumaba.
Blockade of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss. 
Pokazalo se je, da zaviranje signalizacije PD-L1 v modelih brejosti pri miših okvari toleranco za plod in povzroči večjo izgubo plodov.
Pembrolizumab may be restarted within 12 weeks after last dose of KEYTRUDA if the adverse reaction remains at Grade ≤ 1 and corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day. 
Pembrolizumab se lahko začne znova uporabljati v 12 tednih po zadnjem odmerku zdravila KEYTRUDA, če neželeni učinek ostane na ≤ 1. stopnji in je bil odmerek kortikosteroida zmanjšan na ≤ 10 mg prednizona ali ekvivalenta na dan.
15.9 (13.2, NA) 
15,9 (13,2; NP)
At the time of this analysis, the hazard ratio in the overall population (95% CI) was 0.59 (0.45, 0.78) with 84/432 (19.4%) events in the combination arm and 122/429 (28.4%) events in the sunitinib arm. 
V času te analize je bilo razmerje ogroženosti v celokupni populaciji (95 % IZ) 0,59 (0,45; 0,78) z 84/432 (19,4 %) dogodkov v skupini, ki je prejemala kombinacijo obeh zdravil in 122/429 (28,4 %) dogodkov v skupini, ki je prejemala sunitinib.
BRAF mutant with prior BRAF treatment 
mutacija BRAF s predhodnim zdravljenjem BRAF
Not reached (24, NA) 
ni doseženo (24, NP)
The median duration was 2.6 months (range 6 days to 12.0 months). 
Njegovo mediano trajanje je bilo 2,6 meseca (v razponu od 6 dni do 12,0 meseca).
Efficacy results were similar for the 2 mg/kg and 10 mg/kg pembrolizumab arms. 
Rezultati učinkovitosti so bili v skupini z 2 mg/kg in skupini z 10 mg/kg pembrolizumaba podobni.
• pembrolizumab 200 mg intravenously every 3 weeks in combination with axitinib 5 mg orally, twice daily. 
• pembrolizumab v odmerku 200 mg intravensko na 3 tedne v kombinaciji z aksitinibom v odmerku 5 mg peroralno dvakrat na dan.
The initial analysis resulted in a HR for OS of 0.82 (95% CI: 0.67, 1.01) with a one-sided p-value of 0.0316. 
Pri začetni analizi je razmerje ogroženosti (HR) za celokupno preživetje (OS) znašalo 0,82 (95 % IZ: 0,67; 1,01) z enostransko vrednostjo p 0,0316.
Fifteen percent of patients had disease progression following prior platinumcontaining neoadjuvant or adjuvant chemotherapy. 
Petnajstim odstotkom bolnikov je bolezen napredovala po predhodni neoadjuvantni ali adjuvantni kemoterapiji, ki je vključevala platino.
A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were PD-L1 positive (n=671; 80%) vs. PD-L1 negative (n=150; 18%). 
V okviru končne analize v študiji KEYNOTE-006 je bila opravljena analiza podskupin bolnikov, ki so bili PD-L1 pozitivni (n = 671; 80 %), in PD-L1 negativni (n = 150; 18 %).
12-month OS rate 
12-mesečni delež OS
A prolonged time to deterioration in EORTC QLQ-C30 global health status/QoL was observed for patients treated with pembrolizumab compared to investigator's choice chemotherapy (HR 0.70; 95% CI 0.55-0.90). 
Čas do poslabšanja celotnega zdravstvenega stanja/kakovosti življenja po EORTC QLQ-C30 je bil pri bolnikih, zdravljenih s pembrolizumabom, daljši kot pri bolnikih, ki so prejemali kemoterapijo po raziskovalčevi izbiri (razmerje ogroženosti 0,70; 95 % IZ 0,55-0,90).
Table 5 summarises key efficacy measures in patients previously treated or naïve to treatment with ipilimumab, receiving pembrolizumab at a dose of 2 mg/kg based on a minimum follow-up time of 30 months for all patients. 
Preglednica 5 povzema ključna merila učinkovitosti pri bolnikih, predhodno zdravljenih ali še nezdravljenih z ipilimumabom, ki so prejemali pembrolizumab v odmerku 2 mg/kg, na podlagi vsaj 30 mesečnega časa spremljanja pri vseh bolnikih.
The trial demonstrated a statistically significant improvement in OS for all patients randomised to pembrolizumab in combination with chemotherapy compared to standard treatment (HR 0.72; 95% CI 0.60-0.87) and in patients whose tumours expressed PD-L1 CPS ≥ 1 randomised to pembrolizumab monotherapy compared to standard treatment. 
Preskušanje je pokazalo statistično značilno izboljšanje celokupnega preživetja pri vseh bolnikih, randomiziranih na pembrolizumab v kombinaciji s kemoterapijo v primerjavi s standardnim zdravljenjem (HR 0,72; 95 % IZ 0,60 - 0,87), in pri bolnikih, ki so imeli izražen PD-L1 s CPS ≥ 1, randomiziranih na samostojno zdravljenje s pembrolizumabom v primerjavi s standardnim zdravljenjem.
Patients with clinically significant renal (creatinine > 1.5 x ULN) or hepatic (bilirubin > 1.5 x ULN, ALT, AST > 2.5 x ULN in the absence of liver metastases) abnormalities at baseline were excluded from clinical trials, therefore information is limited in patients with severe renal and moderate to severe hepatic impairment. 
Bolniki s klinično pomembnimi motnjami ledvic (kreatinin > 1,5 x ZNM) ali motnjami jeter (bilirubin > 1,5 x ZNM, ALT, AST > 2,5 x ZNM brez prisotnosti metastaz v jetrih) že v izhodišču niso bili vključeni v klinična preskušanja, zato je podatkov pri bolnikih s hudo okvaro ledvic in zmerno do hudo okvaro jeter malo.
Infections and infestations Common pneumonia pneumonia pneumonia 
Infekcijske in parazitske bolezni Pogosti pljučnica pljučnica pljučnica
Corticosteroids may also be given to you before receiving KEYTRUDA in combination with chemotherapy to prevent and/or treat nausea, vomiting, and other side effects caused by chemotherapy. 
Morda vam bodo kortikosteroide predpisali tudi pred uporabo zdravila KEYTRUDA v kombinaciji s kemoterapijo, da bi preprečili in/ali zdravili občutek siljenja na bruhanje (navzeje), bruhanje in druge neželene učinke, ki jih povzroča kemoterapija.
Insulin should be administered for type 1 diabetes, and pembrolizumab should be withheld in cases of Grade 3 hyperglycaemia until metabolic control is achieved (see section 4.2). 
Za sladkorno bolezen tipa 1 je treba uporabiti insulin in uporabo pembrolizumaba v primeru hiperglikemije 3. stopnje zadržati, dokler ni dosežena presnovna urejenost (glejte poglavje 4.2).
Based on Kaplan-Meier estimates; includes 16 patients with responses of 6 months or longer 
Na podlagi Kaplan-Meierjevih ocen; vključuje 16 bolnikov z odgovorom 6 mesecev ali več
Common influenza like illness, chills chills, influenza-like illness oedema aa 
Pogosti gripi podobna bolezen, mrzlica mrzlica, gripi podobna bolezen edem aa
Before you get KEYTRUDA, tell your doctor if you: - have an autoimmune disease (a condition where the body attacks its own cells) - have pneumonia or inflammation of your lungs (called pneumonitis) - were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine - had an allergic reaction to other monoclonal antibody therapies - have or have had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV) - have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) - have liver damage - have kidney damage - have had a solid organ transplant or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic) 
Preden prejmete zdravilo KEYTRUDA, zdravniku povejte: - če imate avtoimunsko bolezen (bolezen, pri kateri telo napada lastne celice), - če imate pljučnico ali vnetje pljuč (imenovano pnevmonitis), - če ste predhodno prejemali ipilimumab, tj. drugo zdravilo za zdravljenje melanoma, ki je pri vas povzročilo resne neželene učinke, - če ste imeli alergijsko reakcijo med zdravljenjem z drugimi monoklonskimi protitelesi, - če imate ali ste imeli kronično virusno okužbo jeter, vključno s hepatitisom B (HBV) ali hepatitisom C (HCV), - če ste okuženi z virusom humane imunske pomanjkljivosti (HIV) ali imate AIDS (sindrom pridobljene imunske pomanjkljivosti), - če imate okvaro jeter, - če imate okvaro ledvic, - če imate presadek čvrstega organa ali presadek kostnega mozga (matičnih celic) z uporabo donorskih matičnih celic (alogenska presaditev).
When you get KEYTRUDA, you can have some serious side effects. 
Ko prejmete zdravilo KEYTRUDA, se vam lahko pojavijo nekateri resni neželeni učinki.
• Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. 
• Parenteralna zdravila je treba pred uporabo pregledati glede prisotnosti delcev in spremembe barve.
Among patients with BRAF mutant tumours, 10 (50%) were previously treated with a BRAF inhibitor. 
Med bolniki, ki so imeli tumorje z mutacijo BRAF, jih je bilo 10 (50 %) predhodno zdravljenih z zaviralcem BRAF.
In this patient population, the most frequent adverse reactions were anaemia (50%), nausea (50%), fatigue (37%), constipation (35%), diarrhoea (30%), neutropaenia (30%), decreased appetite (28%) and vomiting (25%). 
V tej populaciji bolnikov so bili najpogostejši neželeni učinki naslednji: anemija (50 %), navzea (50 %), utrujenost (37 %), zaprtost (35 %), diareja (30 %), nevtropenija (30 %), zmanjšanje apetita (28 %) in bruhanje (25 %).
No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. 
Uradnih študij farmakokinetičnega medsebojnega delovanja zdravil s pembrolizumabom niso izvedli.
The median number of prior lines of therapy administered for the treatment of cHL was 4 (range 1 to 12). 
Mediano število predhodnih linij zdravljenja cHL je bilo 4 (v razponu: od 1 do 12).
In case of liver metastasis with baseline Grade 2 elevation of AST or ALT, hepatitis with AST or ALT increases ≥ 50% and lasts ≥ 1 week 
v primeru metastaz v jetrih z zvišanjem AST ali ALT 2. stopnje glede na izhodišče, hepatitisa z zvišano AST ali ALT ≥ 50 %, kar traja ≥ 1 teden trajno ukinite kožne reakcije
Withhold until adverse reactions recover to Grades 0-1* 
zadržite, dokler se neželeni učinki ne zmanjšajo na stopnjo 0-1*
An updated OS analysis was performed when patients had a median follow-up of 16.6 months (range: 0.1 to 26.3 months). 
Posodobljena analiza celokupnega preživetja je bila izvedena, ko je mediani čas spremljanja bolnikov znašal 16,6 meseca (v razponu od 0,1 do 26,3 meseca).
KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults. 
Zdravilo KEYTRUDA je v kombinaciji s karboplatinom in bodisi paklitakselom bodisi nab-paklitakselom indicirano za prvo linijo zdravljenja metastatskega ploščatoceličnega NSCLC pri odraslih.
Table 13 summarises key efficacy measures. 
Preglednica 13 povzema ključna merila učinkovitosti.
Translucent to white proteinaceous particles may be seen in diluted solution. 
V razredčeni raztopini so lahko vidni prosojni do beli beljakovinski delci.
The 23 patients had a median follow-up from subsequent allogeneic HSCT of 5.1 months (range: 0-26.2 months). 
Pri teh 23 bolnikih je spremljanje od naslednje alogenske HSCT trajalo mediano 5,1 meseca (v razponu: od 0 do 26,2 meseca).
Patients in the placebo arm were offered pembrolizumab as a single agent at the time of disease progression. 
Bolnikom v skupini s placebom so v času napredovanja bolezni ponudili pembrolizumab kot samostojno zdravilo.
Response: Best objective response as confirmed complete response or partial response 
Odgovor: najboljši objektivni odgovor, potrjen kot popolni oziroma delni odgovor
Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) 
3. stopnja ali v primeru suma na Stevens-Johnsonov sindrom (SJS) ali toksično epidermalno nekrolizo (TEN)
The median number of prior lines of therapy administered for the treatment of cHL was 5 (range 2 to 15). 
Mediano število predhodnih linij zdravljenja cHL je bilo 5 (v razponu: od 2 do 15).
The pembrolizumab monotherapy arm remains open only to patients whose tumours express PD-L1 with a CPS ≥ 10. 
Skupina z monoterapijo s pembrolizumabom ostaja odprta samo za bolnike, pri katerih tumorji izražajo PD-L1 s CPS ≥ 10.
erythema, dry skin, vitiligo t, eczema, alopecia, dermatitis acneiform severe skin reactions s, 
eritem, suha koža, vitiligo t, ekcem, alopecija, akneiformni dermatitis hude kožne reakcije s,
A total of 57 NSCLC patients aged ≥ 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control). 
Skupno 57 bolnikov z NSCLC, starih ≥ 75 let, je bilo vključenih v študijo KEYNOTE-189 (35 bolnikov v skupino kombiniranega zdravljenja s pembrolizumabom in 22 bolnikov v kontrolno skupino).
Common hypertension hypertension 
Pogosti hipertenzija hipertenzija
Eighty-six percent had a primary tumour in the lower tract and 14% had a primary tumour in the upper tract. 
Šestinosemdeset odstotkov jih je imelo primarni tumor v spodnjem traktu in 14 % v zgornjem traktu.
Patients with ECOG performance status score ≥ 2 were excluded from the clinical trials of melanoma, NSCLC, cHL, and HNSCC (see sections 4.4 and 5.1). 
Ocena zmogljivosti ≥ 2 po ECOG (Eastern Cooperative Oncology Group) lestvici Bolniki z oceno zmogljivosti ≥ 2 po ECOG lestvici so bili izključeni iz kliničnih preskušanj melanoma, NSCLC, cHL in HNSCC (glejte poglavji 4.4 in 5.1).
Breast-feeding - If you are breast-feeding, tell your doctor. 
Dojenje - Če dojite, morate to povedati zdravniku.
Table 15 summarises key efficacy measures. 
Preglednica 15 povzema ključna merila učinkovitosti.
Patients with BRAF V600E mutant melanoma were not required to have received prior BRAF inhibitor therapy. 
Pri bolnikih, ki so imeli melanom z mutacijo BRAF V600E, ni bilo zahtevano predhodno zdravljenje z zaviralcem BRAF.
No dose adjustment is necessary in patients ≥ 65 years (see section 5.1). 
Pri bolnikih, starih ≥ 65 let, odmerka ni treba prilagoditi (glejte poglavje 5.1).
PD-L1 expression was tested retrospectively by immunohistochemistry assay with the 22C3 anti-PD-L1 antibody. 
Testiranje izraženosti PD-L1 je bilo opravljeno retrospektivno z imunohistokemičnim preizkusom s protitelesom 22C3 proti PD-L1.
Patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior to starting treatment. 
Bolniki so morali imeti kirurško odstranjene bezgavke in so se morali zdraviti z obsevanjem, če je bilo le-to indicirano, v 13 tednih pred začetkom zdravljenja.
Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH. 
Enaintrideset odstotkov bolnikov je imelo oceno zmogljivosti po ECOG lestvici 1, 69 % je imelo oceno zmogljivosti po ECOG lestvici 0 in 32 % jih je imelo zvišan LDH.
PD-L1 testing for patients with NSCLC, urothelial carcinoma, or HNSCC Testing for PD-L1 tumour expression using a validated test is recommended for patients with NSCLC. 
Testiranje PD-L1 pri bolnikih z NSCLC, urotelijskim rakom ali HNSCC Pri bolnikih z NSCLC je priporočljivo opraviti testiranje izraženosti PD-L1 tumorja z validirano preiskavo.
All patients with BRAF mutant tumours were previously treated with a BRAF inhibitor. 
Vsi bolniki, ki so imeli tumorje z mutacijo BRAF, so bili predhodno zdravljeni z zaviralcem BRAF.
Seventy percent had at least two and 35% of patients had three or more prior systemic therapies for advanced melanoma. 
Sedemdeset odstotkov bolnikov je predhodno prejelo vsaj dve in 35 % bolnikov tri ali več sistemskih zdravljenj za napredovali melanom.
Common pain in extremity, myositis w, arthritis myositis w, pain in extremity, arthritis myositis w, arthritis x, 
Pogosti bolečine v okončini, miozitis w, artritis miozitis w, bolečine v okončini, artritis miozitis w, artritis x,
Seventy-six percent of patients received prior cisplatin, 23% had prior carboplatin, and 1% was treated with other platinum-based regimens. 
Šestinsedemdeset odstotkov bolnikov je predhodno prejemalo cisplatin, 23 % je predhodno prejemalo karboplatin in 1 % druge sheme na podlagi platine.
A direct comparison of pembrolizumab when used in combination with chemotherapy to pembrolizumab monotherapy is not available. 
Neposredna primerjava pembrolizumaba v kombinaciji s kemoterapijo in samostojnega zdravljenja s pembrolizumabom ni na voljo.
For patients with Grade 3 or Grade 4 hyperthyroidism that improved to Grade 2 or lower, continuation of pembrolizumab may be considered, after corticosteroid taper, if needed (see sections 4.2 and 4.8). 
Pri bolnikih s hipertiroidizmom 3. ali 4. stopnje, ki se izboljša na 2. ali nižjo stopnjo, se po postopnem zmanjševanju odmerka kortikosteroida (če je potrebno) lahko razmisli o nadaljevanju uporabe pembrolizumaba (glejte poglavji 4.2 in 4.8).
In addition, no safety and efficacy data are available in frailer patients (e.g., ECOG performance status 3) considered not eligible for chemotherapy. 
Poleg tega pri bolnikih šibkejšega zdravja (npr. ocena zmogljivosti 3 po ECOG lestvici), ki niso primerni za zdravljenje s kemoterapijo, podatkov o varnosti in učinkovitosti ni na voljo.
Incidences of Grades 3-5 adverse reactions were 76% for pembrolizumab combination therapy and 71% for sunitinib alone. 
Pojavnost neželenih učinkov 3. do 5. stopnje je bila med kombiniranim zdravljenjem s pembrolizumabom 76 % in pri zdravljenju s sunitinibom samim 71 %.
The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution. 
Koncentrat je bistra ali nekoliko opalescentna, brezbarvna do rahlo rumenkasta raztopina.