natgillin/translations-raw huggingface dataset:
A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were BRAF wild type (n=525; 63%), BRAF mutant without prior BRAF treatment (n=163; 20%) and BRAF mutant with prior BRAF treatment (n=139; 17%) as summarised in Table 7. 
V okviru končne analize v študiji KEYNOTE-006 je bila opravljena analiza podskupin bolnikov z divjim tipom BRAF (n = 525; 63 %), z mutacijo BRAF in brez predhodnega zdravljenja BRAF (n = 163; 20 %) ter z mutacijo BRAF in predhodnim zdravljenjem BRAF (n = 139; 17 %), kot je povzeto v preglednici 7.
OS rate at 24 months 
delež celokupnega preživetja po 24 mesecih
For storage conditions after dilution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po razredčenju zdravila glejte poglavje 6.3.
The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 17.7 months). 
Mediani čas do pojava adrenalne insuficience je bil 5,4 meseca (v razponu od 1 dneva do 17,7 meseca).
Table 11: Efficacy results by PD-L1 expression and BRAF mutation status in KEYNOTE-054 
Preglednica 11: Rezultati učinkovitosti glede na izraženost PD-L1 in status mutacij BRAF v študiji KEYNOTE-054
Based on the severity of the adverse reaction, pembrolizumab should be withheld or permanently discontinued, and corticosteroids should be administered (see section 4.2). 
Glede na izrazitost neželenega učinka je treba zadržati uporabo pembrolizumaba oziroma jo trajno ukiniti in uporabiti kortikosteroide (glejte poglavje 4.2).
* BICR using RECIST 1.1 
* BICR z uporabo RECIST 1.1
Pneumonitis led to discontinuation of pembrolizumab in 98 (1.7%) patients. 
Pnevmonitis je bil razlog za ukinitev zdravljenja s pembrolizumabom pri 98 bolnikih (1,7 %).
Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=344) or 10 mg/kg (n=346) every 3 weeks or docetaxel at a dose of 75 mg/m2 every 3 weeks (n=343) until disease progression or unacceptable toxicity. 
Bolnike so randomizirali (v razmerju 1:1:1) na zdravljenje s pembrolizumabom v odmerku 2 (n = 344) ali 10 mg/kg (n = 346) na 3 tedne ali z docetakselom v odmerku 75 mg/m2 na 3 tedne (n = 343) do napredovanja bolezni ali nesprejemljivih toksičnih sopojavov.
Rare toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema nodosum hair colour changes, lichenoid keratosis, papule 
Stevens-Johnsonov sindrom, nodozni eritem spremembe barve las/dlak, lihenoidna keratoza, papule
patches of skin that have lost colour - inflammation of the sheath that surrounds tendons - increased level of amylase, an enzyme that breaks down starch; increased bilirubin in the blood 
razbarvane lise na koži - vnetje ovojnice, ki obdaja kite - zvišanje vrednosti amilaze (encima, ki razgrajuje škrob), zvišanje bilirubina v krvi
The safety and efficacy of pembrolizumab were investigated in KEYNOTE-040, a multicentre, openlabel, randomised, controlled study for the treatment of histologically confirmed recurrent or metastatic HNSCC of the oral cavity, pharynx or larynx in patients who had disease progression on or after platinum-containing chemotherapy administered for recurrent or metastatic HNSCC or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy, and were not amenable to local therapy with curative intent. 
Varnost in učinkovitost pembrolizumaba so preučevali v študiji KEYNOTE-040, multicentrični, odprti, randomizirani, nadzorovani študiji zdravljenja histološko potrjenega ponovljenega ali metastatskega HNSCC ustne votline, žrela ali grla pri bolnikih, pri katerih je bolezen med zdravljenjem s kemoterapijo, ki je vključevala platino, ali po njem napredovala ali pa je napredovala po zdravljenju s kemoterapijo, ki je vključevala platino, ki je bilo del indukcije, sočasnega ali adjuvantnega zdravljenja, bolniki pa niso bili primerni za lokalno zdravljenje z namenom ozdravitve.
PD-L1 positive 
PD-L1 pozitivni
After careful consideration of the potential increased risk, pembrolizumab may be used with appropriate medical management in these patients. 
Pri takšnih bolnikih je pembrolizumab po skrbni oceni možnega povečanja tveganja za bolnika mogoče uporabiti ob ustreznem zdravstvenem vodenju.
Ocular melanoma 
Očesni melanom
Number at Risk Pembrolizumab + Axitinib: 
število izpostavljenih tveganju pembrolizumab + aksitinib:
The median duration was not reached (range 3 days to 26.2+ months). 
Njegovo mediano trajanje ni bilo doseženo (v razponu od 3 dni do 26,2+ meseca).
Among the 495 patients in KEYNOTE-040, 129 (26%) had tumours that expressed PD-L1 with a TPS ≥ 50% based on the PD-L1 IHC 22C3 pharmDx 
Pri 495 bolnikih v študiji KEYNOTE-040 je 129 bolnikov (26 %) imelo tumorje z izraženostjo PD-L1 s TPS ≥ 50 % na podlagi testa PD-L1, opravljenega z IHC 22C3 pharmDx
Twenty-one percent had received 2 prior systemic regimens in the metastatic setting. 
Enaindvajset odstotkov bolnikov je v okoliščinah z metastazami prejelo 2 predhodni shemi sistemskega zdravljenja.
- Your doctor will give you KEYTRUDA through an infusion into your vein (IV) for about 
- Zdravnik vam bo zdravilo KEYTRUDA dal v veno (i.v.)
Rare immune thrombocytopenic purpura, haemolytic anaemia, pure red cell aplasia, haemophagocytic lymphohistiocytosis eosinophilia 
Redki imunska trombocitopenična purpura, hemolitična anemija, čista aplazija rdečih krvnih celic, hemofagocitna limfohistiocitoza eozinofilija
Caution should be used when considering the use of pembrolizumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immunestimulatory anticancer agents. 
Pri odločitvi glede uporabe pembrolizumaba pri bolnikih, ki so pri predhodnem zdravljenju raka z drugimi zdravili za imunsko stimulacijo imeli hude ali življenjsko nevarne kožne reakcije, je potrebna previdnost.
Chemotherapy n=179 
kemoterapija n = 179
PD-L1 negative 
PD-L1 negativni
KEYTRUDA contains the active substance pembrolizumab, which is a monoclonal antibody. 
Zdravilo KEYTRUDA vsebuje učinkovino pembrolizumab, ki je monoklonsko protitelo.
Number at Risk Pembrolizumab 2 mg/kg: Pembrolizumab 10 mg/kg: Docetaxel: 
vrednost p pembrolizumab 2 mg/kg pembrolizumab 10 mg/kg docetaksel število izpostavljenih tveganju pembrolizumab 2 mg/kg: pembrolizumab 10 mg/kg: docetaksel:
A total of 65 NSCLC patients aged ≥ 75 years were enrolled in study KEYNOTE-407 (34 in the pembrolizumab combination and 31 in the control). 
Skupno je bilo v študijo KEYNOTE-407 vključenih 65 bolnikov z NSCLC, starih ≥ 75 let (34 bolnikov v skupino kombiniranega zdravljenja s pembrolizumabom in 31 bolnikov v kontrolno skupino).
Table 28: Efficacy Results in KEYNOTE-426 
Preglednica 28: Rezultati učinkovitosti v študiji KEYNOTE-426
Pregnancy - You must not use KEYTRUDA if you are pregnant unless your doctor specifically recommends it. - If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. 
- Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
• Equilibrate the vial to room temperature (at or below 25°C). 
• Pustite, da se viala ogreje na sobno temperaturo (25 °C ali manj).
Steady-state concentrations of pembrolizumab were reached by 16 weeks of repeated dosing with an every 3 week regimen and the systemic accumulation was 2.1-fold. 
Pri režimu ponavljajočega se odmerjanja na vsake 3 tedne so bile koncentracije pembrolizumaba v stanju dinamičnega ravnovesja dosežene v 16. tednu, pri čemer je bilo opaženo 2,1-kratno sistemsko kopičenje.
Table 17: Response to pembrolizumab 2 or 10 mg/kg every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010 
Preglednica 17: Odgovor na pembrolizumab v odmerku 2 ali 10 mg/kg na 3 tedne pri predhodno zdravljenih bolnikih z NSCLC v študiji KEYNOTE-010
PD L1 positive 
PD L1 pozitivni
This 96 hour total hold from reconstitution may include up to 6 hours at room temperature (at or below 25°C). 
V celotnih 96 urah od priprave je lahko zdravilo do 6 ur na sobni temperaturi (25 °C ali manj).
The median time to onset of ALT increased was 2.3 months (range: 7 days to 19.8 months). 
Mediani čas do zvišanja vrednosti ALT je bil 2,3 meseca (v razponu od 7 dni do 19,8 meseca).
• KEYTRUDA 200 mg every 3 weeks 
• zdravilo KEYTRUDA 200 mg na 3 tedne
Table 8 summarises efficacy results by PD-L1 expression. 
Preglednica 8 povzema rezultate učinkovitosti glede na izraženost PD-L1.
Nervous system disorders Very common headache dizziness, headache, neuropathy peripheral, dysgeusia headache, dysgeusia 
Bolezni živčevja Zelo pogosti glavobol omotica, glavobol, periferna nevropatija, disgevzija glavobol, disgevzija
Forty-five percent had an ECOG Performance Status of 1, 40% had elevated LDH and 23% had a BRAF mutated tumour. 
Petinštirideset odstotkov bolnikov je imelo oceno zmogljivosti 1 po ECOG lestvici, 40 % jih je imelo zvišan LDH in 23 % jih je imelo tumor z mutacijo BRAF.
Patients were randomised (1:1:1) to receive pembrolizumab 10 mg/kg every 2 (n=279) or 3 weeks (n=277) or ipilimumab 3 mg/kg every 3 weeks (n=278). 
Bolnike so randomizirali (v razmerju 1:1:1) na zdravljenje s pembrolizumabom v odmerku 10 mg/kg na 2 tedna (n = 279) ali na 3 tedne (n = 277) ali na zdravljenje z ipilimumabom v odmerku 3 mg/kg na 3 tedne (n = 278).
The median time to onset of pneumonitis was 3.3 months (range 2 days to 26.8 months). 
Mediani čas do pojava pnevmonitisa je bil 3,3 meseca (v razponu od 2 dni do 26,8 meseca).
What KEYTRUDA contains The active substance is pembrolizumab. 
Kaj vsebuje zdravilo KEYTRUDA Učinkovina je pembrolizumab.
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. 
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za zdravljenje lokalno napredovalega ali metastatskega NSCLC pri odraslih, ki imajo tumorje z ≥ 1 % izraženostjo PD-L1 (TPS) in so bili predhodno zdravljeni z vsaj eno shemo kemoterapije.
Adverse reactions observed in clinical studies of pembrolizumab as monotherapy or in combination with chemotherapy or other anti-tumour medicines or reported from post-marketing use of pembrolizumab are listed in Table 2. 
V preglednici 2 so navedeni neželeni učinki, ki so jih opazili v kliničnih študijah samostojnega zdravljenja s pembrolizumabom ali zdravljenja v kombinaciji s kemoterapijo ali drugimi protitumorskimi zdravili ali o katerih so poročali v obdobju trženja pembrolizumaba.
12.7 (11.5, NA) 
12,7 (11,5; NP)
Placebo + Pemetrexed + Platinum Chemotherapy n=206 
placebo + pemetreksed + kemoterapija na osnovi platine n = 206
The study population characteristics were: median age of 62 years (range: 26 to 90); 38% age 65 or older; 73% male; 79% White and 16% Asian; 80% had a Karnofsky Performance Score (KPS) 90-100 and 20% had KPS 70-80; patient distribution by IMDC risk categories was 31% favourable, 56% intermediate and 13% poor. 
Značilnosti študijske populacije so bile: mediana starost 62 let (v razponu od 26 do 90), 38 % starih 65 let ali več, 73 % moških, 79 % belcev in 16 % Azijcev, 80 % s stanjem zmogljivosti po Karnofskem (KPS - Karnofsky Performance Score) 90-100 ter 20 % s KPS 70-80 in porazdelitev po kategorijah tveganja IMDC 31 % ugodna, 56 % srednja in 13 % slaba.
Uncommon adrenal insufficiency hypophysitis d, thyroiditis hypophysitis d, 
Občasni adrenalna insuficienca hipofizitis d, tiroiditis hipofizitis d, tiroiditis e, adrenalna insuficienca
Table 9 summarizes efficacy results by PD-L1 expression. 
Preglednica 9 povzema rezultate učinkovitosti glede na izraženost PD-L1.
Discard the vial if visible particles are observed. 
Če opazite vidne delce, vialo zavrzite.
Severe skin reactions led to discontinuation of pembrolizumab in 9 (0.2%) patients. 
Hude kožne reakcije so bile razlog za ukinitev zdravljenja s pembrolizumabom pri 9 bolnikih (0,2 %).
Pembrolizumab Carboplatin Paclitaxel/Nab-paclitaxel n=278 
opazovani dogodek pembrolizumab karboplatin paklitaksel/nab-paklitaksel n = 278
Pembrolizumab CL is approximately 23% lower (geometric mean, 195 mL/day [CV%: 40%]) after achieving maximal change at steady-state compared with the first dose (252 mL/day [CV%: 37%]); this decrease in CL with time is not considered clinically meaningful. 
Po doseženi največji spremembi v stanju dinamičnega ravnovesja je očistek pembrolizumaba približno 23 % manjši (geometrijska srednja vrednost 195 ml/dan [KV %: 40 %]) v primerjavi s prvim odmerkom (252 ml/dan [KV %: 37 %]).
The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 22.5 months). 
Mediani čas do pojava hipertiroidizma je bil 1,4 meseca (v razponu od 1 dneva do 22,5 meseca).
For use in combination, see the SmPC for the concomitant therapies. 
Za uporabo v kombinaciji glejte povzetke glavnih značilnosti sočasno uporabljenih zdravil.
The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively. 
Izhodiščne značilnosti te populacije so bile: mediana starost 63 let (42 % starih 65 let ali več), 61 % moških, 72 % belcev in 21 % Azijcev ter 34 % z oceno zmogljivosti 0 in 66 % z oceno zmogljivosti 1 po ECOG lestvici.
• a kind of head and neck cancer called head and neck squamous cell carcinoma. 
• vrste raka glave in vratu, imenovanega ploščatocelični rak glave in vratu,
Adrenal insufficiency led to discontinuation of pembrolizumab in 4 (0.1%) patients. 
Adrenalna insuficienca je bila razlog za ukinitev zdravljenja s pembrolizumabom pri 4 bolnikih (0,1 %).
Eye disorders Common dry eye dry eye dry eye 
Očesne bolezni Pogosti suho oko suho oko suho oko
KEYTRUDA, or if corticosteroid dosing cannot be reduced to ≤ 10 mg prednisone or equivalent per day within 12 weeks, KEYTRUDA should be permanently discontinued. 
* Če se z zdravljenjem povezani toksični učinek v 12 tednih po zadnjem odmerku zdravila KEYTRUDA ne zmanjša na stopnjo 0-1, ali če odmerjanja kortikosteroidov v 12 tednih ni mogoče zmanjšati na ≤ 10 mg prednizona ali ekvivalenta na dan, je treba zdravilo KEYTRUDA trajno ukiniti.
Sixty-three percent had M1c stage and 2% of patients had a history of brain metastases. 
Triinšestdeset odstotkov je imelo M1c stadij in 2 % bolnikov sta imela v anamnezi metastaze v možganih.
Data for the following immune-related adverse reactions are based on patients who received pembrolizumab across four doses (2 mg/kg every 3 weeks, 10 mg/kg every 2 or 3 weeks, or 200 mg every 3 weeks) in clinical studies (see section 5.1). 
Podatki za spodaj opisane imunsko pogojene neželene učinke so pridobljeni pri bolnikih, ki so v kliničnih študijah prejemali pembrolizumab po štirih različnih shemah odmerjanja (2 mg/kg na 3 tedne, 10 mg/kg na 2 ali 3 tedne ali 200 mg na 3 tedne) (glejte poglavje 5.1).
There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development. 
V primeru nastanka vežočih ali nevtralizirajočih protiteles proti pembrolizumabu niso ugotovili spremenjenega farmakokinetičnega ali varnostnega profila.
Complete response % Partial response % 23% Response duration Median in months (range) 
popolni odgovor % delni odgovor % 23 % trajanje odgovora mediana v mesecih (razpon)
Based on patients with a confirmed response by independent review, starting from the date the response was first recorded; n=23 for patients previously treated with ipilimumab; n=18 for patients naïve to treatment with ipilimumab Based on Kaplan-Meier estimation 
Na podlagi najboljšega odgovora "stabilna bolezen" ali boljše Pri bolnikih, ki so imeli po neodvisni presoji potrjen odgovor, za začetek le-tega se upošteva datum, ko je bil odgovor prvič zabeležen; n = 23 za bolnike, predhodno zdravljene z ipilimumabom, in n = 18 za bolnike, ki predhodno niso bili zdravljeni z ipilimumabom
When pembrolizumab is given with axitinib, higher than expected frequencies of Grades 3 and 4 ALT and AST elevations have been reported in patients with advanced RCC (see section 4.8). 
Če je bil pembrolizumab uporabljen z aksitinibom, so pri bolnikih z napredovalim rakom ledvičnih celic poročali o pogostejših zvišanjih vrednosti ALT in AST 3. in 4. stopnje od pričakovanega (glejte poglavje 4.8).
The safety of pembrolizumab in combination with chemotherapy has been evaluated in 1,067 patients with NSCLC or HNSCC receiving 200 mg, 2 mg/kg or 10 mg/kg pembrolizumab every 3 weeks, in clinical studies. 
Varnost pembrolizumaba pri kombiniranem zdravljenju s kemoterapijo so ocenili pri 1.067 bolnikih z NSCLC ali HNSCC, ki so v kliničnih študijah prejemali pembrolizumab v odmerkih 200 mg, 2 mg/kg ali 10 mg/kg na vsake 3 tedne.
The median time to onset of hepatitis was 3.6 months (range 8 days to 21.4 months). 
Mediani čas do pojava hepatitisa je bil 3,6 meseca (v razponu od 8 dni do 21,4 meseca).
Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy. 
Bolnikom, ki so prejemali placebo in kemoterapijo, pri katerih je bolezen po neodvisni presoji napredovala, je bilo ponujeno samostojno zdravljenje s pembrolizumabom.
RFS Hazard ratio* (95% CI) RFS rate at 6 months 
RFS razmerje ogroženosti* (95 % IZ) delež RFS po 6 mesecih
The median time to onset of nephritis was 5.0 months (range 12 days to 21.4 months). 
Mediani čas do pojava nefritisa je bil 5,0 meseca (v razponu od 12 dni do 21,4 meseca).
Standard Treatment* n=133 
standardno zdravljenje* n = 133
Patients were randomised (1:1) to receive either KEYTRUDA 200 mg every 3 weeks (n=270) or investigator's choice of any of the following chemotherapy regimens all given intravenously every 3 weeks (n=272): paclitaxel 175 mg/m 
Bolnike so randomizirali (v razmerju 1:1) na zdravljenje bodisi z 200 mg zdravila KEYTRUDA na 3 tedne (n = 270) ali (po raziskovalčevi izbiri) z eno od naslednjih shem kemoterapije, ki so bile vse uporabljene intravensko na 3 tedne (n = 272): paklitaksel 175 mg/m (n = 84), docetaksel 75 mg/m
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. 
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za prvo linijo zdravljenja metastatskega nedrobnoceličnega pljučnega raka (NSCLC - non-small cell lung carcinoma) pri odraslih, ki imajo tumorje z ≥ 50 % izraženostjo PD-L1 (TPS - tumour proportion score) in brez pozitivnih tumorskih mutacij EGFR ali ALK.
Kaplan Meier curves for OS based on the final analysis are shown in Figures 13 and 14. 
Kaplan-Meierjeve krivulje celokupnega preživetja na podlagi končne analize so prikazane na slikah 13 in 14.
The efficacy of pembrolizumab was evaluated in KEYNOTE-054, a multicentre, randomised, doubleblind, placebo-controlled trial in patients with completely resected stage IIIA (> 1 mm lymph node metastasis), IIIB or IIIC melanoma. 
To je bilo multicentrično, randomizirano, dvojno slepo, s placebom nadzorovano preskušanje pri bolnikih s popolnoma kirurško odstranjenim melanomom v stadiju IIIA (> 1 mm metastaze v bezgavkah), IIIB ali IIIC.
Uncommon amylase increased blood bilirubin increased, amylase increased amylase increased 
Občasni zvišana amilaza zvišan bilirubin v krvi, zvišana amilaza zvišana amilaza
The primary efficacy outcome measures were investigator-assessed recurrence-free survival (RFS) in the whole population and in the population with PD-L1 positive tumours, where RFS was defined as the time between the date of randomisation and the date of first recurrence (local, regional, or distant metastasis) or death, whichever occurs first. 
RFS je bilo opredeljeno kot čas med datumom randomizacije in datumom prve ponovitve (lokalno, regionalno ali oddaljene metastaze) ali nastopa smrti, kar koli se je zgodilo prej.
Table 15: Efficacy Results in KEYNOTE-407 
Preglednica 15: Rezultati učinkovitosti v študiji KEYNOTE-407
In patients with non-squamous NSCLC treated with pembrolizumab in combination with pemetrexed and platinum chemotherapy (n=488), the incidence of nephritis was 1.4% (all Grades) with 0.8% Grade 3 and 0.4% Grade 4. 
Pri bolnikih z neploščatoceličnim NSCLC, ki so se zdravili s pembrolizumabom v kombinaciji s pemetreksedom in kemoterapijo na osnovi platine (n = 488), je pojavnost nefritisa znašala 1,4 % (vse stopnje).
Uncommon tenosynovitis tenosynovitis 
Občasni tendosinovitis tendosinovitis
*Based on the stratified Cox proportional hazard model 
*Na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti
Guillain-Barré syndrome g, 
Guillain-Barréjev sindrom g, miastenični sindrom h, meningitis (aseptični)
Based on the stratified Cox proportional hazard model Based on stratified log-rank test 
Na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti Na podlagi stratificiranega log-rank testa
Psychiatric disorders Common insomnia insomnia insomnia 
Psihiatrične motnje Pogosti nespečnost nespečnost nespečnost
The median time to onset of hypothyroidism was 3.5 months (range 1 day to 19.6 months). 
Mediani čas do pojava hipotiroidizma je bil 3,5 meseca (v razponu od 1 dneva do 19,6 meseca).
Favourable 
ugodna
Figure 10: Kaplan-Meier Curve for Progression-Free Survival in KEYNOTE-407 
Slika 10: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni v študiji KEYNOTE-407
It is unknown whether pembrolizumab is secreted in human milk. 
Ni znano, ali se pembrolizumab izloča v materino mleko.
Patients with the following conditions were excluded from clinical trials: active CNS metastases; ECOG PS ≥ 2 (except for urothelial carcinoma and RCC); HIV, hepatitis B or hepatitis C infection; active systemic autoimmune disease; interstitial lung disease; prior pneumonitis requiring systemic corticosteroid therapy; a history of severe hypersensitivity to another monoclonal antibody; receiving immunosuppressive therapy and a history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for greater than 12 weeks. 
Bolniki, ki niso bili vključeni v klinična preskušanja V klinična preskušanja niso bili vključeni bolniki z: aktivnimi metastazami v osrednjem živčevju, oceno zmogljivosti ≥ 2 po ECOG lestvici (razen pri urotelijskem raku in raku ledvičnih celic), okužbo s HIV, hepatitisom B ali hepatitisom C, aktivno sistemsko avtoimunsko boleznijo, intersticijsko boleznijo pljuč, predhodnim pnevmonitisom, ki je zahteval sistemsko zdravljenje s kortikosteroidi, anamnezo hude preobčutljivosti za drugo monoklonsko protitelo, ki se zdravijo z imunosupresivi in z anamnezo hudih imunsko pogojenih neželenih učinkov med zdravljenjem z ipilimumabom, opredeljenih kot toksičnost 4. ali 3. stopnje, ki je zahtevala več kot 12 tedensko zdravljenje s kortikosteroidi (> 10 mg/dan prednizona ali ekvivalenta).
The recommended dose of KEYTRUDA as monotherapy is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. 
Priporočeni odmerek zdravila KEYTRUDA za samostojno zdravljenje je bodisi 200 mg na 3 tedne ali 400 mg na 6 tednov, apliciran z intravensko infuzijo v 30 minutah.
The median follow-up time was 12.8 months (range: 0.1 to 21.5 months). 
Mediani čas spremljanja je znašal 12,8 meseca (v razponu od 0,1 do 21,5 meseca).
The diluted solution may be stored for up to 96 hours in a refrigerator (2°C - 8°C). 
Razredčeno raztopino lahko shranjujete v hladilniku (2 °C - 8 °C) do skupno 96 ur.
Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement. 
Za zagotovitev ustreznega nadomeščanja hormonov je treba spremljati delovanje ščitnice in vrednosti hormonov.
Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion: 
Bolnike so randomizirali (v razmerju 1:1) v eno od naslednjih terapevtskih skupin z uporabo intravenskega infundiranja: