FrancophonIA/ELRC3.0 huggingface dataset:
English: KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1.
Slovenian: Če v preglednici 1 ni navedeno drugače, je treba zdravilo KEYTRUDA, bodisi kot samostojno bodisi kot kombinirano zdravljenje, trajno ukiniti v primeru imunsko pogojenih neželenih učinkov 4. stopnje ali ponovitve takšnih neželenih učinkov 3. stopnje.
English: Ipilimumab 3 mg/kg every 3 weeks n=278
Slovenian: ipilimumab 3 mg/kg na 3 tedne n = 278
English: An analysis was performed in KEYNOTE-045 in patients who had PD-L1 CPS < 10 [pembrolizumab: n=186 (69%) vs. chemotherapy: n= 176 (65%)] or ≥ 10 [pembrolizumab: n=74 (27%) vs. chemotherapy: n= 90 (33%)] in both pembrolizumab- and chemotherapy-treated arms (see Table 20).
Slovenian: V študiji KEYNOTE-045 je bila narejena analiza pri bolnikih, ki so imeli PD-L1 CPS < 10 [pembrolizumab: n = 186 (69 %), kemoterapija: n = 176 (65 %)] ali ≥ 10 [pembrolizumab: n = 74 (27 %), kemoterapija: n = 90 (33 %)], v obeh skupinah - s pembrolizumabom in s kemoterapijo (glejte preglednico 20).
English: Pembrolizumab Monotherapy n=124
Slovenian: samostojno zdravljenje s pembrolizumabom n = 124
English: Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline.
Slovenian: Pri 616 bolnikih v študiji KEYNOTE-189 so bile izhodiščne značilnosti naslednje: mediana starost 64 let (49 % bolnikov starih 65 let ali starejših), 59 % bolnikov moškega spola, 94 % bolnikov belcev in 3 % bolnikov Azijcev, 43 % bolnikov z oceno zmogljivosti 0 ter 56 % bolnikov z oceno zmogljivosti 1 po ECOG lestvici, 31 % bolnikov PD-L1 negativnih (TPS < 1 %) in 18 % bolnikov z zdravljenimi ali nezdravljenimi metastazami v možganih v izhodišču.
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1).
Slovenian: Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za zdravljenje lokalno napredovalega ali metastatskega urotelijskega raka pri odraslih, predhodno zdravljenih s kemoterapijo, ki je vključevala platino (glejte poglavje 5.1).
English: Table 27: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS ≥ 50% who were previously treated with platinum chemotherapy in KEYNOTE-040
Slovenian: Preglednica 27: Učinkovitost pembrolizumaba v odmerku 200 mg vsake 3 tedne pri bolnikih s HNSCC s TPS ≥ 50 %, ki so se predhodno zdravili s kemoterapijo, ki je vključevala platino, v študiji KEYNOTE-040
English: KEYNOTE-040: Controlled trial in HNSCC patients previously treated with platinum-containing chemotherapy
Slovenian: KEYNOTE-040: kontrolirano preskušanje pri bolnikih s HNSCC, ki so se predhodno zdravili s kemoterapijo, ki je vključevala platino
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede priprave in redčenja zdravila pred dajanjem glejte poglavje 6.6.
English: Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract.
Slovenian: Enainosemdeset odstotkov jih je imelo primarni tumor v spodnjem traktu in 19 % v zgornjem traktu.
English: No dose adjustment is needed for patients with mild hepatic impairment.
Slovenian: Pri bolnikih z blago okvaro jeter prilagoditev odmerka ni potrebna.
English: OS HR (95% CI)
Slovenian: OS HR* (95 % IZ)
English: KEYTRUDA has not been studied in patients with severe renal impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic zdravilo KEYTRUDA ni raziskano (glejte poglavji 4.4 in 5.2).
English: The study excluded patients with autoimmune disease or a medical condition that required immunosuppression.
Slovenian: V študijo niso bili vključeni bolniki z avtoimunsko boleznijo in boleznimi, ki so zahtevale imunosupresijo.
English: EU/1/15/1024/001 (1 vial)
Slovenian: EU/1/15/1024/001 (1 viala)
English: Subgroup analyses by enrollment were performed in KEYNOTE-426 in patients with PD-L1 CPS ≥ 1 [pembrolizumab/axitinib combination: n=243 (56%) vs. sunitinib: n=254 (59%)]; CPS < 1 [pembrolizumab/axitinib combination: n=167 (39%) vs. sunitinib: n=158 (37%)], and in patients with IMDC risk categories of favourable [pembrolizumab/axitinib combination: n=138 (32%) vs. sunitinib: n=131 (31%)]; intermediate [pembrolizumab/axitinib combination: n=238 (55%) vs. sunitinib: n=246 (57%)]; and poor [pembrolizumab/axitinib combination: n=56 (13%) vs. sunitinib: n=52 (12%)].
Slovenian: V študiji KEYNOTE-426 so analize podskupin glede na vključitev izvedli pri bolnikih s PD-L1 CPS ≥ 1 [kombinacija pembrolizumab/aksitinib: n = 243 (56 %) v primerjavi s sunitinibom: n = 254 (59 %)], CPS < 1 [kombinacija pembrolizumab/aksitinib: n = 167 (39 %) v primerjavi s sunitinibom: n = 158 (37 %)] ter pri bolnikih s kategorijo tveganja IMDC ugodna [kombinacija pembrolizumab/aksitinib: n = 138 (32 %) v primerjavi s sunitinibom: n = 131 (31 %)], srednja [kombinacija pembrolizumab/aksitinib: n = 238 (55 %) v primerjavi s sunitinibom: n = 246 (57 %)] in slaba [kombinacija pembrolizumab/aksitinib: n = 56 (13 %) v primerjavi s sunitinibom: n = 52 (12 %)].
English: Patients were treated with pembrolizumab until unacceptable toxicity or disease progression.
Slovenian: Bolnike so s pembrolizumabom zdravili do nesprejemljivih toksičnih učinkov ali napredovanja bolezni.
English: • a kind of lung cancer called non-small cell lung cancer
Slovenian: • vrste pljučnega raka, imenovanega nedrobnocelični pljučni rak,
English: % (95% CI)
Slovenian: % (95 % IZ)
English: Patients were treated with pembrolizumab until disease progression or unacceptable toxicity.
Slovenian: Bolnike so s pembrolizumabom zdravili do napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
English: The median duration was 0.9 months (range 1 day to 8.7+ months).
Slovenian: Njegovo mediano trajanje je bilo 0,9 meseca (v razponu od 1 dneva do 8,7+ meseca).
English: Not reached (NA, NA)
Slovenian: ni dosežena (NP; NP)
English: The primary efficacy outcome was OS in the ITT population.
Slovenian: Primarno merilo izida učinkovitosti je bilo celokupno preživetje (OS) v populaciji z-namenomzdravljenja (ITT - intent to treat).
English: Patients were randomised (2:1) to receive one of the following regimens:
Slovenian: Bolnike so randomizirali (v razmerju 2:1) na zdravljenje z enim od naslednjih režimov zdravljenja:
English: Rare myocarditis myocarditis k, pericarditis
Slovenian: Redki miokarditis miokarditis k,
English: Best Overall Response* by IRO ORR %, (95% CI) Complete response Partial response Disease Control Rate % Response Duration Median in months (range) % ongoing at 24 months PFS Median in months (95% CI) PFS rate at 12 months OS Median in months (95% CI)
Slovenian: najboljši celokupni odgovor* po IRO ORR %, (95 % IZ) popolni odgovor delni odgovor delež nadzora nad boleznijo % trajanje odgovora mediana v mesecih (razpon) % še trajajočih po 24 mesecih preživetje brez napredovanja bolezni (PFS) mediana v mesecih (95 % IZ) delež preživetja brez napredovanja bolezni po 12 mesecih celokupno preživetje (OS) mediana v mesecih (95 % IZ)
English: EU/1/15/1024/002 (1 vial)
Slovenian: EU/1/15/1024/002 (1 viala)
English: Use of pembrolizumab in urothelial carcinoma patients who have received prior platinum-containing chemotherapy
Slovenian: Uporaba pembrolizumaba pri bolnikih z urotelijskim rakom, predhodno zdravljenih s kemoterapijo, ki je vključevala platino
English: Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali pembrolizumab, so poročali o primerih Stevens-Johnsonovega sindroma (SJS) in toksične epidermalne nekrolize (TEN) (glejte poglavje 4.8).
English: * Based on the stratified Cox proportional hazard model Based on stratified log-rank test
Slovenian: * Na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti Na podlagi stratificiranega log-rank testa
English: Hypophysitis resolved in 17 patients, 8 with sequelae.
Slovenian: Izzvenel je pri 17 bolnikih, pri 8 je pustil posledice.
English: • KEYTRUDA 200 mg every 3 weeks, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every
Slovenian: • zdravilo KEYTRUDA 200 mg na 3 tedne, karboplatin z AUC 5 mg/ml/min na 3 tedne ali cisplatin 100 mg/m2 na 3 tedne ter 5-fluorouracil 1.000 mg/m2/dan 4 dni zapored na 3 tedne
English: Use of pembrolizumab for first-line treatment of patients with HNSCC In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see section 4.8).
Slovenian: Uporaba pembrolizumaba za prvo linijo zdravljenja bolnikov s HNSCC Na splošno je bila pri kombiniranem zdravljenju s pembrolizumabom opažena večja pogostnost neželenih učinkov kot pri samostojnem zdravljenju s pembrolizumabom ali pri zdravljenju samo s kemoterapijo, kar odraža vpliv vsake od teh komponent zdravljenja (glejte poglavje 4.8).
English: • Placebo with pemetrexed 500 mg/m 2 and investigator's choice of cisplatin 75 mg/m or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by placebo and pemetrexed 500 mg/m intravenously every 3 weeks (n=206)
Slovenian: • placebo s pemetreksedom v odmerku 500 mg/m 2 in, po izbiri raziskovalca, s cisplatinom v odmerku 75 mg/m ali s karboplatinom (AUC 5 mg/ml/min) intravensko na vsake 3 tedne 4 cikle nato pa s placebom in pemetreksedom v odmerku 500 mg/m 2 intravensko na vsake
English: Table 6: Efficacy results by BRAF mutation status in KEYNOTE-002
Slovenian: Preglednica 6: Rezultati učinkovitosti glede na status mutacij BRAF v študiji KEYNOTE-002
English: Use of pembrolizumab for first-line treatment of patients with NSCLC In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see sections 4.2 and 4.8).
Slovenian: Uporaba pembrolizumaba za prvo linijo zdravljenja bolnikov z NSCLC Na splošno je bila pri kombiniranem zdravljenju s pembrolizumabom opažena večja pogostnost neželenih učinkov kot pri samostojnem zdravljenju s pembrolizumabom ali pri zdravljenju samo s kemoterapijo, kar odraža vpliv vsake od teh komponent zdravljenja (glejte poglavji 4.2 in 4.8).
English: Pneumonitis resolved in 138 patients, 2 with sequelae.
Slovenian: Izzvenel je pri 138 bolnikih, pri 2 je pustil posledice.
English: The median time to onset of hypophysitis was 5.9 months (range 1 day to 17.7 months).
Slovenian: Mediani čas do pojava hipofizitisa je bil 5,9 meseca (v razponu od 1 dneva do 17,7 meseca).
English: Standard Treatment* n=122
Slovenian: standardno zdravljenje* n = 122
English: Grade 4 or recurrent Grade 3
Slovenian: 3. ali 4. stopnja trajno ukinite
English: The primary efficacy outcome measure was ORR as assessed by independent review using RECIST 1.1.
Slovenian: Primarno merilo izida učinkovitosti je bil ORR, ocenjen po neodvisni presoji na podlagi RECIST 1.1.
English: KEYNOTE-052: Open label trial in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy
Slovenian: KEYNOTE-052: odprto preskušanje pri bolnikih z urotelijskim rakom, ki niso primerni za zdravljenje s kemoterapijo, ki vključuje cisplatin
English: Table 7: Efficacy results by BRAF mutation status in KEYNOTE-006
Slovenian: Preglednica 7: Rezultati učinkovitosti glede na status mutacij BRAF v študiji KEYNOTE-006
English: There were no notable effects in the male and female reproductive organs in monkeys based on 1-month and 6-month repeat dose toxicity studies (see section 5.3).
Slovenian: V 1- in 6-mesečnih študijah toksičnosti ponavljajočih se odmerkov pri opicah niso zaznali opaznih učinkov na spolne organe samcev in samic (glejte poglavje 5.3).
English: Table 14: Efficacy results by PD-L1 Expression in KEYNOTE-189
Slovenian: Preglednica 14: Rezultati učinkovitosti glede na izraženost PD-L1 v študiji KEYNOTE-189
English: Table 16: Efficacy results by PD-L1 Expression in KEYNOTE-407
Slovenian: Preglednica 16: Rezultati učinkovitosti glede na izraženost PD-L1 v študiji KEYNOTE-407
English: • a kind of cancer called bladder cancer (urothelial carcinoma)
Slovenian: • vrste raka, imenovane rak sečnega mehurja (urotelijski rak),
English: Renal cell carcinoma KEYNOTE-426: Controlled trial of combination therapy in RCC patients naïve to treatment The efficacy of pembrolizumab in combination with axitinib was investigated in KEYNOTE-426, a randomised, multicentre, open-label, active-controlled trial conducted in patients with advanced RCC with clear cell component, regardless of PD-L1 tumour expression status and International Metastatic RCC Database Consortium (IMDC) risk group categories.
Slovenian: Učinkovitost pembrolizumaba v kombinaciji z aksitinibom so preučevali v študiji KEYNOTE-426, to je randomiziranem, multicentričnem, odprtem, z učinkovino nadzorovanem preskušanju pri bolnikih z napredovalim rakom ledvičnih celic s svetlocelično komponento, ne glede na izraženost PD-L1 tumorja in ne glede na kategorijo tveganja po IMDC (International Metastatic RCC Database Consortium).
English: Gastrointestinal disorders Very common diarrhoea, abdominal pain m, nausea, vomiting, constipation diarrhoea, nausea, vomiting, constipation, abdominal pain diarrhoea, abdominal pain m, nausea, vomiting, constipation
Slovenian: Bolezni prebavil Zelo pogosti diareja, bolečine v trebuhu m, navzea, bruhanje, zaprtost diareja, navzea, bruhanje, zaprtost, bolečine v trebuhu diareja, bolečine v trebuhu m, navzea, bruhanje, zaprtost
English: Assessment of tumour status was performed at 9 weeks after the first dose, then every 6 weeks through the first year, followed by every 12 weeks thereafter.
Slovenian: Stanje tumorja so ocenili 9 tednov po prvem odmerku, potem na 6 tednov prvo leto, pozneje pa na 12 tednov.
English: Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1).
Slovenian: Sekundarni merili izida učinkovitosti sta bili OS in ORR (po oceni BICR z uporabo RECIST 1.1).
English: IIIC ≥ 4 positive lymph nodes) and geographic region (North America, European countries, Australia and other countries as designated).
Slovenian: Randomizacija je bila stratificirana glede na stadije po 7. izdaji kriterijev Ameriškega združenja za zdravljenje raka (AJCC - American Joint Committee on Cancer) (IIIA v primerjavi s IIIB v primerjavi s IIIC (1-3 pozitivne bezgavke) v primerjavi s IIIC (≥ 4 pozitivne bezgavke)) in geografsko področje (Severna Amerika, evropske države, Avstralija in druge države, kot je bilo določeno).
English: Patients were stratified by PD-L1 expression (TPS ≥ 50%), HPV status and ECOG performance status and then randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks (n=247) or one of three standard treatments (n=248): methotrexate 40 mg/m2 once weekly (n=64), docetaxel 75 mg/m2 once every 3 weeks
Slovenian: Bolnike so stratificirali glede na izraženost PD-L1 (TPS ≥ 50 %), status HPV in oceno zmogljivosti po ECOG lestvici in nato randomizirali (v razmerju 1:1) na zdravljenje s pembrolizumabom v odmerku 200 mg na vsake 3 tedne (n = 247) ali na eno od treh standardnih zdravljenj (n = 248):
English: Endpoint n=370
Slovenian: opazovani dogodek n = 370
English: How to store KEYTRUDA
Slovenian: Shranjevanje zdravila KEYTRUDA
English: • a kind of kidney cancer called renal cell carcinoma.
Slovenian: • vrste raka ledvic, imenovanega rak ledvičnih celic.
English: Among the 305 patients in KEYNOTE-024, baseline characteristics were: median age 65 years (54% age 65 or older); 61% male; 82% White, 15% Asian; and ECOG performance status 0 and 1 in 35% and 65%, respectively.
Slovenian: Pri 305 bolnikih v študiji KEYNOTE-024 so bile izhodiščne značilnosti: mediana starost 65 let (54 % starih 65 let ali več), 61 % moških, 82 % belcev, 15 % Azijcev; in 35 % z oceno zmogljivosti 0 ter 65 % z oceno zmogljivosti 1 po ECOG lestvici.
English: Hyperthyroidism occurred in 244 (4.1%) patients, including Grade 2 or 3 cases in 64 (1.1%) and 7 (0.1%) patients, respectively, receiving pembrolizumab.
Slovenian: Hipertiroidizem se je pojavil pri 244 bolnikih (4,1 %), ki so prejemali pembrolizumab; pri 64 bolnikih (1,1 %) je bil 2. stopnje in pri 7 bolnikih (0,1 %) 3. stopnje.
English: Standard Treatment* n=125
Slovenian: standardno zdravljenje* n = 125
English: Table 8: Efficacy results by PD-L1 expression in KEYNOTE-002
Slovenian: Preglednica 8: Rezultati učinkovitosti glede na izraženost PD-L1 v študiji KEYNOTE-002
English: 15 mL Type I glass vial, with a grey bromobutyl stopper and an aluminium seal with an avocado coloured flip-off cap, containing 50 mg pembrolizumab.
Slovenian: 15-ml viala iz stekla tipa I s sivim bromobutilnim zamaškom in aluminijasto zaporko s snemnim pokrovčkom avokadove barve.
English: Assessment of tumour status was performed at 9 weeks, then every 6 weeks through week 52, followed by every 9 weeks through 24 months.
Slovenian: Vrednotenje statusa tumorja so izvedli v 9. tednu, nato na vsakih 6 tednov do 52. tedna in na vsakih 9 tednov do 24. meseca.
English: KEYNOTE-189: Controlled trial of combination therapy in non-squamous NSCLC patients naïve to treatment
Slovenian: KEYNOTE-189: kontrolirano preskušanje kombiniranega zdravljenja pri predhodno še nezdravljenih bolnikih z neploščatoceličnim NSCLC
English: KEYTRUDA in combination with axitinib in RCC For RCC patients treated with KEYTRUDA in combination with axitinib, see the Summary of Product Characteristics (SmPC) regarding dosing of axitinib.
Slovenian: Zdravilo KEYTRUDA v kombinaciji z aksitinibom pri raku ledvičnih celic Za odmerjanje aksitiniba pri bolnikih z rakom ledvičnih celic, ki prejemajo zdravilo KEYTRUDA v kombinaciji z aksitinibom, glejte povzetek glavnih značilnosti (SmPC) aksitiniba.
English: Pembrolizumab + Axitinib N = 432
Slovenian: opazovani dogodek pembrolizumab + aksitinib N = 432
English: Efficacy was evaluated for 276 patients from two defined cohorts, one which included patients previously treated with ipilimumab (and if BRAF V600 mutation-positive, with a BRAF or MEK inhibitor) and the other which included patients naïve to treatment with ipilimumab.
Slovenian: Ena je vključevala bolnike, ki so bili predhodno zdravljeni z ipilimumabom (in zaviralcem BRAF ali MEK, če so imeli pozitivno mutacijo BRAF V600), druga pa bolnike, ki predhodno niso bili zdravljeni z ipilimumabom.
English: Post-authorization efficacy study (PAES) the MAH should submit the final study report of RFS/DMFS and OS data for study KN054: a Phase III Clinical Trial of Pembrolizumab (MK-3475 in Subjects with complete resection of highrisk Stage III melanoma - Final Study Report
Slovenian: Študija učinkovitosti po pridobitvi dovoljenja za promet (PAES): Imetnik dovoljenja za promet z zdravilom mora predložiti končno poročilo študije KN054 za podatke o RFS/DMFS in OS: klinično preskušanje III. faze pembrolizumaba (MK-3475) pri preiskovancih po popolni kirurški odstranitvi visoko tveganega melanoma v stadiju III - končno poročilo študije
English: Hypothyroidism occurred in 645 (11.0%) patients, including Grade 2 or 3 cases in 475 (8.1%) and 8 (0.1%) patients, respectively, receiving pembrolizumab.
Slovenian: Hipotiroidizem se je pojavil pri 645 bolnikih (11,0 %), ki so prejemali pembrolizumab; pri 475 bolnikih (8,1 %) je bil 2. stopnje in pri 8 bolnikih (0,1 %) 3. stopnje.
English: KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2.
Slovenian: Zdravilo KEYTRUDA je humanizirano monoklonsko protitelo, ki se veže na receptor programirane celične smrti 1 (PD-1) in blokira njegovo interakcijo z ligandi PD-L1 in PD-L2. PD-1 receptor je negativni regulator aktivnosti T celic, ki je dokazano povezana z nadzorovanjem imunskega odziva T celic.
English: Patients had PD-L1 expression with a  50% tumour proportion score (TPS) based on the PD-L1 IHC 22C3 pharmDx
Slovenian: Bolniki so imeli ocenjeno  50 % izraženost PD-L1 (TPS) v tumorskih celicah na podlagi testa PD-L1, opravljenega z IHC 22C3 pharmDx
English: Immune-related severe skin reactions occurred in 89 (1.5%) patients, including Grade 2, 3 or 5 cases in 10 (0.2%), 65 (1.1%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab.
Slovenian: Imunsko pogojene hude kožne reakcije so se pojavile pri 89 bolnikih (1,5 %), ki so prejemali pembrolizumab; pri 10 bolnikih (0,2 %) so bile 2. stopnje, pri 65 bolnikih (1,1 %) 3. stopnje in pri 1 bolniku (< 0,1 %) 5. stopnje.
English: Treatment arm OS rate at 24 months OS rate at 36 months HR (95% CI)
Slovenian: zdravljena skupina delež OS po 24 mesecih delež OS po 36 mesecih HR (95 % IZ)
English: The study excluded patients with EGFR or ALK genomic tumour aberrations; autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks.
Slovenian: V študijo niso bili vključeni bolniki s tumorskima genomskima aberacijama EGFR ali ALK, bolniki z avtoimunsko boleznijo, ki je v zadnjih 2 letih zahtevala sistemsko zdravljenje, bolniki z zdravstvenim stanjem, ki je zahtevalo imunosupresivno zdravljenje, ter bolniki, ki so v predhodnih 26 tednih prejeli več kot 30 Gy obsevanja v predelu prsnega koša.
English: Among the 542 randomised patients in KEYNOTE-045, baseline characteristics were: median age 66 years (range: 26 to 88), 58% age 65 or older; 74% male; 72% White and 23% Asian; 56% ECOG performance status of 1 and 1% ECOG performance status of 2; and 96% M1 disease and 4% M0 disease.
Slovenian: Pri 542 bolnikih, randomiziranih v študiji KEYNOTE-045, so bile izhodiščne značilnosti: mediana starost 66 let (v razponu od 26 do 88), 58 % starih 65 let ali več, 74 % moških, 72 % belcev in 23 % Azijcev, 56 % z oceno zmogljivosti po ECOG lestvici 1 in 1 % z oceno zmogljivosti po ECOG lestvici 2, 96 % z boleznijo v stadiju M1 in 4 % z boleznijo v stadiju M0. Sedeminosemdeset odstotkov bolnikov je imelo visceralne metastaze, vključno s 34 % odstotki, ki so imeli metastaze v jetrih.
English: † (95% CI)
Slovenian: † (95 % IZ)
English: Figure 15: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-040 patients with PD-L1 expression (TPS ≥ 50%)
Slovenian: Slika 15: Kaplan-Meierjeva krivulja celokupnega preživetja glede na zdravljeno skupino v študiji KEYNOTE-040 pri bolnikih z izraženostjo PD-L1 (TPS ≥ 50 %)
English: Based on stratified Log rank test
Slovenian: Na podlagi stratificiranega log-rank testa
English: Table 12: Efficacy results in KEYNOTE-024
Slovenian: Preglednica 12: Rezultati učinkovitosti v študiji KEYNOTE-024
English: • Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
Slovenian: • Pred redčenjem je viala s tekočino lahko do 24 ur zunaj hladilnika (temperatura 25°C ali manj).
English: Immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab.
Slovenian: Pri bolnikih, ki so prejemali pembrolizumab, so se pojavili imunsko pogojeni neželeni učinki, vključno s hudimi in smrtnimi primeri.
English: Table 10: Efficacy results in KEYNOTE-054
Slovenian: Preglednica 10: Rezultati učinkovitosti v študiji KEYNOTE-054
English: Standard Treatment* n=235
Slovenian: standardno zdravljenje* n = 235
English: Table 5: Efficacy results in KEYNOTE-001
Slovenian: Preglednica 5: Rezultati učinkovitosti v študiji KEYNOTE-001