FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with 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 were ineligible.
Slovenian: Bolniki z avtoimunsko boleznijo, ki je v zadnjih 2 letih zahtevala sistemsko zdravljenje, bolniki z zdravstvenim stanjem, ki je zahtevalo imunosupresivno zdravljenje, in bolniki, ki so v predhodnih 26 tednih prejeli več kot 30 Gy obsevanja v predelu prsnega koša, niso bili primerni za vključitev v preskušanje.
English: Consider the benefit of treatment with pembrolizumab versus the risk of possible GVHD in patients with a history of allogeneic HSCT.
Slovenian: Pri bolnikih z alogensko HSCT v anamnezi je treba pretehtati korist zdravljenja s pembrolizumabom in tveganje za možni pojav GVHD.
English: Figure 13: Kaplan-Meier curve for overall survival for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
Slovenian: Slika 13: Kaplan-Meierjeva krivulja celokupnega preživetja za pembrolizumab skupaj s kemoterapijo v študiji KEYNOTE-048 z izraženostjo PD-L1 (CPS ≥ 1)
English: 129 patients included: median age 62 years (40% age 65 or older); 81% male; 78% White, 11% Asian, and 2% Black; 23% and 77% with an ECOG performance status 0 or 1, respectively; and 19% with HPV positive tumours.
Slovenian: Izhodiščne značilnosti teh 129 bolnikov so bile naslednje: mediana starost 62 let (40 % bolnikov starih 65 let ali starejših), 81 % bolnikov moškega spola, 78 % bolnikov belcev, 11 % bolnikov Azijcev in 2 % bolnikov črncev, 23 % bolnikov z oceno zmogljivosti 0 in 77 % bolnikov z oceno zmogljivosti 1 po ECOG lestvici ter 19 % bolnikov s HPV pozitivnimi tumorji.
English: Colitis resolved in 84 patients, 2 with sequelae.
Slovenian: Izzvenel je pri 84 bolnikih, pri 2 je pustil posledice.
English: Adrenal insufficiency (primary and secondary) has been reported in patients receiving pembrolizumab.
Slovenian: Pri bolnikih, ki so prejemali pembrolizumab, so poročali o adrenalni insuficienci (primarni in sekundarni).
English: Hyperthyroidism led to discontinuation of pembrolizumab in 3 (0.1%) patients.
Slovenian: Hipertiroidizem je bil razlog za ukinitev zdravljenja s pembrolizumabom pri 3 bolnikih (0,1 %).
English: (See section 4.8).
Slovenian: Version 4.0”).
English: Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction (see sections 4.2 and 4.8).
Slovenian: Pembrolizumab je treba trajno ukiniti, če se kateri koli imunsko pogojeni neželeni učinek 3. stopnje znova pojavi oziroma če se pojavi imunsko pogojeni neželeni učinek 4. stopnje (glejte poglavji 4.2 in
English: KEYTRUDA 50 mg powder for concentrate for solution for infusion.
Slovenian: KEYTRUDA 50 mg prašek za koncentrat za raztopino za infundiranje
English: Eightyfive percent of patients had visceral metastases, including 21% with liver metastases.
Slovenian: Oseminosemdeset odstotkov bolnikov je imelo bolezen v stadiju M1 in 12 % v stadiju M0. Petinosemdeset odstotkov bolnikov je imelo visceralne metastaze, vključno z 21 odstotki, ki so imeli metastaze v jetrih.
English: % with duration ≥ 6-months % with duration ≥ 12-months Time to response Median in months (range) PFS
Slovenian: % s trajanjem ≥ 6 mesecev % s trajanjem ≥ 12 mesecev čas do odgovora mediana v mesecih (razpon) preživetje brez napredovanja bolezni (PFS) število (%) bolnikov z dogodkom mediana v mesecih (95 % IZ)
English: Hypophysitis occurred in 36 (0.6%) patients, including Grade 2, 3 or 4 cases in 13 (0.2%), 19 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab.
Slovenian: Hipofizitis se je pojavil pri 36 bolnikih (0,6 %), ki so prejemali pembrolizumab; pri 13 bolnikih (0,2 %) je bil 2. stopnje, pri 19 bolnikih (0,3 %) 3. stopnje in pri 1 bolniku (< 0,1 %) 4. stopnje.
English: • From a microbiological point of view, the product, once diluted, should be used immediately.
Slovenian: • Z mikrobiološkega stališča je treba razredčeno raztopino uporabiti takoj.
English: #) of patients with duration ≥ 6 months
Slovenian: Þ) bolnikov s trajanjem ≥ 6 mesecev
English: Pembrolizumab 10 mg/kg every 2 weeks n=279
Slovenian: pembrolizumab 10 mg/kg na 2 tedna n = 279
English: Among KEYNOTE-087 patients, the baseline characteristics were median age 35 years (9% age 65 or older); 54% male; 88% White; and 49% and 51% had an ECOG performance status 0 and 1, respectively.
Slovenian: Pri bolnikih v študiji KEYNOTE-087 so bile izhodiščne značilnosti: mediana starost 35 let (9 % starih 65 let ali več), 54 % moških, 88 % belcev; 49 % z oceno zmogljivosti 0 ter 51 % z oceno zmogljivosti 1 po ECOG lestvici.
English: Assessment of tumour status was performed at Week 6 and Week 12, followed by every 9 weeks thereafter.
Slovenian: Vrednotenje tumorja so izvedli v 6. tednu in 12. tednu nato pa na vsakih 9 tednov.
English: Number of events (%) Median in months (95% CI)
Slovenian: celokupno preživetje (OS) število dogodkov (%) mediana v mesecih (95 % IZ)
English: Patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible for the study.
Slovenian: Za sodelovanje v tej študiji niso bili primerni bolniki z rakom nazofarinksa, aktivno avtoimunsko boleznijo, ki je zahtevala sistemsko zdravljenje v zadnjih dveh letih pred tem zdravljenjem, ali z boleznijo, ki je zahtevala imunosupresijo.
English: Among KEYNOTE-013 patients, the baseline characteristics were median age 32 years (7% age 65 or older), 58% male, 94% White; and 45% and 55% had an ECOG performance status 0 and 1, respectively.
Slovenian: Pri bolnikih v študiji KEYNOTE-013 so bile izhodiščne značilnosti: mediana starost 32 let (7 % starih 65 let ali več), 58 % moških, 94 % belcev; 45 % z oceno zmogljivosti 0 ter 55 % z oceno zmogljivosti 1 po ECOG lestvici.
English: Severe infusion-related reactions, including hypersensitivity and anaphylaxis, have been reported in patients receiving pembrolizumab (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali pembrolizumab, so poročali o hudih z infuzijo povezanih reakcijah, vključno s preobčutljivostjo in anafilaksijo (glejte poglavje 4.8).
English: ORR % * Hazard ratio (pembrolizumab combination therapy compared to chemotherapy) based on the stratified Cox proportional hazard model
Slovenian: ORR % * Razmerje ogroženosti (kombinirano zdravljenje s pembrolizumabom v primerjavi s kemoterapijo) na podlagi stratificiranega
English: Common hyperthyroidism hypothyroidism, hyperthyroidism hypophysitis d,
Slovenian: Pogosti hipertiroidizem hipotiroidizem, hipertiroidizem hipofizitis d, tiroiditis e, adrenalna insuficienca
English: Figure 16: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Slovenian: Slika 16: Kaplan-Meierjeva krivulja celokupnega preživetja glede na zdravljeno skupino v študiji KEYNOTE-426 (populacija z-namenom-zdravljenja (ITT))*
English: KEYNOTE-045: Controlled trial in urothelial carcinoma patients who have received prior platinumcontaining chemotherapy
Slovenian: KEYNOTE-045: kontrolirano preskušanje pri bolnikih z urotelijskim rakom, predhodno zdravljenih s kemoterapijo, ki je vključevala platino
English: Pembrolizumab + Platinum Chemotherapy + 5-FU n=116
Slovenian: opazovani dogodek pembrolizumab + kemoterapija s platino + 5-FU n = 116
English: Nephritis led to discontinuation of pembrolizumab in 10 (0.2%) patients.
Slovenian: Nefritis je bil razlog za ukinitev zdravljenja s pembrolizumabom pri 10 bolnikih (0,2 %).
English: L-histidine hydrochloride monohydrate Sucrose
Slovenian: L-histidinijev klorid monohidrat saharoza polisorbat 80
English: th edition identifies a patient population with a better prognosis compared to stage IIIA according to AJCC 7
Slovenian: Pri vrednotenju melanoma v stadiju IIIA po 8. izdaji kriterijev AJCC so odkrili populacijo bolnikov z boljšo prognozo v primerjavi z melanomom v stadiju IIIA po 7. izdaji kriterijev AJCC.
English: Figure 7: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-189 (intent to treat population)
Slovenian: Slika 7: Kaplan-Meierjeva krivulja celokupnega preživetja glede na zdravljeno skupino v študiji KEYNOTE-189 (populacija z-namenom-zdravljenja (ITT))
English: Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P204: A Phase III, Randomised, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma - Final Study Report
Slovenian: Študija učinkovitosti po pridobitvi dovoljenja za promet (PAES): Imetnik dovoljenja za promet z zdravilom mora predložiti končno poročilo študije P204: Randomizirano odprto klinično preskušanje III. faze za primerjavo pembrolizumaba z brentuksimabom vedotinom pri preiskovancih s ponovljenim ali neodzivnim klasičnim Hodgkinovim limfomom (cHL)končno poročilo študije
English: KEYNOTE-024: Controlled trial of NSCLC patients naïve to treatment The safety and efficacy of pembrolizumab were investigated in KEYNOTE-024, a multicentre, controlled study for the treatment of previously untreated metastatic NSCLC.
Slovenian: KEYNOTE-024: kontrolirano preskušanje pri predhodno še nezdravljenih bolnikih z NSCLC Varnost in učinkovitost pembrolizumaba so preučevali v študiji KEYNOTE-024.
English: Nephritis resolved in 13 patients, 3 with sequelae.
Slovenian: Izzvenel je pri 13 bolnikih, pri 3 je pustil posledice.
English: Pembrolizumab + Platinum Chemotherapy + 5-FU n=242
Slovenian: opazovani dogodek pembrolizumab + kemoterapija s platino + 5-FU n = 242
English: PFS Hazard ratio* (95% CI) OS Hazard ratio* (95% CI) ORR %
Slovenian: PFS HR* (95 % IZ) OS HR* (95 % IZ) ORR %
English: KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinumcontaining chemotherapy (see section 5.1).
Slovenian: Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za zdravljenje ponovljenega ali metastatskega ploščatoceličnega raka glave in vratu pri odraslih, ki imajo tumorje z ≥ 50 % izraženostjo PD-L1 (TPS), in pri katerih je bolezen napredovala med zdravljenjem ali po zdravljenju s kemoterapijo, ki je vključevala platino (glejte poglavje 5.1).
English: An HR=0.96 [95% CI 0.37,2.52] in OS, an HR=0.60 [95% CI 0.29,1.21] in PFS, and an ORR of 47% and 42% for pembrolizumab combination vs chemotherapy was reported within this study subgroup.
Slovenian: Pri tej študijski podskupini so pri kombiniranem zdravljenju s pembrolizumabom v primerjavi s kemoterapijo poročali o HR = 0,96 [95 % IZ 0,37; 2,52] za celokupno preživetje (OS), o HR = 0,60 [95 % IZ 0,29; 1,21] za preživetje brez napredovanja bolezni (PFS), za ORR pa 47 % oz. 42 %.
English: Kaplan-Meier curves for OS and PFS based on the final analysis are shown in Figures 1 and 2.
Slovenian: Kaplan-Meierjevi krivulji celokupnega preživetja in preživetja brez napredovanja bolezni na podlagi končne analize sta prikazani na slikah 1 in 2.
English: One vial contains 50 mg of pembrolizumab.
Slovenian: Ena viala vsebuje 50 mg pembrolizumaba.
English: Corticosteroids should be administered (initial dose of 0.5-1 mg/kg/day (for Grade 2 events) and 1-2 mg/kg/day (for Grade ≥ 3 events) prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued (see section 4.2).
Slovenian: Uporabiti je treba kortikosteroide (začetni odmerek 0,5-1 mg/kg/dan (za učinke 2. stopnje) in 1-2 mg/kg/dan (za učinke ≥ 3. stopnje) prednizona ali ekvivalenta, nato se jih postopno zmanjšuje) in glede na izrazitost zvišanja jetrnih encimov uporabo pembrolizumaba zadržati ali pembrolizumab trajno ukiniti (glejte poglavje 4.2).
English: Treatment with pembrolizumab or placebo continued until RECIST 1.1-defined progression of disease as determined by blinded independent central review (BICR), unacceptable toxicity, or a maximum of 24 months.
Slovenian: Zdravljenje s pembrolizumabom ali dajanje placeba se je nadaljevalo do napredovanja bolezni, kar je bilo ocenjeno s slepim neodvisnim centralnim pregledom (BICR) na podlagi meril RECIST 1.1, do pojava nesprejemljivih toksičnih učinkov ali največ 24 mesecev.
English: The efficacy of pembrolizumab was investigated in KEYNOTE-048, a multicentre, randomized, open-label, active-controlled study in patients with histologically confirmed metastatic or recurrent HNSCC of the oral cavity, pharynx or larynx, who had not previously received systemic therapy for recurrent or metastatic disease and who were considered incurable by local therapies.
Slovenian: KEYNOTE-048: kontrolirano preskušanje samostojnega in kombiniranega zdravljenja pri bolnikih s HNSCC, predhodno še nezdravljenih zaradi ponovljene ali metastatske bolezni Učinkovitost pembrolizumaba so preučevali v študiji KEYNOTE-048, to je multicentrični, randomizirani, odprti, z učinkovino nadzorovani študiji pri bolnikih s histološko potrjenim metastatskim ali ponovljenim HNSCC ustne votline, žrela ali grla, ki predhodno niso prejemali sistemskega zdravljenja za ponovljeno ali metastatsko bolezen, ki je bila ocenjena kot neozdravljiva z lokalnimi načini zdravljenja.
English: KEYNOTE-407: Controlled trial of combination therapy in squamous NSCLC patients naïve to treatment
Slovenian: KEYNOTE-407: kontrolirano preskušanje kombiniranega zdravljenja pri predhodno še nezdravljenih bolnikih s ploščatoceličnim NSCLC
English: Each mL of concentrate contains 25 mg of pembrolizumab.
Slovenian: En ml koncentrata vsebuje 25 mg pembrolizumaba.
English: Table 21: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma ineligible for cisplatin-containing chemotherapy in KEYNOTE-052
Slovenian: Preglednica 21: Odgovor na pembrolizumab v odmerku 200 mg na 3 tedne pri bolnikih z urotelijskim rakom, ki niso primerni za zdravljenje s kemoterapijo, ki vsebuje cisplatin, v študiji KEYNOTE-052
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80, water for injections.
Slovenian: Pomožne snovi: L-histidin, L-histidinijev klorid monohidrat, saharoza, polisorbat 80, voda za injekcije.
English: Patients with an ECOG performance status of 2 had to have a hemoglobin ≥ 10 g/dL, could not have liver metastases, and must have received the last dose of their last prior chemotherapy regimen ≥ 3 months prior to enrollment.
Slovenian: V študijo niso bili vključeni bolniki z avtoimunsko boleznijo, boleznimi, ki so zahtevale imunosupresijo, in bolniki, ki so predhodno prejeli že več kot 2 liniji sistemske kemoterapije za metastatski urotelijski rak. Bolniki z oceno zmogljivosti po ECOG lestvici 2 so morali imeti hemoglobin ≥ 10 g/dl, niso smeli imeti metastaz v jetrih in so morali prejeti zadnji odmerek svoje zadnje predhodne sheme kemoterapije ≥ 3 mesece pred vključitvijo v preskušanje.
English: Pembrolizumab + Platinum Chemotherapy + 5-FU n=126
Slovenian: opazovani dogodek pembrolizumab + kemoterapija s platino + 5-FU n = 126
English: An exploratory subgroup analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 1 to < 20 [pembrolizumab plus chemotherapy: n=116 (45%) vs. standard treatment: n=125 (49%) and pembrolizumab monotherapy: n=124 (48%) vs. standard treatment: n=133 (52%)] (see Table 26).
Slovenian: V študiji KEYNOTE-048 je bila izvedena raziskovalna analiza podatkov podskupine pri bolnikih, ki so imeli tumorje z izraženostjo PD-L1 s CPS ≥ 1 do < 20 [pembrolizumab in kemoterapija: n = 116 (45 %) v primerjavi s standardnim zdravljenjem: n = 125 (49 %) in samostojno zdravljenje s pembrolizumabom: n = 124 (48 %) v primerjavi s standardnim zdravljenjem: n = 133 (52 %)] (glejte preglednico 26).
English: A statistically significant improvement in RFS for patients randomised to the pembrolizumab arm compared with placebo was demonstrated in the overall population across resected stage III melanoma per AJCC 7
Slovenian: V celokupni populaciji bolnikov s kirurško odstranjenim melanomom v stadiju III po 7. izdaji kriterijev AJCC je bilo pri bolnikih, randomiziranih v skupino s pembrolizumabom, dokazano statistično pomembno izboljšanje RFS v primerjavi s placebom.
English: Elevated liver enzymes when pembrolizumab is combined with axitinib in RCC In a clinical study of previously untreated patients with RCC receiving pembrolizumab in combination with axitinib, a higher than expected incidence of Grades 3 and 4 ALT increased (20%) and AST increased (13%) were observed.
Slovenian: V klinični študiji pri predhodno nezdravljenih bolnikih z rakom ledvičnih celic, ki so prejemali pembrolizumab v kombinaciji z aksitinibom, je bila pogostnost zvišanj vrednosti ALT ali AST 3. in 4. stopnje večja od pričakovane (zvišanje vrednosti ALT 20 %, zvišanje vrednosti AST 13 %).
English: Hepatitis occurred in 50 (0.8%) patients, including Grade 2, 3 or 4 cases in 8 (0.1%), 31 (0.5%) and 8 (0.1%) patients, respectively, receiving pembrolizumab.
Slovenian: Hepatitis se je pojavil pri 50 bolnikih (0,8 %), ki so prejemali pembrolizumab; pri 8 bolnikih (0,1 %) je bil 2. stopnje, pri 31 bolnikih (0,5 %) 3. stopnje in pri 8 bolnikih (0,1 %) 4. stopnje.
English: Uncommon (may affect up to 1 in 100 people) - inflammation of the pituitary gland situated at the base of the brain; inflammation of the thyroid; decreased secretion of hormones produced by the adrenal glands - type 1 diabetes - seizure - accumulation of fluid around the heart - inflammation of the pancreas - inflammation of the liver - thickened, sometimes scaly, skin growth; acne-like skin problem; inflammation of the skin;
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - vnetje žleze hipofize, ki se nahaja na možganskem dnu, vnetje ščitnice, zmanjšano izločanje hormonov, ki jih proizvajata nadledvični žlezi - sladkorna bolezen tipa 1 - epileptični napad - kopičenje tekočine okoli srca - vnetje trebušne slinavke - vnetje jeter - zadebeljena, včasih luskasta kožna rašča, aknam podobne kožne težave, vnetje kože,
English: One vial of 4 mL contains 100 mg of pembrolizumab.
Slovenian: Ena viala s 4 ml vsebuje 100 mg pembrolizumaba.
English: Pembrolizumab 10 mg/kg every 2 weeks:
Slovenian: pembrolizumab 10 mg/kg na 2 tedna:
English: musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis) w. myositis (myalgia, myopathy, polymyalgia rheumatica and rhabdomyolysis) x. arthritis (joint swelling, polyarthritis and joint effusion) y. tenosynovitis (tendonitis, synovitis and tendon pain) z. nephritis (nephritis autoimmune, tubulointerstitial nephritis and renal failure, renal failure acute, or acute kidney injury with evidence of nephritis, nephrotic syndrome) aa. oedema (oedema peripheral, generalised oedema, fluid overload, fluid retention, eyelid oedema and lip oedema, face oedema, localised oedema and periorbital oedema)
Slovenian: srbeč izpuščaj, pustulozni izpuščaj in kožne lezije) t. vitiligo (depigmentacija kože, hipopigmentacija kože in hipopigmentacija vek) u. lihenoidna keratoza (lichen planus in lichen sclerosus) v. mišično-skeletna bolečina (mišično-skeletno nelagodje, bolečine v hrbtu, mišično-skeletna togost, mišično-skeletna bolečina v prsnem košu in tortikolis) w. miozitis (mialgija, miopatija, revmatična polimialgija in rabdomioliza) x. artritis (oteklost sklepov, poliartritis in sklepni izliv) y. tendosinovitis (tendinitis, sinovitis in bolečina v kitah) z. nefritis (avtoimunski nefritis, tubulointersticijski nefritis in odpoved ledvic, akutna odpoved ledvic ali akutna poškodba ledvic z dokazanim nefritisom, nefrotski sindrom) aa.edem (periferni edem, generaliziran edem, preobremenitev s tekočino, zastajanje tekočine, edem vek, edem ustnic,
English: Colitis occurred in 107 (1.8%) patients, including Grade 2, 3 or 4 cases in 31 (0.5%), 62 (1.1%) and 3 (< 0.1%) patients, respectively, receiving pembrolizumab.
Slovenian: Kolitis se je pojavil pri 107 bolnikih (1,8 %), ki so prejemali pembrolizumab; pri 31 bolnikih (0,5 %) je bil 2. stopnje, pri 62 bolnikih (1,1 %) 3. stopnje in pri 3 bolnikih (< 0,1 %) 4. stopnje.
English: Figure 17: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Slovenian: Slika 17: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni glede na zdravljeno skupino v študiji KEYNOTE-426 (populacija z-namenom-zdravljenja (ITT))*
English: The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80 and water for injections.
Slovenian: Druge sestavine zdravila so L-histidin, L-histidinijev klorid monohidrat, saharoza, polisorbat 80 in voda za injekcije.
English: Assessed by BICR using RECIST 1.1
Slovenian: Ocenjeno z BICR z uporabo meril RECIST 1.1
English: itchy skin; hair loss - inflammation of the liver - muscle pain, aches or tenderness; joint or muscle pain with swelling; inflammation of the sheath that surrounds tendons - sudden kidney damage; inflammation of the kidneys - swelling; flu-like illness; chills - increased calcium in the blood; increased liver enzyme levels in the blood
Slovenian: - bolečine, bolečnost ali občutljivost v mišicah, bolečine v sklepih in mišicah z otekanjem, vnetje ovojnice, ki obdaja kite - nenadna okvara ledvic, vnetje ledvic - otekanje, gripi podobna bolezen, mrzlica - zvišanje kalcija v krvi, zvišana raven jetrnih encimov v krvi
English: From a microbiological point of view, the product, once diluted, should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba razredčeno raztopino uporabiti takoj.
English: An analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 20 [pembrolizumab plus chemotherapy: n=126 (49%) vs. standard treatment: n=110 (43%) and pembrolizumab monotherapy: n=133 (52%) vs. standard treatment: n=122 (48%)] (see Table 25).
Slovenian: V študiji KEYNOTE-048 je bila izvedena analiza podatkov pri bolnikih, ki so imeli tumorje z izraženostjo PD-L1 s CPS ≥ 20 [pembrolizumab in kemoterapija: n = 126 (49 %) v primerjavi s standardnim zdravljenjem: n = 110 (43 %) in samostojno zdravljenje s pembrolizumabom: n = 133 (52 %) v primerjavi s standardnim zdravljenjem: n = 122 (48 %)] (glejte preglednico 25).
English: Combination with chemotherapy
Slovenian: Samostojno zdravljenje Kombinirano zdravljenje s kemoterapijo
English: Figure 14: Kaplan-Meier curve for overall survival for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
Slovenian: Slika 14: Kaplan-Meierjeva krivulja celokupnega preživetja za samostojno zdravljenje s pembrolizumabom v študiji KEYNOTE-048 z izraženostjo PD-L1 (CPS ≥ 1)
English: The following side effects have been reported in clinical trials with pembrolizumab in combination with axitinib:
Slovenian: V kliničnih preskušanjih pembrolizumaba v kombinaciji z aksitinibom so poročali o naslednjih neželenih učinkih:
English: Common dizziness, neuropathy peripheral, lethargy, dysgeusia lethargy dizziness, lethargy, neuropathy peripheral
Slovenian: Pogosti omotica, periferna nevropatija, letargija, disgevzija letargija omotica, letargija, periferna nevropatija
English: 6-month PFS rate 9-month PFS rate 12-month PFS rate OS
Slovenian: 6-mesečni delež PFS 9-mesečni delež PFS 12-mesečni delež PFS celokupno preživetje (OS) število (%) bolnikov z dogodkom 6-mesečni delež OS 12-mesečni delež OS
English: Table 19: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma previously treated with chemotherapy in KEYNOTE-045
Slovenian: Preglednica 19: Odgovor na pembrolizumab v odmerku 200 mg na 3 tedne pri bolnikih z urotelijskim rakom, predhodno zdravljenih s kemoterapijo v študiji KEYNOTE-045
English: and then every 12 weeks thereafter.
Slovenian: delež OS po 12 mes.