FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Fifteen percent of patients had disease progression following prior platinumcontaining neoadjuvant or adjuvant chemotherapy.
Slovenian: Petnajstim odstotkom bolnikov je bolezen napredovala po predhodni neoadjuvantni ali adjuvantni kemoterapiji, ki je vključevala platino.
English: 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%).
Slovenian: 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 %).
English: 12-month OS rate
Slovenian: 12-mesečni delež OS
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Infections and infestations Common pneumonia pneumonia pneumonia
Slovenian: Infekcijske in parazitske bolezni Pogosti pljučnica pljučnica pljučnica
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Based on Kaplan-Meier estimates; includes 16 patients with responses of 6 months or longer
Slovenian: Na podlagi Kaplan-Meierjevih ocen; vključuje 16 bolnikov z odgovorom 6 mesecev ali več
English: Common influenza like illness, chills chills, influenza-like illness oedema aa
Slovenian: Pogosti gripi podobna bolezen, mrzlica mrzlica, gripi podobna bolezen edem aa
English: 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)
Slovenian: 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).
English: When you get KEYTRUDA, you can have some serious side effects.
Slovenian: Ko prejmete zdravilo KEYTRUDA, se vam lahko pojavijo nekateri resni neželeni učinki.
English: • Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: • Parenteralna zdravila je treba pred uporabo pregledati glede prisotnosti delcev in spremembe barve.
English: Among patients with BRAF mutant tumours, 10 (50%) were previously treated with a BRAF inhibitor.
Slovenian: Med bolniki, ki so imeli tumorje z mutacijo BRAF, jih je bilo 10 (50 %) predhodno zdravljenih z zaviralcem BRAF.
English: 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%).
Slovenian: 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 %).
English: No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab.
Slovenian: Uradnih študij farmakokinetičnega medsebojnega delovanja zdravil s pembrolizumabom niso izvedli.
English: The median number of prior lines of therapy administered for the treatment of cHL was 4 (range 1 to 12).
Slovenian: Mediano število predhodnih linij zdravljenja cHL je bilo 4 (v razponu: od 1 do 12).
English: 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
Slovenian: 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
English: Withhold until adverse reactions recover to Grades 0-1*
Slovenian: zadržite, dokler se neželeni učinki ne zmanjšajo na stopnjo 0-1*
English: An updated OS analysis was performed when patients had a median follow-up of 16.6 months (range: 0.1 to 26.3 months).
Slovenian: 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).
English: KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.
Slovenian: Zdravilo KEYTRUDA je v kombinaciji s karboplatinom in bodisi paklitakselom bodisi nab-paklitakselom indicirano za prvo linijo zdravljenja metastatskega ploščatoceličnega NSCLC pri odraslih.
English: Table 13 summarises key efficacy measures.
Slovenian: Preglednica 13 povzema ključna merila učinkovitosti.
English: Translucent to white proteinaceous particles may be seen in diluted solution.
Slovenian: V razredčeni raztopini so lahko vidni prosojni do beli beljakovinski delci.
English: The 23 patients had a median follow-up from subsequent allogeneic HSCT of 5.1 months (range: 0-26.2 months).
Slovenian: Pri teh 23 bolnikih je spremljanje od naslednje alogenske HSCT trajalo mediano 5,1 meseca (v razponu: od 0 do 26,2 meseca).
English: Patients in the placebo arm were offered pembrolizumab as a single agent at the time of disease progression.
Slovenian: Bolnikom v skupini s placebom so v času napredovanja bolezni ponudili pembrolizumab kot samostojno zdravilo.
English: Response: Best objective response as confirmed complete response or partial response
Slovenian: Odgovor: najboljši objektivni odgovor, potrjen kot popolni oziroma delni odgovor
English: Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Slovenian: 3. stopnja ali v primeru suma na Stevens-Johnsonov sindrom (SJS) ali toksično epidermalno nekrolizo (TEN)
English: The median number of prior lines of therapy administered for the treatment of cHL was 5 (range 2 to 15).
Slovenian: Mediano število predhodnih linij zdravljenja cHL je bilo 5 (v razponu: od 2 do 15).
English: The pembrolizumab monotherapy arm remains open only to patients whose tumours express PD-L1 with a CPS ≥ 10.
Slovenian: Skupina z monoterapijo s pembrolizumabom ostaja odprta samo za bolnike, pri katerih tumorji izražajo PD-L1 s CPS ≥ 10.
English: erythema, dry skin, vitiligo t, eczema, alopecia, dermatitis acneiform severe skin reactions s,
Slovenian: eritem, suha koža, vitiligo t, ekcem, alopecija, akneiformni dermatitis hude kožne reakcije s,
English: 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).
Slovenian: 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).
English: Common hypertension hypertension
Slovenian: Pogosti hipertenzija hipertenzija
English: Eighty-six percent had a primary tumour in the lower tract and 14% had a primary tumour in the upper tract.
Slovenian: Šestinosemdeset odstotkov jih je imelo primarni tumor v spodnjem traktu in 14 % v zgornjem traktu.
English: 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).
Slovenian: 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).
English: Breast-feeding - If you are breast-feeding, tell your doctor.
Slovenian: Dojenje - Če dojite, morate to povedati zdravniku.
English: Table 15 summarises key efficacy measures.
Slovenian: Preglednica 15 povzema ključna merila učinkovitosti.
English: Patients with BRAF V600E mutant melanoma were not required to have received prior BRAF inhibitor therapy.
Slovenian: Pri bolnikih, ki so imeli melanom z mutacijo BRAF V600E, ni bilo zahtevano predhodno zdravljenje z zaviralcem BRAF.
English: No dose adjustment is necessary in patients ≥ 65 years (see section 5.1).
Slovenian: Pri bolnikih, starih ≥ 65 let, odmerka ni treba prilagoditi (glejte poglavje 5.1).
English: PD-L1 expression was tested retrospectively by immunohistochemistry assay with the 22C3 anti-PD-L1 antibody.
Slovenian: Testiranje izraženosti PD-L1 je bilo opravljeno retrospektivno z imunohistokemičnim preizkusom s protitelesom 22C3 proti PD-L1.
English: Patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior to starting treatment.
Slovenian: 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.
English: Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: All patients with BRAF mutant tumours were previously treated with a BRAF inhibitor.
Slovenian: Vsi bolniki, ki so imeli tumorje z mutacijo BRAF, so bili predhodno zdravljeni z zaviralcem BRAF.
English: Seventy percent had at least two and 35% of patients had three or more prior systemic therapies for advanced melanoma.
Slovenian: Sedemdeset odstotkov bolnikov je predhodno prejelo vsaj dve in 35 % bolnikov tri ali več sistemskih zdravljenj za napredovali melanom.
English: Common pain in extremity, myositis w, arthritis myositis w, pain in extremity, arthritis myositis w, arthritis x,
Slovenian: Pogosti bolečine v okončini, miozitis w, artritis miozitis w, bolečine v okončini, artritis miozitis w, artritis x,
English: Seventy-six percent of patients received prior cisplatin, 23% had prior carboplatin, and 1% was treated with other platinum-based regimens.
Slovenian: Šestinsedemdeset odstotkov bolnikov je predhodno prejemalo cisplatin, 23 % je predhodno prejemalo karboplatin in 1 % druge sheme na podlagi platine.
English: A direct comparison of pembrolizumab when used in combination with chemotherapy to pembrolizumab monotherapy is not available.
Slovenian: Neposredna primerjava pembrolizumaba v kombinaciji s kemoterapijo in samostojnega zdravljenja s pembrolizumabom ni na voljo.
English: 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).
Slovenian: 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).
English: In addition, no safety and efficacy data are available in frailer patients (e.g., ECOG performance status 3) considered not eligible for chemotherapy.
Slovenian: 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.
English: Incidences of Grades 3-5 adverse reactions were 76% for pembrolizumab combination therapy and 71% for sunitinib alone.
Slovenian: Pojavnost neželenih učinkov 3. do 5. stopnje je bila med kombiniranim zdravljenjem s pembrolizumabom 76 % in pri zdravljenju s sunitinibom samim 71 %.
English: The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution.
Slovenian: Koncentrat je bistra ali nekoliko opalescentna, brezbarvna do rahlo rumenkasta raztopina.
English: The following additional clinically significant, immune-related adverse reactions have been reported in clinical trials or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barré syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis and encephalitis (see sections 4.2 and 4.8).
Slovenian: V kliničnih preskušanjih in v obdobju trženja zdravila so poročali o naslednjih klinično pomembnih imunsko pogojenih neželenih učinkih: uveitisu, artritisu, miozitisu, miokarditisu, pankreatitisu, Guillain-Barréjevem sindromu, miasteničnem sindromu, hemolitični anemiji, sarkoidozi in encefalitisu (glejte poglavji 4.2 in 4.8).
English: Of the 834 patients, 60% were male, 44% were ≥ 65 years (median age was 62 years [range 18-89]) and 98% were white.
Slovenian: Od 834 bolnikov je bilo 60 % moških, 44 % starih ≥ 65 let (mediana starost je bila 62 let [razpon 18-89]) in 98 % je bilo belcev.
English: Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered.
Slovenian: Glede na izrazitost neželenega učinka je treba zadržati uporabo pembrolizumaba in uporabiti kortikosteroide.
English: Ninety percent of patients were treatment naïve, and 10% received prior adjuvant or neoadjuvant platinum-based chemotherapy.
Slovenian: Devetdeset odstotkov bolnikov predhodno še ni bilo zdravljenih, 10 % pa jih je predhodno prejemalo adjuvantno ali neoadjuvantno kemoterapijo na osnovi platine.
English: KEYTRUDA 200 mg every 3 weeks n=514
Slovenian: KEYTRUDA 200 mg vsake 3 tedne n = 514
English: A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were PD-L1 positive (PD-L1 expression in ≥ 1% of tumour and tumour-associated immune cells relative to all viable tumour cells - MEL score) vs. PD-L1 negative.
Slovenian: V okviru končne analize v študiji KEYNOTE-002 je bila opravljena analiza podskupin bolnikov, ki so bili PD-L1 pozitivni (izraženost PD-L1 pri ≥ 1 % tumorskih in s tumorjem povezanih imunskih celic v primerjavi z vsemi razpoložljivimi tumorskimi celicami - ocena po lestvici MEL), in PD-L1 negativni.
English: Of the patients who recovered, 92 (84%) were rechallenged with either pembrolizumab (3%) or axitinib (31%) monotherapy or with both (50%).
Slovenian: Med bolniki, ki so okrevali, so pri 92 (84 %) ponovno uporabili ali pembrolizumab (3 %) ali aksitinib (31 %) kot samostojni zdravljenji ali kombinacijo obeh (50 %).
English: Secondary efficacy outcome measures were ORR and response duration.
Slovenian: Sekundarni merili izida učinkovitosti sta bila ORR in trajanje odgovora.
English: The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function.
Slovenian: Vpliv okvare ledvic na očistek pembrolizumaba so ocenili s populacijskimi farmakokinetičnimi analizami pri bolnikih z blago ali zmerno okvaro ledvic v primerjavi z bolniki z normalnim delovanjem ledvic.
English: Pembrolizumab has not been studied in patients with moderate or severe hepatic impairment (see section 4.2).
Slovenian: Pembrolizumaba niso raziskali pri bolnikih z zmerno ali hudo okvaro jeter (glejte poglavje 4.2).
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 toxicity, except for endocrinopathies that are controlled with replacement hormones (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 toksičen imunsko pogojeni neželeni učinek 4. stopnje, razen v primeru endokrinopatij, ki so obvladljive z nadomeščanjem hormonov (glejte poglavji 4.2 in 4.8).
English: The efficacy of pembrolizumab in combination with carboplatin and either paclitaxel or nabpaclitaxel was investigated in Study KEYNOTE-407, a randomised, double-blind, multicentre, placebo-controlled study.
Slovenian: Učinkovitost pembrolizumaba v kombinaciji s karboplatinom in bodisi paklitakselom bodisi nab-paklitakselom so raziskali v študiji KEYNOTE-407, randomizirani, dvojno slepi, multicentrični, s placebom nadzorovani študiji.
English: Patients on chemotherapy who experienced independently-verified progression of disease were able to crossover and receive pembrolizumab.
Slovenian: Bolniki na kemoterapiji, pri katerih je prišlo do neodvisno potrjenega napredovanja bolezni, so lahko prešli na zdravljenje s pembrolizumabom.
English: The safety of pembrolizumab in combination with axitinib has been evaluated in a clinical study of 429 patients with advanced RCC receiving 200 mg pembrolizumab every 3 weeks and 5 mg axitinib twice daily.
Slovenian: Varnost pembrolizumaba v kombinaciji z aksitinibom so ocenili v klinični študiji pri 429 bolnikih z napredovalim rakom ledvičnih celic, ki so prejemali 200 mg pembrolizumaba na 3 tedne in 5 mg aksitiniba dvakrat na dan.
English: Table 11 summarises efficacy results by PD-L1 expression and BRAF mutation status.
Slovenian: Preglednica 11 prikazuje povzetek rezultatov učinkovitosti glede na izraženost PD-L1 in status mutacij BRAF.
English: The diluted solution must not be frozen.
Slovenian: Razredčene raztopine ne smete zamrzniti.
English: th edition classification, a total of 82 subjects were classified as stage IIIA; 42 in the pembrolizumab arm and 40 in the placebo arm; with a total of 13 RFS events; 6 in the pembrolizumab arm and 7 in the placebo arm.
Slovenian: Po razvrstitvi po 8. izdaji kriterijev AJCC je bil melanom pri skupno 82 bolnikih klasificiran kot stadij IIIA: pri 42 bolnikih v skupini s pembrolizumabom in 40 bolnikih v skupini s placebom; s skupno 13 RFS dogodki: 6 dogodki v skupini s pembrolizumabom in 7 dogodki v skupini s placebom.
English: Common aspartate aminotransferase increased, alanine aminotransferase increased, hypercalcaemia, blood alkaline phosphatase increased, blood bilirubin increased, blood creatinine increased hypercalcaemia, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased
Slovenian: Pogosti zvišana aspartat-aminotransferaza, zvišana alaninaminotransferaza, hiperkalciemija, zvišana alkalna fosfataza v krvi, zvišan bilirubin v krvi, zvišan kreatinin v krvi hiperkalciemija, zvišana alanin-aminotransferaza, zvišana aspartataminotransferaza, zvišana alkalna fosfataza v krvi zvišana alkalna fosfataza v krvi, hiperkalciemija, zvišan bilirubin v krvi
English: Common hyponatraemia, hypokalaemia, hypocalcaemia hyponatraemia, hypocalcaemia hypokalaemia, hyponatraemia, hypocalcaemia
Slovenian: Pogosti hiponatriemija, hipokaliemija, hipokalciemija hiponatriemija, hipokalciemija hipokaliemija, hiponatriemija, hipokalciemija
English: ORR difference, % (95% CI)
Slovenian: razlika ORR, % (95 % IZ)
English: KEYNOTE-054: Placebo-controlled trial for the adjuvant treatment of patients with completely resected melanoma
Slovenian: KEYNOTE-054: S placebom nadzorovano preskušanje adjuvantnega zdravljenja bolnikov s popolnoma kirurško odstranjenim melanomom
English: - If you are a woman who could become pregnant, you must use adequate birth control while you are being treated with KEYTRUDA and for at least 4 months after your last dose.
Slovenian: - Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom KEYTRUDA in vsaj še
English: Hypothyroidism is more frequently reported in patients with HNSCC with prior radiation therapy.
Slovenian: O hipotiroidizmu so pogosteje poročali pri bolnikih s HNSCC, ki so se predhodno zdravili z obsevanjem.