FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Slovenian: 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
English: Twenty-one percent had received 2 prior systemic regimens in the metastatic setting.
Slovenian: Enaindvajset odstotkov bolnikov je v okoliščinah z metastazami prejelo 2 predhodni shemi sistemskega zdravljenja.
English: - Your doctor will give you KEYTRUDA through an infusion into your vein (IV) for about
Slovenian: - Zdravnik vam bo zdravilo KEYTRUDA dal v veno (i.v.)
English: Rare immune thrombocytopenic purpura, haemolytic anaemia, pure red cell aplasia, haemophagocytic lymphohistiocytosis eosinophilia
Slovenian: Redki imunska trombocitopenična purpura, hemolitična anemija, čista aplazija rdečih krvnih celic, hemofagocitna limfohistiocitoza eozinofilija
English: 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.
Slovenian: 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.
English: Chemotherapy n=179
Slovenian: kemoterapija n = 179
English: PD-L1 negative
Slovenian: PD-L1 negativni
English: KEYTRUDA contains the active substance pembrolizumab, which is a monoclonal antibody.
Slovenian: Zdravilo KEYTRUDA vsebuje učinkovino pembrolizumab, ki je monoklonsko protitelo.
English: Number at Risk Pembrolizumab 2 mg/kg: Pembrolizumab 10 mg/kg: Docetaxel:
Slovenian: vrednost p pembrolizumab 2 mg/kg pembrolizumab 10 mg/kg docetaksel število izpostavljenih tveganju pembrolizumab 2 mg/kg: pembrolizumab 10 mg/kg: docetaksel:
English: 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).
Slovenian: 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).
English: Table 28: Efficacy Results in KEYNOTE-426
Slovenian: Preglednica 28: Rezultati učinkovitosti v študiji KEYNOTE-426
English: 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.
Slovenian: - Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
English: • Equilibrate the vial to room temperature (at or below 25°C).
Slovenian: • Pustite, da se viala ogreje na sobno temperaturo (25 °C ali manj).
English: 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.
Slovenian: 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.
English: Table 17: Response to pembrolizumab 2 or 10 mg/kg every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010
Slovenian: 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
English: PD L1 positive
Slovenian: PD L1 pozitivni
English: This 96 hour total hold from reconstitution may include up to 6 hours at room temperature (at or below 25°C).
Slovenian: V celotnih 96 urah od priprave je lahko zdravilo do 6 ur na sobni temperaturi (25 °C ali manj).
English: The median time to onset of ALT increased was 2.3 months (range: 7 days to 19.8 months).
Slovenian: Mediani čas do zvišanja vrednosti ALT je bil 2,3 meseca (v razponu od 7 dni do 19,8 meseca).
English: • KEYTRUDA 200 mg every 3 weeks
Slovenian: • zdravilo KEYTRUDA 200 mg na 3 tedne
English: Table 8 summarises efficacy results by PD-L1 expression.
Slovenian: Preglednica 8 povzema rezultate učinkovitosti glede na izraženost PD-L1.
English: Nervous system disorders Very common headache dizziness, headache, neuropathy peripheral, dysgeusia headache, dysgeusia
Slovenian: Bolezni živčevja Zelo pogosti glavobol omotica, glavobol, periferna nevropatija, disgevzija glavobol, disgevzija
English: Forty-five percent had an ECOG Performance Status of 1, 40% had elevated LDH and 23% had a BRAF mutated tumour.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: The median time to onset of pneumonitis was 3.3 months (range 2 days to 26.8 months).
Slovenian: Mediani čas do pojava pnevmonitisa je bil 3,3 meseca (v razponu od 2 dni do 26,8 meseca).
English: What KEYTRUDA contains The active substance is pembrolizumab.
Slovenian: Kaj vsebuje zdravilo KEYTRUDA Učinkovina je pembrolizumab.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 12.7 (11.5, NA)
Slovenian: 12,7 (11,5; NP)
English: Placebo + Pemetrexed + Platinum Chemotherapy n=206
Slovenian: placebo + pemetreksed + kemoterapija na osnovi platine n = 206
English: 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.
Slovenian: 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.
English: Uncommon adrenal insufficiency hypophysitis d, thyroiditis hypophysitis d,
Slovenian: Občasni adrenalna insuficienca hipofizitis d, tiroiditis hipofizitis d, tiroiditis e, adrenalna insuficienca
English: Table 9 summarizes efficacy results by PD-L1 expression.
Slovenian: Preglednica 9 povzema rezultate učinkovitosti glede na izraženost PD-L1.
English: Discard the vial if visible particles are observed.
Slovenian: Če opazite vidne delce, vialo zavrzite.
English: Severe skin reactions led to discontinuation of pembrolizumab in 9 (0.2%) patients.
Slovenian: Hude kožne reakcije so bile razlog za ukinitev zdravljenja s pembrolizumabom pri 9 bolnikih (0,2 %).
English: Pembrolizumab Carboplatin Paclitaxel/Nab-paclitaxel n=278
Slovenian: opazovani dogodek pembrolizumab karboplatin paklitaksel/nab-paklitaksel n = 278
English: 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.
Slovenian: 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 %]).
English: The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 22.5 months).
Slovenian: Mediani čas do pojava hipertiroidizma je bil 1,4 meseca (v razponu od 1 dneva do 22,5 meseca).
English: For use in combination, see the SmPC for the concomitant therapies.
Slovenian: Za uporabo v kombinaciji glejte povzetke glavnih značilnosti sočasno uporabljenih zdravil.
English: 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.
Slovenian: 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.
English: • a kind of head and neck cancer called head and neck squamous cell carcinoma.
Slovenian: • vrste raka glave in vratu, imenovanega ploščatocelični rak glave in vratu,
English: Adrenal insufficiency led to discontinuation of pembrolizumab in 4 (0.1%) patients.
Slovenian: Adrenalna insuficienca je bila razlog za ukinitev zdravljenja s pembrolizumabom pri 4 bolnikih (0,1 %).
English: Eye disorders Common dry eye dry eye dry eye
Slovenian: Očesne bolezni Pogosti suho oko suho oko suho oko
English: KEYTRUDA, or if corticosteroid dosing cannot be reduced to ≤ 10 mg prednisone or equivalent per day within 12 weeks, KEYTRUDA should be permanently discontinued.
Slovenian: * 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.
English: Sixty-three percent had M1c stage and 2% of patients had a history of brain metastases.
Slovenian: Triinšestdeset odstotkov je imelo M1c stadij in 2 % bolnikov sta imela v anamnezi metastaze v možganih.
English: 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).
Slovenian: 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).
English: There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development.
Slovenian: V primeru nastanka vežočih ali nevtralizirajočih protiteles proti pembrolizumabu niso ugotovili spremenjenega farmakokinetičnega ali varnostnega profila.
English: Complete response % Partial response % 23% Response duration Median in months (range)
Slovenian: popolni odgovor % delni odgovor % 23 % trajanje odgovora mediana v mesecih (razpon)
English: 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
Slovenian: 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
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The median time to onset of hepatitis was 3.6 months (range 8 days to 21.4 months).
Slovenian: Mediani čas do pojava hepatitisa je bil 3,6 meseca (v razponu od 8 dni do 21,4 meseca).
English: Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy.
Slovenian: Bolnikom, ki so prejemali placebo in kemoterapijo, pri katerih je bolezen po neodvisni presoji napredovala, je bilo ponujeno samostojno zdravljenje s pembrolizumabom.
English: RFS Hazard ratio* (95% CI) RFS rate at 6 months
Slovenian: RFS razmerje ogroženosti* (95 % IZ) delež RFS po 6 mesecih
English: The median time to onset of nephritis was 5.0 months (range 12 days to 21.4 months).
Slovenian: Mediani čas do pojava nefritisa je bil 5,0 meseca (v razponu od 12 dni do 21,4 meseca).
English: Standard Treatment* n=133
Slovenian: standardno zdravljenje* n = 133
English: 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
Slovenian: 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
English: 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.
Slovenian: 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.
English: Kaplan Meier curves for OS based on the final analysis are shown in Figures 13 and 14.
Slovenian: Kaplan-Meierjeve krivulje celokupnega preživetja na podlagi končne analize so prikazane na slikah 13 in 14.
English: 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.
Slovenian: 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.
English: Uncommon amylase increased blood bilirubin increased, amylase increased amylase increased
Slovenian: Občasni zvišana amilaza zvišan bilirubin v krvi, zvišana amilaza zvišana amilaza
English: 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.
Slovenian: 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.
English: Table 15: Efficacy Results in KEYNOTE-407
Slovenian: Preglednica 15: Rezultati učinkovitosti v študiji KEYNOTE-407
English: 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.
Slovenian: 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).
English: Uncommon tenosynovitis tenosynovitis
Slovenian: Občasni tendosinovitis tendosinovitis
English: *Based on the stratified Cox proportional hazard model
Slovenian: *Na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti
English: Guillain-Barré syndrome g,
Slovenian: Guillain-Barréjev sindrom g, miastenični sindrom h, meningitis (aseptični)
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: Psychiatric disorders Common insomnia insomnia insomnia
Slovenian: Psihiatrične motnje Pogosti nespečnost nespečnost nespečnost
English: The median time to onset of hypothyroidism was 3.5 months (range 1 day to 19.6 months).
Slovenian: Mediani čas do pojava hipotiroidizma je bil 3,5 meseca (v razponu od 1 dneva do 19,6 meseca).
English: Favourable
Slovenian: ugodna
English: Figure 10: Kaplan-Meier Curve for Progression-Free Survival in KEYNOTE-407
Slovenian: Slika 10: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni v študiji KEYNOTE-407
English: It is unknown whether pembrolizumab is secreted in human milk.
Slovenian: Ni znano, ali se pembrolizumab izloča v materino mleko.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The median follow-up time was 12.8 months (range: 0.1 to 21.5 months).
Slovenian: Mediani čas spremljanja je znašal 12,8 meseca (v razponu od 0,1 do 21,5 meseca).
English: The diluted solution may be stored for up to 96 hours in a refrigerator (2°C - 8°C).
Slovenian: Razredčeno raztopino lahko shranjujete v hladilniku (2 °C - 8 °C) do skupno 96 ur.
English: Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement.
Slovenian: Za zagotovitev ustreznega nadomeščanja hormonov je treba spremljati delovanje ščitnice in vrednosti hormonov.
English: Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion:
Slovenian: Bolnike so randomizirali (v razmerju 1:1) v eno od naslednjih terapevtskih skupin z uporabo intravenskega infundiranja:
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
Slovenian: Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za zdravljenje lokalno napredovalega ali metastatskega urotelijskega raka pri odraslih, ki niso primerni za zdravljenje s kemoterapijo, ki vsebuje cisplatin, in imajo tumorje z izraženostjo PD-L1 ≥ 10, ocenjeno s kombinirano pozitivno oceno (CPS) (glejte poglavje 5.1).
English: The median duration was 1.8 months (range 4 days to 29.2+ months).
Slovenian: Njegovo mediano trajanje je bilo 1,8 meseca (v razponu od 4 dni do 29,2+ meseca).
English: Response: Best objective response as confirmed complete response or partial response Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive)
Slovenian: Odgovor: najboljši objektivni odgovor, potrjen kot popolni oziroma delni odgovor Na podlagi Miettinenove in Nurminenove metode, stratificirane na podlagi ocene zmogljivosti po ECOG lestvici (0 v prim.
English: Combination with axitinib
Slovenian: Kombinirano zdravljenje z aksitinibom
English: The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline.
Slovenian: Značilnosti raziskovane populacije so bile: mediana starost 65 let (razpon: od 29 do 88), 55 % starih 65 let ali več, 81 % moških, 77 % belcev, ocena zmogljivosti po ECOG lestvici 0 (29 %) in 1 (71 %) in 8 % z izhodiščno že zdravljenimi metastazami v možganih.
English: Table 3 summarises key efficacy measures in patients naïve to treatment with ipilimumab at the final analysis performed after a minimum of 21 months of follow-up.
Slovenian: Preglednica 3 povzema ključna merila učinkovitosti končne analize, opravljene po najmanj 21 mesecih spremljanja, pri bolnikih, ki predhodno niso bili zdravljeni z ipilimumabom.
English: 12-month OS rate, % (95% CI)
Slovenian: 12-mesečni delež celokupnega preživetja (OS), % (95 % IZ)
English: The median trough concentrations (Cmin) at steady-state were approximately 22 mcg/mL at a dose of 2 mg/kg every 3 weeks and 29 mcg/mL at a dose of 200 mg every 3 weeks.
Slovenian: Mediana najmanjša koncentracija v stanju dinamičnega ravnovesja (Cmin) je bila ob odmerku 2 mg/kg na 3 tedne približno 22 µg/ml in ob odmerku 200 mg na 3 tedne 29 µg/ml.
English: Number (%) of patients with event Median in months (95% CI)
Slovenian: število (%) bolnikov z dogodkom mediana v mesecih (95 % IZ)