FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Slovenian: Pri bolnikih s hudo okvaro ledvic je na voljo premalo podatkov, zato zaključkov za to populacijo ni mogoče navesti.
English: Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PDL1 positive (tumour membrane expression cut off of 1%, 5% or 10%).
Slovenian: Korist za preživetje je bila opažena ne glede na PD-L1 negativno ali PD-L1 pozitivno označenost tumorja (mejna vrednost ekspresije tumorske membrane 1 %, 5 % ali 10 %).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OPDIVO 10 mg/mL sterile concentrate nivolumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE OPDIVO 10 mg/ml sterilni koncentrat nivolumab i.v.
English: Ipilimumab 3 mg/kg over 90 minutes
Slovenian: Ipilimumab 3 mg/kg v obliki 90-minutne i.v.
English: The first tumour assessments were conducted 4 weeks after the start of treatment and continued thereafter until disease progression or treatment discontinuation.
Slovenian: Prvo vrednotenje tumorja je bilo izvedeno 4 tedne po začetku zdravljenja in se je nadaljevalo do napredovanja bolezni ali prekinitve zdravljenja.
English: In patients treated with nivolumab monotherapy, the incidence of nephritis or renal dysfunction was 2.8% (71/2578).
Slovenian: Pri bolnikih, ki so se zdravili z nivolumabom v monoterapiji, je pojavnost nefritisa ali okvare delovanja ledvic znašala 2,8 % (71/2.578).
English: Do not use OPDIVO after the expiry date which is stated on the carton and on the vial label after EXP.
Slovenian: Zdravila OPDIVO ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: If the patient has developed SJS or TEN with the use of nivolumab or nivolumab in combination with ipilimumab, permanent discontinuation of treatment is recommended (see section 4.2).
Slovenian: Če se med zdravljenjem z nivolumabom pri bolniku pojavi SJS ali TEN, je zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom priporočljivo trajno ukiniti (glejte poglavje 4.2).
English: Updated analysis Minimum follow-up: 24.2 months
Slovenian: Dopolnjena analiza Najmanjše obdobje spremljanja: 24,2 meseca
English: Preparing the infusion Take care to ensure aseptic handling when you prepare the infusion.
Slovenian: Priprava raztopine za infundiranje Pri pripravi raztopine za infundiranje morate zagotoviti aseptične pogoje.
English: Efficacy results are shown in Table 14.
Slovenian: Rezultati učinkovitosti so prikazani v preglednici 14.
English: At 24 months, the OS rate was 66.5 (95% CI 61.8-70.9) for nivolumab in combination with ipilimumab and 52.9 (95% CI 47.9- 57.7) for sunitinib.
Slovenian: Po 24 mesecih je delež celokupnega preživetja pri nivolumabu v kombinaciji z ipilimumabom znašal 66,5 (95 % IZ 61,8-70,9), pri sunitinibu pa 52,9 (95 % IZ 47,9-57,7).
English: Nivolumab has not been studied in patients with moderate (total bilirubin > 1.5 × to 3 × ULN and any AST) or severe hepatic impairment (total bilirubin > 3 × ULN and any AST) (see section 4.2).
Slovenian: Pri bolnikih z zmerno (skupni bilirubin > 1,5 × do 3 × ZMN in katera koli vrednost AST) ali s hudo okvaro jeter (skupni bilirubin > 3 × ZMN in katera koli vrednost AST) uporabe nivolumaba niso raziskovali (glejte poglavje 4.2).
English: No Grade 5 cases were reported.
Slovenian: O primerih stopnje 5 niso poročali.
English: Patients with Karnofsky performance status < 70% and patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study.
Slovenian: Bolnike z oceno stanja telesne zmogljivosti po Karnofskem < 70 % in bolnike z anamnezo zasevkov v možganih ali s trenutnimi zasevki v možganih, aktivno avtoimunsko boleznijo ali zdravstvenimi stanji, ki so zahtevala zdravljenje z zdravili za sistemsko zaviranje imunske odzivnosti, so iz te študije izključili.
English: Cardiac and pulmonary adverse events including pulmonary embolism have also been reported with combination therapy.
Slovenian: Pri kombiniranem zdravljenju so poročali tudi o neželenih učinkih za srce in pljuča, vključno s pljučno embolijo.
English: Resolution occurred in 63 patients (72.4%) with a median time to resolution of 6.1 weeks (range: 0.1+-96.7+); + denotes a censored observation.
Slovenian: Do izboljšanja je prišlo pri 63 bolnikih (72,4 %), mediani čas do izboljšanja pa je znašal 6,1 tedna (razpon: 0,1+-96,7+); + označuje krnjene podatke.
English: The geometric mean clearance (CL), terminal half-life, and average exposure at steady state at 3 mg/kg every 2 weeks of nivolumab were 7.9 mL/h, 25.0 days, and 86.6 μg/mL, respectively, based on a population PK analysis.
Slovenian: Na osnovi podatkov analize populacijske farmakokinetike geometrijski srednji očistek nivolumaba znaša 7,9 ml/uro, končni razpolovni čas 25,0 dni, povprečna izpostavljenost v stanju dinamičnega ravnovesja pri uporabi odmerka 3 mg/kg vsaka 2 tedna pa 86,6 g/ml.
English: Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg
Slovenian: Nivolumab v odmerku 1 mg/kg v kombinaciji z ipilimumabom v odmerku 3 mg/kg*
English: Tumour assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks for the first year and then every 12 weeks thereafter.
Slovenian: Vrednotenje tumorja na osnovi različice 1.1 kriterijev za vrednotenje odziva pri solidnih tumorjih (RECIST v1.1, Response Evaluation Criteria in Solid Tumours, version 1.1) je bilo izvedeno 9 tednov po randomizaciji in se je v prvem letu nadaljevalo na vsakih 6 tednov, nato pa na vsakih 12 tednov.
English: Non-squamous NSCLC
Slovenian: Neploščatocelični NSCLC
English: 95% CI: 3.8, 24.6
Slovenian: 95 % IZ: 3,8; 24,6
English: Common stomatitis, pancreatitis, constipation, dry mouth colitis, stomatitis, pancreatitis, abdominal pain, constipation, dry mouth
Slovenian: Pogosti stomatitis, pankreatitis, zaprtost, suha usta kolitis, stomatitis, pankreatitis, bolečina v trebuhu, zaprtost, suha usta
English: Median age, years (range) Gender
Slovenian: Mediana starost, leta (razpon)
English: 95% CI: 29.0, 53.7
Slovenian: 95 % IZ: 29,0; 53,7
English: Resolution occurred in 186 patients (89.4%) with a median time to resolution of 3.0 weeks (range: 0.1-159.4+).
Slovenian: Do izboljšanja je prišlo pri 186 bolnikih (89,4 %), mediani čas do izboljšanja pa je znašal 3,0 tedna (razpon: 0,1-159,4+).
English: Overall survivald
Slovenian: Celokupno preživetjec
English: Grade 3 thyroid disorders were reported in < 0.1% (2/2578) of patients.
Slovenian: O boleznih ščitnice stopnje 3 so poročali pri < 0,1 % (2/2.578) bolnikov.
English: Grade 2, Grade 3, and Grade 4 adrenal insufficiency (including secondary adrenocortical insufficiency) occurred in 2.9% (16/547), 2.2% (12/547) and 0.4% (2/547) of patients, respectively.
Slovenian: O insuficienci nadledvičnih žlez (vključno s sekundarno adrenokortikalno insuficienco) stopnje 2 so poročali pri 2,9 % (16/547) bolnikov, stopnje 3 pri 2,2 % (12/547) bolnikov in stopnje 4 pri 0,4 % (2/547) bolnikov.
English: 95% CI: 8.6, 23.3
Slovenian: 95 % IZ: 8,6; 23,3
English: Rate (95% CI) At 6 months At 12 months Progression-free survival Events
Slovenian: Delež (95 % IZ) v 6. mesecu v 12. mescu Preživetje brez napredovanja bolezni Dogodki Razmerje ogroženosti
English: Efficacy results for the intermediate/poor risk patients from the primary analysis (minimum follow-up 17.5 months) are shown in Table 19.
Slovenian: Rezultati učinkovitosti iz primarne analize pri bolnikih s srednje ugodnim ali slabim prognostičnim obetom so prikazani v preglednici 19.
English: Overall survivala
Slovenian: Celokupno preživetjea
English: Uncommon tachycardia, pericardial disordersj Rare arrhythmia (including ventricular arrhythmia)d, atrial fibrillation, myocarditisa,f Vascular disorders
Slovenian: Redki aritmija (vključno z ventrikularno aritmijo)d, atrijska fibrilacija, miokarditisa,f
English: Grade 2 and Grade 3 hypophysitis (including lymphocytic hypophysitis) occurred in 5.8% (26/448) and 2.0% (9/448) of patients, respectively.
Slovenian: O vnetju hipofize (vključno z limfocitnim hipofizitisom) stopnje 2 so poročali pri 5,8 % (26/448) bolnikov, o vnetju hipofize (vključno z limfocitnim hipofizitisom) stopnje 3 pa pri 2,0 % (9/448) bolnikov.
English: These subgroup analyses should be interpreted with caution given the small size of the subgroups and lack of statistically significant difference in OS in the all randomised population.
Slovenian: Zaradi majhne velikosti podskupin in pomanjkanja statistično pomembne razlike pri celokupnem preživetju pri celotni randomizirani populaciji je treba te analize po podskupinah interpretirati previdno.
English: OS benefit was observed regardless of tumour PD-L1 expression level.
Slovenian: Korist za celokupno preživetje je bila opažena ne glede na nivo ekspresije PD-L1 tumorja.
English: Gently mix the infusion by manual rotation.
Slovenian: Raztopino za infundiranje z vrtenjem v rokah nežno premešajte.
English: Overall survivalc Events Hazard ratioa (95% CI) Rate (95% CI) at 24 months Confirmed objective response (95% CI) Median duration of response Months (range) Progression-free survival Rate (95% CI) at 24 months
Slovenian: Celokupno preživetjed Dogodki Razmerje ogroženostia (95 % IZ) Delež (95 % IZ) v 60. mesecu Potrjeni objektivni odziv (95 % IZ) Mediana trajanja odziva Meseci (razpon) Preživetje brez napredovanja bolezni Delež (95 % IZ) v 60. mesecu
English: Nivolumab+ipilimumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: < 0.0001 Nivolumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.55 (0.42, 0.73); p-value: < 0.0001
Slovenian: nivolumab+ipilimumab v primerjavi z ipilimumabom (primarna analiza) - HR (99,5 % IZ): 0,42 (0,32; 0,56); p-vrednost: < 0,0001 nivolumab v primerjavi z ipilimumabom (primarna analiza) - HR (99,5 % IZ): 0,55 (0,42; 0,73); p-vrednost:
English: Seventy-three percent of patients had cutaneous melanoma and 10% had mucosal melanoma.
Slovenian: 73 % bolnikov je imelo kožni melanom, 10 % bolnikov pa melanom sluznice.
English: Baseline ECOG performance status was 0 (54%) or 1 (46%).
Slovenian: Ocena stanja telesne zmogljivosti po lestvici ECOG v izhodišču je bila 0 (54 %) ali 1 (46 %).
English: In patients treated with nivolumab monotherapy, the incidence of diarrhoea, colitis, or frequent bowel movements was 13.1% (339/2578).
Slovenian: Pri bolnikih, ki so se zdravili z nivolumabom v monoterapiji, je pojavnost driske, kolitisa ali pogostejšega odvajanja blata znašala 13,1 % (339/2.578).
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare histiocytic necrotising lymphadenitis (Kikuchi lymphadenitis) Blood and lymphatic system disorders Very common neutropaeniaa,b Uncommon eosinophilia Immune system disorders
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Redki histiocitni nekrotizirajoči limfadenitis (Kikuchijev limfadenitis)
English: Table 4:
Slovenian: Slika 4:
English: Median time to onset of these endocrinopathies was 2.8 months (range: 0.3-29.1).
Slovenian: Mediani čas do nastopa teh endokrinopatij je znašal 2,8 meseca (razpon: 0,3-29,1).
English: This study included patients regardless of their tumour PD-L1 status.
Slovenian: Bolnike so v to študijo vključili ne glede na status PD-L1 tumorja.
English: Grade 2 and Grade 3 cases were reported in 13.7% (75/547) and 3.7% (20/547) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 13,7 % (75/547) bolnikov, o primerih stopnje 3 pa pri 3,7 % (20/547) bolnikov.
English: NAME OF THE MEDICINAL PRODUCT OPDIVO 10 mg/mL concentrate for solution for infusion.
Slovenian: IME ZDRAVILA OPDIVO 10 mg/ml koncentrat za raztopino za infundiranje
English: No Grade 4 or 5 cases were reported.
Slovenian: O primerih stopnje 4 ali 5 niso poročali.
English: Inspect the OPDIVO concentrate for particulate matter or discoloration.
Slovenian: Koncentrat zdravila OPDIVO preglejte glede prisotnosti trdnih delcev ali spremembe barve.
English: Sixty-one percent of patients had M1c stage disease at study entry.
Slovenian: Ob vključitvi v študijo je 61 % bolnikov imelo bolezen v stadiju M1c.
English: Six patients (4%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
Slovenian: Šest bolnikov (4 %), ki so bili randomizirani na docetaksel, je kadar koli med študijo prešlo na zdravljenje z nivolumabom.
English: Efficacy results are shown in Table 8.
Slovenian: Rezultati učinkovitosti so prikazani v preglednici 8.
English: Efficacy results are shown in Table 23.
Slovenian: Rezultati učinkovitosti so prikazani v preglednici 23.
English: Treatment should be continued in the presence of hormone replacement therapyb as long as no symptoms are present
Slovenian: Če med hormonskim nadomestnim zdravljenjemb simptomi niso prisotni, je treba zdravljenje nadaljevati.
English: Among all randomised patients, the ORR was 27.2% (95% CI: 22.0, 32.9) in the nivolumab group and 9.8% (95% CI: 5.3, 16.1) in the chemotherapy group.
Slovenian: Med vsemi randomiziranimi bolniki je delež objektivnega odziva v skupini z nivolumabom znašal 27,2 % (95 % interval zaupanja: 22,0; 32,9), v skupini s kemoterapijo pa 9,8 % (95 % interval zaupanja: 5,3; 16,1).
English: Single-arm phase 2 study (CA209063)
Slovenian: Enoskupinska študija 2. faze (študija CA209063)
English: Grade 3 cases were reported in 1.6% (41/2578) of patients.
Slovenian: O primerih stopnje 3 so poročali pri 1,6 % (41/2.578) bolnikov.
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of relapsed or refractory cHL following ASCT was evaluated in two multi-centre, open-label, single-arm studies (CA209205 and CA209039).
Slovenian: Varnost in učinkovitost nivolumaba v odmerku 3 mg/kg kot samostojnega zdravila za zdravljenje ponovljenega ali neodzivnega cHL po ASCT so vrednotili v dveh multicentričnih, odprtih, enoskupinskih študijah (CA209205 in CA209039).
English: Recommended doses and infusion times for intravenous administration of nivolumab in combination with ipilimumab
Slovenian: Preglednica 2: Priporočeni odmerki in časi infundiranja pri intravenski aplikaciji nivolumaba v kombinaciji z ipilimumabom
English: OPDIVO will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 30 or 60 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving.
Slovenian: Pri nadaljevanju zdravljenja (faza zdravljenja samo z enim zdravilom) boste infuzijo, ki bo trajala 30 minut ali 60 minut, prejemali vsaka 2 tedna ali vsake 4 tedne, odvisno od odmerka, ki ga boste prejemali.
English: Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.
Slovenian: V primeru alogenske presaditve matičnih celic vas bo zdravnik nadziral glede znakov morebitnih zapletov.
English: Among the patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in CA209067, 154/313 (49%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Slovenian: Pri bolnikih, ki so se v študiji CA209067 zdravili z nivolumabom v odmerku 1 mg/kg v kombinaciji z ipilimumabom v odmerku 3 mg/kg, so se pri 154/313 bolnikov (49 %) neželeni učinki stopnje 3 ali 4 prvič pojavili med uvodno fazo s kombiniranim zdravljenjem.
English: Based on the severity of the adverse reaction, nivolumab or nivolumab in combination with ipilimumab should be withheld and corticosteroids administered.
Slovenian: Na osnovi resnosti neželenega učinka je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom zadržati in uvesti zdravljenje s kortikosteroidi.
English: For additional information on the safety profile of ipilimumab monotherapy, please refer to the ipilimumab SmPC.
Slovenian: Za dodatne informacije glede opozoril in previdnostnih ukrepov, povezanih z zdravljenjem z ipilimumabom, upoštevajte SmPC za ipilimumab.
English: In intermediate/poor-risk patients, OS benefit was observed in the nivolumab in combination with ipilimumab arm vs. sunitinib regardless of tumour PD-L1 expression.
Slovenian: Pri bolnikih s srednje ugodnim ali slabim prognostičnim obetom so korist za celokupno preživetje v skupini z nivolumabom v kombinaciji z ipilimumabom v primerjavi s skupino s sunitinibom opazili ne glede na ekspresijo PD-L1 tumorja.
English: A total of 418 patients were randomised to receive either nivolumab (n = 210) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or dacarbazine (n = 208) at 1000 mg/m2 every
Slovenian: Skupno 418 bolnikov so randomizirali na zdravljenje z nivolumabom (n = 210) v odmerku 3 mg/kg v obliki 60-minutne intravenske infuzije vsaka 2 tedna ali na zdravljenje z dakarbazinom (n = 208) v odmerku 1.000 mg/m2 vsake 3 tedne.
English: Resolution occurred in 86 patients (85.1%) with a median time to resolution of 6.1 weeks (range: 0.1+-82.9+).
Slovenian: Do izboljšanja je prišlo pri 86 bolnikih (85,1 %), mediani čas do izboljšanja pa je znašal 6,1 tedna (razpon: 0,1+-82,9+).
English: Randomised phase 2 study of nivolumab in combination with ipilimumab and ipilimumab (CA209069)
Slovenian: Randomizirana klinična študija 2. faze za ovrednotenje nivolumaba v kombinaciji z ipilimumabom in ipilimumaba v monoterapiji (študija CA209069)
English: Study CA209069 was a randomised, Phase 2, double-blind study comparing the combination of nivolumab and ipilimumab with ipilimumab alone in 142 patients with advanced (unresectable or metastatic) melanoma with similar inclusion criteria to study CA209067 and the primary analysis in patients with BRAF wild-type melanoma (77% of patients).
Slovenian: Študija CA209069 je bila randomizirana, dvojno slepa študija 2. faze, ki je primerjala uporabo kombinacije nivolumaba in ipilimumaba z uporabo ipilimumaba samega pri 142 bolnikih z napredovalim (neoperabilnim ali metastatskim) melanomom.
English: Patients with active brain metastases or leptomeningeal metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study.
Slovenian: Bolnike z aktivnimi zasevki v možganih ali leptomeningah, aktivno avtoimunsko boleznijo ali zdravstvenimi stanji, ki so zahtevala zdravljenje z zdravili za sistemsko zaviranje imunske odzivnosti, so iz študije izključili.
English: Hazard ratioa 95% CI p-value p<0.0001
Slovenian: Preživetje brez ponovitve bolezni Dogodki Razmerje ogroženostia 95 % IZ p-vrednost p<0,0001
English: One vial of 24 mL contains 240 mg of nivolumab.
Slovenian: Ena viala s 24 ml vsebuje 240 mg nivolumaba.
English: OPDIVO in combination with ipilimumab Melanoma
Slovenian: Zdravilo OPDIVO v kombinaciji z ipilimumabom Melanom
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Slovenian: Če ob dogovorjenem terminu niste uspeli priti, se o prejemu naslednjega odmerka zdravila posvetujte z zdravnikom.
English: Resolution occurred in 191 patients (65.9%) with a median time to resolution of 11.4 weeks (range: 0.1-150.1+).
Slovenian: Do izboljšanja je prišlo pri 191 bolnikih (65,9 %), mediani čas do izboljšanja pa je znašal 11,4 tedna (razpon: 0,1-150,1+).
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.8% (26/547), 6.6% (36/547), and 1.6% (9/547) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 4,8 % (26/547) bolnikov, o primerih stopnje 3 pri 6,6 % (36/547) bolnikov, o primerih stopnje 4 pa pri 1,6 % (9/547) bolnikov.
English: Median Time to Response Months (range)
Slovenian: Mediana časa do odziva Meseci (razpon)
English: Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PD-L1 positive (tumour membrane expression cut off of 5% or 10%).
Slovenian: Korist za preživetje je bila opažena ne glede na PD-L1 negativno ali PD-L1 pozitivno označenost tumorja (mejna vrednost ekspresije tumorske membrane 5 % ali 10 %).
English: The safety and efficacy of nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg or nivolumab 3 mg/kg vs. ipilimumab 3 mg/kg monotherapy for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, double-blind study (CA209067).
Slovenian: Varnost in učinkovitost nivolumaba v odmerku 1 mg/kg v kombinaciji z ipilimumabom v odmerku 3 mg/kg ali nivolumaba v odmerku 3 mg/kg v primerjavi z ipilimumabom v odmerku 3 mg/kg v monoterapiji pri zdravljenju napredovalega (neoperabilnega ali metastatskega) melanoma so vrednotili v randomizirani, dvojno slepi študiji 3. faze (CA209067).
English: Tumour assessments were conducted 12 weeks after randomisation then every 6 weeks for the first year, and every 12 weeks thereafter.
Slovenian: Vrednotenje tumorja je bilo izvedeno 12 tednov po randomizaciji in se je v prvem letu nadaljevalo na vsakih 6 tednov, nato pa na vsakih 12 tednov.
English: In patients with tumour PD-L1 expression ≥1%, ORR was 33.5% for nivolumab (n=179; 95% CI: 26.7, 40.9) and 13.5% for chemotherapy (n=74; 95% CI: 6.7, 23.5).
Slovenian: Pri bolnikih z ekspresijo PD-L1 tumorja ≥1 % je delež objektivnega odziva pri zdravljenju z nivolumabom znašal 33,5 % (n=179; 95% interval zaupanja: 26,7; 40,9), pri zdravljenju s kemoterapijo pa 13,5 % (n=74; 95 % interval zaupanja: 6,7; 23,5).
English: Resolution occurred in 192 patients (72.2%) with a median time to resolution of 11.6 weeks (range: 0.1-126.7+).
Slovenian: Do izboljšanja je prišlo pri 192 bolnikih (72,2 %), mediani čas do izboljšanja pa je znašal 11,6 tedna (razpon: 0,1-126,7+).
English: Figure 6: Overall survival by PD-L1 expression: 1% cut off (CA209067) - Minimum follow-up of 36 months
Slovenian: Celokupno preživetje glede na ekspresijo PD-L1: mejna vrednost 1 % (študija CA209067) - najmanjše obdobje spremljanja 36 mesecev
English: The median age was 61 years (range: 18 to 90 years), 65% of patients were men, and 97% were white.
Slovenian: Mediana starost bolnikov je bila 61 let (razpon: 18 do 90 let), 65 % bolnikov je bilo moškega spola in 97 % bolnikov belcev.
English: Each mL of concentrate contains 10 mg of nivolumab.
Slovenian: En ml koncentrata vsebuje 10 mg nivolumaba.
English: Sixty-four percent of patients were men and 98% were white.
Slovenian: 83 % bolnikov je bilo moškega spola in 83 % bolnikov je bilo belcev.
English: Study CA209063 was a single-arm, open-label study conducted in 117 patients with locally advanced or metastatic squamous NSCLC after two or more lines of therapy; otherwise similar inclusion criteria as study CA209017 were applied.
Slovenian: Študija CA209063 je bila enoskupinska odprta študija, izvedena pri 117 bolnikih z lokalno napredovalim ali metastatskim ploščatoceličnim NSCLC po dveh ali več predhodnih režimih zdravljenja.
English: Randomised phase 3 study vs. dacarbazine (CA209066)
Slovenian: Randomizirana klinična študija 3. faze za ovrednotenje nivolumaba v primerjavi z dakarbazinom (študija CA209066)
English: Grade 2 and Grade 3 cases were reported in 10.4% (57/547) and 4.9% (27/547) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 10,4 % (57/547) bolnikov, o primerih stopnje 3 pa pri 4,9 % (27/547) bolnikov.
English: 95% CI: 1.4, 17.9 OS by tumour PD-L1 expression Minimum follow-up: 13.2 months Number of events (number of patients)
Slovenian: Celokupno preživetje (OS) glede na ekspresijo PD-L1 tumorja Najmanjše obdobje spremljanja: 13,2 meseca Število dogodkov (število bolnikov)
English: In patients treated with nivolumab monotherapy, the incidence of liver function test abnormalities was 6.7% (173/2578).
Slovenian: Pri bolnikih, ki so se zdravili z nivolumabom v monoterapiji, je pojavnost nenormalnih izvidov delovanja jeter znašala 6,7 % (173/2.578).