FrancophonIA/ELRC3.0 huggingface dataset:
English: At the time of this final ORR analysis, results from 120 nivolumab-treated patients and 47 chemotherapy-treated patients who had a minimum of 6 months of follow-up were analysed.
Slovenian: V času končne analize deleža objektivnega odziva so analizirali podatke, pridobljene pri 120 bolnikih, ki so se zdravili z nivolumabom, in 47 bolnikih, ki so se zdravili s kemoterapijo, in so jih spremljali najmanj 6 mesecev.
English: • patients treated with prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways),
Slovenian: • bolniki, ki so se predhodno zdravili z anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 ali anti CTLA-4 protitelesom (vključno z ipilimumabom ali s katerim koli drugim protitelesom ali zdravilom s specifično usmerjenim delovanjem na dodatno stimulacijo celic T ali poti kontrolnih točk),
English: Grade 2 or 3 creatinine elevation
Slovenian: Zvišanje vrednosti kreatinina stopnje 2 ali 3
English: Unless an alternate aetiology has been identified, signs or symptoms of endocrinopathies should be considered immune-related.
Slovenian: Če se ne ugotovi drugačne etiologije, je treba znake in simptome endokrinopatij obravnavati kot imunsko pogojene.
English: Months (range)
Slovenian: Meseci (razpon)
English: P-value is derived from a log-rank test stratified by prior maintenance therapy and line of therapy; the corresponding O'Brien-Fleming efficacy boundary significance level is 0.0408.
Slovenian: b p-vrednost na osnovi testa log-rank, stratificiranega gleda na predhodno vzdrževalno zdravljenje in linije zdravljenja; ustrezna O'Brien-Flemingova mejna vrednost signifikantne učinkovitosti je 0,0408.
English: Blood and lymphatic system disorders Common eosinophilia
Slovenian: Bolezni krvi in limfatičnega sistema Pogosti eozinofilija
English: Common dehydration dehydration
Slovenian: Pogosti dehidracija dehidracija
English: A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, solid tumour type, tumour size, and hepatic impairment.
Slovenian: Analiza podatkov populacijske farmakokinetike ne kaže razlik v očistku nivolumaba glede na starost, spol, raso, vrsto solidnega tumorja, velikost tumorja in okvaro jeter.
English: 208 35.94 (23.06, NR)
Slovenian: 208 35,94 (23,06; ND)
English: Patients with baseline performance score of 2 were included in study CA209171 (see section 5.1).
Slovenian: Bolnike z izhodiščno oceno telesne zmogljivosti 2 so vključili v študijo CA209171 (glejte poglavje 5.1).
English: Responses are summarised in Table 12.
Slovenian: Povzetek odzivov je prikazan v preglednici 12.
English: Results are shown in Table 21.
Slovenian: Rezultati so prikazani v preglednici 21.
English: Phase 3b/4 safety study (CA209374)
Slovenian: Študija varnosti faze 3b/4 (študija CA209374)
English: Table 10: Response rate at week 12 - all response evaluable patients and by subgroup (CA209172)
Slovenian: Preglednica 10: Delež odziva v 12. tednu - vsi bolniki z ovrednotenim odzivom in po podskupinah bolnikov (študija CA209172)
English: dacarbazine (n = 208)
Slovenian: dakarbazin (n = 208)
English: NR = not reached
Slovenian: ND = ni dosežena
English: Guillain-Barré syndrome, demyelination, myasthenic syndrome, encephalitisa,c
Slovenian: Guillain-Barréjev sindrom, demielinizacija, miastenijski sindrom, encefalitisa,c
English: To be taken into consideration when treating patients on a controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija.
English: The volume of OPDIVO concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the OPDIVO concentrate strength is 10 mg/mL).
Slovenian: Volumen koncentrata zdravila OPDIVO za pripravo odmerka (ml) = celotni odmerek v mg deljeno z 10 (jakost koncentrata zdravila OPDIVO je 10 mg/ml).
English: The primary OS analysis was not adjusted to account for subsequent therapies, with 54 (40.6%) patients in the chemotherapy arm subsequently receiving an anti-PD1 treatment.
Slovenian: Primarna analiza celokupnega preživetja ni bila prilagojena tako, da bi upoštevala nadaljnja zdravljenja, pri čemer se je v skupini s kemoterapijo 54 bolnikov (40,6 %) kasneje zdravilo z anti-PD1.
English: Permanent discontinuation of treatment was required in a greater proportion of patients receiving nivolumab in combination with ipilimumab than in those receiving nivolumab monotherapy.
Slovenian: Zdravljenje je bilo treba trajno ukiniti pri večjem deležu bolnikov, ki so se zdravili z nivolumabom v kombinaciji z ipilimumabom, kot pri bolnikih, ki so se zdravili z nivolumabom v monoterapiji.
English: ≥ 1% to < 10%a ≥ 10% to < 50%a ≥ 50%a
Slovenian: ≥ 1 % do < 10 %a ≥ 10 % do < 50 %a ≥ 50 %a
English: For the monotherapy phase, the first dose of nivolumab should be administered; 3 weeks after the last dose of the combination of nivolumab and ipilimumab if using 240 mg every 2 weeks; or 6 weeks after the last dose of the combination of nivolumab and ipilimumab if using 480 mg every 4 weeks.
Slovenian: V fazi zdravljenja v monoterapiji je prvi odmerek nivolumaba treba aplicirati: 3 tedne po zadnjem odmerku kombinacije nivolumaba in ipilimumaba, če se uporablja odmerek 240 mg vsaka 2 tedna; ali 6 tednov po zadnjem odmerku kombinacije nivolumaba in ipilimumaba, če se uporablja odmerek 480 mg vsake 4 tedne.
English: Because of the small size of this subgroup, no definitive conclusions can be drawn from these data.
Slovenian: Zaradi majhne velikosti te podskupine pa definitivnih zaključkov na osnovi teh podatkov ni mogoče navesti.
English: The Kaplan-Meier curves for OS (with a minimum follow-up of 24 months) in intermediate/poor risk patients are shown in Figure 11.
Slovenian: Kaplan-Meierjevi krivulji celokupnega preživetja (z najmanjšim obdobjem spremljanja 24 mesecev) pri bolnikih s srednje ugodnim ali slabim prognostičnim obetom sta prikazani na sliki 11.
English: Not reached (0+-12.5+)
Slovenian: ni dosežena (0+-12,5+)
English: P-value is derived from a log-rank test stratified by prior cetuximab; the corresponding O'Brien-Fleming efficacy boundary significance level is 0.0227.
Slovenian: b p-vrednost na osnovi testa log-rank, stratificiranega gleda na predhodno zdravljenje s cetuksimabom; ustrezna O'Brien-Flemingova mejna vrednost signifikantne učinkovitosti je 0,0227.
English: Of the 306 previously treated patients enrolled in the study, 107 had melanoma and received nivolumab at a dose of 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, or 10 mg/kg for a maximum of 2 years.
Slovenian: Od 306 predhodno zdravljenih bolnikov, ki so bili vključeni v študijo, je 107 bolnikov imelo melanom in so največ 2 leti prejemali nivolumab v odmerku 0,1 mg/kg, 0,3 mg/kg, 1 mg/kg, 3 mg/kg ali 10 mg/kg.
English: Changes in test results
Slovenian: Spremembe, ugotovljene pri preiskavah
English: Patients had an ECOG performance status score of 0 or 1 and were enrolled regardless of their tumour PD-L1 status.
Slovenian: Bolniki so imeli oceno stanja telesne zmogljivosti po lestvici ECOG 0 ali 1 in so bili vključeni ne glede na status PD-L1 tumorja.
English: The OS analysis was not adjusted to account for subsequent therapies received.
Slovenian: Analiza celokupnega preživetja ni bila prilagojena glede na naknadna zdravljenja.
English: An additional line of TKI therapy was allowed for patients with known EGFR mutation or ALK translocation.
Slovenian: Pri bolnikih z znano EGFR mutacijo ali ALK translokacijo je bila dovoljena še dodatna linija zdravljenja z zaviralcem tirozin-kinaze (TKI).
English: Among these 37 patients, treatment with nivolumab resulted in an ORR of 59.5% (22/37).
Slovenian: Pri teh 37 bolnikih je delež objektivnega odziva na zdravljenje z nivolumabom znašal 59,5 % (22/37).
English: chemotherapy (n = 47)
Slovenian: kemoterapija (n = 47)
English: Twenty-two percent of patients had received prior adjuvant therapy.
Slovenian: Dvaindvajset odstotkov bolnikov se je predhodno zdravilo adjuvantno.
English: Of patients evaluable for the presence of antiipilimumab antibodies, the incidence of anti-ipilimumab antibodies ranged from 6.3 to 8.4% and neutralising antibodies against ipilimumab ranged from 0 to 0.3%.
Slovenian: Pri bolnikih, ki so jih ovrednotili na prisotnost protiteles proti ipilimumabu, se je pojavnost protiteles proti ipilimumabu gibala v razponu od 6,3 % do 8,4 %, pojavnost nevtralizirajočih protiteles proti ipilimumabu pa v razponu od 0 % do 0,3 %.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/4 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 mg/4 ml
English: Before initiating treatment with the combination, physicians are advised to carefully evaluate the individual patient and tumour characteristics, taking into consideration the observed benefits and the toxicity of the combination relative to nivolumab monotherapy (see sections 4.8 and 5.1).
Slovenian: Pred uvedbo zdravljenja v kombinaciji mora zdravnik skrbno ovrednotiti posameznega bolnika in lastnosti tumorja, pri čemer mora upoštevati znane koristi in toksične učinke kombinacije v primerjavi z zdravljenjem z nivolumabom v monoterapiji (glejte poglavji 4.8 in 5.1).
English: Objective response, n (%); (95% CI) Complete remission (CR), n (%); (95% CI) Partial remission (PR), n (%); (95% CI)
Slovenian: Objektivni odziv, n (%); (95 % IZ) Popolna remisija (CR), n (%); (95 % IZ) Delna remisija (PR), n (%); (95 % IZ)
English: A total of 945 patients were randomised to receive nivolumab in combination with ipilimumab (n = 314), nivolumab monotherapy (n = 316), or ipilimumab monotherapy (n = 315).
Slovenian: Skupno 945 bolnikov so randomizirali na zdravljenje z nivolumabom v kombinaciji z ipilimumabom (n = 314), nivolumabom v monoterapiji (n = 316) ali ipilimumabom v monoterapiji (n = 315).
English: Very common (may affect more than 1 in 10 people) Decrease in some white blood cells Diarrhoea (watery, loose or soft stools), nausea Skin rash sometimes with blisters, itching Feeling tired or weak
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) zmanjšanje števila nekaterih belih krvnih celic driska (vodeno, kašasto ali mehko blato), siljenje na bruhanje kožni izpuščaj, včasih z mehurčki, srbenje občutek utrujenosti ali šibkosti
English: If diagnosis of corticosteroidrefractory immune-related colitis is confirmed addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered.
Slovenian: V primeru potrditve imunsko pogojenega kolitisa, neodzivnega na kortikosteroide, je treba razmisliti o dodatku alternativnega zaviralca imunske odzivnosti k zdravljenju s kortikosteroidi ali o zamenjavi kortikosteroidnega zdravljenja.
English: In subjects with non-clear cell histology, at a minimum follow-up of approximately 16.7 months ORR and median duration of response were 13.6% and 10.2 months, respectively.
Slovenian: Pri osebah z nejasno celično histologijo je po najmanjšem obdobju spremljanja približno 16,7 meseca delež objektivnega odziva znašal 13,6 %, mediano trajanje odziva pa 10,2 meseca.
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
Slovenian: Opomba: Stopnje toksičnosti so navedene v skladu z različico 4.0 terminološko poenotenih kriterijev neželenih učinkov ameriškega Nacionalnega onkološkega inštituta (NCI-CTCAE v4; National Cancer Institute Common
English: Probability of Overall Survival
Slovenian: Verjetnost celokupnega preživetja
English: During administration of the second phase of treatment (nivolumab monotherapy) following combination treatment, permanently discontinue treatment if Grade 3 diarrhoea or colitis occurs.
Slovenian: Med drugo fazo zdravljenja (zdravljenje z nivolumabom v monoterapiji) po kombiniranem zdravljenju je treba zdravljenje trajno ukiniti, če se pojavita driska ali kolitis stopnje 3.
English: Efficacy by tumour PD-L1 expression: Objective responses to nivolumab were observed regardless of tumour PD-L1 expression.
Slovenian: Učinkovitost glede na ekspresijo PD-L1 tumorja: Objektivni odziv na nivolumab so opazili ne glede na ekspresijo PD-L1 tumorja.
English: OPDIVO infusion is compatible with PVC and polyolefin containers, glass bottles, PVC infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Slovenian: OPDIVO raztopina za infundiranje je kompatibilna z vsebniki iz PVC-ja in poliolefina, steklenicami, infuzijskimi sistemi iz PVC-ja in linijskimi filtri z membranami iz polietersulfona z velikostjo por od 0,2 µm do 1,2 µm.
English: - OPDIVO+ipilimumaba
Slovenian: - Zdravilo OPDIVO+ipilimumaba
English: If not used immediately, chemical and physical in-use stability of OPDIVO has been demonstrated for 24 hours at 2ºC to 8ºC protected from light and a maximum of 8 hours at 20°C-25°C and room light (this 8-hour period of the total 24 hours should be inclusive of the product administration period).
Slovenian: Če se ne uporabi takoj, je bilo dokazano, da je zdravilo OPDIVO med uporabo kemijsko in fizikalno stabilno 24 ur, če se ga shranjuje pri temperaturi od 2 °C do 8 °C, zaščitenega pred svetlobo, in največ 8 ur pri temperaturi od 20 °C do 25 °C in sobni svetlobi (to obdobje 8 ur od skupnih 24 ur pa vključuje tudi obdobje same aplikacije zdravila).
English: (95.92% CI) p-valueb
Slovenian: (95,92 % IZ) p-vrednostb
English: Rapid onset of GVHD has been reported with nivolumab use before and after allogeneic HSCT (see section 4.4).
Slovenian: V povezavi z uporabo nivolumaba pred in po alogenski HSCT so poročali o hitro nastali GVHD (glejte poglavje 4.4).
English: • Persistent Grade 2 or 3 adverse reactions despite management.
Slovenian: • neželenih učinkov stopnje 2 ali 3, ki kljub zdravljenju ne minejo.
English: While both arms of the study received active therapy, the QoL data should be interpreted in the context of the open-label study design and therefore cautiously taken.
Slovenian: Obe skupini v študiji sta se zdravili z učinkovino, vendar pa je podatke o kakovosti življenja treba interpretirati v kontekstu odprte zasnove študije in posledično razlagati previdno.
English: Although ECOG status, baseline glomerular filtration rate (GFR), albumin, body weight, and mild hepatic impairment had an effect on nivolumab CL, the effect was not clinically meaningful.
Slovenian: Stanje telesne zmogljivosti po lestvici ECOG, izhodiščna ocena glomerulne filtracije (GFR - glomerular filtration rate), vrednost albumina, telesna masa in blaga okvara jeter so sicer imeli vpliv na očistek nivolumaba, vendar pa učinek ni bil klinično pomemben.
English: Nivolumab treatment resulted in rapid resolution of B-symptoms in 88.7% (47/53) of the patients, with a median time to resolution of 1.9 months.
Slovenian: Pri zdravljenju z nivolumabom so se B-simptomi hitro izboljšali pri 88,7 % (47/53) bolnikov, mediani čas do izboljšanja pa je znašal 1,9 meseca.
English: 10 (67%) M 5 (33%) F
Slovenian: 10 (67 %) M 5 (33 %) Ž
English: Disease-specific precautions
Slovenian: Za bolezen specifični previdnostni ukrepi
English: Grade 3 or 4 pneumonitis
Slovenian: Pnevmonitis stopnje 3 ali 4
English: Sunitinib (events: 209/422), median and 95.0% CI: 26.97 (22.08, 34.83)
Slovenian: sunitinib (dogodki: 209/422), mediana in 95,0 % IZ: 26,97 (22,08; 34,83)
English: The benefit of treatment with nivolumab versus the risk of possible organ rejection should be considered in these patients.
Slovenian: Pri teh bolnikih je treba pretehtati korist zdravljenja z nivolumabom in tveganje za morebitno zavrnitev organa.
English: Signs and symptoms may include muscle pain, stiffness, weakness, chest pain, or severe fatigue.
Slovenian: Znaki in simptomi lahko vključujejo bolečino v mišicah, okorelost, oslabelost, bolečino v prsnem košu ali hudo utrujenost.
English: OPDIVO acts on your immune system and may cause inflammation in parts of your body.
Slovenian: Zdravilo OPDIVO deluje na imunski sistem in lahko povzroči vnetje posameznih delov telesa.
English: At a minimum follow-up of 9 months, investigator-assessed confirmed ORR was 24.4% (95% CI: 15.3, 35.4).
Slovenian: Po najmanjšem obdobju spremljanja 9 mesecev je z raziskovalčevo oceno potrjeni delež objektivnega odziva znašal 24,4 % (95 % interval zaupanja: 15,3; 35,4).
English: More than one vial of OPDIVO may be necessary to obtain the required dose.
Slovenian: Za potreben odmerek bo morda treba uporabiti več kot eno vialo zdravila OPDIVO.
English: Both nivolumab-containing arms demonstrated greater objective response rates than ipilimumab regardless of PD-L1 expression levels.
Slovenian: Obe skupini zdravljenja z nivolumabom sta pokazali večji delež objektivnega odziva v primerjavi z ipilimumabom ne glede na nivo ekspresije PD-L1.
English: No dose adjustment is required for elderly patients (≥ 65 years) (see section 5.2).
Slovenian: Pri starejših bolnikih (≥ 65 let) odmerka ni treba prilagajati (glejte poglavje 5.2).
English: • Grade 4 or recurrent Grade 3 adverse reactions;
Slovenian: • neželenih učinkov stopnje 4 ali neželenih učinkov stopnje 3, ki se ponovijo,
English: PD-L1 Expression nivolumab investigator's choice OS by tumour PD-L1 expression Number of events (number of patients)
Slovenian: nivolumab izbira raziskovalca Celokupno preživetje glede na ekspresijo PD-L1 tumorja Število dogodkov (število bolnikov)
English: Patients should be monitored for signs and symptoms of nephritis or renal dysfunction.
Slovenian: Bolnike je treba nadzirati glede pojava znakov in simptomov nefritisa ali okvare delovanja ledvic.
English: Responses were assessed per RECIST 1.1 for 588/1008 (58.3%) of patients who continued treatment through week 12 and had a follow-up scan at week 12.
Slovenian: Odzive so ovrednotili na osnovi kriterijev RECIST, različica 1.1, pri 588/1.008 (58,3 %) bolnikov, ki so nadaljevali zdravljenje do 12. tedna in so imeli kontrolni pregled v 12. tednu.
English: Treatment was continued as long as clinical benefit was observed or until treatment was no longer tolerated.
Slovenian: Zdravljenje je trajalo, dokler je bila prisotna klinična korist ali dokler je bolnik zdravljenje prenašal.
English: The primary efficacy population included those intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the International Metastatic RCC Database Consortium (IMDC) criteria (less than one year from time of initial renal cell carcinoma diagnosis to randomisation, Karnofsky performance status <80%, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, platelet count greater than the upper limit of normal, and absolute neutrophil count greater than the upper limit of normal).
Slovenian: Primarna populacija za vrednotenje učinkovitosti je vključevala bolnike s srednje ugodnim ali slabim prognostičnim obetom, ki so imeli vsaj 1 ali več od 6 prognostičnih dejavnikov tveganja v skladu s kriteriji IMDC (International Metastatic RCC Database Consortium) (manj kot eno leto od začetne diagnoze karcinoma ledvičnih celic do randomizacije, ocena stanja telesne zmogljivosti po Karnofskem < 80 %, vrednost hemoglobina manjša od spodnje meje normalne vrednosti, korigirana vrednost kalcija večja od 10 mg/dl, število trombocitov večje od zgornje meje normalne vrednosti in absolutno število nevtrofilcev večje od zgornje meje normalne vrednosti).
English: Median duration of responseg
Slovenian: Mediana trajanja odzivab
English: The majority (75%) of patients had M1c stage disease at study entry.
Slovenian: Večina bolnikov (75 %) je ob vključitvi v študijo imela bolezen v stadiju M1c.
English: In 49 evaluated patients from two cHL studies who underwent allogeneic HSCT after discontinuing nivolumab monotherapy, Grade 3 or 4 acute GVHD was reported in 13/49 patients (26.5%).
Slovenian: Pri 49 ovrednotenih bolnikih iz dveh študij, izvedenih pri cHL, pri katerih je bila opravljena alogenska HSCT po prekinitvi zdravljenja z nivolumabom v monoterapiji, so pri 13/49 bolnikov (26,5 %) poročali o akutni GVHD stopnje 3 ali 4.
English: Uncommon intestinal perforationa, gastritis, duodenitis gastritis
Slovenian: Občasni predrtje črevesaa, gastritis, duodenitis gastritis
English: OPDIVO must be stored in a refrigerator (2°C to 8°C).
Slovenian: Zdravilo OPDIVO shranjujte v hladilniku (2 °C do 8 °C).
English: Randomisation was stratified by prior cetuximab treatment.
Slovenian: Randomizacija je bila stratificirana glede na predhodno zdravljenje s cetuksimabom.
English: Grade 2 myocarditis
Slovenian: Miokarditis stopnje 2
English: Uncommon metabolic acidosis
Slovenian: Občasni metabolična acidoza
English: However, once you are treated with OPDIVO, your doctor may give you corticosteroids to reduce any possible side effects that you may have during your treatment and this will not impact the effect of the medicine.
Slovenian: Med zdravljenjem z zdravilom OPDIVO pa vam zdravnik lahko predpiše zdravljenje s kortikosteroidi za ublažitev katerega koli možnega neželenega učinka, ki se lahko pojavi med zdravljenjem.
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies and for hyperglycaemia and changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation).
Slovenian: Bolnike je treba nadzirati glede pojava kliničnih znakov in simptomov endokrinopatij, hiperglikemije in sprememb delovanja ščitnice (ob uvedbi zdravljenja, periodično med zdravljenjem in kot je indicirano na osnovi kliničnega pregleda).
English: Nivolumab in combination with ipilimumab:
Slovenian: Nivolumab v kombinaciji z ipilimumabom:
English: Signs and symptoms of severe skin reaction may include rash, itching, and peeling of the skin (possibly fatal).
Slovenian: Znaki in simptomi hude kožne reakcije lahko vključujejo izpuščaj, srbenje in luščenje kože (lahko s smrtnim izidom).
English: Systemic immunosuppression
Slovenian: Sistemska imunosupresija
English: Urothelial Carcinoma
Slovenian: Urotelijski karcinom
English: Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumour responses in metastatic melanoma.
Slovenian: Kombinirano posredovano zavrtje z nivolumabom (anti-PD-1) in ipilimumabom (anti-CTLA-4) pri metastatskem melanomu povzroči boljši protitumorski odziv.
English: Grade 4 or recurrent Grade 3 ; persistent Grade 2 or 3 despite treatment modification; inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day
Slovenian: Stopnje 4 ali ponovitev stopnje 3, vztrajanje stopnje 2 ali 3 kljub prilagoditvi zdravljenja, nezmožnost zmanjšanja odmerka kortikosteroida na 10 mg prednizona ali njegovega ekvivalenta na dan
English: In murine syngeneic tumour models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumour activity.
Slovenian: Pri tumorskih modelih na izogenskih miših je dvojna blokada PD-1 in CTLA-4 pokazala sinergistično protitumorsko aktivnost.
English: Quality of life (QoL) with nivolumab remained stable and close to baseline values during treatment, as assessed by valid and reliable scales like the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D utility index and visual analog scale (VAS).
Slovenian: Med zdravljenjem z nivolumabom je kakovost življenja bolnikov ostala stabilna in blizu izhodiščnim vrednostim, kar je bilo ovrednoteno s pomočjo validiranih in zanesljivih lestvic, kot sta QLQ-C30 Evropske organizacije za raziskovanje in zdravljenje raka (EORTC - European Organization for Research and Treatment of Cancer) in indeks EQ-5D ter vizualna analogna lestvica (VAS).
English: Patients with ocular/uveal melanoma were excluded from pivotal clinical trials of melanoma.
Slovenian: Bolnike z očesnim/uvealnim melanomom so izključili iz ključnih kliničnih preskušanj pri melanomu.