FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from SCCHN, adjuvant melanoma and first-line RCC patients 75 years of age or older are too limited to draw conclusions on this population (see sections 4.8 and 5.1).
Croatian: Podaci o bolesnicima s SCCHN-om, adjuvantno liječenim bolesnicima s melanomom i prvolinijski liječenim bolesnicima s RCC-om u dobi od 75 ili više godina preoskudni su da bi se mogli donijeti zaključci o primjeni u toj populaciji (vidjeti dijelove 4.8 i 5.1).
English: Median (95% CI)
Croatian: Medijan (95% CI)
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.
Croatian: Među bolesnicima liječenima nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg u ispitivanju CA209067, u njih 154/313 (49%) prva nuspojava 3. ili 4. stupnja nastupila je tijekom početne faze kombinirane terapije.
English: Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immunerelated colitis.
Croatian: U bolesnika s imunološki uzrokovanim kolitisom refraktornim na kortikosteroide prijavljeni su slučajevi citomegalovirusne (CMV) infekcije/reaktivacije citomegalovirusa.
English: There are no data on the use of nivolumab in combination with ipilimumab in patients with only a non clear-cell histology in first line RCC.
Croatian: Nema podataka o primjeni nivolumaba u kombinaciji s ipilimumabom za prvu liniju liječenja RCC-a u bolesnika čiji je tumor bio isključivo nesvjetlostaničnog histološkog tipa.
English: OPDIVO or OPDIVO in combination with ipilimumab should be permanently discontinued for:
Croatian: Liječenje lijekom OPDIVO ili lijekom OPDIVO u kombinaciji s ipilimumabom potrebno je trajno prekinuti u slučaju:
English: Figure 2: Progression-free survival (CA209067)
Croatian: Preživljenje bez progresije bolesti (CA209067)
English: Patients with active autoimmune disease, ocular melanoma, active brain or leptomeningeal metastases or a known history of prior ipilimumab-related high-grade (Grade 4 per CTCAE v4.0) adverse reactions, except for resolved nausea, fatigue, infusion reactions, or endocrinopathies, were excluded from the study.
Croatian: U ispitivanje nisu bili uključeni bolesnici s aktivnom autoimunom bolešću ili melanomom oka, aktivnim metastazama u mozgu ili leptomeningealnim metastazama, kao ni bolesnici koji su u anamnezi imali prethodnu pojavu nuspojava visokog stupnja (4. stupnja prema CTCAE v4.0) povezanih s liječenjem ipilimumabom, izuzev mučnine, umora, reakcija na infuziju ili endokrinopatija koje su se povukle.
English: Updated analysis Minimum follow-up: 24.2 months
Croatian: Ažurirana analiza Minimalno praćenje: 24,2 mjeseca
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.
Croatian: Stopa OS-a nakon 24 mjeseca iznosila je 66,5 (95% CI: 61,8-70,9) uz nivolumab u kombinaciji s ipilimumabom te 52,9 (95% CI: 47,9- 57,7) uz sunitinib.
English: EU/1/15/1014/001 EU/1/15/1014/002 EU/1/15/1014/003
Croatian: EU/1/15/1014/002
English: Efficacy results are shown in Table 14.
Croatian: Rezultati za djelotvornost prikazani su u Tablici 14.
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.
Croatian: Na temelju PK analize, utvrđeno je da je geometrijska srednja vrijednost klirensa nivolumaba iznosila 7,9 ml/h, a terminalni poluvijek 25,0 dana, dok je prosječna izloženost u stanju dinamičke ravnoteže nakon primjene doze od 3 mg/kg svaka 2 tjedna iznosila 86,6 µg/ml.
English: The estimated 2 and 3 year OS rates were 68% (95% CI: 56, 78) and 61% (95% CI: 49, 71), respectively, for the combination (n = 73) and 53% (95% CI: 36, 68) and 44% (95% CI: 28, 60), respectively, for ipilimumab (n = 37).
Croatian: Procijenjene stope OS-a nakon 2 i 3 godine iznosile su 68% (95% CI: 56, 78) odnosno 61% (95% CI: 49, 71) za kombiniranu terapiju (n = 73) te 53% (95% CI: 36, 68) odnosno 44% (95% CI: 28, 60) za monoterapiju ipilimumabom (n = 37).
English: Number of Subjects at Risk Nivolumab + Ipilimumab
Croatian: Broj ispitanika pod rizikom Nivolumab + ipilimumab
English: Nivolumab+ipilimumab vs nivolumab (descriptive analysis) - HR (95% CI): 0.85 (0.68, 1.07)
Croatian: Nivolumab + ipilimumab naspram nivolumaba (opisna analiza) - omjer hazarda (95% CI): 0,85 (0,68 ; 1,07)
English: Uncommon tachycardia, pericardial disordersj Rare arrhythmia (including ventricular arrhythmia)d, atrial fibrillation, myocarditisa,f Vascular disorders
Croatian: Rijetko aritmija (uključujući ventrikularnu aritmiju)d, fibrilacija atrija, miokarditisa,f
English: The infusion must be administered through a sterile, non-pyrogenic, low protein binding in-line filter with a pore size of 0.2-1.2 μm.
Croatian: Infuzija se mora primijeniti kroz sterilan i nepirogen in-line filtar male sposobnosti vezanja proteina koji ima pore veličine od 0,2-1,2 μm.
English: Six patients (4%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
Croatian: Šest bolesnika (4%) randomiziranih za primanje docetaksela koji su u bilo kojem trenutku prešli na liječenje nivolumabom.
English: Withhold dose(s)
Croatian: Odgoditi primjenu doze(a)
English: PFS rate at 12 months and 95% CI: 49% (44, 55) ──Δ─── Nivolumab (events: 183/316), median and 95% CI: 6.87 (4.34, 9.46).
Croatian: Stopa PFS-a nakon 12 mjeseci i 95% CI: 49% (44, 55) ──Δ─── Nivolumab (događaji: 183/316), medijan i 95% CI: 6,87 (4,34; 9,46).
English: Factors associated with early deaths were ECOG performance status, fast progressive disease on prior platinum therapy and high tumour burden.
Croatian: Eastern Cooperative Oncology Group, ECOG), bolest koja je brzo progredirala na prethodnoj terapiji platinom i veliko tumorsko opterećenje.
English: Efficacy results are shown in Table 8.
Croatian: Rezultati za djelotvornost prikazani su u Tablici 8.
English: After 28 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to nivolumab in combination with ipilimumab had an ORR of 67.6% (95% CI: 57.7, 76.6; n = 102) and 54.7% (95% CI: 47.8, 61.5; n = 212), while those in the nivolumab monotherapy arm had an ORR of 36.7% (95% CI: 27.2, 47.1; n = 98) and 48.2% (95% CI: 41.4, 55.0; n = 218), respectively.
Croatian: Nakon 28 mjeseci praćenja, bolesnici pozitivni na mutaciju BRAF[V600] i oni s divljim tipom gena BRAF randomizirani za liječenje nivolumabom u kombinaciji s ipilimumabom imali su ORR od 67,6% (95% CI: 57,7; 76,6; n = 102) odnosno 54,7% (95% CI: 47,8; 61,5; n = 212), dok su bolesnici u skupini liječenoj nivolumabom u monoterapiji imali ORR od 36,7% (95% CI: 27,2; 47,1; n = 98) odnosno 48,2% (95% CI: 41,4; 55,0; n = 218).
English: Hazard ratioa 95% CI p-value p<0.0001
Croatian: Preživljenje bez recidiva Događaji Omjer hazardaa 95% CI p-vrijednost p<0,0001
English: Rate (95% CI) At 6 months At 12 months Progression-free survival Events
Croatian: Stopa (95% CI) nakon 6 mjeseci nakon 12 mjeseci Preživljenje bez progresije bolesti Događaji Omjer hazardaa
English: Sixty-four percent of patients had no prior clinical benefit (CR/PR or SD) on ipilimumab.
Croatian: Šezdeset i četiri posto bolesnika nije ostvarilo kliničku korist (potpun odgovor/djelomičan odgovor ili stabilnu bolest) tijekom prethodnog liječenja ipilimumabom.
English: The median age was 65 years (range: 18-87), 59% were men, and 99.5% were white.
Croatian: Medijan dobi iznosio je 65 godina (raspon: 18-87), 59% bolesnika bili su muškarci, a 99,5% njih bijelci.
English: Common increased total bilirubin, hypoglycaemia, hypermagnesaemia, hypernatraemia, weight decreased a
Croatian: Često povišene razine ukupnog bilirubina, hipoglikemija, hipermagnezijemija, hipernatrijemija, smanjena tjelesna težina a
English: Nivolumab or nivolumab in combination with ipilimumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Croatian: Primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom potrebno je odgoditi u slučaju osipa 3. stupnja te prekinuti u slučaju osipa 4. stupnja.
English: Squamous NSCLC
Croatian: Planocelularni NSCLC
English: Overall survival Median (95% CI) months
Croatian: Ukupno preživljenje Medijan (95% CI) (mjeseci)
English: Efficacy results are shown in Table 23.
Croatian: Rezultati za djelotvornost prikazani su u Tablici 23.
English: In the absence of data for patients who had been receiving systemic immunosuppressants prior to study entry, and for patients with active brain or leptomeningeal metastases, nivolumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Croatian: S obzirom na nedostatak podataka za bolesnike koji su prije uključivanja u ispitivanje primali sistemske imunosupresive te bolesnike s aktivnim moždanim ili leptomeningealnim metastazama, nivolumab se u tim populacijama mora primjenjivati uz oprez nakon pažljive procjene omjera koristi i rizika za svakog pojedinog bolesnika.
English: Data from the 80 patients from CA209205 Cohort B and from the 15 patients from CA209039 who received prior brentuximab vedotin treatment following ASCT were integrated.
Croatian: Objedinjeni su podaci prikupljeni u 80 bolesnika iz kohorte B u ispitivanju CA209205 te 15 bolesnika iz ispitivanja CA209039 koji su prethodno liječeni brentuksimab vedotinom nakon ASCT-a.
English: The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed PFS and objective response rate (ORR).
Croatian: Ključne sekundarne mjere ishoda za djelotvornost bile su PFS i stopa objektivnog odgovora (engl. objective response rate, ORR) prema ocjeni ispitivača.
English: In patients treated with nivolumab after allogeneic HSCT, rapid-onset and severe GVHD, some with fatal outcome, have been reported in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet, u bolesnika liječenih nivolumabom nakon alogenog HSCT-a prijavljeni su slučajevi brzog nastupa teškog GVHD-a, od kojih su neki imali smrtni ishod.
English: (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) and who have experienced disease progression during or within 6 months of receiving platinum-based therapy regimen and had an ECOG performance status score of 0 or 1.
Croatian: U ispitivanje su bili uključeni bolesnici (u dobi od 18 ili više godina) s histološki potvrđenim relapsirajućim ili metastatskim SCCHN-om (usne šupljine, ždrijela ili grkljana) stadija III/IV koji nije bio pogodan za lokalnu kurativnu terapiju (kiruršku ili radioterapiju, uz kemoterapiju ili bez nje), koji su doživjeli progresiju bolesti tijekom ili unutar 6 mjeseci od liječenja terapijskim protokolom na bazi platine i koji su imali funkcionalni ECOG status 0 ili 1.
English: The total dose of OPDIVO required can be infused directly as a 10 mg/mL solution or can be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection (see section 6.6).
Croatian: Ukupna potrebna doza lijeka OPDIVO može se infundirati izravno kao otopina koncentracije 10 mg/ml ili razrijediti otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%) ili otopinom glukoze za injekciju od 50 mg/ml (5%) (vidjeti dio 6.6).
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
Croatian: Ukupno preživljenjec Događaji Omjer hazardaa (95% CI) Stopa (95% CI) nakon 24 mjeseca Potvrđen objektivan odgovor (95% CI) Medijan trajanja odgovora Mjeseci (raspon) Preživljenje bez progresije bolesti Stopa (95% CI) nakon 24 mjeseca
English: Table 1: Recommended dose and infusion time for intravenous administration of nivolumab monotherapy
Croatian: Tablica 1: Preporučena doza i trajanje infuzije kod intravenske primjene nivolumaba u monoterapiji
English: All patients received nivolumab 3 mg/kg monotherapy intravenously over 60 minutes every 2 weeks.
Croatian: Svi su bolesnici primali monoterapiju nivolumabom u dozi od 3 mg/kg, primijenjenoj intravenski tijekom 60 minuta svaka 2 tjedna.
English: When administered in combination with ipilimumab, OPDIVO should be given first followed by ipilimumab on the same day.
Croatian: Kod primjene u kombinaciji s ipilimumabom, najprije treba primijeniti OPDIVO, a zatim istoga dana i ipilimumab.
English: The median age was 61 years (range: 18 to 90 years), 65% of patients were men, and 97% were white.
Croatian: Medijan dobi iznosio je 61 godinu (raspon: 18-90 godina), 65% bolesnika bili su muškarci, a 97% njih bijelci.
English: Upon improvement, nivolumab or nivolumab in combination with ipilimumab may be resumed after corticosteroid taper.
Croatian: Nakon što nastupi poboljšanje, liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom može se nastaviti nakon postupnog smanjivanja doze kortikosteroida.
English: One vial of 24 mL contains 240 mg of nivolumab.
Croatian: Jedna bočica od 24 ml sadrži 240 mg nivolumaba.
English: Resolution occurred in 186 patients (89.4%) with a median time to resolution of 3.0 weeks (range: 0.1-159.4+).
Croatian: Nuspojave su se povukle u 186 bolesnika (89,4%), a medijan vremena do njihova povlačenja iznosio je 3,0 tjedana (raspon: 0,1-159,4+).
English: Fatal cases have been reported in completed or ongoing clinical studies b
Croatian: Prijavljeni su slučajevi sa smrtnim ishodom u završenim kliničkim ispitivanjima ili onima koja su još u tijeku.
English: Probability of Progression Free Survival
Croatian: Vjerojatnost preživljenja bez progresije bolesti
English: Sixteen patients (6%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
Croatian: Šesnaest bolesnika (6%) randomiziranih za primanje docetaksela koji su u bilo kojem trenutku prešli na liječenje nivolumabom.
English: Among the patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Croatian: Među bolesnicima liječenima nivolumabom u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg u ispitivanju CA209214, u njih 169/547 (31%) prva nuspojava 3. ili 4. stupnja nastupila je tijekom početne faze kombinirane terapije.
English: Figure 6: Overall survival by PD-L1 expression: 1% cut off (CA209067) - Minimum follow-up of 36 months
Croatian: Ukupno preživljenje prema ekspresiji PD-L1: granična vrijednost od 1% (CA209067) - minimalno praćenje od 36 mjeseci
English: Common hypertension
Croatian: Često hipertenzija hipertenzija
English: Monitoring of adrenal function and hormone levels should continue to ensure appropriate corticosteroid replacement is utilised.
Croatian: Potrebno je nastaviti pratiti funkciju nadbubrežne žlijezde i razine hormona kako bi se osigurala primjena odgovarajuće kortikosteroidne nadomjesne terapije.
English: Recommended doses and infusion times for intravenous administration of nivolumab in combination with ipilimumab
Croatian: Tablica 2: Preporučene doze i trajanje infuzije kod intravenske primjene nivolumaba u kombinaciji s ipilimumabom
English: Median time to onset of these endocrinopathies was 2.8 months (range: 0.3-29.1).
Croatian: Medijan vremena do nastupa tih endokrinopatija iznosio je 2,8 mjeseci (raspon: 0,3-29,1).
English: Tumour assessments were conducted 12 weeks after randomisation then every 6 weeks for the first year, and every 12 weeks thereafter.
Croatian: Procjene tumora provedene su 12 tjedana nakon randomizacije, a zatim svakih 6 tjedana tijekom prve godine te svakih 12 tjedana nakon toga.
English: Updated analysis Minimum follow-up: 62.7 months
Croatian: Ažurirana analiza Minimalno praćenje: 62,7 mjeseci
English: General disorders and administration site conditions Very common fatigue, pyrexia fatigue, pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često umor, pireksija umor, pireksija
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for life-threatening hyperthyroidism or hypothyroidism.
Croatian: Liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom mora se trajno prekinuti u slučaju po život opasne hipertireoze ili hipotireoze.
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.
Croatian: Slučajevi 2. stupnja prijavljeni su u 4,8% (26/547) bolesnika, slučajevi 3. stupnja u 6,6% (36/547) bolesnika, a slučajevi 4. stupnja u 1,6% (9/547) bolesnika.
English: Respiratory, thoracic and mediastinal disorders Very common dyspnoea Common pneumonitisa,c, pulmonary embolisma, cough pneumonitis, dyspnoea, pleural effusion, cough
Croatian: Često pneumonitisa,c, plućna embolijaa, kašalj pneumonitis, dispneja, pleuralni izljev, kašalj
English: In the absence of data, nivolumab or nivolumab in combination with ipilimumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Croatian: S obzirom na nedostatak podataka, nivolumab ili nivolumab u kombinaciji s ipilimumabom se u tim populacijama mora primjenjivati uz oprez nakon pažljive procjene potencijalnog omjera koristi i rizika za svakog pojedinog bolesnika.
English: The frequency of cardiac adverse events was lower in the nivolumab group than in the dacarbazine group in the metastatic melanoma without prior treatment population.
Croatian: U populaciji prethodno neliječenih bolesnika s metastatskim melanomom, učestalost srčanih štetnih događaja bila je niža u skupini liječenoj nivolumabom nego u onoj liječenoj dakarbazinom.
English: Grade 2 and Grade 3 cases were reported in 13.7% (75/547) and 3.7% (20/547) of patients, respectively.
Croatian: Slučajevi 2. stupnja prijavljeni su u 13,7% (75/547) bolesnika, a slučajevi 3. stupnja u 3,7% (20/547) bolesnika.
English: The OS HRs for nivolumab in combination with ipilimumab vs. nivolumab monotherapy were 0.71 (95% CI: 0.45, 1.13) for BRAF[V600] mutation-positive patients and 0.97 (95% CI: 0.74, 1.28) for BRAF wild-type patients.
Croatian: Omjeri hazarda za OS uz nivolumab u kombinaciji s ipilimumabom naspram nivolumaba u monoterapiji iznosili su 0,71 (95% CI: 0,45; 1,13) za bolesnike pozitivne na mutaciju BRAF[V600] te 0,97 (95% CI: 0,74; 1,28) za bolesnike s divljim tipom gena BRAF.
English: Grade 3 thyroid disorders were reported in < 0.1% (2/2578) of patients.
Croatian: Poremećaji štitnjače 3. stupnja prijavljeni su u < 0,1% (2/2578) bolesnika.
English: The PFS HRs for nivolumab vs. chemotherapy were 0.76 (95% CI: 0.54, 1.07) in patients with tumour PD-L1 expression ≥1% and 1.92 (95% CI: 1.05, 3.5) in patients with tumour PD-L1 expression <1%.
Croatian: Omjer hazarda za PFS uz nivolumab u usporedbi s kemoterapijom iznosio je 0,76 (95% CI: 0,54; 1,07) u bolesnika s tumorskom ekspresijom PD-L1 ≥ 1% te 1,92 (95% CI: 1,05; 3,5) u bolesnika s tumorskom ekspresijom PD-L1 < 1%.
English: Nervous system disorders Very common headache Common peripheral neuropathy, dizziness headache, peripheral neuropathy, dizziness
Croatian: Često periferna neuropatija, omaglica glavobolja, periferna neuropatija, omaglica
English: Seventeen patients (6%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
Croatian: Sedamnaest bolesnika (6%) randomiziranih za primanje docetaksela koji su u bilo kojem trenutku prešli na liječenje nivolumabom.
English: Baseline characteristics were balanced between the two groups.
Croatian: Početne su značajke bile ravnomjerno raspoređene između obje skupine.
English: In patients treated with nivolumab monotherapy, the incidence of diarrhoea, colitis, or frequent bowel movements was 13.1% (339/2578).
Croatian: U bolesnika liječenih monoterapijom nivolumabom, incidencija proljeva, kolitisa ili čestog pražnjenja crijeva iznosila je 13,1% (339/2578).
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg//kg, the incidence of hypersensitivity/infusion reactions was 4.0% (22/547); all were Grade 1 or 2 in severity.
Croatian: U bolesnika liječenih nivolumabom u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg, incidencija reakcija preosjetljivosti/reakcija na infuziju iznosila je 4,0% (22/547); svi su slučajevi bili 1. ili 2. stupnja težine.
English: The OS HRs for nivolumab vs. chemotherapy were 0.69 (95% CI: 0.49, 0.96) in patients with tumour PD-L1 expression ≥1% and 1.52 (95% CI: 0.89, 2.57) in patients with tumour PD-L1 expression <1%.
Croatian: Omjer hazarda za OS uz nivolumab u usporedbi s kemoterapijom iznosio je 0,69 (95% CI: 0,49; 0,96), u bolesnika s tumorskom ekspresijom PD-L1 ≥ 1 te 1,52 (95% CI: 0,89; 2,57) u bolesnika s tumorskom ekspresijom PD-L1 < 1%.
English: The median age was 55 years (range: 18-86), 58% were men, and 95% were white.
Croatian: Medijan dobi iznosio je 55 godina (raspon: 18 - 86 godina), 58% bolesnika bili su muškarci, a 95% njih bijelci.
English: No Grade 5 cases were reported.
Croatian: Nije prijavljen nijedan slučaj 5. stupnja.
English: Updated analysis Minimum follow-up: 62.6 months
Croatian: Ažurirana analiza Minimalno praćenje: 62,6 mjeseci
English: Data from cHL patients 65 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Croatian: Podaci o primjeni u bolesnika s kHL-om u dobi od 65 ili više godina preoskudni su da bi se na temelju njih donijeli zaključci o primjeni u toj populaciji (vidjeti dio 5.1).
English: Baseline characteristics were balanced across the three treatment groups.
Croatian: Početne su značajke bile ravnomjerno raspoređene između sve tri liječene skupine.
English: Patients in the comparator arm received ipilimumab 3 mg/kg and nivolumab-matched placebo intravenously every 3 weeks for 4 doses followed by placebo every 2 weeks.
Croatian: Bolesnici u usporednoj skupini intravenski su primali ipilimumab u dozi od 3 mg/kg ili placebo koji je formulacijom odgovarao nivolumabu svaka 3 tjedna kod prve 4 doze, nakon čega je uslijedila primjena placeba svaka 2 tjedna.
English: Ipilimumab 1 mg/kg over 30 minutes
Croatian: Ipilimumab 1 mg/kg tijekom 30 minuta
English: Resolution occurred in 191 patients (65.9%) with a median time to resolution of 11.4 weeks (range: 0.1-150.1+).
Croatian: Nuspojave su se povukle u 191 bolesnika (65,9%), a medijan vremena do njihova povlačenja iznosio je 11,4 tjedna (0,1-150,1+).
English: Randomised phase 3 study of nivolumab as monotherapy vs. everolimus (CA209025)
Croatian: Randomizirano ispitivanje faze 3 nivolumaba u monoterapiji naspram everolimusa (CA209025)
English: The magnitude of OS benefit was consistent for ≥ 1%, ≥ 5% or ≥ 10% tumour PD-L1 expression levels (see Table 24).
Croatian: Opseg korisnih učinaka na OS bio je dosljedan kod razina tumorske ekspresije PD-L1 od ≥ 1%, ≥ 5% odnosno ≥ 10% (vidjeti Tablicu 24).
English: Based on the severity of the adverse reaction, nivolumab or nivolumab in combination with ipilimumab should be withheld and corticosteroids administered.
Croatian: Ovisno o težini nuspojave, potrebno je odgoditi primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom i primijeniti kortikosteroide.
English: Median (95% CI) months Rate (95% CI) at 6 months Overall survivalc
Croatian: Medijan (95% CI) (mjeseci) Stopa (95% CI) nakon 6 mjeseci Ukupno preživljenjec
English: Median duration of responseb
Croatian: Medijan trajanja odgovora b
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.
Croatian: U ispitivanje nisu bili uključeni bolesnici kojima je funkcionalni status prema Karnofskom bio < 70%, kao ni bolesnici s prethodnim ili postojećim metastazama u mozgu, aktivnom autoimunom bolešću ili medicinskim stanjima koja zahtijevaju liječenje sistemskim imunosupresivima.