FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall survival could be accompanied by an improvement over time in disease related symptoms and non-disease specific QoL as assessed using valid and reliable scales in the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) and the EuroQoL EQ-5D.
Croatian: Ukupno preživljenje moglo bi s vremenom pratiti i poboljšanje simptoma povezanih s bolešću te kvalitete života nevezane uz specifičnu bolest, koji su se ocjenjivali uz pomoć validiranih i pouzdanih ljestvica iz upitnika za ocjenu simptoma povezanih s bolešću (indeks za bubrežne simptome) radi funkcionalne procjene terapije za rak (engl.
English: Hypophysitis occurred in 4.0% (22/547) of patients.
Croatian: Hipofizitis se javio u 4,0% (22/547) bolesnika.
English: Post authorisation efficacy study (PAES): In order to further elucidate the contribution of ipilimumab to the efficacy and toxicity of the combination regimen of nivolumab and ipilimumab, the MAH should conduct and submit the results of a randomised, clinical study comparing the efficacy and safety of the combination of nivolumab and ipilimumab to nivolumab monotherapy in previously untreated adult patients with intermediate/poorrisk advanced renal cell carcinoma and with an appropriate spectrum of PDL1 expression levels.
Croatian: Ispitivanje djelotvornosti lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (PAES): Kako bi se dodatno razjasnio doprinos ipilimumaba djelotvornosti i toksičnosti kombinirane terapije nivolumabom i ipilimumabom, nositelj odobrenja treba provesti i dostaviti rezultate randomiziranog kliničkog ispitivanja u kojem će se usporediti djelotvornost i sigurnost kombinacije nivolumaba i ipilimumaba u odnosu na monoterapiju nivolumabom kod prethodno neliječenih odraslih bolesnika s uznapredovalim karcinomom bubrežnih stanica umjerenog/visokog rizika i odgovarajućim rasponom razina ekspresije PD-L1.
English: Uncommon metabolic acidosis
Croatian: Manje često metabolička acidoza
English: h p-value is compared to alpha 0.009 in order to achieve statistical significance.
Croatian: h p-vrijednost uspoređena je s alfom od 0,009 radi postizanja statističke značajnosti.
English: Uncommon polyneuropathy, autoimmune neuropathy (including facial and abducens nerve paresis)
Croatian: Manje često polineuropatija, autoimuna neuropatija (uključujući parezu ličnog živca i živca odmicača oka)
English: f p-value is compared to alpha 0.001 in order to achieve statistical significance.
Croatian: f p-vrijednost uspoređena je s alfom od 0,001 radi postizanja statističke značajnosti.
English: Vogt-Koyanagi-Harada syndromeh Cardiac disorders Common tachycardia tachycardia
Croatian: Vogt-Koyanagi-Harada sindromh Srčani poremećaji Često tahikardija tahikardija
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.
Croatian: OPDIVO će se primjenjivati infuzijom (dripom) u venu (intravenski) tijekom razdoblja od 30 ili 60 minuta svaka 2 ili 4 tjedna, ovisno o dozi koju ćete primati.
English: The following side effects have been reported with nivolumab in combination with ipilimumab:
Croatian: Sljedeće nuspojave prijavljene su kada se nivolumab primjenjivao u kombinaciji s ipilimumabom:
English: Open-label phase 1/2 study (CA209032)
Croatian: Otvoreno ispitivanje faze 1/2 (CA209032)
English: Quantifiable tumour PD-L1 expression was measured in 79% of patients in the nivolumab group and 77% of patients in the docetaxel group.
Croatian: Mjerljiva tumorska ekspresija PD-L1 utvrđena je u 79% bolesnika u skupini koja je primala nivolumab i 77% bolesnika u skupini liječenoj docetakselom.
English: Immune system disorders Common infusion related reaction, hypersensitivity infusion-related reaction, hypersensitivity
Croatian: Poremećaji imunološkog sustava Često reakcija na infuziju, preosjetljivost reakcija na infuziju, preosjetljivost
English: Immune-related adverse reactions have occurred at higher frequencies when nivolumab was administered in combination with ipilimumab compared with nivolumab as monotherapy.
Croatian: Imunološki uzrokovane nuspojave javljale su se češće kada se nivolumab primjenjivao u kombinaciji s ipilimumabom nego kada se primjenjivao u monoterapiji.
English: Nivolumab showed numerically less effect on OS (HR 1.85; 95% CI: 0.76, 4.51), PFS (HR=1.76; 95%-CI: 0.77, 4.05) and ORR (9.1% vs. 16.7%).
Croatian: Nivolumab je pokazao brojčano manji učinak na OS (omjer hazarda, HR 1,85; 95% CI: 0,76; 4,51), PFS (HR=1,76; 95% CI: 0,77; 4,05) i ORR (9,1% naspram 16,7%).
English: OPDIVO can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe;
Croatian: OPDIVO se može upotrijebiti za intravensku primjenu: bez razrjeđivanja, nakon prijenosa u infuzijski spremnik uz pomoć odgovarajuće sterilne štrcaljke ili nakon razrjeđivanja, prema sljedećim uputama:
English: Tumour PD-L1 expression level
Croatian: Tumorska ekspresija PD-L1
English: Patients with prior autoimmune disease, and any condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications, as well as patients with prior therapy for melanoma (except patients with surgery, adjuvant radiotherapy after neurosurgical resection for lesions of the central nervous system, and prior adjuvant interferon completed ≥6 months prior to randomisation) 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), were excluded from the study.
Croatian: U ispitivanje nisu bili uključeni bolesnici koji su prethodno imali autoimunu bolest ili bilo koje stanje koje je zahtijevalo sistemsko liječenje kortikosteroidima (≥ 10 mg prednizona ili ekvivalenta na dan) ili drugim imunosupresivima, kao ni bolesnici koji su prethodno primali terapiju za melanom (izuzev bolesnika koji su bili liječeni kirurškim zahvatom, adjuvantnom radioterapijom zbog lezija u središnjem živčanom sustavu nakon neurokirurške resekcije i adjuvantnom terapijom interferonom koja je završila ≥ 6 mjeseci prije randomizacije) te bolesnici koji su prethodno primali terapiju anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 ili anti-CTLA-4 protutijelima (uključujući ipilimumab ili bilo koje drugo protutijelo ili lijek koji ciljano djeluje upravo na putove kostimulacije T-stanica ili njihove kontrolne točke).
English: Nivolumab in combination with ipilimumab should be discontinued for life-threatening or recurrent severe cardiac and pulmonary adverse reactions (see section 4.2).
Croatian: Nivolumab u kombinaciji s ipilimumabom mora se prestati primjenjivati u slučaju po život opasnih ili rekurentnih teških srčanih i plućnih nuspojava (vidjeti dio 4.2).
English: c p-value is compared to alpha 0.002 in order to achieve statistical significance.
Croatian: c p-vrijednost uspoređena je s alfom od 0,002 radi postizanja statističke značajnosti.
English: Additional prespecified subgroup analyses were conducted to evaluate the efficacy by tumour PD-L1 expression at predefined levels of 1%, 5%, and
Croatian: Provedene su i dodatne unaprijed specificirane analize podskupina radi ocjenjivanja djelotvornosti kod unaprijed utvrđenih razina tumorske ekspresije PD-L1 od 1%, 5% i 10%.
English: Disease-related aetiologies should be ruled out.
Croatian: Potrebno je isključiti etiologije povezane s bolešću.
English: Patients were enrolled regardless of their tumour PD-L1 or human papilloma virus (HPV) status.
Croatian: Bolesnici su bili uključeni u ispitivanje neovisno o tumorskom PD-L1 statusu i infekciji humanim papilomavirusom (HPV status).
English: Common oedema (including peripheral oedema), pain oedema (including peripheral oedema), pain, chest pain, chills
Croatian: Često edem (uključujući periferni edem), bol edem (uključujući periferni edem), bol, bol u prsištu, zimica
English: Table 7 presents the percentage for immune-related adverse reactions who were permanently discontinued from treatment by dosing regimen.
Croatian: U Tablici 7 navedeni su postoci slučajeva imunološki uzrokovanih nuspojava koji su doveli do trajnog prekida liječenja, prema režimu doziranja.
English: • Relevant information (e.g., seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns: o Immune-related pneumonitis o Immune-related colitis o Immune-related hepatitis o Immune-related nephritis and renal dysfunction o Immune-related endocrinopathies o Immune-related skin adverse reactions o Other immune-related ARs o Potential risk of ‘Complications including acute graft-versus-host disease (GVHD) and transplant related mortality of allogeneic Haematopoietic Stem Cell Transplant (HSCT)
Croatian: • Relevantne informacije (npr. informacije o ozbiljnosti, težini, učestalosti, vremenu do nastupa i reverzibilnosti nuspojava, prema potrebi) za sljedeće sigurnosne probleme: o imunološki uzrokovan pneumonitis o imunološki uzrokovan kolitis o imunološki uzrokovan hepatitis o imunološki uzrokovan nefritis i bubrežna disfunkcija o imunološki uzrokovane endokrinopatije o imunološki uzrokovane kožne nuspojave o druge imunološki uzrokovane nuspojave o mogući rizik od komplikacija alogene transplantacije hematopoetskih matičnih stanica
English: 51 (64%) M 29 (36%) F
Croatian: 51 (64%) M / 29 (36%) Ž
English: The prescribed dose for the patient is 240 mg or 480 mg given regardless of body weight depending on indication (see section 4.2).
Croatian: Propisana doza za bolesnika ovisi o indikaciji, a iznosi 240 mg ili 480 mg, neovisno o tjelesnoj težini (vidjeti dio 4.2).
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).
Croatian: Ukoliko se kod bolesnika razvije SJS ili TEN uz primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom, preporučuje se trajan prestanak liječenja (vidjeti dio 4.2).
English: Do not use OPDIVO after the expiry date which is stated on the carton and on the vial label after EXP.
Croatian: OPDIVO se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake 'EXP'.
English: The majority of patients had AJCC Stage III disease (81%), and 19% had Stage IV disease.
Croatian: Većina bolesnika imala je bolest stadija III (81%), a 19% njih bolest stadija IV prema AJCC klasifikaciji.
English: How to use OPDIVO
Croatian: Kako primjenjivati OPDIVO
English: The primary efficacy outcome measure was ORR as determined by an IRRC.
Croatian: Primarna mjera ishoda za djelotvornost bio je ORR prema ocjeni IRRC-a.
English: 61 (64%) M 34 (36%) F
Croatian: 61 (64%) M / 34 (36%) Ž
English: ≥ 5 prior lines of systemic therapy
Croatian: ≥ 5 prethodnih linija sistemske terapije Prethodna radioterapija Prethodni ASCT
English: OPDIVO 10 mg/mL concentrate for solution for infusion nivolumab
Croatian: OPDIVO 10 mg/ml koncentrat za otopinu za infuziju nivolumab
English: Figure 7: Recurrence-free Survival (CA209238)
Croatian: Preživljenje bez recidiva (CA209238)
English: Classical Hodgkin Lymphoma
Croatian: Klasični Hodgkinov limfom
English: No Grade 3-5 cases were reported.
Croatian: Nisu prijavljeni slučajevi 3.-5. stupnja.
English: No Grade 5 nephritis or renal dysfunction was reported in these studies.
Croatian: U tim ispitivanjima nije prijavljen nijedan slučaj nefritisa ni bubrežne disfunkcije 5. stupnja.
English: NE = non-estimable
Croatian: NP = ne može se procijeniti
English: Infections and infestations Common pneumonia, upper respiratory tract infection pneumonia, upper respiratory tract infection, conjunctivitis
Croatian: Infekcije i infestacije Često pneumonija, infekcija gornjih dišnih putova pneumonija, infekcija gornjih dišnih putova, konjunktivitis
English: • That OPDIVO treatment may increase the risk of: o Immune-related pneumonitis o Immune-related colitis o Immune-related hepatitis o Immune-related nephritis and renal dysfunction o Immune-related endocrinopathies o Immune-related skin adverse reactions o Other immune-related ARs
Croatian: • Liječenje lijekom OPDIVO može povećati rizik od: o imunološki uzrokovanog pneumonitisa o imunološki uzrokovanog kolitisa o imunološki uzrokovanog hepatitisa o imunološki uzrokovanog nefritisa i bubrežne disfunkcije o imunološki uzrokovanih endokrinopatija o imunološki uzrokovanih kožnih nuspojava o drugih imunološki uzrokovanih nuspojava
English: In patients treated with nivolumab monotherapy, the incidence of pneumonitis, including interstitial lung disease and lung infiltration, was 3.4% (87/2578).
Croatian: U bolesnika liječenih monoterapijom nivolumabom, incidencija pneumonitisa, uključujući intersticijsku bolest pluća i plućne infiltrate, iznosila je 3,4% (87/2578).
English: CA209032 was a Phase 1/2 open-label multi-cohort study which included a cohort of 78 patients (including 18 subjects who received planned crossover treatment with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg combination) with similar inclusion criteria to study CA209275 treated with nivolumab monotherapy 3 mg/kg for urothelial carcinoma.
Croatian: Ispitivanje CA209032 bilo je otvoreno ispitivanje faze 1/2 s većim brojem kohorti, koje je uključivalo kohortu od 78 bolesnika (uključujući 18 ispitanika koji su prema planu prešli na liječenje kombinacijom nivolumaba u dozi od 3 mg/kg i ipilimumaba u dozi od 1 mg/kg), čiji su uključni kriteriji bili slični onima u ispitivanju CA209275, te koji su zbog karcinoma urotela liječeni monoterapijom nivolumabom u dozi od 3 mg/kg.
English: Not known solid organ transplant rejectionh, sarcoidosish Endocrine disorders
Croatian: Nepoznato odbacivanje transplantiranog solidnog organah, sarkoidozah
English: Of the 1008 treated patients, 103 (10%) had ocular/uveal melanoma, 66 (7%) had an ECOG performance score of 2, 165 (16%) had asymptomatic treated and untreated CNS metastases, 13 (1.3%) had treated leptomeningeal metastases, 25 (2%) had autoimmune disease, and 84 (8%) had Grade 3-4 immune-related AEs with prior anti-CTLA-4 therapy.
Croatian: Od 1008 liječenih bolesnika, 103 (10%) bolesnika imala su očni/uvealni melanom, njih 66 (7%) imalo je funkcionalni ECOG status 2, 165 (16%) bolesnika imalo je liječene i neliječene asimptomatske metastaze u SŽS-u, 13 (1,3%) bolesnika imalo je liječene leptomeningealne metastaze, 25 (2%) bolesnika imalo je autoimunu bolest, a 84 (8%) bolesnika imala su imunološki uzrokovane nuspojave 3.
English: OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1).
Croatian: OPDIVO je u monoterapiji indiciran za adjuvantno liječenje odraslih bolesnika s melanomom koji je zahvatio limfne čvorove ili metastazirao, a koji su bili podvrgnuti potpunoj resekciji (vidjeti dio 5.1).
English: Table 3:
Croatian: Slika 3:
English: Life-threatening cases have been reported in completed or ongoing clinical studies.
Croatian: Prijavljeni su slučajevi opasni po život u završenim kliničkim ispitivanjima ili onima koja su još u tijeku.
English: Thereafter it will be given as an infusion over a period of 30 or 60 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single-agent phase).
Croatian: Nakon toga lijek ćete primati u obliku infuzije u trajanju od 30 ili 60 minuta svaka 2 ili 4 tjedna, ovisno o dozi koju ćete primati (faza monoterapije).
English: In non-squamous NSCLC, a higher number of deaths within 3 months was observed in nivolumab compared to docetaxel.
Croatian: Kod neplanocelularnog NSCLC-a, primijećen je veći broj smrtnih slučajeva unutar razdoblja od 3 mjeseca u skupini liječenoj nivolumabom nego u skupini koja je primala docetaksel.
English: Do not stop treatment with OPDIVO unless you have discussed this with your doctor.
Croatian: Nemojte prekinuti liječenje lijekom OPDIVO bez prethodnog razgovora sa svojim liječnikom.
English: 95% CI p-value
Croatian: 95% CI p-vrijednost
English: docetaxel (n = 290)
Croatian: docetaksel (n = 290)
English: In patients treated with nivolumab monotherapy, the incidence of rash was 26.4% (680/2578).
Croatian: U bolesnika liječenih monoterapijom nivolumabom, incidencija osipa iznosila je 26,4% (680/2578).
English: Metabolism and nutrition disorders Very common decreased appetite decreased appetite
Croatian: Poremećaji metabolizma i prehrane Vrlo često smanjen tek smanjen tek
English: Seventy-three percent of patients had cutaneous melanoma and 10% had mucosal melanoma.
Croatian: Sedamdeset i tri posto bolesnika imalo je kožni melanom, a 10% melanom sluznice.
English: A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in six patients (12%) within the first 6 weeks post-transplantation, with three patients responding to steroids.
Croatian: U šest bolesnika (12%) je unutar prvih 6 tjedana nakon transplantacije nastupio febrilni sindrom koji je zahtijevao primjenu steroida i za koji nije utvrđen infektivni uzročnik; tri bolesnika odgovorila su na steroide.
English: What OPDIVO looks like and contents of the pack OPDIVO concentrate for solution for infusion (sterile concentrate) is a clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Croatian: OPDIVO koncentrat za otopinu za infuziju (sterilni koncentrat) je bistra do opalescentna, bezbojna do blijedožuta tekućina koja može sadržavati malu količinu sitnih čestica.
English: Randomised phase 2 study of nivolumab in combination with ipilimumab and ipilimumab (CA209069)
Croatian: Randomizirano ispitivanje faze 2 nivolumaba u kombinaciji s ipilimumabom i ipilimumaba (CA209069)
English: CA209039 is a Phase 1b open-label, multi-centre, dose-escalation, and multidose study of nivolumab in relapsed/refractory hematologic malignancies, including 23 patients with cHL treated with nivolumab 3 mg/kg monotherapy; amongst which, 15 patients received prior brentuximab vedotin treatment as a salvage therapy following ASCT, similar to Cohort B of study CA209205.
Croatian: Ispitivanje CA209039 bilo je otvoreno, multicentrično ispitivanje faze 1b u kojem se ispitivalo povećavanje doze i veći broj doza nivolumaba, provedeno u bolesnika s relapsom/refraktornim oblikom hematoloških zloćudnih bolesti, uključujući 23 bolesnika s kHL-om liječena monoterapijom nivolumabom u dozi od 3 mg/kg, među kojima je njih 15 prethodno liječeno brentuksimab vedotinom kao terapijom spasa nakon ASCT-a, slično kao kohorta B u ispitivanju CA209205.
English: When OPDIVO is given in combination with ipilimumab for the treatment of skin cancer, the recommended dose of OPDIVO is 1 mg of nivolumab per kilogram of your body weight for the first 4 doses (combination phase).
Croatian: Kada se OPDIVO primjenjuje u kombinaciji s ipilimumabom za liječenje raka kože, preporučena doza lijeka OPDIVO je 1 mg nivolumaba po kilogramu tjelesne težine kod prve 4 doze (faza kombinirane terapije).
English: NR = not reached
Croatian: NP = nije postignuto
English: Of the patients who were treated with nivolumab in combination with ipilimumab and evaluable for the presence of anti-nivolumab antibodies, the incidence of anti-nivolumab antibodies was 26.0% with nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks and 37.8% with nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks.
Croatian: Među bolesnicima liječenima nivolumabom u kombinaciji s ipilimumabom u kojih se mogla odrediti prisutnost protutijela na nivolumab, incidencija protutijela na nivolumab iznosila je 26,0% uz nivolumab u dozi od 3 mg/kg i ipilimumab u dozi od 1 mg/kg svaka 3 tjedna te 37,8% uz nivolumab u dozi od 1 mg/kg i ipilimumab u dozi od 3 mg/kg svaka 3 tjedna.
English: Table 19: Efficacy results in intermediate/poor risk patients (CA209214)
Croatian: Tablica 19: Rezultati za djelotvornost u bolesnika s umjerenim/visokim rizikom (CA209214)
English: Table 7: Immune-related adverse reactions leading to permanent discontinuation or requiring high-dose corticosteroids by dosing regimen Nivolumab 3 mg/kg monotherapy
Croatian: Tablica 7: Imunološki uzrokovane nuspojave koje su dovele do trajnog prekida liječenja ili koje su zahtijevale visoke doze kortikosteroida, navedeno prema režimu doziranja Nivolumab u dozi od 3 mg/kg u monoterapiji
English: Both nivolumab-containing arms demonstrated a significant PFS and OS benefit and greater ORR compared with ipilimumab alone.
Croatian: Obje skupine čija je terapija uključivala nivolumab ostvarile su značajne korisne učinke na PFS i OS te veći ORR u odnosu na monoterapiju ipilimumabom.
English: In patients treated with nivolumab monotherapy, the incidence of thyroid disorders, including hypothyroidism or hyperthyroidism, was 9.6% (248/2578).
Croatian: U bolesnika liječenih monoterapijom nivolumabom, incidencija poremećaja štitnjače, uključujući hipotireozu ili hipertireozu, iznosila je 9,6% (248/2578).
English: More patients in the nivolumab arm had poor prognostic factors (elevated LDH and brain metastases) than in the chemotherapy arm.
Croatian: Loše prognostičke faktore (povišene vrijednosti LDH i metastaze u mozgu) imalo je više bolesnika u skupini liječenoj nivolumabom nego u skupini koja je primala kemoterapiju.
English: Uncommon arrhythmia (including ventricular arrhythmia)a,d, atrial fibrillation, myocarditisa,f arrhythmia (including ventricular arrhythmia), myocarditisc
Croatian: Manje često aritmija (uključujući ventrikularnu aritmiju)a,d, fibrilacija atrija, miokarditisa,f aritmija (uključujući ventrikularnu aritmiju), miokarditisc
English: Ipilimumab 3 mg/kg over 90 minutes
Croatian: Ipilimumab 3 mg/kg tijekom 90 minuta
English: OPDIVO concentrate is a clear to opalescent, colourless to pale yellow liquid.
Croatian: Koncentrat lijeka OPDIVO je bistra do opalescentna, bezbojna do blijedožuta tekućina.
English: Squamous Cell Cancer of the Head and Neck (SCCHN) OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1).
Croatian: OPDIVO je u monoterapiji indiciran za liječenje relapsirajućeg ili metastatskog planocelularnog raka glave i vrata (engl. squamous cell cancer of the head and neck, SCCHN) u odraslih bolesnika u kojih je došlo do progresije bolesti tijekom ili nakon terapije na bazi platine (vidjeti dio 5.1).
English: In head and neck cancer, a higher number of deaths within 3 months was observed in nivolumab compared to docetaxel.
Croatian: Kod raka glave i vrata, primijećen je veći broj smrtnih slučajeva unutar razdoblja od 3 mjeseca u skupini liječenoj nivolumabom nego u skupini koja je primala docetaksel.
English: Subsequent systemic therapy was received by 31.8%, 44.3%, and 62.2% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Croatian: Naknadnu sistemsku terapiju primilo je 31,8% bolesnika u skupini liječenoj kombiniranom terapijom, 44,3% bolesnika u skupini liječenoj nivolumabom u monoterapiji te 62,2% bolesnika u skupini liječenoj ipilimumabom.
English: 24 mL of concentrate in a 25 mL vial (Type I glass) with a stopper (coated butyl rubber) and a red matte flip-off seal (aluminium).
Croatian: 24 ml koncentrata u bočici od 25 ml (staklo tipa I) s čepom (obloženim butilnom gumom) i mat crvenim flip- off zatvaračem (aluminij).
English: ≥ 1% to < 10%a
Croatian: ≥ 1% i < 10%a
English: Grade 2 and Grade 3 hypophysitis (including lymphocytic hypophysitis) occurred in 5.8% (26/448) and 2.0% (9/448) of patients, respectively.
Croatian: Hipofizitis 2. stupnja i 3. stupnja (uključujući limfocitni hipofizitis) prijavljen je u 5,8% (26/448) odnosno 2,0% (9/448) bolesnika.
English: Relative to nivolumab monotherapy, an increase in PFS for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.
Croatian: U odnosu na monoterapiju nivolumabom, produljenje PFS-a uz liječenje kombinacijom nivolumaba i ipilimumaba ustanovljeno je samo u bolesnika s niskom razinom tumorske ekspresije PD-L1.