FrancophonIA/ELRC3.0 huggingface dataset:
English: PFS results (with minimum follow up of 18 months) are shown in Figure 2 (all randomised population), Figure 3 (at the tumour PD-L1 5% cut off), and Figure 4 (at the tumour PD-L1 1% cut off).
Croatian: Rezultati za PFS (uz minimalno praćenje od 18 mjeseci) prikazani su na Slici 2 (cjelokupna randomizirana populacija), Slici 3 (granična vrijednost tumorske ekspresije PD L1 od 5%) i Slici 4 (granična vrijednost tumorske ekspresije PD L1 od 1%).
English: For patients with a severe (Grade 3) rash, the scheduled dose of ipilimumab should be withheld.
Croatian: U bolesnika s teškim (3. stupanj) osipom treba odgoditi primjenu planirane doze ipilimumaba.
English: Common musculoskeletal paing arthritis, muscle spasms, muscular weakness
Croatian: Često mišićno koštana bolg artritis, mišićni spazmi, mišićna slabost
English: Immune-related endocrinopathy observed in clinical trials was generally controlled with hormone replacement therapy.
Croatian: Imunološki uzrokovana endokrinopatija primijećena u kliničkim ispitivanjima općenito se mogla kontrolirati hormonskom nadomjesnom terapijom.
English: A total of 676 patients were randomized: 137 to the ipilimumab monotherapy group, 403 to the ipilimumab + gp100 group, and 136 to the gp100 alone group.
Croatian: Ukupno je bilo randomizirano 676 bolesnika: 137 u skupinu koja je primala monoterapiju ipilimumabom, 403 u skupinu koja je primala ipilimumab+ gp100 i 136 u skupinu koja je primala samo gp100.
English: In study CA184070, no immune-related adverse reactions (irAR) ≥Grade 3 were reported for the single patient 12 years of age and older who was treated with ipilimumab 3 mg/kg.
Croatian: U ispitivanju CA184070 nije prijavljena nijedna imunološki uzrokovana nuspojava (engl. immune related adverse reaction, irAR) ≥ 3. stupnja u jedinog bolesnika u dobi od 12 ili više godina liječenog ipilimumabom u dozi od 3 mg/kg.
English: Ipilimumab in combination with nivolumab is used to treat advanced melanoma (a type of skin cancer) in adults advanced renal cell carcinoma (advanced kidney cancer) in adults
Croatian: Ipilimumab u kombinaciji s nivolumabom koristi se za liječenje: uznapredovalog melanoma (jedne vrste raka kože) u odraslih uznapredovalog karcinoma bubrežnih stanica (uznapredovalog raka bubrega) u odraslih
English: The overall safety profile of ipilimumab 3 mg/kg in clinical trial CA184-169 (N=362) was consistent with that established for ipilimumb in patients treated for advanced melanoma.
Croatian: Ukupni sigurnosni profil ipilimumaba 3 mg/kg u kliničkom ispitivanju CA184-169 (N=362) bio je u skladu s onim ustanovljenim za ipilimumab u bolesnika liječenih od uznapredovalog melanoma.
English: Table 4: Adverse reactions in patients with advanced melanoma treated with ipilimumab 3 mg/kg (n= 767)a
Croatian: Tablica 4: Nuspojave u bolesnika s uznapredovalim melanomom koji su liječeni ipilimumabom u dozi od 3 mg/kg (n= 767)a
English: The following side effects have been reported with ipilimumab in combination with nivolumab:
Croatian: Sljedeće nuspojave prijavljene su kada se ipilimumab primjenjivao u kombinaciji s nivolumabom:
English: Patients must be treated according to institutional guidelines for management of sensory neuropathy, and intravenous corticosteroids (e.g. methylprednisolone 2 mg/kg/day) should be initiated immediately.
Croatian: Bolesnici se moraju liječiti u skladu s bolničkim smjernicama za liječenje senzoričke neuropatije i odmah je potrebno uvesti intravenske kortikosteroide (npr. metilprednizolon u dozi 2 mg/kg na dan).
English: A total of 945 patients were randomised to receive ipilimumab in combination with nivolumab (n = 314), nivolumab monotherapy (n = 316), or ipilimumab monotherapy (n = 315).
Croatian: Ukupno je 945 bolesnika bilo randomizirano u skupine koje su primale ipilimumab u kombinaciji s nivolumabom (n = 314), nivolumab u monoterapiji (n = 316) ili ipilimumab u monoterapiji (n = 315).
English: Severe elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin or symptoms of hepatotoxicity
Croatian: Jako povišene vrijednosti aspartat aminotransferaze (AST), alanin aminotransferaze (ALT) ili ukupnog bilirubina ili simptomi hepatotoksičnosti
English: BORR in the 10 mg/kg group was 15.3% (95% CI: 11.8, 19.5) and in the 3 mg/kg group was 12.2% (95% CI: 9.0, 16.0).
Croatian: BORR u skupini 10 mg/kg bio je 15,3% (95% CI: 11,8; 19,5) i u skupini 3 mg/kg bio je 12,2% (95% CI: 9,0; 16,0).
English: The safety and efficacy of YERVOY in children younger than 12 years of age have not been established.
Croatian: Sigurnost i djelotvornost primjene lijeka YERVOY u djece mlađe od 12 godina nisu ustanovljene
English: Be aware of important symptoms of inflammation YERVOY acts on your immune system and may cause inflammation in parts of your body.
Croatian: YERVOY djeluje na Vaš imunološki sustav i može prouzročiti upalu u nekim dijelovima tijela.
English: If pituitary imaging or laboratory tests of endocrine function are abnormal, a short course of high-dose corticosteroid therapy (e.g. dexamethasone 4 mg every 6 hrs or equivalent) is recommended to treat the inflammation of the affected gland, and the scheduled dose of ipilimumab should be withheld (see section 4.2).
Croatian: Ukoliko snimanje hipofize ili laboratorijske pretrage endokrine funkcije pokažu poremećaj, preporučuje se kratkotrajno liječenje visokim dozama kortikosteroida (npr. deksametazon u dozi od 4 mg svakih 6 sati ili ekvivalent) za liječenje upale zahvaćene žlijezde, dok primjenu planirane doze ipilimumaba treba odgoditi (vidjeti dio 4.2).
English: Patients with ocular melanoma, primary CNS melanoma, active brain metastases, human immunodeficiency virus (HIV), hepatitis B, and hepatitis C were not included in the MDX010-20 clinical trial.
Croatian: Bolesnici s melanomom oka, primarnim melanomom središnjeg živčanog sustava, aktivnim metastazama u mozgu, virusom humane imunodeficijencije (HIV), hepatitisom B i hepatitisom C nisu bili uključeni u kliničko ispitivanje MDX010-20.
English: The frequency of severe (Grade 3 or 4) hypopituitarism was reported in 3% of patients.
Croatian: Učestalost teškog hipopituitarizma (3. ili 4. stupanj) zabilježena je u 3% bolesnika.
English: In case of a severe or life-threatening infusion reaction, the ipilimumab or ipilimumab in combination with nivolumab infusion must be discontinued and appropriate medical therapy administered.
Croatian: U slučaju teške ili po život opasne reakcije na infuziju, mora se prekinuti infuzija ipilimumabom, ili ipilimumabom u kombinaciji s nivolumabom i primijeniti odgovarajuća medicinska terapija.
English: YERVOY must be administered with caution in patients with transaminase levels ≥ 5 x ULN or bilirubin levels > 3 x ULN at baseline (see section 5.1).
Croatian: YERVOY se mora primjenjivati s oprezom u bolesnika s početnom razinom transaminaza ≥ 5 x GGN ili početnom razinom bilirubina > 3 x GGN (vidjeti dio 5.1).
English: The pharmacokinetics of ipilimumab was studied in 785 patients with advanced melanoma who received induction doses ranging from 0.3 to 10 mg/kg administered once every 3 weeks for 4 doses.
Croatian: Farmakokinetika ipilimumaba ispitivala se u 785 bolesnika s uznapredovalim melanomom koji su u uvodnoj terapiji primali doze u rasponu od 0,3 do 10 mg/kg svaka 3 tjedna do ukupno 4 doze.
English: If myocarditis is suspected, prompt initiation of a high dose of steroids (prednisone 1 to 2 mg/kg/day or methylprednisolone 1 to 2 mg/kg/day) and prompt cardiology consultation with diagnostic workup according to current clinical guidelines should be initiated.
Croatian: Ako se posumnja na miokarditis, treba odmah uvesti visoku dozu steroida (prednizon u dozi od 1 do 2 mg/kg na dan ili metilprednizolon u dozi od 1 to 2 mg/kg na dan) te bez odgode potražiti savjet kardiologa i učiniti dijagnostičku obradu u skladu s važećim kliničkim smjernicama.
English: Key elements of the Healthcare Professional Adverse Reaction Management Guide:
Croatian: Najvažniji elementi vodiča za zdravstvene radnike za zbrinjavanje nuspojava;
English: Infusion reaction
Croatian: Reakcije na infuziju
English: Grade 2 cases were reported in 2.2% (10/448) of patients.
Croatian: Slučajevi 2. stupnja prijavljeni su u 2,2 % (10/448) bolesnika.
English: a. Summary of safety profile
Croatian: Sažetak sigurnosnog profila
English: Vogt-Koyanagi-Harada syndromee, serous retinal detachment Cardiac disorders
Croatian: Rijetko sindrom Vogt-Koyanagi-Haradae, serozno odljepljenje mrežnicee Srčani poremećaji
English: Thirty-two patients received re-treatment: 8 in the ipilimumab monotherapy group, 23 in the ipilimumab + gp100 group, and 1 in the gp100 group.
Croatian: Trideset i dvoje bolesnika primilo je ponovno liječenje: 8 u skupini koja je primala monoterapiju ipilimumabom, 23 u skupini koja je primala ipilimumab+ gp100 i 1 u skupini koja je primala gp100.
English: Any other adverse reactions that are demonstrated or suspected to be immune-related should be graded according to CTCAE.
Croatian: Svaka druga nuspojava za koju postoji dokaz ili sumnja da je imunološki uzrokovana mora se stupnjevati prema CTCAE.
English: The frequencies of serious adverse reactions in the 10 mg/kg and 3 mg/kg groups were 37% and 18%, with the 3 most common serious adverse reactions being diarrhea (10.7% vs 5.5%), colitis (8.0% vs 3.0%), and hypophysitis (4.4% vs 1.9%).
Croatian: Učestalosti ozbiljnih nuspojava u skupini 10 mg/kg i 3 mg/kg bile su 37% i 18%, a 3 najčešće ozbiljne nuspojave bile su proljev (10,7% naspram 5,5%), kolitis (8,0% naspram 3,0%) i hipofizitis (4,4% naspram 1,9%).
English: Tumour PD-L1 expression was determined using the PD-L1 IHC 288 pharmDx assay.
Croatian: Tumorska ekspresija PD L1 određivala se uz pomoć testa PD L1 IHC 28 8 pharmDx.
English: As YERVOY may be given in combination with nivolumab, it is important that you also read the package leaflet for this medicine.
Croatian: YERVOY se može primjenjivati u kombinaciji s nivolumabom, i važno je da pročitate i uputu o tom lijeku.
English: In other patients with a history of autoimmune disease, ipilimumab should be used with caution after careful consideration of the potential risk-benefit on an individual basis.
Croatian: U drugih bolesnika s autoimunom bolešću u anamnezi ipilimumab treba primjenjivati uz oprez nakon pažljivog razmatranja mogućeg omjera rizika i koristi u svakog bolesnika zasebno.
English: Rare decreased blood thyroid stimulating hormoned, decreased thyroxined, abnormal blood prolactind a
Croatian: Rijetko snižen hormon koji stimulira štitnjaču u krvid, snižen tiroksind, abnormalna razina prolaktina u krvid a
English: - Inflammation of the muscles such as myocarditis (inflammation of the heart muscle), myositis (inflammation of the muscles) and rhabdomyolysis (stiffness in muscles and joints, muscle spasm).
Croatian: - upalu mišića, kao što su miokarditis (upala srčanog mišića), miozitis (upala mišića) i rabdomioliza (ukočenost mišića i zglobova, grčenje mišića).
English: Caution should be used when ipilimumab is administered following prior vemurafenib.
Croatian: Potreban je oprez kada se ipilimumab primjenjuje nakon vemurafeniba.
English: * ipilimumab in combination with nivolumab for the first 4 doses then followed by nivolumab monotherapy in melanoma.
Croatian: * Ipilimumab u kombinaciji s nivolumabom kod prve 4 doze nakon kojih slijedi nivolumab u monoterapiji za melanom.
English: DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
Croatian: DRESS se očituje kao osip s eozinofilijom povezan s jednom ili više sljedećih karakteristika: vrućicom, limfadenopatijom, edemom lica, te uključuje unutarnje organe (jetra, bubrezi, pluća).
English: Cardiac and pulmonary adverse events including pulmonary embolism have also been reported with combination therapy.
Croatian: Kod kombinirane terapije prijavljene su i srčani i plućni štetni događaji uključujući plućnu emboliju.
English: The safety data for patients with unresectable or metastatic melanoma, treated with ipilimumab (3 mg/kg, with a minimum of 3 year follow-up) and enrolled in multi-national, prospective, observational study CA184143 (N= 1151) were similar to what has been reported in ipilimumab clinical trials for advanced melanoma.
Croatian: Sigurnosni podaci u bolesnika s neresektabilnim ili metastatskim melanomom liječeni ipilimumabom (3 mg/kg, minimalno 3 godišnje praćenje) i uključenima u multi-nacionalno prospektivno, opservacijsko ispitivanje CA184143 (N= 1151), bili su slični onima prijavljenima u kliničkim ispitivanjima ipilimumaba kod uznapredovalog melanoma.
English: Overall survival compared between Ipilimumab 10 mg/kg and 3 mg/kg groups showed HR = 0.84 (95% CI: 0.70, 0.99; P-value = 0.04).
Croatian: Ukupno preživljenje uspoređivano između skupina koje su primale ipilimumab 10 mg/kg odnosno 3 mg/kg pokazalo je HR=0,84 (95% CI, 0,70; 0,99, P vrijednost=0,04).
English: Myasthenia gravis-like symptoms have also been reported in < 1% of patients who received higher doses of ipilimumab in clinical trials.
Croatian: Zabilježeni su i simptomi slični miasteniji gravis u < 1% bolesnika koji su primali ipilimumab u visokim dozama u kliničkim ispitivanjima.
English: The chemical and physical in-use stability of the undiluted or diluted concentrate (between 1 and 4 mg/ml) has been demonstrated for 24 hrs at 25°C and 2°C to 8°C.
Croatian: Dokazana kemijska i fizikalna stabilnost nerazrijeđenog ili razrijeđenog koncentrata (između 1 i 4 mg/ml) u primjeni iznosi 24 sata na temperaturi od 25°C i od 2°C do 8°C.
English: Decision whether to withhold a dose should be based on severity.
Croatian: Odluka o odgađanju primjene doze treba se temeljiti na težini nuspojave.
English: Cases of Vogt-Koyanagi-Harada syndrome and serous retinal detachment have been reported post-marketing (see section 4.8).
Croatian: Slučajevi sindroma Vogt-Koyanagi-Harada i seroznog odljepljenja mrežnice prijavljeni su nakon stavljanja lijeka u promet (vidjeti dio 4.8).
English: This study included patients regardless of their tumour PD-L1 status.
Croatian: Bolesnici su se uključivali u ispitivanje neovisno o tumorskom PD-L1 statusu.
English: If immunosuppression with corticosteroids is used to treat an adverse reaction that occurs as a consequence of combination therapy, a taper of at least 1 month duration should be initiated upon improvement.
Croatian: Ako se za liječenje nuspojave koja je posljedica kombinirane terapije primjenjuje imunosupresija kortikosteroidima, njihova se doza mora smanjivati postupno tijekom najmanje 1 mjeseca nakon poboljšanja.
English: - inflammation of the liver (hepatitis) that can lead to liver failure.
Croatian: - upala jetre (hepatitis) koja može dovesti do zatajenja jetre.
English: When administered in combination with nivolumab, the CL of ipilimumab increased by 5.7% in the presence of anti-ipilimumab antibodies and the CL of nivolumab increased by 20% in the presence of presence of anti-nivolumab antibodies.
Croatian: Kod primjene u kombinaciji s nivolumabom, klirens ipilimumaba povećao se za 5,7% u prisutnosti protutijela na ipilimumab, dok se klirens nivolumaba povećao za 20% u prisutnosti protutijela na nivolumab.
English: Signs and symptoms that your glands are not working properly may include headaches, blurry or double vision, tiredness, decreased sexual drive, behavioral changes.
Croatian: Znakovi i simptomi neispravnog rada žlijezda mogu uključivati glavobolje, zamagljen ili dvostruki vid, umor, smanjeni spolni nagon, promjene u ponašanju.
English: From a microbiological point of view, once opened, the medicine should be infused or diluted and infused immediately.
Croatian: S mikrobiološkog stanovišta, nakon otvaranja lijek se treba odmah primijeniti infuzijom ili razrijediti i primijeniti infuzijom.
English: Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).
Croatian: U odnosu na monoterapiju nivolumabom, produljenje preživljenja bez progresije bolesti (engl. progression free survival, PFS) i ukupnog preživljenja (engl. overall survival, OS) uz liječenje kombinacijom nivolumaba i ipilimumaba ustanovljeno je samo u bolesnika s niskom razinom tumorske ekspresije PD L1 (vidjeti dijelove 4.4 i 5.1).
English: In most reported cases prior or concurrent therapy with a PD-1 or PD-L1 inhibitor has occurred.
Croatian: U većini prijavljenih slučajeva se prethodno ili istodobno primjenjivala terapija s PD-1 ili PD-L1 inhibitorima.
English: Based on an exposure-response analysis in 497 patients with advanced melanoma, OS was independent of prior systemic anti-cancer therapy and increased with higher ipilimumab Cminss plasma concentrations.
Croatian: S obzirom na analizu odgovora na izloženost u 497 bolesnika s uznapredovalim melanomom, OS nije ovisio o prethodnoj sistemskoj antitumorskoj terapiji, a povećavao se s porastom minimalnih koncentracija ipilimumaba u plazmi u stanju dinamičke ravnoteže (Cminss).
English: When to permanently discontinue YERVOY as monotherapy
Croatian: Kada trajno prekinuti liječenje lijekom YERVOY u monoterapiji
English: Each ml of concentrate contains 0.1 mmol sodium, which is 2.30 mg sodium.
Croatian: Jedan ml koncentrata sadrži 0,1 mmol natrija, što odgovara 2,30 mg natrija.
English: With protocol-specified management guidelines, time to resolution ranged from 0.7 to 2 weeks.
Croatian: Uz smjernice za liječenje definirane planom ispitivanja, vrijeme do povlačenja iznosilo je od 0,7 do 2 tjedana.
English: YERVOY as monotherapy Melanoma
Croatian: YERVOY u monoterapiji Melanom
English: CA184004/ 022Pooled
Croatian: CA184004/ 022 zbirno
English: Action
Croatian: Djelovanje
English: Immune-related endocrinopathy observed in clinical trials was generally controlled with immunosuppressive therapy and hormone replacement therapy.
Croatian: Imunološki uzrokovana endokrinopatija primijećena u kliničkim ispitivanjima općenito se mogla kontrolirati imunosupresivnom terapijom i hormonskom nadomjesnom terapijom.
English: Rare toxic epidermal necrolysisa,f, StevensJohnson syndromef Musculoskeletal and connective tissue disorders Very common arthralgia musculoskeletal paing, arthralgia
Croatian: Rijetko toksična epidermalna nekrolizaa,f, Stevens-Johnsonov sindroma,f Poremećaji mišićno koštanog sustava i vezivnog tkiva Vrlo često artralgija mišićno-koštana bolg, artralgija
English: Progression Free Survival per Investigator (Months)
Croatian: Preživljenje bez progresije bolesti prema ispitivaču (mjeseci)
English: For ipilimumab-related uveitis, iritis, serous retinal detachment or episcleritis, topical corticosteroid eye drops should be considered as medically indicated.
Croatian: Kod uveitisa, iritisa ili episkleritisa povezanih s ipilimumabom potrebno je razmotriti primjenu kortikosteroidnih kapi za oko prema medicinskoj indikaciji.
English: In a Phase 2 trial, the sequential treatment with vemurafenib followed by 10 mg/kg ipilimumab in patients with BRAF-mutated metastatic melanoma showed a higher incidence of Grade 3+ skin adverse reactions than with ipilimumab alone.
Croatian: U ispitivanju faze II, sekvencijalna primjena s vemurafenibom iza koje slijedi ipilimumab 10 mg/kg u bolesnika s BRAF pozitivnom mutacijom, kod metastatskog melanoma, imala je veću incidenciju kožnih nuspojava stupnja 3+, nego pri primjeni samo ipilimumaba.
English: Gently mix the infusion by manual rotation.
Croatian: Lagano promiješajte infuziju kružnim pokretima ruke.
English: The frequency of severe (Grade 3 or 4) diarrhoea and severe (Grade 3 or 4) colitis was 5% each.
Croatian: Učestalost teškog proljeva (3. ili 4. stupanj) i teškog kolitisa (3. ili 4. stupnja) iznosila je 5%.
English: Signs and symptoms of hepatitis may include eye or skin yellowing (jaundice), pain on the right side of your stomach area, tiredness.
Croatian: Znakovi i simptomi hepatitisa mogu uključivati žutilo bjeloočnica ili kože (žuticu), bol u desnoj strani trbuha, umor.
English: In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with YERVOY (see Tables 3A, 3B, and section 4.4).
Croatian: Osim toga, tijekom liječenja lijekom YERVOY moraju se ocijeniti svi znakovi i simptomi imunološki uzrokovanih nuspojava, uključujući proljev i kolitis (vidjeti Tablice 3A i 3B te dio 4.4).
English: The safety and efficacy of YERVOY have not been studied in patients with hepatic impairment.
Croatian: Sigurnost i djelotvornost lijeka YERVOY nisu ispitane u bolesnika s oštećenom funkcijom jetre.
English: Transient vision loss has been reported in patients with ipilimumab-related ocular inflammations.
Croatian: Prolazan gubitak vida prijavljen je u bolesnika koji su razvili upalu oka povezanu s ipilimumabom.
English: Based on these preliminary data, the concurrent administration of ipilimumab and vemurafenib is not recommended.
Croatian: Na temelju tih početnih podataka, ne preporučuje se istovremena primjena ipilimumaba i vemurafeniba.
English: Overall Survival (proportion)
Croatian: Ukupno preživljenje (razmjer)
English: Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the three treatment groups.
Croatian: Bolesnici s mjerljivom tumorskom ekspresijom PD L1 bili su ravnomjerno raspodijeljeni u sve tri liječene skupine.
English: Unless an alternate etiology has been identified, diarrhoea, increased stool frequency, bloody stool, LFT elevations, rash and endocrinopathy must be considered inflammatory and ipilimumab-related.
Croatian: Osim ako nije utvrđen drugi uzrok, proljev, učestalija stolica, krvava stolica, povišene vrijednosti jetrenih funkcijskih testova, osip i endokrinopatija moraju se smatrati posljedicom upale povezane s lijekom ipilimumab.
English: Excipients: Tris hydrochloride, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Croatian: Pomoćne tvari: trometamin klorid, natrijev klorid, manitol (E421), pentetatna kiselina, polisorbat 80, natrijev hidroksid, kloridna kiselina, voda za injekcije.
English: Among the 382 patients in this group who continued treatment in the single-agent phase, 144 (38%) experienced at least one Grade 3 or 4 adverse reaction during the single-agent phase.
Croatian: Od 382 bolesnika iz te skupine koji su nastavili liječenje u fazi monoterapije, njih 144 (38%) doživjelo je najmanje jednu nuspojavu 3. ili 4. stupnja tijekom faze monoterapije.
English: Among 128 patients who discontinued ipilimumab in combination with nivolumab due to adverse reaction after 18 months of follow-up, median PFS was 16.7 months (95% CI: 10.2, NA).
Croatian: Među 128 bolesnika koji su nakon 18 mjeseci praćenja prekinuli liječenje ipilimumabom u kombinaciji s nivolumabom zbog nuspojave, medijan PFS a iznosio je 16,7 mjeseci (95% CI: 10,2; N.D).
English: Fatal Guillain-Barré syndrome has been reported in clinical trials.
Croatian: U kliničkim je ispitivanjima zabilježen Guillain-Barréov sindrom sa smrtnim ishodom.
English: Figure 1: Overall Survival with ipilimumab 3 mg/kg in pooled analysis
Croatian: Slika 1: Ukupno preživljenje s ipilimumabom 3 mg/kg u zbirnoj analizi
English: The majority were mild to moderate (Grade 1 or 2).
Croatian: Većina nuspojava bila je blage do umjerene težine (1. ili 2. stupnja).
English: Ipilimumab in combination with nivolumab (see section 4.2)
Croatian: Ipilimumab u kombinaciji s nivolumabom (vidi dio 4.2)
English: YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).
Croatian: YERVOY je u kombinaciji s nivolumabom indiciran za prvu liniju liječenja odraslih bolesnika s uznapredovalim karcinomom bubrežnih stanica (engl. renal cell carcinoma, RCC) umjerenog/visokog rizika (vidjeti dio 5.1).
English: How much YERVOY is given
Croatian: Koliko se lijeka YERVOY daje