FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with ipilimumab in combination with nivolumab may occur at any time during or after discontinuation of therapy.
Slovenian: Bolnike je treba neprestano nadzirati (še vsaj do 5 mesecev po aplikaciji zadnjega odmerka), saj se neželeni učinki ipilimumaba v kombinaciji z nivolumabom lahko pojavijo kadarkoli med zdravljenjem ali po ukinitvi zdravljenja.
English: Ipilimumab is associated with inflammatory adverse reactions resulting from increased or excessive immune activity (immune-related adverse reactions), likely to be related to its mechanism of action.
Slovenian: Ipilimumab je povezan z vnetnimi neželenimi učinki, ki so posledica povečane ali prekomerne imunske aktivnosti (imunsko pogojeni neželeni učinki), kar je verjetno povezano z mehanizmom njegovega delovanja.
English: Summary of Adverse Events after up to Four Doses of 3, 5 and 10 mg/kg, All Treated Patients
Slovenian: Povzetek neželenih učinkov po uporabi do štirih odmerkov 3, 5 in 10 mg/kg, vsi zdravljeni bolniki
English: At the recommended dose of 3 mg/kg median OS was similar in the subgroup of females ≥ 50 years of age compared to the overall population: (11.40 vs 11.53 months).
Slovenian: Pri uporabi priporočenega odmerka 3 mg/kg je bila mediana celokupnega preživetja v podskupini žensk, starih 50 let ali starejših, podobna kot v celotni populaciji: (11,40 v primerjavi z 11,53 meseca).
English: Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening.
Slovenian: Vnetje lahko resno škoduje telesu, nekatera vnetna stanja pa lahko tudi ogrozijo življenje.
English: No dose reduction of YERVOY is recommended.
Slovenian: Zmanjšanje odmerka zdravila YERVOY ni priporočljivo.
English: Only very limited data are available in children younger than 12 years of age.
Slovenian: Pri otrocih, mlajših od 12 let, je na voljo zelo malo podatkov.
English: Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Slovenian: Uporabite infuzijski sistem in sterilni, nepirogeni filter, ki minimalno veže proteine (velikost por od 0,2 μm do 1,2 μm).
English: The majority (71-73%) of patients had M1c stage disease and 37-40% of patients had an elevated lactate dehydrogenase (LDH) at baseline.
Slovenian: Večina bolnikov (71-73 %) je imela M1c stadij bolezni in 37-40 % bolnikov je imelo zvišane vrednosti laktat-dehidrogenaze (LDH) v izhodišču.
English: • Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of immune-related adverse reactions in section 4.4 of the SmPC.
Slovenian: • Opozorilo, da lahko ipilimumab povzroči resne neželene učinke na številnih delih telesa, ki lahko povzročijo smrt in zahtevajo hitro ukrepanje, kot je opisano v smernicah za ukrepanje v primeru imunsko pogojenih neželenih učinkov v poglavju 4.4 Povzetka glavnih značilnosti zdravila.
English: • Patient Information Brochures including Alert Cards
Slovenian: • Vodnik z informacijami za bolnike, vključno z opozorilnimi karticami.
English: Overall, no apparent association was observed between antibody development and adverse reactions.
Slovenian: Gledano v celoti, niso ugotovili očitne povezave med razvojem protiteles in pojavom neželenih učinkov.
English: Ipilimumab is a T-cell potentiator that enables the immune response (see section 5.1) and may interfere with immunosuppressive therapy, resulting in an exacerbation of the underlying disease or increased risk of graft rejection.
Slovenian: Ipilimumab je potenciator limfocitov T, ki omogočajo imunski odziv (glejte poglavje 5.1), in lahko vpliva na imunosupresivno zdravljenje, kar lahko povzroči poslabšanje osnovne bolezni ali poveča tveganje za zavrnitev presadka.
English: Table 11: Objective response (CA209067)
Slovenian: Preglednica 11: Objektivni odziv (študija CA209067)
English: Grade 4 creatinine elevation
Slovenian: Zvišanje vrednosti kreatinina stopnje 4
English: How YERVOY is given YERVOY will be given to you in a hospital or clinic under the supervision of an experienced doctor.
Slovenian: Način uporabe zdravila YERVOY Zdravilo YERVOY boste prejeli v bolnišnici pod nadzorom zdravnika z ustreznimi izkušnjami.
English: Objective response (95% CI) Odds ratio (vs. ipilimumab) (99.5% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Duration of response Median (range), months
Slovenian: Objektivni odziv (95% IZ) Razmerje obetov (v primerjavi z ipilimumabom) (99,5% IZ) Popolni odziv (CR) Delni odziv (PR) Stabilna bolezen (SD) Trajanje odziva Mediana (razpon), meseci ni dosežena
English: Data from first-line RCC patients 75 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Slovenian: Pri bolnikih z RCC, zdravljenih v prvi liniji, starih 75 let ali starejših, je na voljo premalo podatkov, zato zaključkov za to populacijo ni mogoče navesti (glejte poglavje 5.1).
English: Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that ipilimumab does not adversely affect them.
Slovenian: Ker obstaja možnost za pojav neželenih učinkov, kot je utrujenost (glejte poglavje 4.8), je treba bolnikom svetovati previdnost pri vožnji in upravljanju s stroji, dokler se z gotovostjo ne izkaže, da ipilimumab pri njih nima škodljivih vplivov na tovrstne aktivnosti.
English: Based on early data, the combination of YERVOY (ipilimumab) and vemurafenib is not recommended due to increased toxicity to the liver.
Slovenian: Na osnovi prvih podatkov kombinacija zdravila YERVOY (ipilimumab) in vemurafeniba ni priporočljiva zaradi povečanega toksičnega vpliva na jetra.
English: Treatment beyond initial investigator-assessed RECIST, version 1.1-defined progression was permitted if the patient had a clinical benefit and was tolerating study drug as determined by the investigator.
Slovenian: Zdravljenje po začetnem napredovanju bolezni po merilih RECIST, različica 1.1 je bilo dovoljeno, če je po presoji raziskovalca pri bolniku bila prisotna klinična korist in je bolnik študijsko zdravilo prenašal.
English: Treatment should be continued in the presence of hormone replacement therapya as long as no symptoms are present
Slovenian: Zdravljenje se ob hormonskem nadomestnem zdravljenju lahko nadaljujea, dokler ni prisotnih simptomov.
English: Two (25.0%) of 8 patients treated with 5 mg/kg and 1 (11.1%) of 9 patients treated with 10 mg/kg reported Grade 3-4 events.
Slovenian: Pri dveh (25,0 %) od 8 bolnikov, ki so se zdravili z odmerkom 5 mg/kg, in 1 (11,1 %) od 9 bolnikov, ki so se zdravili z odmerkom 10 mg/kg, so poročali o neželenih učinkih stopnje 3-4.
English: Symptoms may also include visual field defects, behavioural changes, electrolyte disturbances, and hypotension.
Slovenian: Simptomi lahko vključujejo tudi motnje v vidnem polju, vedenjske spremembe, motnje elektrolitov in hipotenzijo.
English: Additionally, based on these relationships, there were no clinically significant differences between a nivolumab dose of 480 mg every 4 weeks or 3 mg/kg every 2 weeks in advanced melanoma and RCC.
Slovenian: Poleg tega pa na osnovi teh razmerij tudi ni klinično pomembnih razlik med uporabo nivolumaba v odmerku 480 mg vsake 4 tedne ali 3 mg/kg vsaka 2 tedna pri napredovalem melanomu in RCC.
English: Withdraw the required volume of YERVOY concentrate using an appropriate sterile syringe.
Slovenian: Potrebni volumen koncentrata zdravila YERVOY izvlecite v ustrezno sterilno injekcijsko brizgo.
English: Animal reproduction studies have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Ipilimumab is a human monoclonal antibody that is not metabolized by cytochrome P450 enzymes (CYPs) or other drug metabolizing enzymes.
Slovenian: Ipilimumab je humano monoklonsko protitelo, ki se ne presnavlja z encimi citokroma P450 (CYP) ali drugimi presnovnimi encimi.
English: A Phase 3, double-blind study enrolled patients with advanced (unresectable or metastatic) melanoma who had previously been treated with regimens containing one or more of the following: IL-2, dacarbazine, temozolomide, fotemustine, or carboplatin.
Slovenian: Dvojno slepa študija 3. faze je vključevala bolnike z napredovalim (neoperabilnim ali metastatskim) melanomom, ki so se predhodno že zdravili z režimi, ki so vključevala enega ali več naslednjih zdravil: IL-2, dakarbazin, temozolomid, fotemustin ali karboplatin.
English: Median age was 15 years.
Slovenian: Mediana starosti je bila 15 let.
English: If you stop using YERVOY
Slovenian: Če ste prenehali uporabljati zdravilo YERVOY
English: A rare disease in which our immune system makes too many of otherwise normal infection fighting cells called histiocytes and lymphocytes.
Slovenian: Redka bolezen, pri kateri imunski sistem tvori preveč sicer normalnih celic, ki se borijo proti okužbam, imenovanih histiociti in limfociti.
English: Studies to evaluate the mutagenic and carcinogenic potential of ipilimumab have not been performed.
Slovenian: Študije, ki bi ovrednotile mutageni ali kancerogeni potencial ipilimumaba, niso bile izvedene.
English: YERVOY may cause changes in the results of tests carried out by your doctor.
Slovenian: Zdravilo YERVOY lahko povzroči spremembe v rezultatih preiskav, ki jih bo opravil zdravnik.
English: Since gastrointestinal haemorrhage is an adverse reaction with ipilimumab (see section 4.8), patients who require concomitant anticoagulant therapy should be monitored closely.
Slovenian: Ker je gastrointestinalna krvavitev tudi neželeni učinek ipilimumaba (glejte poglavje 4.8), je treba bolnike, ki potrebujejo sočasno zdravljenje z antikoagulanti, skrbno nadzirati.
English: The effect of race was not examined as there was insufficient data in non-Caucasian ethnic groups.
Slovenian: Vpliv rase ni bil ovrednoten, saj je bilo pri ostalih rasah, razen pri belcih, na voljo premalo podatkov.
English: Patients with ocular melanoma were not included in the CA184-169 clinical trial.
Slovenian: Bolniki z očesnim melanomom niso bili vključeni v klinično preskušanje CA184-169.
English: NCI-CTCAE v4 Gradea
Slovenian: Stopnja po NCI-CTCAE v4a
English: Please note that the reaction called DRESS may develop weeks or months after your last dose.
Slovenian: Reakcija, imenovana DRESS, se lahko pojavi šele več tednov ali mesecev po prejemu zadnjega odmerka.
English: Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells.
Slovenian: Ipilimumab je zaviralec CTLA-4 (“CTLA-4 immune checkpoint inhibitor”), ki z zavrtjem T-celičnih inhibitornih signalov, ki se sprožijo preko CTLA-4, poveča število reaktivnih efektorskih celic T, kar mobilizira neposredni T-celični imunski odziv proti tumorskim celicam.
English: YERVOY is for intravenous use.
Slovenian: Zdravilo YERVOY je namenjeno za intravensko uporabo.
English: Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a key regulator of T-cell activity.
Slovenian: Citotoksični T limfocitni antigen 4 (CTLA-4; “Cytotoxic T-lymphocyte antigen-4”) je ključni regulator T-celične aktivnosti.
English: Median OS and estimated 1-year, 2-year, 3-year and 4-year survival rates are presented in Table 9.
Slovenian: Mediana OS in ocenjeni deleži preživetja po 1-letu, 2-letih, 3-letih in 4-letih so prikazani v preglednici 9.
English: Moderate diarrhoea or colitis that either is not controlled with medical management or that persists (5-7 days) or recurs
Slovenian: Prebavila: zmerna driska ali kolitis, ki kljub zdravljenju nista nadzorovana, vztrajata (5-7 dni) ali se ponavljata
English: Two patients treated with ipilimumab 10 mg/kg experienced a partial response, one of which was a durable response for more than 1 year.
Slovenian: Pri dveh bolnikih, ki sta prejemala ipilimumab v odmerku 10 mg/kg, je bil dosežen delni odziv, pri enem trajni odziv, ki je trajal več kot 1 leto.
English: Randomisation was stratified by PD-L1 expression (≥ 5% vs. < 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system.
Slovenian: Randomizacija je bila razslojena glede na ekspresijo PD-L1 (≥ 5 % v primerjavi z < 5 % ekspresije celične membrane tumorja), status BRAF in M stadij po kriterijih Ameriškega združenja za zdravljenje raka (AJCC - American Joint Committee on Cancer).
English: - inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis, Stevens-Johnson syndrome and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
Slovenian: - vnetje kože, ki lahko napreduje do hude kožne reakcije (znana kot toksična epidermalna nekroliza, Stevens Johnsonov sindrom in reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS-Drug Reaction with Eosinophilia and Systemic Symptoms)).
English: Immune-related adverse reactions, which can be severe or life-threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems.
Slovenian: Imunsko pogojeni neželeni učinki, ki so lahko resni ali življenjsko nevarni, lahko prizadenejo prebavila, jetra, kožo, živčevje, endokrine žleze ali druge organske sisteme.
English: You will be treated with YERVOY once every 3 weeks, for a total of 4 doses.
Slovenian: Zdravilo YERVOY boste prejeli enkrat na vsake 3 tedne, vsega skupaj 4 odmerke.
English: “+” denotes a censored observation.
Slovenian: “+” označuje krnjene podatke.
English: Patients with severe (Grade 3 or 4) endocrinopathy controlled with hormone replacement therapy may remain on therapy.
Slovenian: Pri bolnikih s hudo (stopnja 3 ali 4) endokrinopatijo, ki je nadzorovana s hormonskim nadomestnim zdravljenjem, se zdravljenje lahko nadaljuje.
English: Rare cases of toxic epidermal necrolysis (TEN) (including Steven Johnson Syndrome) have been observed, some with fatal outcome.
Slovenian: Poročali so o redkih primerih toksične epidermalne nekrolizie (TEN) (vključno s Stevens-Johnsonovim sindromom), v nekaterih primerih s smrtnimi izidom.
English: Solid organ transplant rejection
Slovenian: Zavrnitev presadka čvrstega organa
English: Preparing the infusion: Take care to ensure aseptic handling when you prepare the infusion.
Slovenian: Priprava raztopine za infundiranje: Pri pripravi raztopine za infundiranje morate zagotoviti aseptične pogoje.
English: The potential risk of treatment to the developing foetus is unknown.
Slovenian: Možno tveganje za razvijajoči se plod ni znano.
English: Use of ipilimumab in combination with nivolumab in melanoma patients with rapidly progressing disease.
Slovenian: Uporaba ipilimumaba v kombinaciji z nivolumabom pri bolnikih z melanomom s hitro napredujočo obliko bolezni
English: One female infant had unilateral renal agenesis of the left kidney and ureter, and one male infant had an imperforate urethra with associated urinary obstruction and subcutaneous scrotal edema.
Slovenian: Ena samička se je skotila z enostransko agenezijo leve ledvice in sečevoda, en samček pa z atrezijo sečnice s posledično obstrukcijo urinskih poti in podkožnim edemom modnika.
English: - inflammation of the nerves that can lead to paralysis.
Slovenian: - vnetje živcev, ki lahko napreduje do ohromelosti.
English: None had any infusion-related or peri-infusional hypersensitivity or anaphylactic reactions.
Slovenian: Pri nobenem bolniku ni prišlo do pojava z infuzijo povezane ali peri-infuzijske preobčutljivosti ali anafilaktične reakcije.
English: YERVOY can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting to up to 5 times the original volume of concentrate (up to 4 parts of diluent to 1 part of concentrate).
Slovenian: Zdravilo YERVOY se lahko aplicira intravensko: brez redčenja, po prenosu v infuzijski vsebnik z ustrezno sterilno injekcijsko brizgo, ali po redčenju do največ 5-kratnega začetnega volumna koncentrata (do 4 deli raztopine za redčenje na 1 del koncentrata).
English: Secondary efficacy endpoints of best overall response rate (BORR), stable disease (SD), disease control rate (DCR), and progression free survival (PFS) were based on mWHO criteria and determined by the investigator's assessment.
Slovenian: Sekundarni opazovani dogodki učinkovitosti: najboljši celokupni delež odziva (BORR-best overall response rate), stabilna bolezen (SD-stable disease), delež nadzorovane bolezni (DCR-disease control rate) in preživetje brez napredovanja bolezni (PFS-progression free survival) so temeljili na modificiranih kriterijih SZO in so jih ovrednotili raziskovalci.
English: YERVOY in combination with nivolumab may cause changes in the results of tests carried out by your doctor.
Slovenian: Zdravilo YERVOY v kombinaciji z nivolumabom lahko povzroči spremembe v rezultatih preiskav, ki jih bo opravil zdravnik.
English: Efficacy results for the intermediate/poor risk patients are shown in Table 12.
Slovenian: Rezultati učinkovitosti pri bolnikih s srednje ugodnim ali slabim prognostičnim obetom so prikazani v preglednici 12.
English: Reported in clinical studies and in the post-marketing setting.
Slovenian: Poročila iz kliničnih preskušanj in iz obdobja po prihodu zdravila na trg.
English: The majority were mild to moderate (Grade 1 or 2).
Slovenian: Večinoma so bili blagi do zmerni (stopnja 1 ali 2).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC11.
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa, oznaka ATC: L01XC11
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.
Slovenian: Na osnovi analize izpostavljenosti-odziva pri 497 bolnikih z napredovalim melanomom, je bilo celokupno preživetje neodvisno od predhodnega sistemskega protitumorskega zdravljenja in večje pri višjih koncentracijah Cminss ipilimumaba v plazmi.
English: For additional information on warnings and precautions associated with nivolumab treatment, please refer to the nivolumab SmPC.
Slovenian: Za dodatne informacije glede opozoril in previdnostnih ukrepov povezanih z zdravljenjem z nivolumabom, upoštevajte SmPC za nivolumab.
English: Rate (95% CI) At 6 months At 12 months Progression-free survival Events
Slovenian: Delež (95 % IZ) v 6. mesecu v 12. mesecu Preživetje brez napredovanja bolezni Dogodki Razmerje ogroženostia
English: With protocol-specified management guidelines, time to resolution ranged from 0.7 to 2 weeks.
Slovenian: Po ukrepanju v skladu s smernicami, določenimi s protokolom, je čas do izboljšanja znašal od 0,7 do 2 tedna.
English: However, patients with brain metastases were included in this study, if they were free of neurologic symptoms related to metastatic brain lesions and if they did not require or receive systemic corticosteroid therapy in the 10 days prior to beginning ipilimumab therapy (see section 5.1).
Slovenian: Bolniki z zasevki v možganih pa so bili vključeni v to študijo, če niso imeli nevroloških simptomov, povezanih z metastatskimi spremembami v možganih in niso potrebovali ali prejemali sistemskega kortikosteroidnega zdravljenja v 10 dneh pred začetkom zdravljenja z ipilimumabom (glejte poglavje 5.1).
English: For patients with a history of autoimmune disease, see also section 4.4.
Slovenian: Za bolnike s predhodno avtoimunsko boleznijo glejte tudi poglavje 4.4.
English: Each ml of this medicinal product contains 0.1 mmol (or 2.30 mg) sodium.
Slovenian: En mililiter tega zdravila vsebuje 0,1 mmol (ali 2,30 mg) natrija.
English: Unexplained motor neuropathy, muscle weakness, or sensory neuropathy lasting > 4 days must be evaluated, and non-inflammatory causes such as disease progression, infections, metabolic syndromes and concomitant medication should be excluded.
Slovenian: Nepojasnjeno motorično nevropatijo, mišično oslabelost ali senzorično nevropatijo, ki trajajo več kot 4 dni, je treba ovrednotiti in izključiti nevnetne vzroke, kot so napredovanje bolezni, okužbe, metabolni sindrom in sočasno uporabljena zdravila.
English: Rare cases of SJS and TEN, some of them with fatal outcome, have been observed.
Slovenian: Poročali so o redkih primerih SJS in TEN, nekateri od njih so se končali s smrtnim izidom.
English: Tumour PD-L1 expression was determined using the PD-L1 IHC 288 pharmDx assay.
Slovenian: Ekspresija PD-L1 tumorja je bila določena s testom PD-L1 IHC 28-8 pharmDx.
English: By subgroup analysis, the observed OS benefit was consistent within most of the subgroups of patients (M [metastases]-stage, prior interleukin-2, baseline LDH, age, sex, and the type and number of prior therapy).
Slovenian: Pri analizi po podskupinah je bila opažena korist pri celokupnem preživetju konsistentna v večini podskupin bolnikov (M [metastaze]-stadij, predhodno zdravljenje z interlevkinom-2, izhodiščna vrednost LDH, starost, spol in vrsta ter število predhodnih zdravljenj).
English: CA184332 and CA184338
Slovenian: CA184332 in CA184338
English: It is not known whether ipilimumab gets into breast milk.
Slovenian: Ni znano, ali se ipilimumab izloča v materino mleko.
English: No differences in the spectrum of irARs reported in adults and the paediatric population were evident.
Slovenian: Razlike v spektru imunsko pogojenih neželenih učinkov pri odraslih in pediatrični populaciji niso bile očitne.
English: Stable disease was achieved in two patients at the ipilimumab 5mg/kg dose, one with a duration of > 22 months.
Slovenian: Stabilna bolezen je bila dosežena pri dveh bolnikih pri uporabi ipilimumaba v odmerku 5 mg/kg, pri enem s trajanjem > 22 mesecev.
English: Guidelines for permanent discontinuation or withholding of doses are described in Tables 3A and 3B for YERVOY as monotherapy, and in Table 3C for YERVOY in combination with nivolumab or administration of the second phase of treatment (nivolumab monotherapy) following combination treatment.
Slovenian: Smernice za trajno ukinitev zdravljenja ali zadržanje odmerka so prikazane v preglednicah 3A in 3B za zdravilo YERVOY v monoterapiji in v preglednici 3C za zdravilo YERVOY v kombinaciji z nivolumabom ali za drugo fazo zdravljenja (nivolumab v monoterapiji) po končanem kombiniranem zdravljenju.
English: Other organ systemsb: (e.g. nephritis, pneumonitis, pancreatitis, non-infectious myocarditis)
Slovenian: Drugi organski sistemib: (npr. nefritis, pljučnica, pankreatitis, ne-infektivni miokarditis)
English: While most immune-related adverse reactions occurred during the induction period, onset months after the last dose of ipilimumab has also been reported.
Slovenian: Večina imunsko pogojenih neželenih učinkov se je pojavila med indukcijskim obdobjem zdravljenja, vendar pa so poročali tudi o neželenih učinkih, ki so se pojavili več mesecev po uporabi zadnjega odmerka ipilimumaba.
English: Storage conditions and shelf life:
Slovenian: Shranjevanje in rok uporabnosti:
English: All Deaths, n (%)
Slovenian: Vsi smrtni izidi, n (%)
English: The use of systemic corticosteroids after starting ipilimumab treatment does not appear to impair the efficacy of ipilimumab.
Slovenian: Kaže, da uporaba sistemskih kortikosteroidov po začetku zdravljenja z ipilimumabom, ne vpliva na učinkovitost ipilimumaba.
English: The Kaplan-Meier OS curve revealed a plateau beginning around year 3 (OS rate = 21% [95% CI: 17-24]) that extended up to 10 years in some patients (see Figure 1).
Slovenian: Kaplan-Meierjeva krivulja celokupnega preživetja je pokazala začetni plato okoli leta 3 (delež celokupnega preživetja = 21 % [95 % IZ: 17-24]), ki je pri nekaterih bolnikih podaljšan do 10-ih let (glejte sliko 1).