FrancophonIA/ELRC3.0 huggingface dataset:
English: The median age was 61 years (range: 21-85) with 38% ≥ 65 years of age and 8% ≥ 75 years of age.
Slovenian: Mediana starost bolnikov je bila 61 let (razpon: 21-85), 38 % bolnikov je bilo starih  65 let, 8 % bolnikov pa  75 let.
English: The median age was 62 years (range: 21 to 85) with 34% ≥65 years of age and 7% ≥75 years of age.
Slovenian: Mediana starost bolnikov je bila 62 let (razpon: 21 do 85), 34 % bolnikov je bilo starih  65 let, 7 % bolnikov pa  75 let.
English: The Kaplan-Meier curves for OS are shown in Figure 12.
Slovenian: Kaplan-Meierjevi krivulji celokupnega preživetja sta prikazani na sliki 12.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of diarrhoea or colitis was 28.2% (154/547).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg, je pojavnost driske ali kolitisa znašala 28,2 % (154/547).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa, oznaka ATC: L01XC17
English: Hazard ratioa 99.8% CI p-valueb, c
Slovenian: Celokupno preživetje Dogodki Razmerje ogroženostia 99,8 % IZ p-vrednostb, c Mediana (95 % IZ)
English: The safety and efficacy of nivolumab 3 mg/kg for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, open-label study (CA209037).
Slovenian: Varnost in učinkovitost nivolumaba v odmerku 3 mg/kg za zdravljenje napredovalega (neoperabilnega ali metastatskega) melanoma so vrednotili v randomizirani, odprti študiji 3. faze (CA209037).
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of thyroid disorders was 27.2% (149/547).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg, je pojavnost bolezni ščitnice znašala 27,2 % (149/547).
English: Median time to onset was 1.4 months (range: 0.027.9).
Slovenian: Mediani čas do nastopa je znašal 1,4 meseca (razpon: 0,0-27,9).
English: Rate (95% CI) At 6 months At 12 months
Slovenian: Delež (95 % IZ) v 6. mesecu v 12. mesecu
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.42 (0.33, 0.54) Nivolumab vs. Ipilimumab - hazard ratio: 0.57 (0.45, 0.72) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.74 (0.58, 0.96)
Slovenian: nivolumab+ipilimumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,42 (0,33; 0,54) nivolumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,57 (0,45; 0,72) nivolumab+ipilimumab v primerjavi z nivolumabom - razmerje ogroženosti: 0,74 (0,58; 0,96)
English: Grade 2, Grade 3, and Grade 4 cases were reported in 6.7% (30/448), 15.4% (69/448), and 1.8% (8/448) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 6,7 % (30/448) bolnikov, o primerih stopnje 3 pri 15,4 % (69/448) bolnikov, o primerih stopnje 4 pa pri 1,8 % (8/448) bolnikov.
English: Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease.
Slovenian: Pri bolnikih s slabšimi prognostičnimi dejavniki in/ali agresivno boleznijo je pred uvedbo zdravljenja treba upoštevati zakasnjen nastop učinka nivolumaba.
English: Nivolumab+Ipilimumab (events: 63/155), median and 95% CI: N.A. (39.06, N.A.) ──Δ─── Nivolumab (events: 71/171), median and 95% CI: N.A. (40.21, N.A.) Ipilimumab (events: 103/164), median and 95% CI: 21.49 months (16.85, 29.08)
Slovenian: Število ogroženih oseb nivolumab + ipilimumab nivolumab ipilimumab nivolumab+ipilimumab (dogodki: 63/155), mediana in 95 % IZ: NP (39,06; NP) ──Δ─── nivolumab (dogodki: 71/171), mediana in 95 % IZ: NP (40,21; NP) ipilimumab (dogodki: 103/164), mediana in 95 % IZ: 21,49 meseca (16,85; 29,08)
English: The primary efficacy outcome measures were OS, ORR and PFS as determined by a Blinded Independent Central Review (BICR) in intermediate/poor risk patients.
Slovenian: Primarno merilo izida učinkovitosti je bil delež objektivnega odziva, kar je bilo ocenjeno s slepim neodvisnim centralnim pregledom (BICR - Blinded Independent Central Review).
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of rash was 48.8% (267/547).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg, je pojavnost izpuščaja znašala 48,8 % (267/547).
English: Randomised phase 3 study vs. chemotherapy (CA209037)
Slovenian: Randomizirana klinična študija 3. faze za ovrednotenje nivolumaba v primerjavi s kemoterapijo (študija CA209037)
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of metastatic or recurrent SCCHN were evaluated in a phase 3, randomised, open-label study (CA209141).
Slovenian: Varnost in učinkovitost nivolumaba v odmerku 3 mg/kg kot samostojnega zdravila za zdravljenje metastatskega ali ponovljenega SCCHN so vrednotili v randomizirani, odprti študiji 3. faze (študija CA209141).
English: Ipilimumab 1 mg/kg over 30 minutes
Slovenian: Ipilimumab 1 mg/kg v obliki 30-minutne i.v.
English: Grade 3 and 4 cases were reported in 0.4% (11/2578) and <0.1% (1/2578) of patients, respectively.
Slovenian: O primerih stopnje 3 so poročali pri 0,4 % (11/2.578) bolnikov, o primerih stopnje 4 pa pri < 0,1 % (1/2.578) bolnikov.
English: The Kaplan-Meier curves for OS are shown in Figure 10.
Slovenian: Kaplan-Meierjevi krivulji celokupnega preživetja sta prikazani na sliki 10.
English: 16.16) and the estimated OS rates were 69.2% (CI: 57.7, 78.2) at 6 months and 45.6% (CI: 34.2, 56.3) at 12 months.
Slovenian: Ocenjeni delež celokupnega preživetja v 6. mesecu je znašal 69,2 % (interval zaupanja: 57,7; 78,2), v 12. mesecu pa 45,6 % (interval zaupanja:
English: The OS HRs for nivolumab vs. chemotherapy were 1.32 (95% CI: 0.75, 2.32) for BRAF mutation-positive patients and 0.83 (95% CI: 0.62, 1.11) for BRAF wild-type patients.
Slovenian: Pri bolnikih z mutacijo BRAF je razmerje ogroženosti za celokupno preživetje pri uporabi nivolumaba v primerjavi s kemoterapijo znašalo 1,32 (95 % interval zaupanja: 0,75; 2,32), pri bolnikih z divjim tipom BRAF pa 0,83 (95 % interval zaupanja: 0,62; 1,11).
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of liver function test abnormalities was 18.5% (101/547).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg, je pojavnost nenormalnih izvidov delovanja jeter znašala 18,5 % (101/547).
English: Median time to onset was 1.2 months (range: 0.0-24.7).
Slovenian: Mediani čas do nastopa je znašal 1,2 meseca (razpon: 0,0-24,7).
English: Data from SCCHN and adjuvant melanoma patients 75 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Slovenian: Pri bolnikih s ploščatoceličnim karcinomom glave in vratu in bolnikih z adjuvantno zdravljenim melanomom, starih 75 let ali starejših, je na voljo premalo podatkov, zato zaključkov za to populacijo ni mogoče navesti (glejte poglavje 5.1).
English: Nivolumab+Ipilimumab (events: 63/123), median and 95% CI: 11.24 (6.93, 23.03) ──Δ─── Nivolumab (events: 77/117), median and 95% CI: 2.83 (2.76, 5.13) Ipilimumab (events: 87/113), median and 95% CI: 2.79 (2.66, 2.96)
Slovenian: Preživetje brez napredovanja bolezni (meseci) Število ogroženih oseb nivolumab + ipilimumab nivolumab ipilimumab nivolumab+ipilimumab (dogodki: 63/123), mediana in 95 % IZ: 11,24 (6,93; 23,03) ──Δ─── nivolumab (dogodki: 77/117), mediana in 95 % IZ: 2,83 (2,76; 5,13) ipilimumab (dogodki: 87/113), mediana in 95 % IZ: 2,79 (2,66; 2,96)
English: Median time to onset was 2.1 months (range: 0.0-16.1).
Slovenian: Mediani čas do nastopa je znašal 2,1 meseca (razpon: 0,0-16,1).
English: The following side effects have been reported with nivolumab in combination with ipilimumab:
Slovenian: Pri uporabi nivolumaba v kombinaciji z ipilimumabom so poročali o naslednjih neželenih učinkih:
English: The PFS HR for nivolumab vs. chemotherapy was 1.03 (95% CI: 0.78, 1.36).
Slovenian: Razmerje ogroženosti za preživetje brez napredovanja bolezni je pri uporabi nivolumaba v primerjavi s kemoterapijo znašalo 1,03 (95 % interval zaupanja: 0,78; 1,36).
English: Skin and subcutaneous tissue disorders Very common rashe, pruritus rashe, pruritus
Slovenian: Bolezni kože in podkožja Zelo pogosti izpuščaje, srbenje izpuščaje, srbenje
English: Table 13: Efficacy results (CA209238)
Slovenian: Preglednica 13: Rezultati učinkovitosti (študija CA209238) nivolumab (n = 453)
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of liver function test abnormalities was 29.5% (132/448).
Slovenian: Pri bolnikih z melanomom, ki so se zdravili z nivolumabom v odmerku 1 mg/kg v kombinaciji z ipilimumabom v odmerku 3 mg/kg, je pojavnost nenormalnih izvidov delovanja jeter znašala 29,5 % (132/448).
English: The majority of cases were Grade 1 or 2 in severity reported in 0.8% (21/2578) and 1.7% (44/2578) of patients respectively.
Slovenian: O primerih stopnje 1 so poročali pri 0,8 % (21/2.578) bolnikov, o primerih stopnje 2 pa pri 1,7% (44/2.578) bolnikov.
English: Randomised phase 3 study vs. docetaxel (CA209017)
Slovenian: Randomizirana klinična študija 3. faze za ovrednotenje nivolumaba v primerjavi z docetakselom (študija CA209017)
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.
Slovenian: Študija CA209039 je odprta, multicentrična študija faze 1b s povečevanjem odmerka in uporabo različnih odmerkov nivolumaba pri ponovitvi/neodzivnosti malignih hematoloških bolezni, ki je vključevala 23 bolnikov s cHL, ki so se zdravili z nivolumabom v odmerku 3 mg/kg v monoterapiji.
English: Hazard ratio 95% CI Rate (95% CI) at 24 months
Slovenian: Dogodki Razmerje ogroženosti 95 % IZ Delež (95 % IZ) v 24. mesecu
English: Upon improvement, nivolumab monotherapy may be resumed after corticosteroid taper.
Slovenian: Po izboljšanju in postopnem zmanjšanju odmerka kortikosteroida se zdravljenje z nivolumabom v monoterapiji lahko nadaljuje.
English: A total of 405 patients were randomised to receive either nivolumab (n = 272) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or chemotherapy (n = 133) which consisted of the investigator's choice of either dacarbazine (1000 mg/m2 every 3 weeks) or carboplatin (AUC 6 every 3 weeks) and paclitaxel (175 mg/m2 every 3 weeks).
Slovenian: Za obliko kemoterapije se je odločil raziskovalec, bolniki pa so tako prejemali dakarbazin (v odmerku 1.000 mg/m2 vsake 3 tedne) ali karboplatin (ciljna vrednost AUC 6 vsake 3 tedne) in paklitaksel (v odmerku 175 mg/m2 vsake 3 tedne).
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of nephritis or renal dysfunction was 8.8% (48/547).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg, je pojavnost nefritisa ali okvare delovanja ledvic znašala 8,8 % (48/547).
English: Monitoring of thyroid function should continue to ensure appropriate hormone replacement is utilised.
Slovenian: Za zagotovitev, da je hormonsko nadomestno zdravljenje ustrezno, je treba kontinuirano nadzirati delovanje ščitnice.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
Slovenian: Pri bolnikih z melanomom, ki so se zdravili z nivolumabom v odmerku 1 mg/kg v kombinaciji z ipilimumabom v odmerku 3 mg/kg, je pojavnost nefritisa ali okvare delovanja ledvic znašala 5,1 % (23/448).
English: When OPDIVO is administered in combination with ipilimumab, if either agent is withheld, the other agent should also be withheld.
Slovenian: Pri uporabi zdravila OPDIVO v kombinaciji z ipilimumabom je treba v primeru zadržanja aplikacije enega zdravila zadržati tudi aplikacijo drugega zdravila.
English: Nivolumab+Ipilimumab (events: 77/155), median and 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (events: 86/171), median and 95% CI: 14.00 (7.03, N.A.) Ipilimumab (events: 129/164), median and 95% CI: 3.91 (2.83, 4.17)
Slovenian: Preživetje brez napredovanja bolezni (meseci) Število ogroženih oseb nivolumab + ipilimumab nivolumab ipilimumab nivolumab+ipilimumab (dogodki: 77/155), mediana in 95 % IZ: 12,35 (8,74; NP) ──Δ─── nivolumab (dogodki: 86/171), mediana in 95 % IZ: 14,00 (7,03; NP) ipilimumab (dogodki: 129/164), mediana in 95 % IZ: 3,91 (2,83; 4.17)
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%.
Slovenian: Pri bolnikih z ekspresijo PD-L1 tumorja ≥ 1 % je razmerje ogroženosti za preživetje brez napredovanja bolezni pri uporabi nivolumaba v primerjavi s kemoterapijo znašalo 0,76 (95 % interval zaupanja: 0,54; 1,07), pri bolnikih z ekspresijo PD-L1 tumorja < 1 % pa 1,92 (95 % interval zaupanja: 1,05; 3,5).
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.7% (21/448), 1.1% (5/448), and 0.2% (1/448) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 4,7 % (21/448) bolnikov, o primerih stopnje 3 pri 1,1 % (5/448) bolnikov, o primerih stopnje 4 pa pri 0,2 % (1/448) bolnikov.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 13.6% (61/448), 15.8% (71/448), and 0.4% (2/448) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 13,6 % (61/448) bolnikov, o primerih stopnje 3 pri 15,8 % (71/448) bolnikov, o primerih stopnje 4 pa pri 0,4 % (2/448) bolnikov.
English: OPDIVO as monotherapy
Slovenian: Zdravilo OPDIVO v monoterapiji
English: Events Hazard ratio 95% CI Rate (95% CI) at 60 months
Slovenian: Dogodki Razmerje ogroženosti 95 % IZ Delež (95 % IZ) v 60. mesecu
English: Table 8: Efficacy Results (CA209066)
Slovenian: Preglednica 8: Rezultati učinkovitosti (študija CA209066) nivolumab (n = 210)
English: Median time to onset was 2.1 months (range: 0.0-27.6).
Slovenian: Mediani čas do nastopa je znašal 2,1 meseca (razpon: 0,0-27,6).
English: CA209205 Cohort B and CA209039
Slovenian: Kohorta B študije CA209205a in študija CA209039
English: A total of 821 patients were randomised to receive either nivolumab 3 mg/kg (n = 410) administered intravenously over 60 minutes every 2 weeks or everolimus (n = 411) 10 mg daily, administered orally.
Slovenian: Skupno 821 bolnikov so randomizirali na zdravljenje z nivolumabom v odmerku 3 mg/kg (n = 410) v obliki 60-minutne intravenske infuzije vsaka 2 tedna ali na zdravljenje z everolimusom (n = 411) v odmerku 10 mg peroralno enkrat na dan. Zdravljenje je trajalo, dokler je bila prisotna klinična korist ali dokler je bolnik zdravljenje prenašal.
English: Median Duration of Response Months (range)
Slovenian: Mediana trajanja odziva Meseci (razpon)
English: 240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes
Slovenian: infuzije ali 480 mg vsake 4 tedne v obliki 60-minutne i.v.
English: Table 17: ORR and OS by tumour PD-L1 expression (CA209057)
Slovenian: Preglednica 17: Delež objektivnega odziva in celokupno preživetje glede na ekspresijo PD-L1 tumorja (študija CA209057)
English: Progression-free survival Events
Slovenian: Preživetje brez napredovanja bolezni
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.55 (0.40, 0.75) Nivolumab vs. Ipilimumab - hazard ratio: 0.54 (0.40, 0.73) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 1.02 (0.73, 1.43)
Slovenian: nivolumab+ipilimumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,55 (0,40; 0,75) nivolumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,54 (0,40; 0,73) nivolumab+ipilimumab v primerjavi z nivolumabom - razmerje ogroženosti: 1,02 (0,73; 1,43)
English: Rate (95% CI) at 12 months
Slovenian: Delež (95 % IZ) v 12. mesecu
English: Grade 3 and 4 cases were reported in 0.7% (19/2578) and <0.1% (1/2578) of patients respectively.
Slovenian: O primerih stopnje 3 so poročali pri 0,7 % (19/2.578) bolnikov, o primerih stopnje 4 pa pri < 0,1 % bolnikov (1/2.578).
English: Patients ≥ 75 years of age represented 8% of all intermediate/poor risk patients in CA209214, and the combination of nivolumab and ipilimumab showed numerically less effect on OS (HR 0.97, 95% CI: 0.48, 1.95) in this subgroup versus the overall population.
Slovenian: V tej podskupini bolnikov je kombinacija nivolumaba z ipilimumabom imela numerično manjši učinek na celokupno preživetje (HR 0,97; 95 % IZ: 0,48; 1,95) v primerjavi s celotno populacijo.
English: n ipilimumab Median OS (95% CI)
Slovenian: n ipilimumab Mediana OS (95 % IZ)
English: Patients with a baseline performance score ≥ 2, active brain metastases or autoimmune disease, symptomatic interstitial lung disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of NSCLC (see sections 4.5 and 5.1).
Slovenian: Bolnike z izhodiščno oceno telesne zmogljivosti ≥ 2, aktivnimi zasevki v možganih ali avtoimunsko boleznijo, simptomatsko boleznijo pljučnega intersticija in bolnike, ki so se pred vključitvijo v študijo zdravili z zdravili za sistemsko zaviranje imunske odzivnosti, so iz ključnih kliničnih preskušanj pri NSCLC izključili (glejte poglavji 4.5 in 5.1).
English: Intestinal perforation, inflammation of the stomach (gastritis), inflammation of the duodenum Skin disease with thickened patches of red skin, often with silvery scales (psoriasis), severe condition of the skin that causes red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body (erythema multiforme) Severe and possibly fatal peeling of the skin (Stevens-Johnson syndrome) Chronic disease of joints (spondyloarthropathy), disease in which the immune system attacks the glands that make moisture for the body, such as tears and saliva (Sjogren's syndrome), aching muscles, muscle tenderness of weakness, not caused by exercise (myopathy), inflammation of the muscles (myositis), stiffness in muscles and joints, muscle spasm (rhabdomyolysis), inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica) Inflammation of the kidney
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) bolezen, ki povzroči vnetje ali povečanje bezgavk (Kikuchijev limfadenitis) življenjsko nevarna alergična reakcija kopičenje kisline v krvi zaradi sladkorne bolezni (diabetična ketoacidoza) zapora žolčnih izvodil začasno vnetje živcev, ki povzroči bolečino, oslabelost in ohromelost v okončinah (Guillain-Barréjev sindrom), izguba zaščitne ovojnice živčne celice (demielinizacija), stanje pri katerem mišice oslabijo in se hitro utrudijo (miastenijski sindrom) vnetje možganov spremembe ritma ali hitrosti utripanja srca, nenormalen srčni ritem, vnetje srčne mišice tekočina v pljučih vnetna bolezen krvnih žil razjeda tankega črevesa hudo luščenje kože, ki je lahko smrtno nevarno (toksična epidermalna nekroliza) ali Stevens-Johnsonov sindrom bolezen, pri kateri imunski sistem napade žleze, ki telesu zagotavljajo vlago, npr. solze in slino (Sjogrenov sindrom), bolečina v mišicah, občutljivost ali oslabelost mišic, ki ni posledica telesne vadbe (miopatija), vnetje mišic (miozitis), okorelost mišic in sklepov, mišični krč (rabdomioliza)
English: Severe infusion reactions have been reported in clinical trials of nivolumab or nivolumab in combination with ipilimumab (see section 4.8).
Slovenian: V kliničnih preskušanjih nivolumaba ali nivolumaba v kombinaciji z ipilimumabom so poročali o pojavu hudih infuzijskih reakcij (glejte poglavje 4.8).
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.42 (0.31, 0.55) Nivolumab vs. Ipilimumab - hazard ratio: 0.44 (0.34, 0.58) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.94 (0.69, 1.28)
Slovenian: nivolumab+ipilimumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,42 (0,31; 0.55) nivolumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,44 (0,34; 0,58) nivolumab+ipilimumab v primerjavi z nivolumabom - razmerje ogroženosti: 0,94 (0,69; 1,28)
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.59 (0.42, 0.82) Nivolumab vs. Ipilimumab - hazard ratio: 0.84 (0.61, 1.16) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.70 (0.49, 0.99)
Slovenian: nivolumab+ipilimumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,59 (0,42; 0,82) nivolumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,84 (0,61; 1,16) nivolumab+ipilimumab v primerjavi z nivolumabom - razmerje ogroženosti: 0,70 (0,49; 0,99)
English: Randomised phase 3 study vs. docetaxel (CA209057)
Slovenian: Randomizirana klinična študija 3. faze za ovrednotenje nivolumaba v primerjavi z docetakselom (študija CA209057)
English: Median time to onset was 1.2 months (range: 0.0-22.6).
Slovenian: Mediani čas do nastopa je znašal 1,2 meseca (razpon: 0,0-22,6).
English: Common hypothyroidism, hyperthyroidism
Slovenian: Občasni dehidracija, metabolična acidoza
English: For symptomatic hypothyroidism, nivolumab or nivolumab in combination with ipilimumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Slovenian: V primeru simptomatskega hipotiroidizma je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom zadržati in po potrebi uvesti zdravljenje z nadomeščanjem ščitničnega hormona.
English: Grade 4 rash
Slovenian: Hipotiroidizem stopnje 4
English: ipilimumab Median OS (95% CI)
Slovenian: ipilimumab Mediana OS (95 % IZ)
English: Depending on your dose, the appropriate amount of OPDIVO will be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection before use.
Slovenian: Odvisno od potrebnega odmerka bodo ustrezno količino zdravila OPDIVO pred uporabo razredčili z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje ali s 5-odstotno (50 mg/ml) raztopino glukoze za injiciranje.
English: The majority of cases were Grade 1 or 2 in severity reported in 1.6% (41/2578) and 0.7% (18/2578) of patients respectively.
Slovenian: O primerih stopnje 1 so poročali pri 1,6 % (41/2.578) bolnikov, o primerih stopnje 2 pa pri 0,7 % (18/2.578) bolnikov.
English: (95% CI) Difference in ORR (95% CI)d p-valuee,f
Slovenian: Potrjen objektivni odziv (BICR) (95 % IZ) Razlika v deležu objektivnega odziva (ORR) (95 % IZ)d p-vrednoste,f
English: Immune-related adverse reaction
Slovenian: Reakcije, povezane z infuzijo
English: Median duration of responseb
Slovenian: Mediana trajanja odzivag
English: OS and PFS were estimated using Kaplan-Meier method.
Slovenian: Celokupno preživetje in preživetje brez napredovanja bolezni sta ocenjeni s Kaplan-Meierjevo metodo.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 1.6% (7/448), 0.9% (4/448), and 0.7% (3/448) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 1,6 % (7/448) bolnikov, o primerih stopnje 3 pri 0,9 % (4/448) bolnikov, o primerih stopnje 4 pa pri 0,7 % (3/448) bolnikov.
English: This helps increase their activity against the melanoma, lung, kidney, lymphoid, head and neck or bladder cancer cells.
Slovenian: Nivolumab s pritrditvijo na PD-1 zavre njegovo delovanje in prepreči, da bi le-ta zavrl delovanje celic T. Na ta način pomaga povečati njihovo aktivnost proti melanomskim, pljučnim, ledvičnim ali limfatičnim rakavim celicam, rakavim celicam glave in vratu ali rakavim celicam sečnega mehurja.