FrancophonIA/ELRC3.0 huggingface dataset:
English: To further investigate the value of biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other methods / assays, and associated cut offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1 (on tumour- and tumour associated immune cells), PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, Tumour mutational burden) as predictive of nivolumab adjuvant therapy efficacy.
Slovenian: Dodatno raziskati še vrednost drugih bioloških označevalcev poleg vrednosti statusa ekspresije PD-L1 na membrani tumorskih celic z IHC (npr. druge metode/testi in pripadajoče mejne vrednosti, ki bi lahko povečali občutljivost in specifičnost predvidevanja odziva na zdravljenje na osnovi PD-L1 (tumorske in s tumorjem povezane imunske celice), PD-L2, tumorje infiltrirajočih limfocitov z določanjem gostote CD8+T, RNA podpisa, breme tumorskih mutacij) kot napovednika učinkovitosti adjuvantnega zdravljenja z nivolumabom.
English: Uncommon tubulointerstitial nephritis, renal failure (including acute kidney injury)a,c General disorders and administration site conditions Very common fatigue
Slovenian: Bolezni sečil Občasni tubulointersticijski nefritis, odpoved ledvic (vključno z akutno odpovedjo ledvic)a,c Splošne težave in spremembe na mestu aplikacije Zelo pogosti utrujenost
English: Monotherapy phase
Slovenian: Faza zdravljenja v monoterapiji
English: Four percent of patients had a history of brain metastasis, and 36% of patients had a baseline LDH level greater than ULN at study entry.
Slovenian: Štirje odstotki bolnikov so imeli anamnezo zasevkov v možganih, 36 % bolnikov pa je ob vstopu v študijo imelo izhodiščno vrednost LDH, večjo od ZMN.
English: Post-marketing event (also see section 4.4).
Slovenian: Neželeni učinek v obdobju trženja zdravila (glejte tudi poglavje 4.4).
English: Grade 2 hypopituitarism occurred in 0.4% (2/547) of patients.
Slovenian: Hipopituitarizem stopnje 2 se je pojavil pri 0,4 % (2/547) bolnikov.
English: Immune system disorders Common infusion related reaction, hypersensitivity infusion-related reaction, hypersensitivity
Slovenian: Bolezni imunskega sistema Pogosti infuzijska reakcija, preobčutljivost infuzijska reakcija, preobčutljivost
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
Slovenian: • Pri zdravljenju z zdravilom OPDIVO se lahko poveča tveganje za: o Imunsko pogojeni pnevmonitis o Imunsko pogojeni kolitis o Imunsko pogojeni hepatitis o Imunsko pogojeni nefritis in okvaro delovanja ledvic o Imunsko pogojene endokrinopatije o Imunsko pogojene neželene učinke na kožo o Druge imunsko pogojene neželene učinke
English: BRAF and tumour PD-L1 status and best response to prior ipilimumab.
Slovenian: Randomizacija je bila stratificirana glede na status BRAF in status PD-L1 tumorja ter najboljši odziv na predhodno zdravljenje z ipilimumabom.
English: OPDIVO as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
Slovenian: Klasični Hodgkinov limfom (cHL - classical Hodgkin lymphoma) Zdravilo OPDIVO je v monoterapiji indicirano za zdravljenje odraslih bolnikov s ponovljenim ali z neodzivnim klasičnim Hodgkinovim limfomom po avtologni presaditvi matičnih celic (ASCTautologous stem cell transplant) in zdravljenju z brentuksimabom vedotinom.
English: Do not use OPDIVO if you are pregnant unless your doctor specifically tells you to.
Slovenian: Med nosečnostjo zdravila OPDIVO ne smete uporabljati, razen na izrecno priporočilo zdravnika.
English: Infections and infestations Common pneumonia, upper respiratory tract infection pneumonia, upper respiratory tract infection, conjunctivitis
Slovenian: Infekcijske in parazitske bolezni Pogosti pljučnica, okužba zgornjih dihal pljučnica, okužba zgornjih dihal, konjunktivitis
English: Adverse reactions reported in the pooled dataset for patients treated with nivolumab monotherapy (n = 2578) are presented in Table 5.
Slovenian: Neželeni učinki so v preglednici 5 navedeni na osnovi zbranih podatkov pri bolnikih, ki so se zdravili z nivolumabom v monoterapiji (n = 2.578).
English: Common oedema (including peripheral oedema), pain oedema (including peripheral oedema), pain, chest pain, chills
Slovenian: Pogosti edem (vključno s perifernim edemom), bolečina edem (vključno s perifernim edemom), bolečina, bolečina v prsnem košu, mrzlica
English: Patients with active autoimmune disease, ocular melanoma, active brain or leptomeningeal metastases or a known history of prior ipilimumab-related high-grade (Grade 4 per CTCAE v4.0) adverse reactions, except for resolved nausea, fatigue, infusion reactions, or endocrinopathies, were excluded from the study.
Slovenian: Bolnike z aktivno avtoimunsko boleznijo, očesnim melanomom, aktivnimi zasevki v možganih ali leptomeningah ali znanimi neželenimi učinki visoke stopnje (stopnja 4 po CTCAE v4.0) pri predhodnem zdravljenju z ipilimumabom, razen navzee, utrujenosti, infuzijskih reakcij ali endokrinopatij, ki so izzvenele, so iz študije izključili.
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).
Slovenian: Zdravilo OPDIVO je v monoterapiji indicirano za adjuvantno zdravljenje odraslih z melanomom, ki se je razširil na bezgavke, ali z metastatsko boleznijo po popolni kirurški odstranitvi (glejte poglavje 5.1).
English: Table 11: Summary of overall survival by PD-L1 expression: 5% cut off - CA209067 - Minimum follow-up of 36 months
Slovenian: Preglednica 11: Povzetek celokupnega preživetja glede na ekspresijo PD-L1: mejna vrednost 5 % - študija CA209067 - najmanjše obdobje spremljanja 36 mesecev
English: Non-Small Cell Lung Cancer
Slovenian: Nedrobnocelični pljučni rak
English: When OPDIVO is given in combination with ipilimumab, you will be given an infusion over a period of 30 minutes, every 3 weeks for the first 4 doses (combination phase).
Slovenian: Pri uporabi zdravila OPDIVO v kombinaciji z ipilimumabom boste pri prvih 4 odmerkih (faza kombiniranega zdravljenja) infuzijo, ki bo trajala 30 minut, prejemali vsake 3 tedne.
English: Once a diagnosis of myocarditis is established, nivolumab or nivolumab in combination with ipilimumab should be withheld or permanently discontinued (see section 4.2).
Slovenian: Če se diagnoza miokarditisa potrdi, je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom zadržati ali trajno ukiniti (glejte poglavje 4.2).
English: Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg**
Slovenian: Nivolumab v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg**
English: For tumour PD-L1 expression, 34% of patients had PD-L1 expression ≥ 5% and 62% had < 5% as determined by clinical trial assay.
Slovenian: Pri 34 % bolnikov je bila ekspresija PD-L1 tumorja ≥ 5%, pri 62 % bolnikov pa < 5%, kar je bilo določeno s testom, uporabljenim v kliničnem preskušanju.
English: Complications of allogeneic HSCT in classical Hodgkin Lymphoma
Slovenian: Zapleti alogenske HSCT pri klasičnem Hodgkinovem limfomu
English: OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).
Slovenian: Zdravilo OPDIVO je v kombinaciji z ipilimumabom indicirano za prvo linijo zdravljenja odraslih bolnikov z napredovalim karcinomom ledvičnih celic s srednje ugodnim ali slabim prognostičnim obetom (glejte poglavje 5.1).
English: Nivolumab 3 mg/kg (events: 184/240), median and 95% CI: 7.72 (5.68,8.77) Investigator's choice (events: 105/121), median and 95% CI: 5.06 (4.04, 6.24)
Slovenian: Število ogroženih oseb nivolumab izbira raziskovalca nivolumab 3 mg/kg (dogodki: 184/240), mediana in 95 % IZ: 7,72 (5,68; 8,77) izbira raziskovalca (dogodki: 105/121), mediana in 95 % IZ: 5,06 (4,04; 6,24)
English: Efficacy results based on investigator-assessed ORR are presented in Table 15 below.
Slovenian: Rezultati učinkovitosti na osnovi deleža objektivnega odziva po oceni raziskovalca so predstavljeni v preglednici 15 v nadaljevanju.
English: The majority of patients were male (73%) and white (87%), and 31% and 69% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively.
Slovenian: Večina bolnikov je bilo moškega spola (73 %) in belcev (87 %), 31 % bolnikov je imelo oceno stanja telesne zmogljivosti po Karnofskem od 70 do 80 %, 69 % bolnikov pa od 90 do 100 %.
English: Randomised phase 3 study of nivolumab vs ipilimumab 10 mg/kg (CA209238)
Slovenian: Randomizirana klinična študija 3. faze za ovrednotenje nivolumaba v primerjavi z ipilimumabom v odmerku 10 mg/kg (študija CA209238)
English: When nivolumab 3 mg/kg was administered in combination with ipilimumab 1 mg/kg, the CL of nivolumab was increased by 1% and the CL of ipilimumab was decreased by 1.5%, which were not considered clinically relevant.
Slovenian: Pri uporabi nivolumaba v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg se je očistek nivolumaba povečal za 1 %, očistek ipilimumaba pa se je zmanjšal za 1,5 %, kar pa ne velja za klinično pomembno.
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.
Slovenian: Pri bolnikih, ki so se zdravili z nivolumabom v kombinaciji z ipilimumabom, in so jih ovrednotili na prisotnost protiteles proti nivolumabu, je pojavnost protiteles proti nivolumabu pri zdravljenju z nivolumabom v odmerku 3 mg/kg in ipilimumabom v odmerku 1 mg/kg vsake 3 tedne znašala 26,0 %, pri zdravljenju z nivolumabom v odmerku 1 mg/kg in ipilimumabom v odmerku 3 mg/kg vsake 3 tedne pa 37,8 %.
English: Uncommon polyneuropathy, autoimmune neuropathy (including facial and abducens nerve paresis)
Slovenian: Občasni polinevropatija, avtoimunska nevropatija (vključno s parezo obraznega in abducentnega živca)
English: More than one vial of OPDIVO concentrate may be needed to give the total dose for the patient.
Slovenian: Za aplikacijo celotnega odmerka boste morda potrebovali več kot eno vialo s koncentratom zdravila OPDIVO.
English: Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, and spinal pain.
Slovenian: Mišično-skeletna bolečina je sestavljen izraz, ki obsega bolečino v hrbtu, bolečino v kosteh, mišičnoskeletno bolečino v predelu prsnega koša, mišično-skeletno nelagodje, bolečino v mišicah, bolečino v vratu, bolečino v okončinah in bolečino v hrbtenici.
English: “+” Denotes a censored observation.
Slovenian: “+” označuje krnjene podatke.
English: “+” denotes a censored observation.
Slovenian: “+” Označuje krnjene podatke.
English: Renal and urinary disorders Common renal failure (including acute kidney injury)a,c renal failure (including acute kidney injury)c
Slovenian: Bolezni sečil Pogosti odpoved ledvic (vključno z akutno odpovedjo ledvic)a,c odpoved ledvic (vključno z akutno odpovedjo ledvic)c
English: If you miss a dose of OPDIVO
Slovenian: Če niste prejeli odmerka zdravila OPDIVO
English: Storage conditions and shelf life
Slovenian: Shranjevanje in rok uporabnosti
English: Table 26: Efficacy results (CA209275)a nivolumab (n = 270)
Slovenian: Preglednica 26: Rezultati učinkovitosti (študija CA209275)a nivolumab (n = 270)
English: Patients with treated brain metastases were eligible if neurologically returned to baseline at least 2 weeks prior to enrolment, and either off corticosteroids, or on a stable or decreasing dose of < 10 mg daily prednisone equivalents.
Slovenian: Bolniki z zdravljenimi zasevki v možganih so bili primerni za vključitev, če se je nevrološko stanje povrnilo do izhodiščnega stanja vsaj 2 tedna pred vključitvijo in se niso zdravili s kortikosteroidi ali pa so se zdravili s stabilnim ali manjšajočim se odmerkom kortikosteroida, ki je ustrezal < 10 mg prednizona na dan.
English: Rate (95% CI) at 12 months “+” denotes a censored observation.
Slovenian: Delež (95 % IZ) v 12. mesecu “+” označuje krnjene podatke.
English: No Grade 3-5 cases were reported.
Slovenian: O primerih stopnje 3-5 niso poročali.
English: In patients treated with nivolumab monotherapy, the incidence of thyroid disorders, including hypothyroidism or hyperthyroidism, was 9.6% (248/2578).
Slovenian: Pri bolnikih, ki so se zdravili z nivolumabom v monoterapiji, je pojavnost bolezni ščitnice, vključno s hipotiroidizmom ali hipertiroidizmom, znašala 9,6 % (248/2.578).
English: In patients treated with nivolumab monotherapy, the incidence of pneumonitis, including interstitial lung disease and lung infiltration, was 3.4% (87/2578).
Slovenian: Pri bolnikih, ki so se zdravili z nivolumabom v monoterapiji, je pojavnost pnevmonitisa, vključno z boleznijo pljučnega intersticija in s pljučnimi infiltrati, znašala 3,4 % (87/2.578).
English: Tumour PD-L1 expression n nivolumab + ipilimumab Median OS (95% CI)
Slovenian: Ekspresija PD-L1 tumorja n nivolumab + ipilimumab Mediana OS (95 % IZ)
English: Study CA209171 was a single-arm, open label study of nivolumab monotherapy in patients with previously treated advanced or metastatic squamous NSCLC.
Slovenian: Študija CA209171 je bila enoskupinska odprta študija uporabe nivolumaba v monoterapiji pri bolnikih s predhodno zdravljenim napredovalim ali metastatskim ploščatoceličnim nedrobnoceličnim pljučnim rakom.
English: 240 mg every 2 weeks over 30 minutes
Slovenian: 240 mg vsaka 2 tedna v obliki 30-minutne i.v.
English: In terms of ORR, increasing PD-L1 expression was associated with larger ORR.
Slovenian: V smislu deleža objektivnega odziva je bila večja ekspresija PD-L1 povezana z večjim deležem objektivnega odziva.
English: The infusion must be administered through a sterile, non-pyrogenic, low protein binding in-line filter with a pore size of 0.2-1.2 μm.
Slovenian: Zdravilo je treba infundirati preko sterilnega, nepirogenega linijskega filtra, ki minimalno veže proteine, z velikostjo por od 0,2 do 1,2 μm.
English: The median duration of treatment was 7.9 months (range: 1 day- 21.4+ months) in nivolumab with ipilimumab- treated patients and was 7.8 months (range: 1 days- 20.2+ months) in sunitinib treated patients.
Slovenian: Pri bolnikih, ki so se zdravili z nivolumabom v kombinaciji z ipilimumabom, je mediana trajanja zdravljenja znašala 7,9 meseca (razpon: 1 dan - 21,4+ meseca), pri bolnikih, ki so se zdravili s sunitinibom, pa 7,8 meseca (razpon: 1 dan - 20,2+ meseca).
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency (including secondary adrenocortical insufficiency), hypophysitis (including hypopituitarism), diabetes mellitus, and diabetic ketoacidosis have been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Slovenian: Pri zdravljenju z nivolumabom v monoterapiji ali zdravljenju z nivolumabom v kombinaciji z ipilimumabom so poročali o hudih endokrinopatijah, vključno s hipotiroidizmom, hipertiroidizmom, insuficienco nadledvičnih žlez (vključno s sekundarno adrenokortikalno insuficienco), vnetjem hipofize (vključno s hipopituitarizmom), diabetesom in diabetično ketoacidozo (glejte poglavje 4.8).
English: Withhold dose(s) until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete
Slovenian: Aplikacijo odmerka (odmerkov) zadržite, dokler simptomi ne izzvenijo, radiografsko ugotovljene nepravilnosti ne izboljšajo in zdravljenje s kortikosteroidi ni končano.
English: Tumour PD-L1 expression level
Slovenian: Vrednost ekspresije PD-L1 tumorja
English: The trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with everolimus at the prespecified interim analysis when 398 events were observed (70% of the planned number of events for final analysis) (Table 18 and Figure 10).
Slovenian: Pri vnaprej predvideni vmesni analizi po 398 opaženih dogodkih (70 % predvidenega števila dogodkov za končno analizo) je preskušanje pokazalo statistično pomembno izboljšanje celokupnega preživetja pri bolnikih, randomiziranih na nivolumab, v primerjavi z everolimusom (preglednica 18 in slika 10).
English: The study included patients (18 years or older) who had disease progression during or following platinum-containing chemotherapy for advanced or metastatic disease or had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Slovenian: V študijo so bili vključeni bolniki (stari 18 let ali starejši), pri katerih je bolezen napredovala med ali po zdravljenju že napredovale ali metastatske bolezni s kemoterapijo, ki je vključevala platino, oziroma je bolezen napredovala v 12 mesecih neoadjuvantnega ali adjuvantnega zdravljenja s kemoterapijo, ki je vključevala platino.
English: Nivolumab monotherapy:
Slovenian: Nivolumab v monoterapiji:
English: Discard the vial if the solution is cloudy, is discoloured, or contains particulate matter other than a few translucentto-white particles.
Slovenian: Če je raztopina motna, kakršne koli drugačne barve ali vsebuje kakršne koli delce, razen nekaj prosojnih do belih delcev, vialo zavrzite.
English: ──Δ─── Nivolumab (events: 50/210), median and 95% CI: N.A. - - -- - - Dacarbazine (events: 96/208), median and 95% CI: 10.84 (9.33, 12.09)
Slovenian: ──Δ─── nivolumab (dogodki: 50/210), mediana in 95 % IZ: ni podatka - - -- - - dakarbazin (dogodki: 96/208), mediana in 95 % IZ: 10,84 (9,33; 12,09)
English: Serious lung infection (pneumonia), bronchitis
Slovenian: Občasni pljučnicaa, bronhitis
English: Table 20: Baseline patient characteristics in CA209205 Cohort B, Cohort C and CA209039
Slovenian: Preglednica 20: Izhodiščne lastnosti bolnikov v kohorti B in kohorti C v študiji CA209205 in študiji CA209039
English: There are no data on the use of nivolumab in combination with ipilimumab in patients with only a non clear-cell histology in first line RCC.
Slovenian: O uporabi nivolumaba v kombinaciji z ipilimumabom za prvo linijo zdravljenja RCC pri bolnikih z le nesvetlocelično histologijo ni podatkov.
English: 95% CI: 4.5, 16.4
Slovenian: 95 % IZ: 4,5; 16,4
English: When OPDIVO is given in combination with ipilimumab for the treatment of advanced kidney cancer, the recommended dose of OPDIVO is 3 mg of nivolumab per kilogram of your body weight for the first 4 doses (combination phase).
Slovenian: Pri uporabi zdravila OPDIVO v kombinaciji z ipilimumabom za zdravljenje napredovalega raka ledvic je priporočeni odmerek zdravila OPDIVO 3 mg nivolumaba na kilogram telesne mase za prve 4 odmerke (faza kombiniranega zdravljenja).
English: Urothelial Carcinoma Open-label phase 2 study (CA209275)
Slovenian: Urotelijski karcinom Odprta študija 2. faze (študija CA209275)
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.
Slovenian: faze z več kohortami, ki je vključevala kohorto 78 bolnikov (vključno z 18 osebami, ki so prejele predvideno navzkrižno zdravljenje s kombinacijo nivolumaba v odmerku 3 mg/k in ipilimumaba v odmerku 1 mg/kg) s podobnimi vključitvenimi kriteriji kot v študiji CA209275 zdravljenja urotelijskega karcinoma z nivolumabom v odmerku 3 mg/kg v monoterapiji.
English: Data from cHL patients 65 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Slovenian: Pri bolnikih s cHL, starih 65 let ali starejših, je na voljo premalo podatkov, zato zaključkov za to populacijo ni mogoče navesti (glejte poglavje 5.1).
English: Number of Subjects at Risk Nivolumab 3 mg/kg
Slovenian: Število ogroženih oseb nivolumab 3 mg/kg docetaksel
English: This analysis showed that not only tumour cell PD-L1 expression but also TAIC PD-L1 expression appeared to be associated with benefit from nivolumab relative to investigator's choice (see Table 25).
Slovenian: Analiza je pokazala, da s koristjo zdravljenja z nivolumabom v primerjavi z zdravljenjem z zdravilom po izbiri raziskovalca ni povezana le ekspresija PD-L1 tumorske celice temveč domnevno tudi ekspresija PD-L1 TAIC (glejte preglednico 25).
English: Median OS for tumour PD-L1 expression ≥ 1% was not reached for nivolumab in combination with ipilimumab, and was 19.61 months in the sunitinib arm (HR = 0.52; 95% CI: 0.34, 0.78).
Slovenian: Pri ekspresiji PD-L1 tumorja ≥ 1 % mediana celokupnega preživetja v skupini z nivolumabom v kombinaciji z ipilimumabom ni bila dosežena, v skupini s sunitinibom pa je znašala 19,61 meseca (HR = 0,52; 95 % IZ: 0,34; 0,78).
English: Samsung Biologics Co. Ltd. 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon, 21987 Korea
Slovenian: Yeonsu-gu, Incheon, 21987 Koreja
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).
Slovenian: Pri uporabi zdravila OPDIVO v kombinaciji z ipilimumabom za zdravljenje kožnega raka je priporočeni odmerek zdravila OPDIVO 1 mg nivolumaba na kilogram telesne mase za prve 4 odmerke (faza kombiniranega zdravljenja).
English: Vogt-Koyanagi-Harada syndromeh Cardiac disorders
Slovenian: Neznana pogostnost sindrom Vogt-Koyanagi-Haradah
English: Uncommon spondyloarthropathy, Sjogren's syndrome, arthritis, myopathy, myositis (including polymyositis)a,e, rhabdomyolysisa,f polymyalgia rheumatica, myositis (including polymyositis), rhabdomyolysis
Slovenian: Občasni spondiloartropatija, Sjogrenov sindrom, artritis, miopatija, miozitis (vključno s polimiozitisom)a,e, rabdomiolizaa,f revmatična polimialgija, miozitis (vključno s polimiozitisom), rabdomioliza
English: For tumour PD-L1 expression < 1%, the median OS was 34.7 months for the nivolumab in combination with ipilimumab, and was 32.2 months in the sunitinib arm (HR = 0.70; 95% CI: 0.54, 0.92).
Slovenian: Pri ekspresiji PD-L1 tumorja < 1 % je mediana celokupnega preživetja v skupini z nivolumabom v kombinaciji z ipilimumabom znašala 34,7 meseca, v skupini s sunitinibom pa 32,2 meseca (HR = 0,70; 95 % IZ: 0,54; 0,92).
English: Tumour PD-L1 expression levels were balanced between the two treatment groups (nivolumab vs. docetaxel) at each of the predefined tumour PD-L1 expression levels of ≥ 1% (53% vs. 55%), ≥ 5% (41% vs. 38%), or ≥ 10% (37% vs. 35%).
Slovenian: Vrednosti ekspresije PD-L1 tumorja so bile med obema skupinama zdravljena uravnotežene (nivolumab v primerjavi z docetakselom) pri vsaki vnaprej določeni vrednoti ekspresije PD-L1 tumorja: ≥ 1 % (53 % v primerjavi s 55 %), ≥ 5 % (41 % v primerjavi z 38 %) ali ≥ 10 % (37 % v primerjavi s 35 %).
English: OPDIVO infusion
Slovenian: infuzije
English: Recurrence-Free Survival (Months)
Slovenian: Preživetje brez ponovitve bolezni (meseci)
English: Table 19: Efficacy results in intermediate/poor risk patients (CA209214)
Slovenian: Preglednica 19: Rezultati učinkovitosti pri bolnikih s srednje ugodnim ali slabim prognostičnim obetom (študija CA209214)
English: Table 25: Efficacy by tumour cell and TAIC PD-L1 expression (CA209141)
Slovenian: Preglednica 25: Učinkovitost glede na ekspresijo PD-L1 tumorske celice in TAIC (študija CA209141)
English: Data from cHL patients 65 years of age or older are too limited to draw conclusions on this population.
Slovenian: Pri bolnikih s cHL, starih 65 let ali starejših, je na voljo premalo podatkov, zato zaključkov za to populacijo ni mogoče navesti.