FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment after disease progression was permitted for patients who had a clinical benefit and did not have substantial adverse effects with the study drug, as determined by the investigator.
Slovenian: Zdravljenje po napredovanju bolezni je bilo dovoljeno, če je po presoji raziskovalca pri bolniku bila prisotna klinična korist in bolnik ni imel pomembnejših neželenih učinkov študijskega zdravila.
English: Respiratory, thoracic and mediastinal disorders Very common dyspnoea Common pneumonitisa,c, pulmonary embolisma, cough pneumonitis, dyspnoea, pleural effusion, cough
Slovenian: Pogosti pnevmonitisa,c, pljučna embolijaa, kašelj pnevmonitis, dispneja, plevralni izliv, kašelj
English: OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.
Slovenian: Karcinom ledvičnih celic (RCC - renal cell carcinoma) Zdravilo OPDIVO je v monoterapiji indicirano za zdravljenje napredovalega karcinoma ledvičnih celic po predhodnem zdravljenju pri odraslih.
English: OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.
Slovenian: Nedrobnocelični pljučni rak (NSCLC - non-small cell lung cancer) Zdravilo OPDIVO je v monoterapiji indicirano za zdravljenje lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka po predhodni kemoterapiji pri odraslih.
English: Patients with any history of or concurrent brain metastases, prior treatment with an mammalian target of rapamycin (mTOR) inhibitor, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study.
Slovenian: Bolnike z anamnezo zasevkov v možganih ali s trenutnimi zasevki v možganih, predhodnim zdravljenjem z zaviralcem mTOR (tarče rapamicina pri sesalcih; mammalian target of rapamycin), aktivno avtoimunsko boleznijo ali zdravstvenimi stanji, ki so zahtevala zdravljenje z zdravili za sistemsko zaviranje imunske odzivnosti, so iz te študije izključili.
English: Seventeen patients (6%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
Slovenian: Sedemnajst bolnikov (6 %), ki so bili randomizirani na docetaksel, je kadar koli med študijo prešlo na zdravljenje z nivolumabom.
English: Resolution occurred in 37 patients (77.1%) with a median time to resolution of 13.2 weeks (range: 0.1+-106.0+).
Slovenian: Do izboljšanja je prišlo pri 37 bolnikih (77,1 %), mediani čas do izboljšanja pa je znašal 13,2 tedna (razpon: 0,1+-106,0+).
English: 80 NR (35.75, NR)
Slovenian: ND (35,75; ND)
English: The safety of re-initiating nivolumab or nivolumab in combination with ipilimumab therapy in patients previously experiencing immune-related myocarditis is not known.
Slovenian: Pri bolnikih s predhodnim pojavom imunsko pogojenega miokarditisa varnost ponovne uvedbe zdravljenja z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom ni znana.
English: ≥ 10% to < 50%a
Slovenian: ≥ 10 % do < 50 %a
English: Sixteen patients (6%) randomised to docetaxel crossed over at any time to receive nivolumab treatment.
Slovenian: Šestnajst bolnikov (6 %), ki so bili randomizirani na docetaksel, je kadar koli med študijo prešlo na zdravljenje z nivolumabom.
English: Resolution occurred in 42 patients (61.8%) with a median time to resolution of 12.1 weeks (range: 0.3-79.1+).
Slovenian: Do izboljšanja je prišlo pri 42 bolnikih (61,8 %), mediani čas do izboljšanja pa je znašal 12,1 tedna (razpon: 0,3-79,1+).
English: The median age was 55 years (range: 18-86), 58% were men, and 95% were white.
Slovenian: Mediana starost bolnikov je bila 55 let (razpon: 18-86), 58 % bolnikov je bilo moškega spola in 95 % bolnikov belcev.
English: Tumour assessments, according to the RECIST, version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks thereafter.
Slovenian: Vrednotenje tumorja na osnovi kriterijev RECIST, različica 1.1, je bilo izvedeno 9 tednov po randomizaciji, nato pa se je nadaljevalo na vsakih 6 tednov.
English: Patients in the combination arm received nivolumab 1 mg/kg over 60 minutes and ipilimumab 3 mg/kg over 90 minutes administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab 3 mg/kg as monotherapy every 2 weeks.
Slovenian: Bolniki v skupini s kombiniranim zdravljenjem so pri prvih 4 odmerkih nivolumab prejemali v odmerku 1 mg/kg v obliki 60-minutne intravenske infuzije, ipilimumab pa v odmerku 3 mg/kg v obliki 90-minutne intravenske infuzije vsake 3 tedne, nato pa je sledilo zdravljenje z nivolumabom v odmerku 3 mg/kg v monoterapiji vsaka 2 tedna.
English: Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the three treatment groups.
Slovenian: Bolniki z merljivo ekspresijo PD-L1 so bili enakomerno porazdeljeni po treh skupinah zdravljenja.
English: The median age was 65 years (range: 18-87), 59% were men, and 99.5% were white.
Slovenian: Mediana starost bolnikov je bila 65 let (razpon: 18-87), 59 % bolnikov je bilo moškega spola in 99,5 % bolnikov belcev.
English: Grade 2 and Grade 3 cases were reported in 20.3% (91/448) and 7.6% (34/448) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 20,3 % (91/448) bolnikov, o primerih stopnje 3 pa pri 7,6 % (34/448) bolnikov.
English: Randomised phase 3 study of nivolumab in combination with ipilimumab vs. sunitinib (CA209214)
Slovenian: Randomizirana klinična študija 3. faze za ovrednotenje nivolumaba v kombinaciji z ipilimumabom v primerjavi s sunitinibom (študija CA209214)
English: Thereafter, the recommended dose of OPDIVO is 240 mg given every 2 weeks or 480 mg given every 4 weeks (single-agent phase).
Slovenian: Po tem je priporočeni odmerek zdravila OPDIVO 240 mg vsaka 2 tedna ali 480 mg vsake 4 tedne (faza zdravljenja samo z enim zdravilom).
English: Grade 3-4 irAEs with Anti-CTLA-4
Slovenian: Imunsko pogojeni neželeni učinki stopnje 3-4 pri antiCTLA-4 zdravljenju
English: Grade 2 and Grade 3 cases were reported in 3.1% (17/547) and 1.1% (6/547), of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 3,1 % (17/547) bolnikov, o primerih stopnje 3 pa pri 1,1 % (6/547) bolnikov.
English: Nervous system disorders Common peripheral neuropathy, headache, dizziness
Slovenian: Bolezni živčevja Pogosti periferna nevropatija, glavobol, omotica
English: Hazard ratio 98.52% CI p-value
Slovenian: Celokupno preživetje Dogodki Razmerje ogroženosti 98,52 % IZ p-vrednost
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA VIALE
English: Problems with your hormone producing glands (including the pituitary, the thyroid, the parathyroid and adrenal glands) that may affect how these glands work.
Slovenian: težave z žlezami, ki izločajo hormone (vključno s hipofizo, ščitnico, obščitnično žlezo in nadledvičnimi žlezami).
English: Median duration of follow-up Months (range)
Slovenian: Mediana trajanja spremljanja Meseci (razpon)
English: Not known hypoparathyroidismh hypoparathyroidismh
Slovenian: Neznana pogostnost hipoparatiroidizemh hipoparatiroidizemh
English: Rare anaphylactic reactionc
Slovenian: Redki anafilaktična reakcijac
English: Nervous system disorders Very common headache Common peripheral neuropathy, dizziness headache, peripheral neuropathy, dizziness
Slovenian: Pogosti periferna nevropatija, omotica glavobol, periferna nevropatija, omotica
English: The total dose of OPDIVO required can be infused directly as a 10 mg/mL solution or can be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection (see section 6.6).
Slovenian: Celotni potrebni odmerek zdravila OPDIVO se lahko infundira neposredno v obliki raztopine s koncentracijo 10 mg/ml ali pa se ga predhodno razredči z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje ali s 5-odstotno (50 mg/ml) raztopino glukoze za injiciranje (glejte poglavje 6.6).
English: ECOG performance scores were 0 for 61% of patients and 1 for 39% of patients.
Slovenian: 61 % bolnikov je imelo oceno stanja telesne zmogljivosti po lestvici ECOG 0, 39 % bolnikov pa 1.
English: Rate (95% CI) at 18 months
Slovenian: Delež (95 % IZ) v 18. mesecu
English: Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immunerelated colitis.
Slovenian: Pri bolnikih z imunsko pogojenim kolitisom, neodzivnim na kortikosteroide, so poročali o okužbi/reaktivaciji okužbe s citomegalovirusom (CMV).
English: The recommended dose is 3 mg/kg nivolumab in combination with 1 mg/kg ipilimumab administered intravenously every 3 weeks for the first 4 doses.
Slovenian: Priporočeni odmerek je 3 mg/kg nivolumaba v kombinaciji z 1 mg/kg ipilimumaba, ki ju bolnik prejme intravensko vsake 3 tedne, in sicer prve 4 odmerke.
English: Grade 2 and Grade 3 thyroid disorders were reported in 15.7% (86/547) and 1.3% (7/547) of patients, respectively.
Slovenian: O boleznih ščitnice stopnje 2 so poročali pri 15,7 % (86/547) bolnikov, o boleznih ščitnice stopnje 3 pa pri 1,3 % (7/547) bolnikov.
English: Thereafter it will be given as an infusion over a period of 30 or 60 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single-agent phase).
Slovenian: Infuzija bo trajala 30 minut ali 60 minut, zdravilo pa boste prejemali vsaka 2 tedna ali vsake 4 tedne, odvisno od odmerka, ki ga boste prejemali.
English: These include:
Slovenian: Zdravnik vam lahko:
English: Resolution occurred in 296 patients (88.1%) with a median time to resolution of 2.1 weeks (range: 0.1-124.4+).
Slovenian: Do izboljšanja je prišlo pri 296 bolnikih (88,1 %), mediani čas do izboljšanja pa je znašal 2,1 tedna (razpon: 0,1-124,4+).
English: Patients were enrolled regardless of their tumour PD-L1 status.
Slovenian: Bolnike so vključili ne glede na status PD-L1 tumorja.
English: Grade 2 and Grade 3 thyroid disorders were reported in 14.5% (65/448) and 1.3% (6/448) of patients, respectively.
Slovenian: O boleznih ščitnice stopnje 2 so poročali pri 14,5 % (65/448) bolnikov, o boleznih ščitnice stopnje 3 pa pri 1,3 % (6/448) bolnikov.
English: Treatment beyond initial investigator-assessed RECIST, version 1.1-defined progression was permitted if the patient had a clinical benefit, did not have rapid disease progression, 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, napredovanje bolezni ni bilo hitro in je bolnik študijsko zdravilo prenašal.
English: The median PFS was 3.7 months (95% CI: 1.9, 9.3).
Slovenian: Mediana vrednost preživetja brez napredovanja bolezni je znašala 3,7 meseca (95 % interval zaupanja: 1,9; 9,3).
English: After 28 months of follow-up, median durations of response for patients with tumour PD-L1 expression level ≥5% were not reached (range: 0+-31.6+) in the combination arm, not reached (range: 2.8-30.6+) in the nivolumab monotherapy arm and not reached (range: 1.4-30.6+) in the ipilimumab arm. At tumour PD-L1 expression <5%, median durations of response were not reached (range: 0+-33.3+) in the combination arm, not reached (range: 0+-32.3+) in the nivolumab monotherapy arm and 18.2 months (range: 0.0+-31.5+) in the ipilimumab monotherapy arm.
Slovenian: Po 28 mesecih spremljanja pri bolnikih z nivojem ekspresije PD-L1 tumorja ≥ 5 % mediana trajanja odziva v skupini s kombiniranim zdravljenjem ni bila dosežena (razpon: 0+-31,6+), v skupini zdravljenja z nivolumabom v monoterapiji ni bila dosežena (razpon: 2,8-30,6+), v skupini zdravljenja z ipilimumabom pa prav tako ni bila dosežena (razpon: 1,4-30,6+).
English: Median time to onset of these endocrinopathies was 1.9 months (range: 0.0-28.1).
Slovenian: Mediani čas do nastopa teh endokrinopatij je znašal 1,9 meseca (razpon: 0,0-28,1).
English: In the absence of data for patients with autoimmune disease, symptomatic interstitial lung disease, active brain metastases and patients who had been receiving systemic immunosuppressants prior to study entry, nivolumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis 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 z avtoimunsko boleznijo, simptomatsko boleznijo pljučnega intersticija, aktivnimi zasevki v možganih in bolnikih, ki so se pred vključitvijo v študijo zdravili z zdravili za sistemsko zaviranje imunske odzivnosti, je zaradi pomanjkanja podatkov treba nivolumab uporabljati previdno in pred uvedbo zdravljenja skrbno ovrednotiti razmerje med možno koristjo in tveganjem pri vsakem bolniku posebej.
English: Single-arm phase 2 study (CA209171)
Slovenian: Enoskupinska študija 2. faze (študija CA209171)
English: Figure 2: Progression-free survival (CA209067)
Slovenian: Preživetje brez napredovanja bolezni (študija CA209067)
English: Median (95% CI) months
Slovenian: Mediana (95 % IZ) meseci
English: No Grade 4 or 5 cases were reported in this study.
Slovenian: O primerih stopnje 4 ali 5 v tej študiji niso poročali.
English: Rash is a composite term which includes maculopapular rash, rash erythematous, rash pruritic, rash follicular, rash macular, rash morbilliform, rash papular, rash pustular, rash papulosquamous, rash vesicular, rash generalised, exfoliative rash, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, dermatitis exfoliative, dermatitis psoriasiform, drug eruption and pemphigoid.
Slovenian: Izpuščaj je sestavljen izraz, ki vključuje makulopapulozni izpuščaj, eritemski izpuščaj, srbeči izpuščaj, folikularni izpuščaj, makulozni izpuščaj, morbiliformni izpuščaj, papulozni izpuščaj, pustulozni izpuščaj, papuloskvamozni izpuščaj, vezikulozni izpuščaj, generalizirani izpuščaj, eksfoliativni izpuščaj, dermatitis, akneiformni dermatitis, alergijski dermatitis, atopični dermatitis, bulozni dermatitis, eksfoliativni dermatitis, psoriaziformni dermatitis, medikamentni izpuščaj in pemfigoid.
English: Efficacy results are shown in Table 16.
Slovenian: Rezultati učinkovitosti so prikazani v preglednici 16.
English: The median OS was 9.7 months (95% CI:7.26,
Slovenian: Mediana celokupnega preživetja je znašala 9,7 meseca (95 % interval zaupanja: 7,26; 16,16).
English: Among the patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Slovenian: Pri bolnikih, ki so se v študiji CA209214 zdravili z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg, so se pri 169/547 bolnikov (31 %) neželeni učinki stopnje 3 ali 4 prvič pojavili med uvodno fazo s kombiniranim zdravljenjem.
English: The recommended dose is 1 mg/kg nivolumab in combination with 3 mg/kg ipilimumab administered intravenously every 3 weeks for the first 4 doses.
Slovenian: Priporočeni odmerek je 1 mg/kg nivolumaba v kombinaciji s 3 mg/kg ipilimumaba, ki ju bolnik prejme intravensko vsake 3 tedne, in sicer prve 4 odmerke.
English: Median (95% CI)
Slovenian: Mediana (95 % IZ)
English: p-value Median (95% CI)
Slovenian: p-vrednost Mediana (95 % IZ)
English: For Grade 2 diarrhoea or colitis, nivolumab or nivolumab in combination with ipilimumab should be withheld.
Slovenian: V primeru driske ali kolitisa stopnje 2 je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom zadržati.
English: Everolimus 10 mg (events: 215/411), median and 95% CI: 19.55 (17.64, 23.06)
Slovenian: everolimus 10 mg (dogodki: 215/411), mediana in 95 % IZ: 19,55 (17,64; 23,06)
English: Uncommon eosinophilia
Slovenian: Občasni eozinofilija
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, double-blind study (CA209066).
Slovenian: Varnost in učinkovitost nivolumaba v odmerku 3 mg/kg pri zdravljenju napredovalega (neoperabilnega ali metastatskega) melanoma so vrednotili v randomizirani, dvojno slepi študiji 3. faze (CA209066).
English: In the absence of data, nivolumab or nivolumab in combination with ipilimumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Slovenian: Zaradi pomanjkanja podatkov je treba nivolumab ali nivolumab v kombinaciji z ipilimumabom pri teh populacijah bolnikov uporabljati previdno in pred uvedbo zdravljenja skrbno ovrednotiti razmerje med možno koristjo in tveganjem pri vsakem bolniku posebej.
English: The first tumour assessments were conducted 12 weeks after randomisation and continued every 6 weeks thereafter for the first year and then every 12 weeks until progression or treatment discontinuation, whichever occurred later.
Slovenian: Prvo vrednotenje tumorja je bilo izvedeno 12 tednov po randomizaciji in se je prvo leto zdravljenja nadaljevalo na vsakih 6 tednov, nato pa na vsakih 12 tednov do napredovanja bolezni ali ukinitve zdravljenja, kar koli se je zgodilo kasneje.
English: OPDIVO must be administered with caution in patients with moderate (total bilirubin > 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment.
Slovenian: Pri bolnikih z zmerno (vrednost skupnega bilirubina > 1,5 × do 3 × zgornja meja normalne vrednosti [ZMN] in katera koli vrednost AST) ali s hudo (vrednost skupnega bilirubina > 3 × ZMN in katera koli vrednost AST) okvaro jeter je treba zdravilo OPDIVO uporabljati previdno.
English: Patients in the comparator arm received ipilimumab 3 mg/kg and nivolumab-matched placebo intravenously every 3 weeks for 4 doses followed by placebo every 2 weeks.
Slovenian: Bolniki v primerjalni skupini so pri prvih 4 odmerkih prejemali ipilimumab v odmerku 3 mg/kg in nivolumabu podoben placebo vsake 3 tedne, nato pa je sledilo prejemanje placeba vsaka 2 tedna.
English: Resolution occurred in 33 patients (94.3%) with a median time to resolution of 6.1 weeks (range: 0.3-35.1).
Slovenian: Do izboljšanja je prišlo pri 33 bolnikih (94,3 %), mediani čas do izboljšanja pa je znašal 6,1 tedna (razpon: 0,3-35,1).
English: In the pooled dataset of nivolumab 3 mg/kg as monotherapy across tumour types (n = 2578) with minimum follow-up ranging from 2.3 to 28 months, the most frequent adverse reactions (≥ 10%) were fatigue (30%), rash (17%), pruritus (13%), diarrhoea (13%), and nausea (12%).
Slovenian: Zbrani podatki iz študij uporabe nivolumaba v odmerku 3 mg/kg v obliki monoterapije pri različnih vrstah tumorjev (n = 2.578) z najmanjšim obdobjem spremljanja v razponu od 2,3 meseca do 28 mesecev kažejo, da so najpogostejši neželeni učinki (≥ 10 %) bili naslednji: utrujenost (30 %), izpuščaj (17 %), srbenje (13 %), driska (13 %) in navzea (12 %).
English: The Kaplan-Meier curves for OS are shown in Figure 8.
Slovenian: Kaplan-Meierjevi krivulji celokupnega preživetja sta prikazani na sliki 8.
English: Median time to onset was 0.9 months (range: 0.0-17.9).
Slovenian: Mediani čas do nastopa je znašal 0,9 meseca (razpon: 0,0-17,9).
English: In the dataset of nivolumab 3 mg/kg as monotherapy for the adjuvant treatment of melanoma (n = 452), the most frequent adverse reactions (≥ 10%) were fatigue (46%), rash (29%), diarrhoea (24%), pruritus (23%), nausea (15%), arthralgia (13%), musculoskeletal pain (11%), and hypothyroidism (11%).
Slovenian: Podatki uporabe nivolumaba v odmerku 3 mg/kg v monoterapiji pri adjuvantnem zdravljenju melanoma (n = 452) kažejo, da so bili najpogostejši neželeni učinki (≥ 10 %) utrujenost (46 %), izpuščaj (29 %), diareja (24 %), pruritus (23 %), navzea (15 %), artralgija (13 %), mišično-skeletna bolečina (11 %) in hipotiroidizem (11 %).
English: Median time to onset was 0.5 months (range: 0.0-19.4).
Slovenian: Mediani čas do nastopa je znašal 0,5 meseca (razpon: 0,0-19,4).
English: In patients with tumour PD-L1 expression <1%, ORR per IRRC was 13.0% (n=69; 95% CI: 6.1, 23.3) and 12.0% (n=25; 95% CI: 2.5, 31.2), respectively.
Slovenian: Pri bolnikih z ekspresijo PD-L1 tumorja < 1 % je delež objektivnega odziva po oceni IRRC pri uporabi nivolumaba znašal 13,0 % (n=69; 95% interval zaupanja: 6,1; 23,3), pri zdravljenju s kemoterapijo pa 12,0 % (n=25; 95 % interval zaupanja: 2,5; 31,2).
English: Common hypercalcaemia, hypermagnesaemia, hypernatraemia, weight decreased hypermagnesaemia, hypernatraemia, weight decreased
Slovenian: Pogosti hiperkalciemija, hipermagneziemija, hipernatriemija, zmanjšanje telesne mase hipermagneziemija, hipernatriemija, zmanjšanje telesne mase
English: Resolution occurred in 124 patients (93.9%) with a median time to resolution of 5.1 weeks (range: 0.1-106.9).
Slovenian: Do izboljšanja je prišlo pri 124 bolnikih (93,9 %), mediani čas do izboljšanja pa je znašal 5,1 tedna (razpon: 0,1-106,9).
English: Relative to nivolumab monotherapy, an increase in PFS for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.
Slovenian: V primerjavi z zdravljenjem z nivolumabom v monoterapiji so pri zdravljenju z nivolumabom v kombinaciji z ipilimumabom podaljšanje preživetja brez napredovanja bolezni ugotovili le pri bolnikih z nizko ekspresijo PD-L1 tumorja.
English: A total of 272 patients were randomised to receive either nivolumab 3 mg/kg (n = 135) administered intravenously over 60 minutes every 2 weeks or docetaxel (n = 137) 75 mg/m2 every 3 weeks.
Slovenian: Skupno 272 bolnikov so randomizirali na zdravljenje z nivolumabom v odmerku 3 mg/kg (n = 135) v obliki 60-minutne intravenske infuzije vsaka 2 tedna ali na zdravljenje z docetakselom (n = 137) v odmerku 75 mg/m2 vsake 3 tedne.
English: Rate (95% CI) at 12 months Rate (95% CI) at 18 months Rate (95% CI) at 24 months a
Slovenian: Delež (95 % IZ) v 12. mesecu Delež (95 % IZ) v 18. mesecu Delež (95 % IZ) v 24. mesecu a
English: It is recommended to continue treatment with nivolumab or nivolumab in combination with ipilimumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Slovenian: Pri klinično stabilnih bolnikih z znaki napredovanja bolezni na začetku zdravljenja, je zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom priporočljivo nadaljevati, dokler se napredovanje bolezni ne potrdi.
English: Median time to onset was 3.6 months (range: 0.2-19.6).
Slovenian: Mediani čas do nastopa je znašal 3,6 meseca (razpon: 0,2-19,6).
English: The median age was 63 years (range: 39-85) with 44% ≥65 years of age and 11% ≥75 years of age.
Slovenian: Mediana starost bolnikov je bila 63 let (razpon: 39-85), 44 % bolnikov je bilo starih  65 let, 11 % bolnikov pa  75 let.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.4% (24/547), 0.7% (4/547), and 0.5% (3/547) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 4,4 % (24/547) bolnikov, o primerih stopnje 3 pri 0,7 % (4/547) bolnikov in o primerih stopnje 4 pri 0,5 % (3/547) bolnikov.
English: Resolution occurred in 140 patients (91.5%) with a median time to resolution of 2.4 weeks (range: 0.1-103.1+).
Slovenian: Do izboljšanja je prišlo pri 140 bolnikih (91,5 %), mediani čas do izboljšanja pa je znašal 2,4 tedna (razpon: 0,1-103,1+).
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of patients with completely resected melanoma were evaluated in a phase 3, randomised, double-blind study (CA209238).
Slovenian: Varnost in učinkovitost nivolumaba v odmerku 3 mg/kg kot samostojnega zdravila pri zdravljenju bolnikov s popolno kirurško odstranjenim melanomom so vrednotili v randomizirani, dvojno slepi študiji 3. faze (CA209238).