natgillin/translations-raw huggingface dataset:
If not used immediately, chemical and physical in-use stability of OPDIVO has been demonstrated for 24 hours at 2ºC to 8ºC protected from light and a maximum of 8 hours at 20°C-25°C and room light (this 8-hour period of the total 24 hours should be inclusive of the product administration period). 
Če se ne uporabi takoj, je bilo dokazano, da je zdravilo OPDIVO med uporabo kemijsko in fizikalno stabilno 24 ur, če se ga shranjuje pri temperaturi od 2 °C do 8 °C, zaščitenega pred svetlobo, in največ 8 ur pri temperaturi od 20 °C do 25 °C in sobni svetlobi (to obdobje 8 ur od skupnih 24 ur pa vključuje tudi obdobje same aplikacije zdravila).
(95.92% CI) p-valueb 
(95,92 % IZ) p-vrednostb
Rapid onset of GVHD has been reported with nivolumab use before and after allogeneic HSCT (see section 4.4). 
V povezavi z uporabo nivolumaba pred in po alogenski HSCT so poročali o hitro nastali GVHD (glejte poglavje 4.4).
• Persistent Grade 2 or 3 adverse reactions despite management. 
• neželenih učinkov stopnje 2 ali 3, ki kljub zdravljenju ne minejo.
While both arms of the study received active therapy, the QoL data should be interpreted in the context of the open-label study design and therefore cautiously taken. 
Obe skupini v študiji sta se zdravili z učinkovino, vendar pa je podatke o kakovosti življenja treba interpretirati v kontekstu odprte zasnove študije in posledično razlagati previdno.
Although ECOG status, baseline glomerular filtration rate (GFR), albumin, body weight, and mild hepatic impairment had an effect on nivolumab CL, the effect was not clinically meaningful. 
Stanje telesne zmogljivosti po lestvici ECOG, izhodiščna ocena glomerulne filtracije (GFR - glomerular filtration rate), vrednost albumina, telesna masa in blaga okvara jeter so sicer imeli vpliv na očistek nivolumaba, vendar pa učinek ni bil klinično pomemben.
Nivolumab treatment resulted in rapid resolution of B-symptoms in 88.7% (47/53) of the patients, with a median time to resolution of 1.9 months. 
Pri zdravljenju z nivolumabom so se B-simptomi hitro izboljšali pri 88,7 % (47/53) bolnikov, mediani čas do izboljšanja pa je znašal 1,9 meseca.
10 (67%) M 5 (33%) F 
10 (67 %) M 5 (33 %) Ž
Disease-specific precautions 
Za bolezen specifični previdnostni ukrepi
Grade 3 or 4 pneumonitis 
Pnevmonitis stopnje 3 ali 4
Sunitinib (events: 209/422), median and 95.0% CI: 26.97 (22.08, 34.83) 
sunitinib (dogodki: 209/422), mediana in 95,0 % IZ: 26,97 (22,08; 34,83)
The benefit of treatment with nivolumab versus the risk of possible organ rejection should be considered in these patients. 
Pri teh bolnikih je treba pretehtati korist zdravljenja z nivolumabom in tveganje za morebitno zavrnitev organa.
Signs and symptoms may include muscle pain, stiffness, weakness, chest pain, or severe fatigue. 
Znaki in simptomi lahko vključujejo bolečino v mišicah, okorelost, oslabelost, bolečino v prsnem košu ali hudo utrujenost.
OPDIVO acts on your immune system and may cause inflammation in parts of your body. 
Zdravilo OPDIVO deluje na imunski sistem in lahko povzroči vnetje posameznih delov telesa.
At a minimum follow-up of 9 months, investigator-assessed confirmed ORR was 24.4% (95% CI: 15.3, 35.4). 
Po najmanjšem obdobju spremljanja 9 mesecev je z raziskovalčevo oceno potrjeni delež objektivnega odziva znašal 24,4 % (95 % interval zaupanja: 15,3; 35,4).
More than one vial of OPDIVO may be necessary to obtain the required dose. 
Za potreben odmerek bo morda treba uporabiti več kot eno vialo zdravila OPDIVO.
Both nivolumab-containing arms demonstrated greater objective response rates than ipilimumab regardless of PD-L1 expression levels. 
Obe skupini zdravljenja z nivolumabom sta pokazali večji delež objektivnega odziva v primerjavi z ipilimumabom ne glede na nivo ekspresije PD-L1.
No dose adjustment is required for elderly patients (≥ 65 years) (see section 5.2). 
Pri starejših bolnikih (≥ 65 let) odmerka ni treba prilagajati (glejte poglavje 5.2).
• Grade 4 or recurrent Grade 3 adverse reactions; 
• neželenih učinkov stopnje 4 ali neželenih učinkov stopnje 3, ki se ponovijo,
PD-L1 Expression nivolumab investigator's choice OS by tumour PD-L1 expression Number of events (number of patients) 
nivolumab izbira raziskovalca Celokupno preživetje glede na ekspresijo PD-L1 tumorja Število dogodkov (število bolnikov)
Patients should be monitored for signs and symptoms of nephritis or renal dysfunction. 
Bolnike je treba nadzirati glede pojava znakov in simptomov nefritisa ali okvare delovanja ledvic.
Responses were assessed per RECIST 1.1 for 588/1008 (58.3%) of patients who continued treatment through week 12 and had a follow-up scan at week 12. 
Odzive so ovrednotili na osnovi kriterijev RECIST, različica 1.1, pri 588/1.008 (58,3 %) bolnikov, ki so nadaljevali zdravljenje do 12. tedna in so imeli kontrolni pregled v 12. tednu.
Treatment was continued as long as clinical benefit was observed or until treatment was no longer tolerated. 
Zdravljenje je trajalo, dokler je bila prisotna klinična korist ali dokler je bolnik zdravljenje prenašal.
The primary efficacy population included those intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the International Metastatic RCC Database Consortium (IMDC) criteria (less than one year from time of initial renal cell carcinoma diagnosis to randomisation, Karnofsky performance status <80%, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, platelet count greater than the upper limit of normal, and absolute neutrophil count greater than the upper limit of normal). 
Primarna populacija za vrednotenje učinkovitosti je vključevala bolnike s srednje ugodnim ali slabim prognostičnim obetom, ki so imeli vsaj 1 ali več od 6 prognostičnih dejavnikov tveganja v skladu s kriteriji IMDC (International Metastatic RCC Database Consortium) (manj kot eno leto od začetne diagnoze karcinoma ledvičnih celic do randomizacije, ocena stanja telesne zmogljivosti po Karnofskem < 80 %, vrednost hemoglobina manjša od spodnje meje normalne vrednosti, korigirana vrednost kalcija večja od 10 mg/dl, število trombocitov večje od zgornje meje normalne vrednosti in absolutno število nevtrofilcev večje od zgornje meje normalne vrednosti).
Median duration of responseg 
Mediana trajanja odzivab
The majority (75%) of patients had M1c stage disease at study entry. 
Večina bolnikov (75 %) je ob vključitvi v študijo imela bolezen v stadiju M1c.
In 49 evaluated patients from two cHL studies who underwent allogeneic HSCT after discontinuing nivolumab monotherapy, Grade 3 or 4 acute GVHD was reported in 13/49 patients (26.5%). 
Pri 49 ovrednotenih bolnikih iz dveh študij, izvedenih pri cHL, pri katerih je bila opravljena alogenska HSCT po prekinitvi zdravljenja z nivolumabom v monoterapiji, so pri 13/49 bolnikov (26,5 %) poročali o akutni GVHD stopnje 3 ali 4.
Uncommon intestinal perforationa, gastritis, duodenitis gastritis 
Občasni predrtje črevesaa, gastritis, duodenitis gastritis
OPDIVO must be stored in a refrigerator (2°C to 8°C). 
Zdravilo OPDIVO shranjujte v hladilniku (2 °C do 8 °C).
Randomisation was stratified by prior cetuximab treatment. 
Randomizacija je bila stratificirana glede na predhodno zdravljenje s cetuksimabom.
Grade 2 myocarditis 
Miokarditis stopnje 2
Uncommon metabolic acidosis 
Občasni metabolična acidoza
However, once you are treated with OPDIVO, your doctor may give you corticosteroids to reduce any possible side effects that you may have during your treatment and this will not impact the effect of the medicine. 
Med zdravljenjem z zdravilom OPDIVO pa vam zdravnik lahko predpiše zdravljenje s kortikosteroidi za ublažitev katerega koli možnega neželenega učinka, ki se lahko pojavi med zdravljenjem.
Patients should be monitored for clinical signs and symptoms of endocrinopathies and for hyperglycaemia and changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation). 
Bolnike je treba nadzirati glede pojava kliničnih znakov in simptomov endokrinopatij, hiperglikemije in sprememb delovanja ščitnice (ob uvedbi zdravljenja, periodično med zdravljenjem in kot je indicirano na osnovi kliničnega pregleda).
Nivolumab in combination with ipilimumab: 
Nivolumab v kombinaciji z ipilimumabom:
Signs and symptoms of severe skin reaction may include rash, itching, and peeling of the skin (possibly fatal). 
Znaki in simptomi hude kožne reakcije lahko vključujejo izpuščaj, srbenje in luščenje kože (lahko s smrtnim izidom).
Urothelial Carcinoma 
Urotelijski karcinom
Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumour responses in metastatic melanoma. 
Kombinirano posredovano zavrtje z nivolumabom (anti-PD-1) in ipilimumabom (anti-CTLA-4) pri metastatskem melanomu povzroči boljši protitumorski odziv.
Grade 4 or recurrent Grade 3 ; persistent Grade 2 or 3 despite treatment modification; inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day 
Stopnje 4 ali ponovitev stopnje 3, vztrajanje stopnje 2 ali 3 kljub prilagoditvi zdravljenja, nezmožnost zmanjšanja odmerka kortikosteroida na 10 mg prednizona ali njegovega ekvivalenta na dan
In murine syngeneic tumour models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumour activity. 
Pri tumorskih modelih na izogenskih miših je dvojna blokada PD-1 in CTLA-4 pokazala sinergistično protitumorsko aktivnost.
Quality of life (QoL) with nivolumab remained stable and close to baseline values during treatment, as assessed by valid and reliable scales like the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D utility index and visual analog scale (VAS). 
Med zdravljenjem z nivolumabom je kakovost življenja bolnikov ostala stabilna in blizu izhodiščnim vrednostim, kar je bilo ovrednoteno s pomočjo validiranih in zanesljivih lestvic, kot sta QLQ-C30 Evropske organizacije za raziskovanje in zdravljenje raka (EORTC - European Organization for Research and Treatment of Cancer) in indeks EQ-5D ter vizualna analogna lestvica (VAS).
Patients with ocular/uveal melanoma were excluded from pivotal clinical trials of melanoma. 
Bolnike z očesnim/uvealnim melanomom so izključili iz ključnih kliničnih preskušanj pri melanomu.
It includes 243 patients who had ASCT; Cohort A included 63 (26%) patients who were brentuximab vedotin naïve; Cohort B included 80 (33%) patients who had received brentuximab vedotin after ASCT failure; and Cohort C included 100 (41%) patients who had received brentuximab vedotin before and/or after ASCT out of which 33 (14%) patients received brentuximab vedotin only prior to ASCT. 
Študija vključuje 243 bolnikov, ki so imeli opravljeno avtologno presaditev matičnih celic (ASCT): v kohorto A je bilo vključenih 63 (26 %) bolnikov, ki se še niso zdravili z brentuksimabom vedotinom, v kohorto B je bilo vključenih 80 (33 %) bolnikov, ki so se zdravili z brentuksimabom vedotinom po neuspešni ASCT, v kohorto C pa je bilo vključenih 100 (41 %) bolnikov, ki so se zdravili z brentuksimabom vedotinom pred in/ali po ASCT, od katerih se je 33 (14 %) bolnikov zdravilo z brentuksimabom vedotinom le pred ASCT.
Apparently meaningful symptom improvement (MID = 2 point change in FKSI-DRS score; p < 0.001) and time to improvement (HR = 1.66 (1.33,2.08), p < 0.001) were significantly better for patients on the nivolumab arm. 
Pomembno izboljšanje simptomov (minimalna pomembna razlika (MID) = 2 točki po lestvici FKSI-DRS; p < 0,001) in časa do izboljšanja (razmerje ogroženosti = 1,66 (1,33; 2,08), p < 0,001) je bilo pomembno boljše pri bolnikih v skupini z nivolumabom.
Common musculoskeletal paing arthritis, muscle spasms, muscular weakness 
Pogosti mišično-skeletna bolečinag artritis, mišični krči, mišična šibkost
Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT) in classical Hodgkin Lymphoma 
Zapleti alogenske presaditve krvotvornih matičnih celic (HSCT - Haematopoietic Stem Cell Transplant) pri klasičnem Hodgkinovem limfomu
Preparation and administration of OPDIVO 
Priprava in aplikacija zdravila OPDIVO
The overall safety profile of nivolumab 3 mg/kg for the adjuvant treatment of melanoma (n = 452) was consistent with that established across tumour types for nivolumab monotherapy. 
Celokupen varnostni profil nivolumaba v odmerku 3 mg/kg je bil pri adjuvantnem zdravljenju melanoma (n = 452) skladen z varnostnim profilom, ugotovljenem pri uporabi nivolumaba v monoterapiji pri drugih vrstah tumorjev.
Grade 3 or 4 myocarditis 
Miokarditis stopnje 3 ali 4
- - -*- - - - Nivolumab+ipilimumab (events: 161/314), median and 95% CI: 11.50 (8.90, 22.18). 
- - -*- - - - nivolumab+ipilimumab (dogodki: 161/314), mediana in 95 % IZ: 11,50 (8,90; 22,18).
OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 
Zdravilo OPDIVO je v monoterapiji ali v kombinaciji z ipilimumabom indicirano za zdravljenje napredovalega (neoperabilnega ali metastatskega) melanoma pri odraslih.
OS may be confounded by dropout, imbalance of subsequent therapies and differences in baseline factors. 
Na celokupno preživetje lahko vplivajo prezgodnja opustitev zdravljenja, neravnovesje pri kasnejših zdravljenjih in razlike v izhodiščnih dejavnikih.
Quantifiable tumour PD-L1 expression was measured in 67% of patients in the nivolumab group and 82% of patients in the investigator's choice group. 
Merljiva ekspresija PD-L1 tumorja je bila izmerjena pri 67 % bolnikov v skupini zdravljenja z nivolumabom in 82 % bolnikov v skupini zdravljenja z zdravilom po izbiri raziskovalca.
Check with your doctor or nurse before you are given OPDIVO if: you have an autoimmune disease (a condition where the body attacks its own cells); you have melanoma of the eye; you were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine; you have been told that your cancer has spread to your brain; you have any history of inflammation of the lungs; you have been taken medicines to suppress your immune system. 
Preden boste prvič prejeli zdravilo OPDIVO se posvetujte z zdravnikom ali medicinsko sestro: če imate avtoimunsko bolezen (stanje, pri katerem telo napada svoje lastne celice); če imate melanom očesa; če ste se predhodno zdravili z ipilimumabom, drugim zdravilom za zdravljenje melanoma, in so se pojavili resni neželeni učinki tega zdravila; če vam je zdravnik povedal, da se je rak razširil v možgane; če ste kdaj imeli vnetje pljuč; če se zdravite z zdravili, ki zavirajo imunski sistem.
Pericardial disorders is a composite term which includes pericarditis, pericardial effusion, cardiac tamponade, and Dressler's syndrome. 
Bolezni perikardija je sestavljen izraz, ki obsega vnetje perikardija, perikardialni izliv, tamponado srca in Dresslerjev sindrom.
Among 131 patients who discontinued the combination due to adverse reaction after 28 months of follow-up, the ORR was 71% (93/131) with 20% (26/131) achieving a complete response and median OS was not reached. 
Pri 131 bolnikih, pri katerih je bilo zdravljenje v kombinaciji zaradi neželenih učinkov po 28 mesecih spremljanja prekinjeno, je delež objektivnega odziva znašal 71 % (93/131), s popolnim odzivom pri 20 % (26/131) bolnikov, mediana OS pa ni bila dosežena.
Treatment with OPDIVO, either as a monotherapy or in combination with ipilimumab, should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient. 
Zdravljenje z zdravilom OPDIVO, bodisi v monoterapiji bodisi v kombinaciji z ipilimumabom, mora trajati, dokler je prisotna klinična korist oziroma dokler bolnik zdravljenje prenaša.
Table 21: Efficacy results in patients with relapsed/refractory classical Hodgkin lymphoma 
Preglednica 21: Rezultati učinkovitosti pri bolnikih s ponovljenim/neodzivnim klasičnim Hodgkinovim limfomom
Patients with mild or moderate infusion reaction may receive nivolumab or nivolumab in combination with ipilimumab with close monitoring and use of premedication according to local treatment guidelines for prophylaxis of infusion reactions. 
Bolniki z blago ali zmerno infuzijsko reakcijo se lahko zdravijo z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom, vendar pa jih je med infundiranjem treba skrbno nadzirati, za preprečevanje infuzijskih reakcij pa uporabiti premedikacijo v skladu z lokalnimi smernicami.
Patients should be monitored for cardiac and pulmonary adverse reactions continuously, as well as for clinical signs, symptoms, and laboratory abnormalities indicative of electrolyte disturbances and dehydration prior to and periodically during treatment. 
Bolnike je treba kontinuirano nadzirati glede pojava neželenih učinkov za srce in pljuča, pa tudi glede kliničnih znakov, simptomov in laboratorijskih nepravilnosti, ki kažejo na motnje elektrolitov in dehidracijo, pred uvedbo zdravljenja in periodično med zdravljenjem.
In this patient population, objective response was reported in 33 patients (31%) with a median duration of response of 22.9 months (95% CI: 17.0, NR). 
Pri tej populaciji bolnikov so o objektivnem odzivu poročali pri 33 bolnikih (31 %) z mediano vrednostjo trajanja odziva 22,9 meseca (95 % interval zaupanja: 17,0; ni doseženo).
The management guidelines for these adverse reactions are described in section 4.4. 
Smernice za zdravljenje teh neželenih učinkov so opisane v poglavju 4.4.
The prescriber must discuss the risks of OPDIVO therapy with the patient. 
Zdravnik mora bolniku pojasniti tveganja, povezana z zdravljenjem z zdravilom OPDIVO.
Nivolumab was continued beyond progression in 44% of patients. 
Pri 44 % bolnikov se je zdravljenje z nivolumabom nadaljevalo po napredovanju bolezni.
Uncommon diabetic ketoacidosisc, diabetes mellitusc diabetic ketoacidosisc, hypopituitarism 
Občasni diabetična ketoacidozac, diabetesc diabetična ketoacidozac, hipopituitarizem
Inflammation of the muscles such as myocarditis (inflammation of the heart muscle), myositis (inflammation of the muscles) and rhabdomyolysis (stiffness in muscles and joints, muscle spasm). 
vnetje mišic, kot so miokarditis (vnetje srčne mišice), miozitis (vnetje mišic) in rabdomioliza (okorelost mišic in sklepov, mišični krč).
Efficacy by BRAF status: Objective responses to nivolumab (according to the definition of the coprimary endpoint) were observed in patients with or without BRAF mutation-positive melanoma. 
Učinkovitost glede na status BRAF: Objektivni odziv na nivolumab (glede na opredelitev sočasnega primarnega opazovanega dogodka) so opazili tako pri bolnikih z melanomom z mutacijo BRAF kot brez nje.
The co-primary efficacy outcome measures were confirmed ORR in the first 120 patients treated with nivolumab, as measured by independent radiology review committee (IRRC) using RECIST, version 1.1, and comparison of OS of nivolumab to chemotherapy. 
Sočasni primarni merili izida učinkovitosti sta bili delež potrjenega objektivnega odziva pri prvih 120 bolnikih, ki so se zdravili z nivolumabom, ki ga je ovrednotil neodvisni odbor za radiološki pregled (IRRC - independent radiology review committee) na osnovi kriterijev RECIST, različica 1.1, in primerjava celokupnega preživetja pri nivolumabu v primerjavi s kemoterapijo.
Table 22: Updated efficacy results in patients with relapsed/refractory classical Hodgkin lymphoma from longer follow up of study CA209205 
Preglednica 22: Dopolnjeni podatki o učinkovitosti pri bolnikih s ponovljenim/neodzivnim klasičnim Hodgkinovim limfomom pri daljšem obdobju spremljanja iz študije CA209205
Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 4.2). 
Pri bolnikih s hudo okvaro ledvic je na voljo premalo podatkov, zato zaključkov za to populacijo ni mogoče navesti (glejte poglavje 4.2).
The 49 patients had a median follow-up from subsequent allogeneic HSCT of 5.6 months (range: 0-19 months). 
Mediano spremljanje 49 bolnikov po alogenski HSCT je trajalo 5,6 meseca (razpon: 0-19 mesecev).
Prior platinum-based therapy was administered in either the adjuvant, neo-adjuvant, primary, recurrent, or metastatic setting. 
Predhodno zdravljenje na osnovi platine je bilo uvedeno v okviru adjuvantnega, neoadjuvantnega, primarnega ali ponovnega zdravljenja ali zdravljenja zasevkov.
The observed PFS results at 18 months of follow-up and ORR and OS results at 28 months of follow-up were consistently demonstrated across subgroups of patients including baseline ECOG performance status, BRAF status, M stage, age, history of brain metastases, and baseline LDH level. 
Opaženi rezultati za PFS po 18 mesecih spremljanja in rezultati za ORR in OS po 28 mesecih spremljanja so bili konsistentni po podskupinah zdravljenja, vključno s stanjem telesne zmogljivosti po lestvici ECOG v izhodišču, statusom BRAF, M stadijem, starostjo, anamnezo zasevkov v možganih in vrednostjo LDH v izhodišču.
Although the clearance of nivolumab was increased by 20% when anti-nivolumab-antibodies were present, there was no evidence of loss of efficacy or altered toxicity profile in the presence of nivolumab antibodies based on the pharmacokinetic and exposure-response analyses for both monotherapy and combination. 
Očistek nivolumaba se je v prisotnosti protiteles proti nivolumabu sicer povečal za 20 %, vendar pa tako pri monoterapiji kot pri kombiniranem zdravljenju na osnovi farmakokinetičnih analiz in analiz izpostavljenost-odziv niso zaznali znakov izgube učinkovitosti ali spremenjenega profila toksičnosti.
Problems with your heart such as a change in the rhythm or rate of the heartbeat or an abnormal heart rhythm. 
Zdravilo lahko povzroči: težave s srcem, kot so spremembe ritma ali hitrosti utripanja srca ali nenormalen srčni ritem.
If you have any questions about ipilimumab, please ask your doctor. 
Če imate o uporabi ipilimumaba kakršno koli vprašanje, se posvetujte z zdravnikom.
PFS results (with minimum follow up of 18 months) are shown in Figure 2 (all randomised population), Figure 3 (at the tumour PD-L1 5% cut off), and Figure 4 (at the tumour PD-L1 1% cut off). 
Rezultati PFS (z najmanjšim obdobjem spremljanja do 18 mesecev) so prikazani na sliki 2 (populacija vseh randomiziranih bolnikov), sliki 3 (pri mejni vrednosti PD-L1 tumorja 5 %) in sliki 4 (pri mejni vrednosti PD-L1 tumorja 1 %).
Grade 2 cases were reported in 2.2% (10/448) of patients. 
O primerih stopnje 2 so poročali pri 2,2 % (10/448) bolnikov.
How to use OPDIVO 
Kako uporabljati zdravilo OPDIVO
Efficacy assessments included investigator-assessed ORR, retrospectively evaluated by an IRRC, and duration of response. 
Vrednotenje učinkovitosti je vključevalo raziskovalčevo oceno deleža objektivnega odziva, kar je retrospektivno ovrednotil tudi neodvisni odbor za radiološki pregled, in trajanje odziva.
In head and neck cancer, a higher number of deaths within 3 months was observed in nivolumab compared to docetaxel. 
Pri bolnikih s karcinomom glave in vratu so v 3 mesecih pri uporabi nivolumaba opazili večje število umrlih kot pri uporabi docetaksela.
CA209214 also randomised 249 favourable risk patients as per IMDC criteria to nivolumab plus ipilimumab (n = 125) or to sunitinib (n = 124). 
V študiji CA209214 je bilo randomiziranih tudi 249 bolnikov z ugodnim prognostičnim obetom po kriterijih IMDC na zdravljenje z nivolumabom v kombinaciji z ipilimumabom (n = 125) ali na zdravljenje s sunitinibom (n = 124).
Nivolumab baseline CL in adjuvant melanoma patients was approximately 40% lower and steady state CL approximately 20 % lower relative to advanced melanoma. 
Pri bolnikih z adjuvantnim zdravljenjem melanoma je bil izhodiščni očistek nivolumaba približno 40 % manjši, očistek v stanju dinamičnega ravnovesja pa približno 20 % manjši, kot pri bolnikih z napredovalim melanomom.
In the nivolumab group there were two patients with CRs and seven patients with PRs who had tumour PD-L1 expression < 1%. 
V skupini z nivolumabom sta bila dva bolnika s popolnim odzivom (CR) in sedem bolnikov z delnim odzivom (PR), ki so imeli ekspresijo PD-L1 tumorja < 1 %.