natgillin/translations-raw huggingface dataset:
Hypophysitis (1 Grade 1, 2 Grade 2, 5 Grade 3, and 1 Grade 4), hypopituitarism (4 Grade 2 and 1 Grade 3), adrenal insufficiency (including secondary adrenocortical insufficiency) (1 Grade 1, 9 Grade 2, and 5 Grade 3), diabetes mellitus (including Type 1 diabetes mellitus) (3 Grade 2 and 1 Grade 3), and diabetic ketoacidosis (2 Grade 3) were reported. 
Poročali so tudi o primerih vnetja hipofize (1 primer stopnje 1, 2 primera stopnje 2, 5 primerov stopnje 3 in 1 primer stopnje 4), hipopituitarizma (4 primeri stopnje 2 in 1 primer stopnje 3), insuficience nadledvičnih žlez (vključno s sekundarno adrenokortikalno insuficienco) (1 primer stopnje 1, 9 primerov stopnje 2 in 5 primerov stopnje 3), diabetesa (vključno z diabetesom tipa 1) (3 primeri stopnje 2 in 1 primer stopnje 3) in diabetične ketoacidoze (2 primera stopnje 3).
Factors associated with early deaths were ECOG performance status, fast progressive disease on prior platinum therapy and high tumour burden. 
Dejavniki, povezani z zgodnejšo umrljivostjo, so bili stanje telesne zmogljivosti po lestvici ECOG (Eastern Cooperative Oncology Group), hitro napredovanje bolezni pri predhodnem zdravljenju s platino in večje tumorsko breme.
The majority of patients were male (75%) and white (88%), all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups were represented, and 34% and 66% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively. 
Večina bolnikov je bilo moškega spola (75 %) in belcev (88 %), zastopane so bile vse rizične skupine po MSKCC (Memorial Sloan Kettering Cancer Center), 34 % bolnikov je imelo oceno stanja telesne zmogljivosti po Karnofskem od 70 do 80 %, 66 % bolnikov pa od 90 do 100 %.
The majority of patients were white (92%) and male (55%). 
Večina bolnikov je bilo belcev (92 %) in moškega spola (55 %).
Squamous Cell Cancer of the Head and Neck 
Ploščatocelični karcinom glave in vratu
If dosing is resumed after a delay, either the combination treatment or OPDIVO monotherapy could be resumed based on the evaluation of the individual patient. 
Če se po prekinitvi zdravljenje nadaljuje, je treba kombinirano zdravljenje ali zdravljenje z zdravilom OPDIVO v monoterapiji nadaljevati na osnovi ocene pri posameznem bolniku.
Confirmed objective response (IRRC) (95% CI) 
Potrjeni objektivni odziv (IRRC) (95 % IZ)
Not known aseptic meningitish 
Neznana pogostnost aseptični meningitish
The prescribed dose for the patient is 240 mg or 480 mg given regardless of body weight depending on indication (see section 4.2). 
Predpisani odmerek za bolnika je 240 mg ali 480 mg ne glede na telesno maso, odvisno od indikacije (glejte poglavje 4.2).
Cases of Vogt-Koyanagi-Harada syndrome and hypoparathyroidism have been reported postmarketing (see section 4.8). 
V obdobju trženja zdravila so poročali o primerih sindroma Vogt-Koyanagi-Harada in hipoparatiroidizma (glejte poglavje 4.8).
OPDIVO can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting according to the following instructions: the final infusion concentration should range between 1 and 10 mg/mL. 
Zdravilo OPDIVO se lahko aplicira intravensko: brez redčenja, po prenosu v infuzijski vsebnik z ustrezno sterilno injekcijsko brizgo, ali po redčenju v skladu z naslednjimi navodili: končna koncentracija raztopine za infundiranje mora biti v razponu od 1 do 10 mg/ml.
Patients that received more than 2 prior lines of chemotherapy with liver metastases were excluded. 
Izključili so tudi bolnike z zasevki v jetrih, ki so se predhodno zdravili z več kot 2 linijama kemoterapije.
ORRs were higher for the combination of nivolumab and ipilimumab relative to nivolumab monotherapy across tumour PD-L1 expression levels (Table 12) after 28 months of follow-up, with a best overall response of complete response correlating to an improved survival rate. 
Po 28 mesecih spremljanja so bili deleži objektivnega odziva večji pri kombinaciji nivolumaba in ipilimumaba v primerjavi z monoterapijo z nivolumabom pri vseh nivojih ekspresije PD-L1 tumorja (preglednica 12) najboljši celokupni odziv popolnega odziva pa je bil v korelaciji z izboljšanjem deleža preživetja.
B-symptoms were present in 22% (53/243) of the patients in CA209205 at baseline. 
V izhodišču so bili B-simptomi prisotni pri 22 % (53/243) bolnikov v študiji CA209205.
CA209039 
Študija CA209039
RFS results are shown in Table 13 and Figure 7 (all randomised population). 
Rezultati preživetja brez ponovitve bolezni (RFS - recurrence-free survival) so prikazani v preglednici 13 in na sliki 7 (populacija vseh randomiziranih bolnikov).
Table 12: Objective response (CA209067) 
Preglednica 12: Objektivni odziv (študija CA209067)
Patients with prior autoimmune disease, and any condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications, as well as patients with prior therapy for melanoma (except patients with surgery, adjuvant radiotherapy after neurosurgical resection for lesions of the central nervous system, and prior adjuvant interferon completed ≥6 months prior to randomisation) prior therapy with, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways), were excluded from the study. 
Bolnike s predhodno avtoimunsko boleznijo in bolnike s katerim koli stanjem, pri katerem je bilo potrebno sistemsko zdravljenje bodisi s kortikosteroidi (≥ 10 mg prednizona ali njegovega ekvivalenta na dan) bodisi z drugimi zdravili za sistemsko zaviranje imunske odzivnosti, pa tudi bolnike s predhodno zdravljenim melanomom (razen bolnikov s predhodnim kirurškim posegom, adjuvantno radioterapijo po nevrokirurški odstranitvi sprememb v osrednjem živčevju in predhodnim adjuvantnim zdravljenjem z interferonom, dokončanim ≥ 6 mesecev pred randomizacijo) ter bolnike, ki so se predhodno zdravili z anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 ali anti CTLA-4 protitelesom (vključno z ipilimumabom ali s katerim koli drugim protitelesom ali zdravilom s specifično usmerjenim delovanjem na dodatno stimulacijo celic T ali poti kontrolnih točk), so iz študije izključili.
Prespecified interim analysis Minimum follow-up: 13.2 months 
Vnaprej predvidena vmesna analiza Najmanjše obdobje spremljanja: 13,2 meseca
In addition, CA209037 excluded patients who have had a Grade 4 adverse reaction that was related to anti-CTLA-4 therapy (see section 5.1). 
Poleg tega pa so iz študije CA209037 izključili tudi bolnike, pri katerih so se pri predhodnem anti-CTLA-4 zdravljenju pojavili neželeni učinki stopnje 4 (glejte poglavje 5.1).
Additional data from 100 patients from CA209205 Cohort C who received brentuximab before and/or after ASCT are also presented. 
Prikazani so tudi dodatni podatki, pridobljeni pri 100 bolnikih iz kohorte C študije CA209205, ki so se zdravili z brentuksimabom pred in/ali po ASCT.
Patients with active autoimmune disease and symptomatic interstitial lung disease were excluded from clinical trials of cHL (see section 5.1). 
Bolnike z aktivno avtoimunsko boleznijo in simptomatsko boleznijo pljučnega intersticija so iz kliničnih preskušanj pri cHL izključili (glejte poglavje 5.1).
An updated OS analysis was performed when all patients had a minimum follow-up of 24 months (see figure 11). 
Po najmanj 24 mesečnem spremljanju bolnikov je bila izvedena dopolnjena analiza celokupnega preživetja (glejte sliko 11).
56 (56%) M 44 (44%) F 
56 (56 %) M 44 (44 %) Ž
What OPDIVO looks like and contents of the pack OPDIVO concentrate for solution for infusion (sterile concentrate) is a clear to opalescent, colourless to pale yellow liquid that may contain few light particles. 
Izgled zdravila OPDIVO in vsebina pakiranja OPDIVO koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra do opalescentna, brezbarvna do svetlorumena tekočina, ki lahko vsebuje nekaj svetlih delcev.
OPDIVO is a medicine used to treat: advanced melanoma (a type of skin cancer) in adults melanoma after complete resection in adults (treatment after surgery is called adjuvant therapy) advanced non-small cell lung cancer (a type of lung cancer) in adults advanced renal cell carcinoma (advanced kidney cancer) in adults classical Hodgkin lymphoma that has come back after or has not responded to previous therapies, including an autologous stem-cell transplant (a transplant of your own blood-producing cells) in adults advanced cancer of the head and neck in adults advanced urothelial carcinoma (bladder and urinary tract cancer) in adults. 
Zdravilo OPDIVO uporabljamo za zdravljenje: napredovalega melanoma (vrsta kožnega raka) pri odraslih melanoma po popolni kirurški odstranitvi pri odraslih (zdravljenje po kirurškem posegu imenujemo adjuvantno zdravljenje) napredovalega nedrobnoceličnega pljučnega raka (vrsta pljučnega raka) pri odraslih napredovalega karcinoma ledvičnih celic (napredovalega ledvičnega raka) pri odraslih klasičnega Hodgkinovega limfoma, ki se je ponovil ali se ni odzval na predhodno zdravljenje, vključno z avtologno presaditvijo matičnih celic (presaditev telesu lastnih krvotvornih celic) pri odraslih napredovalega raka glave in vratu pri odraslih napredovalega urotelijskega karcinoma (raka sečnega mehurja in sečil) pri odraslih.
If myocarditis is suspected, prompt initiation of a high dose of steroids (prednisone 1 to 2 mg/kg/day or methylprednisolone 1 to 2 mg/kg/day) and prompt cardiology consultation with diagnostic workup according to current clinical guidelines should be initiated. 
V primeru suma na miokarditis je treba takoj uvesti zdravljenje z visokimi odmerki kortikosteroidov (prednizon v odmerku 1 do 2 mg/kg/dan ali metilprednizolon v odmerku 1 do 2 mg/kg/dan), se nemudoma posvetovati s kardiologom in opraviti diagnostične preiskave v skladu s trenutnimi kliničnimi smernicami.
following nivolumab therapy' o Potential risk of ‘Risk of GVHD with nivolumab after allogeneic HSCT' 
(GVHD) in umrljivostjo, povezano s presaditvijo' o Možno tveganje za ‘Tveganje za GVHD pri zdravljenju z nivolumabom po alogenski
Forty-two percent of patients were BRAF V600 mutation positive while 45% were BRAF wild type and 13% BRAF were status unknown. 
Dvainštirideset bolnikov je bilo pozitivnih za mutacijo BRAF V600, 45 % bolnikov je imelo divji tip BRAF, pri 13 % bolnikov pa status BRAF ni bil znan.
Table 7 presents the percentage for immune-related adverse reactions who were permanently discontinued from treatment by dosing regimen. 
V preglednici 7 so glede na režim zdravljenja predstavljeni deleži bolnikov z imunsko pogojenimi neželenimi učinki, pri katerih je bilo zdravljenje trajno ukinjeno.
OPDIVO should not be infused concomitantly in the same intravenous line with other medicinal products. 
Zdravila OPDIVO se ne sme infundirati sočasno z drugimi zdravili preko iste intravenske linije.
OS results from this follow-up analysis are shown in Figure 5 (all randomised), Figure 6 (at the tumour PD-L1 1% cut off), and Table 11 (at the tumour PD-L1 5% cut off). 
Rezultati celokupnega preživetja iz te analize spremljanja so prikazani na sliki 5 (vsi randomizirani bolniki), sliki 6 (pri mejni vrednosti PD-L1 tumorja 1 %) in v preglednici 11 (pri mejni vrednosti PD-L1 tumorja 5 %).
To further investigate the value of biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other genomic-based methods/ assays, and associated cut offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1, PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, expression of components of antigen-presentation complexes and/or other inhibitory checkpoint receptors/ligands within tumour, etc.) as predictive of nivolumab + ipilimumab combination therapy efficacy in the context of melanoma studies CA209038, CA209067, or CA209069. 
Dodatno raziskati še vrednost drugih bioloških označevalcev poleg vrednosti statusa ekspresije PD-L1 na membrani tumorskih celic z IHC (npr. druge metode/testi na osnovi genoma in pripadajoče mejne vrednosti, ki bi lahko povečali občutljivost in specifičnost predvidevanja odziva na zdravljenje na osnovi PD-L1, PD-L2, tumorje infiltrirajočih limfocitov z določanjem gostote CD8+T, RNA podpisa, ekspresije komponent antigen-predstavitvenih kompleksov in/ali drugih zaviralnih receptorjev/ligandov kontrolnih točk v tumorju ipd.) kot napovednika učinkovitosti nivolumaba + ipilimumaba pri kombiniranem zdravljenju v kontekstu študij pri melanomu CA209038, CA209067 ali CA209069.
Grade 2 adrenal insufficiency Grade 3 diabetes 
Insuficienca nadledvičnih žlez stopnje 2 Diabetes stopnje 3
Among 128 patients who discontinued nivolumab in combination with ipilimumab due to adverse reaction after 18 months of follow-up, median PFS was 16.7 months (95% CI: 10.2, NA). 
Pri 128 bolnikih, pri katerih je bilo zdravljenje z nivolumabom v kombinaciji z ipilimumabom zaradi neželenih učinkov po 18 mesecih spremljanja prekinjeno, je mediana PFS znašala 16,7 meseca (95 % interval zaupanja: 10,2; NP).
Nivolumab as monotherapy (see section 4.2) 
Nivolumab v monoterapiji (glejte poglavje 4.2)
c p-value is compared to alpha 0.002 in order to achieve statistical significance. 
c p-vrednost v primerjavi z alfa 0,002 za dosego statističnega pomena.
Uncommon psoriasis 
Občasni psoriaza
Hepatic veno-occlusive disease occurred in one patient, who died of GVHD and multi-organ failure. 
Pri enem bolniku so poročali o venookluzivni bolezni jeter, ki je umrl zaradi GVHD in odpovedi več organov.
** nivolumab in combination with ipilimumab for the first 4 doses then followed by nivolumab monotherapy in RCC. 
** nivolumab v kombinaciji z ipilimumabom pri prvih 4 odmerkih in nato nivolumab v monoterapiji pri zdravljenju RCC.
Post authorisation efficacy study (PAES): In order to further elucidate the contribution of ipilimumab to the efficacy and toxicity of the combination regimen of nivolumab and ipilimumab, the MAH should conduct and submit the results of a randomised, clinical study comparing the efficacy and safety of the combination of nivolumab and ipilimumab to nivolumab monotherapy in previously untreated adult patients with intermediate/poorrisk advanced renal cell carcinoma and with an appropriate spectrum of PDL1 expression levels. 
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Da bi podrobneje pojasnili prispevek ipilimumaba k učinkovitosti in toksičnosti kombiniranega režima zdravljenja z nivolumabom in ipilimumabom mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate randomizirane, klinične študije, ki učinkovitost in varnost kombiniranega zdravljenja z nivolumabom in ipilimumabom primerja z zdravljenjem z nivolumabom v monoterapiji pri predhodno nezdravljenih odraslih bolnikih z napredovalim karcinomom ledvičnih celic s srednje ugodnim ali slabim prognostičnim obetom in z ustreznim spektrom ravni ekspresije PD-L1.
Twenty-two percent of patients had tumours that tested BRAF mutation positive and 50% of patients had tumours that were considered PD-L1 positive. 
22 % bolnikov je imelo tumor, ki je bil pri testiranju pozitiven za mutacijo BRAF, 50 % bolnikov pa je imelo tumor, ki so ga označili kot PD-L1 pozitivnega.
Solid organ transplant rejection. 
zavrnitev presadka čvrstega organa.
Patients were enrolled regardless of their tumour PD-L1 or human papilloma virus (HPV) status. 
Bolnike so vključili ne glede na status PD-L1 tumorja ali status humanega virusa papiloma (HPV).
PFS rate at 12 months and 95% CI: 18% (14, 23) 
Delež PFS v 12. mesecu in 95 % IZ: 18 % (14; 23)
Nivolumab with ipilimumab was continued beyond progression in 29% of patients. 
Po napredovanju bolezni se je zdravljenje z nivolumabom v kombinaciji z ipilimumabom nadaljevalo pri 29 % bolnikov.
The median duration of time from initial diagnosis to randomisation was 0.4 years in both the nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg and sunitinib groups. 
Mediana trajanja časa od začetne diagnoze do randomizacije je bila 0,4 leta v obeh skupinah, v skupini z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg, in v skupini s sunitinibom.
Baseline characteristics were balanced between groups except for the proportions of patients who had a history of brain metastasis (19% and 13% in the nivolumab group and chemotherapy group, respectively) and patients with LDH greater than ULN at baseline (51% and 35%, respectively). 
Izhodiščne lastnosti so bile med skupinama uravnotežene, razen za delež bolnikov, ki so imeli zasevke v možganih (19 % bolnikov v skupini z nivolumabom in 13 % bolnikov v skupini s kemoterapijo) in delež bolnikov z izhodiščno vrednostjo LDH, večjo od ZMN (51 % bolnikov v skupini z nivolumabom in 35 % bolnikov v skupini s kemoterapijo).
Grade 3 or 4 elevation in AST, ALT, or total bilirubin 
Zvišanje vrednosti AST, ALT ali skupnega bilirubina stopnje 3 ali 4
Treatment of advanced melanoma 
Zdravljenje napredovalega melanoma
Randomisation was stratified by PD-L1 expression (≥ 5% vs. < 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system. 
Randomizacija je bila stratificirana glede na ekspresijo PD-L1 (≥ 5 % v primerjavi z < 5 % ekspresije celične membrane tumorja), status BRAF in M stadij po kriterijih Ameriškega združenja za zdravljenje raka (AJCC - American Joint Committee on Cancer).
Overall survival Events Hazard ratioa (95% CI) p-valueb Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Rate (95% CI) at 18 months Progression-free survival Events Hazard ratio 95% CI p-value Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Confirmed objective responsec (95% CI) Odds ratio (95% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Median time to response Months (range) Median duration of response Months (range) 
Celokupno preživetje Dogodki Razmerje ogroženostia (95 % IZ) p-vrednostb Mediana (95 % IZ) (meseci) Delež (95 % IZ) v 6. mesecu Delež (95 % IZ) v 12. mesecu Delež (95 % IZ) v 18. mesecu Preživetje brez napredovanja bolezni Dogodki Razmerje ogroženosti 95 % IZ p-vrednost Mediana (95 % IZ) (meseci) Delež (95 % IZ) v 6. mesecu Delež (95 % IZ) v 12. mesecu Potrjeni objektivni odzivc (95 % IZ) Razmerje obetov (95 % IZ) Popolni odziv (CR) Delni odziv (PR) Stabilna bolezen (SD) Mediana časa do odziva Meseci (razpon) Mediana trajanja odziva Meseci (razpon)
h p-value is compared to alpha 0.009 in order to achieve statistical significance. 
h p-vrednost v primerjavi z alfa 0,009 za dosego statističnega pomena.
Overall survival could be accompanied by an improvement over time in disease related symptoms and non-disease specific QoL as assessed using valid and reliable scales in the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) and the EuroQoL EQ-5D. 
Celokupno preživetje bi lahko spremljalo izboljšanje z boleznijo povezanih simptomov in za bolezen nespecifične kakovosti življenja, kar je bilo ovrednoteno s pomočjo validiranih in zanesljivih lestvic FKSI-DRS (Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease
The active substance is nivolumab. 
Učinkovina je nivolumab.
Additional safety and descriptive efficacy data are available from study CA209374, an open-label Phase 3b/4 safety study of nivolumab monotherapy (treated with 240 mg every 2 weeks) for the treatment of patients with advanced or metastatic RCC (n = 142), including 44 patients with non-clear cell histology. 
Iz študije CA209374, odprte študije o varnosti uporabe nivolumaba v monoterapiji (zdravljenje z odmerkom 240 mg vsaka 2 tedna) faze 3b/4, so na voljo dodatni podatki o varnosti in opisni podatki o učinkovitosti pri zdravljenju bolnikov z napredovalim ali metastatskim karcinomom ledvičnih celic (n = 142), vključno s 44 bolniki z nejasno celično histologijo.
When administered in combination with ipilimumab, the CL of nivolumab increased by 20% in the presence of anti-nivolumab antibodies and the CL of ipilimumab increased by 5.7% in the presence of anti-ipilimumab antibodies. 
Pri uporabi v kombinaciji z ipilimumabom se je očistek nivolumaba v prisotnosti protiteles proti nivolumabu povečal za 20 %, očistek ipilimumaba pa se je v prisotnosti protiteles proti ipilimumabu povečal za 5,7 %.
Baseline characteristics were balanced across the three treatment groups. 
Izhodiščne lastnosti so bile med tremi skupinami zdravljenja uravnotežene.
Squamous Cell Cancer of the Head and Neck (SCCHN) OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1). 
Ploščatocelični karcinom glave in vratu (SCCHN - squamous cell cancer of the head and neck) Zdravilo OPDIVO je v monoterapiji indicirano za zdravljenje ponovljenega ali metastatskega ploščatoceličnega karcinoma glave in vratu pri odraslih, pri katerih je bolezen napredovala med zdravljenjem ali po zdravljenju na osnovi platine (glejte poglavje 5.1).
Excipients: sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections. 
Pomožne snovi: natrijev citrat dihidrat, natrijev klorid, manitol (E421), pentetska kislina, polisorbat 80, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
Administer the OPDIVO infusion intravenously over a period of 30 or 60 minutes depending on the dose. 
OPDIVO raztopino za infundiranje morate aplicirati v obliki 30-minutne ali 60-minutne intravenske infuzije, odvisno od odmerka.
Subsequent immunotherapy (including anti-PD1 therapy, anti-CTLA-4 antibody, or other immunotherapy) was received by 14.6%, 29.1%, and 44.1% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively. 
V skupini s kombiniranim zdravljenjem se je naknadno z imunoterapijo (vključno z antiPD1, anti-CTLA-4 protitelesi ali drugo obliko imunoterapije) zdravilo 14,6 % bolnikov, v skupini zdravljenja z nivolumabom v monoterapiji 29,1 % bolnikov, v skupini zdravljenja z ipilimumabom pa 44,1 % bolnikov.
Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the treatment groups. 
Pri bolnikih z merljivo ekspresijo PD-L1 tumorja je bila porazdelitev bolnikov po skupinah zdravljenja uravnotežena.
Results from post-hoc, exploratory analyses indicate that in patients with low (e.g. <1%) to no tumour PD-L1 expression, other patient characteristics (e.g. liver metastases, visceral metastases, baseline haemoglobin <10g/dL and ECOG performance status = 1) might contribute to the clinical outcome. 
Rezultati post-hoc eksploratornih analiz kažejo, da lahko pri bolnikih z majhno ekspresijo PDL1 tumorja (npr. < 1 %) do brez nje k kliničnemu izidu pripomorejo druge lastnosti bolnika (npr. metastaze v jetrih, visceralne metastaze, vrednost hemoglobina <10 g/dl v izhodišču in stanje telesne zmogljivosti po lestvici ECOG = 1).
Objective response (95% CI) Odds ratio (vs. ipilimumab) (99.5% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Duration of response Median (range), months 
Objektivni odziv (95 % IZ) Razmerje obetov (vs. ipilimumab) (99,5 % IZ) Popolni odziv (CR) Delni odziv (PR) Stabilna bolezen (SD) Trajanje odziva Mediana (razpon), meseci ni dosežena
Rare toxic epidermal necrolysisa,f, StevensJohnson syndromef Musculoskeletal and connective tissue disorders Very common arthralgia musculoskeletal paing, arthralgia 
Redki toksična epidermalna nekrolizaa,f, Stevens-Johnsonov sindromf Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti artralgija mišično-skeletna bolečinag, artralgija