natgillin/translations-raw huggingface dataset:
It is to be administered as an intravenous infusion solution over 60 minutes (see section 6.6). 
Dati ga je treba kot raztopino za intravensko infundiranje v obdobju 60 minut (glejte poglavje 6.6).
• has spread within your lung and cannot be removed by surgery, and 
• razširil v pljučih in ga ni mogoče odstraniti z operacijo in
Grade 3-4 (%) 
3.-4. stopnja (%)
The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established. 
Varnost in učinkovitost zdravila IMFINZI pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL. 
Končna koncentracija razredčene raztopine mora biti med 1 mg/ml in 15 mg/ml.
• painful urination 
• boleče uriniranje
This includes herbal medicines and medicines obtained without a prescription. 
To velja tudi za zeliščna zdravila in druga zdravila, ki ste jih dobili brez recepta.
Randomisation was stratified by gender, age (< 65 years vs. ≥ 65 years) and smoking status (smoker vs. non-smoker). 
Randomizacija je bila stratificirana po spolu, starosti (< 65 let in ≥ 65 let) in kadilsko stanje (kadilci in nekadilci).
• Call your doctor straight away to reschedule your appointment. 
• Takoj pokličite zdravnika, da se boste dogovorili za nov datum obiska.
There are insufficient number of patients to determine ADA impact on efficacy. 
Število bolnikov je premajhno, da bi ugotovili, kakšen vpliv imajo ADA na učinkovitost.
If no improvement within 3 to 5 days despite corticosteroids, promptly start additional immunosuppressive therapy. 
Če v 3 do 5 dneh kljub uporabi kortikosteroidov ne pride do izboljšanja, takoj začnite z dodatnim imunosupresivnim zdravljenjem.
Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of IMFINZI. 
Večina teh, učinkov vključno s hudimi, je izzvenela po uvedbi ustreznega zdravljenja ali prenehanju uporabe zdravila IMFINZI.
IMFINZI (n = 476) 
Zdravilo IMFINZI (n = 476)
No overall differences in safety were reported between elderly (≥ 65 years) and younger patients. 
Glede varnosti niso poročali o razlikah med starejšimi (starimi 65 let ali več) in mlajšimi bolniki v celoti.
The corresponding frequency category for each ADR is defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data). 
Ustrezne kategorije pogostnosti za vsak neželeni učinek so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti na podlagi razpoložljivih podatkov).
• It is not known if IMFINZI passes into human breast milk. 
• Ni znano, ali zdravilo IMFINZI prehaja v materino mleko.
Probability of OS 
Verjetnost OS
In the absence of data, durvalumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis. 
Dokler takšnih podatkov ni, je treba durvalumab v teh skupinah bolnikov uporabljati previdno ter po skrbnem individualnem pretehtanju možnih koristi in tveganj za posameznega bolnika.
What IMFINZI is and what it is used for 
Kaj je zdravilo IMFINZI in za kaj ga uporabljamo
The terminal half-life (t1/2), based on baseline CL, was approximately 18 days. 
Terminalni razpolovni čas (t1/2) na podlagi izhodiščnega očistka je bil približno 18 dni.
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. 
Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti lastniško ime in številko serije uporabljenega zdravila.
• you have had an organ transplant; 
• če imate kakšen presajen organ;
However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines. 
Toda če imate neželene učinke, ki vam poslabšajo sposobnost za zbranost in reagiranje, morate biti pri upravljanju vozil in strojev previdni.
Do not store any unused portion of the infusion solution for re-use. 
Morebitnega neporabljenega dela raztopine za infundiranje ne shranjujte za ponovno uporabo.
IMFINZI will be given to you in a hospital or clinic under the supervision of an experienced doctor. 
Zdravilo IMFINZI boste dobili v bolnišnici ali ambulanti pod nadzorstvom izkušenega zdravnika.
Tumour assessments were conducted every 8 weeks for the first 12 months and then every 12 weeks thereafter. 
Ocenjevanje tumorja so izvajali na 8 tednov prvih 12 mesecev, nato pa na 12 tednov.
The solution has a pH of approximately 6.0 and an osmolality of approximately 400 mOsm/kg. 
Raztopina ima pH približno 6,0 in osmolalnost približno 400 mOsm/kg.
Store in the original package in order to protect from light. 
Shranjujte v originalni ovojni za zagotovitev zaščite pred svetlobo.
The improvements in PFS and OS in favour of patients receiving IMFINZI compared to those receiving placebo were consistently observed in all predefined subgroups analysed, including ethnicity, age, gender, smoking history, EGFR mutation status and histology. 
Izboljšanje PFS in OS v korist prejemnikov zdravila IMFINZI v primerjavi s prejemniki placeba so dosledno opažali v vseh vnaprej določenih analiziranih podskupinah, vključno z etnično pripadnostjo, starostjo, spolom, anamnezo kajenja, stanjem mutacij EGFR in histologijo.
Talk to your doctor straight away if you get any of the following side effects, that have been reported in clinical trials with durvalumab, and includes the serious side effects listed in section 2: 
Nemudoma se posvetujte z zdravnikom, če se vam pojavi kateri od naslednjih neželenih učinkov, ki so jih zabeležili v kliničnih preizkušanjih z durvalumabom in vključujejo resne neželene učinke, navedene v poglavju 2:
For single use only. 
samo za enkratno uporab
Disease characteristics were as follows: Stage IIIA (53%), Stage IIIB (45%), histological sub-groups of squamous (46%), non-squamous (54%). 
Značilnosti bolezni so bile: stadij IIIA (53 %), stadij IIIB (45 %), histološki podskupini ploščatocelični (46 %), neploščatocelični (54 %).
Night sweats 
• nočno znojenje
ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal. 
ALT: alanin-aminotransferaza; AST: aspartat-aminotransferaza; ZNM: zgornja meja normalne vrednosti.
Patient-reported symptoms, function and health-related quality of life (HRQoL) were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13). 
Simptome, funkcijo in zdravstveno kakovost življenja po navedbi bolnikov so evidentirali z uporabo EORTC QLQ-C30 in njegovega modula za pljučnega raka (EORTC QLQ-LC13).
One patient also received infliximab treatment. 
En bolnik je prejemal tudi zdravljenje z infliksimabom.
PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune cells in tumour microenvironment. 
PD-L1 lahko inducirajo vnetni signali (npr. IFN-gama) in je lahko izražen tako na tumorskih celicah kot na imunskih celicah v mikrookolju tumorja.
Grade 3 or 4, or any Grade with positive biopsy 
3. ali 4. stopnja ali katera koli stopnja s pozitivno biopsijo trajno prenehajte uporabljati
Recommended treatment modifications for IMFINZI and management recommendations 
Priporočene prilagoditve zdravljenja z zdravilom IMFINZI in priporočila za obvladovanje
A decision must be made whether to discontinue breast feeding or to discontinue or abstain from durvalumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba, ali naj ženska prekine z dojenjem ali naj prekine zdravljenje z durvalumabom oziroma sploh ne začne zdravljenja z njim, pri čemer je treba upoštevati koristi dojenja za otroka in koristi zdravljenja za žensko.
Eight patients experienced hypothyroidism following hyperthyroidism. 
Osmim bolnikom se je po hipertiroidizmu pojavil hipotiroidizem.
Secondary efficacy endpoints included PFS at 12 months (PFS 12) and 18 months (PFS 18) from randomisation and Time from Randomisation to Second Progression (PFS2). 
Sekundarni cilji študije učinkovitosti so obsegali PFS po 12 mesecih (PFS 12) in 18 mesecih (PFS 18) od randomizacije, in čas od randomizacije do drugega napredovanja bolezni (PFS2).
• reaction to the infusion of the medicine that can cause fever or flushing 
• reakcija na infundiranje zdravila, ki lahko povzroči vročino ali zardevanje
No formal pharmacokinetic (PK) drug-drug interaction studies have been conducted with durvalumab. 
Z durvalumabom niso izvedli formalnih farmakokinetičnih (PK) študij medsebojnega delovanja zdravil.
IMFINZI will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage. 
Zdravilo IMFINZI vam bodo odmerjali v bolnišnici ali ambulanti in za shranjevanje zdravila bodo odgovorni zdravstveni delavci.
• Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. 
• Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
• a condition leading to high blood sugar levels (type 1 diabetes mellitus) 
• bolezen, ki povzroča visoke koncentracije sladkorja v krvi (sladkorna bolezen tipa 1)
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino (učinkovine) ali katero koli pomožno snov, navedeno v poglavju 6.1.
• Ask your doctor if you can breast-feed during or after treatment with IMFINZI. 
• Vprašajte zdravnika, ali smete dojiti med zdravljenjem z zdravilom IMFINZI in po njem.
What you need to know before you are given IMFINZI 
Kaj morate vedeti, preden boste dobili zdravilo IMFINZI
Data on patients aged 75 years of age or older are limited. 
Podatkov o bolnikih, ki so stari 75 let ali več, je malo.
g frequency is based on events not observed in the PACIFIC Study but observed in other clinical trials (n=1889). 
Pogostnost se nanaša na dogodke, ki jih niso opažali v študiji PACIFIC, opažali pa so jih v drugih kliničnih študijah (n = 1889).
Pack size of 1 vial. 
Pakiranje vsebuje 1 vialo.
Durvalumab has no or negligible influence on the ability to drive and use machines. 
Durvalumab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• if you are allergic to durvalumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”). 
• če ste alergični na durvalumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6
Based on population PK analysis, slightly lower exposure are expected in ADA-positive patients however, the reduction of PK exposure is less than 30% compared to a typical patient and is not considered clinically relevant. 
Na podlagi populacijske farmakokinetične analize je mogoče pri bolnikih s prisotnimi ADA pričakovati nekoliko manjšo izpostavljenost zdravilu, vendar je farmakokinetična izpostavljenost za manj kot 30 % manjša od izpostavljenosti pri tipičnem bolniku in ne velja za klinično pomembno.
IMFINZI is for intravenous use. 
Zdravilo IMFINZI je namenjeno za intravensko uporabo.
Given the mechanism of action of IMFINZI, other potential immune-mediated adverse reactions may occur. 
Glede na mehanizem delovanja zdravila IMFINZI se lahko pojavijo še drugi potencialno imunsko pogojeni učinki.
The LC13 and C30 were assessed at baseline, every 4 weeks for the first 8 weeks, followed by every 8 weeks until completion of the treatment period or discontinuation of IMFINZI due to toxicity or disease progression. 
LC13 in C30 so ocenili izhodiščno, potem na 4 tedne prvih 8 tednov in nato na 8 tednov do konca obdobja zdravljenja ali do prenehanja zdravljenja z zdravilom IMFINZI zaradi toksičnosti ali napredovanja bolezni.
Durvalumab is produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. 
Durvalumab je pridobljen v celicah sesalcev (jajčnik kitajskega hrčka) s tehnologijo rekombinantne DNK.
Available toxicological data in cynomolgus monkeys have shown low levels of durvalumab in breast milk on Day 28 after birth (see section 5.3). 
Razpoložljivi toksikološki podatki pri opicah cynomolgus so pokazali nizko koncentracijo durvalumaba v materinem mleku 28. dan po rojstvu (glejte poglavje 5.3).
Events of pancreatitis have been reported in patients in the clinical study programme. 
V programu kliničnih študij so pri bolnikih poročali o primerih pankreatitisa.
Human IgG1 is known to cross the placental barrier and placental transfer of durvalumab was confirmed in animal studies. 
Znano je, da človeški IgG1 prehajajo skozi placentno pregrado in prehajanje durvalumaba skozi placento so potrdili s študijami na živalih.
No dose adjustment is required for elderly patients (≥ 65 years of age) (see section 5.1). 
Starejšim bolnikom (starost ≥ 65 let) odmerka ni treba prilagoditi (glejte poglavje 5.1).
k includes colitis, enteritis, enterocolitis, and proctitis. 
Vključuje kolitis, enteritis, enterokolitis in proktitis.
What IMFINZI is and what it is used for What you need to know before you are given IMFINZI How you are given IMFINZI Possible side effects 
Kaj je zdravilo IMFINZI in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo IMFINZI Kako boste dobili zdravilo IMFINZI Možni neželeni učinki
It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. 
Pri klinično stabilnih bolnikih z začetnimi znaki napredovanja bolezni je priporočeno z zdravljenjem nadaljevati, dokler napredovanje bolezni ni potrjeno.
Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 5.2). 
Podatkov o bolnikih s hudo okvaro ledvic je premalo, da bi lahko sklepali o tej skupini bolnikov (glejte poglavje 5.2).
Patients were enrolled regardless of their tumour PD-L1 expression level. 
Bolniki so bili vključeni v študijo ne glede na stopnjo ekspresije PD-L1 v njihovem tumorju.
• a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis). 
• stanje, pri katerem mišice postanejo oslabele in se hitro utrudijo (miastenija gravis)
The recommended dose is 10 mg of durvalumab per kilogram of your body weight. 
Priporočeni odmerek je 10 mg durvalumaba na kilogram telesne mase.
Across all studies, IMFINZI was administered at a dose of 10 mg/kg every 2 weeks. 
V vseh študijah so zdravilo IMFINZI uporabljali v odmerku 10 mg/kg na 2 tedna.
includes cough and productive cough. 
Vključuje kašelj in produktiven kašelj.
If not used immediately, the total time from vial puncture to start of the administration should not exceed 24 hours at 2 ºC to 8 ºC or 12 hours at room temperature (up to 25 ºC). 
Če zdravilo ni uporabljeno takoj, celotni čas od vboda v vialo do začetka infundiranja ne sme preseči 24 ur na temperaturi od 2 do 8 ºC ali 12 ur na sobni temperaturi (do 25 ºC).
After withhold, IMFINZI can be resumed within 12 weeks if the adverse reactions improved to ≤ Grade 1 and the corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day. 
Po odložitvi uporabe je mogoče zdravilo IMFINZI znova začeti uporabljati v času 12 tednov, če se neželeni učinki izboljšajo na ≤ 1. stopnjo in je odmerek kortikosteroida zmanjšan na ≤ 10 mg prednizona ali ekvivalenta na dan.
It is available in packs containing either 1 glass vial of 2.4 mL of concentrate or 1 glass vial of 10 mL of concentrate. 
Na voljo je v pakiranjih, ki vsebujejo bodisi 1 stekleno vialo z 2,4 ml koncentrata ali 1 stekleno vialo z 10 ml koncentrata.
PD-L1 Unknown 
Neznan status PD-L1
The data for the following immune-mediated adverse reactions reflect the combined safety database of 1889 patients which includes the PACIFIC Study and two additional studies (a multi-cohort, open-label clinical trial in patients with advanced solid tumours, and an open-label study in patients with locally advanced or metastatic NSCLC). 
Podatki za naslednje imunsko pogojene neželene učinke odražajo podatke iz kombinirane podatkovne baze o varnosti za 1889 bolnikov, kar vključuje podatke iz študije PACIFIC in dveh dodatnih študij (multikohortnega, odprtega kliničnega preizkušanja pri bolnikih z napredovalimi parenhimskimi tumorji ter odprte študije pri bolnikih z lokalno napredovalim ali metastatskim NSCLC).
IMFINZI should be discontinued for Grade 4 adverse reactions (with the exception of Grade 4 laboratory abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms and clinical judgment). 
Z uporabo zdravila IMFINZI je treba prenehati v primeru neželenih učinkov 4. stopnje (razen v primeru laboratorijskih nepravilnosti 4. stopnje, pri katerih naj odločitev o prekinitvi uporabe zdravila temelji na spremljajočih kliničnih znakih oziroma simptomih in na klinični presoji zdravnika).
Table 2 lists the incidence of adverse reactions in patients with locally advanced, unresectable NSCLC in the PACIFIC Study, based on the frequency of that adverse reaction type regardless of investigator assessed causality. 
Preglednica 2 navaja pojavnost neželenih učinkov pri bolnikih z lokalno napredovalim neoperabilnim NSCLC v študiji PACIFIC glede na pogostnost posameznega neželenega učinka, ne glede na raziskovalčevo oceno vzročnosti.
There is no information on overdose with durvalumab. 
Informacij o prevelikem odmerjanju durvalumaba ni.
IMFINZI works by helping your immune system fight your cancer. 
Zdravilo IMFINZI deluje tako, da imunskemu sistemu pomaga premagati raka.
Data from patients with moderate and severe hepatic impairment are limited. 
Podatkov pri bolnikih z zmerno ali hudo okvaro jeter je malo.
Upon improvement to ≤ Grade 1, corticosteroid taper should be initiated and continued over at least 1 month. 
Po izboljšanju na ≤ 1. stopnjo je treba začeti s postopnim zmanjševanjem kortikosteroida in ga zmanjševati v obdobju vsaj 1 meseca.
Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). 
Durvalumab je popolnoma človeško imunoglobulinsko monoklonsko protitelo G1-kapa (IgG1κ), ki selektivno blokira medsebojno delovanje PD-L1 s PD-1 in CD80 (B7.1).
Number of patients at risk 
Število bolnikov, izpostavljenih tveganju
The European Medicines Agency has deferred the obligation to submit the results of studies with durvalumab in all subsets of the paediatric population in the treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z durvalumabom za vse skupine pediatrične populacije za zdravljenje malignih novotvorb (razen tumorjev osrednjega živčevja ter novotvorb hematopoetskega in limfatičnega tkiva) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm etiology or exclude alternate etiologies. 
V primeru domnevnih imunsko pogojenih neželenih učinkov je treba opraviti ustrezno ovrednotenje za potrditev etiologije oziroma izključitev druge etiologije.
The efficacy of IMFINZI was evaluated in the PACIFIC Study, a randomised, double-blind, placebo-controlled, multicentre study in 713 patients with locally advanced, unresectable NSCLC. 
Učinkovitost zdravila IMFINZI so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani multicentrični študiji PACIFIC pri 713 bolnikih z lokalno napredovalim neoperabilnim NSCLC.
Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation. 
Selektivna blokada medsebojnih delovanj PD-L1/PD-1 in PD-L1/CD80 izboljša protitumorske imunske odzive in poveča aktivacijo celic T.
Throughout the duration of the study to Week 48, there was no clinically meaningful difference between IMFINZI and placebo groups in symptoms, functioning and HRQoL (as assessed by a difference of greater than or equal to 10 points). 
Med potekom študije do 48. tedna med skupino z zdravilom IMFINZI in skupino s placebom ni bilo klinično pomembne razlike v simptomih, funkciji in zdravstveni kakovosti življenja (ocenjeno na podlagi razlike 10 točk ali več).
Talk to your doctor straight away if you get any of the side effects listed above. 
Nemudoma se posvetujte z zdravnikom, če se vam pojavi kateri od zgoraj navedenih neželenih učinkov.
Concentrate for solution for infusion (sterile concentrate). 
koncentrat za raztopino za infundiranje (sterilen koncentrat)
When you get IMFINZI, you can have some serious side effects (see section 2). 
Ko dobite zdravilo IMFINZI, se vam lahko pojavijo nekateri resni neželeni učinki (glejte poglavje 2).
Age (19-96 years), body weight (34-149 kg), gender, positive anti-drug antibody (ADA) status, albumin levels, LDH levels, creatinine levels, soluble PD-L1, tumour type, race or ECOG status had no clinically significant effect on the PK of durvalumab. 
Starost (19-96 let), telesna masa (34-149 kg), spol, pozitivna protitelesa proti zdravilu (ADA), koncentracija albumina, koncentracija LDH, koncentracija kreatinina, topni PD-L1, vrsta tumorja, rasa in stanje ECOG niso klinično pomembno vplivali na farmakokinetiko durvalumaba.
Radiation pneumonitis is frequently observed in patients receiving radiation therapy to the lung and the clinical presentation of pneumonitis and radiation pneumonitis is very similar. 
Pri bolnikih, zdravljenih z radioterapijo pljuč, je pogost radiacijski pnevmonitis in klinična slika pnevmonitisa in radiacijskega pnevmonitisa je zelo podobna.
• you have liver problems. 
• če imate težave z jetri.
• you have lung problems or breathing problems; 
• če imate težave s pljuči ali dihanjem;
Data from NSCLC patients 75 years of age or older are limited. 
Za bolnike z NSCLC, ki so stari 75 let ali več, je na voljo le malo podatkov.
Number of patients at risk Month 
Število bolnikov izpostavljenih tveganju Mesec
Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system. 
Ekspresija liganda za programirano celično smrt 1 (PD-L1 - “programmed cell death ligand-1”) je adaptiven imunski odziv, ki se tumorjem pomaga izogniti, da bi jih imunski sistem zaznal in odstranil.
PFS and OS results are summarised in Figures 3, 4, 5 and 6. 
Rezultati preživetja brez napredovanja bolezni (PFS) in celokupnega preživetja (OS) so prikazani na slikah 3, 4, 5 in 6.
Of the 1570 patients who were treated with IMFINZI 10 mg/kg every 2 weeks and evaluable for the presence of anti-drug antibodies (ADAs), 2.9% (45/1570) of patients tested positive for treatment-emergent ADAs. 
Od 1570 bolnikov, zdravljenih na 2 tedna z zdravilom IMFINZI v odmerku 10 mg/kg in ocenljivih za prisotnost pozitivnih protiteles proti zdravilu (ADAs - “anti-drug antibodies”,), je bilo 2,9 % (45/1570) testiranih bolnikov pozitivnih za ADA, nastala med zdravljenjem.
Additional subgroup analyses were conducted to evaluate the efficacy by tumour PD-L1 expression (≥ 25%, 1-24%, ≥ 1%, < 1%) and for patients whose PD-L1 status cannot be established (PD-L1 unknown). 
Za vrednotenje učinkovitosti glede na tumorsko ekspresijo PD-L1 so izvedli dodatno analizo podatkov po podskupinah (≥ 25 %, 1-24 %, ≥ 1 %, < 1 %) in pri bolnikih, pri katerih statusa PD-L1 ni bilo mogoče ugotoviti (neznan status PD-L1).
The most frequent Grade 3-4 adverse reaction was pneumonia (6.5% vs 5.6% in placebo). 
Najbolj pogost neželeni učinek 3.-4. stopnje je bila pljučnica (6,5 % v primerjavi s 5,6 % pri uporabi placeba).
OS Number of deaths (%) Median (months) (95% CI) 
OS Število smrti (%) Mediana (meseci) (95 % IZ)