FrancophonIA/ELRC3.0 huggingface dataset:
English: However, patients who had prior anti-CTLA-4 treatment could be enrolled, as long as the last dose was received at least 6 weeks prior to randomization, and there was no history of severe immunerelated adverse effects from anti-CTLA-4 (NCI CTCAE Grades 3 and 4).
Slovenian: Vključeni pa so bili lahko bolniki, ki so predhodno prejemali zdravila proti CTLA-4, če so zadnji odmerek takšnega zdravila prejeli vsaj 6 tednov pred randomizacijo in v anamnezi niso imeli hudih imunsko pogojenih neželenih učinkov (stopnje 3. oz. 4. po NCI CTCAE) takšnega zdravljenja.
English: Of the 62 patients, two experienced a fatal event.
Slovenian: Pri dveh od teh 62 bolnikov se je končal s smrtjo.
English: Based on population PK and exposure-response analyses age (21-89 years), region, ethnicity, renal impairment, mild hepatic impairment, level of PD-L1 expression, or ECOG performance status have no effect on atezolizumab pharmacokinetics.
Slovenian: Populacijska farmakokinetika in analize izpostavljenost-odziv kažejo, da starost (21-89 let), regija, etnična pripadnost, okvara ledvic, blaga okvara jeter, raven izražanja PD-L1 ali stanje zmogljivosti po ECOG nimajo vpliva na farmakokinetiko atezolizumaba.
English: Patients who had prior treatment with CD137 agonists or immune checkpoint blockade therapies (anti-PD-1, and anti-PD-L1 therapeutic antibodies) were not eligible.
Slovenian: Bolniki, predhodno zdravljeni z agonisti CD137 ali zaviralci imunskih kontrolnih točk (zdravili proti PD-1 in terapevtskimi protitelesi proti PD-L1), niso bili primerni za vključitev.
English: The safety of atezolizumab as monotherapy is based on pooled data in 3,178 patients across multiple tumour types.
Slovenian: Informacije o varnosti atezolizumaba v monoterapiji temeljijo na združenih podatkih 3178 bolnikov z različnimi vrstami tumorjev.
English: Weekly administration of atezolizumab to female monkeys at an estimated AUC approximately 6 times the AUC in patients receiving the recommended dose caused an irregular menstrual cycle pattern and a lack of newly formed corpora lutea in the ovaries which were reversible.
Slovenian: Tedenska uporaba atezolizumaba pri opičjih samicah pri ocenjeni AUC, ki je bila približno 6-krat večja od AUC pri bolnikih, ki so prejemali priporočen odmerek, je povzročila nereden vzorec menstruacijskega ciklusa in odsotnost novonastalih rumenih telesc v jajčnikih, ki sta bila reverzibilna.
English: The effect of severe renal impairment on the pharmacokinetics of atezolizumab is unknown.
Slovenian: Učinek hude okvare ledvic na farmakokinetiko atezolizumaba ni znan.
English: • elevated liver enzymes (shown in tests), which may be a sign of an inflamed liver
Slovenian: • zvišanje jetrnih encimov (pokaže se na preiskavah krvi), ki je lahko znak vnetja jeter
English: Patients were treated until loss of clinical benefit as assessed by the investigator or unacceptable toxicity.
Slovenian: Bolnike so zdravili do izgube klinične koristi po oceni raziskovalca ali do nesprejemljive toksičnosti.
English: Hypothyroidism or hyperthyroidism
Slovenian: Hipotiroidizem ali hipertiroidizem
English: Patients were randomised (1:1) to receive either atezolizumab or chemotherapy.
Slovenian: Bolniki so bili randomizirani (1:1) na prejemanje atezolizumaba ali kemoterapije.
English: The PFS, ORR and DOR results from the primary analysis as well as the exploratory OS final analysis results are summarized in Table 12.
Slovenian: Rezultati PFS, ORR in DOR iz primarne analize in rezultati eksploratorne končne analize OS so povzeti v preglednici 12.
English: • inflammation of the mouth or lips
Slovenian: • vnetje ust ali ustnic
English: Comparisons with respect to OS between the treatment arm and control arm within the IC2/3, IC1/2/3, and ITT (Intention-to-treat, i.e. all comers) populations were tested using a hierarchical fixed-sequence procedure based on a stratified log-rank test at two-sided level of 5% as follows: step 1) IC2/3 population; step 2) IC1/2/3 population; step 3) all comers population.
Slovenian: Primerjave celokupnega preživetja med zdravljeno in kontrolno skupino znotraj populacije IC2/3, IC1/2/3 in ITT (intention-to-treat; z namenom zdraviti, tj. vsi neselekcionirani bolniki) so testirali z uporabo hierarhičnega postopka s fiksnim zaporedjem glede na stratificiran dvostranski 5-% test log-rang, kot sledi: korak 1): populacija IC2/3; korak 2) populacija IC1/2/3; korak 3) vsi neselekcionirani bolniki.
English: Docetaxel (n = 425)
Slovenian: docetaksel (n = 425)
English: OS results were similar for patients aged < 65 and ≥ 65 subgroups, respectively.
Slovenian: Rezultati OS so bili podobni pri bolnikih, starih < 65 let, in pri bolnikih, starih ≥ 65 let.
English: The primary efficacy endpoint for IMvigor211 is overall survival (OS).
Slovenian: Primarni opazovani dogodek učinkovitosti za IMvigor211 je celokupno preživetje (OS, overall survival).
English: • Reminder to carry the Patient Alert Card at all times and to show it to all healthcare professionals that may treat them.
Slovenian: • Opomnik, naj imajo bolniki opozorilno kartico za bolnika vedno pri sebi in jo pokažejo vsem zdravstvenim delavcem, ki jih zdravijo.
English: All prescribers of Tecentriq must be familiar with the Physician Information and Management Guidelines.
Slovenian: Vsi zdravniki, ki predpisujejo zdravilo Tecentriq, morajo biti dobro seznanjeni z Informacijami za zdravnika in Smernicami za vodenje bolnikov.
English: The majority of patients were male (65%), white (80%), and 9% had brain metastases and most patients were current or previous smokers (97%).
Slovenian: Večina bolnikov je bila moških (65 %), belcev (80 %), 9 % jih je imelo zasevke v možganih in večina bolnikov je bila sedanjih ali nekdanjih kadilcev (97 %).
English: The schedule of administration must be adjusted to maintain the appropriate interval between doses.
Slovenian: Urnik dajanja zdravila je treba nato prilagoditi ustreznemu presledku med odmerki.
English: The baseline and prognostic disease characteristics of the IMvigor210 Cohort 1 study population were overall comparable to patients in the clinic who would be considered cisplatin ineligible but would be eligible for a carboplatin-based combination chemotherapy.
Slovenian: Izhodiščne in prognostične značilnosti bolezni 1. kohorte študijske populacije IMvigor210 so bile na splošno primerljive z značilnostmi bolnikov, ki niso bili primerni za zdravljenje s cisplatinom, vendar pa bi bili primerni za kombinirano kemoterapijo na osnovi karboplatina.
English: If a planned dose of Tecentriq is missed, it should be administered as soon as possible.
Slovenian: V primeru izpuščenega načrtovanega odmerka zdravila Tecentriq je treba odmerek dati čim prej.
English: The iDMC did not recommend any change of therapy for patients who had already been randomized to and were receiving treatment in the monotherapy arm. No other changes were recommended.
Slovenian: Odbor iDMC ni priporočil spremembe zdravljenja za bolnike, ki so že bili randomizirani v skupino z monoterapijo in so zdravljenje že začeli prejemati.
English: • inflammation of the heart muscle
Slovenian: • vnetje srčne mišice
English: You will be given Tecentriq by a doctor experienced in cancer treatment in a hospital or clinic.
Slovenian: Zdravilo Tecentriq vam bo dal zdravnik z izkušnjami pri zdravljenju raka v bolnišnici ali ambulanti.
English: Programmed death-ligand 1 (PD-L1) may be expressed on tumour cells and/or tumour-infiltrating immune cells, and can contribute to the inhibition of the antitumour immune response in the tumour microenvironment.
Slovenian: Ligand za programirano celično smrt 1 (PD-L1) je lahko izražen na tumorskih celicah in/ali celicah imunskega sistema, ki infiltrirajo tumor, in lahko pripomore k zavrtju protitumorskega imunskega odziva v mikrookolju tumorja.
English: You must not be given Tecentriq if:
Slovenian: Zdravila Tecentriq ne smete dobiti:
English: Tell your doctor straight away if you notice any of the side effects below or if they get worse.
Slovenian: Zdravnika morate takoj obvestiti, če opazite katerega od spodaj navedenih neželenih učinkov ali če se kakšen neželen učinek poslabša.
English: The key results of this study with a median survival follow-up of 21 months are summarised in Table 10.
Slovenian: Ključni rezultati te študije z medianim spremljanjem preživetja 21 mesecev so povzeti v preglednici 10.
English: Tecentriq works by attaching to a specific protein in your body called programmed death-ligand 1 (PD-L1).
Slovenian: Zdravilo Tecentriq deluje tako, da se v telesu veže na specifično beljakovino, imenovano ligand za programirano celično smrt 1 (PD-L1).
English: • Stop your treatment with Tecentriq.
Slovenian: • konča vaše zdravljenje z zdravilom Tecentriq.
English: • performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Slovenian: • Pripravo mora izvesti usposobljeno osebje v aseptičnih pogojih v skladu s pravili dobre prakse,
English: Tecentriq will be stored by the healthcare professionals at the hospital or clinic.
Slovenian: Shranjevanje zdravila Tecentriq Zdravilo Tecentriq bodo shranjevali zdravstveni delavci v bolnišnici ali ambulanti.
English: • nerve damage resulting in possible numbness, pain, and/or loss of motor function (peripheral neuropathy)
Slovenian: • okvara živcev, ki ima lahko za posledico omrtvičenost, bolečine in/ali poslabšanje zmožnosti gibanja (periferna nevropatija)
English: NE (14.1, NE)
Slovenian: NO (14,1; NO)
English: The key results are summarised in Table 9 and Kaplan-Meier curves for OS and PFS are presented in Figures 6 and 8, respectively.
Slovenian: Ključni rezultati so povzeti v preglednici 9; Kaplan-Meierjevi krivulji OS in PFS sta prikazani na slikah 6 in 8.
English: An updated OS analysis was performed with a median follow up of 18 months, OS results are presented in Table 6 and Kaplan-Meier curves in Figure 5.
Slovenian: Posodobljena analiza celokupnega preživetja je bila narejena z mediano 18-mesečnim spremljanjem; rezultati OS so prikazani v preglednici 6 in s Kaplan-Meierjevima krivuljama na sliki 5.
English: Ask your doctor if you should stop breast-feeding or if you should stop treatment with Tecentriq.
Slovenian: Z zdravnikom se posvetujte, ali nehate dojiti ali nehate z zdravljenjem z zdravilom Tecentriq.
English: Includes reports of encephalitis, meningitis, photophobia.
Slovenian: Vključuje poročila o encefalitisu, meningitisu, fotofobiji.
English: Approximately half the patients had received a taxane (51%) or anthracycline (54%) in the (neo)adjuvant setting.
Slovenian: Približno polovica bolnikov je (neo)adjuvantno prejemala nek taksan (51 %) ali antraciklin (54 %).
English: The recommended dose is 1,200 milligrams (mg) every three weeks.
Slovenian: Priporočeni odmerek je 1200 miligramov (mg) na tri tedne.
English: There were 24.2% of patients who received only prior platinum-containing adjuvant or neoadjuvant therapy and progressed within 12 months.
Slovenian: 24,2 % bolnikov je predhodno prejemalo le adjuvantno ali neoadjuvantno zdravljenje na osnovi platine in jim je bolezen napredovala v 12 mesecih.
English: In addition, nab-paclitaxel is administered on days 8 and 15.
Slovenian: Dodatno se nab-paklitaksel aplicira še 8. in 15. dan.
English: Hypersensitivity to atezolizumab or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na atezolizumab ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: An analysis was also performed with a median duration of survival follow-up of 21.1 months for
Slovenian: Za 2. kohorto je bila opravljena tudi analiza z medianim trajanjem spremljanja preživetja 21,1 meseca.
English: It is unknown whether atezolizumab is excreted in human milk.
Slovenian: Ni znano, ali se atezolizumab pri človeku izloča v materino mleko.
English: A population pharmacokinetic analysis indicates that central compartment volume of distribution is 3.28 L and volume at steady-state is 6.91 L in the typical patient.
Slovenian: Populacijska farmakokinetična analiza kaže, da sta pri tipičnem bolniku volumen centralnega prostora 3,28 l in volumen v stanju dinamičnega ravnovesja 6,91 l.
English: • low levels of magnesium, which can cause weakness and muscle cramping, numbness and pain in the arms and legs
Slovenian: • nizka vrednost magnezija, ki lahko povzroči šibkost in mišične krče kot tudi omrtvičenost in bolečine v rokah in nogah
English: Myocarditis occurred in < 0.1% (2/8,000) of patients across all atezolizumab clinical trials in multiple tumour types and treatment combinations.
Slovenian: Miokarditis se je pojavil pri < 0,1 % (2/8000) bolnikov v vseh kliničnih preskušanjih z atezolizumabom in kombiniranim zdravljenjem pri več vrstah tumorjev.
English: In addition, no incompatibilities have been observed with in-line filter membranes composed of polyethersulfone or polysulfone, and infusion sets and other infusion aids composed of PVC, PE, polybutadiene, or polyetherurethane.
Slovenian: Poleg tega niso opazili nobenih inkompatibilnosti z vmesnim filtrom membrane, sestavljene iz polietersulfona ali polisulfona, infuzijskimi seti in drugimi infuzijskimi pripomočki, izdelanimi iz PVC, PE, polibutadiena ali polieteruretana.
English: If the first infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
Slovenian: Če bolnik prvo infuzijo dobro prenese, je mogoče vse nadaljnje infuzije dati v 30 minutah.
English: Atezolizumab is administered as an intravenous infusion.
Slovenian: Atezolizumab se daje z intravensko infuzijo.
English: • Delay giving your next dose of Tecentriq.
Slovenian: • odloži dajanje naslednjega odmerka zdravila Tecentriq,
English: From the PD-L1+/BRCA1/2 mutant subgroup, 19 patients received atezolizumab plus nabpaclitaxel and 26 placebo plus nab-paclitaxel.
Slovenian: Iz podskupine z mutacijo PD-L1+/BRCA1/2 je 19 bolnikov prejemalo atezolizumab in nab-paklitaksel, 26 pa placebo in nab-paklitaksel.
English: • have been given medicines to stimulate your immune system
Slovenian: • ste dobili zdravila za spodbudo imunskega sistema,
English: Includes reports of diabetes mellitus, type 1 diabetes mellitus, diabetic ketoacidosis, ketoacidosis.
Slovenian: Vključuje poročila o sladkorni bolezni, sladkorni bolezni tipa 1, diabetični ketoacidozi, ketoacidozi.
English: What Tecentriq is and what it is used for
Slovenian: Kaj je zdravilo Tecentriq in za kaj ga uporabljamo
English: Each vial contains 1,200 mg of atezolizumab (in 20 mL).
Slovenian: Ena viala vsebuje 1200 mg atezolizumaba (v 20 ml).
English: Chemotherapy (n = 464)
Slovenian: kemoterapija (n = 464)
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Slovenian: V primeru prevelikega odmerjanja je treba bolnike skrbno nadzorovati glede znakov in simptomov neželenih učinkov in uvesti je treba ustrezno simptomatsko zdravljenje.
English: Randomisation was stratified by sex, presence of liver metastases and PD-L1 expression on TC and IC.
Slovenian: Randomizacija je bila stratificirana po spolu, prisotnosti zasevkov v jetrih in izražanju PD-L1 na TC in IC.
English: 12-month OS (%)*** 18-month OS (%)***
Slovenian: 12-mesečno OS (%)*** 18-mesečno OS (%)***
English: Incudes reports of hypophysitis and temperature regulation disorder.
Slovenian: Vključuje poročila o hipofizitisu in motnji regulacije temperature.
English: There are insufficient data for the subgroup of patients that would be unfit for any chemotherapy; therefore atezolizumab should be used with caution in these patients, after careful consideration of the potential balance of risks and benefits on an individual basis.
Slovenian: Za podskupino bolnikov, neprimernih za katero koli kemoterapijo, ni dovolj podatkov, zato je treba atezolizumab pri njih uporabljati previdno, po temeljitem pretehtanju razmerja med možnimi tveganji in koristmi za vsakega posameznega bolnika.
English: Kaplan-Meier curves for OS and PFS are presented in Figures 12 and 13.
Slovenian: Kaplan-Meierjevi krivulji OS in PFS sta prikazani na slikah 12 in 13.
English: • high blood sugar
Slovenian: • visok krvni sladkor • prehlad
English: PD-L1 expression of ≥ 5% in IC
Slovenian: PD-L1 ≥ 5 % v IC
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying unique identifier included.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako
English: Etoposide is also administered by intravenous infusion on days 2 and 3.
Slovenian: Etopozid v intravenski infuziji se aplicira tudi 2. in 3. dan.
English: The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of atezolizumab, including immunerelated pneumonitis, hepatitis, colitis, hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, neuropathies, meningoencephalitis, pancreatitis, and infusion related reactions, and how to manage them.
Slovenian: Izobraževalni program je namenjen povečanju ozaveščenosti in zagotavljanju informacij o znakih in simptomih nekaterih pomembnih ugotovljenih tveganj atezolizumaba, vključno z imunsko pogojenim pnevmonitisom, hepatitisom, kolitisom, hipotiroidizmom, hipertiroidizmom, insuficienco nadledvičnih žlez, hipofizitisom, sladkorno boleznijo tipa I, nevropatijami, meningoencefalitisom, pankreatitisom in z infundiranjem povezanimi reakcijami ter njihovem obvladovanju.
English: The schedule of administration must be adjusted to maintain a 3-week interval between doses.
Slovenian: Urnik dajanja zdravila je treba nato prilagoditi 3-tedenskemu presledku med odmerki.
English: Includes reports of musculoskeletal pain and myalgia.
Slovenian: x Vključuje poročila o mišično-skeletni bolečini in mialgiji.
English: Tecentriq is for intravenous use.
Slovenian: Zdravilo Tecentriq je namenjeno za intravensko uporabo.
English: A population pharmacokinetic analysis suggests that steady-state is obtained after 6 to 9 weeks (2 to 3 cycles) of repeated dosing.
Slovenian: Populacijska farmakokinetična analiza kaže, da je stanje dinamičnega ravnovesja doseženo po 6 do 9 tednih (2 do 3 ciklih) ponavljajoče se uporabe.
English: Reminder to distribute the patient alert card to all patients receiving treatment with Tecentriq and to advise them to show it to any healthcare professional who may treat them.
Slovenian: Opomnik za razdeljevanje opozorilne kartice za bolnika vsem bolnikom, ki prejemajo zdravljenje z zdravilom Tecentriq, in nasvet, da jo pokažejo vsem zdravstvenim delavcem,
English: Most immune-related adverse reactions occurring during treatment with atezolizumab were reversible with interruptions of atezolizumab and initiation of corticosteroids and/or supportive care.
Slovenian: Večina imunsko pogojenih neželenih učinkov, ki so se pojavili med zdravljenjem z atezolizumabom, je bila po prekinitvi atezolizumaba in uvedbi kortikosteroidov in/ali podpornega zdravljenja reverzibilna.
English: Since atezolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected.
Slovenian: Ker se atezolizumab odstrani iz obtoka s katabolizmom, ni pričakovati presnovnih medsebojnih delovanj med zdravili.
English: Atezolizumab is an Fc-engineered, humanised immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and provides a dual blockade of the PD-1 and B7.1 receptors, releasing PD-L1/PD-1 mediated inhibition of the immune response, including reactivating the antitumour immune response without inducing antibody-dependent cellular cytotoxicity.
Slovenian: Atezolizumab je humanizirano G1-imunoglobulinsko (IgG1) monoklonsko protitelo z inženirsko obdelano domeno Fc, ki se neposredno veže na PD-L1 in povzroči dvojno blokado receptorjev PD-1 in B7-1, odpravi s PD-L1/PD-1 posredovano zavrtje imunskega odziva in reaktivira protitumorski imunski odziv brez indukcije celične citotoksičnosti, odvisne od protiteles.
English: ‡ Stratified by presence of liver metastases, and by prior taxane treatment.
Slovenian: ‡ stratificirani glede na prisotnost zasevkov v jetrih in predhodno zdravljenje s taksanom.
English: • low oxygen levels, which may cause shortness of breath as a consequence of inflamed lungs
Slovenian: • nizka raven kisika, ki lahko povzroči težko dihanje, kar je posledica vnetja pljuč (hipoksija)
English: The key results of this study with a median survival follow-up of 21 months are summarised in Table 5.
Slovenian: Ključni rezultati te študije z medianim spremljanjem preživetja 21 mesecev so povzeti v preglednici 5.
English: The prescriber must discuss the risks of Tecentriq therapy with the patient.
Slovenian: Zdravnik, ki predpiše zdravilo, se mora z bolnikom pogovoriti o tveganjih zdravljenja z zdravilom Tecentriq.
English: p-value1
Slovenian: p-vrednost1
English: 6.6 Special precautions for disposal and other handling Tecentriq does not contain any antimicrobial preservative or bacteriostatic agents and should be prepared by a healthcare professional using aseptic technique to ensure the sterility of prepared solutions.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Tecentriq ne vsebuje protimikrobnega konzervansa ali bakteriostatikov; da se zagotovi sterilnosti pripravljenih raztopin, ga mora pripraviti zdravstveni delavec z upoštevajem aseptičega postopka.
English: In studies IMpower150 and IMpower133, data for patients ≥75 years of age are too limited to draw conclusions on this population.
Slovenian: Podatkov iz študij IMpower150 in IMpower133 je za bolnike, stare ≥ 75 let, premalo, da bi lahko sklepali o tej populaciji.
English: If you stop receiving Tecentriq
Slovenian: Če ste prenehali dobivati zdravilo Tecentriq
English: i.e. excluding patients with EGFR mutations or ALK rearrangements.
Slovenian: brez bolnikov z dokazanimi mutacijami EGFR ali preureditvami ALK.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with atezolizumab 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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z atezolizumabom za vse skupine pediatrične populacije za zdravljenje malignih novotvorb (razen tumorjev osrednjega živčevja ter novotvorb hematopoetskega in limfnega tkiva) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The infusions must not be administered as an intravenous push or bolus.
Slovenian: Infuzij se ne sme dajati kot hiter intravenski odmerek ali bolus.
English: Details for the significant adverse reactions for atezolizumab when given in combination are presented if clinically relevant differences were noted in comparison to atezolizumab monotherapy.
Slovenian: Podrobnosti o pomembnih neželenih učinkih atezolizumaba v kombinaciji so prikazani, če so bile ugotovljene klinično pomembne razlike v primerjavi z atezolizumabom v monoterapiji.
English: An updated analysis was performed with a median duration of survival follow-up of 17.2 months for Cohort 1 and is summarised in Table 4.
Slovenian: Za 1. kohorto je bila opravljena posodobljena analiza z medianim trajanjem spremljanja preživetja 17,2 meseca; povzeta je v preglednici 4.
English: Grade 3 or 4: (ALT or AST > 5 x ULN
Slovenian: 3. ali 4. stopnja: (ALT ali AST > 5-kratna ZNM
English: Instructions for dilution
Slovenian: Navodila za razredčenje
English: The bag should be gently inverted to mix the solution in order to avoid foaming.
Slovenian: Vrečko z raztopino je treba previdno obračati, da bi preprečili penjenje raztopine.
English: The median number of treatment cycles was 7 for atezolizumab and 6 for nab-paclitaxel in each treatment arm.
Slovenian: Mediano število ciklov zdravljenja je bilo v vsaki zdravljeni skupini 7 za atezolizumab in 6 za za nab-paklitaksel.
English: PD-L1 expression of ≥ 1% in IC
Slovenian: PD-L1 ≥ 1 % v IC