natgillin/translations-raw huggingface dataset:
Small cell lung cancer 
Drobnocelični rak pljuč
Patients with previously untreated UC and TNBC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1). 
Testiranje PD-L1 pri bolnikih z urotelijskim karcinomom in TNRD Bolnike s predhodno nezdravljenim urotelijskim karcinomom in TNRD je treba za zdravljenje izbrati na podlagi tumorskega izražanja PD-L1, potrjenega z validirano preiskavo (glejte poglavje 5.1).
Treatment with atezolizumab should be withheld if Grade 2 event (ALT or AST > 3 to 5 x ULN or blood bilirubin > 1.5 to 3 x ULN) persists for more than 5 to 7 days, and 1 to 2 mg/kg/day of prednisone or equivalent should be started. 
Če hepatitis 2. stopnje (ALT ali AST > 3- do 5-kratna ZNM ali bilirubin v krvi > 1,5- do 3-kratna ZNM) traja več kot 5 do 7 dni, je treba zdravljenje z atezolizumabom zadržati, in uvesti prednizon v odmerku 1 do 2 mg/kg/dan (ali ekvivalent).
Patients should be monitored for signs and symptoms of myocarditis. 
Bolnike je treba nadzorovati glede znakov in simptomov, ki kažejo na miokarditis.
b Includes reports of pneumonia, bronchitis, lung infection, lower respiratory tract infection, infective exacerbation of COPD, infectious pleural effusion, tracheobronchitis, atypical pneumonia, lung abscess, pyopneumothorax. 
b Vključuje poročila o pljučnici, bronhitisu, okužbi pljuč, okužbi spodnjih dihal, poslabšanju KOPB zaradi okužbe, infekcijskem plevralnem izlivu, traheobronhitisu, atipični pljučnici, pljučnem abscesu, piopnevmotoraksu.
• inflammation of the lung (pneumonitis): symptoms may include new or worsening cough, shortness of breath, and chest pain 
• vnetje pljuč (pnevmonitis): med simptomi so lahko novonastal kašelj ali poslabšanje kašlja, težko dihanje in bolečine v prsih;
Tecentriq in combination with nab-paclitaxel in 1L mTNBC The recommended dose of Tecentriq is 840 mg administered by intravenous infusion, followed by 100 mg/m2 nab-paclitaxel. 
Priporočeni odmerek zdravila Tecentriq je 840 mg v intravenski infuziji, ki ji sledi 100 mg/m nab-paklitaksela.
Tumour assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, Day 1 and then every 9 weeks thereafter. 
Ocene tumorjev so izvedli na vsakih 6 tednov po 1. dnevu 1. cikla v prvih 48 tednih in nato na vsakih 9 tednov.
Prognostic risk factors included time from prior chemotherapy of < 3 months, 
Napovedni dejavniki tveganja so vključevali čas od predhodne kemoterapije < 3 mesece, stanje zmogljivosti po ECOG > 0 in hemoglobin < 10 g/dl.
During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by nab-paclitaxel and carboplatin every three weeks for four or six cycles. 
Med uvodno fazo je priporočeni odmerek zdravila Tecentriq 1200 mg v intravenski infuziji, čemur sledita nab-paklitaksel in nato karboplatin na vsake tri tedne, skupno štiri ali šest ciklov.
Investigator-assessed DOR (RECIST 1.1)** ^ 
DOR po oceni raziskovalca (RECIST 1.1)** ^
How Tecentriq is given 
Kako se daje zdravilo Tecentriq
After dilution, one mL of solution should contain approximately 3.2 mg of Tecentriq (840 mg/264 mL). 
Po razredčenju vsebuje en mililiter raztopine približno 3,2 mg zdravila Tecentriq (840 mg/264 ml).
QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 mL vial of concentrate contains 840 mg of atezolizumab*. 
Ena 14-ml viala s koncentratom vsebuje 840 mg atezolizumaba*.
After dilution (see section 6.6), one mL of solution contains approximately 3.2 mg of atezolizumab for the 840 mg dose and approximately 6.0 mg of atezolizumab for the 1680 mg dose. 
Po razredčenju (glejte poglavje 6.6) 1 ml raztopine vsebuje približno 3,2 mg atezolizumaba v 840-mg odmerku in približno 6 mg atezolizumaba v 1680-mg odmerku.
Atezolizumab (1,200 mg)a 
atezolizumab (1200 mg)a + nab-paklitaksel
Induction (Four 21-Day Cycles) 
Uvodno zdravljenje (štirje 21-dnevni cikli)
IMpassion130 (WO29522): Randomised phase III trial in locally advanced or metastatic TNBC patients previously untreated for metastatic disease 
Preskušanje IMpassion130 (WO29522): randomizirano preskušanje faze III pri bolnikih z lokalno napredovalim ali razsejanim TNRD, predhodno še nezdravljenih zaradi razsejane bolezni
Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis and type 1 diabetes mellitus, including diabetic ketoacidosis have been observed in clinical trials with atezolizumab (see section 
V kliničnih preskušanjih atezolizumaba so opažali hipotiroidizem, hipertiroidizem, insuficienco nadledvičnih žlez, hipofizitis in sladkorno bolezen tipa 1, vključno z diabetično ketoacidozo (glejte poglavje 4.8).
The median time to onset was 1.5 months (range 6 days to 18.8 
Mediani čas do pojava je bil 1,5 meseca (razpon: od 6 dni do 18,8 meseca).
Carboplatin and etoposide were administered until completion of 4 cycles, or progressive disease or unacceptable toxicity, whichever occurs first c 
b Karboplatin in etopozid so uporabljali do dokončanja 4 ciklov, napredovanja bolezni ali nesprejemljivih toksičnih učinkov,
POPLAR (GO28753): Randomised phase II trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy 
POPLAR (GO28753): Randomizirano preskušanje faze II pri bolnikih z lokalno napredovalim ali razsejanim NDRP, ki so bili predhodno zdravljeni s kemoterapijo
Tecentriq 840 mg concentrate for solution for infusion atezolizumab 
Tecentriq 840 mg koncentrat za raztopino za infundiranje atezolizumab
IMpower150 (GO29436): Randomised phase III trial in chemotherapy-naïve patients with metastatic non-squamous NSCLC, in combination with paclitaxel and carboplatin with or without bevacizumab 
IMpower150 (GO29436): Randomizirano preskušanje faze III pri bolnikih z razsejanim neploščatoceličnim NDRP, predhodno še nezdravljenih s kemoterapijo, v kombinaciji s paklitakselom in karboplatinom (z bevacizumabom ali brez njega)
Respiratory, thoracic, and mediastinal disorders Very common cough, dyspnoea dyspnoea, cough 
Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti kašelj, dispneja dispneja, kašelj pogosti pnevmonitisq, hipoksija,
Figure 9: Forest plot of progression free survival by PD-L1 expression (IMpower130) 
Slika 9: Drevesni diagram preživetja brez napredovanja bolezni glede na izražanje PD-L1 (IMpower130)
Tumour assessments were conducted every 6 weeks for the first 36 weeks, and every 9 weeks thereafter. 
Ocenjevanje odgovora tumorja so prvih 36 tednov izvajali na 6 tednov, nato pa vsakih 9 tednov.
Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab 
Tecentriq 1200 mg koncentrat za raztopino za infundiranje atezolizumab
A Phase I/III, randomised, multicentre, double-blind, placebo-controlled study, IMpower133, was conducted to evaluate the efficacy and safety of atezolizumab in combination with carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC). 
Randomizirano, multicentrično, dvojno slepo, s placebom kontrolirano študijo faze I/III IMpower133 so izvedli z namenom ovrednotenja učinkovitosti in varnosti atezolizumaba v kombinaciji s karboplatinom in etopozidom pri bolnikih z razsejanim drobnoceličnim rakom pljuč (angl. extensivestage small cell lung cancer), ki predhodno še niso prejemali kemoterapije.
Treatment may be resumed when rash is resolved and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day 
Zdravljenje se lahko znova začne, ko izpuščaj mine in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan.
The median duration was 26 days (range 6 days to 14.5+ months; + denotes a censored value). 
Mediano trajanje je bilo 26 dni (razpon: od 6 dni do 14,5+ meseca; + označuje krnjeno vrednost).
• mouth and throat pain 
• bolečina v ustih in žrelu
Other endpoints Investigator-assessed ORR (RECIST 1.1)** ^ 
ORR po oceni raziskovalca (RECIST 1.1)** ^
Cardiac disorders Rare myocarditisp Vascular disorders Common hypotension 
Srčne bolezni redki miokarditisp
The median time to onset was 2.1 months (range 21 days to 15.7 months). 
Mediani čas do pojava je bil 2,1 meseca (razpon: od 21 dni do 15,7 meseca).
• inflammation of the intestines (colitis): symptoms may include diarrhoea (watery, loose or soft stools), blood in stools, and stomach pain 
• vnetje črevesa (kolitis): med simptomi so lahko driska (vodeno, redko ali mehko blato), kri v blatu in bolečine v trebuhu;
Grade 4 or any grade of recurrent pancreatitis 
Pankreatitis 4. stopnje ali ponovitev pankreatitisa ne glede na stopnjo
Figure 2: Kaplan-Meier curve for overall survival in the ITT population (IMpower150) 
Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji ITT (IMpower150)
(creatinine level > 1.5 to 3.0 x baseline or > 1.5 to 3.0 x ULN) 
2. stopnja: koncentracija kreatinina > 1,5 do 3,0kratna izhodiščna vrednost ali > 1,5 do 3,0-kratna ZNM)
What Tecentriq is used for 
Za kaj uporabljamo zdravilo Tecentriq
Pneumonitis led to discontinuation of atezolizumab in 12 (0.4%) patients. 
Zaradi pnevmonitisa je zdravljenje z atezolizumabom končalo 12 (0,4 %) bolnikov.
Meningoencephalitis requiring the use of corticosteroids occurred in 0.2% (6/3,178) of patients receiving atezolizumab and four patients discontinued atezolizumab. 
Meningoencefalitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 0,2 % (6/3178) bolnikov, ki so prejemali atezolizumab; štirje bolniki so prenehali z atezolizumabom.
Baseline ECOG performance status was 0 (43%) or 1 (57%). 
Izhodiščno stanje zmogljivosti po ECOG je bilo 0 (43 %) ali 1 (57 %).
Table 8: Intravenous treatment regimens (IMpower130) Treatment 
Intravenski shemi zdravljenja (IMpower130)
Arm A Atezolizumab + nab-paclitaxel + carboplatin 
Skupina A atezolizumab + nab-paklitaksel + karboplatin
Docetaxel was administered 75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression. 
Docetaksel so uporabljali v odmerku 75 mg/m v intravenski infuziji 1. dan vsakega 3-tedenskega cikla do napredovanja bolezni.
No overall differences in safety were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy. 
Med bolniki, starimi ≥ 65 let, in mlajšimi bolniki, ki so prejemali monoterapijo z atezolizumabom, niso opazili razlik v varnosti.
Investigator-assessed PFS (RECIST v1.1) - Primary analysis 
PFS po oceni raziskovalca (RECIST v1.1) - primarna analiza Število dogodkov (%)
Hypothyroidism: 
Tecentriq:
No overall differences in efficacy were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy. 
Med bolniki, starimi ≥ 65 let, in mlajšimi bolniki, ki so prejemali atezolizumab, niso opazili razlik v učinkovitosti.
For the description of Tecentriq trials, refer to the Tecentriq 1,200 mg concentrate for solution for infusion Summary of Product Characteristics (SmPC) section 5.1. 
Za opis preskušanj zdravila Tecentriq glejte poglavje 5.1 Povzetka glavnih značilnosti zdravila (SmPC) zdravila Tecentriq 1200 mg koncentrat za raztopino za infundiranje.
• a cancer that affects the lungs, called small cell lung cancer (SCLC). 
• rakom, ki prizadene pljuča in ga imenujemo drobnocelični rak pljuč.
musculoskeletal painx arthralgia, musculoskeletal painx, back pain 
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti artralgija, bolečina v hrbtu, mišično-skeletna bolečinax artralgija, mišično-skeletna bolečinax, bolečina v hrbtu občasni miozitisy
• After dilution, one mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose. 
• Po razredčenju 1 ml raztopine za injiciranje vsebuje približno 3,2 mg atezolizumaba v 840-mg odmerku in približno 6,0 mg atezolizumaba v 1680-mg odmerku.
Baseline ECOG performance status was 0 (35%) or 1 (65%). 
Izhodiščno stanje zmogljivosti po ECOG je bilo 0 (35 %) ali 1 (65 %).
Tumour specimens were evaluated prospectively for PD-L1 expression on tumour cells (TC) and tumour-infiltrating immune cells (IC). 
Vzorce tumorjev so prospektivno ocenili glede izražanja PD-L1 na tumorskih celicah in celicah imunskega sistema, ki infiltrirajo tumor.
Tecentriq monotherapy 
Zdravilo Tecentriq v monoterapiji
CI = confidence interval; DOR=duration of response; IC = tumour-infiltrating immune cells; IRF = independent review facility; NE = not estimable; ORR = objective response rate; OS = overall survival; 
IZ = interval zaupanja, DOR = trajanje odgovora, IC = celice imunskega sistema, ki infiltrirajo tumor, IRF = skupina za neodvisni pregled, NO = ni ocenljivo, ORR = delež objektivnega odgovora, OS = celokupno preživetje, PFS = preživetje brez napredovanja bolezni; RECIST = merila RECIST (Response Evaluation
The primary analysis of study IMvigor211 did not meet its primary endpoint of OS. Atezolizumab did not demonstrate a statistically significant survival benefit compared to chemotherapy in patients with previously treated, locally advanced or metastatic urothelial carcinoma. 
Za atezolizumab niso dokazali statistično značilne koristi za preživetje v primerjavi s kemoterapijo pri bolnikih s predhodno zdravljenim, lokalno napredovalim ali razsejanim urotelijskim karcinomom.
Figure 10: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK) 
Slika 10: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji za primarno analizo (neselekcionirani bolniki) (OAK)
95% CI: 0.63, 1.72 for OS, respectively). 
% IZ: 0,59; 1,47 za PFS in RO 1,04, 95-% IZ: 0,63; 1,72 za OS).
Figure 11 summarises the results of OS in the ITT and PD-L1 subgroups, demonstrating OS benefit with atezolizumab in all subgroups, including those with PD-L1 
Slika 11 povzema rezultate celokupnega preživetja v podskupini ITT in podskupinah PD-L1; rezultati kažejo korist atezolizumaba za celokupno preživetje v vseh podskupinah, tudi tistih z izražanjem PD-L1 < 1 % v tumorskih celicah in imunskih celicah, ki infiltrirajo tumor.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo za intravensko uporabo po razredčenju
During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion followed by carboplatin, and then etoposide administered by intravenous infusion on day 1. 
Med uvodno fazo je 1. dan cikla priporočeni odmerek zdravila Tecentriq 1200 mg v intravenski infuziji, čemur sledita najprej karboplatin in nato etopozid v intravenski infuziji.
Pneumonitis occurred in 2.7% (87/3,178) of patients who received atezolizumab monotherapy. 
Pnevmonitis se je pojavil pri 2,7 % (87/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Figure 2: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK) 
Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji za primarno analizo (neselekcionirani bolniki) (OAK)
Includes reports of urinary tract infection, cystitis, pyelonephritis, escherichia urinary tract infection, urinary tract infection bacterial, kidney infection, pyelonephritis acute, urinary tract infection fungal, urinary tract infection pseudomonal. 
Vključuje poročila o okužbi sečil, cistitisu, pielonefritisu, okužbi sečil z bakterijo Escherichia, bakterijski okužbi sečil, okužbi ledvic, akutnem pielonefritisu, glivični okužbi sečil, okužbi sečil z bakterijo Pseudomonas.
IMpower133 (GO30081): Randomised phase I/III trial in patients with chemotherapy-naïve extensivestage SCLC, in combination with carboplatin and etoposide 
IMpower133 (GO30081): randomizirano preskušanje faze I/III v kombinaciji s karboplatinom in etopozidom pri bolnikih z razsejanim DRP, predhodno še nezdravljenih s kemoterapijo
Arm B (Atezolizumab + Bevacizumab + Paclitaxel + Carboplatin) 
Skupina B (atezolizumab + bevacizumab + paklitaksel + karboplatin)
Adrenal insufficiency led to discontinuation of atezolizumab in 1 (<0.1%) patient. 
Zaradi insuficience nadledvičnih žlez je zdravljenje z atezolizumabom prenehal 1 (< 0,1 %) bolnik.
(hypoxia) 
(trombocitopenija)
Nervous system disorders Very Common peripheral neuropathyl , dizziness, headache 
Bolezni živčevja zelo pogosti periferna nevropatijal, omotica, glavobol pogosti sinkopa občasni
The confirmed ORR per investigator-assessed mRECIST was 29.0% (95% CI: 20.4, 38.9) in patients with PD-L1 expression ≥ 5%, 23.7% (95% CI: 18.1, 30.1) in patients with PD-L1 expression ≥ 1%, and 19.7% (95% CI: 15.4, 24.6) in all comers. 
Potrjeni deleži celokupnega odgovora po oceni raziskovalca glede na merila mRECIST so bili 29,0 % (95-% IZ: 20,4; 38,9) pri bolnikih z izražanjem PD-L1 ≥ 5 %, 23,7 % (95-% IZ: 18,1; 30,1) pri bolnikih z izražanjem PD-L1 ≥ 1 % in 19,7 % (95-% IZ: 15,4; 24,6) pri vseh neselekcioniranih bolnikih.
Treatment with atezolizumab should be withheld for ≥ Grade 3 serum amylase or lipase levels increased (> 2 x ULN), or Grade 2 or 3 pancreatitis, and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started. 
V primeru zvišanja serumske amilaze ali lipaze ≥ 3. stopnje (> 2-kratna ZNM) ali pankreatitisa 2. ali 3. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti zdravljenje z intravenskimi kortikosteroidi (1 do 2 mg/kg/dan metilprednizolona ali ekvivalenta).
Rare nephritisaa 
Okvara ledvic
For the recommended dose of 840 mg: fourteen mL of Tecentriq concentrate should be withdrawn from the vial and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection. 
Za priporočeni 840-mg odmerek: 14 ml koncentrata zdravila Tecentriq je treba vzeti iz viale in ga razredčiti v 250-ml infuzijski vrečki iz polivinilklorida (PVC), poliolefina (PO), polietilena (PE) ali polipropilena (PP), ki vsebuje 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje.
Gastrointestinal disorders Very common nausea, vomiting, diarrhoear nausea, diarrhoear, constipation, vomiting 
Bolezni prebavil zelo pogosti navzea, bruhanje, diarejar navzea, diarejar, zaprtost, bruhanje pogosti bolečine v trebuhu, kolitiss,
Patients with NSCLC that had clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging, were excluded from the pivotal clinical study 
Bolniki z NDRP ter jasnim vraščanjem v velike žile prsnega koša ali jasno kavitacijo pljučnih lezij, prikazano s slikanjem, so bili izključeni iz ključne klinične študije IMpower150, potem ko je bilo zabeleženih več primerov pljučne krvavitve s smrtnim izidom, ki je znan dejavnik tveganja zdravljenja z bevacizumabom.
Paclitaxel was administered 175 mg/m2 by intravenous infusion over 3 hours on day 1 of each 3-week cycle until disease progression or unacceptable toxicity. 
Paklitaksel so dajali v odmerku 175 mg/m z intravensko infuzijo v 3 urah na 1. dan vsakega 3tedenskega cikla do napredovanja bolezni ali nesprejemljive toksičnosti.
OAK (GO28915): Randomised phase III trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy 
OAK (GO28915): Randomizirano klinično preskušanje faze III pri bolnikih z lokalno napredovalim ali razsejanim NDRP, ki so bili predhodno zdravljeni s kemoterapijo
For symptomatic adrenal insufficiency, atezolizumab should be withheld and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started. 
V primeru simptomatske insuficience nadledvičnih žlez je treba uporabo atezolizumaba odložiti in uvesti zdravljenje z intravenskimi kortikosteroidi (metilprednizolonom v odmerku 1 do 2 mg/kg/dan ali ekvivalentom).
The median duration was 24 days (range 3 days to 12.0+ months; + denotes a censored value). 
Mediano trajanje je bilo 24 dni (razpon: od 3 dni do 12,0+ meseca; + označuje krnjeno vrednost).
Patients should be monitored for clinical signs and symptoms of endocrinopathies. 
Bolnike je treba spremljati glede znakov in simptomov endokrinopatij.
ORR (IRF-assessed; RECIST v1.1) 
ORR (po oceni IRF; RECIST v1.1)
No dedicated studies of atezolizumab have been conducted in patients with renal impairment. 
Namenskih študij z atezolizumabom pri bolnikih z okvaro ledvic niso izvedli.
• infection of the lung 
• okužba sečil
Tumour specimens were evaluated prospectively for PD-L1 expression on tumour-infiltrating immune cells (IC) and the results were used to define the PD-L1 expression subgroups for the analyses described below. 
Tumorske vzorce so ovrednotili prospektivno na izražanje PD-L1 imunskih celic, ki infiltrirajo tumor, in rezultate uporabili za določitev podskupin izražanja PD-L1 za spodaj opisano analizo.
The median time to onset was 5.2 months (range: 5.1 to 5.3 months). 
Mediani čas do pojava je bil 5,2 meseca (razpon: od 5,1 do
Figure 6: Kaplan-Meier curves for overall survival (IMpower130) 
Slika 6: Kaplan-Meierjeva krivulja celokupnega preživetja (IMpower130)
Pancreatitis, including increases in serum amylase and lipase levels, has been observed in clinical trials with atezolizumab (see section 4.8). 
V kliničnih preskušanjih z atezolizumabom so opazili pankreatitis, vključno z zvišanjem amilaze in lipaze v serumu (glejte poglavje 4.8).
Atezolizumab (n = 425) 
Opazovani dogodek učinkovitosti atezolizumab (n = 425)
Initiation of systemic corticosteroids (at a dose of 1 to 2 mg/kg/day of prednisone or equivalent) should be considered. 
V poštev pride uvedba sistemskih kortikosteroidov v odmerku 1 do 2 mg/kg/dan prednizona (ali ekvivalenta).
Arm C (Bevacizumab + Paclitaxel + Carboplatin) 
Skupina C (bevacizumab + paklitaksel + karboplatin)
No reproductive or teratogenicity studies in animals have been conducted with atezolizumab. 
Študij o sposobnosti razmnoževanja in o teratogenosti pri živalih z atezolizumabom niso izvedli.
Nephritis occurred in < 0.1% (3/3,178) of patients who received atezolizumab. 
Nefritis se je pojavil pri < 0,1 % (3/3178) bolnikov, ki so prejemali atezolizumab.
No. of complete response (%) 95% CI 
Št. popolnih odgovorov (%) 95-% IZ
Cohort 1 included previously untreated patients with locally advanced or metastatic UC who were ineligible or unfit for cisplatin-based chemotherapy or had disease progression at least 12 months after treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. 
V 1. kohorto so bili vključeni še nezdravljeni bolniki z lokalno napredovalim ali razsejanim urotelijskim karcinomom, ki niso bili primerni ali sposobni za kemoterapijo na osnovi platine ali jim je bolezen napredovala najmanj
12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and the patient is stable on replacement therapy (if required). 
≤ 10 mg prednizona (ali ekvivalenta) na dan, bolnik pa je stabilen na nadomestnem zdravljenju.
• The diluted solution should not be kept more than 24 hours at 2 °C to 8 °C or 8 hours at ambient temperature (≤ 25 °C), unless dilution has taken place in controlled and validated aseptic conditions. 
8 ur pri sobni temperaturi (≤ 25 °C), razen če je redčenje potekalo v kontroliranih in validiranih aseptičnih pogojih.
Other endpoints Investigator-assessed ORR (RECIST v1.1)^ 
Drugi dogodki učinkovitosti ORR po oceni raziskovalca (RECIST v1.1)^
Treatment with atezolizumab should be permanently discontinued for Grade 4 hypophysitis. 
V primeru hipofizitisa 4. stopnje je treba zdravljenje z atezolizumabom trajno ukiniti.
Treatment with atezolizumab may be resumed when serum amylase and lipase levels improve to ≤ Grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day. 
Zdravljenje z atezolizumabom se lahko znova začne, ko se serumska amilaza in lipaza v 12 tednih znižata na ≤ 1. stopnjo, ali simptomi pankreatitisa minejo, odmerek kortikosteroidov pa je zmanjšan na ≤ 10 mg prednizona na dan (ali ekvivalenta).
Once symptoms improve, treatment with 1 to 2 mg/kg/day of prednisone or equivalent should follow. 
Ko se simptomi izboljšajo, je treba zdravljenje nadaljevati s prednizonom v odmerku 1 do 2 mg/kg/dan ali ekvivalentom.