natgillin/translations-raw huggingface dataset:
Treatment with atezolizumab must be permanently discontinued for any grade of meningitis or encephalitis. 
V primeru meningitisa ali encefalitisa je treba zdravljenje z atezolizumabom trajno ukiniti ne glede na njuno stopnjo.
Submission of study results: 31 December 
31. december
Figure 8: Kaplan-Meier curves for progression free survival (IMpower130) 
Slika 8: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (IMpower130)
Tumour specimens were evaluated for PD-L1 expression on tumour cells (TC) and tumour-infiltrating immune cells (IC) and the results were used to define the PD-L1 expression subgroups for the analyses described below. 
Vzorce tumorjev so ocenjevali glede izražanja PD-L1 na tumorskih celicah (TC) in imunskih celicah, ki infiltrirajo tumor (IC); te rezultate so uporabili za določitev podskupin izražanja PD-L1 v analizi, ki je opisana v nadaljevanju.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab 
IME ZDRAVILA IN POT(I) UPORABE Tecentriq 1200 mg koncentrat za raztopino za infundiranje atezolizumab intravenska uporaba
Randomisation was stratified by PD-L1 expression status on IC, by the number of prior chemotherapy regimens and by histology. 
Randomizacija je bila stratificirana glede na stanje izražanja PD-L1 na imunskih celicah, ki infiltrirajo tumor, glede na število predhodnih shem kemoterapije in glede na histologijo.
For Grade 3 diarrhoea or colitis, treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started. 
V primeru diareje ali kolitisa 3. stopnje je treba uvesti zdravljenje z intravenskimi kortikosteroidi (1 do 2 mg/kg/dan metilprednizolona ali ekvivalenta).
compared to 57.5%), Grade 5 events (6.1% compared to 2.5%), adverse events of special interest to atezolizumab (52.4% compared to 48.0%), as well as adverse events leading to withdrawal of any study treatment (33.8% compared to 13.3%). 
V študiji pri zdravljenju NDRP v prvi liniji (IMpower150) so opazili splošno večjo pogostnost neželenih učinkov v skupini s kombinacijo štirih zdravil (atezolizumab, bevacizumab, paklitaksel in karboplatin) v primerjavi s skupino z atezolizumabom, paklitakselom in karboplatinom, vključno z neželenimi učinki 3. in 4. stopnje (63,6 % v primerjavi s 57,5 %), neželenimi učinki 5. stopnje (6,1 % v primerjavi z 2,5 %), neželenimi učinki posebnega pomena za atezolizumab (52,4 % v primerjavi z 48,0 %) in tudi neželenimi učinki, ki so vodili do ukinitve katerega koli študijskega zdravljenja (33,8 % v primerjavi s 13,3 %).
Hyperthyroidism occurred in 0.9% (30/3,178) of patients who received atezolizumab monotherapy. 
Hipertiroidizem se je pojavil pri 0,9 % (30/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
No dedicated studies of atezolizumab have been conducted in patients with hepatic impairment. 
Namenskih študij z atezolizumabom pri bolnikih z okvaro jeter niso izvedli.
PFS (IRF-assessed; RECIST v1.1) 
PFS (po oceni IRF; RECIST v1.1)
The median duration was 1.4 months (range 0 day to 21.2+ months; + denotes a censored value). 
Mediano trajanje je bilo 1,4 meseca (razpon: od 0 dni do 21,2+ meseca; + označuje krnjeno vrednost).
DOR (IRF-assessed; RECIST v1.1) 
DOR (po oceni IRF; RECIST v1.1)
Treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started. 
Uvesti je treba zdravljenje z intravenskimi kortikosteroidi (metilprednizolonom v odmerku 1 do 2 mg/kg/dan ali ekvivalentom).
Kaplan-Meier curves for OS in the ITT population are presented in Figure 10. 
Kaplan-Meierjevi krivulji celokupnega preživetja v populaciji ITT sta prikazani na sliki 10.
The paclitaxel starting dose for patients of Asian race/ethnicity was 175 mg/m due to higher overall level of haematologic toxicities in patients from Asian countries compared with those from non-Asian countries c 
b Zaradi na splošno večjega deleža hematoloških toksičnih učinkov pri bolnikih iz azijskih držav kot pri bolnikih iz neazijskih držav je bil začetni odmerek paklitaksela za bolnike azijske rase/etnične pripadnosti 175 mg/m c Paklitaksel in karboplatin so uporabljali do dokončanja 4 ali 6 ciklov, napredovanja bolezni ali nesprejemljivih toksičnih učinkov, kar od tega se je zgodilo prej.
The median age was 64 years (range 18 to 
Mediana starost je bila 64 let (razpon: od 18 do 86 let).
Stratified hazard ratio‡^ (95% CI) p-value Based on the stratified log-rank test For informational purposes; in the ITT population, comparisons between Arm A and Arm B were not included in the pre-specified analysis hierarchy ‡ Stratified by sex, presence of liver metastases and PD-L1 expression on TC and IC 
p-vrednost1,2 1 na osnovi stratificiranega testa log-rang za informativne namene; v populaciji ITT primerjavi med skupino A in skupino B nista bili vključeni v predhodno določeno hierarhijo analiz stratificirani glede na spol, prisotnost zasevkov v jetrih in tumorsko izražanje PD-L1 na TC in IC * Posodobljena analiza PFS in vmesna analiza OS na klinični presečni datum 22. januar 2018 ^ Skupina A je primerjalna skupina za vsa razmerja ogroženosti
Atezolizumaba (1,200 mg) 
atezolizumaba (1200 mg) + paklitaksel
Figure 12: Kaplan-Meier curve for overall survival (IMpower133) 
Slika 12: Kaplan-Meierjeva krivulja celokupnega preživetja (IMpower133)
^ The Arm C is the comparison group for all hazard ratios * Updated PFS analysis and interim OS analysis at clinical cut-off 22 January 2018 PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1. 
3 najboljši celokupni odgovor za popolni odgovor in delni odgovor stratificirani glede na spol, prisotnost zasevkov v jetrih in tumorsko izražanje PD-L1 na TC in IC ^ skupina C je primerjalna skupina za vsa razmerja ogroženosti * posodobljena analiza PFS in vmesna analiza OS na klinični presečni datum 22. januar 2018 PFS = preživetje brez napredovanja bolezni (progression-free survival); RECIST = merila RECIST (Response
• inflammation of the liver 
• okužba pljuč
Hypothyroidism occurred in 5.2% (164/3,178) of patients who received atezolizumab monotherapy. 
Hipotiroidizem se je pojavil pri 5,2 % (164/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Rare myasthenic syndrome o 
meningoencefalitis n redki miastenijski sindromo
Treatment with atezolizumab must be permanently discontinued for any grade of myasthenic syndrome / myasthenia gravis or Guillain-Barré syndrome. 
Pri bolnikih, zdravljenih z atezolizumabom, so opažali miastenijski sindrom/miastenijo gravis ali Guillain-Barréjev sindrom, ki je lahko življenje ogrožujoč.
Atezolizumab was administered until loss of clinical benefit as assessed by investigator b 
a Atezolizumab so uporabljali do izgube klinične koristi po oceni raziskovalca.
Atezolizumab was administered as a fixed dose of 1,200 mg by intravenous infusion every 3 weeks. 
Atezolizumab so aplicirali v fiksnem odmerku 1200 mg z intravensko infuzijo na 3 tedne.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Tecentriq 840 mg concentrate for solution for infusion atezolizumab 
IME ZDRAVILA IN POT(I) UPORABE Tecentriq 840 mg koncentrat za raztopino za infundiranje atezolizumab intravenska uporaba
Overall, 41% of enrolled patients had PD-L1 expression ≥1%, 27% had liver metastases and 7% asymptomatic brain metastases at baseline. 
27 % je imelo zasevke v jetrih in 7 % nesimptomatske zasevke v možganih izhodiščno.
Patients were excluded if they had history of autoimmune disease, administration of a live, attenuated vaccine within 28 days prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to randomisation, active or untreated CNS metastases, clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging. 
V študijo niso bili vključeni bolniki, ki so imeli v anamnezi avtoimunsko bolezen; ki so prejeli živo, oslabljeno cepivo v 28 dneh pred randomizacijo; ki so uporabljali sistemska imunostimulacijska sredstva v 4 tednih pred randomizacijo ali sistemska imunosupresivna zdravila v 2 tednih pred randomizacijo; ki so imeli aktivne ali nezdravljene zasevke v osrednjem živčevju; ali ki so imeli jasno vraščanje v velike žile prsnega koša ali jasno kavitacijo pljučnih lezij, prikazano s slikanjem.
A phase III, open-label, randomised study, GO29537 (IMpower130), was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel and carboplatin, in chemotherapy-naïve patients with metastatic non-squamous NSCLC. 
Randomizirano študijo faze III z odprtim načrtom zdravljenja GO29537 (IMpower130) so izvedli z namenom ugotavljanja učinkovitosti in varnosti atezolizumaba v kombinaciji z nab-paklitakselom in karboplatinom pri bolnikih z razsejanim neploščatoceličnim NDRP, ki predhodno še niso prejemali kemoterapije.
Investigator-assessed PFS (RECIST v1.1)* 
PFS po oceni raziskovalca (RECIST v1.1)*
Skin and subcutaneous tissue disorders Very Common rashw, pruritus rashw, pruritus 
Bolezni kože in podkožja zelo pogosti izpuščaj w, srbenje izpuščaj w, srbenje
Hepatitis occurred in 2.0% (62/3,178) of patients who received atezolizumab monotherapy. 
Hepatitis se je pojavil pri 2,0 % (62/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
A phase III, double-blind, two-arm, multi-center, international, randomised, placebo-controlled study, IMpassion130, was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel, in patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. 
Dvojno slepo randomizirano, s placebom nadzorovano multicentrično mednarodno študijo faze III z dvema skupinama IMpassion130 so izvedli zaradi ovrednotenja učinkovitosti in varnosti atezolizumaba v kombinaciji z nab-paklitakselom pri bolnikih z inoperabilnim lokalno napredovalim ali razsejanim TNRD, ki predhodno še niso prejemali kemoterapije zaradi razsejane bolezni.
Docetaxel was administered 75 mg/m by intravenous infusion on day 1 of each 3-week cycle until disease progression or unacceptable toxicity. 
Docetaksel so dajali v odmerku 75 mg/m z intravensko infuzijo 1. dan vsakega 3-tedenskega cikla do napredovanja bolezni ali nesprejemljive toksičnosti.
Based on the stratified log-rank test For informational purposes; in the ITT population, comparisons between Arm B and Arm C as well as between Arm A and Arm C were not formally tested yet as per the pre-specified analysis hierarchy Overall best response for complete response and partial response ‡ Stratified by sex, presence of liver metastases and PD-L1 tumour expression on TC and IC 
2 za informativne namene; v populaciji ITT primerjave med skupino B in skupino C kot tudi med skupino A in skupino C še niso formalno preskusili v skladu s predhodno določeno hierarhijo analiz
Stratified by sex and PD-L1 expression on TC and IC ^ Confirmed ORR and DoR are exploratory endpoints 
*** le za opisne namene ^ potrjena ORR in DOR sta eksploratorna opazovana dogodka
Upon improvement to Grade ≤ 1, corticosteroid should be tapered over ≥ 1 month. 
Po izboljšanju na ≤ 1. stopnjo je treba odmerek kortikosteroidov postopoma zmanjševati v obdobju ≥ 1 meseca.
NAME OF THE MEDICINAL PRODUCT Tecentriq 1,200 mg concentrate for solution for infusion. 
IME ZDRAVILA Tecentriq 1200 mg koncentrat za raztopino za infundiranje
What Tecentriq is 
Kaj je zdravilo Tecentriq
PFS improvements were also shown in patients with EGFR mutations or ALK rearrangements (HR of 0.55, 95% CI: 0.35, 0.87; median PFS 
Prav tako je bilo ugotovljeno izboljšanje PFS pri bolnikih z dokazanimi mutacijami EGFR ali preureditvami ALK (RO 0,55; 95-% IZ: 0,35; 0,87; mediano PFS 10,0 v primerjavi s 6,1 meseca) in zasevki v jetrih (RO 0,41; 95-% IZ: 0,26; 0,62; mediano PFS 8,2 v primerjavi s 5,4 meseca).
Tecentriq in combination with nab-paclitaxel and carboplatin 
Zdravilo Tecentriq v kombinaciji z nab-paklitakselom in karboplatinom
A phase III, open-label, multicenter, international, randomised study, IMpower150, was conducted to evaluate the efficacy and safety of atezolizumab in combination with paclitaxel and carboplatin, with or without bevacizumab, in chemotherapy-naïve patients with metastatic non-squamous NSCLC. 
Multicentrična, mednarodna, randomizirana študija faze III z odprtim načrtom zdravljenja IMpower150 je bila izvedena z namenom ugotavljanja učinkovitosti in varnosti atezolizumaba v kombinaciji s paklitakselom in karboplatinom (z bevacizumabom ali brez njega) pri bolnikih z razsejanim neploščatoceličnim NDRP, ki še niso prejemali kemoterapije.
Pancreatitis led to the discontinuation of atezolizumab in 3 (< 0.1%) patients. 
Zaradi pankreatitisa so zdravljenje z atezolizumabom prenehali 3 (< 0,1 %) bolniki.
If you notice any of the side effects above or if they get worse, tell your doctor straight away. 
Če opazite katerega od zgoraj naštetih neželenih učinkov ali se kakšen neželen učinek poslabša,
In the population pharmacokinetic analysis, no clinically important differences in the clearance of atezolizumab were found in patients with mild (estimated glomerular filtration rate [eGFR] 60 to 
Populacijska farmakokinetična analiza ni pokazala klinično pomembnih razlik med očistkom atezolizumaba pri bolnikih z blago (ocenjena hitrost glomerulne filtracije [eGFR] od 60 do 89 ml/min/1,73 m2; n = 208)
QLQ-LC13 was observed with atezolizumab compared to docetaxel (HR of 0.71, 95% CI: 0.49, 1.05; 
Atezolizumab je v primerjavi z docetakselom podaljšal čas do poslabšanja bolečin v prsih po navedbi bolnika, merjenih z EORTC QLQ-LC13 (RO 0,71, 95-% IZ: 0,49, 1,05; mediana ni bila dosežena v nobeni skupini).
The median duration was 2.1 months (range 0 day to 22.0+ months; + denotes a censored value). 
Mediano trajanje je bilo 2,1 meseca (razpon: od 0 dni do 22,0+ mesecev; + označuje krnjeno vrednost).
NAME OF THE MEDICINAL PRODUCT Tecentriq 840 mg concentrate for solution for infusion. 
IME ZDRAVILA Tecentriq 840 mg koncentrat za raztopino za infundiranje
Immune related adverse reaction 
Imunsko pogojeni neželeni učinek
How to store Tecentriq 
Kako uporabljati zdravilo Tecentriq
Stratifiedǂ hazard ratio (95% CI) 12-month OS (%)** 
Mediani čas do dogodkov (meseci) 95-% IZ Stratificiranoǂ razmerje ogroženosti (95-% IZ) p-vrednost** 12-mesečno OS (%)*** 18-mesečno OS (%)***
Treatment with atezolizumab should be permanently discontinued for Grade 4, or any grade of recurrent pancreatitis. 
V primeru pankreatitisa 4. stopnje ali ponovnega pankreatitisa ne glede na stopnjo je treba zdravljenje z atezolizumabom trajno ukiniti.
Common hypokalaemia, hyponatraemia, hyperglycaemia hypokalaemia, hyponatraemia, hypomagnesaemia 
Presnovne in prehranske motnje zelo pogosti zmanjšan apetit zmanjšan apetit pogosti hipokaliemija, hiponatriemija, hiperglikemija hipokaliemija, hiponatriemija, hipomagneziemija
Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin 
Uporaba atezolizumaba v kombinaciji z bevacizumabom, paklitakselom in karboplatinom
Clear, colourless to slightly yellowish liquid. 
koncentrat za raztopino za infundiranje bistra, brezbarvna do rahlo rumenkasta tekočina
Pneumonitis requiring the use of corticosteroids occurred in 1.6% (51/3,178) of patients receiving atezolizumab monotherapy. 
Pnevmonitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 1,6 % (51/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Colitis led to discontinuation of atezolizumab in 8 (0.3%) patients. 
Zaradi kolitisa je zdravljenje z atezolizumabom prenehalo 8 (0,3 %) bolnikov.
≤ Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day. 
0. ali 1. stopnjo in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan.
Figure 13: Kaplan-Meier curve for progression-free survival (IMpower133) 
Slika 13: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (IMpower133)
95% CI Stratified hazard ratio (95% CI) 
Stratificirano razmerje ogroženosti (95-% IZ)
Common abdominal pain, colitiss, dysphagia, oropharyngeal paint stomatitis, dysgeusia 
disfagija, orofaringealna bolečinat stomatitis, disgevzija občasni pankreatitis u
The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq followed by bevacizumab, is administered by intravenous infusion every three weeks. 
Uvodni fazi zdravljenja sledi faza vzdrževanja brez kemoterapije, med katero se na tri tedne uporabi zdravilo Tecentriq v odmerku 1200 mg v intravenski infuziji, ki mu sledi bevacizumab.
Österreich Roche Austria GmbH 
Roche Registration GmbH
If symptoms improve to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month. 
Če se simptomi izboljšajo na ≤ 1. stopnjo, je treba odmerek kortikosteroidov postopoma zmanjševati v obdobju ≥ 1 meseca.
The demographic and baseline disease characteristics of the study population were well balanced between the treatment arms. 
Demografske in izhodiščne značilnosti raziskovane populacije so bile med terapevtskima skupinama dobro uravnotežene.
Dose delay or discontinuation (see also sections 4.4 and 4.8) Table 1: Dose modification advice for Tecentriq 
Zapoznitev odmerka ali prenehanje uporabe (glejte tudi poglavji 4.4 in 4.8)
For the recommended dose of 1680 mg: twenty-eight mL of Tecentriq concentrate should be withdrawn from two vials of Tecentriq 840 mg and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 
Za priporočeni 1680-mg odmerek: 28 ml koncentrata zdravila Tecentriq je treba vzeti iz dveh vial zdravila Tecentriq 840 mg 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.
Maintenance (21-day cycles) 
(21-dnevni cikli)
Hypophysitis Hypophysitis occurred in < 0.1% (2/3,178) of patients who received atezolizumab monotherapy. 
Hipofizitis se je pojavil pri < 0,1 % (2/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Colitis occurred in 1.1% (34/3,178) of patients who received atezolizumab monotherapy. 
Kolitis se je pojavil pri 1,1 % (34/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Myocarditis has been observed in clinical trials with atezolizumab (see section 4.8). 
V kliničnih preskušanjih z atezolizumabom so opazili miokarditis (glejte poglavje 4.8).
3 weeks until disease progression. 
- še 5 mesecev po zadnjem odmerku.
This study excluded patients who had a history of autoimmune disease; active or corticosteroid-dependent brain metastases; administration of a live, attenuated vaccine within 28 days prior to enrolment; and administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to enrolment. 
V to študijo niso bili vključeni bolniki, ki so imeli avtoimunsko bolezen v anamnezi; simptomatske ali od kortikosteroidov odvisne zasevke v možganih; ki so prejeli živo, oslabljeno cepivo v 28 dneh pred vključitvijo, ki so uporabljali sistemska imunostimulatorna sredstva v 4 tednih pred vljučitvijo ali sistemska imunosupresivna zdravila v 2 tednih pred vključitvijo.
Pancreatitis requiring the use of corticosteroids occurred in 0.1% (4/3,178) of patients receiving atezolizumab monotherapy. 
Pankreatitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 0,1 % (4/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
The study met its co-primary endpoints in Cohort 2, demonstrating statistically significant ORRs per IRF-assessed RECIST v1.1 and investigator-assessed mRECIST 
Študija je dosegla soprimarne opazovane dogodke v 2. kohorti in je pokazala statistično značilno boljše deleže objektivnih odgovorov po oceni IRF v skladu z merili RECIST v1.1 ter po oceni raziskovalcev v skladu z merili mRECIST v primerjavi z vnaprej opredeljenim 10-odstotnim kontrolnim historičnim deležem odgovora.
The rate of infusion should be reduced or treatment should be interrupted in patients with Grade 1 or 2 infusion-related reactions. 
Pri bolnikih, ki imajo z infundiranjem povezane reakcije 1. ali 2. stopnje, je treba hitrost infundiranja zmanjšati ali zdravljenje prekiniti.
Secondary and exploratory endpoints Investigator-assessed ORR (RECIST 1.1) 
Stratificirano razmerje ogroženosti‡ (95-% IZ) Sekundarni in eksploratorni dogodki učinkovitosti ORR po oceni raziskovalca (RECIST 1.1)
Includes reports of oropharyngeal pain, oropharyngeal discomfort, throat irritation. 
t Vključuje poročila o orofaringealni bolečini, orofaringealnem nelagodju, draženju žrela.
Cohort 2. 
Preglednica 2.
Myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome, which may be life threatening, were observed in patients receiving atezolizumab. 
V primeru miastenijskega sindroma/miastenije gravis ali Guillain-Barréjevega sindroma je treba zdravljenje z atezolizumabom trajno prekiniti ne glede na njihovo stopnjo.
Secondary efficacy endpoints evaluated per investigator-assessed Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 are objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR). 
Sekundarni opazovani dogodki učinkovitosti po oceni raziskovalca so delež objektivnega odgovora (ORR, objective response rate), preživetje brez napredovanja bolezni (PFS, progression-free survival) in trajanje odgovora (DOR, duration of response) po merilih RECIST (Response Evaluation Criteria in Solid Tumors) v1.1.
95% CI Stratifiedǂ hazard ratio (95% CI) 
Stratificiranoǂ razmerje ogroženosti (95% IZ)
Hepatitis requiring the use of corticosteroids occurred in 0.6% (18/3,178) of patients receiving atezolizumab monotherapy. 
Hepatitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 0,6 % (18/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Diabetes mellitus occurred in 0.3% (11/3,178) of patients who received atezolizumab monotherapy. 
Sladkorna bolezen se je pojavila pri 0,3 % (11/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
• underactive thyroid gland (hypothyroidism) 
• premajhno delovanje žleze ščitnice (hipotiroidizem)
Table 2: Summary of adverse reactions occurring in patients treated with atezolizumab Atezolizumab monotherapy 
Povzetek neželenih učinkov pri bolnikih, zdravljenih z atezolizumabom
Figure 4: Kaplan-Meier curve for PFS in the ITT population (IMpower150) 
Slika 4: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji ITT (IMpower150)
Treatment with atezolizumab must be permanently discontinued for Grade 3 or Grade 4 events (ALT or AST > 5.0 x ULN or blood bilirubin > 3 x ULN). 
V primeru učinkov 3. ali 4. stopnje (ALT ali AST > 5,0-kratna ZNM ali bilirubin v krvi > 3-kratna ZNM) je treba zdravljenje z atezolizumabom trajno ukiniti.
Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 myocarditis. 
V primeru miokarditisa 3. ali 4. stopnje je treba zdravljenje z atezolizumabom trajno ukiniti.
Immune-related neuropathies 
Imunsko pogojene nevropatije
should also have received targeted therapies before receiving Tecentriq (see section 5.1). 
Bolniki z EGFR mutiranim ali ALK pozitivnim NDRP morajo pred uvedbo zdravila Tecentriq prejeti tudi tarčna zdravljenja (glejte poglavje 5.1).
Investigator-assessed DOR (RECIST v1.1) 
DOR po oceni raziskovalca (RECIST v1.1)
IMpower130 (GO29537): Randomised phase III trial in chemotherapy-naïve patients with metastatic non-squamous NSCLC, in combination with nab-paclitaxel and carboplatin 
IMpower130 (GO29537): randomizirano preskušanje faze III atezolizumaba v kombinaciji z nab paklitakselom in karboplatinom pri bolnikih z razsejanim neploščatoceličnim NDRP, predhodno še nezdravljenih s kemoterapijo
Adrenal insufficiency requiring the use of corticosteroids occurred in 0.3% (9/3,178) of patients receiving atezolizumab monotherapy. 
Insuficienca nadledvičnih žlez, zaradi katere je bilo treba uporabiti kortikosteroide, se je pojavila pri 0,3 % (9/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.