FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time to onset was 4.7 months (range 15 days to 17.2 months).
Slovenian: Mediani čas do pojava je bil 4,7 mesece (razpon: od 15 dni do 17,2 meseca).
English: • a cancer that affects the bladder and the urinary system, called urothelial carcinoma.
Slovenian: • rakom, ki prizadene sečni mehur ali druga sečila in ga imenujemo urotelijski karcinom.
English: Guillain-Barré syndrome requiring the use of corticosteroids occurred in < 0.1% (2/3,178) of patients receiving atezolizumab monotherapy.
Slovenian: Guillain-Barréjev sindrom, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri < 0,1 % (2/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
English: Treatment may be resumed if the event improves to ≤ Grade 1 within 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).
Slovenian: Zdravljenje se lahko znova začne, če se neželeni učinek v 12 tednih izboljša na ≤ 1. stopnjo in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan, bolnik pa je stabilen na nadomestnem zdravljenju (če je potrebno).
English: After dilution, one mL of solution should contain approximately 4.4 mg of Tecentriq (1,200 mg/270 mL).
Slovenian: Po razredčenju vsebuje en mililiter raztopine približno 4,4 mg zdravila Tecentriq (1200 mg/270 ml).
English: For Grade 2 diarrhoea or colitis, if symptoms persist > 5 days or recur, treatment with 1 to 2 mg/kg/day prednisone or equivalent should be started.
Slovenian: Če simptomi diareje ali kolitisa 2. stopnje trajajo > 5 dni ali se ponovijo, je treba uvesti zdravljenje s prednizonom v odmerku 1 do 2 mg/kg/dan (ali ekvivalenta).
English: Adrenal insufficiency
Slovenian: Insuficienca naledvičnih žlez
English: During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by bevacizumab, paclitaxel, and then carboplatin every three weeks for four or six cycles.
Slovenian: Med uvodno fazo je priporočeni odmerek zdravila Tecentriq 1200 mg v intravenski infuziji, čemur sledijo bevacizumab, paklitaksel in nato karboplatin na tri tedne, skupno štiri ali šest ciklov.
English: Baseline ECOG performance status was 0 (37%) or 1 (63%).
Slovenian: Izhodiščno stanje zmogljivosti po ECOG je bilo 0 (37 %) ali 1 (63 %).
English: Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy.
Slovenian: Zdravilo Tecentriq je kot monoterapija indicirano za zdravljenje odraslih bolnikov z lokalno napredovalim ali razsejanim NDRP, ki so bili predhodno zdravljeni s kemoterapijo.
English: 1-year OS rate (%)
Slovenian: 1-letno celokupno preživetje (%)
English: Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):
Slovenian: Zdravilo Tecentriq je kot monoterapija indicirano za zdravljenje odraslih bolnikov z lokalno napredovalim ali razsejanim urotelijskim karcinomom, ki:
English: Treatment with atezolizumab may be resumed if metabolic control is achieved on insulin replacement therapy.
Slovenian: Zdravljenje z atezolizumabom se lahko znova začne, če je presnova urejena z insulinskim zdravljenjem.
English: 22 months showed a median OS of 12.6 months in patients treated with atezolizumab, vs. 9.7 months in patients treated with docetaxel (HR of 0.69, 95% CI: 0.52, 0.92).
Slovenian: Posodobljena analiza po skupno 200 zabeleženih smrtih in z medianim spremljanjem preživetja 22 mesecev je pokazala mediano celokupno preživetje 12,6 meseca pri prejemnikih atezolizumaba in 9,7 meseca pri prejemnikih docetaksela (RO 0,69, 95-% IZ: 0,52; 0,92).
English: Treatment with atezolizumab must be permanently discontinued for Grade 4 (life threatening; urgent intervention indicated) diarrhoea or colitis.
Slovenian: V primeru diareje ali kolitisa 4. stopnje (življenje ogrožujoče stanje; potrebno je nujno ukrepanje) je treba zdravljenje z atezolizumabom trajno ukiniti.
English: The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by intravenous infusion every three weeks.
Slovenian: Uvodni fazi zdravljenja sledi faza vzdrževanja brez kemoterapije, med katero se zdravilo Tecentriq v odmerku 1200 mg v intravenski infuziji aplicira na tri tedne.
English: NSCLC patients (hazard ratio [HR] of 0.73, 95% CI: 0.60, 0.89; median OS of 15.6 vs. 11.2 months for atezolizumab and docetaxel, respectively) and squamous NSCLC patients (HR of 0.73, 95% CI: 0.54, 0.98; median OS of 8.9 vs. 7.7 months for atezolizumab and docetaxel, respectively).
Slovenian: Celokupno preživetje se je z atezolizumabom v primerjavi z docetakselom izboljšalo tako pri bolnikih z neploščatoceličnim NDRP (razmerje ogroženosti [RO] 0,73, 95-% IZ: 0,60; 0,89; mediano celokupno preživetje 15,6 meseca z atezolizumabom in 11,2 meseca z docetakselom) kot pri bolnikih s ploščatoceličnim NDRP (RO 0,73; 95-% IZ: 0,54; 0,98; mediano celokupno preživetje 8,9 meseca z atezolizumabom in 7,7 z docetakselom).
English: Small cell lung cancer
Slovenian: Drobnocelični rak pljuč
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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).
English: Patients should be monitored for signs and symptoms of myocarditis.
Slovenian: Bolnike je treba nadzorovati glede znakov in simptomov, ki kažejo na miokarditis.
English: 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.
Slovenian: b Vključuje poročila o pljučnici, bronhitisu, okužbi pljuč, okužbi spodnjih dihal, poslabšanju KOPB zaradi okužbe, infekcijskem plevralnem izlivu, traheobronhitisu, atipični pljučnici, pljučnem abscesu, piopnevmotoraksu.
English: • inflammation of the lung (pneumonitis): symptoms may include new or worsening cough, shortness of breath, and chest pain
Slovenian: • vnetje pljuč (pnevmonitis): med simptomi so lahko novonastal kašelj ali poslabšanje kašlja, težko dihanje in bolečine v prsih;
English: 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.
Slovenian: Priporočeni odmerek zdravila Tecentriq je 840 mg v intravenski infuziji, ki ji sledi 100 mg/m nab-paklitaksela.
English: Tumour assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, Day 1 and then every 9 weeks thereafter.
Slovenian: Ocene tumorjev so izvedli na vsakih 6 tednov po 1. dnevu 1. cikla v prvih 48 tednih in nato na vsakih 9 tednov.
English: Prognostic risk factors included time from prior chemotherapy of < 3 months,
Slovenian: Napovedni dejavniki tveganja so vključevali čas od predhodne kemoterapije < 3 mesece, stanje zmogljivosti po ECOG > 0 in hemoglobin < 10 g/dl.
English: 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.
Slovenian: 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.
English: Investigator-assessed DOR (RECIST 1.1)** ^
Slovenian: DOR po oceni raziskovalca (RECIST 1.1)** ^
English: How Tecentriq is given
Slovenian: Kako se daje zdravilo Tecentriq
English: After dilution, one mL of solution should contain approximately 3.2 mg of Tecentriq (840 mg/264 mL).
Slovenian: Po razredčenju vsebuje en mililiter raztopine približno 3,2 mg zdravila Tecentriq (840 mg/264 ml).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 mL vial of concentrate contains 840 mg of atezolizumab*.
Slovenian: Ena 14-ml viala s koncentratom vsebuje 840 mg atezolizumaba*.
English: 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.
Slovenian: 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.
English: Atezolizumab (1,200 mg)a
Slovenian: atezolizumab (1200 mg)a + nab-paklitaksel
English: Induction (Four 21-Day Cycles)
Slovenian: Uvodno zdravljenje (štirje 21-dnevni cikli)
English: IMpassion130 (WO29522): Randomised phase III trial in locally advanced or metastatic TNBC patients previously untreated for metastatic disease
Slovenian: Preskušanje IMpassion130 (WO29522): randomizirano preskušanje faze III pri bolnikih z lokalno napredovalim ali razsejanim TNRD, predhodno še nezdravljenih zaradi razsejane bolezni
English: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis and type 1 diabetes mellitus, including diabetic ketoacidosis have been observed in clinical trials with atezolizumab (see section
Slovenian: 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).
English: The median time to onset was 1.5 months (range 6 days to 18.8
Slovenian: Mediani čas do pojava je bil 1,5 meseca (razpon: od 6 dni do 18,8 meseca).
English: Carboplatin and etoposide were administered until completion of 4 cycles, or progressive disease or unacceptable toxicity, whichever occurs first c
Slovenian: b Karboplatin in etopozid so uporabljali do dokončanja 4 ciklov, napredovanja bolezni ali nesprejemljivih toksičnih učinkov,
English: POPLAR (GO28753): Randomised phase II trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
Slovenian: POPLAR (GO28753): Randomizirano preskušanje faze II pri bolnikih z lokalno napredovalim ali razsejanim NDRP, ki so bili predhodno zdravljeni s kemoterapijo
English: Tecentriq 840 mg concentrate for solution for infusion atezolizumab
Slovenian: Tecentriq 840 mg koncentrat za raztopino za infundiranje atezolizumab
English: 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
Slovenian: 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)
English: Tel: +371 - 6 7039831
Slovenian: Roche Latvija SIA Tel: +371 - 6 7039831
English: Respiratory, thoracic, and mediastinal disorders Very common cough, dyspnoea dyspnoea, cough
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti kašelj, dispneja dispneja, kašelj pogosti pnevmonitisq, hipoksija,
English: Figure 9: Forest plot of progression free survival by PD-L1 expression (IMpower130)
Slovenian: Slika 9: Drevesni diagram preživetja brez napredovanja bolezni glede na izražanje PD-L1 (IMpower130)
English: Tumour assessments were conducted every 6 weeks for the first 36 weeks, and every 9 weeks thereafter.
Slovenian: Ocenjevanje odgovora tumorja so prvih 36 tednov izvajali na 6 tednov, nato pa vsakih 9 tednov.
English: Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab
Slovenian: Tecentriq 1200 mg koncentrat za raztopino za infundiranje atezolizumab
English: 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).
Slovenian: 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.
English: Treatment may be resumed when rash is resolved and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day
Slovenian: Zdravljenje se lahko znova začne, ko izpuščaj mine in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan.
English: The median duration was 26 days (range 6 days to 14.5+ months; + denotes a censored value).
Slovenian: Mediano trajanje je bilo 26 dni (razpon: od 6 dni do 14,5+ meseca; + označuje krnjeno vrednost).
English: • mouth and throat pain
Slovenian: • bolečina v ustih in žrelu
English: Other endpoints Investigator-assessed ORR (RECIST 1.1)** ^
Slovenian: ORR po oceni raziskovalca (RECIST 1.1)** ^
English: Cardiac disorders Rare myocarditisp Vascular disorders Common hypotension
Slovenian: Srčne bolezni redki miokarditisp
English: The median time to onset was 2.1 months (range 21 days to 15.7 months).
Slovenian: Mediani čas do pojava je bil 2,1 meseca (razpon: od 21 dni do 15,7 meseca).
English: • inflammation of the intestines (colitis): symptoms may include diarrhoea (watery, loose or soft stools), blood in stools, and stomach pain
Slovenian: • vnetje črevesa (kolitis): med simptomi so lahko driska (vodeno, redko ali mehko blato), kri v blatu in bolečine v trebuhu;
English: Grade 4 or any grade of recurrent pancreatitis
Slovenian: Pankreatitis 4. stopnje ali ponovitev pankreatitisa ne glede na stopnjo
English: Figure 2: Kaplan-Meier curve for overall survival in the ITT population (IMpower150)
Slovenian: Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji ITT (IMpower150)
English: (creatinine level > 1.5 to 3.0 x baseline or > 1.5 to 3.0 x ULN)
Slovenian: 2. stopnja: koncentracija kreatinina > 1,5 do 3,0kratna izhodiščna vrednost ali > 1,5 do 3,0-kratna ZNM)
English: What Tecentriq is used for
Slovenian: Za kaj uporabljamo zdravilo Tecentriq
English: Pneumonitis led to discontinuation of atezolizumab in 12 (0.4%) patients.
Slovenian: Zaradi pnevmonitisa je zdravljenje z atezolizumabom končalo 12 (0,4 %) bolnikov.
English: Meningoencephalitis requiring the use of corticosteroids occurred in 0.2% (6/3,178) of patients receiving atezolizumab and four patients discontinued atezolizumab.
Slovenian: 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.
English: Baseline ECOG performance status was 0 (43%) or 1 (57%).
Slovenian: Izhodiščno stanje zmogljivosti po ECOG je bilo 0 (43 %) ali 1 (57 %).
English: Table 8: Intravenous treatment regimens (IMpower130) Treatment
Slovenian: Intravenski shemi zdravljenja (IMpower130)
English: Arm A Atezolizumab + nab-paclitaxel + carboplatin
Slovenian: Skupina A atezolizumab + nab-paklitaksel + karboplatin
English: Docetaxel was administered 75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression.
Slovenian: Docetaksel so uporabljali v odmerku 75 mg/m v intravenski infuziji 1. dan vsakega 3-tedenskega cikla do napredovanja bolezni.
English: No overall differences in safety were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Slovenian: Med bolniki, starimi ≥ 65 let, in mlajšimi bolniki, ki so prejemali monoterapijo z atezolizumabom, niso opazili razlik v varnosti.
English: Investigator-assessed PFS (RECIST v1.1) - Primary analysis
Slovenian: PFS po oceni raziskovalca (RECIST v1.1) - primarna analiza Število dogodkov (%)
English: Hypothyroidism:
Slovenian: Tecentriq:
English: No overall differences in efficacy were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Slovenian: Med bolniki, starimi ≥ 65 let, in mlajšimi bolniki, ki so prejemali atezolizumab, niso opazili razlik v učinkovitosti.
English: 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.
Slovenian: Za opis preskušanj zdravila Tecentriq glejte poglavje 5.1 Povzetka glavnih značilnosti zdravila (SmPC) zdravila Tecentriq 1200 mg koncentrat za raztopino za infundiranje.
English: • a cancer that affects the lungs, called small cell lung cancer (SCLC).
Slovenian: • rakom, ki prizadene pljuča in ga imenujemo drobnocelični rak pljuč.
English: musculoskeletal painx arthralgia, musculoskeletal painx, back pain
Slovenian: 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
English: • 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.
Slovenian: • 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.
English: Baseline ECOG performance status was 0 (35%) or 1 (65%).
Slovenian: Izhodiščno stanje zmogljivosti po ECOG je bilo 0 (35 %) ali 1 (65 %).
English: Tumour specimens were evaluated prospectively for PD-L1 expression on tumour cells (TC) and tumour-infiltrating immune cells (IC).
Slovenian: Vzorce tumorjev so prospektivno ocenili glede izražanja PD-L1 na tumorskih celicah in celicah imunskega sistema, ki infiltrirajo tumor.
English: Tecentriq monotherapy
Slovenian: Zdravilo Tecentriq v monoterapiji
English: 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;
Slovenian: 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
English: 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.
Slovenian: Za atezolizumab niso dokazali statistično značilne koristi za preživetje v primerjavi s kemoterapijo pri bolnikih s predhodno zdravljenim, lokalno napredovalim ali razsejanim urotelijskim karcinomom.
English: Figure 10: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK)
Slovenian: Slika 10: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji za primarno analizo (neselekcionirani bolniki) (OAK)
English: 95% CI: 0.63, 1.72 for OS, respectively).
Slovenian: % IZ: 0,59; 1,47 za PFS in RO 1,04, 95-% IZ: 0,63; 1,72 za OS).
English: 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
Slovenian: 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.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo za intravensko uporabo po razredčenju
English: 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.
Slovenian: 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.
English: Pneumonitis occurred in 2.7% (87/3,178) of patients who received atezolizumab monotherapy.
Slovenian: Pnevmonitis se je pojavil pri 2,7 % (87/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
English: Figure 2: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK)
Slovenian: Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji za primarno analizo (neselekcionirani bolniki) (OAK)
English: 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.
Slovenian: 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.
English: IMpower133 (GO30081): Randomised phase I/III trial in patients with chemotherapy-naïve extensivestage SCLC, in combination with carboplatin and etoposide
Slovenian: IMpower133 (GO30081): randomizirano preskušanje faze I/III v kombinaciji s karboplatinom in etopozidom pri bolnikih z razsejanim DRP, predhodno še nezdravljenih s kemoterapijo
English: Grenzacherstrasse 124
Slovenian: F. Hoffmann-La Roche AG Grenzacherstrasse 124 4070 Basel
English: Arm B (Atezolizumab + Bevacizumab + Paclitaxel + Carboplatin)
Slovenian: Skupina B (atezolizumab + bevacizumab + paklitaksel + karboplatin)
English: Adrenal insufficiency led to discontinuation of atezolizumab in 1 (<0.1%) patient.
Slovenian: Zaradi insuficience nadledvičnih žlez je zdravljenje z atezolizumabom prenehal 1 (< 0,1 %) bolnik.
English: (hypoxia)
Slovenian: (trombocitopenija)
English: Roche a/s c/o Icepharma hf
Slovenian: Roche a/s c/o Icepharma hf Sími: +354 540 8000
English: Nervous system disorders Very Common peripheral neuropathyl , dizziness, headache
Slovenian: Bolezni živčevja zelo pogosti periferna nevropatijal, omotica, glavobol pogosti sinkopa občasni
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: Rare nephritisaa
Slovenian: Okvara ledvic