natgillin/translations-raw huggingface dataset:
The effect of moderate or severe hepatic impairment (bilirubin > 1.5 × to 3 × ULN and any AST or bilirubin > 3 × ULN and any AST) on the pharmacokinetics of atezolizumab is unknown.
Vpliv zmerne ali hude okvare jeter (bilirubin > 1,5- do 3-kratna ZNM ne glede na AST ali bilirubin > 3-kratna ZNM ne glede na AST) na farmakokinetiko atezolizumaba ni znan.
Exploratory subgroup analyses were performed in patients with PD-L1 expression ≥ 1%, exploring prior (neo)adjuvant treatment, BRCA1/2 mutation and asymptomatic brain metastases at baseline.
Pri bolnikih z izražanjem PD-L1 ≥ 1 % so opravili eksploratorne analize podskupin; v njih so raziskovali predhodno (neo)adjuvantno zdravljenje, mutacije BRCA1/2 in nesimptomatske zasevke v možganih izhodiščno.
If you are not sure, talk to your doctor or nurse before you are given Tecentriq.
Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden dobite zdravilo Tecentriq.
Atezolizumab in combination therapy
Atezolizumab v kombinirani terapiji
A total of 902 patients were enrolled and stratified by presence of liver metastases, prior taxane treatment, and by PD-L1 expression status in tumour-infiltrating immune cells (IC) (PD-L1 stained tumour-infiltrating immune cells [IC] <1% of tumour area vs. ≥ 1% of the tumour area) assessed by the VENTANA PD-L1 (SP142) Assay.
Skupaj sta bila vključena 902 bolnika; bolnike so stratificirali glede na prisotnost zasevkov v jetrih, predhodno zdravljenje s taksani in stanje izražanja PD-L1 v tumorskih infiltratih imunskih celic (IC) (za PD-L1 barvani tumorski infiltrati imunskih celic [IC] < 1 % površine tumorja v primerjavi z ≥ 1 % površine tumorja), ocenjeno s preizkusom VENTANA PD-L1 (SP142).
• The other ingredients are L-histidine, glacial acetic acid, sucrose, polysorbate 20 and water for injections.
• Druge sestavine zdravila so L-histidin, koncentrirana ocetna kislina, saharoza, polisorbat 20 in voda za injekcije.
In an exploratory analysis with longer follow up (median: 24.1 months), the median OS for both arms was unchanged relative to the primary analysis, with HR = 0.82 (95% CI: 0.67, 1.01).
V eksploratorni analizi z daljšim spremljanjem (mediana: 24,1 meseca) je bilo mediano OS v obeh skupinah glede na primarno analizo nespremenjeno; RO je bilo 0,82 (95-% IZ: 0,67; 1,01).
For Cohort 2, median DOR was not reached in any PD-L1 expression subgroup or in all comers, however was reached in patients with PD-L1 expression < 1% (13.3 months; 95% CI 4.2, NE).
V 2. kohorti mediano trajanje odgovora ni bilo doseženo v nobeni od podskupin izražanja PD-L1 in tudi ne med neselekcioniranimi bolniki, doseženo pa je bilo pri bolnikih z izražanjem PD-L1 < 1 % (13,3 meseca, 95-% IZ: 4,2; ni ocenljivo).
Atezolizumab spares the PD-L2/PD-1 interaction allowing PD-L2/PD-1 mediated inhibitory signals to persist.
Atezolizumab ne vpliva na interakcijo PD-L2/PD-1 in tako ohrani s PD-L2/PD-1 posredovane zaviralne signale.
The co-primary efficacy endpoints included investigator-assessed progression free survival (PFS) in the ITT population and in patients with PD-L1 expression ≥ 1% per RECIST v1.1 as well as overall survival (OS) in the ITT population and in patients with PD-L1 expression ≥ 1%.
Soprimarani opazovani dogodki učinkovitosti so obsegali preživetje brez napredovanja bolezni (PFS) po oceni raziskovalca v populaciji ITT in pri bolnikih z izražanjem PD-L1 ≥ 1 % po merilih RECIST v1.1 ter celokupno preživetje (OS) v populaciji ITT in pri bolnikih z izražanjem PD-L1 ≥ 1 %.
Patients were treated until loss of clinical benefit as assessed by the investigator.
Bolnike so zdravili do izgube klinične koristi po oceni raziskovalca.
It is a clear, colourless to slightly yellowish liquid.
Je bistra, brezbarvna do rahlo rumenkasta tekočina.
For symptomatic hypothyroidism, atezolizumab should be withheld and thyroid hormone replacement should be initiated as needed.
V primeru simptomatskega hipotiroidizma je treba uporabo atezolizumaba odložiti in uvesti nadomeščanje ščitničnih hormonov, kot je potrebno.
Post-authorisation efficacy study (PAES): In order to further evaluate the efficacy of atezolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer, the MAH should submit the final OS results of study IMvigor210.
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Za nadaljnjo oceno učinkovitosti atezolizumaba pri zdravljenju bolnikov z lokalno napredovalim ali razsejanim rakom urotelija mora imetnik dovoljenja za promet z zdravilom predložiti končne rezultate glede celokupnega preživetja iz študije IMvigor210.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,200 mg/20 mL
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1200 mg/20 ml
The median age was 55 years (range: 20-86).
Mediana starost je bila 55 let (razpon: od 20 do 86 let).
Use of atezolizumab in combination with nab-paclitaxel in metastatic triple negative breast cancer
Uporaba atezolizumaba v kombinaciji z nab-paklitakselom pri razsejanem trojno negativnem raku dojk
• type 1 diabetes, including acid in the blood produced from diabetes (diabetic ketoacidosis): symptoms may include feeling more hungry or thirsty than usual, need to urinate more often, weight loss, and feeling tired
• sladkorna bolezen tipa 1, vključno z zakisanostjo krvi zaradi sladkorne bolezni (diabetična ketoacidoza): med simptomi so lahko večja lakota ali žeja kot po navadi, pogosto uriniranje, hujšanje in utrujenost;
Fifty-nine percent of patients in the nab-paclitaxel and carboplatin arm received any cancer immunotherapy after disease progression, which includes atezolizumab as crossover treatment (41% of all patients), compared to 7.3% of patients in the atezolizumab, nab paclitaxel and carboplatin arm.
Devetinpetdeset odstotkov (59 %) bolnikov v skupini z nab-paklitakselom in karboplatinom je po napredovanju bolezni prejemalo katero koli imunoterapijo za zdravljenje raka (to vključuje navzkrižni prehod na zdravljenje z atezolizumabom (41 % vseh bolnikov)); v primerjavi s skupino z atezolizumabom, nab-paklitakselom in karboplatinom, kjer je bilo takšnih bolnikov 7,3 %.
Secondary efficacy endpoints included objective response rate (ORR) and duration of response (DOR) per RECIST v1.1.
Sekundarni opazovani dogodki učinkovitosti so vključevali delež objektivnega odgovora (ORR) in trajanje odgovora (DOR) po merilih RECIST v1.1.
Immune-related adverse reactions with atezolizumab may occur after the last dose of atezolizumab.
Imunsko pogojeni neželeni učinki, povezani z atezolizumabom, se lahko pojavijo po zadnjem odmerku atezolizumaba.
Exposure to atezolizumab increased dose proportionally over the dose range 1 mg/kg to 20 mg/kg including the fixed dose 1,200 mg administered every 3 weeks.
Izpostavljenost atezolizumabu se je v razponu odmerkov od 1 mg/kg do 20 mg/kg povečevala sorazmerno z odmerkom, vključno s fiksnim odmerkom 1200 mg, apliciranim na 3 tedne.
The data below reflect information for significant adverse reactions for atezolizumab as monotherapy in clinical studies (see section 5.1).
Spodnji podatki prikazujejo informacije o pomembnih neželenih učinkih monoterapije z atezolizumabom v kliničnih študijah (glejte poglavje 5.1).
No studies have been conducted to investigate the pharmacokinetics of atezolizumab in children or adolescents.
Študij za proučitev farmakokinetike atezolizumaba pri otrocih in mladostnikih niso izvedli.
Myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome and Meningoencephalitis
Miastenijski sindrom/miastenija gravis, Guillain-Barréjev sindrom in meningoencefalitis
For each 21-day cycle, Tecentriq, nab-paclitaxel, and carboplatin are administered on day 1.
V vsakem 21-dnevnem ciklu se zdravilo Tecentriq, nab-paklitaksel in karboplatin aplicirajo 1. dan.
472 patients described atezolizumab pharmacokinetics for the dose range: 1 to 20 mg/kg with a linear two-compartment disposition model with first-order elimination.
Populacijska analiza, ki je vključila 472 bolnikov, je popisala farmakokinetiko atezolizumaba v razponu odmerkov od 1 do 20 mg/kg z linearnim modelom dvoprostornega odstranjevanja z izločanjem prvega reda.
Patients with event (%) Median (months) (95% CI)
Bolniki z dogodkom (%) Mediana (meseci) (95-% IZ)
The majority of patients were white (70%).
Večina bolnikov je bila belcev (70 %).
There was no evidence of efficacy in patients with asymptomatic brain metastases at baseline, although the number of patients treated was small; the median PFS was 2.2 months in the atezolizumab plus nab-paclitaxel arm (n=15) compared to 5.6 months in the placebo plus nabpaclitaxel arm (n=11) (HR 1.40; 95% CI 0.57, 3.44).
Pri bolnikih z nesimptomatskimi zasevki v možganih izhodiščno ni bilo dokazov o učinkovitosti, vendar je bilo število zdravljenih bolnikov majhno; mediano PFS je bilo 2,2 meseca v skupini, ki je prejemala atezolizumab in nab-paklitaksel (n = 15), v primerjavi s 5,6 meseca v skupini, ki je prejemala placebo in nab-paklitaksel (n = 11) (RO 1,40; 95-% IZ: 0,57, 3,44).
There were 310 patients treated with atezolizumab 1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit.
310 bolnikov so zdravili z atezolizumabom v odmerku 1200 mg v intravenski infuziji na 3 tedne do izgube klinične koristi.
The majority of patients were white (82%).
Večina bolnikov je bila belcev (82 %).
Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway in murine pregnancy models can lead to immune-related rejection of the developing foetus resulting in foetal death (see section 5.3).
Študije na živalih so pokazale, da zavrtje poti PD-L1/PD-1 v modelih brejosti pri miših lahko povzroči imunsko zavrnitev razvijajočega se ploda s posledično smrtjo ploda (glejte poglavje 5.3).
e Includes reports of white blood cell count decreased and leukopenia.
Vključuje poročila o zmanjšanju števila belih krvnih celic in levkopeniji.
OTHER SPECIAL WARNING(S), IF NECESSARY Do not shake the vial
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
For ES-SCLC and for first-line NSCLC, in patients given Tecentriq in combination with carboplatin and nab-paclitaxel, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity.
Pri razsejanem DRP in v prvi liniji NDRP pri bolnikih, ki prejemajo zdravilo Tecentriq v kombinaciji s karboplatinom in nab-paklitakselom, je priporočljivo bolnike zdraviti z zdravilom Tecentriq do napredovanja bolezni ali do pojava neobvladljivih toksičnih učinkov.
Grade 3 or 4 serum amylase or lipase levels increased (> 2 x ULN) or Grade 2 or 3 pancreatitis
Zvišanje amilaze ali lipaze v serumu 3. ali 4. stopnje (> 2,0-kratna ZNM) ali pankreatitis 2. ali 3. stopnje
12-month PFS (%)
12-mesečno PFS (%)
shortness of breath, and chest pain
težko dihanje in bolečine v prsih;
Tecentriq has not been studied in patients with moderate or severe hepatic impairment (see section 5.2).
Zdravila Tecentriq pri bolnikih z zmerno ali hudo okvaro jeter niso preskušali (glejte poglavje 5.2).
OS interim analysis*
Vmesna analiza OS*
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 840 mg/14 mL
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 840 mg/14 ml
h Includes reports of hyperthyroidism, Basedow's disease, endocrine ophthalmopathy, exophthalmos.
h Vključuje poročila o hipertiroidizmu, Basedowi bolezni, endokrini oftalmopatiji, eksoftalmusu.
Dose modifications during treatment
Prilagoditev odmerka med zdravljenjem
o Incudes reports of myasthenia gravis.
o Vključuje poročila o miasteniji gravis.
It is recommended that patients are treated with Tecentriq until loss of clinical benefit (see section 5.1) or unmanageable toxicity.
Zdravljenje z zdravilom Tecentriq je priporočljivo nadaljevati, dokler je klinično koristno (glejte poglavje 5.1) ali dokler se ne pojavijo neobvladljivi toksični učinki.
Patients were randomised to receive atezolizumab 840 mg or placebo by intravenous infusions on days 1 and 15 of every 28-day cycle, plus nab-paclitaxel (100 mg/m2) administered via intravenous infusion on days 1, 8 and 15 of every 28-day cycle.
Bolnike so randomizirali na prejemanje 840-mg atezolizumaba ali placeba v intravenski infuziji 1. in 15. dan vsakega 28-dnevnega cikla ter nab-paklitaksela (100 mg/m2) v intravenski infuziji 1., 8. in
The rate of complete response per IRF-RECIST v1.1 in the all comer population was 6.1% (95% CI: 3.7, 9.4).
Delež popolnega odgovora po oceni IRF glede na merila RECIST v1.1 v populaciji vseh neselekcioniranih bolnikov je bil 6,1 % (95-% IZ: 3,7; 9,4).
Use of atezolizumab in urothelial carcinoma for previously untreated patients who are considered cisplatin ineligible
Uporaba atezolizumaba pri urotelijskem karcinomu pri predhodno nezdravljenih bolnikih, ki niso primerni za zdravljenje s cisplatinom
6-month PFS (%) 12-month PFS (%)
6-mesečno PFS (%) 12-mesečno PFS (%)
• severe reactions associated with infusion (events occurring during the infusion or within one day of the infusion): may include fever, chills, shortness of breath and flushing.
• hujšo reakcijo, povezano z infundiranjem zdravil (dogodki, ki se pojavijo med infuzijo ali v enem dnevu po infuziji): zvišana telesna temperatura, mrzlica, težko dihanje in zardevanje.
Physicians should consult the nab-paclitaxel summary of product characteristics (SmPC) for specific precautions and contraindications of this medicine.
Glede posebnih previdnostnih ukrepov in kontraindikacij nab-paklitaksela morajo zdravniki prebrati povzetek glavnih značilnosti (SmPC) tega zdravila.
In study IMpower150, age ≥ 65 was associated with a diminished effect of atezolizumab in patients receiving atezolizumab in combination with carboplatin and paclitaxel.
V študiji IMpower150 je bila starost ≥ 65 let povezana z zmanjšanim učinkom atezolizumaba pri bolnikih, ki so prejemali atezolizumab v kombinaciji s karboplatinom in paklitakselom.
Bladder was the primary tumour site for 71.1% of patients and 25.4% of patients had upper tract urothelial carcinoma.
Pri 71,1 % bolnikov je bilo mesto primarnega tumorja mehur, 25,4 % bolnikov pa je imelo urotelijski karcinom zgornjega trakta.
Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
Zdravilo Tecentriq je v kombinaciji z nab-paklitakselom indicirano za zdravljenje odraslih bolnikov z inoperabilnim lokalno napredovalim ali razsejanim trojno negativnim rakom dojk (TNRD), katerih tumorji izražajo PD-L1 v ≥ 1 % in predhodno še niso prejemali kemoterapije zaradi razsejane bolezni.
The Adverse Drug Reactions (ADRs) are listed by MedDRA system organ class (SOC) and categories of frequency in Table 2 for atezolizumab given as monotherapy or as combination therapy.
Neželeni učinki zdravila so navedeni po organskih sistemih MedDRA in kategorijah pogostnosti v preglednici 2 za atezolizumab v monoterapiji ali kombinaciji.
Figure 3 summarises the results of OS in the ITT and PD-L1 subgroups.
Slika 3 povzema rezultate celokupnega preživetja v populaciji ITT in podskupinah PD-L1.
u Includes reports of autoimmune pancreatitis, pancreatitis, pancreatitis acute, lipase increased, amylase increased.
Vključuje poročila o avtoimunskem pankreatitisu, pankreatitisu, akutnem pankreatitisu, zvišani lipazi, zvišani amilazi.
Each mL contains 60 mg of atezolizumab.
En mililiter vsebuje 60 mg atezolizumaba.
Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic, grey flip-off cap containing 14 mL of concentrate for solution for infusion.
Viala iz stekla tipa I z zamaškom iz butilne gume in aluminijasim tesnilom z odstranljivo plastično sivo zaporko, ki vsebuje 14 ml koncentrata za raztopino za infundiranje.
The pharmacokinetic properties of atezolizumab 840 mg administered every 2 weeks and atezolizumab 1,200 mg administered every 3 weeks are comparable.
Farmakokinetične lastnosti 840-mg atezolizumaba, ki se daje na 2 tedna, in 1200-mg atezolizumaba, ki se daje na 3 tedne, so primerljive.
No clinical data are available on the possible effects of atezolizumab on fertility.
Kliničnih podatkov o možnih učinkih atezolizumaba na plodnost ni.
For TNBC, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity (see section 5.1).
Pri TNRD je zdravljenje z zdravilom Tecentriq priporočljivo nadaljevati do napredovanja bolezni ali dokler se ne pojavijo neobvladljivi toksični učinki (glejte poglavje 5.1).
Treatment may be resumed when the event is resolved
Zdravljenje se lahko znova začne, ko se neželeni učinek razreši.
In the population pharmacokinetic analysis, there were no clinically important differences in the clearance of atezolizumab between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 × to 1.5 × ULN and any AST, n= 71) and normal hepatic function (bilirubin and AST ≤
Populacijska farmakokinetična analiza ni pokazala klinično pomembnih razlik med očistkom atezolizumaba pri bolnikih z blago okvaro jeter (bilirubin ≤ ZNM in AST > ZNM ali bilirubin od < 1,0- do 1,5-kratna ZNM in kakršna koli AST, n = 71) in bolnikih z normalnim delovanjem jeter (bilirubin in AST ≤ ZNM, n = 401).
Tecentriq is used in combination with anticancer medicine (chemotherapy called nab-paclitaxel): if your doctor tested your cancer and found high levels of a specific protein in your body called program death ligand (PD-L1) when the cancer has spread to other parts of the body and has not been treated with anticancer medicines (chemotherapy) or else when the cancer has come back in the breast after previous treatment.
Zdravilo Tecentriq uporabljamo v kombinaciji z zdravilom proti raku (kemoterapijo, imenovano nab-paklitaksel): če je vaš zdravnik pri testiranju raka ugotovil, da imate v telesu visoko raven specifične beljakovine, imenovane ligand za programirano celično smrt 1 (PD-L1), če se je rak razširil na druge dele telesa in se še niste zdravili z zdravili proti raku (kemoterapijo) ali če se je rak dojk po predhodnem zdravljenju ponovil.
Asymptomatic patients with abnormal thyroid function tests can receive atezolizumab.
Asimptomatski bolniki z nenormalnimi izvidi testiranja delovanja ščitnice lahko prejmejo atezolizumab.
Approximately 10% of patients had known EGFR mutation, 4% had known ALK rearrangements, 14% had liver metastasis at baseline, and most patients were current or previous smokers (80%).
Približno 10 % bolnikov je imelo znano mutacijo EGFR, 4 % jih je imelo znano preureditev ALK, 14 % jih je imelo izhodiščno zasevke v jetrih in večina bolnikov je bila trenutnih ali nekdanjih kadilcev (80 %).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer 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.
Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika in običajno ne presegajo 24 ur pri temperaturi od 2 do 8 °C ali 8 ur pri sobni temperaturi (≤ 25 °C), razen če je redčenje potekalo v kontroliranih in validiranih aseptičnih pogojih.
• have been given medicines to suppress your immune system
• ste dobili zdravila za zavrtje imunskega sistema,
y Includes reports of myositis, rhabdomyolysis, polymyalgia rheumatica, dermatomyositis, muscle abscess, myoglobin urine present.
Vključuje poročila o miozitisu, rabdomiolizi, revmatični polimialgiji, dermatomiozitisu, mišičnem abscesu, prisotnosti mioglobina v urinu.
A population pharmacokinetic analysis suggests that steady-state is obtained after 6 to 9 weeks after multiple doses.
Populacijska farmakokinetična analiza kaže, da je stanje dinamičnega ravnovesja doseženo po 6 do 9 tednih večkratnega odmerjanja.
or blood bilirubin > 3 x ULN)
ali bilirubin v krvi > 3-kratna ZNM)
Grade 4 or recurrent Grade 3
4. stopnja ali ponovljena 3. stopnja
Tecentriq is given as a drip into a vein (an intravenous infusion).
Zdravilo Tecentriq se daje v veno (v obliki intravenske infuzije).
Per second interim analysis for OS and exploratory PFS analysis at clinical cut off January 2
po drugi vmesni analizi OS in eksploratorni analizi PFS na klinični presečni datum 2. januar 2019;
Table 9: Summary of efficacy from IMpower130 in the primary analysis (ITT-WT population) Efficacy endpoints
Povzetek učinkovitosti iz študije IMpower130 v primarni analizi (populacija ITTdivji tip)
For ≥ Grade 3 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L), atezolizumab should be withheld.
V primeru hiperglikemije ≥ 3. stopnje (glukoza na tešče > 250 mg/dl ali 13,9 mmol/l) je treba uporabo atezolizumaba odložiti.
If you miss a dose of Tecentriq
Če ste izpustili odmerek zdravila Tecentriq
Induction (Four or Six 21-day cycles)
Uvodno zdravljenje (štiri ali šest 21-dnevnih ciklov)
No incompatibilities have been observed between Tecentriq and intravenous bags with product-contacting surfaces of polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP).
Inkompatibilnosti med zdravilom Tecentriq in intravenskimi vrečkami iz polivinilklorida (PVC), poliolefina (PO), polietilena (PE) ali polipropilena (PP) niso opazili.
Table 12: Summary of efficacy (IMpower133) Key efficacy endpoints
Povzetek učinkovitosti (IMpower133) Ključni opazovani dogodki učinkovitosti
Patients had a median survival follow up time of 18.6 months and showed improved OS and PFS with atezolizumab, nab-paclitaxel and carboplatin as compared to the control.
Mediani čas spremljanja preživetja bolnikov je bil 18,6 meseca; celokupno preživetje in preživetje brez napredovanja bolezni sta bila boljša z atezolizumabom, nab-paklitakselom in karboplatinom kakor s primerjavo.
The median duration was 16.8 months (range: 0 day to 16.8 months).
Mediano trajanje je bilo 16,8 meseca (razpon: od 0 dni do 16,8 meseca).
Tumour assessments were performed every 8 weeks (± 1 week) for the first 12 months after Cycle 1, day 1 and every 12 weeks (± 1 week) thereafter.
Tumorje so ocenjevali na 8 tednov (± 1 teden) prvih 12 mesecev po 1. ciklu 1. dan, pozneje pa na 12 tednov (± 1 teden).
A total of 1,202 patients were enrolled and were randomised (1:1:1) to receive one of the treatment regimens described in Table 5.
Skupno sta bila vključena 1202 bolnika, ki so jih v razmerju 1:1:1 randomizirali na prejemanje ene od shem zdravljenja, opisanih v preglednici 5.
Treatment with insulin should be initiated for type 1 diabetes mellitus.
V primeru sladkorne bolezni tipa 1 je treba uvesti zdravljenje z insulinom.
Approximately three-quarters of patients had non-squamous histology (74%), 10% had known EGFR mutation, 0.2% had known ALK rearrangements, 10% had CNS metastases at baseline, and most patients were current or previous smokers (82%).
Približno tri četrtine bolnikov je imelo neploščatocelično histologijo (74 %), 10 % jih je imelo znano mutacijo EGFR, 0,2 % jih je imelo preureditev ALK, 10 % jih je imelo izhodiščno zasevke v osrednjem živčevju in večina bolnikov je bila trenutnih ali nekdanjih kadilcev (82 %).
Most patients were male (81%), and the majority of patients were White (91%).
Večina bolnikov je bila moških (81 %), in večina je bila belcev (91 %).
Grade 2:
2. stopnja:
Cohort 2 included patients who received at least one platinum-based chemotherapy regimen for locally advanced or metastatic UC or had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
V 2. kohorto so bili vključeni bolniki, ki so predhodno prejeli vsaj eno shemo kemoterapije na osnovi platine zaradi lokalno napredovalega ali razsejanega urotelijskega karcinoma, ali jim je bolezen napredovala v 12 mesecih po zdravljenju z neoadjuvantno ali adjuvantno kemoterapijo, ki je vsebovala platino.