natgillin/translations-raw huggingface dataset:
No reproductive and development toxicity studies have been conducted with atezolizumab; however, based on the 26-week repeat dose toxicity study, atezolizumab had an effect on menstrual cycles at an estimated AUC approximately 6 times the AUC in patients receiving the recommended dose and was reversible (see section 5.3).
Toda glede na 26-tedensko študijo toksičnosti ponavljajočih se odmerkov je atezolizumab vplival na menstruacijske cikluse ob ocenjeni AUC, ki je bila približno 6-krat tolikšna, kot je AUC pri bolnikih med uporabo priporočenega odmerka; ta učinek je bil reverzibilen (glejte poglavje 5.3).
The majority of the patients were male (59%) and white (90%).
Večina bolnikov je bila moških (59 %) in belcev (90 %).
At the time of the interim OS analysis, patients had a median follow-up of 19.7 months.
Ob času vmesne analize celokupnega preživetja (OS) je mediano spremljanje bolnikov trajalo 19,7 meseca.
*Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed death-ligand 1 (PD-L1) monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
*Atezolizumab je humanizirano monoklonsko protitelo IgG1 z inženirsko obdelano domeno Fc, ki je pridobljeno iz celic jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA in deluje na ligand za programirano celično smrt 1 (PD-L1).
No. of deaths (%)
OS Število smrti (%)
79639 Grenzach-Whylen
79639 Grenzach-Whylen NEMČIJA
LIST OF EXCIPIENTS Excipients: L-histidine, glacial acetic acid, sucrose, polysorbate 20, water for injections
SEZNAM POMOŽNIH SNOVI Pomožne snovi: L-histidin, koncentrirana ocetna kislina, saharoza, polisorbat 20, voda za injekcije
• itching of the skin
• srbenje kože
Grade 2: (ALT or AST > 3 to 5 x upper limit of normal [ULN]
(ALT ali AST > 3- do 5-kratna zgornja normalna meja [ZNM]
Table 5: Intravenous treatment regimens (IMpower150) Treatment regimen
Intravenske sheme zdravljenja (IMpower150) Shema zdravljenja
• If you become pregnant while you are being treated with Tecentriq tell your doctor.
• Če med zdravljenjem z zdravilom Tecentriq zanosite, morate o tem obvestiti zdravnika.
A total of 403 patients were enrolled and randomised (1:1) to receive one of the treatment regimens described in Table 11.
Skupno so bili vključeni 403 bolniki, ki so jih v razmerju 1:1 randomizirali na prejemanje ene od shem zdravljenja, opisanih v preglednici 11.
After dilution (see section 6.6), one mL of solution contains approximately 4.4 mg of atezolizumab.
Po razredčenju (glejte poglavje 6.6) 1 ml raztopine vsebuje približno 4,4 mg atezolizumaba.
Carcinogenicity studies have not been performed to establish the carcinogenic potential of atezolizumab.
Študij kancerogenosti za ugotavljanje kancerogenosti atezolizumaba niso izvedli.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 840 mg/14 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 840 mg/14 ml
For all treated patients, the median duration of treatment was 2.8 months for the atezolizumab arm, 2.1 months for the vinflunine and paclitaxel arms and 1.6 months for the docetaxel arm.
Pri vseh zdravljenih bolnikih je bilo mediano trajanje zdravljenja 2,8 meseca za skupino, zdravljeno z atezolizumabom, 2,1 meseca za skupini, zdravljeni z vinfluninom ali paklitakselom, in 1,6 meseca za skupino, zdravljeno z docetakselom.
Table 5: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Povzetek učinkovitosti v populaciji za primarno analizo (vsi neselekcionirani bolniki)* (OAK)
• The active substance is atezolizumab.
• Učinkovina je atezolizumab.
Both patients required the use of corticosteroids.
Pri obeh bolnikih je bilo treba uporabiti kortikosteroide.
• flu-like illness
• gripi podobna bolezen • mrzlica
Two patients required the use of corticosteroids.
Pri dveh bolnikih je bilo treba uporabiti kortikosteroide.
Tumour assessments were conducted every 9 weeks for the first 54 weeks, and every 12 weeks thereafter.
Ocene tumorjev so izvedli vsakih 9 tednov v prvih 54 tednih in nato na vsakih 12 tednov.
Hypophysitis occurred in 0.4% (2/473) of patients who received atezolizumab in combination with nab-paclitaxel and carboplatin.
Hipofizitis se je pojavil pri 0,4 % (2/473) bolnikov, ki so prejemali atezolizumab v kombinaciji z nab paklitakselom in karboplatinom.
Grade 3 or 4 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L)
Sladkorna bolezen tipa 1 Hiperglikemija 3. ali 4. stopnje (glukoza na tešče > 250 mg/dl ali 13,9 mmol/l)
Description of the signs and symptoms of immune-related adverse reactions.
- z infundiranjem povezane reakcije Opis znakov in simptomov imunsko pogojenih neželenih učinkov.
Patients had to be eligible for taxane monotherapy (i.e. absence of rapid clinical progression, life-threatening visceral metastases, or need for rapid symptom and/or disease control) and were excluded if they had received prior chemotherapy in the neoadjuvant or adjuvant setting within the last 12 months, a history of autoimmune disease; administration of a live, attenuated vaccine within 4 weeks prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomisation; untreated, symptomatic or corticosteroid-dependent brain metastases.
Bolniki so morali biti primerni za monoterapijo s taksani (tj. niso smeli imeti hitrega kliničnega napredovanja, življenje ogrožajočih visceralnih zasevkov ali potrebe po hitrem obvladanju simptomov in/ali bolezni) in niso bili vključeni, če: so predhodno v zadnjih 12 mesecih neoadjuvantno ali adjuvantno prejemali kemoterapijo, so imeli v anamnezi avtoimunsko bolezen, so prejeli živo oslabljeno cepivo v 4 tednih pred randomizacijo, so prejeli sistemske imunostimulanse v 4 tednih ali sistemske imunosupresive v 2 tednih pred randomizacijo, ali če so imeli nezdravljene, simptomatske ali od kortikosteroidov odvisne zasevke v možganih.
For symptomatic hyperthyroidism, atezolizumab should be withheld and an anti-thyroid medicinal product should be initiated as needed.
V primeru simptomatskega hipertiroidizma je treba uporabo atezolizumaba odložiti in uvesti zdravila za zdravljenje hipertiroze, kot je potrebno.
Triple-negative breast cancer
Trojno negativni rak dojk
Patients were randomised (1:1) to receive either atezolizumab or docetaxel.
Bolnike so v razmerju 1:1 randomizirali na prejemanje atezolizumaba ali docetaksela.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,200 mg/20 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1200 mg/20 ml
In study IMpower150, age ≥ 65 was associated with an increased risk of developing adverse events in patients receiving atezolizumab in combination with bevacizumab, carboplatin and paclitaxel.
V študiji IMpower150 je bila starost ≥ 65 povezana s povečanim tveganjem za pojav neželenih učinkov pri bolnikih, ki so prejemali atezolizumab v kombinaciji z bevacizumabom, karboplatinom in paklitakselom.
Neutropenia and peripheral neuropathies occurring during treatment with atezolizumab and nabpaclitaxel may be reversible with interruptions of atezolizumab and/or nab-paclitaxel.
Nevtropenija in periferne nevropatije, ki se pojavijo med zdravljenjem z atezolizumabom in nabpaklitakselom, so lahko reverzibilne, če zdravljenje z atezolizumabom in/ali nab-paklitakselom prekinemo.
• low white blood cell count with and without fever, which can increase the risk of infection
• majhno število belih krvnih celic z zvišano telesno temperaturo ali brez nje, ki lahko poveča tveganje za okužbo (nevtropenija, levkopenija)
Based on a population pharmacokinetic analysis, no dose adjustment is required for patients with mild hepatic impairment.
Glede na populacijsko farmakokinetično analizo bolnikom z blago okvaro jeter odmerka ni treba prilagoditi.
In study IMpower150, there are no data on the efficacy of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in EGFR+ patients who have progressed previously on erlotinib+bevacizumab.
V študiji IMpower150 ni podatkov o učinkovitosti atezolizumaba v kombinaciji z bevacizumabom, paklitakselom in karboplatinom pri bolnikih z dokazano mutacijo EGFR, ki jim je bolezen napredovala tekom zdravljenja z erlotinibom in bevacizumabom.
Investigator-assessed Overall Best Response3* (RECIST 1.1)
12-mesečno OS (%) Najboljši celokupni odgovor*3 po oceni raziskovalca (RECIST 1.1)
Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic aqua flip-off cap containing 20 mL of concentrate solution for infusion.
Viala iz stekla tipa I z zamaškom iz butilne gume in aluminijasim tesnilom z odstranljivo plastično modro zaporko, ki vsebuje 20 ml koncentrata za raztopino za infundiranje.
Appropriate management of patients with abnormal thyroid function tests at baseline should be considered.
Razmisliti je treba o ustrezni izhodiščni obravnavi bolnikov z nenormalnimi testi delovanja ščitnice.
No formal pharmacokinetic drug interaction studies have been conducted with atezolizumab.
Formalnih študij farmakokinetičnega medsebojnega delovanja zdravil z atezolizumabom niso izvedli.
79639 Grenzach-Wyhlen
79639 Grenzach-Wyhlen Nemčija
CI = confidence interval; DOR = duration of response; OS = overall survival.
IZ = interval zaupanja; DOR (duration of response) = trajanje odgovora; OS (overall survival) = celokupno preživetje.
In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section
Pri bolnikih z EGFR mutiranim ali ALK pozitivnim NDRP je zdravilo Tecentriq v kombinaciji z bevacizumabom, paklitakselom in karboplatinom indicirano le, ko so izčrpana ustrezna tarčna zdravljenja (glejte poglavje 5.1).
Table 11: Intravenous treatment regimens (IMpower133) Treatment regimen
Intravenske sheme zdravljenja (IMpower133) Shema zdravljenja
In Cohort 2, the co-primary efficacy endpoints were confirmed ORR as assessed by an IRF using RECIST v1.1 and investigator-assessed ORR according to Modified RECIST (mRECIST) criteria.
V 2. kohorti so bili soprimarni opazovani dogodki učinkovitosti potrjen delež objektivnega odgovora po oceni IRF z uporabo meril RECIST v1.1 in delež objektivnega odgovora po oceni raziskovalca glede na spremenjena merila RECIST (mRECIST).
One patient required the use of corticosteroids and treatment with atezolizumab was discontinued.
En bolnik je potreboval kortikosteroide in je prenehal z zdravljenjem z atezolizumabom.
If symptoms improve to ≤ Grade 1, taper corticosteroids as clinically indicated.
Če se simptomi izboljšajo na ≤ 1. stopnjo, je treba odmerek kortikosteroidov zmanjšati, kot je klinično indicirano.
The median time to onset was 7.7 months (range: 5.0 to 8.8 months).
Mediani čas do pojava je bil 7,7 meseca (razpon: od 5,0 do 8,8 meseca).
# Primary efficacy endpoints were PFS and OS and they were analysed in the ITT-wild-type (WT) population,
Mediana v mesecih 95-% IZ Primarna opazovana dogodka učinkovitosti sta bila PFS in OS; analizirana sta bila v populaciji ITT-divji-tip, t.j.
At the time of the final analysis for PFS, patients had a median follow up time of 15.3 months.
Ob času končne analize preživetja brez napredovanja bolezni (PFS) je mediano spremljanje bolnikov trajalo 15,3 meseca.
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Event Version 4.0 (NCI-CTCAE v.4.
Opomba: Stopnje toksičnosti so navedene po merilih NCI-CTCAE V.4 (National Cancer Institute Common
Diabetes mellitus led to the discontinuation of atezolizumab in < 0.1% (3/3,178) patients.
Zaradi sladkorne bolezni je atezolizumab prenehalo uporabljati < 0,1 % (3/3178) bolnikov.
Figure 5: Kaplan-Meier Curve for Overall Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
Slika 5: Kaplan-Meierjeva krivulja celokupnega preživetja pri bolnikih z izražanjem PD-L1 ≥ 1 % (IMpassion130)
Only a few patients had severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2; n=8) (see section 4.2).
29 ml/min/1,73 m2) je imelo le malo bolnikov (n = 8) (glejte poglavje 4.2).
• inflammation or problems of the nerves (neuropathy): symptoms may include muscle weakness and numbness, tingling in hands and feet
• vnetje ali motnje živcev (nevropatija): med simptomi so lahko mišična šibkost in omrtvičenost ali mravljinčenje v dlaneh in stopalih;
Figure 1: Kaplan-Meier curve for overall survival (IMvigor211)
Slika 1: Kaplan-Meierjeva krivulja celokupnega preživetja (IMvigor211)
Per the pre-specified hierarchical testing order, the IC2/3 population was tested first, with an OS HR of 0.87 (95% CI: 0.63, 1.21; median OS of 11.1 vs. 10.6 months for atezolizumab and chemotherapy respectively).
Glede na vnaprej določeno hierarhično testiranje so populacijo IC2/3 testirali najprej z razmerjem ogroženosti za celokupno preživetje 0,87 (95-% IZ: 0,63; 1,21; mediano celokupno preživetje 11,1 meseca za atezolizumab v primerjavi z 10,6 meseca za kemoterapijo).
q Includes reports of pneumonitis, lung infiltration, bronchiolitis, interstitial lung disease, radiation pneumonitis.
Vključuje poročila o pnevmonitisu, infiltraciji pljuč, bronhiolitisu, intersticijski bolezni pljuč, radiacijskem pnevmonitisu.
The median age was 64 years (range: 26 to 90 years) with 10% of patients ≥75 years of age.
Mediana starost je bila 64 let (razpon: od 26 do 90 let) in 10 % bolnikov je bilo starih ≥ 75 let.
Treatment with atezolizumab may be resumed when symptoms are controlled and thyroid function is improving.
Zdravljenje z atezolizumabom se lahko znova začne, ko so simptomi obvladani in se delovanje ščitnice izboljšuje.
Table 6: Summary of updated efficacy in the ITT population (IMpower150) Efficacy endpoint
Povzetek posodobljenih podatkov o učinkovitosti v populaciji ITT (IMpower150) Opazovani dogodek učinkovitosti
22.9 months), the median OS for both arms was unchanged relative to the primary OS interim analysis.
V eksploratorni končni analizi OS z daljšim spremljanjem (mediana: 22,9 meseca) je bilo mediano OS za obe skupini glede na vmesno primarno analizo OS nespremenjeno.
Tecentriq used in combination with anticancer medicines The following side effects have been reported in clinical trials when Tecentriq is given in combination with anticancer medicines:
Uporaba zdravila Tecentriq v kombinaciji z zdravili proti raku Ko so v kliničnih preskušanjih uporabljali zdravilo Tecentriq v kombinaciji z drugimi zdravili proti raku, so poročali o naslednjih neželenih učinkih:
89 mL/min/1.73 m2; n=208) or, moderate (eGFR 30 to 59 mL/min/1.73 m2; n=116) renal impairment compared to patients with normal (eGFR greater than or equal to 90 mL/min/1.73 m2; n=140) renal function.
ali zmerno (eGFR 30 do 59 ml/min/1,73 m 2; n = 116) okvaro ledvic in bolnikih z normalnim delovanjem ledvic (eGFR ≥ 90 ml/min/1,73 m 2; n = 140).
The median age was 67 years (range: 31 to 88), and 77.1% of patients were male.
Mediana starost je bila 67 let (razpon: 31 do 88) in 77,1% bolnikov je bilo moških.
IMvigor130 (WO30070): Phase III multi-center, randomized, placebo-controlled study of atezolizumab as monotherapy and in combination with platinum-based chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma
IMvigor130 (WO30070): Multicentrična, randomizirana, s placebom primerjana študija faze III atezolizumaba v monoterapiji in kombinaciji s kemoterapijo na osnovi platine pri bolnikih z nezdravljenim, lokalno napredovalim ali razsejanim urotelijskim karcinomom
Guillain-Barré syndrome led to discontinuation of atezolizumab in 1 patient (< 0.1%).
Zaradi Guillain-Barréjevega sindroma je zdravljenje z atezolizumabom prenehal 1 bolnik (< 0,1 %).
Patients with ES-SCLC were treated with atezolizumab until disease progression.
Bolnike z razsejanim DRP so zdravili z atezolizumabom do napredovanja bolezni.
Patients receiving treatment regimen B were able to crossover and receive atezolizumab monotherapy following disease progression.
Bolniki, ki so prejemali terapevtsko shemo B, so lahko po napredovanju bolezni navzkrižno prešli na prejemanje monoterapije z atezolizumabom.
Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).
Zdravilo Tecentriq je v kombinaciji z nab-paklitakselom in karboplatinom indicirano kot prva linija zdravljenja odraslih bolnikov z razsejanim neploščatoceličnim NDRP, ki ni EGFR mutiran ali ALK pozitiven (glejte poglavje 5.1).
The median DOR was not reached in any PD-L1 expression subgroup or in all comers.
Mediano trajanje odgovora ni bilo doseženo ne v kateri od podskupin izražanja PD-L1 ne med neselekcioniranimi bolniki.
The most common adverse reactions (≥ 20%) were nausea (37.4%), fatigue (36.4%), neutropenia (33.7%), anaemia (33.2%), diarrhoea (29.5%), rash (28.5%), constipation (27.0%), peripheral neuropathy (26.8%), decreased appetite (24.6%), thrombocytopenia (21.2%) and cough (20.1%).
Najpogostejši neželeni učinki (≥ 20 %) so bili navzea (37,4 %), utrujenost (36,4 %), nevtropenija (33,7 %), anemija (33,2 %), diareja (29,5 %), izpuščaj (28,5 %), zaprtost (27,0 %), periferna nevropatija (26,8 %), zmanjšan apetit (24,6 %), trombocitopenija (21,2 %) in kašelj (20,1 %).
Includes reports of cytokine release syndrome, hypersensitivity, anaphylaxis.
Vključuje poročila o sindromu sproščanja citokinov, preobčutljivosti, anafilaksiji.
Based on the severity of the adverse reaction, atezolizumab should be withheld and corticosteroids administered.
Glede na izrazitost neželenega učinka je treba uporabo atezolizumaba odložiti in uvesti kortikosteroide.
• low platelet count, which may make you more likely to bruise or bleed
• majhno število trombocitov, zaradi česar ste lahko bolj nagnjeni k podplutbam ali krvavitvam
Investigator-assessed confirmed DOR (RECIST 1.1)^
Potrjeno DOR po oceni raziskovalca (RECIST 1.1)^
Based on a population pharmacokinetic analysis, no dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Glede na populacijsko farmakokinetično analizo bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 5.2).
The median time to onset was 4.9 months (range: 0 day to 31.3 months).
Mediani čas do pojava je bil 4,9 meseca (razpon: od 0 dni do 31,3 meseca).
Treatment may be resumed when symptoms are controlled by thyroid replacement therapy and TSH levels are decreasing
Zdravljenje se lahko znova začne, ko so simptomi obvladani z nadomestnim zdravljenjem s ščitničnimi hormoni in se koncentracija TSH znižuje.
The median time to onset was 3.4 months (range 3 days to 24.8 months).
Mediani čas do pojava je bil 3,4 meseca (razpon: od 3 dni do 24,8 meseca).
Tecentriq is an anti-cancer medicine that contains the active substance atezolizumab.
Zdravilo Tecentriq je zdravilo za zdravljenje rakavih obolenj, ki vsebuje učinkovino atezolizumab.
Stratified hazard ratio
Stratificirano razmerje ogroženosti
Immune-related meningoencephalitis
Imunsko pogojeni meningoencefalitis
If particulates or discoloration are observed, the solution should not be used.
Če opazite, da je raztopina spremenjene barve ali da so v njej delci, je ne smete uporabiti.
2,759 patients across multiple tumour types.
Varnost atezolizumaba v kombinaciji z drugimi učinkovinami so ocenili pri 2759 bolnikih z različnimi vrstami tumorjev.
Patients should be closely monitored for signs and symptoms that are suggestive of acute pancreatitis.
Bolnike je treba nadzorovati glede znakov in simptomov, ki kažejo na akutni pankreatitis.
z Includes reports of proteinuria, protein urine present, haemoglobinurea, nephrotic syndrome.
Vključuje poročila o proteinuriji, prisotnosti beljakovin v urinu, hemoglobinuriji, nefrotskem sindromu.
Treatment with atezolizumab should be permanently discontinued for Grade 4 or grade 3 recurrent myositis, or when unable to reduce the corticosteroid dose to the equivalent of ≤ 10 mg prednisone per day within 12 weeks after onset.
Zdravljenje z atezolizumabom je treba trajno ukiniti v primeru miozitisa 4. stopnje ali ponovljenega miozitisa 3. stopnje ali kadar ni mogoče zmanjšati odmerka kortikosteroidov na ekvivalent ≤ 10 mg prednizona na dan v 12 tednih od začetka zdravljenja.
Patients with Grade 1 or 2 infusion-related reactions may continue to receive atezolizumab with close monitoring; premedication with antipyretic and antihistamines may be considered.
Bolniki, ki imajo z infundiranjem povezane reakcije 1. ali 2. stopnje, lahko še naprej prejemajo atezolizumab pod natančnim nadzorom;
The median time to onset was 13.1 months (range: 9.0 to 17.5 months).
Mediani čas do pojava je bil 13,1 meseca (razpon: od 9,0 do 17,5 meseca).
How much Tecentriq is given
Koliko zdravila Tecentriq boste dobili
Maintenance (21-Day Cycles)
Vzdrževanje (21-dnevni cikli)
• inflammation of the thyroid, adrenal glands and the pituitary gland (hypothyroidism, hyperthyroidism, adrenal insufficiency or hypophysitis): symptoms may include tiredness, weight loss, weight gain, change in mood, hair loss, constipation, dizziness, headaches, increased thirst, increased urination and changes in vision.
• vnetje ščitnice, nadledvičnih žlez in hipofize (premajhno delovanje žleze ščitnice (hipotiroidizem), prekomerno delovanje žleze ščitnice (hipertiroidizem), poslabšanje delovanja nadledvičnih žlez ali vnetje hipofize (hipofizitis)): med simptomi so lahko utrujenost, hujšanje, povečanje telesne mase, spremembe razpoloženja, izpadanje las; zaprtost, omotica, glavoboli, povečana žeja, povečano odvajanje urina in spremembe vida;
Pancreatitis, including amylase increased and lipase increased, occurred in 0.6% (18/3,178) of patients who received atezolizumab monotherapy.
Pankreatitis, vključno z zvišanjem amilaze in zvišanjem lipaze, se je pojavil pri 0,6 % (18/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Hyperthyroidism:
Hipertiroidizem
Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).
Zdravilo Tecentriq je v kombinaciji s karboplatinom in etopozidom indicirano kot prva linija zdravljenja odraslih bolnikov z razsejanim drobnoceličnim rakom pljuč (DRP) (glejte poglavje 5.1).
Data for patients ≥ 75 years of age are too limited to draw conclusions on this population.
Za bolnike, stare ≥ 75 let, je podatkov premalo, da bi navedli zaključke o tej populaciji.
AST increased, ALT increased, hepatitisv
hepatitisv zvišanje AST, zvišanje ALT
Fourteen point seven percent of patients had liver metastases at baseline, and most patients were current or previous smokers (90%).
Štirinajst celih sedem odstotka (14,7 %) bolnikov je imelo izhodiščno zasevke v jetrih in večina bolnikov je bila sedanjih ali nekdanjih kadilcev (90 %).
The median time to onset was 3.6 months (range 3 days to 9.9 months).
Mediani čas do pojava je bil 3,6 mesece (razpon: od 3 dni do 9,9 meseca.
• inflammation of the heart muscle (myocarditis): symptoms may include shortness of breath, decreased exercise tolerance, feeling tired, chest pain, swelling of the ankles or legs, irregular heartbeat, and fainting
• vnetje srčne mišice (miokarditis): med simptomi so lahko težko dihanje, zmanjšanje tolerance za vadbo, utrujenost, bolečina v prsih, otekanje gležnjev ali nog, neredno bitje srca, omedlevica;
• overactive thyroid gland (hyperthyroidism)
• prekomerno delovanje žleze ščitnice (hipertiroidizem)
Figure 7: Forest plot of overall survival by PD-L1 expression (IMpower130)
Slika 7: Drevesni diagram celokupnega preživetja glede na izražanje PD-L1 (IMpower130)
The key results in the all comer population are summarised in Table 3.
Ključni rezultati v populaciji neselekcioniranih bolnikov so povzeti v preglednici 3.
Patients with locally advanced or metastatic UC who are ineligible for cisplatin therapy were treated with atezolizumab until disease progression.
Bolnike z lokalno napredovalim ali razsejanim urotelijskim karcinomom, neprimerne za zdravljenje s cisplatinom, so zdravili z atezolizumabom do napredovanja bolezni.
No developmental and reproductive studies were conducted with atezolizumab.
Študij razvoja in reproduktivnih študij z atezolizumabom niso izvedli.