FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 6 - Summary of efficacy in patients with PD-L1 expression ≥1% (IMpassion130) Key efficacy endpoints
Slovenian: Povzetek učinkovitosti pri bolnikih z izražanjem PD-L1 ≥ 1 % (IMpassion130) Ključni opazovani dogodki učinkovitosti atezolizumab +
English: The OS rate at 12 month was 37% in all comers.
Slovenian: Pri neselekcioniranih bolnikih je bil delež celokupnega preživetja po 12 mesecih 37 %.
English: Includes reports of acne, acne pustular, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis bullous, dermatitis exfoliative generalised, drug eruption, eczema, eczema infected, erythema, erythema multiforme, erythema of eyelid, exfoliative rash, eyelid rash, fixed eruption, folliculitis, furuncle, generalised erythema, palmar-plantar erythrodysaesthesia syndrome, rash , rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash papulosquamous, rash pruritic, rash pustular, rash vesicular, seborrhoeic dermatitis, skin exfoliation, skin toxicity, skin ulcer, toxic epidermal necrolysis, toxic skin eruption.
Slovenian: w Vključuje poročila o aknah, pustularnih aknah, dermatitisu, akneiformnem dermatitisu, alergijskem dermatitisu, buloznem dermatitisu, generaliziranem eksfoliativnem dermatitisu, izpuščaju zaradi zdravil, ekcemu, ekcemski okužbi, eritemu, multiformnem eritemu, eritemu veke, eksfoliativnem izpuščaju, izpuščaju na veki, izpuščaju, ki se ponavlja, folikulitisu, furunklu, generaliziranem eritemu, sindromu palmo-plantarne eritrodisestezije, izpuščaju, eritematoznem izpuščaju, generaliziranem izpuščaju, makularnem izpuščaju, makulopapuloznem izpuščaju, papuloznem izpuščaju, papuloskvamoznem izpuščaju, srbečem izpuščaju, pustularnem izpuščaju, vezikularnem izpuščaju, seboroičnem dermatitisu, eksfoliaciji kože, kožni toksičnosti, kožni razjedi, toksični epidermalni nekrolizi, toksičnem kožnem izpuščaju.
English: Each 14 mL vial contains 840 mg of atezolizumab.
Slovenian: Ena 14-ml viala vsebuje 840 mg atezolizumaba.
English: For the description of studies with Tecentriq administered every 3 weeks at 1,200 mg, refer to the Tecentriq 1,200 mg concentrate for solution for infusion SmPC.
Slovenian: Za opis študij zdravila Tecentriq, apliciranega v odmerku 1200 mg na 3 tedne, glejte povzetek glavnih značilnosti zdravila Tecentriq 1200 mg koncentrat za raztopino za infundiranje.
English: • inflammation of the kidneys (nephritis); symptoms may include changes in urine output and color, pain in pelvis, and swelling of the body and may lead to failure of the kidneys
Slovenian: • vnetje ledvic (nefritis): med simptomi so lahko spremembe v izločanju urina in njegovi barvi, bolečina v medenici in otekanje telesa; vodi lahko v odpoved ledvic;
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 20 mL vial of concentrate contains 1,200 mg atezolizumab After dilution, 1 mL of solution contains approximately 4.4 mg of atezolizumab
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena 20-ml viala s koncentratom vsebuje 1200 mg atezolizumaba Po redčenju 1 ml raztopine vsebuje približno 4,4 mg atezolizumaba
English: Patients with PD-L1 expression <1% did not show improved OS when atezolizumab was added to nab-paclitaxel (HR of 0.97, 95% CI 0.78, 1.20).
Slovenian: Bolnikom z izražanjem PD-L1 < 1 % se OS po dodatku atezolizumaba nab-paklitakselu ni izboljšalo (RO 0,97; 95% IZ 0,78, 1,20).
English: Post-authorisation efficacy study (PAES): In order to evaluate the efficacy of atezolizumab monotherapy versus atezolizumab plus carboplatin/gemcitabine versus placebo plus cisplatin/gemcitabine in patients with locally advanced or metastatic urothelial cancer who are platinum -ineligible and -eligible patients, the MAH should submit the final CSR of study IMvigor130.
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Za ovrednotenje učinkovitosti monoterapije atezolizumaba v primerjavi z atezolizumabom in karboplatinom/gemcitabinom v primerjavi s placebom in cisplatinom/gemcitabinom pri bolnikih z lokalno napredovalim ali razsejanim rakom urotelija, ki so ali niso primerni za zdravljenje na osnovi platine, mora imetnik dovoljenja za promet z zdravilom predložiti končno poročilo klinične študije IMvigor130.
English: The median duration was 8.0 months (range 18 days to 8.3+ months; + denotes a censored value).
Slovenian: Mediano trajanje je bilo 8,0 meseca (razpon: od 18 dni do 8,3+ meseca; + označuje krnjeno vrednost).
English: g Includes reports of autoimmune hypothyroidism, autoimmune thyroiditis, blood thyroid stimulating hormone abnormal, blood thyroid stimulating hormone decreased, blood thyroid stimulating hormone increased, euthyroid sick syndrome, goitre, hypothyroidism, myxoedema, thyroid disorder, thyroid function test abnormal, thyroiditis, thyroiditis acute, thyroxine decreased, thyroxine free decreased, thyroxine free increased, thyroxine increased, tri-iodothyronine decreased, tri-iodothyronine free abnormal, tri-iodothyronine free decreased, tri-iodothyronine free increased.
Slovenian: g Vključuje poročila o avtoimunskem hipotiroidizmu, avtoimunskem tiroiditisu, nenormalnem tiroideostimulirajočem hormonu v krvi, znižanju tiroideo-stimulirajočega hormona v krvi, zvišanju tiroideostimulirajočega hormona v krvi, sindromu evtiroidne bolezni, golši, hipotiroidizmu, miksedemu, motnji ščitnice, nenormalnih izvidih preiskav delovanja ščitnice, tiroiditisu, akutnem tiroiditisu, znižanju tiroksina, znižanju prostega tiroksina, zvišanju prostega tiroksina, zvišanju tiroksina, znižanju trijodotironina, nenormalnem prostem trijodotironinu, znižanju prostega trijodotironina, zvišanju prostega trijodotironina.
English: However, it may be stopped if the side effects become too much of a problem.
Slovenian: Vendar pa je zdravljenje treba ukiniti, če postanejo neželeni učinki neobvladljivi.
English: • inflammation of the brain (encephalitis) or inflammation of the membrane around the spinal cord and brain (meningitis): symptoms may include neck stiffness, headache, fever, chills, vomiting, eye sensitivity to light, confusion and sleepiness
Slovenian: • vnetje možganov (encefalitis) ali vnetje open, ki obdajajo hrbtenjačo in možgane (meningitis): med simptomi so lahko togost vratu, glavobol, zvišana telesna temperatura, mrzlica, bruhanje, občutljivost oči na svetlobo, zmedenost in zaspanost;
English: Baseline ECOG performance status was 0 (45.6%) or 1 (54.4%).
Slovenian: Izhodiščno stanje zmogljivosti po ECOG je bilo 0 (45,6 %) ali 1 (54,4 %).
English: Patients should be monitored for clinical signs and symptoms of meningitis or encephalitis.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov meningitisa ali encefalitisa.
English: The metabolism of atezolizumab has not been directly studied.
Slovenian: Presnova atezolizumaba ni neposredno raziskana.
English: Grade 2 or 3 Diarrhoea (increase of ≥ 4
Slovenian: Driska 2. ali 3. stopnje (povečanje za ≥ 4 iztrebljanja na dan v primerjavi z izhodiščem)
English: Both patients required corticosteroids and discontinued atezolizumab.
Slovenian: Oba bolnika sta potrebovala kortikosteroide in prenehala z zdravljenjem z atezolizumabom.
English: Patients should be monitored for signs and symptoms of hepatitis.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov hepatitisa.
English: The most common adverse reactions (> 10%) were fatigue (35.9%), decreased appetite
Slovenian: Najpogostejši neželeni učinki (≥ 20 %) so bili navzea (37,4 %), utrujenost (36,4 %),
English: • after prior platinum-containing chemotherapy, or
Slovenian: • so bili predhodno zdravljeni s kemoterapijo na osnovi platine ali
English: The median age was 63 years (range: 31 to 90), and 60% of patients were male.
Slovenian: Mediana starost je bila 63 let (razpon: od 31 do 90 let) in 60 % bolnikov je bilo moških.
English: ǂ Stratified by chemotherapy (vinflunine vs. taxane), status on IC (< 5% vs. ≥ 5%), number of prognostic risk factors (0 vs. 1-3), and liver metastases (yes vs. no).
Slovenian: ǂ Stratificirani glede na kemoterapijo (vinflunin v primerjavi s taksanom), stanje izražanja na imunskih celicah, ki infiltrirajo tumor (< 5 % v primerjavi z ≥ 5 %), število napovednih dejavnikov tveganja (0 v primerjavi 1-3) in zasevke v jetrih (da v primerjavi z ne).
English: 12-month OS (%)
Slovenian: 6-mesečno OS (%)
English: v Includes reports of ascites, autoimmune hepatitis, hepatocellular injury, hepatitis, hepatitis acute, hepatotoxicity, liver disorder, drug-induced liver injury, hepatic failure, hepatic steatosis, hepatic lesion, oesophageal varices haemorrhage, varices oesophageal.
Slovenian: Vključuje poročila o ascitesu, avtoimunskem hepatitisu, hepatocelularni poškodbi, hepatitisu, akutnem hepatitisu, hepatotoksičnosti, bolezni jeter, z zdravilom povzročeni poškodbi jeter, odpovedi jeter, steatozi jeter, hepatičnih lezijah, krvavitvah iz ezofagalnih varic, ezofagalnih varicah.
English: Blood and lymphatic system disorders Very common anaemia, thrombocytopeniac, neutropeniad, leukopeniae
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti anemija, trombocitopenijac, nevtropenijad, levkopenijae pogosti trombocitopenijac zmanjšano število limfocitov
English: The median age was 64 years (range: 33 to 85), and 61% of patients were male.
Slovenian: Mediana starost je bila 64 let (razpon: od 33 do 85 let) in 61 % bolnikov je bilo moških.
English: For Grade 2 or Grade 3 hypophysitis, atezolizumab should be withheld and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started, and hormone replacement should be initiated as needed.
Slovenian: Pri hipofizitisu 2. ali 3. stopnje je treba uporabo atezolizumaba odložiti in uvesti intravenske kortikosteroide (metilprednizolon v odmerku 1 do 2 mg/kg/dan ali ekvivalent), po potrebi pa je treba uvesti nadomestne hormone.
English: The median time to onset was 5.4 months (range: 0.7 to 11.0 months).
Slovenian: Mediani čas do pojava je bil 5,4 meseca (razpon: od 0,7 do 11,0 meseca).
English: Data for patients ≥75 years of age are too limited to draw conclusions on this population.
Slovenian: Podatkov za bolnike, stare ≥ 75 let, je premalo, da bi lahko sklepali o tej populaciji.
English: Figure 3: Forest plot of overall survival by PD-L1 expression in the ITT population, Arm B vs. C (IMpower150)
Slovenian: Slika 3: Drevesni diagram celokupnega preživetja glede na izražanje PD-L1 v populaciji ITT, skupina B glede na skupino C (IMpower150)
English: ORR was 15.3% vs. 14.7% and median DOR was 18.6 months vs. 7.2 months for atezolizumab vs. docetaxel, respectively.
Slovenian: Delež objektivnega odgovora je bil 15,3 % z atezolizumabom in 14,7 % z docetakselom, mediano trajanje odgovora pa 18,6 meseca z atezolizumabom in 7,2 meseca z docetakselom.
English: Patients with locally advanced or metastatic UC who are ineligible for cisplatin therapy and locally advanced unresectable or metastatic TNBC were treated with atezolizumab until disease progression.
Slovenian: Bolnike z lokalno napredovalim ali razsejanim urotelijskim karcinomom, neprimerne za zdravljenje s cisplatinom, in lokalno napredovalim inoperabilnim ali razsejanim TNRD so zdravili z atezolizumabom do napredovanja bolezni.
English: Infections and infestations Very common urinary tract infectiona lung infectionb
Slovenian: Infekcijske in parazitske bolezni zelo pogosti okužba sečila okužba pljučb
English: Hypophysitis occurred in 0.8% (3/393) of patients who received atezolizumab with bevacizumab, paclitaxel, and carboplatin.
Slovenian: Hipofizitis se je pojavil pri 0,8 % (3/393) bolnikov, ki so prejemali atezolizumab z bevacizumabom, paklitakselom in karboplatinom.
English: Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in EGFR+ patients with NSCLC who have progressed on erlotinib+bevacizumab
Slovenian: Uporaba atezolizumaba v kombinaciji z bevacizumabom, paklitakselom in karboplatinom pri bolnikih z NDRP in dokazano mutacijo EGFR, ki jim je bolezen pri zdravljenju z erlotinibom in bevacizumabom napredovala
English: Mutagenicity studies have not been performed to establish the mutagenic potential of atezolizumab.
Slovenian: Študij mutagenosti za ugotavljanje mutagenosti atezolizumaba niso izvedli.
English: Figure 11: Forest plot of overall survival by PD-L1 expression in the primary analysis population (OAK)
Slovenian: Slika 11: Drevesni diagram celokupnega preživetja glede na izražanje PD-L1 v populaciji za primarno analizo (OAK)
English: The primary analysis was conducted in all patients, excluding those with EGFR mutations or ALK
Slovenian: Primarna analiza je bila izvedena pri vseh bolnikih, a z izključitvijo tistih, ki so imeli mutacije EGFR ali preureditve ALK; to je bilo opredeljeno kot populacija ITT-divji tip (n = 679).
English: Atezolizumaba (1,200 mg) + bevacizumabd (15 mg/kg) + paclitaxel (200 mg/m2)b,c carboplatinc (AUC 6)
Slovenian: atezolizumaba (1200 mg) + bevacizumabd (15 mg/kg) + paklitaksel (200 mg/m2)b,c karboplatinc (AUC 6)
English: Paclitaxel and carboplatin are administered until completion of 4 or 6 cycles, or progressive disease, or unacceptable toxicity whichever occurs first d.
Slovenian: c Nab-paklitaksel in karboplatin so uporabljali do dokončanja 4 ali 6 ciklov, napredovanja bolezni ali nesprejemljivih toksičnih učinkov, kar od tega se je zgodilo prej.
English: l Includes reports of neuropathy peripheral, autoimmune neuropathy, peripheral sensory neuropathy, polyneuropathy, herpes zoster, peripheral motor neuropathy, neuralgic amyotrophy, peripheral sensorimotor neuropathy, toxic neuropathy, axonal neuropathy, lumbosacral plexopathy, neuropathic arthropathy, peripheral nerve infection.
Slovenian: l Vključuje poročila o periferni nevropatiji, avtoimunski nevropatiji, periferni sezorični nevropatiji, polinevropatiji, herpes zostru, periferni motorični nevropatiji, nevralgični amiotropiji, periferni senzorimotorični nevropatiji, toksični nevropatiji, aksonalni nevropatiji, lumbosakralni pleksopatiji, nevropatski artropatiji, okužbi perifernega živca.
English: Talk to your doctor or nurse before you are given Tecentriq if you:
Slovenian: Pred začetkom prejemanja zdravila Tecentriq se posvetujte z zdravnikom ali medicinsko sestro, če:
English: Patients with previously untreated UC 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 Bolnike s predhodno nezdravljenim urotelijskim karcinomom je treba za zdravljenje izbrati na podlagi tumorskega izražanja PD-L1, potrjenega z validirano preiskavo (glejte poglavje 5.1).
English: Data for patients with brain metastases are too limited to draw conclusions on this population.
Slovenian: Podatkov za bolnike z zasevki v možganih je premalo, da bi lahko sklepali o tej populaciji.
English: • inflammation of the pituitary gland situated at the base of the brain
Slovenian: • vnetje hipofize, ki se nahaja v možganskem dnu
English: Tecentriq in combination therapy
Slovenian: Zdravilo Tecentriq v kombinaciji
English: How Tecentriq works
Slovenian: Kako deluje zdravilo Tecentriq
English: If you miss an appointment, make another one straight away.
Slovenian: Če ste izpustili obisk pri zdravniku, ga obiščite takoj.
English: Investigator-assessed PFS (RECIST v1.1) - Updated exploratory analysis4
Slovenian: PFS po oceni raziskovalca (RECIST v1.1) - posodobljena eksploratorna analiza4 Število dogodkov (%)
English: • a cancer that affects the lungs, called non-small cell lung cancer.
Slovenian: • rakom, ki prizadene pljuča in ga imenujemo nedrobnocelični rak pljuč.
English: • If you could become pregnant, you must use effective contraception; while you are being treated with Tecentriq and for 5 months after the last dose.
Slovenian: • Če bi lahko zanosili, morate uporabljati učinkovito kontracepcijo:
English: The median duration was 2.8 months (range 15 days to 9.5+ months; + denotes a censored value).
Slovenian: Mediano trajanje je bilo 2,8 meseca (razpon: od 15 dni do 9,5+ meseca; + označuje krnjeno vrednost).
English: Second-line treatment of non-small cell lung cancer
Slovenian: Druga linija zdravljenja nedrobnoceličnega raka pljuč
English: • Description of the main signs and symptoms of the following safety concerns and reminder of the importance of notifying their treating physician immediately if symptoms occur, persist or worsen: Immune-Related Hepatitis Immune-Related Pneumonitis Immune-Related Colitis Immune-Related Pancreatitis
Slovenian: • Opis glavnih znakov in simptomov naslednjih varnostnih tveganj in opozorilo o pomenu takojšnjega obveščanja zdravnika, če se simptomi pojavijo, vztrajajo ali se poslabšajo: imunsko pogojeni hepatitis imunsko pogojeni pnevmonitis imunsko pogojeni kolitis imunsko pogojeni pankreatitis imunsko pogojene endokrinopatije (sladkorna bolezen tipa 1, hipotiroidizem, hipertiroidizem, insuficienca nadledvičnih žlez, hipofizitis) imunsko pogojene nevropatije (Guillain-Barréjev sindrom, miastenijski sindrom/miastenija gravis) imunsko pogojeni meningoencefalitis imunsko pogojeni miokarditis imunsko pogojeni nefritis imunsko pogojeni miozitis z infundiranjem povezane reakcije
English: The primary efficacy endpoint for Cohort 1 was confirmed objective response rate (ORR) as assessed by an independent review facility (IRF) using RECIST v1.1.
Slovenian: Primarni opazovani dogodek učinkovitosti v 1. kohorti je bil potrjen delež objektivnega odgovora, ki ga je ocenila skupina za neodvisni pregled (IRF, independent review facility) na podlagi meril RECIST
English: The demographic and baseline disease characteristics of the primary analysis population were well balanced between the treatment arms.
Slovenian: Demografske in izhodiščne značilnosti bolezni populacije, vključene v primarno analizo, so bile med zdravljenima skupinama dobro uravnotežene.
English: No. of complete response (%) No. of partial response (%)
Slovenian: Št. popolnih odgovorov (%) Št. delnih odgovorov (%)
English: Figure 3: Forest plot of overall survival by PD-L1 expression in the primary analysis population (OAK)
Slovenian: Slika 3: Drevesni diagram celokupnega preživetja glede na izražanje PD-L1 v populaciji za primarno analizo (OAK)
English: No. of confirmed responders (%)
Slovenian: Št. bolnikov s potrjenim odgovorom (%)
English: IMvigor211 (GO29294): Randomised trial in locally advanced or metastatic UC patients previously treated with chemotherapy
Slovenian: IMvigor211 (GO29294): Randomizirano preskušanje pri bolnikih z lokalno napredovalim ali razsejanim urotelijskim karcinomom, ki so bili predhodno zdravljeni s kemoterapijo
English: Patients with PD-L1 expression <1% did not show improved PFS when atezolizumab was added to nab-paclitaxel (HR of 0.94, 95% CI 0.78, 1.13).
Slovenian: Bolnikom z izražanjem PD-L1 < 1 % se PFS po dodatku atezolizumaba nab-paklitakselu ni izboljšalo (RO 0,94; 95-% IZ 0,78, 1,13).
English: Patients with event (%)
Slovenian: Št. bolnikov z odgovorom (%)
English: After dilution, one mL of solution should contain approximately 6.0 mg of Tecentriq (1680 mg/278 mL).
Slovenian: Po razredčenju vsebuje en mililiter raztopine približno 6,0 mg zdravila Tecentriq (1680 mg/278 ml).
English: The median time to onset 7.2 months (range: 24 days to 13.7 months).
Slovenian: Mediani čas do pojava je bil 7,2 meseca (razpon: od 24 dni do 13,7 meseca).
English: • a cancer that arises from the breast, called triple negative breast cancer.
Slovenian: • rakom dojk, imenovanim trojno negativni rak dojk.
English: Uncommon Guillain-Barré syndromem, meningoencephalitisn
Slovenian: Guillain-Barréjev sindromm, meningoencefalitisn redki miastenijski sindromo
English: • inflammation of the lung (pneumonitis): symptoms may include new or worsening cough,
Slovenian: • vnetje pljuč (pnevmonitis): med simptomi so lahko novonastal kašelj ali poslabšanje kašlja,
English: It is used if: the lung cancer has spread to other parts of the body (extensive-stage) you have not received any prior chemotherapy for extensive-stage SCLC.
Slovenian: Pri tem raku ga uporabljamo, če: - se je razširil v druge dele telesa (razsejana oblika), - za zdravljenje razsejanega drobnoceličnega raka pljuč predhodno še niste prejeli kemoterapije.
English: What Tecentriq contains
Slovenian: Kaj vsebuje zdravilo Tecentriq
English: Tecentriq used alone The following side effects have been reported in clinical trials with Tecentriq used alone:
Slovenian: Ko so v kliničnih preskušanjih uporabljali samo zdravilo Tecentriq, so poročali o naslednjih neželenih učinkih:
English: • inflammation of the membrane around the spinal cord and brain
Slovenian: • vnetje open, ki obdajajo hrbtenjačo in možgane
English: Hepatitis led to discontinuation of atezolizumab in 6 (< 0.2%) patients.
Slovenian: Zaradi hepatitisa je zdravljenje z atezolizumabom prenehalo 6 (< 0,2 %) bolnikov.
English: To treat extensive-stage SCLC, Tecentriq will be given to you in combination with carboplatin and etoposide.
Slovenian: Za zdravljenje razsejanega drobnoceličnega raka pljuč boste prejeli zdravilo Tecentriq v kombinaciji s karboplatinom in etopozidom.
English: Hyperthyroidism, Adrenal Insufficiency and Hypophysitis) - Immune-Related Neuropathies (Guillain-Barre Syndrome, Myasthenic Syndrome /
Slovenian: hipertiroidizem, insuficienca nadledvičnih žlez, hipofizitis) - imunsko pogojene nevropatije (Guillain-Barréjev sindrom, miastenijski sindrom/miastenija gravis) - imunsko pogojeni meningoencefalitis - imunsko pogojeni miokarditis - imunsko pogojeni nefritis
English: • inflammation of the liver (hepatitis): symptoms may include yellowing of skin or eyes, nausea, vomiting, bleeding or bruising, dark urine, and stomach pain
Slovenian: • vnetje jeter (hepatitis): med simptomi so lahko porumenelost kože ali oči, slabost (siljenje na bruhanje), bruhanje, krvavitve ali podplutbe, temen urin in bolečine v trebuhu;
English: Each 14 mL vial of concentrate contains 840 mg atezolizumab After dilution, 1 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: Ena 14-ml viala s koncentratom vsebuje 840 mg atezolizumaba Po redčenju 1 ml raztopine vsebuje približno 3,2 mg atezolizumaba v 840-mg odmerku in približno 6 mg atezolizumaba v 1680-mg odmerku
English: The confirmed ORRs per IRF-RECIST v1.1 were 28.0% (95% CI: 19.5, 37.9) in patients with PD-L1 expression ≥ 5%, 19.3% (95% CI: 14.2, 25.4) in patients with PD-L1 expression ≥ 1%, and 15.8% (95% CI: 11.9, 20.4) in all comers.
Slovenian: Potrjeni deleži objektivnih odgovorov po oceni IRF glede na merila RECIST v1.1 so bili 28,0 % (95% IZ: 19,5; 37,9) pri bolnikih z izražanjem PD-L1 ≥ 5 %, 19,3 % (95-% IZ: 14,2, 25,4) pri bolnikih izražanjem PD-L1 ≥ 1 % in 15,8 % (95-% IZ: 11,9; 20,4) pri vseh neselekcioniranih bolnikih.
English: d Includes reports of neutropenia, neutrophil count decreased, febrile neutropenia, neutropenic sepsis, granulocytopenia.
Slovenian: d Vključuje poročila o nevtropeniji, zmanjšanju števila nevtrofilcev, febrilni nevtropeniji, nevtropenični sepsi,
English: Patients should be monitored for symptoms of motor and sensory neuropathy.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov motorične in senzorične nevropatije.
English: Administration of atezolizumab could cause foetal harm, including embryo-foetal lethality.
Slovenian: Pričakovati je mogoče, da uporaba atezolizumaba lahko škoduje plodu, vključno s smrtjo zarodka ali ploda.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One 20 mL vial of concentrate contains 1,200 mg atezolizumab*.
Slovenian: Ena 20-ml viala s koncentratom vsebuje 1200 mg atezolizumaba*.
English: Figure 5: Forest plot of progression free survival by PD-L1 expression in the ITT population, Arm B vs. C (IMpower150)
Slovenian: Slika 5: Drevesni diagram preživetja brez napredovanja bolezni glede na izražanje PD-L1 v populaciji ITT, skupina B glede na skupino C (IMpower150)
English: Vinflunine was administered 320 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Slovenian: Vinflunin so dajali v odmerku 320 mg/m z intravensko infuzijo 1. dan vsakega 3-tedenskega cikla do napredovanja bolezni ali nesprejemljive toksičnosti.