natgillin/translations-raw huggingface dataset:
Prior use of cisplatin may also result in a decrease of etoposide total body clearance in children.
Pri predhodni uporabi cisplatina pri otrocih se celotni telesni očistek etopozida zmanjša.
VEPESID and associated names (see Annex I) 50 mg capsule, soft VEPESID and associated names (see Annex I) 100 mg capsule, soft
VEPESID in povezana imena (glejte Prilogo I) 50 mg mehke kapsule VEPESID in povezana imena (glejte Prilogo I) 100 mg mehke kapsule
Testicular atrophy, spermatogenesis arrest, and growth retardation were reported in rats and mice.
Pri podganah in miših so poročali o atrofiji testisov, zavrti spermatogenezi in upočasnjeni rasti.
VEPESID and associated names should not be administered to patients with neutrophil counts less than 1,500 cell/mm3 or platelet counts less than 100,000cells/mm
Zdravila VEPESID in povezana imena ne smejo jemati bolniki s številom nevtrofilcev pod 1.500/mm3 ali s številom trombocitov pod 100.000/mm3, razen v primeru, ko je število celic zmanjšano zaradi maligne bolezni.
VEPESID and associated names contains
Zdravilo VEPESID in povezana imena vsebuje
How to take VEPESID and associated names
Kako jemati zdravilo VEPESID in povezana imena
Other side effects experienced with VEPESID and associated names that are;
Drugi neželeni učinki, ki so jih opazili pri zdravljenju z zdravilom VEPESID in povezana imena, so
56% (45% of the dose was excreted as etoposide) and faecal recovery of radioactivity was 44% of the administered dose at 120 hours.
Po intravenski aplikaciji 14Cetopozida (100 do 124 mg/m2) je bila srednja vrednost reaktivnega odmerka v urinu 56 % (45 % kot etopozid) v 120 urah, v blatu pa 44 % v 120 urah.
Citric acid, anhydrous (E330) Macrogol 400 (E1521) Glycerol (85 per cent) (E422) Water, purified
Vsebina kapsule brezvodna citronska kislina (E330) makrogol 400 (E1521) 85-odstotni glicerol (E422)
Each capsule contains 100 mg etoposide
Ena kapsula vsebuje 100 mg etopozida.
Recurrent or refractory testicular cancer
Rekurentni ali refraktarni rak mod
common acute leukaemia
pogosti akutna levkemija
Women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Bolnicam v rodni dobi je treba med zdravljenjem in do 6 mesecev po njem odsvetovati nosečnost.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the second line treatment of Hodgkin's lymphoma in adults.
Zdravilo VEPESID in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za drugo linijo zdravljenja Hodgkinovega limfoma pri odraslih.
Reproductive system and breast disorders not known infertility
Motnje reprodukcije in dojk neznana neplodnost
Leucopenia and severe leucopenia (less than 1,000 cells/mm 91% and 3 to 17%, respectively, for etoposide.
Levkopenijo so opazili pri 60 do 91 % in hudo levkopenijo (pod 1.000 celic/mm3) pri 3 do 17 % bolnikov, trombocitopenijo pa pri 22 do 41 % bolnikov in hudo trombocitopenijo (manj kot 50.000 celic/mm3) pri 1 do 20 % bolnikov, ki so se zdravili z etopozidom.
Do not open any <blister> <bottle> in which there is evidence of capsule leakage.
Ne odpirajte <pretisnega omota> <stekleničke>, v katerem opazite puščanje kapsule.
• 1.22 mg of sodium ethyl parahydroxybenzoate (E215) and
• 1,22 mg natrijevega etilparahidroksibenzoata (E215) in
You must not breastfeed while you are taking VEPESID and associated names.
Med jemanjem zdravila VEPESID in povezana imena ne smete dojiti.
VEPESID and associated names 50mg Soft Capsules VEPESID and associated names 100mg Soft Capsules [See Annex I - To be completed nationally]
VEPESID in povezana imena 50 mg mehke kapsule VEPESID in povezana imena 100 mg mehke kapsule [glejte Prilogo I - izpolni država članica] etopozid
• sleepiness or tiredness
• mravljinčenje ali otopelost dlani in stopal
Etoposide may cause adverse reactions that affect the ability to drive and use machines such as fatigue, somnolence,
Etopozid lahko povzroči neželene učinke, ki vplivajo na sposobnost vožnje in upravljanja s stroji, npr. utrujenost, somnolenca, navzea, bruhanje, kortikalna slepota, preobčutljivostne reakcije s hipotenzijo.
• 0.93 mg of sodium ethyl parahydroxybenzoate (E215) and
• 0,93 mg natrijevega etilparahidroksibenzoata (E215) in
Do not open any blister in which there is evidence of capsule leakage.
Ne odpirajte pretisnega omota, v katerem opazite puščanje kapsule.
Etoposide, therefore, is cleared by both renal and nonrenal processes, ie, metabolism and biliary excretion.
Etopozid se torej poleg ledvičnih in neledvičnih poti izloča tudi s presnovo in preko žolča.
Do not open any <bottle> <blister> in which there is evidence of capsule leakage.
Ne odpirajte <stekleničke > <pretisnega omota>, v katerem opazite puščanje kapsule.
Within-patient variability
Razlike pri bolnikih
An alternative dosage schedule for VEPESID and associated names capsules is 50 mg/m2/day for 2 to 3 weeks, with courses repeated after a one week rest period or upon recovery from myelosuppression.
Alternativni režim odmerjanja kapsul zdravila VEPESID in povezana imena je 50 mg/m2/dan v obdobju 2 do 3 tedne.
The occurrence of acute leukaemia, which can occur with or without myelodysplastic syndrome, has been described in patients that were treated with etoposide containing chemotherapeutic regimens.
Pri bolnikih, ki so bili zdravljeni s kemoterapevtiki, in pri katerih je režim zdravljenja vključeval tudi etopozid, so opisali pojav akutne levkemije, ki se je pojavila z ali brez mielodisplastičnega sindroma.
Do not open any bottle in which there is evidence of capsule leakage.
Ne odpirajte stekleničke, v kateri opazite puščanje kapsule.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults.
Zdravilo VEPESID in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje drobnoceličnega pljučnega raka pri odraslih.
Cross resistance between anthracyclines and etoposide has been reported in preclinical experiments.
V predkliničnih študijah so poročali o navzkrižni rezistenci med antraciklini in etopozidom.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister strip 50mg and 100mg
Pretisni omot 50 mg in 100 mg
The following adverse reactions were reported from VEPESID and associated names clinical studies and post-marketing experience.
V kliničnih študijah z zdravilom VEPESID in povezana imena in v obdobju trženja zdravila so poročali o naslednjih neželenih učinkih.
An 11q23 chromosome abnormality has been observed in some cases of secondary leukaemia in patients who have received epipodophyllotoxins.
Pri nekaterih bolnikih s sekundarno levkemijo, ki so se zdravili z epipodofilotoksini, so opazili okvaro kromosoma 11q23.
Fatal myelosuppression has been reported following etoposide administration.
Po uporabi etopozida so poročali o smrti zaradi mielosupresije.
- The active substance is etoposide.
- Učinkovina je etopozid.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory non-Hodgkin's lymphoma in adults.
Zdravilo VEPESID in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje ponovljenega ali refraktarnega ne-Hodgkinovega limfoma pri odraslih.
Impaired renal function
Okvarjeno delovanje ledvic
• infertility
• omotica
Impaired hepatic function
Okvarjeno delovanje jeter
Care must be taken whenever handling cytostatic products.
Pri rokovanju s citotoksičnimi zdravili je potrebna previdnost.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults.
Zdravilo VEPESID in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje neepitelijskega raka jajčnikov pri odraslih.
• tingling or numbness in hands and feet Rare side effects (affecting between 1 in 1,000 and 1 in 10,000 people)
Redki neželeni učinki (pojavijo se pri manj kot 1 od 1000 bolnikov in več kot 1 od 10.000 bolnikov)
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory acute myeloid leukaemia in adults.
Zdravilo VEPESID in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje ponovljene ali refraktarne akutne mieloblastne levkemije pri odraslih.
Thrombocytopenia and severe thrombocytopenia (less
(Stevens-Johnsonov sindrom in toksična epidermalna nekroliza)
• temporary hair loss
• prehodno izpadanje las
See section 4.
- Navodilo shranite.
[See Annex I - To be completed nationally] This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}>
Nadirs tend to occur earlier with intravenous administration compared to oral
Najnižje vrednosti se običajno pojavijo prej v primeru intravenske kot v primeru peroralne uporabe.
Etoposide shows low penetration into the CSF.
Etopozid slabo prehaja v cerebrospinalno tekočino.
• dizziness
• driska
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of recurrent or refractory testicular cancer in adults.
Zdravilo VEPESID in povezana imena je, v kombinaciji z drugimi odobrenimi kemoterapevtiki, indicirano za zdravljenje rekurentnega ali refraktarnega raka mod pri odraslih.
What VEPESID looks like and contents of the pack
Izgled zdravila VEPESID in povezana imena in vsebina pakiranja
Pregnancy
Izdelovalec
Dose of Etoposide
Odmerek etopozida
Myelosuppression (see section 4.4) with fatal outcome has been reported following administration of etoposide.
Po uporabi etopozida so poročali o smrti zaradi mielosupresije (glejte poglavje 4.4).
Talk to your doctor or pharmacist before taking VEPESID and associated names
Pred začetkom uporabe zdravila VEPESID in povezana imena se posvetujte z zdravnikom ali farmacevtom:
• skin problems such as itching or rash Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people)
Občasni neželeni učinki (pojavijo se pri manj kot 1 od 100 bolnikov in več kot 1 od 1000 bolnikov)
• damage to the liver (hepatotoxicity) Common side effects (affecting between 1 in 10 and 1 in 100 people)
Pogosti neželeni učinki (pojavijo se pri manj kot 1 od 10 bolnikov in več kot 1 od 100 bolnikov) • akutna levkemija
What VEPESID and associated names is and what it is used for
Kaj je zdravilo VEPESID in povezana imena in za kaj ga uporabljamo To zdravilo se imenuje VEPESID in povezana imena.
Haematological Toxicity
Hematotoksičnost
Date
Lot
The name of this medicine is VEPESID and associated names.
Kaj vsebuje zdravilo VEPESID in povezana imena
In children, elevated SGPT levels are associated with reduced drug total body clearance.
Pri otrocih se celotni telesni očistek etopozida zmanjša pri zvišanih vrednostih SGPT in tudi po predhodni uporabi cisplatina.
Reports than 50,000 platelets/mm of fever and infection were also very common in patients with neutropenia treated with etoposide.
Pri bolnikih z nevtropenijo, ki so se zdravili z etopozidom, so zelo pogosto poročali o zvišani telesni temperaturi in okužbah.
• generally feeling unwell (malaise)
• občutek splošne slabosti in neugodja
Events are death due to any cause.
Dogodki so smrti iz kakršnega koli vzroka.
The MTD was not reached.
MTD ni bil dosežen.
Representative risk factors for these analyses were:
Reprezentativni dejavniki tveganja za te analize so bili:
Contributions to the mechanism of action by other antibody associated functions have not been excluded.
Prispevkov k mehanizmu delovanja drugih funkcij, povezanih s protitelesi, niso izključili.
A risk to the newborn/infant cannot be excluded.
Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
In this study in 36 patients, no new safety concerns were reported.
V tej študiji s 36 bolniki niso poročali o morebitnih novih varnostnih vprašanjih.
The dose of this medicine depends on your body weight.
Odmerek tega zdravila je odvisen od vaše telesne mase.
In general, these types of reactions occur within minutes to several hours following completion of the infusion.
Na splošno se te vrste reakcij pojavijo v nekaj minutah do nekaj urah po končanju infundiranja.
Additional follow up and evaluation may be warranted if no alternative diagnosis can be established.
Morda bo potrebno dodatno spremljanje in vrednotenje, če ne bo mogoče postaviti alternativnih diagnoz.
The safety and efficacy of ADCETRIS in children less than 18 years have not yet been established.
Varnost in učinkovitost zdravila ADCETRIS pri otrocih, mlajših od 18 let, še nista bili dokazani.
Continue with the same dose and schedule
Nadaljujte z enakim odmerkom in režimom.
FDG-NEGATIVE
FDG-NEGATIVNO
Dose and frequency
Odmerek in pogostnost
Final study report: 31/12/2020
Končno poročilo študije: 31. 12. 2020.
You should also inform your partner or caregivers about your treatment, since they may notice symptoms that you are not aware of.
O zdravljenju obvestite tudi svojega partnerja ali negovalca, ker lahko opazijo simptome, ki se jih sami ne zavedate.
• Two or more prior salvage therapies.
• Dve predhodni reševalni zdravljenji ali več.
Number of deaths c
Število smrti c
This includes herbal medicines and other medicines you can obtain without a prescription.
To vključuje zdravila rastlinskega izvora in druga zdravila, ki jih lahko dobite brez recepta.
Exposures were approximately dose proportional.
Izpostavljenost je bila približno sorazmerna z odmerkom.
You and your partner must use two methods of effective contraception during your treatment with this medicine.
Vi in vaš partner morate med uporabo tega zdravila uporabljati dve obliki učinkovite kontracepcije.
Serious infections and opportunistic infections
Resne okužbe in oportunistične okužbe
The investigator assessments were generally consistent with the independent review of the scans.
Ocena raziskovalca je bila na splošno skladna z neodvisnimi pregledi posnetkov.
However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C-8 °C.
Vendar pa je dokazana kemična in fizikalna stabilnost uporabe za 24 ur pri temperaturi od 2 °C do 8 °C.
Direct the stream toward the wall of the vial and not directly at the cake or powder.
Tok usmerite proti steni viale in ne neposredno na pogačo ali prašek.
The safety and efficacy results in these studies were consistent with results in Study C25001.
Rezultati glede varnosti in učinkovitosti iz teh študij se ujemajo z rezultati iz študije C25001.
Grade 1 (paraesthesia and/or loss of reflexes, with no loss of function)
1. stopnja (parestezija in/ali izguba refleksov, brez izgube funkcije)
Median per Investigator
Mediana po raziskovalcu
If you feel unwell during treatment then do not drive or operate machines.
Če se med zdravljenjem ne počutite dobro, ne vozite vozil in ne upravljajte strojev.
However, they may develop more than several hours after completion of the infusion but this is uncommon.
Vendar pa se lahko razvijejo tudi več ur po infundiranju zdravila, čeprav je to neobičajno.
The results of these post-hoc analyses suggest increased clinical benefit for patients with two or more risk factors but no difference based on any of the individual risk factors.
Rezultati teh naknadnih analiz nakazujejo povečane klinične prednosti za bolnike z dvema ali več dejavniki tveganja, vendar brez razlike glede na posamične dejavnike tveganja.
Eligible patients were required to have at least one of the following risk factors:
Da je bil bolnik primeren, je moral imeti vsaj enega od treh naslednjih dejavnikov tveganja:
It is not for use in children.
Zdravilo ni namenjeno za uporabo pri otrocih.
Total storage time of the solution from reconstitution to infusion should not exceed 24 hours.
Skupni čas shranjevanja raztopine od rekonstitucije do infundiranja ne sme preseči 24 ur.
Table 14 includes the results for ORR4 and other key secondary endpoints.
Preglednica 14 vsebuje rezultate za ORR4 in druge ključne sekundarne opazovane dogodke.
Calculated from a weighted Holm's procedure
Izračunana iz utežene Holmove metode
Your doctor will perform regular blood tests to make sure that it is safe for you to receive this medicine.
Zdravnik bo redno opravljal krvne preiskave, da se prepriča, ali lahko to zdravilo varno uporabljate.
MMAE did not induce any major CYP450 enzymes in primary cultures of human hepatocytes.
MMAE ne inducira nobenih pomembnejših encimov CYP450 v primarnih kulturah človeških hepatocitov.
This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
Stratification factors at randomisation.
Dejavniki stratifikacije pri randomizaciji.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
Currently available data are described in sections 4.8, 5.1 and 5.2.
Trenutno razpoložljivi podatki so navedeni v poglavjih 4.8, 5.1 in 5.2.
Determining dosage amount:
Določanje količine odmerka:
It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Pomembno je, da zdravnika pred zdravljenjem ali med njim obvestite, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
Patients with Stage IV Disease
Bolniki z boleznijo stadija IV
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
Indicates results from non-stratified analysis.
Prikazani rezultati nestratificirane analize.
Lonza AG Lonzastrasse 3930 Visp Switzerland
Lonza AG Lonzastrasse 3930 Visp Švica
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Stable Disease
Stabilna bolezen
The recommended dose of ADCETRIS is infused over 30 minutes.
Priporočeni odmerek zdravila ADCETRIS se infundira v 30 minutah.
A lesser amount of MMAE (28%) was excreted in the urine.
Manjša količina MMAE (28%) se je izločila z urinom.
Fatal outcomes have been reported.
Poročali so tudi o usodnih izidih.
Discontinue treatment a.
Prekinite zdravljenje a.
Post-hoc analyses were performed to evaluate the impact of increased risk (number of risk factors) on clinical benefit (Table 8).
Naknadne analize so bile izvedene za ovrednotenje vpliva povečanega tveganja (število dejavnikov tveganja) na klinične prednosti (preglednica 8).
Represents pooling of preferred terms.
Predstavlja združene podatke za preferenčne izraze.
Investigations Very common:
Preiskave Zelo pogosti:
If you are an older patient (≥ 65 years of age) you may experience serious adverse events more frequently.
Če ste starejši bolnik (stari ≥ 65 let), se lahko resni neželeni dogodki pri vas pojavijo pogosteje.
These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes.
Ti podatki kažejo, da je mogoče učinkovitost in varnost ekstrapolirati na druge CD30-pozitivne podtipe CTCL.
Infusion reactions to this medicine may affect more than 1 in 10 people.
Infuzijske reakcije na to zdravilo se lahko pojavijo pri več kot 1 od 10 bolnikov.
The dosing recommendations for patients aged 65 and older are the same as for adults.
Priporočeno odmerjanje za bolnike, stare 65 let in več, je enako kot za odrasle.
Store in a refrigerator
Shranjujte v hladilniku.
Stratified log-rank test was not performed for PFS per Investigator.
Stratificirani test log-rank po raziskovalcu za PFS ni bil opravljen.
A negative JCV PCR does not exclude PML.
Negativni test PCR za JCV ne izključuje PML.
Per Ann Arbor Staging IPFP = International Prognostic Factor Project
Razvrstitev po klasifikaciji Ann Arbor IPFP = International Prognostic Factor Project (Mednarodni projekt za prognostične dejavnike)
Of these 33 patients who received the RP2D, 32 were evaluable for response.
Izmed 33 bolnikov, ki so prejeli odmerek RP2D, je bilo pri 32 mogoče oceniti odziv.
One patient in each arm had incomplete staging data and are not included in the table
Pri enem bolniku v vsaki skupini so bili podatki nepopolni in niso vključeni v preglednico.
Women must continue using contraception for 6 months following the last dose of Adcetris.
Ženske morajo kontracepcijo uporabljati še 6 mesecev po zadnjem odmerku zdravila Adcetris.
The significance of this finding in stage IV HL patients with no extranodal disease is not established due to small patient numbers and low event rates (14 events).
Pomembnosti te ugotovitve za bolnike z HL stadija IV brez ekstranodalne bolezni ni mogoče ovrednotiti zaradi majhnega števila bolnikov in nizke stopnje pojavnosti dogodkov (14 primerov).
Death without either prior progression or more than one missed assessment visit.
Smrtni primeri ne vključujejo bolnikov s predhodnim napredovanjem ali več kot enim zgrešenim obiskom za ovrednotenje.
If you have these symptoms prior to treatment with this medicine, tell your doctor immediately about any changes in these symptoms.
Če imate te simptome že pred začetkom zdravljenja s tem zdravilom, takoj obvestite zdravnika, če se ti simptomi spremenijo.
In vitro, the binding of MMAE to human serum plasma proteins ranged from 68-82%.
In vitro je bil razpon vezave MMAE na beljakovine v serumu človeške plazme med 68-82%.
You may be given other medicines such as anti-histamines, corticosteroids or paracetamol to help reduce any of the reactions above if you have already experienced these when receiving this type of medicine.
Morda boste prejeli druga zdravila, kot so - antihistaminiki, kortikosteroidi ali paracetamol, ki pomagajo zmanjšati morebitne zgoraj navedene reakcije, če ste jih pri uporabi te vrste zdravila že doživeli.
Number of Risk Factors = 1
Število dejavnikov tveganja = 1
See the fertility section below pertaining to advice for women whose male partners are being treated with ADCETRIS.
Glejte spodnje poglavje za plodnost, ki vsebuje nasvet za ženske, katerih moški partnerji se zdravijo z zdravilom ADCETRIS.
These features make CD30 a target for therapeutic intervention.
Zaradi teh značilnosti je CD30 tarča za terapevtski poseg.
Procedures for proper handling and disposal of anticancer medicines should be considered.
Upoštevati morate postopke za pravilno ravnanje z zdravili proti raku in njihovo odstranjevanje.
Date of first authorisation: 25 October 2012
Datum prve odobritve: 25. oktober 2012 Datum zadnjega podaljšanja: 10. september 2018
Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.
Bolnike je treba med zdravljenjem skrbno nadzirati glede pojava možnih resnih in oportunističnih okužb.
If you think you have previously had a similar reaction, tell your doctor BEFORE you are given this medicine.
Če menite, da ste že prej imeli podobne reakcije, obvestite zdravnika, PREDEN dobite to zdravilo.
Number of patients with disease progression or death a
Število bolnikov z napredovanj em bolezni ali smrtjo a