natgillin/translations-raw huggingface dataset:
The overall conclusion is that that the efficacy dataset as a whole is adequate to support the efficacy of the product in target species pigs at the dose of 22.5 mg florfenicol/kg body weight given by intramuscular administration as a single injection for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Splošni zaključek Odbora je, da je podatkovni niz kot celota primeren za podporo učinkovitosti zdravila pri ciljni vrsti prašičev pri odmerku 22,5 mg florfenikola/kg telesne mase, ki se daje intramuskularno z enkratnim injiciranjem za zdravljenje okužb dihal, ki jih povzročajo sevi bakterij Actinobacillus pleuropneumoniae in Pasteurella multocida, ki so občutljive za florfenikol.
Belgium Emdoka bvba John Lijsenstraat 16
Madžarska Emdoka bvba John Lijsenstraat 16
Florgane 300 mg/ml suspension for injection contains florfenicol as active ingredient.
Florgane 300 mg/ml raztopina za injiciranje vsebuje zdravilno učinkovino florfenikol.
Luxembourg Emdoka bvba John Lijsenstraat 16
Luksemburg Emdoka bvba John Lijsenstraat 16
Plasmid mediated resistance has only been scarcely identified among porcine respiratory pathogens without indication of spreading.
Med prašičjimi respiratornimi patogeni so le redko poročali o odpornosti, pridobljeni s plazmidi, brez sledu širjenja.
The intended use in pigs is for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Zdravilo je namenjeno zdravljenju prašičev z okužbami dihal, ki jih povzročajo sevi bakterij Actinobacillus pleuropneumoniae in Pasteurella multocida, ki so občutljive za florfenikol.
Greece
Grčiji
The applicant submitted an application for a decentralised procedure for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names.
Predlagatelj je predložil vlogo za decentralizirani postopek za zdravilo Florgane 300 mg/ml raztopina za injiciranje za govedo in prašiče, in povezana imena.
Spain1
Španija1
Czech Republic Emdoka bvba John Lijsenstraat 16
Nizozemska Emdoka bvba John Lijsenstraat 16
Considering the MIC data from most recent isolates, obtained from pigs suffering from respiratory disease in the last 5 years florfenicol exhibited consistent MICs with MIC90 ranges of 0.25-1 µg/ml for
Glede na podatke o MIK, pridobljenih iz najnovejših izoliranih patogenov prašičev z boleznimi dihal v zadnjih 5 letih, so za florfenikol veljale enakomerne MIK z razponom MIK90 od 0,25 do 1 µg/ml za patogen P. A. pleuropneumoniae ter 0,5 µg/ml za patogen P. multocida.
Scientific conclusions and grounds for the granting of the extension of the marketing authorisation for Florgane 300 mg/ml suspension for injection for cattle to the target species pigs
Znanstveni zaključki in razlogi za odobritev razširitve dovoljenja za promet z zdravilom Florgane 300 mg/ml raztopina za injiciranje za govedo na ciljno vrsto prašičev
Bulgaria
Bolgariji
Slovakia
Slovaška republika
The reference veterinary medicinal product is Nuflor Swine Injectable Solution 300 mg/ml.
Referenčno zdravilo za uporabo v veterinarski medicini je Nuflor Swine 300 mg/ml raztopina za injiciranje.
Thus, the impact on development of florfenicol resistance when used in the proposed dose of 22.5 mg/kg bw IM once compared to authorised dosing regimens can hardly be estimated.
Zato je skoraj nemogoče oceniti, kako predlagani enkratni intramuskularni odmerki 22,5 mg/kg telesne mase vplivajo na razvoj odpornosti na florfenikol v primerjavi z odobrenimi načini odmerjanja.
In conclusion, the benefit-risk ratio is considered positive for Florgane300 mg/ml suspension for injection for cattle and pigs.
V zaključku je Odbor presodil, da je razmerje med koristmi in tveganji zdravila Florgane 300 mg/ml raztopina za injiciranje za govedo in prašiče pozitivno.
Overall summary of the scientific evaluation of Florgane 300 mg/ml suspension for injection for cattle and pigs
Splošni povzetek znanstvenega vrednotenja zdravila Florgane 300 mg/ml raztopina za injiciranje za govedo in prašiče
Grounds for the granting of the extension of the marketing authorisation for Florgane 300 mg/ml suspension for injection for cattle to the target species pigs
Razlogi za odobritev razširitve dovoljenja za promet z zdravilom Florgane 300 mg/ml raztopina za injiciranje za govedo na ciljno vrsto prašičev
The reference product was Nuflor Swine Injectable Solution 300 mg/ml.
Referenčno zdravilo je bilo zdravilo Nuflor Swine 300 mg/ml raztopina za injiciranje.
Florgane 300 mg/ml will not differ from the previous florfenicol formulations as far as the plasma elimination phase and sub-therapeutic periods are concerned.
Kar zadeva fazo plazemske eliminacije in koncentracije pod terapevtsko ravnijo, se zdravilo Florgane 300 mg/ml ne bo razlikovalo od prejšnjih pripravkov s florfenikolom.
Further information on Opdivo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/opdivo.
Nadaljnje informacije o zdravilu Opdivo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/opdivo.
What measures are being taken to ensure the safe and effective use of Opdivo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Opdivo?
• melanoma, a type of skin cancer.
• melanoma, tj. vrste kožnega raka.
Opdivo received a marketing authorisation valid throughout the EU on 19 June 2015.
Za zdravilo Opdivo je bilo 19. junija 2015 izdano dovoljenje za promet, veljavno po vsej EU.
An overview of Opdivo and why it is authorised in the EU
Pregled zdravila Opdivo in zakaj je odobreno v EU
Other information about Opdivo
Druge informacije o zdravilu Opdivo
As for all medicines, data on the use of Opdivo are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Opdivo stalno spremljajo.
Studies of classical Hodgkin lymphoma involved only a small number of patients.
V študije klasičnega Hodgkinovega limfoma je bilo vključeno le manjše število bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opdivo have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Opdivo, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The Agency therefore decided that Opdivo's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Opdivo večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
What benefits of Opdivo have been shown in studies?
Kakšne koristi je zdravilo Opdivo izkazalo v študijah?
After treatment, cancer cells were partially or completely cleared in around 66% of patients (63 out of 95).
Po zdravljenju so bile rakave celice delno ali v celoti odstranjene pri okoli 66 % (63 od 95) bolnikov.
Treatment with Opdivo must be started and supervised by a doctor experienced treating cancer.
Zdravljenje z zdravilom Opdivo mora začeti in nadzorovati zdravnik z izkušnjami z zdravljenjem raka.
What is Opdivo and what is it used for?
Kaj je zdravilo Opdivo in za kaj se uporablja?
Opdivo was used on its own and not compared with any other medicine.
Zdravilo Opdivo se je uporabljalo samostojno in ga niso primerjali z nobenim drugim zdravilom.
The company will also provide further data on the long-term benefits of Opdivo and carry out studies to try to identify which patients are most likely to benefit from treatment with the medicine.
Predložilo bo tudi dodatne podatke o dolgotrajnih koristih jemanja zdravila Opdivo in izvedlo študije, s katerimi bo poskušalo ugotoviti, katerim bolnikom bo zdravljenje s tem zdravilom najverjetneje koristilo.
The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.
Priskrbelo bo tudi opozorilno kartico za bolnike, ki bo vsebovala informacije o tveganjih tega zdravila in navodila, kdaj se posvetovati z zdravnikom, če se pojavijo simptomi.
What are the risks associated with Opdivo?
Kakšna tveganja so povezana z zdravilom Opdivo?
The dose and frequency to be given depends on the condition and whether it is used alone or in combination with ipilimumab.
Odmerek in pogostnost infundiranja sta odvisna od tega, ali se zdravilo uporablja samostojno ali v kombinaciji z ipilimumabom.
As it is not clear how much ipilimumab contributes to the benefits when given in combination with Opdivo in patients with advanced renal cell carcinoma, the company must conduct a study to determine the precise contribution of ipilimumab and if the risks associated with ipilimumab can be further minimised.
Ker ni jasno, v kolikšni meri ipilimumab doprinese h koristim zdravljenja, kadar se uporablja v kombinaciji z zdravilom Opdivo pri bolnikih z napredovalim karcinomom ledvičnih celic, mora podjetje izvesti študijo za določitev natančnega doprinosa ipilimumaba in raziskati, ali je mogoče tveganja, povezana s to učinkovino, še dodatno zmanjšati.
Why is Opdivo authorised?
Zakaj je bilo zdravilo Opdivo odobreno?
The doctor may need to delay doses if certain side effects occur, or stop treatment altogether if side effects are severe.
Zdravnik bo morda moral počakati z naslednjimi odmerki, če se pojavijo določeni neželeni učinki, ali popolnoma prekiniti zdravljenje, če so neželeni učinki resni.
Most will go away with appropriate treatment or on stopping Opdivo.
Večina učinkov izzveni z ustreznim zdravljenjem ali prekinitvijo uporabe zdravila Opdivo.
For more information about using Opdivo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Opdivo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Opdivo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Opdivo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
In the study, 20% of patients (54 out of 270) responded to treatment and had a tumour size reduction.
V študiji se je 20 % (54 od 270) bolnikov odzvalo na zdravljenje in so se njihovi tumorji zmanjšali.
In studies of urothelial cancer where other treatments had failed, patients responded to treatment with Opdivo.
V študijah urotelnega raka, pri katerem druga zdravljenja niso bila uspešna, so se bolniki odzvali na zdravljenje z zdravilom Opdivo.
However, high response rates were seen in these patients, in whom other treatments had failed and who had few other treatment options.
Kljub temu so opazili visoke stopnje odziva na zdravljenje pri bolnikih, pri katerih druge oblike zdravljenja niso bile uspešne ali ki so imeli manj možnosti zdravljenja.
Patients given only ipilimumab lived for 2.9 months without their disease getting worse.
Bolniki, ki so prejemali samo ipilimumab, so živeli 2,9 meseca brez poslabšanja bolezni.
• classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell), that has not improved or has returned after an autologous stem cell transplant (a procedure where the bone marrow is replaced with the patient's own stem cells to form new bone marrow that produces healthy blood cells).
• klasičnega Hodgkinovega limfoma, tj. raka limfocitov (vrste belih krvnih celic), ki se ni odzval na zdravljenje ali se je ponovil po avtologni presaditvi matičnih celic (postopku, pri katerem bolnikov kostni mozeg nadomestijo z njegovimi lastnimi matičnimi celicami, da začnejo tvoriti nov kostni mozeg, ki proizvaja zdrave krvne celice).
Opdivo is also commonly associated with side effects related to the activity of the immune system on body organs.
Zdravilo Opdivo je pogosto povezano tudi z neželenimi učinki, ki se pojavijo zaradi delovanja imunskega sistema na telesne organe.
In this study, where patients were followed up for at least 6 months, around 32% (38 out of 120) of patients given Opdivo responded to treatment and had a reduction in their tumours compared with about 11% (5 out of 47) of patients given investigator's choice of treatment (dacarbazine or a combination of carboplatin and paclitaxel).
V tej študiji, v kateri so bolnike spremljali vsaj šest mesecev, se je približno 32 % (38 od 120) bolnikov, ki so prejemali zdravilo Opdivo, odzvalo na zdravljenje, saj so se njihovi tumorji zmanjšali, v primerjavi s približno 11 % (5 od 47) bolnikov, ki so prejemali zdravljenje, ki ga je izbral raziskovalec (dakarbazin ali kombinacijo karboplatina in paklitaksela).
The results showed that in patients at moderate or high risk of their cancer getting worse, patients given the combination lived overall longer than those given sunitinib.
Rezultati so pokazali, da so v skupini bolnikov z zmernim ali visokim tveganjem za poslabšanje raka, na splošno dlje časa živeli tisti, ki so prejemali omenjeno kombinacijo, kot tisti, ki so prejemali sunitinib.
The company that markets Opdivo will provide educational packs for doctors who are expected to prescribe Opdivo containing information on how the medicine should be used, how to manage side effects, particularly those related to the activity of the immune system, and possible risks for classical Hodgkin lymphoma patients if they go on to have an allogeneic stem cell transplant (a transplant of stem cells from a donor).
Podjetje, ki trži zdravilo Opdivo, bo pripravilo izobraževalno gradivo za zdravnike, ki naj bi predpisovali to zdravilo, v katerem bodo informacije o načinu njegove uporabe, obvladovanju neželenih učinkov, zlasti tistih, povezanih z delovanjem imunskega sistema, ter o možnih tveganjih pri bolnikih s klasičnim Hodgkinovim limfomom, pri katerih bo izvedena alogenska presaditev krvotvornih matičnih celic (presaditev matičnih celic darovalca).
More patients were alive after 2 years with Opdivo and ipilimumab treatment (64%) than with Opdivo alone (59%) or ipilimumab alone (45%).
Po dveh letih je živelo več bolnikov, ki so prejemali kombinirano zdravljenje z zdravilom Opdivo in ipilimumabom (64 %), kot tistih, ki so prejemali samo zdravilo Opdivo (59 %) ali samo ipilimumab (45 %).
For the full list of side effects and restrictions with Opdivo, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Opdivo glejte navodilo za uporabo.
The European Medicines Agency considered that Opdivo has been convincingly shown to benefit patients with certain advanced cancers (melanoma, NSCLC, renal cell carcinoma or SCCHN) by either increasing patients' survival or the time they could live without their disease getting worse.
Evropska agencija za zdravila je menila, da so pri zdravilu Opdivo prepričljivo dokazane koristi za bolnike z nekaterimi napredovalimi oblikami raka (melanomom, nedrobnoceličnim pljučnim rakom, karcinomom ledvičnih celic ali ploščatoceličnim karcinomom glave in vratu), saj je podaljšalo čas njihovega preživetja ali čas, ko so lahko živeli brez poslabšanja bolezni.
Opdivo is a cancer medicine used to treat the following:
Opdivo je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje naslednjih bolezni:
The first study, involving 418 previously untreated advanced melanoma patients, found that patients treated with Opdivo survived longer than patients who received the cancer medicine dacarbazine: 73% of patients treated with Opdivo were alive at 12 months compared with 42% of patients given dacarbazine.
V prvi študiji, ki je vključevala 418 predhodno nezdravljenih bolnikov z napredovalim melanomom, so ugotovili, da so bolniki, ki so se zdravili z zdravilom Opdivo, živeli dlje kot tisti, ki so jemali zdravilo za zdravljenje raka dakarbazin: 73 % bolnikov, zdravljenih z zdravilom Opdivo, je bilo po dvanajstih mesecih še živih v primerjavi z 42 % tistih, ki so prejemali dakarbazin.
Patients treated with Opdivo lived on average 31 months before the cancer came back or before a new melanoma occurred or they died, compared with 24 months for patients treated with ipilimumab.
Bolniki, ki so prejemali zdravilo Opdivo, so v povprečju živeli 31 mesecev, preden se je bodisi rak ponovil bodisi pojavil nov melanom bodisi so umrli, v primerjavi s 24 meseci pri bolnikih, ki so se zdravili z ipilimumabom.
The most common side effects with Opdivo (which may affect more than 1 in 10 people) include tiredness, diarrhoea, nausea (feeling sick), rash and itching, pain in joints, muscles and bones, and hypothyroidism (an underactive thyroid gland), most of which are mild to moderate in severity.
Najpogostejši neželeni učinki zdravila Opdivo (ki lahko prizadenejo več kot 1 osebo od 10) so utrujenost, driska, navzeja (slabost), izpuščaj in srbenje, bolečine v sklepih, mišicah in kosteh ter hipotiroidizem (nezadostno delovanje ščitnice), njihova resnost pa je večinoma blaga do zmerna.
Side effects from Opdivo were considered manageable with appropriate measures and were outweighed by the benefits.
Neželeni učinki zdravila Opdivo veljajo ob ustreznih ukrepih za obvladljive in jih odtehtajo njegove koristi.
• advanced renal cell carcinoma, a kidney cancer.
• napredovalega karcinoma ledvičnih celic, tj. raka ledvic.
Other common side effects with Opdivo in combination with ipilimumab, which are also mostly mild or moderate, include pyrexia (fever), thyroid issues, decreased appetite, vomiting, colitis (inflammation of the gut), abdominal (belly) pain, headache and breathing difficulty.
Drugi pogosti neželeni učinki zdravila Opdivo v kombinaciji z ipilimumabom, ki so tudi večinoma blagi ali zmerni, so pireksija (povišana telesna temperatura), težave s ščitnico, zmanjšan tek, bruhanje, kolitis (vnetje prebavil), bolečine v trebuhu, glavobol in težave z dihanjem.
The active substance in Opdivo, nivolumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Učinkovina v zdravilu Opdivo, nivolumab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna receptor (prijemališče), imenovano PD-1, ki se nahaja na določenih celicah imunskega sistema, imenovanih celice T, in se veže nanjo.
The average survival with Opdivo was 12.2 months, compared with 9.4 months with docetaxel.
Povprečni čas preživetja pri zdravilu Opdivo je bil 12,2 meseca, pri docetakselu pa 9,4 meseca.
Opdivo is used on its own or with another cancer medicine, ipilimumab, to treat adults whose cancer has spread to other parts of the body or cannot be surgically removed.
Zdravilo Opdivo se uporablja samostojno ali skupaj z drugim zdravilom za zdravljenje raka, ipilimumabom, za zdravljenje odraslih, pri katerih se je rak razširil na druge dele telesa ali ga ni mogoče kirurško odstraniti.
The study included patients whose cancer cells produced high levels of PD-L1 as well as patients whose cancer cells produced low levels of PD-L1.
Študija je vključevala bolnike, pri katerih so rakave celice proizvajale velike količine beljakovine PD-L1, in tudi bolnike, pri katerih so rakave celice proizvajale majhne količine te beljakovine.
Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Rakave celice lahko tvorijo beljakovine (PD-L1 in PD-L2), ki se vežejo na ta receptor in onemogočijo delovanje celic T, tako da te ne morejo napasti rakavih celic.
The second study looked at 405 advanced melanoma patients whose disease had got worse despite previous treatment with a cancer medicine.
V drugi študiji so proučevali 405 bolnikov z napredovalim melanomom, pri katerih se je bolezen poslabšala kljub prejšnjemu zdravljenju z zdravilom za zdravljenje raka.
By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Nivolumab z vezavo na receptor prepreči, da bi beljakovini PD-L1 in PD-L2 onemogočili delovanje celic T, s čimer se poveča sposobnost imunskega sistema za uničevanje rakavih celic.
It is used on its own when treatment with platinum-based cancer medicines has not worked.
Kot samostojno zdravilo se uporablja, kadar zdravljenje z zdravili za zdravljenje raka na osnovi platine ni bilo uspešno.
Opdivo was used on its own and was compared with another cancer medicine (cetuximab, methotrexate or docetaxel) chosen by the treating doctor.
Zdravilo Opdivo so uporabljali samostojno in ga primerjali z drugim zdravilom za zdravljenje raka (cetuksimabom, metotreksatom ali docetakselom) po izbiri lečečega zdravnika.
Opdivo was studied in one main study and a supportive study involving a total of 95 adults with classical Hodgkin lymphoma whose disease had not responded or had returned after autologous stem cell transplantation and treatment with brentuximab vedotin.
Zdravilo Opdivo so proučevali v eni glavni študiji in eni podporni študiji, v kateri je bilo skupaj vključenih 95 odraslih bolnikov s klasičnim Hodgkinovim limfomom, pri katerih se bolezen ni odzvala na zdravljenje ali se je ponovila po presaditvi avtolognih matičnih celic in zdravljenju z brentuksimabom vedotinom.
A third study in 906 adults with melanoma who had undergone surgery and who were at high risk of the cancer coming back compared Opdivo with ipilimumab.
V tretji študiji, ki je vključevala 906 odraslih z melanomom, pri katerih je bil opravljen kirurški poseg in je obstajalo visoko tveganje za ponovitev raka, so zdravilo Opdivo primerjali z ipilimumabom.
Improvements in the time patients lived without their disease getting worse when treated with Opdivo plus ipilimumab relative to Opdivo used on its own were only seen for patients whose cancer cells produced low levels of PD-L1.
Podaljšanje časa, ko so bolniki ob zdravljenju z zdravilom Opdivo in ipilimumabom živeli brez poslabšanja bolezni v primerjavi z bolniki, ki so bili zdravljeni samo z zdravilom Opdivo, je bilo opaženo pri bolnikih, pri katerih so rakave celice proizvajale majhne količine PD-L1.
Opdivo is used on its own in patients whose cancer is progressing despite treatment with platinum-based cancer medicines;
Zdravilo Opdivo se uporablja kot samostojno zdravilo pri bolnikih, pri katerih rak napreduje kljub zdravljenju z zdravili za zdravljenje raka na osnovi platine;
How is Opdivo used?
Kako se zdravilo Opdivo uporablja?
It is also used on its own in patients who have had surgery for the removal of melanoma that has spread to the lymph nodes or elsewhere in the body.
Kot samostojno zdravilo se uporablja tudi pri bolnikih, ki so jim kirurško odstranili melanom, ki se je razširil na limfne vozle ali druge dele telesa;
One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Opdivo and ipilimumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib.
V eni glavni študiji, ki je vključevala 1 096 odraslih bolnikov s predhodno nezdravljenim napredovalim karcinomom ledvičnih celic, so zdravljenje z zdravilom Opdivo v kombinaciji z ipilimumabom primerjali z zdravljenjem z drugim zdravilom za zdravljenje karcinoma ledvičnih celic, in sicer sunitinibom.
Patients who were given Opdivo plus ipilimumab lived for another 11.5 months without their disease getting worse and patients given only Opdivo lived for another 6.9 months without their disease getting worse.
Bolniki, ki so prejemali zdravilo Opdivo in ipilimumab, so živeli povprečno še 11,5 meseca brez poslabšanja bolezni; tisti, ki pa so prejemali samo zdravilo Opdivo, so živeli še 6,9 meseca brez poslabšanja bolezni.
Opdivo was compared with everolimus (another cancer medicine) in one main study involving 821 patients with advanced renal cell carcinoma whose disease advanced despite previous treatment.
Zdravilo Opdivo so z everolimusom (drugim zdravilom za zdravljenje raka) primerjali v eni glavni študiji, v katero je bilo vključenih 821 bolnikov z napredovalim karcinomom ledvičnih celic, pri katerih je bolezen kljub predhodnemu zdravljenju napredovala.