FrancophonIA/ELRC3.0 huggingface dataset:
English: The study showed that Ocaliva was more effective than placebo at reducing the blood levels of bilirubin and ALP: levels decreased by the required amount in 47% (34 out of 73) of patients treated with Ocaliva 10 mg and in 46% (32 out of 70) of patients treated with increasing doses of Ocaliva (from 5 mg up to 10 mg), compared with 10% (7 out of 73) of patients on placebo.
Slovenian: Študija je pokazala, da je zdravilo Ocaliva učinkovitejše od placeba pri zniževanju ravni bilirubina in ALP v krvi: raven se je znižala za potrebno količino pri 47 % (34 od 73) bolnikov, zdravljenih z zdravilom Ocaliva v odmerku 10 mg, in pri 46 % (32 od 70) bolnikov, zdravljenih z naraščajočimi odmerki zdravila Ocaliva (od 5 mg do 10 mg), v primerjavi z 10 % (7 od 73) bolnikov, ki so prejemali placebo.
English: As for all medicines, data on the use of Ocaliva is continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ocaliva stalno spremljajo.
English: However, the clinical benefits of Ocaliva need to be demonstrated in further studies.
Slovenian: Kljub temu je treba klinične koristi zdravila Ocaliva dokazati z nadaljnjimi študijami.
English: Since Ocaliva has been granted a conditional authorisation, the company that markets Ocaliva will provide additional data from two studies to confirm the effectiveness and safety of the medicine.
Slovenian: Ker je zdravilo Ocaliva pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila dodatne podatke iz dveh študij in tako potrdila učinkovitost in varnost zdravila.
English: Patients with primary biliary cholangitis have limited treatment options.
Slovenian: Bolniki s primarnim biliarnim holangitisom imajo omejene možnosti zdravljenja.
English: It works mainly by attaching to receptors in the liver and gut (farnesoid X receptors) which control the production of bile.
Slovenian: Deluje predvsem tako, da se pritrdi na receptorje v jetrih in črevesju (farnezoidne receptorje X), ki nadzorujejo nastajanje žolča.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ocaliva have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ocaliva upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: An overview of Ocaliva and why it is authorised in the EU
Slovenian: Pregled zdravila Ocaliva in zakaj je odobreno v EU
English: The safety profile of the medicine was considered to be favourable, with side effects that were tolerable and manageable with supportive treatment (e.g. for itching) and dose adjustments.
Slovenian: Varnostni profil zdravila je bil ocenjen kot ugoden, z znosnimi neželenimi učinki, ki jih je mogoče obvladovati s podpornim zdravljenjem (npr. srbenje) in prilagoditvijo odmerka.
English: Ocaliva has been given ‘conditional authorisation'.
Slovenian: Zdravilo Ocaliva je pridobilo „pogojno dovoljenje za promet“.
English: The first study is designed to demonstrate the clinical benefit of Ocaliva, while the second study will investigate the benefits of Ocaliva in patients with moderate to severe liver disease.
Slovenian: Prva študija je namenjena dokazovanju klinične koristi zdravila Ocaliva, druga študija pa bo proučila koristi tega zdravila pri bolnikih z zmerno do hudo boleznijo jeter.
English: Ocaliva is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Ocaliva je na voljo v obliki tablet (5 in 10 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: Side effects reported with Ocaliva are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ocaliva, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Primary biliary cholangitis is rare, and Ocaliva was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 July 2010.
Slovenian: Primarni biliarni holangitis je redka bolezen, zato je bilo zdravilo Ocaliva 27. julija 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The measure of effectiveness was based on the number of patients whose blood levels of the substances bilirubin and ALP (markers of liver damage) decreased by at least 15% (for ALP) and below a certain value considered normal (for bilirubin) after 1 year of treatment.
Slovenian: Merilo učinkovitosti je temeljilo na številu bolnikov, pri katerih se je količina bilirubina in ALP (označevalcev jetrne poškodbe) v krvi po enoletnem zdravljenju zmanjšala za vsaj 15 % (za ALP) in pod določeno vrednost, ki velja za normalno (za bilirubin).
English: The most common side effects with Ocaliva are itching (which may affect more than 6 in 10 people) and tiredness (which may affect more than 2 in 10 people).
Slovenian: Najpogostejša neželena učinka zdravila Ocaliva sta srbenje (ki se lahko pojavi pri več kot 6 bolnikih od 10) in utrujenost (ki se lahko pojavi pri več kot 2 bolnikih od 10).
English: What benefits of Ocaliva have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ocaliva izkazalo v študijah?
English: It is used together with another medicine, ursodeoxycholic acid (UDCA), in patients who do not respond sufficiently to UDCA alone, and on its own in patients who cannot take UDCA.
Slovenian: Uporablja se skupaj z drugim zdravilom, ursodeoksiholno kislino (UDCA), pri bolnikih, pri katerih odziv na ursodeoksiholno kislino ni zadosten, in samostojno pri bolnikih, ki ursodeoksiholne kisline ne morejo jemati.
English: Ocaliva is used to treat adults with a liver disease known as primary biliary cholangitis.
Slovenian: Zdravilo Ocaliva se uporablja za zdravljenje odraslih z boleznijo jeter, znano kot primarni biliarni holangitis.
English: The active substance in Ocaliva, obeticholic acid, is a modified form of a bile acid (the main components of bile).
Slovenian: Zdravilna učinkovina v zdravilu Ocaliva, obetiholna kislina, je spremenjena oblika ene od žolčnih kislin (glavnih sestavin žolča).
English: What are the risks associated with Ocaliva?
Slovenian: Kakšna tveganja so povezana z zdravilom Ocaliva?
English: Ocaliva was compared with placebo (a dummy treatment) in a main study involving 217 adults with primary biliary cholangitis who either had been taking UDCA for at least 1 year, or who could not take UDCA.
Slovenian: Zdravilo Ocaliva so primerjali s placebom (zdravilom brez zdravilne učinkovine) v glavni študiji, ki je vključevala 217 odraslih s primarnim biliarnim holangitisom, ki so bodisi jemali UDCA vsaj eno leto bodisi tega niso mogli jemati.
English: Reductions in bilirubin and ALP were to an extent which is indicative of an improvement in the condition of the liver.
Slovenian: Ravni bilirubina in ALP sta se znižali v obsegu, ki kaže na izboljšanje stanja jeter.
English: Ocaliva must not be used in patients whose bile ducts are completely blocked.
Slovenian: Zdravilo Ocaliva se ne sme uporabljati pri bolnikih s popolno blokado žolčevodov.
English: Ocaliva has been shown to reduce the blood levels of bilirubin and ALP in patients with primary biliary cholangitis, including those who could not be treated with UDCA.
Slovenian: Zdravilo Ocaliva dokazano zmanjšuje ravni bilirubina in ALP v krvi pri bolnikih s primarnim biliarnim holangitisom, vključno z bolniki, ki se z UDCA ne morejo zdraviti.
English: For more information about using Ocaliva, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ocaliva glejte navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: After a few months, if Ocaliva is well tolerated the dose can be increased.
Slovenian: Če bolnik zdravilo Ocaliva dobro prenaša, se odmerek po nekaj mesecih lahko poveča.
English: What information is still awaited for Ocaliva?
Slovenian: Katere informacije o zdravilu Ocaliva še pričakujemo?
English: Primary biliary cholangitis is an autoimmune condition in which there is gradual destruction of the small bile ducts in the liver.
Slovenian: Primarni biliarni holangitis je avtoimunska bolezen, pri kateri mali žolčevodi v jetrih postopoma propadajo.
English: By attaching to these receptors, Ocaliva reduces the production of bile in the liver, preventing it from building up and damaging the liver tissue.
Slovenian: Zdravilo Ocaliva s pritrditvijo na te receptorje zmanjša nastajanje žolča v jetrih in tako prepreči njegovo kopičenje ter poškodbe jetrnega tkiva.
English: Ocaliva contains the active substance obeticholic acid.
Slovenian: Zdravilo Ocaliva vsebuje zdravilno učinkovino obetiholno kislino.
English: These ducts transport fluid called bile from the liver to the intestines, where it is used to help digest fats.
Slovenian: Po teh vodih se tekočina, imenovana žolč, prenaša iz jeter do črevesja, kjer pomaga pri prebavi maščob.
English: As a result of the damage to the ducts, bile builds up in the liver causing damage to the liver tissue.
Slovenian: Zaradi poškodbe žolčevodov se žolč kopiči v jetrih in tako poškoduje jetrno tkivo.
English: How is Ocaliva used?
Slovenian: Kako se zdravilo Ocaliva uporablja?
English: How does Ocaliva work?
Slovenian: Kako zdravilo Ocaliva deluje?
English: Other information about Ocaliva
Slovenian: Druge informacije o zdravilu Ocaliva
English: Doses can be reduced or treatment may need to be stopped in patients who experience intolerable itching (a possible side effect with Ocaliva).
Slovenian: Pri bolnikih, ki občutijo nevzdržno srbenje (možni neželeni učinek zdravila Ocaliva), se odmerek lahko zmanjša ali pa se zdravljenje prekine.
English: For the list of all side effects with Ocaliva, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ocaliva, glejte navodilo za uporabo.
English: Intravenous use vial (glass)
Slovenian: 200 mg prašek za raztopino za infundiranje intravenska uporaba viala (steklena)
English: It is used for:
Slovenian: Uporablja se pri:
English: Further information on Tarceva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Tarceva.
Slovenian: Več informacij o zdravilu Tarceva je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Tarceva.
English: The medicine is available as tablets (25, 100 and 150 mg).
Slovenian: Zdravilo je na voljo v obliki tablet (25, 100 in 150 mg).
English: Tarceva received a marketing authorisation valid throughout the EU on 19 September 2005.
Slovenian: Za zdravilo Tarceva je bilo 19. septembra 2005 izdano dovoljenje za promet, veljavno po vsej EU.
English: Tarceva is taken at least one hour before or two hours after food.
Slovenian: Zdravilo Tarceva je treba vzeti vsaj eno uro pred obrokom ali dve uri po njem.
English: Pancreatic cancer
Slovenian: Rak trebušne slinavke
English: Patients taking Tarceva should stop smoking, as smoking can decrease the amount of the medicine in the blood.
Slovenian: Bolniki, ki jemljejo zdravilo Tarceva, morajo prenehati kaditi, saj lahko kajenje zniža količino zdravila v krvi.
English: What measures are being taken to ensure the safe and effective use of Tarceva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tarceva?
English: If needed (for example because of side effects), the dose may be reduced in 50-mg steps.
Slovenian: Po potrebi (na primer zaradi neželenih učinkov) se lahko odmerek postopoma zmanjšuje, vsakič za 50 mg.
English: As a result of this block, the tumour cells can no longer receive the messages needed for growing and for spreading (metastasis).
Slovenian: Posledica tega zaviranja je, da tumorske celice ne prejemajo več sporočil, potrebnih za svojo rast in širjenje (metastaze).
English: Other information about Tarceva
Slovenian: Druge informacije o zdravilu Tarceva
English: The European Medicines Agency therefore decided that Tarceva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Tarceva večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: An overview of Tarceva and why it is authorised in the EU
Slovenian: Pregled zdravila Tarceva in zakaj je odobreno v EU
English: The medicine contains the active substance erlotinib.
Slovenian: Zdravilo vsebuje učinkovino erlotinib.
English: As for all medicines, data on the use of Tarceva are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tarceva stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tarceva have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tarceva upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Why is Tarceva authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Tarceva odobreno v EU?
English: Side effects reported with Tarceva are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Tarceva, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Tarceva can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Tarceva je le na recept, zdravljenje z njim pa mora biti pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: What is Tarceva and what is it used for?
Slovenian: Kaj je zdravilo Tarceva in za kaj se uporablja?
English: What are the risks associated with Tarceva?
Slovenian: Kakšna tveganja so povezana z zdravilom Tarceva?
English: What benefits of Tarceva have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Tarceva izkazalo v študijah?
English: The active substance in Tarceva, erlotinib, belongs to the group ‘EGFR inhibitors'.
Slovenian: Učinkovina v zdravilu Tarceva, erlotinib, spada v skupino zaviralcev EGFR.
English: As a result, Tarceva helps to stop the cancer from growing and spreading through the body.
Slovenian: Zato zdravilo Tarceva pripomore k ustavljanju rasti in širjenja raka po telesu.
English: The study found no advantage to early use of the medicine, as patients treated with Tarceva early in the study did not live longer than those treated with Tarceva later in the study (after the disease had progressed).
Slovenian: V tej študiji niso opazili nobenih prednosti zgodnje uporabe zdravila, saj bolniki, ki so se z zdravilom Tarceva zdravili zgodaj v študiji, niso živeli dlje v primerjavi z bolniki, ki so se z zdravilom Tarceva zdravili pozneje v študiji (ko je bolezen že napredovala).
English: For more information about using Tarceva, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Tarceva glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: As Tarceva seems more effective in patients with pancreatic cancer who develop a rash, treatment should be re-assessed after 4 to 8 weeks if no rash has developed.
Slovenian: Ker se zdravilo Tarceva zdi učinkovitejše pri zdravljenju bolnikov z rakom trebušne slinavke, pri katerih se pojavi izpuščaj, je treba zdravljenje ponovno pretehtati po štirih do osmih tednih, če se izpuščaj ne pojavi.
English: Tarceva is also used in patients with metastatic pancreatic cancer, in combination with gemcitabine (another cancer medicine).
Slovenian: Zdravilo Tarceva se uporablja tudi pri bolnikih z metastatskim rakom trebušne slinavke v kombinaciji z gemcitabinom (drugim zdravilom za zdravljenje raka).
English: Stable means that the cancer has neither improved nor worsened with chemotherapy (medicines to treat cancer);
Slovenian: „Stabilna“ pomeni, da rak med kemoterapijo (zdravili za zdravljenje raka) ni niti napredoval niti se ni poslabšal;
English: Erlotinib blocks EGFRs, which can be found on some tumour cells.
Slovenian: Erlotinib zavira receptorje EGFR, ki so na površini nekaterih tumorskih celic.
English: Tarceva can prolong the time the patients live without their disease getting worse and prolong life in some patients.
Slovenian: Zdravilo Tarceva lahko podaljša čas brez poslabšanja bolezni in čas preživetja pri nekaterih bolnikih.
English: Among the patients who took Tarceva, the average survival was 8.6 months in those whose tumours were ‘EGFR IHC-positive' (had EGFRs on the cell surface), and 5.0 months in those whose tumours were EGFR IHC-negative.
Slovenian: Pri bolnikih, ki so jemali zdravilo Tarceva, je bil povprečni čas preživetja 8,6 meseca pri tistih s tumorji z „EGFR, pozitivnim za IHC“ (na površini celic so imeli EGFR), in 5,0 meseca pri tistih s tumorji z „EGFR, negativnim za IHC“.
English: The greatest benefit was in a subgroup of 49 patients with EGFR activating mutations: those taking Tarceva (22 patients) lived for an average of 44.6 weeks without their disease getting worse, compared with 13 weeks for those taking placebo (27 patients).
Slovenian: Največje koristi so bile v podskupini 49 bolnikov z EGFR-aktivirajočimi mutacijami: pri 22 bolnikih, ki so prejemali zdravilo Tarceva, je bil čas do poslabšanja bolezni v povprečju 44,6 tedna v primerjavi s 13 tedni pri 27 bolnikih, ki so prejemali placebo.
English: The study compared how long patients survived when Tarceva was used early in the study with how long they survived when Tarceva was used later in the study.
Slovenian: V študiji so čas preživetja bolnikov, kadar je bilo zdravilo Tarceva uporabljeno na začetku študije, primerjali z rezultati njihovega preživetja, kadar je bilo to zdravilo uporabljeno pozneje v študiji.
English: • patients with EGFR activating mutations whose disease is stable after initial chemotherapy.
Slovenian: • bolnikih z EGFR-aktivirajočimi mutacijami, pri katerih je bolezen po začetni kemoterapiji stabilna.
English: Tarceva in combination with gemcitabine was studied in 569 patients with pancreatic cancer that was advanced, unresectable (that cannot be removed by surgery) or metastatic.
Slovenian: Zdravilo Tarceva so v kombinaciji z gemcitabinom proučevali pri 569 bolnikih z napredovalim, neoperabilnim (ki ga ni mogoče odstraniti s kirurškim posegom) ali metastatskim rakom trebušne slinavke.
English: How is Tarceva used?
Slovenian: Kako se zdravilo Tarceva uporablja?
English: Tarceva is a cancer medicine used in non-small-cell lung cancer (NSCLC) that is advanced (the cancer has started to spread) or metastatic (it has already spread to other parts of the body).
Slovenian: Tarceva je zdravilo proti raku, ki se uporablja za zdravljenje napredovalega (ki se je začel širiti) ali metastatskega (ki se je razširil na druge dele telesa) nedrobnoceličnega pljučnega raka.
English: The side effects reported with Tarceva are considered manageable.
Slovenian: Neželeni učinki, opaženi pri uporabi zdravila Tarceva, veljajo za obvladljive.
English: For the full list of side effects and restrictions with Tarceva, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Tarceva glejte navodilo za uporabo.
English: In the study of Tarceva used in combination with gemcitabine for pancreatic cancer, the most common side effects were tiredness (affecting 73% of patients), rash (69%) and diarrhoea (48%).
Slovenian: V študiji z zdravilom Tarceva, uporabljenim v kombinaciji z gemcitabinom za zdravljenje raka trebušne slinavke, so bili najpogostejši neželeni učinki utrujenost (pri 73 % bolnikov), izpuščaji (pri 69 % bolnikov) in driska (pri 48 % bolnikov).
English: • previously untreated patients whose cancer cells have certain changes (‘activating mutations') in the gene for a protein called epidermal growth factor receptor (EGFR);
Slovenian: • bolnikih, pri katerih se na rakavih celicah pojavijo spremembe („aktivirajoče mutacije“) v genu za beljakovino, imenovano receptor za epidermalni rastni dejavnik (EGFR), ki se predhodno še niso zdravili;
English: Patients with NSCLC should be tested for EGFR activating mutation before starting Tarceva, unless previous chemotherapy has not worked and other treatments are not suitable.
Slovenian: Pri bolnikih z nedrobnoceličnim pljučnim rakom je treba pred začetkom zdravljenja z zdravilom Tarceva opraviti teste za EGFR-aktivirajoče mutacije, razen če predhodna kemoterapija ni delovala in druga zdravljenja zanje niso primerna.
English: • The fourth study compared Tarceva with placebo in 731 patients in whom at least one previous chemotherapy treatment had not worked.
Slovenian: • V četrti študiji so zdravilo Tarceva primerjali s placebom pri 731 bolnikih, pri katerih vsaj eno predhodno zdravljenje s kemoterapijo ni bilo uspešno.
English: In studies, the most common side effects with Tarceva when used as monotherapy for lung cancer were rash (affecting 75% of patients), diarrhoea (54%), loss of appetite and tiredness (52% each).
Slovenian: V študijah so bili najpogostejši neželeni učinki zdravila Tarceva, kadar je bilo uporabljeno kot samostojno zdravilo za zdravljenje pljučnega raka, izpuščaji (pri 75 % bolnikov), driska (pri 54 % bolnikov), izguba teka in utrujenost (pri 52 % bolnikov).
English: For pancreatic cancer, it is 100 mg daily.
Slovenian: Običajni odmerek pri nedrobnoceličnem pljučnem raku je 150 mg na dan, pri raku trebušne slinavke pa 100 mg na dan.
English: Patients taking Tarceva survived for an average of 6.7 months, compared with 4.7 months for the patients taking placebo.
Slovenian: Bolniki, ki so jemali zdravilo Tarceva, so preživeli povprečno 6,7 meseca, medtem ko so bolniki, ki so jemali placebo, preživeli 4,7 meseca.
English: • A third study compared Tarceva with placebo in 643 patients with advanced NSCLC whose cancer cells did not have EGFR activating mutations and whose disease was stable after 4 cycles of treatment with platinum-containing chemotherapy.
Slovenian: • V tretji študiji so zdravilo Tarceva primerjali s placebom pri 643 bolnikih z napredovalim nedrobnoceličnim pljučnim rakom, pri katerih rakave celice niso imele EGFR-aktivirajočih mutacij in pri katerih je bila bolezen stabilna po štirih ciklih zdravljenja s kemoterapijo s platino.
English: • patients without EGFR activating mutations in whom previous chemotherapy has not worked and other treatments are unsuitable.
Slovenian: • bolnikih brez EGFR-aktivirajočih mutacij, pri katerih predhodna kemoterapija ni delovala, druga zdravljenja pa zanje niso primerna.
English: • The first study compared Tarceva with chemotherapy in 173 patients with advanced NSCLC with activating EGFR mutations who had not received previous chemotherapy.
Slovenian: • V prvi študiji so zdravilo Tarceva primerjali s kemoterapevtikom pri 173 bolnikih z napredovalim nedrobnoceličnim pljučnim rakom z EGFR-aktivirajočimi mutacijami, ki predhodno niso prejemali kemoterapije.
English: • patients with EGFR activating mutations in whom previous chemotherapy has not worked;
Slovenian: • bolnikih z EGFR-aktivirajočimi mutacijami, pri katerih predhodna kemoterapija ni delovala;
English: • The second study compared Tarceva with placebo (a dummy treatment) in 889 patients with advanced or metastatic NSCLC whose disease had not got worse after 4 cycles of treatment with platinum-containing chemotherapy.
Slovenian: • V drugi študiji so zdravilo Tarceva primerjali s placebom (zdravilom brez učinkovine) pri 889 bolnikih z napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih se bolezen po štirih ciklih zdravljenja s kemoterapijo s platino ni poslabšala.