FrancophonIA/ELRC3.0 huggingface dataset:
English: These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre-treated breast cancer patients with pre-existing liver metastases and/or abnormal baseline liver function tests.
Slovenian: Te razlike so bile verjetno posledica različnih populacij bolnikov, saj so v študijah faze 2 sodelovali bolniki, ki še niso prejemali kemoterapije, in tudi bolnice s karcinomom dojke, ki so v preteklosti večkrat prejele kemoterapijo, s predhodno obstoječimi metastazami v jetrih in/ali nenormalnimi izhodiščnimi vrednostmi testov jetrnega delovanja.
English: − if you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon) (may indicate a blood clot in the blood vessels of the lungs)
Slovenian: − Če doživite nenadno težko dihanje, močno bolečino v prsih ali kašelj s krvavim izmečkom (občasno) (lahko kaže na krvni strdek v krvnih žilah v pljučih).
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1,500 cells/mm³ and platelets should be ≥ 100,000 cells/mm³.
Slovenian: Pred začetkom kateregakoli ciklusa kemoterapije morajo bolniki izpolnjevati naslednja merila: absolutno število nevtrofilcev (ANC) mora biti ≥ 1500 celic/mm³ ter število trombocitov ≥ 100.000 celic/mm³.
English: The pemetrexed maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Slovenian: Profila varnosti vzdrževalnega zdravljenja s pemetreksedom iz obeh študij, JMEN in PARAMOUNT,
English: You will always receive Pemetrexed medac by infusion into one of your veins.
Slovenian: Zdravilo Pemetreksed medac boste vedno prejeli v obliki infuzije v veno.
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed medac powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Slovenian: Bolnišnični farmacevt, medicinska sestra ali zdravnik bo prašek Pemetreksed medac, preden ga boste prejeli, zmešal z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: 75 % of previous dose (both pemetrexed and cisplatin)
Slovenian: 75 % predhodnega odmerka (pemetrekseda in cisplatina)
English: Pemetrexed medac must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Slovenian: Zdravilo Pemetreksed medac smemo dajati le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije za zdravljenje raka.
English: 67801 Blansko Czech Republic Tel.: +420 516 427 311 Fax: +420 516 417 350
Slovenian: Tel.: +420 516 427 311 Faks: +420 516 417 350
English: Not known (frequency cannot be estimated from the available data)
Slovenian: − anafilaktični šok (huda alergijska reakcija) Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: Limited clinical data from a separate randomized, Phase 3, controlled trial, suggest that efficacy data (overall survival, progression free survival) for pemetrexed are similar between patients previously pre-treated with docetaxel (n = 41) and patients who did not receive previous docetaxel treatment (n = 540).
Slovenian: Omejeni klinični podatki iz ločeno randomiziranih, kontroliranih preskušanj faze 3, nakazujejo, da so podatki o učinkovitosti (skupno preživetje, preživetje brez napredovanja) za pemetreksed podobni med bolniki, ki so bili predhodno zdravljeni z docetakselom (n = 41) in bolniki, ki niso prejeli predhodnega zdravljenja z docetakselom (n = 540).
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatične ga sistema
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted>
Slovenian: <Sprejeta je utemeljitev, da Braillova pisava ni potrebna.>
English: − conjunctivitis (inflamed eye)
Slovenian: − konjunktivitis (vnetje očesa)
English: Pemetrexed medac is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Slovenian: Pemetreksed medac se daje tudi v kombinaciji s cisplatinom, za začetno zdravljenje bolnikov z napredovalim stadijem pljučnega raka.
English: The infusion will last approximately 10 minutes.
Slovenian: Infuzija bo trajala približno
English: This is equivalent to 2.70% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: 2,70 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis)
Slovenian: Obvestite zdravnika, če se pojavijo hud izpuščaj, srbenje ali mehurčki (StevensJohnsonov sindrom ali toksična epidermalna nekroliza).
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 - 1,000 µg) on a daily basis.
Slovenian: Bolniki morajo dnevno jemati peroralno folno kislino ali multivitaminski pripravek, ki jo vsebuje (350 - 1000 µg).
English: a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥ CTC Grade 2 bleeding
Slovenian: a Ta merila ustrezajo Merilom pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998), definiciji za ≥ CTC stopnjo krvavitve 2
English: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity.
Slovenian: * Glejte CTC Nacionalnega inštituta za rakava obolenja, različico 2, za vsako stopnjo toksičnosti.
English: Pemetrexed in combination with cisplatin
Slovenian: Pemetreksed v kombinaciji s cisplatinom
English: In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1,600 mg/day) and acetylsalicylic acid at higher dose (≥ 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Slovenian: Pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina ≥ 80 ml/min) lahko visoki odmerki nesteroidnih protivnetnih zdravil (NSAID-i, denimo, ibuprofen > 1600 mg dnevno) in acetilsalicilna kislina v visokih odmerkih (≥ 1,3 g dnevno) zmanjšajo eliminacijo pemetrekseda in tako lahko povečajo pojavnost neželenih učinkov pemetrekseda.
English: Pemetrexed medac is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Slovenian: Zdravilo Pemetreksed medac je namenjeno tudi zdravljenju bolnikov z napredovalim stadijem pljučnega raka, katerih bolezen se širi po tem, ko je bila že uporabljena druga začetna kemoterapija.
English: Pemetrexed has a steady-state volume of distribution of 9 l/m².
Slovenian: Pemetreksed ima volumen porazdelitve v stanju dinamičnega ravnovesja 9 l/m².
English: − if you have pain, redness, swelling or sores in your mouth (very common)
Slovenian: − Če imate bolečine, rdečino, oteklino ali razjede v ustni votlini (zelo pogosto).
English: This medicine contains less than 1 mmol sodium (23 mg) per 100 mg vial, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 mg vialo, kar v bistvu pomeni ‘brez natrija'.
English: The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N = 519), and compared to patients who received > 6 cycles of pemetrexed (N = 281).
Slovenian: Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N = 519) in jo primerjali z bolniki, ki so prejeli > 6 ciklov pemetrekseda
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.> 18.
English: − if you experience bleeding from the gums, nose or mouth or any bleeding that would not stop reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common)
Slovenian: − Če vam krvavijo dlesni, krvavite iz nosu ali ustne votline, ali se pojavi kakršnakoli krvavitev, ki se noče ustaviti, rdečkasto ali rožnato obarvan urin, nepričakovane podplutbe (ker imate lahko manj trombocitov, kot je normalno, kar je zelo pogosto).
English: For instructions on reconstitution and dilution of Pemetrexed medac before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije in redčenja zdravila Pemetreksed medac pred dajanjem glejte poglavje 6.6.
English: − If you have further questions, ask your doctor or pharmacist.
Slovenian: − Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (3501,000 µg) that you must take once a day while you are taking Pemetrexed medac.
Slovenian: Zdravnik vam bo predpisal peroralno folno kislino (vitamin) ali multivitaminski pripravek, ki jo vsebuje (350-1000 µg), ki ga boste morali med prejemanjem zdravila Pemetreksed medac jemati enkrat dnevno.
English: In a study conducted in beagle dog by intravenous bolus injection for 9 months, testicular findings (degeneration/necrosis of the seminiferous epithelium) have been observed.
Slovenian: V 9-mesečni študiji, ki so jo izvedli na psih pasme beagle tako, da so jim dajali intravenske injekcije v bolusu, so opazovali spremembe na testisih (degeneracija/nekroza pemetreksed placebo pemetreksed placebo
English: Type I glass vial with rubber (bromobutyl rubber coated with fluoropolymer) stopper containing 100, 500 or 1,000 mg of pemetrexed.
Slovenian: 6.5 Vrsta ovojnine in vsebina Viala iz stekla tipa I z gumijasto (brombutilna guma, prevlečena s fluoropolimerom) zaporko, ki vsebuje 100, 500 ali 1000 mg pemetrekseda.
English: • 95 % CI for HR
Slovenian: • 95 % IZ za RT
English: − allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Slovenian: − Alergijska reakcija: če se pojavi izpuščaj (zelo pogosto) / pekoč ali zbadajoč občutek (pogosto), ali povišana telesna temperatura (pogosto).
English: The recommended dose of cisplatin is 75 mg/m² BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Slovenian: Priporočeni odmerek cisplatina je 75 mg/m² TP, infundiran v dveh urah približno 30 minut po zaključku infuzije pemetrekseda prvi dan vsakega 21-dnevnega ciklusa.
English: Warnings and precautions Talk to your doctor or pharmacist before using Pemetrexed medac if:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Pemetreksed medac se posvetujte z zdravnikom ali farmacevtom:
English: What Pemetrexed medac looks like and contents of the pack Pemetrexed medac is a powder for concentrate for solution for infusion in a glass vial with rubber stopper.
Slovenian: Izgled zdravila Pemetreksed medac in vsebina pakiranja Pemetreksed medac je prašek za koncentrat za raztopino za infundiranje v stekleni viali z gumijastim zamaškom.
English: Log Rank p-value* Overall response rate** (95 % CI)
Slovenian: Log Rank p-vrednost* Skupna stopnja odziva**
English: Dose for cisplatin (mg/m²)
Slovenian: Odmerek cisplatina (mg/m²)
English: Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
Slovenian: Med zdravljenjem s pemetreksedom je treba prenehati z dojenjem (glejte poglavje 4.3).
English: Table 1 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Haematologic toxicities Nadir ANC < 500/mm³ and nadir platelets ≥ 50,000/mm³
Slovenian: Preglednica 1 - Preglednica za prilagajanje odmerkov zdravila Pemetreksed medac (kot edine učinkovine ali v kombinaciji) in cisplatina - Hematološke toksičnosti Najnižji ANC < 500/mm³ in najnižje število trombocitov ≥ 50.000/mm³
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1,500 cells/mm³ and platelet count returns to ≥ 100,000 cells/mm³.
Slovenian: Pri bolnikih moramo biti med zdravljenjem pozorni na morebiten pojav mielosupresije, pemetrekseda pa bolnikom ne smemo dajati, dokler se absolutno število nevtrofilcev (ANC) ne povrne na ≥ 1500 celic/mm³ ter število trombocitov na ≥ 100.000 celic/mm³.
English: Creatinine elevation 10.7 Creatinine clearance decreased**
Slovenian: Znižan očistek kreatinina**
English: − you have had or are going to have radiation therapy, as there may be an early or late radiation reaction with Pemetrexed medac.
Slovenian: − če ste imeli ali če boste imeli zdravljenje z obsevanjem, saj ob jemanju zdravila Pemetreksed medac lahko pride do zgodnje ali pozne reakcije na obsevanje;
English: − colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding)
Slovenian: − kolitis (vnetje sluznice debelega črevesa, ki ga lahko spremlja krvavitev iz črevesa ali danke)
English: The PFS and OS results in patients with squamous cell histology suggested no advantage for pemetrexed over placebo.
Slovenian: Rezultati preživetja brez napredovanja in skupnega preživetja pri bolnikih s ploščatocelično histologijo ne kažejo prednosti za pemetreksed nad placebom.
English: Table 3 - Dose modification table for premetrexed (as single agent or in combination) and cisplatin - Neurotoxicity
Slovenian: Preglednica 3 - Preglednica za prilagajanje odmerkov pemetrekseda (kot edine učinkovine ali v kombinaciji) in cisplatina - Nevrotoksičnost
English: − if you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common)
Slovenian: − Če ste utrujeni, omotični, se hitro zadihate, ste bledi (ker imate morda manj hemoglobina, kot je normalno, kar je zelo pogosto).
English: This is equivalent to 5.40% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: 5,40 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: The median time from the start of pemetrexed plus cisplatin induction therapy to the start of maintenance treatment was 2.96 months on both the pemetrexed arm and the placebo arm. Randomised patients received maintenance treatment until disease progression.
Slovenian: Mediana časa od začetka zdravljenja z indukcijsko terapijo s pemetreksedom in cisplatinom do začetka vzdrževalnega zdravljenja je bila 2,96 meseca tako v skupini s pemetreksedom, kot v skupini s placebom.
English: ITT population (N = 1,725)
Slovenian: NZ populacija (N = 1725)
English: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤ 6 cycles: 3.3 %, > 6 cycles: 6.4 %: p = 0.046).
Slovenian: so opazili pri dolgotrajnejši izpostavljenosti pemetreksedu (≤ 6 ciklov: 3,3 %, > 6 ciklov: 6,4 %:
English: − hepatitis (inflammation of the liver)
Slovenian: − hepatitis (vnetje jeter)
English: For precautions to be taken before handling or administering Pemetrexed medac, see section 6.6.
Slovenian: Za previdnostne varnostne ukrepe pri ravnanju z in dajanju zdravila Pemetreksed medac glejte poglavje 6.6.
English: 50 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Slovenian: 50 % predhodnega odmerka a Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998)
English: Table 2 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Non-haematologic toxicitiesa,b
Slovenian: Preglednica 2 - Preglednica za prilagajanje odmerkov pemetrekseda (kot edine učinkovine ali v kombinaciji) in cisplatina - Nehematološke toksičnosti a,b
English: − bullous conditions (blistering skin diseases) including Stevens-Johnson syndrome and Toxic epidermal necrolysis
Slovenian: − bulozna stanja (bolezni s kožnimi mehurji), vključno s Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo
English: Pemetrexed medac 100 mg powder for concentrate for solution for infusion This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg vial, that is to say essentially ‘sodium-free'.
Slovenian: Pemetreksed medac 100 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 mg vialo, kar v bistvu pomeni ‘brez natrija'.
English: CTC
Slovenian: NZ
English: Mannitol (E421)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol (E421)
English: Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion This medicinal product contains 108 mg sodium per 1,000 mg vial, equivalent to 5.40% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: Pemetreksed medac 1.000 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje 108 mg natrija na 1.000 mg vialo, kar je enako 5,40 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: Nadir platelets < 50,000/mm³ regardless of nadir ANC
Slovenian: Najnižje število trombocitov < 50.000/mm³ ne glede na najnižji ANC
English: When prepared as directed, reconstituted and infusion solutions of pemetrexed contain no antimicrobial preservatives.
Slovenian: Rekonstituirane raztopine in raztopine za infundiranje Po pripravi, skladni z navodili, rekonstituirane raztopine in raztopine pemetrekseda za infundiranje ne vsebujejo nobenih protimikrobnih konzervansov.
English: − fever
Slovenian: − vročina
English: Fax: +49 4103 8006-100
Slovenian: Tel.: +49 4103 8006-0 Faks: +49 4103 8006-100
English: Fax: +34 936401146
Slovenian: Tel.: +34 936401516 Faks: +34 936401146
English: − lower limb swelling with pain and redness
Slovenian: − otekanje spodnjih okončin z bolečino in pordelostjo
English: Pemetrexed medac 500 mg powder for concentrate for solution for infusion This medicinal product contains 54 mg sodium per 500 mg vial, equivalent to 2.70% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: Pemetreksed medac 500 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje 54 mg natrija na 500 mg vialo, kar je enako 2,70 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated patients
Slovenian: Učinkovitost pemetrekseda skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu Randomizirani in zdravljeni bolniki
English: There is no relevant use of Pemetrexed medac in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Slovenian: Zdravilo Pemetreksed medac ni namenjeno za uporabo pri pediatrični populaciji za indikacijo malignega plevralnega mezotelioma in nedrobnoceličnega karcinoma pljuč.
English: − diarrhoea
Slovenian: − diareja
English: Superiority p-value
Slovenian: Log Rank p-vrednost*
English: The recommended dose of Pemetrexed medac is 500 mg/m² of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Priporočeni odmerek zdravila Pemetreksed medac je 500 mg/m² telesne površine (TP), dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
English: What Pemetrexed medac is and what is it used for Pemetrexed medac is a medicine used in the treatment of cancer.
Slovenian: Pemetreksed medac je zdravilo, ki ga uporabljamo pri zdravljenju raka.
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed medac.
Slovenian: V sedmih dneh pred prvim odmerkom zdravila Pemetreksed medac morate vzeti vsaj 5 odmerkov.
English: Pemetrexed medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1).
Slovenian: Zdravilo Pemetreksed medac je indicirano kot monoterapija za vzdrževalno zdravljenje lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega karcinoma, ki nima pretežno ploščatocelične histologije pri bolnikih, pri katerih bolezen ni napredovala neposredno po kemoterapiji na osnovi platine (glejte poglavje 5.1).
English: Each 500 mg vial contains approximately 54 mg sodium.
Slovenian: Pomožna snov z znanim učinkom Vsaka 500 mg viala vsebuje približno 54 mg natrija.
English: − if you start feeling chest pain (common) or having a fast heart rate (uncommon)
Slovenian: − Če se pojavi bolečina v prsnem košu (pogosto) ali hitro bitje srca (občasno).
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed medac is 500 mg/m² BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Pemetreksed kot samostojno zdravilo Pri bolnikih, pri katerih zdravimo nedrobnocelični pljučni karcinom po predhodni kemoterapiji, je priporočeni odmerek zdravila Pemetreksed medac 500 mg/m² TP, dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
English: Gemcitabine + cisplatin
Slovenian: Pemetreksed + Cisplatin Gemcitabin + Cisplatin
English: Patients also required lower administration of erythropoietin/darbopoietin (10.4 % versus 18.1 %, p < 0.001), G-CSF/GM-CSF (3.1 % versus 6.1 %, p = 0.004), and iron preparations (4.3 % versus 7.0 %, p = 0.021).
Slovenian: Bolniki so potrebovali tudi nižje odmerjanje eritropoetina/darbepoetina (10,4 % proti 18,1 %, p < 0,001), G-CSF/GM-CSF (3,1 % proti 6,1 %,
English: A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95 % CI = 0.84 - 1.05).
Slovenian: NSCLC, zdravljenje prvega izbora Multicentrična, randomizirana, odprta študija faze 3 pemetrekseda skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri bolnikih, ki v preteklosti še niso prejemali kemoterapije, z lokalno napredovalim ali metastatskim (stopnja IIIb ali IV) nedrobnoceličnim karcinomom pljuč (NSCLC), je pokazala, da je pemetreksed skupaj s cisplatinom (Populacija z namenom zdraviti, [NZ] populacija n = 862) dosegel prvotno končno točko in pokazal podobno klinično učinkovitost, kot gemcitabin skupaj s cisplatinom (NZ n = 863) v skupnem preživetju (prilagojeno razmerje tveganja 0,94; 95 % IZ = 0,84 - 1,05).
English: Overall Survival
Slovenian: Verjetnost preživetja
English: Dose of pemetrexed (mg/m²)
Slovenian: Odmerek pemetrekseda (mg/m²)
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p < 0.001)
Slovenian: a Statistično pomembna za prednost, s celotnim intervalom zaupanja za RT znatno pod 1,17645 mejo prednosti (p < 0,001).
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95 % CI = 0.64 - 0.96, p = 0.0195).
Slovenian: Po indukcijskem zdravljenju s pemetreksedom skupaj s cisplatinom (4 cikli) je bilo zdravljenje s pemetreksedom statistično boljše od placeba glede skupnega preživetja (mediana 13,9 mesecev v primerjavi z 11,0 meseci, razmerje tveganja = 0,78, 95 % CI = 0,64 - 0,96, p = 0,0195).
English: Time to treatment failure (TTTF - months)
Slovenian: • RT (95 % IZ) Čas do neuspeha zdravljenja (Time to treatment failure, TTTF - meseci)