FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a 10 minute period.
Danish: Pemetrexeds farmakokinetiske egenskaber efter enkeltstofadministration er blevet vurderet hos 426 cancerpatienter med forskellige typer massive tumorer i doser på 0,2-838 mg/m2 infunderet over 10
English: This routinely involves blood tests, including checks on your liver and kidney function.
Danish: Dette involverer rutinemæssigt blodprøver, herunder kontrol af din lever- og nyrefunktion.
English: When using Armisarte in combination with cisplatin:
Danish: Når Armisarte tages sammen med cisplatin:
English: The use of Armisarte should be avoided during pregnancy.
Danish: Armisarte må ikke anvendes under graviditet.
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04.
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, folsyreanaloger, ATC-kode L01BA04
English: N=229 1.23 Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Danish: N=229 Forkortelser: CI = konfidensinterval; ITT = intent-to-treat; N = samlet populationsstørrelse.
English: Rare (may affect up to 1 in 1,000 people) - Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Danish: Sjælden (forekommer hos op til 1 ud af 1000 patienter) - Radiation recall (et hududslæt, der ligner en alvorlig solskoldning), som kan opstå på hud, der tidligere har været udsat for strålebehandling, dage eller op til år efter strålebehandlingen.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Armisarte and then approximately every 9 weeks (corresponding to 3 courses of Armisarte treatment).
Danish: De vil også få en injektion med B12-vitamin (1.000 mikrogram) i løbet af ugen op til første dosis Armisarte og derefter cirka hver 9. uge (svarende til 3 Armisarte -behandlingsforløb).
English: Response rate (%) (95 % CI) Stable disease (%)
Danish: Respons (n: kvalificeret til respons) Responsrate (%) (95 %-CI) Stabil sygdom (%)
English: The appropriate volume of pemetrexed concentrate must be diluted to 100 ml with 5% glucose solution and administered as an intravenous infusion over 10 minutes.
Danish: Passende mængde pemetrexedkonsentrat skal fortyndes til 100 ml med 5 % glucoseopløsning og indgives som langsom intravenøs infusion over 10 minutter.
English: A hospital pharmacist, nurse or doctor will have mixed the Armisarte concentrate with 5% glucose solution for injection before it is given to you.
Danish: Hospitalsapoteket, lægen eller sygeplejersken blander på forhånd Armisarte koncentrat med 5 % glucose injektionsvæske, opløsning, før det indgives til Dem.
English: You must continue taking the folic acid for 21 days after the last dose of Armisarte.
Danish: De skal fortsætte med at tage folsyre i 21 dage efter indgift af den sidste dosis Armisarte.
English: For intravenous use after dilution.
Danish: Til intravenøs brug efter fortynding.
English: Armisarte must only be diluted with 5% glucose solution, without preservative.
Danish: Armisarte må kun fortyndes med 5% glucoseopløsning,uden konserveringsmiddel.
English: If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive Armisarte.
Danish: Hvis De har eller tidligere har haft nyreproblemer, skal De tale med Deres læge eller hospitalsapoteket, da De muligvis ikke må få Armisarte.
English: Armisarte should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Armisarte skal administreres som intravenøs infusion over 10 minutter på den første dag i hver 21dages serie.
English: For instructions on dilution of Armisarte before administration, see section 6.6.
Danish: For instruktioner vedrørende fortynding af Armisarte før administration, se pkt.
English: Armisarte concentrate for solution for infusion (sterile concentrate) is a clear, colourless to slightly yellowish or yellow-greenish solution.
Danish: Armisarte koncentrat til infusionsvæske, opløsning (koncentrat, sterilt) er en klar, farveløs til svagt gulligt eller gul-grønlig opløsning.
English: Armisarte can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
Danish: Armisarte kan ordineres til Dem, hvis De har fremskreden lungekræft, og Deres sygdom har reageret på behandling, eller hvis den stort set er uforandret efter den indledende kemoterapibehandling.
English: Armisarte 25 mg/ml concentrate for solution for infusion will always be given to you by a healthcare professional.
Danish: Armisarte 25 mg/ml koncentrat til infusionsvæske, opløsning vil altid blive givet til dig af sundhedspersonal.
English: Pemetrexed belongs to a group of medicines known as folic acid analogues and disrupts processes that are essential for cells to divide.
Danish: Pemetrexed tilhører en gruppe af lægemidler kendt som folsyreanaloger og forstyrrer processer, der er afgørende for celler til at dele sig.
English: ***Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies.
Danish: *** Den integrerede bivirkningstabel kombinerer resultaterne fra de to studier JMEN (pemetrexed vedligeholdelsesbehandling (N=663)) og PARAMOUNT (pemetrexed-induktionsbehandling efterfulgt af pemetrexed-vedligeholdelsesbehandling (N=539)).
English: Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Danish: Effekt af pemetrexed versus docetaxel mod NSCLC - ITT-population Pemetrexed
English: Contents of the pack and other information What Armisarte contains
Danish: Pakningsstørrelser og yderligere oplysninger Armisarte indeholder:
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).
Danish: Begrænsede kliniske data fra et andet randomiseret fase 3 kontrolleret studie tyder på, at effektdata (total overlevelse, progressionsfri overlevelse) for pemetrexed er sammenlignelig for patienter, som tidligere er behandlet med docetaxel (n=41), og patienter, som ikke tidligere har fået docetaxelbehandling (n=540).
English: Dose of pemetrexed (mg/m2)
Danish: Dosis af pemetrexed (mg/m2)
English: Use aseptic techniques during dilution of pemetrexed for intravenous infusion administration.
Danish: Anvend aseptisk teknik ved fortynding af pemetrexed til intravenøs infusion.
English: Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent pemetrexed studies (n=164) and the Phase 3 single agent pemetrexed study described above, with the exception of neutropenia (12.8 % versus 5.3 %, respectively) and alanine aminotransferase elevation (15.2 % versus 1.9 %, respectively).
Danish: De klinisk relevante laboratorierelaterede toksiciteter af grad 3 og 4 var ensartede mellem de integrerede fase 2-resultater fra tre studier med pemetrexed som enkeltstofbehandling (n = 164) og det fase 3-enkeltstofstudie med pemetrexed, som er beskrevet ovenfor, med undtagelse af neutropeni (12,8 % versus 5,3 %) og forhøjet alaninaminotransferase (15,2 % versus 1,9 %).
English: Other medicines and Armisarte
Danish: Brug af anden medicin sammen med Armisarte
English: EU/1/15/1063/001 4 ml vial EU/1/15/1063/002 20 ml vial EU/1/15/1063/004 34 ml vial EU/1/15/1063/003 40 ml vial
Danish: EU/1/15/1063/001 4 ml hætteglas EU/1/15/1063/002 20 ml hætteglas EU/1/15/1063/004 34 ml hætteglas EU/1/15/1063/003 40 ml hætteglas
English: Women must use effective contraception during treatment with Armisarte.
Danish: Kvinder skal anvende effektive svangerskabsforebyggende midler under behandlingen med Armisarte.
English: Common Pain Oedema Renal Disorders Common Renal disorders**** Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT=serum glutamic oxaloacectic aminotransferase; SGPT=serum glutamic pyruvic aminotransferase.
Danish: Forkortelser: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute.
English: Infusion Solution: Chemical and physical in-use stability of infusion solution of pemetrexed was demonstrated for 3 days at room temperature and 21 days at refrigerated temperature.
Danish: Infusionsopløsning: Infusionsopløsninger af pemetrexed har vist sig at have en kemisk og fysisk holdbarhed på 3 dage ved stuetemperatur og 21 dage ved køleskabstemperatur.
English: Colourless glass vial (type I) with type I rubber (bromobutyl) serum stopper and an aluminium cap with polypropylene disk.
Danish: Farveløs hætteglas (type I) med type 1 gummiserumprop (bromobutyl) og aluminiumshætte med polypropylen skive.
English: Armisarte is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Danish: Armisarte anvendes sammen med cisplatin, en anden medicin mod kræft, til behandling af malignt pleuramesoteliom, en kræftform som påvirker lungehinderne, til patienter, som ikke tidligere har fået kemoterapi.
English: Gemcitabine/ cisplatin (N=830)
Danish: Gemcitabin/ cisplatin (N = 830)
English: The active substance is pemetrexed.
Danish: Aktivt stof: Pemetrexed.
English: Cytotoxic Must only be diluted in 5% glucose solution.
Danish: Må kun fortyndes i 5 % glucoseopløsning
English: One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid) One vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diacid) One vial of 34 ml concentrate contains 850 mg pemetrexed (as pemetrexed diacid) One vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid)
Danish: Et 4 ml hætteglas indeholder 100 mg pemetrexed (som pemetrexeddiacid) Et 20 ml hætteglas indeholder 500 mg pemetrexed (som pemetrexeddiacid) Et 34 ml hætteglas indeholder 850 mg pemetrexed (som pemetrexeddiacid) Et 40 ml hætteglas indeholder 1000 mg pemetrexed (som pemetrexeddiacid)
English: Chemical and physical in-use stability of infusion solution of pemetrexed was demonstrated for 3 days at room temperature and 21 days at refrigerated temperature.
Danish: Infusionsopløsninger af pemetrexed har vist sig at have en kemisk og fysisk holdbarhed på 3 dage ved stuetemperatur og 21 dage ved køleskabstemperatur.
English: Package leaflet: Information for the user Armisarte 25 mg/ml concentrate for solution for infusion pemetrexed
Danish: Indlægsseddel: Information til brugeren Armisarte 25 mg/ml koncentrat til infusionsvæske, opløsning
English: Armisarte is provided in a colourless glass vial with rubber stopper and an aluminium cap with polypropylene disk.
Danish: Armisarte er anbragt i et farveløs hætteglas med gummirop og aluminiumshætte med polypropylen skive.
English: Armisarte is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Danish: Armisarte er også en behandling til patienter med fremskreden lungekræft, hvor sygdommen har udviklet sig, efter anden indledende behandling med kemoterapi har været forsøgt.
English: Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4% versus 28.9%, p<0.001), red blood cell transfusions (16.1% versus 27.3%, p<0.001) and platelet transfusions (1.8% versus 4.5%, p=0.002).
Danish: Patienter, der blev behandlet med pemetrexed og cisplatin, havde brug for færre transfusioner (16,4 % mod 28,9 %; p<0,001), transfusioner af røde blodlegemer (16,1 % mod 27,3 %; p<0,001) og blodpladetransfusioner (1,8 % mod 4,2 %; p=0,002).
English: Very common (may affect more than 1 in 10 people) - Low white blood cells - Low haemoglobin level (anaemia) - Low platelet count - Diarrhoea - Vomiting - Pain, redness, swelling or sores in your mouth - Nausea - Loss of appetite - Fatigue (tiredness) - Skin rash, peeling of the skin - Hair loss - Constipation - Loss of sensation - Kidney: abnormal blood tests
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 patienter) - Lavt antal hvide blodlegemer - Lavt hæmoglobin niveau (anæmi) - Lavt antal blodplader - Diarré - Opkastning - Smerter, rødmen, hævelse eller sår i munden - Kvalme - Appetitløshed - Træthed - Udslæt, afskalning af huden - Hårtab - Forstoppelse - Nedsat føleevne - Nyrer: abnorme blodprøveresultater
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with Armisarte.
Danish: hvis De ammer, skal De afbryde amningen under behandlingen med Armisarte.
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95 % CI = 0.94-1.15), and overall response rate was 30.6% (95 % CI = 27.3-33.9) for pemetrexed plus cisplatin versus 28.2% (95 % CI = 25.0-31.4) for gemcitabine plus cisplatin.
Danish: Progressionsfri overlevelse (PFS) og størrelsen af det totale respons var ens mellem de to behandlingsarme: Middel PFS var 4,8 måneder for pemetrexed plus cisplatin mod 5,1 måneder for gemcitabin plus cisplatin (justeret hazard ratio 1.04; 95 % CI = 0,94-1,15) og det totale respons var 30,6 % (95 % CI = 27,3- 33,9) for pemetrexed plus cisplatin mod 28,2 % (95 % CI = 25,0-31,4) for gemcitabin plus cisplatin.
English: Armisarte is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Danish: Armisarte er også en behandling, som gives i kombination med cisplatin, som 1. linje-behandling af patienter med fremskreden lungecancer.
English: During the study, low-dose folic acid and vitamin B12 supplementation was introduced to patients therapy to reduce toxicity.
Danish: I løbet af studiet blev patienternes behandling suppleret med et lavdosistilskud af folsyre og B12vitamin for at mindske toksiciteten.
English: 1 x 4 ml vial (100 mg/4 ml) 1 x 20 ml vial (500 mg/20 ml) 1 x 34 ml vial (850 mg/34 ml) 1 x 40 ml vial (1000 mg/40 ml)
Danish: Pakningsstørrelser 1 x 4 ml hætteglas (100 mg/4 ml) 1 x 20 ml hætteglas (500 mg/20 ml) 1 x 34 ml hætteglas (850 mg/34 ml) 1 x 40 ml hætteglas (1000 mg/40 ml)
English: A multicentre, randomised, open label phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent To Treat population n=283) and 7.9 months for patients treated with docetaxel (ITT n=288).
Danish: Et åbent, randomiseret fase 3-multicenterstudie med pemetrexed versus docetaxel til patienter med lokalt fremskreden eller metastatisk NSCLC (ikke-småcellet lungekræft), der tidligere var behandlet med kemoterapi, har vist en median-overlevelsestid på 8,3 måneder for patienter, som blev behandlet med pemetrexed (intent-to-treat-population n = 283), og 7,9 måneder for patienter, som blev behandlet med docetaxel (ITT n = 288).
English: Nadir platelets <50,000 /mm 3 regardless of nadir ANC
Danish: Nadir for trombocytter < 50.000 /mm3 uanset ANC-nadir
English: - Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis - Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) - Hepatitis (inflammation of the liver) - Anaphylactic shock (severe allergic reaction)
Danish: - Immun-medieret hæmolytisk anæmi (antistof-medieret ødelæggelse af de røde blodlegemer) - Leverbetændelse (hepatitis) - Anafylaktisk shock (alvorlig allergisk reaktion)
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are receiving Armisarte.
Danish: Vitamintilskud: De skal tage en folsyretablet eller en multivitamin indeholdende folsyre (3501000 mikrogram) 1 gang dagligt, mens De tager Armisarte.
English: Nadir platelets <50,000/mm 3 with bleedinga, regardless of nadir ANC
Danish: Nadir for trombocytter < 50.000/ mm3 med blødninga uanset ANC-nadir
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).
Danish: Et randomiseret, åbent, fase 3-multicenterstudie af pemetrexed plus cisplatin mod gemcitabin plus cisplatin med patienter, der ikke tidligere har fået kemoterapi, med lokalt fremskreden eller metastatisk (fase IIIb eller IV) ikke-småcellet lungecancer (NSCLC) viste, at pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n=865) mødte dets primære endepunkt og viste lignende klinisk virkning som gemcitabin plus cisplatin (ITT n=863) på total overlevelse (justeret hazard ratio 0,94; 95 % CI = 0,84-1,05).
English: Common (may affect up to 1 in 10 people) - Allergic reaction: skin rash / burning or prickling sensation - Infection including sepsis - Fever - Dehydration - Kidney failure - Irritation of the skin and itching - Hives - Increased skin pigmentation - Chest pain - Muscle weakness - Conjunctivitis (inflamed eye) - Upset stomach - Pain in the abdomen - Taste change - Liver: abnormal blood tests - Watery eyes - Dizziness
Danish: Almindelig (forekommer hos op til 1 ud af 10 patienter) - Allergisk reaktion: udslæt/en brændende eller prikkende fornemmelse - Infektion, inklusive sepsis (blodforgiftning) - Feber - Dehydrering (væskemangel) - Nyresvigt - Hudirritation og -kløe - Nældefeber - Øget hudpigmentering - Brystsmerter - Muskelsvaghed - Bindehindebetændelse (øjenbetændelse) - Mavegener - Mavesmerter - Smagsforstyrrelser - Lever: abnorme blodprøveresultater - Rindende øjne - Svimmelhed
English: CTCa Grade
Danish: CTCa-grad
English: 4 ml vial 20 ml vial 34 ml vial 40 ml vial
Danish: 4 ml hætteglas 20 ml hætteglas 34 ml hætteglas 40 ml hætteglas
English: Excipients: trometamol, anhydrous citric acid, methionine and water for injections.
Danish: Hjælpestoffer: trometamol, vandfri citronsyre, metionin og vand til injektionsvæsker.
English: 50% of previous dose (both pemetrexed and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Danish: 50 % af tidligere dosis (både pemetrexed og cisplatin) aDisse kriterier opfylder National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
English: Actavis Italy S.p.A. Viale Pasteur 10
Danish: Viale Pasteur 10
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (n=441) with that of placebo plus BSC (n=222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first line doublet therapy containing Cisplatin or Carboplatin in combination with Gemcitabine, Paclitaxel, or Docetaxel.
Danish: Et randomiseret, dobbeltblindt, placebokontrolleret fase 3-multicenterstudie (JMEN) sammenlignede virkning og sikkerhed af vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC) (n = 441) med placebo plus BSC (n = 222) hos patienter med lokalt fremskreden (trin IIIB) eller metastatisk (trin IV) ikke-småcellet lungecancer (NSCLC), som ikke fik bedring efter 4 serier med 1. linje-dubletbehandling bestående af cisplatin eller carboplatin sammen med gemcitabin, paclitaxel eller docetaxel.
English: The other ingredients are trometamol (for pH adjustment), anhydrous citric acid, methionine and water for injection.
Danish: Øvrige indholdsstoffer: trometamol (til pH-justering), citronsyre, vandfri, metionin, vand til injektionsvæsker.
English: For precautions to be taken before handling or administering pemetrexed, see section 6.6.
Danish: For information om sikkerhedsforanstaltninger, der skal tages før håndtering og administration af pemetrexed, se pkt.
English: Pemetrexed solutions are for single use only.
Danish: Dette lægemiddel er kun beregnet til engangsbrug.
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR=0.78; 95 % CI = 0 .61-1.00, p=0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n=172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95 % CI = 1.08-2.26, p = 0.018).
Danish: En analyse af virkningen på NSCLCs histologi for behandlingens virkning på overlevelse var til fordel for pemetrexed versus docetaxel bortset fra cancerformer hovedsageligt bestående af pladeepitelceller (n=399; 9,3 versus 8,0 måneder, justeret HR= 0,78; 95 % CI= 0,61-1,00; p= 0,047) og til fordel for docetaxel for carcinom af pladeepitelceller (n= 172; 6,2 versus 7,4 måneder, justeret HR = 1,56; 95 %
English: Pemetrexed/cisplatin
Danish: Cisplatin pemetrexed/ cisplatin
English: Trometamol (for pH adjustment) Anhydrous citric acid Methionine
Danish: Trometamol (til pH-justering) Citronsyre, vandfri Metionin
English: 50% of previous dose 100% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Danish: 50 % af tidligere dosis a National Cancer Institute Common Toxicity Criteria (CTC v 2.0; NCI 1998)
English: Nadir ANC < 500/mm3 and nadir platelets
Danish: ANC-nadir < 500 /mm3 og nadir for trombocytter ≥ 50.000 /mm3
English: Breast-feeding must be discontinued during Armisarte treatment.
Danish: Amningen skal afbrydes under behandling med Armisarte.
English: Pemetrexed 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).
Danish: Pemetrexed er indiceret som monoterapi til vedligeholdelsesbehandling af lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller, hos patienter, hvis sygdom ikke har vist progression umiddelbart efter platinbaseret kemoterapi (se pkt.
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n=472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio=0.64, 95 % CI=0.51-0.81, p=0.0002).
Danish: Studiets primære endepunkt blev mødt og viste en statistisk signifikant forbedring i PFS i pemetrexedarmen over for placebo-armen (n = 472, uafhængigt evalueret population; median på henholdsvis 3,9 måneder og 2,6 måneder) (hazard ratio = 0,64; 95% CI = 0,51-0,81; p = 0,0002).
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated patients
Danish: Effekt af pemetrexed sammen med cisplatin versus cisplatin alene til patienter med malignt pleuramesoteliom Randomiseret og behandlet