natgillin/translations-raw huggingface dataset:
Hos patienter med en normal nyrefunktion (kreatinin-clearance ≥ 80 ml/min) kan høje doser af nonsteroide anti-inflammatoriske lægemidler (NSAID-præparater såsom ibuprofen > 1600 mg/dag) og acetylsalicylsyre i høje doser (≥ 1,3 g daglig) nedsætte udskillelsen af pemetrexed, og dermed øge forekomsten af bivirkninger relateret til pemetrexed. 
In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of nonsteroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 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.
Fortæl altid lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig. 
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Der blev ikke set nogen klinisk relevante forskelle i sikkerhedsprofilen for Pemetrexed inden for de histologiske undergrupper. 
There were no clinically relevant differences observed for the safety profile of pemetrexed within the histology subgroups.
Nervesystemet Almindelig 
Nervous system disorders
For information om sikkerhedsforanstaltninger, der skal tages før håndtering og administration af Pemetrexed Sandoz, se pkt. 
For precautions to be taken before handling or administering Pemetrexed Sandoz, see section 6.6.
● Hvis du bløder fra gummer, næse eller mund eller får anden blødning, som ikke vil stoppe, rødlig eller lyserødlig urin, uventede blå mærker (fordi du muligvis har færre blodplader end normalt, hvilket er meget almindeligt). 
• 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).
100 % af tidligere dosis a National Cancer Institute Common Toxicity Criteria (CTC v 2.0; NCI 1998) b Undtagen neurotoksicitet 
100% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
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 minutter. 
426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a
64,3 % af pemetrexed-patienterne og 71,7 % af placebo-patienterne fik behandling efter studiet. 
The percentage of patients that received post-study treatment was 64.3% for pemetrexed and 71.7% for placebo.
Median var 4 serier af vedligeholdelsesbehandling med pemetrexed og 4 serier med placebo. 
Patients received a median of 4 cycles of maintenance treatment with pemetrexed and 4 cycles of placebo.
Kemisk og fysisk stabilitet af Pemetrexed Sandoz infusionsopløsning er påvist i 4 dage ved 2-8 °C og i 2 dage under 25° C. 
Chemical and physical in-use stability of infusion solutions of Pemetrexed Sandoz has been demonstrated for 4 days at 2°C to 8°C and for 2 days below 25°C.
Sjældne bivirkninger omfatter Stevens-Johnson syndrom og toksisk epidermal nekrolyse. 
Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Nedsat kreatininclearance** 
Very common Creatinine clearance decreased**
Patienterne behøvede ligeledes mindre erythropoietin/darbopoietin (10,4 % mod 18,1 %, p<0,001), G-CSF/GM-CSF (3,1 % mod 6,1 %; p=0,004) og midler med jern (4,3 5 mod 7,0 %; p=0,021). 
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).
A. ETIKETTERING 
6 A. LABELLING
Pemetrexed Sandoz 100 mg indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. at det i princippet er ”natrium-frit”. 
Pemetrexed Sandoz 100 mg contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Klinisk effekt: 
Clinical efficacy
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). 
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).
Tyktarmsbetændelse (betændelse i tyktarmen, som kan ledsages af blødning fra tarm eller endetarm). 
• Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding)
Hvis du ammer, skal du fortælle din læge dette. 
If you are breast-feeding, tell your doctor.
Ebewe Pharma Ges.m.b.H Nfg.KG Mondseestrasse 11, Unterach 4866 Østrig 
Mondseestrasse 11, Unterach 4866 Austria
Det skal du vide, før du begynder at bruge Pemetrexed Sandoz 
What you need to know before you use Pemetrexed Sandoz
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev rapporteret hos > 5 % af 168 patienter med mesoteliom, som var randomiseret til behandling med cisplatin og pemetrexed, og 163 patienter med mesoteliom, som var randomiseret til enkeltstofbehandling med cisplatin. 
The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed, and 163 patients with mesothelioma randomised to receive single-agent cisplatin.
Pemetrexed Sandoz indeholder natrium 
Pemetrexed Sandoz contains sodium
Fishers eksakte p-niveau* 
Fisher's exact p-value* < 0.001
Gemcitabin/ cisplatin (n = 830) 
Gemcitabine/ Cisplatin (N = 830)
Pemetrexed Sandoz 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. 
Pemetrexed Sandoz 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.
Nadir for trombocytter < 50.000 /mm3 uanset ANC-nadir 
Nadir platelets < 50,000/mm3 regardless of nadir ANC
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). 
A multi-centre, 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 [ITT] population N = 283) and 7.9 months for patients treated with docetaxel (ITT N = 288).
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev vurderet som muligt relateret til studiesubstans, og som blev rapporteret hos > 5 % af de 839 patienter med NSCLC, der blev randomiseret til at få cisplatin og pemetrexed, samt de 830 patienter med NSCLC, som blev randomiseret til at få cisplatin og gemcitabin. 
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5 % of 839 patients with NSCLC who were randomised to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomised to receive cisplatin and gemcitabine.
Lavt antal blodplader 
• Low white blood cells
Pemetrexed Sandoz er et pulver til koncentrat til infusionsvæskeopløsning i hætteglas. 
Pemetrexed Sandoz is a powder for concentrate for solution for infusion in a glass vial.
Vitamintilskud: Du skal tage en folsyretablet eller en multivitamin indeholdende folsyre (3501000 mikrogram) 1 gang dagligt, mens du tager Pemetrexed Sandoz. 
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 taking Pemetrexed Sandoz.
Bulløse tilstande (hudsygdomme med blæredannelser), inklusive Stevens-Johnson syndrom og toksisk epidermal nekrolyse. 
• Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis
Kemisk og fysisk stabilitet af Pemetrexed Sandoz rekonstitueret opløsning er påvist i 4 dage ved 2-8 °C og i 4 dage under 25° C. 
Chemical and physical in-use stability of reconstituted solutions of Pemetrexed Sandoz has been demonstrated for 4 days at 2°C to 8°C and for 4 days below 25°C.
Almindelig Dehydrering Meget almindelig 
Common Dehydration
De forventede komplikationer ved overdosering omfattede knoglemarvshæmning, som ytrede sig ved neutropeni, trombocytopeni og anæmi. 
Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia, and anaemia.
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev rapporteret hos >5 % af 265 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed og tilskud af folsyre og B12-vitamin, og 276 patienter, som var randomiseret til enkeltstofbehandling med docetaxel. 
The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single-agent pemetrexed with folic acid and vitamin B12 supplementation, and 276 patients randomly assigned to receive single-agent docetaxel.
Nedsat neutrofiler/ granulocyter 
Neutrophils/Granulocyte s decreased
Det er ikke relevant at bruge pemetrexed til malignt pleuramesoteliom og ikke-småcellet lungecancer i den pædiatriske population. 
Paediatric population: There is no relevant use of pemetrexed in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Til patienter, der behandles for ikke-småcellet lungecancer efter tidligere behandling med kemoterapi, er den anbefalede dosis af Pemetrexed Sandoz 500 mg/m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie. 
Pemetrexed Sandoz as single agent In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
AC: Pemetrexed + Cisplatin GC: Gemcitabin + Cisplatin 
Pemetrexed + Cisplatin Gemcitabine + Cisplatin
PARAMOUNT: Kaplan Meier-kurver for progressionsfri overlevelse (PFS) og total overlevelse (OS, overall survival) for pemetrexed-induktionsbehandling efterfulgt af pemetrexed- vedligeholdelsesbehandling vs. placebo hos patienter med NSCLC bortset fra cancer hovedsagelig bestående af pladeepitelceller (målt fra randomiseringen) 
PARAMOUNT: Kaplan-Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
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 % CI= 1,08- 2,26; p= 0,0018). 
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 hazard ratio (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).
Pemetrexed er inkompatibelt med fortyndinger indeholdende calcium, herunder Ringers-laktat-injektion og 
Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection.
Når Pemetrexed Sandoz tages sammen med cisplatin: 
When using Pemetrexed Sandoz in combination with cisplatin:
Nadir for trombocytter < 50.000/ mm3 med blødninga uanset ANC-nadir 
Nadir platelets < 50,000/mm3 with bleedinga, regardless of nadir ANC
Lever: abnorme blodprøveresultater Rindende øjne 
• Liver: abnormal blood tests
EU/1/15/1037/002 
EU/1/15/1037/001 EU/1/15/1037/002 EU/1/15/1037/003
Den anbefalede dosis af pemetrexed er 500 mg/m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie. 
The recommended dose of pemetrexed 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.
Almindelig Nedsat trombocytter Diarré 
Common Platelets decreased Diarrhoea
Intravenøs brug efter rekonstitution og fortynding 
Intravenous use after reconstitution and dilution
Amningen skal afbrydes under behandling med Pemetrexed Sandoz. 
Breast-feeding must be discontinued during Pemetrexed Sandoz treatment.
Pemetrexed Sandoz er også en behandling, som gives i kombination med cisplatin, som indledende behandling af patienter med fremskreden lungecancer. 
Pemetrexed Sandoz is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Pemetrexed Sandoz er også en behandling til patienter med fremskreden lungekræft, hvor sygdommen har udviklet sig, efter anden indledende behandling med kemoterapi har været forsøgt. 
Pemetrexed Sandoz is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1000 mg 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 mg
NSCLC, 1. linje-behandling Et randomiseret, åbent, fase3-multicenterstudie afpemetrexedpluscisplatin 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). 
A multi-centre, 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 (HR) 0.94; 95% CI= 0.84-1.05).
Median-tiden fra start af pemetrexed og cisplatininduktionsbehandling til start af vedligeholdelsesbehandling var 2,96 måneder i både pemetrexed- og placeboarmen. 
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.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 500 mg 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg
Pemetrexed Sandoz 1000 mg indeholder 108 mg natrium pr. hætteglas. 
Pemetrexed Sandoz 1000 mg contains 108 mg sodium per vial.
Patienter med let til moderat nyreinsufficiens (kreatinin-clearance på 45-79 ml/min) skal undgå at tage non-steroide anti-inflammatoriske lægemidler (NSAID-præparater) såsom ibuprofen og acetylsalicylsyre (>1,3 g daglig) i mindst 2 dage før, på dagen for og i mindst 2 dage efter indgift af pemetrexed (se pkt. 
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, and acetylsalicylic acid (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Nedsat leukocytter 
Leucocytes decreased
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. 
A multi-centre, 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.
Nedsat neutrofiler 
Neutrophils decreased
Pemetrexed Sandoz 500 mg indeholder 54 mg natrium pr. hætteglas. 
Pemetrexed Sandoz 500 mg contains 54 mg sodium per vial.
Diarré 
• Diarrhoea
Pemetrexed Sandoz 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. 
Pemetrexed Sandoz 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).
Målt fra starttidspunktet for pemetrexed plus cisplatin førstelinje-induktionsbehandling var den mediane overlevelse 16,9 måneder for pemetrexedarmen og 14,0 måneder for placebo-armen (hazard ratio= 0,78, 95 % CI= 0,64-0,96). 
From the start of pemetrexed plus cisplatin first-line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Den passende mængde rekonstitueret pemetrexedopløsning skal fortyndes yderligere til 100 ml med 0,9% natriumchlorid-injektionsvæske (uden konserveringsmiddel) eller med glucose-injektionsvæske 50 mg/ml (5%) (uden konserveringsmiddel), og indgives som langsom intravenøs infusion over 10 minutter. 
The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative) or with glucose 50 mg/ml (5%) solution for injection (without preservative) and administered as an intravenous infusion over 10 minutes.
Studiets primære endepunkt blev mødt og viste en statistisk signifikant forbedring i PFS i pemetrexed - armen 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). 
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).
Hurtig puls 
• Fast heart rate
Tabel 3 - Dosisjustering for Pemetrexed Sandoz (som enkeltstof eller i kombination) og cisplatin - neurotoksicitet 
Dose modification table for Pemetrexed Sandoz (as single agent or in combination) and cisplatin - Neurotoxicity
Den gennemsnitlige overlevelse (OS, overall survival) for den totale population (n = 663) var 13,4 måneder for pemetrexed-delen og 10,6 måneder for placebodelen, hazard ratio = 0,79 (95% CI = 0,65- 0,95; p = 0,01192). 
The median OS for the overall population (N = 663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI= 0.65-0.95, p = 0.01192).
Median-tid til tumorprogression (måneder) (95 %-CI) 
Median time to tumour progression (months)
Mænd rådes til ikke at gøre en kvinde gravid hverken under eller i op til 6 måneder efter behandlingen med Pemetrexed Sandoz. 
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Sandoz and should therefore use effective contraception during treatment with Pemetrexed Sandoz and for up to 6 months afterwards.
Hos patienter med let til moderat nyreinsufficiens (kreatinin-clearance 45-79 ml/min) bør samtidig administration af pemetrexed og NSAID-præparater (for eksempel ibuprofen) eller acetylsalicylsyre i højere doser undgås 2 dage inden, på behandlingsdagen og i mindst 2 dage efter indgift af pemetrexed (se pkt. 
In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min), the concomitant administration of pemetrexed with NSAIDs (e.g., ibuprofen) or acetylsalicylic acid at higher dose should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Se indlægssedlen for yderligerer information. 
See package leaflet for further information.
Efter rekonstitution indeholder hvert hætteglas 25 mg/ml pemetrexed. 
After reconstitution each vial contains 25 mg/ml of pemetrexed.
Forkortelser: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase; 
Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring i PFS i pemetrexed- delen i forhold til placebodelen (n = 581, en uafhængig overvåget population, gennemsnit på henholdsvis 4 måneder og 2 måneder) (hazard ratio = 0,60, 95% CI = 0,49-0,73; p < 0,00001). 
The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (N = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60,95% CI = 0.49-0.73, p < 0.00001).
Et multi-center, randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie (PARAMOUNT) sammenlignede virkningen og sikkerheden af fortsat vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC, Best Supportive Care) (Nn=359) med placebo plus BSC (n=180) hos patienter med lokalt fremskreden (stadium IIIB) eller metastaserende (stadium IV) ikke-småcellet lungecancer (NSCLC) bortset fra cancer hovedsageligt bestående af pladeepitelceller, som ikke progredierede efter 4 serier med 1. linjedubletbehandling bestående af pemetrexed i kombination med cisplatin. 
A multi-centre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (N = 359) with that of placebo plus BSC (N = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first-line doublet therapy of pemetrexed in combination with cisplatin.
Domaniewska 50C 
Domaniewska 50C 02-672 Warszawa