FrancophonIA/ELRC3.0 huggingface dataset:
English: EMPHACIS, a multicentre, randomised, single-blind phase 3 study of pemetrexed plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with pemetrexed and cisplatin had a clinically meaningful 2.8-month median survival advantage over patients receiving cisplatin alone.
Danish: EMPHACIS, et randomiseret, enkeltblindet, fase 3-multicenterstudie med pemetrexed sammen med cisplatin versus cisplatin alene til patienter, der ikke tidligere havde fået kemoterapi, og som led af malignt pleuramesoteliom, viste, at de patienter, som blev behandlet med pemetrexed og cisplatin, havde en klinisk meningsfuld længere median levetid på 2,8 måneder end patienter, som kun blev behandlet med cisplatin.
English: EU/1/15/1055/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/15/1055/002
English: Neutrophils decreased
Danish: Nedsat neutrofiltal
English: 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).
Danish: Median total overlevelse for den totale population (n=663) var 13,4 måneder for pemetrexed-armen og 10,6 måneder for placeboarmen, hazard ratio = 0,79 (95 % CI= 0,65-0,95; p= 0,01192).
English: Hydrochloric acid (pH adjustment) Sodium hydroxide (pH adjustment)
Danish: Mannitol (E421) Saltsyre (pH-justering) Natriumhydroxid (pH-justering)
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) for patienter med lokalt fremskreden (stadie IIIB) eller metastatisk (stadie IV) ikke-småcellet lungecancer (NSCLC), som ikke progredierede efter 4 serier med 1. linje-dubletbehandling bestående af cisplatin eller carboplatin sammen med gemcitabin, paclitaxel eller docetaxel.
English: As a result, concomitant use of live attenuated vaccines is not recommended (see section 4.3 and 4.5).
Danish: Som et resultat heraf frarådes samtidig administration af levende svækkede vacciner (se pkt.
English: CIAMBRA 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: CIAMBRA anvendes sammen med cisplatin, der er en anden medicin mod kræft, og bruges til behandling af malignt pleuramesoteliom, en kræftform som påvirker lungehinderne.
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;
Danish: En analyse af virkningen på NSCLC's 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 karcinom af pladeepitelceller (n= 172; 6,2 versus 7,4 måneder, justeret HR= 1,56; 95 % CI= 1,08-2,26; p= 0,0018).
English: The recommended dose of CIAMBRA is 500 mg/m of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Den anbefalede dosis af CIAMBRA er 500 mg/m² legemsoverflade infunderet intravenøst over 10 minutter på den første dag i hver 21-dages-serie.
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Danish: Den passende mængde rekonstitueret pemetrexedopløsning skal fortyndes yderligere til 100 ml med 0,9 % natriumchloridinjektionsvæske, uden konserveringsmiddel, og administreres som langsom intravenøs infusion over 10 minutter.
English: CIAMBRA as single agent
Danish: CIAMBRA givet alene
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Danish: De klinisk relevante CTC-toksiciteter af alle grader, der blev rapporteret hos ≥ 1 % og ≤ 5 % af de patienter, som var randomiseret til pemetrexed, omfatter: febril neutropeni, infektion, nedsat trombocyttal, diarré, forstoppelse, alopeci, udslæt/kløe, feber (uden neutropeni), sygdom i øjets overflade (inklusive konjunktivitis), øget tåreflåd, svimmelhed og motorisk neuropati.
English: 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, and administered as an intravenous infusion over 10 minutes.
Danish: Den passende mængde rekonstituerede pemetrexedopløsning skal fortyndes yderligere til 100 ml med 0,9 %-natriumchloridinjektionsvæske, uden konserveringsmiddel, og administreres som langsom intravenøs infusion over 10 minutter.
English: 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).
Danish: Målt fra starttidspunktet for 1. linje-induktionsbehandling med pemetrexed plus cisplatin var median overlevelsen 16,9 måneder for pemetrexed-armen og 14,0 måneder for placeboarmen (hazard ratio= 0,78, 95 % CI= 0,64-0,96).
English: Therefore, the use of pemetrexed in patients with creatinine clearance of < 45 ml/min is not recommended (see section 4.2).
Danish: Pemetrexed anbefales derfor ikke til patienter med en kreatininclearance på < 45 ml/min.
English: JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology:
Danish: JMEN: Kaplan Meier-kurver for progressionsfri overlevelse (PFS) og overlevelse (overall survival - OS) for pemetrexed versus placebo hos patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller:
English: Pancytopenia- combined low counts of white cells, red cells and platelets Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their CIAMBRA therapy.
Danish: Ødemer (væskeophobning i væv, som medfører hævelse) Nogle patienter har oplevet et hjertetilfælde, et slagtilfælde eller et ”mini-slagtilfælde”, mens de har fået CIAMBRA, sædvanligvis i kombination med anden kræftbehandling Pancytopeni - en kombination af lavt antal hvide blodlegemer, røde blodlegemer og blodplader Strålingspneumonitis (arvæv i de fineste bronkier samt alveolerne på grund af strålebehandling) kan opstå hos patienter, som også behandles med stråling enten før, under eller efter deres behandling med CIAMBRA
English: Common Leukocytes decreased
Danish: Nedsat hæmoglobin Almindelig Nedsat leukocyttal
English: 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)
Danish: PARAMOUNT: Kaplan Meier-kurver for progressionsfri overlevelse (PFS) og overlevelse (overall survival - OS) for fortsat vedligeholdelsesbehandling med pemetrexed versus placebo hos patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (målt fra randomiseringen)
English: The PFS and OS results in patients with squamous cell histology suggested no advantage for pemetrexed over placebo.
Danish: Resultaterne for progressionsfri overlevelse og total overlevelse for patienter med cancer hovedsageligt bestående af cancer hovedsageligt bestående pladeepitelceller tydede ikke på nogen fordel med pemetrexed frem for placebo.
English: CIAMBRA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section
Danish: CIAMBRA er indiceret som 2. linjes monoterapi til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: Frequency Event*
Danish: Hyppighed Bivirkning**
English: 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 aspirin (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section
Danish: 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 administration af pemetrexed (se pkt.
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).
Danish: Efter induktionsbehandling med pemetrexed plus cisplatin (4 serier) var behandling med pemetrexed statistisk overlegen i forhold til placebo med hensyn til total overlevelse (median 13,9 måneder versus 11,0 måneder, hazard ratio = 0,78, 95 % CI= 0,64-0,96, p=0,0195).
English: Grade toxicity
Danish: Toksicitet grad
English: For single use only.
Danish: Dette lægemiddel er kun beregnet til engangsbrug.
English: NL Menarini Benelux NV/SA Tel: +32 (0)2 721 4545
Danish: Tlf: +352 264976 NL Menarini Benelux NV/SA Tel: +32 (0)2 721 4545
English: CIAMBRA 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: CIAMBRA 500 milligram: Hvert hætteglas indeholder 500 milligram pemetrexed (som pemetrexeddinatrium hemipentahydrat).
English: A multicentre, 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.
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret fase 3-multicenterstudie (PARAMOUNT) sammenlignede virkningen og sikkerheden af fortsat vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC, Best Supportive Care) (n=359) med placebo plus BSC (n=180) hos patienter med lokalt fremskreden (stadie IIIB) eller metastaserende (stadie IV) ikke-småcellet lungecancer (NSCLC) bortset fra cancer hovedsageligt bestående af pladeepitelceller, som ikke progredierede efter 4 serier med 1. linje-dubletbehandling bestående af pemetrexed i kombination med cisplatin.
English: CIAMBRA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: CIAMBRA er indiceret til behandling sammen med cisplatin som 1. linjebehandling til patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: The vial is covered with a shrink-wrapped plastic sleeve .
Danish: Hætteglasset er beskyttet af en muffe i krympeplast.
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of CIAMBRA is 500 mg/m
Danish: Til patienter, der behandles for ikke-småcellet lungecancer efter tidligere behandling med kemoterapi, er den anbefalede dosis af CIAMBRA 500 mg/m² legemsoverflade infunderes intravenøst over 10 minutter på den første dag i hver 21-dages-serie.
English: Grade 34 toxicity
Danish: Toksicitet grad 3-4
English: Low haemoglobin level (anaemia) Low platelet count
Danish: Lavt hæmoglobinniveau (blodmangel) Lavt antal blodplader
English: There is no relevant use of CIAMBRA in the paediatric population.
Danish: Det er ikke relevant at bruge CIAMBRA til børn og unge.
English: CIAMBRA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: CIAMBRA 100 milligram: Hvert hætteglas indeholder 100 milligram pemetrexed (som pemetrexeddinatrium hemipentahydrat).
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Sundhedsstyrelsens hjemmeside http://www.sst.dk.
English: Leukocytes decreased
Danish: Nedsat leukocyttal
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 800 patients randomly assigned to receive single agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
Danish: Bivirkningerne blev rapporteret hos > 5 % af de 800 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed, og de 402 patienter, som var randomiseret til placebo i studiet med vedligeholdelsesbehandling med pemetrexed (JMEN: n=663) og studiet med induktionsbehandling med pemetrexed efterfulgt af vedligeholdelsesbehandling med pemetrexed (PARAMOUNT: n=539).
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: Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring af progressionsfri overlevelse i pemetrexed-armen over for placeboarmen (n=472, uafhængigt evalueret population; median var henholdsvis 3,9 måneder og 2,6 måneder) (hazard ratio = 0,64; 95 % CI= 0,51-0,81; p= 0,0002).
English: For patients with NSCLC other than predominantly squamous cell histology (n = 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p = 0.00001).
Danish: For patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n=430, uafhængig overvåget population) var median progressionsfri overlevelse 4,4 måneder for pemetrexed-armen og 1,8 måneder for placeboarmen, hazard ratio = 0,47, 95 % CI = 0,37-0,60; p=0,00001.
English: MT Menarini International Operations Luxembourg S.A. Tel: +352 264976
Danish: MT Menarini International Operations Luxembourg S.A. Tel: +352 264976 NO Menarini International Operations Luxembourg S.A.
English: Squamous cell (N=473)
Danish: Pladeepitelceller (n=473)
English: 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).
Danish: Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring af progressionsfri overlevelse i pemetrexed-armen i forhold til placebodelen (n=581, en uafhængig evalueret population, median på henholdsvis 4 måneder og 2 måneder) (hazard ratio = 0,60, 95 % CI = 0,49-0,73; p <0,00001).
English: These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥CTC Grade 2 bleeding
Danish: 50 % af tidligere dosis (både CIAMBRA og cisplatin) a Disse kriterier opfylder National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition på ≥CTC grad 2 blødning.
English: Neutrophils/ Granulocytes decreased Leukocytes decreased Haemoglobin decreased Platelets decreased
Danish: Nedsat neutrofiltal/ granulocyttal Nedsat leukocyttal Nedsat hæmoglobin Almindelig Nedsat trombocy
English: Each 10 mL vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Hver enkelt 10 ml hætteglas indeholder 100 mg pemetrexed (i form af pemetrexeddinatrium hemipentahydrat).
English: CIAMBRA in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Danish: CIAMBRA er indiceret til behandling af patienter, der ikke tidligere har fået kemoterapi, med inoperabelt malignt pleuramesoteliom i kombination med cisplatin.
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Danish: Ved at inkludere induktionsfasen blev median overlevelse for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller 18,6 måneder for pemetrexed-armen og 13,6 måneder for placeboarmen, hazard ratio = 0,71, 95 % CI = 0,56-0,88; p=0,002.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Danish: Median overlevelse for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n=481) var 15,5 måneder for pemetrexed-armen og 10,3 måneder for placeboarmen (hazard ratio = 0,70, 95 % CI= 0,56-0,88, p= 0,002).
English: General disorders and administratio n site conditions
Danish: Almene symptomer og reaktioner på administrations -stedet
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with CIAMBRA/ radiation therapy.
Danish: Betændelse i spiserørets overflade er forekommet med CIAMBRA i kombination med strålebehandling
English: The vial contains 100 mg or 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Et hætteglas indeholder 100 milligram eller 500 milligram pemetrexed (i form af pemetrexeddinatrium hemipentahydrat).
English: BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Danish: Den anbefalede dosis cisplatin er 75 mg/m² legemsoverflade infunderet over 2 timer cirka 30 minutter efter afsluttet infusion af pemetrexed på den første dag i hver 21-dages-serie.
English: Each 50 mL vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Hver enkelt 50 ml hætteglas indeholder 500 mg pemetrexed (i form af pemetrexeddinatrium hemipentahydrat).
English: CIAMBRA 500 mg powder for concentrate for solution for infusion Pemetrexed
Danish: CIAMBRA 500 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Neutrophils/ Granulocytes decreased
Danish: Nedsat neutrofiltal/ granulocyttal
English: Neutrophils/ Granulocyte s decreased Leukocytes decreased
Danish: Nedsat neutrofiltal/ granulocytt Nedsat leukocyttal Nedsat hæmoglobin Almindelig Nedsat tromboc
English: In clinical studies, patients with creatinine clearance of ≥ 45 ml/min required no dose adjustments other than those recommended for all patients.
Danish: I kliniske studier var der til patienter med en kreatininclearance på ≥ 45 ml/min.
English: CIAMBRA 100 mg powder for concentrate for solution for infusion Pemetrexed
Danish: CIAMBRA 100 mg pulver til koncentrat til infusionsvæske, opløsning.
English: BE Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
Danish: Tel: +43 1 879 95 85-0 BE Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
English: 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 aspirin at higher dose should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Danish: 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 administration af pemetrexed (se pkt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun beregnet til engangsbrug.
English: IS Menarini International Operations Luxembourg S.A. Sími: +352 264976
Danish: IS Menarini International Operations Luxembourg S.A. Sími: +352 264976 IT A. Menarini Industrie Farmaceutiche Riunite s.r.l.
English: Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hvert hætteglas med 500 mg rekonstitueres med 20 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Rash/ desquamation
Danish: Udslæt/ hudafskalning
English: Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hvert hætteglas med 100 mg rekonstitueres med 4,2 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95% CI = 0.47-0.74).
Danish: Investigatorernes gennemsnitlige vurdering af progressionsfri overlevelse for de randomiserede patienter var 6,9 måneder for pemetrexed-armen og 5,6 måneder for placeboarmen (hazard ratio = 0,59; 95 % CI= 0,47-0,74) målt fra start af 1. linje-induktionsbehandling med pemetrexed og cisplatin.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Log Rank p-value* Overall response rate** (95 % CI)
Danish: Samlet responsrate** (95 % CI)
English: After reconstitution (see section 6.6), each vial contains 25 mg/mL of pemetrexed.
Danish: 6.6), indeholder hvert hætteglas 25 mg/ml pemetrexed.
English: CIAMBRA 500 mg
Danish: INFORMATION I BRAILLESKRIFT CIAMBRA 500 mg
English: If you have heart disease or a history of heart disease, please tell your doctor.
Danish: Informer Deres læge, hvis De har en hjertesygdom eller tidligere har haft en hjertesygdom.
English: (N = 222)
Danish: cisplatin (n=222)
English: Grade
Danish: ASATforhøjelse
English: CIAMBRA 100 mg
Danish: INFORMATION I BRAILLESKRIFT CIAMBRA 100 mg
English: Taste disturbance 8.1
Danish: Forhøjet kreatinin 10,1*
English: Constipation
Danish: ASATøgning