natgillin/translations-raw huggingface dataset:
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.
Tid til behandlingssvigt (TTTF - måneder) (N = 283)
Time to treatment failure (TTTF - months)
Ikke almindelige tilfælde af akut nyresvigt er rapporteret ved brug af pemetrexed alene og i kombinationsbehandling med andre cytostatika (se pkt.
Uncommon cases of acute renal failure have been reported with pemetrexed alone or in association with other chemotherapeutic agents (see section 4.4).
Kontakt lægen eller sundhedspersonalet, før De får Pemetrexed Pfizer.
Warnings and precautions Talk to your doctor or hospital pharmacist before receiving Pemetrexed Pfizer.
Pemetrexed Pfizer 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 Pfizer 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.
95 %-CIformedianen HR
• 95% CI for HR
Diarré uden kolostomi
Stomatitis/Pharyngitis Diarrhoea without colostomy
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev vurderet som muligt relateret til forsøgsmedicinen, 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 medicinal product 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.
Almindelig Pruritus Alopeci
Rash/ desquamation Common Pruritus Alopecia
I løbet af studiet blev patienternes behandling suppleret med et lavdosistilskud af folsyre og B12vitamin for at mindske toksiciteten.
During the study, low-dose folic acid and vitamin B12 supplementation was introduced to patients' therapy to reduce toxicity.
Et randomiseret, åbent, fase 3-multicenterstudie af pemetrexed plus cisplatin versus gemcitabin plus cisplatin med patienter, der ikke tidligere har fået kemoterapi, med lokalt fremskreden eller metastatisk (fase III b eller IV) ikke-småcellet lungecancer (NSCLC) viste, at pemetrexed plus cisplatin (intent-to-treat [ITT] population N=862) mødte dets primære endepunkt og viste lignende klinisk virkning som gemcitabin plus cisplatin (ITT N=863) på total overlevelse (HR 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 (HR 0.94; 95% CI= 0.84-1.05).
Effektparameter pemetrexed/ cisplatin (N = 226)
Efficacy parameter pemetrexed / cisplatin (N = 226)
PARAMOUNT: Kaplan-Meier-kurver for progressionsfri overlevelse (PFS) og total overlevelse (OS) for pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling versus 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)
Efter rekonstitution indeholder opløsningen 25 mg/ml pemetrexed.
After reconstitution as directed, the solution contains 25 mg/ml of pemetrexed.
Toksicitet i grad 3-4
Grade 3-4 toxicity
Progressionsfrioverlevelse(PFS)ogstørrelsen afdettotale responsvarens mellemde to behandlingsarme:medianPFS var4,8 månederforpemetrexed plus cisplatinmod5,1 månederfor gemcitabinplus cisplatin (justerethazardratio1.04;95 %CI= 0,94-1,15)ogdettotale respons var 30,6 %(95 %CI= 27,3-33,9)forpemetrexed plus cisplatin mod28,2 %(95 %CI= 25,0-31,4)for gemcitabinplus cisplatin.
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 (HR) 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.
Dette tyder på, at pemetrexed kan nedsætte fertiliteten hos hanner.
This suggests that pemetrexed may impair male fertility.
Hyppighed* Bivirkning**
Frequency* Event**
Almene symptomer og symptomer på administrationsstedet
General disorders and administration site conditions
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 (intent-to-treat, 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).
Pemetrexed anbefales derfor ikke til patienter med en kreatininclearance på < 45 ml/min (se pkt.
Therefore, the use of pemetrexed in patients with creatinine clearance of <45 ml/min is not recommended (see section 4.2).
Hvis pemetrexedopløsning kommer i kontakt med slimhinderne, skal de skylles grundigt med vand.
If pemetrexed solutions contact the mucous membranes, flush thoroughly with water.
Patienter med let til moderat nyreinsufficiens (kreatininclearance 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 2 dage før, på dagen for og i 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).
Pemetrexed var hverken mutagent i in vitro-testen for kromosomafvigelse hos kinesiske hamstere eller i Ames-testen.
Pemetrexed was not mutagenic in either the in vitro chromosome aberration test in Chinese hamster ovary cells, or the Ames test. Pemetrexed has been shown to be clastogenic in the in vivo micronucleus test in the mouse.
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.
Pemetrexed Pfizer indeholder:
What Pemetrexed Pfizer contains
Nyrer og urinveje Almindelig Nyresygdomme**** 7,6 0,9 1,7 0,0 Forkortelser: ALAT = alaninaminotransferase; ASAT = aspartataminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute.
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.
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.
Det frarådes, at kønsmodne mænd gør en kvinde gravid under behandlingen og i op til 6 måneder efter behandlingen.
Sexually mature males are advised not to father a child during the treatment and up to 6 months thereafter.
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, 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= 0,018).
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, (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).
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.
EMPHACIS, a multi-centre, 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.
Da der ikke foreligger data om potentielle interaktioner mellem pemetrexed og NSAID-præparater med længere halveringstid, såsom piroxicam og rofecoxib, skal behandling med disse afbrydes hos patienter med let til moderat nyreinsufficiens mindst 5 dage før, på behandlingsdagen og i mindst 2 dage efter indgift af pemetrexed (se pkt.
In the absence of data regarding potential interaction with NSAIDs having longer half-lives such as piroxicam or rofecoxib, the concomitant administration with pemetrexed in patients with mild to moderate renal insufficiency should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Parenterale lægemidler bør kontrolleres visuelt for partikler og misfarvning før indgivelse.
Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration.
50 % af tidligere dosis (både pemetrexed og cisplatin) Disse kriterier opfylder National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition på ≥CTC grad 2 blødning.
50% of previous dose (both pemetrexed and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
De klinisk relevante CTC-toksiciteter, som blev rapporteret hos < 1 % af de patienter, der var randomiseret til pemetrexed, omfattede supraventrikulær arytmi.
Clinically relevant CTC toxicities that were reported in < 1% of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Median overlevelse i måneder (95% CI)
Median overall survival in months (95% CI)
Pemetrexedinfusionsopløsninger, der er forberedt som angivet ovenfor, er kompatible med indgivelsessæt og dropposer, som er belagt med polyvinylchlorid og polyolefin.
Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chlorideand polyolefin- lined administration sets and infusion bags.
Tilfælde af pnemonia interstitialis med respiratorisk insufficiens, sommetider dødeligt, er ikke almindeligt rapporteret hos patienter behandlet med pemetrexed i kliniske studier.
In clinical trials, cases of interstitial pneumonitis with respiratory insufficiency, sometimes fatal, have been reported uncommonly in patients treated with pemetrexed.
Kvinder i den fertile alder skal anvende effektiv kontraception under behandling med pemetrexed.
Women of childbearing potential must use effective contraception during treatment with pemetrexed.
Den mediane tid fra start af pemetrexed og cisplatin induktionsbehandling til start af vedligeholdelsesbehandling var 2,96 måneder i både pemetrexedog 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.
Pemetrexed Pfizer er også en behandling til patienter med fremskreden lungekræft, hvor sygdommen har udviklet sig, efter anden indledende behandling med kemoterapi har været forsøgt.
Pemetrexed Pfizer is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Der er rapporteret sjældne tilfælde af immunmedieret hæmolytisk anæmi hos patienter behandlet med pemetrexed.
Rarely, immune-mediated haemolytic anaemia has been reported in patients treated with pemetrexed.
Patienter med nedsat leverfunktion
Patients with hepatic impairment
Amningen skal afbrydes under behandling med pemetrexed.
Breast-feeding must be discontinued during pemetrexed treatment.
Tid til behandlingssvigt (måneder) (95 % - CI)
Time to treatment failure (months) (95% CI)
Pemetrexed Pfizer er også en behandling, som gives i kombination med cisplatin, som første behandling af patienter med fremskreden lungecancer.
Pemetrexed Pfizer is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Almindelig ALAT-forhøjelse ASAT-forhøjelse
Common ALT (SGPT) elevation
Følgende oplysninger er tiltænkt læger og sundhedspersonale:
The following information is intended for healthcare professionals only: Instructions for use, handling and disposal
Nedsat kreatininclearance**
Creatinine elevation Creatinine clearance decreased**
Efter induktionsbehandling med pemetrexed plus cisplatin (4 serier) var behandling med pemetrexed statistisk superior 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).
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).
** I henhold til National Cancer Institute CTC (v2.0; NCI 1998), bør alopeci kun rapporteres som grad 1 eller 2.
**According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
N=863 0,94
N = 863 0.94a
Lever og galdeveje
Unopened vial
Amning skal ophøre under behandling med pemetrexed (se pkt.
Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
National Cancer Institute Common Toxicity Criteria (CTC v 2.0; NCI 1998) Undtagen neurotoksicitet
100% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
Single use only SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Pemetrexed Pfizer 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 Pfizer 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
Forstoppelse Almindelig Dyspepsi
Common Dyspepsia
Sådan skal De bruge Pemetrexed Pfizer
How to use Pemetrexed Pfizer
De klinisk relevante CTC-toksiciteter, som blev rapporteret hos < 1 % af de patienter, som blev randomiseret til pemetrexed, omfatter: allergisk reaktion/overfølsomhed, erythema multiforme, supraventrikulær arytmi og lungeemboli.
Clinically relevant CTC toxicity that was reported in <1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
National Cancer Institute Common Toxicity Criteria (CTC v 2.0; NCI 1998)
50% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Hos patienter med let til moderat nyreinsufficiens (kreatininclearance 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 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 doses should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Hos patienter med let til moderat nyreinsufficiens, som er egnet til behandling med pemetrexed, skal behandling med NSAID-præparater med en lang halveringstid afbrydes mindst 5 dage før, på dagen for og i mindst 2 dage efter indgift af pemetrexed (se pkt.
In patients with mild to moderate renal insufficiency eligible for pemetrexed therapy, NSAIDs with long elimination half-lives should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.5).
Almindelig Konjunctivitis
Common Conjunctivitis
Den uafhængige evaluering af patienternes skanninger bekræftede investigatorernes vurdering af PFS. Investigatorernes mediane PFS-vurdering for de randomiserede patienter var 6,9 måneder for pemetrexedarmen og 5,6 måneder for placeboarmen (hazard ratio = 0,59; 95 % CI = 0,47-0,74) målt fra start af pemetrexed og cisplatin førstelinje-induktionsbehandling.
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).
Der blev set en påvirkning af testiklerne (degenerering/nekrose af seminiferous epithelium) i et studie udført på beaglehunde, der fik intravenøse bolusinjektioner i 9
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.
Hyppighed Bivirkning**
Frequency Event**
Studiets primære endepunkt blev mødt og viste en statistisk signifikant forbedring i PFS i pemetrexedarmen over for placebo (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).
Kvinder i den fødedygtige alder skal anvende effektive svangerskabsforebyggende midler under behandlingen med pemetrexed (se pkt.
Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
Pemetrexed Pfizer 100 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Pfizer 500 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Pfizer 1.000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion pemetrexed
Median tid til tumorprogression (måneder) (95 % - CI)
Median time to tumour progression (months) (95% CI)
Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring i PFS i pemetrexedarmen i forhold til placeboarmen (N=581, en uafhængig overvåget population, median 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).
***I henhold til National Cancer Institute CTC (v2.0; NCI 1998), smagsforstyrrelser og alopeci bør kun rapporteres som grad 1 eller 2.
***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Den mediane samlede overlevelse (OS) 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 =
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).
Under kliniske studier med pemetrexed er der ikke almindeligt rapporteret om svære kardiovaskulære hændelser herunder myokardieinfarkt og cerebrovaskulære hændelser, sædvanligvis når pemetrexed gives i kombination med et andet cytotoksisk lægemiddelstof.
Serious cardiovascular events, including myocardial infarction and cerebrovascular events have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
95 %-CI for HR p-værdifornon-inferioritet(HR) Progressionsfri overlevelse (måneder)
Progression-free survival (months)
Samlet responsrate** (95 % - CI)
Overall response rate** 41.3% (95% CI)