FrancophonIA/ELRC3.0 huggingface dataset:
English: • You could have increased levels of the yellow pigment bilirubin in the blood which might cause jaundice (a yellowing of the skin, mucous membranes and eyes).
Danish: • De kan få et øget indhold af det gule farvestof, bilirubin, i blodet, hvilket kan forårsage gulsot (gulfarvning af hud, slimhinder og øjne).
English: Blood creatinine increased Blood albumin decreased
Danish: Forhøjet kreatin i blodet Nedat albumin i blodet
English: In this case you may experience one or more of the following signs: fever, difficulty in breathing, redness or flushing of the skin or a rash, feeling sick (nausea) or being sick (vomiting; see section 4).
Danish: I så fald kan De opleve et eller flere af følgende tegn: Feber, åndedrætsbesvær, hudrødme eller hududslæt, kvalme eller opkastning (se punkt 4).
English: For the treatment of ovarian cancer Yondelis is administered every three weeks as a 3-hour infusion at a dose of 1.1 mg/m2, immediately after PLD 30 mg/m2.
Danish: Til behandling af ovariecancer indgives Yondelis hver tredje uge som en 3-timers infusion med en dosis på 1,1 mg/m2 umiddelbart efter PLD 30 mg/m2.
English: Special caution is advised and dose adjustments may be necessary in patients with hepatic impairment since systemic exposure to trabectedin is increased and the risk of hepatotoxicity might be increased.
Danish: Hos patienter med nedsat leverfunktion tilrådes det at udvise særlig forsigtighed, og dosisjusteringer kan være nødvendige, da den systemiske eksponering for trabetedin vil være øget, og risikoen for levertoksicitet kan være øget.
English: Treatment with the combination arm resulted in a 21% risk reduction for disease progression compared to PLD alone (HR=0.79, CI: 0.65-0.96, p=0.0190).
Danish: Kombinationsbehandlingen resulterede i en 21 % risikoreduktion med hensyn til sygdomsprogression sammenlignet med PLD alene (HR=0,79; CI: 0,65-0,96; p=0,0190).
English: In this trial trabectedin was administered either at 1.5 mg/m2 as a 24-hour intravenous infusion every 3 weeks or at 0.58 mg/m2 weekly as a 3-hour intravenous infusion for 3-weeks of a 4-week cycle.
Danish: I dette studie blev trabectedin indgivet enten ved 1,5 mg/m2 som en 24-timers intravenøs infusion hver 3. uge eller ved 0,58 mg/m2 ugentlig som en 3-timers intravenøs infusion i 3 uger i en cyklus på 4 uger.
English: Capillary leak syndrome (CLS) is a rare entity characterized by recurrent and unpredictable attacks of capillary leakage of plasma fluid and proteins throughout the endothelium.
Danish: Kapillærlækage-syndrom (CLS), der er kendetegnet ved tilbagevendende og uforudsigelige anfald af kapillær lækage af plasmavæske og proteiner gennem endotelet, forekommer sjældent.
English: Yondelis should not be used in children below 18 years with paediatric sarcomas because of efficacy concerns (see 5.1 for results of paediatric sarcoma study).
Danish: Yondelis bør ikke anvendes til børn under 18 år med pædiatriske sarkomer på grund af problemstillinger vedrørende virkning (se pkt.
English: • If you experience severe muscle pain or weakness as it could be a sign of damage to your muscles (rhabdomyolysis; see section 4).
Danish: • Hvis De får kraftig muskelsmerte eller -svaghed, da det kunne være tegn på beskadigelse af musklerne (rabdomyolyse; se pkt.
English: Since the systemic exposure to trabectedin is on average approximately doubled (see section 5.2) due to hepatic impairment and therefore the risk of toxicities might be increased, patients with clinically relevant liver diseases, such as active chronic hepatitis, must be closely monitored and the dose adjusted if needed.
Danish: 5.2) på grund af den nedsatte leverfunktion, og risikoen for toksiciteter kan blive øget, skal patienter med klinisk relevante leversygdomme såsom aktiv kronisk hepatitis monitoreres nøje og dosis om nødvendigt justeres.
English: Additional efficacy data are available from a randomized active-controlled phase III study of trabectedin vs. dacarbazine (Study ET743-SAR-3007), in patients treated for unresectable or metastatic lipo- or leiomyosarcoma who have been previously treated with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and one additional cytotoxic chemotherapy regimen.
Danish: Yderligere virkningsdata er tilgængelige fra et randomiseret, aktivt kontrolleret fase 3-studie af trabectedin versus dacarbazin (forsøg ET743-SAR-3007) hos patienter, der er under behandling for ikke-resektabel eller metastatisk lipo- eller leiomyosarkom, og som tidligere har modtaget mindst en behandling med antracyklin og ifosfamid eller en behandling med antracyklin og en yderligere cytotoksisk kemoterapikur.
English: The efficacy and safety of trabectedin in soft tissue sarcoma is based in a randomised trial in patients with locally advanced or metastatic lipo- or leiomyosarcoma, whose disease had progressed or relapsed after treatment with at least anthracyclines and ifosfamide.
Danish: Virkningen og sikkerheden af trabectedin til behandling af bløddelssarkom er baseret på et randomiseret studie med patienter med lokalt fremskredet eller metastatisk lipo- eller leiomyosarkom, hvis sygdom havde udviklet sig eller var recidiveret efter behandling med antracykliner og ifosfamid som mindstekrav.
English: Anaemia occurred in 93% and 94% of patients treated with the monotherapy and combination regimens respectively.
Danish: Anæmi optrådte hos henholdsvis 93 % og 94 % af de patienter, der blev behandlet med monoterapiog kombinationsregimerne.
English: This medicine contains potassium, less than 1 mmol (39 mg) per vial, and can therefore be considered as essentially “potassium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (39 mg) kalium pr. hætteglas og kan derfor betragtes som i det væsentlige kaliumfrit.
English: • You could have mucosal inflammation as a swelling redness of the inside of the mouth leading to painful ulcers and mouth sores inflammation of the mouth (stomatitis), or as an inflammation of the gastrointestinal tract when Yondelis is used with PLD.
Danish: • De kan få betændelse i slimhinder som en hævelse og rødme inde i munden, hvilket kan medføre smertefulde sår og betændelse i munden med sår (stomatitis), eller som betændelse i mave-tarm-kanalen, når Yondelis andvendes med PLD.
English: Fatal adverse reactions have occurred in 1.9% and 0.9% of patients treated with the monotherapy and combination regimens respectively.
Danish: Letale bivirkninger er forekommet hos 1,9 % og 0,9 % af de patienter, der blev behandlet med henholdsvis monoterapi- og kombinationsterapiregimer.
English: Bleeding events associated to thrombocytopenia occurred in < 1% of patients treated with the monotherapy regimen.
Danish: Blødningshændelser associeret med trombocytopeni optrådte hos < 1 % af patienterne.
English: Palpitations* Left ventricular dysfunction*
Danish: Hjertebanken* Venstre ventikel dysfunktion*
English: Yondelis is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.
Danish: Yondelis er indiceret til behandling af voksne patienter med fremskredet bløddelssarkom (STS) efter fejlslagen behandling med antracykliner og ifosfamid, eller til patienter som er uegnede til at modtage disse stoffer.
English: - The other ingredients are sucrose, potassium dihydrogen phosphate, phosphoric acid (for pH-adjustment) and potassium hydroxide (for pH-adjustment).
Danish: - Øvrige indholdsstoffer: Saccharose, kaliumdihydrogenfosfat, phosphorsyre (til pH-justering) og kaliumhydroxid (til pH-justering).
English: - The active substance is trabectedin.
Danish: - Aktivt stof: trabectedin.
English: The concomitant use of trabectedin with alcohol must be avoided (see section 4.5).
Danish: Samtidig brug af trabectedin og alkohol skal undgås (se pkt.
English: The lesions may either dry out and desquamate, or blister with ulceration.
Danish: Læsionerne kan enten tørre ud og skalle af, eller der kan dannes vabler med sår.
English: Additional efficacy data are available from a randomized, open-label, multicenter phase II study [JapicCTI-121850] conducted in Japanese patients with translocation-related sarcoma (TRS), most common being myxoid round-cell liposarcoma (n=24), synovial sarcoma (n=18), mesenchymal chondrosarcoma (n=6), and extraskeletal Ewing sarcoma/PNET, alveolar soft part sarcoma, alveolar rhabdomyosarcoma and clear cell sarcoma (n=5 each).
Danish: Yderligere effektdata er tilgængelige fra et randomiseret, åbent fase II-multicenterstudie [JapicCTI121850] udført hos japanske patienter med translokationsrelaterede sarkomer (TRS), hvor de mest almindelige var myksoid rundcellet liposarkom (n=24), synovialt sarkom (n=18), mesenkymalt kondrosarkom (n=6) og ekstraskeletalt Ewings sarkom/PNET, alveolært bløddelssarkom, alveolært rabdomyosarkom og klarcellet sarkom (n=5 for hver).
English: Advice on conservation of ovules or sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with Yondelis.
Danish: Der bør inden behandlingen søges rådgivning vedrørende opbevaring af æg eller sæd på grund af risikoen for irreversibel infertilitet på grund af behandlingen med Yondelis.
English: The primary efficacy endpoint of the study was OS, which included 381 death events (66% of all randomized patients): 258 (67.2%) deaths in the trabectedin group and 123 (63.7%) deaths in the dacarbazine group (HR 0.927 [95% CI: 0.748, 1.150; p=0.4920]).
Danish: Forsøgets primære endepunkt var samlet overlevelse (OS), som omfattede 381 tilfælde af dødsfald (66 % af alle randomiserede patienter): 258 (67,2 %) dødsfald i trabectedin-gruppen og 123 (63,7 %) dødsfald i dacarbazin-gruppen (HR 0,927 [95 % CI: 0,748, 1,150; p=0,4920]).
English: Inspect the parenteral solution visually for particles prior to intravenous administration.
Danish: Den parenterale opløsning skal inspiceres visuelt for partikler inden intravenøs indgift.
English: Intravenous administration through a central venous line is strongly recommended (see sections 4.4 and 6.6).
Danish: Intravenøs administration gennem et centralt venekateter anbefales på det kraftigste (se pkt.
English: Yondelis is given to you under the supervision of a physician experienced in the use of chemotherapy.
Danish: Yondelis vil blive givet til Dem under overvågning af en læge, der har erfaring i brugen af kemoterapi.
English: Cases of Capillary Leak Syndrome (CLS) have been reported with trabectedin (including cases with fatal outcomes).
Danish: Der er blevet indberettet tilfælde af kapillærlækage-syndrom (Capillary Leak Syndrome - CLS) med trabectedin (herunder tilfælde med dødeligt udfald).
English: For the treatment of soft tissue sarcoma, the recommended dose is 1.5 mg/m2 body surface area, administered as an intravenous infusion over 24 hours with a three-week interval between cycles.
Danish: Til behandling af bløddelssarkom er den anbefalede dosis 1,5 mg/m2 legemsoverflade, indgivet som en intravenøs infusion over 24 timer med et interval på tre uger mellem cyklusserne.
English: The most common adverse reactions of any severity grade were neutropenia, nausea, vomiting, increase in AST/ALT, anaemia, fatigue, thrombocytopenia, anorexia and diarrhoea.
Danish: De mest almindelige bivirkninger af en eller anden sværhedsgrad var neutropeni, kvalme, opkastning, forhøjelser af ASAT/ALAT, anæmi, træthed, trombocytopeni, anoreksi og diaré.
English: 12 months PFS rate (95% CI) (%) Independent oncology review, all randomised n=336
Danish: 12 måneder PFS-rate (95 % CI) (%) 25,8 (19,7-32,3) Uafhængig onkologisk evaluering, alle randomiserede n=336
English: Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Danish: I kombination med pegyleret liposomal doxorubicin (PLD) er Yondelis indiceret til behandling af patienter med recidiverende platinsensitiv ovariecancer.
English: Duration of the response was 6.5 months No responses were observed for Ewing sarcoma and NRSTS, [RR: 0% CI95% (0%-30.9%)].
Danish: Der blev ikke observeret nogen respons for Ewings sarkom og NRSTS [RR: 0 % (95 % CI: 0 %-30,9 %)].
English: Caution should be taken if medicinal products associated with hepatotoxicity are administered concomitantly with trabectedin, since the risk of hepatotoxicity may be increased.
Danish: Der bør udvises forsigtighed, hvis lægemidler, der associeres med levertoksicitet, administreres samtidig med trabectedin, da risikoen for levertoksicitet kan være forøget.
English: Women of childbearing potential must use effective contraception during treatment and 3 months thereafter, and immediately inform the treating physician if a pregnancy occurs (see section 5.3).
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i yderligere 3 måneder derefter samt omgående informere den behandlende læge, dersom der forekommer graviditet (se pkt.
English: The patients received the trabectedin dose of 1.2 mg/m2 recommended for Japanese patients [1.2 mg/m2 once every 3 weeks (q3wk 24-h)].
Danish: Patienterne fik trabectedindosen på 1,2 mg/m2, der anbefales for japanske patienter [1,2 mg/m2 én gang hver 3. uge].
English: Renal toxicological findings were detected in multi-cycle toxicity studies conducted in monkeys.
Danish: Der blev påvist nyretoksiske fund i toksicitetsstudier med mange cyklusser, der blev udført med aber.
English: • You may notice unexplained partial or general swelling (oedema), with possible lightheadedness, dizziness or thirst (low blood pressure).
Danish: • De kan bemærke uforklarlige delvise eller generelle hævelser (ødem), eventuelt ledsaget af svimmelhed eller tørst (lavt blodtryk).
English: Therefore, the concomitant use of trabectedin with strong CYP3A4 inducers (e.g., rifampicin, phenobarbital, Saint John's Wort) should be avoided if possible (see section 4.4).
Danish: Derfor bør samtidig anvendelse af trabectedin og stærke CYP3A4-inducere (fx rifampicin, phenobarbital, perikon) om muligt undgås (se pkt.
English: Capillary Leak Syndrome (CLS): Cases of Capillary Leak Syndrome (CLS) have been reported with trabectedin (including cases with fatal outcomes) (see section 4.4).
Danish: Kapillærlækage-syndrom (CLS): Der er blevet indberettet tilfælde af kapillærlækage-syndrom (Capillary Leak Syndrome - CLS) med trabectedin (herunder tilfælde med dødeligt udfald) (se pkt.
English: The geometric mean dose normalized trabectedin exposure (AUC) increased by 97% (90% CI: 20%, 222%) in 6 patients with moderate hepatic impairment (increased serum bilirubin levels from 1.5 to 3 x ULN and increase of aminotransferases (AST or ALT) < 8 x ULN) following administration of a single trabectedin dose of 0.58 mg/m2 (n=3) or 0.9 mg/m2 (n=3) compared to 9 patients with normal liver function following administration of a single trabectedin dose of 1.3 mg/m2 (see sections 4.2 and 4.4).
Danish: Den geometriske normaliserede trabectedineksponering (AUC) ved middeldosis steg med 97 % (90 % CI: 20 %, 222 %) hos 6 patienter med moderat nedsat leverfunktion (forhøjede serumbilirubinniveauer fra 1,5 til 3 x ULN og stigning i aminotransferaser (ASAT eller ALAT) < 8 x ULN) efter administration af en enkelt trabectedindosis på 0,58 mg/m2 (n=3) eller 0,9 mg/m2 (n=3) sammenlignet med 9 patienter med normal leverfunktion efter administration af en enkelt trabectedindosis på 1,3 mg/m2 (se pkt.
English: If you have fever you should seek medical attention immediately.
Danish: Hvis De får feber, skal De omgående søge lægehjælp.
English: During postmarketing experience, hypersensitivity reactions with very rare occurrence of fatal outcome, have been reported in association with trabectedin administration either alone or in combination with PLD (see sections 4.3 and 4.8).
Danish: Efter markedsføring er der i meget sjældne tilfælde indberettet overfølsomhedsreaktioner med dødelig udgang i forbindelse med administration af trabedtedin, enten alene eller i kombination med PLD (se pkt.
English: Potassium hydroxide (for pH-adjustment)
Danish: Kaliumhydroxid (til pH-justering)
English: Phosphoric acid (for pH-adjustment)
Danish: Phosphorsyre (til pH-justering)
English: Nervous System Disorders
Danish: Psykiske forstyrrelser Insomni Nervesystemet
English: Yondelis must be reconstituted and further diluted prior to intravenous infusion.
Danish: Yondelis skal rekonstitueres og yderligere fortyndes inden intravenøs infusion.
English: Adequate contraceptive precautions must be used by women of childbearing potential when receiving Yondelis and for 3 months following the end of treatment.
Danish: Kvinder, der kan få børn, skal benytte sikker prævention, mens de får Yondelis og i 3 måneder efter behandlingens afslutning.
English: In patients with PFI ≥ 6 months (65% in Yondelis+PLD and 63% in PLD arm), median PFS was 9.7 months in the Yondelis+PLD arm compared with 7.2 months in the PLD monotherapy arm (HR=0.66, CI: 0.52-0.85).
Danish: Hos patienter med et PFI ≥ 6 måneder (65 % i Yondelis+PLD- og 63 % i PLD-armen) var den mediane PFS 9,7 måneder i Yondelis+PLD-armen sammenlignet med 7,2 måneder i PLD-monoterapiarmen (HR=0,66; CI: 0,52-0,85).
English: What you need to know before you are given Yondelis
Danish: Det skal De vide, før De begynder at få Yondelis
English: The final analysis showed no significant difference with a median survival follow-up of 21.2 months resulted in a median of 13.7 months (95% CI: 12.2, 16.0) for the trabectedin arm and 13.1 months [95% CI: 9.1, 16.2] for the dacarbazine arm.
Danish: Den endelige analyse viste ingen signifikant forskel med en median opfølgning på overlevelse på 21,2 måneder resulterende i en median på 13,7 måneder (95 % CI: 12,2, 16,0) for trabectedin-gruppen og 13,1 måneder (95 % CI: 9,1, 16,2) for dacarbazin-gruppen.
English: The use of any diluent other than 50 mg/ml (5%) glucose solution for infusion for this line flushing may cause precipitation of PLD (see also PLD Summary of Product Characteristics for specific handling instructions).
Danish: Brugen af et andet fortyndingsmiddel end 50 mg/ml (5 %) glucoseinfusionsvæske, opløsning, til denne gennemskylning af slangen kan forårsage udfældning af PLD (se også produktresuméet for PLD for specifikke anvisninger vedrørende håndteringen.)
English: • feel pain in your back and joints
Danish: • opleve åndedrætsbesvær og hoste få ondt i ryggen eller i leddene
English: Rare: may affect up to 1 in 1,000 people
Danish: Sjælden: kan forekomme hos op til 1 ud af 1.000 behandlede
English: This medicine contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially “potassium-free”.
Danish: Dette lægemiddel indeholder, mindre end 1 mmol (39 mg) kalium pr. hætteglas, d.v.s. det er i det væsentlige kaliumfrit.
English: Pol. Ind. La Mina 28770 Colmenar Viejo (Madrid) Spain
Danish: Pol. Ind. La Mina 28770 Colmenar Viejo (Madrid) Spanien
English: Anaemia:
Danish: Anæmi:
English: Close monitoring of toxicities is required in patients receiving trabectedin in combination with potent CYP3A4 inhibitors (e.g. oral ketoconazole, fluconazole, ritonavir, clarithromycin or aprepitant) and such combinations should be avoided if possible.
Danish: Tæt monitorering af toksiciteter er nødvendig hos patienter, der modtager trabectedin kombineret med potente CYP3A4-inhibitorer (fx oralt ketoconazol, fluconazol, ritonavir,
English: • You could also experience dizziness, low blood pressure and flushing or skin rash.
Danish: • De kan også blive svimmel, lavt blodtryk og anfaldsvis ansigtsrødme eller hududslæt.
English: Each carton contains 1 vial of either 0.25 mg or 1 mg of trabectedin.
Danish: Hvert karton indeholder 1 hætteglas med enten 0,25 mg eller 1 mg trabectedin.
English: Yondelis must not be given to patients who are breast-feeding.
Danish: Yondelis må ikke gives til patienter, der ammer.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/07/417/001
English: Patients should seek advice on ovules or sperm conservation prior to treatment because of the risk of irreversible infertility due to therapy with Yondelis.
Danish: Patienter bør søge råd vedrørende opbevaring af æg og sæd inden behandlingen på grund af risikoen for permanent ufrugtbarhed på grund af behandlingen med Yondelis.
English: Shake the vial until complete dissolution.
Danish: Ryst hætteglasset, indtil pulveret er helt opløst.
English: Overall, 384 patients were randomized to the trabectedin group [1.5 mg/m once every 3 weeks (q3wk 24-h)] and
Danish: I alt blev 384 patienter randomiseret til trabectedin-gruppen [1,5 mg/m2 én gang hver 3. uge (q3wk 24-h)] og 193 patienter til dacarbazingruppen (1 g/m2 én gang hver 3. uge).
English: Diluted solution After dilution, chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Danish: Fortyndetopløsning: Efter fortynding er der påvist kemisk og fysisk stabilitet i 30 timer op til 25 ºC.
English: The use of any diluent other than 50 mg/ml (5%) glucose solution for infusion may cause precipitation of PLD.
Danish: Brugen af et andet fortyndingsmiddel end 50 mg/ml (5 %) glucoseinfusionsvæske, opløsning, kan forårsage udfældning af PLD.
English: In-use stability of the solutions
Danish: Opløsningernes stabilitet under brug:
English: - If you have any further questions, ask your doctor.
Danish: - Spørg lægen, hvis der er mere, De vil vide.
English: Caution should be taken if medicinal products associated with rhabdomyolysis (e.g. statins), are administered concomitantly with trabectedin, since the risk of rhabdomyolysis may be increased
Danish: Der bør udvises forsigtighed, hvis lægemidler, der associeres med rabdomyolyse (f.eks. statiner), administreres samtidig med trabectedin, da risikoen for rabdomyolyse kan være forøget.
English: Reconstituted solution After reconstitution, chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Danish: Rekonstitueret opløsning: Efter rekonstitution er der påvist kemisk og fysisk stabilitet i 30 timer op til 25 ºC.
English: The study primary endpoint was PFS, that showed a statistically significant improvement in favour of trabectedin over BSC [HR=0.07; 95% CI: 0.03-0.16; p<0.0001], with a median PFS in the trabectedin group of 5.6 months [95% CI: 4.1-7.5] and in the BSC group of 0.9 months [95% CI: 0.7-1.0].
Danish: Studiets primære endepunkt var progressionsfri overlevelse (PFS), som viste en statistisk signifikant forbedring for trabectedin i forhold til BSC [HR=0,07; 95 % CI: 0,03-0,16; p<0,0001] med en median PFS i trabectedin-gruppen på 5,6 måneder [95 % CI: 4,1-7,5] og på 0,9 måneder i BSC-gruppen [95 % CI: 0,7-1,0].
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/417/002
English: • You may feel severe muscle aches and pain, stiffness and muscle weakness.
Danish: • De kan få svære muskelsmerter, stivhed og muskelsvækkelse.
English: Before Yondelis is given to you, it is reconstituted and diluted for intravenous use.
Danish: Inden De får indgivet Yondelis, bliver det opløst og fortyndet til intravenøs brug.
English: In the final analysis, the effect of the Yondelis+PLD combination vs. PLD alone on overall survival was more pronounced in patients with PFI ≥ 6 months (platinum-sensitive population: 27.0 vs. 24.1 months, HR=0.83, CI: 0.67-1.04) than in those with PFI < 6 months (platinum-resistant population: 14.2 vs. 12.4 months, HR=0.92, CI: 0.
Danish: I den endelige analyse var effekten af Yondelis+PLD-kombinationen vs. PLD alene på den samlede overlevelse mere udtalt hos patienter med et PFI ≥ 6 måneder (platinsensitiv population: 27,0 vs. 24,1 måneder: HR=0,83; CI: 0,67-1,04) end hos patienter med et PFI < 6 måneder (platinresistent population: 14,2 vs. 12,4 måneder: HR=0,92; CI: 0,70-1,21).
English: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 1mg of trabectedin.
Danish: Type I farveløst glashætteglas med butylgummiprop, dækket af en aluminium flip-off-forsegling, indeholdende 1 mg trabectedin.