FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with VcR-CAP in a clinical trial System Organ Class
Danish: Tabel 8: Bivirkninger hos patienter med mantle-celle-lymfom, som blev behandlet med VcR-CAP i et klinisk studie
English: There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma.
Danish: Der er ikke data, der tyder på, at dosisjustering er nødvendig hos patienter med myelomatose eller mantle-celle-lymfom, der er ældre end 65 år.
English: Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Danish: Mantel-Haenszel-estimat af den fælles oddsratio for stratificerede tabeller er benyttet, med IPI-risiko og sygdomsstadie som stratifkationsfaktorer.
English: Time to response CR+PR (days)
Danish: Tiden indtil respons CR + PR (dage)
English: VELCADE powder has to be dissolved before administration.
Danish: VELCADE pulver skal opløses, før det gives.
English: Janssen-Cilag B.V. Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: + 31 76 711 1111
Danish: Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: + 31 76 711 1111
English: Table 7: Adverse reactions in patients with Multiple Myeloma treated with VELCADE in clinical trials, and all post-marketing adverse reactions regardless of indication System Organ Class
Danish: Tabel 7: Bivirkninger hos patienter med myelomatose behandlet med VELCADE i kliniske studier samt alle bivirkninger efter markedsføring, uanset indikation Systemorganklasse Frekvens
English: Patients in the VcTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Danish: Patienter i henholdsvis VcTDx- og TDx-gruppen havde en gennemsnitsalder på 57 versus 56 år, 99 % versus 98 % af patienterne var kaukasere, og 58 % versus 54 % var mænd.
English: • Non-haematological toxicities should have resolved to Grade 1 or baseline.
Danish: • Ikke-hæmatologisk toksicitet skal være bedret til grad 1 eller baseline-niveau.
English: Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Danish: Hazard ratio-estimat er baseret på en Cox-model stratificeret efter IPI-risiko og sygdomsstadie.
English: You must read the package leaflets of all medicinal products to be taken in combination with VELCADE for information related to these medicines before starting treatment with VELCADE.
Danish: Læs indlægssedlerne for alle de lægemidler, som du skal tage sammen med VELCADE, for at få oplysninger om disse lægemidler, før du begynder på behandlingen med VELCADE.
English: Patients receiving VELCADE in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Danish: Patienter, der får VELCADE i kombination med thalidomid, skal overholde det særlige svangerskabsforebyggende program for thalidomid.
English: Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Danish: Absorption Efter intravenøs bolusindgift af en dosis på 1,0 mg/m2 og 1,3 mg/m2 til 11 patienter med myelomatose og kreatininclearance-værdier på mere end 50 ml/min., var de gennemsnitlige maksimale plasmakoncentrationer af bortezomib efter første dosis henholdsvis 57 og 112 ng/ml.
English: Patients were administered intravenous doses of 0.7 to 1.3 mg/m 2 of VELCADE twice weekly.
Danish: Patienterne fik administreret intravenøse doser VELCADE på 0,7 til 1,3 mg/m 2 to gange ugentlig.
English: • Bacterial and viral infections
Danish: • Bakterie- og virusinfektioner
English: For dose adjustments, see Table 5 below.
Danish: Se Tabel 5 nedenfor vedrørende dosisjusteringer.
English: VELCADE contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Danish: VELCADE indeholder det aktive stof bortezomib, som er en såkaldt proteasomhæmmer.
English: Neutrophils were lowest at Day 11 of each cycle of VELCADE treatment and typically recovered to baseline by the next cycle.
Danish: Neutrofiltal var lavest på dag 11 i hver cyklus af VELCADE-behandlingen og var typisk vendt tilbage til baseline-niveau ved næste cyklus.
English: • Hearing loss, deafness or ringing in the ears, ear discomfort
Danish: • Tab af hørelse, døvhed eller ringen for ørene, ubehag i ørerne
English: In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose.
Danish: Ved efterfølgende doser lå de gennemsnitlige maksimale observerede plasmakoncentrationer på 67-106 ng/ml for en dosis på 1,0 mg/m2 og på 89-120 ng/ml for en dosis på 1,3 mg/m
English: VELCADE intravenous arm
Danish: VELCADE intravenøs gruppe
English: VELCADE treatment must be withheld at the onset of any ≥ Grade 3 VELCADE-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section 4.4).
Danish: VELCADE-behandling skal indstilles ved forekomst af ≥ grad 3 VELCADE-relateret ikkehæmatologisk toksicitet (undtagen neuropati) eller ≥ grad 3 hæmatologisk toksicitet (se også pkt.
English: • to report any adverse event, or medication error experienced with the administration of VELCADE 3.5 mg.
Danish: • at eventuelle bivirkninger eller fejlmedicinering i forbindelse med administration af VELCADE 3,5 mg bør indberettes.
English: The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study.
Danish: Nadir for det gennemsnitlige trombocyttal var ca. 40 % af værdien ved baseline i myelomatose-studierne med monoterapi og 50 % i MCL-studiet.
English: Retreatment of patients with relapsed multiple myeloma In a study in which VELCADE retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a VELCADE-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Danish: Genbehandling af patienter med recidiverende myelomatose I et studie, hvor VELCADE-behandling blev gentaget hos 130 patienter med recidiverende myelomatose, som tidligere havde opnået mindst partielt respons med et regime, der omfattede VELCADE, var de hyppigste bivirkninger af alle grader, der indtraf hos mindst 25 % af patienterne, trombocytopeni (55 %), neuropati (40 %), anæmi (37 %), diaré (35 %) og obstipation (28 %).
English: A total of 74 evaluable patients were administered dexamethasone in combination with VELCADE.
Danish: I alt har 74 vurderbare patienter fået dexamethason sammen med VELCADE.
English: Median PFS by investigator assessment was 30.7 months in the VcR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Danish: Median for investigatorbedømt PFS var 30,7 måneder i VcR-CAP-gruppen og 16,1 måneder i R-CHOP-gruppen (Hazard ratio [HR] = 0,51; p < 0,001).
English: • Altered levels of consciousness, confusion, memory impairment or loss
Danish: • Forandringer i bevidsthedsniveau, forvirring, nedsat eller tab af hukommelse
English: Date of latest renewal: 10 January 2014
Danish: Dato for første markedsføringstilladelse: 21. april 2008 Dato for seneste fornyelse: 10. januar 2014
English: In the Phase III study patients who received VELCADE subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of VELCADE.
Danish: I fase III-studiet havde patienter, der fik VELCADE subkutant sammenlignet med som intravenøs administration, en 13 % lavere samlet forekomst af behandlingsrelaterede bivirkninger i form af toksicitet af grad 3 eller derover, og en 5 % lavere forekomst af seponering af behandling med VELCADE.
English: • Weight loss, loss of taste
Danish: • Vægttab, tab af smagssans
English: Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction
Danish: Sjælden Anafylaktisk shock, amyloidose, immunkompleks-medieret (type III) overfølsomhedsreaktion
English: Based on Log rank test stratified with IPI risk and stage of disease.
Danish: Baseret på log-rank-test stratificeret efter IPI-risiko og sygdomsstadie.
English: The resulting solution is then injected into a vein rapidly, over 3 to 5 seconds.
Danish: Opløsningen bliver derefter indsprøjtet i en vene over 3-5 sekunder.
English: • Multi-organ failure
Danish: • Svigt af flere organer
English: VELCADE must be reconstituted by a healthcare professional.
Danish: VELCADE skal rekonstitueres af sundhedspersonale.
English: VELCADE therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Danish: VELCADE-behandlingen skal indstilles, indtil symptomerne på toksiciteten er vurderet til grad 1 eller baseline.
English: Day 1, 2, 3, 4
Danish: Dag 1, 2, 3, 4
English: The incidence of herpes zoster among patients in the Vc+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Danish: Forekomsten af herpes zoster blandt patienter i Vc+M+P-behandlingsgruppen var 17 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3 % hos patienter, der havde fået antiviral profylakse.
English: Hazard ratio (95% CI) p-value Response rate population e n=668
Danish: (95 % CI) Hazard ratio (95 % CI) p-værdi Responsrate population e n = 668
English: • Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
Danish: • Infektioner, herunder urinvejsinfektioner, influenza, herpes virus infektioner, øreinfektion og cellulitis
English: Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Danish: Hepatitis B-virus (HBV)-reaktivering og -infektion
English: In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly.
Danish: Fra en uddybende effektanalyse rapporteredes en responsrate på 67,3 % (inklusive en CR-rate på 28,6 %) bestemt ud fra hæmatologisk respons (M-protein) hos 49 evaluerbare patienter, der fik de maksimale tilladte doser på 1,6 mg/m2 en gang ugentligt og
English: When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose-normalised bortezomib AUC.
Danish: Ved sammenligning med patienter med normal leverfunktion ændrede en let nedsættelse af leverfunktionen ikke bortezomibs AUC justeret i forhold til standarddosis.
English: In the Phase III study comparing VELCADE administered intravenously versus subcutaneously, the incidence of Grade  2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Danish: I fase III-studiet til sammenligning af VELCADE administreret intravenøst versus subkutant var forekomsten af hændelser med ≥ grad 2 perifer neuropati 24 % i gruppen, der fik subkutane injektioner, og 41 % i gruppen, der fik intravenøse injektioner (p = 0,0124).
English: The median TTP was 6.5 months for the VELCADE monotherapy patients compared with 9.3 months for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients.
Danish: Den gennemsnitlige TTP var 6,5 måned for patienter i monoterapi med VELCADE sammenlignet med 9,3 måneder for patienter i kombinationsbehandling med VELCADE plus pegyleret liposomal doxorubicin.
English: Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Danish: Thalidomid-dosis øges kun til 100 mg fra uge 3 i cyklus 1, hvis 50 mg tåles, og til 200 mg fra og med cyklus 2, hvis 100 mg tåles.
English: The following medicinal products are administered on day 1 of each VELCADE 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m 2, cyclophosphamide at 750 mg/m 2 and doxorubicin at 50 mg/m
Danish: Følgende lægemidler administreres som intravenøse infusioner på dag 1 i hver 3-ugers behandlingscyklus med VELCADE: rituximab 375 mg/m 2, cyclophosphamid 750 mg/m 2 og doxorubicin 50 mg/m
English: Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors.
Danish: Patienterne skal monitoreres omhyggeligt, når der gives bortezomib sammen med kraftige CYP3A4hæmmere.
English: The duration of overall response was 21.4 months longer in the VcR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Danish: Varigheden af det samlede respons var 21,4 måneder længere i VcR-CAP-gruppen (median 36,5 måneder kontra 15,1 måneder i R-CHOP-gruppen).
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
Danish: Demografiske og baseline-sygdomskarakteristika var generelt afbalanceret mellem de to behandlingsarme: Den mediane patientalder var 66 år, 74 % var mænd, 66 % var kaukasere og 32 % asiater, 69 % af patienterne havde et positivt knoglemarvsaspirat og/eller en positiv knoglemarvsbiopsi for MCL, 54 % af patienterne havde en IPI-score (International Prognostic Index) på ≥ 3, og 76 % var i sygdomsstadie IV. Behandlingens varighed (median = 17 uger) og varigheden af opfølgningen (median = 40 måneder) var sammenlignelige i de to behandlingsarme.
English: Day 29 rest period
Danish: dag 29 pause
English: Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Danish: Der er i sjældne tilfælde rapporteret mulige immunkompleksmedierede reaktioner, f.eks. serumsyge, polyarthritis med udslæt og proliferativ glomerulonefritis.
English: One hundred and twenty seven matched pairs of patients were identified.
Danish: Der blev identificeret ethundredeogsyvogtyve matchede par patienter.
English: Uncommon Hepatitis B, Infection*, Bronchopneumonia
Danish: Hepatitis B-infektion*, bronkopneumoni
English: CR+nCR+ PR+MR Median duration Days (months) Time to response CR+PR (days)
Danish: CR + nCR+ PR+MR Median varighed dage (måneder) Tiden indtil respons CR + PR (dage)
English: The incidence of herpes zoster among patients in the VcR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Danish: Forekomsten af herpes zoster blandt patienter i VcR-CAP-armen var 10,7 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3,6 % hos patienter, der havde fået antiviral profylakse (se pkt.
English: • Changes in or abnormal bowel function
Danish: • Forandringer i eller unormalt afføringsmønster
English: An odds ratio (OR) > 1 indicates an advantage for VcR-CAP.
Danish: En oddsratio (OR) > 1 angiver en fordel for VcR-CAP.
English: VELCADE might cause tiredness, dizziness, fainting, or blurred vision.
Danish: VELCADE kan forårsage træthed, svimmelhed, besvimelse og uklart/sløret syn.
English: When toxicity resolves re-initiate VELCADE treatment and reduce dose to 0.7 mg/m2 once per week.
Danish: Når toksiciteten er forsvundet, gives VELCADE igen, dosis reduceres til 0,7 mg/m2 en gang om ugen.
English: VELCADE must be reconstituted by a healthcare professional (see section 6.6).
Danish: VELCADE skal rekonstitueres af sundhedspersonale (se pkt.
English: Concomitant medicinal products
Danish: Samtidig behandling med andre lægemidler
English: • Bruises, falls and injuries
Danish: • Blodudtrædninger, fald og skader
English: • Ringing in the ears, ear discomfort
Danish: • Ringen for ørene, ubehag i ørerne
English: Instructions for reconstitution VELCADE must be reconstituted by a healthcare professional.
Danish: Instruktioner for rekonstitution VELCADE skal rekonstitueres af sundhedspersonale.
English: • Platelet counts should be ≥ 70 x 10
Danish: • Trombocyttal skal være ≥ 70 x 10
English: Therefore, you will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Danish: Du vil derfor få taget regelmæssige blodprøver før og under din behandling med VELCADE for at kontrollere niveauet af dine blodlegemer.
English: Confirm concentration on vial to ensure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Danish: Kontroller koncentrationen på hætteglasset for at sikre, at den korrekte dosis anvendes til intravenøs administration (1 mg/ml).
English: If you are given VELCADE for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure,
Danish: Hvis du får VELCADE for myelomatose eller mantle-celle-lymfom, skal du straks kontakte din læge, hvis du oplever nogle af nedenstående bivirkninger: - muskelkramper, muskelsvaghed - forvirring, synstab eller -forstyrrelser, blindhed, krampeanfald, hovedpiner - åndenød, hævede fødder eller ændringer i din hjerterytme, højt blodtryk, træthed, besvimelse - hoste og vejrtrækningsbesvær eller trykken for brystet.
English: Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Danish: Bemærkelsesværdige forskelle i MCL-patientpopulationen sammenlignet med patienter i myelomatose-studierne var en ≥ 5 % højere forekomst af hæmatologiske bivirkninger (neutropeni, trombocytopeni, leukopeni, anæmi, lymfopeni), perifer sensorisk neuropati, hypertension, pyreksi, pneumoni, stomatitis og hårsygdomme.
English: In patients developing PRES, VELCADE should be discontinued.
Danish: Hos patienter, der udvikler PRES, skal behandlingen med VELCADE seponeres.
English: Gastrointestinal and intracerebral haemorrhage, have been reported in association with VELCADE treatment.
Danish: Gastrointestinal og intracerebral blødning er blevet rapporteret i forbindelse med VELCADEbehandling.
English: In patients aged ≥ 75 years, both regimens, VcR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Danish: Patienter ≥ 75 år tolererede begge regimer dårligere, både VcR-CAP og R-CHOP (se pkt.
English: There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving VELCADE (see section 4.8).
Danish: Der er rapporteret sjældne tilfælde af akut diffus lungesygdom (infiltration) med ukendt ætiologi, f.eks. pneumonitis, interstitiel pneumoni, lungeinfiltration og ARDS (Acute Respiratory Distress Syndrome) hos patienter i VELCADE-behandling (se pkt.
English: The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the VELCADE monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients.
Danish: Median OS var 30,8 måneder (95 % CI: 25,2-36,5 måneder) for patienter i monoterapi med VELCADE og 33,0 måneder (95 % CI: 28,9-37,1 måneder) for patienter i kombinationsbehandling med VELCADE plus pegyleret liposomal doxorubicin.
English: The following medicinal products are given on day 1 of each VELCADE 21-day treatment cycle as intravenous infusions:
Danish: Følgende lægemidler gives som intravenøse infusioner på dag 1 i hver 21-ugers behandlingscyklus med VELCADE:
English: • Breakdown of muscle fibers leading to other complications
Danish: • Henfald af muskelfibre med følgetilstande
English: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m
Danish: Rituximab 375 mg/m2, cyclophosphamid 750 mg/m2 og doxorubicin 50 mg/m
English: Withhold VELCADE treatment until symptoms of toxicity have resolved.
Danish: VELCADE-behandlingen seponeres, indtil toksicitetssymptomerne er forsvundet.
English: b (95% CI)=0.63 (0.50; 0.79) p-value d < 0.001
Danish: HR b(95 % CI) = 0,63 (0,50; 0,79) p-værdi d < 0,001
English: • Benign cysts
Danish: • Godartede cyster
English: VELCADE combination treatment with dexamethasone In the absence of any direct comparison between VELCADE and VELCADE in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of VELCADE in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the VELCADE monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Danish: VELCADE-kombinationsbehandling med dexamethason Der blev på grund af mangel på en direkte sammenligning af VELCADE og VELCADE i kombination med dexamethason hos patienter med progressiv myelomatose, gennemført en statistisk "matchet par"-analyse for at sammenligne resultaterne fra den ikke-randomiserede arm med VELCADE i kombination med dexamethason (åbent fase II-studie MMY-2045) med resultaterne fra VELCADE-monoterapiarmene fra forskellige randomiserede fase III-studier (M34101-039 [APEX] og DOXIL MMY-3001) med samme indikation.
English: Dosage adjustments for transplant eligible patients For VELCADE dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Danish: Dosisjustering til transplantationsegnede patienter For justering af VELCADE-dosis: retningslinjerne for dosisændringer som beskrevet for monoterapi skal følges.
English: • Problems with your ear, bleeding from your ear
Danish: • Øreproblemer, blødning fra øre
English: OUTER CARTON, VELCADE 1 mg
Danish: YDRE KARTON, VELCADE 1 mg
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the VcR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Danish: Patienterne i begge behandlingsarme fik i gennemsnit 6 cyklusser, hvor 14 % af patienterne i VcR-CAP-armen og 17 % af patienterne i R-CHOP-armen fik 2 supplerende cyklusser.
English: Aseptic technique must be strictly observed throughout the handling of VELCADE, since it contains no preservative.
Danish: Det er yderst vigtigt, at der anvendes aseptisk teknik under håndteringen af VELCADE, da det ikke indeholder konserveringsmiddel.
English: • Inflammation of a vein, blood clots in your veins and lungs
Danish: • Betændelse i en vene, blodpropper i vener eller lunger
English: ≤ 0.75 x 10
Danish: ANC-værdien ≤ 0,75 x 10
English: A hazard ratio less than 1 indicates an advantage for VMP Nominal p-value based on the stratified log-rank test adjusted for stratification factors: 2-microglobulin, albumin, and region p-value for Response Rate (CR+PR) from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors
Danish: Et risikoforhold på mindre end 1 indikerer en fordel for VMP Nominel p-værdi baseret på den stratificerede log-rank-test justeret for stratifikationsfaktorer: 2-mikroglobulin, albumin og region p-værdi for responsrate (CR+PR) fra Cochran-Mantel-Haenszel chi-square-test justeret for stratifikationsfaktorer Responspopulation omfatter patienter, som havde målbar sygdom ved baseline CR = fuldstændigt respons; PR = partielt respons.