natgillin/translations-raw huggingface dataset:
Den mediane varighed af komplet respons var 42,1 måneder i VcR-CAP-gruppen sammenlignet med 18 måneder i R-CHOP-gruppen.
The median duration of complete response was 42.1 months in the VcR-CAP group compared with 18 months in the R-CHOP group.
Efter en intravenøs bolus- eller subkutan injektion af en dosis på 1,3 mg/m2 hos patienter med myelomatose (n = 14 i den intravenøse gruppe, n = 17 i den subkutane gruppe) sås samme totale systemiske eksponering efter gentagne doser (AUClast) for subkutan og intravenøs administration.
Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Vc = VELCADE; Dex = dexamethason CR = fuldstændigt respons; nCR = næsten fuldstændigt respons PR = partielt respons; MR = minimalt respons
Vc=VELCADE; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Denne interimanalyse viste en TTP-risikoreduktion på 45 % (95 % CI, 29-57 %, p < 0,0001) for patienter behandlet med kombinationsbehandlingen VELCADE og pegyleret liposomal doxorubicin.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of VELCADE and pegylated liposomal doxorubicin.
Udviklingstoksicitetsstudier på rotter og kaniner har vist embryo/fosterdødelighed ved maternelt toksiske doser, men ingen direkte embryo/fostertoksicitet ved ikke maternelt toksiske doser.
Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic doses, but no direct embryo-foetal toxicity below maternally toxic doses.
Der skal udvises forsigtighed, når bortezomib kombineres med CYP3A4- eller CYP2C19substrater (se pkt.
Caution should be exercised when bortezomib is combined with CYP3A4- or CYP2C19 substrates (see section 4.5).
Tabel 13: Effektresultater fra studie MMY-3010
Table 13: Efficacy results from study MMY-3010
• for at minde patienter, der modtager VELCADE sammen med thalidomid, om, at de skal overholde det svangerskabsforebyggende program for thalidomid, og med reference til produktresuméet for thalidomid for yderligere oplysninger.
• to remind that patients receiving VELCADE in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
Dosisjustering under behandlingen af patienter med tidligere ubehandlet mantle-celle-lymfom Før påbegyndelse af en ny behandlingscyklus:
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy:
Særligt skal du fortælle lægen, hvis du bruger medicin, som indeholder følgende aktive stoffer: - ketoconazol, som bruges til behandling af svampeinfektioner - ritonavir, bruges til behandling af Hiv-infektion - rifampicin, et antibiotikum, som bruges til at behandle bakterie-infektioner - carbamazepin, phenytoin eller phenobarbital til behandling af epilepsi - perikon (Hypericum perforatum), naturmedicin som bruges mod depression eller andre lidelser - tabletter til behandling af sukkersyge (diabetes)
In particular, tell your doctor if you are using medicines containing any of the following active substances: - ketoconazole, used to treat fungal infections ritonavir, used to treat HIV infection - rifampicin, an antibiotic used to treat bacterial infections - carbamazepine, phenytoin or phenobarbital used to treat epilepsy - St. John's Wort (Hypericum perforatum), used for depression or other conditions - oral antidiabetics
• et redskab til beregning af dosis, hvor den ordinerende læge kan indlæse patientens højde og vægt for ud fra disse at beregne arealet af legemsoverfladen og derved fastsætte en passende dosering af VELCADE.
• a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate VELCADE dose.
Et farmakokinetisk studie er foretaget hos patienter med varierende grad af nedsat nyrefunktion, som blev klassificeret i følgende grupper i henhold til deres kreatininclearance (CrCl): Normal (CrCl ≥ 60 ml/min/1,73 m2, n = 12), Mild (CrCl = 40-59 ml/min/1,73 m2, n = 10), Moderat
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate
Inkluderer alle CR + CRu, efter IRC, knoglemarv og LDH.
Include all CR+CRu, by IRC, bone marrow and LDH.
VELCADE-behandling skal tilbageholdes
VELCADE therapy should be withheld
Der skal udvises forsigtighed, ved behandling af patienter med tidligere synkope, der får lægemidler som er kendt for at være forbundet med hypotension, eller patienter som er dehydreret pga. tilbagevendende diaré eller opkastning.
Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting.
• Sprøjt opløsningen som en 3-5 sek. intravenøs bolusinjektion gennem et perifert eller centralt intravenøst kateter ind i en vene.
• Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
VELCADE-behandlingen skal indstilles, indtil symptomerne på toksicitet er bedret til grad 2 eller bedre.
VELCADE therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Seks VELCADE-cyklusser anbefales, men patienter med et respons, som først dokumenteres ved cyklus 6, kan gives yderligere to VELCADE-cyklusser.
Six VELCADE cycles are recommended, although for patients with a response first documented at cycle 6, two additional VELCADE cycles may be given.
Progressiv myelomatose
Progressive multiple myeloma
Det primære effektendepunkt var TTP, og det sekundære effektendepunkt var OS og ORR (CR+PR), hvor kriterierne fra The European Group for Blood and Marrow Transplantation (EBMT) blev brugt.
The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Tabel 10: Forekomst af perifer neuropati i studie LYM-3002 efter toksicitet og behandlingsseponering som følge af perifer neuropati VcR-CAP (N = 240)
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy VcR-CAP (N=240)
Logrank-test justeret for stratifikationsfaktorer: ISS-score og antal tidligere linjer.
Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Dexamethason blev administreret i kombination med VELCADE til 83 patienter i cyklus 1, mens yderligere 11 patienter fik dexamethason i løbet af efterfølgende VELCADE behandlingscyklusser.
Dexamethasone was administered in combination with VELCADE to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of VELCADE retreatment cycles.
Den mediane OS var 90,7 måneder for VcR-CAP-gruppen sammenlignet med 55,7 måneder for R-CHOP-gruppen (HR = 0,66; p = 0,001).
Median OS was 90.7 months for the VcR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
VELCADE 3,5 mg rekonstitueret opløsning indgives subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
VELCADE 3.5 mg reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
HÆTTEGLAS VELCADE 3,5 mg FLAG-LABEL
VIAL VELCADE 3.5 mg FLAG LABEL
Skift behandlingsplanen for VELCADE til 1,3 mg/m2 en gang om ugen
Change VELCADE treatment schedule to 1.3 mg/m2 once per week
p-værdi fra Cochran-Mantel-Haenszel chi-square-testen justeret for stratifikationsfaktorer; analyse ud fra behandling udelukker opdeling på tidligere behandling
p-value from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history
Patienterne havde IgG/IgA/lette kæder af myelomer i henholdsvis 63 %/25 %/8 % tilfælde, mediant hæmoglobin på 105 g/l og mediant trombocyttal på 221,5 x 10
Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 10
I fase III-studiet med hidtil ubehandlede myelomatosepatienter var den samlede forekomst af herpes zoster-reaktivering større hos patienter behandlet med VELCADE+melphalan+prednison sammenlignet med melphalan+prednison (14 % versus 4 %).
In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with VELCADE+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Progressionsfri overlevelse (IRC) Hændelser n (%)
Progression free survival (IRC) Events n (%)
• Graf over induktionstransplantationsregimer.
• Induction Transplant Regimens Graph.
Erythema multiforme, urticaria, akut febril neutrofil dermatose, toksisk huderuption, toksisk epidermal nekrolyse Stevens-Johnsons syndrom
Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis Stevens-Johnson syndrome
Hætteglas inden anbrud 3 år
Unopened vial 3 years
Melphalan og prednison bør begge gives oralt på dag 1, 2, 3 og 4 i den første uge af hver behandlingscyklus med VELCADE.
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each VELCADE treatment cycle.
På baggrund af det begrænsede bidrag (7 %) fra CYP2D6 til metaboliseringen af bortezomib, forventes det ikke, at CYP2D6-fænotypen som metaboliserer dårligt, påvirker den samlede disponering for bortezomib.
Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
• Besvær eller problemer med at sove, svedeture eller angst, humørsvingninger, nedsat humør,
• Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
• Gulfarvning af øjne og hud (gulsot)
• Yellow discolouration of eyes and skin (jaundice)
Fertilitet Der er ikke udført fertilitetsstudier med VELCADE (se pkt.
Fertility Fertility studies were not conducted with VELCADE (see section 5.3).
130 patienter (≥ 18 år) med myelomatose, som tidligere havde haft mindst partielt respons på et VELCADE holdigt regime, fik ny behandling ved progression.
One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a VELCADE-containing regimen were retreated upon progression.
I tilfælde af VELCADE-relateret neuropatisk smerte og/eller perifer neuropati indstilles og/eller modificeres VELCADE-behandlingen som beskrevet i tabel 1.
For VELCADE-related neuropathic pain and/or peripheral neuropathy, hold and/or modify VELCADE as outlined in Table 1.
Alder Bortezomibs farmakokinetik blev karakteriseret efter intravenøs bolus-administration af 1,3 mg/m2 to gange om ugen hos 104 pædiatriske patienter (2-16 år) med akut lymfoblastær leukæmi (ALL) eller akut myeloid leukæmi (AML).
The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 pediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
• symptomer på tumorlysesyndrom, som f.eks. muskelkramper, muskelsvaghed, forvirring,
• symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion,
De væsentligste effektresultater er præsenteret i Tabel 13.
Main efficacy results are presented in Table 13.
Et fase II-forsøg med en enkelt arm vedrørende aktivitet, sikkerhed og farmakokinetik udført af Children's Oncology Group vurderede virkningen af at tilføje bortezomib til reinduktionskemoterapi med flere stoffer hos pædiatriske og unge voksne patienter med lymfoid malignitet (akut præ-B-celle lymfoblastær leukæmi [ALL], T-celle ALL og T-celle lymfoblastært lymfom [LL]).
A Phase II, single-arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi-agent re-induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
Samlet overlevelse efter 1 år (%) (95 % CI)
1-year Overall Survival (%) (95% CI)
Resultater fra in vitro-, ex-vivo- og dyremodelforsøg med bortezomib tyder på, at bortezomib øger osteoblastdifferentieringen og -aktiviteten samt hæmmer osteoklastfunktionen.
Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
Tabel 8: Bivirkninger hos patienter med mantle-celle-lymfom, som blev behandlet med VcR-CAP i et klinisk studie
Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with VcR-CAP in a clinical trial System Organ Class
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.
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.
Mantel-Haenszel-estimat af den fælles oddsratio for stratificerede tabeller er benyttet, med IPI-risiko og sygdomsstadie som stratifkationsfaktorer.
Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Tiden indtil respons CR + PR (dage)
Time to response CR+PR (days)
VELCADE pulver skal opløses, før det gives.
VELCADE powder has to be dissolved before administration.
Tabel 7: Bivirkninger hos patienter med myelomatose behandlet med VELCADE i kliniske studier samt alle bivirkninger efter markedsføring, uanset indikation Systemorganklasse Frekvens
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
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.
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.
• Ikke-hæmatologisk toksicitet skal være bedret til grad 1 eller baseline-niveau.
• Non-haematological toxicities should have resolved to Grade 1 or baseline.
Hazard ratio-estimat er baseret på en Cox-model stratificeret efter IPI-risiko og sygdomsstadie.
Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
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.
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.
Patienter, der får VELCADE i kombination med thalidomid, skal overholde det særlige svangerskabsforebyggende program for thalidomid.
Patients receiving VELCADE in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
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.
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.
Patienterne fik administreret intravenøse doser VELCADE på 0,7 til 1,3 mg/m 2 to gange ugentlig.
Patients were administered intravenous doses of 0.7 to 1.3 mg/m 2 of VELCADE twice weekly.
• Bakterie- og virusinfektioner
• Bacterial and viral infections
Se Tabel 5 nedenfor vedrørende dosisjusteringer.
For dose adjustments, see Table 5 below.
VELCADE indeholder det aktive stof bortezomib, som er en såkaldt proteasomhæmmer.
VELCADE contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Neutrofiltal var lavest på dag 11 i hver cyklus af VELCADE-behandlingen og var typisk vendt tilbage til baseline-niveau ved næste cyklus.
Neutrophils were lowest at Day 11 of each cycle of VELCADE treatment and typically recovered to baseline by the next cycle.
• Tab af hørelse, døvhed eller ringen for ørene, ubehag i ørerne
• Hearing loss, deafness or ringing in the ears, ear discomfort
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
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.
VELCADE intravenøs gruppe
VELCADE intravenous arm
VELCADE-behandling skal indstilles ved forekomst af ≥ grad 3 VELCADE-relateret ikkehæmatologisk toksicitet (undtagen neuropati) eller ≥ grad 3 hæmatologisk toksicitet (se også pkt.
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).
• at eventuelle bivirkninger eller fejlmedicinering i forbindelse med administration af VELCADE 3,5 mg bør indberettes.
• to report any adverse event, or medication error experienced with the administration of VELCADE 3.5 mg.
Nadir for det gennemsnitlige trombocyttal var ca. 40 % af værdien ved baseline i myelomatose-studierne med monoterapi og 50 % i MCL-studiet.
The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study.
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 %).
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%).
I alt har 74 vurderbare patienter fået dexamethason sammen med VELCADE.
A total of 74 evaluable patients were administered dexamethasone in combination with VELCADE.
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).
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).
• Forandringer i bevidsthedsniveau, forvirring, nedsat eller tab af hukommelse
• Altered levels of consciousness, confusion, memory impairment or loss
Dato for første markedsføringstilladelse: 21. april 2008 Dato for seneste fornyelse: 10. januar 2014
Date of latest renewal: 10 January 2014
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.
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.
• Vægttab, tab af smagssans
• Weight loss, loss of taste
Sjælden Anafylaktisk shock, amyloidose, immunkompleks-medieret (type III) overfølsomhedsreaktion
Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction
Baseret på log-rank-test stratificeret efter IPI-risiko og sygdomsstadie.
Based on Log rank test stratified with IPI risk and stage of disease.
Opløsningen bliver derefter indsprøjtet i en vene over 3-5 sekunder.
The resulting solution is then injected into a vein rapidly, over 3 to 5 seconds.
• Svigt af flere organer
• Multi-organ failure
VELCADE skal rekonstitueres af sundhedspersonale.
VELCADE must be reconstituted by a healthcare professional.
VELCADE-behandlingen skal indstilles, indtil symptomerne på toksiciteten er vurderet til grad 1 eller baseline.
VELCADE therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Dag 1, 2, 3, 4
Day 1, 2, 3, 4
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.
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.
(95 % CI) Hazard ratio (95 % CI) p-værdi Responsrate population e n = 668
Hazard ratio (95% CI) p-value Response rate population e n=668
• Infektioner, herunder urinvejsinfektioner, influenza, herpes virus infektioner, øreinfektion og cellulitis
• Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
Hepatitis B-virus (HBV)-reaktivering og -infektion
Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
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
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.
Ved sammenligning med patienter med normal leverfunktion ændrede en let nedsættelse af leverfunktionen ikke bortezomibs AUC justeret i forhold til standarddosis.
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose-normalised bortezomib AUC.
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).
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).
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.
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.