FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af forsøg med referencelægemidlet, som indeholder bortezomib, i alle undergrupper af den pædiatriske population med myelomatose (se pkt.
English: • Reconstitution, dosing and administration booklet
Danish: • Hæfte om rekonstitution, dosering og administration
English: • Reconstitution poster
Danish: • Plakat om rekonstitution
English: This study included 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of bortezomib by either the subcutaneous or intravenous route for 8 cycles.
Danish: I dette forsøg deltog 222 patienter med recidiverende/refraktær myelomatose, der blev randomiseret i forholdet 2:1 til behandling med 1,3 mg/m2 bortezomib i 8 cyklusser, enten subkutant eller intravenøst.
English: The following medicinal products are given on day 1 of each bortezomib 21-day treatment cycle as intravenous infusions:
Danish: Følgende lægemidler gives som intravenøse infusioner på dag 1 i hver 21-ugers behandlingscyklus med bortezomib:
English: • advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
Danish: og s.c. anvendelse, herunder information om behovet for at skifte injektionssteder ved s.c. anvendelse
English: • Genital pain, problem having an erection
Danish: • Smerter i kønsorganerne, erektionsproblemer
English: Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*, C-reactive protein increased
Danish: Hyperbilirubinæmi*, unormale proteinanalyser*, vægtstigning, unormal blodprøve*, forhøjet C-reaktivt protein
English: Main efficacy results are presented in Table 13.
Danish: De væsentligste effektresultater ses i tabel 13.
English: The duration of overall response was 21.4 months longer in the BR-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 BRCAP-gruppen (medianværdi 36,5 måneder vs. 15,1 måneder i R-CHOP-gruppen).
English: In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Danish: I forsøg med patienter med recidiverende myelomatose, som blev behandlet med bortezomib, og med patienter med tidligere ubehandlet MCL, som blev behandlet med bortezomib i kombination med rituximab, cyclophosphamid, doxorubicin og prednison (BR-CAP), var en af de mest almindelige hæmatologiske bivirkninger forbigående thrombocytopeni.
English: performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Danish: I en multivariansanalyse var responsraten uafhængig af myelomtype, performance status, kromosom 13-deletionsstatus og antallet eller typen af tidligere behandlinger.
English: There was a trend towards prolonged overall survival favouring the BR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BR-CAP group.
Danish: Den estimerede 4-årige overlevelsesrate var 53,9% i R-CHOP-gruppen og 64,4% i BR-CAP-gruppen.
English: Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Danish: Sjælden Malign neoplasme, leukaemia plasmacytica, nyrecellekarcinom, masse, mycosis fungoides, benign neoplasme*
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4
Danish: Dag 1, 2, 3, 4 Dag 8, 9, 10, 11Cyklus 2 til 4
English: Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Danish: Neutrofiltallet var lavest på dag 11 i hver cyklus af behandling med bortezomib og var typisk vendt tilbage til baseline-niveau ved den næste cyklus.
English: Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
Danish: Patienter med tidligere behandlet let-kæde AL-amyloidose Der blev udført et åbent, ikke-randomiseret fase I/II-forsøg for at fastlægge bortezomibs sikkerhed og virkning hos patienter, der tidligere var blevet behandlet for AL-amyloidose.
English: Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Danish: Du må ikke køre bil, eller betjene værktøj eller maskiner, hvis du får sådanne bivirkninger.
English: Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.
Danish: Klinisk virkning hos tidligere ubehandlede myelomatosepatienter Et prospektivt, internationalt, randomiseret (1:1), åbent klinisk fase III-forsøg (MMY-3002 VISTA) med 682 patienter blev gennemført for at fastlægge, om bortezomib (1,3 mg/m som intravenøs injektion) i kombination med melphalan (9 mg/m 2) og prednison (60 mg/m 2) medførte en forbedring i tid indtil progression (TTP) sammenlignet med melphalan (9 mg/m2) og prednison (60 mg/m2) til patienter med tidligere ubehandlet myelomatose.
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 bortezomib (see section 4.8).
Danish: Der er indberettet sjældne tilfælde af akut diffus lungesygdom (infiltration) med ukendt ætiologi, for eksempel pneumonitis, interstitiel pneumoni, lungeinfiltration og ARDS (Acute Respiratory Distress Syndrome) hos patienter i behandling med bortezomib (se pkt.
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, anaemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Danish: MCL-patientpopulationen sammenlignet med patienter i myelomatose-forsøgene er en ≥ 5% højere forekomst af hæmatologiske bivirkninger (neutropeni, thrombocytopeni, leukopeni, anæmi, lymfopeni), perifer sensorisk neuropati, hypertension, pyreksi, pneumoni, stomatitis og hårsygdomme.
English: • Hearing loss, deafness or ringing in the ears, ear discomfort
Danish: • Høretab, døvhed eller ringen for ørerne, ubehag i ørerne
English: Overall survival* Events (deaths) n (%) Median a (95% CI)
Danish: Samlet overlevelse* Hændelser (dødsfald) n (%) Median a
English: The active substance is bortezomib.
Danish: Aktivt stof: bortezomib.
English: In the Phase III study patients who received bortezomib 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 bortezomib.
Danish: I fase III-forsøget havde patienter, der fik bortezomib subkutant sammenlignet med intravenøst indgivet, en 13% lavere samlet forekomst af bivirkninger i forbindelse med behandlingen i form af toksicitet grad 3 og en 5% lavere forekomst af seponering af behandling med bortezomib.
English: Refer to the Summary of Product Characteristics of rituximab for more information.
Danish: Der er yderligere oplysninger i produktresuméet for rituximab.
English: The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Danish: Den samlede forekomst af hepatitis B-infektioner var sammenlignelig hos patienter i BR-CAPgruppen og patienter i R-CHOP-gruppen (henholdsvis 0,8% vs. 1,2%).
English: • diarrhoea, constipation, nausea or vomiting
Danish: • diaré, forstoppelse, kvalme eller opkastning
English: • Arthritis, including inflammation of the joints in the fingers, toes, and the jaw
Danish: • Leddegigt, herunder betændelse i leddene i fingre, tæer og kæbe
English: The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Danish: Forsøgets primære effektendepunkt var responsraterne efter induktion og efter transplantation (CR+nCR).
English: The reconstituted solution should be used immediately after preparation.
Danish: Den rekonstituerede opløsning skal anvendes umiddelbart efter klargøring.
English: • Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
Danish: • Søvnbesvær eller søvnproblemer, svedeture, angst, humørsvingninger, nedtrykthed,
English: and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day bortezomib treatment cycle.
Danish: på dag 1 og prednison 100 mg/m2 oralt på dag 1 til og med dag 5 i bortezomib-behandlingscyklussens 21 dage.
English: Platelets were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Danish: Thrombocyttallet var lavest på dag 11 i hver cyklus af behandling med bortezomib og var typisk vendt tilbage til baseline-niveau ved den næste cyklus.
English: Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy
Danish: Tabel 9: Forekomsten af perifer neuropati ved induktionsbehandling, inddelt efter toksicitet og behandlingsseponering på grund af perifer neuropati
English: Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the Bortezomib Hospira treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib Hospira injection.
Danish: Pegyleret liposomal doxorubicin administreres i en dosis på 30 mg/m² på dag 4 af behandlingscyklussen med Bortezomib Hospira som en 1-times intravenøs infusion, der administreres efter injektionen af Bortezomib Hospira.
English: Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Toxicity
Danish: Tabel 5: Dosisjusteringer under behandlingen af patienter med tidligere ubehandlet mantle-cellelymfom
English: • Death
Danish: • Dødsfald
English: Bortezomib will be administered by a health care professional experienced in the use of cytotoxic medicines.
Danish: Bortezomib vil blive givet af sundhedspersonale, som har erfaring med anvendelse af cytostatika.
English: Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Danish: Der foreligger begrænsede oplysninger om genbehandling med bortezomib af recidiverende myelomatose.
English: • Redness and pain at injection site
Danish: • Rødmen og smerter på injektionsstedet
English: In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Danish: Fra forsøg, hvor bortezomib blev administreret som induktionsbehandling i kombination med dexamethason (forsøg IFM-2005-01) og dexamethason-thalidomid (forsøg MMY-3010), ses forekomsten af perifer neuropati ved kombinationsbehandlingerne i nedenstående tabel:
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Danish: I forsøget IFM-2005-01 blev bortezomib i kombination med dexamethason [BDx, n=240] sammenlignet med vincristin-doxorubicin-dexamethason [VDDx, n=242].
English: In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
Danish: I generelle toksicitetsforsøg med flere cyklusser med rotter og aber omfattede de vigtigste målorganer mave-tarm-kanalen (som gav opkastning og/eller diaré), hæmatopoietiske og lymfatiske væv (som gav perifere blodcytopenier), lymfoid vævsatrofi og hæmatopoietisk knoglemarvs-hypocellularitet, perifer neuropati (set hos aber, mus og hunde) som involverer sensoriske nerveaxoner og mindre forandringer i nyrerne.
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
Danish: Ved de efterfølgende doser var de gennemsnitlige maksimale plasmakoncentrationer, der blev observeret, inden for intervallet 67-106 ng/ml for dosis på 1,0 mg/m2 og 89-120 ng/ml for dosis på 1,3 mg/m2.
English: Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis Stevens-Johnson syndrome
Danish: Erythema multiforme, urticaria, akut febril neutrofil dermatose, toksisk huderuption, toksisk epidermal nekrolyse
English: Main efficacy results are presented in Table 12.
Danish: De væsentligste effektresultater ses i tabel 12.
English: You will have to take regular blood tests before and during your treatment with Bortezomib Hospira, to check your blood cell counts regularly.
Danish: Det er nødvendigt, at du får taget regelmæssige blodprøver før og under din behandling med Bortezomib Hospira for at kontrollere niveauet af dine blodlegemer.
English: Bortezomib is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Danish: Bortezomib gives intravenøst eller subkutant på dag 1, 4, 8 og 11, efterfulgt af en pause uden behandling.
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib Hospira treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Danish: Dosisjusteringer under behandling og reinitiering af behandlingen som monoterapi Behandling med Bortezomib Hospira skal afbrydes ved forekomst af enhver ikke-hæmatologisk toksicitet grad 3 eller enhver hæmatologisk toksicitet grad 4, bortset fra neuropati som beskrevet nedenfor (se også pkt.
English: Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Danish: Dexamethason gives i en dosis på 40 mg gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i den 28dages behandlingscyklus med bortezomib, og thalidomid gives dagligt gennem munden i en dosis på 50 mg frem til dag 14 i den første cyklus, og hvis du kan tåle thalidomiddosen, øges den til 100 mg på dag 15-28 og kan derefter øges igen til 200 mg dagligt fra og med den anden cyklus.
English: Pruritus*, Dermatitis*, Rash*
Danish: Kløe*, dermatitis*, udslæt*
English: In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Danish: Fra forsøget LYM-3002, hvor bortezomib blev administreret sammen med rituximab, cyclophosphamid, doxorubicin og prednison (R-CAP), ses forekomsten af perifer neuropati i kombinationsbehandlingerne i tabellen nedenfor:
English: When Bortezomib Hospira is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with Bortezomib Hospira.
Danish: Hvis Bortezomib Hospira gives i kombination med andre lægemidler, bør produktresuméerne for disse lægemidler gennemgås, inden behandling med Bortezomib Hospira initieres.
English: If you have not been treated before for mantle cell lymphoma, you will receive bortezomib intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Danish: Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få bortezomib intravenøst eller subkutant sammen med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison.
English: If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive bortezomib intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Danish: Hvis du ikke er blevet behandlet for myelomatose tidligere, og du er egnet til at få transplantation med blodstamceller, vil du få bortezomib intravenøst eller subkutant samtidig med lægemidlerne dexamethason, eller dexamethason og thalidomid, som induktionsbehandling.
English: Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Danish: Hyperbilirubinæmi*, unormale proteinanalyser*, vægttab, vægtstigning
English: What you need to know before you use Bortezomib Hospira
Danish: Det skal du vide, før du begynder at bruge Bortezomib Hospira
English: Bortezomib Hospira reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Bortezomib Hospira rekonstitueret opløsning administreres som en intravenøs bolusinjektion af 3-5 sekunders varighed gennem et perifert eller centralt intravenøst kateter efterfulgt af skylning med natriumchlorid 9 mg/ml (0,9%) injektionsvæske.
English: Note: Bortezomib Hospira is a cytotoxic agent.
Danish: Bemærk: Bortezomib Hospira er et cytotoksisk middel.
English: In addition, when Bortezomib Hospira is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics.
Danish: Når Bortezomib Hospira gives i kombination med andre cytostatika, bør passende dosisreduktion af disse præparater desuden overvejes i tilfælde af toksicitet og i overensstemmelse med anbefalingerne i de respektive produktresuméer.
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Danish: Hos patienter med MCL (forsøg LYM-3002) var der en højere forekomst (56,7% vs. 5,8%) af thrombocytopeni grad ≥ 3 i bortezomib-gruppen (BR-CAP) sammenlignet med non-bortezomibgruppen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison [R-CHOP]).
English: • Redness or pain at the injection site
Danish: • Rødmen eller smerter på injektionsstedet
English: For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Danish: 5.3 vedrørende prækliniske kardiovaskulære forsøg af sikkerhedsfarmakologien.
English: Type I glass 10 ml vial with a rubber stopper and an aluminium seal containing 2.5 mg, 3 mg or 3.5 mg bortezomib.
Danish: Hætteglas på 10 ml (type I-glas) med gummiprop og aluminiumsforsegling, der indeholder 2,5 mg, 3 mg eller 3,5 mg bortezomib.
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Danish: Hos patienter med MCL (forsøg LYM-3002) var forekomsten af herpes zoster-infektion 6,7% i BRCAP-gruppen og 1,2% i R-CHOP-gruppen (se pkt.
English: In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Danish: I forsøg MMY-3010 blev induktionsbehandling med bortezomib i kombination med thalidomid og dexamethason [BTDx, n=130] sammenlignet med thalidomid-dexamethason [TDx, n=127].
English: SC or IV use only.
Danish: Kun til s.c. eller i.v.
English: Bortezomib Hospira is for single use only.
Danish: Bortezomib Hospira er kun beregnet til engangsbrug.
English: If, despite these measures, pregnancy occurs, tell your doctor immediately.
Danish: Du skal straks kontakte lægen, hvis du på trods af dette alligevel bliver gravid.
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: β2-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: En hazard ratio på mindre end 1 indikerer en fordel for VMP Nominel p-værdi baseret på den stratificerede log-rank-test justeret for stratifikationsfaktorer: β2 -mikroglobulin, albumin og region d.
English: Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Danish: Perifer neuropati omfatter de foretrukne termer: perifer sensorisk neuropati, perifer neuropati, perifer motorisk neuropati og perifer sensomotorisk neuropati
English: Fertility Fertility studies were not conducted with Bortezomib Hospira (see section 5.3).
Danish: Fertilitet Der er ikke udført fertilitetsforsøg med Bortezomib Hospira (se pkt.
English: • Wasting, or loss of body mass
Danish: • Afmagring eller tab af kropsmasse
English: OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p values by Cochran Mantel-Haenszel test.
Danish: OR for responsrater baseret på Mantel-Haenszel-estimat af den fælles odds ratio for stratificerede tabeller;
English: During clinical trials, hypoglycaemia and hyperglycaemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycaemics.
Danish: Der er i kliniske forsøg indberettet hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale antidiabetika.
English: Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Danish: Til bekræftelse af PRESdiagnosen anvendes billeddiagnostik af hjernen, fortrinsvis magnetisk resonans (MR).
English: Hepatitis B Virus (HBV) reactivation and infection
Danish: Reaktivering og infektion af hepatitis B-virus (HBV) Mantle-celle-lymfom
English: 1.3 The reconstituted solution is preservative free and should be used immediately after preparation.
Danish: 1.3 Den rekonstituerede opløsning indeholder ingen konserveringsmidler og skal anvendes umiddelbart efter klargøring.
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP).
Danish: HBV-infektion med fatale udfald forekom hos 0,8% (n=2) af patienterne i non-bortezomib-gruppen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison; R-CHOP) og hos 0,4% (n=1) af patienterne i gruppen på bortezomib plus rituximab, cyclophosphamid, doxorubicin og prednison (BRCAP).
English: > 1.0 x -1.5 x ULN Any
Danish: > 1,0 x -1,5 x ULN Vilkårligt