FrancophonIA/ELRC3.0 huggingface dataset:
English: BTK's pivotal role in signalling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis and adhesion.
Danish: BTK's pivotale rolle i signalering gennem B-cellers overfladereceptorer resulterer i aktivering af de signalveje, der er nødvendige for Bcelletransport, kemotaksi og adhæsion.
English: The median time since diagnosis was 52.6 months (treatment-naïve patients=6.5 months and previously treated patients=94.3 months).
Danish: Mediantiden siden diagnose var 52,6 måneder (behandlingsnaive patienter = 6,5 måneder og tidligere behandlede patienter = 94,3 måneder).
English: Do not take IMBRUVICA
Danish: Tag ikke IMBRUVICA
English: Per IRC.
Danish: IRC.
English: In patients at high risk and where alternatives to IMBRUVICA are non-suitable, tightly controlled treatment with anticoagulants should be considered.
Danish: Hos patienter med høj risiko, og hvor alternativer til IMBRUVICA er uegnede, skal en nøje kontrolleret behandling med antikoagulantia overvejes.
English: Very common Arthralgia Muscle spasms Musculoskeletal pain
Danish: Meget almindelig Artralgi Muskelspasmer Muskuloskeletale smerter*
English: Patients treated for MCL in clinical studies received IMBRUVICA at 560 mg once daily and patients treated for CLL or WM in clinical studies received IMBRUVICA at 420 mg once daily.
Danish: Patienter, som blev behandlet for MCL i kliniske studier, fik IMBRUVICA i en dosis på 560 mg en gang dagligt, og patienter, som blev behandlet for CLL eller WM i kliniske studier, fik IMBRUVICA i en dosis på 420 mg en gang dagligt.
English: IMBRUVICA contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: IMBRUVICA indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.
English: The BCR pathway is implicated in the pathogenesis of several B-cell malignancies, including MCL, diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, and CLL.
Danish: BCR-signalvejen er involveret i patogenesen for adskillige B-cellesygdomme, herunder MCL, diffust storcellet B-cellelymfom (DLBCL), follikulært lymfom og CLL.
English: Total N=111
Danish: I alt N = 111
English: No human data on the effects of ibrutinib on fertility are available.
Danish: Der foreligger ingen data om ibrutinibs indvirkning på fertiliteten hos mennesker.
English: Bulky disease <5 cm
Danish: Omfattende sygdom < 5 cm
English: • non-melanoma skin cancer, most frequently squamous cell and basal cell skin cancer
Danish: • non-melanom hudkræft, oftest pladecellekarcinom og basalcellekarcinom
English: To minimise the potential for an interaction in the GI tract, oral narrow therapeutic range, P-gp or BCRP substrates such as digoxin or methotrexate should be taken at least 6 hours before or after IMBRUVICA.
Danish: For at minimere potentialet for interaktion i mavetarm-kanalen skal orale P-gp- og BCRP-substrater med et smalt terapeutisk område, såsom digoxin eller methotrexat, indtages mindst 6 timer før eller efter IMBRUVICA.
English: The median OS was 67.7 months [95% CI (61.0, not estimable)] in the IMBRUVICA arm.
Danish: Den mediane OS var 67,7 måneder [95 % CI (61,0; kan ikke estimeres) i IMBRUVICA-gruppen.
English: These include minor bleeding events such as contusion, epistaxis, and petechiae; and major bleeding events, some fatal, including gastrointestinal bleeding, intracranial haemorrhage, and haematuria.
Danish: Disse omfatter mindre blødningshændelser såsom kontusion, epistaxis og petekkier, og større blødningshændelser, nogle med dødelig udgang, herunder gastrointestinal blødning, intrakraniel blødning og hæmaturi.
English: • inflammation of the fatty tissue underneath the skin
Danish: • betændelse i fedtvævet under huden
English: Based on in vitro data, ibrutinib is a weak CYP2B6 inducer and may have the potential to affect the expression of other enzymes and transporters regulated via the constitutive androstane receptor (CAR), e.g. CYP2C9, CYP2C19, UGT1A1 and MRP2.
Danish: Baseret på in vitro-data er ibrutinib en svag CYP2B6-induktor og kan potentielt påvirke ekspressionen af andre enzymer og transportører, der reguleres via den konstitutive androstanreceptor (CAR), f.eks. CYP2C9, CYP2C19, UGT1A1 og MRP2.
English: Ibrutinib is a potent, small-molecule inhibitor of Bruton's tyrosine kinase (BTK).
Danish: Ibrutinib er en potent, småmolekylær hæmmer af Brutons tyrosinkinase (BTK).
English: If you forget to take IMBRUVICA
Danish: Hvis du har glemt at tage IMBRUVICA
English: In vitro studies indicated that ibrutinib is a weak reversible inhibitor toward CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and intestinal (but not hepatic) CYP3A4 and does not display clinically relevant time-dependent inhibition of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP2D6.
Danish: In vitro-studier indikerede, at ibrutinib er en svag, reversibel hæmmer af CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og intestinal (men ikke hepatisk) CYP3A4 og ikke udviser nogen klinisk relevant tidsafhængig hæmning af CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP2D6.
English: There have been reports of bleeding events in patients treated with IMBRUVICA, both with and without thrombocytopenia.
Danish: Der er indberettet blødningshændelser hos patienter i behandling med IMBRUVICA, både med og uden trombocytopeni.
English: The dihydrodiol metabolite is at most a weak inducer of CYP450 isoenzymes in vitro.
Danish: Dihydrodiol-metabolitten er højst en svag induktor af CYP-isoenzymer in vitro.
English: The most common grade 3/4 adverse reactions (≥5%) were neutropenia, pneumonia, and thrombocytopenia.
Danish: De hyppigste grad 3/4-bivirkninger (≥ 5 %) var neutropeni, pneumoni og trombocytopeni.
English: Toxicity occurrence
Danish: Forekomst af toksicitet
English: Periodically monitor all patients clinically for cardiac arrhythmia.
Danish: Alle patienter skal jævnligt monitoreres klinisk for kardiel arytmi.
English: Grapefruit and Seville oranges should be avoided during IMBRUVICA treatment, as these contain moderate inhibitors of CYP3A4 (see section 4.2).
Danish: Grapefrugt og pomeranser skal undgås under behandling med IMBRUVICA, da disse indeholder moderate CYP3A4hæmmere (se pkt.
English: At baseline, 56% of patients had at least one tumour ≥5 cm, 26% had del11q.
Danish: Ved baseline havde 56 % af patienterne mindst én tumor ≥ 5 cm, og 26 % havde del11q.
English: Agents that may have their plasma concentrations altered by ibrutinib Ibrutinib is a P-gp and breast cancer resistance protein (BCRP) inhibitor in vitro.
Danish: Stoffer hvis koncentration i plasma kan ændres af ibrutinib Ibrutinib er en hæmmer af P-gp og brystcancerresistensprotein (BCRP) in vitro.
English: Based on in vitro data, ibrutinib is a weak reversible inhibitor towards CYP3A4 at the intestinal level and may therefore increase the exposure to CYP3A4 substrates sensitive to gut CYP3A metabolism.
Danish: Baseret på in vitro-data er ibrutinib en svag, reversibel hæmmer af intestinal CYP3A4 og kan derfor øge eksponeringen af CYP3A4-substrater, der er følsomme for CYP3A-metabolisme i tarmen.
English: Patients randomised to ofatumumab were censored when starting IMBRUVICA if applicable.
Danish: Patienter, der blev randomiseret til ofatumumab, blev censureret ved start på IMBRUVICA, hvis relevant.
English: On the contrary, co-administration of CYP3A4 inducers may lead to decreased IMBRUVICA exposure and consequently a risk for lack of efficacy.
Danish: I modsætning hertil kan co-administration af CYP3A4-induktorer medføre formindsket IMBRUVICA-eksponering med deraf følgende risiko for manglende effekt.
English: • Take the capsules orally (by mouth) with a glass of water.
Danish: • Kapslerne skal indtages gennem munden (oralt) sammen med et glas vand.
English: Caution should be exercised if co-administering ibrutinib with CYP3A4 substrates administered orally with narrow therapeutic range (such as dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus and tacrolimus).
Danish: Der skal udvises forsigtighed, hvis ibrutinib administreres sammen med oralt administrerede CYP3A4-substrater med et smalt terapeutisk område (som f.eks. dihydroergotamin, ergotamin, fentanyl, ciclosporin, sirolimus og tacrolimus).
English: If the toxicity reoccurs, the once daily dose should be reduced by one capsule (140 mg).
Danish: Hvis toksiciteten forekommer igen, skal dosis en gang dagligt reduceres med én kapsel (140 mg).
English: Avoid concomitant use of strong or moderate CYP3A4 inducers (e.g., carbamazepine, rifampicin, phenytoin).
Danish: Undgå samtidig brug af potente eller moderate CYP3A4-induktorer (f.eks. carbamazepin, rifampicin, phenytoin).
English: Febrile neutropenia Leukocytosis Lymphocytosis
Danish: Febril neutropeni Leukocytose Lymfocytose
English: Bleeding-related events
Danish: Blødningsrelaterede hændelser
English: • Swallow the capsules whole.
Danish: • Kapslerne skal synkes hele.
English: In patients with baseline cytopenias, sustained hematologic improvement was: platelets 77.1% versus 42.9%; haemoglobin 84.3% versus 45.5% for ibrutinib and chlorambucil respectively.
Danish: Hos patienter med cytopenier ved baseline var den hæmatologiske forbedring: blodplader 77,1 % kontra 42,9 %, hæmoglobin 84,3 % kontra 45,5 % for hhv. ibrutinib og chlorambucil.
English: If patients have positive hepatitis B serology, a liver disease expert should be consulted before the start of treatment and the patient should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Danish: For patienter, der testes positive for HBV-infektion, anbefales det at konsultere en læge med erfaring i behandlingen af hepatitis B. Hvis patienten har positiv hepatitis B-serologi, bør en ekspert i leversygdomme konsulteres før påbegyndelse af behandling, og patienten skal monitoreres og behandles i henhold til lokale medicinske standarder for at forebygge hepatitis B-reaktivering.
English: In an in vitro study, ibrutinib demonstrated inhibition of collagen-induced platelet aggregation.
Danish: I et in vitro-studie udviste ibrutinib hæmning af collageninduceret blodpladeaggregation.
English: Cases of progressive multifocal leukoencephalopathy (PML) including fatal ones have been reported following the use of ibrutinib within the context of a prior or concomitant immunosuppressive therapy.
Danish: Der er rapporteret tilfælde af progressiv multifokal leukoencefalopati (PML), heraf nogle med dødelig udgang, ved anvendelse af ibrutinib i forbindelse med forudgående eller samtidig immunsuppressiv behandling.
English: Tell your doctor immediately if you notice or someone notices in you: sudden numbness or weakness in the limbs (especially on one side of the body), sudden confusion, trouble speaking or understanding speech, sight loss, difficulty walking, loss of balance or lack of coordination, sudden severe headache with no known cause.
Danish: Kontakt straks lægen, hvis du oplever følgende (eller hvis en anden person bemærker følgende hos dig): pludselig følelsesløshed eller svaghed i arme og ben (navnlig i den ene side af kroppen), pludselig forvirring, tale- eller forståelsesbesvær, synstab, gangbesvær, tab af balance- eller koordinationsevnen, pludselig svær hovedpine uden kendt årsag.
English: No specific clinical studies have been conducted in patients with renal impairment.
Danish: Der er ikke udført specifikke kliniske studier hos patienter med nedsat nyrefunktion.
English: • Take the tablets orally (by mouth) with a glass of water.
Danish: • Tabletterne skal tages gennem munden (oralt) sammen med et glas vand.
English: The median age was 67 years (range, 47 to 90 years).
Danish: Medianalderen var 67 år (interval: 47 til 90 år).
English: The dihydrodiol metabolite of ibrutinib is a weak inhibitor toward CYP2B6, CYP2C8, CYP2C9, and CYP2D6.
Danish: Ibrutinibs dihydrodiol-metabolit er en svag hæmmer af CYP2B6, CYP2C8, CYP2C9 og CYP2D6.
English: Use as directed by your physician.
Danish: Anvend efter lægens anvisninger.
English: The study enrolled patients who were 65 years of age or older or <65 years of age with coexisting medical conditions, reduced renal function as measured by creatinine clearance <70 mL/min, or presence of del17p/TP53 mutation.
Danish: Studiet inkluderede patienter i alderen 65 år eller derover eller < 65 år med samtidige medicinske tilstande, reduceret nyrefunktion, målt ud fra en kreatininclearance på < 70 ml/min eller med del17p/TP53-mutation.
English: • allergic reaction, sometimes severe, that may include a swollen face, lip, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives)
Danish: • allergisk reaktion, der til tider kan være alvorlig, og som kan omfatte hævelser af ansigtet, læberne, munden, tungen eller halsen, synke- eller vejrtrækningsbesvær, kløende udslæt (nældefeber)
English: Latency from the initiation of treatment with ibrutinib to the onset of ischaemic central nervous vascular conditions was in the most cases after several months (more than 1 month in 78% and more than 6 months in 44% of cases) emphasising the need for regular monitoring of patients (please see section 4.4 Cardiac arrhythmia and Hypertension and section 4.8).
Danish: Latenstiden fra påbegyndelse af behandling med ibrutinib til forekomst af iskæmiske vaskulære tilstande i centralnervesystemet var i de fleste tilfælde flere måneder (over 1 måned i 78 % af tilfældene og over 6 måneder i 44 % af tilfældene), hvilket understreger behovet for regelmæssig monitorering af patienterne (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with IMBRUVICA in all subsets of the paediatric population in MCL, CLL and lymphoplasmacytic lymphoma (LPL) (for information on paediatric use, see section 4.2).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med IMBRUVICA i alle undergrupper af den pædiatriske population med MCL, CLL og lymfoplasmacytisk lymfom (LPL) (se pkt.
English: Cases of hepatitis B reactivation have been reported in patients receiving IMBRUVICA.
Danish: Der foreligger rapporter om tilfælde af hepatitis B-reaktivering hos patienter, der får IMBRUVICA.
English: The effect of impaired liver function varied substantially between individuals, but on average a 2.7-, 8.2-, and 9.8-fold increase in ibrutinib exposure (AUClast) was observed in subjects with mild (n=6, Child-Pugh class A), moderate (n=10, Child-Pugh class B) and severe (n=8, Child-Pugh class C) hepatic impairment, respectively.
Danish: Effekten af nedsat leverfunktion varierede betydeligt fra person til person, men i gennemsnit sås der en stigning på 2,7, 8,2 og 9,8 gange i eksponeringen for ibrutinib (AUClast) hos forsøgspersoner med hhv. let (n = 6, Child-Pugh klasse A), moderat (n = 10, Child-Pugh klasse B) og svært (n = 8, Child-Pugh klasse C) nedsat leverfunktion.
English: Preparations containing St. John's Wort are contraindicated during treatment with IMBRUVICA, as efficacy may be reduced.
Danish: Præparater, som indeholder perikon, er kontraindiceret under behandling med IMBRUVICA, da effekten kan blive reduceret.
English: IRC evaluated.
Danish: IRC-vurderet.
English: White opaque, hard capsule of 22 mm in length, marked with “ibr 140 mg” in black ink.
Danish: Hvid uigennemsigtig, hård kapsel, 22 mm lang, mærket med “ibr 140 mg” med sort farve.
English: Cases of atrial fibrillation and atrial flutter have been reported particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation.
Danish: Tilfælde af atrieflimren og atrieflagren er især rapporteret hos patienter med kardielle risikofaktorer, hypertension, akutte infektioner samt anamnese med atrieflimren.
English: Stop taking IMBRUVICA and tell a doctor straight away if you notice any of the following side effects: itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat - you may be having an allergic reaction to the medicine.
Danish: Hold op med at tage IMBRUVICA, og fortæl det til en læge med det samme, hvis du oplever nogen af følgende bivirkninger: kløende udslæt med knopper, åndedrætsbesvær, opsvulmen af ansigtet, læberne, tungen eller svælgetder kan være tale om en allergisk reaktion på lægemidlet.
English: The response rate per IRC observed in the monotherapy arm was 71% (0% CR, 29% VGPR, 42% PR).
Danish: Responsraten, der ifølge IRC blev observeret i monoterapigruppen, var 71 % (0 % CR, 29 % VGPR, 42 % PR).
English: Severe cardiac disease Patients with severe cardiovascular disease were excluded from IMBRUVICA clinical studies.
Danish: Patienter med alvorlig kardiovaskulær sygdom blev ekskluderet fra kliniske studier med IMBRUVICA.
English: • Waldenström's macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes.
Danish: • Waldenströms makroglobulinæmi (WM), en kræftform, der påvirker den type hvide blodlegemer, der kaldes lymfocytter.
English: IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
Danish: IMBRUVICA som monoterapi er indiceret til behandling af voksne patienter med Waldenströms makroglobulinæmi (WM), som har fået mindst én tidligere behandling, eller som førstelinjebehandling til patienter, for hvem kemo-immunterapi ikke er egnet.
English: • painful arms or legs
Danish: • smerter i arme eller ben
English: IMBRUVICA was administered until disease progression or unacceptable toxicity.
Danish: IMBRUVICA blev administreret indtil sygdomsprogression eller uacceptabel toksicitet.
English: Fifty-seven patients randomised to ofatumumab crossed over following progression to receive IMBRUVICA.
Danish: 57 patienter, der var randomiseret til ofatumumab, skiftede efter progression til IMBRUVICA.
English: • medicines called calcium channel blockers for high blood pressure or chest pain - diltiazem or verapamil
Danish: • medicin kaldet calciumantagonister mod for højt blodtryk eller smerter i brystet - diltiazem eller verapamil
English: The median duration of treatment for CLL/SLL was 51 months (range, 0.2 to 98 months) with 70% and 52% of patients receiving treatment for more than 2 years and 4 years, respectively.
Danish: Medianvarigheden af behandlingen af CLL/SLL var 51 måneder (interval 0,2 til 98 måneder), hvor henholdsvis 70 % og 52 % af patienterne modtog behandling i mere end 2 år og 4 år.
English: Ibrutinib is an in vitro inhibitor of P-gp and BCRP (see section 4.5).
Danish: Ibrutinib er en in vitro hæmmer af P-gp og BCRP (se pkt.
English: Efficacy results for Study MCL3001 are shown in Table 3 and the Kaplan-Meier curve for PFS in Figure 1.
Danish: Effektresultater for studie MCL3001 er vist i tabel 3 og Kaplan-Meier-kurver for PFS i figur 1.
English: Cases of cerebrovascular accident, transient ischaemic attack and ischaemic stroke including fatalities have been reported with the use of ibrutinib, with and without concomitant atrial fibrillation and/or hypertension.
Danish: Der er rapporteret om cerebrovaskulære hændelser, transitoriske iskæmiske attakker og iskæmiske slagtilfælde, herunder med dødelig udgang, ved anvendelse af ibrutinib, med og uden samtidig atrieflimren og/eller hypertension.
English: IMBRUVICA with food
Danish: Brug af IMBRUVICA sammen med mad
English: In patients who develop atrial fibrillation on therapy with IMBRUVICA a thorough assessment of the risk for thromboembolic disease should be undertaken.
Danish: Hos patienter, som udvikler atrieflimren ved behandling med IMBRUVICA, skal der foretages en omhyggelig vurdering af risikoen for tromboembolisk sygdom.
English: Responses to IMBRUVICA are shown in Table 2.
Danish: Respons på IMBRUVICA er vist i tabel 2.
English: Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each.
Danish: Hver karton til 30 dage indeholder 30 filmovertrukne tabletter i 3 paphylstre med 10 filmovertrukne tabletter i hvert.
English: Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each.
Danish: Hver karton til 28 dage indeholder 28 filmovertrukne tabletter i 2 paphylstre med 14 filmovertrukne tabletter i hvert.
English: These may be signs and symptoms of stroke.
Danish: Disse symptomer kan være tegn på et slagtilfælde.
English: The overall response rate per IRC observed in the monotherapy arm was 87% (0% CR, 29% VGPR, 42% PR, 16% MR).
Danish: Den samlede responsrate observeret ifølge IRC i monoterapigruppen var 87 % (0 % CR, 29 % VGPR, 42 % PR, 16 % MR).
English: Patients with CLL who received at least one prior therapy Single agent
Danish: Patienter med CLL, som tidligere havde fået mindst en behandling Monoterapi
English: Ibrutinib was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse at oral doses up to 2000 mg/kg/day with an exposure margin of approximately 23 (males) to 37 (females) times the human AUC of ibrutinib at a dose of 560 mg daily.
Danish: Ibrutinib var ikke karcinogent i et 6-måneders studie af transgene mus (Tg.rasH2) ved orale doser på op til 2000 mg/kg/dag med en eksponeringsmargin på ca. 23 (hanner) til 37 (hunner) gange human AUC for ibrutinib ved en dosis på 560 mg dagligt.
English: Women of child-bearing potential/Contraception in females Based on findings in animals, IMBRUVICA may cause foetal harm when administered to pregnant women.
Danish: Baseret på fund i dyreforsøg kan IMBRUVICA medføre fosterskader, hvis det administreres til gravide kvinder.
English: Study PCYC-1127-CA had a separate monotherapy arm of 31 patients with previously treated WM who failed prior rituximab-containing therapy and received single agent IMBRUVICA.
Danish: PCYC-1127-CA-studiet havde en separat monoterapigruppe med 31 patienter med tidligere behandlet WM, som ikke havde responderet på tidligere rituximab-indeholdende behandling og fik monoterapi med IMBRUVICA.
English: • medicines for fungal infections - posaconazole, ketoconazole, itraconazole, fluconazole or voriconazole
Danish: • medicin mod svampeinfektioner - posaconazol, ketoconazol, itraconazol, fluconazol eller voriconazol
English: Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA.
Danish: Der skal tages højde for risici og fordele ved behandlingen med antikoagulantia eller trombocytfunktionshæmmende midler, når disse administreres sammen med IMBRUVICA.
English: A randomised, multicenter, open-label phase 3 study (PCYC-1115-CA) of IMBRUVICA versus chlorambucil was conducted in patients with treatment-naïve CLL who were 65 years of age or older.
Danish: Et randomiseret, åbent fase 3-multicenterstudie (PCYC-1115-CA) med IMBRUVICA kontra chlorambucil blev udført med patienter med behandlingsnaiv CLL, som var 65 år eller ældre.
English: The median duration of treatment for MCL was 11 months (range, 0 to 87 months) with 31% and 17% of patients receiving treatment for more than 2 years and 4 years, respectively.
Danish: Medianvarigheden af behandlingen af MCL var 11 måneder (interval 0 til 87 måneder), hvor henholdsvis 31 % og 17 % af patienterne modtog behandling i mere end 2 år og 4 år.
English: Table 9: Efficacy Results in patients with CLL (Study CLL3001)
Danish: Tabel 9: Effektresultater hos patienter med CLL (CLL3001-studiet)
English: 120 capsules
Danish: 90 kapsler 120 kapsler
English: At baseline, 39.2% of patients had Rai Stage IV, 45.1% had bulky disease (≥5 cm), 35.3% had deletion 17p and 31.4% had deletion 11q.
Danish: Ved baseline havde 39,2 % af patienterne Rai-stadie IV, 45,1 % havde omfangsrig sygdom (≥ 5 cm), 35,3 % havde deletion 17p og 31,4 % havde deletion 11q.
English: In patients with preexisting atrial fibrillation requiring anticoagulant therapy, alternative treatment options to IMBRUVICA should be considered.
Danish: Hos patienter med præeksisterende atrieflimren, som kræver behandling med antikoagulantia, skal alternative behandlingsmuligheder til IMBRUVICA overvejes.