FrancophonIA/ELRC3.0 huggingface dataset:
English: Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe
Danish: Biopoin 10.000 IE/1 ml injektionsvæske, opløsning, i fyldt injektionssprøjte
English: Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Danish: Biopoin 2.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte 2 år
English: EU/1/09/565/006 6 pre-filled syringes with safety device EU/1/09/565/031 6 pre-filled syringes with safety needle
Danish: EU/1/09/565/005 6 fyldte injektionssprøjter EU/1/09/565/006 6 fyldte injektionssprøjter med sikkerhedsanordning EU/1/09/565/031 6 fyldte injektionssprøjter med sikkerhedskanyle
English: EU/1/09/565/004 6 pre-filled syringes with safety device EU/1/09/565/030 6 pre-filled syringes with safety needle
Danish: EU/1/09/565/001 6 fyldte injektionssprøjter EU/1/09/565/002 6 fyldte injektionssprøjter med sikkerhedsanordning EU/1/09/565/030 6 fyldte injektionssprøjter med sikkerhedskanyle
English: Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Danish: Biopoin 3.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte 2 år
English: Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Danish: Biopoin 5.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte Epoetin theta
English: Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Danish: Biopoin 30.000 IE/1 ml injektionsvæske, opløsning, i fyldt injektionssprøjte 1 ml injektionsvæske i en fyldt injektionssprøjte (type I-glas) med sprøjtehætte (brombutylgummi), stempelprop (teflonbehandlet chlorbutylgummi) og kanyle (rustfrit stål) eller kanyle (rustfrit stål) med sikkerhedskappe (sikkerhedskanyle) eller kanyle (rustfrit stål) med sikkerhedsanordning.
English: Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Danish: Biopoin 5.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte 0,5 ml injektionsvæske i en fyldt injektionssprøjte (type I-glas) med sprøjtehætte (brombutylgummi), stempelprop (teflonbehandlet chlorbutylgummi) og kanyle (rustfrit stål) eller kanyle (rustfrit stål) med sikkerhedskappe (sikkerhedskanyle) eller kanyle (rustfrit stål) med sikkerhedsanordning.
English: Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Danish: Biopoin 30.000 IE/1 ml injektionsvæske, opløsning, i fyldt injektionssprøjte Epoetin theta
English: Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Danish: Biopoin 4.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte 0,5 ml injektionsvæske i en fyldt injektionssprøjte (type I-glas) med sprøjtehætte (brombutylgummi), stempelprop (teflonbehandlet chlorbutylgummi) og kanyle (rustfrit stål) eller kanyle (rustfrit stål) med sikkerhedskappe (sikkerhedskanyle) eller kanyle (rustfrit stål) med sikkerhedsanordning.
English: 1 pre-filled syringe containing 1 ml.
Danish: 1 fyldt injektionssprøjte, der rummer 1 ml.
English: Confirm visually that the needle is fully engaged in the safety shield under the lock (see picture 15).
Danish: Kig efter, at kanylen er helt omsluttet af sikkerhedskappen under låsen (se figur 15) 10. Hver injektionssprøjte må kun bruges til én injektion.
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Danish: Biopoin 1.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte Epoetin theta
English: Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Danish: Biopoin 4.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte Epoetin theta
English: Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Danish: Biopoin 2.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte Epoetin theta
English: Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Danish: Biopoin 10.000 IE/1 ml injektionsvæske, opløsning, i fyldt injektionssprøjte 1 ml injektionsvæske i en fyldt injektionssprøjte (type I-glas) med sprøjtehætte (brombutylgummi), stempelprop (teflonbehandlet chlorbutylgummi) og kanyle (rustfrit stål) eller kanyle (rustfrit stål) med sikkerhedskappe (sikkerhedskanyle) eller kanyle (rustfrit stål) med sikkerhedsanordning.
English: Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Danish: Biopoin 10.000 IE/1 ml injektionsvæske, opløsning, i fyldt injektionssprøjte Epoetin theta
English: Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Danish: Biopoin 2.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte 0,5 ml injektionsvæske i en fyldt injektionssprøjte (type I-glas) med sprøjtehætte (brombutylgummi), stempelprop (teflonbehandlet chlorbutylgummi) og kanyle (rustfrit stål) eller kanyle (rustfrit stål) med sikkerhedskappe (sikkerhedskanyle) eller kanyle (rustfrit stål) med sikkerhedsanordning.
English: Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Danish: Biopoin 3.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte Epoetin theta
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Danish: Biopoin 1.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte 0,5 ml injektionsvæske i en fyldt injektionssprøjte (type I-glas) med sprøjtehætte (brombutylgummi), stempelprop (teflonbehandlet chlorbutylgummi) og kanyle (rustfrit stål) eller kanyle (rustfrit stål) med sikkerhedskappe (sikkerhedskanyle) eller kanyle (rustfrit stål) med sikkerhedsanordning.
English: Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Danish: Biopoin 3.000 IE/0,5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte 0,5 ml injektionsvæske i en fyldt injektionssprøjte (type I-glas) med sprøjtehætte (brombutylgummi), stempelprop (teflonbehandlet chlorbutylgummi) og kanyle (rustfrit stål) eller kanyle (rustfrit stål) med sikkerhedskappe (sikkerhedskanyle) eller kanyle (rustfrit stål) med sikkerhedsanordning.
English: 6 pre-filled syringes with safety needle containing 1 ml.
Danish: 6 fyldte injektionssprøjter med sikkerhedskanyle, der rummer 1 ml.
English: This is expected and may last for a few months.
Danish: Dette er forventeligt og kan vare i et par måneder.
English: Talk to your doctor about what your test results mean.
Danish: Tal med din læge om, hvad dine testresultater betyder.
English: • Tell your doctor immediately if you become pregnant.
Danish: • Fortæl det straks til lægen, hvis du bliver gravid.
English: Repeat CT scans required to confirm response.
Danish: Gentagne CT-scanninger kræves for at bekræfte respons.
English: 48-month follow-up
Danish: 48 måneders opfølgning
English: • if you have ever had or might now have a hepatitis B infection.
Danish: • Hvis du har haft eller muligvis nu har en hepatitis B-infektion.
English: Your doctor may adjust your dose.
Danish: Din læge kan justere din dosis.
English: Long-term safety
Danish: Langtidssikkerhed
English: After a single oral administration of radiolabeled [
Danish: Efter en enkelt oral administration af radioaktivt mærket [
English: The median DOR was not reached.
Danish: Median DOR blev ikke nået.
English: Recommended dose modifications are described below:
Danish: Anbefalede modifikationer af dosis er beskrevet nedenfor:
English: This does not necessarily mean that your blood cancer is getting worse.
Danish: Det betyder ikke nødvendigvis, at din blodkræft bliver værre.
English: Final Analysis at 65-month follow-up
Danish: Endelig analyse efter 65 måneders opfølgning
English: This is because it has not been studied in these age groups.
Danish: Det skyldes, at medicinen ikke er undersøgt hos disse aldersgrupper.
English: Some of these infections have been associated with hospitalisation and death.
Danish: Nogle af disse infektioner er blevet forbundet med hospitalsindlæggelse og dødsfald.
English: Patients should be closely monitored.
Danish: Patienterne skal monitoreres nøje.
English: Includes events with fatal outcome.
Danish: Omfatter hændelser med dødelig udgang.
English: Lower level term (LLT) used for selection.
Danish: LLT-term (Lower Level Term) brugt til valget.
English: Hydration should be maintained and serum creatinine levels monitored periodically.
Danish: Hydrering skal opretholdes, og serumkreatinin monitoreres regelmæssigt.
English: The half-life of ibrutinib is 4 to 13 hours.
Danish: Halveringstiden for ibrutinib er 4 til 13 timer.
English: This is because it can increase the amount of IMBRUVICA in your blood.
Danish: Det skyldes, at dette kan øge mængden af IMBRUVICA i dit blod.
English: CLL and WM
Danish: CLL og WM
English: The following adverse effects were seen in studies of 13-weeks duration in rats and dogs.
Danish: Følgende bivirkninger blev set i 13-ugers studier med rotter og hunde.
English: Your doctor will check your blood counts before or during the treatment and in rare cases they may need to give you another medicine.
Danish: Din læge vil kontrollere dine blodtal før eller under behandlingen, og i sjældne tilfælde kan det blive nødvendigt at give dig anden medicin.
English: Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandling med dette lægemiddel bør indledes og monitoreres af en læge, der har erfaring med brug af lægemidler mod cancer.
English: Not known (frequency cannot be estimated from available data)
Danish: Ikke kendt (kan ikke vurderes ud fra forhåndenværende data)
English: Rai stage 0/I/II
Danish: Rai-stadie 0/I/II
English: Frequency (All grades)
Danish: Hyppighed (Alle grader)
English: The DOR ranged from 3.9 to 24.2+ months.
Danish: DOR lå fra 3,9 til 24,2+ måneder.
English: Hazard ratio based on non-stratified analysis
Danish: Hazard ratio baseret på ikke-stratificeret analyse
English: Tell a doctor straight away if you notice any of the following side effects:
Danish: Fortæl det til en læge med det samme, hvis du oplever nogen af følgende bivirkninger:
English: This means you should tell your doctor if you take other medicines that increase your risk of bleeding.
Danish: Det betyder, at du skal fortælle det til lægen, hvis du tager anden medicin, der kan øge din risiko for blødning.
English: Most patients with fatal infections also had neutropenia.
Danish: De fleste patienter med dødelige infektioner havde også neutropeni.
English: No clinical data are available on this interaction.
Danish: Der foreligger ingen kliniske data vedrørende denne interaktion.
English: • medicines for depression - nefazodon
Danish: • medicin mod depression - nefazodon
English: Each pack contains one bottle.
Danish: Hver pakning indeholder én beholder.
English: The mechanism for the bleeding-related events is not fully understood.
Danish: Mekanismen bag blødningsrelaterede hændelser er ikke fuldt afklaret.
English: Co-administration with CYP substrates
Danish: Administration sammen med CYP-substrater
English: A risk to breast-fed children cannot be excluded.
Danish: En risiko for børn der ammer kan ikke udelukkes.
English: Apparent clearance (CL/F) is approximately 1,000 L/h.
Danish: Tilsyneladende clearance (CL/F) er ca. 1.000 l/t.
English: By blocking this protein, IMBRUVICA helps kill and reduce the number of cancer cells.
Danish: Ved at blokere dette protein er IMBRUVICA med til at dræbe og reducere antallet af kræftceller.
English: • diarrhoea, your doctor may need to give you a fluid and salt replacement or another medicine
Danish: • diarré, det kan være nødvendigt, at din læge giver dig ekstra væske og salt eller et andet lægemiddel
English: Not reached (1.9+, 36.4+)
Danish: Ikke nået (1,9+; 36,4+)
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Danish: Alle patienter vil blive undersøgt grundigt af deres læge for tegn på en sådan infektion, før behandlingen påbegyndes.
English: Monitor for signs and symptoms of bleeding.
Danish: Monitorer for tegn og symptomer på blødning.
English: This is because IMBRUVICA could cause hepatitis B to become active again.
Danish: Dette skyldes, at IMBRUVICA kan få hepatitis B til at blive aktiv igen.
English: Spontaneous reports from post-marketing experience.
Danish: Spontane indberetninger efter markedsføring.
English: Ibrutinib is rapidly absorbed after oral administration with a median Tmax of 1 to 2 hours.
Danish: Ibrutinib absorberes hurtigt efter oral administration, med en median Tmax på 1 til 2 timer.
English: Pancreatic findings partially recovered during comparable reversal periods.
Danish: Pankreatiske fund blev delvis afhjulpet under sammenlignelige perioder med revertering.
English: When you take a tablet, fill in the day of the week or the date in the space provided.
Danish: Når du tager en tablet, skal du udfylde ugedagen eller datoen i det angivne felt.
English: Median time to response was 1.9 months.
Danish: Mediantid til respons var 1,9 måneder.
English: p-value associated with response rate was <0.0001.
Danish: p-værdien forbundet med responsraten var < 0,0001.
English: IMBRUVICA should not be used in children and adolescents.
Danish: IMBRUVICA bør ikke anvendes til børn og unge.
English: The IRC estimated median DOR was 19.6 months.
Danish: IRC fandt en estimeret median DOR på 19,6 måneder.
English: Patients who ingested more than the recommended dose should be closely monitored and given appropriate supportive treatment.
Danish: Patienter, der tager mere end den anbefalede dosis, skal monitoreres nøje og gives relevant understøttende behandling.
English: Table 10: ORR and DOR in patients with WM
Danish: Tabel 10: ORR og DOR hos patienter med WM
English: The safety and efficacy of IMBRUVICA in children and adolescents aged 0 to 18 years have not been established.
Danish: IMBRUVICAs sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er ikke klarlagt.
English: No specific dose adjustment is required for elderly patients (aged ≥65 years).
Danish: Ingen specifik dosisjustering er påkrævet for ældre patienter (i alderen ≥ 65 år).
English: IMBRUVICA may make you bleed more easily.
Danish: IMBRUVICA kan medføre, at du bløder lettere.
English: The apparent volume of distribution at steady state (Vd, ss/F) was approximately 10,000 L.
Danish: Det tilsyneladende fordelingsvolumen ved steady state (Vd, ss/F) var cirka 10.000 l.
English: • if you have high blood pressure
Danish: • hvis du har forhøjet blodtryk
English: It is currently unknown whether ibrutinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method.
Danish: Det vides ikke på nuværende tidspunkt, om ibrutinib kan reducere effekten af hormonale kontraceptiva, og kvinder, som anvender hormonale kontraceptiva, bør derfor tillige benytte en barrieremetode.
English: Therefore, no precautions are necessary in patients with different CYP2D6 genotypes.
Danish: Derfor er det ikke nødvendig med forholdsregler for patienter med forskellige CYP2D6-genotyper.
English: • if you have recently had any surgery, especially if this might affect how you absorb food or medicines from your stomach or gut
Danish: • hvis du har gennemgået en operation for nylig, især hvis dette kan have betydning for, hvordan din mave eller dine tarme absorberer mad eller medicin
English: All gastrointestinal, lymphoid and bone findings recovered following recovery periods of 6-13 weeks.
Danish: Alle gastrointestinale, lymfoide og knoglerelaterede fund blev afhjulpet efter restitutionsperioder på 6-13 uger.
English: Rare (may affect up to 1 in 1,000 people) • severely increased white blood cell count that may cause cells to clump together.
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer) • kraftigt forhøjet antal hvide blodlegemer, som kan få disse til at klumpe sig sammen.
English: Of the 1200 patients treated with IMBRUVICA, 64% were 65 years of age or older.
Danish: Af de 1.200 patienter, som blev behandlet med IMBRUVICA, var 64 % 65 år eller ældre.
English: Rate of Sustained Haemoglobin Improvement b, c
Danish: Rate for varig forbedring i hæmoglobin b, c
English: Number of prior lines
Danish: Antal tidligere linjer
English: It belongs to a class of medicines called protein kinase inhibitors.
Danish: Det tilhører en gruppe af lægemidler, der kaldes proteinkinasehæmmere.
English: Adverse reactions leading to dose reduction occurred in approximately 7% of patients.
Danish: Bivirkninger, som medførte dosisreduktion, forekom hos ca. 7 % af patienterne.
English: This is because IMBRUVICA may affect the way some other medicines work.
Danish: Dette skyldes, at IMBRUVICA kan påvirke den måde, visse andre lægemidler virker på.
English: Ibrutinib has minimal renal clearance; urinary excretion of metabolites is <10% of the dose.
Danish: Ibrutinib har minimal renal clearance; udskillelse af metabolitter i urinen er < 10 % af dosis.
English: Frequencies are rounded to the nearest integer.
Danish: Hyppigheder er afrundet til nærmeste heltal.
English: All PRs achieved; p<0.0001 for ORR.
Danish: Alle PR'er blev opnået; p < 0,0001 for ORR.
English: Supplements such as fish oil and vitamin E preparations should be avoided.
Danish: Kosttilskud såsom fiskeolie og præparater med E-vitamin bør undgås.
English: This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.
Danish: Denne observerede lymfocytose er en farmakodynamisk effekt og bør ikke anses for progressiv sygdom i fravær af andre kliniske fund.
English: The primary endpoint in this study was investigator-assessed overall response rate (ORR).
Danish: Dette studies primære endepunkt var investigatorvurderet samlet responsrate (ORR).
English: The dihydrodiol metabolite and other metabolites are P-gp substrates.
Danish: Dihydrodiol-metabolitten og andre metabolitter er P-gp-substrater.
English: • Do not breast-feed while you are taking this medicine.
Danish: • Undlad at amme, mens du tager dette lægemiddel.
English: • if you are planning to have any surgery- your doctor may ask you to stop taking IMBRUVICA for a short time (3 to 7 days) before and after your surgery.
Danish: • hvis du planlægger at gennemgå en operation - din læge vil muligvis bede dig om at holde op med at tage IMBRUVICA i en kortere periode (3 til 7 dage) før og efter operationen
English: It is not known whether ibrutinib or its metabolites are excreted in human milk.
Danish: Det er ukendt, om ibrutinib eller dets metabolitter udskilles i human mælk.
English: Monitor complete blood counts monthly.
Danish: Komplette blodtal skal monitoreres månedligt.
English: Forty-five percent of patients were treatment-naïve, and 55% of patients were previously treated.
Danish: 45 % af patienterne var behandlingsnaive, og 55 % af patienterne var tidligere behandlet.
English: IMBRUVICA has minor influence on the ability to drive and use machines.
Danish: IMBRUVICA påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: The study enrolled 269 patients with CLL.
Danish: Der blev rekrutteret 269 patienter med CLL til studiet.
English: The overall known safety profile of IMBRUVICA-exposed patients remained consistent, other than an increasing prevalence of hypertension, with no new safety concerns identified.
Danish: Den samlede kendte sikkerhedsprofil for IMBRUVICA-eksponerede patienter forblev konsekvent, bortset fra en øgning i prævalensen af hypertension, og der blev ikke identificeret nye sikkerhedsmæssige betænkeligheder.
English: Carcinogenicity/genotoxicity
Danish: Karcinogenicitet/genotoksicitet
English: You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability to drive or use any tools or machines.
Danish: Du kan føle dig træt eller svimmel, efter at du har taget IMBRUVICA, og det kan påvirke din evne til at køre eller anvende værktøj eller maskiner.
English: It also slows down the worsening of the cancer.
Danish: Det medvirker også til, at kræften forværres langsommere.
English: Reported cases of invasive fungal infections have been associated with fatal outcomes.
Danish: Rapporterede tilfælde af invasive svampeinfektioner har været forbundet med dødelig udgang.
English: The ORR and DOR were assessed using criteria adopted from the Third International Workshop of WM.
Danish: ORR og DOR blev vurderet i henhold til kriterierne fra Third International Workshop of WM.
English: Median OS not reached for both arms.
Danish: Median-OS ikke nået for begge grupper.
English: IMBRUVICA should be held at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
Danish: IMBRUVICA skal tilbageholdes mindst 3 til 7 dage før og efter operation, afhængigt af typen af operation og risikoen for blødning.
English: Involvement of CYP2D6 in the metabolism of ibrutinib appears to be minimal.
Danish: Involvering af CYP2D6 i metaboliseringen af ibrutinib er tilsyneladende minimal.
English: Ibrutinib exposure increases with doses up to 840 mg.
Danish: Eksponering for ibrutinib øges med doser op til 840 mg.
English: Median DOR (CR+PR) (months)
Danish: Median DOR (CR+PR) (måneder)
English: With a median follow-up time on study of 34 months (range, 8.6+ to 37.7 months), the median duration of response has not been reached.
Danish: Med en median opfølgningstid i studiet på 34 måneder (interval: 8,6+ til 37,7 måneder), blev medianvarigheden for respons ikke nået.
English: Capsule shell Gelatin
Danish: Kapselskal Gelatine
English: Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater were excluded from the study.
Danish: Patienter med ECOG-performancestatus (Eastern Cooperative Oncology Group) på 3 eller derover blev ekskluderet fra studiet.
English: Paediatric population No pharmacokinetic studies were performed with IMBRUVICA in patients under 18 years of age.
Danish: Pædiatrisk population Der er ikke udført farmakokinetiske studier med IMBRUVICA hos patienter under 18 år.
English: ORR (%) p-value p<0.0001
Danish: ORR (%) p-værdi p < 0,0001