FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, 55% of patients had one or more BCR-ABL kinase domain mutation at entry with the most frequent being: T315I (29%), F317L (8%), E255K (4%) and E359V (4%).
Danish: Generelt havde 55 % af patienterne en eller flere BCR-ABL-kinase-domæne-mutationer ved indtræden, hvor den oftest forekommende var: T315I (29 %), F317L (8 %), E255K (4 %) og E359V (4 %).
English: Effective contraception must be used during treatment.
Danish: Der skal anvendes sikker kontraception under behandlingen.
English: In 67% of CP-CML patients in the R/I cohort, no mutations were detected at study entry.
Danish: Hos 67 % af CP-CML-patienterne i R/I-kohorten blev der ikke konstateret nogen mutationer ved indtræden i forsøget.
English: • a complete blood count This will be repeated every 2 weeks for the first 3 months after starting the therapy.
Danish: • et fuldstændigt blodbillede Det vil blive gentaget hver 2. uge i de første 3 måneder af behandlingen.
English: Iclusig use may be resumed at the same, or a reduced dose, after the event is resolved or controlled.
Danish: Anvendelsen af Iclusig kan genoptages med den samme eller en nedsat dosis, når bivirkningen er ophørt eller under kontrol.
English: In a cell-based accelerated mutagenesis assay, no mutation in BCR-ABL was detected that could confer resistance to 40 nM ponatinib.
Danish: I en cellebaseret accelereret mutagenese-undersøgelse blev der ikke konstateret nogen mutation i BCR-ABL som kunne påvise resistens over for 40 nM ponatinib.
English: Ponatinib is not displaced by concomitant administration of ibuprofen, nifedipine, propranolol, salicylic acid, or warfarin.
Danish: Ponatinib fortrænges ikke ved samtidig administration af ibuprofen, nifedipin, propranolol, salicylsyre eller warfarin.
English: At the time of reporting, 25 CP-CML patients were in MCyR (median duration of MCyR had not been reached).
Danish: På rapporteringstidspunktet var 25 patienter med CP-CML i MCyR (median varighed af MCyR var ikke nået).
English: • inability to develop or maintain an erection
Danish: • manglende evne til at få eller vedligeholde rejsning
English: ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD United Kingdom
Danish: ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD Storbritannien
English: At doses of 15 mg or greater, 32 of 34 patients (94%) demonstrated a ≥50% reduction of CRKL phosphorylation, a biomarker of BCR-ABL inhibition, in peripheral blood mononuclear cells.
Danish: Ved doser på 15 mg eller derover viste 32 ud af 34 patienter (94 %) en ≥50 % reduktion af CRKL-fosforylering, en biomarkør for BCR-ABL-hæmning, i perifere mononukleære celler i blod.
English: - increased levels of the serum proteins lipase or amylase.
Danish: - øgede niveauer af serumproteinerne lipase eller amylase
English: Although plasma ponatinib exposures increased to steady-state levels with continuous dosing, a population pharmacokinetic analysis predicts a limited increase in apparent oral clearance within the first two weeks of continuous dosing, which is not considered clinically relevant.
Danish: Selv om plasmaeksponeringen af ponatinib øgedes til steady state niveau ved kontinuerlig dosering, forudsiger en populationsfarmakokinetisk analyse en begrænset stigning i den tilsynaladende orale clearance inden for de første to uger med kontinuerlig dosering; dette anses ikke for at være klinisk relevant.
English: The anti-leukaemic activity of Iclusig was also evaluated in a phase 1 dose escalation study that included 65 CML and Ph+ ALL patients; the study is ongoing.
Danish: Iclusigs anti-leukæmiske aktivitet blev også evalueret i et fase 1 dosiseskaleringsstudie, hvor 65 patienter med CML og Ph+ ALL deltog; studiet er fortsat i gang.
English: Table 2 Dose modifications for pancreatitis and elevation of lipase/amylase Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase
Danish: Tabel 2 Dosisjusteringer ved pancreatitis og forhøjelse af lipase/amylase Grad 2 pancreatitis og/eller asymptomatisk forhøjelse af lipase/amylase
English: Ponatinib did not exhibit genotoxic properties when evaluated in the standard in vitro and in vivo systems.
Danish: Ponatinib havde ingen gentoksiske egenskaber, da det blev vurderet i standard in vitro- og in vivo-systemerne.
English: Neutropenia (ANC decreased)
Danish: Neutropeni (nedsat ANC)
English: In this kind of leukaemia, some of the DNA (genetic material) has become rearranged to form an abnormal chromosome, the Philadelphia chromosome.
Danish: I denne form for leukæmi, omdannes noget af DNA (arvemateriale) til et unormalt kromosom, Philidelphiakromosomet.
English: Dose modifications or interruption of dosing should be considered for the management of haematological and non-haematological toxicities.
Danish: Dosismodifikationer eller doseringsafbrydelse skal overvejes til styring af hæmatologisk og ikke-hæmatologisk toksicitet.
English: Multiple doses of 90 mg per day for 12 days in a patient resulted in pneumonia, systemic inflammatory response, atrial fibrillation, and asymptomatic, moderate pericardial effusion.
Danish: Flere doser på 90 mg per dag i 12 dage hos en patient medførte pneumoni, systemisk inflammatorisk respons, atrieflimren og asymptomatisk, moderat perikardiel effusion.
English: If lipase elevations are accompanied by abdominal symptoms, Iclusig should be withheld and patients evaluated for evidence of pancreatitis (see section 4.2).
Danish: Hvis lipaseforhøjelser er ledsaget af abdominale symptomer, skal Iclusig seponeres og patienterne skal undersøges for tegn på pancreatitis (se pkt.
English: Ponatinib is metabolized to an inactive carboxylic acid by esterases and/or amidases, and metabolized by CYP3A4 to an N-desmethyl metabolite that is 4 times less active than ponatinib.
Danish: Ponatinib metaboliseres til en inaktiv carboxylsyre af esteraser og/eller amidaser og metaboliseres af CYP3A4 til en N-desmethylmetabolit, som er 4 gange mindre aktiv end ponatinib.
English: The majority of patients who underwent dose reduction maintained response (MCyR and MMR) for the duration of currently available follow-up.
Danish: De fleste patienter, hvor dosis blev reduceret, opretholdt respons (MCyR og MMR) igennem den nu foreliggende opfølgning.
English: This medicinal product contains lactose monohydrate.
Danish: Dette lægemiddel indeholder lactosemonohydrat.
English: The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients who received 30 mg, 45 mg, or 60 mg Iclusig once daily.
Danish: Iclusigs potentiale for forlængelse af QT-intervallet blev vurderet hos 39 patienter med leukæmi, som fik 30 mg, 45 mg eller 60 mg Iclusig én gang dagligt.
English: Gender, race and body weight were not predictive in explaining ponatinib pharmacokinetic intersubject variability.
Danish: Køn, race og legemsvægt var ikke prædiktiv med hensyn til at forklare ponatinibs farmakokinetiske variabilitet mellem forsøgspersoner.
English: Dose adjustments to 30 mg once daily or 15 mg once daily were allowed for the management of treatment toxicity.
Danish: Dosisjusteringer til 30 mg én gang dagligt eller 15 mg én gang dagligt blev tilladt til styring af behandlingstoksicitet.
English: Iclusig is associated with severe (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4) thrombocytopenia, neutropenia, and anaemia.
Danish: Iclusig er forbundet med svær (National Cancer Institute Common Terminology Criteria for Adverse Events grad 3 eller 4) trombocytopeni, neutropeni og anæmi.
English: Table 4 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥2% of patients in any disease group Laboratory Test
Danish: Tabel 4 Forekomst af klinisk relevant grad 3/4* laboratorieanormalier hos ≥2 % af patienter i alle sygdomsgrupper Laboratorieundersøgelser
English: Further data on maintenance of response are required in order to make a formal recommendation for dose modifications in the absence of an adverse event as a risk minimisation strategy (see sections 4.2 and 4.4).
Danish: Yderligere data om opretholdelse af respons er nødvendige for at kunne give en formel anbefaling af dosismodifikation som en risikominimeringsstrategi i fravær af bivirkninger (se pkt.
English: The safety and efficacy of Iclusig in patients less than 18 years of age have not been established.
Danish: Pædiatrisk population Iclusigs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE24
Danish: Farmakoterapeutisk klassifikation: antineoplastisk middel, protein-kinase-hæmmer, ATC-kode: L01XE24
English: Talk to your doctor or pharmacist before taking Iclusig if you have:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Iclusig, hvis du:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Iclusig in children from birth to less than 1 year in CML and Ph+ ALL.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Iclusig til børn fra fødslen til under 1 år hos CML og Ph+ ALL.
English: In each Member State, the Marketing Authorisation Holder shall agree the format and content of the educational programme, including communication media, distribution modalities, and any other aspects of the programme with the National Competent Authority.
Danish: Indehaveren af markedsføringstilladelsen og den relevante nationale myndighed i hver enkelt medlemsstat skal blive enige om indholdet og formatet af uddannelsesprogrammet, herunder en kommunikationsplan og alle andre aspekter af programmet.
English: Therefore, ponatinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) or BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine) and may increase their therapeutic effect and adverse reactions.
Danish: Af denne grund kan ponatinib have potentialet for at øge plasmakoncentrationer af samtidigt administrerede substrater af P-gp (f.eks. digoxin, dabigatran, colchicin, pravastatin) eller BCRP (f.eks. methotrexat, rosuvastatin, sulfasalazin) og kan øge deres terapeutiske virkning og bivirkninger.
English: Liver function tests should be performed prior to treatment initiation and monitored periodically, as clinically indicated.
Danish: Leverfunktionsanalyser skal udføres før behandlingsstart, og leverfunktionen skal monitoreres jævnligt, som klinisk indiceret.
English: Following either a high-fat and low-fat meal, plasma ponatinib exposures (Cmax and AUC) were not different versus fasting conditions.
Danish: Efter enten et fedtrigt eller fedtfattigt måltid var eksponeringer af ponatinib i plasma (Cmax og AUC) ikke anderledes end under fasteforhold.
English: For patients whose adverse reactions are resolved or attenuated in severity, Iclusig may be restarted and escalation of the dose back to the daily dose used prior to the adverse reaction may be considered, if clinically appropriate.
Danish: Hos patienter, hvor bivirkninger er ophørt eller reduceret i sværhedsgrad, kan det overvejes at genoptage behandlingen med Iclusig og optrappe dosis til den daglige dosis, som blev anvendt før bivirkningen, hvis det er klinisk relevant.
English: Grade 3 pancreatitis
Danish: Grad 3 pancreatitis
English: Patients with estimated creatinine clearance of ≥ 50 mL/min should be able to safely receive Iclusig with no dosage adjustment.
Danish: Patienter med estimeret kreatinin-clearance på ≥ 50 ml/min bør uden risiko kunne tage Iclusig uden der er foretaget dosisjustering.
English: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 D-93055 Regensburg Germany
Danish: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 D-93055 Regensburg Tyskland
English: Ponatinib inhibits the activity of other clinically relevant kinases with IC50 values below 20 nM and has demonstrated cellular activity against RET, FLT3, and KIT and members of the FGFR, PDGFR, and VEGFR families of kinases.
Danish: Ponatinib hæmmer aktiviteten af andre klinisk relevante kinaser med IC50 værdier under 20 nM og har vist cellulær aktivitet mod RET, FLT3 og KIT og medlemmer af FGFR, PDGFR og VEGFR familier af kinaser.
English: Overall (N=83)
Danish: Generelt (N=83)
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette legemiddel inden for 6 måneder efter godkendelsen.
English: Fertility The effect of Iclusig on male and female fertility is unknown.
Danish: Fertilitet Det er ukendt, om Iclusig påvirker mandlig og kvindelig fertilitet.
English: Haematologic support such as platelet transfusion and haematopoietic growth factors can be used during treatment if clinically indicated.
Danish: Hæmatologisk støtte som f.eks. transfusion af trombocytter og hæmatopoietiske vækstfaktorer kan anvendes under behandlingen, hvis det er klinisk indiceret.
English: Congestive heart failure
Danish: Kongestiv hjerteinsufficiens
English: In preclinical mutagenesis studies, 40 nM was determined as the concentration of ponatinib sufficient to inhibit viability of cells expressing all tested BCR-ABL mutants by >50% (including T315I) and suppress the emergence of mutant clones.
Danish: I prækliniske mutagenese-studier blev 40 nM fastlagt som koncentrationen af ponatinib, som var tilstrækkelig til at hæmme levedygtigheden af celler, der eksprimerer alle testede BCR-ABL-mutanter med >50 % (herunder T315I) og undertrykke udviklingen af mutante kloner.
English: Caution is recommended in patients with a history of pancreatitis or alcohol abuse.
Danish: Forsigtighed anbefales ved behandling af patienter med pancreatitis eller alkoholmisbrug i anamnesen.
English: • evaluations of your heart function and the condition of your arteries and veins
Danish: • en vurdering af din hjertefunktion og dine blodårers tilstand
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TILL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Patients aged 65 and over are more likely to be affected by side effects.
Danish: Det er mere sandsynligt, at patienter over 65 vil blive påvirket af bivirkninger.
English: If a dose reduction is considered, the following factors should be to taken into account in the individual benefit-risk assessment: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels (see sections 4.4 and 5.1).
Danish: Hvis dosisreduktion overvejes, skal følgende faktorer tages i betragtning i den individuelle benefit-risk-vurdering: kardiovaskulær risiko, bivirkninger ved ponatinib-behandling, tid til cytogenetisk respons og BCRABL-transskriptniveaue (se pkt.
English: Medicinal product interactions
Danish: Interaktioner med lægemidler
English: Ponatinib at doses of 3, 10, and 30 mg/kg produced increases in urine output and electrolyte excretions and caused a decrease in gastric emptying in safety pharmacology studies in rats.
Danish: Ponatinib ved doser på 3, 10 og 30 mg/kg producerede stigninger i urin-output og elektrolytudskillelse og forårsagede et fald i gastrisk udtømning i sikkerhedsfarmakologiske studier hos rotter.
English: - alkaline phosphatase
Danish: - alkalisk fosfatase
English: Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia.
Danish: Behandlingen skal initieres af en læge med erfaring i diagnosticering og behandling af patienter med leukæmi.
English: Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath.
Danish: Akut klinisk intervention kan være nødvendig ved hypertension forbundet med konfusion, hovedpine, brystsmerter og kortåndethed.
English: • pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels.
Danish: • pravastatin, rosuvastatin: lægemidler, der sænker kolesterolniveauet
English: Unchanged ponatinib accounted for 24% and <1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites.
Danish: Uomdannet ponatinib stod for hhv. 24 % og <1 % af den administrerede dosis i fæces og urin, mens resten af dosis bestod af metabolitter.
English: Co administration of strong CYP3A4 inducers such as carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, and St. John's Wort with ponatinib should be avoided, and alternatives to the CYP3A4 inducer should be sought, unless the benefit outweighs the possible risk of ponatinib underexposure.
Danish: Samtidig administration af potente CYP3A4-induktorer som f.eks. carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin og perikon med ponatinib bør undgås, og alternativer til CYP3A4induktorer bør søges, medmindre fordelen opvejer den mulige risiko for undereksponering af ponatinib.
English: Treatment-emergent hypertension occurred in Iclusig-treated patients.
Danish: Behandlingsrelateret hypertension er forekommet hos Iclusig-behandlede patienter.
English: Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triplebond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase.
Danish: Ponatinib er en potent pan-BCR-ABL-hæmmer med strukturelle elementer, herunder en tredobbelt kulstof-kulstof-binding, som muliggør høj affinitetsbinding til naturligt forekommende BCR-ABL og mutante former for ABL-kinase.
English: All patients were administered 45 mg of Iclusig once-daily with the possibility of dose de-escalations and dose interruptions followed by dose resumption and re-escalation.
Danish: Alle patienter fik 45 mg Iclusig én gang dagligt med muligheden for dosis deeskaleringer og dosisafbrydelse efterfulgt af dosisgenoptagelse og -re-eskalering.
English: Dose modifications for neutropenia (ANC* < 1.0 x 109/L) and thrombocytopenia (platelet < 50 x 109/L) that are unrelated to leukaemia are summarized in Table 1.
Danish: Dosismodifikationer ved neutropeni (ANC* < 1,0 x 109/l) og trombocytopeni (trombocyttal < 50 x 109/l), som ikke er relateret til leukæmi, er opsummeret i tabel 1.
English: Periodic safety update reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: • Information on important adverse reactions for which monitoring and/or dose adjustment are recommended as outlined in the SmPC: pancreatitis, increased amylase and lipase levels, myelosuppression, liver function test abnormalities, haemorrhage, cardiac failure/left ventricular dysfunction, vascular occlusive events and hypertension.
Danish: • Information om vigtige bivirkninger, for hvilke der anbefales overvågning og/eller dosisjustering som beskrevet i produktresuméet: pancreatitis, forhøjede amylase- og lipaseniveauer, myelosuppression, unormale leverfunktionsprøver, hæmoragi, hjerteinsufficiens/nedsat funktion af venstre ventrikel, vaskulære okklusive hændelser og hypertension.
English: Cerebral haemorrhage and gastrointestinal haemorrhage were the most commonly reported serious bleeding events.
Danish: Cerebral blødning og gastrointestinal blødning var de hyppigst rapporterede alvorlige blødningshændelser.
English: Patients should be advised not to swallow the desiccant canister found in the bottle.
Danish: Patienterne bør informeres om, at de ikke må synke den dåse med tørremiddel, som der findes i flasken.
English: Majora (MaHR)
Danish: ”Major”a (MaHR)
English: • upper airway infection
Danish: • infektion i øvre luftveje
English: It is unknown whether Iclusig is excreted in human milk.
Danish: Det er ukendt, om Iclusig udskilles i human mælk.
English: In the phase 2 trial, 87 CP-CML patients achieved MCyR at a dose of 45 mg, 45 CP-CML patients achieved MCyR after a dose reduction to 30 mg, mostly for adverse events.
Danish: I fase 2-forsøget opnåede 87 CP-CML- patienter MCyR med en dosis på 45 mg, 45 CP-CML-patienter opnåede MCyR efter dosisreduktion til 30 mg, hovedsagelig på grund af bivirkninger.
English: • high blood pressure
Danish: • har for højt blodtryk
English: The geometric mean (CV%) Cmax and AUC(0-τ) exposures achieved for ponatinib 45 mg daily at steady state were 77 ng/mL (50%) and 1296 ng•hr/mL (48%), respectively.
Danish: De geometriske gennemsnitlige (CV %) Cmax and AUC(0-τ) eksponeringer, opnået for ponatinib 45 mg dagligt ved steady state, var hhv. 77 ng/ml (50 %) og 1296 ng•t/ml (48 %).
English: • liver tests Liver function tests will be performed periodically, as indicated by your doctor.
Danish: • undersøgelse af leverfunktionen Blodprøver til vurdering af leverfunktionen vil blive taget jævnligt som indiceret af lægen.
English: (95% CI) Completeb (CHR)
Danish: (95 % KI) Kompletb (CHR)
English: • rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections.
Danish: • rifabutin, rifampicin: lægemidler, der bruges til at behandle tuberkulose og visse andre infektioner
English: • low calcium, phosphate or potassium levels in the blood
Danish: • lave niveauer af calcium, fosfat eller kalium i blodet
English: The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients and no clinically significant QT prolongation was observed (see section 5.1).
Danish: Iclusigs potentiale for forlængelse af QT-intervallet blev vurderet hos 39 patienter med leukæmi, og ingen klinisk signifikant QT-forlængelse blev observeret (se pkt.
English: • increased tendency to bleed or bruise
Danish: • øget tendens til blødning eller blå mærker
English: Following single and multiple 45 mg doses of Iclusig, the terminal elimination half-life of ponatinib was 22 hours, and steady state conditions are typically achieved within 1 week of continuous dosing.
Danish: Efter enkelte og flere 45 mg doser af Iclusig var den terminale udskillelseshalveringstid af ponatinib 22 timer, og steady state tilstande opnås typisk inden for 1 uge af kontinuerlig dosering.
English: Iclusig belongs to a group of medicines called tyrosine kinase inhibitors.
Danish: Iclusig tilhører en gruppe lægemidler, der kaldes tyrosin-kinase-hæmmere.
English: Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig.
Danish: Patienter skal overvåges for tegn og symptomer, der er forenelige med hjerteinsufficiens, og skal behandles som klinisk indiceret, herunder seponering af Iclusig.
English: At daily doses of 45 mg, the geometric mean (CV%) apparent steady state volume of distribution is 1101 L (94%) suggesting that ponatinib is extensively distributed in the extravascular space.
Danish: Ved daglige doser på 45 mg er det tilsyneladende steady state fordelingsvolumen 1101 l (94 %) (geometrisk gennemsnit (CV %)), hvilket tyder på, at ponatinib fordeles i omfattende grad i det ekstravaskulære rum.
English: • The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 3000, polyvinyl alcohol, titanium dioxide (E171).
Danish: • Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, natriumstivelsesglycolat, silica (kolloid vandfri), magnesiumstearat, talkum, macrogol 4000, polyvinylalkohol, titandioxid (E171).
English: Within the range of clinically relevant doses evaluated in patients (15 mg to 60 mg), ponatinib exhibited dose proportional increases in both Cmax and AUC.
Danish: Inden for området af klinisk relevante doser, evalueret hos patienter (15 mg til 60 mg), øges ponatinib proportionelt med dosis i både Cmax og AUC.
English: • chest pain not in connection with the heart
Danish: • brystsmerter, som ikke har noget med hjertet at gøre
English: - alanine aminotransferase
Danish: - alaninaminotransferase
English: What you need to know before you take Iclusig
Danish: Det skal du vide, før du begynder at bruge Iclusig
English: CP-CML patients who received fewer prior TKIs attained higher cytogenetic, haematological, and molecular responses.
Danish: CP-CML-patienter, som har fået færre tidligere TKI'er, opnåede højere cytogenetisk, hæmatologisk og molekulært respons.