FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may change the dose of these medicines, change the dose of Bosulif, or switch you to a different medicine.
Danish: Lægen vil eventuelt ændre dosis af disse lægemidler eller af Bosulif eller ordinere et andet lægemiddel.
English: Modeling studies indicate that bosutinib binds the kinase domain of BCR-ABL. Bosutinib is also an inhibitor of Src family kinases including Src, Lyn and Hck.
Danish: Modelleringsforsøg tyder på, at bosutinib binder kinasedomænet i BCR-ABL. Bosutinib hæmmer også kinaserne af Src-familien, herunder Src, Lyn og Hck.
English: After 500 mg bosutinib daily with food, Cmax was 200 (6) ng/mL and AUCss was 3,640 (12) ng•h/mL.
Danish: Efter 500 mg bosutinib dagligt med føde var Cmax200 (6) ng/ml og AUCss var 3.640 (12) ng•t/ml.
English: Effects of other medicinal products on bosutinib
Danish: Andre lægemidlers indvirkning på bosutinib
English: If you are taking any of them, tell your doctor.
Danish: Hvis du tager nogle af disse lægemidler, skal du fortælle det til lægen.
English: Treatment with bosutinib is associated with elevations in serum transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]).
Danish: Behandling med bosutinib er forbundet med stigning i serum-aminotransferaser (ALAT (alaninaminotransferase), ASAT (aspartataminotransferase)).
English: Also tell your doctor if you are losing weight or have experienced swelling of your feet, ankles, legs, hands or face.
Danish: Fortæl det også til lægen, hvis du oplever vægttab eller har oplevet hævelse af fødder, ankler, ben, hænder eller ansigt.
English: Do not take Bosulif - if you are allergic to bosutinib or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for bosutinib eller et af de øvrige indholdsstoffer i Bosulif (angivet i punkt 6).
English: After a minimum of 12 months of follow-up in the mITT population, 77.6% of patients treated with bosutinib (N=241) and 72.4% of patients treated with imatinib (N=239) were still receiving first-line treatment.
Danish: Efter opfølgning på mindst 12 måneder i mITT-populationen fik 77,6 % af de patienter, der blev behandlet med bosutinib (N=241) og 72,4 % af de patienter, der blev behandlet med imatinib (N=239) stadig førstevalgsbehandling.
English: You should ask your doctor if use of your treatment for vomiting may result in a greater risk of heart arrhythmias.
Danish: Spørg lægen, om den behandling, du får mod opkastninger, kan medføre en større risiko for hjerterytmeforstyrrelser.
English: The evaluable population includes patients who had a valid baseline disease assessment.
Danish: Den evaluerbare population inkluderer patienter med valid sygdomsvurdering ved baseline.
English: Excretion of unchanged bosutinib in urine was low with approximately 1% of the dose in both healthy subjects and those with advanced malignant solid tumours.
Danish: Udskillelsen af uomdannet bosutinib i urin var lav med ca. 1 % af dosis hos både raske frivillige og forsøgsdeltagere med fremskredne maligne solide tumorer.
English: The data from this study indicate that bosutinib does not prolong the QTc in healthy subjects at the dose of 500 mg daily with food, and under conditions that give rise to supratherapeutic plasma concentrations.
Danish: Data fra dette studie tyder på, at bosutinib ikke forlænger QT-intervallet hos raske frivillige ved dosis på 500 mg dagligt sammen med føde eller under forhold, der giver anledning til supraterapeutiske plasmakoncentrationer.
English: If blood counts remain low for > 2 weeks, upon recovery reduce dose by 100 mg and resume treatment.
Danish: Hvis blodtallene forbliver lave i mere end 2 uger, reduceres dosis efter bedring med 100 mg, og behandlingen genoptages.
English: This medicinal product has been authorised under a so-called “conditional approval” scheme.
Danish: Dette lægemiddel er blevet godkendt under såkaldt ”betingede omstændigheder”.
English: - infection of the lung (pneumonia), influenza, bronchitis.
Danish: - lungebetændelse, influenza, bronkitis.
English: - imatinib, used to treat a type of leukaemia.
Danish: - imatinib, der anvendes til behandling af en type leukæmi.
English: - bosentan, used to lower high blood pressure in the lungs (pulmonary artery hypertension).
Danish: - bosentan, der anvendes til at sænke forhøjet blodtryk i lungerne (pulmonal arteriel hypertension).
English: Tell your doctor if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the QT interval”, or if you faint (loss of consciousness) or have an irregular heart beat while taking Bosulif.
Danish: Fortæl det til lægen, hvis du har en hjerteforstyrrelse såsom et unormalt elektrisk signal, der kaldes ”forlænget QT-interval”, eller hvis du besvimer (mister bevidstheden) eller får uregelmæssig puls, mens du tager Bosulif.
English: In faeces, bosutinib and N-desmethyl bosutinib were the major drug-related components.
Danish: Bosutinib og N-desmethylbosutinib var de vigtigste lægemiddelrelaterede komponenter i fæces.
English: If cytopoenia recurs, reduce dose by an additional 100 mg upon recovery and resume treatment.
Danish: Hvis der igen opstår cytopeni, reduceres dosis med yderligere 100 mg efter bedring, og behandlingen genoptages.
English: - chloroquine, halofantrine used to treat malaria.
Danish: - chloroquin og halofantrin, der anvendes til behandling af malaria.
English: After a minimum of 12 months of follow-up in the mITT population, discontinuations due to disease progression to AP or BP CML for bosutinib-treated patients were 0.4% compared to 1.7% for imatinib-treated patients.
Danish: Efter opfølgning på mindst 12 måneder i mITT-populationen var seponering på grund af sygdomsprogression til AP eller BP CML for bosutinib-behandlede patienter på 0,4 % sammenlignet med 1,7 % for imatinib-behandlede patienter.
English: Tell your doctor if you have a heart disorders, such as arrhythmias or an abnormal electrical signal called “prolongation of the QT interval”.
Danish: Fortæl det til lægen, hvis du har en hjertesygdom, f.eks. hjerterytmeforstyrrelser eller et unormalt elektrisk signal, såkaldt ”forlængelse af QTintervallet".
English: - life-threatening allergic reaction (anaphylactic shock).
Danish: - livstruende allergisk reaktion (anafylaktisk shock).
English: If clinically appropriate, re-escalation to the dose prior to the dose reduction taken once daily should be considered (see section 4.4).
Danish: Hvis det er klinisk relevant, kan det overvejes at vende tilbage til dosis fra før reduktionen, som tages 1 gang dagligt (se pkt.
English: Treatment of nausea or vomiting with such medicines together with Bosulif may result in a greater risk of dangerous heart arrhythmias.
Danish: Denne medicin til behandling af kvalme og opkastninger kan sammen med Bosulif øge risikoen for farlige forstyrrelser i hjerterytmen.
English: Caution is recommended in patients with previous history of pancreatitis.
Danish: Det anbefales at udvise forsigtighed hos patienter med pankreatitis i anamnesen.
English: - nafcillin, an antibiotic used to treat bacterial infections.
Danish: - nafcillin, der er et antibiotikum til behandling af bakterieinfektioner.
English: Dispose unused medicinal product in accordance with local requirements.
Danish: Bortskaf ikke anvendt lægemiddel i henhold til lokale retningslinjer.
English: In case lipase elevations are accompanied by abdominal symptoms, bosutinib should be interrupted and appropriate diagnostic measures considered to exclude pancreatitis (see section 4.2).
Danish: Hvis lipasestigning er ledsaget af abdominale symptomer, skal behandlingen med bosutinib afbrydes og passende diagnostiske tiltag overvejes med henblik på udelukkelse af pankreatitis (se pkt.
English: Bosutinib treatment reduced the size of CML tumours growing in nude mice and inhibited growth of murine myeloid tumours expressing imatinib-resistant forms of BCR-ABL. Bosutinib also inhibits receptor tyrosine kinases c-Fms, EphA and B receptors, Trk family kinases, Axl family kinases, Tec family kinases, some members of the ErbB family, the non-receptor tyrosine kinase Csk, serine/threonine kinases of the Ste20 family, and 2 calmodulin-dependent protein kinases.
Danish: Bosutinibbehandling reducerede størrelsen af CML-tumorer, der voksede i nøgne mus, og hæmmede væksten af murine myeloide tumorer, der udtrykte imatinib-resistente former af BCR-ABL. Bosutinib hæmmer også receptortyrosinkinase c-Fms, EphA- og B-receptorer, Trk-familie-kinaserne, Axl-familie-kinaserne, Tec-familie-kinaserne, visse medlemmer af ErbB-familien, nonreceptortyrosinkinasen Csk, serin-/treonine-kinaserne fra Ste20-familien og to calmodulin-afhængige proteinkinaser.
English: Reproductive toxicity and development toxicity
Danish: Reproduktionstoksicitet og udviklingstoksicitet
English: Y253H E255K/V F359C/I/V
Danish: F359C/I/V
English: - The other ingredients are: microcrystalline cellulose (E460), croscarmellose sodium (E468), poloxamer 188, povidone (E1201) and magnesium stearate (E470b).
Danish: - Øvrige indholdsstoffer: Mikrokrystallinsk cellulose (E460), croscarmellosenatrium (E468), poloxamer 188, povidon (E1201) og magnesiumstearat (E470b).
English: Caution should be exercised in patients with relevant cardiac disorders (see section 4.4).
Danish: Der skal udvises forsigtighed hos patienter med relevante hjertesygdomme (se pkt.
English: The antiemetic agent, domperidone, has the potential to increase QT interval (QTc) prolongation and to induce “torsade de pointes”- arrhythmias; therefore, co-administration with domperidone should be avoided.
Danish: Det antiemetiske middel domperidon kan potentielt forlænge QT-intervallet (QTc) og inducere torsades de pointes-arytmier, derfor skal samtidig administration undgås.
English: If you stop taking Bosulif
Danish: Hvis du holder op med at tage Bosulif
English: Patients receiving bosutinib should have liver function tests prior to treatment initiation and monthly for the first 3 months of treatment, and as clinically indicated.
Danish: Patienter, der får bosutinib, skal have testet deres leverfunktion, før behandlingen påbegyndes og månedligt i de første tre behandlingsmåneder samt efter klinisk behov.
English: In particular, you should ask your doctor if you want to use a medicine containing domperidone for the treatment of nausea and/or vomiting.
Danish: Du skal især tale med lægen, hvis du overvejer at bruge medicin, som indeholder domperidon mod kvalme og opkastning.
English: Statistically significant comparison at the pre-specified significance level; based on CMH test stratified by geographical region and Sokal score at randomisation.
Danish: Statistisk signifikant sammenligning på det forhåndsdefinerede signifikansniveau; baseret på CMH-test, der er stratificeret efter geografisk område og Sokal-score ved randomisering.
English: Patients with diarrhoea and vomiting should be managed using standard-of-care treatment, including an antidiarrhoeal or antiemetic medicinal product and/or fluid replacement.
Danish: Patienter med diarré og opkastning skal behandles med standardbehandling, inklusive antidiarrémidler eller antiemetika og/eller væskesubstitution.
English: Your doctor should do blood tests to check your liver function prior to your starting treatment with Bosulif and for the first 3 months of treatment with Bosulif, and as clinically indicated.
Danish: Lægen bør tage blodprøver for at kontrollere din leverfunktion, før du starter behandling med Bosulif, i de første tre måneder af behandlingen med Bosulif og derefter efter behov.
English: Bosutinib activity in vitro in hERG assays suggested a potential for prolongation of cardiac ventricular repolarisation (QTc).
Danish: Bosutinibs aktivitet in vitro i hERG-analyser tyder på, at det har potentiale til at forlænge den kardiale-ventrikulære repolarisering (QT-intervallet).
English: The trial randomised 536 patients (268 in each treatment group) with Ph+ or Ph- newly-diagnosed CP CML (intent-to-treat population [ITT]) including 487 patients with Ph+ CML harbouring b2a2 and/or b3a2 transcripts and baseline BCR-ABL copies > 0 (modified intent-to-treat [mITT] population).
Danish: I forsøget blev 536 patienter (268 i hver behandlingsgruppe) med nydiagnosticeret Ph+ eller Ph- CP CML (intent-to-treat-population (ITT)) randomiseret, herunder 487 patienter med Ph+ CML med b2a2- og/eller b3a2-transskripter og baseline-BCR-ABL-kopier > 0 (modificeret intent-to-treat-population (mITT)).
English: Platelets < 50 × 109/L
Danish: Trombocytter < 50 x 10 9/l
English: Bosutinib minimally inhibits platelet-derived growth factor (PDGF) receptor and c-Kit.
Danish: Bosutinib hæmmer PDGF-receptoren (platelet derived growth factor) og cKit i minimal grad.
English: In a rat fertility study, fertility was slightly decreased in males.
Danish: I et fertilitetsforsøg med rotter var fertiliteten let nedsat hos handyr.
English: Pfizer ApS Tlf: +45 44 20 11 00
Danish: Danmark Pfizer ApS Tlf: +45 44 20 11 00
English: Summary of safety profile
Danish: Sikkerhedsprofil
English: Patients with serum creatinine > 1.5 × ULN were excluded from the CML studies.
Danish: Patienter med serumkreatinin > 1,5 x ULN blev udelukket fra CML-studierne.
English: The analyses allow baseline responders who maintained response post-baseline to be responders.
Danish: I analysen tillades baseline-respondenter som fastholdt respons efter baseline.
English: Patients with serum creatinine > 1.5×ULN were excluded from CML studies.
Danish: Patienter med serumkreatinin > 1,5 x ULN blev udelukket fra CML-studier.
English: Among the 994 patients with diarrhoea, 180 patients (18%) were managed with treatment interruption and of these 170 (94%) were rechallenged with bosutinib.
Danish: Blandt de 994 patienter med diarré afbrød 180 patienter (18 %) behandlingen, og 170 af disse patienter (94 %) genoptog senere bosutinib-behandlingen.
English: Women of childbearing potential should be advised to use effective contraception during treatment with bosutinib and for at least 1 month after the last dose and to avoid becoming pregnant while receiving bosutinib.
Danish: Kvinder i den fertile alder skal rådes til at anvende sikker kontraception under behandlingen med bosutinib og i mindst 1 måned efter den sidste dosis for at undgå graviditet under behandlingen med bosutinib.
English: In in vitro studies, bosutinib inhibits proliferation and survival of established CML cell lines, Ph+ ALL cell lines, and patient-derived primary primitive CML cells.
Danish: I in vitro-studier hæmmer bosutinib proliferationen og overlevelsen af etablerede CML-cellelinjer, Ph+ akut lymfoblastisk leukæmi-cellelinjer og patientderiverede primære primitive CML-celler.
English: The tablet film-coating contains polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b) and iron oxide yellow (E172, for Bosulif 100 mg and 400 mg) or iron oxide red (E172, for Bosulif 400 mg and 500 mg).
Danish: Tabletternes filmovertræk indeholder polyvinylalkohol, titandioxid (E171), macrogol 3350, talcum (E553b) og gul jernoxid (E172, 100 mg og 400 mg tablet) eller rød jernoxid (E172, 400 mg og 500 mg tablet).
English: Rare side effects (may affect up to 1 in 1,000 people): - severe skin disorder (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative (scaly, peeling) rash.
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter): - alvorlig hudsygdom pga. en allergisk reaktion, (erythema multiforme, Stevens-Johnsons syndrom, toksisk epidermal nekrolyse), udslæt med afstødning af hudens øverste lag.
English: At least 1 Grade 3 or Grade 4 adverse reaction was reported for 814 (63.9%) patients.
Danish: Der blev set mindst 1 grad 3- eller 4-bivirkning hos 814 (63,9%) af patienterne.
English: Table 6 - Response by baseline BCR-ABL mutation status in CP CML evaluable population: prior imatinib and dasatinib and/or nilotinib (third-line)
Danish: Skema 6 - Respons efter baseline-BCR-ABL-mutationsstatus hos den CP CML-evaluerbare population: tidligere behandling med imatinib og dasatinib og/eller nilotinib (tredje linie)
English: - diarrhoea, vomiting, stomach pain, nausea.
Danish: - diarré, opkastning, mavesmerter, kvalme.
English: The solubility of bosutinib is pH-dependent and absorption is reduced when gastric pH is increased (see section 4.5).
Danish: Opløseligheden af bosutinib er pH-afhængig, og absorptionen reduceres i takt med stigende pH (se pkt.
English: Ph+ CP CML with prior treatment with imatinib and dasatinib or nilotinib
Danish: Ph+ CP CML tidligere behandlet med imatinib og dasatinib eller nilotinib
English: Repeated-dose toxicity
Danish: Toksicitet efter gentagne doser
English: The following adverse reactions were reported in patients in bosutinib clinical studies (Table 2).
Danish: Nedenstående bivirkninger er set hos patienter i kliniske studie med bosutinib (skema 2).
English: In vitro and in vivo studies indicated that bosutinib (parent compound) undergoes predominantly hepatic metabolism in humans.
Danish: In vitro- og in vivo-studier tyder på, at bosutinib (moderstoffet) fortrinsvis metaboliseres i leveren hos mennesker.
English: In vitro studies indicate that bosutinib has a low potential to inhibit breast cancer resistance protein (BCRP, systemically), organic anion transporting polypeptide (OATP)1B1, OATP1B3, organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2 at clinically relevant concentrations, but may have the potential to inhibit BCRP in the gastrointestinal tract and OCT1.
Danish: In vitro-studier tyder på, at bosutinib har lavt potentiale for at hæmme brystcancer-resistensprotein (BCRP, systemisk), organisk anion-transporterende polypeptid (OATP)1B1, OATP1B3, organisk anion-transportør (OAT)1, OAT3, organisk kation-transportør (OCT)2 i klinisk relevante koncentrationer, men har muligvis potentiale for at hæmme BCRP i mave-tarmkanalen og OCT1.
English: - phenytoin and carbamazepine, used to treat epilepsy.
Danish: - phenytoin og carbamazepin, der anvendes til behandling af epilepsi.
English: Short-acting antacids should be considered as an alternative to PPIs and administration times of bosutinib and antacids should be separated (i.e. take bosutinib in the morning and antacids in the evening) whenever possible.
Danish: Det bør overvejes at anvende korttidsvirkende antacida i stedet for PPI'er, og bosutinib og antacida skal om muligt administreres på separate tidspunkter (f.eks. kan bosutinib tages om morgenen og antacida om aftenen).
English: Of these patients, 268 (400 mg starting dose) and 248 (500 mg starting dose) are from the 2 Phase 3 studies in previously untreated CML patients, 570 and 63 are from 2 Phase 1/2 studies in previously treated Ph+ leukaemias, and 123 patients from a Phase 4 study in previously treated CML.
Danish: Af disse patienter deltog 268 (startdosis på 400 mg) og 248 (startdosis på 500 mg) i de 2 fase 3-studier hos tidligere ikke-behandlede CML-patienter, og 570 henholdsvis 63 deltog i de 2 fase 1/2-studier hos tidligere behandlede patienter med Ph+-leukæmi, og 123 patienter deltog i et fase 4-studie hos tidligere behandlede CML-patienter.
English: Diarrhoea and vomiting
Danish: Diarré og opkastning
English: At least 1 adverse reaction of any toxicity grade was reported for 1,240 (97.5%) patients.
Danish: Der blev set mindst 1 bivirkning af alle grader hos 1.240 (97,5%) af patienterne.
English: Histopathologically, luminal dilation, goblet cell hyperplasia, haemorrhage, erosion, and oedema of the intestinal tract, and sinus erythrocytosis and haemorrhage in the mesenteric lymph nodes, were observed.
Danish: Der blev set histopatologisk luminal dilation, slimcellehyperplasi, hæmoragi, erosion og ødem i tarmkanalen og sinus-erytrocytose og hæmoragi i de mesenteriale lymfeknuder.
English: The primary efficacy endpoint was the proportion demonstrating a major molecular response (MMR) at 12 months (48 weeks) in the bosutinib treatment group compared with that in the imatinib treatment group in the mITT population.
Danish: Det primære effektendepunkt var andelen, der udviste major molekylært respons (MMR) efter 12 måneder (48 uger) i bosutinib-behandlingsgruppen, sammenlignet med andelen i imatinibbehandlingsgruppen i mITT-populationen.
English: Newly-diagnosed CP Ph+ CML The recommended dose is 400 mg bosutinib once daily.
Danish: Nydiagnosticeret CP Ph+ CML Den anbefalede dosis er 400 mg bosutinib 1 gang dagligt.
English: Mutation assessed No mutation At least 1 mutation Dasatinib resistant mutations E255K/V F317L Nilotinib resistant mutations c
Danish: Mindst 1 mutation Dasatinib-resistente mutationer E255K/V
English: Treatment with bosutinib is associated with myelosuppression, defined as anaemia, neutropenia, and thrombocytopenia.
Danish: Myelosuppression Behandling med bosutinib er forbundet med myelosuppression, defineret som anæmi, neutropeni og trombocytopeni.
English: If you forget to take Bosulif
Danish: Hvis du har glemt at tage Bosulif
English: The Kaplan-Meier estimates of OS at 48 weeks for bosutinib and imatinib patients in the mITT population were 99.6% (95% CI: 97.1%, 99.9%) and 97.9% (95% CI: 95.0%, 99.1%), respectively.
Danish: Kaplan-Meier-estimaterne af OS efter 48 uger for bosutinib- og imatinib-patienter i mITTpopulationen var henholdsvis 99,6 % (95 % CI: 97,1 %-99,9 %) og 97,9 % (95 % CI: 95,0 %-99,1 %).
English: Overall, % (95% CI) Major, % (95% CI) Complete, % (95% CI)
Danish: Samlet, % (95 % CI) Major, % (95 % CI) Komplet, % (95 % CI)
English: Bosutinib is not recommended for use during pregnancy, or in women of childbearing potential not using contraception.
Danish: Det frarådes at anvende bosutinib under graviditeten og hos kvinder i den fertile alder, der ikke anvender kontraception.
English: If you have any questions about how Bosulif works or why this medicine has been prescribed for you, ask your doctor.
Danish: Kontakt lægen, hvis du har spørgsmål om, hvordan Bosulif virker, eller hvorfor du har fået ordineret dette lægemiddel.
English: The median time to MMR for responders was 24.7 weeks versus 36.3 weeks for the bosutinib treatment and imatinib treatment groups, respectively, in the mITT population.
Danish: Mediantiden til MMR for respondenter var 24,7 uger over for 36,3 uger for henholdsvis bosutinib-behandlingsgruppen og imatinib-behandlingsgruppen i mITT-populationen.
English: Cmax of bosutinib in plasma increased 2.4-fold, 2-fold, and 1.5-fold, respectively, in Child-Pugh classes A, B, and C; and bosutinib AUC in plasma increased 2.3-fold, 2-fold, and 1.9-fold, respectively.
Danish: Cmax af bosutinib i plasma var 2,4 gange, 2 gange og 1,5 gange højere ved hhv. Child-Pugh-klasse A, B og C, mens AUC af bosutinib var hhv. 2,3 gange, 2 gange og 1,9 gange højere.
English: Based on the large reduction in bosutinib exposure that occurred when bosutinib was co-administered with rifampicin, increasing the dose of bosutinib when co-administering with strong or moderate CYP3A inducers is unlikely to sufficiently compensate for the loss of exposure.
Danish: Baseret på den store reduktion i bosutinib-eksponeringen når det blev administreret sammen med rifampicin, er det sandsynligvis ikke tilstrækkeligt at øge bosutinibdosis for at kompensere for den reducerede eksponering ved administration sammen med potente eller moderate CYP3A-induktorer.
English: If possible, show the doctor the pack, or this leaflet.
Danish: Medbring om muligt pakningen eller denne indlægsseddel.
English: Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.
Danish: I nogle tilfælde har dette medført akut leversvigt eller fulminant hepatitis, førende til levertransplantation eller fatalt udfald.
English: The primary efficacy endpoint of the study was the major cytogenetic response (MCyR) rate at Week 24 in patients with imatinib-resistant CP CML previously treated with only 1 prior TKI (imatinib).
Danish: Det primære effektmål i dette studie var major cytogenetisk respons (MCyR)-rate i uge 24 hos patienter med imatinibresistent CP CML, som forinden kun var blevet behandlet med 1 TKI (imatinib).
English: Time to OHR for responders only, weeks (95% CI)
Danish: Tid til OHR hos respondenter alene, uger (95 % CI)