FrancophonIA/ELRC3.0 huggingface dataset:
English: Infusion-related reactions is a composite term that includes the term infusion-related reaction and the following events occurring with the first 48 hours of infusion and event lasted <=2 days: pyrexia, cytokine release syndrome, hypotension, myalgia, acute kidney injury, hypertension, rash, tachypnea, swelling face, face oedema and rash erythematous.
Danish: Infusionsrelaterede reaktioner er en sammensat term, der omfatter termen infusionsrelateret reaktion og følgende bivirkninger, der er opstået inden for de første 48 timer efter infusionen, og som har varet <=2 dage: pyreksi, cytokinfrigivelsessyndrom, hypotension, myalgi, akut nyreskade, hypertension, udslæt, takypnø, hævelser i ansigtet, ansigtsødem og erytematøst udslæt.
English: Prior alloHSCT ECOG status - n (%)
Danish: Tidligere allo-HSCT ECOG-status - n (%)
English: However patients have been treated with blinatumomab in clinical studies after clearance of CSF blasts with CNS directed therapy (such as intrathecal chemotherapy).
Danish: Der er dog patienter, som er blevet behandlet med blinatumomab i kliniske studier efter fjernelse af CSV-blastceller med behandling rettet mod CNS (for eksempel intratekal kemoterapi).
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or 4 hours at or below 27°C.
Danish: Den kemiske og fysiske stabilitet efter åbning er påvist i 24 timer ved 2 °C - 8 °C eller 4 timer ved maksimalt 27 °C.
English: There were no effects on male or female reproductive organs in toxicity studies with the murine surrogate.
Danish: Der var ingen virkninger på hanners eller hunners forplantningsorganer i toksicitetsstudier med det murine surrogat.
English: ), see table 4.
Danish: ), se tabel 4.
English: Patients were randomised 2:1 to receive BLINCYTO or 1 of 4 prespecified, investigator-selected, SOC backbone chemotherapy regimens.
Danish: Patienterne blev randomiseret i forholdet 2:1 til at få BLINCYTO eller 1 ud af 4 præspecificerede af investigator udvalgte SB kemoterapiregimer af rygrad.
English: 3 Thrombocytopenia includes platelet count decreased and thrombocytopenia.
Danish: 3 Thrombocytopeni omfatter fald i thrombocytter samt thrombocytopeni.
English: Peripheral B-cell counts decreased rapidly to an undetectable level during treatment at doses ≥ 5 mcg/m 2/day or ≥ 9 mcg/day in the majority of patients.
Danish: Antallet af perifere B-celler faldt hurtigt til et ikke-påviseligt niveau under behandlingen ved doser på ≥ 5 mikrog/m2/dag eller ≥ 9 mikrog/dag hos størstedelen af patienterne.
English: For patients with ≥ 50% leukaemic blasts in bone marrow or > 15,000/microlitre peripheral blood leukaemic blast counts treat with dexamethasone (not to exceed 24 mg/day).
Danish: Patienter med ≥ 50 % leukæmiske blastceller i knoglemarv eller et antal leukæmiske blastceller i perifert blod på > 15.000/mikroliter behandles med dexamethason (ikke over 24 mg/dag).
English: Storage conditions and shelf life
Danish: Opbevaringsbetingelser og holdbarhed
English: Patients in 3
Danish: Patienter i 3.
English: BLINCYTO is used when acute lymphoblastic leukaemia has come back or has not responded to previous treatment (referred to as relapsed/refractory acute lymphoblastic leukaemia).
Danish: BLINCYTO anvendes, hvis akut lymfoblastisk leukæmi er vendt tilbage eller ikke har reageret på tidligere behandling (det kaldes recidiveret/refraktær akut lymfoblastisk leukæmi).
English: The recommended dose for the PK expansion and efficacy parts of the study was determined to be 5 mcg/m 2/day on days 1-7 and 15 mcg/m 2/day on days 8-28 for cycle 1, and 15 mcg/m2/day on days 1-28 for subsequent cycles.
Danish: Den anbefalede dosis for studiets dele til farmakokinetisk udbygning og undersøgelse af effekt blev bestemt til at være 5 mikrog/m2/dag på dag 1-7 og 15 mikrog/m2/dag på dag 8-28 i cyklus 1, og 15 mikrog/m2/dag på dag 1-28 i de efterfølgende cyklusser.
English: BLINCYTO is usually given for 2 treatment cycles if you have relapsed/refractory acute lymphoblastic leukaemia, or for 1 treatment cycle if you have minimal residual disease acute lymphoblastic leukaemia.
Danish: BLINCYTO gives normalt i 2 behandlingscyklusser, hvis du har recidiveret/refraktær akut lymfoblastisk leukæmi, eller i 1 behandlingscyklus, hvis du har minimal residual sygdom i forbindelse med akut lymfoblastisk leukæmi.
English: The infusion bag must be changed at least every 96 hours by a healthcare professional for sterility reasons.
Danish: Af hensyn til steriliteten skal infusionsposen udskiftes for mindst hver 96 timer af sundhedspersonalet.
English: • the infusion bag empties before the scheduled bag change
Danish: • Infusionsposen tømmes før den planlagte udskiftning af posen.
English: Incomplete depletion of B-cells occurred at doses of 0.5 mcg/m 2/day and 1.5 mcg/m 2/day and in a few non-responders at higher doses.
Danish: Ufuldstændig depletering af B-celler forekom ved doser på 0,5 mikrog/m2/dag og 1,5 mikrog/m2/dag hos nogle få non-respondenter ved højere doser.
English: Serious and grade ≥ 3 adverse reactions (such as ALT increased, AST increased, and blood bilirubin increased) were observed in 1.5% and 13.6% of patients respectively.
Danish: Der blev observeret alvorlige bivirkninger og bivirkninger grad ≥ 3 (for eksempel forhøjet ALAT, forhøjet ASAT og forhøjet bilirubin i blodet) hos henholdsvis 1,5 % og 13,6 % af patienterne.
English: - if you are breast-feeding.
Danish: - hvis du ammer.
English: Consequently, as a precautionary measure, breast-feeding is contraindicated during and for at least 48 hours after treatment with blinatumomab.
Danish: Som en sikkerhedsforanstaltning er amning derfor kontraindiceret under behandling og i mindst 48 timer efter behandling med blinatumomab.
English: Direct the water for injections toward the side of the vial during reconstitution.
Danish: Ret vandet til injektion mod siden af hætteglasset under rekonstitution.
English: At the clinical doses of 9 mcg/day and 28 mcg/day for the treatment of relapsed/refractory ALL, the mean (SD) Css was 230 (359) pg/mL and 612 (532) pg/mL, respectively.
Danish: Ved kliniske doser på 9 mikrog/dag og 28 mikrog/dag i behandlingen af recidiveret/refraktær ALL var den gennemsnitlige (SD) Css henholdsvis 230 (359) pg/ml og 612 (532) pg/ml.
English: Intravenous use after reconstitution and dilution.
Danish: Intravenøs anvendelse efter rekonstitution og fortynding.
English: The metabolic pathway of blinatumomab has not been characterised.
Danish: Blinatumomabs metaboliseringsvej er ikke beskrevet.
English: The most serious adverse reactions that may occur during blinatumomab treatment include: infections (24.8%), neurologic events (13.8%), neutropenia/febrile neutropenia (10.1%), cytokine release syndrome (3.3%), and tumour lysis syndrome (0.7%).
Danish: De mest alvorlige bivirkninger, der kan opstå i forbindelse med behandling med blinatumomab, inkluderer: infektioner (24,8 %), neurologiske hændelser (13,8 %), neutropeni/febril neutropeni (10,1 %), cytokinfrigivelsessyndrom (3,3 %) og tumorlysesyndrom (0,7 %).
English: Do not use BLINCYTO: - if you are allergic to blinatumomab or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke BLINCYTO: - hvis du er allergisk over for blinatumomab eller et af de øvrige indholdsstoffer i BLINCYTO
English: At the recommended doses, the mean (SD) steady state concentration (Css) values were 162 (179) and 533 (392) pg/mL at 5 and 15 mcg/m2/day doses, respectively.
Danish: Med de anbefalede doser var de gennemsnitlige (SD) værdier for steady state-koncentration (Css) 162 (179) og 533 (392) pg/ml ved doser på henholdsvis 5 og 15 mikrog/m2/dag.
English: During treatment, especially in the first few days after treatment start, you may experience a severe low white blood cell count (neutropenia), severe low white blood cell count with a fever (febrile neutropenia), elevated liver enzymes, or elevated uric acid.
Danish: Under behandlingen, især i de første par dage efter starten af behandlingen, vil du muligvis opleve et kraftigt fald i antallet af hvide blodlegemer (neutropeni), et kraftigt fald i antallet af hvide blodlegemer sammen med feber (febril neutropeni), stigninger i leverenzymer eller stigninger i urinsyre.
English: Complete remission (CR) CR a/CRh*
Danish: Komplet remission (CR) CR a/CRh*
English: Characteristic
Danish: Karakteristika
English: A single cycle of treatment of BLINCYTO induction or consolidation is 28 days (4 weeks) of continuous intravenous infusion followed by a 14 day (2 week) treatment-free interval (total 42 days).
Danish: En enkelt behandlingscyklus af BLINCYTO induktionseller konsolideringsbehandling er 28 dages (4 ugers) kontinuerlig intravenøs infusion adskilt af et 14 dages (2 ugers) behandlingsfrit interval (samlet 42 dage).
English: 100 day mortality after alloHSCT n/N (%), [95% CI]
Danish: 100-dages mortalitet efter allo-HSCT n/N (%), [95 % CI]
English: Among treated patients, the median age was 8 years (range: 7 months to 17 years), 40 out of 70 (57.1%) had undergone allogeneic HSCT prior to receiving BLINCYTO, and 39 out of 70 (55.7%) had refractory disease.
Danish: De behandlede patienters mediane alder var 8 år (interval: 7 måneder til 17 år), 40 ud af 70 (57,1 %) havde fået allogen HSCT, inden de fik BLINCYTO, og 39 ud af 70 (55,7 %) havde refraktær sygdom.
English: Overall survival
Danish: Samlet overlevelse
English: Unopened vials: - Store and transport refrigerated (2°C - 8°C).
Danish: Uåbnede hætteglas: - Opbevares og transporteres i køleskab (2 °C - 8 °C).
English: Haemophagocytic histiocytosis/macrophage activation syndrome (MAS) has been uncommonly reported in the setting of CRS.
Danish: Der er i ikke almindelige tilfælde indberettet hæmofagocytisk histiocytose/makrofagaktiveringssyndrom (MAS) i forbindelse med CRS.
English: The target therapeutic dose of BLINCYTO delivered does not change.
Danish: Den målsatte terapeutiske dosis BLINCYTO, der tilføres, er den samme.
English: Other clinically relevant (as determined by treating physician) adverse reactions
Danish: Andre klinisk relevante (ifølge den behandlende læge) bivirkninger
English: Blinatumomab is a bispecific T-cell engager antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells.
Danish: Blinatumomab er en bispecific T-cell engager antistofplatform, som binder specifikt til CD19, der udtrykkes på overfladen af celler med oprindelse i B-linjen, og CD3, der udtrykkes på overfladen af T-celler.
English: Tell your doctor, pharmacist or nurse immediately if you became pregnant whilst receiving BLINCYTO.
Danish: Fortæl det straks til lægen, apotekspersonalet eller sundhedspersonalet, hvis du bliver gravid, mens du får BLINCYTO.
English: The hazard ratio (95% CI) was 0.71 (0.55, 0.93) between treatment arms favouring BLINCYTO, indicated a 29% reduction in hazard rate in the BLINCYTO arm (p-value = 0.012 (stratified log-rank test)), see figure 1.
Danish: Hazard ratio (95 % CI) var 0,71 (0,55; 0,93) mellem behandlingsarmene i BLINCYTOs favør, hvilket viste et fald på 29 % i hazard ratio i BLINCYTOarmen (p-værdi = 0,012 [stratificeret log-rank-test]) - se figur 1.
English: Solution (stabiliser): Colourless-to-slightly yellow, clear solution with a pH of 7.0.
Danish: Opløsning (stabilisator): Farveløs til lysegul klar opløsning med en pH-værdi på 7,0.
English: If you have a catheter for infusion, it is very important to keep the area around the catheter clean; otherwise you could get an infection.
Danish: Hvis du får anlagt et kateter til infusionen, er det meget vigtigt, at du holder området omkring kateteret rent.
English: Table 1 provides instructions for patients weighing greater than or equal to 45 kg whereas table 2 and table 3 provide instructions for patients weighing less than 45 kg.
Danish: Tabel 1 indeholder instruktioner for patienter, der vejer 45 kg eller derover, og tabel 2 og tabel 3 indeholder instruktioner for patienter, der vejer under 45 kg.
English: Patients in 2
Danish: Patienter i 2.
English: 28 mcg/day via continuous infusion
Danish: 28 mikrog/dag ved kontinuerlig infusion
English: Nervous system disorders a
Danish: Nervesystemet a
English: 7 Tachycardia includes sinus tachycardia, supraventricular tachycardia and tachycardia.
Danish: Takykardi omfatter sinustakykardi, supraventrikulær takykardi og takykardi.
English: 5 Leukocytosis includes leukocytosis and white blood cell count increased.
Danish: Leukocytose omfatter leukocytose og stigning i hvide blodlegemer.
English: • rapid heart rate (tachycardia)
Danish: • hurtig hjerterytme (takykardi)
English: 9 mcg/day via continuous infusion
Danish: 9 mikrog/dag ved kontinuerlig infusion
English: Frequency categories were determined from the crude incidence rate reported for each adverse reaction in clinical studies of patients with B-precursor ALL (N = 843).
Danish: Frekvensgrupperne blev fastlagt ud fra den rå incidensrate, der er indberettet for hver bivirkning i kliniske studier med patienter med B-prækursor ALL (N = 843).
English: In patients with non-CNS/non-testes extramedullary disease (defined as at least 1 lesion ≥ 1.5 cm) at screening (N = 8/189) clinical response rates (25% [95% CI: 3.2-65.1] were lower compared with patients with no evidence of extramedullary disease (N = 181, 43.6% [95% CI: 36.3 - 51.2]) (see figure 2).
Danish: Hos patienter med ekstramedullær sygdom uden for CNS/uden for testes (defineret som mindst 1 læsion på ≥ 1,5 cm) ved screeningen (N = 8/189) var de kliniske responsrater (25 % [95 % CI: 3,2 - 65,1] lavere end hos patienter uden tegn på ekstramedullær sygdom (N = 181, 43,6 % [95 % CI: 36,3 - 51,2]) (se figur 2).
English: Grade 3 (CTCAE version 4.0) or higher (severe or life-threatening) neurologic events following initiation of blinatumomab administration included encephalopathy, seizures, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders.
Danish: Neurologiske hændelser grad 3 (CTCAE version 4.0) eller derover (alvorlige eller livstruende) efter initiering af blinatumomab omfattede encefalopati, kramper, taleforstyrrelser, bevidsthedsforstyrrelser, konfusion og desorientering samt koordinations- og balanceforstyrrelser.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Due to the potential depletion of B-cells in newborns following exposure to blinatumomab during pregnancy, newborns should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant's B-cell count has recovered (see section 4.6).
Danish: På grund af muligheden for depletering af B-celler hos nyfødte efter eksponering for blinatumomab under graviditeten skal nyfødte monitoreres for depletering af B-celler, og vaccinationer med levende virusser skal udsættes, indtil barnets antal B-celler igen er inden for det normale område (se pkt.
English: Cytokine release syndrome and infusion reactions
Danish: Cytokinfrigivelsessyndrom og infusionsreaktioner
English: Survival Probability
Danish: Overlevelsessandsynlighed
English: • fever (pyrexia), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (oedema), chills
Danish: • feber (pyreksi), hævelse i ansigt, læber, mund, tunge eller hals, der kan give problemer med at synke eller trække vejret (ødem), kulderystelser
English: Do not shake the reconstituted solution.
Danish: Den rekonstituerede opløsning må ikke omrystes.
English: In a post-hoc sensitivity analysis, compared to SOC, BLINCYTO consistently delayed the time to clinically meaningful deterioration of HRQoL (≥ 10-point worsening from baseline) for global health status [median BLINCYTO versus SOC: 8.1 months versus 1.0 month; HR = 0.60 (95% CI = 0.42, 0.85)], functional scales, symptom scales and individual items.
Danish: Sammenlignet med standardbehandlingen udsatte BLINCYTO i en post hoc-sensitivitetsanalyse konsekvent tiden indtil klinisk relevant forværring af HRQoL (≥ 10 point forværring i forhold til baseline) for global helbredsstatus [medianBLINCYTO vs. SB: 8,1 måneder vs. 1,0 måned; HR = 0,60 (95 % CI = 0,42; 0,85)], funktionelle skalaer, symptomskalaer og individuelle punkter.
English: - Store in the original carton in order to protect from light.
Danish: - Opbevares i den originale karton for at beskytte mod lys.
English: To coat the infusion bag, using a syringe, aseptically transfer 5.5 mL of the solution (stabiliser) to the infusion bag.
Danish: Brug en sprøjte til overfladebehandling af infusionsposen og overfør 5,5 ml af opløsningen (stabilisatoren) aseptisk til infusionsposen.
English: When considering the use of BLINCYTO as a treatment for Philadelphia chromosome negative MRD positive B-precursor ALL, quantifiable MRD should be confirmed in a validated assay with minimum sensitivity of 10
Danish: Hvis det overvejes at bruge BLINCYTO som behandling af Philadelphia-kromosom-negativ MRD-positiv B-prækursor ALL, skal kvantificerbart MRD bekræftes i en valideret analyse med en minimumssensitivitet på 10
English: Number of subjects at Risk
Danish: Antal patienter med risiko måneder
English: Disseminated intravascular coagulation (DIC) and capillary leak syndrome (CLS, e.g. hypotension, hypoalbuminaemia, oedema and haemoconcentration) have been commonly associated with CRS (see section 4.8).
Danish: Dissemineret intravaskulær koagulation (DIC) og kapillær lækage-syndrom (CLS, fx hypotension, hypoalbuminæmi, ødem og hæmokoncentration) har almindeligvis været forbundet med CRS (se pkt.
English: • Sterile single-use disposable syringes
Danish: • Sterile engangssprøjter.
English: Each BLINCYTO pack contains 1 vial of powder for concentrate for solution for infusion and 1 vial of solution (stabiliser):
Danish: Hver BLINCYTO-pakning indeholder 1 hætteglas med pulver til koncentrat til infusionsvæske, opløsning, og 1 hætteglas med opløsning (stabilisator):
English: • Do not refrigerate or freeze the package.
Danish: • Du må ikke opbevare pakningen i køleskabet eller fryseren.
English: MRD status at screening was determined from bone marrow aspirations using flow cytometry or polymerase chain reaction (PCR) at a minimum sensitivity of 10
Danish: MRD-status ved screening blev fastlagt ud fra knoglemarvsaspirater ved brug af flowcytometri eller polymerasekædereaktion (PCR) med en minimumssensitivitet på 10
English: Discard the remaining solution (stabiliser) vial.
Danish: Kassér den resterende opløsning (stabilisator) i hætteglasset.
English: Consequently, newborns should be monitored for B-cell depletion and vaccinations with live virus vaccines should be postponed until the infant's B-cell count has recovered (see section 4.4).
Danish: Nyfødte skal derfor monitoreres for depletering af B-celler, og vaccinationer med levende virusser skal udsættes, indtil barnets antal B-celler igen er inden for det normale område (se pkt.
English: • The addition of water for injections to the powder for concentrate results in a total volume of 3.08 mL for a final BLINCYTO concentration of 12.5 mcg/mL.
Danish: • Tilsætning af vand til injektionsvæsker i pulveret til koncentrat giver en samlet volumen på 3,08 ml med en endelig BLINCYTO-koncentration på 12,5 mikrog/ml.
English: Solution (stabiliser)
Danish: Opløsning (stabilisator)
English: Aseptic preparation
Danish: Aseptisk klargøring
English: Discontinue BLINCYTO permanently if more than one convulsion occurs.
Danish: Seponér BLINCYTO permanent, hvis der er mere end ét krampeanfald.
English: Immunisations
Danish: Immunisering
English: Pharmacokinetic analyses showed an approximately 2-fold difference in mean blinatumomab clearance values between patients with moderate renal dysfunction and normal renal function.
Danish: Farmakokinetiske analyser viste en omtrent dobbelt forskel i den gennemsnitlige clearance af blinatumomab hos patienter med moderat nyredysfunktion og patienter med normal nyrefunktion.
English: • if you have ever had neurological problems, for example, shaking (or tremor), abnormal sensations, seizures, memory loss, confusion, disorientation, loss of balance, or difficulty in speaking.
Danish: • Hvis du tidligere har haft neurologiske problemer, for eksempel rysten (tremor), abnorme fornemmelser, krampeanfald, hukommelsestab, forvirring, desorientering, tab af balance eller taleproblemer.
English: • 10 mL solution in a vial (type I glass) with a stopper (elastomeric rubber), seal (aluminium)
Danish: • 10 ml opløsning i et hætteglas (type I-glas) med en prop (elastomer), forsegling (aluminium) og vippelåg
English: 4.5 months (3.6, 9.0)
Danish: 4,5 måneder (3,6; 9,0)
English: At a dose higher than the recommended dose, a case of fatal cardiac failure occurred in the setting of life-threatening cytokine release syndrome (CRS) and tumour lysis syndrome (TLS), see section 4.4.
Danish: Ved en dosis, der var højere end den anbefalede dosis, opstod der et tilfælde af fatal hjerteinsufficiens i forbindelse med livstruende cytokinfrigivelsessyndrom (CRS) og tumorlysesyndrom (TLS), se pkt.
English: Patients with low tumour burden (< 50%) responded best to BLINCYTO treatment with CR/CRh* rate of 72.9% (CI 59.7 - 83.6).
Danish: Patienter med lille tumorbyrde (< 50 %) reagerede bedst på behandling med BLINCYTO med en CR/CRh*-rate på 72,9 % (CI: 59,7 - 83,6).
English: There is limited experience in patients with a history or presence of clinically relevant central nervous system (CNS) pathology (e.g. epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis) as they were excluded from clinical trials.
Danish: Der er begrænset erfaring med patienter med anamnetisk eller aktuel klinisk relevant patologi i CNS (fx epilepsi, kramper, parese, afasi, slagtilfælde, alvorlige hjerneskader, demens, Parkinsons sygdom, cerebellar sygdom, organisk hjernesyndrom, psykose), da disse patienter har været udelukket fra kliniske studier.
English: • Recommendation for patients not to drive while receiving BLINCYTO A link to the package leaflet
Danish: • Anbefaling til patienterne om ikke at køre bil, mens de får BLINCYTO Et link til indlægssedlen
English: Your doctor will take regular blood tests during treatment with BLINCYTO.
Danish: Din læge vil regelmæssigt tage blodprøver under behandlingen med BLINCYTO.
English: • increased levels of white blood cell count (leucocytosis), decreased levels of certain white blood cells (lymphopenia)
Danish: • forhøjede niveauer af hvide blodlegemer (leukocytose), nedsatte niveauer af bestemte hvide blodlegemer (lymfopeni)
English: Leukocytosis Lymphopenia
Danish: Leukocytose Lymfopeni
English: Capillary leak syndrome was observed in 1 patient in the phase II clinical study in adult patients with relapsed or refractory B-precursor ALL and in 1 patient in the phase 2 clinical study in adult patients with MRD positive B-precursor ALL.
Danish: Der blev observeret kapillær lækage-syndrom hos 1 patient i det kliniske fase II-studie hos voksne patienter med recidiveret eller refraktær B-prækursor ALL samt hos 1 patient i det kliniske fase II-studie hos voksne patienter med MRD-positiv B-prækursor ALL.
English: Infusion reactions may be clinically indistinguishable from manifestations of CRS (see section 4.8).
Danish: Klinisk kan infusionsreaktioner være svære at skelne fra manifestationer af CRS (se pkt.
English: Patients with the highest tumour burden as measured by the percentage of bone marrow blast cells at baseline (≥ 90%) still had a clinically meaningful response with a CR/CRh* rate of 21.6% (CI 12.9 - 32.7) (see figure 2).
Danish: Patienter med den største tumorbyrde, målt som procentdelen af blastceller i knoglemarv ved baseline (≥ 90 %), havde alligevel en klinisk relevant respons med en CR/CRh*-rate på 21,6 % (CI: 12,9 - 32,7) (se figur 2).