FrancophonIA/ELRC3.0 huggingface dataset:
English: Increases in QTcF interval of > 450 msec and > 500 msec were observed in 26/162 (16%) and none of the patients in the inotuzumab ozogamicin arm versus 12/124 (10%) and 1/124 (1%) patients in the Investigator's choice of chemotherapy arm, respectively (see section 4.8).
Danish: Stigninger i QTcF interval på > 450 msek og > 500 msek blev observeret hos henholdsvis 26/162 (16 %) og ingen af patienterne i inotuzumab ozogamicin-armen versus 12/124 (10 %) og 1/124 (1 %) af patienterne i behandlingsarmen med investigators valg af kemoterapi (se pkt.
English: There was a trend in favour of BESPONSA, improvement grade small, for estimated mean postbaseline scores (BESPONSA and Investigator's choice, respectively) in global health status/Quality of Life (QoL) (62.1 versus 57.8), cognitive functioning (85.3 versus 82.5), dyspnoea (14.7 versus 19.4), diarrhoea (5.9 versus 8.9), fatigue (35.0 versus 39.4).
Danish: Der var en tendens til fordel for BESPONSA, forbedringsgrad lille, for estimerede gennemsnitlige efter-baseline-scorer (hhv. BESPONSA og investigators valg) for overordnet helbredsstatus/livskvalitet (QoL) (62,1 versus 57,8), kognitiv funktion (85,3 versus 82,5), dyspnø (14,7 versus 19,4), diarré (5,9 versus 8,9), træthed (35,0 versus 39,4).
English: TLS occurred shortly after the end of the inotuzumab ozogamicin infusion and resolved with medical management.
Danish: TLS forekom generelt kort efter endt infusion af inotuzumab ozogamicin og forsvandt med medicinsk behandling.
English: • infusion related reaction (see section 2); signs and symptoms include fever and chills or breathing problems during or shortly after the BESPONSA infusion.
Danish: • Reaktion i forbindelse med infusionen (se afsnit 2), symptomerne kan være feber og kulderystelser eller vejtrækningsbesvær under eller kort tid efter infusionen af BESPONSA.
English: Hepatotoxicity, including severe, life-threatening, and sometimes fatal hepatic VOD/SOS, was reported in patients with relapsed or refractory ALL receiving BESPONSA (see section 4.8).
Danish: Der er rapporteret levertoksicitet, herunder svær, livstruende og nogle gange letal hepatisk VOD/SOS, hos patienter med recidiverende eller refraktær ALL, der får BESPONSA (se pkt.
English: For patients who develop abnormal liver tests, liver tests and clinical signs and symptoms of hepatotoxicity should be monitored more frequently.
Danish: Hos patienter, der udvikler abnorme levertal, anbefales hyppigere monitorering af levertallene og kontrol for symptomer på levertoksicitet.
English: Tell your doctor if you have symptoms, such as dizziness, lightheadedness or fainting.
Danish: Fortæl lægen, hvis du bliver svimmel, ør eller besvimer.
English: For clinical management of myelosuppression/cytopenias, see section 4.4.
Danish: 4.4 vedrørende klinisk behandling af myelosuppression/cytopeni.
English: In repeat dose toxicity studies in rats and monkeys, female reproductive findings included atrophy of ovaries, uterus, vagina, and mammary gland.
Danish: I toksicitetsstudier med gentagne doser hos rotter og aber omfattede de fund, der vedrørte reproduktionsevnen hos hunner, atrofi af ovarier, uterus, vagina og mælkekirtler.
English: For instructions on reconstitution and dilution of BESPONSA before administration, see section 6.6.
Danish: Anvisninger i rekonstituering og fortynding af BESPONSA inden administration er anført i pkt.
English: Adverse reactions reported in patients with relapsed or refractory B-cell precursor ALL who received BESPONSA
Danish: Bivirkninger indberettet fra patienter med recidiverende eller refraktær B-celle prækursor ALL, som fik BESPONSA
English: A third cycle may be considered for those patients who do not achieve a CR/CRi and MRD negativity after 2 cycles.
Danish: En tredje cyklus kan overvejes til patienter, der ikke opnår CR/CRi og MRDnegativitet efter 2 cyklusser.
English: Furthermore, at month 24, the survival probability was 38.0% (95% CI: 27.4, 48.5) for patients who underwent a follow-up HSCT compared to 8.0% (95% CI: 3.3, 15.3) for patients who did not undergo a follow-up HSCT in the BESPONSA arm.
Danish: I tilføjelse hertil, var sandsynligheden for overlevelse ved 24 måneder i BESPONSA-armen 38,0 % (95% CI: 27,4-48,5) for patienter som fik opfølgende HSCT sammenlignet med 8,0 % (95 % CI: 3,3-15,3) for patienter, som ikke fik en opfølgende HSCT.
English: Inotuzumab ozogamicin has not been studied in patients with end-stage renal disease (see section 4.2).
Danish: Inotuzumab ozogamicin er ikke undersøgt hos patienter med nyresygdom i slutstadiet (se pkt.
English: Patients with relapsed or refractory ALL who have received 1 or 2 prior treatment regimens for ALL - Study 1
Danish: Patienter med recidiverende eller refraktær ALL, der havde fået 1 eller 2 tidligere behandlingsregimer for ALL - Studie 1
English: Venoocclusive disease may be fatal and is associated with rapid weight gain, pain in the upper right side of your abdomen (belly), increase in the size of the liver, build-up of fluid causing abdominal swelling, and blood tests showing increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes).
Danish: Veno-okklusiv sygdom kan være dødelig og er forbundet med hurtig vægtstigning, smerter i den øverste højre side af maven, forstørret lever, væskeophobning som giver udspiling af maven, og blodprøver som viser forhøjet bilirubin og/eller leverenzymer (kan give gulfarvning af hud og øjne).
English: In the Phase 2 portion of the study, patients had to have received at least 2 prior treatment regimens for ALL and patients with Ph+ B-cell ALL had to have failed treatment with at least 1 TKI.
Danish: I fase 2 delen af studiet skulle patienterne have fået mindst 2 tidligere behandlingsregimer for ALL og patienter med Ph
English: Permanently discontinue treatment (see section 4.4).
Danish: Seponer behandlingen permanent (se pkt.
English: In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide is a substrate of P-glycoprotein (P-gp).
Danish: N-acetyl-gamma-calicheamicin dimethylhydrazid in vitro er et substrat af P-glykoprotein (Pgp).
English: Patients with relapsed or refractory ALL who have received 2 or more prior treatment regimens for ALL - Study 2
Danish: Patienter med recidiverende eller refraktær ALL, der havde fået 2 eller flere tidligere behandlingsregimer for ALL - Studie 2
English: At month 24, the survival probability was 38.0% (95% CI: 27.4, 48.5) versus 35.5% (95% CI: 20.1, 51.3) for BESPONSA and Investigator's choice of chemotherapy, respectively.
Danish: Sandsynligheden for overlevelse ved 24 måneder var 38,0 % (95% CI: 27,4-48,5) versus 35,5 % (95 % CI: 20,1-51,3) for henholdsvis BESPONSA og investigators valg af kemoterapi.
English: a +/- 2 days (maintain a minimum of 6 days between doses).
Danish: +/- 2 dage (oprethold 6 dage mellem doser).
English: BESPONSA should be administered with caution in patients who have a history of, or predisposition to QT interval prolongation, who are taking medicinal products that are known to prolong QT interval (see section 4.5) and in patients with electrolyte disturbances.
Danish: BESPONSA skal administreres med forsigtighed til patienter, der tidligere har haft eller er disponeret for forlænget QT-interval, som tager lægemidler kendt for at forlænge QT-intervallet (se pkt.
English: • have serious ongoing liver disease, e.g., cirrhosis (a condition in which the liver does not function properly due to long-term damage), nodular regenerative hyperplasia (a condition with signs and symptoms of portal hypertension that can be caused by chronic use of medicines), active hepatitis (a disease characterised by inflammation of the liver).
Danish: • hvis du har en alvorlig leversygdom, fx skrumpelever (hvor leveren ikke fungerer ordentligt på grund af langvarige skader), eller sygdom med symptomer på grund af øget modstand ved blodets gennemstrømning gennem leveren (nodulær regenerativ hyperplasi), som kan være forårsaget af kronisk brug af lægemidler, eller aktiv leverbetændelse (en sygdom, hvor der er betændelsestilstand i leveren).
English: BESPONSA contains no bacteriostatic preservatives.
Danish: BESPONSA indeholder ikke bakteriostatiske konserveringsmidler.
English: Storage times and conditions for reconstituted and diluted BESPONSA solution
Danish: Opbevaringstider og -forhold for rekonstitueret og fortyndet BESPONSA-opløsning
English: In the pivotal study (N=164), maximum increases in QT interval corrected for heart rate using the Fridericia formula (QTcF) ≥ 30 msec and ≥ 60 msec from baseline were measured in 30/162 (19%) and 4/162 (3%) patient, respectively.
Danish: I pivotalstudiet (N = 164) blev der målt maksimale stigninger i QT-interval korrigeret for hjertefrekvens vha. Fridericia-formlen (QTcF) ≥ 30 msek og ≥ 60 msek fra baseline hos henholdsvis 30/162 (19 %) og 4/162 (3 %) patienter.
English: In the pivotal study (N=164), hyperbilirubinaemia and increased transaminases were reported in 35 (21%) and 43 (26%) patients, respectively.
Danish: I pivotalstudiet (N = 164) blev der indberettet hyperbilirubinæmi og forhøjede transaminaser hos hhv. 35 (21 %) og 43 (26 %) patienter.
English: Signs and symptoms of VOD/SOS should be monitored closely in all patients, especially post HSCT.
Danish: Overvåg nøje alle patienter for symptomer på VOD/SOS, især efter HSCT.
English: Depending on the severity of the infusion related reaction, discontinuation of the infusion or administration of steroids and antihistamines should be considered (see section 4.2).
Danish: Afhængigt af hvor alvorlig reaktionen er, bør det overvejes at stoppe infusionen eller administrere steroid og antihistamin (se pkt.
English: In those patients who proceeded directly to HSCT, there was a median gap of 4.8 weeks (range: 1-19 weeks) between the last dose of inotuzumab ozogamicin and HSCT.
Danish: Hos de patienter, som fortsatte direkte til HSCT, var mediantiden mellem sidste dosis af inotuzomab ozogamicin og HSCT 4,8 uger (interval: 1-19 uger).
English: Increases in Grade ≥ 3 amylase and lipase were reported in 3 (2%) and 7 (4%) patients, respectively.
Danish: Der blev indberettet forhøjet amylase og lipase af grad ≥ 3 hos hhv. 3 (2 %) og 7 (4 %) patienter.
English: Based on in vitro data, coadministration of inotuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) or uridine diphosphate-glucuronosyltransferase (UGT) drug metabolising enzymes are unlikely to alter exposure to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Danish: Baseret på in vitro-data vil samtidig administration af inotuzumab ozogamicin og hæmmere eller inducere af cytokrom P450 (CYP) eller uridindiphosphat-glucuronosyltransferase (UGT) sandsynligvis ikke ændre eksponeringen for N-acetyl-gamma-calicheamicin-dimethylhydrazid.
English: In the pivotal study (N=164), increases in amylase and lipase were reported in 8 (5%) and 15 (9%) patients, respectively.
Danish: I pivotalstudiet (N = 164) blev der indberettet forhøjet amylase og lipase hos hhv. 8 (5 %) og 15 (9 %) patienter.
English: Eligible patients were ≥ 18 years of age with relapsed or refractory B-cell precursor ALL.
Danish: Egnede patienter var ≥ 18 år med recidiverende eller refraktær B-celle prækursor ALL.
English: Storage conditions and shelf life
Danish: Opbevaringsforhold og holdbarhed
English: Hazard ratio [95% CI] = 0.450 [0.348-0.581] 2-sided p-value < 0.0001
Danish: Risikorate [95 % CI] = 0,450 [0,348-0,581] 2-sidet p-værdi < 0,0001
English: Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment.
Danish: Alle patienter, der ikke opnår CR/CRi inden for 3 cyklusser, skal have seponeret behandlingen (se pkt.
English: Always use this medicine exactly as your doctor, pharmacist, or nurse has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
English: Grade 4 thrombocytopenia and neutropenia were reported in 46 (28%) and 45 (27%) patients, respectively.
Danish: Der blev indberettet grad 4 trombocytopeni og neutropeni hos hhv. 46 (28 %) og 45 (27 %) patienter.
English: progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi.
Danish: PFS blev defineret som tid fra randomiseringsdato til tidligste dato for følgende hændelser: død, sygdomsprogression (inklusive objektiv progression, recidiv fra CR/CRi, seponering af behandling pga. generel forringelse af helbredsstatus) og start på ny induktionsterapi eller HSCT efter behandlingen uden opnåelse af CR/CRi.
English: Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA (see section 4.2).
Danish: Forhøjede leverenzymer kan nødvendiggøre dosisafbrydelse, -nedsættelse eller permanent seponering af BESPONA (se pkt.
English: For full information on dosage and dose modifications please refer to the Summary of Product Characteristics.
Danish: Se venligst produktresumeet for den fulde information om dosering og dosisjustering.
English: The frequencies of specific infections were: sepsis and bacteraemia (17%), lower respiratory tract infection (12%), upper respiratory tract infection (12%), fungal infection (9%), viral infection (7%), gastrointestinal infection (4%), skin infection (4%), and bacterial infection (1%).
Danish: Hyppigheden af følgende typer af specifikke infektioner var: sepsis og bakteriæmi (17 %), nedre luftvejsinfektion (12 %), øvre luftvejsinfektion (12 %), svampeinfektion (9 %), virusinfektion (7 %), gastrointestinal infektion (4 %), hudinfektion (4 %) og bakteriel infektion (1 %).
English: • Gently swirl the vial to aid dissolution.
Danish: • Hvirvl forsigtigt glasset for at fremme opløsning.
English: Inotuzumab ozogamicin was clastogenic in vivo in the bone marrow of male mice.
Danish: Inotuzumab ozogamicin var klastogent in vivo i knoglemarven hos hanmus.
English: Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.2).
Danish: Der anbefales præmedicinering med kortikosteroid, antipyretika og antihistamin inden dosering (se pkt.
English: If platelet count decreases, interrupt the next cycle of treatment until platelet count recovers to ≥ 50 × 109/La.
Danish: Hvis trombocyttallet falder, skal næste cyklus afbrydes, indtil trombocyttallet ≥ 50 × 10
English: Based on a population pharmacokinetic analysis in 765 patients, the clearance of inotuzumab ozogamicin in patients with hepatic impairment defined by National Cancer Institute Organ Dysfunction Working Group (NCI ODWG) category B1 (total bilirubin ≤ ULN and AST > ULN; n=133) or B2 (total bilirubin > 1.0-1.5 × ULN and AST any level; n=17) was similar to patients with normal hepatic function (total bilirubin/AST ≤ ULN; n=611) (see section 4.2).
Danish: Baseret på en populationsfarmakokinetisk analyse af 765 patienter var clearance af inotuzumab ozogamicin hos patienter med nedsat leverfunktion, defineret af National Cancer Institute Organ Dysfunction Working Group (NCI ODWG) kategori B1 (total bilirubin ≤ ULN og ASAT > ULN, n = 133) eller B2 (total bilirubin > 1,0-1,5 × ULN og ASAT af alle niveauer, n = 17) den samme som hos patienter med normal leverfunktion (total bilirubin/ASAT ≤ ULN, n = 611) (se pkt.
English: ECG and electrolytes should be obtained prior to the start of treatment and periodically monitored during treatment (see sections 4.8 and 5.2).
Danish: Der skal tages EKG og måles elektrolytter inden behandlingsstart samt periodisk under behandlingen (se pkt.
English: Of the 9 patients with Ph+ B-cell ALL, 1 patient had received 1 previous TKI and 1 patient had received no prior TKIs.
Danish: + B-celle ALL, havde 1 patient fået en TKI tidligere og 1 patient havde ikke fået en TKI tidligere.
English: In the pivotal study (N=164), thrombocytopenia and neutropenia were reported in 83 (51%) and 81 (49%) patients, respectively.
Danish: I pivotalstudiet (N = 164) blev der indberettet trombocytopeni og neutropeni hos hhv. 83 (51 %) og 81 (49 %) patienter.
English: Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Danish: Inotuzumab ozogamicin er et antistof-lægemiddel-konjugat (ADC) sammensat af et rekombinant humaniseret IgG4 kappa CD22-rettet monoklonalt antistof (produceret i ovarieceller fra kinesisk hamster vha. rekombinant DNA-teknologi), der bindes kovalent til N-acetyl-gamma-calicheamicin dimethylhydrazid.
English: In repeat dose toxicity studies in rats, male reproductive findings included testicular degeneration, associated with hypospermia, and prostatic and seminal vesicle atrophy.
Danish: I toksicitetsstudier med gentagne doser hos rotter inkluderede fund vedrørende reproduktion hos hanner degeneration af testiklerne associeret med hypospermi og atrofi af prostata og sædblæren.
English: Administer diluted solution as a 1-hour infusion at a rate of 50 mL/h at room temperature (20 °C-25 °C).
Danish: Administrer den fortyndede opløsning som infusion over 1 time ved en hastighed på 50 ml/time ved stuetemperatur (20-25 °C).
English: Administration of inotuzumab ozogamicin to female rats at the maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) prior to mating and during the first week of gestation resulted in embryo-foetal toxicity, including increased resorptions and decreased viable embryos.
Danish: 2,3 gange den kliniske eksponering hos mennesker baseret på AUC) inden parring og i løbet af den første gestationssuge resulterede i embryoføtal toksicitet, inklusive øget resorption og færre levedygtige embryoner.
English: Treatment with BESPONSA may prolong QT interval (a change in electrical activity of the heart that can cause serious irregular heart rhythms).
Danish: Behandling med BESPONSA kan muligvis forårsage en alvorlig uregelmæssig hjerterytme (ændring i de elektriske impulser i hjertet, som kaldes forlængelse af QT-intervallet).
English: The frequencies of specific bleeding/haemorrhagic events were: epistaxis (15%), upper gastrointestinal haemorrhage (6%), lower gastrointestinal haemorrhage (4%), and central nervous system (CNS) haemorrhage (1%).
Danish: Hyppigheden af følgende typer af specifikke blødning/hæmoragiske hændelser var: næseblod (15 %), øvre gastrointestinal blødning (6 %), nedre gastrointestinal blødning (4 %), blødning i centralnervesystemet (CNS) (1 %).
English: Day 15a
Danish: Dag 15
English: Grade ≥ 3 hyperbilirubinaemia and increased transaminases were reported in 9 (6%) and 11 (7%) patients, respectively.
Danish: Der blev indberettet grad ≥ 3 hyperbilirubinæmi og forhøjede transaminaser hos hhv. 9 (6 %) og 11 (7 %) patienter.
English: Grade 3/4 bleeding/haemorrhagic events were reported in 8/164 (5%) patients.
Danish: Der blev indberettet grad 3/4 blødning/hæmoragiske hændelser hos 8/164 (5 %) patienter.
English: There was also a trend for better OS with BESPONSA for patients with other prognostic factors (Ph-, no prior HSCT, ≥ 90% leukaemic blasts CD22-positive at baseline, no baseline peripheral blasts, and baseline haemoglobin ≥ 10 g/dL, based on exploratory analyses).
Danish: -, ingen tidligere HSCT,  90 % positivitet for CD22 i leukæmiske blaster ved baseline, ingen perifere blaster ved baseline og baseline hæmoglobin ≥ 10 g/dl, baseret på eksplorativ analyse.
English: For patients proceeding to haematopoietic stem cell transplant (HSCT), the recommended duration of treatment is 2 cycles.
Danish: Hos patienter, der skal fortsætte med hæmatopoietisk stamcelletransplantation (HSCT), anbefales 2 behandlingscyklusser.
English: • Abnormally high levels of lipase (an enzyme needed to process dietary fat) in the blood
Danish: • Unormalt højt indhold af lipase i blodet (et enzym, der er nødvendigt for, at kroppen kan fordøje fedt fra maden)
English: Inotuzumab ozogamicin is an ADC composed of a CD22-directed monoclonal antibody that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Danish: Inotuzumab ozogamicin er et ADC sammensat af et CD22-rettet monoklonalt antistof, der bindes kovalent til N-acetyl-gamma-calicheamicin dimethylhydrazid.
English: Common Increased lipase (9%)
Danish: Forhøjet amylase (5 %) Forhøjet lipase (9 %)
English: Study 1: Efficacy results in patients ≥ 18 years of age with relapsed or refractory B-cell precursor ALL who received 1 or 2 prior treatment regimens for ALL
Danish: Studie 1: Resultater hos patienter ≥18 år med recidiverende eller refraktær B-celle prækursor ALL, som har fået 1 eller 2 tidligere behandlingsregimer for ALL
English: Study 2: Efficacy results in patients ≥ 18 years of age with relapsed or refractory B-cell precursor ALL who received 2 or more prior treatment regimens for ALL
Danish: Studie 2: Resultater hos patienter ≥18 år med recidiverende eller refraktær B-celle prækursor ALL, som har fået 2 eller flere tidligere behandlingsregimer for ALL
English: BESPONSA 1 mg powder for concentrate for solution for infusion inotuzumab ozogamicin
Danish: BESPONSA 1 mg pulver til koncentrat til infusionsvæske, opløsning inotuzumab ozogamicin
English: • If the medicine works well and you are going to receive a stem cell transplant (see section 2),
Danish: • Hvis behandlingen fungerer godt, og du skal have en stamcelletransplantation (se afsnit 2), får du 2 eller højst 3 behandlingsforløb.
English: The recommended BESPONSA dose was determined to be 1.8 mg/m2/cycle administered at a dose of 0.8 mg/m2 on Day 1 and 0.5 mg/m2 on Days 8 and 15 of a 28-day cycle with a dose reduction upon achieving CR/CRi.
Danish: Den anbefalede BESPONSA-dosis blev fastlagt til 1,8 mg/m 2/cyklus administreret ved en dosis på 0,8 mg/m 2 på dag 1 og 0,5 mg/m 2 på dag 8 og 15 i en cyklus på 28 dage med dosisnedsættelse efter opnåelse af CR/CRi.
English: • High levels of liver enzymes (which can be indicators of liver injury) in the blood
Danish: • Højt indhold af leverenzymer i blodet (der kan være tegn på leverskade)
English: N-acetyl-gamma-calicheamicin is covalently attached to the antibody via an acid-cleavable linker.
Danish: N-acetyl-gamma-calicheamicin er kovalent forbundet med antistoffet med en syrelabil binding.
English: • low number of blood cells known as neutrophils, (sometimes accompanied with fever), red blood cells, white blood cells, lymphocytes, or low number of blood components known as platelets (see section 2); signs and symptoms include developing an infection or fever or bruising easily or getting nose bleeds on a regular basis.
Danish: • Lavt antal blodlegemer (neutrofile) sommetider ledsaget af feber, røde blodlegemer, hvide blodlegemer, lymfocytter eller et lavt antal blodplader (se afsnit 2), symptomerne kan være betændelse eller feber, eller at man let får blå mærker eller ofte får næseblod.
English: Men with female partners of childbearing potential should use effective contraception during treatment with BESPONSA and for at least 5 months after the last dose.
Danish: Mænd med kvindelige partnere i den fertile alder skal anvende sikker kontraception under behandlingen med BESPONSA og i mindst 5 måneder efter sidste dosis.
English: For clinical management of hepatotoxicity, including VOD/SOS, see section 4.4.
Danish: 4.4 vedrørende klinisk behandling af levertoksicitet, herunder VOD/SOS.
English: Abbreviations: ALL=acute lymphoblastic leukaemia; ANC=absolute neutrophil counts; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; DoR=duration of remission; HSCT=haematopoietic stem cell transplant; MRD=minimal residual disease; N/n=number of patients; OS=overall survival; PFS=progression-free survival.
Danish: Forkortelser: ALL = akut lymfoblastær leukæmi, ANC = absolut neutrofiltal, CI = konfidensinterval, CR = komplet remission, CRi = komplet remission med delvis hæmatologisk restitution, DoR = varighed af remission, HSCT = hæmatopoietisk stamcelletransplantation, MRD = minimal residualsygdom, N/n = antal patienter, OS = samlet overlevelse, PFS = progressionsfri overlevelse.