natgillin/translations-raw huggingface dataset:
Blodanalyser skal udføres på ny forud for hver dosisøgning i titreringsfasen. 
Blood chemistries should be reassessed prior to each subsequent dose increase during the titration phase.
Blodprøveanalyser skal monitoreres og abnormiteter korrigeres øjeblikkeligt. 
Blood chemistries should be monitored and abnormalities managed promptly.
Dosisændring ved anden toksicitet 
Dose modifications for other toxicities
Substrater for P-gp, BCRP og OATP1B1 
Substrates of P-gp, BCRP, and OATP1B1
Nedsat nyrefunktion (CrCl < 80 ml/min) øger risikoen yderligere. 
Reduced renal function (CrCl <80 ml/min) further increases the risk.
Venetoclax bør kun administreres til patienter med svært nedsat nyrefunktion, hvis fordelene opvejer risiciene, og disse patienter skal monitoreres nøje for tegn på toksicitet på grund af den øgede risiko for tumorlysesyndrom (se pkt. 
Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS (see section 4.4).
I fase 2- og 1-studierne blev 352 patienter med tidligere behandlet CLL, som inkluderede 212 patienter med 17p-deletion og 146 patienter, der havde oplevet behandlingssvigt ved en B-celle-receptor-hæmmer behandlet med venetoclax i monoterapi (se pkt. 
In the phase 2 and phase 1 studies, 352 patients with previously treated CLL, which included 212 patients with 17p deletion and 146 patients who had failed a B-cell receptor pathway inhibitor were treated with venetoclax monotherapy (see section 5.1).
Drik den samme mængde væske (mindst 1,5 til 2 liter dagligt) fra to dage før, dosis øges, samt på dagen for dosisøgning. 
Drink the same amount of water (at least 1.5 to 2 litres daily) two days before and on the day that your dose is increased.
Figur 2: Kaplan-Meier-kurver over overlevelse (intent-to-treat population) i MURANO 
Figure 2: Kaplan-Meier curves of overall survival (intent-to-treat population) in MURANO
- hvis du er allergisk over for det aktive stof venetoclax eller et af de øvrige indholdsstoffer i Venclyxto (angivet i punkt 6) 
- you are allergic to the active substance venetoclax or any of the other ingredients of this medicine (listed in section 6).
• Hvis der er gået mere end 8 timer, siden du skulle have taget din dosis, skal du lade være med at tage din dosis den dag. 
• If it is more than 8 hours since the time you usually take your dose, do not take the dose that day.
I dosistitreringsfasen skal behandlingen afbrydes og patienterne monitoreres nøje for tegn og symptomer på tumorlysesyndrom (feber, kulderystelser, kvalme, opkastning, forvirring, åndenød, krampeanfald, uregelmæssig hjertefrekvens, mørk eller grumset urin, usædvanlig træthed, muskel- eller ledsmerter, abdominalsmerter og udspilet abdomen) og anden toksicitet (se pkt. 
During dose-titration phase, treatment should be interrupted and patients should be monitored carefully for signs and symptoms of TLS (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain and distension) along with other toxicities (see section 4.2).
Aktivt stof: venetoclax. 
The active substance is venetoclax.
Før administration: Inden den første dosis skal der udføres blodanalyser hos alle patienter med henblik på vurdering af nyrefunktionen, og eksisterende abnormiteter skal korrigeres. 
Pre-dose: For all patients, blood chemistries should be assessed prior to the initial dose to evaluate kidney function and correct pre-existing abnormalities.
Der sås ingen effekt på fertiliteten i studier af fertilitet og tidlig fosterudvikling hos han- og hunmus. 
No effects on fertility were observed in fertility and early embryonic development studies in male and female mice.
Rituximab blev initieret efter 5ugers dosistitreringsplanen med 375 mg/m2 i cyklus 1 og 500 mg/m2 i cyklus 2-6. 
Rituximab was initiated after the 5-week dose-titration schedule at 375 mg/m2 for Cycle 1 and 500 mg/m2 for Cycles 26.
Det er ukendt, om det aktive stof i Venclyxto udskilles i mælken hos mennesker. 
It is not known whether the active substance in Venclyxto passes into breast milk.
Den observerede PFS-fordel ved venetoclax + rituximab sammenlignet med bendamustin + rituximab var konsistent observeret på tværs af alle undergrupper af evaluerede patienter, hvilket inkluderede alder (< 65, ≥ 65 år og < 75, ≥ 75 år), tidligere behandlingslinier (1, >1), udbredt sygdom (< 5 cm, ≥ 5 cm), 17p-deletion, 11q-deletion, TP53-mutation, IgVH mutation og refraktær mod relaps ved den seneste behandling (figur 3). 
The observed PFS benefit of venetoclax + rituximab compared with bendamustine + rituximab was consistently observed across all subgroups of patients evaluated, including age (< 65, ≥ 65 years and < 75, ≥ 75 years), prior lines of therapy (1, >1), bulky disease (< 5 cm, ≥ 5 cm), 17p deletion, 11q deletion, TP53 mutation, IgVH mutation, and refractory versus relapse to most recent therapy (Figure 3).
Du må ikke amme, mens du tager dette lægemiddel. 
Do not breast-feed while you are taking this medicine.
Administrationen af et oralt P-gp- eller BCRP-substrat, som kan hæmmes i mave-tarm-kanalen (f.eks. dabigatranexetilat), skal være adskilt så meget som muligt fra administrationen af venetoclax for at minimere en potentiel interaktion. 
For an orally administered P-gp or BCRP substrate sensitive to inhibition in the gastrointestinal tract (e.g., dabigatran exetilate), its administration should be separated from venetoclax administration as much as possible to minimise a potential interaction.
Testikulær toksicitet (tab af kimceller) blev observeret i studier af generel toksicitet hos hunde ved eksponeringer på 0,5-18 gange eksponeringen (AUC) hos mennesker ved den anbefalede dosis. 
Testicular toxicity (germ cell loss) was observed in general toxicity studies in dogs at exposures of 0.5 to 18 times the human AUC exposure at the recommended dose.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet med det samme, hvis du får et eller flere af de symptomer på tumorlysesyndrom, der er anført i punkt 4. 
Tell your doctor, pharmacist or nurse immediately if you get any of the symptoms of TLS listed in section 4.
Du skal begynde at drikke mindst 1,5 til 2 liter vand dagligt fra to dage før, du starter behandlingen med Venclyxto. 
You should start drinking at least 1.5 to 2 litres of water daily two days before starting Venclyxto.
I en farmakokinetisk populationsanalyse blev venetoclax' tilsyneladende fordelingsvolumen (Vdss/F) hos patienter estimeret til 256-321 liter. 
The population estimate for apparent volume of distribution (Vdss/F) of venetoclax ranged from 256-321 L in patients.
Alle seks patienter gennemførte dosistitreringen og opnåede den anbefalede daglige dosis på 400 mg venetoclax. 
All six patients completed the dose titration and reached the recommended daily dose of 400 mg of venetoclax.
De filmovertrukne tabletter leveres i æsker med 7 (i blistre med 1 tablet) eller 14 tabletter (i blistre med 2 tabletter) eller en multipakning med 112 tabletter (4x28 i blistre med 4 tabletter) 
The film-coated tablets are supplied in cartons containing either 7 (in blisters of 1 tablet) or 14 tablets (in blisters of 2 tablets); or a multipack containing 112 tablets (4 x 28 tablets (in blisters of 4 tablets)).
Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og kosttilskud. 
This includes medicines obtained without a prescription, herbal medicines and supplements.
Venetoclax metaboliseres hovedsagelig via CYP3A. 
Venetoclax is predominantly metabolised by CYP3A.
Rituximab bør adminstreres efter patienten har afsluttet dosistitreringsplanen og har fået den anbefalede daglige dosis på 400 mg venetoclax i 7 dage. 
Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg venetoclax for 7 days.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier af Venclyxto i alle undergrupper af den pædiatriske population med CLL (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with Venclyxto in all subsets of the paediatric population in CLL (see section 4.2 for information on paediatric use).
På vurderingstidspunktet var den mediane behandlingsvarighed af venetoclax 14,3 måneder (interval: 0,1-31,4 måneder). 
At the time of evaluation, median duration of treatment with venetoclax was 14.3 months (range: 0.1 to 31.4 months).
Venetoclax forventes ikke at hæmme OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 eller MATE2K ved klinisk relevante koncentrationer. 
Venetoclax is not expected to inhibit OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K at clinically relevant concentrations.
Efter administration: Hos patienter med risiko for tumorlysesyndrom skal blodanalyser monitoreres 6-8 timer samt 24 timer efter den første dosis venetoclax. 
Post-dose: For patients at risk of TLS, blood chemistries should be monitored at 6 to 8 hours and at 24 hours after the first dose of venetoclax.
Fortæl det altid til lægen, hvis du tager et eller flere af følgende lægemidler, da Venclyxto kan påvirke deres virkning: 
Tell your doctor if you take any of the following medicines as Venclyxto may affect how they work:
• infektion i de øvre luftveje - tegnene kan f.eks. være løbende næse, ondt i halsen eller hoste 
• upper respiratory tract infection - signs include runny nose, sore throat or cough
Hvis din læge vurderer, at du er i risiko for at få tumorlysesyndrom, kan du blive behandlet på hospitalet, så du om nødvendigt kan få ekstra væske i en blodåre (væskedrop), få taget blodprøver oftere og blive overvåget for bivirkninger. 
If your doctor thinks that you are at risk of TLS, you may be treated in the hospital so that you can be given extra fluids into the vein if needed, have your blood tests more often and be checked for side effects.
Hvis en galdesyre-kompleksdanner skal administreres sammen med venetoclax, skal produktresuméet for galdesyre-kompleksdanneren følges for at mindske risikoen for interaktion, og venetoclax skal administreres mindst 4-6 timer efter kompleksdanneren. 
If a bile acid sequestrant is to be co-administered with venetoclax, the SmPC for the bile acid sequestrant should be followed to reduce the risk for an interaction, and venetoclax should be administered at least 4-6 hours after the sequestrant.
Filmovertræk: 
In the film-coating:
Dosisjustering er ikke nødvendigt hos patienter med let eller moderat nedsat leverfunktion. 
No dose adjustment is recommended in patients with mild or moderate hepatic impairment.
Venclyxto i kombination med rituximab er indiceret til behandling af kronisk lymfatisk leukæmi (CLL) hos voksne patienter, der har fået mindst en tidligere behandling. 
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Tabel 2: Dosisændring ved tumorlysesyndrom og anden toksicitet 
Table 2: Dose modification for TLS and other toxicities
Samtidig administration af CYP- og UGT-substrater 
Co administration with CYP and UGT substrates
Venclyxto-tabletter er tilgængelige i blisterkort, der er pakket i æsker: 
Venclyxto tablets are provided in blisters which are packed in cartons as follows:
En risiko for børn, som ammes, kan ikke udelukkes. 
A risk to the breast-feeding child cannot be excluded.
Det mediane antal tidligere cancerbehandlinger var 4 (interval: 1-15) for patienter i ibrutinib-gruppen og 3 (interval: 1-11) for patienter i idelalisib-gruppen. 
The median number of prior oncology treatments was 4 (range: 1 to 15) in ibrutinib-treated patients and 3 (range: 1 to 11) in idelalisib-treated patients.
Venetoclax i kombination med rituximab til behandling af patienter med CLL, der har fået mindst en tidligere behandling - studie GO28667 (MURANO) 
Venetoclax in combination with rituximab for the treatment of patients with CLL who have received at least one prior therapy - study GO28667 (MURANO)
o Når du får behandling med Venclyxto i kombination med rituximab, vil du få en dosis på 400 mg dagligt i 24 måneder. 
o When you are receiving Venclyxto therapy in combination with rituximab, you will receive the 400 mg daily dose for 24 months.
Du skal starte behandlingen med at tage en lav dosis Venclyxto i 1 uge. 
You will begin treatment with Venclyxto at a low dose for 1 week.
Administration sammen med et fedtfattigt måltid øgede venetoclax-eksponeringen med ca. 3,4 gange, og administration sammen med et fedtrigt måltid øgede venetoclax-eksponeringen med 5,1-5,3 gange i forhold til administration under faste. 
Administration with a low-fat meal increased venetoclax exposure by approximately 3.4-fold and administration with a high-fat meal increased venetoclax exposure by 5.1- to 5.3-fold compared to fasting conditions.
I monoterapi-studierne, var de mest almindelige bivirkninger neutropeni/nedsat neutrofiltal, diarré, kvalme, anæmi, træthed og infektion i de øvre luftveje. 
In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.
I prækliniske studier har venetoclax vist cytotoksisk aktivitet i tumorceller, der har overekspression af BCL-2. 
In non-clinical studies, venetoclax has demonstrated cytotoxic activity in tumour cells that overexpress BCL-2.
Nedsat nyrefunktion (kreatininclearance [CrCl] < 80 ml/min) øger risikoen yderligere. 
Reduced renal function (creatinine clearance [CrCl] <80 ml/min) further increases the risk.
Samtidig administration af venetoclax og andre potente CYP3A4-hæmmere formodes at kunne øge venetoclax-AUC gennemsnitlig 5,8-7,8 gange. 
Co-administration of venetoclax with other strong CYP3A4 inhibitors is predicted to increase venetoclax AUC by on average 5.8- to 7.8-fold.
Det primære effektmål var den samlede responsrate (ORR) vurderet af en uafhængig review-komité på baggrund af 2008-retningslinjerne fra IWCLL opdateret af NCI-WG. 
The primary efficacy endpoint was overall response rate (ORR) as assessed by an Independent Review Committee (IRC) using the IWCLL updated NCI-WG guidelines (2008).
Hvis der hos en patient ses ændringer i blodprøver, der kan være tegn på tumorlysesyndrom, skal venetoclaxdosering undlades den efterfølgende dag. 
If a patient experiences blood chemistry changes suggestive of TLS, the following day's venetoclax dose should be withheld.
• nedsat antal hvide blodlegemer, de såkaldte lymfocytter 
• lower number of white blood cells called lymphocytes
Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (CrCl ≥ 30 ml/min og < 90 ml/min) (se pkt. 
No dose adjustment is needed for patients with mild or moderate renal impairment (CrCl ≥30 ml/min and <90 ml/min) (see section 5.2).
Startdosis er 20 mg venetoclax én gang dagligt i 7 dage. 
The starting dose is 20 mg of venetoclax once daily for 7 days.
Nogle lægemidler kan også påvirke den måde, Venclyxto virker på. 
Also some other medicines can affect the way Venclyxto works.
Risikoen mindskes, efterhånden som tumorbyrden falder i løbet af venetoclax-behandlingen (se pkt. 
The risk may decrease as tumour burden decreases with venetoclax treatment (see section 4.4).
Midler mod hyperurikæmi skal administreres 2-3 dage inden påbegyndelse af venetoclax-behandling hos patienter med højt urinsyreniveau eller med risiko for tumorlysesyndrom; disse midler kan administreres i hele titreringsfasen. 
Anti-hyperuricaemic agents should be administered 2 to 3 days prior to starting treatment with venetoclax in patients with high uric acid levels or at risk of TLS and may be continued through the titration phase.
Hos kaniner medførte venetoclax maternel toksicitet, men ingen føtal toksicitet, ved eksponeringer svarende til 0,1 gange eksponeringen (AUC) hos mennesker ved den anbefalede dosis. 
In rabbits, venetoclax produced maternal toxicity, but no foetal toxicity at exposures of 0.1 times the human AUC exposure at the recommended dose.
Ved at blokere virkningen af dette protein hjælper Venclyxto med at dræbe kræftcellerne og reducere antallet af dem. 
Blocking this protein helps to kill and lower the number of cancer cells.
Den mediane behandlingstid for de 158 patienter var 17 måneder (interval: 0 til 34 måneder). 
The median time on treatment for 158 patients was 17 months (range: 0 to 34 months).
I det åbne, randomiserede fase 3-studie (MURANO), var incidensen af TLS 3% (6/194) hos patienter behandlet med venetoclax + rituximab. 
In the open-label, randomised phase 3 study (MURANO), the incidence of TLS was 3% (6/194) in patients treated with venetoclax + rituximab.
Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, skal du tale med lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel. 
If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine.
In vitro-studier tyder på, at venetoclax ikke hæmmer eller inducerer CYP1A2, CYP2B6, CYP2C19, CYP2D6 eller CYP3A4 ved klinisk relevante koncentrationer. 
In vitro studies indicated that venetoclax is not an inhibitor or inducer of CYP1A2, CYP2B6, CYP2C19, CYP2D6 or CYP3A4 at clinically relevant concentrations.
Anvisningerne for "Forebyggelse af tumorlysesyndrom" skal følges (se pkt. 
The instructions for “Prevention of tumour lysis syndrome” should be followed (see section 4.2).
En farmakokinetisk populationsanalyse, der omfattede 219 personer med let nedsat nyrefunktion (CrCl ≥ 60 og < 90 ml/min), 86 personer med moderat nedsat nyrefunktion (CrCl ≥ 30 og < 60 ml/min) og 217 personer med normal nyrefunktion (CrCl ≥ 90 ml/min), viste, at venetoclax-eksponeringen hos personer med let til moderat nedsat nyrefunktion svarer til eksponeringen hos personer med normal nyrefunktion. 
Based on a population pharmacokinetic analysis that included 219 subjects with mild renal impairment (CrCl ≥60 and <90 ml/min), 86 subjects with moderate renal impairment (CrCl ≥30 and <60 ml/min) and 217 subjects with normal renal function (CrCl ≥90 ml/min), venetoclax exposures in subjects with mild or moderate renal impairment are similar to those with normal renal function.
Venetoclax hæmmer ikke UGT1A4, UGT1A6, UGT1A9 og UGT2B7. 
Venetoclax is not an inhibitor of UGT1A4, UGT1A6, UGT1A9 and UGT2B7.
• 112 (4 x 28) tabletter (4 æsker med 7 blisterkort hver med 4 tabletter). 
• 112 (4 x 28) tablets (4 cartons of 7 blisters each with 4 tablets).
Hyppigheden af bivirkninger ved Venclyxto er vist i tabel 3. 
The frequencies of adverse reactions reported with Venclyxto are summarised in Table 3.
• uden tilstedeværelse af 17p-deletion eller TP53-mutation hos voksne patienter, hvor både kemoimmunbehandling og en B-celle-receptor-hæmmer har fejlet. 
• in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Venetoclax er en svag hæmmer af CYP2C8, CYP2C9 og UGT1A1 in vitro, men forventes ikke at forårsage klinisk relevant hæmning. 
Venetoclax is a weak inhibitor of CYP2C8, CYP2C9 and UGT1A1 in vitro, but it is not predicted to cause clinically relevant inhibition.
Doseringsplanen med dosistitrering over 5 uger er udformet for at reducere tumorbyrden gradvist og mindske risikoen for tumorlysesyndrom. 
The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumour lysis syndrome.
I de indledende fase 1-studier til dosisbestemmelse, der havde en kortere (2-3 ugers) titreringsfase og en højere startdosis, var incidensen af tumorlysesyndrom 13 % (10/77; 5 tilfælde af tumorlysesyndrom i henhold til laboratorieværdier, 5 tilfælde af klinisk tumorlysesyndrom), herunder 2 tilfælde med dødelig udgang og 3 tilfælde med akut nyresvigt, hvoraf 1 var dialysekrævende. 
In the initial Phase 1 dose-finding studies, which had a shorter (2 to 3 week) titration phase and higher starting dose, the incidence of TLS was 13% (10/77; 5 laboratory TLS; 5 clinical TLS), including 2 fatal events and 3 events of acute renal failure, 1 requiring dialysis.
Ud fra dyreforsøg vurderes det, at Venclyxto kan forårsage ufrugtbarhed hos manden (lavt antal eller fravær af sædceller). 
Based on findings in animals, Venclyxto may cause male infertility (low or no sperm count).
Hvis det er nødvendigt at anvende en moderat CYP3A-hæmmer, skal start- og titreringsdoserne af venetoclax reduceres med mindst 50 %. 
If a moderate CYP3A inhibitor must be used, the initiation and titration doses of venetoclax should be reduced by at least 50%.
Neutropeni af grad 3 og 4 er rapporteret hos patienter, der har fået venetoclax i kombinationsstudiet med rituximab (GO28667/MURANO) og i monoterapi-studierne (se pkt. 
Grade 3 or 4 neutropenia has been reported in patients treated with venetoclax in the combination study with rituximab (GO28667/MURANO) and in the monotherapy studies (see section 4.8).
I studier af den embryo-føtale udvikling hos mus var venetoclax forbundet med øget postimplantationstab og nedsat fostervægt ved eksponeringer svarende til 1,1 gange eksponeringen (AUC) hos mennesker ved den anbefalede dosis. 
In embryo-foetal development studies in mice, venetoclax was associated with increased post-implantation loss and decreased foetal body weight at exposures of 1.1 times the human AUC exposure at the recommended dose.
CR = komplet remission; CRi = komplet remission med ufuldstændig knoglemarvsregeneration; IRC = uafhængig review-kommité; MRD = minimal residual sygdom; nPR = nodulær partiel remission; NA = ikke tilgængelig; NR = ikke opnået; ORR = den samlede responsrate (CR + CRi + nPR + PR); PR = partiel remission. 
CR = complete remission; CRi = complete remission with incomplete marrow recovery; IRC = independent review committee; MRD = minimal residual disease; nPR = nodular partial remission; NA = not available; NR = not reached; ORR = overall response rate (CR + CRi + nPR + PR); PR = partial remission.
Følg den normale doseringsplan næste dag. 
Return to your normal dose schedule the next day.
• hvis du har nyreproblemer, da din risiko for at få en bivirkning, der kaldes tumorlysesyndrom, i så fald kan øges 
• you have any kidney problems as your risk for a side effect called tumour lysis syndrome may increase
Baseret på en farmakokinetisk populationsanalyse har syrehæmmende midler (f.eks. protonpumpehæmmere, H2-receptor-antagonister og antacida) ingen indvirkning på venetoclax' biotilgængelighed. 
Based on population pharmacokinetic analysis, gastric acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) do not affect venetoclax bioavailability.
37 % (34/91) af patienterne var fludarabinrefraktære, 81 % (30/37) havde umuteret IgVH-gen, og 72 % (60/83) havde TP53-mutation. 
Of the patients, 37% (34/91) were fludarabine refractory, 81% (30/37) harboured the unmutated IgVH gene, and 72% (60/83) had TP53 mutation.
ORR for patienter med 17p-deletion og/eller TP53-mutation var 72 % (33/46) (95 %) KI: 56,5; 84,0) i gruppe A og 67 % (8/12) (95 % KI: 34,9; 90,1) i gruppe B. For patienter uden 17p-deletion og/eller TP53mutation var ORR 69 % (31/45) (95 % KI: 53,4; 81,8) i gruppe A og 71 % (17/24) (95 % KI: 48,9; 87,4) i gruppe B. 
The ORR for patients with 17p deletion and/or TP53 mutation was 72% (33/46) (95% CI: 56.5, 84.0) in Arm A and 67% (8/12) (95% CI: 34.9, 90.1) in Arm B. For patients without 17p deletion and/or TP53 mutation, the ORR was 69% (31/45) (95% CI: 53.4, 81.8) in Arm A and 71% (17/24) (95% CI: 48.9, 87.4) in Arm B.
25 % (32/127) af patienterne var MRD-negative i det perifere blod, inklusive 8 patienter, som også var MDR-negativ i knoglemarven. 
Twenty-five percent (32/127) of patients were MRD negative in the peripheral blood, including 8 patients who were also MRD negative in bone marrow.
Dyrestudier med venetoclax har vist toksiske virkninger, herunder dosisafhængige reduktioner i lymfocytter og røde blodlegemer. 
Toxicities observed in animal studies with venetoclax included dose -dependent reductions in lymphocytes and red blood cell mass.