FrancophonIA/ELRC3.0 huggingface dataset:
English: In the phase 3 pivotal studies in MF, grade 3 or 4 urinary tract infection was reported in 1.0% of patients, herpes zoster in 4.3% and tuberculosis in 1.0%.
Danish: I de pivotale kliniske fase 3-studier med MF rapporteredes urinvejsinfektioner af grad 3 eller 4 hos 1,0% af patienterne, herpes zoster hos 4,3% og tuberkulose hos 1,0%.
English: A single dose of 15 mg is recommended for MF patients with platelet count between 100,000/mm and 200,000/mm
Danish: En enkelt dosis på 15 mg anbefales til MFpatienter med trombocyttal mellem 100.000/mm og 200.000/mm
English: c grade 3 (<8.0 - 6.5g/dl)
Danish: 3 (<8,0-6,5g/dl)
English: In this arm, 83% of patients were still on treatment at the time of the week 80 data cut-off. Of patients who achieved a primary response at week 32, 80% maintained their response for at least 48 weeks after the initial response.
Danish: Ud af de patienter, der opnåede et primært respons ved uge 32, opretholdt 80% deres respons i mindst 48 uger efter det initielle respons.
English: In patients with severe renal impairment (creatinine clearance less than 30 ml/min) the recommended starting dose based on platelet count for MF patients should be reduced by approximately 50% to be administered twice daily.
Danish: Hos MF-patienter med stærkt nedsat nyrefunktion (kreatinin-clearance under 30 ml/min) skal den anbefalede startdosis baseret på trombocyttal reduceres med ca. 50% til administration to gange daglig.
English: The mean change in the global health status at week 24, as measured by EORTC QLQ C30 was +12.3 for Jakavi and -3.4 for placebo (p<0.0001).
Danish: Ved uge 24 var den gennemsnitlige ændring i den almene helbredstilstand +12,3 for Jakavi og -3,4 for placebo (p>0,0001) målt ved EORTC QLQ-C30.
English: In the randomised period of the pivotal studies, the rate of patients experiencing thrombocytopenia was lower in PV (16.8%) patients compared to MF (69.8%) patients.
Danish: I den randomiserede periode af de pivotale studier var andelen af patienter, som oplevede trombocytopeni, lavere for PV-patienter (16,8%) sammenlignet med MF-patienter (69,8%).
English: mean values showed little difference between the ruxolitinib-treated and the control-treated MF patients.
Danish: I COMFORT-II viste de gennemsnitlige værdier lille forskel mellem ruxolitinibbehandlede og kontrolbehandlede MF-patienter.
English: During the randomised period, platelet transfusions were administered to 4.7% of patients receiving ruxolitinib and to 4.0% of patients receiving control regimens.
Danish: Under randomiseringsperioden blev trombocyttransfusioner givet til 4,7% af de patienter, som fik ruxolitinib, og til 4,0% af de patienter, som fik kontrolbehandlinger.
English: Thrombocytopenia b
Danish: Trombocytopeni b
English: The primary composite endpoint was the proportion of patients achieving both an absence of phlebotomy eligibility (HCT control) and a ≥35% reduction in spleen volume from baseline at week 32.
Danish: Det primære sammensatte endepunkt var andelen af patienter, der opnåede både fravær af indikation for flebotomi (HCT-kontrol) og ≥35% reduktion i miltvolumen fra baseline ved uge 32.
English: The primary endpoint defined as the proportion of patients achieving HCT control (absence of phlebotomy eligibility) at week 28 was met (62.2% in the Jakavi arm versus 18.7% in the BAT arm).
Danish: Det primære endepunkt, defineret som andelen af patienter, der opnåede HCTkontrol (fravær af indikation for flebotomi) ved uge 28, blev nået (62,2% i Jakavi-armen versus 18,7% i BAT-armen).
English: Most of these patients had histories of extended treatment with hydroxyurea and prior NMSC or pre-malignant skin lesions.
Danish: De fleste af disse patienter havde været i langvarig behandling med hydroxycarbamid og havde non-melanom hudkræft eller præmaligne hudlæsioner i anamnesen.
English: The three most frequent non-haematological laboratory abnormalities were raised alanine aminotransferase (27.2%), raised aspartate aminotransferase (19.9%) and hypercholesterolaemia (16.9%).
Danish: De tre hyppigste ikke-hæmatologiske laboratorieabnormaliteter er forhøjet alanin-aminotransferase (27,2%), forhøjet aspartat-aminotransferase (19,9%) og hyperkolesterolæmi (16,9%).
English: The starting dose of Jakavi was based on platelet count.
Danish: Startdosis for Jakavi var baseret på trombocyttal.
English: Intracranial bleeding was reported in 1% of patients exposed to ruxolitinib and 0.9% exposed to reference treatments.
Danish: Intrakraniel blødning blev rapporteret hos 1% af patienter, der har været eksponeret for ruxolitinib og hos 0,9% eksponeret for referencebehandlinger.
English: c grade 4 (<6.5g/dl)
Danish: 4 (<6,5g/dl)
English: More frequent monitoring (e.g. twice a week) of haematology parameters and of clinical signs and symptoms of ruxolitinib-related adverse drug reactions is recommended while on strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes.
Danish: Hyppigere monitorering (fx. to gange ugentligt) af hæmatologiparametre og af kliniske tegn og symptomer på ruxolitinib-relaterede bivirkninger anbefales under behandling med stærke CYP3A4hæmmere eller hæmmere af både CYP2C9- og CYP3A4-enzymer.
English: - St. John's wort (Hypericum perforatum), a herbal product used to treat depression.
Danish: - Prikbladet perikum (Hypericum perforatum), et naturlægemiddel, der bruges til behandling af depression.
English: Following a single oral dose of [14C]-labelled ruxolitinib in healthy adult subjects, elimination was predominately through metabolism, with 74% of radioactivity excreted in urine and 22% via faeces.
Danish: C]-mærket ruxolitinib, givet til sunde, voksne forsøgspersoner, skete elimineringen hovedsagelig via metabolisering, hvorved 74% af radioaktiviteten udskiltes i urin og 22% via fæces.
English: The most frequently reported adverse drug reactions were thrombocytopenia and anaemia.
Danish: De hyppigst rapporterede bivirkninger er trombocytopeni og anæmi.
English: In COMFORT-I, 45.9% subjects in the Jakavi group achieved a ≥50% improvement from baseline in the week 24 total symptom score (measured using MFSAF diary v2.0), as compared to 5.3% in the placebo group (p<0.0001 using chi-square test).
Danish: I COMFORT-I opnåede 45,9% af patienterne i Jakavi-gruppen en forbedring på ≥50% i forhold til baseline i den samlede symptomscore i uge 24 (målt ved MFSAF-dagbog v2.0) sammenlignet med 5,3% af patienterne i placebogruppen (p<0,0001 med anvendelse af chi
English: Dual CYP2C9 and CYP3A4 inhibitors
Danish: Hæmmere af både CYP2C9 og CYP3A4
English: However, plasma AUC values of ruxolitinib metabolites tended to increase with increasing severity of renal impairment, and were most markedly increased in the subjects with severe renal impairment.
Danish: AUC-værdierne for ruxolitinib-metabolitter var tilbøjelige til at stige med graden af nedsat nyrefunktion og steg mest markant hos forsøgspersoner med stærkt nedsat nyrefunktion.
English: The three most frequent non-haematological adverse reactions were dizziness (9.2%), constipation (8.7%) and hypertension (6.5%).
Danish: De tre hyppigste ikke-hæmatologiske bivirkninger var svimmelhed (9,2%), forstoppelse (8,7%) og hypertension (6,5%).
English: The key secondary endpoint defined as the proportion of patients achieving complete haematological remission at week 28 was also met (23.0% in the Jakavi arm versus 5.3% in the BAT arm).
Danish: Det vigtigste sekundære endepunkt, defineret som andelen af patienter, der opnåede komplet hæmatologisk remission ved uge 28, blev også nået (23,0% i Jakavi-armen versus 5,3% i BAT-armen).
English: A study in healthy subjects indicated that ruxolitinib did not inhibit the metabolism of the oral CYP3A4 substrate midazolam.
Danish: Et studie med raske frivillige indikerede, at ruxolitinib ikke hæmmer metaboliseringen af oral midazolam, som er et CYP3A4-substrat.
English: The probability of maintaining spleen response (≥35% reduction) on Jakavi for at least 24 weeks was 89% in COMFORT-I and 87% in COMFORT-II; 52% maintained spleen responses for at least 48 weeks in COMFORT-II.
Danish: Sandsynligheden for at bevare milt-respons (≥35% reduktion) i mindst 24 uger under behandling med Jakavi var 89% i COMFORT-I og 87% i COMFORT-II.
English: If you forget to take Jakavi
Danish: Hvis du har glemt at tage Jakavi
English: In the randomised, placebo-controlled study COMFORT-I 60.6% of Jakavi-treated MF patients and 37.7% of placebo-treated MF patients received red blood cell transfusions during randomised treatment.
Danish: I det randomiserede placebo-kontrollerede studie, COMFORT-I, fik 60,6% af de MF-patienter, der fik Jakavi, og 37,7% af dem, der fik placebo, erytrocyttransfusioner under randomiseret behandling.
English: The recommended starting dose for PV patients with severe renal impairment is 5 mg twice daily.
Danish: Den anbefalede startdosis til PV-patienter med stærkt nedsat nyrefunktion er 5 mg to gange dagligt.
English: The three most frequent non-haematological laboratory abnormalities (any CTCAE grade) identified as adverse reactions were raised aspartate aminotransferase (26.1%), raised alanine aminotransferase (22.3%) and hypercholesterolaemia (20.7%).
Danish: De tre hyppigste ikke-hæmatologiske laboratorieabnormiteter (alle CTCAE grader), der blev identificeret som bivirkninger, var forhøjet aspartataminotransferase (26,1%), forhøjet alaninaminotransferase (22,3%) og hyperkolesterolæmi (20,7%).
English: Haematological adverse reactions (any CTCAE grade) included anaemia (40.8%) and thrombocytopenia (16.8%).
Danish: Hæmatologiske bivirkninger (alle CTCAE-grader) omfattede anæmi (40,8%) og trombocytopeni (16,8%).
English: Component of a multipack.
Danish: Delpakning til multipakning.
English: Jakavi is also used to treat patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Danish: Jakavi anvendes også til behandling af patienter med polycythæmia vera, som er resistente over for eller ikke kan tåle behandling med hydroxycarbamid.
English: In phase 3 clinical studies in MF, median time to onset of first CTCAE grade 2 or higher anaemia was 1.5 months.
Danish: I kliniske fase 3-studier i MF var mediantiden til første start på anæmi af CTCAE-grad 2 eller højere 1,5 måneder.
English: Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Danish: Jakavi er indiceret til behandling af voksne patienter med polycythæmia vera, som er resistente over for eller ikke tåler hydroxycarbamid.
English: A dose modification is recommended in patients with severe renal impairment and end-stage renal disease (see section 4.2).
Danish: Dosisjustering anbefales hos patienter med stærkt nedsat nyrefunktion og nyresygdom i slutstadiet (se pkt.
English: Treatment should be discontinued in patients with platelet count less than 50,000/mm or absoute neutrophil count less than 500/mm
Danish: Behandlingen skal ophøre hos patienter med en trombocyttælling på under 50.000/mm eller en absolut neutrofiltælling på under 500/mm
English: Constipation a
Danish: Forstoppelse a
English: If you stop taking Jakavi
Danish: Hvis du holder op med at tage Jakavi
English: 10 g/litre below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 5 g/litre below baseline.
Danish: Hos patienter, der fik ruxolitinib, nåede middelfaldet i hæmoglobin et lavpunkt på ca. 10 g/liter under baseline efter 8 til 12 ugers behandling og steg derefter gradvis il en ny, stabil tilstand med ca. 5 g/liter under baseline.
English: Hepatobiliary disorders Raised alanine aminotransferase b
Danish: Lever og galdeveje Forhøjet alaninaminotransferase b
English: In animal studies, no effect on fertility was observed.
Danish: Der er ikke observeret nogen effekt på fertiliteten i dyreforsøg.
English: The primary efficacy endpoint was proportion of subjects achieving ≥35% reduction from baseline in spleen volume at week 24 as measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Danish: Det primære effektendepunkt var andelen af forsøgspersoner, der opnåede en reduktion i miltvolumen på ≥35% i forhold til baseline ved uge 24, målt med Magnetic Resonance Imaging (MRI) eller Computed Tomography (CT).
English: Pharmacokinetic/pharmacodynamic simulations based on available data in this population suggest that the starting dose for MF patients with ESRD on haemodialysis is a single dose of 15-20 mg or two doses of 10 mg given 12 hours apart, to be administered post-dialysis and only on the day of haemodialysis.
Danish: Farmakokinetiske/farmakodynamiske simulationer baseret på de tilgængelige data for denne population tyder på, at startdosis for MF-hæmodialysepatienter med nyresygdom i slutstadiet er en enkelt dosis på 15-20 mg eller to doser på 10 mg med 12 timers interval administreret post-dialyse og kun på hæmodialysedagen.
English: Secondary endpoints included proportion of patients achieving a ≥35% reduction of spleen volume from baseline at week 24 and duration of maintenance of a ≥35% reduction from baseline spleen volume.
Danish: Sekundære endepunkter inkluderede andelen af patienter, der opnåede en reduktion i miltvolumen fra baseline til uge 24, og varigheden af bevarelsen af en reduktion i miltvolumen på ≥35% i forhold til baseline.
English: Thrombocytopenia is generally reversible and is usually managed by reducing the dose or temporarily withholding Jakavi (see sections 4.2 and 4.8).
Danish: Trombocytopeni er generelt reversibel og håndteres normalt ved at reducere dosis eller afbryde behandlingen med Jakavi midlertidigt (se pkt.
English: - A subject with multiple occurrences of an ADR is counted only once in that ADR category.
Danish: - En patient med flere tilfælde af samme bivirkning er kun medtalt én gang i bivirkningskategorien.
English: The recommended starting dose of ruxolitinib in MF is 15 mg twice daily for patients with a platelet count between 100,000/mm and 200,000/mm and 20 mg twice daily for patients with a platelet count of >200,000/mm 3.
Danish: Den anbefalede dosis af ruxolitinib til MF er 15 mg to gange dagligt til patienter med et trombocyttal mellem 100.000/mm og 200.000/mm og 20 mg to gange dagligt til patienter med trombocyttal
English: The three most frequent non-haematological adverse drug reactions were bruising (21.3%), dizziness (15.3%) and headache (14.0%).
Danish: De tre hyppigste ikke-hæmatologiske bivirkninger er blå mærker (21,3%), svimmelhed (15,3%) og hovedpine (14,0%).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: In healthy subjects given ruxolitinib (50 mg single dose) following the potent CYP3A4 inducer rifampicin (600 mg daily dose for 10 days), ruxolitinib AUC was 70% lower than after administration of ruxolitinib alone.
Danish: Hos raske forsøgspersoner, der fik ruxolitinib (enkeltdosis på 50 mg) efter den stærke CYP3A4inducer rifampicin (daglig dosis på 600 mg i 10 dage), var ruxolitinib AUC 70% lavere end efter administration af ruxolitinib alene.
English: Long term safety data from two pivotal phase 3 studies assessed 457 patients with MF who were treated with ruxolitinib, including patients initially randomised to ruxolitinib (n=301; exposure 0.368.1 months, median exposure 33.4 months) and patients who received ruxolitinib after crossing over from control treatments (n=156; exposure: 0.5-59.8 months, median exposure 25.0 months).
Danish: Langtidsdata for sikkerhed fra to pivotale fase 3-studier blev vurderet for 457 patienter med MF, som blev behandlet med ruxolitinib, herunder patienter, der initialt var randomiseret til ruxolitinib (n = 301, eksponering 0,3-68,1 måneder, median eksponering 33,4 måneder) og patienter, som fik ruxolitinib efter skift fra kontrolbehandling (n = 156, eksponering 0,5-59,8 måneder, median eksponering 25,0 måneder).
English: Gastrointestinal bleeding was reported in 5.0% of patients exposed to ruxolitinib compared to 3.1% exposed to reference treatments.
Danish: Gastrointestinal blødning blev rapporteret hos 5,0% af patienter eksponeret for ruxolitinib og hos 3,1%, der har været eksponeret for referencebehandlinger.
English: Further dose modifications should be based on the safety and efficacy of the medicinal product (see sections 4.2 and 5.2).
Danish: Yderligere dosisjusteringer skal baseres på lægemidlets sikkerhed og effekt (se pkt.
English: When administering ruxolitinib with strong CYP3A4 inhibitors the unit dose of ruxolitinib should be reduced by approximately 50%, to be administered twice daily.
Danish: Når ruxolitinib administreres sammen med stærke CYP3A4-hæmmere, skal enhedsdosis af ruxolitinib reduceres med ca. 50% og administreres to gange dagligt.
English: In COMFORT-II, after a median follow-up of 55.9 months, the death rate in patients randomised to the ruxolitinib arm was 40.4% (59 of 146 patients) versus 47.9% (35 of 73 patients) in patients randomized to best available therapy (BAT).
Danish: Efter en median opfølgningsperiode på 55,9 måneder i COMFORT II var dødeligheden hos patienter, der var randomiseret til ruxolitinib, 40,4% (59 ud af 146 patienter) mod 47,9% (35 ud af 73 patienter) hos patienter, der var randomiseret til bedste tilgængelige behandling (BAT).
English: Other bleeding events (including events such as epistaxis, post-procedural haemorrhage and haematuria) were reported in 13.3% of patients treated with ruxolitinib and 10.3% treated with reference treatments.
Danish: Andre blødningshændelser (inklusive hændelser såsom næseblod, post-procedural blødning og hæmaturia) blev rapporteret hos 13,3% af patienter behandlet med ruxolitinib og 10,3% behandlet med referencebehandlinger.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apoteketspersonalet, hvis der er noget, du er i tvivl om.
English: In the comparative period of phase 3 studies in PV patients, bleeding events (including intracranial and gastrointestinal, bruising and other bleeding events) were reported in 16.8% of patients treated with ruxolitinib, 15.3% of patients receiving best available therapy in RESPONSE study and 12.0% of patients receiving best available therapy in RESPONSE 2 study.
Danish: I den sammenlignende periode af fase 3-studierne med PV-patienter blev blødningshændelser (inklusive intrakranielle og gastrointestinale blødninger, blå mærker og andre blødningshændelser) rapporteret hos 16,8% af patienterne i ruxolitinib-armen, 15,3% af patienterne i armen med den bedste tilgængelige terapi i RESPONSE studiet og 12,0% af patienterne med den bedste tilgængelige terapi i RESPONSE 2-studiet.
English: The maximum dose of ruxolitinib is 25 mg twice daily.
Danish: Den maksimale dosis ruxolitinib er 25 mg to gange dagligt.
English: c grade
Danish: Grad c
English: What you need to know before you take Jakavi
Danish: Det skal du vide, før du begynder at tage Jakavi
English: There was a 31% reduction in the risk of death in the ruxolitinib arm as compared to placebo (HR 0.69; 95% CI 0.50-0.96; p=0.025).
Danish: Der var en 31% reduktion i risikoen for dødsfald i ruxolitinib-armen sammenlignet med placebo-armen (HR 0,69; 95% KI 0,50-0,96; p = 0,025).
English: The primary efficacy endpoint was proportion of patients achieving ≥35% reduction from baseline in spleen volume at week 48 as measured by MRI or CT.
Danish: Det primære effektendepunkt var andelen af patienter, der opnåede en ≥35% reduktion i miltvolumen ved uge 48, målt med MRI eller CT.
English: The safety and effectiveness of Jakavi in paediatric patients have not been established (see section 5.1, “Paediatric population”).
Danish: Sikkerheden og effekten af Jakavi til pædiatriske patienter er ikke klarlagt (se pkt.
English: The concurrent use of haematopoietic growth factors and ruxolitinib has not been studied.
Danish: Samtidig anvendelse af hæmatopoetiske vækstfaktorer og ruxolitinib er ikke undersøgt.
English: - if you experience chronic coughing with blood-tinged sputum, fever, night sweats and weight loss (these can be signs of tuberculosis).
Danish: - hvis du oplever feber, kuldegysninger eller andre symptomer på infektioner - hvis du oplever kronisk hoste med blodigt opspyt, feber, nattesved og vægttab (dette kan være tegn på tuberkulose).
English: Common (may affect up to 1 in 10 people): - fever, cough, difficult or painful breathing, wheezing, pain in chest when breathing (possible symptoms of pneumonia) - frequently passing wind (flatulence)
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer): - feber, hoste, vanskelig eller smertefuld vejrtrækning, hvæsen, smerter i brystet, når man trækker vejret (mulige symptomer på lungebetændelse) - øget luft i tarmen (flatulens) - forstoppelse - højt blodtryk (hypertension), som også kan være årsag til svimmelhed og hovedpine
English: There was a 33% reduction in risk of death in the ruxolitinib arm compared to the BAT arm (HR 0.67; 95% CI 0.44-1.02; p=0.062).
Danish: Der var en 33% reduktion i risikoen for dødsfald i ruxolitinib-armen sammenlignet med BAT-armen (HR 0,67; 95% KI 0,44-1,02; p = 0,062).
English: Gastrointestinal disorders Flatulence a
Danish: Mave-tarm-kanalen Flatulens a
English: Jakavi contains lactose
Danish: Jakavi indeholder lactose
English: - The recommended starting dose in polycythaemia vera is 10 mg twice daily.
Danish: - Den anbefalede sædvanlige startdosis ved polycythæmia vera er 10 mg 2 gange daglig.
English: Based on unbound AUC, the exposure at the NOAEL (no observed adverse effect level) in juvenile rats treated as early as postnatal day 7 was 0.3-fold that of adult patients at 25 mg twice daily, while reduced bone growth and fractures occurred at exposures that were 1.5- and 13-fold that of adult patients at 25 mg twice daily, respectively.
Danish: Baseret på ubundet AUC, var eksponeringen hos juvenile rotter ved NOAEL (no observed adverse effect level), behandlet så tidligt som dag 7 postnatalt, 0,3 gange højere end hos voksne patienter ved en dosis på 25 mg to gange dagligt.
English: For patients with end-stage renal disease on haemodialysis the starting dose for MF patients should be based on platelet counts (see section 4.2).
Danish: Hos MF-patienter med nyresygdom i slutstadiet og i hæmodialyse skal startdosis baseres på trombocyttælling (se pkt.
English: In the phase 3 clinical studies in MF, in patients who developed grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks.
Danish: Hos MF-patienter i de kliniske fase 3-studier, som udviklede trombocytopeni grad 3 eller 4, var mediantiden til start ca. 8 uger.
English: Other bleeding events (including events such as epistaxis, post-procedural haemorrhage, gingival bleeding) were reported in 8.7% of patients treated with ruxolitinib, 6.3% of patients treated with best available therapy in RESPONSE study and 6.7% of patients treated with best available therapy in RESPONSE 2 study.
Danish: Andre blødningshændelser (inklusive hændelser som næseblod, post-procedural blødning og gingival blødning) blev rapporteret hos 8,7% af patienterne i ruxolitinib-armen, 6,3% af patienterne i armen med bedste tilgængelige terapi i RESPONSE-studiet og 6,7% af patienterne i armen med bedste tilgængelige terapi i RESPONSE 2studiet.
English: - The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate, povidone, hydroxypropylcellulose, lactose monohydrate.
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, magnesiumstearat, kolloid vandfri silica,
English: In COMFORT-II, after a median follow-up of 34.7 months, the death rate in patients randomised to ruxolitinib was 19.9% versus 30.1% in patients randomised to best available treatment (BAT); HR 0.48; 95% CI 0.28-0.85; p=0.009.
Danish: Efter en median opfølgningsperiode på 34,7 måneder i COMFORT-II var dødeligheden hos patienter, der var randomiseret til ruxolitinib, 19,9% mod 30,1% hos patienter, der var randomiseret til bedst tilgængelig terapi (BAT): HR 0,48; 95% KI 0,28-0,85; p=0,009.