natgillin/translations-raw huggingface dataset:
I COMFORT-II viste de gennemsnitlige værdier lille forskel mellem ruxolitinibbehandlede og kontrolbehandlede MF-patienter.
mean values showed little difference between the ruxolitinib-treated and the control-treated MF patients.
Under randomiseringsperioden blev trombocyttransfusioner givet til 4,7% af de patienter, som fik ruxolitinib, og til 4,0% af de patienter, som fik kontrolbehandlinger.
During the randomised period, platelet transfusions were administered to 4.7% of patients receiving ruxolitinib and to 4.0% of patients receiving control regimens.
Trombocytopeni b
Thrombocytopenia b
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.
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.
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).
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).
De fleste af disse patienter havde været i langvarig behandling med hydroxycarbamid og havde non-melanom hudkræft eller præmaligne hudlæsioner i anamnesen.
Most of these patients had histories of extended treatment with hydroxyurea and prior NMSC or pre-malignant skin lesions.
De tre hyppigste ikke-hæmatologiske laboratorieabnormaliteter er forhøjet alanin-aminotransferase (27,2%), forhøjet aspartat-aminotransferase (19,9%) og hyperkolesterolæmi (16,9%).
The three most frequent non-haematological laboratory abnormalities were raised alanine aminotransferase (27.2%), raised aspartate aminotransferase (19.9%) and hypercholesterolaemia (16.9%).
Startdosis for Jakavi var baseret på trombocyttal.
The starting dose of Jakavi was based on platelet count.
Intrakraniel blødning blev rapporteret hos 1% af patienter, der har været eksponeret for ruxolitinib og hos 0,9% eksponeret for referencebehandlinger.
Intracranial bleeding was reported in 1% of patients exposed to ruxolitinib and 0.9% exposed to reference treatments.
4 (<6,5g/dl)
c grade 4 (<6.5g/dl)
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.
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.
- Prikbladet perikum (Hypericum perforatum), et naturlægemiddel, der bruges til behandling af depression.
- St. John's wort (Hypericum perforatum), a herbal product used to treat depression.
C]-mærket ruxolitinib, givet til sunde, voksne forsøgspersoner, skete elimineringen hovedsagelig via metabolisering, hvorved 74% af radioaktiviteten udskiltes i urin og 22% via fæces.
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.
De hyppigst rapporterede bivirkninger er trombocytopeni og anæmi.
The most frequently reported adverse drug reactions were thrombocytopenia and anaemia.
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
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).
Hæmmere af både CYP2C9 og CYP3A4
Dual CYP2C9 and CYP3A4 inhibitors
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.
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.
De tre hyppigste ikke-hæmatologiske bivirkninger var svimmelhed (9,2%), forstoppelse (8,7%) og hypertension (6,5%).
The three most frequent non-haematological adverse reactions were dizziness (9.2%), constipation (8.7%) and hypertension (6.5%).
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).
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).
Et studie med raske frivillige indikerede, at ruxolitinib ikke hæmmer metaboliseringen af oral midazolam, som er et CYP3A4-substrat.
A study in healthy subjects indicated that ruxolitinib did not inhibit the metabolism of the oral CYP3A4 substrate midazolam.
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.
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.
Hvis du har glemt at tage Jakavi
If you forget to take Jakavi
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.
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.
Den anbefalede startdosis til PV-patienter med stærkt nedsat nyrefunktion er 5 mg to gange dagligt.
The recommended starting dose for PV patients with severe renal impairment is 5 mg twice daily.
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%).
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%).
Hæmatologiske bivirkninger (alle CTCAE-grader) omfattede anæmi (40,8%) og trombocytopeni (16,8%).
Haematological adverse reactions (any CTCAE grade) included anaemia (40.8%) and thrombocytopenia (16.8%).
Delpakning til multipakning.
Component of a multipack.
Jakavi anvendes også til behandling af patienter med polycythæmia vera, som er resistente over for eller ikke kan tåle behandling med hydroxycarbamid.
Jakavi is also used to treat patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
I kliniske fase 3-studier i MF var mediantiden til første start på anæmi af CTCAE-grad 2 eller højere 1,5 måneder.
In phase 3 clinical studies in MF, median time to onset of first CTCAE grade 2 or higher anaemia was 1.5 months.
Jakavi er indiceret til behandling af voksne patienter med polycythæmia vera, som er resistente over for eller ikke tåler hydroxycarbamid.
Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Dosisjustering anbefales hos patienter med stærkt nedsat nyrefunktion og nyresygdom i slutstadiet (se pkt.
A dose modification is recommended in patients with severe renal impairment and end-stage renal disease (see section 4.2).
Behandlingen skal ophøre hos patienter med en trombocyttælling på under 50.000/mm eller en absolut neutrofiltælling på under 500/mm
Treatment should be discontinued in patients with platelet count less than 50,000/mm or absoute neutrophil count less than 500/mm
Forstoppelse a
Constipation a
Hvis du holder op med at tage Jakavi
If you stop taking Jakavi
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.
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.
Lever og galdeveje Forhøjet alaninaminotransferase b
Hepatobiliary disorders Raised alanine aminotransferase b
Der er ikke observeret nogen effekt på fertiliteten i dyreforsøg.
In animal studies, no effect on fertility was observed.
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).
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).
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.
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.
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.
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.
Trombocytopeni er generelt reversibel og håndteres normalt ved at reducere dosis eller afbryde behandlingen med Jakavi midlertidigt (se pkt.
Thrombocytopenia is generally reversible and is usually managed by reducing the dose or temporarily withholding Jakavi (see sections 4.2 and 4.8).
- En patient med flere tilfælde af samme bivirkning er kun medtalt én gang i bivirkningskategorien.
- A subject with multiple occurrences of an ADR is counted only once in that ADR category.
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
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.
De tre hyppigste ikke-hæmatologiske bivirkninger er blå mærker (21,3%), svimmelhed (15,3%) og hovedpine (14,0%).
The three most frequent non-haematological adverse drug reactions were bruising (21.3%), dizziness (15.3%) and headache (14.0%).
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
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.
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.
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).
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).
Gastrointestinal blødning blev rapporteret hos 5,0% af patienter eksponeret for ruxolitinib og hos 3,1%, der har været eksponeret for referencebehandlinger.
Gastrointestinal bleeding was reported in 5.0% of patients exposed to ruxolitinib compared to 3.1% exposed to reference treatments.
Yderligere dosisjusteringer skal baseres på lægemidlets sikkerhed og effekt (se pkt.
Further dose modifications should be based on the safety and efficacy of the medicinal product (see sections 4.2 and 5.2).
Når ruxolitinib administreres sammen med stærke CYP3A4-hæmmere, skal enhedsdosis af ruxolitinib reduceres med ca. 50% og administreres to gange dagligt.
When administering ruxolitinib with strong CYP3A4 inhibitors the unit dose of ruxolitinib should be reduced by approximately 50%, to be administered twice daily.
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).
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).
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.
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.
Spørg lægen eller apoteketspersonalet, hvis der er noget, du er i tvivl om.
Check with your doctor or pharmacist if you are not sure.
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.
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.
Den maksimale dosis ruxolitinib er 25 mg to gange dagligt.
The maximum dose of ruxolitinib is 25 mg twice daily.
Grad c
c grade
Det skal du vide, før du begynder at tage Jakavi
What you need to know before you take Jakavi
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).
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).
Det primære effektendepunkt var andelen af patienter, der opnåede en ≥35% reduktion i miltvolumen ved uge 48, målt med MRI eller CT.
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.
Sikkerheden og effekten af Jakavi til pædiatriske patienter er ikke klarlagt (se pkt.
The safety and effectiveness of Jakavi in paediatric patients have not been established (see section 5.1, “Paediatric population”).
Samtidig anvendelse af hæmatopoetiske vækstfaktorer og ruxolitinib er ikke undersøgt.
The concurrent use of haematopoietic growth factors and ruxolitinib has not been studied.
- 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).
- if you experience chronic coughing with blood-tinged sputum, fever, night sweats and weight loss (these can be signs of tuberculosis).
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
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)
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).
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).
Mave-tarm-kanalen Flatulens a
Gastrointestinal disorders Flatulence a
Jakavi indeholder lactose
Jakavi contains lactose
- Den anbefalede sædvanlige startdosis ved polycythæmia vera er 10 mg 2 gange daglig.
- The recommended starting dose in polycythaemia vera is 10 mg twice daily.
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.
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.
Hos MF-patienter med nyresygdom i slutstadiet og i hæmodialyse skal startdosis baseres på trombocyttælling (se pkt.
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).
Hos MF-patienter i de kliniske fase 3-studier, som udviklede trombocytopeni grad 3 eller 4, var mediantiden til start ca. 8 uger.
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.
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.
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.
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose, magnesiumstearat, kolloid vandfri silica,
- The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate, povidone, hydroxypropylcellulose, lactose monohydrate.
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.
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.
Efterfølgende doser (enkeltdosis på 20 mg eller to doser på 10 mg med 12 timers interval til MF-patienter; enkeltdosis på 10 mg eller to doser på 5 mg med 12 timers interval til PV-patienter) skal kun administreres på hæmodialysedagen efter hver dialysesession.
Subsequent doses (single dose of 20 mg or two doses of 10 mg given 12 hours apart in MF patients; single dose of 10 mg or two doses of 5 mg given 12 hours apart in PV patients) should be administered only on haemodialysis days following each dialysis session.
3 (<1.000-500/mm
c grade 3 (<1,000 - 500/mm
Kolloid vandfri silica Natriumstivelseglycolat (type A) Povidon K30
Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Sodium starch glycolate (Type A) Povidone K30
Hos sunde forsøgspersoner medførte samtidig administration af ruxolitinib (enkeltdosis på 10 mg) med erythromycin 500 mg to gange dagligt i fire dage ruxolitinib Cmax og AUC, som var henholdsvis 8% og 27% højere end med ruxolitinib alene.
In healthy subjects co-administration of ruxolitinib (10 mg single dose) with erythromycin 500 mg twice daily for four days resulted in ruxolitinib Cmax and AUC that were higher by 8% and 27%, respectively, than with ruxolitinib alone.
Langtidssikkerhed blev evalueret på baggrund af data fra to fase 3-studier, som inkluderede data fra patienter, som initielt var randomiseret til ruxolitinib (n=184; eksponering 0,03 til 43,5 måneder, medianeksponering 18,9 måneder) og patienter, som fik ruxolitinib efter at krydse over fra kontrolbehandling (n=149; eksponering: 0,2 til 33,5 måneder, medianeksponering 12,0 måneder).
Long-term safety was evaluated using data from two phase 3 studies including data from patients initially randomised to ruxolitinib (n=184; exposure 0.03 to 43.5 months, median exposure 18.9 months) and patients who received ruxolitinib after crossing over from control treatments (n=149; exposure: 0.2 to 33.5 months, median exposure 12.0 months): With longer exposure, the cumulative frequency of adverse events increased but no new safety findings emerged.
- Cimetidin, medicin som bruges til behandling af halsbrand.
- Cimetidine, a medicine to treat heartburn.
Hyppigheden af herpes zoster var sammenlignelig hos PV-patienter (4,3%) og hos MF-patienter (4,0%).
The rate of herpes zoster was similar in PV (4.3%)
14 tabletter 56 tabletter
14 tablets 56 tablets
Yderligere dosisjusteringer skal ske under nøje monitorering af sikkerhed og effekt (se pkt.
Additional dose modifications should be made with careful monitoring of safety and efficacy (see sections 4.2 and 5.2).
4 (<25.000/mm
c grade 4 (<25,000/mm
Efter en median opfølgningsperiode på 61,7 måneder i COMFORT-I var dødeligheden hos patienter randomiseret til ruxolitinib 44,5% (69 ud af 155 patienter) mod 53,2% (82 ud af 154 patienter) hos patienter, der var randomiseret til placebo.
In COMFORT-I, after a median follow-up of 61.7 months, the death rate in patients randomised to the ruxolitinib arm was 44.5% (69 of 155 patients) versus 53.2% (82 of 154) in patients randomised to placebo.