natgillin/translations-raw huggingface dataset:
I begge studier tilskrives den lavere dødeligehed i ruxolitinib-armen hovedsagelig resultaterne fra undergrupperne post-polycythæmia vera og post-essentiel trombocytose.
In both studies, the lower death rates noted in the ruxolitinib arm were predominantly driven by the results obtained in the post polycythaemia vera and post essential thrombocythaemia subgroups.
En signifikant højere procentdel af patienterne i Jakavi-gruppen opnåede en reduktion i miltvolumen på ≥35% (Tabel 2) i forhold til baseline uanset tilstedeværelse eller fravær af JAK2V617F-mutationen eller sygdomsundertype (primær MF, MF efter polycythæmia vera, MF efter essentiel trombocytose).
A significantly higher proportion of patients in the Jakavi group achieved ≥35% reduction from baseline in spleen volume (Table 2) regardless of the presence or absence of the JAK2V617F mutation or the disease subtype (primary MF, post-polycythaemia vera MF, post-essential thrombocythaemia MF).
I klinisk relevante koncentrationer hæmmer ruxolitinib ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4 og er ikke en stærk induktor af CYP1A2, CYP2B6 eller CYP3A4, baseret på in vitro studier.
At clinically relevant concentrations, ruxolitinib does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 and is not a potent inducer of CYP1A2, CYP2B6 or CYP3A4 based on in vitro studies.
I de to pivotale studier, COMFORT-I og COMFORT-II, var den mediane eksponeringsvarighed af Jakavi 10,8 måneder (fra 0,3 til 23,5 måneder) i randomiseringsperioden.
In the randomised period of the two pivotal studies, COMFORT-I and COMFORT-II, the median duration of exposure to Jakavi was 10.8 months (range 0.3 to 23.5 months).
Der er begrænset data til at anbefale en startdosis til patienter med trombocyttal mellem 50.000/mm og <100.000/mm3.
There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm and <100,000/mm 3.
Der blev ikke rapporteret intrakranielle eller gastrointestinale blødningshændelser hos patienter, som fik ruxolitinib.
No intracranial bleeding or gastrointestinal haemorrhage events were reported in patients receiving ruxolitinib.
Intrakraniel blødning
Intracranial bleeding
Der anbefales ingen dosisjustering, når ruxolitinib administreres sammen med milde eller moderate CYP3A4-hæmmere (f.eks. erythromycin).
No dose adjustment is recommended when ruxolitinib is co-administered with mild or moderate CYP3A4 inhibitors (e.g. erythromycin).
Dosisreduktion skal overvejes, hvis trombocyttallet falder til under 100.000/mm
Dose reductions should be considered if the platelet count decreases below 100,000/mm
Signifikant flere patienter behandlet med Jakavi (23%) opnåede primært respons (p<0,0001) sammenlignet med BAT (0,9%).
Significantly more patients treated with Jakavi (23%) achieved a primary response (p<0.0001) compared to BAT (0.9%).
Der foreligger ingen data om ruxolitinibs effekt på human fertilitet.
There are no human data on the effect of ruxolitinib on fertility.
Ruxolitinib er elimineret gennem metabolisme katalyseret ved CYP3A4 og CYP2C9.
Ruxolitinib is eliminated through metabolism catalysed by CYP3A4 and CYP2C9.
Frekvensen af svær (dvs. CTCAE grad 3 og 4) trombocytopeni var lavere hos PV-patienter (2,7%) end hos MF-patienter (11,6%).
The frequency of severe (i.e. CTCAE grade 3 and 4) thrombocytopenia was lower in PV (2.7%) than in MF (11.6%) patients.
66% af patienterne behandlet med ruxolitinib rapporterede en forbedring allerede fire uger efter behandlingsstart sammenlignet med 19% af patienterne behandlet med BAT.
66% of patients treated with ruxolitinib compared to 19% treated with BAT reported an improvement as early as four weeks after beginning treatment.
Patienterne randomiseredes i forholdet 2:1 til ruxolitinib og bedste tilgængelige terapi.
Patients were randomised 2:1 to ruxolitinib versus best available therapy.
To randomiserede fase 3-undersøgelser (COMFORT-I og COMFORT-II) blev gennemført med patienter med MF (primær MF, MF efter polycythæmia vera eller MF efter essentiel trombocytose).
Two randomised phase 3 studies (COMFORT-I and COMFORT-II) were conducted in patients with MF (primary MF, post-polycythaemia vera MF or post-essential thrombocythaemia MF).
I kliniske fase 3studier med MF sås hverken CTCAE grad 3 eller 4 hyperkolesterolæmi eller forhøjet aspartataminotransferase eller CTCAE grad 4 forhøjet alaninaminotransferanse
In phase 3 clinical studies in MF, neither CTCAE grade 3 or 4 hypercholesterolaemia, raised aspartate aminotransferase nor CTCAE grade 4 raised alanine aminotransferase were observed.
- Phenytoin, carbamazepin eller phenobarbital og andre midler mod epilepsi, som bruges til at standse krampeanfald.
- Phenytoin, carbamazepine or phenobarbital and other anti-epileptics used to stop seizures or fits.
En patient, som blev behandlet med ruxolitinib, oplevede en grad 3 blødningshændelse (post-procedural blødning).
One patient treated with ruxolitinib experienced a grade 3 bleeding event (post-procedural bleeding); no grade 4 bleeding was reported.
Hos hvalpene observeredes et fald i den gennemsnitlige initiale kropsvægt samt en kort periode med nedsat stigning i den gennemsnitlige kropsvægt.
In the pups, decreased mean initial body weights and short period of decreased mean body weight gain were observed.
Der blev rapporteret sepsis hos 3,0% af patienterne i kliniske fase 3-studier.
In phase 3 clinical studies sepsis was reported in 3.0% of patients.
Dette omfatter medicin, der bruges til behandling af svampeinfektioner (fx ketoconazol, itraconazol, posaconazol, fluconazol og voriconazol), medicin, der bruges til behandling af visse typer bakterieinfektioner (antibiotika, som fx clarithromycin, telithromycin, ciprofloxacin eller erythromycin), lægemidler, der bruges til behandling af virusinfektioner, herunder HIV-infektion/AIDS (fx amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), og lægemidler, der bruges til behandling af hepatitis C (boceprevir, telaprevir).
These include medicines used to treat fungal diseases (such as ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole), medicines used to treat certain types of bacterial infections (antibiotics such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin), medicines to treat viral infections, including HIV infection/AIDS (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), medicines to treat hepatitis C (boceprevir, telaprevir).
Hyperkolesterolæmi b
Hypercholesterolaemia b
Der er rapporteret stigning i hepatitis B-virusmængde (HBV-DNA-titer), med eller uden tilsvarende stigninger i alanin-aminotransferase og aspartat-aminotransferase, hos patienter med kronisk HBVinfektion i behandling med Jakavi.
Hepatitis B viral load (HBV-DNA titre) increases, with and without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Jakavi.
Et andet randomiseret, åbent, aktiv-kontrolleret fase 3b-studie (RESPONSE 2) blev udført hos 149 PV-patienter, som var resistente eller intolerante overfor hydroxycarbamid, men som ikke havde palpabel splenomegali.
A second randomised, open label, active-controlled phase 3b study (RESPONSE 2) was conducted in 149 PV patients who were resistant to, or intolerant of, hydroxyurea but without palpable splenomegaly.
Ved at blokere virkningen af visse enzymer (kaldet Janus-associerede kinaser) kan Jakavi reducere miltens størrelse hos patienter med myelofibrose og lindre symptomer, som fx feber, nattesved, knoglesmerter og vægttab.
By blocking the action of certain enzymes (called Janus Associated Kinases), Jakavi can reduce the size of the spleen in patients with myelofibrosis and relieve symptoms such as fever, night sweats, bone pain and weight loss in patients with myelofibrosis.
Anæmi b
Anaemia b
Ruxolitinib medførte 2 timer efter doseringen en maksimal hæmning af STAT3-fosforylering, som 8 timer senere igen var tæt på baseline hos både sunde forsøgspersoner og MF-patienter, hvilket tyder på, at der ikke sker nogen akkumulering, hverken af uomdannet lægemiddel eller aktive metabolitter.
Ruxolitinib resulted in maximal inhibition of STAT3 phosphorylation 2 hours after dosing which returned to near baseline by 8 hours in both healthy subjects and MF patients, indicating no accumulation of either parent or active metabolites.
I COMFORT-II-studiet var anvendelsen af erytrocyttransfusioner 53,4% i Jakavi-armen og 41,1% i armen med bedste tilgængelige terapi.
In the COMFORT-II study the rate of packed red blood cell transfusions was 53.4% in the Jakavi arm and 41.1% in the best available therapy arm.
De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at ruxolitinib/metabolitter udskilles i human mælk (se pkt.
Available pharmacodynamic/toxicological data in animals have shown excretion of ruxolitinib and its metabolites in milk (see section 5.3).
Hæmodialyse forventes ikke at fremskynde elimineringen af ruxolitinib.
Haemodialysis is not expected to enhance the elimination of ruxolitinib.
Efter en enkelt dosis ruxolitinib på 25 mg til patienter med forskellige grader af nedsat leverfunktion steg den gennemsnitlige AUC for ruxolitinib hos patienter med let, moderat og stærkt nedsat leverfunktion med henholdsvis 87%, 28% og 65% sammenlignet med patienter med normal leverfunktion.
Following a single ruxolitinib dose of 25 mg in patients with varying degrees of hepatic impairment, the mean AUC for ruxolitinib was increased in patients with mild, moderate and severe hepatic impairment by 87%, 28% and 65%, respectively, compared to patients with normal hepatic function.
Bedst tilgængelige behandling
Best available therapy
Behandling med Jakavi kan give hæmatologiske bivirkninger, herunder trombocytopeni, anæmi og neutropeni.
Treatment with Jakavi can cause haematological adverse drug reactions, including thrombocytopenia, anaemia and neutropenia.
Ruxolitinib hæmmer JAK-STAT-signalering og celleproliferation i cytokinafhængige cellemodeller af hæmatologiske maligniteter samt i Ba/F3-celler, som er gjort cytokinuafhængige ved at udtrykke det JAK2V617F-muterede protein, med IC50 fra 80-320 nM.
Ruxolitinib inhibits JAK-STAT signalling and cell proliferation of cytokine-dependent cellular models of haematological malignancies, as well as of Ba/F3 cells rendered cytokine-independent by expressing the JAK2V617F mutated protein, with IC50 ranging from 80-320 nM.
Der iagttoges ingen påvirkninger af fertiliteten.
No effects were noted on fertility.
Trafik- og arbejdssikkerhed Hvis du føler dig svimmel, når du har taget Jakavi, må du ikke køre bil eller betjene maskiner.
Driving and using machines If you experience dizziness after taking Jakavi, do not drive or use machines.
Der er ingen tilgængelige data vedrørende dosering til patienter, som behandles med peritonealdialyse eller kontinuerlig venovenøs hæmofiltration (se pkt.
No data is available for dosing patients who are undergoing peritoneal dialysis or continuous venovenous haemofiltration (see section 5.2).
MF-patienter blev ikke refraktære med hensyn til de farmakodynamiske virkninger efter længere tids behandling med ruxolitinib.
MF patients did not become refractory to the pharmacodynamic effects of ruxolitinib treatment over time.
I COMFORT-I og COMFORT-II var de demografiske og sygdomsmæssige karakteristika for patienterne i de to behandlingsarme sammenlignelige.
In COMFORT-I and COMFORT-II, patient baseline demographics and disease characteristics were comparable between the treatment arms.
Ruxolitinib hæmmer cytokininduceret STAT3-fosforylering i fuldblod fra sunde forsøgspersoner, MFpatienter og PV-patienter.
Ruxolitinib inhibits cytokine-induced STAT3 phosphorylation in whole blood from healthy subjects, MF patients and PV patients.
Jakavi er indiceret til behandling af sygdomsrelateret splenomegali eller symptomer hos voksne patienter med primær myelofibrose (også kaldet kronisk idiopatisk myelofibrose), myelofibrose efter polycythæmia vera eller myelofibrose efter essentiel trombocytose.
Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
Lægerne skal holde patienter, der behandles med Jakavi, under nøje observation for symptomer på infektioner og straks påbegynde passende behandling.
Physicians should carefully observe patients receiving Jakavi for signs and symptoms of infections and initiate appropriate treatment promptly.
Komplet blodtælling skal monitoreres som klinisk indiceret, og dosis justeres efter behov (se pkt.
Complete blood counts should be monitored as clinically indicated and dose adjusted as required (see sections 4.2 and 4.8).
Liste over bivirkninger fra kliniske studier i tabel
Tabulated list of adverse drug reactions from clinical studies
Patienter med trombocyttal på 100.000/mm til 200.000/mm 3, før de startede med ruxolitinib, havde en højere frekvens af trombocytopeni grad 3 eller 4 end patienter med trombocyttal på >200.000/mm
Patients with a platelet count of 100,000/mm to 200,000/mm before starting ruxolitinib had a higher frequency of grade 3 or 4 thrombocytopenia compared to patients with platelet count >200,000/mm
50% dosisreduktion bør overvejes, når der anvendes lægemidler, som både hæmmer CYP2C9- og CYP3A4-enzymer (fx fluconazol).
50% dose reduction should be considered when using medicinal products which are dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole).
Jakavi-tabletterne leveres i blisterpakninger indeholdende 14 eller 56 tabletter eller multipakninger indeholdende 168 (3 pakninger med 56) tabletter.
Jakavi tablets are supplied in blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets
Under det kliniske forsøg vurderes alvorligheden af bivirkninger på grundlag af CTCAE, hvor grad 1 = mild, grad 2 = moderat, grad 3 = svær og grad 4 = livstruende.
In the clinical study programme the severity of adverse drug reactions was assessed based on the CTCAE, defining grade 1 = mild, grade 2 = moderate, grade 3 = severe and grade 4=life-threatening.
14 tabletter
14 tablets
Gastrointestinal blødning
Gastrointestinal bleeding
De sekundære endepunkter omfattede varigheden af en vedligeholdt reduktion i miltvolumen på ≥35% i forhold til baseline, andelen af patienter med ≥50% reduktion af den samlede symptomscore, ændringer i den samlede symptomscore fra baseline til uge 24, målt efter den modificerede MF Symptom Assessment Form (MFSAF)-dagbog, v2.0, samt den samlede overlevelse.
Secondary endpoints included duration of maintenance of a ≥35% reduction from baseline in spleen volume, proportion of patients who had ≥50% reduction in total symptom score, changes in total symptom scores from baseline to week 24, as measured by the modified MF Symptom Assessment Form (MFSAF) v2.0 diary, and overall survival.
Primært sammensat endepunkt ved uge 32
Primary composite endpoint at week 32
CYP3A4-induktorer (såsom, men ikke begrænset til avasimib, carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin, perikon (Hypericum perforatum)) Patienterne skal monitoreres nøje, og dosis skal titreres under hensyntagen til sikkerhed og effekt (se pkt.
CYP3A4 inducers (such as, but not limited to, avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin (rifampicin), St.John's wort (Hypericum perforatum)) Patients should be closely monitored and the dose titrated based on safety and efficacy (see section 4.2).
1 og 2
c grade 1 and 2
Neutropeni (absolut neutrofiltælling <500) var generelt reversibel og håndteredes ved at afbryde behandlingen med Jakavi midlertidigt (se pkt.
Neutropenia (absolute neutrophil count <500) was generally reversible and was managed by temporarily withholding Jakavi (see sections 4.2 and 4.8).
Multipakning: 168 (3 pakninger med 56) tabletter
Multipack: 168 (3 packs of 56) tablets.
Non-melanom hudkræft, inklusive basalcelle-, pladecelle- og Merkelcelle-karcinom, er rapporteret hos patienter behandlet med ruxolininib.
Non-melanoma skin cancers (NMSCs), including basal cell, squamous cell, and Merkel cell carcinoma, have been reported in patients treated with ruxolitinib.
Nervesystemet Svimmelhed a
Nervous system disorders Dizziness a
Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer): - højt niveau af kolesterol eller fedt i blodet (hyperkolesterolæmi/hypertriglyceridæmi) - unormale resultater af prøver for leverfunktionen - svimmelhed - hovedpine - unrinvejsinfektion - vægtforøgelse
Very common (may affect more than 1 in 10 people): - high level of cholesterol or fat in the blood (hypertriglyceridaemia) - abnormal liver function test results - dizziness - headache - urinary tract infections - weight gain
I randomiseringsperioden i det pivotale studie med PV-patienter steg det gennemsnitlige systoliske blodtryk med 0,65 mmHg i ruxolitinib-armen mod et fald på 2 mmHg i BAT-armen.
In the randomised period of the pivotal study in PV patients, the mean systolic blood pressure increased by 0.65 mmHg in the ruxolitinib arm versus a decrease of 2 mmHg in the BAT arm.
Behandlingen skal ophøre ved trombocyttal under 50.000/mm eller absolutte neutrofiltal under 500/mm
Treatment should be discontinued for platelet counts less than 50,000/mm or absolute neutrophil counts less than 500/mm
Startdosis for Jakavi skal reduceres hos patienter med stærkt nedsat nyrefunktion.
The starting dose of Jakavi should be reduced in patients with severe renal impairment.
Blå mærker blev hyppigere rapporteret hos patienter, der tog ruxolitinib, end hos patienter, der fik referencebehandling (21,3% vs. 11,6%).
Bruising events were more frequently reported in patients taking ruxolitinib compared with the reference treatments (21.3% versus 11.6%).
Et andet studie med raske frivillige indikerede, at ruxolitinib ikke påvirker farmakokinetikken af et oralt kontraceptivum indeholdende ethinylestradiol og levonorgestrel.
Another study in healthy subjects indicated that ruxolitinib does not affect the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel.
Der foreligger begrænsede data til bestemmelse af den bedste dosering til hæmodialysepatienter med nyresygdom i slutstadiet.
There are limited data to determine the best dosing options for patients with end-stage renal disease (ESRD) on haemodialysis.
Hæmatologiske bivirkninger (alle Common Terminology Criteria for Adverse Events [CTCAE]grader) omfatter anæmi (82,4%), trombocytopeni (69,8%) og neutropeni (16,6%).
Haematological adverse drug reactions (any Common Terminology Criteria for Adverse Events [CTCAE] grade) included anaemia (82.4%), thrombocytopenia (69.8%) and neutropenia (16.6%).
I de fase 3 pivotale kliniske studier med MF blev der ved mindst et af besøgene registreret en stigning i systolisk blodtryk på 20 mmHg eller mere fra baseline hos 31,5% af patienter sammenlignet med 19,5% af de kontrolbehandlede patienter.
In the phase 3 pivotal clinical studies in MF an increase in systolic blood pressure of 20 mmHg or more from baseline was recorded in 31.5% of patients on at least one visit compared with 19.5% of the control-treated patients.
I den randomiserede periode af det pivotale studie hos PV-patienter blev der rapporteret en (0,5%) CTCAE grad 3 og ingen grad 4 urinvejsinfektion.
In the randomised period of the pivotal study in PV patients, one (0.5%) CTCAE grade 3 and no grade 4 urinary tract infection was reported.
- Den maksimale dosis er 25 mg to gange daglig.
- The maximum dose is 25 mg twice daily.
Jakavi indeholder lactose (mælkesukker).
Jakavi contains lactose (milk sugar).
Der er ikke fundet en årsagssammenhæng med ruxolitinib.
A causal relationship to ruxolitinib has not been established.
Samtidig brug af cytoreduktive terapier eller hæmatopoetiske vækstfaktorer og Jakavi er ikke blevet undersøgt.
The concomitant use of cytoreductive therapies or haematopoietic growth factors with Jakavi has not been studied.
Der sås ingen påvirkning ved en evaluering af de neurofarmakologiske effekter af ruxolitinib.
No effects were noted in an evaluation of the neuropharmacological effects of ruxolitinib.
Stærke CYP3A4-hæmmere (såsom, men ikke begrænset til boceprevir, clarithromycin, indinavir, itraconazol, ketoconazol, lopinavir/ritonavir, ritonavir, mibefradil, nefazodon, nelfinavir, posaconazol, saquinavir, telaprevir, telithromycin, voriconazol) Hos raske forsøgspersoner medførte administration af ruxolitinib (enkeltdosis på 10 mg) sammen med ketoconazol, som er en stærk CYP3A4-hæmmer, i et ruxolitinib Cmax og AUC, som var henholdsvis 33% og 91% højere end med ruxolitinib alene.
Strong CYP3A4 inhibitors (such as, but not limited to, boceprevir, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole) In healthy subjects co-administration of ruxolitinib (10 mg single dose) with a strong CYP3A4 inhibitor, ketoconazole, resulted in ruxolitinib Cmax and AUC that were higher by 33% and 91%, respectively, than with ruxolitinib alone.
Initialdosis af Jakavi var 10 mg to gange dagligt.
The starting dose of Jakavi was 10 mg twice daily.
Urinvejsinfektioner a,d
Infections and infestations Urinary tract infections a,d
I den randomiserede periode af det pivotale studie for PV blev neutropeni rapporteret hos tre patienter (1,6%), hvor en af patienterne udviklede CTCAE grad 4 neutropeni.
In the randomised period of the pivotal study in PV patients, neutropenia was reported in three patients (1.6%) of which one patient developed CTCAE grade 4 neutropenia.
Efter en enkelt dosis ruxolitinib på 25 mg var ruxolitinibs eksponering omtrent ens hos forsøgspersoner med forskellige grader af nedsat nyrefunktion og forsøgspersoner med normal nyrefunktion.
Following a single ruxolitinib dose of 25 mg, the exposure of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with normal renal function.
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%.
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%.
En enkelt dosis på 15 mg anbefales til MFpatienter med trombocyttal mellem 100.000/mm og 200.000/mm
A single dose of 15 mg is recommended for MF patients with platelet count between 100,000/mm and 200,000/mm
3 (<8,0-6,5g/dl)
c grade 3 (<8.0 - 6.5g/dl)
Ud af de patienter, der opnåede et primært respons ved uge 32, opretholdt 80% deres respons i mindst 48 uger efter det initielle respons.
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.
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.
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.
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.
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).
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%).
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.