natgillin/translations-raw huggingface dataset:
CNS- blødning, synkope, tremor, amnesi Sjældne: cerebrovaskulært tilfælde, forbigående iskæmisk tilfælde, krampe
CNS bleeding, syncope, tremor, amnesia Rare: cerebrovascular accident, transient ischaemic attack, convulsion
Øjne Almindelig: synsforstyrrelser (inklusive synsforstyrrelser, sløret syn og nedsat syn), tørre øjne Ikke almindelige: konjunktivitis
Eye disorders Common: visual disorder (including visual disturbance, vision blurred, and visual acuity reduced), dry eye Uncommon: conjunctivitis
Øre og labyrint Almindelig: tinnitus Ikke almindelig: vertigo
Ear and labyrinth disorders Common: tinnitus Uncommon: vertigo
ARDS (acute respiratory distress syndrome)
Respiratory, thoracic and mediastinal disorders Common: pulmonary oedema, lung infiltration, pneumonitis Uncommon: bronchospasm, pulmonary hypertenstion, asthma Rare: acute respiratory distress syndrome
Mave- tarmkanalen Almindelige: colitis (inklusive neutropenisk colitis), gastritis, obstipation, forstyrrelser i det orale, bløde væv Ikke almindelige: pankreatitis, øvre gastrointestinalt ulcus, esophagitis, ascites, analfissur, dysfagi
Gastrointestinal disorders Common: colitis (including neutropenic colitis), gastritis, constipation, oral soft tissue disorder Uncommon: pancreatitis, upper gastrointestinal ulcer, oesophagitis, ascites, anal fissure, dysphagia
Nyrer og urinveje Ikke almindelige: nyresvigt, hyppig vandladning, proteinuria
Renal and urinary disorders Uncommon: renal failure, urinary frequency, proteinuria
Hud og subkutane væv Almindelige: alopeci, dermatitis (inklusive eksem), akne, tør hud, urticaria, hyperhidrosis Ikke almindelige: akut febril neutrofil dermatosis, fotosensitivitet, pigmenteringsforstyrrelse, panniculitis, hudsår, bulløse tilstande, negleforstyrrelser, palmar- plantar erytrodysæstesisyndrom
Skin and subcutaneous tissue disorders Common: alopecia, dermatitis (including eczema), acne, dry skin, urticaria, hyperhidrosis Uncommon: acute febrile neutrophilic dermatosis, photosensitivity, pigmentation disorder, panniculitis, skin ulcer, bullous conditions, nail disorder, palmar-plantar erythrodysesthesia syndrome
Knogler, led, muskler og bindevæv Almindelig: muskelinflammation, muskelsvaghed Ikke almindelige: rhabdomyolyse, stivhed i bevægeapparatet Sjælden: tendonitis
Musculoskeletal and connective tissue disorders Common: muscle inflammation, muscular weakness Uncommon: rhabdomyolysis, musculoskeletal stiffness Rare: tendonitis
Metabolisme og ernæring Almindelig: appetitforstyrrelser Ikke almindelig: hyperuricæmi
Metabolism and nutrition disorders Common: appetite disturbances Uncommon: hyperuricaemia
Infektioner og parasitære sygdomme Almindelige: sepsis (inklusive med fatalt resultat), pneumoni (inklusiv bakteriel, viral og mykotisk), øvre luftvejsinfektion/ inflammation, viral herpes infektion, enterocolitis
Infections and infestations Common: sepsis (including fatal outcome), pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/ inflammation, herpes viral infection, enterocolitis infection
Traumer, forgiftninger og behandlingskomplikationer Almindelig: kontusion
Injury, poisoning, and procedural complications Common: contusion
11 Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Ikke almindelig: tumorlysissyndrom
Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: tumour lysis syndrome
Vaskulære sygdomme Almindelig: hypertension, flushing Ikke almindelige: hypotension, tromboflebitis Sjælden: livedo reticularis
Vascular disorders Common: hypertension, flushing Uncommon: hypotension, thrombophlebitis Rare: livedo reticularis
Almene symptomer og reaktioner på administrationsstedet Almindelige: generaliseret ødem, kulderystelser Ikke almindelige: utilpashed Sjælden: temperaturintolerans
11 General disorders and administration site conditions Common: generalised oedema, chills Uncommon: malaise Rare: temperature intolerance
Immunsystemet Ikke almindelig: hypersensitivitet (inklusive erythema nodosum)
Immune System Disorders Uncommon: hypersensitivity (including erythema nodosum)
Lever og galdeveje Ikke almindelige: hepatitis, cholestasis Sjælden: cholecystitis
Hepatobiliary disorders Uncommon: hepatitis, cholestasis Rare: cholecystitis
Det reproduktive system og mammae Ikke almindelige: gynækomasti, uregelmæssig menstruation
Reproductive system and breast disorders Uncommon: gynecomastia, irregular menstruation
Psykiske forstyrrelser Almindelige: depression, søvnløshed Ikke almindelige: angst, konfusion, affektlabilitet, nedsat libido
Psychiatric disorders Common: depression, insomnia Uncommon: anxiety, confusional state, affect lability, libido decreased
Abnormaliteter ved laboratorieundersøgelser:
Laboratory test abnormalities:
Cytopenier (thrombocytopeni, neutropeni og anæmi) var et vedvarende fund ved CML.
In CML, cytopenias (thrombocytopenia, neutropenia, and anaemia) were a consistent finding.
Forekomst af cytopenier afhang tydeligvis også af sygdommens stadie.
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease.
Hæmatologiske laboratorieabnormaliteter af CTC- grad 3/ 4 i kliniske forsøg
CTC Grades 3/ 4 Haematological Laboratory Abnormalities in Clinical Studies
Kronisk fase (n= 1. 150)
Lymphoid Blast Phase
Accelereret fase (n= 502)
Haematology Parameters
blastfase (n= 280)
a Myeloid Blast Chronic Phase Accelerated Phase Phase (n= 1150) (n= 502) (n= 280) Percent (%) of Patients
Neutropeni Trombocytopeni Anæmi
Neutropenia Thrombocytopenia Anaemia a
Data vedrørende den kroniske fase inkluderer patienter behandlet med enhver dosis af SPRYCEL.
The chronic phase data include patients treated with any dose of SPRYCEL.
CTC- grader: neutropeni (grad 3 ≥ 0, 5– 1, 0 × 109/ l, grad 4 < 0, 5 × 109/ l); trombocytopeni (grad 3 ≥ 10– 50 × 109/ l, grad 4 < 10 × 109/ l); anæmi (hæmoglobin grad 3 ≥ 65– 80 g/ l, grad 4 < 65 g/ l).
CTC grades: neutropenia (Grade 3 ≥ 0.5– 1.0 × 109/ l, Grade 4 < 0.5 × 109/ l); thrombocytopenia (Grade 3 ≥ 10– 50 × 109/ l, Grade 4 < 10 × 109/ l); anaemia (hemoglobin Grade 3 ≥ 65– 80 g/ l, Grade 4 < 65 g/ l).
I Fase III- forsøg vedrørende dosisoptimering med patienter med CML i kronisk fase var hyppigheden af neutropeni, trombocytopeni og anæmi lavere i den gruppe, der fik SPRYCEL 100 mg 1 gang dagligt end i den gruppe, der fik SPRYCEL 70 mg 2 gange dagligt.
In the Phase III dose-optimisation study in patients with chronic phase CML, the frequency of neutropenia, thrombocytopenia and anaemia was lower in the SPRYCEL 100 mg once daily than in the SPRYCEL 70 mg twice daily group.
Hos 1% af patienterne blev behandlingenpermanent seponeret.
In patients who experienced severe myelosuppression, recovery generally occurred following brief dose interruptions and/ or reductions and permanent discontinuation of treatment occurred in 1% of patients.
12 Biokemi:
Biochemistry:
Dog blev der rapporteret stigninger med en øget hyppighed på 4- 7% hos patienter med CML i myeloid eller lymfoid blastfase eller Ph+ ALL.
Grade 3 or 4 elevations of transaminases or bilirubin were reported in < 5% of patients with chronic or accelerated phase CML but elevations were reported with an increased frequency of 4 to 7% in patients with myeloid or lymphoid blast CML and Ph+ ALL.
I Fase III- forsøg vedrørende dosisoptimering blev forhøjet transaminase og bilirubin grad 3 og 4 indberettet hos ≤ 1% af patienterne med CML i kronisk fase med ensartet lav forekomst i de 4 behandlingsgrupper.
In the phase III dose optimisation studies, grade 3 or 4 elevations of transaminases or bilirubin were reported in ≤ 1% of patients with chronic phase CML with similar low
Der blev indberettet stigninger hos 1 - 4% af patienterne med CML i fremskreden fase og Ph+ALL.
12 incidence in the four treatment groups; elevations were reported in 1% to 4% of patients with advanced phase CML and Ph+ALL.
5% af de dasatinib- behandlede patienter, som havde normale baselineniveauer, oplevede grad 3 eller 4 forbigående hypokalcæmi på et tidspunkt under forløbet.
Approximately 5% of the dasatinib-treated patients who had normal baseline levels experienced grade 3 or 4 transient hypocalcemia at some time during the course of the study.
Generelt var fald i calcium ikke forbundet med kliniske symptomer.
In general; there was no association of decreased calcium with clinical symptoms.
Patienter der udviklede grad 3 - eller 4- hypocalcæmi kom sig ofte med oralt calciumtilskud.
Patients developing grade 3 or 4 hypocalcemia often had recovery with oral supplementation.
Der blev indberettet grad 3 - og 4- hypokalcæmi og hypofosfatæmi hos patienter i alle CML- faser, men med øget hyppighed hos patienter med CML i myeloid eller lymfoid blastfase og Ph+ ALL.
Grade 3 and 4 hypocalcemia and hypophosphatemia were reported in patients with all phases of CML but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML and Ph+ ALL.
Alle EKG blev aflæst centralt.
In 5 Phase II clinical trials in patients with leukaemia, repeated baseline and on-treatment ECGs were obtained at pre-specified time points and read centrally for 865 patients receiving SPRYCEL 70 mg twice daily.
QT- intervallet korrigeredes for hjertefrekvens ved Fridericias metode.
QT interval was corrected for heart rate by Fridericia's method.
Ved alle post - dosis tidspunkter på dag 8 var gennemsnitlige ændringer fra baseline i QTcF- intervaller 4- 6 msek, med forbundne øvre 95% konfidensintervaller < 7 msek.
At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 -6 msec, with associated upper 95% confidence intervals < 7 msec.
Blandt de 2. 182 patienter som fik SPRYCEL i kliniske forsøg, blev QTc- forlængelse indberettet som bivirkning hos 18 patienter.
Of the 2,182 patients who received SPRYCEL in clinical trials, 18 had QTc prolongation reported as an adverse event.
4. 4).
Seventeen patients (< 1%) experienced a QTcF > 500 msec (see section 4.4).
Erfaring i kliniske forsøg med overdosis af SPRYCEL er begrænset til isolerede tilfælde.
Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases.
Den højeste indberettede dosis, som ikke er forbundet med kliniske symptomer, er 280 mg per dag i 1 uge.
The highest reported dose ingested was 280 mg per day for one week with no associated clinical symptoms.
Relevant understøttende behandling bør ligeledes institueres.
Since dasatinib is associated with severe myelosuppression (see section 4.4), patients who ingested more than the recommended dose should be closely monitored for myelosuppression and appropriate supportive treatment given.
Proteinkinase- hæmmer, ATC- kode:
Protein kinase inhibitor, ATC code:
Dasatinib hæmmer aktivitet af BCR- ABL kinasen og kinaser, der tilhører SRC- kinasefamilien samt en række andre udvalgte onkogene kinaser, inklusive c- KIT, ephrinreceptor- kinaser og PDGFβ - receptorer.
Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected oncogenic kinases including c-KIT, ephrin (EPH) receptor kinases, and PDGFβ receptor.
Dasatinib et en potent, subnanomolær hæmmer af BCR- ABL- kinase med effekt ved en koncentration på 0, 6- 0, 8 nM.
Dasatinib is a potent, subnanomolar inhibitor of the BCR-ABL kinase with potency at concentration of 0.6-0.8 nM.
Det bindes både til inaktive og aktive konformationer af BCR- ABL - enzymet.
It binds to both the inactive and active conformations of the BCR-ABL enzyme.
In vitro er dasatinib aktivt i leukæmiske cellelinier, der repræsenterer varianter af imatinibfølsom og - resistent sygdom.
In vitro, dasatinib is active in leukaemic cell lines representing variants of imatinib-sensitive and resistant disease.
Disse ikke- kliniske forsøg har vist, at dasatinib kan overvinde imatinibresistens, der stammer fra BCR- ABL overekspression, BCR- ABL kinasedomæmemutationer, aktivering af andre signalveje der involverer kinaser, der tilhører SRC- kinasefamilien (LYN, HCK), og multimedicinskresistens genetisk overekspression.
These non-clinical studies show that dasatinib can overcome imatinib resistance resulting from BCR-ABL overexpression, BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multidrug resistance gene overexpression.
Derudover hæmmer dasatinib kinaser, der tilhører SRC- kinasefamilien, ved subnanomolære koncentrationer.
Additionally, dasatinib inhibits SRC family kinases at subnanomolar concentrations.
I separate eksperimenter med murine modeller af CML, forebyggede dasatinib in- vivo progression af kronisk CML til blastfase og forlængede overlevelsen hos mus med patient- deriverede CML - cellelinier placeret forskellige steder, inklusive centralnervesystemet.
In vivo, in separate experiments using murine models of CML, dasatinib prevented the progression of chronic CML to blast phase and prolonged the survival of mice bearing patient-derived CML cell lines grown at various sites, including the central nervous system.
13 Kliniske forsøg:
Clinical trials:
Der er i fase I- forsøg observeret hæmatologisk og cytogenetisk respons i alle faser af CML og Ph+ ALL hos de første 84 behandlede patienter, som blev fulgt i op til 27 måneder.
In the Phase I study, haematologic and cytogenetic responses were observed in all phases of CML and in Ph+ ALL in the first 84 patients treated and followed for up to 27 months.
Der er ialt evalueret 2. 182 patienter i kliniske forsøg; af disse var 25% ≥ 65 år og 5% ≥ 75 år.
A total of 2,182 patients were evaluated in clinical trials; of these 25% were ≥ 65 years of age and 5% were ≥ 75 years of age.
Sikkerhed og effekt af dasatinib er endnu ikke undersøgt hos børn.
Safety and efficacy of dasatinib have not yet been studied in paediatric patients.
Fase- II kliniske forsøg med CML:
13 Phase II clinical trials in CML:
Der er udført 4 kliniske, ukontrollerede, åbne, Fase II, enkeltarmsforsøg for at bestemme sikkerhed og effekt af dasatinib hos patienter med kronisk, accelereret eller myeloid blastfase CML, som enten var resistente eller intolerante over for imatinib.
Four single-arm, uncontrolled, open-label phase II clinical trials were conducted to determine the safety and efficacy of dasatinib in patients with CML in chronic, accelerated, or myeloid blast phase, who were either resistant or intolerant to imatinib.
Ét randomiseret, ikke- komparativt forsøg udførtes med patienter i kronisk fase, som oplevede behandlingssvigt ved initial behandling med 400 eller 600 mg imatinib.
One randomized non-comparative trial was conducted in chronic phase patients who failed initial treatment with 400 or 600 mg imatinib.
4. 2).
Dose modifications were allowed for improving activity or management of toxicity (see section 4.2).
CML i kronisk fase:
Chronic Phase CML:
Der er udført 2 kliniske forsøg med patienter, der er resistente eller intolerante over for imatinib; det primære effekt- endpoint i disse forsøg var McyR (Major Cytogenetic Response):
Two clinical trials were conducted in patients resistant or intolerant to imatinib; the primary efficacy endpoint in these trials was Major Cytogenetic Response (MCyR).
1 - Et åbent, randomiseret, non- komparativt multicenter- forsøg med patienter med behandlingssvigt ved initial behandling med 400 eller 600 mg imatinib.
1- An open-label, randomised, non-comparative multicenter study was conducted in patients who failed initial treatment with 400 or 600 mg imatinib.
Patienterne randomiseredes (2: 1) til enten dasatinib (70 mg 2 gange daglig) eller imatinib (400 mg 2 gange daglig).
They were randomised (2:1) to either dasatinib (70 mg twice daily) or imatinib (400 mg twice daily).
Det primære endpoint var MCyR ved 12 uger.
The primary endpoint was MCyR at 12 weeks.
Der foreligger resultater for 150 patienter:
Results are available for 150 patients:
101 var randomiseret til dasatinib og 49 til imatinib (alle imatinib - resistente).
101 were randomised to dasatinib and 49 to imatinib (all imatinib-resistant).
Gennemsnitlig tid fra diagnose til randomisering var 64 måneder i dasatinib- gruppen og 52 måneder i imatinib- gruppen.
The median time from diagnosis to randomisation was 64 months in the dasatinib group and 52 months in the imatinib group.
Alle patienter var ekstensivt forbehandlede.
All subjects were extensively pretreated.
Tidligere fuldstændig hæmatologisk respons (CHR) på imatinib sås hos 93% af den overordnede patientpopulation.
Prior complete haematologic response (CHR) to imatinib was achieved in 93% of the overall patient population.
Tidligere MCyR med imatinib sås hos henholdsvis 28% og 29% af patienterne i dasatinib - og imatinib- armen.
A prior MCyR to imatinib was achieved in 28% and 29% of the patients in the dasatinib and imatinib arms, respectively.
Gennemsnitlig behandlingsvarighed var 23 måneder for dasatinib (med 44% af patienterne behandlet i > 24 måneder indtil dato) og 3 måneder for imatinib (med 10% af patienterne behandlet i > 24 måneder til dato).
Median duration of treatment was 23 months for dasatinib (with 44% of patients treated for > 24 months to date) and 3 months for imatinib (with 10% of patients treated for > 24 months to date).
I dasatinib- armen opnåede 93% af patienterne CHR inden cross - over og i imatinib- armen opnåede 82% af patienterne CHR inden cross- over.
Ninety-three percent of patients in the dasatinib arm and 82% of patients in the imatinib arm achieved a CHR prior to crossover.
MCyR forekom hyppigere i dasatinib- armen (36%) end i imatinib- armen (29%) efter 3 måneder.
At 3 months, a MCyR occurred more often in the dasatinib arm (36%) than in the imatinib arm (29%).
Særligt bør det bemærkes, at 22% af patienterne indberettede et fuldstændigt cytogent respons (CCyR) i dasatinib- armen, mens kun 8% opnåede CCyR i imatinib- armen.
Notably, 22% of patients reported a complete cytogenetic response (CCyR) in the dasatinib arm while only 8% achieved a CCyR in the imatinib arm.
Med længere behandling og opfølgning (middelværdi på 24 måneder) opnåedes MCyR hos 53% af de dasatinib- behandlede patienter (CCyR hos 44%) og 33% af de imatinib- behandlede patienter (CCyR hos 18%) inden cross - over.
With longer treatment and follow-up (median of 24 months), MCyR was achieved in 53% of the dasatinib-treated patients (CCyR in 44%) and 33% of the imatinib-treated patients (CCyR in 18%) prior to crossover.
Blandt patienter som fik imatinib 400 mg inden inklusion i forsøget opnåedes MCyR hos 61% af patienterne i dasatinib- armen og 50% i imatinib- armen.
Among patients who had received imatinib 400 mg prior to study entry, MCyR was achieved in 61% of patients in the dasatinib arm and 50% in the imatinib arm.
Baseret på Kaplan- Meier- estimater var andelen af patienter som opretholdt MCyR i et år 92% (95% KI:
Based on the Kaplan-Meier estimates, the proportion of patients who maintained MCyR for 1 year was 92% (95% CI:
[85% - 100%]) for dasatinib (CCyR 97%, 95% KI:
[85%-100%]) for dasatinib (CCyR 97%, 95% CI:
[92% - 100%]) og 74% (95% KI:
[92%-100%]) and 74% (95% CI:
[49% - 100%]) for imatinib (CCyR 100%).
[49%-100%]) for imatinib (CCyR 100%).
Andelen af patienter som opretholdt MCyR i 18 måneder var 90% (95% KI:
The proportion of patients who maintained MCyR for 18 months was 90% (95% CI:
[82% - 98%]) for dasatinib (CCyR 94%, 95% CI:
[82%-98%]) for dasatinib (CCyR 94%, 95% CI:
[87% - 100%]) og 74% (95% KI:
[87%-100%]) and 74% (95% CI:
Baseret på Kaplan- Meier- estimater var andelen af patienter med progressionsfri overlevelse (PFS) i et år 91% (95% KI:
Based on the Kaplan-Meier estimates, the proportion of patients who had progression-free survival (PFS) for 1 year was 91% (95% CI:
[85% - 97%]) for dasatinib og 73% (95% KI:
[85%-97%]) for dasatinib and 73% (95% CI:
[54% - 91%]) for imatinib.
[54%-91%]) for imatinib.
Andelen af patienter med PFS efter to år var 86% (95% KI:
The proportion of patients who had PFS at 2 years was 86% (95% CI:
[78% - 93%]) for dasatinib og 65% (95% KI:
[78%-93%]) for dasatinib and 65% (95% CI:
[43% - 87%]) for imatinib.
[43%-87%]) for imatinib.
14 Ialt 43% af patienterne i dasatinib- armen og 82% i imatinib- armen oplevede behandlingssvigt, defineret som sygdomsprogression eller cross- over til den anden behandling (manglende respons, intolerans over for forsøgsmedicinen mv.).
A total of 43% of the patients in the dasatinib arm, and 82% in the imatinib arm had treatment failure, defined as disease progression or cross-over to the other treatment (lack of response, study drug intolerance, etc.).
Hyppigheden af større molekylært respons (defineret som BCR- ABL/ kontroltranskriptioner ≤ 0, 1% ved RQ- PCR i perifert blod) inden cross- over var 29% for dasatinib og 12% for imatinib.
The rate of major molecular response (defined as BCR-ABL/ control transcripts ≤ 0.1% by RQ-PCR in peripheral blood samples) prior to crossover was 29% for dasatinib and 12% for imatinib.
2 - Et åbent, enkeltarms -, multicenter- forsøg med patienter med resistens eller intolerans over for imatinib (dvs. patienter som oplevede signifikant toksicitet under behandling med imatinib hvor fortsat behandling var udelukket).
14 2- An open-label, single-arm, multicenter study was conducted in patients resistant or intolerant to imatinib (i. e. patients who experienced significant toxicity during treatment with imatinib that precluded further treatment).
38% af patienterne havde baseline- mutationer, der vides at medføre imatinib - resistens.
Thirty-eight percent of patients had baseline mutations known to confer imatinib resistance.
Den gennemsnitlige varighed af behandling med dasatinib var 24 måneder med 51% af patienterne behandlet i > 24 måneder til dato.
Median duration of treatment on dasatinib was 24 months with 51% of patients treated for > 24 months to date.
Effektresultaterne er angivet i Tabel 5.
Efficacy results are reported in Table 5.
MCyR opnåedes hos 55% af de imatinib- resistente patienter og 82% af de imatinib- intolerante patienter. Med en minimumsopfølgning på 24 måneder, har kun 21 ud af de 240 patienter som opnåede et MCyR progredieret og MCyRs gennemsnitlige varighed er ikke bestemt.
With a minimum of 24 months follow-up, 21 of the 240 patients who had achieved a MCyR had progressed and the median duration of MCyR had not been reached.
Baseret på Kaplan- Meier- estimaterne opretholdt 95% (95% KI:
Based on the Kaplan-Meier estimates, 95% (95% CI:
[92% - 98%]) af patienterne MCyR i et år og 88% (95% KI:
[92%-98%]) of the patients maintained MCyR for 1 year and 88% (95% CI:
[83% - 93%]) opretholdt MCyR i to år.
[83%-93%]) maintained MCyR for 2 years.
Andelen af patienter som opretholdt CCyR i et år var 97% (95% KI:
The proportion of patients who maintained CCyR for 1 year was 97% (95% CI:
[94% - 99%]) og 90% (95% KI:
[94%-99%]) and for 2 years was 90% (95% CI:
[86% - 95%]) i to år.
[86%-95%]).
55% af de imatinib - resistente patienter uden tidligere MCyR med imatinib (n= 288) opnåede MCyR med dasatinib.
Fifty-five percent of the imatinib-resistant patients with no prior MCyR to imatinib (n= 288) achieved a MCyR with dasatinib.
Der sås 45 forskellige BCR- ABL- mutationer hos 38% af patienterne inkluderet i forsøget.
There were 45 different BCR-ABL mutations in 38% of patients enrolled in this trial.
Der opnåedes fuldstændigt hæmatologisk respons eller MCyR hos patienter med en række BCR- ABL - mutationer forbundet med imatinib- resistens bortset fra T315I.
Complete haematologic response or MCyR was achieved in patients harboring a variety of BCR-ABL mutations associated with imatinib resistance except T315I.
Hyppigheden af MCyR efter to år var ens for patienter med BCR- ABL- mutation, P- loop- mutation eller ingen mutation ved baseline (henholdsvis 63%, 61% og 62%).
The rates of MCyR at 2 years were similar whether patients had any baseline BCR-ABL mutation, P-loop mutation, or no mutation (63%, 61% and 62%, respectively).
Blandt imatinib- resistente patienter var den estimerede hyppighed af PFS 88% (95% KI:
Among imatinib-resistant patients, the estimated rate of PFS was 88% (95% CI:
[84% - 92%]) efter et år og 75% (95% KI:
[84%-92%]) at 1 year and 75% (95% CI:
[69% - 81%]) efter to år.
[69%-81%]) at 2 years.