natgillin/translations-raw huggingface dataset:
Adverse reactions and their frequencies reported in Table 1 are based on the main registration studies.
V preglednici 1 navedeni neželeni učinki in njihove pogostnosti temeljijo na glavnih registracijskih študijah.
Adverse reactions in clinical studies
Neželeni učinki v kliničnih študijah
Uncommon:
zelo pogosti: pogosti: občasni:
Weight increased Weight decreased Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
zvečanje telesne mase zmanjšanje telesne mase zvišan kreatinin v krvi, zvišana kreatin- kinaza v krvi, zvišana laktat- dehidrogenaza v krvi, zvišana alkalna fosfataza v krvi
Cardiac disorders
Srčne bolezni občasni:
Blood amylase increased
zvišana amilaza v krvi palpitacije, tahikardija, kongestivno popuščanje srca1, pljučni edem
Palpitations, tachycardia, cardiac failure congestive1, pulmonary oedema Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
aritmija, atrijska fibrilacija, zastoj srca, miokarni infarkt, angina pektoris, perikardialni izliv
Uncommon:
Bolezni krvi in limfatičnega sistema zelo pogosti: pogosti: občasni:
Neutropenia, thrombocytopenia, anaemia Pancytopenia, febrile neutropenia Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
nevtropenija, trombocitopenija, anemija pancitopenija, febrilna nevtropenija trombocitemija, limfopenija, depresija kostnega mozga, eozinofilija, limfadenopatija
Haemolytic anaemia
hemolitična anemija 10 glavobol2
Headache2 Dizziness, paraesthesia, taste disturbance, hypoaesthesia Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
vrtoglavost, parestezije, motnje okušanja, hipestezije migrena, somnolenca, sinkopa, periferna nevropatija, motnje spomina, išias, sindrom nemirnih nog, tremor, možganska krvavitev
Cataract, glaucoma, papilloedema
katarakta, glavkom, edem papile vidnega živca z motnjami labirinta vrtoglavica, zvonjenje v ušesih, izguba sluha
Ear and labyrinth disorders Uncommon:
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti: občasni:
Respiratory, thoracic and mediastinal disorders
dispneja, krvavitev iz nosu, kašelj plevralni izliv3, bolečine v žrelu in grlu, vnetje žrela
Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain4 Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
plevritična bolečina, pljučna fibroza, pljučna hipertenzija, pljučna krvavitev navzea, driska, bruhanje, dispepsija, bolečine v trebuhu4
Stomatitis, mouth ulceration, gastrointestinal haemorrhage5, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
flatulenca, napihnjen trebuh, gastroezofagealni refluks, obstipacija, suha usta, gastritis stomatitis, razjede ustne sluznice, krvavitev iz prebavil5, spahovanje, melena, ezofagitis, ascites, želodčna razjeda, hematemeza, vnetje ustnice, disfagija, pankreatitis
Renal and urinary disorders Uncommon:
občasni:
Common:
Bolezni kože in podkožja zelo pogosti: pogosti:
Periorbital oedema, dermatitis/ eczema/ rash Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
periorbitalni edemi, dermatitis/ ekcem/ izpuščaj pruritus, edem obraza, suha koža, eritem, alopecija, nočno potenje, fotosenzitivna reakcija
Acute febrile neutrophilic dermatosis (Sweet’ s syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome
akutna febrilna nevtrofilna dermatoza (Sweetov sindrom), sprememba barve nohtov, angionevrotični edem, mehurčkast izpuščaj, multiformni eritem, levkocitoklastični vaskulitis, Stevens- Johnsonov sindrom
Musculoskeletal and connective tissue disorders Very common:
Bolezni mišično- skeletnega sistema in vezivnega tkiva zelo pogosti:
Muscle spasm and cramps, musculoskeletal pain including myalgia, arthralgia, bone pain6
mišični spazmi in krči, mišično- skeletne bolečine, vključno z mialgijo, artralgijo in bolečinami v kosteh6
Rare:
pogosti: občasni: redki:
Uncommon:
Presnovne in prehranske pogosti: občasni:
Joint swelling Joint and muscle stiffness Muscular weakness, arthritis disorders Anorexia Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
otekanje sklepov okorelost sklepov in mišic oslabelost mišic, artritis motnje anoreksija hipokaliemija, povečan tek, hipofosfatemija, zmanjšan tek, dehidracija, protin, hiperurikemija, hiperkalciemija, hiperglikemija, hiponatriemija
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia7, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Infekcijske in parazitske bolezni herpes zoster, herpes simpleks, nazofaringitis, pljučnica7, sinuzitis, flegmona, občasni: okužba zgornjih dihal, gripa, okužba sečil, gastroenteritis, sepsa redki:
Vascular disorders8
Žilne bolezni8
Flushing, haemorrhage Hypertension, haematoma, peripheral coldness, hypotension, Raynaud’ s phenomenon
navali rdečice, krvavitev hipertenzija, hematom, hladni distalni deli udov, hipotenzija, Raynaudov fenomen
Uncommon:
Splošne težave in spremembe na mestu aplikacije zelo pogosti: pogosti: občasni:
Fluid retention and oedema, fatigue Weakness, pyrexia, anasarca, chills, rigors Chest pain, malaise
zastajanje tekočine in edemi, utrujenost oslabelost, zvišana telesna temperatura, anasarka, mrazenje, okorelost bolečine v prsnem košu, slabo počutje
Rare:
Bolezni jeter, žolčnika in žolčevodov pogosti: občasni: redki:
Increased hepatic enzymes Hyperbilirubinaemia, hepatitis, jaundice Hepatic failure9, hepatic necrosis
zvišani jetrni encimi hiperbilirubinemija, hepatitis, zlatenica odpoved jeter9, nekroza jeter
Insomnia Depression, libido decreased, anxiety Confusional state
nespečnost depresija, zmanjšan libido, anksioznost zmedenost
1 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
1 Dogodke v zvezi s srcem, vključno s kongestivno odpovedjo srca, so na podlagi enote bolnik - leto pogosteje opažali pri bolnikih s transformacijo CML kot pri bolnikih s kroničnim potekom CML.
3 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML.
3 O plevralnem izlivu so pogosteje poročali pri bolnikih z GIST in bolnikih s transformacijo CML (kronična mieloična levkemija v pospešeni fazi:
4+5 Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
4+5 Bolečine v trebuhu in krvavitev iz prebavil so najpogosteje opažali pri bolnikih z GIST.
6 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
6 Mišično- skeletne bolečine in z njimi povezane dogodke so pogosteje opažali pri bolnikih s CML kot pri bolnikih z GIST.
7 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
7 O pljučnici so najpogosteje poročali pri bolnikih s transformacijo CML in pri bolnikih z GIST.
8 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
8 Navali rdečice so bili najpogostejši pri bolnikih z GIST, krvavitve (hematomi in krvavitve) pa so bile najpogostejše pri bolnikih z GIST in s transformacijo CML (CML- AP in CML- BC).
9 Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
9 Poročali so o nekaj primerih odpovedi jeter in nekroze jeter s smrtnim izidom.
The following types of reactions have been reported mainly from post-marketing experience with Glivec.
O naslednjih vrstah neželenih učinkov so poročali večinoma iz postmarketinških izkušenj z zdravilom Glivec.
This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications.
To vključuje tako spontano sporočene primere kot tudi resne neželene dogodke iz študij v teku, iz programov razširjene uporabe, študij klinične farmakologije in raziskovalnih študij neodobrenih indikacij.
Table 2
12 Preglednica 2
Adverse reactions from post-marketing reports
Neželeni učinki iz postmarketinških poročil
Immune system disorders
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) pogostnost neznana:
Tumour haemorrhage/ tumour necrosis
krvavitev iz tumorja/ nekroza tumorja
Not known:
Bolezni imunskega sistema pogostnost neznana:
Not known:
Bolezni živčevja
Pericarditis, cardiac tamponade
perikarditis, tamponada srca
Nervous system disorders Not known:
pogostnost neznana:
Cerebral oedema
možganski edem
Vitreous haemorrhage
krvavitev v steklovino
Respiratory, thoracic and mediastinal disorders Not known:
Bolezni dihal, prsnega koša in mediastinalnega prostora akutna respiratorna odpoved1, intersticijska pljučna bolezen pogostnost neznana:
Gastrointestinal disorders Not known:
Bolezni prebavil pogostnost neznana:
Ileus/ intestinal obstruction, gastrointestinal perforation, diverticulitis
ileus/ zapora črevesja, perforacija želodca ali črevesa, divertikulitis
Not known:
Bolezni kože in podkožja pogostnost neznana: pogostnost neznana:
Lichenoid keratosis, lichen planus Toxic epidermal necrolysis
lihenoidna keratoza, lichen planus toksična epidermalna nekroliza
Musculoskeletal and connective tissue disorders Not known:
Bolezni mišično- skeletnega sistema in vezivnega tkiva pogostnost neznana:
Avascular necrosis/ hip necrosis
avaskularna nekroza/ nekroza kolka
Thrombosis/ embolism
tromboza/ embolija
1 Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
1 Poročali so o primerih s smrtnim izidom pri bolnikih z napredovalo boleznijo, s hudimi okužbami, hudo nevtropenijo in z drugimi resnimi spremljajočimi stanji.
12 Laboratory test abnormalities Haematology In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study).
Podatki kažejo, da so lahko citopenije pogostejše pri velikih odmerkih ≥ 750 mg (študija prve faze), vendar pa je pojavljanje citopenij tudi nedvomno odvisno od stadija bolezni.
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/ l) and thrombocytopenias (platelet count < 50 x 109/ l) being between 4 and 6 times higher in blast crisis and accelerated phase (59– 64% and 44– 63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Nevtropenija 3. ali 4. stopnje (ANC < 1, 0 x 109/ l) in trombocitopenija (koncentracija trombocitov < 50 x 109/ l) sta bili štirikrat do šestkrat pogostejši v blastni krizi in pospešeni fazi (nevtropenija 59– 64% in trombocitopenija 44– 63%) kot pri na novo diagnosticiranih bolnikih v kronični fazi CML (nevtropenija 16, 7% in trombocitopenija 8, 9%).
In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/ l) and thrombocytopenia (platelet count < 10 x 109/ l) were observed in 3.6% and < 1% of patients, respectively.
V na novo diagnosticirani kronični fazi CML sta bili odkriti nevtropenija 4. stopnje (ANC < 0, 5 x 109/ l) in trombocitopenija 4. stopnje (< 10 x 109/ l) pri 3, 6% oziroma < 1% bolnikov.
The median duration of the neutropenic and thrombocytopenic episodes usually ranged from 2 to 3 weeks, and from 3 to 4 weeks, respectively.
Povprečno trajanje nevtropeničnih oziroma trombocitopeničnih epizod je bilo navadno 2– 3 tedne oziroma 3– 4 tedne.
In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Pri pediatričnih bolnikih s CML so izmed toksičnih učinkov najpogosteje opažali citopenije 3. ali 4. stopnje, ki vključuje nevtropenijo, trombocitopenijo in anemijo.
In patients with GIST, grade 3 and 4 anaemia was reported in 5.4% and 0.7% of patients, respectively, and may have been related to gastrointestinal or intra-tumoural bleeding in at least some of these patients.
Anemija je bila lahko vsaj pri nekaterih od teh bolnikov povezana z gastrointestinalnimi ali intratumorskimi krvavitvami.
Grade 3 and 4 neutropenia was seen in 7.5% and 2.7% of patients, respectively, and grade 3 thrombocytopenia in 0.7% of patients.
Nevtropenijo 3. in 4. stopnje so odkrili pri 7, 5% oziroma 2, 7% bolnikov, trombocitopenijo 3. stopnje pa pri 0, 7% bolnikov.
Biochemistry Severe elevation of transaminases (< 5%) or bilirubin (< 1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Navadno so to urejali z zmanjšanjem odmerka ali s prekinitvijo zdravljenja (povprečno trajanje teh epizod je bilo približno en teden).
Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1% of CML patients.
13 manj kot 1% bolnikov s CML.
In GIST patients (study B2222), 6.8% of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Pri bolnikih z GIST (študija B2222) so ugotovili 6, 8% zvišanj ALT (alanin- aminotransferaza) stopnje 3 ali 4 in 4, 8% zvišanj AST (aspartat- aminotransferaza) stopnje 3 ali 4.
Bilirubin elevation was below 3%.
Zvišanje bilirubina je bilo pod 3%.
Experience with doses greater than 800 mg is limited.
Izkušnje z odmerki, večjimi od 800 mg, so omejene.
Isolated cases of Glivec overdose have been reported.
Poročali so o posameznih primerih prevelikega odmerjanja zdravila Glivec.
A patient with myeloid blast crisis inadvertently took Glivec 1,200 mg for 6 days and experienced Grade 1 elevations of serum creatinine, Grade 2 ascites and elevated liver transaminase levels, and Grade 3 elevations of bilirubin.
Bolnik z mieloidno blastno krizo je nenamerno jemal po 1. 200 mg zdravila Glivec 6 dni, kar je imelo za posledico zvišanje serumskega kreatinina 1. stopnje, ascites 2. stopnje, zvišane ravni jetrnih transaminaz in zvišanje bilirubina 3. stopnje.
Treatment was temporarily interrupted and there was complete reversal of all abnormalities within one week.
Zdravljenje je bilo začasno prekinjeno in vse nenormalnosti so v enem tednu popolnoma izginile.
Treatment was resumed at a dose of 400 mg without recurrence of problems.
Nato se je bolnik spet začel zdraviti z odmerkom 400 mg, ne da bi se težave ponovile.
Another patient developed severe muscle cramps after taking Glivec 1,600 mg daily for six days.
Pri drugem bolniku so se po šestdnevnem jemanju zdravila Glivec v odmerku 1. 600 mg na dan razvili težki mišični krči.
Following interruption of treatment, complete resolution of muscle cramps occurred, treatment was subsequently resumed.
Po prekinitvi zdravljenja so mišični krči povsem izginili, pozneje se je zdravljenje spet začelo.
Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC code:
Farmakoterapevtska skupina: zaviralec protein- tirozin- kinaze, oznaka ATC:
Imatinib is a protein-tyrosine kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Imatinib je zaviralec protein- tirozin- kinaze, ki močno zavira Bcr- Abl tirozin- kinazo na in vitro, celični in in vivo ravni.
The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Spojina selektivno zavira proliferacijo in inducira apoptozo pri Bcr- Abl pozitivnih celičnih linijah, pa tudi pri svežih limfatičnih celicah bolnikov s CML, s prisotnim kromosomom Philadelphia, in z akutno limfoblastno levkemijo (ALL).
In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
In vivo spojina kaže protitumorsko aktivnost, če se uporablja kot edino sredstvo, v živalskih modelih z Bcr- Abl pozitivnimi tumorskimi celicami.
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.
Imatinib je tudi zaviralec receptorskih tirozin- kinaz za rastni faktor iz trombocitov (PDGF- platelet - derived growth factor), PDGF- R in dejavnik matičnih celic (SCF- stem cell factor), c- Kit, in zavira celične dogodke, ki jih posredujeta PDGF in SCF.
Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/ MPD, HES/ CEL and DFSP.
Konstitutivna aktivacija receptorja za rastni faktor iz trombocitov, ali Abl protein- tirozin- kinaze kot posledica združitve različnih sodelujočih proteinov ali konstitutivna tvorba PDGF sta vpleteni v patogenezo MDS/ MPD, HES/ CEL in DFSP.
Clinical studies in chronic myeloid leukaemia The effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival.
Klinične študije pri kronični mieloični levkemiji Učinkovitost zdravila Glivec temelji na stopnji celotnega hematološkega in citogenetičnega odziva ter preživetju brez napredovanja bolezni.
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Razen za na novo diagnosticirano CML v kronični fazi ni kontroliranih kliničnih preskušanj, ki bi dokazovala klinično koristnost, na primer izboljšanje bolezenskih simptomov ali povečano preživetje.
Three large, international, open-label, non-controlled phase II studies were conducted in patients with Philadelphia chromosome positive (Ph+) CML in advanced, blast or accelerated phase disease, other Ph+ leukaemias or with CML in the chronic phase but failing prior interferon-alpha (IFN) therapy.
Opravili so tri velike mednarodne odprte nekontrolirane študije druge faze pri bolnikih s CML, s prisotnim kromosomom Philadelphia (Ph+), v napredovali, blastni ali pospešeni fazi bolezni, z drugimi Ph+ levkemijami ali s CML v kronični fazi, a po predhodnem neuspešnem zdravljenju z interferonom alfa (IFN).
One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML.
Eno veliko odprto, multicentrično, mednarodno randomizirano študijo tretje
In all clinical studies 38– 40% of patients were ≥ 60 years of age and 10– 12% of patients were ≥ 70 years of age.
V vseh kliničnih študijah je bilo 38– 40% bolnikov starih ≥ 60 let, 10– 12% bolnikov pa je bilo starih ≥ 70 let.
Chronic phase, newly diagnosed:
Kronična faza, na novo diagnosticirana:
This phase III study in adult patients compared treatment with either single-agent Glivec or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
V tej študiji tretje faze z odraslimi bolniki so primerjali zdravljenje z zdravilom Glivec kot edinim zdravilom na eni strani in s kombinacijo interferona alfa (IFN) s citarabinom (Ara- C) na drugi strani.
Patients showing lack of response (lack of complete haematological response (CHR) at 6 months, increasing WBC, no major cytogenetic response (MCyR) at 24 months), loss of response (loss of CHR or MCyR) or severe intolerance to treatment were allowed to cross over to the alternative treatment arm.
Bolnikom, pri katerih se je pokazala odsotnost odziva (odsotnost popolnega hematološkega odziva (CHR- complete haematological response) pri 6 mesecih, povečanje WBC, odsotnost pomembnega citogenetičnega odziva (MCyR) pri 24 mesecih), izguba odziva (izguba CHR ali MCyR) ali težko neprenašanje zdravljenja, je bilo dovoljeno preiti na krak alternativnega zdravljenja.
In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/ m2/ day subcutaneously in combination with subcutaneous Ara-C 20 mg/ m2/ day for 10 days/ month.
Na kraku z IFN so bili bolniki zdravljeni 10 dni na mesec s tarčnim odmerkom IFN 5 MIU/ m2/ dan subkutano v kombinaciji s subkutanim Ara- C 20 mg/ m2/ dan.
A total of 1,106 patients were randomised, 553 to each arm.
Randomiziranih je bilo skupno 1. 106 bolnikov, 553 na vsak krak.
Median age was 51 years (range 18– 70 years), with 21.9% of patients ≥ 60 years of age.
Povprečna starost je bila 51 let (razpon 18– 70 let), 21, 9% bolnikov je bilo starih ≥ 60 let.
There were 59% males and 41% females; 89.9% caucasian and 4.7% black patients.
Moških je bilo 59%, žensk pa 41%; 89, 9% je bilo belcev, 4, 7% pa črncev.
Five years after the last patient had been recruited, the median duration of first-line treatment was 60 and 8 months in the Glivec and IFN arms, respectively.
Pet let po vključitvi zadnjega bolnika je bilo mediano trajanje zdravljenja z zdravili prvega izbora v kraku z zdravilom Glivec 60 mesecev, v kraku z IFN pa 8 mesecev.
The median duration of second-line treatment with Glivec was 45 months.
Mediano trajanje zdravljenja z zdravilom Glivec kot zdravilom drugega izbora je bilo 45 mesecev.
Overall, in patients receiving first-line Glivec, the average daily dose delivered was 389 ± 71 mg.
Povprečni dnevni odmerek v skupini vseh bolnikov, ki so prejemali zdravilo Glivec kot zdravilo prvega izbora, je bil 389 ± 71 mg.
Progression was defined as any of the following events: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite
Napredovanje je bilo definirano kot katerikoli od sledečih dogodkov: napredovanje v pospešeno fazo ali blastno krizo, smrt, izguba popolnega hematološkega odziva ali pomembnega citogenetičnega odziva, oziroma pri bolnikih, ki niso dosegli popolnega hematološkega odziva, rast WBC kljub ustreznemu zdravljenju.
Major cytogenetic response, haematological response, molecular response (evaluation of minimal residual disease), time to accelerated phase or blast crisis and survival are main secondary endpoints.
Pomemben citogenetski odziv, hematološki odziv, molekularni odziv (ovrednotenje minimalne rezidualne bolezni), čas do pospešene faze ali blastne krize in preživetje so poglavitni sekundarni cilji opazovanja.
Response data are shown in Table 3.
Podatke o odzivnosti kaže preglednica 3.
Response in newly diagnosed CML Study (60-month data)
Odziv v študiji na novo diagnosticirane CML (podatki pri 60 mesecih)
IFN+Ara-C
Glivec IFN+Ara- C n=553 n=553
(Best response rates) Haematological response
(Najboljše odzivnosti) Hematološki odziv bolniki s popolnim hematološkim odzivom, število (%)
Cytogenetic response Major response n (%)
Citogenetični odziv bolniki s pomembnim odzivom, število (%)
[95% CI] Complete CyR n (%) Partial CyR n (%)
[95% interval zaupanja] bolniki s popolnim citogenetičnim
Molecular response Major response at 12 months (%) Major response at 24 months (%) * p < 0.001, Fischer’ s exact test
Molekularni odziv pomemben odziv pri 12 mesecih (%) pomemben odziv pri 24 mesecih (%) * p < 0, 001, Fischerjev eksaktni test
40%* 54%
40% * 54%
2%* NA**
2% * NA **
** insufficient data, only two patients available with samples Haematological response criteria (all responses to be confirmed after ≥ 4 weeks):
WBC < 10 x 109/ l, trombociti < 450 x 109/ l, mielociti+metamielociti < 5% v krvi, brez blastov in