FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with risk factors of QTc prolongation or risk factors of Torsade de pointes should be monitored with continuous cardiac monitoring (ECG).
Croatian: Bolesnike koji su pod rizikom od produljenja QTc intervala ili od torsade de pointes mora se nadzirati neprekidnim praćenjem kardiološkog statusa (EKG).
English: In order to prevent the development of the APL differentiation syndrome during induction treatment, prednisone (0.5 mg/kg body weight per day throughout induction treatment) may be administered from day 1 of arsenic trioxide application to the end of induction therapy in APL patients.
Croatian: Radi sprječavanja razvoja sindroma diferencijacije APL-a tijekom indukcijskog liječenja, može se primjenjivati prednizon (0,5 mg/kg tjelesne težine na dan tijekom indukcijskog liječenja) od 1. dana primjene arsenovog trioksida do kraja indukcijske terapije u bolesnika s APL-om.
English: Patients with newly diagnosed acute promyelocytic leukaemia Your doctor will give you Arsenic trioxide Accord once every day as an infusion.
Croatian: Bolesnici s novodijagnosticiranom akutnom promijelocitnom leukemijom Liječnik će Vam dati lijek Arsenov trioksid Accord svakog dana jedanput dnevno kao infuziju.
English: There is limited clinical data on the use of arsenic trioxide in the elderly population.
Croatian: Dostupni su ograničeni podaci o primjeni arsenovog trioksida u starije populacije.
English: 44% of relapsed/refractory APL patients experienced symptoms that could be associated with neuropathy; most were mild to moderate and were reversible upon cessation of treatment with arsenic trioxide.
Croatian: 44 % bolesnika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje imalo je simptome koji su se mogli povezati s neuropatijom; većina ih je bila blaga do umjerena te su postali reverzibilni nakon prekida liječenja arsenovim trioksidom.
English: One patient treated under a compassionate use program died from cerebral infarct due to leukocytosis, following treatment with chemotherapeutic medicinal products to lower WBC count.
Croatian: Jedan bolesnik liječen u programu milosrdnog davanja lijeka umro je od moždanog infarkta zbog leukocitoze nakon liječenja kemoterapeuticima za snižavanje razine leukocita.
English: Alanine amino transferase increased
Croatian: Pretrage porast alanin aminotransferaze
English: If QTc prolongation does not recur within 7 days of restarting treatment at the reduced dose, treatment with arsenic trioxide can be resumed at 0.11 mg/kg body weight per day for a second week.
Croatian: Ako ne nastupi produljenje QTc intervala unutar 7 dana od ponovnog početka liječenja pri smanjenoj dozi, liječenje arsenovim trioksidom može se nastaviti u dozi od 0,11 mg/kg tjelesne težine na dan tijekom drugog tjedna.
English: As soon as bilirubin and/or SGOT and/or alkaline phosphatase are decreased to below 4 times the normal upper level, treatment with arsenic trioxide should be resumed at 50 % of the previous dose during the first 7 days.
Croatian: Čim se vrijednosti bilirubina i/ili SGOT-a i/ili alkalne fosfataze smanje ispod 4-struke vrijednosti gornje granice normale, liječenje arsenovim trioksidom potrebno je nastaviti s 50% prethodne doze tijekom prvih 7 dana.
English: The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the hydrolysis product arsenious acid (AsIII).
Croatian: Anorganski, liofilizirani oblik arsenovog trioksida odmah stvara hidrolitički produkt arsenične kiseline (AsIII) kad se stavi u otopinu.
English: Additional information about QT prolonging medicinal agents is provided in Section 4.4.
Croatian: Dodatne informacije o lijekovima koji produljuju QT interval nalaze se u dijelu 4.4.
English: Type I transparent colorless glass vial sealed with a silicon-oil free, elastomer type, grey rubber stopper made of bromobutyl and aluminium seal with a plastic flip off cap containing 10 ml of concentrate.
Croatian: I zatvorena čepom od elastomerne, sive, bromobutilne gume bez silikonskog ulja s aluminijskim prstenom i plastičnom flip-off kapicom, koja sadrži 10 ml koncentrata.
English: Limited reproductive toxicity studies of arsenic trioxide in animals indicate embryotoxicity and teratogenicity (neural tube defects, anophthalmia and microphthalmia) at administration of 1-10 times the recommended clinical dose (mg/m2).
Croatian: Ograničena ispitivanja reproduktivne toksičnosti arsenovog trioksida na životinjama ukazuju na embriotoksičnost i teratogenost (oštećenja neuralne cijevi, anoftalmiju i mikroftalmiju) pri primjeni 110 puta većih doza od preporučene kliničke doze (mg/m2).
English: 18-Month survival
Croatian: 18-mjesečni
English: During consolidation, ATRA was given at the same dose for periods of 2 weeks on and 2 weeks off for a total of 7 courses, and arsenic trioxide was given at the same dose 5 days per week, 4 weeks on and 4 weeks off, for a total of 4 courses.
Croatian: Tijekom konsolidacije, ATRA se davala u istoj dozi tijekom razdoblja od 2 tjedna nakon čega su slijedila 2 tjedna pauze, u ukupno 7 ciklusa, a arsenov trioksid davao se u istoj dozi 5 dana u tjednu tijekom 4 tjedna, nakon čega su slijedila 4 tjedna pauze, u ukupno 4 ciklusa.
English: Patients who reach an absolute QT interval value > 500 msec must be reassessed and immediate action must be taken to correct concomitant risk factors, if any, while the risk/benefit of continuing versus suspending arsenic trioxide therapy must be considered.
Croatian: Bolesnici koji postignu apsolutnu vrijednost QT intervala > 500 ms moraju se ponovno podvrgnuti pregledu te je potrebno hitno djelovati kako bi se korigirali istodobni čimbenici rizika, ako postoje, te je potrebno razmotriti omjer rizika/dobrobiti nastavka liječenja naspram prekida terapijom arsenovim trioksidom.
English: In the case of the reappearance of symptoms arsenic trioxide should be reduced to the previous dosage.
Croatian: U slučaju ponovne pojave simptoma potrebno je sniziti arsenov trioksid na prethodnu dozu.
English: The mechanism of action of arsenic trioxide is not completely understood.
Croatian: Mehanizam djelovanja arsenovog trioksida nije potpuno razjašnjen.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ukoliko uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause QT/QTc interval prolongation such as macrolide antibiotics, the antipsychotic thioridazine, or medicinal products known to cause hypokalemia or hypomagnesaemia.
Croatian: Preporučuje se oprez kad se arsenov trioksid primjenjuje istodobno s drugim lijekovima za koje se zna da uzrokuju produljenje QT/QTc intervala poput makrolidnih antibiotika, antipsihotika tioridazina ili lijekovima za koje se zna da uzrokuju hipokalemiju ili hipomagnezijemiju.
English: QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Croatian: Produljenje QT intervala može uzrokovati ventrikularnu aritmiju tipa torsade de pointes, koja može biti smrtonosna.
English: Arsenic trioxide Accord must be given under the supervision of a physician experienced in the treatment of acute leukaemias.
Croatian: Lijek Arsenov trioksid Accord mora se dati pod nadzorom liječnika koji je iskusan u liječenju akutnih leukemija.
English: Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RAR alpha by RT-PCR or micro speckled PML nuclear distribution in leukemic cells were included.
Croatian: Uključeni su bili bolesnici s novodijagnosticiranim APL-om koji je bio potvrđen prisutnošću translokacije t(15; 17) ili PML-RAR alfa metodom RT-PCR ili mikro raspršenom nuklearnom distribucijom PML-a u leukemijskim stanicama.
English: In a follow-up treatment after consolidation, 7 patients in the single institution study and 18 patients in the multicentre study received further maintenance therapy with arsenic trioxide.
Croatian: U kontrolnom praćenju nakon konsolidacije, 7 je bolesnika u monocentričnom i 18 u multicentričnom ispitivanju primilo nastavak terapije održavanja arsenovim trioksidom.
English: Arsenic trioxide must be administered intravenously at a fixed dose of 0.15 mg/kg/day given daily until complete remission is achieved (less than 5% blasts present in cellular bone marrow with no evidence of leukaemic cells).
Croatian: Arsenov trioksid mora se primjenjivati intravenski pri fiksnoj dozi od 0,15 mg/kg/dan, svaki dan, sve dok se ne postigne potpuna remisija (manje od 5% blasta prisutnih u stanicama koštane srži bez dokaza leukemičnih stanica).
English: If you have any further question on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: Hyperleukocytosis was never treated with additional chemotherapy and resolved on continuation of arsenic trioxide.
Croatian: Hiperleukocitoza nikad nije bila liječena dodatnom kemoterapijom te se povukla pri nastavku liječenja arsenovim trioksidom.
English: Renal impairment Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 mL/min) or moderate renal impairment (creatinine clearance of 30-49 mL/min).
Croatian: Oštećenje bubrega Plazmatski klirens AsIII nije bio izmijenjen u bolesnika s blagim oštećenjem bubrega (klirens kreatinina od 50 do 80 ml/min) ili umjerenim oštećenjem bubrega (klirens kreatinina od 30 do 49 ml/min).
English: Women of childbearing potential and men must use effective contraception during treatment with arsenic trioxide.
Croatian: Žene reproduktivne dobi i muškarci moraju koristiti učinkovitu kontracepciju tijekom liječenja arsenovim trioksidom.
English: In post authorisation experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported for the treatment of malignancies other than APL with arsenic trioxide.
Croatian: Prema iskustvu nakon stavljanja lijeka u promet, sindrom diferencijacije, poput sindroma retinoatne kiseline, bio je zabilježen i kada su arsenovim trioksidom liječene druge maligne bolesti osim APL-a.
English: Men should also use effective contraception during treatment with Arsenic trioxide Accord.
Croatian: Muškarci također moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom Arsenov trioksid
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
Croatian: Kemijska i fizikalna stabilnost u primjeni dokazane su tijekom 24 sata na temperaturi od 25°C i tijekom 48 sati na temperaturi od 2°C do 8°C.
English: Arsenic trioxide has no or negligible influence on the ability to drive and use machines.
Croatian: Arsenov trioksid ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Cytogenetic confirmation of conversion to a normal genotype and reverse transcriptase - polymerase chain reaction (RT-PCR) detection of PML/RARα conversion to normal are shown in table 5 below.
Croatian: Citogenetska potvrda konverzije u normalni genotip i detekcija konverzije PML/RARα u normalnu reakcijom obrnute transkriptaze - lančane polimeraze (RT-PCR), prikazane su u tablici 5 u nastavku.
English: During arsenic trioxide treatment, 14 of the 52 patients in the APL studies in the relapsed setting had one or more symptoms of APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis (see section 4.4).
Croatian: Tijekom liječenja arsenovim trioksidom, 14 od 52 bolesnika s APL-om u fazi relapsa imali su jedan ili više simptoma sindroma diferencijacije APL-a, koji karakteriziraju vrućica, dispneja, porast tjelesne težine, plućni infiltrati i pleuralni ili perikardijalni izljevi, s leukocitozom ili bez nje (vidjeti dio 4.4).
English: Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing arsenic trioxide.
Croatian: Tri bolesnika iz monocentričnog ispitivanja i 15 bolesnika iz multicentričnog ispitivanja podvrgnuli su se transplantaciji matičnih stanica nakon dovršetka liječenja arsenovim trioksidom.
English: Baseline white blood cell (WBC) counts did not correlate with development of leukocytosis on study, and WBC counts during consolidation therapy were not as high as during induction.
Croatian: Početne vrijednosti leukocita nisu korelirale s razvojem leukocitoze u ispitivanju, a broj leukocita tijekom konsolidacijske terapije nije bio tako visok kao tijekom indukcije.
English: Mortality in the pivotal studies in the relapsed setting from disseminated intravascular coagulation (DIC) associated haemorrhage was very common (> 10%), which is consistent with the early mortality reported in the literature.
Croatian: U pivotalnim je ispitivanjima bolesti u fazi relapsa vrlo često bio prijavljivan (> 10%) mortalitet zbog krvarenja povezanog s diseminiranom intravaskularnom koagulacijom (DIK), što je u skladu s preuranjenim mortalitetom opisanim u literaturi.
English: The influence of arsenic trioxide on the efficacy of other antileukaemic medicinal products is unknown.
Croatian: Drugi lijekovi protiv leukemije Utjecaj arsenovog trioksida na djelotvornost drugih lijekova protiv leukemije nije poznat.
English: If this happens, treatment with Arsenic trioxide Accord must be stopped immediately and your doctor will treat the arsenic overdose.
Croatian: Arsenov trioksid Accord mora se odmah prekinuti, a Vaš će liječnik liječiti predoziranje arsenom.
English: Twenty relapsed/refractory APL patients (50 %) experienced leukocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leukopheresis was not required.
Croatian: Dvadeset bolesnika s APL-om koji je u fazi relapsa/refraktoran na liječenje (50%), imalo je leukocitozu; međutim, kod svih tih bolesnika broj leukocita bio je u padu ili se normalizirao do vremena remisije koštane srži pa citotoksična terapija ili leukofereza nije bila potrebna.
English: Arsenic trioxide Accord is expected to have no or negligible influence on your ability to drive and use machines.
Croatian: Za lijek Arsenov trioksid Accord očekuje se da ne utječe ili da zanemarivo utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.
Croatian: Jedan je bolesnik (koji je primao više lijekova istodobno, uključujući i amfotericin B) imao asimptomatsku torsade de pointes tijekom indukcijske terapije arsenovim trioksidom za relaps APL-a.
English: Arsenic trioxide Accord must be diluted with a solution containing glucose or a solution containing sodium chloride.
Croatian: Lijek Arsenov trioksid Accord mora se razrijediti otopinom koja sadrži glukozu ili natrijev klorid.
English: Thereafter, in the absence of worsening of the previous toxicity, arsenic trioxide might be resumed at full dosage.
Croatian: Nakon toga, u odsutnosti pogoršanja prethodne toksičnosti, liječenje arsenovim trioksidom može se nastaviti u punoj dozi.
English: Those serious adverse reactions attributed to arsenic trioxide included APL differentiation syndrome (3), leukocytosis (3), prolonged QT interval (4, 1 with torsade de pointes), atrial fibrillation/atrial flutter (1), hyperglycaemia (2) and a variety of serious adverse reactions related to haemorrhage, infections, pain, diarrhoea, nausea.
Croatian: Te ozbiljne nuspojave pripisane arsenovom trioksidu uključivale su sindrom diferencijacije APL-a (3), leukocitozu (3), produljeni QT interval (4, 1 s torsade de pointes), fibrilaciju atrija/undulaciju atrija (1), hiperglikemiju (2) i razne ozbiljne nuspojave povezane s krvarenjem, infekcijama, boli, proljevom, mučninom.
English: In your first treatment cycle, you may be treated every day up to 60 days at most or until your doctor determines that your disease is better.
Croatian: Vašem prvom ciklusu liječenja možda ćete dobivati lijek Arsenov trioksid Accord svaki dan, do najviše 60 dana ili dok liječnik ne utvrdi da Vam je bolje.
English: Arsenic trioxide Accord must then be diluted immediately with 100 to 250 ml of glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Lijek Arsenov trioksid Accord mora se odmah razrijediti pomoću 100 do 250 ml otopine glukoze za injekciju 50 mg/ml (5 %) ili otopine natrijevog klorida 9 mg/ml (0,9 %) za injekciju.
English: Arsenic trioxide Accord must not be mixed with, or infused through the same tube with other medicines.
Croatian: Lijek Arsenov trioksid Accord ne smije se miješati ili davati infuzijom kroz istu cjevčicu s drugim lijekovima.
English: - difficulty in breathing - coughing - chest pain - fever
Croatian: - otežano disanje - kašalj - bolovi u prsima
English: Cytotoxic: handle with caution.
Croatian: Citotoksično: rukovati s oprezom
English: - If you have further questions, please ask your doctor or your pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: In your first treatment cycle, you may be treated every day up to 50 days at most or until your doctor determines that your disease is better.
Croatian: Vašem prvom ciklusu liječenja možda ćete dobivati Arsenov trioksid Accord svaki dan, do najviše 50 dana ili dok liječnik ne utvrdi da Vam je bolje.
English: In newly diagnosed patients with low to intermediate risk APL leukocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8).
Croatian: U novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika razvila se leukocitoza tijekom indukcijske terapije u 35 od 74 (47%)
English: The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products (such as class Ia and III antiarrythmics (e.g. quinidine, amiodarone, sotalol, dofetilide), antipsychotics (e.g. thioridazine), antidepressants (e.g. amitriptyline), some macrolides (e.g. erythromycin), some antihistamines (e.g. terfenadine and astemizole), some quinolone antibiotics (e.g. sparfloxacin), and other individual medicinal products known to increase QT interval (e.g. cisapride)), a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, amphotericin B or other conditions that result in hypokalemia or hypomagnesaemia.
Croatian: Rizik od torsade de pointes povezan je sa stupnjem produljenja QT intervala, istodobnom primjenom lijekova koji produljuju QT interval (poput antiaritmika klase Ia i III (primjerice, kinidina, amiodarona, sotalola, dofetilida), antipsihotika (primjerice, tioridazina), antidepresiva (primjerice, amitriptilina), nekih makrolida (primjerice, eritromicina), nekih antihistaminika (primjerice, terfenadina i astemizola), nekih kinolonskih antibiotika (primjerice, sparfloksacina) i drugih pojedinačnih lijekova za koje je poznato da produljuju QT interval (primjerice, cisaprid)), anamnezom torsade de pointes, već postojećim produljenjem QT intervala, kongestivnim zatajenjem srca, primjenom diuretika koji troše kalij, amfotericina B ili s drugim stanjima koja rezultiraju hipokalemijom ili hipomagnezijemijom.
English: Arsenic trioxide must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in section 4.4 must be followed.
Croatian: 4.2 Doziranje i način primjene Arsenov trioksid mora se primijeniti pod nadzorom liječnika koji je iskusan u liječenju akutnih leukemija te se mora pridržavati posebnih postupaka nadzora opisanih u dijelu 4.4.
English: Arsenic trioxide Accord must be administered intravenously over 1-2 hours.
Croatian: Lijek Arsenov trioksid Accord mora se primjenjivati intravenski tijekom 1-2 sata.
English: In newly diagnosed APL patients treated with arsenic trioxide and ATRA, APL differentiation syndrome was observed in 19 % including 5 severe cases.
Croatian: U bolesnika s novodijagnosticiranim APL-om liječenih arsenovim trioksidom i ATRA-om, sindrom diferencijacije APL-a primijećen je u njih 19% uključujući 5 teških slučajeva.
English: The total clearance of AsIII over the single dose range of 7-32 mg (administered as 0.15 mg/kg) is 49 L/h and the renal clearance is 9 L/h.
Croatian: Ukupni klirens AsIII u rasponu pojedinačnih doza od 732 mg (primijenjenih kao 0,15 mg/kg) iznosi 49 l/h, a bubrežni klirens je 9 l/h.
English: You must talk to your doctor or nurse before using Arsenic trioxide Accord, if - you have impaired kidney function.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite lijek Arsenov trioksid Accord, ako:
English: The use of arsenic trioxide in patients on dialysis has not been studied.
Croatian: Primjena arsenovog trioksida u bolesnika na dijalizi nije proučavana.
English: Arsenic trioxide Accord must be diluted before administration.
Croatian: Lijek Arsenov trioksid Accord mora se razrijediti prije primjene.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva pruritus
English: Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week.
Croatian: Arsenov trioksid mora se primjenjivati intravenski pri dozi od 0,15 mg/kg/dan, 5 dana u tjednu.
English: Arsenic trioxide must be administered intravenously over 1-2 hours.
Croatian: Arsenov trioksid mora se primjenjivati intravenski tijekom 1-2 sata.
English: ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF ARSENIC TRIOXIDE ACCORD SINCE NO PRESERVATIVE IS PRESENT.
Croatian: Potrebno je pridržavati se strogih zahtjeva aseptičke tehnike tijekom rukovanja lijekom Arsenov trioksid Accord s obzirom da lijek ne sadrži konzervans.
English: Hyperglycaemia
Croatian: Hiperleukocitoza
English: Related adverse reactions of CTC grade 3 and 4 occurred in 37% of relapsed/refractory APL patients in clinical trials.
Croatian: Sažetak sigurnosnog profila Povezane nuspojave CTC stupnja 3 ili 4 pojavile su se u 37% ispitanika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje u kliničkim ispitivanjima.
English: Arsenic trioxide is to be administered intravenously at a dose of 0.15 mg/kg/day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks.
Croatian: Arsenov trioksid primjenjuje se intravenski pri dozi od 0,15 mg/kg/dan po 25 doza koje se daju 5 dana u tjednu, nakon čega slijedi 2 dana pauze, a cijeli se ciklus ponavlja tijekom 5 tjedana.
English: Arsenic trioxide Accord contains arsenic trioxide which is an anticancer medicine.
Croatian: Arsenov trioksid Accord sadrži arsenov trioksid, lijek za liječenje raka.
English: What Arsenic trioxide Accord looks like and contents of the pack
Croatian: Kako lijek Arsenov trioksid Accord izgleda i sadržaj pakiranja
English: In newly diagnosed patients with low to intermediate risk APL, gastrointestinal toxicity, grade 3-4 neutropenia and grade 3 or 4 thrombocytopenia occurred, however these were 2.2 times less frequent in patients treated with arsenic trioxide in combination with ATRA compared to patients treated with ATRA + chemotherapy.
Croatian: U novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika pojavili su se gastrointestinalna toksičnost, neutropenija 3.-4. stupnja i trombocitopenija 3. ili 4. stupnja, međutim ti su učinci bili 2,2 puta manje česti u bolesnika liječenih arsenovim trioksidom u kombinaciji s ATRAom u usporedbi s bolesnicima liječenima kombinacijom ATRA + kemoterapija (vidjeti tablicu 2).