natgillin/translations-raw huggingface dataset:
Management of severe infection, bleeding/haemorrhage and other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require a dosing interruption, dose reduction, or discontinuation of treatment (see section 4.2). 
Obvladovanje hude okužbe, krvavitve in drugih učinkov mielosupresije, vključno s hudo nevtropenijo ali trombocitopenijo, lahko zahteva prekinitev odmerjanja, zmanjšanje odmerka ali prekinitev zdravljenja (glejte poglavje 4.2).
Based on a population pharmacokinetic analysis, age, race, and gender did not significantly affect inotuzumab ozogamicin disposition. 
Glede na populacijsko farmakokinetično analizo starost, rasa in spol niso pomembno vplivali na odstranjevanje inotuzumab ozogamicina.
Inotuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody that specifically recognises human CD22. 
Inotuzumab je humanizirano protitelo, imunoglobulin razreda G podtipa 4 (IgG4), ki specifično prepoznava humani CD22.
• Add the reconstituted solution to an infusion container with sodium chloride 9 mg/mL (0.9%) solution for injection, to a total nominal volume of 50 mL. 
• Rekonstituirano raztopino dodajte v infuzijski vsebnik z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje do skupnega nominalnega volumna 50 ml.
BESPONSA should be administered with caution in patients who have a history of, or predisposition to QT interval prolongation, who are taking medicinal products that are known to prolong QT interval (see section 4.5) and in patients with electrolyte disturbances. 
Zdravilo BESPONSA je treba uporabljati previdno pri bolnikih, ki imajo podaljšanje intervala QT v anamnezi ali so nagnjeni k podaljšanju intervala QT, pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšajo interval QT (glejte poglavje 4.5), ter pri bolnikih z motnjami elektrolitov.
Inotuzumab ozogamicin (which has a density of 1.02 g/mL at 20 °C/68 °F) is light sensitive and should be protected from ultraviolet light during reconstitution, dilution, and administration. 
Inotuzumab ozogamicin (ki ima gostoto 1,02 g/ml pri 20 °C/68 °F) je občutljiv na svetlobo in ga je treba med rekonstitucijo, redčenjem in uporabo zaščititi pred ultravijolično svetlobo.
In 234 patients with relapsed or refractory ALL, the clearance of inotuzumab ozogamicin at steady state was 0.0333 L/h, and the terminal elimination half-life (t½) at the end of Cycle 4 was approximately 12.3 days. 
Pri 234 bolnikih z recidivno ali refraktarno ALL je bil očistek inotuzumab ozogamicina v stanju dinamičnega ravnovesja 0,0333 l/h, končni razpolovni čas izločanja (t½) ob koncu 4. cikla pa je znašal približno 12,3 dneva.
Based on a population pharmacokinetic analysis in 765 patients, body surface area was found to significantly affect inotuzumab ozogamicin disposition. 
S populacijsko farmakokinetično analizo pri 765 bolnikih so ugotovili, da telesna površina pomembno vpliva na odstranjevanje inotuzumab ozogamicina.
In the Phase 2 portion of the study, 8/35 (22.9%) patients had a follow-up HSCT. 
V 2. fazi študije so 8/35 (22,9 %) bolnikom v nadaljevanju opravili PKMC.
By central and local laboratory tests, 231/253 (91.3%) patients and 130/253 (51.4%) patients, respectively, had ≥ 70% CD22-positive leukaemic blasts at baseline. 
Rezultati preskusov centralnega oziroma lokalnega laboratorija kažejo, da je 231/253 (91,3 %) bolnikov oziroma 130/253 (51,4 %) bolnikov imelo ≥ 70% CD22-pozitivnih levkemičnih blastov ob izhodišču.
• QT interval prolongation (see section 2); signs and symptoms include a change in electrical activity of the heart that can cause serious irregular heart rhythms. 
• podaljšanje intervala QT (glejte poglavje 2); znaki in simptomi vključujejo spremembo električne aktivnosti srca, kar lahko povzroči resno neredno bitje srca.
Population pharmacokinetic/pharmacodynamic evaluation suggested a correlation between increasing inotuzumab ozogamicin serum concentrations and prolongation of QTc intervals in ALL and non-Hodgkin's lymphoma (NHL) patients. 
Populacijsko farmakokinetično/farmakodinamično vrednotenje je pokazalo povezavo med zvečanjem koncentracij inotuzumab ozogamicina v serumu in podaljšanjem intervalov QTc pri bolnikih z ALL in ne-Hodgkinovim limfomom (NHL).
Depending on the severity of the infusion related reaction, consider discontinuation of the infusion or administration of steroids and antihistamines. 
Glede na resnost z infuzijo povezane reakcije razmislite o prekinitvi infundiranja ali uporabi steroidov in antihistaminikov.
Hepatotoxicity, including venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS) 
Hepatotoksičnost, vključno z venookluzivno boleznijo jeter/sindromom obstrukcije sinusoidov (VOD/SOS)
BESPONSA (N=35) 
Zdravilo BESPONSA (n = 35)
ECG and electrolytes should be obtained prior to the start of treatment and periodically monitored during treatment (see sections 4.8 and 5.2). 
Pred začetkom zdravljenja je treba pridobiti EKG in vrednosti elektrolitov in jih med zdravljenjem redno spremljati (glejte poglavji 4.8 in 5.2).
Tumour lysis syndrome (2%) Hyperuricaemia (4%) 
sindrom tumorske lize (2 %) hiperurikemija (4 %)
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD/SOS=venoocclusive disease/sinusoidal obstruction syndrome. 
Okrajšave: ALT = alanin-aminotransferaza; AST = aspartat-aminotransferaza; ZMN = zgornja meja normale; VOD/SOS = venookluzivna bolezen jeter/sindrom obstrukcije sinusoidov.
Overdoses may result in adverse reactions that are consistent with the reactions observed at the recommended therapeutic dose (see section 4.8). 
Preveliko odmerjanje lahko povzroči neželene učinke, ki so skladni z učinki, opaženimi pri priporočenem terapevtskem odmerku (glejte poglavje 4.8).
In clinical studies of BESPONSA in patients with relapsed or refractory ALL, 7/236 (3%) patients tested positive for anti-inotuzumab ozogamicin antibodies. 
V kliničnih preskušanjih z zdravilom BESPONSA pri bolnikih z recidivno ali refraktarno ALL je bilo 7/236 (3 %) bolnikov pozitivnih na protitelesa proti inotuzumab ozogamicinu.
Instructions for reconstitution, dilution, and administration 
Navodila za rekonstitucijo, redčenje in uporabo
Permanently discontinue treatment (see section 4.4). 
Zdravljenje trajno prekinite (glejte poglavje 4.4).
BESPONSA must be reconstituted and diluted before administration. 
Zdravilo BESPONSA je treba pred uporabo rekonstituirati in razredčiti.
Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death. 
Aktivacija N-acetil-gama-kaliheamicin dimetilhidrazida inducira pretrganja dvojno vijačne DNK, kar posledično inducira zaustavitev celičnega cikla in apoptotično celično smrt.
- Protect from light. 
- Zaščitite pred svetlobo.
Grade 3/4 TLS was reported in 3 (2%) patients. 
O TLS stopnje 3/4 so poročali pri 3 (2 %) bolnikih.
if you have certain side effects. 
BESPONSA, če imate določene neželene učinke.
Pregnant women, or patients becoming pregnant while receiving inotuzumab ozogamicin, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the fetus. 
Če inotuzumab ozogamicin uporabljajo nosečnice, če bolnica med prejemanjem inotuzumaba ozogamicina zanosi ali če se z inotuzumab ozogamicinom zdravijo bolniki, ki so partnerji nosečnic, jih je treba seznaniti z morebitno nevarnostjo za plod.
MedDRA System organ class Very common 
Organski sistem po MedDRA Zelo pogosti
A third cycle may be considered for those patients who do not achieve a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) and minimal residual disease (MRD) negativity after 2 cycles (see section 4.4). 
O 3. ciklu lahko razmislimo pri tistih bolnikih, ki po 2 ciklih ne dosežejo popolne remisije (CR - Complete Remission) ali popolne remisije z delnim hematološkim okrevanjem (CRi - Complete Remission with incomplete haematological recovery) in negativnega izvida za minimalno rezidualno bolezen (MRD - Minimal Residual Disease) (glejte poglavje 4.4).
Because of the potential for adverse reactions in breast-fed children, women must not breast-feed during treatment with BESPONSA and for at least 2 months after the final dose (see section 5.3). 
Zaradi možnosti za neželene učinke pri dojenih otrocih ženske med zdravljenjem z zdravilom BESPONSA in vsaj 2 meseca po zadnjem odmerku ne smejo dojiti (glejte poglavje 5.3).
VOD/SOS was reported up to 56 days after the last dose of inotuzumab ozogamicin without an intervening HSCT. 
O VOD/SOS so poročali do 56 dni po zadnjem odmerku inotuzumab ozogamicina brez posredovanja s PKMC.
Following administration of multiple doses, a 5.3 times accumulation of inotuzumab ozogamicin was observed between Cycles 1 and 4. 
Po uporabi večkratnih odmerkov so med 1. in 4. ciklom opazili 5,3-kratno kopičenje inotuzumab ozogamicina.
d VOD/SOS includes 1 additional patient with Venoocclusive liver disease that occurred at Day 56 with no intervening HSCT. 
VOD/SOS vključuje 1 dodatnega bolnika, ki se mu je venookluzivna bolezen jeter pojavila 56. dan brez posredovanja s PKMC.
The primary analysis of CR/CRi and MRD negativity was conducted in the initial 218 randomised patients and the analysis of OS, PFS, DoR, and HSCT rate was conducted in all 326 randomised patients. 
Primarno analizo CR/CRi in negativnega izvida za MRD so opravili pri prvotnih 218 randomiziranih bolnikih, analizo OS, PFS, DoR in stopnje PKMC pa pri vseh 326 randomiziranih bolnikih.
The mean (SD) maximum serum concentration (Cmax) of inotuzumab ozogamicin was 308 ng/mL (362). 
Največja povprečna (SD) koncentracija (Cmax) inotuzumab ozogamicina v serumu je bila 308 ng/ml (362).
• have elevations in amylase or lipase enzymes that may be a sign of problems with your pancreas or liver and gallbladder or bile ducts. 
• imate zvečane vrednosti encimov amilaze ali lipaze, kar je lahko znak težav s trebušno slinavko ali jetri in žolčnikom ali žolčevodom.
• have serious ongoing liver disease, e.g., cirrhosis (a condition in which the liver does not function properly due to long-term damage), nodular regenerative hyperplasia (a condition with signs and symptoms of portal hypertension that can be caused by chronic use of medicines), active hepatitis (a disease characterised by inflammation of the liver). 
• imate resno bolezen jeter, npr. cirozo (stanje, pri katerem jetra zaradi dolgotrajne poškodbe ne delujejo pravilno), nodularno regenerativno hiperplazijo (stanje z znaki in simptomi zvišanega krvnega tlaka v portalni veni (portalna hipertenzija), ki ga lahko povzroča kronična uporaba zdravil), aktivni hepatitis (bolezen, za katero je značilno vnetje jeter).
Pancytopeniab (2%) 
pancitopenija b (2 %)
TLS occurred shortly after the end of the inotuzumab ozogamicin infusion and resolved with medical management. 
TLS se je pojavil kmalu po koncu infundiranja inotuzumab ozogamicina ter je izzvenel z medicinsko obravnavo.
For patients proceeding to haematopoietic stem cell transplant (HSCT), the recommended duration of treatment is 2 cycles. 
Pri bolnikih, pri katerih bodo opravili presaditev krvotvornih matičnih celic (PKMC), je priporočeno trajanje zdravljenja 2 cikla.
An increase in QTcF interval of > 450 msec was observed in 26/162 (16%) patients. 
Podaljšanje intervala QTcF za > 450 ms so opazili pri 26/162 (16 %) bolnikov.
If ANC decreases, interrupt the next cycle of treatment until recovery of ANC to ≥ 1 × 109/L. 
Če se ANC zmanjša, prekinite naslednji cikel zdravljenja, dokler se ANC ne vrne na ≥ 1 × 10
c MRD negativity was defined by flow cytometry as leukaemic cells comprising < 1 × 10-4 (< 0.01%) of bone marrow nucleated cells. 
Negativen izvid za MRD so opredelili s pretočno citometrijo kot levkemične celice, ki predstavljajo < 1 × 10 (< 0,01 %) jedrnih celic kostnega mozga.
Storage times and conditions for reconstituted and diluted BESPONSA solution 
Čas in pogoji shranjevanja za rekonstituirano in razredčeno raztopino zdravila BESPONSA
Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment (see Summary of Product Characteristics section 4.2). 
Pri vseh bolnikih, ki v 3 ciklih ne dosežejo CR/CRi, zdravljenje prekinite (glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila).
Table 8 shows the storage times and conditions for reconstitution, dilution, and administration of BESPONSA. 
Preglednica 8 prikazuje čase shranjevanja in pogoje rekonstitucije, redčenja in uporabe zdravila BESPONSA.
• have a history of, or tendency to have, QT interval prolongation (a change in electrical activity of the heart that can cause serious irregular heart rhythms), are taking medicines that are known to prolong QT interval, and/or have abnormal electrolyte (e.g., calcium, magnesium, potassium) levels. 
• ste v preteklosti imeli podaljšanje intervala QT ali ste nagnjeni k temu (sprememba električne aktivnosti srca, kar lahko povzroči resno neredno bitje srca), jemljete zdravila, za katera je znano, da podaljšajo interval QT, in/ali imate nenormalne ravni elektrolitov (npr. kalcija, magnezija, kalija).
Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agent, monoclonal antibodies, ATC code: L01XC26. 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, druga zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC26.
Once attached to the lymphoblastic leukaemia cells, the medicine delivers a substance into the cells that interferes with the cells' DNA and eventually kills them. 
Po pritrditvi na limfoblastne levkemične celice zdravilo vanje dostavi snov, ki ovira delovanje DNK v celicah in jih sčasoma uniči.
In the pivotal study (N=164), infusion related reactions were reported in 17 (10%) patients. 
V ključnem preskušanju (n = 164) so o reakcijah, povezanih z infuzijo, poročali pri 17 (10 %) bolnikih.
No patients with relapsed or refractory ALL who were treated with BESPONSA in clinical trials had undergone HSCT within the previous 4 months. 
Pri nobenem od bolnikov z recidivno ali refraktarno ALL, ki so jih v kliničnih preskušanjih zdravili z zdravilom BESPONSA, v predhodnih 4 mesecih niso opravili PKMC.
The median age was 45 years (range 20-79); 76.4% were Salvage status ≥ 2; 31.9% had received a prior HSCT and 22.2% were Ph+. 
Mediana starost je bila 45 let (razpon: 20-79 let); 76,4 % je imelo rešilni status ≥ 2; pri 31,9 % so predhodno opravili PKMC in 22,2 % je imelo Ph
Increased amylase and lipase 
Zvečanje amilaze in lipaze
Sucrose Polysorbate 80 Sodium chloride Tromethamine 
saharoza polisorbat 80 natrijev klorid trometamol
Interrupt the infusion and institute appropriate medical management. 
Infundiranje prekinite in zagotovite ustrezno medicinsko obravnavo.
In the pivotal clinical study (N=164), VOD/SOS was reported in 23 (14%) patients including 5 (3%) patients during study therapy or in follow-up without an intervening HSCT. 
V ključnem kliničnem preskušanju (n = 164) so o VOD/SOS poročali pri 23 (14 %) bolnikih, vključno s 5 (3 %) bolniki med zdravljenjem v preskušanju ali spremljanjem po preskušanju brez posredovanja s PKMC.
Your doctor will take an electrocardiogram (ECG) and blood tests to measure electrolytes (e.g., calcium, magnesium, potassium) before the first dose of BESPONSA and repeat these tests during treatment. 
Zdravnik bo pred prvim odmerkom zdravila BESPONSA pridobil elektrokardiogram (EKG) in vrednosti preiskav krvi za določitev elektrolitov (npr. kalcija, magnezija, kalija); preiskave bodo med zdravljenjem ponovljene.
If these patients do proceed to HSCT, signs and symptoms of VOD/SOS should be monitored closely (see section 4.2). 
Če pri teh bolnikih opravite PKMC, jih je treba skrbno spremljati glede znakov in simptomov VOD/SOS (glejte poglavje 4.2).
- Patients with serious ongoing hepatic disease (e.g., cirrhosis, nodular regenerative hyperplasia, 
- Bolniki z resno boleznijo jeter (npr. ciroza, nodularna regenerativna hiperplazija, aktivni hepatitis).
Ascites (4%) Abdominal distension (6%) 
ascites (4 %) napihnjenost trebuha (6 %)
a, b, c, d, e, f For definition, see Table 6 (with the exception that CR/CRi was not per EAC for Study 2) 
Za definicijo glejte preglednico 6 (z izjemo, da CR/CRi ni bil po EAC za Študijo 2).
This included 70 and 18 patients in the BESPONSA and Investigator's choice of chemotherapy arm, respectively, who proceeded directly to HSCT. 
To je vključevalo 70 bolnikov v skupini z zdravilom BESPONSA in 18 bolnikov v skupini s kemoterapijo po izbiri raziskovalca, ki so nadaljevali neposredno na PKMC.
The median age was 47 years (range: 18-79 years), 206 (63%) patients had a duration of first remission < 12 months, and 55 (17%) patients had undergone an HSCT prior to receiving BESPONSA or Investigator's choice of chemotherapy. 
Mediana starost je bila 47 let (razpon: 18-79 let), 206 (63 %) bolnikov je imelo prvo remisijo trajajočo < 12 mesecev in pri 55 (17 %) bolnikov so pred prejemom zdravila BESPONSA ali kemoterapije po izbiri raziskovalca opravili PKMC.
In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide was primarily metabolised via nonenzymatic reduction. 
In vitro se je N-acetil-gama-kaliheamicin dimetilhidrazid primarno presnavljal preko neencimske redukcije.
The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic product. 
Majhna molekula, N-acetil-gama-kaliheamicin, je citotoksično zdravilo.
Therefore, the concomitant use of inotuzumab ozogamicin with medicinal products known to prolong QT interval or to induce Torsades de Pointes should be carefully considered. 
Zato je treba skrbno razmisliti glede sočasne uporabe inotuzumab ozogamicina z zdravili, za katera je znano, da podaljšajo interval QT ali povzročajo Torsades de pointes.
Due to the risk of VOD/SOS, for patients proceeding to HSCT, the recommended duration of treatment with inotuzumab ozogamicin is 2 cycles; a third cycle may be considered for those patients who do not achieve a CR or CRi and MRD negativity after 2 cycles (see section 4.2). 
Zaradi tveganja za VOD/SOS sta pri bolnikih, pri katerih bodo opravili PKMC, priporočljiva 2 cikla zdravljenja z inotuzumab ozogamicinom; o 3. ciklu lahko razmislimo pri tistih bolnikih, ki po 2 ciklih ne dosežejo CR ali CRi in negativnega izvida za MRD (glejte poglavje 4.2).
• Reconstitute each 1 mg vial with 4 mL of water for injection, to obtain a single-use solution of 0.25 mg/mL of BESPONSA. 
• Eno 1 mg vialo rekonstituirajte s 4 ml vode za injekcije, da dobite raztopino zdravila BESPONSA 0,25 mg/ml za enkratno uporabo.
In the event of an overdose, the infusion should be temporarily interrupted, and patients should be monitored for liver and haematological toxicities (see section 4.2). 
V primeru prevelikega odmerjanja je treba infundiranje začasno prekiniti in bolnike spremljati glede jetrne in hematološke toksičnosti (glejte poglavje 4.2).
Patients should be observed during, and for at least 1 hour after the end of infusion for symptoms of infusion related reactions (see section 4.4). 
Med infundiranjem in vsaj 1 uro po koncu infundiranja je treba bolnike opazovati glede simptomov z infuzijo povezanih reakcij (glejte poglavje 4.4).
BESPONSA acts by attaching to cells with a protein called CD22. 
Zdravilo BESPONSA deluje tako, da se pritrdi na celice, ki imajo beljakovino, imenovano CD22.
Table 5 shows the adverse reactions reported in patients with relapsed or refractory ALL who received BESPONSA. 
Preglednica 5 prikazuje neželene učinke, o katerih so poročali pri bolnikih z recidivno ali refraktarno ALL, ki so prejemali zdravilo BESPONSA.
For clinical management of hepatotoxicity, including VOD/SOS, see section 4.4. 
Za klinično obvladovanje hepatotoksičnosti, vključno z VOD/SOS, glejte poglavje 4.4.
f In the standard definition of PFS, defined as the time from date of randomisation to earliest date of the following events: death, progressive disease (including objective progression and relapse from CR/CRi), the HR was 0.568 (2-sided p-value=0.0002) and median PFS was 5.6 months and 3.7 months in the BESPONSA and Investigator's choice of chemotherapy arm, respectively. 
Pri standardni definiciji PFS, opredeljeni kot čas od datuma randomizacije do najzgodnejšega datuma naslednjih dogodkov: smrt, napredovala bolezen (vključno z objektivnim napredovanjem in ponovitvijo bolezni od CR/CRi), je bilo razmerje ogroženosti 0,568 (2-stranska vrednost p = 0,0002) in mediana PFS za zdravilo BESPONSA 5,6 mesecev ter za kemoterapijo po izbiri raziskovalca 3,7 mesecev.
For storage conditions after reconstitution and dilution, see section 6.3. 
Za pogoje shranjevanja po rekonstituciji in redčenju zdravila glejte poglavje 6.3.
When considering the use of BESPONSA as a treatment for relapsed or refractory B cell ALL, baseline CD22 positivity of > 0% using a validated and sensitive assay is required prior to initiating treatment (see section 5.1). 
Pri odločanju glede uporabe zdravila BESPONSA za zdravljenje recidivne ali refraktarne B-celične ALL je treba pred začetkom zdravljenja z uporabo validiranega in občutljivega preskusa določiti izhodiščno pozitivnost CD22 > 0 % (glejte poglavje 5.1).
Dose modification of BESPONSA may be required based on individual safety and tolerability (see section 4.4). 
Odmerek zdravila BESPONSA bo morda treba prilagoditi glede na posameznikovo varnost in prenašanje (glejte poglavje 4.4).
Unopened vials 
Neodprta viala
Tumour lysis syndrome (TLS) 
Sindrom tumorske lize (TLS)
Lymphoblastic leukaemia cells have this protein. 
To beljakovino imajo limfoblastne levkemične celice.
In patients who underwent a follow-up HSCT, the median OS was 11.9 months (95% CI: 9.2, 20.6) for BESPONSA versus 19.8 months (95% CI: 14.6, 26.7) for Investigator's choice of chemotherapy. 
Pri bolnikih, ki so jim v nadaljevanju opravili PKMC, je bila mediana OS 11,9 mesecev (95 % IZ: 9,2; 20,6) za zdravilo BESPONSA v primerjavi z 19,8 mesecev (95 % IZ: 14,6; 26,7) za kemoterapijo po izbiri raziskovalca.
• Excess of uric acid in the blood 
• presežek sečne kisline v krvi
CD22 expression was assessed using flow cytometry based on bone marrow aspirate. 
Izraženost CD22 so ocenjevali s pretočno citometrijo na osnovi aspirata kostnega mozga.
The mean (SD) simulated total area under the concentration-time curve (AUC) per cycle at steady state was 100 mcgh/mL (32.9). 
Povprečna (SD) simulirana skupna površina pod krivuljo koncentracije zdravila v odvisnosti od časa (AUC) na cikel v stanju dinamičnega ravnovesja je bila 100 μgh/ml (32,9).
In the pivotal study (N=164), TLS, which may be life-threatening or fatal, was reported in 4/164 (2%) patients. 
V ključnem preskušanju (n = 164) so o TLS, ki je lahko življenjsko ogrožajoč ali smrten, poročali pri 4/164 (2 %) bolnikov.
2-sided p-value < 0.0001 
2-stranska vrednost p < 0,0001
A total of 79/164 (48.2%) patients in the BESPONSA arm and 36/162 (22.2%) patients in the Investigator's choice of chemotherapy arm had a follow-up HSCT. 
Pri skupno 79/164 (48,2 %) bolnikov v skupini z zdravilom BESPONSA in 36/162 (22,2 %) bolnikov v skupini s kemoterapijo po izbiri raziskovalca so v nadaljevanju opravili PKMC.
No patients had an increase in QTcF interval > 500 msec. Grade 2 QT interval prolongation was reported in 2/164 (1%) patients. 
Noben bolnik ni imel podaljšanega intervala QTcF za > 500 ms. O podaljšanju intervala QT stopnje 2 so poročali pri 2/164 (1 %) bolnikov.
The most common reasons for treatment discontinuation were: disease progression/relapse (30 [41.7%)], resistant disease (4 [5.6%]); HSCT (18 [25.0%]), and adverse events 
Najpogostejši razlogi za prenehanje zdravljenja so bili: napredovanje bolezni/relaps (30 (41,7 %)), odporna bolezen (4 (5,6 %)), PKMC (18 (25,0 %)) in neželeni učinki (13 (18,1 %)).
• have a history of liver problems or liver diseases or if you have signs and symptoms of a serious condition called hepatic venoocclusive disease, a condition in which the blood vessels in the liver become damaged and blocked by blood clots. 
• ste v preteklosti imeli težave z jetri ali bolezen jeter ali če imate znake in simptome resnega stanja, ki se imenuje venookluzivna bolezen jeter, stanja, pri katerem krvni strdki poškodujejo in zamašijo žile v jetrih.