FrancophonIA/ELRC3.0 huggingface dataset:
English: There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with Kymriah.
Slovenian: Podatkov o izpostavljenosti zdravilu je premalo, da bi lahko podali priporočila, kako dolgo po zdravljenju z zdravilom Kymriah je treba uporabljati kontracepcijo.
English: See Table 4 for efficacy results from this study.
Slovenian: Za rezultate glede učinkovitosti v tej študiji glejte preglednico 4.
English: Patients treated with Kymriah should not donate blood, organs, tissues and cells for transplantation.
Slovenian: Bolniki, ki prejmejo zdravilo Kymriah, ne smejo darovati krvi, organov, tkiv ali celic za presaditev.
English: Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer.
Slovenian: Pri bolnikih, ki prejmejo zdravilo Kymriah, lahko pride do razvoja sekundarnih malignomov ali do ponovitve predhodnega raka.
English: For autologous use only.
Slovenian: Samo za avtologno uporabo.
English: • You have an infection.
Slovenian: • če prebolevate okužbo.
English: The medicine can be used in children and young adults up to 25 years of age with this cancer.
Slovenian: Zdravilo je mogoče uporabljati pri otrocih in mladih odraslih, ki so stari največ 25 let in imajo to vrsto raka.
English: All contents of the infusion bags should be infused.
Slovenian: Infundirati je treba celotno vsebino vseh infuzijskih vrečk.
English: Patients with a history of active CNS disorder or inadequate renal, hepatic, pulmonary or cardiac function were excluded from the studies.
Slovenian: Bolniki, ki so imeli v anamnezi aktivno bolezen centralnega živčevja ali nezadostno delovanje ledvic, jeter, pljuč ali srca, niso bili vključeni v študije.
English: Elm Park, Merrion Road Dublin 4
Slovenian: Elm Park, Merrion Road
English: The concentration of CAR-positive viable T cells is dependent on indication and patient body weight (for B-cell acute lymphoblastic leukaemia [ALL]).
Slovenian: Koncentracija CAR-pozitivnih viabilnih celic T je odvisna od indikacije in bolnikove telesne mase (pri bolnikih z B-celično akutno limfoblastno levkemijo (ALL)).
English: For example, Kymriah should not be washed (spun down and resuspended in new media) prior to infusion.
Slovenian: Zdravila Kymriah se na primer pred infundiranjem ne sme oprati (centrifugirati in resuspendirati v novem mediju).
English: Contains genetically-modified cells.
Slovenian: Vsebuje gensko spremenjene celice.
English: Arrhythmia includes atrial fibrillation and supraventricular tachycardia.
Slovenian: Izraz aritmija vključuje atrijsko fibrilacijo in supraventrikularno tahikardijo.
English: The scatter plots of cellular kinetic parameters versus age (22-76 years) revealed no relevant relationship between cellular kinetic parameters (AUC0-28d and Cmax) with age.
Slovenian: Razsevni diagram parametrov celične kinetike glede na starost (v okviru od 22 do 76 let) ne kaže pomembne povezanosti parametrov celične kinetike (AUC0-28d in Cmax) s starostjo.
English: Prior to Kymriah infusion, infection prophylaxis should follow standard guidelines based on the degree of preceding immunosuppression.
Slovenian: Pred infundiranjem zdravila Kymriah je treba izvesti profilakso proti okužbam v skladu s standardnimi smernicami na osnovi stopnje predhodne imunosupresije.
English: • Your doctor will take some of your blood using a catheter placed in your vein (a procedure called leukapheresis).
Slovenian: • Zdravnik vam bo skozi kateter, ki bo vstavljen v vašo veno, odvzel nekaj krvi (postopek imenujemo levkafereza).
English: • An antihistamine such as diphenhydramine.
Slovenian: • antihistaminik, kot je difenhidramin.
English: Before you are given Kymriah your doctor will:
Slovenian: Preden boste prejeli zdravilo Kymriah, bo zdravnik:
English: Kymriah should be thawed at 37°C using either a water bath or dry thaw method until there is no visible ice in the infusion bag.
Slovenian: Zdravilo Kymriah je treba odmrzovati pri 37 °C bodisi v vodni kopeli ali s suhim odmrzovanjem tako dolgo, da v infuzijski vrečki ni več vidnih delcev ledu.
English: In case of neurological events, patients should be diagnostically worked up and managed depending on the underlying pathophysiology and in accordance with local standard of care.
Slovenian: V primeru nevroloških dogodkov je treba pri bolnikih izvesti diagnostične preiskave in bolnike zdraviti glede na patofiziološke vzroke in v skladu z lokalnimi standardi oskrbe.
English: Adverse drug reactions from these clinical studies (Table 2) are listed by MedDRA system organ class.
Slovenian: Neželeni učinki iz navedenih dveh kliničnih študij (preglednica 2) so navedeni po organskih sistemih klasifikacije MedDRA.
English: Kymriah is intended for autologous use only (see section 4.4).
Slovenian: Zdravilo Kymriah je namenjeno samo za avtologno uporabo (glejte poglavje 4.4).
English: In patients with low immunoglobulin levels pre-emptive measures such as infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be taken according to age and standard guidelines.
Slovenian: Pri bolnikih z nizkimi vrednostmi imunoglobulinov je treba proaktivno začeti z ukrepi, kot so preventiva pred okužbami, profilaksa z antibiotiki in nadomeščanje imunoglobulinov v skladu s starostjo bolnika in standardnimi smernicami.
English: The full analysis set (FAS) includes all patients infused with Kymriah.
Slovenian: set bolnikov za celotno analizo (ful analysis set, FAS) vključuje vse bolnike, ki so prejeli infuzijo zdravila Kymriah.
English: Some of your white blood cells are separated from your blood and the rest of your blood is returned to your vein.
Slovenian: Iz krvi bodo izločili nekatere izmed vaših levkocitov, preostalo kri pa vam bodo vrnili v veno.
English: Efficacy analysis set (EAS) includes patients infused with Kymriah at least 3 months prior to data cutoff date.
Slovenian: set bolnikov za analizo učinkovitosti (efficacy analysis set, EAS) vključuje bolnike, ki so prejeli infuzijo zdravila Kymriah najmanj 3 mesece pred presečnim datumom za zbiranje podatkov.
English: Preparation of the infusion bag
Slovenian: Pripravljanje infuzijske vrečke
English: • Thirst
Slovenian: • žeja
English: • Flu-like illness
Slovenian: • gripi podobna bolezen,
English: Kymriah is indicated for the treatment of:
Slovenian: Zdravilo Kymriah je indicirano za zdravljenje:
English: The safety of immunisation with live viral vaccines during or following Kymriah treatment has not been studied.
Slovenian: Varnosti imunizacije z živimi virusnimi cepivi v času zdravljenja z zdravilom Kymriah ali po njem niso proučevali.
English: The CD3 zeta component is critical for initiating T-cell activation and antitumour activity, while 4-1BB enhances the expansion and persistence of tisagenlecleucel.
Slovenian: Komponenta CD3 zeta je bistvenega pomena, saj sproži aktivacijo celic T in njihovo protitumorsko delovanje, medtem ko domena 4-1BB spodbuja ekspanzijo in obstojnost tisagenlecleucela.
English: When Kymriah is infused into your blood, the modified T cells will find the cancer cells and destroy them.
Slovenian: Ko vam zdravilo Kymriah infundirajo v kri, spremenjene celice T poiščejo rakave celice in jih uničujejo.
English: Each bag contains 10 mL to 50 mL of dispersion.
Slovenian: Ena infuzijska vrečka vsebuje 10 ml do 50 ml disperzije.
English: Patients not previously exposed to dextran and DMSO should be observed closely during the first minutes of the infusion period.
Slovenian: Bolnike, ki predhodno še niso bili izpostavljeni dekstranu ali dimetilsulfoksidu, je treba v prvih minutah infundiranja skrbno opazovati.
English: Patient educational programme
Slovenian: Izobraževalni program za bolnike
English: • Your white blood cells are frozen and sent away to make Kymriah.
Slovenian: • Vaše levkocite bodo nato zamrznili in jih poslali v postopek za izdelavo zdravila Kymriah.
English: The cellular composition and the final cell number varies between individual patient batches.
Slovenian: Celična sestava in končno število celic v zdravilu se razlikuje med posameznimi serijami zdravila, ki so pripravljene za vsakega bolnika posebej.
English: Women who are breast-feeding should be advised of the potential risk to the breast-fed infant.
Slovenian: Ženske, ki dojijo, je treba opozoriti na možno tveganje za dojenega otroka.
English: All material that has been in contact with Kymriah (solid and liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local biosafety guidelines.
Slovenian: Z vsemi snovmi in predmeti, ki so bili v stiku z zdravilom Kymriah, (s trdnimi in tekočimi odpadki) je treba ravnati kot s potencialno kužnimi odpadki in jih kot take tudi zavreči v skladu z lokalnimi smernicami o biološki varnosti.
English: - After the first 10 days following the infusion, the patient should be monitored at the physician's discretion.
Slovenian: - Po prvih 10 dneh po infuziji je bolnika treba spremljati, če zdravnik meni, da je to potrebno.
English: The majority of patients who had cytopenias at day 28 following Kymriah treatment resolved to Grade 2 or below within three months after treatment.
Slovenian: Pri večini bolnikov, ki so imeli 28. dan po odmerjanju zdravila Kymriah citopenijo, se je ta v roku treh mesecev po zdravljenju umirila najmanj do 2. stopnje.
English: The infusion bag should be placed inside a second, sterile bag during thawing to protect ports from contamination and avoid spills in the unlikely event of the bag leaking.
Slovenian: Infuzijsko vrečko je treba med odmrzovanjem namestiti v drugo sterilno vrečko za zaščito vhodov pred kontaminacijo in za preprečitev polivanja v primeru malo verjetne možnosti, da vrečka pušča.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki kategoriji pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: ** With reported sequelae of secondary cerebral oedema.
Slovenian: ** Skupaj s posledicami sekundarnega možganskega edema, o katerih so poročali.
English: • Paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
Slovenian: • pediatričnih in mladih odraslih bolnikov, ki so stari do 25 let in imajo B-celično akutno limfoblastno levkemijo (ALL), ki je neodzivna, v relapsu po presaditvi ali v drugem ali kasnejšem relapsu.
English: Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Slovenian: Bolniki, ki so seropozitivni na virus hepatitisa B (HBV), virus hepatitisa C (HCV) ali virus humane imunske pomanjkljivosti (HIV)
English: Pre-treatment conditioning (lymphodepleting chemotherapy)
Slovenian: Predhodna priprava na zdravljenje (limfodeplecija s kemoterapijo)
English: Dispose of as per local biosafety guideline.
Slovenian: Zavrzite v skladu z lokalnimi smernicami o biološki varnosti.
English: Febrile neutropenia and infections
Slovenian: Febrilna nevtropenija in okužbe
English: Patients should be closely monitored for signs or symptoms of these events, including fever.
Slovenian: Bolnike je treba skrbno spremljati glede znakov in simptomov navedenih zapletov, vključno z zvišano telesno temperaturo.
English: Infections and febrile neutropenia
Slovenian: Okužbe in febrilna nevtropenija
English: MRD (minimal residual disease) negative was defined as MRD by flow cytometry <0.01%.
Slovenian: MRD-negativnost (negativen izvid za minimalno rezidualno bolezen, minimal residual disease) je bil opredeljena z vrednostjo MRD pri pretočni citometriji <0,01 %.
English: Kymriah will always be given to you by a doctor.
Slovenian: Zdravilo Kymriah vam bo v vsakem primeru dal zdravnik.
English: Concomitant disease
Slovenian: Sočasna prisotnost drugih bolezni
English: Monitoring after infusion - Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities.
Slovenian: Spremljanje bolnika po prejemu infuzije - Prvih 10 dni po infuziji je bolnike priporočljivo vsakodnevno spremljati glede znakov in simptomov morebitnega sindroma sproščanja citokinov, nevroloških dogodkov in drugih toksičnih učinkov.
English: Diffuse large B-cell lymphoma (DLBCL)
Slovenian: Difuzni velikocelični limfom B (DLBCL)
English: What Kymriah is and what it is used for What you need to know before you are given Kymriah How Kymriah is given
Slovenian: Kaj je zdravilo Kymriah in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Kymriah Kako dajemo zdravilo Kymriah Možni neželeni učinki
English: Therapy should be initiated under the direction of and supervised by a healthcare professional experienced in the treatment of haematological malignancies and trained for administration and management of patients treated with Kymriah.
Slovenian: Zdravljenje je treba uvesti po navodilu in pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hematoloških malignih bolezni in je usposobljen za apliciranje zdravila in vodenje bolnikov, ki prejemajo zdravilo Kymriah.
English: Age (years) Mean (standard deviation) Median (minimum - maximum) Age category (years) - n (%) <65 years ≥65 years Sex - n (%) Male Female Prior haematopoietic stem cell transplant (SCT) - n (%) No Yes Stage III/IV disease at study entry - n (%) No Yes Number of prior lines of antineoplastic therapy - n (%)
Slovenian: Starost (leta) povprečje (standardna deviacija ) mediana (najmanjša vrednost - največja vrednost) Starostna skupina (leta) - n (%) <65 let ≥65 let Spol - n (%) moški ženski Predhodna presaditev krvotvornih matičnih celic (SCT) - n (%) ne da Stadij bolezni III/IV ob vstopu v študijon (%)
English: Prior transplantation
Slovenian: Predhodna presaditev
English: Cytokine release syndrome was graded with the Penn scale as follows: Grade 1: mild reactions, e.g. reactions requiring supportive care; Grade 2: moderate reactions, e.g. reactions requiring intravenous therapies; Grade 3: severe reactions, e.g. reactions requiring low-dose vasopressors or supplemental oxygen; Grade 4: life-threatening reactions, e.g. those requiring high-dose vasopressors or intubation; Grade 5: death.
Slovenian: Stopnje sindroma sproščanja citokinov so po lestvici Penn opredelili takole: stopnja 1: blage reakcije, npr. reakcije, pri katerih je potrebna podporna oskrba; stopnja 2: zmerne reakcije npr. reakcije, pri katerih je potrebno intravensko zdravljenje; stopnja 3: hude reakcije, npr. reakcije, pri katerih je potrebno zdravljenje z nizkimi odmerki vazokonstriktorjev ali dovajanje kisika; stopnja 4: življenjsko nevarne reakcije, npr. reakcije, pri katerih je potrebno zdravljenje z visokimi odmerki vazokonstriktorjev ali intubacija; stopnja 5: smrt.
English: Seizure includes seizure, generalised tonic-clonic seizures and status epilepticus.
Slovenian: Izraz konvulzije vključuje konvulzije, generalizirane tonično klonične krče in epileptični status.
English: When the full volume of Kymriah has been infused, the infusion bag should be rinsed with 10 to 30 mL sodium chloride 9 mg/mL (0.9%) solution for injection by back priming to ensure as many cells as possible are infused into the patient.
Slovenian: Ko bolniku steče celotna količina zdravila Kymriah, je treba infuzijsko vrečko s povratnim pretokom izprati z 10 do 30 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, kar bolniku zagotavlja, da z infuzijo prejme kar največje možno število celic.
English: Blood, organ, tissue and cell donation
Slovenian: Darovanje krvi, organov, tkiv ali celic
English: Influenza-like illness Multiple organ dysfunction syndrome
Slovenian: mrazenje astenija gripi podobna bolezen sindrom večorganske disfunkcije
English: You should not be given Kymriah:
Slovenian: Zdravila Kymriah ne smete prejeti:
English: Attention to signs and symptoms of infection should be implemented according to age and standard specific guidelines.
Slovenian: V tem času je potrebna pozornost na znake in simptome okužbe v skladu s starostjo bolnika in standardnimi specifičnimi smernicami.
English: • problems such as altered or decreased consciousness, delirium, confusion, agitation, seizures, difficulty speaking and understanding speech, loss of balance.
Slovenian: • težave, kot so stanja spremenjene ali zmanjšane zavesti, delirij, zmedenost, agitacija (huda tesnoba in nemir), napad s krči, oteženo govorjenje in razumevanje govorjene besede, izguba občutka za ravnotežje;
English: DLBCL: The safety and efficacy of Kymriah in children and adolescents below 18 years of age have not yet been established.
Slovenian: Difuzni velikocelični limfom B: Varnost in učinkovitost zdravila Kymriah pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: The T cells are taken from your blood and a new gene is put into the T cells so that they can then find the cells causing your cancer.
Slovenian: Za izdelavo zdravila Kymriah odvzamejo celice T iz vaše krvi in vanje vstavijo nov gen, zaradi katerega so potem sposobne poiskati tiste celice, ki pri vas povzročajo raka.
English: The adverse reactions described in this section were identified in 111 patients infused with Kymriah in one global multicentre international study, i.e. the ongoing pivotal clinical study CCTL019C2201.
Slovenian: Neželene učinke, ki so navedeni v tem poglavju, so ugotavljali pri 111 bolnikih, ki so jim infundirali zdravilo Kymriah v eni globalni multicentrični mednarodni študiji: gre za ključno klinično študijo CCTL019C2201, ki še poteka.
English: How does Kymriah work?
Slovenian: Kako deluje zdravilo Kymriah?
English: Of four patients with active CNS leukaemia (i.e. CNS-3) included in study B2101J, three experienced cytokine release syndrome (Grade 2-4) and transient neurological abnormalities (Grade 1-3) that resolved within 1-3 months of infusion.
Slovenian: Izmed štirih bolnikov z aktivno levkemijo centralnega živčevja (kar pomeni stopnje CNS-3), ki so bili vključeni v študijo B2101J, je pri treh prišlo do sindroma sproščanja citokinov (stopnje 2-4) in do prehodnih nevroloških nepravilnosti (stopnje 1-3), ki so izzvenele v 1-3 mesecih od prejema infuzije.
English: Administer antipyretics, oxygen, intravenous fluids and/or low-dose vasopressors as needed.
Slovenian: Bolniku dajte po potrebi antipiretike, kisik, intravenske tekočine in/ali nizke odmerke vazokonstriktorjev.
English: % relapse free probability at 6 months % relapse free probability at 12 months Other secondary endpoints
Slovenian: % verjetnosti poteka brez relapsa po 6 mesecih % verjetnosti poteka brez relapsa po 12 mesecih 63,7 Drugi sekundarni cilj opazovanja
English: In the event of febrile neutropenia, infection should be evaluated and managed appropriately with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated.
Slovenian: V primeru febrilne nevtropenije je treba okužbo opredeliti in bolnika ustrezno zdraviti z antibiotiki širokega spektra, nadomeščanjem tekočin in drugimi ukrepi podporne oskrbe v skladu z medicinskimi indikacijami.
English: Prior treatment with anti-CD19 therapy
Slovenian: Predhodna uporaba zdravil proti antigenu CD19
English: The medicine can be used in adults (18 years of age or older) with this cancer.
Slovenian: Zdravilo je mogoče uporabljati pri odraslih, ki so stari 18 let ali več in imajo to vrsto raka.
English: • If you become pregnant or think you may be pregnant after treatment with Kymriah, talk your doctor immediately.
Slovenian: • Če po zdravljenju z zdravilom Kymriah zanosite ali menite, da ste morda noseči, se takoj pogovorite s svojim zdravnikom.
English: It is not known whether Kymriah has the potential to be transferred to the foetus via the placenta and could cause foetal toxicity, including B-cell lymphocytopenia.
Slovenian: Ni znano, ali se zdravilo Kymriah lahko preko placente prenese v plod in ali lahko deluje toksično na plod ter med drugim povzroči B-celično limfocitopenijo.
English: Kymriah treatment should be delayed in some patient groups at risk (see section 4.4).
Slovenian: Pri nekaterih rizičnih skupinah bolnikov je treba zdravljenje z zdravilom Kymriah odložiti (glejte poglavje 4.4).
English: • Administer high-dose or multiple vasopressors, oxygen, mechanical ventilation and/or other supportive care as needed.
Slovenian: • Bolniku dajte visoke odmerke ali več različnih vazokonstriktorjev in kisik ter mu po potrebi uvedite mehansko ventilacijo in/ali druge podporne ukrepe.
English: • Shortness of breath, laboured breathing, rapid breathing, fluid in the lungs
Slovenian: • zadihanost, povečan napor pri dihanju, hitro dihanje, zastajanje tekočine v pljučih
English: Grade 3 and 4 adverse reactions were reported in 89% of patients.
Slovenian: O neželenih učinkih stopnje 3 oziroma 4 so poročali pri 89 % bolnikov.
English: • B-cell acute lymphoblastic leukaemia (B-cell ALL) - a form of cancer that affects some other types of white blood cells.
Slovenian: • B-celične akutne limfoblastne levkemije (B-celične ALL) - vrste raka, ki prizadene nekatere druge vrste levkocitov.
English: • If no clinical improvement within 12 to 18 hours of the first tocilizumab dose, or worsening at any time, administer methylprednisolone 2 mg/kg as an initial dose, then 2 mg/kg per day until vasopressors and high-flow oxygen are no longer needed, then taper.
Slovenian: • Če v 12 do 18 urah po prvem odmerku tocilizumaba ne pride do kliničnega izboljšanja ali če kadarkoli v poteku zdravljenja pride do poslabšanja, bolniku aplicirajte metilprednizolon 2 mg/kg za začetni odmerek in nato 2 mg/kg na dan, dokler bolnik potrebuje vazokonstriktorje in dovajanje kisika z visokim pretokom, nato pa metilprednizolon postopno ukinite.
English: 34% of the patients experienced an infection of any type within 8 weeks.
Slovenian: V 8 tednih je do okužbe katerekoli vrste prišlo pri 34 % bolnikov.
English: This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhoea and bloody stools.
Slovenian: Do tega pride, če presajene celice napadajo vaše telo in povzročajo simptome, kot so izpuščaj, občutek slabosti, bruhanje, diareja in krvavo blato.
English: Not reached (10.0, NE4) Not reached (10.0, NE4)
Slovenian: vrednost ni dosežena (10,0, NMO4)
English: The type and duration of bridging therapy was left to the discretion of the physician.
Slovenian: O vrsti in trajanju premostitvenega zdravljenja je zdravnik odločal po svoji presoji.
English: Ethylene vinyl acetate (EVA) infusion bag with polyvinyl chloride (PVC) tubing and a luer spike interconnector closed by a luer-lock cap containing either 10-30 mL (50 mL bags) or 30-50 mL (250 mL bags) cell dispersion.
Slovenian: Infuzijska vrečka iz etilen vinil acetata (EVA) s cevnim sistemom iz polivinilklorida (PVC) in interkonektorjem z nastavkom luer z ostro konico in luer-lock zaporko vsebuje bodisi 10-30 ml celične disperzije (50-mililitrske vrečke) ali 30-50 ml celične disperzije (250-mlilitrske vrečke).
English: The product should be administered immediately after thawing.
Slovenian: Zdravilo je treba aplicirati takoj po odmrznitvi.
English: A colourless to slightly yellow dispersion.
Slovenian: disperzija za infundiranje Brezbarvna do rahlo rumenkasta disperzija.
English: • Look for signs of infection; any infection will be treated before you are given Kymriah.
Slovenian: • pregledal, ali imate znake okužbe, in v primeru okužbe poskrbel za zdravljenje, preden vam bo dal zdravilo Kymriah,
English: Special populations No differences in efficacy or safety were observed between different age subgroups.
Slovenian: Posebne skupine bolnikov Med različnimi podskupinami po starosti niso opažali razlik glede učinkovitosti in varnosti zdravila.
English: Pain includes pain and pain in extremity.
Slovenian: Izraz bolečine vključuje bolečine in bolečine v okončinah.
English: One patient died due to disease progression and the remaining three patients achieved a CR or CRi and remain alive 1.5-2 years after infusion.
Slovenian: Eden od bolnikov je umrl zaradi napredovanja bolezni, drugi trije bolniki pa so dosegli popolno remisijo (CR) ali popolno remisijo z nepopolno normalizacijo števila krvnih celic (CRi) in ostali živi 1,5-2 leti po prejemu infuzije.