FrancophonIA/ELRC3.0 huggingface dataset:
English: If no improvement within 24 hours after starting tocilizumab, administer dexamethasone 10 mg intravenously every 6 hours if not already taking other corticosteroids.
Slovenian: Če v 24 urah po uvedbi tocilizumaba ni izboljšanja, se daje deksametazon 10 mg intravensko vsakih 6 ur, če bolnik ne jemlje drugih kortikosteroidov.
English: If any of the above apply to you (or you are not sure), talk to your doctor before being given YESCARTA.
Slovenian: Če kar koli od zgoraj navedenega velja za vas (ali niste prepričani), se pogovorite z zdravnikom ali medicinsko sestro, preden boste prejeli zdravilo YESCARTA.
English: Patients treated with YESCARTA should not donate blood, organs, tissues, and cells for transplantation.
Slovenian: Bolniki, zdravljeni z zdravilom YESCARTA, ne smejo darovati krvi, organov, tkiva ali celic za presaditev.
English: For severe or life-threatening CRS, consider intensive-care supportive therapy.
Slovenian: Pri resnem ali življenje ogrožajočem CRS razmislite o podpornem zdravljenju z intenzivno nego.
English: Patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection
Slovenian: Bolniki, okuženi z virusom humane imunske pomanjkljivosti (HIV), virusom hepatitisa B (HBV) in virusom hepatitisa C (HCV)
English: Contents: approximately 68 mL of cell dispersion.
Slovenian: Vsebina: približno 68 ml celične disperzije.
English: YESCARTA is intended for autologous use only (see section 4.4).
Slovenian: Zdravilo YESCARTA je namenjeno samo za avtologno uporabo (glejte poglavje 4.4).
English: YESCARTA should not be administered to patients with active infections or inflammatory disease until these conditions have resolved.
Slovenian: Zdravila YESCARTA se ne sme dajati bolnikom z aktivno okužbo ali vnetno boleznijo, dokler ta stanja ne izzvenijo.
English: On the basis of the scientific conclusions for axicabtagene ciloleucel the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing axicabtagene ciloleucel is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za aksicabtagen ciloleucel odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) aksicabtagen ciloleucel, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: The safety of immunisation with live viral vaccines during or following YESCARTA treatment has not been studied.
Slovenian: Varnosti imunizacije z živimi virusnimi cepivi med zdravljenjem z zdravilom YESCARTA ali po njem niso preučili.
English: Prior treatment with anti-CD19 therapy
Slovenian: Predhodno zdravljenje s terapijo proti CD19
English: Adverse reactions reported from clinical trials and post-marketing setting are presented below.
Slovenian: Neželeni učinki iz kliničnih preskušanj in obdobja trženja, o katerih so poročali, so predstavljeni spodaj.
English: N/A
Slovenian: n/s n/s
English: Special population
Slovenian: Posebna populacija
English: YESCARTA can cause side effects to your immune system that may be serious or life-threatening, and can lead to death.
Slovenian: Zdravilo YESCARTA lahko povzroči neželene učinke za imunski sistem, ki so lahko resni ali smrtno nevarni in povzročijo smrt.
English: Small clumps of cellular material should disperse with gentle manual mixing.
Slovenian: Majhne grudice celičnega materiala se morajo z nežnim ročnim mešanjem razpustiti.
English: This sequence of events leads to apoptosis and necrosis of CD19-expressing target cells.
Slovenian: To sosledje dogodkov povzroči apoptozo in nekrozo ciljnih celic, ki izražajo CD19.
English: Precautions to be taken for the disposal of the medicinal product
Slovenian: Varnostni ukrepi za odstranjevanje zdravila
English: 6229EV Maastricht The Netherlands
Slovenian: 6229EV Maastricht
English: Serious hypersensitivity reactions including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA.
Slovenian: Resne preobčutljivostne reakcije, vključno z anafilakso, so lahko posledica dimetilsulfoksida (DMSO) ali rezidualnega gentamicina v zdravilu YESCARTA.
English: • Fever, which may be a symptom of an infection.
Slovenian: • zvišano telesno temperaturo, ki je lahko simptom okužbe.
English: (c) Refer to tocilizumab summary of product characteristics for details.
Slovenian: (c) Za podrobnosti glejte povzetek glavnih značilnosti zdravila za tocilizumab.
English: Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment with YESCARTA.
Slovenian: Cepljenja z živimi virusnimi cepivi se ne priporoča najmanj 6 tednov pred začetkom kemoterapije za uničenje limfocitov, med zdravljenjem z zdravilom YESCARTA in do imunskega okrevanja po zdravljenju z zdravilom YESCARTA.
English: YESCARTA is a clear to opaque, white to red dispersion for infusion, supplied in an infusion bag individually packed in a metal cassette.
Slovenian: Zdravilo YESCARTA je bistra do motna, bela do rdeča disperzija za infuzijo, na voljo v infuzijski vreči, posamično pakirani v kovinsko kaseto.
English: Life-threatening symptoms.
Slovenian: Smrtno nevarni simptomi.
English: YESCARTA comprises engineered human T cells, therefore there are no representative in vitro assays, ex vivo models, or in vivo models that can accurately address the toxicological characteristics of the human product.
Slovenian: Zdravilo YESCARTA so umetno proizvedene človeške T-celice, zato ni reprezentativnih testov in vitro, modelov ex vivo ali modelov in vivo, s katerimi bi lahko natančno preučili toksikološke značilnosti zdravila za ljudi.
English: Only cytopenias that resulted in (i) new or worsening clinical sequelae or (ii) that required therapy or (iii) adjustment in current therapy are included in Table 3.
Slovenian: V preglednico 3 so vključene samo citopenije, ki so privedle do (i) novih kliničnih posledic ali do njihovega poslabšanja ali (ii) zaradi katerih je bilo potrebno zdravljenje ali (iii) prilagoditev trenutnega zdravljenja.
English: Grade 3 or higher (severe, life-threatening, or fatal) infections occurred in 26% of patients.
Slovenian: Okužbe 3. ali višje stopnje (hude, življenje ogrožajoče ali usodne) so se pojavile pri 26 % bolnikov.
English: Due to the on-target, off-tumour effect of YESCARTA, a period of B-cell aplasia is expected following treatment.
Slovenian: Zaradi učinka zdravila YESCARTA na ciljno mesto zunaj tumorja se po zdravljenju pričakuje obdobje B-celične aplazije.
English: The safety data described in this section reflect exposure to YESCARTA in ZUMA-1, a Phase 1/2 study in which 108 patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) received CAR-positive T cells based on a recommended dose which was weightbased.
Slovenian: Podatki o varnosti, opisani v tem poglavju, odražajo izpostavljenost zdravilu YESCARTA v ZUMA-1, študiji faze 1/2, v kateri je 108 bolnikov s ponovljenim/neodzivnim B-celičnim ne-Hodgkinovim limfomom (NHL) prejelo CAR-pozitivne T-celice, na osnovi priporočenega odmerka glede na telesno maso.
English: These include the use of tocilizumab or tocilizumab and corticosteroids for moderate, severe, or life-threatening CRS as summarised in Table 1.
Slovenian: Ti vključujejo uporabo tocilizumaba ali tocilizumaba in kortikosteroidov pri zmernem, hudem ali smrtno nevarnem CRS, kot je povzeto v preglednici 1.
English: For special precautions for disposal, see section 6.6.
Slovenian: Za posebna navodila za odstranjevanje glejte poglavje 6.6.
English: A causal relationship between dysphagia and axicabtagene ciloleucel was confirmed, based on the evidence from 15 post-marketing cases and 4 clinical trial cases of dysphagia.
Slovenian: Vzročna povezava med disfagijo in aksicabtagen ciloleucelom je bila potrjena na podlagi dokazov iz 15 primerov v obdobju trženja in 4 primerov iz kliničnih preskušanj.
English: For storage conditions after thawing of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja odtajanega zdravila glejte poglavje 6.3.
English: YESCARTA is made from your own white blood cells and should only be given to you.
Slovenian: Zdravilo YESCARTA je narejeno iz vaših lastnih belih krvnih celic in ga lahko prejmete samo vi.
English: No studies have been conducted to evaluate the effects of YESCARTA on fertility, reproduction, and development.
Slovenian: Študij za oceno vpliva zdravila YESCARTA na plodnost, sposobnost razmnoževanja in razvoj niso izvedli.
English: In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.
Slovenian: V primeru febrilne nevtropenije je treba oceniti prisotnost okužbe in jo zdraviti s širokospektralnimi antibiotiki, tekočinami in drugo podporno oskrbo, kot je zdravstveno indicirano.
English: The DOR was longer in patients who achieved CR compared to patients with a best response of PR (Table 5).
Slovenian: DOR je bilo daljše pri bolnikih, ki so dosegli CR, v primerjavi z bolniki z najboljšim odzivom PR (preglednica 5).
English: The median dose was 2.0 x 106 anti-CD19 CAR T cells/kg.
Slovenian: Mediana odmerka je bila 2,0 x 106 anti-CD19 CAR T-celic/kg.
English: Concomitant disease
Slovenian: Sočasna bolezen
English: The other ingredients (excipients) are: Cryostor CS10, sodium chloride, human albumin.
Slovenian: Druge sestavine (pomožne snovi) so: Cryostor CS10, natrijev klorid, humani albumin.
English: Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered.
Slovenian: Bolnike z zdravstveno pomembno okvaro delovanja srca je treba obravnavati po standardih intenzivne nege in razmisliti o ukrepih, kot je ehokardiografija.
English: Due to the potential for neurologic events, including altered mental status or seizures, patients should refrain from driving or operating heavy or potentially dangerous machines until at least 8 weeks after infusion or until resolution of neurologic adverse reactions.
Slovenian: Zaradi možnih nevroloških dogodkov, vključno s spremenjenim duševnim stanjem ali epileptičnimi napadi, naj bolniki vsaj 8 tednov po infundiranju, ali dokler nevrološki neželeni učinki ne izzvenijo, ne vozijo in ne upravljajo nevarnih strojev.
English: - have signs or symptoms of graft-versus-host disease.
Slovenian: - če imate znake ali simptome bolezni presadka proti gostitelju.
English: Tumour lysis syndrome (TLS)
Slovenian: Sindrom tumorske lize (TLS, tumour lysis syndrome)
English: • Look for signs of infection; any infection will be treated before you are given YESCARTA.
Slovenian: • preveril znake okužbe; morebitno okužbo bodo zdravili, preden boste prejeli zdravilo
English: • Tocilizumab and emergency equipment should be available prior to infusion and during the monitoring period.
Slovenian: • Pred infundiranjem in v obdobju spremljanja morata biti pripravljena tocilizumab in oprema za ukrepanje v nujnih primerih.
English: YESCARTA 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 YESCARTA.
Slovenian: Zdravljenje z zdravilom YESCARTA mora uvesti in potek zdravljenja nadzorovati zdravstveni delavec, ki ima izkušnje z zdravljenjem hematoloških malignih obolenj in je usposobljen za dajanje zdravila in obravnavo bolnikov, zdravljenih z zdravilom YESCARTA.
English: Cumulatively, 33 (31%) of 108 subjects received intravenous immunoglobulin therapy at the time of the 24-month analysis.
Slovenian: Skupno 33 (31 %) od 108 bolnikov je ob času analize po 24 mesecih prejelo intravensko imunoglobulinsko zdravljenje.
English: * Dysphagia has been reported in the setting of neurologic toxicity and encephalopathy
Slovenian: * O disfagiji so poročali ob prisotnosti nevrološke toksičnosti in encefalopatije.
English: The MAH shall ensure that in each Member State where YESCARTA is marketed, all HCPs who are expected to prescribe, dispense, and administer YESCARTA shall be provided with a guidance document to: - facilitate identification of CRS and serious neurologic adverse reactions - facilitate management of the CRS and serious neurologic adverse reactions - ensure adequate monitoring of CRS and serious neurologic adverse reactions - facilitate provision of all relevant information to patients - ensure that adverse reactions are adequately and appropriately reported - ensure that detailed instructions about the thawing procedure are provided - before treating a patient, ensure that 4 doses of tocilizumab for each patient are available on site
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo v vsaki državi članici, kjer je zdravilo YESCARTA na trgu, vsem zdravstvenim delavcem, za katere se pričakuje, da bodo zdravilo YESCARTA predpisovali, izdajali in dajali, predloženo gradivo s smernicami za: - lažjo identifikacijo CRS in resnih nevroloških neželenih učinkov, - lažjo obravnavo CRS in resnih nevroloških neželenih učinkov, - zagotovitev primernega spremljanja glede CRS in resnih nevroloških neželenih učinkov, - lažje podajanje vseh pomembnih informacij bolnikom, - zagotovitev ustreznega in primernega poročanja neželenih učinkov,
English: The DOR was longer in patients who achieved CR, as compared to patients with a best response of partial response (PR).
Slovenian: DOR je bilo daljše pri bolnikih, ki so dosegli CR, v primerjavi z bolniki, katerih najboljši odziv je bil delni odziv (PR, partial response).
English: Peak levels of anti-CD19 CAR T cells occurred within the first 8 to 15 days after YESCARTA infusion.
Slovenian: Največje vrednosti anti-CD19 CAR T-celic so se pojavile v prvih 8 do 15 dneh po infundiranju zdravila YESCARTA.
English: • Since YESCARTA is made from your own white blood cells, your cells will be collected from you to prepare your medicine.
Slovenian: • Ker se zdravilo YESCARTA izdela iz vaših lastnih krvnih celic, vam bodo za pripravo zdravila vzeli vaše celice.
English: Patients who experience Grade 2 or higher neurologic toxicities should be monitored with continuous cardiac telemetry and pulse oximetry.
Slovenian: Bolnike, pri katerih se pojavijo znaki nevrološke toksičnosti 2. ali višje stopnje, je treba spremljati s stalno srčno telemetrijo in pulzno oksimetrijo.
English: Patients with a history of CNS disorders such as seizures or cerebrovascular ischaemia may be at increased risk.
Slovenian: Pri bolnikih z motnjami osrednjega živčnega sistema v anamnezi, kot so epileptični napadi ali cerebrovaskularna ishemija, je tveganje lahko večje.
English: Serious adverse reactions that may be associated with CRS included acute kidney injury, atrial fibrillation, ventricular tachycardia, cardiac arrest, cardiac failure, capillary leak syndrome, hypotension, hypoxia, and HLH/MAS.
Slovenian: Resni neželeni učinki, ki so lahko povezani s CRS, so vključevali akutno poškodbo ledvic, atrijsko fibrilacijo, ventrikularno tahikardijo, zastoj srca, srčno popuščanje, sindrom kapilarne krvavitve, hipotenzijo, hipoksijo in HLH/MAS.
English: Sixty-six patients were evaluable for cell-of-origin classifications (germinal center B-cell type [GCB] or activated B-cell type [ABC]).
Slovenian: Pri 66 bolnikih je bilo mogoče oceniti razvrstitev celice, iz katere se je limfom razvil (germinalni center B-celičnega tipa [GCB] ali aktiviran B-celični tip [ABC]).
English: In addition worsening of underlying organ pathologies can occur in the setting of CRS.
Slovenian: Ob CRS se lahko pojavi tudi poslabšanje predhodnih patologij organov.
English: Thirty were found to have double expressor DLBCL (overexpression of both MYC and BCL-2 protein); 5 were found to have HGBCL with MYC, BCL-2 or BCL-6 gene rearrangement (double- and triple-hit); and 2 were found to have HGBCL not otherwise specified.
Slovenian: Pri 30 bolnikih je bilo ugotovljeno, da imajo dvojno ekspresijo DLBCL (čezmerna ekspresija beljakovin MYC in BCL-2); pri 5 bolnikih je bilo ugotovljeno, da imajo HGBCL s preureditvijo genov v MYC, BCL-2 ali BCL-6 (»double-hit« in »triple-hit« limfom); in pri 2 je bilo ugotovljeno, da imata HGBCL, ki ni drugače opredeljen.
English: The safety and efficacy of YESCARTA in children and adolescents below 18 years of age have not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila YESCARTA pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
English: Anti-CD19 CAR T cell levels decreased toward background levels by Month 3 after infusion.
Slovenian: Stopnje anti-CD19 CAR T-celic so se do 3. meseca po infundiranju znižale proti izvornim stopnjam.
English: See section 4.4 for monitoring and management guidance.
Slovenian: Za spremljanje in navodila za ukrepanje glejte poglavje 4.4.
English: The initiation of B-cell recovery was first noted at Month 9, when 56% of patients had detectable B-cells.
Slovenian: Začetek obnavljanja B-celic so prvič opazili v 9. mesecu, ko je bilo B-celice mogoče zaznati pri 56 % bolnikov.
English: • Extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells.
Slovenian: • izjemno utrujenost, šibkost ali kratko sapo, kar so lahko simptomi pomanjkanja rdečih krvnih celic.
English: A single infusion bag contains approximately 68 mL of cell dispersion.
Slovenian: Ena infuzijska vreča vsebuje približno 68 ml celične disperzije.
English: A causal relationship between spinal cord lesions and axicabtagene ciloleucel was confirmed, based on the evidence from two clinical trial cases; one case with an event of quadriplegia (in the setting of myelitis) and second case with events of muscular weakness and leukoencephalopathy, and one spontaneous case report with an event of spinal cord oedema.
Slovenian: Vzročna povezava med lezijami hrbtenjače in aksicabtagen ciloleucelom je bilo potrjena na podlagi dokazov iz dveh primerov iz kliničnih preskušanj; en primer s kvadriplegijo (ob prisotnosti mielitisa) in drugi primer z mišično šibkostjo in levkoencefalopatijo, ter na podlagi enega spontano poročanega primera z edemom hrbtenjače.
English: Patients with a history of CNS disorders (such as seizures or cerebrovascular ischemia), cardiac ejection fraction of less than 50% or room air oxygen saturation of less than 92%, or autoimmune disease requiring systemic immunosuppression were ineligible.
Slovenian: Bolniki z boleznimi OŽS (kot so epileptični napadi ali cerebrovaskularna ishemija), iztisnim deležem srca manj kot 50 % ali nasičenostjo s kisikom na sobnem zraku manj kot 92 % ali avtoimunsko boleznijo, ki jo je bilo treba zdraviti s sistemsko imunosupresijo, niso bili primerni.
English: Grade 3 or higher prolonged cytopenias following YESCARTA infusion occurred very commonly and included thrombocytopenia, neutropenia, and anaemia.
Slovenian: Dolgotrajne citopenije 3. ali višje stopnje so se po infundiranju zdravila YESCARTA pojavile zelo pogosto in so vključevale trombocitopenijo, nevtropenijo in anemijo.
English: • Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential CRS, neurologic events and other toxicities.
Slovenian: • Bolnike je treba prvih 10 dni po infundiranju vsak dan spremljati glede znakov in simptomov morebitnega CRS, nevroloških dogodkov in drugih toksičnosti.
English: You should not be given YESCARTA if you are allergic to any of the ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo YESCARTA Zdravila YESCARTA ne smete dobiti, če ste alergični na katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If you have lymphoma this might include fever, feeling weak, night sweats, sudden weight loss.
Slovenian: Če imate limfom, to lahko vključuje zvišano telesno temperaturo, občutek šibkosti, nočno potenje, nenadno izgubo telesne mase.
English: Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted.
Slovenian: Premostitvena kemoterapija med levkaferezo in kemoterapijo za uničenje limfocitov ni bila dovoljena.
English: Immunoglobulin levels should be monitored after treatment with YESCARTA and managed using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.
Slovenian: Po zdravljenju z zdravilom YESCARTA je treba spremljati ravni imunoglobulinov in stanje obvladovati s pomočjo previdnostnih ukrepov proti okužbam, antibiotične profilakse in nadomeščanja imunoglobulinov.
English: Of the 52 patients who achieved CR, 7 patients had SD and 9 had PR at their initial tumour assessment and converted to CR as late as 6.5 months.
Slovenian: Med 52 bolniki, ki so dosegli CR, je imelo 7 bolnikov SB in 9 jih je imelo PR ob začetni oceni tumorja, ki se je v CR spremenil šele po 6,5 meseca.
English: This medicinal product contains 300 mg sodium per infusion, equivalent to 15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 300 mg natrija na infundiranje, kar je enako 15 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO, in znaša 2 g.
English: Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs or symptoms of CRS and/or neurologic events.
Slovenian: Zdravnik naj razmisli o hospitalizaciji prvih 10 dni po infundiranju ali ob prvih znakih ali simptomih CRS in/ali nevroloških dogodkov.
English: No concurrent CRS
Slovenian: Brez sočasnega CRS
English: Other neurologic adverse reactions have been reported less frequently in clinical trials and included dysphagia (5%), myelitis (0.2%), and quadriplegia (0.2%).
Slovenian: O drugih nevroloških neželenih učinkih so v kliničnih preskušanjih poročali z manjšo pogostnostjo in so vključevali disfagijo (5 %), mielitis (0,2 %) in kvadriplegijo (0,2 %).
English: Signs and symptoms of TLS should be monitored and events managed according to standard guidelines.
Slovenian: TLS in pojav obravnavati po standardnih smernicah.
English: Patients treated with YESCARTA may develop secondary malignancies.
Slovenian: Pri bolnikih, zdravljenih z zdravilom YESCARTA, se lahko razvijejo sekundarna maligna obolenja.
English: It is used to treat aggressive conditions in adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) affecting your lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes and other organs in your body.
Slovenian: Uporablja se za zdravljenje agresivnih bolezni pri odraslih z difuznim velikoceličnim B-limfomom (DLBCL, diffuse large B-cell lymphoma) in primarnim mediastinalnim velikoceličnim B-limfomom (PMBCL), ki prizadenejo tkivo vaših bezgavk (del imunskega sistema), kar prizadene vrsto belih krvnih celic, ki se imenujejo B-limfociti, in druge organe v vašem telesu.
English: No reproductive and developmental toxicity animal studies have been conducted with YESCARTA to assess whether it can cause foetal harm when administered to a pregnant woman (see section 5.3).
Slovenian: Študij o vplivu zdravila YESCARTA na sposobnost razmnoževanja in razvoj na živalih, v katerih bi ocenili, ali zdravilo lahko škoduje plodu, če se uporablja pri nosečnicah (glejte poglavje 5.3), niso izvedli.
English: Your doctor may do blood tests to check for side effects.
Slovenian: Zdravnik lahko s krvnimi testi preverja, ali imate neželene učinke.
English: The infection will be treated before the YESCARTA infusion.
Slovenian: Okužba bo zdravljena, preden boste prejeli infuzijo zdravila YESCARTA.
English: 6 month OS (%) [95% CI] 9 month OS (%) [95% CI] 12 month OS (%) [95% CI]
Slovenian: 6-mesečno OS (%) [95-% IZ] 9-mesečno OS (%) [95-% IZ] 12-mesečno OS (%) [95-% IZ] 24-mesečno OS (%) [95-% IZ]
English: • Chills, extreme tiredness, weakness, dizziness, headache, cough, shortness of breath, or rapid heartbeat, which may be symptoms of a condition known as cytokine release syndrome.
Slovenian: • mrzlico, izjemno utrujenost, šibkost, omotičnost, glavobol, kašelj, kratko sapo ali hitro bitje srca, saj so lahko to simptomi bolezni, znane kot sindrom sproščanja citokinov.