FrancophonIA/ELRC3.0 huggingface dataset:
English: Kymriah contains genetically-modified human blood cells.
Danish: Kymriah indeholder genetisk modificerede humane blodceller.
English: Infused patients
Danish: Inkluderede patienter Infunderede patienter
English: Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah (see section 4.5).
Danish: Vaccination med levende virus-vacciner anbefales ikke i mindst 6 uger før starten af lymfodepleterende kemoterapi, under behandling med Kymriah, og indtil immunsystemet er normaliseret efter behandling med Kymriah (se pkt.
English: Sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prime the tubing prior to infusion and to rinse it after infusion.
Danish: Natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion bør anvendes til at prime slangerne før infusion og til at skylle dem efter infusion.
English: In some cases, disseminated intravascular coagulation (DIC), with low fibrinogen levels, capillary leak syndrome (CLS), and haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) have been reported in the setting of cytokine release syndrome.
Danish: I relation til cytokinfrigivelsessyndrom er der i nogle tilfælde blevet rapporteret dissemineret intravaskulær koagulation (DIC), med lave fibrinogenniveauer, kapillær lækage-syndrom (CLS) og hæmafagocytisk lymfohistiocytose/makrofagaktiveringssyndrom (HLH/MAS).
English: Content of dextran 40 and dimethyl sulfoxide (DMSO)
Danish: Indhold af dextran 40 og dimethylsulfoxid (DMSO)
English: Accordingly, healthcare professionals should employ appropriate precautions (wearing gloves and glasses) when handling leukapheresis material or Kymriah to avoid potential transmission of infectious diseases.
Danish: Derfor skal læger og øvrigt sundhedspersonale tage passende forsigtighedshensyn (bære handsker og briller) under håndtering af leukaferesemateriale eller Kymriah for at undgå potentiel overførsel af smittefarlige sygdomme.
English: Disseminated intravascular coagulation
Danish: Dissemineret vaskulær koagulation Koagulopati
English: The most common non-haematological adverse reactions were cytokine release syndrome (77%), infections (65%), hypogammaglobulinaemia (47%), pyrexia (40%) and decreased appetite (39%).
Danish: De mest almindelige ikke-hæmatologiske bivirkninger var cytokinfrigivelsessyndrom (77 %), infektioner (65 %), hypogammaglobulinæmi (47 %), pyreksi (40 %) og nedsat appetit (39 %).
English: Vascular disorders Hypotension Hypertension
Danish: Hypotension Hypertension
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: The pivotal study (B2202) is a multicentre, single-arm phase II study in paediatric and young adult patients with r/r B-cell acute lymphoblastic leukaemia.
Danish: Det pivotale studie (B2202) er et enkeltarm fase II-multicenterstudie hos pædiatriske og unge voksne patienter med r/r B-celle akut lymfoblastær leukæmi.
English: Table 1 Cytokine release syndrome management algorithm
Danish: Tabel 1 Algoritme til håndtering af cytokinfrigivelsessyndrom
English: How Kymriah is given
Danish: Sådan bliver Kymriah givet
English: If any of the above apply to you (or you are not sure), talk to your doctor before being given Kymriah.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), så tal med lægen, før du får behandling med Kymriah.
English: Tisagenlecleucel also traffics and persists in cerebrospinal fluid in paediatric and young adult B-cell ALL patients (Study B2101J) for up to 1 year.
Danish: Tisagenlecleucel fordeles også til cerebrospinalvæsken hos pædiatriske og unge voksne B-celle ALLpatienter (studie B2101J) og persisterer i den i op til 1 år.
English: Speech disorders includes speech disorders, dysarthria and aphasia.
Danish: Taleforstyrrelse omfatter taleforstyrrelser, dysartri og afasi.
English: • Stroke causing, for example, weakness, loss of balance, difficulty with speech, visual disturbance, difficulty swallowing
Danish: • Slagtilfælde, som kan forårsage fx svaghed, tab af balance, talebesvær, synsforstyrrelser,
English: • The other ingredients are glucose, sodium chloride, human albumin solution, dextran 40 for injection, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, and water for injections.
Danish: • Øvrige indholdsstoffer: glucose, natriumchlorid, human albuminopløsning, dextran 40 til parenteral anvendelse, dimethylsulfoxid, natriumgluconat, natriumacetat, kaliumchlorid, magnesiumchlorid, natrium-N-acetyltryptophan, natriumcaprylat, aluminium, vand til injektionsvæsker.
English: Also contains: glucose, sodium chloride, human albumin solution, dextran 40 for injection, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, water for injections.
Danish: Indeholder også: glucose, natriumchlorid, human albuminopløsning, dextran 40 til parenteral anvendelse, dimethylsulfoxid, natriumgluconat, natriumacetat, kaliumchlorid, magnesiumchlorid, natrium-N-acetyltryptophan, natriumcaprylat, aluminium, vand til injektionsvæsker.
English: Sodium chloride Human albumin solution Dextran 40 for injection Dimethylsulfoxide Sodium gluconate Sodium acetate
Danish: Natriumchlorid Human albuminopløsning Dextran 40 til injektion Dimethylsulfoxid Natriumgluconat Natriumacetat Kaliumchlorid Magnesiumchlorid Natrium-N-acetyltryptophan Natriumcaprylat Aluminium
English: Healthcare professionals handling Kymriah should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Danish: Sundhedspersonale, der skal håndtere Kymriah, bør derfor tage passende forholdsregler (bære handsker og briller) for at undgå potentiel transmission of smitsomme sygdomme.
English: Key secondary endpoint
Danish: Sekundært nøgleendepunkt
English: Kymriah contains sodium, dimethylsulfoxide (DMSO) and dextran 40.
Danish: Kymriah indeholder natrium, dimethylsulfoxid (DMSO) og dextran 40.
English: 1-3 infusion bags containing a total of 1.2 x 106 to 6 x 108 CAR-positive viable T cells.
Danish: 1-3 infusionsposer indeholdende totalt 1,2 x 106 til 6 x 108 CAR-positive levende T-celler.
English: Your doctor handling Kymriah will therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Danish: Din læge, der skal håndtere Kymriah, vil derfor tage passende forholdsregler (bruge handsker og sikkerhedsbriller) for at undgå potentiel overførsel af smitsomme sygdomme.
English: Asthenia
Danish: synkebesvær
English: Cardiac failurek) Arrhythmial) Cardiac arrest
Danish: Hjertesvigtk) Arytmil) Hjertestop
English: Overall survival (OS)3 % survival probability at 6 months % survival probability at 12 months Median (months) (95% CI)
Danish: Samlet overlevelse (OS)3 % overlevelsessandsynlighed efter 6 måneder 56,2 % overlevelsessandsynlighed efter 12 måneder 40,2 Median (måneder) (95 % CI)
English: If no response to second dose of tocilizumab, consider a third dose of tocilizumab or pursue alternative measures for treatment of cytokine release syndrome.
Danish: En tredje dosis tocilizumab eller andre metoder til behandling af cytokinfrigivelsessyndrom skal overvejes, hvis der ikke er respons på anden dosis tocilizumab.
English: The co-administration of agents known to inhibit T-cell function has not been formally studied.
Danish: Samtidig administration af stoffer, der vides at hæmme T-celle funktionen, er ikke blevet undersøgt i studier.
English: Kymriah should be transported within the facility in closed, break-proof, leak-proof containers.
Danish: Kymriah skal transporteres inden for behandlingscenteret i lukkede, brudsikre, lækagesikre transportbeholdere.
English: In adult DLBCL, patients, Grade 3 and 4 cytopenias not resolved by day 28 were reported based on laboratory findings and included thrombocytopenia (41%), lymphopenia (28%), neutropenia (24%), leukopenia (21%) and anaemia (14%).
Danish: Hos voksne DLBCL-patienter blev der rapporteret cytopenier af grad 3 og 4, der ikke var forsvundet ved dag 28, på baggrund af laboratoriefund, og de omfattede trombocytopeni (41 %), lymfopeni (28 %), neutropeni (24 %), leukopeni (21 %) og anæmi (14 %).
English: In paediatric and young adult B-cell ALL patients, Grade 3 and 4 cytopenias not resolved by day 28 were reported based on laboratory findings and included leukopenia (55%), neutropenia (53%), lymphopenia (43%), thrombocytopenia (41%) and anaemia (12%).
Danish: Hos pædiatriske og unge voksne B-celle ALL-patienter blev der rapporteret cytopenier af grad 3 og 4, der ikke var forsvundet ved dag 28, på baggrund af laboratoriefund, og de omfattede leukopeni (55 %), neutropeni (53 %), lymfopeni (43 %), trombocytopeni (41 %) og anæmi (12 %).
English: Preparation for infusion
Danish: Forberedelse af infusionsposen
English: intravenous daily for 3 days starting with the first dose of fludarabine).
Danish: 3 dage startende med den første dosis af cytarabin).
English: The most common Grade 3 and 4 non-haematological adverse reactions were infections (32%) and cytokine release syndrome (22%).
Danish: Den mest almindelige ikke-hæmatologiske bivirkninger af grad 3 og 4 var infektioner (32 %) og cytokinfrigivelsessyndrom
English: For special precautions for disposal see section 6.6.
Danish: For særlige forholdsregler for bortskaffelse, se pkt.
English: Autologous human T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
Danish: Autologe humane T-celler genetisk modificerede ex vivo ved brug af en lentiviral vektor, som koder for en anti-CD19 kimær antigenreceptor (CAR).
English: Infused N=75 n (%)
Danish: Infunderede N=75 n (%)
English: Acute kidney injury includes acute kidney injury, anuria, azotaemia, blood creatinine increased, renal failure, renal tubular dysfunction and renal tubular necrosis.
Danish: Akut nyreskade omfatter akut nyreskade, anuri, azotæmi, forøget kreatinin i blodet, nyresvigt, renal tubulær dysfunktion og renal tubulær nekrose.
English: Cellular kinetics in paediatric and young adult B-cell ALL patients
Danish: Cellekinetik hos pædiatriske og unge voksne patienter med B-celle ALL
English: Peripheral neuropathyg) Speech disordersh) Seizurei)
Danish: Perifær neuropatig) Taleforstyrrelseh) Krampeanfaldi)
English: Patient educational programme
Danish: Uddannelsesmateriale til patienter
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er, med den alvorligste bivirkning anført først.
English: Contains 1.2 x 106 to 6 x 108 CAR+ viable T cells.
Danish: Indeholder 1,2 x 106 til 6 x 108 CAR+ levende T-celler.
English: Deliriumc) Anxiety Sleep disorderd)
Danish: Deliriumc) Angst
English: Cough includes cough, productive cough and upper-airway cough syndrome.
Danish: Hoste omfatter hoste, produktiv hoste og øvre luftvej-hoste-syndrom.
English: Enrolled N=92 n (%)
Danish: Inkluderede N=92 n (%)
English: The MAH must ensure on-site, immediate access to 4 doses of tocilizumab for each patient as CRS management medication prior to treating patients.
Danish: Før patienterne behandles, skal markedsføringsindehaveren sikre, at stedet har øjeblikkelig adgang til 4 doser af tocilizumab til hver patient til behandling af cytokinfrigivelsessyndrom(CRS).
English: INFUSION BAG LABEL
Danish: LABEL TIL INFUSIONSPOSE
English: NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 x 106 - 6 x 108 cells dispersion for infusion tisagenlecleucel (CAR+ viable T cells)
Danish: Kymriah 1,2 x 106 - 6 x 108 celler, infusionsvæske, dispersion tisagenlecleucel (CAR+ levende T-celler)
English: Sterile sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prime the tubing prior to infusion as well as rinse it afterwards.
Danish: Der bør anvendes steril natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion til at prime slangerne før infusion og til at skylle dem efter infusion.
English: Enrolled N=165 n (%)
Danish: Inkluderede N=165 n (%)
English: Update reports:
Danish: Kymriah indeholder:
English: What you need to know before you are given Kymriah
Danish: Det skal du vide, før du får behandling med Kymriah
English: If the patient experienced a previous Grade 4 haemorrhagic cystitis with cyclophosphamide, or demonstrated a chemorefractory state to a cyclophosphamide-containing regimen administered shortly before lymphodepleting chemotherapy, then the following should be used: - Cytarabine (500 mg/m2 intravenous daily for 2 days) and etoposide (150 mg/m2 intravenous daily for 3 days starting with the first dose of cytarabine).
Danish: Hvis patienten oplevede en forudgående hæmoragisk cystitis af grad 4 med cyclophosphamid eller udviste en kemorefraktær tilstand i forbindelse med et cyclophosphamid-indeholdende regime administreret kort tid før lymfodepleterende kemoterapi, bør følgende anvendes: - Cytarabin (500 mg/m2 intravenøst daglig i 2 dage) og etoposid (150 mg/m2 intravenøst daglig i
English: Each infusion bag of Kmyriah contains tisagenlecleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells).
Danish: Hver infusionspose af Kymriah indeholder tisagenlecleucel celledispersion i en batch-afhængig koncentration af autologe T-celler, som er genetisk modificerede til at udtrykke en anti-CD19 kimær antigenreceptor (CAR-positive levedygtige Tceller).
English: A summary of cellular kinetic parameters of tisagenlecleucel in paediatric and young adult B-cell ALL patients is provided in Table 7 below.
Danish: I tabel 7 nedenfor er der givet en opsummering af cellekinetiske parametre for tisagenlecleucel hos pædiatriske og unge voksne patienter med B-celle ALL.
English: Kymriah is an immunocellular therapy containing tisagenlecleucel, autologous T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
Danish: Kymriah er en cellulær immunterapi, der indeholder tisagenlecleucel, autologe T-celler genetisk modificerede ex vivo ved brug af en lentiviral vektor, som koder for en anti-CD19 kimær antigenreceptor (CAR).
English: A summary of cellular kinetic parameters of tisagenlecleucel in DLBCL patients is provided in Table 8 below.
Danish: I tabel 8 nedenfor er der givet en opsummering af cellekinetiske parametre for tisagenlecleucel hos DLBCL-patienter.
English: In DLBCL patients, across the weight ranges (38.4 to 186.7 kg), the scatter plots of qPCR cellular kinetic parameters versus weight revealed no apparent relationship between cellular kinetic parameters with weight.
Danish: Hos DLBCL-patienter viste scatter-plot af qPCR cellekinetiske parametre versus vægt ingen tilsyneladende sammenhæng mellem cellekinetiske parametre og vægt på tværs af vægtintervallerne (38,4 til 186,7 kg).
English: Dispersion for infusion.
Danish: Infusionsvæske, dispersion.
English: • Nausea, vomiting
Danish: • Kvalme, opkastning
English: Nominal one-sided exact p-value based on H0: ORR ≤20% vs. Ha: ORR >20% CR (complete remission) was defined as <5% of blasts in the bone marrow, circulating blasts in blood should be <1%, no evidence of extramedullary disease, and full recovery of peripheral blood counts (platelets >100,000/μL and absolute neutrophil counts [ANC] >1,000/μL) without blood transfusion.
Danish: CR (komplet remission) var defineret som <5 % blaster i knoglemarven, cirkulerende blaster i blodet skulle være <1 %, ingen påvisning af ekstramedullær sygdom og fuldstændig normalisering af antallet af perifere blodceller (trombocyttal>100.000/μl og absolut neutrofiltal [ANC] >1.000/μl) uden blodtransfusion.
English: Fluid overload Hypermagnesaemia Hyponatraemia Hyperphosphataemia Tumour lysis syndrome
Danish: Væske overbelastning Hypermagnesiæmi Hyponatriæmi Hyperfosfatæmi Tumorlysesyndrom
English: The most common Grade 3 and 4 haematological laboratory abnormalities were white blood cells decreased (99%), neutrophils decreased (95%), lymphocytes decreased (95%), platelets decreased (77%) and haemoglobin decreased (53%).
Danish: De mest almindelige hæmatologiske laboratorieanomalier af grad 3 og 4 var fald i antal hvide blodceller (99 %), fald i neutrofiltal (95 %), fald i lymfocyttal (95 %), fald i trombocyttal (77 %) og fald i hæmoglobinniveau (53 %).
English: Sodium and potassium content
Danish: Natrium- og kaliumindhold
English: • Changes in blood test results that report on how the liver and kidneys are working (high levels of: liver enzymes, bilirubin, creatinine)
Danish: • Ændringer i blodprøveresultater, der viser hvordan lever og nyrer fungerer (højt niveau af:
English: Primary endpoint
Danish: Primært endepunkt
English: The most common (>25%) Grade 3 and 4 haematological laboratory abnormalities were lymphocyte count decreased (95%), neutrophil count decreased (81%), white blood cell count decreased (77%), haemoglobin decreased (59%) and platelet count decreased (55%).
Danish: De mest almindelige (>25 %) hæmatologiske laboratorieanomalier af grad 3 og 4 var fald i lymfocyttal (95 %), fald i neutrofiltal (81 %), fald i antal hvide blodceller (77 %), fald i hæmoglobinniveau (59 %) og fald i trombocyttal (55 %).
English: • Loss of appetite, weight loss
Danish: • Appetitløshed, vægttab
English: The recommended lymphodepleting chemotherapy regimen is: - Fludarabine (25 mg/m2 intravenous daily for 3 days) and cyclophosphamide (250 mg/m2
Danish: Det anbefalede lymfodepleterende kemoterapi-regime er: - Fludarabin (25 mg/m2 intravenøst daglig i 3 dage) og cyclophosphamid (250 mg/m2 intravenøst daglig i 3 dage startende med den første dosis af fludarabin).
English: Each ethylene vinyl acetate (EVA) infusion bag of Kymriah contains tisagenlecleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells) (see section 4.2).
Danish: Hver ethylenvinylacetat (EVA) infusionspose med Kymriah indeholder tisagenlecleucel celledispersion i en batch-afhængig koncentration af autologe T-celler, der er genetisk modificerede til at udtrykke en anti-CD19 kimær antigenreceptor (CAR-positive levende T-celler) (se pkt.
English: The recommended lymphodepleting chemotherapy regimen is: - Fludarabine (30 mg/m2 intravenous daily for 4 days) and cyclophosphamide (500 mg/m2
Danish: Det anbefalede lymfodepleterende kemoterapi-regime er: - Fludarabin (30 mg/m2 intravenøst daglig i 4 dage) og cyclophosphamid (500 mg/m2 intravenøst daglig i 2 dage startende med den første dosis af fludarabin).
English: A minimum of four doses of tocilizumab for use in the event of cytokine release syndrome and emergency equipment must be available prior to infusion.
Danish: Inden infusion skal der være mindst fire doser tocilizumab og nødudstyr tilgængelige til brug i tilfælde af cytokinfrigivelsessyndrom.
English: 1-3 bags contain a total of 1.2 x 106 - 6 x 108 CAR+ viable T cells.
Danish: 1-3 poser indeholdende i alt 1,2 x 106 - 6 x 108 CAR+ levende T-celler.
English: After thawing, the product should be kept at room temperature (20°C-25°C) and infused within 30 minutes to maintain maximum product viability, including any interruption during the infusion.
Danish: Efter optøning bør produktet opbevares ved stuetemperatur (20 °C-25 °C) og infunderes inden for 30 minutter for at bevare maksimal levedygtighed, herunder medregnet afbrydelser under infusion.
English: Headachee) Encephalopathyf) Dizziness
Danish: Hovedpinee) Encefalopatif) Svimmelhed
English: • Nerve pain
Danish: • Nervesmerter
English: Once Kymriah has been thawed and is at room temperature (20°C-25°C), it should be infused within 30 minutes to maintain maximum product viability, including any interruption during the infusion.
Danish: Når Kymriah er blevet optøet og har opnået stuetemperatur (20 °C-25 °C), bør det infunderes inden for 30 minutter for at opretholde den maksimale levedygtighed af produktet, herunder også inkluderet eventuelle afbrydelser under infusionen.
English: What Kymriah looks like and contents of the pack Kymriah is a cell dispersion for infusion.
Danish: Kymriah er en celledispersion til infusion.
English: There is limited experience of use of Kymriah in patients with active CNS leukaemia and active CNS lymphoma.
Danish: Aktiv leukæmi eller lymfom i centralnervesystemet (CNS) Der er begrænset erfaring med brug af Kymriah i patienter med aktiv leukæmi eller lymfom i CNS.
English: Responding patients (CR/CRi)
Danish: Responderende patienter (CR/CRi) N=80
English: Sex - n (%)
Danish: Køn - n (%)
English: • Muscle and joint aches, muscle spasms, back pain
Danish: • Muskel og ledsmerter, muskelkramper, rygsmerte
English: • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Danish: • Voksne patienter med recidiverende eller refraktært diffust storcellet B-celle lymfom (DLBCL)
English: • Fast heart beat
Danish: • Hurtig hjerterytme
English: • Bloating (abdominal distension), accumulation of fluid in the abdomen
Danish: • Oppustethed (udspilet mave), væskeansamling i maven
English: Prolonged cytopenias
Danish: Cytopenier af længere varighed
English: Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered.
Danish: Patienter med medicinsk signifikant hjertedysfunktion skal behandles i forhold til standarder for kritisk behandling, og forholdsregler såsom ekkokardiografi bør overvejes Tumornekrosefaktor (TNF)-antagonister anbefales ikke til håndtering af Kymriah-relateret cytokinfrigivelsessyndrom.
English: For clinical management of cytokine release syndrome, see section 4.4 and Table 1.
Danish: For klinisk håndtering af cytokinfrigivelsessyndrom, se pkt.
English: Febrile neutropenia was frequently observed in patients after Kymriah infusion (see section 4.8) and may be concurrent with cytokine release syndrome.
Danish: Febril neutropeni blev hyppigt observeret hos patienter efter infusion af Kymriah (se pkt.
English: Mouth haemorrhage Stomatitis
Danish: Blødning i munden Stomatitis
English: How you are given Kymriah
Danish: Sådan bliver du behandlet med Kymriah
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.
Danish: • Pædiatriske og unge voksne patienter op til 25 år med B-celle akut lymfoblastær leukæmi
English: • Heart failure, stopped heart beat
Danish: • Hjertesvigt, hjertestop
English: Cardiac disorders Tachycardiaj)
Danish: Takykardij)
English: Oedema includes oedema peripheral, generalised oedema, localised oedema and face oedema.
Danish: Ødem omfatter perifært ødem, generaliseret ødem, lokaliseret ødem og ansigtsødem.
English: Of 92 patients enrolled, 75 received infusion with Kymriah; for 7 patients (8%) Kymriah could not be manufactured; reasons for discontinuation prior to Kymriah infusion included death (n=7; 8%) or adverse events (n=3; 3%) while awaiting Kymriah manufacturing in the clinical study.
Danish: Årsager til at udgå inden Kymriah infusion var død (n=7; 8 %) eller bivirkninger (n=3; 3 %), mens man ventede på produktion af Kymriah i det kliniske studie.
English: • Nosebleeds
Danish: • Næseblod
English: Tlast
Danish: Tsidst
English: Acute kidney injuryq)
Danish: Nyrer og urinveje Akut nyreskadeq)
English: Abdominal distension Ascites
Danish: Udspilet abdomen Ascites
English: • Jaundice
Danish: • Gulsot
English: Pyrexia Fatigue Oedemar) Pains) Chills
Danish: Pyreksi Træthed Ødemr) Smertes) Kulderystelser
English: Cytokine release syndrome
Danish: Sværhedsgrad af cytokinfrigivelsessyndrom