natgillin/translations-raw huggingface dataset:
Patienterne fik en median på 7 doser avelumab (interval: 1 dosis til 95 doser), og den mediane behandlingsvarighed var 17 uger (interval: 2 uger til 208 uger).
Patients received a median of 7 doses of avelumab (range: 1 dose to 95 doses), and the median duration of treatment was 17 weeks (range: 2 weeks to 208 weeks).
(ORR) var 62,1 % (95 % CI: 42,3; 79,3) hvor der for 4 (14 %) af patienterne blev rapporteret om et komplet respons, og 14 (48 %) havde et partielt respons.
The objective response rate (ORR) was 62.1% (95% CI: 42.3, 79.3) with 4 (14%) of patients reported to have a complete response and 14 (48%) to have a partial response.
Patienterne skal overvåges for hyperglykæmi eller andre tegn og symptomer på diabetes.
Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Samlet blev det rapporteret, at 52 (59 %) af patienterne havde fået 1 tidligere behandling mod MCC, 26 (30 %) havde fået 2 tidligere behandlinger, og 10 (11 %) havde fået 3 eller flere tidligere behandlinger.
Overall, 52 (59%) patients were reported to have had 1 prior anti-cancer therapy for MCC, 26 (30%) with 2 prior therapies, and 10 (11%) with 3 or more prior therapies.
• Hætteglasset skal inspiceres visuelt for partikler og misfarvning.
• The vial should be visually inspected for particulate matter and discoloration.
Det primære endepunkt for effekt for del A var det bekræftede bedste samlede respons (best overall response, BOR); sekundære endepunkter for effekt omfattede varigheden af responset (duration of response, DOR) og progressionsfri overlevelse (progression free survival, PFS).
For Part A, the major efficacy outcome measure was confirmed best overall response (BOR); secondary efficacy outcome measures included duration of response (DOR), and progression-free survival (PFS).
• Beskrivelse af de vigtigste tegn og symptomer på de følgende sikkerhedsovervejelser, og en påmindelse om vigtigheden af straks at informere den behandlende læge, hvis symptomerne opstår, varer ved eller forværres: o Immunrelateret pneumonitis o Immunrelateret hepatitis o Immunrelateret colitis o Immunrelateret pankreatitis o Immunrelateret myokarditis o Immunrelaterede endokrinopatier (diabetes mellitus, tyreoideasygdomme, binyreinsufficiens) o Immunrelateret nefritis og nyredysfunktion o Andre immunrelaterede bivirkninger, herunder myositis, hypopituitarisme, uveitis og Guillain-Barrés syndrom) o Infusionsrelaterede reaktioner
• Description of the main signs and symptoms of the following safety concerns and reminder of the importance of notifying their treating physician immediately if symptoms occur, persist or worsen: o Immune-Related Pneumonitis o Immune-Related Hepatitis o Immune-Related Colitis o Immune-Related Pancreatitis o Immune-Related Myocarditis o Immune-Related Endocrinopathies (diabetes mellitus, thyroid disorders, adrenal insufficiency) o Immune-related nephritis and renal dysfunction o Other immune-related adverse reactions including myositis, hypopituitarism, uveitis and Guillain-Barre Syndrome o Infusion-Related Reactions
Ubrugte dele af koncentratet eller af den fortyndede infusionsopløsning må ikke opbevares til genbrug.
Do not store any unused portion of the concentrate or of the diluted infusion solution for reuse.
• leverbetændelse (hepatitis) eller andre leverproblemer,
• inflammation of your liver (hepatitis) or other liver problems;
Bavencio er indiceret som monoterapi ved behandling af voksne patienter med metastatisk Merkelcelle karcinom (MCC).
Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Den anbefalede dosis af Bavencio som monoterapi er 800 mg, administreret intravenøst over 60 minutter hver 2. uge.
The recommended dose of Bavencio as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks.
• Forhøjet antal af en type hvide blodlegemer (eosinofiler)
• Increase in the number of a type of white blood cells (eosinophils)
Ud af de 1.738 patienter, der blev behandlet med avelumab 10 mg/kg som en intravenøs infusion hver 2. uge, kunne 1.627 evalueres for, om der opstod antidrug-antistoffer (anti-drug antibodies, ADA) under behandlingen, og 96 (5,9 %) blev testet positiv.
Of 1,738 patients treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks, 1,627 were evaluable for treatment-emergent anti-drug antibodies (ADA) and 96 (5.9%) tested positive.
Der blev ikke fundet nogen klinisk vigtige forskelle i clearance af avelumab mellem patienter med let (glomerulær filtrationsrate (GFR) 60 til 89 ml/min, Cockcroft-Gault kreatininclearance (CrCL), n = 623), moderat (GFR 30 til 59 ml/min, n = 320) og patienter med normal (GFR ≥ 90 ml/min, n = 671) nyrefunktion.
No clinically important differences in the clearance of avelumab were found between patients with mild (glomerular filtration rate (GFR) 60 to 89 mL/min, Cockcroft-Gault Creatinine Clearance (CrCL); n=623), moderate (GFR 30 to 59 mL/min, n=320) and patients with normal (GFR ≥ 90 mL/min, n=671) renal function.
Autoimmun colitis, autoimmun pankreatitis, enterocolitis, ileus, nekrotiserende pankreatitis
Autoimmune colitis, autoimmune pancreatitis, enterocolitis, ileus, pancreatitis necrotizing
Seponer permanent
Permanently discontinue
Øvrige indholdsstoffer: Mannitol, koncentreret eddikesyre, polysorbat 20, natriumhydroxid, vand til injektionsvæsker (se punkt 2 ”Bavencio har et lavt natriumindhold”).
The other ingredients are mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”).
Median i måneder (95 % CI)
Median in months (95% CI)
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer)
Very common (may affect more than 1 in 10 people)
• betændelse i musklerne (myositis).
• inflammation of your muscles (myositis).
Kontakt lægen, før du får Bavencio:
Talk to your doctor before receiving Bavencio:
Bavencio er et klart, farveløst til let gulligt koncentrat til infusionsvæske, opløsning (koncentrat, sterilt).
Bavencio is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate).
Data for immunrelaterede bivirkninger for avelumab som monoterapi er baseret på 1.650 patienter i fase I-studiet EMR100070-001 af solide tumorer, og 88 patienter i studie EMR100070-003, og for avelumab i kombination med axitinib er baseret på 489 patienter i studie B9991002 og B9991003 (se pkt.
Data for immune-related adverse reactions for avelumab as a monotherapy are based on 1,650 patients in the phase I study EMR100070-001 in solid tumours and 88 patients in study EMR100070-003, and for avelumab in combination with axitinib are based on 489 patients in study B9991002 and B9991003 (see section 5.1).
Avelumab bør genoptages, når den immunrelaterede bivirkning falder til grad 1 eller derunder, efter en nedtrapning af kortikosteroider.
Avelumab should be resumed when the immune-related adverse reaction returns to Grade 1 or less following corticosteroid taper.
Hvis opløsningen er afkølet, skal den fortyndede opløsning i de intravenøse poser have stuetemperatur før brug.
If refrigerated, allow the diluted solution in the intravenous bags to come to room temperature prior to use.
Alle 31 patienter med immunrelateret hepatitis blev behandlet for hepatitis, herunder 30 (96,8 %) patienter behandlet med kortikosteroider, og 1 patient med et non-steroidt immunosuppressivum.
All 31 patients with immune-related hepatitis were treated for hepatitis including 30 (96.8%) patients treated with corticosteroids and 1 patient with a non-steroidal immunosuppressant.
Fra et mikrobiologisk synspunkt bør den fortyndede opløsning infunderes straks, medmindre fortyndingsmetoden udelukker risikoen for mikrobiel kontaminering.
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the diluted solution should be infused immediately.
Median, måneder (95 % CI)
Median, months (95% CI)
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Bavencio i alle undergrupper af den pædiatriske population ved behandling af Merkelcellekarcinom og renalcellekarcinom (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Bavencio in all subsets of the paediatric population for the treatment of Merkel cell carcinoma and renal cell carcinoma (see section 4.2 for information on paediatric use).
Komplet respons (CR) n (%) Partielt respons (PR) n (%)
Complete response (CR) n (%) Partial response (PR) n (%)
Nefritis og renaldysfunktion
Nephritis and renal dysfunction
Alvorlige bivirkninger var immunrelaterede bivirkninger og infusionsrelateret reaktion (se pkt.
Serious adverse reactions were immune-related adverse reactions and infusion-related reaction (see section 4.4).
Så meget Bavencio vil du modtage
How much Bavencio you will receive
Resultater (N=116)
Results (N=116)
Lymfopeni, eosinofili
Lymphopenia, eosinophilia
Efter del B havde inkluderet alle, blev der udført en efterfølgende interimanalyse med 116 patienter, som fik mindst én dosis af avelumab og med mindst 7 måneders opfølgning på tidspunktet for dataafskæringen (cut-off-dato 14. september 2018).
After Part B was fully enrolled, a subsequent interim analysis was conducted with 116 patients who received at least one dose of avelumab and with at least 7 months of follow-up at the time of the data cut-off (cut-off date 14 September 2018).
Hyppighederne defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Bavencio indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, og derfor er det i det væsentlige natriumfrit.
Bavencio contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Analysen af progressionsfri overlevelse (PFS) var baseret på 39 patienter, som fik mindst én dosis af avelumab med en median PFS på 9,1 måneder (95 % CI: 1,9 kunne ikke estimeres) og en estimeret PFS-rate efter 3 måneder ved Kaplan-Meier på 67 % (95% CI: 48; 80).
Analysis of progression-free survival (PFS) was based on 39 patients who received at least one dose of avelumab, with median PFS of 9.1 months (95% CI: 1.9, not estimable) and estimated 3-month PFS rate by Kaplan-Meier of 67% (95% CI: 48, 80).
Hypotyroidisme skal behandles med erstatningsbehandling med et antityreoidea lægemiddel, efter behov.
Hypothyroidism should be managed with replacement therapy and hyperthyroidism with anti-thyroid medicinal product, as needed.
Patienterne skal overvåges for tegn og symptomer på infusionsrelaterede reaktioner, herunder pyreksi, kulderystelser, rødme, hypotension, dyspnø, hvæsende vejrtrækning, rygsmerter, abdominalsmerter og urticaria.
Patients should be monitored for signs and symptoms of infusion-related reactions including pyrexia, chills, flushing, hypotension, dyspnoea, wheezing, back pain, abdominal pain, and urticaria.
Positiv (n = 46)
Positive (n=46)
• Brochure med patientinformation
• Patient Information Brochure
Bavencio i kombination med axitinib er indiceret som førstevalgsbehandling af voksne patienter med fremskredent renalcellekarcinom (RCC) (se pkt.
Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).
Godkendelse under betingede omstændigheder
Conditional approval
Nedsat leverfunktion blev defineret i henhold til kriterierne for leverdysfunktion fra National Cancer Institute (NCI).
Hepatic impairment was defined by National Cancer Institute (NCI) criteria of hepatic dysfunction.
Hos patienter behandlet med avelumab i kombination med axitinib blev der rapporteret grad 3 og grad 4 forhøjet ALAT og forhøjet ASAT hos hhv. 9 % og 7 % af patienterne.
In patients treated with avelumab in combination with axitinib, Grades 3 and Grade 4 increased ALT and increased AST were reported in 9% and 7% of patients, respectively.
• Forhøjet eller nedsat blodtryk
• Increases or decreases in blood pressure
E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE VILKÅR
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Afbryd, indtil bivirkningerne bedres til grad 0-1, genoptag infusionen med 50 % langsommere hastighed
Withhold until adverse reactions recover to Grade 0-1; restart infusion with a 50% slower rate
Patienterne skal overvåges for tegn og symptomer på binyreinsufficiens under og efter behandlingen.
Patients should be monitored for signs and symptoms of adrenal insufficiency during and after treatment.
Responsrate, CR+PR** n (%) (95 % CI)
Response rate, CR+PR** n (%) (95% CI)
Dette er ikke almindeligt.
This is uncommon.
Den præspecificerede interimanalyse for del B omfattede 39 patienter, som fik mindst én dosis af avelumab og 29 patienter med en minumumsopfølgning på 13 uger på tidspunktet for dataafskæringen (cut-off-dato 24. marts 2017).
The prespecified interim analysis for Part B included 39 patients who received at least one dose of avelumab and 29 patients with a minimum 13 weeks of follow-up at the time of the data cut-off (cut-off date 24 March 2017).
Den største gennemsnitlige maksimale reduktion (% variationskoefficient [coefficient of variation, CV %]) fra værdien ved baseline med forskellige tumortyper var ca. 32,1 % (CV 36,2 %).
In the supplemental analysis, avelumab CL was found to decrease over time: the largest mean maximal reduction (% coefficient of variation [CV%]) from baseline value with different tumour types was approximately 32.1% (CV 36.2%).
Bavencio er en klar, farveløs til let gullig opløsning.
Bavencio is a clear, colourless to slightly yellow solution.
Baseret på bivirkningens sværhedsgrad, skal avelumab afbrydes, og der skal administreres kortikosteroider.
Based on the severity of the adverse reaction, avelumab should be withheld and corticosteroids to be administered.
Avelumab er et humant, monoklonalt IgG1-antistof rettet mod det immunmodulerende ligandprotein på celleoverfladen, PD-L1.Det fremstilles i ovariecellerne fra kinesiske hamstere ved hjælp af rekombinant dna-teknologi.
Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
Dette er meget almindeligt.
This is very common.
Grad 3 eller grad 4 pneumonitis eller tilbagevendende grad 2 pneumonitis
Grade 3 or Grade 4 pneumonitis or recurrent Grade 2 pneumonitis
Hvis opløsningen er uklar, misfarvet eller hvis den indeholder partikler, må hætteglasset ikke anvendes.
If the solution is cloudy, discoloured, or contains particulate matters, the vial should be discarded.
Detaljerede retningslinjer for behandling af immunrelaterede bivirkninger beskrives i pkt.
Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Bivirkninger rapporteret for 489 patienter med fremskredent RCC behandlet i 2 kliniske studier med avelumab i kombination med axitinib vises i tabel 3.
Adverse reactions reported for 489 patients with advanced RCC treated in two clinical studies with avelumab in combination with axitinib are presented in Table 3.
De følgende bivirkninger er blevet indberettet i de kliniske studier med avelumab alene: Nogle bivirkninger har måske ikke symptomer, og kan kun opdages ved blodprøver.
Some side effects may not have symptoms and may only be discovered through blood tests.
Bekræftet objektiv responsrate (ORR)
Confirmed objective response rate (ORR)
Dette er almindeligt.
This is common.
Behandlingsmodifikation
Treatment modification
Reducer infusionshastigheden med
Reduce infusion rate by
Hyppighederne defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Meget almindelig Nedsat appetit Almindelig
Decreased appetite
En dosisreduktion i henhold til produktinformation for axitinib bør overvejes, hvis axitinib genoptages.
Dose reduction according to the axitinib product information should be considered if rechallenging with axitinib.
Kvinder i den fertile alder skal rådes til at undgå graviditet, mens de får avelumab, og de bør anvende sikker kontraception under behandlingen med avelumab og i mindst 1 måned efter den sidste dosis avelumab.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving avelumab and should use effective contraception during treatment with avelumab and for at least 1 month after the last dose of avelumab.
Uddannelsesprogrammet er beregnet til at øge kendskabet og give oplysninger om tegn og symptomer på visse vigtige identificerede risici ved avelumab, herunder immunrelateret pneumonitis, hepatitis, colitis, pankreatitis, myokarditis, tyreoideasygdomme, binyreinsufficiens, type 1 diabetes mellitus, nefritis og nyredysfunktion, myositis, hypopituitarisme, uveitis, Guillain-Barrés syndrom og infusionsrelaterede reaktioner, og hvordan de skal behandles.
The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of avelumab, including immune-related pneumonitis, hepatitis, colitis, pancreatitis, myocarditis, thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, nephritis and renal dysfunction, myositis, hypopituitarism, uveitis, GuillainBarre syndrome and infusion related reactions, and how to manage them.
Behandlingsmodifikationer
Treatment modifications
Resultater (N = 88)
Results (N=88)
(≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
< 1/1,000); very rare (< 1/10,000).
Hos patienter med infusionsrelaterede reaktioner af grad 2 skal infusionen midlertidigt afbrydes, indtil reaktionen er af grad 1 eller er forsvundet, og så kan infusionen påbegyndes igen med en 50 % langsommere infusionshastighed (se pkt.
For patients with Grade 2 infusion-related reactions, the infusion should be temporary discontinued until Grade 1 or resolved, then the infusion will restart with a 50% slower infusion rate (see section 4.2).
Ud af de 480 patienter med mindst et gyldigt ADA-resultat på et vilkårligt tidspunkt, behandlet med avelumab 10 mg/kg som en intravenøs infusion hver 2. uge i kombination med axitinib 5 mg to gange dagligt, kunne 453 evalueres for ADA, som opstod under behandlingen, og 66 (14,6 %) testede positivt.
Of the 480 patients with at least one valid ADA result at any time point treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily, 453 were evaluable for treatment-emergent ADA and 66 (14.6%) tested positive.
• Tegn på betændelse i musklerne (myositis) kan omfatte muskelsmerter eller svaghed.
• Signs of inflammation of the muscles (myositis) may include muscle pain or weakness.
• Øjenbetændelse
• Inflammation of the eye
I tilfælde af en overdosering, skal patienterne overvåges nøje for tegn og symptomer på bivirkninger.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions.
Tabel 4 opsummerer endepunkter for virkning hos patienter, der fik avelumab ved den anbefalede dosis for studie EMR100070-003, del A, med en minimumsopfølgning på 36 måneder.
Table 4 summarises efficacy endpoints in patients receiving avelumab at the recommended dose for study EMR100070-003, Part A, with a minimum follow-up of 36 months.
Figur 1: Kaplan-Meier-estimater af progressionsfri overlevelse (PFS) pr. RECIST v1.1, IERC (del A, minimumsopfølgning på 36 måneder)
Figure 1: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part A, minimum follow-up of 36 months)
Koncentreret eddikesyre Polysorbat 20
Glacial acetic acid Polysorbate 20
Avelumabs sikkerhed i kombination med axitinib er blevet evalueret hos 489 patienter med fremskredent RCC, der fik 10 mg/kg avelumab hver 2. uge, og axitinib 5 mg oralt to gange dagligt i 2 kliniske studier.
The safety of avelumab in combination with axitinib has been evaluated in 489 patients with advanced RCC receiving 10 mg/kg avelumab every 2 weeks and axitinib 5 mg orally twice daily in two clinical studies.
Spørg lægen eller sundhedspersonalet, før du får Bavencio, hvis:
Check with your doctor or nurse before you receive Bavencio if:
Endokrinopatier (hypotyroidisme, hypertyroidisme, adrenal insufficiens, hyperglykæmi)
Endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia)
Avelumab bør tilbageholdes i tilfælde af formodet immunrelateret pankreatitis.
Avelumab should be withheld in the event of suspected immune-related pancreatitis.
Anbefaling om dosisjustering for axitinib, når det anvendes sammen med Bavencio Når Bavencio administreres i kombination med axitinib henvises til produktinformationen for axitinib for anbefalinger om dosisjusteringer for axitinib.
Dose modification advice for axitinib when used with Bavencio When Bavencio is administered in combination with axitinib, please refer to the axitinib product information for recommended dose modifications for axitinib.
Negativ (n = 31)
Negative (n=31)
Grad 3 eller grad 4 infusionsrelateret reaktion
Grade 3 or Grade 4 infusion-related reaction
Der er ikke tilstrækkelige data for patienter med svært nedsat nyrefunktion til doseringsanbefalinger.
There are insufficient data in patients with severe renal impairment for dosing recommendations.
Hvis kortikosteroiderne anvendes til at behandle en bivirkning, skal behandlingen med kortikosteroider nedtrappes over mindst 1 måned, efter forbedring er observeret.
If corticosteroids are used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Patienter med tidligere systemisk behandling rettet mod fremskredent eller metastatisk RCC; tidligere systemisk immunterapeutisk behandling med IL-2-, IFN-α-, anti-PD-1-, anti-PD-L1- eller anti-CTLA-4-antistoffer eller aktive hjernemetastaser, aktiv autoimmunsygdom, der kan forværres, når der fås immunstimulerende midler, andre tidligere maligniteter i anamnesen inden for de sidste 5 år, organtransplantation, var ikke egnede.
Patients with prior systemic therapy directed at advanced or metastatic RCC; prior systemic immunotherapy treatment with IL-2, IFN-α, anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or active brain metastasis; active autoimmune disease that might deteriorate when receiving an immunostimulatory agents; a history of other malignancies within the last 5 years; organ transplant were ineligible.
• Influenzalignende sygdom (herunder feberfornemmelser, muskelsmerter)
• Flu-like illness (includes feeling of fever, muscle aches)
Forhøjet kreatinin i blodet, forhøjet amylase, forhøjet lipase, forhøjet gamma-glutamyltransferase, forhøjet basisk phosphatase i blodet, forhøjet kreatinphosphokinase i blodet, nedsat tyroideastimulerende hormon i blodet, forhøjede transaminaser
Blood creatinine increased, amylase increased, lipase increased, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinase increased, blood thyroid stimulating hormone decreased, transaminases increased
12-måneders PFS-rate ved K-M, (95 % CI)** 52,4% (47,4; 57,2) 18-måneders PFS-rate ved K-M, (95 % CI)** 43,9% (38,8; 49,0)
12-month PFS rate by K-M, (95% CI)** 52.4% (47.4, 57.2) 18-month PFS rate by K-M, (95% CI)** 43.9% (38.8, 49.0)
Mediantiden til type 1 diabetes mellitus opstod var 1,9 måneder (interval: 1,1 måneder til 7,3 måneder).
The median time to onset of Type 1 diabetes mellitus was 1.9 months (range: 1.1 months to 7.3 months).
ASAT eller ALAT over 5 gange ULN eller totalt bilirubin over 3 gange ULN
AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
Objektiv responsrate (ORR)
Objective response rate (ORR)