natgillin/translations-raw huggingface dataset:
Tumorprøver blev evalueret prospektivt for PD-L1-ekspression i tumorinfiltrerende immunceller (IC), og resultaterne blev brugt til at definere de PD-L1-ekspressionssubgrupper, der er anvendt i nedenfor beskrevne analyser.
Tumour specimens were evaluated prospectively for PD-L1 expression on tumour-infiltrating immune cells (IC) and the results were used to define the PD-L1 expression subgroups for the analyses described below.
Alle patienter
Elderly patients
Tumorprøver blev evalueret for PD-L1ekspression på tumorceller (TC) og tumorinfiltrerede immunceller (IC), og resultaterne blev brugt til af definere subgrupperne af PD-L1-ekspression i analyserne beskrevet nedenfor.
Tumour specimens were evaluated for PD-L1 expression on tumour cells (TC) and tumour-infiltrating immune cells (IC) and the results were used to define the PD-L1 expression subgroups for the analyses described below.
Mediantid til hændelse var 1,5 måneder (interval: 6 dage til 18,8 måneder).
The median time to onset was 1.5 months (range 6 days to 18.8
Data for patienter ≥ 75 år er for begrænsede til at kunne drage en konklusion vedrørende denne population.
Data for patients ≥75 years of age are too limited to draw conclusions on this population.
Pancreatitis førte til seponering af atezolizumab hos 3 (< 0,1%) patienter.
Pancreatitis led to the discontinuation of atezolizumab in 3 (< 0.1%) patients.
Inkluderer indberetninger om urinvejsinfektioner, cystitis, pyelonefritis, escherichia urinvejsinfektion, bakteriel urinvejsinfektion, nyreinfektion, akut pyelonefritis, fungal urinvejsinfektion, pseudomonas urinvejsinfekton.
Includes reports of urinary tract infection, cystitis, pyelonephritis, escherichia urinary tract infection, urinary tract infection bacterial, kidney infection, pyelonephritis acute, urinary tract infection fungal, urinary tract infection pseudomonal.
Inkluderer indberetninger om pneumonitis, lungeinfiltration, bronchiolitis, interstitiel lungesygdom, strålingspneumonitis r
q Includes reports of pneumonitis, lung infiltration, bronchiolitis, interstitial lung disease, radiation pneumonitis.
Barnets gavn af amning og kvindens gavn af behandling skal afvejes, og på den baggrund bør det besluttes om eventuel amning bør ophøre eller om behandling med Tecentriq skal seponeres.
A decision must be made whether to discontinue breast-feeding or to discontinue Tecentriq therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
I en eksploratorisk endelig analyse af samlet overlevelse med længere opfølgningstid (median: 22,9 måneder) var median samlet overlevelse for begge arme uændret i forhold til den primære interimanalyse af samlet overlevelse.
22.9 months), the median OS for both arms was unchanged relative to the primary OS interim analysis.
Tecentriq indeholder:
The recommended dose of Tecentriq is:
Demografi og baseline karakteristika for sygdommen i den primære analysepopulation var velbalanceret behandlingsarmene imellem.
The demographic and baseline disease characteristics of the primary analysis population were well balanced between the treatment arms.
4.8 og 5.1).
8.1 months).
IMpower133 (GO30081): Randomiseret fase I/III-studie med patienter med småcellet lungekræft i udvidet stadie, der ikke tidligere er behandlet med kemoterapi, i kombination med carboplatin og etoposid
IMpower133 (GO30081): Randomised phase I/III trial in patients with chemotherapy-naïve extensivestage SCLC, in combination with carboplatin and etoposide
Medianttid til hændelse var 7,2 måneder (interval: 24 dage til 13,7 måneder).
The median time to onset 7.2 months (range: 24 days to 13.7 months).
Co-primære endepunkter Samlet overlevelse*
Co-primary endpoints OS analysis*
Figur 10: Kaplan-Meier-kurve over samlet overlevelse i den primære analysepopulation (alle patienter) (OAK)a
Figure 10: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK)
· en kræftform, ikke-småcellet lungekræft, der rammer lungerne.
• a cancer that affects the lungs, called non-small cell lung cancer.
Behandlingen kan genoptages hvis bivirkningen er forbedret til ≤grad 1 inden for 12 uger, og kortikosteroiddosis er reduceret til ≤10 mg/dag prednison eller ækvivalent produkt, og patienten er stabil i substitutionsbehandling (hvis dette er nødvendigt).
Treatment may be resumed if the event improves to ≤ Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and the patient is stable on replacement therapy (if required).
Figur 2: Kaplan-Meier-kurve over samlet overlevelse i den primære analysepopulation (alle patienter) (OAK)a
Figure 2: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK)
Medianvarighed var 2,8 dage (interval: 15 dage til 9,5+ måneder; + angiver en censureret værdi).
The median duration was 2.8 months (range 15 days to 9.5+ months; + denotes a censored value).
Påmindelse om at have patientkortet på sig altid og at vise det til alle sundhedspersoner, som behandler dem. - Kortet skal også anmode om, at kontaktinformation til lægen er indført og det bør indeholde en advarsel om at patienten er i behandling med Tencentriq, til alle sundhedspersoner, som kan behandle patienten, herunder også i nødstilfælde.
• The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Tecentriq.
Der er gennemført et åbent, internationalt, randomiseret, fase III-multicenter-studie (IMvigor211) med henblik på at evaluere effekt og sikkerhed af atezolizumab sammenlignet med kemoterapi (investigators valg mellem vinflunin, docetaxel eller paclitaxel) hos patienter med lokalt fremskredent eller metastatisk urotelialt carcinom, der havde oplevet progression under eller efter platinbaseret regime.
A phase III, open-label, multi-center, international, randomised study, (IMvigor211), was conducted to evaluate the efficacy and safety of atezolizumab compared with chemotherapy (investigator's choice of vinflunine, docetaxel, or paclitaxel) in patients with locally advanced or metastatic UC who progressed during or following a platinum-containing regimen.
Behandling med atezolizumab skal seponeres permanent ved grad 3 eller 4 pneumonitis.
Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 pneumonitis.
Tecentriq givet sammen med kemoterapi
Tecentriq used in combination with anticancer medicines
Tidligere ubehandlede patienter med urotelialt carcinom eller triplenegativ brystkræft, skal udvælges til behandling baseret på tumor ekspression af PD-L1, som skal bekræftes ved en valideret test (se pkt.
Patients with previously untreated UC and TNBC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1).
I kohorte 1 blev 119 patienter behandlet med atezolizumab 1200 mg ved intravenøs infusion hver 3. uge indtil sygdomsprogression.
In Cohort 1, 119 patients were treated with atezolizumab 1,200 mg by intravenous infusion every
Patienter, der havde modtaget levende, svækket vaccine inden for 28 dage inden rekruttering, systemiske immunstimulerende midler inden for 4 uger inden rekruttering eller systemisk immunsuppressiv behandling inden for 2 uger inden rekruttering til studiet kunne ikke inkluderes i kliniske studier.
Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment; systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal products within 2 weeks prior to study entry were excluded from clinical trials.
Almene symptomer og reaktioner på administrationsstedet Meget almindelig Pyreksi, træthed, asteni
General disorders and administration site conditions Very Common pyrexia, fatigue, asthenia pyrexia, fatigue, asthenia
Data fra patienter med svær nedsat nyrefunktion er for begrænsede til, at der kan drages konklusioner vedrørende denne population.
Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Brug af atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin
Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin
Arm A (Atezolizumab + carboplatin + etoposid)
Arm A (Atezolizumab + carboplatin + etoposide)
Investigatorvurderet progressionsfri overlevelse (RECIST v1.1) - primær analyse
Investigator-assessed PFS (RECIST v1.1) - Primary analysis
En patient havde behov for kortikosteroidbehandling og fik seponeret behandlingen med atezolizumab.
One patient required the use of corticosteroids and treatment with atezolizumab was discontinued.
Kaplan-Meier-kurven for samlet overlevelse i hele populationen præsenteres i figur 1.
The Kaplan-Meier curve for OS in the all comer population is presented in Figure 1.
Hypokaliæmi, hyponatriæmi, hypomagnesæmi
Common hypokalaemia, hyponatraemia, hyperglycaemia hypokalaemia, hyponatraemia, hypomagnesaemia
6.6), indeholder én ml opløsning ca. 4,4 mg atezolizumab.
After dilution (see section 6.6), one mL of solution contains approximately 4.4 mg of atezolizumab.
Andenlinjebehandling af ikke-småcellet lungekræft
Second-line treatment of non-small cell lung cancer
Den primære analyse blev udført på alle patienter, undtagen dem med EGFR mutationer eller ALK-rearrangementer, defineret som ITT-WT-populationen (n=679).
The primary analysis was conducted in all patients, excluding those with EGFR mutations or ALK
Tabel 7: Opsummering af opdateret effekt for arm A versus arm B i ITT-populationen (IMpower150)
Table 7: Summary of updated efficacy for Arm A vs.
Effektstudie efter godkendelse (PAES): Indehaveren af markedsføringstilladelse skal indsende den endelige kliniske studierapport for studiet IMvigor 130, for at vurdere effekten af atezolizumab monoterapi versus atezolizumab plus carboplatin/gemcitabin versus placebo plus cisplatin/gemcitabin hos patienter med lokalt fremskredent eller metastatisk urotelialt carcinom, som ikke er egnet til platinholdig behandling, samt dem som er egnet til platinholdig behandling.
Post-authorisation efficacy study (PAES): In order to evaluate the efficacy of atezolizumab monotherapy versus atezolizumab plus carboplatin/gemcitabine versus placebo plus cisplatin/gemcitabine in patients with locally advanced or metastatic urothelial cancer who are platinum -ineligible and -eligible patients, the MAH should submit the final CSR of study IMvigor130.
Det anbefales, at patienterne behandles med Tecentriq indtil der ikke længere er klinisk gavn af behandlingen (se pkt.
It is recommended that patients are treated with Tecentriq until loss of clinical benefit (see section 5.1) or unmanageable toxicity.
Der er observeret tilfælde af myositis, inklusive dødelige tilfælde, i kliniske studier med atezolizumab (se pkt.
Cases of myositis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8).
Der blev ikke vist statistisk signifikant overlevelse med atezolizumab sammenlignet med kemoterapi hos patienter med tidligere behandlet, lokalt fremskredent eller metastatisk urotelialt carcinom.
The primary analysis of study IMvigor211 did not meet its primary endpoint of OS. Atezolizumab did not demonstrate a statistically significant survival benefit compared to chemotherapy in patients with previously treated, locally advanced or metastatic urothelial carcinoma.
≤10 mg/dag prednison, eller ækvivalent produkt, og patienten er stabil på substitutionsbehandling (hvis dette er nødvendigt).
12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and the patient is stable on replacement therapy (if required).
Behandlingen kan genoptages, når der er etableret metabolisk kontrol med insulinsubstitutionsbehandling.
Withhold Tecentriq Treatment may be resumed when metabolic control is achieved on insulin replacement therapy
Der er konstateret colitis hos 1,1% (34/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
Colitis occurred in 1.1% (34/3,178) of patients who received atezolizumab monotherapy.
· en kræftform, triplenegativ brystkræft, der påvirker brystet.
• a cancer that arises from the breast, called triple negative breast cancer.
Median (måneder) (95% konfidenseinterval) 12,3 (6,0 ; NE) 14,1 (9,2 ; NE) 15,9 (10,4 ; NE)
14.1 (9.2, NE) 15.9 (10.4, NE)
ECOG-performancestatus ved baseline var 0 (45,6%) eller 1 (54.4%).
Baseline ECOG performance status was 0 (45.6%) or 1 (54.4%).
Behandling igangsættes med intravenøse kortikosteroider (1 til 2 mg/kg/dag methylprednisolon eller ækvivalent produkt).
Treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Demografiske og baseline sygdomskarakteristika i studiepopulationen var velafbalanceret behandlingsarmene imellem.
The demographic and baseline disease characteristics of the study population were well balanced between the treatment arms.
Roche Pharma AG Emil-Barell-Strasse 1 D-79639
Roche Pharma AG Emil-Barell-Strasse 1
Mediantid til hændelse var 2,1 måneder (interval: 21 dage til 15,7 måneder).
The median time to onset was 2.1 months (range 21 days to 15.7 months).
ekspression ≥1% var generelt repræsentativt for den brede studiepopulation.
Patient demographics and baseline tumour disease in patients with PD-L1 expression ≥1% were generally representative of the broader study population.
Overfølsomhed over for atezolizumab eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to atezolizumab or to any of the excipients listed in section 6.1.
Ved grad 3 diarré eller colitis igangsættes behandling med intravenøst kortikosteroid (1 til 2 mg/kg/dag methylprednisolon eller ækvivalent produkt).
For Grade 3 diarrhoea or colitis, treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Brug af atezolizumab i kombination med bevacizumab, paclitaxel og carboplatin ved metastatisk ikke-planocellulært ikke-småcellet lungekræft
Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in metastatic non-squamous non-small cell lung cancer
Stratificeret hazardratio‡ (95% konfidensinterval) p-værdi
Stratified hazard ratio‡ (95% CI) p-value
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 14 ml koncentrat indeholder 840 mg atezolizumab Efter fortynding indeholder 1 ml opløsning ca. 3,2 mg atezolizumab for en dosis på 840 mg og 6,0 mg atezolizumab for en dosis på 1680 mg.
Each 14 mL vial of concentrate contains 840 mg atezolizumab After dilution, 1 mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose.
Effektstudie efter godkendelse (PAES): Indehaveren af markedsføringstilladelsen skal indsende de endelige resultater for den samlede overlevelse i studiet IMvigor 210, for at yderligere vurdere effekten af atezolizumab til behandling af patienter med lokalt fremskredent eller metastatisk urotelialt carcinom.
Post-authorisation efficacy study (PAES): In order to further evaluate the efficacy of atezolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer, the MAH should submit the final OS results of study IMvigor210.
Hvert 14 ml hætteglas indeholder 840 mg atezolizumab.
Each 14 mL vial contains 840 mg of atezolizumab.
Et 14 ml hætteglas med koncentrat indeholder 840 mg atezolizumab*
QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 mL vial of concentrate contains 840 mg of atezolizumab*.
Medianvarigheden var 26 dage (interval: 6 dage til 14,5+ måneder; + angiver en censureret værdi).
The median duration was 26 days (range 6 days to 14.5+ months; + denotes a censored value).
Grad 2: (ALAT eller ASAT >3 til 5 gange øvre referencegrænse eller blod-bilirubin >1,5 til 3 gange øvre referencegrænse)
Grade 2: (ALT or AST > 3 to 5 x upper limit of normal [ULN]
Patienter blev ekskluderet fra studiet, hvis de havde: Aktive eller ubehandlede CNS-metastaser, autoimmun sygdom i anamnesen, fået administreret levende, svækket vaccine inden for 4 uger inden randomisering eller fået administreret systemiske immunsupprimerende midler inden for 1 uge inden randomisering.
Patients were excluded if they had active or untreated CNS metastases; history of autoimmune disease; administration of live, attenuated vaccine within 4 weeks prior to randomisation; administration of systemic immunosuppressive medications within 1 week prior to randomisation.
Der er konstateret pneumonitis hos 2,7% (87/3.178) af de patienter, der har fået atezolizumab enkeltstofbehandling.
Pneumonitis occurred in 2.7% (87/3,178) of patients who received atezolizumab monotherapy.
Patienter med ikke-småcellet lungekræft, der havde tydelig tumorinfiltration i de store thorakale kar eller tydelig kavitation af lunge læsioner, set på billeddannelse, blev udelukket fra hovedstudiet IMpower150 efter adskillige tilfælde af dødelige lungeblødninger, som er en kendt risikofaktor ved behandling med bevacizumab.
Patients with NSCLC that had clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging, were excluded from the pivotal clinical study
Den observerede forbedring i samlet overlevelse blev påvist på tværs af subgrupper, inklusive patienter med hjernemetastaser ved baseline (hazardratio 0,54; 95%
The observed OS improvement was consistently demonstrated across subgroups of patients including those with brain metastases at baseline (HR of 0.54, 95% CI: 0.31, 0.94; median OS of 20.1
Meningoencefalitis med behov for kortikosteroidbehandling sås hos 0,2% (6/3.178) af patienterne behandlet med atezolizumab og 4 patienter fik seponeret behandlingen med atezolizumab.
Meningoencephalitis requiring the use of corticosteroids occurred in 0.2% (6/3,178) of patients receiving atezolizumab and four patients discontinued atezolizumab.
Der er gennemført et randomiseret, dobbeltblindet, toarmet, internationalt, placebo-kontrolleret fase III-multicenterstudie (IMpassion130) med henblik på at evaluere effekt og sikkerhed af atezolizumab i kombination med nab-paclitaxel, hos patienter med inoperabel lokalt fremskredent eller metastatisk triplenegativ brystkræft, som ikke tidligere havde modtaget kemoterapi for metastatisk sygdom.
A phase III, double-blind, two-arm, multi-center, international, randomised, placebo-controlled study, IMpassion130, was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel, in patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease.
Behandlingsretningslinjer for disse bivirkninger beskrives i pkt.
The management guidelines for these adverse reactions are described in sections 4.2 and 4.4.
· en kræftform, småcellet lungekræft, der rammer lungerne.
• a cancer that affects the lungs, called small cell lung cancer (SCLC).
Guillain-Barré-syndrom med behov for kortikosteroidbehandling sås hos <0,1% (2/3.178) af patienterne behandlet med atezolizumab enkeltstofbehandling.
Guillain-Barré syndrome requiring the use of corticosteroids occurred in < 0.1% (2/3,178) of patients receiving atezolizumab monotherapy.
(Response Evaluation Criteria in Solid Tumors) er objektiv responsrate, progressionsfri overlevelse samt varighed af respons.
Secondary efficacy endpoints evaluated per investigator-assessed Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 are objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR).
Der er set nefritis hos < 0,1% (3/3.178) af patienterne, der fik atezolizumab.
Nephritis occurred in < 0.1% (3/3,178) of patients who received atezolizumab.
Figur 2: Kaplan-Meier-kurve for samlet overlevelse i ITT-populationen (IMpower150)
Figure 2: Kaplan-Meier curve for overall survival in the ITT population (IMpower150)
Data fra patienter med hjernemetastaser er for begrænsede til kunne drage en konklusion vedrørende denne population.
Data for patients with brain metastases are too limited to draw conclusions on this population.
Medianvarighed af progressionfri overlevelse (måneder)
Median duration of PFS (months)
Placebo aAtezolizumab blev administeret indtil investigator vurderet mangel af klinisk effekt.
Atezolizumab was administered until loss of clinical benefit as assessed by investigator b
Hypothyroidismeg
Common hypothyroidismg
w Inkluderer indberetninger om akne, pustuløs akne, dermatitis, akneiform dermatitis, allergisk dermatitis, bulløs dermatitis, generaliseret eksfoliativ dermatitis, lægemiddeleruption, eksem, betændt eksem, erythem, erythema multiforme, øjenlågserythem, eksfoliativt udslæt, øjenlågsudslæt, fast eruption, follikulitis, furunkel, generaliseret erytem, palmar-plantar erytrodysæstetisk syndrom, udslæt, erythematøst udslæt, generaliseret udslæt, makuløst udslæt, makulo-papuløst udslæt, papuløst udslæt, papuløst skællet udslæt, pruritisk udslæt,
Includes reports of acne, acne pustular, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis bullous, dermatitis exfoliative generalised, drug eruption, eczema, eczema infected, erythema, erythema multiforme, erythema of eyelid, exfoliative rash, eyelid rash, fixed eruption, folliculitis, furuncle, generalised erythema, palmar-plantar erythrodysaesthesia syndrome, rash , rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash papulosquamous, rash pruritic, rash pustular, rash vesicular, seborrhoeic dermatitis, skin exfoliation, skin toxicity, skin ulcer, toxic epidermal necrolysis, toxic skin eruption.
Der er gennemført et fase I/III, randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie, IMpower133, for at evaluere atezolizumabs effekt og sikkerhed i kombination med carboplatin og etoposid hos patienter med småcellet lungekræft i udvidet stadie, der ikke tidligere er behandlet med kemoterapi.
A Phase I/III, randomised, multicentre, double-blind, placebo-controlled study, IMpower133, was conducted to evaluate the efficacy and safety of atezolizumab in combination with carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).
En patient havde behov for kortikosteroider og fik seponeret behandlingen med atezolizumab.
One patient required corticosteroids and discontinued atezolizumab.
Antal respondenter (%) 95% konfidensinterval Antal med komplet respons (%) Antal med partial respons (%) Antal med stabil sygdom (%) Investigatorvurderet varighed af respons n=109
No. of complete response (%) No. of partial response (%) No. of stable disease (%)
ECOG-status ved baseline var 0 (37%) eller 1 (63%).
Baseline ECOG performance status was 0 (37%) or 1 (63%).
Figur 13: Kaplan-Meier-kurve for progressionsfri overlevelse (IMpower133)
Figure 13: Kaplan-Meier curve for progression-free survival (IMpower133)
Begge patienter havde behov for kortikosteroider og fik seponeret behandlingen med atezolizumab.
Both patients required corticosteroids and discontinued atezolizumab.
Medianalderen var 64 år (interval: 18 til 86 år).
The median age was 64 years (range 18 to
6.6), indeholder én ml opløsning ca. 3,2 mg atezolizumab for en dosis på 840 mg og 6,0 mg atezolizumab for en dosis på 1680 mg.
• After dilution, one mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose.
Til den anbefalede dosis på 840 mg: Træk 14 ml Tecentriq koncentrat fra hætteglasset, som fortyndes i en 250 ml polyvinylchlorid (PVC), polyolefin (PO), polyethylen (PE) eller polypropylen (PP) infusionspose indeholdende natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning.
For the recommended dose of 840 mg: fourteen mL of Tecentriq concentrate should be withdrawn from the vial and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Der er gennemført en opdateret analyse for samlet overlevelse med en medianopfølgning på 18 måneder.
An updated analysis with a total of 200 deaths observed and a median survival follow-up of