natgillin/translations-raw huggingface dataset:
Samlet var der ikke evidens for en ændret farmakokinetisk profil, en øget forekomst af infusionsreaktioner eller påvirkning af virkningen med anti-avelumab-antistofudvikling. 
Overall, there was no evidence of altered pharmacokinetic profile, increased incidence of infusion reactions or effects on efficacy with anti-avelumab antibody development.
Tabel 1: Retningslinjer for at afbryde eller seponere Bavencio Behandlingsrelateret bivirkning 
Table 1: Guidelines for withholding or discontinuation of Bavencio Treatment-related adverse reaction
De fleste af disse, herunder svære reaktioner, gik væk, efter at der blev påbegyndt passende medicinsk behandling, eller efter at avelumab blev seponeret (se ”Beskrivelse af udvalgte bivirkninger” nedenfor). 
Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of avelumab (see “Description of selected adverse reactions” below).
Patienterne skal overvåges for ændringer af tyreoideafunktionen (ved behandlingsstart, periodisk i løbet af behandlingen og som indiceret baseret på klinisk evaluering), og for kliniske tegn og symptomer på tyreoideasygdomme. 
Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders.
• Merkelcellekarcinom (MCC), en sjælden form for hudkræft, når det er metastatisk (har spredt sig til andre dele af kroppen). 
• Merkel cell carcinoma (MCC), a rare type of skin cancer, when it is metastatic (has spread to other parts of the body).
Hos de resterende 1,4 % (6/439) af patienterne opstod infusionsrelaterede reaktioner efter de første 4 infusioner, og alle var grad 1 eller grad 2. 
In the remaining 1.4% (6/439) of patients, infusion-related reactions occurred after the first 4 infusions and all were of Grade 1 or Grade 2.
47 (53 %) af patienterne havde viscerale metastaser. 
Forty-seven (53%) of the patients had visceral metastases.
Opbevares i køleskab (2 °C til 8 °C). 
Store in a refrigerator (2°C to 8°C).
Hvis der ikke ses nogen forbedring i løbet af 24 timer med kortikosteroider, skal yderligere immunsuppression (f.eks. mycophenolat, infliximab, anti-thymocytglobulin) overvejes. 
If no improvement within 24 hours on corticosteroids, additional immunosuppression (e.g., mycophenolate, infliximab, anti-thymocyte globulin) should be considered.
Det er ukendt, om avelumab udskilles i human mælk. 
It is unknown whether avelumab is excreted in human milk.
Serumkreatinin på over 6 gange ULN Seponer permanent 
Serum creatinine more than 6 times ULN Permanently discontinue
Det er meget vigtigt, at du overholder alle dine aftaler for behandling med Bavencio. 
It is very important for you to keep all your appointments to receive Bavencio.
Axitinib kunne afbrydes eller reduceres til 3 mg to gange dagligt og efterfølgende til 2 mg to gange dagligt for at håndtere toksicitet. 
Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity.
PD-L-ekspression ved cut-off på 1 % 
PD-L1 expression at cut-off of 1%
Patienter blev inkluderet uanset prognostiske risikogrupper eller ekspression af tumor-PD-L1, og skulle have mindst en målbar læsion, defineret ved Response Evaluation Criteria in Solid Tumours (RECIST)-version 1.1, som ikke tidligere var blevet bestrålet. 
Patients were included irrespective of prognostic risk groups or tumour PD-L1 expression and had to have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 that was not been previously irradiated.
• Grad 2 eller grad 3 kliniske tegn eller symptomer på en immunrelateret bivirkning, der ikke er beskrevet ovenfor. 
• Grade 2 or Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above.
Bavencio binder sig til PD-L1, og blokerer denne beskyttende effekt, hvilket giver immunsystemet mulighed for at angribe tumorcellerne. 
Bavencio binds to PD-L1, and blocks this protective effect, allowing the immune system to attack the tumour cells.
Det kan være nødvendigt at udsætte eller afbryde behandlingen, baseret på individuel sikkerhed og tolerabilitet. 
Dosing delay or discontinuation may be required based on individual safety and tolerability; see Table 1.
PD-L1-ekspression ved cut-off på 5 % 
PD-L1 expression at cut-off of 5%
Kvinder i den fertile alder/kontraception 
Women of childbearing potential/Contraception
Bekræftet pankreatitis 
Confirmed pancreatitis
Serumkreatinin over 1,5 og op til 6 gange ULN 
Serum creatinine more than 1.5 and up to 6 times ULN
Yderligere sekundære endepunkter omfattede objektivt respons (OR), tid til respons (TTR) og varighed af respons (duration of response, DOR). 
Additional secondary endpoints included objective response (OR), time to response (TTR) and duration of response (DOR).
Indehaveren af markedsføringstilladelsen skal sikre, at alle patienter/plejere, som forventes at bruge Bavencio, i alle medlemslande, hvor Bavencio markedsføres, har adgang til/har fået følgende uddannelsespakke: 
The MAH shall ensure that in each Member State where Bavencio is marketed, all patients/carers who are expected to use Bavencio have access to/are provided with the following educational package:
Hepatotoksicitet (i kombination med axitinib) 
Hepatotoxicity (in combination with axitinib)
De fleste immunrelaterede bivirkninger med avelumab var reversible, og blev behandlet med en midlertidig eller permanent seponering af avelumab, administration af kortikosteroider og/eller støttende behandling. 
Most immune-related adverse reactions with avelumab were reversible and managed with temporary or permanent discontinuation of avelumab, administration of corticosteroids and/or supportive care.
Grad 2 pneumonitis 
Grade 2 pneumonitis
Den observerede hazard ratio (HR) for OS var 0,80 (95 % CI: 0,616; 1,027) for avelumab i kombination med axitinib, sammenlignet med sunitinib. 
The observed hazard ratio (HR) for OS was 0.80 (95% CI: 0.616, 1.027) for avelumab in combination with axitinib compared to sunitinib.
• eller stoppe behandlingen med Bavencio helt. 
• or stop your treatment with Bavencio altogether.
• du har en infektion med human immundefektvirus (HIV), eller erhvervet immundefektsyndrom 
• you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS);
PD-1/PD-L1-mekanismen menes at være involveret i at opretholde tolerance over for fosteret i løbet af hele drægtighedsperioden. 
The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy.
Træthed er en meget almindelig bivirkning ved Bavencio, og det kan påvirke din evne til at føre motorkøretøj eller betjene maskiner. 
Tiredness is a very common side effect of Bavencio and can affect your ability to drive or to use machines.
Pædiatrisk population Bavencios sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt. 
The safety and efficacy of Bavencio in children and adolescents below 18 years of age have not been established.
Toogtyve ud af 29 (76 %) responderende patienter havde respons inden for 7 uger efter den første dosis avelumab. 
Twenty-two out of 29 (76%) patients with response were reported to have responded within 7 weeks after the first dose of avelumab.
Del B inkluderede patienter med histologisk bekræftet metastatisk MCC, som var behandlingsnaive med hensyn til systemisk behandling af metastatisk sygdom. 
Part B included patients with histologically confirmed metastatic MCC who were treatment-naïve to systemic therapy in the metastatic setting.
Administration af avelumab og axitinib var tilladt efter den RECIST-definerede sygdomsprogression, baseret på investigatorens vurdering af patientens benefit/risk-forhold og kliniske tilstand, herunder præstationsstatus, kliniske symptomer, uønskede hændelser og laboratoriedata. 
Administration of avelumab and axitinib was permitted beyond RECIST-defined disease progression based on investigator's assessment of the patient's benefit-risk and clinical condition, including performance status, clinical symptoms, adverse events and laboratory data.
• Livstruende eller grad 4 bivirkning (undtagen endokrinopatier, kontrolleret med hormonbehandling) 
• Life threatening or Grade 4 adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy)
Ud af disse patienter oplevede ingen immunrelateret pneumonitis grad ≥ 3. 
Of these patients, none experienced immune-related pneumonitis Grade ≥ 3.
Hos patienter, hvor de immunrelaterede bivirkninger ikke kan kontrolleres med kortikosteroider, kan det overvejes at administrere andre systemiske immunsuppressive midler. 
In patients, whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants may be considered.
Brochuren med patientinformation skal indeholde de følgende nøglebeskeder: 
The Patient Information brochure shall contain the following key messages:
• Vedvarende grad 2 eller grad 3 immunmedierede bivirkninger, der varer 12 uger eller længere 
• Persistent Grade 2 or Grade 3 immune-mediate adverse reactions lasting 12 weeks or longer
Det er ukendt, om Bavencio udskilles i brystmælken. 
It is unknown if Bavencio passes into your breast milk.
Der er derfor risiko for, at avelumab kan transmitteres fra moderen til det udviklende foster. 
Therefore, avelumab has the potential to be transmitted from the mother to the developing foetus.
Humane IgG1-immunoglobuliner vides at krydse placentabarrieren. 
Human IgG1 immunoglobulins are known to cross the placental barrier.
Steady-state-eksponeringen var ca. uniform over en bredt legemsvægtsinterval (30-204 kg) for den legemsvægtnormaliserede dosering. 
Steady-state exposure was approximately uniform over a wide range of body weights (30 to 204 kg) for body weight normalised dosing.
Figur 2 angiver Kaplan-Meier-kurven for PFS fra den efterfølgende interimanalyse med de 116 patienter, der indgik i del B med en minimumsopfølgning på 7 måneder. 
Figure 2 presents the Kaplan-Meier curve for PFS from the subsequent interim analysis with 116 patients enrolled into Part B with a minimum follow-up of 7 months.
Det primære endepunkt for effekt for del B var respons varighed, defineret som objektivt respons (komplet respons (CR) eller partielt respons (PR)) med en varighed på mindst 6 måneder; sekundære effekt endepunkter omfattede BOR, DOR, PFS og OS. 
For Part B, the major efficacy outcome measure was durable response, defined as objective response (complete response (CR) or partial response (PR)) with a duration of at least 6 months; secondary outcome measures included BOR, DOR, PFS, and OS.
Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD-list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Patienterne fik avelumab med en dosis på 10 mg/kg hver 2. uge indtil sygdomsprogression eller uacceptabel toksicitet. 
Patients received avelumab at a dose of 10 mg/kg every 2 weeks until disease progression or unacceptable toxicity.
Patienter, som tolererede axitinib 5 mg to gange dagligt uden axitinibrelaterede uønskede hændelser af grad 2 eller derover i 2 på hinanden følgende uger, kunne øge dosis til 7 mg og efterfølgende til 10 mg to gange dagligt. 
Patients who tolerated axitinib 5 mg twice daily without Grade 2 or greater axitinib-related adverse events for 2 consecutive weeks could increase to 7 mg and then subsequently to 10 mg twice daily.
• Hævelse i arme, fødder eller ben 
• Swelling in the arms, feet or legs
De mest almindelige grad ≥ 3 bivirkninger var anæmi (6,0 %), dyspnø (3,9 %) og abdominalsmerter (3,0 %). 
The most common Grade ≥ 3 adverse reactions were anaemia (6.0%), dyspnoea (3.9%), and abdominal pain (3.0%).
Behandlingen med avelumab bør genoptages, når der er opnået metabolisk kontrol med insulinbehandling. 
Treatment with avelumab should be resumed when metabolic control is achieved on insulin replacement therapy.
Autoimmun tyroiditis, hypofysitis 
Autoimmune thyroiditis, hypophysitis
I 1-måneds og 3-måneders toksikologistudier med gentagne doser hos aber, var der ingen bemærkelsesværdig virkning på de hunlige reproduktionsorganer. 
In 1-month and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the female reproductive organs.
Mediantiden til respons var 6 uger (interval: 6 uger til 36 uger) efter den første dosis avelumab. 
The median time to response was 6 weeks (range: 6 weeks to 36 weeks) after the first dose of avelumab.
Steady-state-koncentrationen af avelumab blev nået efter ca. 4 til 6 uger (2 til 3 cyklusser) med en gentagen dosering på 10 mg/kg hver 2. uge, og den systemiske akkumulation var ca. 1,25 gange. 
Steady-state concentrations of avelumab were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing at 10 mg/kg every 2 weeks, and systemic accumulation was approximately 1.25-fold.
Kaplan-Meier-kurven over PFS for de 88 patienter (del A) med metastatisk MCC er angivet i figur 1. 
The Kaplan-Meier curve of PFS of the 88 patients (Part A) with metastatic MCC is presented in Figure 1.
• Følelse af træthed eller svaghed 
• Feeling tired or weak
Avelumabs virkning og sikkerhed blev undersøgt i studie EMR100070-003 med to dele. 
The efficacy and safety of avelumab was investigated in the study EMR100070-003 with two parts.
Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser hos Cynomolgus-aber, der fik administreret intravenøse doser af 20, 60 eller 140 mg/kg én gang ugentligt i 1 måned og 3 måneder, efterfulgt af en 2-måneders rekonvalescensperiode efter 3-måneders doseringsperioden. 
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity in Cynomolgus monkeys administered intravenously doses of 20, 60 or 140 mg/kg once a week for1 month and 3 months, followed by a 2-month recovery period after the 3-month dosing period.
Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, monoklonale antistoffer, ATCkode: L01XC31. 
Pharmacotherapeutic group: Other antineoplastic agents, monoclonal antibodies, ATC code: L01XC31.
• Sunitinib 50 mg en gang dagligt oralt i 4 uger, efterfulgt af 2 uger uden (N = 444) indtil radiografisk eller klinisk progression eller uacceptabel toksicitet. 
• Sunitinib 50 mg once daily orally for 4 weeks followed by 2 weeks off (N=444) until radiographic or clinical progression or unacceptable toxicity.
Behandling med avelumab og axitinib fortsatte indtil RECIST v1.1-defineret sygdomsprogression i henhold til vurdering fra en blindet uafhængig central bedømmelse (blinded independent central review, BICR) eller uacceptabel toksicitet. 
Treatment with avelumab and axitinib continued until RECIST v1.1-defined progression of disease by Blinded Independent Central Review (BICR) assessment or unacceptable toxicity.
Hos ADA-positive patienter kan der være en øget risiko for infusionsrelaterede reaktioner (ca. 40 % og 25 % hos hhv. ADA-altid-positive og ADA-aldrig-positive patienter). 
In ADA positive patients, there may be an increased risk for infusion-related reactions (about 40% and 25% in ADA ever-positive and ADA never-positive patients, respectively).
Patientfordelingens risikogrupper ifølge International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) var 21 % favorabel, 62 % intermediær og 16 % dårlig. 
Patient distribution by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups was 21% favourable, 62% intermediate, and 16% poor.
Renalcellekarcinom (studie B9991003) 
Renal cell carcinoma (study B9991003)
Patienterne skal overvåges for øget serumkreatinin før behandlingen, og periodisk under behandlingen. 
Patients should be monitored for elevated serum creatinine prior to and periodically during treatment.
Avelumab har også vist sig at inducere naturel killer celler (NK) direkte tumorcellelyse via antistofafhængig cellemedieret cytotoksicitet (antibody-dependent cell mediated cytotoxicity, ADCC). 
Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
Indlægsseddel: Information til patienten Bavencio 20 mg/ml koncentrat til infusionsvæske, opløsning avelumab Dette lægemiddel er underlagt supplerende overvågning. 
Package leaflet: Information for the patient Bavencio 20 mg/mL concentrate for solution for infusion avelumab This medicine is subject to additional monitoring.
Hazard ratio (95 % CI) p-værdi* 
Hazard ratio (95% CI) p-value*
Den anbefalede dosis af avelumab er 800 mg hver 2. uge. 
The recommended dose of avelumab is 800 mg every 2 weeks.
Den mediane varighed for responset kunne ikke estimeres (95 % CI: 4 måneder, kunne ikke estimeres) med en varighed på minimum 1,2 måneder til maksimum 8,3 måneder. 
The median duration of response was not estimable (95% CI: 4 months, not estimable) with a minimum of 1.2 months to a maximum of 8.3 months duration.
Hvis du oplever bivirkninger bør du tale med din læge. 
If you get any side effects, talk to your doctor.
Ved infusionsrelaterede reaktioner af grad 1 skal infusionshastigheden nedsættes med 50 % for den aktuelle infusion. 
For Grade 1 infusion-related reactions, the infusion rate should be slowed by 50% for the current infusion.
• Følelsesløshed, prikkende fornemmelse, svaghed, brændende fornemmelse i arme eller ben 
• Numbness, tingling, weakness, burning sensation in arms or legs
• Den fortyndede opløsning blandes ved at vende posen forsigtigt på hovedet for at undgå skumdannelse eller for kraftig rystning af opløsningen. 
• The diluted solution should be mixed by gently inverting the bag in order to avoid foaming or excessive shearing of the solution.
• Type 1 diabetes, herunder syre i blodet fra sukkersyge (diabetisk ketoacidose), 
• Type 1 diabetes, including acid in the blood produced from diabetes (diabetic ketoacidosis);
Hvis vedvarende (længere end 5 dage), skal kortikosteroidbehandling med prednison eller lignende overvejes, efterfulgt af en nedtrapning. 
If persistent (greater than 5 days), corticosteroid therapy with prednisone or equivalent followed by a taper should be considered.
Du må ikke amme, mens du får Bavencio, og i mindst 1 måned efter din sidste dosis. 
Do not breast-feed while receiving Bavencio and for at least 1 month after your last dose.
Eksponeringen af avelumab blev øget dosisproportionalt i dosisområdet på 10 mg/kg til 20 mg/kg hver 2. uge. 
The exposure of avelumab increased dose-proportionally in the dose range of 10 mg/kg to 20 mg/kg every 2 weeks.
IHC: Immunhistokemi; MCV: Merkelcelle-polyomavirus; ORR: objektiv responsrate a Baseret på data fra patienter, som kunne evalueres for PD-L1 b Baseret på data fra patienter, som kunne evalueres for MCV med immunhistokemi (IHC) 
IHC: Immunohistochemistry; MCV: Merkel cell polyomavirus; ORR: objective response rate a Based on data from patients evaluable for PD-L1 b Based on data from patients evaluable for MCV by immunohistochemistry (IHC)
De primære endepunkter for virkning var progressionsfri overlevelse (progression-free survival, PFS), evalueret ved BICR ved brug af RECIST v1.1 og samlet overlevelse (overall survival, OS) ved førstevalgsbehandling af patienter med fremskredent RCC, som har PD-L1-positive tumorer (PD-L1ekspressionsniveau ≥ 1 %). 
The primary efficacy endpoints were progression-free survival (PFS), as assessed by BICR using RECIST v1.1 and overall survival (OS) in the first-line treatment of patients with advanced RCC who have PD-L1-positive tumours (PD-L1 expression level ≥ 1%).
Patienterne skal overvåges hyppigere for ændringer af leverfunktionen og symptomer, sammenlignet med når avelumab anvendes som monoterapi. 
Patients should be more frequently monitored for changes in liver function and symptoms as compared to when avelumab is used as monotherapy.
• Guillain-Barrés syndrom (en sygdom i immunsystemet, der kan forårsage nervebetændelse og føre til smerter, svaghed, muskelsvaghed og gangbesvær) 
• Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking)
Hos symptomatiske patienter skal der udføres en kardiologisk konsultation og laboratorieundersøgelser for at sikre, at de relevante behandlinger påbegyndes på et tidligt stadie. 
In symptomatic patients, obtain cardiologic consultation and laboratory investigations to ensure the initiation of appropriate measures at an early stage.
Fra et mikrobiologisk synspunkt bør lægemidlet fortyndes og straks infunderes umiddelbart efter anbrud. 
From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately.
Type 1 diabetes mellitus gik ikke væk hos nogen af patienterne på tidspunktet for data cut-off. 
Type 1 diabetes mellitus did not resolve in any of the patients at the time of data cut-off.
Vurderingen af tumorresponset blev udført hver 6. uge af en uafhængig komité, der gennemgik endepunkterne (Independent Endpoint Review Committee, IERC) ved hjælp af evalueringskriterier for respons i solide tumorer (Response Evaluation Criteria in Solid Tumours, RECIST) v1.1. 
Tumour response assessments were performed every 6 weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Patientinformationskortet skal indeholde de følgende nøglebeskeder: 
The Patient Alert Card shall contain the following key messages:
Tyreoideasygdomme (hypotyroidisme/hypertyroidisme) Tyreoideasygdomme kan opstå på alle tidspunkter under behandlingen (se pkt. 
Thyroid disorders (hypothyroidism/hyperthyroidism) Thyroid disorders can occur at any time during treatment (see section 4.8).
Hver ml koncentrat indeholder 20 mg avelumab. 
Each mL of concentrate contains 20 mg of avelumab.
Et hætteglas på 10 ml indeholder 200 mg avelumab. 
One vial of 10 mL contains 200 mg of avelumab.
Avelumab bør afbrydes, og der bør administreres anti-hyperglykæmika til patienter med grad ≥ 3 hyperglykæmi. 
Avelumab should be withheld and antihyperglycaemics in patients with Grade ≥ 3 hyperglycaemia should be administered.
Lægemiddeludslæt, erythema multiforme, psoriasis 
Drug eruption, erythema multiforme, psoriasis
Patientfordelingens risikogrupper ifølge Memorial Sloan-Kettering Cancer Center (MSKCC) var 22 % favorabel, 65 % intermediær og 11 % dårlig. 
Patient distribution by Memorial Sloan-Kettering Cancer Center (MSKCC) risk groups was 22% favourable, 65% intermediate, and 11% poor.
De vigtigste sekundære endepunkter var PFS baseret på BICRbedømmelse i henhold til RECIST v1.1 og OS uanset PD-L1-ekspression. 
The key secondary endpoints were PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PD-L1 expression.
Ikke almindelig Tubulointerstitiel nefritis* 
Tubulo-interstitial nephritis*
Pakningsstørrelser og yderligere oplysninger Bavencio indeholder: 
Contents of the pack and other information What Bavencio contains
Bavencio indeholder det aktive stof avelumab, et monoklonalt antistof (en form for protein), som binder sig til et specifikt mål i kroppen kaldet PD-L1. 
Bavencio contains the active substance avelumab, a monoclonal antibody (a type of protein) that attaches to a specific target in the body called PD-L1.
• betændelse i hjertet (myokarditis), 
• inflammation of your heart (myocarditis);
Merkelcellekarcinom (studie EMR100070-003) 
Merkel cell carcinoma (study EMR100070-003)
Hos patienter med ALAT ≥ 3 gange ULN (grad 2-4, n = 82) bedredes ALAT til grad 0-1 hos 92 %. 
In patients with ALT ≥ 3 times ULN (Grades 2-4, n=82), ALT resolved to Grades 0-1 in 92%.