natgillin/translations-raw huggingface dataset:
Immunrelateret myokarditis 
Immune-related myocarditis
• Tegn på leverproblemer, herunder leverbetændelse (hepatitis) kan omfatte gulfarvning af huden (gulsot) eller det hvide i øjnene, svær kvalme eller opkastning, smerter i højre side af maveområdet (abdomen), døsighed, mørk urin (tefarvet), større tendens til blødning eller blå mærker end normalt, mindre sultfølelse end normalt, træthed eller unormale leverfunktionsprøver. 
• Signs of liver problems, including inflammation of the liver (hepatitis) may include yellowing of your skin (jaundice) or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual, tiredness or abnormal liver function tests.
Figur 3: Kaplan-Meier-estimater for progressionsfri overlevelse baseret på BICR-bedømmelsen hos patienter uanset ekspression af PD-L1 
Figure 3: Kaplan-Meier estimates for progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Der er ikke udført fertilitetsstudier med avelumab. 
Fertility studies have not been conducted with avelumab.
Immunrelaterede tyreoideasygdomme, immunrelateret binyreinsufficiens og type 1 diabetes mellitus er blevet rapporteret hos patienter, der fik avelumab (se pkt. 
Immune-related thyroid disorders, immune-related adrenal insufficiency, and Type 1 diabetes mellitus have been reported in patients receiving avelumab (see section 4.8).
Bivirkninger Infektioner og parasitære sygdomme 
Adverse reactions Infections and infestations
SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE VILKÅR 
SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Vurderingen af tumorstatus blev udført ved baseline, efter randomisering efter 6 uger, derefter hver 6. uge op til 18 måneder efter 
Assessment of tumour status was performed at baseline, after randomisation at 6 weeks, then every 6 weeks thereafter up to 18 months after randomisation, and every 12 weeks thereafter until documented confirmed disease progression by BICR.
Der skal udføres en tilstrækkelig evaluering af formodede, immunrelaterede bivirkninger for at bekræfte ætiologien eller udelukke andre årsager. 
For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes.
Immunrelateret hepatitis gik væk hos 27 (87,1 %) af de 31 patienter på tidspunktet for data cut-off. 
Immune-related hepatitis resolved in 27 (87.1%) of the 31 patients at the time of data cut-off.
Ikke almindelig Binyreinsufficiens*, hypertyroidisme*, tyroiditis*, autoimmun tyroiditis*, akut binyrebarkinsufficiens*, autoimmun hypotyroidisme*, hypopituitarisme* 
Adrenal insufficiency*, hyperthyroidism*, thyroiditis*, autoimmune thyroiditis*, adrenocortical insufficiency acute*, autoimmune hypothyroidism*, hypopituitarism*
Bivirkninger Blod og lymfesystem 
Adverse reactions Blood and lymphatic system disorders
• Patientinformationskort 
• Patient Information brochure
Pankreatitis* 
Pancreatitis*
For oplysninger om doseringen af axitinib henvises til produktinformationen for axitinib. 
For information on the posology of axitinib, please refer to the axitinib product information.
• Tegn på betændelse i lungerne (pneumonitis) kan være vejrtrækningsbesvær eller hoste. 
• Signs of inflammation of the lungs (pneumonitis) may be breathing difficulties or cough.
To tilfælde med dødelig udgang er blevet rapporteret hos patienter, der fik avelumab i kombination med axitinib (se pkt. 
Two fatal cases have been reported in patients receiving avelumab in combination with axitinib (see section 4.8).
Merkelcelle-karcinom 
Merkel cell carcinoma
Hos patienter behandlet med avelumab i kombination med axitinib udviklede 24,7 % (121/489) af patienterne immunrelaterede tyreoideasygdomme, herunder 111 (22,7 %) patienter med hypotyroidisme, 17 (3,5 %) med hypertyroidisme og 7 (1,4 %) med tyroiditis. 
In patients treated with avelumab in combination with axitinib, 24.7% (121/489) of patients developed immune-related thyroid disorders, including 111 (22.7%) patients with hypothyroidism, 17 (3.5%) with hyperthyroidism, and 7 (1.4%) with thyroiditis.
Median PFS, måneder (95 % CI) 3 måneders PFS-rate ved K-M, (95 % CI) 6 måneders PFS-rate ved K-M, (95 % CI) 12 måneders PFS-rate ved K-M, (95 % CI) CI: Konfidensinterval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier * Effektdata med en minimumsopfølgning på 7 måneder (cut-off-dato 14. september 2018) ** CR eller PR blev bekræftet ved en efterfølgende tumorvurdering a Baseret på antallet af patienter med et bekræftet respons (CR eller PR) 
Median PFS, months (95% CI) 3-month PFS rate by K-M, (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier * Efficacy data with a minimum follow-up of 7 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Bekræftet myokarditis 
Confirmed myocarditis
Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) 
Uncommon (may affect up to 1 in 100 people)
• Tegn på infusionsrelaterede reaktioner, såsom stakåndethed eller hvæsende vejrtrækning, 
• Signs of infusion-related reactions such as shortness of breath or wheezing, chills or shaking,
Endepunkter for effekt (del A) (pr. RECIST v1.1, IERC) 
Efficacy endpoints (Part A) (per RECIST v1.1, IERC)
Tabel 2: Bivirkninger hos patienter i behandling med avelumab som monoterapi i klinisk studie EMR100070-003 og bivirkninger fra et fase I-studie (EMR100070-001) af solide tumorer 
Table 2: Adverse reactions in patients treated with avelumab as monotherapy in clinical study EMR100070-003 and adverse reactions from a phase I study (EMR100070-001) in solid tumours
Binyreinsufficiens gik over hos 4 (44,4 %) af de 9 patienter på tidspunktet for data cut-off. 
Adrenal insufficiency resolved in 4 (44.4%) of the 9 patients at the time of data cut-off.
• Tegn på betændelse i hjertet (myokarditis) kan omfatte vejrtrækningsbesvær, svimmelhed eller besvimelse, feber, brystsmerter og trykken for brystet eller influenzalignende symptomer. 
• Signs of inflammation of the heart (myocarditis) may include trouble breathing, dizziness or fainting, fever, chest pain and chest tightness or flu like symptoms.
Hvis PD-L1-signallering blokeres, har det vist sig at forstyrre tolerancen over for fosteret i murine drægtighedsmodeller og at føre til et øget fostertab. 
Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss.
Median PFS, måneder (95 % CI) 6 måneders PFS-rate ved K-M, (95 % CI) 12 måneders PFS-rate ved K-M, (95 % CI) 24 måneders PFS-rate ved K-M, (95 % CI) 36 måneders PFS-rate ved K-M, (95 % CI) CI: Konfidensinterval, RECIST: Response Evaluation Criteria in Solid Tumours, IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier; + angiver en censureret værdi * Data for virkning med en minimumsopfølgning på 36 måneder (cut-off-dato 14. september 2018) ** CR eller PR blev bekræftet ved en efterfølgende tumorvurdering a Baseret på antallet af patienter med et bekræftet respons (CR eller PR) 
Median PFS, months (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) 24-month PFS rate by K-M, (95% CI) 36-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier; +denotes a censored value * Efficacy data with a minimum follow-up of 36 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Perifert ødem, influenzalignende sygdom 
Oedema peripheral, influenza like illness
Meget almindelig Træthed, pyreksi, perifert ødem Almindelig 
Fatigue, pyrexia, oedema peripheral
Ikke almindelig Autoimmun hepatitis*, akut leversvigt*, leversvigt*, hepatitis* 
Autoimmune hepatitis*, acute hepatic failure*, hepatic failure*, hepatitis*
Immunrelateret pneumonitis 
Immune-related pneumonitis
Patienterne skal overvåges for ændring af leverfunktionen og symptomer på immunrelateret hepatitis, og andre årsager end immunrelateret hepatitis skal udelukkes. 
Patients should be monitored for changes in liver function and symptoms of immune-related hepatitis and causes other than immune-related hepatitis should be ruled out.
Patienterne skal overvåges for tegn og symptomer på immunrelateret myokarditis. 
Patients should be monitored for signs and symptoms of immune-related myocarditis.
• Mindre sultfølelse, vægttab 
• Feeling less hungry, weight loss
Det skal administreres i løbet af 60 minutter som en intravenøs infusion med et sterilt, ikke-pyrogent, lavproteinbindende 0,2 mikrometer in-line- eller add-on-filter. 
It is administered over 60 minutes as an intravenous infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter.
Grad 2 infusionsrelateret reaktion 
Grade 2 infusion-related reaction
Effekt endepunkter (del B) (pr. RECIST v1.1, IERC) 
Efficacy endpoints (Part B) (per RECIST v1.1, IERC)
Mundtørhed, colitis 
Dry mouth, colitis
Hos patienter behandlet med avelumab i kombination med axitinib opstod der type 1 diabetes mellitus uden en alternativ ætiologi hos 1,0% (5/489) af patienterne. 
In patients treated with avelumab in combination with axitinib, Type 1 diabetes mellitus without an alternative aetiology occurred in 1.0% (5/489) of patients.
Ud af disse patienter var der 18 (3,7 %) patienter med grad 3 og 3 (0,6 %) patienter med grad 4 immunrelateret hepatitis. 
Of these patients, there were 18 (3.7%) patients with Grade 3 and 3 (0.6%) patients with Grade 4 immune-related hepatitis.
Immunrelateret hepatitis gik væk hos 9 (56 %) af de 16 patienter på tidspunktet for data cut-off. 
Immune-related hepatitis resolved in 9 (56%) of the 16 patients at the time of data cut-off.
Grad 4 colitis eller diarré eller tilbagevendende grad 3 colitis 
Grade 4 colitis or diarrhoea or recurrent Grade 3 colitis
Medianvarigheden var 2,6 måneder (interval: 3,3 uger til over 7,9 måneder). 
The median duration was 2.6 months (range: 3.3 weeks to more than 7.9 months).
Hos patienter behandlet med avelumab som monoterapi opstod der type 1 diabetes mellitus uden en alternativ ætiologi hos 0,1 % (2/1.738) af patienterne, herunder to grad 3-reaktioner, der førte til permanent seponering af avelumab. 
In patients treated with avelumab as monotherapy, Type 1 diabetes mellitus without an alternative aetiology occurred in 0.1% (2/1,738) of patients including two Grade 3 reactions that led to permanent discontinuation of avelumab.
• Der skal anvendes en infusionspose af en passende størrelse (helst 250 ml), som indeholder enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning, eller med 4,5 mg/ml (0,45 %) natriumchlorid injektionsvæske, opløsning. 
• An infusion bag of appropriate size (preferably 250 mL) containing either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection should be used.
Avelumab skal seponeres permanent, hvis der bekræftes immunrelateret myokarditis (se pkt. 
Avelumab should be permanently discontinued if immune-related myocarditis is confirmed (see section 4.2).
Dosisjustering er ikke nødvendig for patienter med let eller moderat nedsat nyrefunktion (se pkt. 
No dose adjustment is needed for patients with mild or moderate renal impairment (see section 5.2).
Medianvarigheden kunne ikke estimeres (interval: 8 dage til over 23,9 måneder). 
The median duration was not estimable (range: 8 days to more than 23.9 months).
• Nedsat nyrefunktion 
• Decreased kidney function
Minimum, maksimum (måneder) ≥ 6 måneder ved K-M, (95 % CI) ≥ 12 måneder ved K-M, (95 % CI) ≥ 24 måneder ved K-M, (95 % CI) ≥ 36 måneder ved K-M, (95 % CI) 
Minimum, maximum (months) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI) ≥ 24 months by K-M, (95% CI) ≥ 36 months by K-M, (95% CI)
Vurder formodede immunrelaterede bivirkninger grundigt, for at bekræfte ætiologien eller for at udelukke andre årsager. 
For suspected immune-related adverse reactions, ensure adequate evaluation to confirm aetiology or to rule out other causes.
Patienter med de følgende sygdomme blev ekskluderet fra kliniske studier: aktive metastaser i centralnervesystemet (CNS), aktiv eller tidligere autoimmunsygdom, andre maligniteter inden for de seneste 5 år, organtransplantation, sygdomme, der kræver terapeutisk immunsuppression eller aktiv HIV-infektion eller hepatitis B eller C. 
Patients with the following conditions were excluded from clinical trials: active central nervous system (CNS) metastasis; active or a history of autoimmune disease; a history of other malignancies within the last 5 years; organ transplant; conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C.
Ikke almindelig Lægemiddeloverfølsomhed, anafylaktiske overfølsomhedsreaktioner, type I overfølsomhed 
Drug hypersensitivity, hypersensitivity anaphylactic reaction, Type I hypersensitivity
Medianvarigheden var 2,8 måneder (interval: 3 dage til over 15,5 måneder). 
The median duration was 2.8 months (range: 3 days to more than 15.5 months).
Alle 3 patienter med immunrelateret pneumonitis blev behandlet med højdosis kortikosteroider i en median periode på 3,3 måneder (interval: 3 uger til 22,3 måneder). 
All 3 patients with immune-related pneumonitis were treated with high-dose corticosteroids for a median of 3.3 months (range: 3 weeks to 22.3 months).
Der er blevet rapporteret træthed efter administration af avelumab (se pkt. 
Fatigue has been reported following administration of avelumab (see section 4.8).
Avelumab skal seponeres permanent, hvis der bekræftes immunrelateret pankreatitis (se pkt. 
Avelumab should be permanently discontinued if immune-related pancreatitis is confirmed (see section 4.2).
Der er blevet rapporteret immunrelateret myokarditis hos patienter, der fik avelumab. 
Immune-related myocarditis has been reported in patients receiving avelumab.
Immunrelateret colitis 
Immune-related colitis
• Tegn på nyrebetændelse kan omfatte unormale nyrefunktionsprøver, mindre hyppigt vandladningsbehov, blod i urinen eller hævede ankler. 
• Signs of inflammation of the kidney may include abnormal kidney function tests, urinating less than usual, blood in your urine, or swelling in your ankles.
• betændelse i bugspytkirtlen (pankreatitis), 
• inflammation of your pancreas (pancreatitis);
Ud af disse patienter var der 1 (0,2 %) patient med grad 3 type 1 diabetes mellitus. 
Of these patients, there was 1 (0.2%) patient with Grade 3 Type 1 diabetes mellitus.
Immunrelateret pneumonitis gik væk hos 2 (66,7 %) af de 3 patienter på tidspunktet for data cut-off. 
Immune-related pneumonitis resolved in 2 (66.7%) of the 3 patients at the time of data cut-off.
Patienterne skal overvåges for tegn og symptomer på immunrelateret pneumonitis, og andre årsager end immunrelateret pneumonitis skal udelukkes. 
Patients should be monitored for signs and symptoms of immune-related pneumonitis and causes other than immune-related pneumonitis should be ruled out.
Medianvarigheden var 2,1 uger (interval: 2 dage til 8,9 måneder). 
The median duration was 2.1 weeks (range: 2 days to 8.9 months).
• Tegn på tarmbetændelse (colitis) kan omfatte diarré (løs afføring) eller flere afføringer end normalt, blod i afføringen eller mørke, tjæreagtige, klæbrige afføringer, eller svære mavesmerter eller ømhed. 
• Signs of inflammation of the intestines (colitis) may include diarrhoea (loose stools) or more bowel movements than usual, blood in your stools or dark, tarry, sticky stools, or severe stomach (abdomen) pain or tenderness.
Begge patienter med immunrelateret nefritis blev behandlet med højdosis kortikosteroider i en mediantid på 1,1 måneder (interval: 3 dage til 1,9 uger). 
All 2 patients with immune-related nephritis were treated with high-dose corticosteroids for a median of 1.1 weeks (range: 3 days to 1.9 weeks).
Ud af disse patienter var der 1 (0,1 %) patient med et dødeligt udfald, 1 (0,1 %) patient med grad 4 og 5 (0,3 %) patienter med grad 3 immunrelateret pneumonitis. 
Of these patients, there was 1 (0.1%) patient with a fatal outcome, 1 (0.1%) patient with Grade 4, and 5 (0.3%) patients with Grade 3 immune-related pneumonitis.
Udslæt*, pruritus*, makulopapuløst udslæt*, tør hud Ikke almindelig Kløende udslæt*, erytem*, generaliseret udslæt*, psoriasis*, erytematøst udslæt*, makulært udslæt*, papulært udslæt*, eksfoliativ dermatitis*, erythema multiforme*, pemfigoid*, generaliseret pruritus*, eksem, dermatitis 
Rash pruritic*, erythema*, rash generalised*, psoriasis*, rash erythematous*, rash macular*, rash papular*, dermatitis exfoliative*, erythema multiforme*, pemphigoid*, pruritus generalised*, eczema, dermatitis
• Forhøjet blodtryk 
• Increases in blood pressure
Dette er meget almindeligt for skjoldbruskkirtlen, almindeligt for binyrerne og ikke almindeligt for hypofysen. 
This is very common for thyroid gland, common for adrenal glands, and uncommon for pituitary gland.
Hypotension, rødme 
Hypotension, flushing
Tyreoideasygdommene gik væk hos 7 (7 %) af de 98 patienter på tidspunktet for data cut-off. 
Thyroid disorders resolved in 7 (7%) of the 98 patients at the time of data cut-off.
Patienter med aktiv eller tidligere metastase i centralnervesystemet (CNS), aktiv eller tidligere autoimmunsygdom, andre tidligere maligniteter inden for de seneste 5 år, organtransplantation, sygdomme, der kræver terapeutisk immunsuppression eller aktiv infektion med HIV eller hepatitis B eller C, blev ekskluderet. 
Patients with active or a history of central nervous system (CNS) metastasis; active or a history of autoimmune disease; a history of other malignancies within the last 5 years; organ transplant; conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C were excluded.
Immunrelaterede endokrinopatier 
Immune-related endocrinopathies
§ Reaktion kun observeret i studie EMR100070-003 (del B) efter dataafskæringen i den samlede analyse, derfor er hyppigheden estimeret 
Infusion related reaction * Immune-related adverse reaction based on medical review § Reaction only observed from study EMR 100070-003 (Part B) after the data cut-off of the pooled analysis, hence frequency estimated
Mediantiden til immunrelateret pneumonitis opstod var 3,7 måneder (interval: 2,7 måneder til 8,6 måneder). 
The median time to onset of immune-related pneumonitis was 3.7 months (range: 2.7 months to 8.6 months).
Avelumabs sikkerhed som monoterapi er blevet evalueret i kliniske studier hos 1.738 patienter med solide tumorer, herunder metastatisk MCC. 
The safety of avelumab as monotherapy has been evaluated in 1,738 patients with solid tumours including metastatic MCC receiving 10 mg/kg every 2 weeks of avelumab in clinical studies.
Immunrelateret nefritis gik væk hos 1 (50 %) af de 2 patienter på tidspunktet for data cut-off. 
Immune-related nephritis resolved in 1 (50%) of the 2 patients at the time of data cut-off.
Patienterne skal overvåges for tegn og symptomer på immunrelateret pankreatitis. 
Patients should be monitored for signs and symptoms of immune-related pancreatitis.
• Røde, kløende, skællende pletter på huden 
• Red, itchy, scaly patches on the skin
Immunrelateret colitis gik væk hos 18 (70 %) af de 26 patienter på tidspunktet for data cut-off. 
Immune-related colitis resolved in 18 (70%) of 26 patients at the time of data cut-off.
Studiepopulationens karakteristika var en medianalder på 61 år (interval: 27,0 til 88,0), 38 % af patienterne var 65 år eller ældre, 75 % var mænd, 75 % var kaukasere og ECOG performance score var 0 (63 %) eller 1 (37 %). 
The study population characteristics were: median age of 61 years (range: 27.0 to 88.0), 38% of patients were 65 years or older, 75% were male, 75% were White, and the ECOG performance score was 0 (63%) or 1 (37%).
Hos patienter behandlet med avelumab som monoterapi udviklede 6 % (98/1.738) af patienterne immunrelaterede tyreoideasygdomme, herunder 90 (5 %) af patienterne med hypotyroidisme, 7 (0,4 %) med hypertyroidisme og 4 (0,2 %) med tyroiditis. 
In patients treated with avelumab as monotherapy, 6% (98/1,738) of patients developed immune-related thyroid disorders, including 90 (5%) patients with hypothyroidism, 7 (0.4%) with hyperthyroidism, and 4 (0.2%) with thyroiditis.
Immunrelateret pneumonitis gik væk hos 12 (57 %) af de 21 patienter på tidspunktet for data cut-off. 
Immune-related pneumonitis resolved in 12 (57%) of the 21 patients at the time of data cut-off.
Avelumab blev seponeret hos 4,7 % (23/489) af patienterne, på grund af immunrelateret hepatitis. 
Avelumab was discontinued in 4.7% (23/489) of patients due to immune-related hepatitis.
Immunrelateret pankreatitis 
Immune-related pancreatitis
Ud af disse patienter var der 2 (0,1 %) patienter med et dødeligt udfald og 11 (0,6 %) patienter med grad 3 immunrelateret hepatitis. 
Of these patients, there were 2 (0.1%) patients with a fatal outcome, and 11 (0.6%) patients with Grade 3 immune-related hepatitis.
Medianvarigheden var 2,5 måneder (interval: 1 dag til over 7,4 måneder). 
The median duration was 2.5 months (range: 1 day to more than 7.4 months).
Bavencio 20 mg/ml koncentrat, sterilt avelumab i.v. 
Bavencio 20 mg/mL sterile concentrate avelumab
• Tegn på betændelse i bugspytkirtlen (pankreatitis) kan omfatte mavesmerter, kvalme og opkastning. 
• Signs of inflammation of the pancreas (pancreatitis) may include abdominal pain, nausea and vomiting.
Infusionen skal administreres med et steril, ikke-pyrogen, lavproteinbindende 0,2 mikrometer in-line- eller add-on-filter. 
Administer the infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or addon filter.
Mediantiden til immunrelateret nefritis opstod var 1,2 måneder (interval: 2,9 uger til 1,8 måneder). 
The median time to onset of immune-related nephritis was 1.2 months (range: 2.9 weeks to 1.8 months).
Formodet pankreatitis 
Suspected pancreatitis
Tabel 6: Efterfølgende interimanalyse af respons på avelumab 10 mg/kg hver 2. uge hos patienter med metastatisk MCC i studie EMR100070-003 (del B)* 
Table 6: Subsequent interim analysis of response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part B)*
Håndteringsanvisninger Anvend aseptisk teknik for at forberede infusionsvæsken, opløsningen. 
Handling instructions An aseptic technique for the preparation of the solution for infusion should be used.
Medianvarigheden var 7 uger (interval: 4 dage til over 4 måneder). 
The median duration was 7 weeks (range: 4 days to more than 4 months).
Immunrelatet colitis gik over hos 10 (76,9 %) af de 13 patienter på tidspunktet for data cut-off. 
Immune-related colitis resolved in 10 (76.9%) of 13 patients at the time of data cut-off.
Ud af de 88 patienter var 65 (74 %) mænd, medianalderen var 73 år (interval 33 år til 88 år), 81 (92 %) af patienterne var kaukasere, og 49 (56 %) patienter og 39 (44 %) patienter havde en Eastern Cooperative Oncology Group (ECOG) performancestatus på hhv. 0 og 1. 
Of the 88 patients, 65 (74%) were male, the median age was 73 years (range 33 years to 88 years), 81 (92%) patients were Caucasian, and 49 (56%) patients and 39 (44%) patients with an Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1, respectively.
Hypertyroidisme, binyreinsufficiens, tyroiditis 
Hyperthyroidism, adrenal insufficiency, thyroiditis
• Nedsat blodtryk 
• Decreases in blood pressure
Grad 2 eller grad 3 colitis eller diarré Afbryd, indtil bivirkningerne bedres til grad 0-1 
Grade 2 or Grade 3 colitis or diarrhoea Withhold until adverse reactions recover to