FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy endpoints (Part B) (per RECIST v1.1, IERC)
Danish: Effekt endepunkter (del B) (pr. RECIST v1.1, IERC)
English: Dry mouth, colitis
Danish: Mundtørhed, colitis
English: 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.
Danish: 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.
English: Of these patients, there were 18 (3.7%) patients with Grade 3 and 3 (0.6%) patients with Grade 4 immune-related hepatitis.
Danish: Ud af disse patienter var der 18 (3,7 %) patienter med grad 3 og 3 (0,6 %) patienter med grad 4 immunrelateret hepatitis.
English: Immune-related hepatitis resolved in 9 (56%) of the 16 patients at the time of data cut-off.
Danish: Immunrelateret hepatitis gik væk hos 9 (56 %) af de 16 patienter på tidspunktet for data cut-off.
English: Grade 4 colitis or diarrhoea or recurrent Grade 3 colitis
Danish: Grad 4 colitis eller diarré eller tilbagevendende grad 3 colitis
English: The median duration was 2.6 months (range: 3.3 weeks to more than 7.9 months).
Danish: Medianvarigheden var 2,6 måneder (interval: 3,3 uger til over 7,9 måneder).
English: 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.
Danish: 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.
English: • 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.
Danish: • 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.
English: Avelumab should be permanently discontinued if immune-related myocarditis is confirmed (see section 4.2).
Danish: Avelumab skal seponeres permanent, hvis der bekræftes immunrelateret myokarditis (se pkt.
English: No dose adjustment is needed for patients with mild or moderate renal impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig for patienter med let eller moderat nedsat nyrefunktion (se pkt.
English: The median duration was not estimable (range: 8 days to more than 23.9 months).
Danish: Medianvarigheden kunne ikke estimeres (interval: 8 dage til over 23,9 måneder).
English: • Decreased kidney function
Danish: • Nedsat nyrefunktion
English: 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)
Danish: 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)
English: For suspected immune-related adverse reactions, ensure adequate evaluation to confirm aetiology or to rule out other causes.
Danish: Vurder formodede immunrelaterede bivirkninger grundigt, for at bekræfte ætiologien eller for at udelukke andre årsager.
English: 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.
Danish: 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.
English: Drug hypersensitivity, hypersensitivity anaphylactic reaction, Type I hypersensitivity
Danish: Ikke almindelig Lægemiddeloverfølsomhed, anafylaktiske overfølsomhedsreaktioner, type I overfølsomhed
English: The median duration was 2.8 months (range: 3 days to more than 15.5 months).
Danish: Medianvarigheden var 2,8 måneder (interval: 3 dage til over 15,5 måneder).
English: 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).
Danish: 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).
English: Fatigue has been reported following administration of avelumab (see section 4.8).
Danish: Der er blevet rapporteret træthed efter administration af avelumab (se pkt.
English: Avelumab should be permanently discontinued if immune-related pancreatitis is confirmed (see section 4.2).
Danish: Avelumab skal seponeres permanent, hvis der bekræftes immunrelateret pankreatitis (se pkt.
English: Immune-related myocarditis has been reported in patients receiving avelumab.
Danish: Der er blevet rapporteret immunrelateret myokarditis hos patienter, der fik avelumab.
English: Immune-related colitis
Danish: Immunrelateret colitis
English: • 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.
Danish: • Tegn på nyrebetændelse kan omfatte unormale nyrefunktionsprøver, mindre hyppigt vandladningsbehov, blod i urinen eller hævede ankler.
English: • inflammation of your pancreas (pancreatitis);
Danish: • betændelse i bugspytkirtlen (pankreatitis),
English: Of these patients, there was 1 (0.2%) patient with Grade 3 Type 1 diabetes mellitus.
Danish: Ud af disse patienter var der 1 (0,2 %) patient med grad 3 type 1 diabetes mellitus.
English: Immune-related pneumonitis resolved in 2 (66.7%) of the 3 patients at the time of data cut-off.
Danish: Immunrelateret pneumonitis gik væk hos 2 (66,7 %) af de 3 patienter på tidspunktet for data cut-off.
English: Patients should be monitored for signs and symptoms of immune-related pneumonitis and causes other than immune-related pneumonitis should be ruled out.
Danish: Patienterne skal overvåges for tegn og symptomer på immunrelateret pneumonitis, og andre årsager end immunrelateret pneumonitis skal udelukkes.
English: The median duration was 2.1 weeks (range: 2 days to 8.9 months).
Danish: Medianvarigheden var 2,1 uger (interval: 2 dage til 8,9 måneder).
English: • 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.
Danish: • 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.
English: 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).
Danish: Begge patienter med immunrelateret nefritis blev behandlet med højdosis kortikosteroider i en mediantid på 1,1 måneder (interval: 3 dage til 1,9 uger).
English: 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.
Danish: 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.
English: Rash pruritic*, erythema*, rash generalised*, psoriasis*, rash erythematous*, rash macular*, rash papular*, dermatitis exfoliative*, erythema multiforme*, pemphigoid*, pruritus generalised*, eczema, dermatitis
Danish: 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
English: • Increases in blood pressure
Danish: • Forhøjet blodtryk
English: This is very common for thyroid gland, common for adrenal glands, and uncommon for pituitary gland.
Danish: Dette er meget almindeligt for skjoldbruskkirtlen, almindeligt for binyrerne og ikke almindeligt for hypofysen.
English: Hypotension, flushing
Danish: Hypotension, rødme
English: Thyroid disorders resolved in 7 (7%) of the 98 patients at the time of data cut-off.
Danish: Tyreoideasygdommene gik væk hos 7 (7 %) af de 98 patienter på tidspunktet for data cut-off.
English: 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.
Danish: 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.
English: Immune-related endocrinopathies
Danish: Immunrelaterede endokrinopatier
English: 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
Danish: § Reaktion kun observeret i studie EMR100070-003 (del B) efter dataafskæringen i den samlede analyse, derfor er hyppigheden estimeret
English: Pack size of 1 vial.
Danish: Pakningsstørrelse på 1 hætteglas.
English: The median time to onset of immune-related pneumonitis was 3.7 months (range: 2.7 months to 8.6 months).
Danish: Mediantiden til immunrelateret pneumonitis opstod var 3,7 måneder (interval: 2,7 måneder til 8,6 måneder).
English: 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.
Danish: Avelumabs sikkerhed som monoterapi er blevet evalueret i kliniske studier hos 1.738 patienter med solide tumorer, herunder metastatisk MCC.
English: Immune-related nephritis resolved in 1 (50%) of the 2 patients at the time of data cut-off.
Danish: Immunrelateret nefritis gik væk hos 1 (50 %) af de 2 patienter på tidspunktet for data cut-off.
English: Patients should be monitored for signs and symptoms of immune-related pancreatitis.
Danish: Patienterne skal overvåges for tegn og symptomer på immunrelateret pankreatitis.
English: • Red, itchy, scaly patches on the skin
Danish: • Røde, kløende, skællende pletter på huden
English: Immune-related colitis resolved in 18 (70%) of 26 patients at the time of data cut-off.
Danish: Immunrelateret colitis gik væk hos 18 (70 %) af de 26 patienter på tidspunktet for data cut-off.
English: 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%).
Danish: 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 %).
English: 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.
Danish: 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.
English: Immune-related pneumonitis resolved in 12 (57%) of the 21 patients at the time of data cut-off.
Danish: Immunrelateret pneumonitis gik væk hos 12 (57 %) af de 21 patienter på tidspunktet for data cut-off.
English: Avelumab was discontinued in 4.7% (23/489) of patients due to immune-related hepatitis.
Danish: Avelumab blev seponeret hos 4,7 % (23/489) af patienterne, på grund af immunrelateret hepatitis.
English: Immune-related pancreatitis
Danish: Immunrelateret pankreatitis
English: Of these patients, there were 2 (0.1%) patients with a fatal outcome, and 11 (0.6%) patients with Grade 3 immune-related hepatitis.
Danish: Ud af disse patienter var der 2 (0,1 %) patienter med et dødeligt udfald og 11 (0,6 %) patienter med grad 3 immunrelateret hepatitis.
English: The median duration was 2.5 months (range: 1 day to more than 7.4 months).
Danish: Medianvarigheden var 2,5 måneder (interval: 1 dag til over 7,4 måneder).
English: Bavencio 20 mg/mL sterile concentrate avelumab
Danish: Bavencio 20 mg/ml koncentrat, sterilt avelumab i.v.
English: • Signs of inflammation of the pancreas (pancreatitis) may include abdominal pain, nausea and vomiting.
Danish: • Tegn på betændelse i bugspytkirtlen (pankreatitis) kan omfatte mavesmerter, kvalme og opkastning.
English: Administer the infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or addon filter.
Danish: Infusionen skal administreres med et steril, ikke-pyrogen, lavproteinbindende 0,2 mikrometer in-line- eller add-on-filter.
English: The median time to onset of immune-related nephritis was 1.2 months (range: 2.9 weeks to 1.8 months).
Danish: Mediantiden til immunrelateret nefritis opstod var 1,2 måneder (interval: 2,9 uger til 1,8 måneder).
English: Suspected pancreatitis
Danish: Formodet pankreatitis
English: 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)*
Danish: 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)*
English: Handling instructions An aseptic technique for the preparation of the solution for infusion should be used.
Danish: Håndteringsanvisninger Anvend aseptisk teknik for at forberede infusionsvæsken, opløsningen.
English: The median duration was 7 weeks (range: 4 days to more than 4 months).
Danish: Medianvarigheden var 7 uger (interval: 4 dage til over 4 måneder).
English: Immune-related colitis resolved in 10 (76.9%) of 13 patients at the time of data cut-off.
Danish: Immunrelatet colitis gik over hos 10 (76,9 %) af de 13 patienter på tidspunktet for data cut-off.
English: 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.
Danish: 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.
English: Hyperthyroidism, adrenal insufficiency, thyroiditis
Danish: Hypertyroidisme, binyreinsufficiens, tyroiditis
English: • Decreases in blood pressure
Danish: • Nedsat blodtryk
English: Grade 2 or Grade 3 colitis or diarrhoea Withhold until adverse reactions recover to
Danish: Grad 2 eller grad 3 colitis eller diarré Afbryd, indtil bivirkningerne bedres til grad 0-1
English: Patients should be monitored for signs and symptoms of immune-related colitis and causes other than immune-related colitis should be ruled out.
Danish: Patienterne skal overvåges for tegn og symptomer på immunrelateret colitis, og andre årsager end immunrelateret colitis skal udelukkes.
English: Immune-related colitis Immune-related colitis has been reported in patients receiving avelumab (see section 4.8).
Danish: Immunrelateret colitis Der er blevet rapporteret immunrelateret colitis hos patienter, der fik avelumab (se pkt.
English: Avelumab should be withheld for Grade 2 or Grade 3 nephritis until resolution to ≤ Grade 1 and permanently discontinued for Grade 4 nephritis.
Danish: Avelumab bør afbrydes ved grad 2 eller grad 3 nefritis, indtil reaktionen er reduceret til ≤ grad 1, og permanent seponeres for grad 4 nefritis.
English: The median duration was 1.3 weeks (range: more than 4 days to 1.3 weeks).
Danish: Medianvarigheden var 1,3 uger (interval: over 4 dage til 1,3 uger).
English: The median duration was not estimable (range: 2 days to more than 6 months).
Danish: Medianvarigheden kunne ikke estimeres (interval: 2 dage til over 6 måneder).
English: Avelumab was discontinued in 0.2% (1/489) of patients due to Type 1 diabetes mellitus.
Danish: Avelumab blev seponeret hos 0,2 % (1/489) af patienterne, på grund af type 1 diabetes mellitus.
English: No dose adjustment is needed for patients with mild hepatic impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig for patienter med let nedsat leverfunktion (se pkt.
English: The median duration was not estimable (range: 1 day to more than 26 months).
Danish: Medianvarigheden kunne ikke estimeres (interval: 1 dag til over 26 måneder).
English: Rechallenge with Bavencio or axitinib or sequential rechallenge with both Bavencio and axitinib after recovery should be considered.
Danish: Ved bedring bør det overvejes at genoptage behandlingen med Bavencio eller axitinib eller at genoptage kombinationsbehandlingen sekventielt med både Bavencio og axitinib.
English: The median time to onset of immune-related adrenal insufficiency was 5.5 months (range: 3.6 weeks to 8.7 months).
Danish: Mediantiden til immunrelateret binyreinsufficiens opstod var 5,5 måneder (interval: 3,6 uger til 8,7 måneder).
English: Table 5 summarises the PD-L1 expression and MCV status of patients with metastatic MCC in study EMR100070-003 (Part A).
Danish: Tabel 5 opsummerer PD-L1-ekpression og MCV-status for patienter med metastatisk MCC i studie EMR100070-003 (del A).
English: Immune-related pneumonitis occurred in patients treated with avelumab.
Danish: Der opstod immunrelateret pneumonitis hos patienter, der blev behandlet med avelumab.
English: Headache, dizziness, neuropathy peripheral
Danish: Hovedpine, svimmelhed, perifer neuropati Ikke almindelig Guillain-Barrés syndrom*
English: In patients treated with avelumab in combination with axitinib, immune-related nephritis occurred in 0.4% (2/489) of patients.
Danish: Hos patienter behandlet med avelumab i kombination med axitinib opstod der immunrelateret nefritis hos 0,4 % (2/489) af patienterne.
English: • Decrease in the number of platelets in the blood
Danish: • Nedsat antal blodplader i blodet
English: Avelumab should be withheld for Grade 3 or Grade 4 endocrinopathies until resolution (see section 4.2).
Danish: Avelumab bør afbrydes ved grad 3 eller grad 4 endokrinopatier, indtil reaktionerne forsvinder (se pkt.
English: In patients treated with avelumab as monotherapy, immune-related myocarditis occurred in less than 1% (5/4,000) of patients across clinical trials in multiple tumour types and in 0.6% (3/489) of patients receiving avelumab in combination with axitinib including 2 (0.4%) patients with fatal outcome.
Danish: Hos patienter behandlet med avelumab som monoterapi opstod der immunrelateret myokarditis hos mindre end 1 % (5/4.000) af patienterne i alle kliniske studier af flere tumortyper, og hos 0,6 % (3/489) af patienterne, der fik avelumab i kombination med axitinib, herunder hos 2 (0,4 %) af patienterne med dødelig udgang.
English: Immune-related hepatitis occurred in patients treated with avelumab.
Danish: Der opstod immunrelateret hepatitis hos patienter, der blev behandlet med avelumab.
English: All 8 patients with immune-related adrenal insufficiency were treated with corticosteroids, 4 (50%) of the 8 patients received high-dose systemic corticosteroids (≥ 40 mg prednisone or equivalent) followed by a taper for a median of 1 day (range: 1 day to 24 days).
Danish: Alle 8 patienter med immunrelateret binyreinsufficiens blev behandlet med kortikosteroider, 4 (50 %) af de 8 patienter fik højdosis systemiske kortikosteroider (≥ 40 mg prednison eller tilsvarende) efterfulgt af en nedtrapning i en mediantid på 1 dag (interval: 1 dag til 24 dage).
English: After administration of Bavencio, the line should be flushed with either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection.
Danish: Efter administration af Bavencio skal slangen skylles med enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning, eller med 4,5 mg/ml (0,45 %) natriumchlorid injektionsvæske, opløsning.
English: Eight (88.9%) patients with immune-related adrenal insufficiency were treated with corticosteroids and 2 (25%) of the 8 patients received high-dose corticosteroids (≥ 40 mg prednisone or equivalent) for a median of 8 days (range: 5 days to 11 days).
Danish: 8 (88,9%) patienter med immunrelateret binyreinsufficiens blev behandlet med kortikosteroider og 2 (25 %) af de 8 patienter fik højdosis kortikosteroider (≥ 40 mg prednison eller tilsvarende) i en mediantid på 8 dage (interval: 5 dage til 11 dage).
English: In patients treated with avelumab as monotherapy, immune-related pancreatitis occurred in less than 1% (1/4,000) of patients across clinical trials in multiple tumour types and in 0.6% (3/489) of patients receiving avelumab in combination with axitinib including 2 (0.4%) patients with fatal outcome.
Danish: Hos patienter behandlet med avelumab som monoterapi opstod der immunrelateret pankreatitis hos mindre end 1 % (1/4.000) af patienterne i alle kliniske studier af flere tumortyper, og hos 0,6 % (3/489) af patienterne, der fik avelumab i kombination med axitinib, herunder hos 2 (0,4 %) af patienterne med dødelig udgang.
English: Thyroid disorders
Danish: Tyreoideasygdomme
English: Treatment-related adverse reaction
Danish: Behandlingsrelateret bivirkning
English: may include extreme tiredness, rapid heartbeat, increased sweating, changes in mood or behaviour, such as irritability or forgetfulness, feeling cold, very low blood pressure (fainting, dizziness, fatigue, nausea), weight change or headache.
Danish: såsom irritabilitet eller glemsomhed, kuldefølelse, meget lavt blodtryk (besvimelse, svimmelhed, træthed, kvalme), vægtændringer eller hovedpine.
English: Bavencio has to be diluted with either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection.
Danish: Bavencio skal fortyndes med enten 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning, eller med 4,5 mg/ml (0,45 %) natriumchlorid injektionsvæske, opløsning.
English: If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, both Bavencio and axitinib should be permanently discontinued and corticosteroid therapy should be considered.
Danish: ULN eller totalt bilirubin ≥ 3 gange ULN, skal både Bavencio og axitinib seponeres permanent, og der bør overvejes kortikosteroidbehandling.
English: Of the 39 patients, 30 (77%) were male, the median age was 75 years (range: 47 to 88 years), 33 (85%) were Caucasian, and 31 (79%) and 8 (21%) had an ECOG performance status of 0 and 1 respectively.
Danish: Ud af de 39 patienter var 30 (77 %) mænd med en medianalder på 75 år (interval: 47 til 88 år), 33 (85 %) var kaukasere og 31 (79 %) og 8 (21 %) havde en ECOG performancestatus på hhv. 0 og 1.
English: Of these patients, there were 9 (1.8%) patients with Grade 3 immune-related colitis.
Danish: Ud af disse patienter var der 9 (1,8 %) patienter med grad 3 immunrelateret colitis.