FrancophonIA/ELRC3.0 huggingface dataset:
English: 90 minutes administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab 3 mg/kg as monotherapy every 2 weeks.
Danish: over 90 minutter hver 3. uge givet 4 gange og efterfulgt af nivolumab 3 mg/kg som monoterapi hver 2. uge.
English: After 28 months of follow-up, median durations of response for patients with tumour PD-L1 expression level ≥5% were not reached (range: 0+-31.6+) in the combination arm, not reached (range: 2.8-30.6+) in the nivolumab monotherapy arm and not reached (range: 1.4-30.6+) in the ipilimumab arm. At tumour PD-L1 expression <5%, median durations of response were not reached (range: 0+-33.3+) in the combination arm, not reached (range: 0+-32.3+) in the nivolumab monotherapy arm and 18.2 months (range: 0.0+-31.5+) in the ipilimumab monotherapy arm.
Danish: Efter en opfølgningsperiode på 28 måneder blev median responsvarighed hos patienter med PD-L1tumorekspressionsniveau ≥ 5 % ikke nået (0+ -31,6+) i kombinationsarmen, ikke nået (2,8-30,6+) i nivolumab-monoterapi-armen og ikke nået (1,4-30,6+) i ipilimumab-armen.
English: Patients with ocular melanoma, primary CNS melanoma and active brain metastases were not included in the MDX010-20 trial (see section 5.1).
Danish: Patienter med okulært melanom, primært CNS-melanom og aktive hjernemetastaser blev ikke inkluderet i MDX010-20-forsøget (se pkt.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 3.0% for anaemia (all Grade 3), 0.7% for thrombocytopaenia, 0.6% for leucopoenia, 5.1% for lymphopaenia, 1.1% for neutropaenia, 2.0% for increased alkaline phosphatase, 4.8% for increased AST, 6.5% for increased ALT, 1.1% for increased total bilirubin, 2.1% for increased creatinine, 7.2% for hyperglycaemia, 1.8% for hypoglycemia,12.2% for increased amylase, 20.1% for increased lipase, 0.4% for hypocalcaemia, 1.3% for hypercalcaemia, 2.4% for hyperkalemia, 1.1% for hypermagnesaemia, 0.4% for hypomagnesaemia 1.9% for hypokalaemia, and 9.9% for hyponatraemia.
Danish: Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var andelen af patienter, som oplevede en forværring fra baseline til en grad 3 eller 4 abnorm laboratorietest, følgende: 3,0 % med anæmi (alle grad 3), 0,7 % med trombocytopeni, 0,6 % med leukopeni, 5,1 % med lymfopeni, 1,1 % med neutropeni, 2,0 % med forhøjet alkalisk phosphatase, 4,8 % med forhøjet ASAT, 6,5 % med forhøjet ALAT, 1,1 % med forhøjet total-bilirubin, 2,1 % med forhøjet kreatinin, 7,2 % med hyperglykæmi, 1,8 % med hypoglykæmi, 12,2 % med forhøjet amylase, 20,1 % med forhøjet lipase, 0,4 % med hypocalcæmi, 1,3 % med hypercalcæmi, 2,4 % med hyperkaliæmi, 1,1 % med hypermagnesiæmi, 0,4 % med hypomagnesiæmi, 1,9 % med hypokaliæmi og 9,9 % med hyponatriæmi.
English: Grade 2 and Grade 3 hypopituitarism occurred in 0.4% (2/448) and 0.7% (3/448) of patients, respectively.
Danish: Grad 2 og grad 3 hypopituitarisme forekom hos henholdsvis 0,4 % (2/448) og 0,7 % (3/448) af patienterne.
English: Common adrenal insufficiency, hypopituitarism, hypophysitis, hyperthyroidism, thyroiditis adrenal insufficiencyc, hypophysitisc,
Danish: Almindelig binyrebarkinsufficiens, hypopituitarisme, hypofysitis, hypertyroidisme, tyroiditis binyrebarkinsufficiensc, hypofysitisc,
English: Fatal hepatic failure has been reported in < 1% of patients who received ipilimumab 3 mg/kg monotherapy.
Danish: Der er rapporteret om dødelig leversvigt hos <1 % af de patienter, der fik ipilimumab 3 mg/kg monoterapi.
English: The chemical and physical in-use stability of the undiluted or diluted infusion solution (between 1 and 4 mg/ml) has been demonstrated for 24 hours at room temperature (20°C to 25°C) or when refrigerated (2°C to 8°C).
Danish: Det er påvist, at det ufortyndede eller fortyndede koncentrat (mellem 1 og 4 mg/ml) har en kemisk og fysisk anvendelsesstabilitet ved stuetemperatur (20 °C til 25 °C) i 24 timer eller i køleskab (2‑8 °C).
English: In the dataset of ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC (n = 547), with a minimum follow-up of 17.5 months, the most frequent adverse reactions (≥ 10%) were fatigue (48%), rash (34%), pruritus (28%), diarrhoea (27%), nausea (20%), hypothyroidism (16%), musculoskeletal pain (15%), arthralgia (14%), decreased appetite (14%), pyrexia (14%), vomiting (11%), hyperthyroidism (11%).
Danish: De hyppigste bivirkninger (≥ 10 %) i datasættet for ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg ved RCC (n = 547) med en minimum opfølgningsperiode på 17,5 måneder, var træthed (48 %), udslæt (34 %), pruritus (28 %), diarre (27 %), kvalme (20 %), hypotyroidisme (16 %), muskuloskeletale smerter (15 %), artralgi (14 %), appetitløshed (14 %), pyreksi (14 %), opkastning (11 %) og hypertyroidisme (11 %).
English: When YERVOY is given in combination with nivolumab for the treatment of advanced kidney cancer, the recommended dose of YERVOY is 1 mg of ipilimumab per kilogram of your body weight every 3 weeks for the first 4 doses (combination phase).
Danish: Hvis YERVOY gives sammen med nivolumab til behandlingen af fremskreden nyrekræft, er den anbefalede dosis YERVOY 1 mg ipilimumab pr. kilogram kropsvægt hver 3. uge for de første 4 doser (kombinationsfasen).
English: Uncommon mental status changes, depression, decreased libido Nervous system disorders
Danish: Psykiske lidelser Almindelig konfusion Ikke almindelig ændring af mental tilstand, depression, nedsat libido
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg, the incidence of hypersensitivity/infusion reactions was 4.0% (22/547); all were Grade 1 or 2 in severity.
Danish: Hos patienter, som blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af overfølsomheds-/infusionsreaktioner 4,0 % (22/547); de var alle grad 1 eller 2 i sværhedsgrad.
English: Grade 2 or 3 creatinine elevation Withhold dose(s) until creatinine returns to baseline and management with corticosteroids is complete
Danish: Dosis/doser udsættes, indtil kreatinin vender tilbage til baseline, og behandling med kortikosteroider er afsluttet
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 2.8% for anaemia (all Grade 3), 1.2% for thrombocytopaenia, 0.5% for leucopoenia, 6.7% for lymphopaenia, 0.7% for neutropaenia, 4.3% for increased alkaline phosphatase, 12.4% for increased AST, 15.3% for increased ALT, 1.2% for increased total bilirubin, 2.4% for increased creatinine, 5.3% for hyperglycaemia, 8.7% for increased amylase, 19.5% for increased lipase, 1.2% for hypocalcaemia, 0.2% each for hypernatraemia and hypercalcaemia, 0.5% for hyperkalemia, 0.3% for hypermagnesaemia, 4.8% for hypokalaemia, and 9.5% for hyponatraemia.
Danish: Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var andelen af patienter, som oplevede en forværring fra baseline til en grad 3 eller 4 abnorm laboratorietest, følgende: 2,8 % med anæmi (alle grad 3), 1,2 % med trombocytopeni, 0,5 % med leukopeni, 6,7 % med lymfopeni, 0,7 % med neutropeni, 4,3 % med forhøjet alkalisk phosphatase, 12,4 % med forhøjet ASAT, 15,3 % med forhøjet ALAT, 1,2 % med forhøjet total-bilirubin, 2,4 % med forhøjet kreatinin, 5,3 % med hyperglykæmi, 8,7 % med forhøjet amylase, 19,5 % med forhøjet lipase, 1,2 % med hypocalcæmi, 0,2 % med hypernatriæmi og hypercalcæmi, 0,5 % med hyperkaliæmi, 0,3 % med hypermagnesiæmi, 4,8 % med hypokaliæmi og 9,5 % med hyponatriæmi.
English: Gently mix the infusion by manual rotation.
Danish: Blandes forsigtigt ved omrøring.
English: Ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg**
Danish: Ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg**
English: When YERVOY is given in combination with nivolumab for the treatment of skin cancer, the recommended dose of YERVOY is 3 mg of ipilimumab per kilogram of your body weight every 3 weeks for the first 4 doses (combination phase).
Danish: Hvis YERVOY gives sammen med nivolumab til behandlingen af hudkræft, er den anbefalede dosis YERVOY 3 mg ipilimumab pr. kilogram kropsvægt hver 3. uge for de første 4 doser (kombinationsfasen).
English: The safety and efficacy of YERVOY in children younger than 12 years of age have not been established.
Danish: YERVOYs sikkerhed og virkning hos børn under 12 år er ikke klarlagt.
English: In the pooled dataset of ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma (n = 448) with minimum follow-up ranging from 6 to 28 months, the most frequent adverse reactions (≥ 10%) were rash (52%), fatigue (46%), diarrhoea (43%), pruritus (36%), nausea (26%), pyrexia (19%), decreased appetite (16%), hypothyroidism (16%), colitis (15%), vomiting (14%), arthralgia (13%), abdominal pain (13%), headache (11%), and dyspnoea (10%).
Danish: De hyppigste bivirkninger (≥ 10 %) i det puljede datasæt for ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg ved melanom (n = 448) med en opfølgningsperiode som minimum spændte fra 6 til 28 måneder, var udslæt (52 %), træthed (46 %), diarré (43 %), pruritus (36 %), kvalme (26 %), pyreksi (19 %), appetitløshed (16 %), hypotyroidisme (16 %), colitis (15 %), opkastning (14 %), artralgi (13 %), abdominalsmerter (13 %), hovedpine (11 %) og dyspnø (10 %).
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of ipilimumab (see section 4.4 for management of immune-related adverse reactions).
Danish: De fleste af disse bivirkninger, hvoraf nogle er alvorlige, forsvandt efter initiering af passende medicinsk behandling eller seponering af ipilimumab (se pkt.
English: Rare (may affect up to 1 in 1,000 people) inflammatory disease of blood vessels (most commonly head arteries) inflammation of the anus and the rectal wall (marked by bloody stools and a frequent urge to defecate) skin disease characterized by dry red patches covered with scales (psoriasis) inflammation and redness of the skin (erythema multiforme) a type of severe skin reaction characterized by rash accompanied by one or more of the following features: fever, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidneys or lungs (a reaction called DRESS).
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) betændelsessygdom i blodårerne (som regel i arterierne i hovedet) inflammation i endetarmsåbningen og indersiden af endetarmen (kendetegnet ved blodig afføring og hyppig afføring) hudsygdom kendetegnet ved tørre, røde pletter dækket af skæl (psoriasis) betændelse og rødme af huden (erythema multiforme) en bestemt type hudreaktion kendetegnet ved udslæt sammen med en eller flere af følgende træk: feber, hævelse af ansigt eller lymfekirtler, øget mængde eosinofile celler (en bestemt slags hvide blodlegemer), påvirkning af lever, nyrer eller lunger (en reaktion kaldet DRESS).
English: Upon improvement, ipilimumab in combination with nivolumab may be resumed after corticosteroid taper, if needed.
Danish: Når der indtræder bedring, kan ipilimumab i kombination med nivolumab genoptages efter nedtrapning af eventuelle kortikosteroider.
English: Severe rash should be managed with high-dose corticosteroid at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Alvorligt udslæt skal behandles med højdosis-kortikosteroid med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag.
English: Uncommon sepsisb, septic shockb, urinary tract infection, respiratory tract infection Neoplasms benign, malignant and unspecified (including cysts and polyps) Common tumour pain
Danish: Ikke almindelig sepsisb, septisk shockb, urinvejsinfektion, luftvejsinfektion Benigne, maligne og uspecificerede tumorer (inkl.
English: Ipilimumab is associated with serious immune-related gastrointestinal reactions.
Danish: Ipilimumab er associeret med svære immunrelaterede gastrointestinale bivirkninger.
English: In the ipilimumab 3 mg/kg monotherapy group, median OS was 22 months and 8 months for patients with SD and those with PD, respectively.
Danish: I ipilimumab 3 mg/kg monoterapigruppen var den mediane OS 22 måneder og 8 måneder for patienter med henholdsvis SD og PD. På dette tidspunkt i analysen blev medianer ikke nået for patienter med CR eller PR.
English: If the patient has developed SJS or TEN with the use of ipilimumab in combination with nivolumab, permanent discontinuation of treatment is recommended (see section 4.2).
Danish: Permanent seponering af behandlingen anbefales, hvis patienten har udviklet SJS eller TEN i forbindelse med behandling med ipilimumab i kombination med nivolumab (se pkt.
English: Immune-related neurological reactions
Danish: Immunrelaterede neurologiske bivirkninger
English: Immune-related hepatotoxicity
Danish: Immunrelateret hepatotoksicitet
English: For symptomatic Grade 2 adrenal insufficiency, ipilimumab in combination with nivolumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Danish: Ved symptomatisk grad 2 binyrebarkinsufficiens bør ipilimumab i kombination med nivolumab udsættes og fysiologisk kortikosteroidsubstitution initieres efter behov.
English: In the ipilimumab 3 mg/kg monotherapy group, rash and pruritus of any severity were each reported in 26% of patients.
Danish: I monoterapigruppen, som fik ipilimumab 3 mg/kg, blev udslæt og pruritus uanset sværhedsgrad rapporteret hos 26 % af patienterne.
English: For patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, time to onset of moderate to very severe (Grade 2-4) immune-related endocrinopathy ranged from 7 to nearly 20 weeks from the start of treatment.
Danish: Hos patienter, som fik ipilimumab 3 mg/kg monoterapi i MDX010-20, indtrådte moderat til svær (Grad 2-4) immunrelateret endokrinopati fra 7 til næsten 20 uger efter behandlingsstart.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 5 mg ipilimumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml koncentrat indeholder 5 mg ipilimumab.
English: Each ml of concentrate contains 5 mg of ipilimumab.
Danish: En ml koncentrat indeholder 5 mg ipilimumab.
English: Among the patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in CA209067, 154/313 (49%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Danish: Blandt de patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg i CA209067, opstod grad 3 eller 4 bivirkninger i den indledende kombinationsfase for 154/313 (49 %).
English: Median Months (95% CI)
Danish: Mediane antal måneder (95 % CI)
English: Common gastrointestinal haemorrhage, colitisb,c, constipation, gastroesophageal reflux disease, abdominal pain, mucosal inflammationd
Danish: Almindelig gastrointestinal blødning, colitisb,c, obstipation, gastro‑øsofageal reflukssygdom, mavesmerter, mucosainflammationd
English: Based on the severity of the adverse reaction, ipilimumab, or ipilimumab in combination with nivolumab should be withheld and corticosteroids administered.
Danish: Afhængigt af bivirkningens sværhedsgrad bør ipilimumab eller ipilimumab i kombination med nivolumab udsættes og kortikosteroider administreres.
English: The median time to onset of moderate to severe or fatal (Grade 2 to 5) skin adverse reactions was 3 weeks from start of treatment (range 0.9 to 16 weeks).
Danish: Mediantiden fra behandlingsstart til indtræden af svære eller dødelige (Grad 2-5) hudbivirkninger var 3 uger (0,9‑16 uger).
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg, the incidence of hypersensitivity/infusion reactions was 3.8% (17/448); all were Grade 1 or 2 in severity.
Danish: Hos patienter, som blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af overfølsomheds-/infusionsreaktioner 3,8 % (17/448); de var alle grad 1 eller 2 i sværhedsgrad.
English: Patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of ipilimumab in combination with nivolumab (see sections 4.5 and 5.1).
Danish: Patienter med hjernemetastaser i anamnesen, aktiv autoimmun sygdom eller sygdomstilstande, der krævede systemisk immunsuppression, blev udelukket fra de kliniske studier med ipilimumab i kombination med nivolumab (se pkt.
English: Investigations Common increased alanine aminotransferasec, increased aspartate aminotransferasec, increased blood alkaline phosphatased, increased blood bilirubin, weight decreased Uncommon increased gamma-glutamyltransferased, increased blood creatinine, increased blood thyroid stimulating hormone, decreased blood cortisol, decreased blood corticotrophin, increased lipasec, increased blood amylasec, positive antinuclear antibodyd, decreased blood testosterone
Danish: Ikke almindelig forhøjet gamma-glutamyltransferased, forhøjet kreatinin, forhøjet tyroidstimulerende hormon, nedsat kortisol, nedsat kortikotropin (ACTH), forhøjet lipasec, forhøjet amylasec, positive antinukleære antistofferd, nedsat testosteron i blodet
English: Withhold dose(s) until laboratory values return to baseline and management with corticosteroids, if needed, is complete
Danish: Dosis/doser udsættes, indtil laboratorieværdierne vender tilbage til baseline, og eventuel behandling med kortikosteroider er afsluttet
English: For symptomatic hyperthyroidism, ipilimumab in combination with nivolumab should be withheld and antithyroid medication should be initiated as needed.
Danish: Ved symptomatisk hyperotyroidisme bør ipilimumab i kombination med nivolumab udsættes og antityroide lægemidler initieres efter behov.
English: Severe diarrhoea or colitis has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Danish: Svær diarré eller colitis er observeret med ipilimumab i kombination med nivolumab (se pkt.
English: Fatal Guillain-Barré syndrome has been reported in < 1% of patients who received ipilimumab 3 mg/kg in combination with gp100.
Danish: Der er rapporteret om dødelig Guillain-Barré syndrom hos <1 % af de patienter, som fik ipilimumab 3 mg/kg i kombination med gp100.
English: Cytomegalovirus (CMV) infection/reactivation evaluated with viral PCR on biopsy, and other viral, bacterial and parasitic etiology).
Danish: Det bør overvejes at tilføje et andet immunosuppressivt stof til kortikosteroid-behandlingen ved kortikosteroid-refraktær immunrelateret colitis, hvis andre årsager er udelukket (herunder cytomegalovirus (CMV)-infektion/reaktivering, som vurderet ved viral PCR på biopsi, og andre virale, bakterielle og parasitære ætiologier).
English: - histiocytosis haematophagic.
Danish: - hæmatofagisk histiocytose.
English: If resolution to Grades 0-1 or return to baseline occurs, ipilimumab may be resumed (see section 4.2).
Danish: Hvis remission/ophør til Grad 0-1 eller tilbagevenden til samme niveau som ved behandlingsstart indtræder, kan ipilimumab genoptages (se pkt.
English: Grade 2 elevation in AST, ALT, or total bilirubin
Danish: Grad 2 forhøjelse i ASAT, ALAT eller total-bilirubin
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of diarrhoea or colitis was 46.7% (209/448).
Danish: Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af diarré eller colitis 46,7 % (209/448).
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg, the incidence of liver function test abnormalities was 29.5% (132/448).
Danish: Hos patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg var hyppigheden af abnorme leverfunktionstests 29,5 % (132/448).
English: Abnormal kidney function tests (increased amounts of creatinine in your blood) High (hyperglycaemia) or low (hypoglycaemia) sugar levels in the blood A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot) An increased level of the enzyme that breaks down fats and of the enzyme that breaks down starch Increased or decreased amount of calcium or potassium Increased or decreased blood levels of magnesium or sodium Decrease in body weight
Danish: Disse kan være: unormale prøveresultater for leverfunktionen (øget mængde af leverenzymerne aspartataminotransferase, alanin-aminotransferase eller alkalisk phosphatase i blodet, øget indhold af nedbrydningsproduktet bilirubin i blodet) unormale prøveresultater for nyrefunktionen (øget mængde kreatinin i blodet) høje (hyperglykæmi) eller lave (hypoglykæmi) blodsukkerniveauer nedsat antal røde blodlegemer (som transporterer ilt), hvide blodlegemer (som er vigtige for at kunne bekæmpe infektioner) eller blodplader (celler der hjælper blodet til at størkne) øget mængde af enzymet, der nedbryder fedtstoffer, og af enzymet, der nedbryder stivelse forhøjet eller nedsat mængde calcium eller kalium forhøjet eller nedsat mængde magnesium eller natrium i blodet vægttab
English: Resolution occurred in 124 patients (93.9%) with a median time to resolution of 5.1 weeks (range: 0.1-106.9).
Danish: Resolution forekom hos 124 patienter (93,9 %) med en mediantid til resolution på 5,1 uger (0,1-106,9).
English: Ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg
Danish: Ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg
English: • List of important immune-related adverse reactions (irARs) and their symptoms, as outlined in section 4.4 of the Summary of Product Characteristics (SmPC): o Inflammation of the gastrointestinal tract, such as colitis, which can lead to bowel perforation o Inflammation of the liver, such as hepatitis, which can lead to liver failure o Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis) o Inflammation of the nerves that can lead to neuropathy o Inflammation of the endocrine system.
Danish: 4.4 i produktresuméet (SmPC): o Inflammation i mave-tarmkanalen, f.eks. colitis, som kan medføre perforation af tarmen o Leverbetændelse, f.eks. hepatitis, som kan medføre leversvigt o Inflammation i huden, som kan medføre alvorlige hudreaktioner (toksisk epidermal nekrolyse) o Nervebetændelse, som kan medføre neuropati o Inflammation i det endokrine system, herunder binyrerne, hypofysen eller skjoldbruskkirtlen o Øjeninflammation o Andre immunrelaterede bivirkninger (f.eks. pneumonitis, glomerulonephritis,
English: Among the patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Danish: Blandt de patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg i CA209214, opstod grad 3 eller 4 bivirkninger i den indledende kombinationsfase for 169/547 (31 %).
English: Ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg
Danish: Ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg
English: If you have any questions about nivolumab, please ask your doctor.
Danish: Tal med din læge, hvis du har spørgsmål om nivolumab.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of diarrhoea or colitis was 28.2% (154/547).
Danish: Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af diarré eller colitis 28,2 % (154/547).
English: Grade 2, Grade 3, and Grade 4 cases were reported in 0.5% (3/547), 2.4% (13/547), and 0.4% (2/547) of patients, respectively.
Danish: Grad 2, grad 3 og grad 4 tilfælde blev rapporteret hos henholdsvis 0,5 % (3/547), 2,4 % (13/547) og 0,4 % (2/547) af patienterne.