FrancophonIA/ELRC3.0 huggingface dataset:
English: To dilute the YERVOY concentrate, you can use either: sodium chloride 9 mg/ml (0.9%) solution for injection; or 50 mg/ml (5%) glucose solution for injection
Danish: Til fortynding af YERVOY koncentrat kan der anvendes enten: natriumchlorid 9 mg/ml (0,9 %) injektionsvæske; eller 50 mg/ml (5 %) glucose injektionsvæske
English: If applicable, dilute with the required volume of sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection.
Danish: Hvis det er relevant udføres fortynding med den påkrævede mængde natriumchlorid 9 mg/ml (0,9 %) injektionsvæske eller 50 mg/ml (5 %) glucose injektionsvæske.
English: Persistent diarrhoea or colitis should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Danish: Vedvarende diarré eller colitis bør behandles med kortikosteroider med en dosis ækvivalent med methylprednisolon 0,51 mg/kg/dag.
English: Very common (may affect more than 1 in 10 people) underactive thyroid gland (which can cause tiredness or weight gain), overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss) loss of appetite headache shortness of breath (dyspnoea) inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools), vomiting or feeling sick (nausea), stomach pain skin rash sometimes with blisters, itching pain in the muscles and bones (musculoskeletal pain), painful joints (arthralgia) feeling tired or weak, fever
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) nedsat funktion af skjoldbruskkirtlen (hvilket kan medføre træthed eller vægtstigning), øget funktion af skjoldbruskkirtlen (som kan medføre hurtig hjerterytme (puls), svedudbrud og vægttab) manglende appetit hovedpine åndenød (dyspnø) betændelseslignende reaktion i tarmene (colitis), diarré (vandig, løs eller blød afføring), opkastning eller kvalme, mavesmerter hududslæt, undertiden med blærer, kløe smerter i muskler og knogler (muskuloskeletale smerter) og smerter i led (artralgi) træthed eller svaghedsfølelse, feber
English: Median time to onset was 2.6 months (range: 0.25-20.6).
Danish: Mediantid til indtræden var 2,6 måneder (0,25-20,6).
English: Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that ipilimumab does not adversely affect them.
Danish: 4.8) bør patienten tilrådes at udvise forsigtighed under kørsel eller betjening af maskiner, indtil patienten med sikkerhed ved, at ipilimumab ikke påvirker hans/hendes evne til at føre motorkøretøj eller betjene maskiner.
English: Severe hepatitis has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Danish: Svær hepatitis er observeret med ipilimumab i kombination med nivolumab (se pkt.
English: Eye disorders Common uveitis, blurred vision blurred vision
Danish: Øjne Almindelig uveitis, slørret syn sløret syn
English: The median time to onset of severe or fatal (Grade 3 to 5) immune-related gastrointestinal reactions was 8 weeks (range 5 to 13 weeks) from the start of treatment.
Danish: 5.1), var mediantiden til indtræden af svære eller dødelige (Grad 3-5) immunrelaterede gastrointestinale bivirkninger 8 uger (5 til 13 uger) efter behandlingsstart.
English: Hypersensitivity/Infusion Reaction Immune-related adverse reaction requiring high-dose corticosteroidsa,b
Danish: Immunrelateret bivirkning, der krævede behandling med højdosiskortikosteroidera,b
English: One 40 ml vial contains 200 mg of ipilimumab.
Danish: Et 40 ml hætteglas indeholder 200 mg ipilimumab.
English: A group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour lysis syndrome) An inflammatory disorder (most likely of autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt-Koyanagi-Harada syndrome) Inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial disorders)
Danish: Andre bivirkninger, som er blevet rapporteret (hyppighed ikke kendt) med ipilimumab i kombination med nivolumab, inkluderer: afstødning af transplanterede solide organer en række stofskiftekomplikationer efter kræftbehandling karakteriseret ved høje koncentrationer af kalium og phosphat i blodet og lav koncentration af calcium i blodet (tumorlysesyndrom) en betændelseslignende sygdom (højst sandsynligt af autoimmun oprindelse), der påvirker øjnene, huden og membranerne i ørerne, hjernen og rygmarven (Vogt-Koyanagi-Harada syndrom) betændelseslignende reaktion i sækken, der ligger omkring hjertet, og ophobning af væske omkring hjertet (sygdomme i perikardiet)
English: When ipilimumab 3 mg/kg was administered in combination with nivolumab 1 mg/kg, the CL of ipilimumab was increased by 9% and the CL of nivolumab was increased by 29%, which was not considered clinically relevant.
Danish: Ipilimumabs CL øgedes med 9 % og nivolumabs CL øgedes med 29 %, når ipilimumab 3 mg/kg blev administreret i kombination med nivolumab 1 mg/kg, hvilket ikke blev anset for klinisk relevant.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of pneumonitis including interstitial lung disease was 6.2% (34/547).
Danish: Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af pneumonitis, herunder interstitiel lungesygdom, 6,2 % (34/547).
English: Uncommon respiratory failure, acute respiratory distress syndromeb, lung infiltration, pulmonary oedema, pneumonitis, allergic rhinitis
Danish: Almindelig dyspnø, hoste Ikke almindelig respirationssvigt, akut respiratorisk distress syndromb, lungeinfiltrat, lungeødem,
English: Uncommon uveitisc, vitreous haemorrhage, iritisc, eye oedemad, blepharitisd, reduced visual acuity, foreign body sensation in eyes, conjunctivitis
Danish: Almindelig sløret syn, øjensmerter Ikke almindelig uveitisc, glaslegemeblødning, iritisc, øjenødemd, blefaritisd, nedsat synsskarphed, fornemmelse af fremmedlegeme i øjet, konjunktivitis
English: Immune-related endocrinopathy
Danish: Immunrelateret endokrinopati
English: Based on the severity of myotoxicity, ipilimumab in combination with nivolumab should be withheld or discontinued (see section 4.2), and appropriate treatment instituted.
Danish: Afhængigt af sværhedsgraden af myotoksicitet skal behandlingen med ipilimumab i kombination med nivolumab udsættes eller seponeres (se pkt.
English: Laboratory abnormalities with ipilimumab in combination with nivolumab
Danish: Laboratorietestabnormiteter ved ipilimumab i kombination med nivolumab
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of liver function test abnormalities was 18.5% (101/547).
Danish: Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af abnorme leverfunktionstests 18,5 % (101/547).
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of pneumonitis including interstitial lung disease, was 7.8% (35/448).
Danish: Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af pneumonitis, herunder interstitiel lungesygdom, 7,8 % (35/448).
English: Ipilimumab is associated with serious immune-related neurological adverse reactions.
Danish: Ipilimumab er associeret med svære immunrelaterede neurologiske bivirkninger.
English: For Grade 2 (symptomatic) pneumonitis, ipilimumab in combination with nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 2 (symptomatisk) pneumonitis bør ipilimumab i kombination med nivolumab udsættes og kortikosteroider initieres med en dosis ækvivalent med methylprednisolon 1 mg/kg/dag.
English: Not known solid organ transplant rejectionh Endocrine disorders Very common hypothyroidism hypothyroidism, hyperthyroidism
Danish: Det endokrine system Meget almindelig hypotyroidisme hypotyroidisme, hypertyroidisme
English: For Grade 2 or 3 serum creatinine elevation, ipilimumab in combination with nivolumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 2 eller 3 stigning i serumkreatinin bør ipilimumab i kombination med nivolumab udsættes, og kortikosteroider initieres med en dosis ækvivalent med methylprednisolon 0,5-1 mg/kg/dag.
English: Resolution occurred in 37 patients (77.1%) with a median time to resolution of 13.2 weeks (range: 0.1+-106.0+).
Danish: Resolution forekom hos 37 patienter (77,1 %) med en mediantid til resolution på 13,2 uger (0,1+
English: Immune system disorders Uncommon hypersensitivity Very rare anaphylactic reaction Endocrine disorders Common hypopituitarism (including hypophysitis)c, hypothyroidismc Uncommon adrenal insufficiencyc, secondary adrenocortical insufficiencyd, hyperthyroidismc, hypogonadism
Danish: Almindelig hypopituitarisme (herunder hypofysitis)c, hypotyroidismec Ikke almindelig binyrebarkinsufficiensc, sekundær binyrebarkinsufficiensd, hypertyroidismec, hypogonadisme
English: In patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, time to onset of moderate to severe or fatal (Grade 2-5) immune-related hepatotoxicity ranged from 3 to 9 weeks from the start of treatment.
Danish: Hos patienter, som fik ipilimumab 3 mg/kg monoterapi i MDX010-20, indtrådte moderat til svær eller dødelig (Grad 2-5) immunrelateret levertoksicitet mellem 3 til 9 uger efter behandlingsstart.
English: triad of symptoms (meningism): neck stiffness, intolerance of bright light and headache, flu-like discomfort inflammation of the heart muscle, weakness of the heart muscle, fluid around the heart inflammation of the liver or the pancreas, nodules of inflammatory cells in various organs of your body infection within the abdomen painful skin lesions of the arms and legs and face (erythema nodosum) overactive pituitary gland decreased function of the parathyroid gland inflammation of the eye, eye muscle inflammation decreased hearing poor blood circulation which makes toes and fingers numb or pale damage to the tissues of the hands and feet resulting in redness, swelling and blisters
Danish: række af symptomer (meningitis): nakkestivhed, følsomhed over for stærkt lys og hovedpine, influenza-lignende ubehag betændelse i hjertemusklen, svaghed i hjertemusklen, væske omkring hjertet betændelse i leveren eller skjoldbruskkirtlen, små knuder af inflammationsceller (celler, der er involveret i kroppens selvforsvar mod diverse skadelige stimuli) i forskellige organer i kroppen bughulebetændelse smertefulde hudlæsioner på arme, ben og ansigt (erythema nodosum) overaktiv hypofyse nedsat funktion af biskjoldbruskkirtlen øjenbetændelse, inflammation i øjenmuskulaturen nedsat hørelse dårlig blodcirkulation som gør fingre og tæer følelsesløse eller hvide vævsskader i hænder og fødder med rødme, hævelse og blæredannelse
English: For symptomatic hypothyroidism, ipilimumab in combination with nivolumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Danish: Ved symptomatisk hypotyroidisme bør ipilimumab i kombination med nivolumab udsættes og substitutionsbehandling med thyroideahormon initieres efter behov.
English: In patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, the median time to onset of moderate to severe or fatal (Grade 2-5) skin adverse reactions was 3 weeks (range 0.9-16 weeks) from start of treatment.
Danish: Hos patienter, der fik ipilimumab 3 mg/kg monoterapi i MDX010-20, indtrådte moderate til svære eller dødelige (Grad 2-5) hudbivirkninger med en mediantid på 3 uger (0,9-16 uger) efter behandlingsstart.
English: Severe nephritis and renal dysfunction have been observed with ipilimumab in combination with nivolumab (see section 4.8).
Danish: Svær nefritis og nedsat nyrefunktion er observeret med ipilimumab i kombination med nivolumab (se pkt.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of rash was 48.8% (267/547).
Danish: Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af udslæt 48,8 % (267/547).
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of thyroid disorders was 25.2% (113/448).
Danish: Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af thyroidearelaterede bivirkninger 25,2 % (113/448).
English: Uncommon vasculitis, angiopathyb, peripheral ischaemia, orthostatic hypotension Rare temporal arteritisd
Danish: Almindelig hypotension, rødmen, hedeture Ikke almindelig vaskulitis, angiopatib, perifer iskæmi, ortostatisk hypotension
English: Rare serous retinal detachment serous retinal detachment
Danish: Sjælden serøs nethindeløsning serøs nethindeløsning
English: Ipilimumab is associated with serious immune-related hepatotoxicity.
Danish: Ipilimumab er associeret med alvorlig immunrelateret levertoksicitet.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of thyroid disorders was 27.2% (149/547).
Danish: Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af thyroidearelaterede bivirkninger 27,2 % (149/547).
English: b. Tabulated list of adverse reactions
Danish: b. Tabel over bivirkninger
English: For symptomatic diabetes, ipilimumab in combination with nivolumab should be withheld, and insulin replacement should be initiated as needed.
Danish: Ved symptomatisk diabetes bør ipilimumab i kombination med nivolumab udsættes og insulinbehandling initieres efter behov.
English: Nivolumab+Ipilimumab (events: 63/155), median and 95% CI: N.A. (39.06, N.A.) ──Δ─── Nivolumab (events: 71/171), median and 95% CI: N.A. (40.21, N.A.) Ipilimumab (events: 103/164), median and 95% CI: 21.49 months (16.85, 29.08)
Danish: Nivolumab+ipilimumab (hændelser: 63/155), median og 95 % CI: N.A. (39,06; N.A.) ──Δ─── Nivolumab (hændelser: 71/171), median og 95 % CI: N.A. (40,21; N.A.) Ipilimumab (hændelser: 103/164), median og 95 % CI: 21,49 måneder (16,85; 29,08)
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 mg/kg/day methylprednisolone equivalents and ipilimumab in combination with nivolumab must be permanently discontinued.
Danish: Hvis der opstår forværring, eller der ikke sker bedring på trods af initiering af kortikosteroider, skal kortikosteroiddosis øges op til en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag, og ipilimumab i kombination med nivolumab skal seponeres permanent.
English: Nivolumab+Ipilimumab (events: 59/123), median and 95% CI: N.A. (26.45, N.A.) ──Δ─── Nivolumab (events: 71/117), median and 95% CI: 23.46 months (13.01, 36.53) Ipilimumab (events: 77/113), median and 95% CI: 18.56 months (13.67, 23.20)
Danish: Nivolumab+ipilimumab (hændelser: 59/123), median og 95 % CI: N.A. (26,45; N.A.) ──Δ─── Nivolumab (hændelser: 71/117), median og 95 % CI: 23,46 måneder (13,01; 36,53) Ipilimumab (hændelser: 77/113), median og 95 % CI: 18,56 måneder (13,67; 23,20)
English: If you miss a dose of YERVOY
Danish: Hvis du har glemt at bruge YERVOY
English: If you have any further questions about your treatment or the use of this medicine, ask your doctor.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of nephritis or renal dysfunction was 8.8% (48/547).
Danish: Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af nefritis eller nedsat nyrefunktion 8,8 % (48/547).
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of rash was 65.0% (291/448).
Danish: Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af udslæt 65,0 % (291/448).
English: Median duration of responseg
Danish: Median responsvarighedg
English: Nivolumab+ipilimumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: < 0.0001 Nivolumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.55 (0.42, 0.73); p-value: < 0.0001
Danish: Nivolumab versus ipilimumab (primær analyse) - HR (99,5 % CI): 0,55 (0,42; 0,73); p-værdi: < 0,0001 Nivolumab+ipilimumab versus nivolumab (deskriptiv analyse) - HR (95 % CI): 0,76 (0,62; 0,95)
English: At the time of this analysis, the hazard ratio was 0.66; (99.8% CI 0.48-0.91) with 166/425 events in the combination arm and 209/422 events in the sunitinib arm. At 18 months, the OS rate was 74.3 (95% CI 69.8-78.2) for ipilimumab in combination with nivolumab and 59.9 (95% CI 54.9-64.5) for sunitinib.
Danish: Hazard ratio var ved analysetidspunktet 0,66; (99,8 % CI 0,48-0,91) med 166/425 hændelser i kombinationsarmen, og 209/422 hændelser i sunitinib-armen.
English: One 10 ml vial contains 50 mg of ipilimumab.
Danish: Et 10 ml hætteglas indeholder 50 mg ipilimumab.
English: Ipilimumab in combination with nivolumab (see section 4.2)
Danish: Ipilimumab i kombination med nivolumab (se pkt.
English: Ipilimumab must be permanently discontinued in patients with severe (Grade 3 or 4) diarrhoea or colitis (see section 4.2), and systemic high-dose intravenous corticosteroid therapy should be initiated immediately.
Danish: Ipilimumab skal seponeres permanent hos patienter med svær (Grad 3 eller 4) diarre eller colitis (se pkt.
English: Flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection at the end of the infusion.
Danish: slangen med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske eller 50 mg/ml (5 %) glucose injektionsvæske.
English: Common (may affect up to 1 in 10 people) tumour pain underactive function of the thyroid gland which can cause tiredness or weight gain, underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain dehydration confusion damage to the nerves (causing pain, weakness and cramps), dizziness, headache, blurred vision, pain in the eye low blood pressure, temporary redness of the face and neck, feeling of intense heat with sweating and rapid heart beat shortness of breath (dyspnoea), cough bleeding in the stomach or intestine, inflammation of the intestines (colitis), constipation, heartburn, stomach pain abnormal function of the liver inflammation of the inner surface lining of a particular organ inflammation and redness of the skin, skin colour change in patches (vitiligo), hives (itchy, bumpy rash), hair loss or thinning, excessive sweating at night, dry skin pain in muscles and joints(arthralgia), muscle spasms shivering, lack of energy, oedema (swelling), pain flu-like illness weight loss
Danish: Almindelige bivirkninger (kan forekomme hos færre end 1 ud af 10 personer) tumorsmerter nedsat funktion af skjoldbruskkirtlen, hvilket kan medføre træthed eller vægtstigning, nedsat funktion (hypopituitarisme) af eller betændelseslignende reaktion (hypofysitis) i hypofysen, der er placeret nederst i hjernen væskemangel forvirring nerveskader (medfører smerter, svaghed og kramper), svimmelhed, hovedpine sløret syn, øjensmerter lavt blodtryk, forbigående rødme i ansigtet og på halsen, intens varmefølelse med svedudbrud og hurtig hjertebanken åndenød (dyspnø), hoste blødning i maven eller tarmene, tarmbetændelse (tyktarmsbetændelse), forstoppelse, halsbrand, mavesmerter unormal leverfunktion betændelseslignende reaktion (inflammation) på indersiden af visse organer inflammation og rødme på huden, farveændringer som pletter på huden (vitiligo), nældefeber (kløende, hævet udslæt), hårtab eller udtynding af håret, voldsom nattesved, tør hud muskelsmerter og ledsmerter (artralgi), muskelkramper kulderystelser, manglende energi, væskeansamlinger (hævelse), smerter influenza‑lignende sygdom vægttab
English: These additional reactions occurred at a frequency of < 1% unless otherwise noted: meningism, myocarditis, pericardial effusion, cardiomyopathy, autoimmune hepatitis, erythema nodosum, autoimmune pancreatitis, hyperpituitarism, hypoparathyroidism, infectious peritonitis, episcleritis, scleritis, Raynaud's phenomenon, palmar-plantar erythrodysaesthesia syndrome, cytokine release syndrome, sarcoidosis,
Danish: meningisme, myokarditis, perikardieeffusion, kardiomyopati, autoimmun hepatitis, erythema nodosum, autoimmun pancreatitis, hyperpituitarisme, hypoparatyroidisme, infektiøs peritonitis, episcleritis, scleritis, Raynaudfænomen, palmar-plantar erythrodysæstesi syndrom, cytokinfrigivelsessyndrom, sarkoidose, nedsat gonadotropin, leukopeni, polycytæmi, lymfocytose, okulær myositis og neurosensorisk høretab.
English: For Grade 3 or 4 pneumonitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 3 eller 4 pneumonitis skal ipilimumab i kombination med nivolumab seponeres permanent, og kortikosteroider skal initieres med en dosis ækvivalent med methylprednisolon 2-4 mg/kg/dag.
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.55 (0.40, 0.75) Nivolumab vs. Ipilimumab - hazard ratio: 0.54 (0.40, 0.73) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 1.02 (0.73, 1.43)
Danish: Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,55 (0,40; 0,75) Nivolumab versus ipilimumab - hazard ratio: 0,54 (0,40; 0,73) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 1,02 (0,73; 1,43)
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and ipilimumab in combination with nivolumab must be permanently discontinued.
Danish: Hvis der opstår forværring, eller der ikke sker bedring på trods af initiering af kortikosteroider, skal kortikosteroiddosis øges op til en dosis ækvivalent med methylprednisolon 24 mg/kg/dag, og ipilimumab i kombination med nivolumab skal seponeres permanent.
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
Danish: Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af nefritis eller nedsat nyrefunktion 5,1 % (23/448).
English: Investigationsb
Danish: Undersøgelser
English: NAME OF THE MEDICINAL PRODUCT YERVOY 5 mg/ml concentrate for solution for infusion 2.
Danish: YERVOY 5 mg/ml koncentrat til infusionsvæske, opløsning 2.
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.59 (0.42, 0.82) Nivolumab vs. Ipilimumab - hazard ratio: 0.84 (0.61, 1.16) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.70 (0.49, 0.99)
Danish: Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,59 (0,42; 0,82) Nivolumab versus ipilimumab - hazard ratio: 0,84 (0,61; 1,16) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 0,70 (0,49; 0,99)
English: The hazard ratio (HR) for comparison of OS between ipilimumab monotherapy and gp100 was 0.66 (95% CI: 0.51, 0.87; p = 0.0026).
Danish: De regimer, der indeholdt ipilimumab, viste en statistisk signifikant fordel over for gp100-kontrolgruppen i forhold til OS. Hazard ratio (HR) for OS var 0,66 (95 % CI: 0,51; 0,87; p = 0,0026) til fordel for ipilimumab monoterapi sammenlignet med gp100.