FrancophonIA/ELRC3.0 huggingface dataset:
English: Study CA184070 was a multi-center, Phase 1, open-label, dose-escalation study of ipilimumab in paediatric patients ≥1 year to ≤ 21 years of age with measurable/evaluable, untreatable, relapsed or refractory solid malignant tumors without a curative option with standard therapy.
Danish: CA184070 var et åbent, multi-center, dosiseskalerings fase 1 studie af ipilimumab i pædiatriske patienter ≥1 år til ≤ 21 år med målbare/evaluerbare, uhelbredelige, recidiverende eller refraktære solide maligne tumorer uden mulighed for helbredelse med standardbehandling.
English: Patients ≥ 75 years of age represented 8% of all intermediate/poor risk patients in CA209214, and the combination of ipilimumab with nivolumab showed numerically less effect on OS (HR 0.97, 95% CI: 0.48, 1.95) in this subgroup versus the overall population.
Danish: Patienter ≥ 75 år udgjorde 8 % af alle mellem- eller højrisikopatienter i CA209214, og kombinationen af ipilimumab og nivolumab viste numerisk mindre effekt på OS (HR 0,97; 95 % CI: 0,48; 1,95), i denne undergruppe versus den samlede population.
English: A drug-interaction study in adults of ipilimumab administered alone and in combination with chemotherapy (dacarbazine or paclitaxel/carboplatin) was conducted evaluating interaction with CYP isozymes (particularly CYP1A2, CYP2E1, CYP2C8, and CYP3A4) in patients with treatment-naive advanced melanoma.
Danish: Der er i voksne blevet udført et lægemiddelinteraktionsstudie med ipilimumab administreret alene og i kombination med kemoterapi (dacarbazin eller paclitaxel/carboplatin), der undersøgte interaktion med CYP-isozymer (især CYP1A2, CYP2E1, CYP2C8 og CYP3A4) hos behandlingsnaive patienter med fremskredent melanom.
English: BORR was similar in the 10 mg/kg and 3 mg/kg groups.
Danish: BORR var ensartet i grupperne 10 mg/kg og 3 mg/kg.
English: Stable disease was achieved for 260 days in one patient on ipilimumab 3 mg/kg and approximately 14 months in one patient on ipilimumab 10 mg/kg.
Danish: Stabil sygdom blev opnået i 260 dage hos en patient på ipilimumab 3 mg/kg og i omkring 14 måneder hos en patient på ipilimumab 10 mg/kg.
English: Transient vision loss has been reported in patients with ipilimumab-related ocular inflammations.
Danish: Der er rapporteret om forbigående synstab hos patienter med ipilimumab-relaterede øjeninflammationer.
English: Results from exploratory multivariate analyses identified patient and tumour characteristics (ECOG performance status, M stage, baseline LDH, BRAF mutation status, PD-L1 status, and gender) which might contribute to the survival outcome.
Danish: Resultater fra eksplorative, multivariate analyser viser patient- og tumorkarakteristika (ECOG-performance-score, M-stadie, LDH ved baseline, BRAF-mutationsstatus, PD-L1-status og køn), som kan være medvirkende til overlevelsesudfaldet.
English: Symptoms of nerve problems may include muscle weakness, numbness or tingling in your hands or feet, loss of consciousness or difficulty waking up.
Danish: Symptomerne på nerveproblemer kan være muskelsvaghed, følelsesløshed eller snurren i hænder og fødder, tab af bevidsthed eller problemer med at vågne.
English: Cardiac and pulmonary adverse events including pulmonary embolism have also been reported with combination therapy.
Danish: Kardielle og pulmonale bivirkninger, herunder lungeemboli, er også rapporteret i forbindelse med kombinationsbehandling.
English: For patients with a severe (Grade 3) rash, the scheduled dose of ipilimumab should be withheld.
Danish: Hos patienter med svært (Grad 3) udslæt bør den planlagte dosis af ipilimumab udsættes.
English: Based on these preliminary data, the concurrent administration of ipilimumab and vemurafenib is not recommended.
Danish: På baggrund af disse præliminære data kan samtidig administration af ipilimumab og vemurafenib ikke anbefales.
English: For patients who required re-treatment, the BORR was 38% (3/8 patients) in the ipilimumab monotherapy group, and 0% in the gp100 group.
Danish: For patienter, som havde behov for genbehandling, var BORR 38 % (3/8 patienter) i ipilimumab‑monoterapigruppen og 0 % i gp100-gruppen.
English: Patients must be evaluated for evidence of gastrointestinal perforation or peritonitis.
Danish: Patienten skal undersøges for tegn på gastrointestinal perforation eller peritonitis.
English: ≥ Grade 3 immune-related reactionsc
Danish: ≥ Grad 3 immunrelaterede reaktionerc
English: The majority were mild to moderate (Grade 1 or 2).
Danish: Størstedelen var lette til moderate (Grad 1 eller 2).
English: A total of 945 patients were randomised to receive ipilimumab in combination with nivolumab (n = 314), nivolumab monotherapy (n = 316), or ipilimumab monotherapy (n = 315).
Danish: I alt 945 patienter blev randomiseret til at få enten ipilimumab i kombination med nivolumab(n = 314), nivolumab-monoterapi (n = 316) eller ipilimumab-monoterapi (n = 315).
English: Signs and symptoms that your glands are not working properly may include headaches, blurry or double vision, tiredness, decreased sexual drive, behavioral changes.
Danish: Tegn og symptomer på at dine kirtler ikke virker ordentligt kan være hovedpine, sløret syn eller dobbeltsyn, træthed, nedsat sexlyst, ændret adfærd.
English: In addition, iritis, haemolytic anaemia, amylase elevations, multi-organ failure, and pneumonitis have been reported in patients treated with ipilimumab 3 mg/kg + gp100 peptide vaccine in MDX010-20.
Danish: Derudover er der rapporteret om iritis, hæmolytisk anæmi, amylaseforhøjelser, multiorgansvigt og pneumonitis hos patienter i behandling med ipilimumab 3 mg/kg + gp100 peptidvaccine i MDX010-20.
English: Ipilimumab 3 mg/kg was administered to four patients and ipilimumab 10 mg/kg was administered to eight patients.
Danish: Ipilimumab 3 mg/kg blev administreret til fire patienter og ipilimumab 10 mg/kg blev administreret til otte patienter.
English: Ipilimumab CL increased with increasing body weight and with increasing LDH at baseline; however, no dose adjustment is required for elevated LDH or body weight after administration on a mg/kg basis.
Danish: CL af ipilimumab øgedes i takt med øget kropsvægt og øget LDH ved behandlingsstart; dosisjustering er imidlertid ikke nødvendig ved øget LDH eller kropsvægt efter administration på basis af mg/kg dosering.
English: Patients with mild to moderate (Grade 1 or 2) diarrhoea (an increase of up to 6 stools per day) or suspected mild to moderate colitis (e.g. abdominal pain or blood in stools) may remain on ipilimumab.
Danish: Patienter med let til moderat (Grad 1 eller 2) diarre (en stigning på op til 6 gange afføring pr. dag) eller mistænkt let til moderat colitis (f.eks. mavesmerter eller blod i afføringen) kan eventuelt fortsætte med ipilimumab.
English: The median duration of treatment was 7.9 months (range: 1 day- 21.4+ months) in ipilimumab with nivolumab- treated patients and was 7.8 months (range: 1 days- 20.2+ months) in sunitinib-treated patients.
Danish: Den mediane behandlingsvarighed var 7,9 måneder (1 dag-21,4+ måneder) hos ipilimumab med nivolumabbehandlede patienter og 7,8 måneder (1 dag-20,2+ måneder) hos sunitinib-behandlede patienter.
English: Tris hydrochloride (2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride) Sodium chloride
Danish: Tris‑hydrochlorid (2-amino-2-hydroxymethyl-1,3-propandiolhydrochlorid) Natriumchlorid
English: Overall survival in MDX010-20 Ipilimumab 3 mg/kg n= 137
Danish: Samlet overlevelse i MDX010-20 Ipilimumab 3 mg/kg n= 137
English: Myasthenia gravis-like symptoms have also been reported (see section 4.8).
Danish: Der er også rapporteret om myasthenia gravis-lignende symptomer (se pkt.
English: Based on population pharmacokinetic analysis, the following mean (percent coefficient of variation) parameters of ipilimumab were obtained: terminal half-life of 15.4 days (34.4%); systemic CL of 16.8 ml/h (38.1%); and volume of distribution at steady-state of 7.47 l (10.1%).
Danish: Baseret på en farmakokinetisk populationsanalyse blev følgende gennemsnitlige (variationskoefficient i procent) parametre for ipilimumab nået: halveringstid på 15,4 dage (34,4 %); systemisk CL på 16,8 ml/time (38,1 %); og fordelingsvolumen ved steady-state på 7,47 l (10,1 %).
English: For additional information on clinical efficacy and safety associated with the dosing recommendations of nivolumab when administered as monotherapy following combination therapy with ipilimumab, please refer to the nivolumab SmPC.
Danish: For yderligere information om klinisk virkning og sikkerhed forbundet med den anbefalede dosering for nivolumab, når det administreres som monoterapi efterfulgt af kombinationsterapi med ipilimumab, se venligst produktresuméet for nivolumab.
English: No specific dose adjustment is necessary in this population (see section 5.1).
Danish: Det er ikke nødvendigt med dosisjustering til denne population (se pkt.
English: Polyethersulfone (0.2 μm to 1.2 μm) and nylon (0.2 μm) in-line filters
Danish: In-line filtre af polyetersulfon (0,2 μm til 1,2 μm) og nylon (0,2 μm)
English: In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Danish: I tilfælde af en overdosis skal patienten monitoreres tæt for tegn og symptomer på bivirkninger og passende symptomatisk behandling iværksættes.
English: Unless otherwise specified, the data below reflect exposure to ipilimumab at 3 mg/kg in clinical trials of melanoma.
Danish: Medmindre andet er angivet, afspejler nedenstående data eksponering for ipilimumab ved 3 mg/kg i kliniske forsøg ved melanom.
English: Study CA209069 was a randomised, Phase 2, double-blind study comparing the combination of nivolumab and ipilimumab with ipilimumab alone in 142 patients with advanced (unresectable or metastatic) melanoma with similar inclusion criteria to study CA209067 and the primary analysis in patients with BRAF wild-type melanoma (77% of patients).
Danish: Studie CA209069 var et randomiseret, dobbeltblindet fase 2-studie, som sammenlignede kombinationen af nivolumab og ipilimumab med ipilimumab alene hos 142 patienter med fremskredent (inoperabelt eller metastatisk) melanom med lignende inklusionskriterier som i studie CA209067 og den primære analyse hos patienter med BRAF-vildtype-melanom (77 % af patienterne).
English: mg/kg group experienced a Grade 1 and Grade 3 on-study endocrine irAR of hyperglycemia.
Danish: To patienter i 10 mg/kg-gruppen oplevede en Grad 1 og Grad 3 on-study endokrin irAR i form af hyperglykæmi.
English: DCR (%) (95% CI) Median PFS (months) (95% CI)
Danish: DCR (%) (95 % CI) Median PFS (måneder) (95 % CI)
English: Rare decreased blood thyroid stimulating hormoned, decreased thyroxined, abnormal blood prolactind a
Danish: Sjælden forhøjet tyroidstimulerende hormon i blodetd, nedsat thyroxind, unormalt niveau af prolaktin i blodetd a
English: YERVOY in combination with nivolumab Melanoma
Danish: YERVOY i kombination med nivolumab Melanom
English: The total ipilimumab dose in mg = the patient's weight in kg × the prescribed dose in mg/kg.
Danish: Den totale ipilimumab dosis i mg = patientens vægt i kg × den ordinerede dosis i mg/kg.
English: Tumour PD-L1 expression was determined using the PD-L1 IHC 288 pharmDx assay.
Danish: PD-L1-tumorekspression blev bestemt ved hjælp af PD-L1 IHC 28-8 pharmDx-analysen.
English: Upon improvement, ipilimumab may be resumed (see section 4.2).
Danish: Efter forbedring kan ipilimumab eventuelt genoptages (se pkt.
English: PFS results (with minimum follow up of 18 months) are shown in Figure 2 (all randomised population), Figure 3 (at the tumour PD-L1 5% cut off), and Figure 4 (at the tumour PD-L1 1% cut off).
Danish: PFS-resultater (opfølgningsperioden var minimum 18 måneder) er vist i figur 2 (hele populationen randomiseret), figur 3 (ved tumor-PD-LI 5 % cut-off) og figur 4 (ved tumor-PD-L1 1 % cut-off).
English: Grade 4 or recurrent Grade 3 ; persistent Grade 2 or 3 despite treatment modification ; inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day
Danish: Grad 4 eller recidiverende grad 3; vedvarende grad 2 eller 3 på trods af behandlingsmodifikation; ikke muligt at reducere kortikosteroiddosis til 10 mg prednison dagligt eller en dosis ækvivalent hermed
English: Of the patients who were treated with ipilimumab in combination with nivolumab and evaluable for the presence of anti-ipilimumab antibodies, the incidence of anti-ipilimumab antibodies ranged from 6.3 to 8.4%%.
Danish: Af de patienter, som blev behandlet med ipilimumab i kombination med nivolumab og var evaluerbare for tilstedeværelse af anti-ipilimumab-antistoffer, var forekomsten af anti-ipilimumab-antistoffer mellem 6,3 og 8,4 %.
English: • Placeholder including the weblink of the Package Leaflet on the EMA website
Danish: • Link til indlægssedlen på EMA's hjemmeside.
English: Table 4: Adverse reactions in patients with advanced melanoma treated with ipilimumab 3 mg/kg (n= 767)a
Danish: Tabel 4: Bivirkninger hos patienter med fremskredent melanom, der behandles med ipilimumab 3 mg/kg (n=767)a
English: Study CA184178 was a non-randomized, multicenter, open-label Phase 2 study, in adolescent patients 12 to < 18 years of age with previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma.
Danish: Forsøg CA184178 var et non-randomiseret, multicenter, åbent fase 2 studie i unge patienter 12 til < 18 år med tidligere behandlet eller ubehandlet, inoperabelt Stadie III eller Stadie IV malignt melanom.
English: When administered in combination with nivolumab, nivolumab should be given first followed by YERVOY on the same day.
Danish: Når YERVOY administreres i kombination med nivolumab, skal nivolumab administreres først og efterfølges af YERVOY på den samme dag.
English: There were no reports of severe (Grade 3 or 4) AST or ALT elevation.
Danish: Der var ingen rapporter om svær (Grad 3 eller 4) forhøjet ASAT eller ALAT.
English: Adults and adolescents 12 years of age and older
Danish: Melanom Voksne og unge på 12 år og derover
English: Advanced Melanoma
Danish: Fremskredent melanom Fremskredent melanom
English: For patients with a history of autoimmune disease, see also section 4.4.
Danish: For patienter med autoimmun sygdom i anamnesen, se også pkt.
English: YERVOY must be administered with caution in patients with transaminase levels ≥ 5 x ULN or bilirubin levels > 3 x ULN at baseline (see section 5.1).
Danish: YERVOY skal administreres med forsigtighed til patienter med aminotransferaseniveauer ≥ 5 x ULN (øvre grænse for normalområdet) eller bilirubinniveauer > 3 x ULN ved behandlingsstart (se pkt.
English: Once a diagnosis of myocarditis is established, ipilimumab in combination with nivolumab should be withheld or permanently discontinued (see section 4.2).
Danish: Så snart diagnosen myocarditis er fastslået, skal ipilimumab i kombination med nivolumab udsættes eller seponeres permanent (se pkt.
English: Table 12: Efficacy results in intermediate/poor risk patients (CA209214)
Danish: Tabel 12: Effektresultater hos mellem- eller højrisikopatienter (CA209214)
English: YERVOY concentrate is a clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates.
Danish: YERVOY koncentrat er en klar til let opaliserende, farveløs til lysegul væske, der kan indeholde lyse (få) partikler.
English: By subgroup analysis, the observed OS benefit was consistent within most of the subgroups of patients (M [metastases]-stage, prior interleukin-2, baseline LDH, age, sex, and the type and number of prior therapy).
Danish: Ved sub-gruppeanalyse var den observerede OS‑fordel til stede i de fleste patient sub-grupper (M [metastase] -stadium, tidligere interleukin-2, LD-udgangsniveau, alder og køn samt typen og antallet af tidligere behandlinger).
English: Therefore, ipilimumab should not be used in children younger than 12 years of age.
Danish: Derfor bør ipilimumab ikke anvendes til børn under 12 år.
English: The volume of YERVOY concentrate to prepare the dose (ml) = the total dose in mg, divided by 5 (the YERVOY concentrate strength is 5 mg/ml).
Danish: Mængden af YERVOY koncentrat til klargøring af dosis (ml) = den totale dosis i mg, divideret med 5 (styrken af YERVOY koncentrat er 5 mg/ml).
English: Frequencies are based on pooled data from 9 clinical trials investigating the ipilimumab 3 mg/kg dose in melanoma.
Danish: Hyppighederne er baserede på samlede data fra 9 kliniske forsøg, der undersøgte en ipilimumab-dosis på 3 mg/kg ved melanom.
English: Systemic high-dose corticosteroid with or without additional immunosuppressive therapy may be required for management of severe immune-related adverse reactions.
Danish: Systemiske højdosis kortikosteroider med eller uden yderligere immunosuppressiv terapi kan være nødvendig til behandling af alvorlige immunrelaterede bivirkninger.
English: Table 6: Immune-related adverse reactions leading to permanent discontinuation or requiring high-dose corticosteroids by dosing regimen
Danish: Tabel 6: Immunrelaterede bivirkninger, der førte til permanent seponering eller der krævede behandling med højdosis-kortikosteroider ud fra dosisregime
English: YERVOY in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Danish: YERVOY i kombination med nivolumab er indiceret til behandling af fremskredent (inoperabelt eller metastatisk) melanom hos voksne.
English: None had any infusion-related or peri-infusional hypersensitivity or anaphylactic reactions.
Danish: Ingen udviklede infusionsrelaterede reaktioner eller peri-infusionshypersensitivitet eller anafylaktiske reaktioner.
English: - inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis, Stevens-Johnson syndrome and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
Danish: - betændelseslignende reaktion (inflammation) i huden, som kan medføre alvorlige hudreaktioner (kendt som toksisk epidermal nekrolyse, Stevens-Johnsons syndrom og lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS)).
English: If pituitary imaging or laboratory tests of endocrine function are abnormal, a short course of high-dose corticosteroid therapy (e.g. dexamethasone 4 mg every 6 hrs or equivalent) is recommended to treat the inflammation of the affected gland, and the scheduled dose of ipilimumab should be withheld (see section 4.2).
Danish: Hvis pituitær scanning eller laboratorieundersøgelser af endokrinfunktionen er abnorme, anbefales et kort behandlingsforløb med højdosis kortikosteroid (f.eks. dexamethason 4 mg hver 6 time eller tilsvarende) til behandling af inflammationen i den påvirkede glandel, og den planlagte ipilimumab-dosis bør udsættes (se pkt.
English: In a Phase 2 trial, the sequential treatment with vemurafenib followed by 10 mg/kg ipilimumab in patients with BRAF-mutated metastatic melanoma showed a higher incidence of Grade 3+ skin adverse reactions than with ipilimumab alone.
Danish: Et fase 2 forsøg har vist, at sekventiel behandling med vemurafenib efterfulgt af 10 mg/kg ipilimumab i patienter med BRAF-muteret metastatisk melanom gav anledning til højere incidens af Grad 3+ hudbivirkninger end behandling med ipilimumab alene.
English: In intravenous repeat-dose toxicology studies in monkeys, ipilimumab was generally well tolerated.
Danish: I toksikologiske studier med intravenøs gentagen dosering hos aber var ipilimumab veltolereret.
English: Decision whether to discontinue YERVOY should be based on severity.
Danish: Beslutningen om at seponere YERVOY bør være baseret på sværhedsgrad.
English: Ipilimumab as monotherapy or in combination with a PD-1 or PD-L1 inhibitor
Danish: Ipilimumab som monoterapi eller i kombination med en PD-1- eller PD-L1-hæmmer
English: Renal and urinary disorders Common renal failure (including acute kidney injury)a,c renal failure (including acute kidney injury)c
Danish: Nyrer og urinveje Almindelig nyresvigt (herunder akut nyreskade)a,c nyresvigt (herunder akut nyreskade)c
English: The first tumour assessments were conducted 12 weeks after randomisation and continued every 6 weeks thereafter for the first year and then every 12 weeks until progression or treatment discontinuation, whichever occurred later.
Danish: Den første tumorvurdering blev udført 12 uger efter randomisering, og blev derefter foretaget hver 6. uge i det første år og herefter hver 12. uge indtil progression eller seponering, alt efter, hvad der indtraf sidst.
English: Ipilimumab is a human monoclonal antibody that is not metabolized by cytochrome P450 enzymes (CYPs) or other drug metabolizing enzymes.
Danish: Ipilimumab er et humant monoklonalt antistof, som ikke metaboliseres af CYP-enzymer eller andre lægemiddelmetaboliserende enzymer.
English: How much YERVOY is given
Danish: Så meget YERVOY skal du have
English: Figure 7: Kaplan-Meier curves of OS in intermediate/poor risk patients (CA209214)
Danish: Figur 7: Kaplan-Meier-kurverne for OS hos mellem- eller højrisikopatienter (CA209214)
English: A total of 676 patients were randomized: 137 to the ipilimumab monotherapy group, 403 to the ipilimumab + gp100 group, and 136 to the gp100 alone group.
Danish: I alt 676 patienter blev randomiseret: 137 til ipilimumab monoterapigruppen, 403 til ipilimumab + gp100-gruppen og 136 til gp100-gruppen alene.
English: a NE= not estimable
Danish: a NE= ikke estimerbar
English: The frequency of severe (Grade 3 or 4) diarrhoea and severe (Grade 3 or 4) colitis was 5% each.
Danish: Forekomsten af svær (Grad 3 eller 4) diarre og svær (Grad 3 eller 4) colitis var 5 % for begge bivirkninger.
English: What you need to know before you use YERVOY
Danish: Det skal du vide, før du begynder at bruge YERVOY
English: The following adverse reactions suspected to be immune-related have been reported in patients treated with ipilimumab 3 mg/kg monotherapy in MDX010-20: uveitis, eosinophilia, lipase elevation, and glomerulonephritis.
Danish: Følgende bivirkninger, som formodes at være immunrelaterede, er rapporteret hos patienter, i behandling med ipilimumab 3 mg/kg monoterapi i MDX010-20: uveitis, eosinofili, lipaseforhøjelse og glomerulonefritis.
English: The use of systemic corticosteroids at baseline, before starting ipilimumab, should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of ipilimumab.
Danish: Brug af systemiske kortikosteroider bør undgås, inden behandling med ipilimumab indledes, på grund af den potentielle risiko for, at de vil påvirke ipilimumabs farmakodynamiske aktivitet og effekt.
English: Administer the YERVOY infusion intravenously over a period of 30 or 90 minutes, depending on the dose.
Danish: YERVOY infusion administreres intravenøst over en periode på 30 eller 90 minutter alt afhængig af dosis.
English: SAEs, drug-related, n (%) AEs leading to study drug discontinuation, n (%) Drug-related AEs leading to study drug discontinuation, n (%) irAEs, n (%)
Danish: AE'er som førte til seponering af behandling (n (%) Lægemiddelrelaterede AE'er, som førte til seponering af behandling (n (%) irAE'er, n (%) AE, n (%) Lægemiddelrelaterede AE'er, n (%)
English: Increases in AST and ALT or total bilirubin should be evaluated to exclude other causes of hepatic injury, including infections, tumour progression, or concomitant medication and monitored until resolution.
Danish: Stigninger i ASAT og ALAT eller total‑bilirubin bør vurderes for at udelukke andre årsager til leverskade, som f.eks. infektioner, tumorprogression eller samtidig medicinering og bør monitoreres indtil remission/ophør.
English: Nephritis and Renal Dysfunction Endocrinopathies
Danish: Nefritis og nedsat nyrefunktion Endokrinopatier
English: In MDX010-20 (see section 5.1), ipilimumab at 3 mg/kg with or without gp100 increased ALC throughout the induction dosing period, but no meaningful change in ALC was observed in the control group of patients who received an investigational gp100 peptide vaccine alone.
Danish: 5.1) medførte ipilimumab 3 mg/kg med eller uden gp100 en stigning i ALC gennem hele induktionsperioden, men der blev ikke observeret nogen relevant ændring i ALC i kontrolgruppen af patienter, der udelukkende fik en gp100‑peptid testvaccine.