FrancophonIA/ELRC3.0 huggingface dataset:
English: Empliciti powder for concentrate for solution for infusion (powder for concentrate) is a white to off white whole or fragmented cake provided in a glass vial.
Danish: Empliciti pulver til koncentrat til infusionsvæske (pulver til koncentrat) er hvidt til råhvidt i en hel eller fragmenteret blok i et hætteglas.
English: Prior therapies included: stem cell transplant (55%), bortezomib (70%) melphalan (65%), thalidomide (48%), and lenalidomide (6%).
Danish: Tidligere behandlinger inkluderede stamcelletransplantation (55%), bortezomib (70%), melphalan (65%), thalidomid (48%) og lenalidomid (6%).
English: The other ingredients (excipients) are sucrose, sodium citrate (see section 2 “Empliciti contains sodium”), citric acid monohydrate, and polysorbate 80.
Danish: Øvrige indholdsstoffer: saccharose, natriumcitrat (se afsnit 2 “Empliciti indeholder natrium”), citronsyremonohydrat og polysorbat 80.
English: Of 390 patients across four clinical studies who were treated with Empliciti and evaluable for the presence of anti-product antibodies, 72 patients (18.5%) tested positive for treatment-emergent anti-product antibodies by an electrochemiluminescent (ECL) assay.
Danish: Af 390 patienter i fire kliniske studier, som blev behandlet med Empliciti og analyseret for forekomst af antistoffer mod lægemidlet, blev 72 patienter (18,5%) testet positive for antistoffer mod lægemidlet dannet i forbindelse med behandlingen ved hjælp af en elektrokemiluminescensanalyse (ECL).
English: Decreased sensitivity, especially in the skin Allergic reactions (hypersensitivity) Pain in the mouth/throat region/sore throat
Danish: Allergiske reaktioner (overfølsomhed) Smerter i munden/halsen/ondt i halsen
English: After reconstitution and dilution The reconstituted solution should be transferred from the vial into the infusion bag immediately.
Danish: Efter rekonstitution og fortynding Det rekonstituerede koncentrat skal straks overføres fra hætteglasset til infusionsposen.
English: The entire Empliciti infusion should be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (with a pore size of 0.2-1.2 µm) using an automated infusion pump.
Danish: Empliciti-infusionsvæsken skal administreres via et infusionssæt og et sterilt pyrogenfrit filter med lav proteinbinding (porestørrelse 0,2 μm til 1,2 μm) ved hjælp af en automatisk infusionspumpe.
English: The powder is white to off white whole or fragmented cake.
Danish: Pulveret er hvidt til råhvidt i en hel eller fragmenteret blok.
English: Upon resolution to ≤ Grade 1, Empliciti should be restarted at 0.5 mL/min and may be gradually increased at a rate of 0.5 mL/min every 30 minutes as tolerated to the rate at which the infusion reaction occurred.
Danish: Når reaktionen er aftaget til ≤ grad 1, kan Empliciti-infusionen genoptages ved 0,5 ml/min og infusionshastigheden gradvist øges med 0,5 ml/min hvert 30. minut afhængigt af, hvordan det tåles, op til hastigheden, hvor infusionsreaktionen opstod.
English: If symptoms do not recur, the infusion rate may be gradually escalated every 30 minutes to a maximum of 5 mL/min (see section 4.2 Method of administration).
Danish: Hvis symptomerne ikke opstår igen, kan infusionshastigheden gradvist øges hvert 30. minut til højst 5 ml/min (se pkt.
English: On days that Empliciti is not administered but a dose of dexamethasone is scheduled (Days 8 and 22 of cycle 3 and all subsequent cycles), dexamethasone should be given 40 mg orally.
Danish: På dage, hvor Empliciti ikke administreres, men hvor der er planlagt en dosis dexamethason (dag 8 og 22 i cyklus 3 og alle efterfølgende cyklusser), gives 40 mg dexamethason oralt.
English: IRC Assessedf
Danish: IRC-vurderet f
English: Diarrhoea
Danish: Diarre
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Infusionsreaktioner
English: Patients who have escalated to 5 mL/min at 10 mg/kg dose must decrease the rate to 3 mL/min at the first infusion at 20 mg/kg.
Danish: Patienter hvor dosis er øget til 5 ml/min ved 10 mg/kg skal hastigheden nedsættes til 3 ml/min ved første infusion ved 20 mg/kg.
English: PFS (ITT) Hazard Ratio [95% CI] Stratified log-rank test p-valuea Median PFS in months [95% CI]
Danish: PFS (ITT) Hazard Ratio [95% CI] p-værdi for log-rank testa Median PFS i måneder [95% CI]
English: In cycles 3 and beyond, once every 2 weeks on days 1 and 15.
Danish: I cyklus 3 og derefter, en gang hver anden uge på dag 1 og 15.
English: Each vial contains either 300 mg or 400 mg of elotuzumab.
Danish: Et hætteglas indeholder enten 300 mg eller 400 mg elotuzumab.
English: Cycle 1, Dose 2
Danish: Cyklus 1, Dosis 2
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C − 8°C protected from light.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og og betingelser før brug brugerens ansvar og er normalt ikke mere end 24 timer ved 2°C - 8°C beskyttet mod lys.
English: After reconstitution, the reconstituted solution should be transferred from the vial to the infusion bag immediately.
Danish: Efter rekonstitution skal det rekonstituerede koncentrat straks overføres fra hætteglasset til infusionsposen.
English: The Empliciti infusion should be used immediately.
Danish: Empliciti-infusionsvæsken bør anvendes straks.
English: Improvements observed in PFS were consistent across subsets regardless of age (< 65 versus ≥ 65), risk status, presence or absence of cytogenetic categories del17p or t(4;14), ISS stage, number of prior therapies, prior immunomodulatory exposure, prior bortezomib exposure, relapsed or refractory status or renal function as shown in Table 9.
Danish: Fremskridt i PFS var konsistent på tværs af forsøgspersonerne uanset alder (< 65 versus ≥ 65), risikostatus, med eller uden tilstedeværelse af del17p eller t(4;14) (høj cytogenetisk risiko), ISS-stadium, antal tidligere behandlinger, tidligere immunmodulerende eksponering, tidligere bortezomib-eksponering, recidiverende eller refraktær status og nyrefunktion.
English: No clinically important differences in the pharmacokinetics of elotuzumab were found between patients with severe renal impairment (with and without dialysis) and patients with normal renal function (see section 4.2).
Danish: Der blev ikke fundet klinisk signifikante forskelle i elotuzumabs farmakokinetik mellem patienter med svært nedsat nyrefunktion (med og uden dialyse) og patienter med normal nyrefunktion (se pkt.
English: No dose adjustment of Empliciti is required for patients with mild (CrCl = 60 - 89 mL/min), moderate (CrCl = 30 - 59 mL/min), severe (CrCl < 30 mL/min) renal impairment or end stage renal disease requiring dialysis (see section 5.2).
Danish: Dosisjustering af Empliciti er ikke nødvendig hos patienter med let (CrCl = 60-89 ml/min), moderat (CrCl = 30-59 ml/min), svært (CrCl < 30 ml/min) nedsat nyrefunktion eller terminal nyresygdom, der kræver dialyse (se pkt.
English: Posology for administration with lenalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 1 for the dosing schedule.
Danish: Dosering ved administration sammen med lenalidomid og dexamethason Varigheden for hver behandlingscyklus er 28 dage, se doseringsskemaet i tabel 1.
English: The geometric mean volume of distribution of elotuzumab at the recommended dosing regimen in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone at steady state is 5.7 L (CV: 23%) and 5.6 L (CV: 21%) respectively.
Danish: Elotuzumabs geometriske, gennemsnitlige fordelingsvolumen ved det anbefalede doseringsregime i kombination med lenalidomid/dexamethason eller pomalidomid/dexamethason ved steady state er henholdsvis 5,7 l (CV: 23%) og 5,6 l (CV: 21%).
English: Gently mix the infusion by manual rotation.
Danish: Bland forsigtigt infusionvæsken ved at bevæge posen manuelt.
English: These cells divide out of control and collect in the bone marrow.
Danish: Disse celler deler sig ukontrolleret og ophobes i knoglemarven, hvilket medfører knogleskader og nyreskader.
English: Cycle 1, Dose 1
Danish: Cyklus 1, Dosis 1
English: When Empliciti is given in combination with lenalidomide or pomalidomide, you must follow the pregnancy prevention programme for lenalidomide or pomalidomide respectively (see package leaflet for lenalidomide or pomalidomide).
Danish: Når Empliciti gives sammen med lenalidomid eller pomalidomid, skal du følge instruktionerne for graviditetsforebyggelse for henholdsvis lenalidomid eller pomalidomid (se indlægssedlen for lenalidomid eller pomalidomid).
English: You should use a condom while taking Empliciti and for 180 days after stopping treatment to ensure your partner does not become pregnant.
Danish: Du skak bruge kondom, mens du er i behandling med Empliciti og i 180 dage efter, du er stoppet med behandlingen.
English: HR (95% CI): 0.54 (0.34, 0.86) p-value: 0.0078
Danish: HR (95% CI): 0,54 (0,34; 0,86) p-værdi: 0,0078
English: The chromosomal abnormalities as determined by the FISH of del(17p), t(4;14) and t(14;16) were present in 5%, 11%
Danish: FISH af del(17p), t(4;14) og t(14;16) var tilstede hos henholdsvis 5%, 11% og 7% af patienterne.
English: The pharmacokinetics (PK) of elotuzumab was studied in patients with multiple myeloma.
Danish: Elotuzumabs farmakokinetik blev undersøgt hos patienter med myelomatose.
English: 21.4 [16.6, NE]
Danish: 21,4 [16,6; NE (ikke estimerbar)]
English: Posology for administration with pomalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 2 for the dosing schedule.
Danish: Dosering ved administration sammen med pomalidomid og dexamethason Varigheden for hver behandlingscyklus er 28 dage, se doseringsskemaet i tabel 2.
English: Patients receiving Empliciti in combination with lenalidomide or pomalidomide should adhere to the pregnancy prevention programme of lenalidomide or pomalidomide respectively.
Danish: Patienter, der får Empliciti i kombination med lenalidomid eller pomalidomid, skal henholdsvis følge lenalidomids eller pomalidomids program for svangerskabsforebyggelse.
English: 28-Day Cycles 3+ Day of Cycle 1 8 15 22 1 8 15 22
Danish: Cyklus 28-dages cyklusser 1 og 2 28-dages cyklusser 3+ Cyklusdag 1 8 15 22 1 8 15 22
English: The effect of renal impairment on the pharmacokinetics of elotuzumab was evaluated in patients with normal renal function (CrCl > 90 mL/min; N = 8), severe renal impairment not requiring dialysis (CrCl <30 mL/min; N = 9), or end-stage renal disease requiring dialysis (CrCl < 30 mL/min; N = 9).
Danish: Effekten af nedsat nyrefunktion på elotuzumabs farmakokinetik blev undersøgt hos patienter med normal nyrefunktion (CrCl > 90 ml/min; N = 8), svært nedsat nyrefunktion uden dialyse (CrCl <30 ml/min; N = 9) og terminal nyresygdom med dialyse (CrCl < 30 ml/min; N = 9).
English: Empliciti should be initiated at an infusion rate of 0.5 mL/min for 10 mg/kg dose and 3 mL/min for 20 mg/kg dose.
Danish: Empliciti skal initieres med en infusionshastighed på 0,5 ml/min for en dosis på 10 mg/kg og 3 ml/min for en dosis på 20 mg/kg.
English: Sodium citrate Citric acid monohydrate Polysorbate 80
Danish: Citronsyremonohydrat Polysorbat 80
English: Excipients: sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80.
Danish: Hjælpestoffer: saccharose, natriumcitrat, citronsyremonohydrat og polysorbat 80.
English: Empliciti should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Før administration skal Empliciti kontrolleres visuelt for partikler og misfarvning.
English: Discard the solution if any particulate matter or discolouration is observed.
Danish: Kasser koncentratet, hvis der observeres partikler eller misfarvning.
English: The rates of deep vein thromboses observed between treatment arms were similar for patients given prophylaxis with low molecular weight heparin (2.2% in both treatment arms), and for patients given vitamin K antagonists the rates were 0% for patients treated with E-Ld and 6.7% for patients treated with Ld.
Danish: Hyppigheden af dyb venetrombose i de 2 behandlingsarme var den samme hos patienter, der fik lavmolekylært heparin som profylakse (2,2% i begge behandlingsarme); for patienter, der fik vitamin K-antagonist, var hyppigheden 0% i E-Ld-armen og 6,7% i Ld-armen.
English: The total elotuzumab dose in mg equals the patient's weight in kg multiplied by the elotuzumab dose (10 or 20 mg/kg).
Danish: Total elotuzumab-dosis i mg svarer til patientens vægt i kg multipliceret med elotuzumab-dosis (10 eller 20 mg/kg).
English: Empliciti will be given to you together with lenalidomide and dexamethasone or together with pomalidomide and dexamethasone.
Danish: Du vil få Empliciti sammen med lenalidomid og dexamethason eller sammen med pomalidomid og dexamethason.
English: On days that Empliciti is administered, dexamethasone should be given as 28 mg orally once daily between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti on days 1, 8, 15, and 22 of repeated 28-day cycles.
Danish: På dage, hvor Empliciti administreres, gives dexamethason 28 mg oralt en gang mellem 3 og 24 timer før Empliciti plus 8 mg intravenøst 45-90 minutter før Empliciti på dag 1, 8, 15 og 22 i gentagne cyklusser af 28 dages varighed.
English: A total of 117 patients were randomised in a 1:1 ratio to receive treatment: 60 to elotuzumab in combination with pomalidomide and dexamethasone (E-Pd) and 57 to pomalidomide and dexamethasone (Pd).
Danish: I alt 117 patienter blev randomiseret i forholdet 1:1 til at modtage behandling: 60 til elotuzumab i kombination med pomalidomid og dexamethason (E-Pd) og 57 til pomalidomid og dexamethason (Pd).
English: One patient was reported to be overdosed with 23.3 mg/kg of elotuzumab in combination with lenalidomide and dexamethasone.
Danish: En patient fik en overdosis med 23,3 mg/kg elotuzumab i kombination med lenalidomid og dexamethason.
English: Figure 1: CA204004 Progression free survival
Danish: Figur 1: CA204004 Progressionsfri overlevelse
English: Pneumoniac
Danish: Pneumonib
English: A total of 646 patients were randomised to receive treatment: 321 to Empliciti in combination with lenalidomide and dexamethasone and 325 to lenalidomide and dexamethasone.
Danish: I alt 646 patienter blev randomiseret til at få behandling: 321 til Empliciti i kombination med lenalidomid og dexamethason og 325 til lenalidomid og dexamethason.
English: An open-label study (CA204007) evaluated the pharmacokinetics of elotuzumab in combination with lenalidomide and dexamethasone in patients with multiple myeloma with varying degrees of renal impairment (classified using the CrCl values).
Danish: Et åbent studie (CA204007) undersøgte farmakokinetikken af elotuzumab i kombination med lenalidomid og dexamethason hos patienter med myelomatose med forskellige grader af nedsat nyrefunktion (klassificeret efter CrCl).
English: The safety data of elotuzumab have been assessed from a total of 682 patients with multiple myeloma treated with elotuzumab in combination with lenalidomide and dexamethasone (451 patients), bortezomib and dexamethasone (103 patients) or pomalidomide and dexamethasone (128 patients) pooled across 8 clinical trials.
Danish: Elotuzumabs sikkerhedsdata er blevet vurderet på baggrund af i alt 682 patienter med myelomatose, som blev behandlet med elotuzumab i kombination med lenalidomid og dexamethason (451 patienter), bortezomib og dexamethason (103 patienter) eller pomalidomid og dexamethason (128 patienter).
English: The volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection should be adjusted so as to not exceed 5 mL/kg of patient weight at any given dose of Empliciti.
Danish: Volumen af natriumchloridinfusionsvæske 9 mg/ml (0,9%) eller 5% glucoseinfusionsvæske skal justeres, så volumenet af infusionsvæsken ikke overstiger 5 ml/kg legemsvægt ved enhver given dosis af Empliciti.
English: There were no SPM events reported in patients treated in the Empliciti combined with pomalidomide and dexamethasone study arm (N = 60) and 1 (1.8%) in patients treated in the pomalidomide and dexamethasone arm (N = 55) in study CA204125.
Danish: Der blev ikke rapporteret SPM hændelser hos patienter behandlet i armen Empliciti kombineret med pomalidomid og dexamethason (N = 60) og 1 (1,8%) hos patienter behandlet i armen med pomalidomid og dexamethason (N = 55) i forsøget CA204125.
English: The reconstituted solution should be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection to obtain a final infusion concentration range between 1 mg/mL and 6 mg/mL.
Danish: Den rekonstituerede opløsning skal fortyndes med natriumchloridinfusionsvæske 9 mg/ml (0,9%) eller 5% glucoseinfusionsvæske for at opnå en færdige koncentration i infusionsvæsken på mellem 1 mg/ml og 6 mg/ml.
English: E-Pd 60 48 43 37 32 25 7 1 1 1 1
Danish: E-Pd 60 48 43 37 32 25 7 1 1 1 1 Pd 57 42 31 22 16 10 6 2 1
English: On days that Empliciti is not administered but a dose of dexamethasone is scheduled (Days 8, 15 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally to patients ≤ 75 years old and 20 mg orally to patients > 75 years old.
Danish: På dage, hvor Empliciti ikke administreres, men hvor der er planlagt en dosis dexamethason (dag 8, 15 og 22 i cyklus 3 og alle efterfølgende cyklusser), gives 40 mg oralt til patienter ≤ 75 år og 20 mg oralt til patienter > 75 år.
English: Table 9: CA204004 Efficacy results for subsets
Danish: Tabel 9: CA204004 Effektresultater for undergrupper
English: The incidence of pneumonia was higher in the Empliciti combined with lenalidomide and dexamethasone arm compared to lenalidomide and dexamethasone arm reported at 15.1% vs. 11.7% with a fatal outcome at 0.6% vs. 0%, respectively.
Danish: Pneumoni var hyppigere i armen med Empliciti kombineret med lenalidomid og dexamethason end i armen med lenalidomid og dexamethason og blev rapporteret hos 15,1% versus 11,7%, pneumoni med dødelig udgang blev rapporteret hos henholdsvis 0,6% versus 0%.
English: Refractory
Danish: Refraktær
English: For women taking Empliciti
Danish: Kvinder, der bruger Empliciti
English: Calculate the volume (mL) of diluent (either sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection) needed to make up the solution for infusion for the patient.
Danish: Beregn volumen (ml) af fortyndingsvæsken (enten natriumchloridinfusionsvæske 9 mg/ml (0,9%) eller 5% glucoseinfusionsvæske) der skal bruges til at klargøre infusionsvæsken til patienten.
English: The solution for infusion may be stored for a maximum of 8 hours of the total 24 hours at 20°C − 25°C and room light.
Danish: Ud af de i alt 24 timer må infusionsvæsken højst opbevares 8 timer ved 20°C - 25°C og i dagslys.
English: There is no human experience with elotuzumab during pregnancy.
Danish: Der er ingen erfaring med anvendelse af elotuzumab til gravide kvinder.
English: Table 8: CA204004 Efficacy results
Danish: Tabel 8: CA204004 Effektresultater
English: Dexamethasone (mg) intravenously Dexamethasone (mg) orally  75 years old 28 28 28 28 28 40 40 40 Dexamethasone (mg) orally > 75 years old 8 8 8 8 8 20 20 20 Day of Cycle 1 8 15 22 1 8 15 22
Danish: Dexamethason (mg) intravenøst Dexamethason (mg) oralt  75 år Dexamethason (mg) oralt > 75 år Cyklusdag 1 8 15 22 1 8 15 22
English: For additional information concerning pomalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Danish: For yderligere oplysninger om pomalidomid og dexamethason henvises til de respektive produktresuméer.
English: On weeks with Empliciti infusion, dexamethasone was administered before Empliciti as a divided dose: subjects  75 years an oral dose of 28 mg and an intravenous dose of 8 mg, and in subjects > 75 years an oral dose of 8 mg and an intravenous dose of 8 mg. On weeks without an Empliciti infusion and in the control group, dexamethasone was administered in subjects  75 years as an oral dose of 40 mg and in subjects > 75 years as an oral dose of 20 mg dexamethasone.
Danish: På de uger med Emplicitiinfusion, blev dexamethasone administeret før Empliciti som en delt dosis: forsøgspersoner  75 år en oral dosis på 28 mg og en intravenøs dosis på 8 mg, og for forsøgspersoner > 75 år en oral dosis på 8 mg og en intravenøs dosis på 8 mg. På uger uden en Empliciti-infusion og hos kontrolgruppen, blev dexamethason administreret til forsøgspersoner 75 år som en oral dosis på 40 mg og hos forsøgspersoner > 75 år som en oral dosis på 20 mg dexamethason.
English: The recommended dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day.
Danish: Den anbefalede dosis lenalidomid er 25 mg oralt en gang dagligt på dag 1-21 i gentagne cyklusser af 28 dages varighed og mindst 2 timer efter Empliciti-infusionen, når det administreres samme dag.
English: The recommended dose of pomalidomide is 4 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day.
Danish: Den anbefalede dosis pomalidomid er 4 mg oralt en gang dagligt på dag 1-21 i gentagne cyklusser af 28 dages varighed og mindst 2 timer efter Empliciti-infusionen, når det administreres samme dag.
English: Figure 2: CA204004 Overall survival
Danish: Figur 2: CA204004 Samlet overlevelse
English: For additional information concerning lenalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Danish: For yderligere oplysninger om lenalidomid og dexamethason henvises til de respektive produktresumeer.
English: Aseptically reconstitute each Empliciti vial with a syringe of adequate size and an 18 gauge or smaller needle as shown in Table 12.
Danish: Hvert Empliciti-hætteglas rekonstitueres aseptisk med en sprøjte af passende størrelse og en 18 gauge kanyle eller mindre som vist i tabel 12.
English: c The term pneumonia is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal pneumonia.
Danish: c Pneumoni er en sammensat term, der omfatter følgende termer: pneumoni, atypisk pneumoni, bronkopneumoni, lobær pneumoni, bakteriel pneumoni, fungal pneumoni, influenzapneumoni og pneumokokpneumoni.
English: There was no clear causal evidence of altered pharmacokinetic, efficacy, or toxicity profiles with anti-product antibody development based on the population pharmacokinetic and exposure-response analyses.
Danish: Baseret på farmakokinetisk populationsanalyse og eksponering-respons-analyseeksponering responsanalyse var der ingen tydelig kausal evidens for ændret farmakokinetik, virkning eller toksicitetsprofil som følge af udvikling af antistoffer mod lægemidlet.
English: The effect of hepatic impairment on the clearance of Empliciti was evaluated by population PK analyses in patients with mild hepatic impairment (total bilirubin [TB] ≤ the upper limit of normal [ULN] and AST > ULN or TB < 1 to 1.5 × ULN and any AST; N = 33).
Danish: Effekten af nedsat leverfunktion på Empliciticlearance blev undersøgt i populationsfarmakokinetiske analyser hos patienter med let nedsat leverfunktion (total-bilirubin [TB] ≤ den øvre normale grænse [ULN] og ASAT > ULN eller TB < 1 til 1,5 x ULN og enhver ASAT; N = 33).
English: Eligible patients were randomised in a 1:1 ratio to receive either Empliciti in combination with lenalidomide and dexamethasone or lenalidomide and dexamethasone (Ld).
Danish: Egnede patienter blev randomiseret i forholdet 1:1 til at få enten Empliciti i kombination med lenalidomid og dexamethason eller lenalidomid og dexamethason (Ld).
English: Table 2: Recommended dosing schedule of Empliciti in combination with pomalidomide and dexamethasone
Danish: Tabel 2: Anbefalet doseringsskema for Empliciti i kombination med pomalidomid og dexamethason
English: HR (97.61% CI): 0.68 (0.55, 0.85) p-value: 0.0001
Danish: HR (97,61% CI): 0,68 (0,55; 0,85) p-: 0,0001