FrancophonIA/ELRC3.0 huggingface dataset:
English: • Shortness of breath with everyday activities or at rest, irregular heartbeat, racing pulse, tiredness, dizziness, and fainting spells, which can be signs of a condition known as pulmonary hypertension
Danish: • Stakåndethed i forbindelse med dagligdags aktiviteter eller i hvile, uregelmæssig hjerterytme (puls), hurtig puls, træthed, svimmelhed og besvimelsesanfald, hvilket kan være tegn på en tilstand, der kaldes for pulmonal hypertension
English: The PFS benefit of Kd was consistently observed in all subgroups, including patients ≥ 75 years of age (n = 143), patients with high risk (n = 210) genetic mutations, and patients with baseline creatinine clearance of 30 - < 50 mL/min (n = 128).
Danish: Kd-armens PFS-fordel blev observeret konsekvent i alle delgrupper, herunder hos patienter ≥ 75 år (n = 143), patienter med genetiske mutationer med høj risiko (n = 210) og patienter med kreatininclearance 30 - < 50 ml/min (n = 128) ved baseline.
English: - The other ingredients are betadex sulfobutyl ether sodium, anhydrous citric acid (E330) and sodium hydroxide (see section 2 ‘Kyprolis contains sodium').
Danish: - Øvrige indholdsstoffer: betadexsulfobutylethernatrium, vandfri citronsyre (E 330) og natriumhydroxid (se afsnit 2 ‘Kyprolis indeholder natrium').
English: 15 mg/m2 dose cycle 1, day 1 for mild, moderate, severe renal impairment and chronic dialysis versus normal renal function were 124.36%, 111.07%, 84.73% and 121.72%, respectively.
Danish: Den geometriske gennemsnitsratio for AUClast ved dosen på 15 mg/m2 (cyklus 1, dag 1) ved let, moderat og svært nedsat nyrefunktion og kronisk dialyse vs. normal nyrefunktion var henholdsvis 124,36 %, 111,07 %, 84,73 % og 121,72 %.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Kyprolis 10 mg powder for solution for infusion Each vial contains 10 mg of carfilzomib.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Kyprolis 10 mg pulver til infusionsvæske, opløsning Hvert hætteglas indeholder 10 mg carfilzomib.
English: Nonetheless, considering the fast elimination of carfilzomib, notably a rapid decline in systemic concentration 5 minutes after the end of infusion, the risk of clinically relevant interactions with substrates of OATP1B1 and UGT1A1 is probably low.
Danish: Ikke desto mindre er risikoen for klinisk relevante interaktioner med substrater for OATP1B1 og UGT1A1 sandsynligvis lav i betragtning af den hurtige eliminering af carfilzomib, herunder især det hurtige fald i den systemiske koncentration 5 minutter efter infusionens afslutning.
English: Other medicines and Kyprolis
Danish: Brug af anden medicin sammen med Kyprolis
English: Serious adverse events related to worsening renal function were more common in subjects with baseline renal dysfunction (see section 4.2).
Danish: Alvorlige bivirkninger forbundet med forværring af nyrefunktionen var hyppigere hos patienter med nyredysfunktion ved baseline (se pkt.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan optræde hos op til 1 ud af 10 personer)
English: There is no known specific antidote for carfilzomib overdose.
Danish: Der findes ingen kendt antidot til carfilzomib.
English: Symptoms may include fever, chills, arthralgia, myalgia, facial flushing, facial oedema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina.
Danish: Symptomerne kan være feber, kulderystelser, artralgi, myalgi, ansigtsrødme, ansigtsødem, opkastning, svækkelse, stakåndethed, hypotension, synkope, trykken for brystet og angina.
English: When combined with lenalidomide and dexamethasone, Kyprolis is administered intravenously as a 10 minute infusion, on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28) as shown in table 1.
Danish: Ved kombination med lenalidomid og dexamethason administreres Kyprolis intravenøst som en 10-minutters infusion to dage i træk hver uge i tre uger (dag 1, 2, 8, 9, 15 og 16) efterfulgt af en 12-dages hvileperiode (dag 17 til 28) som vist i tabel 1.
English: In study PX-171-009 the incidence of venous thromboembolic events was 15.6% in the KRd arm and 9.0% in the Rd arm. Grade ≥ 3 venous thromboembolic events were reported in 5.6% of patients in the KRd arm and 3.9% of patients in the Rd arm.
Danish: I studie PX-171-009 var forekomsten af venøse tromboemboliske hændelser 15,6 % i KRd-armen og 9,0 % i Rd-armen.
English: Acute kidney injury Renal failure Renal impairment Decreased creatinine renal clearance
Danish: Akut nyreskade Nyreinsufficiens Nedsat nyrefunktion Nedsat kreatininclearance
English: The study showed significant improvement in PFS for patients in the Kd arm over those in the Vd arm (HR: 0.53, 95% CI: 0.44, 0.65 [p value < 0.0001]) (see figure 3).
Danish: Studiet viste en signifikant forbedring i PFS for patienterne i Kd-armen i forhold til patienterne i Vd-armen (HR 0,53; 95 % CI: 0,44; 0,65 [p < 0,0001]) (se figur 3).
English: • Yellowing of your skin and eyes (jaundice), abdominal pain or swelling, nausea or vomiting, which could be symptoms of liver problems including liver failure.
Danish: • Gulfarvning af hud og øjne (gulsot), mavesmerter eller opsvulmet mave, kvalme eller opkastning, som kan være symptomer på leverproblemer, blandt andet leversvigt.
English: Male patients must use effective contraception measures during and for 3 months following treatment if their partner is pregnant or of childbearing potential and not using effective contraception (refer to section 4.6).
Danish: Mandlige patienter skal bruge sikker kontraception under behandlingen og i 3 måneder efter behandlingen, hvis deres partner er gravid eller i den fertile alder og ikke bruger sikker kontraception (se pkt.
English: Cardiac failure Myocardial infarction Atrial fibrillation Tachycardia Ejection fraction decreased Palpitations
Danish: Hjerteinsufficiens Myokardieinfarkt Atriefibrillering Takykardi Nedsat ejektionsfraktion Palpitationer
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk/.
English: The mean steady-state volume of distribution of a 20 mg/m2 dose of carfilzomib was 28 L. When tested in vitro, the binding of carfilzomib to human plasma proteins averaged 97% over the concentration range of 0.4 to 4 micromolar.
Danish: Ved test in vitro var carfilzomibs binding til humane plasmaproteiner i gennemsnit 97 % over hele koncentrationsintervallet på 0,4 til 4 mikromol.
English: When combined with dexamethasone, Kyprolis is administered intravenously as a 30 minute infusion on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16) followed by a 12-day rest period (days 17 to 28) as shown in table 2.
Danish: Ved kombination med dexamethason administreres Kyprolis intravenøst som en 30-minutters infusion to dage i træk hver uge i tre uger (dag 1, 2, 8, 9, 15 og 16) efterfulgt af en 12-dages hvileperiode (dag 17 til 28) som vist i tabel 2.
English: However, higher subject incidence of hepatic function abnormalities, ≥ grade 3 adverse events and serious adverse events have been reported in patients with mild or moderate baseline hepatic impairment compared with patients with normal hepatic function (see sections 4.4 and 5.2).
Danish: Der er dog rapporteret højere forekomst af leverfunktionsanomalier, bivirkninger ≥ grad 3 og alvorlige bivirkninger hos patienter med let eller moderat nedsat leverfunktion ved baseline sammenlignet med patienter med normal leverfunktion (se pkt.
English: In addition and according to the agreed case definition by Mentzer et al., two cases of level 1, one case of level 2 and one case of level 3 were identified.
Danish: Desuden blev der identificeret to tilfælde af niveau 1, ét tilfælde af niveau 2 og ét tilfælde af niveau 3, i henhold til den tilfældedefinition der anvendes af Mentzer et al. I overensstemmelse med den mærkning og de risikominimeringstiltag, der foreslås af Segec et al., er medtagelse af en advarsel om PML i pkt.
English: Multi-organ dysfunction syndrome
Danish: Multiorgandysfunktionsyndrom
English: • Stop dose If recovered to ≥ 0.5 x 109/L, continue at same dose level
Danish: • Stop dosering Fortsæt med samme dosisniveau, hvis tallet kommer tilbage på ≥ 0,5 x 109/l
English: Visually inspect for particulate matter and discolouration prior to administration.
Danish: Undersøg infusionsvæsken visuelt inden administration for partikler og misfarvning.
English: However, in patients with mild or moderate baseline hepatic impairment, all of whom had solid tumours, there was a higher subject incidence of hepatic function abnormalities, ≥ grade 3 adverse events and serious adverse events compared with subjects with normal hepatic function (see section 4.2).
Danish: Hos patienter med solide tumorer og let eller moderat nedsat leverfunktion ved baseline var der imidlertid en øget forekomst af leverfunktionsanomalier, bivirkninger ≥ grad 3 og alvorlige bivirkninger sammenlignet med patienter med normal leverfunktion (se pkt.
English: • Chest pains, shortness of breath, or if there is swelling of your feet, which may be symptoms of heart problems
Danish: • Brystsmerter, stakåndethed eller hævede fødder, hvilket kan være tegn på hjerteproblemer
English: A statistically significant advantage in OS was observed in patients in the Kd arm compared to patients in the Vd arm (HR = 0.791; 95% CI: 0.65, 0.96; p-value = 0.010) (see figure 4).
Danish: Der blev observeret en statistisk signifikant fordel i OS hos patienter i Kd-armen sammenlignet med patienter i Vd-armen (HR = 0,791; 95 % CI: 0,65; 0,96; p-værdi = 0,010) (se figur 4).
English: • Viral infection
Danish: • Virusinfektion
English: • Difficulty breathing, rapid breathing and/or fingertips and lips looking slightly blue (acute respiratory distress syndrome)
Danish: • Vejrtrækningsproblemer, hurtig vejrtrækning og/eller svagt blåfarvede fingerspidser og læber
English: • Inflammation of the nose and throat
Danish: • Betændelseslignende tilstand (inflammation) i næse og hals
English: Based on a number of angioedema cases reported in relation to carfilzomib monotherapy or combination therapy, 5 of which with positive dechallenge, and the plausible mechanism considering possible class effect (bortezomib has angioedema included in section 4.8 of SmPC), as well as presented cases which suggest causal role of carfilzomib, the PRAC considers that the product information (PI) should be updated to include this adverse reaction.
Danish: På baggrund af et antal tilfælde af angioødem, der er rapporteret i forbindelse med monoterapi eller kombinationsterapi med carfilzomib, hvoraf 5 havde positiv dechallenge, og den plausible mekanisme under hensyntagen til en mulig klasseeffekt (angioødem er medtaget i pkt.
English: Cases of acute renal failure have been reported in patients who received Kyprolis.
Danish: Der er indberettet tilfælde af akut nyreinsufficiens hos patienter, der fik Kyprolis.
English: If Kyprolis is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be apprised of the potential hazard to the foetus.
Danish: Patienten skal informeres om den potentielle fare for fosteret, hvis Kyprolis anvendes under graviditet, eller hvis patienten bliver gravid, mens hun tager dette lægemiddel.
English: • Unusual bruising or bleeding, such as a cut, that takes longer than usual to stop bleeding; or internal bleeding such as coughing up blood, vomiting up blood, dark tarry stools, or bright red blood in your stools; or bleeding in the brain leading to sudden numbness or paralysis on one side of the face, legs or arms, sudden severe headache or trouble seeing or difficulty speaking or swallowing
Danish: • Usædvanlige blå mærker eller blødninger, for eksempel en rift, der er længere tid end normalt om at holde op med at bløde, eller du får en indre blødning og hoster blod op, kaster blod op, får mørk, tjæreagtig afføring eller lyst, rødt blod i afføringen, eller du får en blødning i hjernen, der fører til pludselig følelsesløshed eller lammelse i den ene side af ansigt, ben eller arme, pludselig kraftig hovedpine eller problemer med at se, tale eller synke
English: Kaplan-Meier curve of overall survival in relapsed multiple myelomaa
Danish: Kaplan-Meier-kurve over data for den samlede overlevelse ved recidiveret myelomatosea
English: First Kyprolis dose reduction
Danish: Første reduktion af Kyprolis-dosis
English: Cases of tumour lysis syndrome (TLS), including with fatal outcome, have been reported in patients who received Kyprolis.
Danish: Der er indberettet tilfælde af tumorlysesyndrom (TLS), herunder tilfælde med dødeligt udfald, hos patienter, der fik Kyprolis.
English: In phase 3 clinical studies the incidence of adverse events of acute renal failure was higher in subjects with lower baseline creatinine clearance than that among subjects with higher baseline creatinine clearance.
Danish: I kliniske fase 3-studier var forekomsten af akut nyreinsufficiens højere hos patienter med lavere kreatininclearance ved baseline end hos patienter med højere kreatininclearance ved baseline.
English: HR (95% CI); 1-sided p-valueb
Danish: HR (95 % CI); 1-sidet p-værdib
English: If tolerated, the dose should be increased on day 8 of cycle 1 to 56 mg/m2 (maximum dose 123 mg).
Danish: Hvis dosis tolereres, forhøjes den til 56 mg/m2 (maksimumdosis 123 mg) på dag 8 i cyklus 1.
English: In vitro, carfilzomib inhibits OATP1B1 with an IC50 = 2.01 µM whereas it is unknown whether carfilzomib may or not inhibit other transporters OATP1B3, OAT1, OAT3, OCT2 and BSEP, at the systemic level.
Danish: Det vides derimod ikke, hvorvidt carfilzomib kan hæmme andre transportører (OATP1B3, OAT1, OAT3, OCT2 og BSEP) ved systemiske koncentrationer.
English: Dose level reductions for Kyprolis
Danish: Dosisreduktioner for Kyprolis
English: Summary of efficacy analysis in relapsed multiple myeloma study 2011-003
Danish: Resumé af effektanalysen i studie 2011-003, recidiveret myelomatose
English: No starting dose adjustment for Kyprolis is recommended in patients with baseline mild, moderate, or severe renal impairment or patients on chronic dialysis based on available pharmacokinetic data (see section 5.2).
Danish: Baseret på de tilgængelige farmakokinetiske data anbefales justering af initialdosis af Kyprolis ikke til patienter med let, moderat eller svært nedsat nyrefunktion ved baseline eller patienter i kronisk dialyse (se pkt.
English: • Bleeding in the lungs
Danish: • Blodprop i lungerne
English: Third Kyprolis dose reduction
Danish: Tredje reduktion af Kyprolis-dosis
English: Kyprolis will be given to you together with lenalidomide and dexamethasone, or only with dexamethasone.
Danish: Du vil få Kyprolis sammen med lenalidomid og dexamethason eller kun sammen med dexamethason.
English: Increased blood uric acid
Danish: Forhøjet urinsyre i blodet
English: How to use Kyprolis
Danish: Sådan skal du bruge Kyprolis
English: Hypertensive emergency
Danish: Akut hypertensiv krise
English: Gastrointestinal haemorrhage Dyspepsia Toothache
Danish: Gastrointestinal blødning Dyspepsi Tandpine
English: This study evaluated Kyprolis at an initial dose of 20 mg/m2, which was increased to 27 mg/m2 on cycle 1, day 8, administered twice weekly for 3 out of 4 weeks as a 10 minute infusion.
Danish: I dette studie blev Kyprolis undersøgt som en 10-minutters infusion med initialdosis på 20 mg/m2, der blev øget til 27 mg/m2 på dag 8 i cyklus 1, og administreret to gange om ugen i 3 ud af 4 uger.
English: Cases of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism with fatal outcomes, have been reported in patients who received Kyprolis.
Danish: Der er indberettet tilfælde af venøse tromboemboliske hændelser, herunder dyb venetrombose og lungeemboli med dødelige udfald, hos patienter, der fik Kyprolis.
English: At doses between 20 and 56 mg/m2, there was a dose-dependent increase in exposure.
Danish: Der var en dosisafhængig stigning i eksponering ved doser på mellem 20 og 56 mg/m2.
English: • Bleeding in the stomach and bowels
Danish: • Blødning i mave og tarme
English: Kyprolis and dexamethasone
Danish: Kyprolis og dexamethason
English: Betadex sulfobutyl ether sodium Anhydrous citric acid (E330) Sodium hydroxide (for pH adjustment)
Danish: Betadexsulfobutylethernatrium Vandfri citronsyre (E 330) Natriumhydroxid (til justering af pH)
English: If tolerated, the dose should be increased on day 8 of cycle 1 to 27 mg/m2 (maximum dose 60 mg).
Danish: Hvis dosis tolereres, forhøjes den til 27 mg/m2 (maksimumdosis 60 mg) på dag 8 i cyklus 1.
English: In patients who received prior lenalidomide (38%), median PFS was 12.9 months in the Kd arm versus 7.3 months in the Vd arm (HR = 0.69, 95% CI: 0.52, 0.92), ORR was 70.1% versus 59.3%.
Danish: Hos de patienter, der tidligere havde fået lenalidomid (38 %), var median-PFS 12,9 måneder i Kd-armen vs. 7,3 måneder i Vd-armen (HR = 0,69; 95 % CI: 0,52; 0,92), og ORR var 70,1 % vs.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1060/002
English: In study 2011 003 the incidence of venous thromboembolic events was 12.5% in the Kd arm and 3.3% in the bortezomib plus dexamethasone (Vd) arm. Grade ≥ 3 venous thromboembolic events were reported in 3.5% of patients in the Kd arm and 1.8% of patients in the Vd arm.
Danish: I studie 2011-003 var forekomsten af venøse tromboemboliske hændelser 12,5 % i Kd-armen og 3,3 % i Vd-armen (bortezomib plus dexamethason).
English: Cardiac disorders are known adverse drug reactions of carfilzomib.
Danish: Hjertesygdom er en kendt bivirkning ved carfilzomib.
English: • A history of blood clots in your veins
Danish: • Du har tidligere haft blodpropper i venerne
English: Febrile neutropenia HUS
Danish: Febril neutropeni
English: KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide, dexamethasone; PFS = progression-free survival; HR = hazard ratio; CI = confidence interval; IMWG = International Myeloma Working Group; EBMT = European blood and marrow transplantation; mo = months Note: The response and PD outcomes were determined using standard objective IMWG/EBMT response criteria.
Danish: KRd = Kyprolis, lenalidomid og dexamethason; Rd = lenalidomid og dexamethason; PFS = progressionsfri overlevelse; HR = hazard ratio; CI = konfidensinterval; IMWG = International Myeloma Working Group; EBMT = European Society for Blood and Marrow Transplantation; mdr.
English: Acute renal failure
Danish: Akut nyreinsufficiens
English: Summary of efficacy analysis in relapsed multiple myeloma study PX-171-009 KRd combination therapy KRd arma (N = 396)
Danish: Resumé af effektanalysen i studie PX-171-009, recidiveret myelomatose
English: In patients who received prior bortezomib (54%), median PFS was 15.6 months in the Kd arm versus 8.1 months in the Vd arm (HR = 0.56, 95% CI: 0.44, 0.73), ORR was 71.2% versus 60.3%.
Danish: Hos de patienter, der tidligere havde fået bortezomib (54 %), var median-PFS 15,6 måneder i Kd-armen vs. 8,1 måneder i Vd-armen (HR = 0,56; 95 % CI: 0,44; 0,73), og ORR var 71,2 % vs.
English: Fatigue, dizziness, fainting, blurred vision, somnolence and/or a drop in blood pressure have been observed in clinical trials.
Danish: I kliniske studier er der observeret træthed, svimmelhed, besvimelse, sløret syn, døsighed og/eller blodtryksfald.
English: • Serious lung infection (pneumonia)
Danish: • Alvorlig lungebetændelse
English: • Unusual bleeding, including easy bruising, bleeding from an injury, such as a cut, that takes longer than expected to stop, or internal bleeding such as coughing up blood, vomiting up blood, dark tarry stools, or bright red blood in your stools; or bleeding in the brain leading to sudden numbness or paralysis on one side of the face, legs or arms, sudden severe headache or trouble seeing or difficulty speaking or swallowing.
Danish: • Usædvanlige blødninger - hvis du for eksempel har let ved at få blå mærker, du let bløder på grund af en skade (det kan være en rift, der er længere tid end forventet om at holde op med at bløde), eller du får en indre blødning og hoster blod op, kaster blod op, får mørk, tjæreagtig afføring eller lyst, rødt blod i afføringen, eller du får en blødning i hjernen, der fører til pludselig følelsesløshed eller lammelse i den ene side af ansigt, ben eller arme, pludselig kraftig hovedpine eller problemer med at se, tale eller synke.
English: Kyprolis 60 mg powder for solution for infusion Each vial contains 60 mg of carfilzomib.
Danish: Kyprolis 60 mg pulver til infusionsvæske, opløsning Hvert hætteglas indeholder 60 mg carfilzomib.
English: In patients refractory to lenalidomide (25%), median PFS was 8.6 months in the Kd arm versus 6.6 months in the Vd arm (HR = 0.80, 95% CI: 0.57, 1.11), ORR was 61.9% versus 54.9%.
Danish: Hos de patienter, der var refraktære for lenalidomid (25 %), var median-PFS 8,6 måneder i Kd-armen vs. 6,6 måneder i Vd-armen (HR = 0,80; 95 % CI: 0,57; 1,11), og ORR var 61,9 % vs.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1060/001
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; PFS = progression-free survival; mo = months; HR = hazard ratio; CI = confidence interval
Danish: Kd = Kyprolis plus dexamethason; Vd = bortezomib plus dexamethason; PFS = progressionsfri overlevelse; mdr.
English: Kyprolis 30 mg powder for solution for infusion Each vial contains 30 mg of carfilzomib.
Danish: Kyprolis 30 mg pulver til infusionsvæske, opløsning Hvert hætteglas indeholder 30 mg carfilzomib.
English: • Aching muscles
Danish: • Muskelspasmer
English: Hepatic toxicity
Danish: Hæmatologisk toksicitet
English: Overall, the subject incidence of certain adverse events (including cardiac arrhythmias, cardiac failure (see section 4.4), dyspnoea, leukopenia and thrombocytopenia) in clinical trials with Kyprolis was higher for patients who were ≥ 75 years of age compared to patients who were < 75 years of age.
Danish: 4.4], dyspnø, leukopeni og trombocytopeni) samlet set højere hos patienter ≥ 75 år end hos patienter < 75 år.
English: • Lung infection
Danish: • Lungeinfektion
English: Cases of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism with fatal outcomes, have been reported in patients who received Kyprolis (see section 4.4).
Danish: Der er rapporteret tilfælde af venøse tromboemboliske hændelser, herunder dyb venetrombose og lungeemboli med dødeligt udfald, hos patienter, der fik Kyprolis (se pkt.
English: For other concomitant medicinal products that may be required, such as the use of antacid prophylaxis, refer to the current lenalidomide and dexamethasone summary of product characteristics.
Danish: Der henvises til de gældende produktresuméer for lenalidomid og dexamethason hvad angår andre samtidige medicinske behandlinger, der kan være behov for, for eksempel anvendelse af profylakse mod mavesyrerelaterede forstyrrelser.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1060/003
English: Together with Kyprolis you will also be given either lenalidomide and dexamethasone, or only dexamethasone.
Danish: Du vil også få enten lenalidomid og dexamethason eller kun dexamethason sammen med Kyprolis.
English: Vomiting Diarrhoea Constipation Abdominal pain Nausea
Danish: Obstipation Abdominalsmerter Nausea
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; OS = overall survival; mo = months; HR = hazard ratio; CI = confidence interval
Danish: Kd = Kyprolis plus dexamethason; Vd = bortezomib plus dexamethason; OS = samlet overlevelse; mdr.