FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients >75 years received a dexamethasone dose of 20 mg once daily on days 1, 8, 15, and 22 of each 28-day cycle.
Danish: Patienter > 75 år fik en dosis dexamethason på 20 mg én gang dagligt på dag 1, 8, 15 og 22 i hver 28-dages cyklus.
English: Pregnancy warning
Danish: Advarsel mht. graviditet
English: Cholestasis◊, Abnormal liver function tests◊
Danish: Almindelig Kolestasis◊, unormale leverfunktionstest◊
English: Lenalidomide is present in human semen at extremely low levels during treatment and is undetectable in human semen 3 days after stopping the substance in the healthy subject (see section 5.2).
Danish: Lenalidomid er til stede i human sæd i ekstremt små mængder under behandlingen og kan ikke påvises i den humane sæd 3 dage efter seponering af stoffet hos raske forsøgspersoner (se pkt.
English: • Yellow pigmentation to the skin, mucus membrane or eyes (jaundice), pale coloured stools, dark coloured urine, itchy skin, rash, pain or swelling of the stomach -these may be symptoms of injury to the liver (hepatic disorder).
Danish: • Gulfarvning af hud, slimhinder eller øjne (gulsot), lys afføring, mørk urin, hudkløe, udslæt, smerter eller opsvulmet mave - dette kan være symptomer på leverskade (leversygdom).
English: The dose of dexamethasone was reduced to 40 mg orally once daily on days 1 to 4 of each 28-day cycle after the first 4 cycles of therapy.
Danish: Dosis af dexamethason blev reduceret til 40 mg oralt, én gang dagligt på dag 1 til 4 i hver 28-dages cyklus efter de første 4 cyklusser af behandlingen.
English: In clinical trials in previously treated myeloma patients with lenalidomide/dexamethasone compared to controls, mainly comprising of basal cell or squamous cell skin cancers.
Danish: *I kliniske studier med myelom-patienter, der tidligere er blevet behandlet; lenalidomid/dexamethason sammenlignet med kontroller; hovedsageligt bestående af basalcelle- eller planocellulær hudcancer.
English: Ischemia, Peripheral ischemia, Intracranial venous sinus thrombosis
Danish: Iskæmi, perifer iskæmi, intrakraniel venøs sinustrombose
English: Serious side effects which may affect more than 1 in 10 people (very common) Lenalidomide may reduce the number of white blood cells that fight infection and also the blood cells which help the blood to clot (platelets) which may lead to bleeding disorders such as nosebleeds and bruising.
Danish: Lenalidomid kan nedsætte antallet af de hvide blodlegemer, som bekæmper infektioner og også af de blodlegemer, som hjælper blodet med at størkne (blodplader), hvilket kan føre til blødningsforstyrrelser som f.eks. næseblod og blå mærker.
English: Venous thromboembolic events, predominantly deep vein thrombosis and pulmonary embolism^,◊
Danish: Meget almindelig Venøse tromboemboliske hændelser, hovedsageligt dyb venetrombose og lungeemboli^,◊
English: Hypokalaemia◊, Hyperglycaemia, Hypocalcaemia◊, Diabetes mellitus◊, Hypophosphataemia, Hyponatraemia◊, Hyperuricaemia, Gout, Decreased appetite, Weight decreased
Danish: Hypokaliæmi◊, hyperglykæmi◊, hypokalcæmi◊, diabetes mellitus◊, hypofosfatæmi, hyponatriæmi◊, hyperurikæmi, podagra, nedsat appetit, vægttab
English: Lenalidomide Accord hard capsules are available in OPA-AL-PVC/Aluminium foil perforated unit dose blister.
Danish: Lenalidomide Accord hårde kapsler fås i perforeret enkeltdosisblister af OPA-ALPVC/aluminiumfolie.
English: Grade 3−4 ADRs/Frequency
Danish: Grad 3-4 bivirkninger/hyppighed
English: Intracranial haemorrhage^, Transient ischaemic attack, Cerebral ischemia
Danish: Ikke almindelig Intrakraniel blødning^, transitorisk cerebral iskæmi, cerebral iskæmi
English: In vitro studies indicate that lenalidomide is not a substrate of human breast cancer resistance protein (BCRP), multidrug resistance protein (MRP) transporters MRP1, MRP2, or MRP3, organic anion transporters (OAT) OAT1 and OAT3, organic anion transporting polypeptide 1B1 (OATP1B1), organic cation transporters (OCT) OCT1 and OCT2, multidrug and toxin extrusion protein (MATE) MATE1, and organic cation transporters novel (OCTN) OCTN1 and OCTN2.
Danish: In vitro-studier indikerer, at lenalidomid ikke er et substrat for humant brystcancer-resistensprotein (BCRP), multidrug-resistensprotein (MRP)-transporter MRP1, MRP2 eller MRP3, organisk aniontransporter (OAT) OAT1 og OAT3, organisk aniontransporterende polypeptid 1B1 (OATP1B1),
English: Very Common Fatigue, Asthenia, Pyrexia
Danish: Meget almindelig Træthed, asteni, pyreksi
English: This study investigated the use of combination therapy of MPR (melphalan 0.18 mg/kg orally on days 1 to 4 of repeated 28-day cycles; prednisone 2 mg/kg orally on days 1 to 4 of repeated 28-day cycles; and lenalidomide 10 mg/day orally on days 1 to 21 of repeated 28-day cycles) for induction therapy, up to 9 cycles.
Danish: Dette studie undersøgte anvendelsen af kombinationsbehandling med MPR (melphalan 0,18 mg/kg oralt på dag 1 til 4 af gentagne 28-dages cyklusser, prednison 2 mg/kg oralt på dag 1 til 4 af gentagne 28-dages cyklusser og lenalidomid 10 mg/dag oralt på dag 1 til 21 af gentagne 28-dages cyklusser) til induktionsbehandling, op til 9 cyklusser.
English: • Local country specific arrangements for a prescription for Lenalidomide Accord to be dispensed
Danish: • Lokale, national-specifikke foranstaltninger for at Lenalidomide Accord, der ordineres på recept, kan udleveres
English: A higher rate of infections was observed with lenalidomide in combination with dexamethasone than with MPT in patients with NDMM who are not eligible for transplant, and with lenalidomide maintenance compared to placebo in patients with NDMM who had undergone ASCT.
Danish: En højere infektionshyppighed blev observeret med lenalidomid i kombination med dexamethason sammenlignet med melphalan, prednison og thalidomid (MPT) hos patienter med NDMM, der ikke er egnede til transplantation, og med lenalidomid-vedligeholdelsesbehandling sammenlignet med placebo hos patienter med NDMM, der har gennemgået ASCT.
English: This increase was not observed in clinical trials of newly diagnosed multiple myeloma in patients taking lenalidomide in combination with low dose dexamethasone compared to thalidomide in combination with melphalan and prednisone.
Danish: Denne stigning blev ikke observeret i kliniske studier hos nydiagnosticerede patienter med myelomatose, der tog lenalidomid i kombination med lavdosis dexamethason, sammenlignet med thalidomid i kombination med melphalan og prednison.
English: • Infection of the sinuses that surround the nose
Danish: • Infektion i bihulerne i begge sider af næsen
English: Response rate
Danish: Responsfrekvens
English: Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide (see section 4.4).
Danish: Patienter, der tidligere har haft alvorligt udslæt i forbindelse med thalidomidbehandling, bør ikke få lenalidomid (se pkt.
English: Safety advice for women of childbearing potential
Danish: Råd om sikkerhed, som er relevante for fertile kvinder
English: Cerebrovascular accident◊, Dizziness, Syncope
Danish: Cerebrovaskulær hændelse◊, svimmelhed, synkope
English: In patients receiving lenalidomide in combination with dexamethasone until progression or for 18 months, the hematologic SPM incidence rate (0.16 per 100 person-years) was not increased as compared to thalidomide in combination with melphalan and prednisone (0.79 per 100 person-years).
Danish: Hos patienter, der fik lenalidomid i kombination med dexamethason indtil progression eller i 18 måneder, var den hæmatologiske forekomst af SPM (0,16 pr. 100 personår) ikke øget i sammenligning med thalidomid i kombination med melphalan og prednison (0,79 pr. 100 personår).
English: The data were not adjusted according to the longer duration of treatment in the lenalidomide-containing arms continued until disease progression versus the placebo arms in the pivotal multiple myeloma studies (see section 5.1).
Danish: Data er ikke blevet justeret i forhold til den længere behandlingsvarighed i de lenalidomid-arme, der fortsatte til sygdomsprogression, versus placebo-armene i de pivotale myelomatosestudier (se pkt.
English: Reduced visual acuity
Danish: Nedsat nyrefunktion
English: It is recommended that your partner seeks medical advice.
Danish: Din partner bør kontakte en læge.
English: Anaemia ◊, Haemorrhagic disorder^, Leucopenias
Danish: anæmi◊, blødningsforstyrrelser^, leukopeni
English: Tabulated summary of post-marketing adverse reactions
Danish: Oversigt over bivirkninger efter markedsføring i tabelform
English: For each subsequent drop below 30 x 109/L
Danish: for hvert efterfølgende fald til under 30 x 109/l
English: Cases of AML have been observed in clinical trials of newly diagnosed multiple myeloma in patients taking lenalidomide treatment in combination with melphalan or immediately following HDM/ASCT (see section 4.4).
Danish: Der er blevet observeret tilfælde af AML i kliniske studier af nydiagnosticeret myelomatose hos patienter, der får behandling med lenalidomid i kombination med melphalan eller lige efter HDM/ASCT (se pkt.
English: The results of PFS at unblinding, following a preplanned interim analysis, using a cut-off of 17 December 2009 (15.5 months follow up) showed a 62% reduction in risk of disease progression or death favoring lenalidomide (HR = 0.38; 95% CI 0.27, 0.54; p <0.001).
Danish: Resultaterne for PFS ved afblinding i henhold til en forud planlagt interimanalyse med 17. december 2009 som skæringsdato (15,5 måneders opfølgning) viste et fald på 62% i risiko for sygdomsprogression eller død til fordel for lenalidomid (HR = 0,38; 95% CI 0,27-0,54; p <0,001).
English: Lenalidomide in combination with dexamethasone until disease progression in patients who are not eligible for transplant
Danish: Lenalidomid i kombination med dexamethason indtil sygdomsprogression hos patienter, der ikke er egnede til transplantation
English: Fatigue◊, Oedema (including peripheral oedema), Pyrexia◊, Asthenia, Influenza like illness syndrome (including pyrexia, cough, myalgia, musculoskeletal pain, headache and rigors)
Danish: Meget almindelig Træthed◊, ødemer (herunder perifere ødemer), pyreksi◊, asteni, influenzalignende sygdom (herunder pyreksi, hoste, myalgi, muskuloskeletale smerter, hovedpine og kulderystelser)
English: Moderate renal impairment (30  CLcr < 50 mL/min)
Danish: Moderat nedsat nyrefunktion (30 ml/min≤ kreatininclearance < 50 ml/min)
English: How to take Lenalidomide Accord 4.
Danish: Sådan skal du tage Lenalidomide Accord 4.
English: The efficacy and safety of lenalidomide maintenance was assessed in two phase 3 multicenter, randomised, double-blind 2-arm, parallel group, placebo-controlled studies: CALGB 100104 and IFM
Danish: Virkning og sikkerhed ved lenalidomid som vedligeholdelsesbehandling blev vurderet i 2 randomiserede, dobbeltblinde, placebo-kontrollerede fase III-multicenterstudier med parallelle grupper og to arme: CALGB 100104 og IFM 2005-02.
English: • Patients with hepatic impairment
Danish: • Patienter med nedsat nyrefunktion
English: • When lenalidomide is used to treat multiple myeloma in patients who have had a bone marrow transplant.
Danish: • Når lenalidomid anvendes til at behandle myelomatose hos patienter, som har gennemgået en knoglemarvstransplantation, tages det alene.
English: Acute hepatic failure^, Hepatitis toxic^, Cytolytic hepatitis^, Cholestatic hepatitis^, Mixed cytolytic/cholestatic hepatitis^
Danish: Lever og galdeveje Ikke kendt Akut leversvigt^, toksisk hepatitis^, cytolytisk hepatitis^, kolestatisk hepatitis^, blandet cytolytisk/kolestatisk hepatitis^
English: The recommended starting dose is lenalidomide 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles for up to 9 cycles, melphalan 0.18 mg/kg orally on days 1 to 4 of repeated 28-day cycles, prednisone 2 mg/kg orally on days 1 to 4 of repeated 28-day cycles.
Danish: Den anbefalede startdosis er lenalidomid 10 mg oralt én gang dagligt på dag 1-21 af gentagne 28dages cyklusser i op til 9 cyklusser, melphalan 0,18 mg/kg oralt på dag 1 til 4 af gentagne 28-dages cyklusser, prednison 2 mg/kg oralt på dag 1 til 4 af gentagne 28-dages cyklusser.
English: The risk of ATE is lower in patients with multiple myeloma treated with lenalidomide monotherapy than in patients with multiple myeloma treated with lenalidomide in combination therapy.
Danish: Risikoen for arteriel tromboemboli er mindre hos patienter med myelomatose, der behandles med lenalidomid-monoterapi, end hos patienter med myelomatose, der behandles med lenalidomid i kombinationsbehandling.
English: The patients at risk of TLS and TFR are those with high tumour burden prior to treatment.
Danish: Det er patienter med stor tumorbyrde inden behandlingen, som har risiko for at få TLS og TFR.
English: • Production of much more or much less urine than usual (which may be a symptom of kidney failure), passing blood in the urine
Danish: • Øget eller nedsat urinproduktion (hvilket kan være et symptom på nyresvigt), blod i urinen
English: ADRs reported in post-marketing use in patients treated with lenalidomide System Organ
Danish: Bivirkninger indberettet efter markedsføring hos patienter, der blev behandlet med lenalidomid
English: Patients in both treatment groups took 40 mg of dexamethasone orally once daily on days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy.
Danish: Patienter i begge behandlingsgrupper tog 40 mg dexamethason oralt én gang dagligt på dag 1 til 4, 9 til 12 og 17 til 20 i hver 28-dages cyklus i de første 4 cyklusser af behandlingen.
English: The results of PFS at unblinding, following a preplanned interim analysis, using a cut-off of 7 July 2010 (31.4 months follow up) showed a 48% reduction in risk of disease progression or death favoring lenalidomide (HR = 0.52; 95% CI 0.41, 0.66; p <0.001).
Danish: Resultaterne af PFS ved afblinding i henhold til en forud planlagt interimanalyse med 7. juli 2010 som skæringsdato (31,4 måneders opfølgning) viste et fald på 48 % i risiko for sygdomsprogression eller død til fordel for lenalidomid (HR = 0,52; 95% CI 0,41-0,66; p <0,001).
English: Resume lenalidomide at next lower dose level once daily.
Danish: Genoptag lenalidomid ved det næste lavere dosisniveau én gang dagligt.
English: For patients older than 75 years of age treated with lenalidomide in combination with dexamethasone, the starting dose of dexamethasone is 20 mg once daily on days 1, 8, 15 and 22 of each 28-day treatment cycle.
Danish: For patienter over 75 år i behandling med lenalidomid i kombination med dexamethason er startdosis for dexamethason 20 mg/dag på dag 1, 8, 15 og 22 i hver 28-dages behandlingscyklus.
English: The demographics and disease-related baseline characteristics of the patients were well balanced in all 3 arms; notably, approximately 50% of the patients enrolled in each arm had the following characteristics; ISS Stage III, and creatinine clearance < 60 mL/min.
Danish: Især havde ca. 50 % af patienter, der indgik i hver arm, de følgende karakteristika: ISS trin III og kreatininclearance < 60 ml/min.
English: The data were not adjusted according to the longer duration of treatment in the lenalidomide-containing arms continued until disease progression versus the comparator arms in the pivotal multiple myeloma studies (see section 5.1).
Danish: Data er ikke blevet justeret i forhold til den længere behandlingsvarighed i lenalidomid-baserede arme, der fortsatte behandling til sygdomsprogression, versus komparator-arme i de pivotale myelomatosestudier (se pkt.
English: The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
Danish: Den anbefalede startdosis af lenalidomid er 25 mg oralt én gang dagligt på dag 1 til 21 i gentagne cyklusser af 28-dages varighed.
English: Lenalidomide must be discontinued for angioedema, grade 4 rash, exfoliative or bullous rash, or if Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspectedand should not be resumed following discontinuation from these reactions.
Danish: Lenalidomid skal seponeres ved angioødem, grad 4 udslæt, eksfoliativt eller udslæt med blæredannelser, eller hvis der er mistanke om Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) eller lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS).
English: Patients in the Rd and Rd18 arms took lenalidomide 25 mg once daily on days 1 to 21 of 28-day cycles according to protocol arm. Dexamethasone 40 mg was dosed once daily on days 1, 8, 15, and 22 of each 28-day cycle.
Danish: Patienterne i Rd- og Rd18-armene tog lenalidomid 25 mg én gang dagligt på dag 1 til 21 af 28-dages cyklusser, i henhold til protokollens arm. Dexamethason 40 mg blev doseret én gang dagligt på dag 1, 8, 15 og 22 i hver 28-dages cyklus.
English: Lenalidomide Accord contains lactose
Danish: Lenalidomide Accord indeholder lactose
English: Pneumonia◊, Upper respiratory tract infection◊, Bacterial, viral and fungal infections (including opportunistic infections)◊, Nasopharyngitis, Pharyngitis, Bronchitis◊
Danish: Pneumoni◊, infektion i de øvre luftveje◊, bakterie-, virus og svampeinfektioner (herunder opportunistiske infektioner)◊, nasofaryngitis, faryngitis, bronkitis◊
English: Dose level -1
Danish: Dosisniveau -1
English: Lenalidomidea
Danish: Lenalidomida
English: A haemoglobin concentration above 12 g/dl should lead to discontinuation of erythropoietic agents.
Danish: Hvis hæmoglobinkoncentrationen stiger til over 12 g/dl (7,4 mmol/l), bør behandlingen med erytropoietiner seponeres.
English: • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Danish: Vasektomien skal bekræftes af to negative sædanalyser
English: Lenalidomide Accord contains lactose.
Danish: Lenalidomide Accord indeholder lactose.
English: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Silica, kolloid vandfri Magnesiumstearat
English: Cases of hypothyroidism and cases of hyperthyroidism have been reported (see section 4.4 Thyroid disorders).
Danish: Der er rapporteret tilfælde af hypo- og hypertyroidisme (se pkt.
English: The median overall survival in the extended follow-up analysis of the pooled studies is 164.3 weeks (95% CI: 145.1, 192.6) in patients treated with len/dex versus 136.4 weeks (95% CI: 113.1, 161.7) in patients treated with placebo/dex.
Danish: Den mediane samlede overlevelse i den forlængede opfølgningsanalyse af de poolede resultater er 164,3 uger (95 %-konfidensinterval: 145,1; 192,6) hos patienter behandlet med len/dex versus 136,4 uger (95 %-konfidensinterval: 113,1; 161,7) hos patienter behandlet med placebo/dex.
English: Titanium dioxide (E171)
Danish: Gelatine Titandioxid (E171)
English: Not Known Acquired haemophilia
Danish: Ikke kendt Erhvervet hæmofili
English: • Documentation of childbearing status potential
Danish: • Dokumentation om status for fertilitet
English: For women taking lenalidomide
Danish: For kvinder, der tager lenalidomid
English: (95% CI 88.8, NE) in the lenalidomide arm versus 88.1 months (95% CI 80.7, 108.4) in the placebo arm.
Danish: måneder (95% CI 88,8; NE) i lenalidomid-armen versus 88,1 måneder (95% CI 80,7-108,4) i placeboarmen.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Accord
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: In clinical trials of newly diagnosed multiple myeloma patients not eligible for transplant, a 4.9-fold increase in incidence rate of hematologic SPM (cases of acute myeloid leukaemia [AML], myelodysplastic syndrome [MDS)]) has been observed in patients receiving lenalidomide in combination with melphalan and prednisone until progression (1.75 per 100 person-years) compared with melphalan in combination with prednisone (0.36 per 100 person-years).
Danish: I kliniske studier hos patienter med nydiagnosticeret myelomatose, som ikke var egnede til transplantation, er der observeret en 4,9-doblet stigning i forekomsten af hæmatologisk SPM (tilfælde af akut myeloid leukæmi [AML], myelodysplastisk syndrom [MDS],) hos patienter, der fik lenalidomid i kombination med melphalan og prednison indtil progression (1,75 pr. 100 personår), sammenlignet med melphalan i kombination med prednison (0,36 pr. 100 personår).
English: Leucopenia◊, Lymphopenia
Danish: anæmi, leukopeni◊, lymfopeni
English: • Women of childbearing potential unless all of the conditions of the Pregnancy Prevention
Danish: • Kvinder i den fertile alder, medmindre alle betingelserne i “Programmet til svangerskabsforebyggelse” er overholdt (se pkt.
English: Multiple myeloma
Danish: Myelomatose
English: An increase of second primary malignancies (SPM) has been observed in clinical trials in previously treated myeloma patients receiving lenalidomide/dexamethasone (3.98 per 100 person-years) compared to controls (1.38 per 100 person-years).
Danish: I kliniske studier med tidligere behandlede myelom-patienter, blev der observeret sekundær primær malignitet (SPM) hyppigere hos patienter, der fik lenalidomid/dexamethason (3,98 pr. 100 personår), sammenlignet med kontrollerne (1,38 pr. 100 personår).
English: 5 mg once daily.
Danish: 5 mg daglig
English: What you need to know before you take Lenalidomide Accord Do not take Lenalidomide Accord :
Danish: Det skal du vide, før du begynder at tage Lenalidomide Accord
English: Tabulated summary for combination therapy in MM
Danish: Oversigt over kombinationsbehandling i tabelform ved MM
English: • Skin eruptions, skin cracking, flaking or peeling skin
Danish: • Hududslæt, revner i huden og afskalning af huden
English: The contribution of renal excretion to total clearance in subjects with normal renal function was 90%, with 4% of lenalidomide eliminated in faeces.
Danish: Hos patienter med normal nyrefunktion udgjorde den andel, som blev udskilt via nyrerne, 90 % af den samlede clearance, og 4 % blev udskilt i fæces.
English: Recommended coursea once daily a At the physician's discretion, if neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide.
Danish: Genoptag lenalidomid ved det næste lavere dosisniveau ªHvis neutropeni efter lægens vurdering er den eneste toksicitet på et dosisniveau, tilføjes granulocyt-kolonistimulerende faktor (G-CSF) og dosisniveauet af lenalidomid opretholdes
English: Lenalidomide in combination with dexamethasone in patients who are not eligible for stem cell transplantation
Danish: Lenalidomid i kombination med dexamethason hos patienter, der ikke er egnet til stamcelletransplantation
English: Overall survival Median [95% CI], weeks 1-year Overall survival rate
Danish: Samlet overlevelse, median [95 %konfidensinterval], uger 1-års samlet overlevelse p = 0,045
English: Common Sepsis◊,b, Bacteraemia, Lung infection◊, Lower respiratory tract infection bacterial, Bronchitis◊, Influenza◊, Gastroenteritis◊, Herpes zoster◊, Infection◊
Danish: lungeinfektion◊, bakteriel nedre luftvejsinfektion, bronkitis◊, influenza◊, gastroenteritis◊, herpes zoster◊, infektion◊
English: Common Fatigue◊, Pyrexia◊, Asthenia
Danish: Almindelig Træthed◊, pyreksi◊, asteni
English: A 2.12-fold increase in incidence rate of solid tumour SPM has been observed in patients receiving lenalidomide (9 cycles) in combination with melphalan and prednisone (1.57 per 100 person-years) compared with melphalan in combination with prednisone (0.74 per 100 person-years).
Danish: Der er observeret en 2,12-doblet stigning i forekomsten af solid tumor SPM hos patienter, der fik lenalidomid (9 cyklusser) i kombination med melphalan og prednison (1,57 pr. 100 personår), sammenlignet med melphalan i kombination med prednison (0,74 pr. 100 personår).
English: HR [95% CI]; p-value MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p Overall survival (months) Mediana OS time, months (95% CI)
Danish: HR [95 % CI], p-værdi MPR+R vs. MPp+p MPR+R vs. MPR+p MPR+p vs. MPp+p Samlet overlevelse (måneder) Mediana OS-tid, måneder (95 % CI)