FrancophonIA/ELRC3.0 huggingface dataset:
English: NSMM-5001: The MAH should conduct a global, prospective, non-interventional, observational study in multiple myeloma patients and provide a report of descriptive data on 1,000 patients including 200 RRMM patients treated with ixazomib.
Danish: NSMM-5001: Indehaveren af markedsføringstilladelsen skal gennemføre et globalt, prospektivt, ikke-intervenerende observationsstudie hos patienter med myelomatose og frembringe en rapport med deskriptive data fra 1.000 patienter, herunder 200 RRMM-patienter behandlet med ixazomib.
English: NINLARO is used with lenalidomide (a medicine which affects how your immune system works) and dexamethasone (an anti-inflammatory medicine).
Danish: NINLARO anvendes sammen med lenalidomid (et lægemiddel, som påvirker den måde, immunsystemet fungerer på) og dexamethason (et lægemiddel mod inflammation (betændelseslignende reaktioner)).
English: The capsules should not be opened or crushed.
Danish: Kapslerne må ikke åbnes eller knuses.
English: Takeda GmbH Production Site Singen Robert Bosch Strasse 8 78224 Singen Germany
Danish: Takeda GmbH Production Site Singen Robert Bosch Strasse 8 78224 Singen Tyskland
English: Ixazomib exhibits a multi-exponential disposition profile.
Danish: Ixazomib udviser en multieksponentiel fordelingsprofil.
English: • irregular heart rate (arrhythmia)
Danish: • uregelmæssig hjerterytme (arytmi)
English: Patients with renal impairment received a starting dose of lenalidomide according to its SmPC.
Danish: Patienter med nedsat nyrefunktion fik en startdosis af lenalidomid i henhold til produktresumeet.
English: • low platelet counts (thrombocytopenia) which may increase the risk of nose bleeds and you may easily bruise
Danish: • lavt antal trombocytter (trombocytopeni), hvilket kan øge risikoen for næseblod, og at du nemt får blå mærker
English: Patients included in studies with ixazomib who received antiviral prophylaxis had a lower incidence of herpes zoster infection compared to patients who did not receive prophylaxis.
Danish: I studier med ixazomib havde patienter, som fik antiviral profylakse, en lavere forekomst af herpes zoster-infektion sammenlignet med patienter, som ikke fik profylakse.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Kapsel, hård
English: Ixazomib did not induce CYP1A2, CYP2B6, and CYP3A4/5 activity or corresponding immunoreactive protein levels.
Danish: Ixazomib inducerede ikke CYP1A2-, CYP2B6- og CYP3A4/5-aktivitet eller tilhørende immunreaktive proteinniveauer.
English: In case of capsule breakage, avoid raising dust during clean-up.
Danish: Hvis en kapsel går itu, undgå at hvirvle støv op under oprydningen.
English: Days 23 to 28
Danish: Dag 23 til 28
English: The data presented below is the pooled safety data from the pivotal, Phase 3, global C16010 study (n=720) and the double-blind, placebo-controlled C16010 China Continuation Study (n=115).
Danish: Data præsenteret herunder udgør de puljede sikkerhedsdata fra det pivotale globale C16010 fase 3-studie (N = 720) og det dobbeltblinde, placebokontrollerede C16010 China Continuation Study (n = 115).
English: After oral administration, peak plasma concentrations of ixazomib were achieved at approximately one hour after dosing.
Danish: Efter oral indgivelse blev maksimal ixazomib-plasmakoncentration nået ca. en time efter dosering.
English: Platelet counts should be monitored at least monthly during ixazomib treatment.
Danish: Trombocytter skal monitoreres mindst en gang om måneden under behandling med ixazomib.
English: Ixazomib is not an inhibitor of P-gp, BCRP, MRP2, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1, or MATE2-K. Ixazomib is not expected to cause transporter-mediated drug-drug interactions.
Danish: Ixazomib hæmmer ikke P-gp, BCRP, MRP2, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1 eller MATE2-K. Ixazomib forventes ikke at forårsage transportørmedierede lægemiddelinteraktioner.
English: Progression-Free Survival Events, n (%)
Danish: Progressionsfri overlevelse Tilfælde, n (%) Median (måneder) p-værdi*
English: Treatment must be initiated and monitored under the supervision of a physician experienced in the management of multiple myeloma.
Danish: Behandlingen skal påbegyndes og superviseres af en læge med erfaring i behandling af myelomatose.
English: If you have liver or kidney problems, your doctor may prescribe NINLARO capsules containing 3 mg.
Danish: Hvis du har lever- eller nyreproblemer, kan lægen udskrive NINLARO-kapsler, der indeholder 3 mg.
English: Brain imaging, preferably Magnetic Resonance Imaging, is used to confirm the diagnosis.
Danish: Billeddiagnostisk undersøgelse af hjernen (MR-scanning bør foretrækkes) anvendes til at bekræfte diagnosen.
English: • yellow discoloration of eyes and skin (jaundice which could be a symptom of liver impairment)
Danish: • gulfarvning af øjne og hud (gulsot, hvilket kan være symptom på nedsat leverfunktion)
English: A double dose should not be taken to make up for a missed dose.
Danish: Tag ikke dobbeltdosis som kompensation for en manglende dosis.
English: Fifty seven percent of patients had undergone prior stem cell transplantation.
Danish: 57% af patienterne havde gennemgået stamcelletransplantation.
English: Ixazomib has minor influence on the ability to drive or use machines.
Danish: Ixazomib påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: People with multiple myeloma have cancerous plasma cells, also called myeloma cells, which can damage the bones.
Danish: Personer med myelomatose har kræftramte plasmaceller, også kaldet myelomceller, som kan beskadige knoglerne.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ixazomib in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ixazomib i alle undergrupper af den pædiatriske population ved myelomatose (se pkt.
English: If you have side effects, your doctor may prescribe NINLARO capsules containing 3 mg or 2.3 mg.
Danish: Hvis du får bivirkninger, kan lægen udskrive NINLARO-kapsler, der indeholder 3 mg eller 2,3 mg.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejersken eller apotekspersonalet.
English: Common side effects may affect up to 1 in 10 people:
Danish: Almindelige bivirkninger, som kan forekomme hos op til 1 ud af 10 personer:
English: Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
Danish: Ixazomib binder fortrinsvist til og hæmmer den kymotrypsinlignende aktivitet af beta 5-underenheden af 20S-proteasomet.
English: The recommended dose of dexamethasone is 40 mg taken once a week on the same day for all 4 weeks of the cycle.
Danish: Den anbefalede dosis af dexamethason er 40 mg, der skal tages én gang om ugen på den samme ugedag i alle 4 uger i cyklussen.
English: In vitro, ixazomib affected cell types found in the bone marrow microenvironment including vascular endothelial cells, osteoclasts and osteoblasts.
Danish: In vitro påvirkede ixazomib celletyper, der blev fundet i knoglemarvens mikromiljø, herunder vaskulære endotelceller, osteoklaster og osteoblaster.
English: Ixazomib is not recommended during pregnancy as it can cause foetal harm when administered to a pregnant woman.
Danish: Ixazomib anbefales ikke under graviditet, da det kan forårsage fosterskader, når det anvendes til en gravid kvinde.
English: At clinically relevant ixazomib concentrations, in vitro studies using human cDNA-expressed cytochrome P450 isozymes indicate that no specific CYP isozyme predominantly contributes to ixazomib metabolism and non-CYP proteins contribute to overall metabolism.
Danish: Ved klinisk relevante ixazomib-koncentrationer tyder in vitro-studier med humane cDNA-udtrykte CYP-isozymer på, at der ikke er et specifikt CYP-isozym, der fortrinsvist bidrager til metaboliseringen af ixazomib, og at ikke-CYP-proteiner bidrager til den samlede metabolisme.
English: Three percent of patients in the ixazomib regimen and 1% of patients in the placebo regimen had a platelet count ≤ 10,000/mm3 during treatment.
Danish: 3% af patienterne i ixazomib-gruppen og 1% af patienterne i placebogruppen havde trombocyttal ≤ 10.000/mm3 under behandlingen.
English: Ixazomib is not a reversible or a time-dependent inhibitor of CYPs 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5.
Danish: Ixazomib er ikke en reversibel eller tidsafhængig hæmmer af CYP'erne 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 eller 3A4/5.
English: In the event that a ixazomib dose is delayed or missed, the dose should be taken only if the next scheduled dose is ≥ 72 hours away.
Danish: Hvis en ixazomib-dosis forsinkes eller glemmes, må dosis kun tages, hvis der er ≥ 72 timer til den næste planlagte dosis.
English: The most common adverse reactions were blurred vision (5% in the ixazomib regimen and 4% in the placebo regimen), dry eye (4% in the ixazomib regimen and 1% in the placebo regimen), conjunctivitis (5% in the ixazomib regimen and 1% in the placebo regimen) and cataract (4% in the ixazomib regimen and 5% in the placebo regimen).
Danish: De hyppigste øjenbivirkninger var sløret syn (5% i ixazomib-gruppen og 4% i placebogruppen), tørre øjne (4% i ixazomib-gruppen og 1% i placebogruppen) og konjunktivitis (5% i ixazomib-gruppen og 1% i placebogruppen) og katarakt (4% i ixazomib-gruppen og 5% i placebogruppen).
English: At concentrations exceeding those observed clinically, ixazomib was metabolized by multiple CYP isoforms with estimated relative contributions of 3A4 (42.3%), 1A2 (26.1%), 2B6 (16.0%), 2C8 (6.0%), 2D6 (4.8%), 2C19 (4.8%) and 2C9 (< 1%).
Danish: Ved koncentrationer, der er højere end de klinisk observerede, blev ixazomib metaboliseret af flere CYP-isoformer med anslået relative bidrag fra 3A4 (42,3%), 1A2 (26,1%), 2B6 (16,0%), 2C8 (6,0%), 2D6 (4,8%), 2C19 (4,8%) o
English: Takeda GmbH Takeda (Werk Singen) Robert Bosch Straße 8 78224 Singen Germany
Danish: Takeda GmbH Takeda (Werk Singen) Robert Bosch Straße 8 78224 Singen Tyskland
English: Co-administration of ixazomib with rifampicin decreased ixazomib Cmax by 54% and AUC by 74%.
Danish: Samtidig behandling med ixazomib og rifampicin reducerede ixazomib-Cmax med 54% og AUC med 74%.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measure:
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: The frequency of severe (Grade 3-4) events of hypokalaemia was higher in the ixazomib regimen (5%) than the placebo regimen (<1%).
Danish: Hyppigheden af alvorlige (grad 3-4) hændelser med hypokalæmi var højere i ixazomib-gruppen (5%) end i placebogruppen (< 1%).
English: Concomitant medicinal products
Danish: Samtidig brug af lægemidler
English: A missed dose should not be taken within 72 hours of the next scheduled dose.
Danish: En manglende dosis må ikke tages inden for 72 timer før den næste planlagte dosis.
English: Ixazomib induced apoptosis of several tumour cell types in vitro.
Danish: Ixazomib inducerede apoptose i flere typer tumorceller in vitro.
English: Thromboprophylaxis is recommended in patients being treated with ixazomib in combination with lenalidomide and dexamethasone, and should be based on an assessment of the patient's underlying risks and clinical status.
Danish: Tromboseprofylakse anbefales til patienter, der er i behandling med ixazomib i kombination med lenalidomid og dexamethason, og skal baseres på en vurdering af patientens underliggende risici og kliniske status.
English: Days 16 to 21
Danish: Dag 16 til 21
English: Table 1: Ixazomib dose reduction steps Recommended starting dose* First reduction to
Danish: Tabel 1: Dosisreduktionstrin for ixazomib Anbefalet startdosis*
English: • severe skin rashes such as red to purple bumps (Sweet's syndrome) or rash with skin peeling and mouth sores (Stevens-Johnson syndrome)
Danish: • alvorligt hududslæt som røde til lilla knopper (Sweets syndrom) eller udslæt med hudafskalning og sår i munden (Stevens-Johnsons syndrom)
English: Capsule contents Microcrystalline cellulose Magnesium stearate Talc
Danish: Kapselindhold Mikrokrystallinsk cellulose Magnesiumstearat Talcum
English: Diarrhoea, constipation, nausea and vomiting have been reported with ixazomib, occasionally requiring use of antiemetic and antidiarrhoeal medicinal products and supportive care (see section 4.8).
Danish: Der er rapporteret om diarré, obstipation, kvalme og opkastning med ixazomib, hvilket lejlighedsvis kræver brug af antiemetika og lægemidler mod diarré samt understøttende behandling (se pkt.
English: Grade 3 adverse reactions were reported in 2% of patients in both regimens.
Danish: Bivirkninger af grad 3 blev rapporteret hos 2% af patienterne i begge grupper.
English: At the final analysis for OS at a median follow up of 19.8 months, OS was improved for patients treated in the ixazomib regimen compared with placebo [p-value=0.0014, HR=0.42, 95% CI: 0.242, 0.726 ]).
Danish: Ved den endelige analyse for OS, med en median for opfølgning på 19,8 måneder var OS forbedret for patienter, der blev behandlet i ixazomib-gruppen sammenlignet med placebo [p-værdi = 0,0014, HR = 0,42, 95% CI: 0,242, 0,726]).
English: The efficacy and safety of ixazomib in combination with lenalidomide and dexamethasone was evaluated in an international randomised, double-blind, placebo-controlled, multicenter Phase 3 superiority study (C16010) in patients with relapsed and/or refractory multiple myeloma who had received at least one prior therapy.
Danish: Ixazomibs effekt og sikkerhed i kombination med lenalidomid og dexamethason blev evalueret i et internationalt randomiseret, dobbeltblindt, placebokontrolleret fase 3-multicenterstudie (C16010) hos patienter med recidiverende og/eller refraktær myelomatose, som havde fået mindst én tidligere behandling.
English: • rapid death of cancer cells that may cause dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (tumour lysis syndrome)
Danish: • hurtig død af kræftceller, der kan forårsage svimmelhed, nedsat vandladning, forvirring, opkastning, kvalme, hævelse, åndenød eller forstyrrelser i hjerterytmen (tumorlysesyndrom)
English: NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Danish: NINLARO i kombination med lenalidomid og dexamethason er indiceret til behandling af voksne patienter med myelomatose, som har fået mindst én tidligere behandling.
English: A total of 722 patients (intent-to-treat [ITT] population) were randomised in a 1:1 ratio to receive either the combination of ixazomib, lenalidomide, and dexamethasone (N=360; ixazomib regimen) or placebo, lenalidomide and dexamethasone (N=362; placebo regimen) until disease progression or unacceptable toxicity.
Danish: I alt 722 patienter (intent-to-treat-population) (ITT-population) blev randomiseret i forholdet 1:1 og fik enten kombinationen af ixazomib, lenalidomid og dexamethason (N = 360, ixazomib-gruppen) eller placebo plus lenalidomid og dexamethason (N = 362, placebogruppen) indtil sygdomsprogression eller uacceptabel toksicitet.
English: Patients enrolled in the trial had multiple myeloma that was refractory, including primary refractory, had relapsed after prior therapy, or had relapsed and was refractory to any prior therapy.
Danish: De patienter, der deltog i studiet, havde myelomatose, der var refraktær, herunder primær refraktær, havde recidiveret efter tidligere behandling eller havde recidiveret og var refraktær over for enhver tidligere behandling.
English: • Withhold ixazomib until peripheral neuropathy recovers to ≤ Grade 1 without pain or patient's baseline.
Danish: Udsæt ixazomib, indtil perifer neuropati er bedret til ≤ grad 1 uden smerter eller til patientens baseline-niveau.
English: Placebo + Lenalidomide and Dexamethasone (N = 362)
Danish: Placebo + lenalidomid og dexamethason (N = 362)
English: Protein produced by myeloma cells can damage the kidneys.
Danish: Protein dannet af myelomceller kan beskadige nyrerne.
English: However, ixazomib was negative in an in vivo comet assay in mice, in which percent tail DNA was assessed in the stomach and liver.
Danish: Derimod var ixazomib negativ i en in vivo comet-metode, i hvilken procent DNA i halen blev vurderet i celler fra mave og lever hos mus.
English: Ixazomib is given in combination with lenalidomide.
Danish: Ixazomib gives i kombination med lenalidomid.
English: Patients received ixazomib 4 mg or placebo on Days 1, 8, and 15 plus lenalidomide (25 mg) on Days 1 through 21 and dexamethasone (40 mg) on Days 1, 8, 15, and 22 of a 28-day cycle.
Danish: Patienterne fik ixazomib 4 mg eller placebo på dag 1, 8 og 15 samt lenalidomid (25 mg) på dag 1 til 21 og dexamethason (40 mg) på dag 1, 8, 15 og 22 i en 28-dages cyklus.
English: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have been uncommonly reported with ixazomib (see section 4.8).
Danish: Lægemiddelinducerede leverskader, hepatocellulære skader, hepatisk steatose, kolestatisk hepatitis og levertoksicitet er i sjældne tilfælde blevet rapporteret i forbindelse med ixazomib (se pkt.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne anført efter, hvor alvorlige de er.
English: Infections and infestations Upper respiratory tract infection
Danish: Infektioner og parasitære sygdomme Infektion i de øvre luftveje
English: Thrombocytopenia (platelet count) Platelet count < 30,000/mm3
Danish: Trombocytopeni (trombocyttal) Trombocyttal < 30.000/mm3
English: After oral administration of a radiolabeled dose, 70% of total drug-related material in plasma was accounted for by ixazomib.
Danish: Efter oral indgivelse af en radioaktivt mærket dosis udgjorde ixazomib 70% af de samlede lægemiddelrelaterede stoffer i plasma.
English: • cold-like symptoms (upper respiratory tract infection)
Danish: • influenzalignende symptomer (infektion i øvre luftveje)
English: NINLARO, lenalidomide and dexamethasone are taken in 4-week treatment cycles.
Danish: NINLARO, lenalidomid og dexamethason tages i behandlingscyklusser på 4 uger.
English: Skin and subcutaneous tissue disorders Rash*
Danish: Hud og subkutane væv Udslæt*
English: Thrombocytopenia did not result in an increase in haemorrhagic events or platelet transfusions.
Danish: Trombocytopeni resulterede ikke i en stigning i blødningstilfælde eller trombocyttransfusioner.
English: Ixazomib was not mutagenic in a bacterial reverse mutation assay (Ames assay) or clastogenic in a bone marrow micronucleus assay in mice.
Danish: Ixazomib var ikke mutagent i en bakteriel tilbagemutationstest (Ames' test) eller klastogent i en mikronukleus test i knoglemarv fra mus.
English: The most frequently reported adverse reactions (≥ 20%) across 417 patients treated within the ixazomib regimen and 418 patients within the placebo regimen were diarrhoea (39% vs. 32%), thrombocytopenia (33% vs. 21%), neutropenia (33% vs. 30%), constipation (30% vs. 22%), peripheral neuropathy (25% vs. 20%), nausea (23% vs. 18%), peripheral oedema (23% vs. 17%), vomiting (20% vs. 10%) and upper respiratory tract infection (21% vs. 16%).
Danish: De hyppigst rapporterede bivirkninger (≥ 20%) blandt de 417 patienter, der blev behandlet i ixazomib-gruppen og de 418 patienter i placebogruppen, var diarré (39% mod 32%), trombocytopeni (33% mod 21%), neutropeni (33% mod 30%), obstipation (30% mod 22%), perifer neuropati (25% mod 20%), kvalme (23% mod 18%), perifert ødem (23% mod 17%), opkastning (20% mod 10%) og infektion i de øvre luftveje (21% mod 16%).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Takeda Pharma A/S
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Takeda Pharma A/S
English: 1 hard capsule
Danish: 1 hård kapsel
English: Administration with a high-fat meal decreased ixazomib AUC by 28% compared with administration after an overnight fast (see section 4.2).
Danish: Indgivelse sammen med et fedtrigt måltid reducerede ixazomib-AUC med 28% sammenlignet med indgivelse efter faste natten over (se pkt.
English: Post-authorisation efficacy study (PAES) C16010: To provide an interim report of overall survival at the time of the 3rd interim analysis and to provide a final report for the final analysis of OS from the phase 3, randomized, double-blind study C16010 in adult patients with relapsed and/or refractory multiple myeloma.
Danish: Virkningsstudie efter tilladelse til markedsføring (PAES) C16010: Med henblik på at frembringe en foreløbig rapport for den samlede overlevelse på tidspunktet for den 3. interim-analyse og en endelig rapport med den endelige analyse af den samlede overlevelse i det randomiserede, dobbeltblinde fase 3-studie C16010 hos voksne patienter med recidiverende og/eller refraktær myelomatose.
English: *Recommended reduced dose of 3 mg in the presence of moderate or severe hepatic impairment, severe renal impairment or end-stage renal disease (ESRD) requiring dialysis.
Danish: *Anbefalet reduceret startdosis på 3 mg i tilfælde af moderat eller alvorligt nedsat leverfunktion, alvorligt nedsat nyrefunktion eller dialysekrævende terminal nyresygdom (ESRD).
English: In multi-cycle repeated-dose toxicity studies conducted in rats and dogs, the principal target organs included the gastrointestinal tract, lymphoid tissues, and the nervous system.
Danish: I toksicitetsstudier hos rotter og hunde med gentagen dosering og flere cyklusser omfattede de vigtigste målorganer mave-tarm-kanalen, lymfevæv og nervesystemet.
English: The dose should be adjusted for severe (Grade 3-4) symptoms (see section 4.2).
Danish: Dosis skal justeres ved alvorlige (grad 3-4) symptomer (se pkt.
English: At the 4 mg dose, mean change from baseline in QTcF was estimated to be 0.07 msec (90% CI; -0.22, 0.36) from the model based analysis.
Danish: Ved 4 mg-dosen blev den gennemsnitlige ændring i QTcF i forhold til baseline estimeret til 0,07 ms (90% CI 90% -0,22; 0,36) i den modelbaserede analyse.
English: Thromboprophylaxis was recommended for all patients in both treatment groups according to the lenalidomide SmPC.
Danish: Tromboseprofylakse blev anbefalet til alle patienter i de to behandlingsgrupper i henhold til produktresuméet for lenalidomid.
English: Multiple myeloma is a cancer of the blood which affects a type of cell, called the plasma cell.
Danish: Myelomatose er en type kræft i blodet, som påvirker en celletype, kaldet plasmaceller.
English: At the primary analysis (median follow up of 8 months and a median of 6 cycles), the median PFS was 6.7 months in the ixazomib regimen compared to 4 months in the placebo regimen (p-value=0.035, HR=0.60).
Danish: Ved den primære analyse (median for opfølgning var 8 måneder og en median på 6 behandlingsserier) var median PFS 6,7 måneder i ixazomib-gruppen mod 4 måneder i placebogruppen (p-værdi = 0,035, HR = 0,60).
English: The other ingredients are: In the capsule: microcrystalline cellulose, magnesium stearate and talc.
Danish: Øvrige indholdsstoffer: Kapsel: mikrokrystallinsk cellulose, magnesiumstearat og talcum.
English: At this analysis, estimated median PFS was 20 months in the ixazomib regimen and 15.9 months in the placebo regimen (HR=0.82 [95% CI (0.67, 1.0)]) in the ITT population.
Danish: Ved denne analyse var den estimerede mediane PFS 20 måneder i ixazomib-gruppen og 15,9 måneder i placebogruppen (HR = 0,82 [95% CI (0,67; 1,0)]) i ITT-populationen.