FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients who experienced peripheral neuropathy the median time of onset of peripheral neuropathy was 8 weeks.
Danish: For patienter, som oplevede perifer neuropati, var den mediane tid til debut af perifer neuropati 8 uger.
English: Gastrointestinal (GI) complications including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, some with fatal outcomes, have been reported in patients treated with ADCETRIS.
Danish: Gastrointestinale (GI) komplikationer omfattende intestinal obstruktion, ileus, enterocolitis, netropenisk colitis, erosion, mavesår, perforation og blødning, nogle med dødelig udgang, er rapporteret hos patienter behandlet med ADCETRIS.
English: Pre-specified subgroup analyses of modified PFS per IRF were performed for the ITT population including age, region, cancer stage at baseline, baseline extranodal sites, number of IPFP risk factors, baseline B symptoms, Cycle 2 PET assessment, Cycle 2 PET Deauville score, and receipt of alternative first-line medication (AFM).
Danish: IRF hos ITT populationen, herunder alder, område, cancerstadie ved baseline, ekstranodale steder ved baseline, antal IPFP-risikofaktorer, B-symptomer ved baseline, PET-vurdering i behandlingsserie 2, PET Deauville-score i behandlingsserie 2 samt brug af alternativ førstelinjemedicin (AFM).
English: Each single use vial must be reconstituted with 10.5 mL of water for injections to a final concentration of 5 mg/mL.
Danish: Hvert hætteglas til engangsbrug skal rekonstitueres med 10,5 ml vand til injektion til en endelig koncentration på 5 mg/ml.
English: ADCETRIS must not be administered as an intravenous push or bolus.
Danish: ADCETRIS må ikke administreres som en intravenøs bolus- eller hurtig injektion.
English: The safety data in patients retreated with ADCETRIS (SGN35-006, see section 5.1) were consistent with those observed in the combined pivotal phase 2 studies, with the exception of peripheral motor neuropathy, which had a higher incidence (28% vs. 9% in the pivotal phase 2 studies) and was primarily Grade 2.
Danish: 5.1) svarede til dem, der blev observeret i de kombinerede pivotale fase 2-studier, med undtagelse af perifer motorisk neuropati, som havde en højere forekomst (28 % kontra 9 % i de pivotale fase 2studier), og som primært var Grad 2.
English: Median Cmax, AUC, and Tmax of MMAE after a single 1.8 mg/kg dose were 3.73 ng/mL, 17.3 ng*day/mL, and 1.92 days, respectively, in patients < 12 years of age and 6.33 ng/mL, 42.3 ng*day/mL, and 1.82 days, respectively, in patients ≥ 12 years of age.
Danish: Median Cmax, AUC og Tmax for MMAE efter en enkelt dosis på 1,8 mg/kg var henholdsvis 3,73 ng/ml, 17,3 ng*dag/ml og 1,92 dage hos patienter < 12 år og henholdsvis 6,33 ng/ml, 42,3 ng*dag/ml og 1,82 dage hos patienter ≥ 12 år.
English: A study evaluated the PK of brentuximab vedotin and MMAE after the administration of 1.2 mg/kg of ADCETRIS to patients with mild (n = 4), moderate (n = 3) and severe (n = 3) renal impairment.
Danish: Et studie evaluerede farmakokinetikken for brentuximab vedotin og MMAE efter administration af ADCETRIS 1,2 mg/kg til patienter med let (n = 4), moderat (n = 3) og svært (n = 3) nedsat nyrefunktion.
English: A study evaluated the PK of brentuximab vedotin and MMAE after the administration of 1.2 mg/kg of ADCETRIS to patients with mild (Child-Pugh A; n = 1), moderate (Child-Pugh B; n = 5) and severe (Child-Pugh C; n = 1) hepatic impairment.
Danish: Et studie evaluerede farmakokinetikken for brentuximab vedotin og MMAE efter administration af ADCETRIS 1,2 mg/kg til patienter med let (Child-Pugh A; n=1), moderat (Child-Pugh B; n=5) eller svært (Child-Pugh C; n=1) nedsat leverfunktion.
English: 32 years (18-76)
Danish: 32 år (18-76)
English: 35 years (18-82)
Danish: 35 år (18-82)
English: ADCETRIS should be held for any suspected case of acute pancreatitis.
Danish: Behandlingen med ADCETRIS skal stilles i bero ved enhver mistanke om akut pancreatitis.
English: Objective response (CR + PR) Complete remission (CR)
Danish: Objektiv responsrate (CR + PR) Komplet remission (CR)
English: Study C25001
Danish: Studie C25001
English: In the clinical trial of ADCETRIS as combination therapy, neutropenia led to dose delays in 24% of patients.
Danish: I det kliniske forsøg med ADCETRIS som kombinationsbehandling medførte neutropeni doseringsudsættelse hos 24 % af patienterne.
English: Infusion reactions
Danish: Infusionsreaktioner
English: Ten (10) patients (17%) received 16 cycles of ADCETRIS; the median number of cycles received was 7 (range, 1 to 16).
Danish: Ti (10) patienter (17 %) modtog 16 behandlingsserier ADCETRIS; og det mediane antal modtagne behandlingsserier var 7 (interval fra 1 til 16).
English: Median Cmax and AUC of ADC after a single 1.8 mg/kg dose were 29.8 µg/ mL and 67.9 µg*day/ mL, respectively, in patients < 12 years of age and 34.4 µg/mL and 77.8 µg*day/mL, respectively, in patients ≥ 12 years of age.
Danish: Median Cmax og AUC for ADC efter en enkelt dosis på 1,8 mg/kg var henholdsvis 29,8 µg/ml og 67,9 µg*dag/ml hos patienter < 12 år og henholdsvis 34,4 µg/ml og 77,8 µg*dag/ml hos patienter ≥ 12 år.
English: Study SG035-0004
Danish: Studie SG035-0004
English: Patient characteristics
Danish: Patientkarakteristika
English: Patients were treated with 1.8 mg/kg of ADCETRIS intravenously over 30 minutes every 3 weeks for up to 16 cycles or physician's choice for up to 48 weeks.
Danish: Patienterne blev behandlet med 1,8 mg/kg ADCETRIS intravenøst over 30 minutter hver 3. uge i op til 16 behandlingsserier eller lægens valg i op til 48 uger.
English: The appropriate amount of reconstituted Adcetris must be withdrawn from the vial(s) and added to an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection in order to achieve a final concentration of 0.4-1.2 mg/mL Adcetris.
Danish: Den passende mængde rekonstitueret Adcetris skal trækkes op af hætteglasset/ne og tilsættes til infusionsposen indeholdende natriumchlorid 9 mg/ml (0,9%) injektionsvæske for at opnå en endelig koncentration på 0,4-1,2 mg/ml Adcetris.
English: If you are an older patient (≥ 65 years of age) you may experience serious adverse events more frequently.
Danish: Bivirkningerne kan optræde hyppigere hos ældre patienter (≥ 65 år).
English: ADCETRIS may cause peripheral neuropathy, both sensory and motor.
Danish: ADCETRIS kan medføre både sensorisk og motorisk perifer neuropati.
English: IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus and cough were reported in 13% of patients.
Danish: Der blev rapporteret IRR, som for eksempel hovedpine, udslæt, rygsmerter, opkastning, kulderystelser, kvalme, dyspnø, pruritus og hoste, hos 13 % af patienterne.
English: Extranodal involvement at time of diagnosis, n (%) IPFP
Danish: n (%) III IV Ikke relevant Mangler Ekstranodal involvering på tidspunktet for diagnosticering, n (%) IPFP
English: Preparation of infusion solution
Danish: Klargøring af infusionsopløsningen
English: Post-hoc subgroup analyses of modified PFS per IRF for patients with Stage IV disease were performed including age, region, baseline extranodal sites, number of IPFP risk factors, baseline B symptoms, baseline ECOG status and gender.
Danish: IRF for patienter med stadie IV-sygdom, herunder alder, område, ekstranodale steder ved baseline, antal IPFP-risikofaktorer, B-symptomer ved baseline, ECOG-status ved baseline og køn.
English: Withhold dose until toxicity returns to ≤ Grade 1 or baseline, then restart treatment at a reduced dose of 1.2 mg/kg up to a maximum of 120 mg every 3 weeks
Danish: Seponer dosis, indtil toksiciteten vender tilbage til ≤ Grad 1 eller baseline, genoptag derefter behandlingen med en reduceret dosis på 1,2 mg/kg op til højst 120 mg hver 3. uge
English: Table 14: Efficacy results in CTCL patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks (ITT population)
Danish: Tabel 14: Virkningsresultater hos CTCL-patienter behandlet med 1,8 mg/kg ADCETRIS hver 3. uge (ITT-population)
English: Median Cmax, AUC and Tmax of MMAE after a single 1.8 mg/kg of the ADC in a phase 1 study was approximately 4.97 ng/ mL, 37.03 ng/ mL x day and 2.09 days respectively.
Danish: Median Cmax, AUC og Tmax of MMAE efter en enkelt 1,8 mg/kg dosis ADC i et fase 1-studie var henholdsvis cirka 4,97 ng/ml, 37,03 ng/ml x dag og 2,09 dag.
English: Table 7: Efficacy results in HL patients at increased risk of relapse or progression following ASCT treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Danish: Tabel 7: Resultater for effekt hos HL-patienter med øget risiko for recidiv eller progression efter ASCT behandlet med 1,8 mg/kg ADCETRIS hver 3. uge
English: In combination therapy with AVD, advanced age was a risk factor for febrile neutropenia.When ADCETRIS is administered in combination with AVD, primary prophylaxis with G-CSF is recommended for all patients regardless of age beginning with the first dose.
Danish: Når ADCETRIS administreres i kombination med AVD, anbefales primær profylakse med G-CSF til alle patienter uanset alder, startende med den første dosis.
English: Study SG035-0003
Danish: Studie SG035-0003
English: Phase 1 of the study assessed the safety profile (see section 4.8), determined the paediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D),
Danish: 4.8), fastlagde den maksimale tolererede dosis (MTD) for pædiatriske patienter og/eller den anbefalede fase 2-dosis (RP2D) samt vurderede ADCETRIS' farmakokinetik (se pkt.
English: General disorders and administration site conditions Very common:
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
English: Provision of the results of the ongoing Non-Interventional Post-Authorization Safety Study (PASS) conducted in HL and sALCL patient populations (Study MA25101).
Danish: Forelæggelse af resultaterne af det igangværende ikke-intervenerende sikkerhedsstudie efter godkendelse (PASS) udført med patientpopulationer med Hodgkins lymfom (HL) og systemisk anaplastisk storcellet lymfom (sALCL) (Studie MA25010).
English: The efficacy and safety of ADCETRIS as a single agent was evaluated in an open-label, single-arm, multicenter study in 58 patients with relapsed or refractory sALCL.
Danish: Virkningen og sikkerheden for ADCETRIS som enkeltstofbehandling blev evalueret i et open-label, enkelt-armet multicenter-studie på 58 patienter med recidiverende eller refraktær sALCL.
English: A fever with a low white blood cell count may be a sign of serious infection experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (this may be a potentially life-threatening complication known as tumour lysis syndrome) experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin that may be life-threatening (this may be a serious skin reaction known as Stevens-Johnson syndrome and toxic epidermal necrolysis) have new or worsening stomach pain, nausea, vomiting, constipation as these may be symptoms of a serious and potentially fatal stomach or intestinal complication (gastrointestinal complications)
Danish: Feber samtidigt med lavt antal hvide blodlegemer kan være et tegn på alvorlig infektion - oplever svimmelhed, mindre vandladning, konfusion, opkastning, kvalme, hævelse, kortåndethed eller forstyrrelser af hjerterytmen (dette kan være en livstruende komplikation, der kaldes tumorlysesyndrom) - oplever influenza-lignende symptomer efterfulgt af et smertefuldt rødt eller lilla udslæt, der breder sig og danner blærer herunder omfattende afskalning af huden, hvilket kan være livstruende (dette kan være en alvorlig hudreaktion kaldet Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse)
English: For patients who experienced peripheral neuropathy the median time of onset of peripheral neuropathy was 12 weeks.
Danish: For patienter, som oplevede perifer neuropati, var den mediane tid til debut af perifer neuropati 12 uger.
English: In clinical trials, neutropenia led to dose delays in 14% of patients.
Danish: I kliniske forsøg medførte neutropeni doseringsudsættelse hos 14 % af patienterne.
English: For more detailed information, see “Infusion reactions” in section 4. have any problems with a change in the sensitivity of the skin, especially in the hands or feet, such as numbness, tingling, a burning sensation, pain, discomfort or weakness (neuropathy) have headaches, feel tired, experience dizziness, look pale (anaemia), or have unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (thrombocytopenia) develop chills or shivering, or feel warm; you should take your temperature as you may have a fever.
Danish: - har problemer med en forandring af hudens følsomhed, specielt i hænder eller fødder, så som følelsesløshed, snurren, en brændende fornemmelse, smerter, ubehag eller svækkelse (neuropati) - har hovedpine, føler dig træt, oplever svimmelhed, ser bleg ud (anæmi) eller har usædvanlige blødninger eller blåfarvning under huden, bløder længere end normalt efter en blodprøve eller bløder fra tandkødet (trombocytopeni) - får kuldegysninger eller kulderystelser eller føler dig varm; du bør tage din temperatur, da du kan have feber.
English: Seven patients with relapsed sALCL received a starting dose of 1.8 mg/kg and one patient received a starting dose of 1.2 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks.
Danish: Syv patienter med recidiverende sALCL fik en startdosis på 1,8 mg/kg, og én patient fik en startdosis på 1,2 mg/kg ADCETRIS administreret intravenøst over 30 minutter hver 3. uge.
English: In the event of new or worsening pulmonary symptoms (e.g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients should be treated appropriately.
Danish: I tilfælde af nye eller forværrede lungesymptomer (f.eks. hoste, dyspnø) skal en diagnostisk evaluering straks udføres og patienterne behandles på passende vis. Overvej at tilbageholde ADCETRIS-dosis under evalueringen og indtil symptomatisk forbedring.
English: Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment.
Danish: Kvinder i den fertile alder bør benytte to effektive præventionsmetoder under og i 6 måneder efter behandling med brentuximab vedotin.
English: Overall Survival
Danish: Samlet overlevelse
English: The efficacy and safety of ADCETRIS as a single agent was evaluated in a pivotal open-label, single-arm, multicenter study in 102 patients with relapsed or refractory HL.
Danish: Virkningen og sikkerheden for ADCETRIS som enkeltstofsbehandling blev evalueret i et pivotalt open-label, enkelt-armet multicenter-studie på 102 patienter med recidiverende eller refraktær HL.
English: Table 13: Summary of baseline patient and disease characteristics in the phase 3 CTCL Study (ITT Population)
Danish: Tabel 13: Oversigt over patient- og sygdomskarakteristika ved baseline i fase 3-CTCL-studiet (ITT-population)
English: Missing
Danish: Mangler
English: 37 years (18-83)
Danish: 37 år (18-83)
English: IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus, cough, infusion site pain and pyrexia were reported in 9% of patients.
Danish: Der blev rapporteret IRR, som for eksempel hovedpine, udslæt, rygsmerter, opkastning, kulderystelser, kvalme, dyspnø, pruritus, hoste, smerter på infusionsstedet og pyreksi, hos 9 % af patienterne.
English: 33M (52%)/31F (48%)
Danish: 33 M (52%)/31 K (48%)
English: Figure 2: Modified progression-free survival per IRF in patients with Stage IV disease (ADCETRIS + AVD vs. ABVD)
Danish: IRF hos patienter med stadie IV-sygdom (ADCETRIS + AVD kontra ABVD)
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Danish: 4.8, 5.1 og 5.2.
English: Unknown
Danish: Ikke kendt:
English: Twenty patients with relapsed or refractory HL received a starting dose of 1.8 mg/kg and one patient received a starting dose of 1.2 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks.
Danish: 20 patienter med recidiverende eller refraktært HL fik en startdosis på 1,8 mg/kg, og én patient fik en startdosis på 1,2 mg/kg ADCETRIS administreret intravenøst over 30 minutter hver 3. uge.
English: 2.16 vials
Danish: 2,16 hætteglas
English: Table 11: Summary of baseline patient and disease characteristics in the phase 2 relapsed or refractory sALCL study
Danish: Tabel 11: Oversigt over patient- og sygdomskarakteristika ved baseline i fase 2-studiet af recidiverende eller refraktær sALCL
English: The infusion line should be flushed following administration with sodium chloride 9 mg/ mL (0.9%) solution for injection, 5% dextrose for injection, or Lactated Ringer's for injection.
Danish: Infusionsslangen skal gennemskylles efter administrationen med natriumchlorid 9 mg/ml (0,9%) injektionsopløsning, 5% dextrose til injektion eller Ringerlaktat til injektion.
English: 2.88 vials
Danish: 2,88 hætteglas
English: 1.44 vials
Danish: 1,44 hætteglas
English: If the patient's weight is more than 100 kg, the dose calculation should use 100 kg (see section 6.6).
Danish: Hvis patienten vejer mere end 100 kg, skal dosiskalkulationen beregnes ud fra 100 kg (se pkt.
English: Progression Free Survival (PFS) per IRF Median (months)
Danish: IRF Median (måneder)
English: Study C25003
Danish: Studie C25003
English: Table 10: Efficacy results in relapsed or refractory Hodgkin lymphoma patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Danish: Tabel 10: Virkningsresultater hos patienter med recidiverende eller refraktært Hodgkins lymfom behandlet med 1,8 mg/kg ADCETRIS hver 3. uge
English: Disease stage at initial diagnosis of HL Stage I
Danish: Sygdomsstadie a ved indledende diagnosticering af HL,
English: Withhold dose until toxicity returns to ≤ Grade 1 or baseline, then restart treatment at a reduced dose of 1.2 mg/kg every 3 weeks
Danish: Seponer dosis, indtil toksiciteten vender tilbage til ≤ Grad 1 eller baseline, og genoptag derefter behandlingen med en reduceret dosis på 1,2 mg/kg hver 3. uge
English: After reconstitution each vial contains 5 mg/ml of brentuximab vedotin
Danish: Efter rekonstitution indeholder hvert hætteglas 5 mg/ml brentuximab vedotin.
English: Manufacturer
Danish: PRODUKTRESUMÉ
English: Figure 1: Modified progression-free survival per IRF in the ITT population (ADCETRIS + AVD vs. ABVD)
Danish: IRF hos ITT-populationen (ADCETRIS + AVD kontra ABVD)
English: Patients were treated with ADCETRIS 1.8 mg/kg intravenously over 30 minutes every 3 weeks for up to 16 cycles.
Danish: Patienterne blev behandlet med ADCETRIS 1,8 mg/kg intravenøst over 30 minutter hver 3. uge i op til 16 behandlingsserier.
English: Grade 3 (< 1,000-500/mm < 1.0-0.5 x 10 9/L) or
Danish: Grade 3 (<1,000-500/mm <1,0-0,5 x 10
English: have new or worsening shortness of breath or cough as these may be symptoms of a serious and potentially fatal lung complication (pulmonary toxicity) are taking, or have previously taken, medicines which may affect your immune system, such as chemotherapy or immunosuppressive agents have, or think you have, an infection.
Danish: - får eller tidligere har fået medicin, der kan påvirke dit immunsystem, så som kemoterapi eller immunsuppressive midler - har eller tror du har en infektion.
English: Table 6: Summary of baseline patient and disease characteristics in the phase 3 HL post-ASCT Study
Danish: Tabel 6: Oversigt over patient- og sygdomskarakteristika ved baseline i HL post ASCT fase 3-studiet
English: The efficacy and safety of ADCETRIS were evaluated in a randomised, double-blind, placebo-controlled, 2-arm multicenter trial in 329 patients with HL at risk of relapse or progression following ASCT.
Danish: Sikkerheden og effekten af ADCETRIS blev evalueret hos 329 patienter med HL med risiko for recidiv eller progression efter ASCT i et randomiseret, dobbeltblindt, placebokontrolleret multicenterforsøg med 2 arme.
English: Progression Free Survival per IRF
Danish: Progressionsfri overlevelse (PFS) iht.
English: Tlf: +47 6676 3030 infonorge@takeda.com
Danish: Takeda Nycomed AS Tlf: +47 6676 3030 infonorge@takeda.com
English: Table 12: Efficacy results in relapsed or refractory sALCL patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks
Danish: Tabel 12: Virkningsresultater hos patienter med recidiverende eller refraktær sALCL behandlet med 1,8 mg/kg ADCETRIS hver 3. uge
English: Very common side effects (may affect more than 1 in 10 people) decreased level of white blood cells decreased level of blood platelets decreased level of white blood cells with a fever upper respiratory tract infection decrease in weight infection nausea abdominal pain unusual hair loss or thinning muscle pain joint pain or painful, swollen joints dizziness increased liver enzyme levels decreased appetite not being able to sleep bone pain sore or inflammation in the mouth
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - nedsat antal hvide blodlegemer - nedsat antal blodplader - nedsat antal hvide blodlegemer med deraf følgende feber - infektion i de øvre luftveje - vægttab - infektion - kvalme - mavesmerter - usædvanligt hårtab eller udtynding - muskelsmerter - ledsmerter eller smertende, hævede led - svimmelhed - forhøjede leverenzymniveauer - nedsat appetit - søvnløshed - knoglesmerter - ømhed eller betændelse i munden
English: 37M (58%)/27F (42%)
Danish: 37 M (58%)/27 K (42%)
English: Patients were treated with 1.8 mg/kg of ADCETRIS or matching placebo intravenously over 30 minutes every 3 weeks for up to 16 cycles.
Danish: Patienterne blev behandlet med 1,8 mg/kg ADCETRIS eller en tilsvarende placebodosis givet intravenøst i løbet af 30 minutter hver 3. uge i op til 16 behandlingsserier.
English: If you get any side effects, talk to your doctor.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Number of Risk Factors ≥ 3
Danish: Antal risikofaktorer = 1 Antal risikofaktorer ≥ 2 Antal risikofaktorer ≥ 3
English: Table 9: Summary of baseline patient and disease characteristics in the phase 2 relapsed or refractory HL study
Danish: Tabel 9: Oversigt over patient- og sygdomskarakteristika ved baseline i fase 2-studiet af recidiverende eller refraktær HL
English: - Stevens-Johnson syndrome and toxic epidermal necrolysis - a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin - decreased level of white blood cells with a fever - damage to the nerves and nerve coverings (demyelinating polyneuropathy)
Danish: - nye eller tilbagevendende cytomegalovirusinfektioner (CMV) - infektion i blodet (blodforgiftning) og/eller septisk shock (en livstruende form for blodforgiftning) - Stevens-Johnsons syndrom og toksisk epidermal nekrolyse - en sjælden, alvorlig sygdom, hvor du kan opleve influenza-lignende symptomer efterfulgt af et smertefuldt rødt eller lilla udslæt, der spreder sig og danner blærer, herunder omfattende afskalning af huden - nedsat antal hvide blodlegemer med deraf følgende feber - skader på nerver og nerveskeder (demyeliniserende polyneuropati)
English: The recommended starting dose for the retreatment of patients who have previously responded to treatment with ADCETRIS is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Danish: Den anbefalede startdosis ved genbehandling af patienter, som tidligere har responderet på behandling med ADCETRIS, er 1,8 mg/kg administreret som en intravenøs infusion over 30 minutter hver 3. uge.
English: An exploratory intra-patient analysis showed that approximately 69% of the sALCL patients treated with ADCETRIS as part of the SG035-0004 clinical study experienced an improvement in clinical benefit as measured by longer progression free survival (PFS) compared with their most recent prior line of therapy.
Danish: ADCETRIS som en del af det kliniske studie SG035-0004 oplevede en klinisk forbedring målt ved længere progressionsfri overlevelse (PFS) sammenlignet med deres seneste tidligere behandling.