natgillin/translations-raw huggingface dataset:
I studiet af ADCETRIS som kombinationsbehandling med AVD hos 662 patienter med ikke tidligere behandlet fremskreden HL (C25003) var de mest almindelige bivirkninger (≥ 10 %): neutropeni, kvalme, obstipation, opkastning, træthed, perifer sensorisk neuropati, diarré, pyreksi, alopeci, perifer motorisk neuropati, vægttab, abdominalsmerter, anæmi, stomatit, febril neutropeni, knoglesmerter, insomni, appetitmangel, hoste, hovedpine, artralgi, rygsmerter, dyspnø, myalgi, infektion i de øvre luftveje og forhøjet alaninaminotransferase.
In the study of ADCETRIS as combination therapy with AVD in 662 patients with previously untreated advanced HL (C25003), the most common adverse reactions (≥ 10%) were: neutropenia, nausea, constipation, vomiting, fatigue, peripheral sensory neuropathy, diarrhoea, pyrexia, alopecia, peripheral motor neuropathy, decreased weight, abdominal pain, anaemia, stomatitis, febrile neutropenia, bone pain, insomnia, decreased appetite, cough, headache, arthralgia, back pain, dyspnoea, myalgia, upper respiratory tract infection, alanine aminotransferase increased.
Objektiv responsrate (CR + PR) Komplet remission (CR) Partiel remission (PR)
Objective response rate (CR + PR) Complete remission (CR) Partial remission (PR)
Brentuximab vedotin medførte embryo-føtal letalitet hos drægtige hunrotter.
Brentuximab vedotin caused embryo-foetal lethality in pregnant female rats.
378 M (57) 286 K (43)
378M (57) 286F (43)
Området for DOR var 1,2+ måneder til 43+ måneder, og den mediane opfølgningstid fra første dosis for patienter, der opnåede objektiv respons (OR) iht.
The range of DOR was 1.2+ months to 43+ months and the median follow-up time from first dose for patients who achieved objective response (OR) per IRF was 9.0 months.
Hæmatologiske toksiciteter
Haematological toxicities
Perifer sensorisk neuropati, perifer motorisk neuropati
Peripheral sensory neuropathy, peripheral motor neuropathy
58,5 år (22-83)
58.5 years (22-83)
Fuldblodstal skal monitoreres før administration af hver enkelt dosis af denne behandling (se pkt.
Complete blood counts should be monitored prior to administration of each dose of this treatment (see section 4.4).
Se produktresuméet for de kemoterapeutika, der gives i kombination med ADCETRIS, ved behandling af patienter med ikke tidligere behandlet HL.
Refer to the summary of product characteristics (SmPC) of chemotherapy agents given in combination with ADCETRIS for patients with previously untreated HL.
Hud og subkutane væv Meget almindelig:
Skin and subcutaneous tissue disorders Very common:
Et multieksponentielt fald i ADC-serumkoncentrationer blev observeret ved en terminal halveringstid på cirka 4 til 6 dage.
A multiexponential decline in ADC serum concentrations was observed with a terminal half-life of approximately 4 to 6 days.
ADCETRIS' virkning og sikkerhed som enkeltstof blev evalueret i et åbent, randomiseret, pivotalt fase 3-multicenterstudie med 128 patienter med histologisk bekræftet CD30+ CTCL.
The efficacy and safety of ADCETRIS as a single agent was evaluated in a pivotal phase 3, openlabel, randomised, multicentre study in 128 patients with histologically confirmed CD30+ CTCL.
Der skal gennemføres et enkelt-armet studie med en population tilsvarende sALCL-populationen, som skal kortlægge responsraten, varigheden af respons, tiden ind til anden ASCT samt data for underliggende populationer (inkluderende men ikke nødvendigvis forbeholdt ALK status og alder).
To perform a single-arm study in a similar patient population as the sALCL population investigating response rate, duration of response, rate of (second) ASCT and data in subpopulations (including but not necessarily restricted to ALK status and age) based on a CHMP agreed protocol (Study C25006).
ORR4 blev fastlagt gennem en uafhængig vurdering af Global Response Score (GRS)bestående af hudevalueringer (mSWAT, modified severity weighted assessment tool, som vurderet af investigator), nodal og visceral radiologisk vurdering samt påvisning af cirkulerende Sézary-celler (Olsen 2011).
The primary endpoint was objective response rate that lasts at least 4 months (ORR4) (duration from first response to last response ≥ 4 months), as determined by an independent review of the Global Response Score (GRS) consisting of skin evaluations (modified severity weighted assessment tool [mSWAT] as assessed per investigator), nodal and visceral radiographic assessment, and detection of circulating Sézary cells (Olsen 2011).
Ekstrakutan sygdom
Extracutaneous disease
Sådan gives Adcetris
How Adcetris is given
Det mediane antal serier var 7 (interval 1 til 16 serier).
The median number of cycles was 7 (range 1 to 16 cycles).
I kliniske forsøg forekom behandlingsrelateret neuropati hos 59 % af populationen, og perifer motorisk neuropati forekom hos 14 % af patienterne.
In clinical trials treatment emergent neuropathy occurred in 59% of the population, peripheral motor neuropathy occurred in 14% of patients.
I stadie IV-populationen fik 35 % færre patienter, der fik behandling med ADCETRIS + AVD, efterfølgende salvage-kemoterapi (n = 45) sammenlignet med de patienter, der fik behandling med ABVD (n = 69), og 22 % færre patienter, der fik behandling med ADCETRIS + AVD, fik højdosiskemoterapi og transplantation (n = 29) sammenlignet med de patienter, der fik behandling med ABVD (n = 37).
In the Stage IV population, 35% fewer patients treated with ADCETRIS + AVD received subsequent salvage chemotherapy (n = 45) compared with those treated with ABVD (n = 69) and 22% fewer patients treated with ADCETRIS + AVD received high-dose chemotherapy and transplant (n = 29) compared with those treated with ABVD (n = 37).
ADCETRIS er indiceret til behandling af voksne patienter med CD30+ HL med øget risiko for recidiv eller progression efter autolog stamcelletransplantation (ASCT) (se pkt.
ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1).
For de patienter, som tidligere havde fået > 1 cancerrelateret behandling, blev CR som bedste samlede respons rapporteret for 6 patienter (12 %), og PR blev rapporteret for 19 patienter (39 %).
For the patients who received > 1 prior cancer-related treatment, a best overall response of CR was reported for 6 patients (12%); PR was reported for 19 patients (39%).
Citronsyremonohydrat (til justering af pH) Natriumcitrat-dihydrat (til justering af pH) α,α-trehalosedihydrat Polysorbat 80
Citric acid monohydrate (for pH-adjustment) Sodium citrate dihydrate (for pH-adjustment) α,α-Trehalose dihydrate Polysorbate 80
Farmakokinetikken for brentuximab vedotin ADC og MMAE efter en intravenøs infusion af brentuximab vedotin over 30 minutter administreret som 1,4 mg/kg eller 1,8 mg/kg hver 3. uge blev evalueret i et fase 1/2 klinisk forsøg med 36 pædiatriske patienter (i alderen 7-17 år) med r/r HL og sALCL (børn i alderen 7-11 år: n = 12 og unge i alderen 12-17 år: n = 24) (se pkt.
The pharmacokinetics of brentuximab vedotin ADC and MMAE following a 30-minute intravenous infusion of BV administered at 1.4 mg/kg or 1.8 mg/kg given every 3 weeks were evaluated in a phase 1/2 clinical trial of 36 paediatric patients (7-17 years of age) with r/r HL and sALCL (children aged 7-11 years, n = 12 and adolescents aged 12 to 17 years, n = 24) (see section 5.1).
Maksimale plasmakoncentrationer for MMAE blev observeret cirka 2 dage efter afslutning af infusionen og udviste et monoeksponentielt fald med en t1/2z på cirka 3 til 4 dage.
MMAE were observed approximately 2 days after the end of infusion, and exhibited a mono-exponential decline with a t1/2z of approximately 3 to 4 days.
Analyserne viste konsekvent en tendens til fordel for de patienter, som fik ADCETRIS + AVD sammenlignet med patienter, som fik ABVD, i de fleste subgrupper.
The analyses showed a consistent trend towards benefit for patients who received ADCETRIS + AVD compared with patients who received ABVD in most subgroups.
ADCETRIS er indiceret til behandling af voksne patienter med CD30+ kutant T-cellelymfom (CTCL) efter mindst 1 forudgående systemisk behandling (se pkt.
ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (see section 5.1).
62 år (22-83)
62 years (22-83)
Sikkerheden, farmakokinetikken samt antitumoraktiviteten ved ADCETRIS er evalueret hos 36 pædiatriske patienter (i alderen 7-17 år) med r/r HL og sALCL (fordelt på børn i alderen 7-11 år: n=12 og unge i alderen 12-17 år: n=24) i et åbent fase 1/2 enkeltstof dosiseskalerings multicenterstudie (C25002).
The safety, pharmacokinetics and anti-tumour activity of ADCETRIS in 36 paediatric patients (7-17 years of age) with r/r HL and sALCL (children aged 7-11 years, n = 12 and adolescents aged 12 to 17 years, n = 24) were evaluated in a phase 1/2 open-label, single-agent, multicentre doseescalation study (C25002).
Uåbnede hætteglas: Opbevares i køleskab (2 °C-8 °C).
Unopened vial: Store in a refrigerator (2 °C-8 °C).
9/l, feber ≥ 38,5°C; ref. CTCAE v3) er rapporteret ved behandling med ADCETRIS.
0C; ref CTCAE v3) has been reported with treatment with ADCETRIS.
Du kan finde yderligere oplysninger om Adcetris på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/ og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Tabel 15: Beregninger for patienter, der får den anbefalede dosis på 1,8 mg/kg ADCETRIS for et vægtinterval mellem 60 kg og 120 kg
Table 15: Sample calculations for patients receiving the recommended dose of 1.8 mg/kg of ADCETRIS for weights ranging from 60 kg to 120 kg
Tilbagehold behandling med ADCETRIS, indtil toksicitet er ≤ Grad 2, og genoptag derefter behandlingen med en reduceret dosis på 0,9 mg/kg hver 2. uge.
Withhold treatment with ADCETRIS until toxicity is ≤ Grade 2, then restart treatment at a reduced dose to 0.9 mg/kg every 2 weeks.
IRR ses hyppigere og er sværere hos patienter med antistoffer mod brentuximab vedotin (se pkt.
IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin (see section 4.8).
Total dosis = patientvægt multipliceret med den anbefalede dosis [1,2 mg/kg
Total dose = patient weight multiplied by recommended dose [1.2 mg/kg a])
Typisk Cmax og AUC for ADC efter en enkelt 1,8 mg/kg dosis i et fase 1-studie var henholdsvis cirka 31,98 μg/ml og 79,41 μg/ml x dag.
Typical Cmax and AUC of ADC after a single 1.8 mg/kg in a phase 1 study was approximately 31.98 μg/ mL and 79.41 μg/ mL x day respectively.
Sikkerhedsdata fra patienter med recidiverende eller refraktær HL, som ikke havde fået en autolog stamcelletransplantation, og som blev behandlet med den anbefalede dosis på 1,8 mg/kg hver tredje uge i enten et enkelt-armet fase 4-studie (n = 60), i fase 1 dosisoptrapnings- og klinisk farmakologiske studier (n = 15 patienter) eller i et NPP (n = 26 patienter) (se pkt.
The safety data in patients with relapsed or refractory HL who had not received an autologous stem cell transplant and were treated with the recommended dose of 1.8 mg/kg every three weeks in a single-arm phase 4 study (n = 60), the phase 1 dose escalation and clinical pharmacology studies (n = 15 patients) and in the NPP (n = 26 patients) (see section 5.1) were consistent with the safety profile of the pivotal clinical studies.
Området for DOR var 0,1 måneder til 39,1+ måneder, og den mediane opfølgningstid fra første dosis for patienter, der opnåede objektiv respons (OR) iht.
The range of DOR was 0.1 months to 39.1+ months and the median follow-up time from first dose for patients who achieved objective response (OR) per IRF was 15.5 months.
Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN) er rapporteret for ADCETRIS, herunder dødelige tilfælde.
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS.
Bemærk: Hvis patienten vejer mere end 100 kg, skal dosiskalkulationen gå ud fra 100 kg.
Note: If patient's weight is more than 100 kg, the dose calculation should use 100 kg.
Median alder (interval)
Median age (range)
Stevens-Johnsons syndrom/toksisk epidermal nekrolyse
Stevens-Johnson syndrome/toxic epidermal necrolysis
Kvalme, diarré, opkastning, obstipation, abdominalsmerter
Nausea, diarrhoea vomiting, constipation, abdominal pain
Det mediane antal serier var 7 (interval 2 til 37 serier).
The median number of cycles was 7 (range, 2 to 37 cycles).
Medicin af denne type (monoklonale antistoffer) kan give infusionsreaktioner, så som: - Udslæt - Kortåndethed - Åndedrætsbesvær - Hoste - Strammen over brystet - Feber - Rygsmerter - Kulderystelser - Hovedpine - Kvalme eller opkastning.
Medicines of this type (monoclonal antibodies) can cause infusion reactions such as: a rash shortness of breath difficulty breathing cough a tight chest fever back pain chills headache feeling sick (nausea) or being sick (vomiting).
Vejledning i rekonstitution
Instructions for reconstitution
Skal fortyndes i 150 ml diluent og administreres ved intravenøs infusion over 30 minutter hver 3. uge.
b. To be diluted in 150 mL of diluent and administered by intravenous infusion over 30 minutes every 3 weeks.
IRF efter patienternes CTCL-undertype, lægens valg af behandling, ECOG-status ved baseline, alder, køn og geografisk område.
Pre-specified subgroup analyses of ORR4 per IRF were performed by patients' CTCL subtype, physicians' choice of treatment, baseline ECOG status, age, gender, and geographic region.
- åndenød eller hoste (kan forekomme hos mere end 1 ud af 10 personer) - influenza-lignende symptomer efterfulgt af et smertefuldt rødt eller lilla udslæt, der breder sig og danner blærer herunder omfattende afskalning af huden (kan forekomme hos op til 1 ud af 100 personer) - En forandring i følelse eller følsomhed, specielt i huden, følelsesløshed, snurren, ubehag, en brændende fornemmelse, svaghed eller smerte i hænder eller fødder (neuropati; kan forekomme hos flere end 1 ud af 10 personer) - En følelse af svaghed (kan forekomme hos flere end 1 ud af 10 personer) - Forstoppelse (kan forekomme hos flere end 1 ud af 10 personer) - Diarré, opkastning (kan forekomme hos flere end 1 ud af 10 personer) - Kuldegysninger eller kulderystelser (kan forekomme hos op til 1 ud af 10 personer) - Træthedsfølelse, hyppig vandladning, øget tørst, øget appetit med utilsigtet vægttab og irritabilitet (dette kan være tegn på hyperglykæmi, som kan forekomme hos op til 1 ud af 10 personer) - Usædvanlig blødning eller blå mærker under huden, længere blødning end normalt efter blodprøvetagning, eller blødning fra tandkødet (dette kan være tegn på trombocytopeni, som kan forekomme hos op til 1 ud af 10 personer) - hovedpine, oplever svimmelhed, ser bleg ud (dette kan være tegn på anæmi, der kan forekomme hos flere end 1 ud af 10 personer)
- shortness of breath or cough (may affect more than 1 in 10 people) - flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin (may affects up to 1 in 100 people) - a change in feeling or sensitivity, especially in the skin, numbness, tingling, discomfort, a burning sensation, weakness, or pain in the hands or feet (neuropathy; may affect more than 1 in 10 people) - a feeling of weakness (may affect more than 1 in 10 people) - constipation (may affect more than 1 in 10 people) - diarrhoea, vomiting (may affect more than 1 in 10 people) - chills or shivering (may affect up to 1 in 10 people) - feeling tired, frequent urination, increased thirst, increased appetite with unintended weight loss, and irritability (these may be signs of hyperglycaemia, which may affect up to1 in 10 people) - unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (these may be signs of thrombocytopenia which may affect up to 1 in 10 people) - headaches, experience dizziness, look pale (these may be signs of anaemia, which may affect more than 1 in 10 people)
398 M (59) 272 K (41)
398M (59) 272F (41)
• HL, som forekom < 12 måneder efter primær behandling, eller HL, som var refraktær overfor primær behandling
• HL that occurred <12 months or HL that was refractory to frontline therapy
I det kliniske forsøg med ADCETRIS som kombinationsbehandling forekom behandlingsrelateret neuropati hos 67 % af populationen; perifer motorisk neuropati forekom hos 11 % af patienterne.
In the clinical trial of ADCETRIS as combination therapy, treatment emergent neuropathy occurred in 67% of the population; peripheral motor neuropathy occurred in 11% of patients.
Stevens-Johnsons syndrom og toksisk epidermal nekrolyse
Stevens-Johnson syndrome and toxic epidermal necrolysis
Total dosis = patientvægt multipliceret med den anbefalede dosis [1,8 mg/kg
Total dose = patient weight multiplied by recommended dose [1.8 mg/kg a])
Objektiv responsrate (CR + PR)
Objective response rate (CR + PR)
Sygdomskarakteristika Mediant antal tidligere kemoterapiregimer (interval)
Median number of prior chemotherapy regimens (range)
Stratificeret Hazard Ratio
Stratified Hazard Ratio
Virkningen hos ældre patienter med stadie IV-sygdom i A + AVD-armen (patienter ≥ 60 år [n = 118] [HR = 0,80; 95 % CI (0,42; 1,53)] og ≥ 65 år [n = 78] [HR = 0,78; 95 % CI (0,36; 1,67)]) viste større gavn sammenlignet med ældre patienter i ITT-populationen.
The efficacy in elderly patients with Stage IV disease in the A + AVD arm (patients ≥ 60 years of age [n = 118] [HR = 0.80, 95% CI (0.42, 1.53)] and ≥ 65 years of age [n = 78] [HR = 0.78, 95% CI (0.36, 1.67)]) showed better benefit compared with elderly patients in ITT population.
Øvrige indholdsstoffer: Citronsyremonohydrat, natriumcitratdihydrat, α,α-trehalose-dihydrat og polysorbat 80.
- The other ingredients are citric acid monohydrate, sodium citrate dihydrate, α,α-trehalose dihydrate, and polysorbate 80.
Psykiske forstyrrelser Meget almindelig:
Psychiatric Disorders Very common:
Hvert engangs-hætteglas skal rekonstitueres med 10,5 ml vand til injektioner til en endelig koncentration på 5 mg/ml.
Each single use vial must be reconstituted with 10.5 mL of water for injections to a final concentration of 5 mg/ mL.
Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) - Tumorlysesyndrom - en potentielt livstruende tilstand, hvor du kan opleve svimmelhed, nedsat vandladning, forvirring, opkastning, kvalme, hævelse, stakåndethed eller forstyrrelser af hjerterytmen.
Uncommon side effects (may affect up to 1 in 100 people) - Tumour lysis syndrome - a potentially-life threatening condition in which you may experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.
Otteogtyve patienter (47 %) fik efterfølgende ASCT efter et mediant antal serier på 7 (interval 4 til 16 serier) med behandling med ADCETRIS.
Twenty-eight patients (47%) went on to receive SCT after a median of 7 cycles (range, 4 to 16 cycles) of ADCETRIS treatment.
Opbevares i den originale yderpakning for at beskytte mod lys.
Keep the vial in the outer carton in order to protect from light.
Bivirkninger (monoterapi) Bivirkninger (kombinationsbehandling)
Adverse reactions (combination therapy)
Hvert hætteglas indeholder et overskud på 10 %, hvilket giver 55 mg Adcetris per hætteglas og et samlet rekonstitueret mængde på 11 ml.
Each vial contains a 10% overfill giving 55 mg of Adcetris per vial and a total reconstituted volume of 11 mL.
Modificering af dosisplan Modificering af dosisplan
Modification of dosing schedule
Knoglemarvsinvolvering på tidspunktet for diagnosticering eller indgang i studiet, n (%) B-symptomer a, n (%)
Bone marrow involvement at time of diagnosis or study entry, n (%)
Independent Review Facility (IRF), defineret som tid fra randomisering til sygdomsprogression eller død, eller evidens for ikke-komplet respons (non-CR) efter fuldførelse af førstelinjebehandling iht.
The primary endpoint in Study C25003 was modified PFS (mPFS) per independent review facility (IRF), defined as time from randomisation to disease progression, death, or evidence of non-complete response (non-CR) after completion of first-line therapy per IRF followed by subsequent anticancer therapy.
3,6 hætteglas
3.6 vials
Nervesystemet Meget almindelig:
Nervous system disorders Very common:
Efter fortynding infunderes Adcetris-opløsningen umiddelbart ved den anbefalede infusionshastighed.
Following dilution, infuse the ADCETRIS solution immediately at the recommended infusion rate.
33 år (18-71)
33 years (18-71)
Infektioner og parasitære sygdomme Meget almindelig:
Infections and infestations Very common:
Kutant T-cellelymfom
Cutaneous T-cell lymphoma
Adcetris 50 mg pulver til koncentrat til infusionsvæske, opløsning brentuximab vedotin
Adcetris 50 mg powder for concentrate for solution for infusion brentuximab vedotin
Yderligere oplysninger om ADCETRIS findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Patientkarakteristika før den første administration af ADCETRIS viste behandlingssvigt på flere tidligere kemoterapi regimer (median på 3 med et interval på 1 til 7).
Baseline patient characteristics showed failure from multiple prior chemotherapy regimens (median of 3 with a range of 1 to 7) before first administration with ADCETRIS.
For patienter, som oplevede perifer neuropati, var den mediane tid til debut af perifer neuropati 8 uger.
For patients who experienced peripheral neuropathy the median time of onset of peripheral neuropathy was 8 weeks.
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.
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.
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).
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).
Hvert hætteglas til engangsbrug skal rekonstitueres med 10,5 ml vand til injektion til en endelig koncentration på 5 mg/ml.
Each single use vial must be reconstituted with 10.5 mL of water for injections to a final concentration of 5 mg/mL.
ADCETRIS må ikke administreres som en intravenøs bolus- eller hurtig injektion.
ADCETRIS must not be administered as an intravenous push or bolus.
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.
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.