FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep the vial in the original carton in order to protect from light.
Slovenian: Vialo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (17%), pyrexia (6%), and neutropenia (3%).
Slovenian: Resni neželeni učinki, ki so se pojavili ≥3% bolnikov, so vključevali febrilno nevtropenijo (17%), pireksijo (6%) in nevtropenijo (3%).
English: In clinical trials, the majority of patients had resolution or improvement of their symptoms (see section 4.8).
Slovenian: Pri večini bolnikov v kliničnih preskušanjih so simptomi izzveneli ali so se izboljšali (glejte poglavje 4.8).
English: For further efficacy results see Table 10.
Slovenian: Za nadaljnje rezultate učinkovitosti glejte preglednico 10.
English: Patients should be closely monitored for new or worsening neurological, cognitive, or behavioural signs or symptoms, which may be suggestive of PML.
Slovenian: Bolnike je treba skrbno nadzirati glede nastanka novih ali poslabšanja obstoječih nevroloških, kognitivnih ali vedenjskih znakov ali simptomov, ki lahko nakazujejo na PML.
English: Immediate and delayed infusion-related reactions (IRR), as well as anaphylactic reactions, have been reported.
Slovenian: Poročali so tako o takojšnjih in zakasnelih reakcijah, povezanih z infundiranjem (IRR, »infusion-related reactions«), kot o anafilaktičnih reakcijah.
English: The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration.
Slovenian: Rekonstituirano raztopino vizualno preglejte glede morebitne vsebnosti tujih delcev in/ali spremembe barve.
English: See Table 1 below for appropriate dosing recommendations (see also section 4.4).
Slovenian: Za ustrezna priporočila za odmerjanje glejte preglednico 1 spodaj (glejte tudi poglavje 4.4).
English: ADCETRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents.
Slovenian: Zdravilo ADCETRIS se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil proti raku.
English: Overall response rates for MF were 54-66%; pcALCL, 67%; SS, 50%; LyP, 92%; and mixed CTCL histology, 82-85%.
Slovenian: Celokupni odziv (ORR) za MF je bil 54-66%, za pcALCL 67%, SS 50%, LyP 92% in CTCL mešanega tipa 82-85%.
English: Not reached
Slovenian: Ni dosežena
English: See section 2 for further information about sodium.
Slovenian: Za dodatne informacije o natriju glejte poglavje 2.
English: 6.7 months
Slovenian: 6,7 mesecev
English: Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out.
Slovenian: Vzročna povezava z zdravilom ADCETRIS sicer ni bila ugotovljena, vendar pa tveganja toksičnosti za pljuča ni mogoče izključiti.
English: For a reduced dose, use 1.2 mg/kg for the calculation.
Slovenian: Za zmanjšani odmerek pri izračunu uporabite 1,2 mg/kg.
English: The exposure of MMAE (as assessed by AUC14D between Cycle 1 and Cycle 3) appeared to decrease with time by approximately 50%.
Slovenian: Izpostavljenost MMAE (ocenjeno z AUC14D med 1. in 3. ciklom) se je zmanjšala za približno 50%.
English: In clinical trials, serious infections and opportunistic infections occurred in 10% of patients, sepsis or septic shock occurred in < 1% of the patients.
Slovenian: V kliničnih preskušanjih so se resne okužbe in oportunistične okužbe pojavile pri 10% bolnikov, sepsa ali septični šok pa sta se pojavila pri < 1% bolnikov.
English: In case of overdose, the patient should be closely monitored for adverse reactions, particularly neutropenia, and supportive treatment should be administered (see section 4.4).
Slovenian: V primeru prevelikega odmerjanja je treba bolnika skrbno nadzirati glede pojava neželenih učinkov, zlasti nevtropenije, in uvesti podporno zdravljenje (glejte poglavje 4.4).
English: The primary endpoint of PFS was met and showed a difference in median PFS of 18.8 months in favour of the treatment arm.
Slovenian: Primarni opazovani dogodek PFS je bil dosežen in je pokazal mediano razliko PFS 18,8 mesecev v korist skupine z zdravilom ADCETRIS.
English: Modification of dose and schedule
Slovenian: Sprememba odmerka in režim
English: The median observation time (time to death or last contact) from first dose was 71.4 months.
Slovenian: Mediani čas opazovanja bolnikov (čas do smrti ali zadnjega stika) od prvega odmerka je bil 71,4 meseca.
English: Patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately 1 year) (see section 5.1).
Slovenian: Bolniki, pri katerih se bolezen stabilizira ali izboljša, naj prejmejo vsaj 8 ciklov in do največ 16 ciklov (približno 1 leto) (glejte poglavje 5.1).
English: Not reached (95% CI [26.4, -])
Slovenian: Ni doseženo (95% IZ [26,4, -])
English: Percent Difference (95% CI)
Slovenian: Odstotek razlike (95% CI)
English: Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage.
Slovenian: Znotraj celice se s proteolitičnim cepljenjem sprošča ena sama opredeljena aktivna komponenta, MMAE.
English: If Grade 3 or Grade 4 neutropenia develops, refer to section 4.2.
Slovenian: Če se razvije nevtropenija 3. ali 4. stopnje, glejte poglavje 4.2.
English: Table 2: Dosing recommendations for new or worsening peripheral sensory or motor neuropathy
Slovenian: Preglednica 2: Priporočila za odmerjanje za primere nove ali poslabšane periferne senzorične ali motorične nevropatije
English: The most commonly reported opportunistic infections were herpes zoster and herpes simplex.
Slovenian: Oportunistični okužbi, o katerih so najpogosteje poročali, sta bili herpes zoster in herpes simpleks.
English: 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).
Slovenian: Primarni opazovani dogodek je bil objektivni odziv na zdravljenje, ki traja vsaj 4 mesece (ORR4) (trajanje od prvega odziva do zadnjega odziva ≥ 4 mesece), kot ga določa neodvisni pregled ocene globalnega odziva (GRS, “Global Response Score”), ki ga sestavljajo ocene kože (prilagojeno orodje za ocenjevanje z uteženimi stopnjami resnosti [mSWAT, “modified severity weighted assessment tool”] po oceni raziskovalca), radiografska ocena bezgavk in visceralnih organov ter odkrivanje Sézaryjevih celic v obtoku (Olsen 2011).
English: Interaction with medicinal products metabolised through CYP3A4 route (CYP3A4 inhibitors/inducers)
Slovenian: Medsebojno delovanje z zdravili, ki se presnavljajo z encimom CYP3A4 (zaviralci/induktorji CYP3A4)
English: 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).
Slovenian: Izvesti študijo z enim krakom na populaciji bolnikov, ki je podobna populaciji s sALCL ter preučiti delež odzivnosti, trajanje odziva, pogostnost (druge) presaditve avtolognih matičnih celic in podatke v pod-populacijah (vključno z, a ne nujno omejeno na, stanje anaplastične limfomske kinaze in starost) po dogovorjenem protokolu CHMP (Študija C25006).
English: All patients had a histologically confirmed CD30-expressing disease.
Slovenian: Vsi bolniki so imeli histološko potrjeno bolezen z izraženim CD30.
English: Adcetris is to be given to adults only.
Slovenian: Zdravilo Adcetris se daje samo odraslim.
English: Adcetris is used to treat patients with advanced classical Hodgkin lymphoma who have not had treatment before.
Slovenian: Zdravilo Adcetris uporabljamo za zdravljenje bolnikov z napredovalim klasičnim Hodgkinovim limfomom, ki se predhodno še niso zdravili.
English: Store in a refrigerator (2 °C-8 °C).
Slovenian: Shranjujte v hladilniku (2 ºC-8 ºC).
English: MMAE is further metabolised mainly to an equally potent metabolite; however, its exposure is an order of magnitude lower than that of MMAE.
Slovenian: MMAE se nadalje presnovi, pretežno v enako učinkovit presnovek; vendar je njegova izpostavljenost za red velikosti manjša od MMAE, zato ni verjetno, da znatno prispeva k sistemskim učinkom MMAE.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije in redčenja zdravila pred dajanjem glejte poglavje 6.6.
English: At the time of the primary analysis, the median follow-up time for both arms was 30 months (range, 0 to 50).
Slovenian: V času primarne analize, je bil mediani čas spremljanja za obe skupini 30 mesecev [razpon od 0 do 50].
English: Best response to salvage therapy pre-ASCT Complete Response
Slovenian: Najboljši odziv na reševalno zdravljenje pred avtologno PKMC Popolni odziv
English: The primary objective was to evaluate the effect of brentuximab vedotin on cardiac ventricular re-polarization and the predefined primary analysis was the change in QTc from baseline to multiple time points in Cycle 1.
Slovenian: Primarni cilj je bil ocenitev učinka brentuksimaba vedotina na repolarizacijo srčnih ventriklov in predefinirana primarna analiza je bila sprememba intervala QTc od izhodišča do številnih časovnih točk v 1. ciklu.
English: Relapse occurred <12 months Relapse occurred > = > 12 months a.
Slovenian: Ponovitev s pričetkom < 12 mesecev Ponovitev s pričetkom ≥ 12 mesecev a.
English: Patient characteristics n = 58
Slovenian: Značilnosti bolnika n = 58
English: Complete remission (CR) was 33% (34 of 102 patients in the ITT set).
Slovenian: Popolno remisijo (CR) je doseglo 33% (34 od vseh 102 bolnikov, ki so bili vključeni v študijo [ITT]).
English: Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops.
Slovenian: Bolnike je treba skrbno nadzirati glede pojava zvišane telesne temperature in jo zdraviti po najboljši medicinski praksi, če se pojavi febrilna nevtropenija.
English: Patients should be monitored for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paraesthesia, discomfort, a burning sensation, neuropathic pain or weakness.
Slovenian: Bolnike je treba spremljati glede simptomov nevropatije, kot so hipestezija, hiperestezija, parestezija, nelagodje, pekoč občutek, nevropatska bolečina ali oslabelost.
English: Patients with pcALCL received either prior radiation therapy or at least 1 prior systemic therapy and patients with MF received at least 1 prior systemic therapy.
Slovenian: Bolniki s pcALCL so bili podvrženi predhodni radiacijski terapiji ali vsaj enemu predhodnemu sistemskemu zdravljenju, bolniki z MF pa so prejemali vsaj eno predhodno sistemsko zdravljenje.
English: The RP2D was determined to be 1.8 mg/kg.
Slovenian: Priporočeni odmerek faze II (RP2D) je bil 1,8 mg/kg.
English: Overall Survival
Slovenian: Celokupno preživetje
English: Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV.
Slovenian: Predlagano vrednotenje PML vključuje nevrološko posvetovanje, magnetnoresonančno slikanje možganov, poudarjeno z gadolinijem, in analizo cerebrospinalne tekočine za DNA JCV s pomočjo polimerazne verižne reakcije ali biopsijo možganov z dokazi za JCV.
English: The doctor or nurse will dispose of this medicine.
Slovenian: Zdravilo bo zavrgel zdravnik ali medicinska sestra.
English: CD30 positivity was defined as ≥10% target lymphoid cells demonstrating membrane, cytoplasmic, and/or Golgi staining pattern based on an immunohistochemistry assay (Ventana anti-CD30 [Ber-H2]).
Slovenian: Pozitivnost na CD30 je bila opredeljena kot ≥ 10% ciljnih limfoidnih celic z dokazanimi vzorci membranskega, citoplazemskega in/ali Golgijevega barvanja na podlagi imunohistokemijske preiskave (Ventana anti-CD30 [Ber-H2]).
English: If peripheral sensory or motor neuropathy emerges or worsens during treatment see Table 2 below for appropriate dosing recommendations (see section 4.4).
Slovenian: Če se med zdravljenjem pojavi ali poslabša periferna senzorična ali motorična nevropatija, glejte spodnjo preglednico 2 za ustrezna priporočila za odmerjanje (glejte poglavje 4.4).
English: Patient characteristics n = 102
Slovenian: Značilnosti bolnika n = 102
English: It is given by your doctor or nurse over 30 minutes.
Slovenian: Dal vam ga bo zdravnik ali medicinska sestra v obliki 30-minutne infuzije.
English: In vivo data in animals and humans suggest that only a small fraction of MMAE released from brentuximab vedotin is metabolised.
Slovenian: Podatki in vivo pri živalih in ljudeh kažejo, da se le majhen del MMAE, ki se sprosti iz brentuksimaba vedotina, presnovi.
English: The elimination of MMAE was limited by its rate of release from ADC, typical apparent CL and half life of MMAE was 19.99 l/day and 3-4 days respectively.
Slovenian: Izločanje MMAE omejuje stopnja njegovega izločanja iz ADC, običajni navidezni očistek MMAE je 19,99 l/dan in njegov razpolovni čas 3-4 dni.
English: The ORR was 47% in response-evaluable patients with r/r HL, 53% in patients with r/r sALCL and 60% in sALCL patients in first relapse.
Slovenian: Delež ORR je bil 47% pri bolnikih z r/r HL, pri katerih je bilo mogoče oceniti odziv, pri bolnikih z r/r sALCL je bil ta delež 53% in pri bolnikih sALCL pri prvi ponovitvi 60%.
English: In a phase 1 dose finding and safety study (SGN35-009), unacceptable pulmonary toxicity (including 2 fatal events) was noted in 11 of 25 patients (44%) treated with brentuximab vedotin plus ABVD.
Slovenian: Pri študiji 1. faze za določanje odmerka in varnosti zdravila (SGN35-009) so opazili nesprejemljive toksične učinke na pljuča (vključno z 2 smrtnima primeroma) pri 11 od 25 bolnikov (44%), zdravljenih z brentuksimabom vedotinom v kombinaciji z ABVD.
English: Median number of skin-directed therapies (range) Median number of systemic therapies (range) MF, n (%)
Slovenian: Mediano število predhodnih zdravljenj (razpon) Mediano število zdravljenj, usmerjenih na kožo (razpon) Mediano število sistemskih zdravljenj (razpon) MF, n (%)
English: MMAE exposures decreased after multiple doses of brentuximab vedotin with approximately 50% to 80% of the exposure of the first dose being observed at subsequent doses.
Slovenian: Izpostavljenost MMAE se je zmanjšala po več odmerkih brentuksimaba vedotina, pri čemer je bilo pri naslednjih odmerkih opaženih približno 50% do 80% izpostavljenosti prvega odmerka.
English: Post-hoc Risk Factor Analyses
Slovenian: Naknadne analize dejavnikov tveganja
English: Bleomycin
Slovenian: Bleomicin
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ADCETRIS in one or more subsets of the paediatric population in the treatment of Hodgkin lymphoma and treatment of anaplastic large cell lymphoma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom ADCETRIS za eno ali več podskupin pediatrične populacije pri zdravljenju Hodgkinovega limfoma in pri zdravljenju anaplastičnega velikoceličnega limfoma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Slovenian: Zato je treba moškim, ki se zdravijo s tem zdravilom, svetovati, da si dajo pred zdravljenjem zamrzniti in shraniti vzorce sperme.
English: IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin (see section 4.8).
Slovenian: IRR so lahko pogostejše in hujše pri bolnikih s protitelesi proti brentuksimabu vedotinu (glejte poglavje 4.8).
English: 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.
Slovenian: Lastnosti bolnikov v izhodišču so izkazovale neuspešnost številnih predhodnih vrst kemoterapije (mediana 3 z razponom od 1 do 7) pred prvo uporabo zdravila ADCETRIS.
English: The median overall survival (OS) is 40.5 months (the median observation time (time to death or last contact) from first dose was 35.1 months (range 1.8 to 72.9+ months).
Slovenian: Mediani čas celokupnega preživetja (OS) je znašal 40,5 meseca (mediani čas opazovanja bolnikov (čas do smrti ali zadnjega stika) od prvega odmerka je bil 35,1 meseca (v razponu 1,8 do 72,9+ mesecev)).
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o tem zdravilu.
English: Complete Response (CR) per IRF n (%)
Slovenian: Popoln odziv (CR) po IRF n (%)
English: 42.9 months (95% CI [30.4, 42.9])
Slovenian: 42,9 meseca (95% IZ [30,4, 42,9])
English: However, results of repeat-dose toxicity studies in rats indicate the potential for brentuximab vedotin to impair male reproductive function and fertility.
Slovenian: Vendar pa rezultati študij toksičnosti pri ponavljajočih se odmerkih pri podganah kažejo na potencial brentuksimaba vedotina, da okvari reprodukcijsko sposobnost in plodnost pri moških.
English: An updated analysis conducted after 3 years of follow-up showed a sustained PFS improvement per IRF (HR = 0.58 [95% CI (0.41, 0.81)]).
Slovenian: Posodobljena analiza, ki je bila izvedena po 3 letih spremljanja, je pokazala trajno izboljšanje PFS po IRF (RO = 0,58 [95% IZ (0,41, 0,81)]).
English: Serious adverse drug reactions occurred in 12% of patients.
Slovenian: Resni neželeni učinki zdravila so se pojavili pri 12% bolnikov.
English: = Number of ADCETRIS vials needed
Slovenian: = Število potrebnih vial zdravila ADCETRIS
English: Primary refractory HL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Slovenian: Primarni refraktarni HL je opredeljen kot nedoseganje popolne remisije ali napredovanje v roku 3 mesecev od končanega začetnega zdravljenja.
English: Among patients who experienced peripheral neuropathy, the median follow up time from end of treatment until last evaluation was approximately 91 weeks.
Slovenian: Pri bolnikih, ki so imeli periferno nevropatijo, je mediani čas spremljanja od konca zdravljenja do zadnje ocenitve znašal približno 91 tednov.
English: These data indicate the absence of clinically relevant QT prolongation due to brentuximab vedotin administered at a dose of 1.8 mg/kg every 3 weeks in patients with CD30-expressing malignancies.
Slovenian: Ti podatki nakazujejo na odsotnost klinično pomembnega podaljšanja intervala QT zaradi uporabe brentuksimaba vedotina, danega v odmerku 1,8 mg/kg vsake 3 tedne pri bolnikih z malignostmi, ki izražajo CD30.
English: Percent Difference (95% CI) p-value
Slovenian: Odstotek razlike (95% CI) p-vrednost
English: Per IRF, the ORR was 51% (95% CI [36%, 66%]) for the patients who had received > 1 prior cancer-related treatment and 45% (95% CI [17%, 77%]) for the patients who had received 1 prior cancer-related treatment.
Slovenian: Po oceni IRF je znašal delež ORR 51% (95% IZ [36%, 66%]) pri bolnikih, ki so prejeli > 1 predhodno zdravljenje, povezano z rakom, in 45% (95% IZ [17%, 77%]) z pri bolnikih, ki so prejeli 1 predhodno zdravljenje, povezano z rakom.
English: There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with renal impairment, where serum creatinine is ≥ 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance is ≤ 40 mL/minute.
Slovenian: Na voljo ni nobenih podatkov o izkušnjah iz kliničnih preskušanj z uporabo zdravila ADCETRIS v kombinaciji s kemoterapijo pri bolnikih z okvaro ledvic, pri katerih serumski kreatinin znaša ≥ 2,0 mg/dl in/ali kreatininski očistek oz. izračunani kreatininski očistek znaša ≤ 40 ml/minuto.
English: There were no formal drug-drug interaction studies with brentuximab vedotin and bleomycin(B).
Slovenian: Izvedene ni bilo nobene uradne študije o medsebojnem delovanju zdravil z brentuksimabom vedotinom in bleomicinom (B).
English: 31 years (15-77)
Slovenian: 31 let (15-77)
English: Relapsed or refractory HL
Slovenian: Ponovljen ali refraktarni HL
English: Management of TLS may include aggressive hydration, monitoring of renal function, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
Slovenian: Zdravljenje TLS lahko vključuje agresivno hidriranje, spremljanje delovanja ledvic, popravek nenormalnih elektrolitov, zdravljenje hiperurikemije in podporno nego.
English: 3.6 vials
Slovenian: 3,6 viale
English: ADCETRIS dosing should be permanently discontinued if a diagnosis of PML is confirmed.
Slovenian: Uporabo zdravila ADCETRIS je treba trajno ukiniti, če se diagnoza PML potrdi.
English: Men are advised not to father a child during treatment with this medicine and for up to 6 months following the last dose of this medicine.
Slovenian: Moškim svetujemo, da med zdravljenjem s tem zdravilom in še do 6 mesecev po uporabi zadnjega odmerka tega zdravila ne spočne otroka.
English: Patients who have experienced a prior IRR should be premedicated for subsequent infusions.
Slovenian: Bolniki, ki so že imeli IRR, morajo pred naslednjim infundiranjem prejeti premedikacijo.
English: The median modified PFS by IRF assessment was not reached in either treatment arm.
Slovenian: Mediano modificirano PFS (“progression free survival”) po oceni IRF ni bilo doseženo v nobenem od dveh krakov zdravljenja.
English: The estimated overall survival rate at 5 years was 41% (95% CI [31%, 51%]).
Slovenian: Ocenjeno celokupno 5-letno preživetje je bilo 41% (95% IZ [31%, 51%]).
English: Patients should be monitored during and after infusion (see section 4.4).
Slovenian: Bolnike je treba nadzirati med infundiranjem in po njem (glejte poglavje 4.4).
English: Febrile neutropenia was reported in 21% of the patients who did not receive primary prophylaxis with G-CSF (see section 4.2).
Slovenian: O febrilni nevtropeniji so poročali pri 21% bolnikov, ki niso prejeli primarne profilakse z G-CSF (glejte poglavje 4.2).
English: Median time from HL diagnosis to first dose (range)
Slovenian: Mediani čas od diagnoze HL do prvega odmerka (razpon)
English: Two percent of patients required dose reduction and < 1% discontinued one of more of the study drugs due to neutropenia.
Slovenian: Zmanjšanje odmerka je bilo potrebno pri dveh odstotkih bolnikov, prekinitev dajanja enega od več zdravil v sklopu študije zaradi nevtropenije pa je bila potrebna pri < 1% bolnikov.
English: Of the study's 60 patients, 49 patients (82%) received > 1 prior cancer-related treatment and 11 patients (18%) received 1 prior cancer-related treatment.
Slovenian: Od 60 bolnikov, ki sodelovali v študiji, je 49 bolnikov (82%) prejelo > 1 predhodno zdravljenje, povezano z rakom, in 11 bolnikov (18%) je prejelo 1 predhodno zdravljenje, povezano z rakom.
English: Hodgkin lymphoma
Slovenian: Hodgkinov limfom
English: PET scan Status prior to ASCT FDG-AVID
Slovenian: Stanje PET slikanja pred avtologno PKMC FDG-AVID
English: Results from these phase 1 studies and from the NPP experience showed, that in patients with relapsed or refractory HL without prior ASCT, clinically meaningful responses can be achieved as evidenced by an investigator-assessed, objective response rate of 54% and a complete remission rate of 22% after a median of 5 cycles of ADCETRIS.
Slovenian: Rezultati študij 1. faze in izkušnje NPP kažejo, da je pri bolnikih s ponovljenim ali z refraktarnim HL brez predhodne presaditve avtolognih matičnih celic mogoče doseči klinično pomemben odziv, kar dokazuje 54-% delež objektivnega odziva glede na ocene preiskovalcev in 22-% delež popolne remisije po mediani 5 ciklusov zdravljenja z zdravilom ADCETRIS.