FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy and safety of ADCETRIS were evaluated in two additional open-label studies in 108 patients with relapsed CD30+ CTCL (including MF and pcALCL as well as SS, LyP and mixed CTCL histology), regardless of CD30 expression level.
Slovenian: Učinkovitost in varnost zdravila ADCETRIS sta bili ocenjeni v dveh dodatnih odprtih študijah pri 108 bolnikih s ponovitvijo CD30-pozitivnega CTCL (vključno z MF in pcALCL, kakor tudi SS, LyP in CTCL mešanega tipa), ne glede na stopnjo izražanja CD30.
English: Instructions for reconstitution
Slovenian: Navodila za rekonstitucijo
English: Pulmonary toxicity
Slovenian: Toksičnost za pljuča
English: Symptoms of an anaphylactic reaction may include, but are not limited to, urticaria, angioedema, hypotension and bronchospasm.
Slovenian: Simptomi anafilaktične reakcije lahko med drugimi vključujejo urtikarijo, angioedem, hipotenzijo in bronhospazem.
English: Liver function should be tested before initiating the treatment and routinely monitored in patients receiving ADCETRIS.
Slovenian: Pri bolnikih, ki prejemajo zdravilo ADCETRIS, je treba pred začetkom zdravljenja preveriti jetrno funkcijo in jo nato rutinsko spremljati.
English: Histologically confirmed CD30-expressing disease Disease characteristics
Slovenian: Histološko potrjena bolezen z izraženim CD30 Značilnosti bolezni
English: For intravenous use after reconstitution and dilution Read the package leaflet
Slovenian: za intravensko uporabo po rekonstituciji in razredčenju Pred uporabo preberite priloženo navodilo!
English: Adcetris is a white to off-white cake or powder for concentrate for solution for infusion provided in a glass vial.
Slovenian: Zdravilo Adcetris je bela do belkasta pogača ali prašek za koncentrat za raztopino za infundiranje v stekleni viali.
English: 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.
Slovenian: Razpon trajanja odziva je znašal od 1,2+ meseca do 43+ meseca, mediani čas spremljanja od prvega odmerka za bolnike, ki so dosegli objektivni odziv (OR) po IRF, pa je bil 9,0 mesecev.
English: 24.1 months (95% CI [11.5, -])
Slovenian: 24,1 meseca (95% IZ [11,5, -])
English: Patients experiencing hepatotoxicity may require a delay, change in dose or discontinuation of ADCETRIS.
Slovenian: Pri bolnikih, pri katerih se pojavi hepatotoksičnost, bo morda potrebno začasno prekiniti zdravljenje, spremeniti odmerek ali trajno prekiniti zdravljenje z zdravilom ADCETRIS.
English: There were no relevant differences in the patient and disease characteristics between the two arms.
Slovenian: Med krakoma ni bilo pomembnih razlik glede značilnosti bolnikov in bolezni.
English: Use of ADCETRIS in combination with chemotherapy should be avoided in patients with moderate and severe hepatic impairment.
Slovenian: Uporabi zdravila ADCETRIS v kombinaciji s kemoterapijo se je treba izogibati pri bolnikih z zmerno in hudo okvaro jeter.
English: Each single use vial must be reconstituted with 10.5 mL of water for injections to a final concentration of 5 mg/ mL.
Slovenian: Eno enoodmerno vialo morate rekonstituirati z 10,5 ml vode za injekcije do končne koncentracije 5 mg/ml.
English: In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology.
Slovenian: V dveh študijah 2. faze z enim krakom, v katerih so preučevali zdravilo ADCETRIS, je prišlo do aktivnosti bolezni pri podtipih Sézaryjev sindrom (SS), limfomatoidna papuloza (LyP, “lymphomatoid papulosis”) in CTCL mešanega tipa.
English: Men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Slovenian: Moškim, ki se zdravijo s tem zdravilom, svetujemo, da si dajo pred zdravljenjem zamrzniti in shraniti vzorce sperme.
English: The objective response rate (ORR) per IRF assessment was 75% (76 of 102 patients in the intent-to-treat [ITT] set) and tumour reduction was achieved in 94% of patients.
Slovenian: Delež objektivnega odziva (ORR) je po oceni IRF znašal 75% (76 od vseh 102 bolnikov, ki so bili vključeni v študijo (ITT), zmanjšanje tumorja pa je bilo doseženo pri 94% bolnikov.
English: In the clinical trial of ADCETRIS as combination therapy, serious infections including opportunistic infections occurred in 15% of patients; sepsis, neutropenic sepsis, septic shock or bacteraemia occurred in 4% of the patients.
Slovenian: V kliničnih preskušanjih zdravila ADCETRIS v obliki kombiniranega zdravljenja so se resne okužbe, vključno z oportunističnimi okužbami, pojavile pri 15% bolnikov; sepsa, nevtropenična sepsa, septični šok ali bakteremija se je pojavila pri 4% bolnikov.
English: Patients were stratified by these disease types and randomised 1:1 to receive either ADCETRIS or the physician's choice of either methotrexate or bexarotene.
Slovenian: Bolniki, ki so jih stratificirali po tipih bolezni, so v razmerju 1 : 1 randomizirano prejemali bodisi zdravilo ADCETRIS bodisi zdravilo po izbiri zdravnika, ki je bilo metotreksat ali beksaroten.
English: The serum and plasma pharmacokinetic characteristics of ADC and MMAE respectively following administration of brentuximab vedotin in combination with AVD were similar to that in monotherapy.
Slovenian: Serumske in plazemske farmakokinetične značilnosti ADC oz. MMAE po dajanju brentuksimaba vedotina v kombinaciji z AVD so bile podobne kot pri samostojnem zdravljenju.
English: NOT DONE
Slovenian: NI IZVEDENO
English: The population pharmacokinetics of brentuximab vedotin were examined from several studies, including data from 380 patients up to 87 years old (34 patients ≥65-< 75 and 17 patients ≥75 years of age).
Slovenian: Populacijsko farmakokinetiko brentuksimaba vedotina so preučili na podlagi različnih študij, ki so vključevale podatke 380 bolnikov, starih do 87 let (34 bolnikov, starih ≥ 65- < 75, in 17 bolnikov, starih ≥ 75 let).
English: Unopened vial: Store in a refrigerator (2 °C-8 °C).
Slovenian: Neodprta viala: Shranjujte v hladilniku (2 ºC-8 ºC).
English: Number of vials needed = total volume to be diluted divided by total volume per vial [10 mL/vial])
Slovenian: Število potrebnih vial = skupni volumen, ki ga je treba razredčiti, deljen s skupnim volumnom na vialo [10 ml/vialo])
English: Frequency not known: Progressive multifocal leukoencephalopathy Blood and lymphatic system disorders Very common:
Slovenian: progresivna multifokalna levkoencefalopatija Bolezni krvi in limfatičnega sistema Zelo pogosti:
English: Adverse events that led to treatment discontinuation in ≥ 2% of patients included peripheral sensory neuropathy, peripheral neuropathy, and peripheral motor neuropathy.
Slovenian: Neželeni dogodki, ki so privedli do prekinitve zdravljenja pri ≥ 2% bolnikov, so vključevali periferno senzorično nevropatijo, periferno nevropatijo in periferno motorično nevropatijo.
English: 378M (57) 286F (43)
Slovenian: 378 M (57) 286 Ž (43)
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Table 5: Efficacy results for previously untreated HL patients treated with 1.2 mg/kg of ADCETRIS + AVD on days 1 and 15 of a 28-day cycle (ITT and Stage IV)
Slovenian: Preglednica 5: Rezultati učinkovitosti zdravljenja z 1,2 mg/kg zdravila ADCETRIS + AVD pri predhodno nezdravljenih bolnikih s HL, na 1. in 15. dan v 28-dnevnem ciklu (ITT in stadij IV)
English: Median number of prior chemotherapy regimens (range)
Slovenian: Mediano število predhodnih kemoterapij (razpon)
English: Figure 3: Kaplan-Meier Plot of PFS per IRF in Patients with ≥ 2 Risk Factors
Slovenian: Slika 3: Kaplan-Meierjeva krivulja preživetja za PFS po IRF pri bolnikih z ≥ 2 dejavnikoma tveganja
English: Use of ADCETRIS in combination with chemotherapy should be avoided in patients with severe renal impairment.
Slovenian: Uporabi zdravila ADCETRIS v kombinaciji s kemoterapijo se je treba izogibati pri bolnikih s hudo okvaro ledvic.
English: The frequency of febrile neutropenia was 11% in patients who received primary prophylaxis with G-CSF.
Slovenian: Pogostnost febrilne nevtropenije pri bolnikih, ki so prejeli primarno profilakso z G-CSF, je bila 11%.
English: In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 36% of patients.
Slovenian: Pri bolnikih, ki so prejemali zdravilo ADCETRIS v okviru kombiniranega zdravljenja, so se resni neželeni učinki pojavili v 36% primerov.
English: Patients should be carefully monitored during and after infusion.
Slovenian: Bolnike je treba med infundiranjem in po njem skrbno nadzirati.
English: Additionally, the population pharmacokinetics of brentuximab vedotin in combination with AVD were examined, including data from 661 patients up to 82 years old (42 patients ≥ 65-< 75 and 17 patients ≥ 75 years of age).
Slovenian: Poleg tega so proučili tudi populacijsko farmakokinetiko brentuksimaba vedotina v kombinaciji z AVD, pri čemer so bili vključeni podatki za 661 bolnikov, starih do 82 let (42 bolnikov, starih ≥ 65 - < 75, in 17 bolnikov, starih ≥ 75 let).
English: Adcetris is used to treat cutaneous T-cell lymphoma (CTCL) in patients who have previously received at least one medicine that travels through the bloodstream.
Slovenian: Zdravilo Adcetris uporabljamo za zdravljenje kožnega T-celičnega limfoma (CTCL, “cutaneous T-cell lymphoma”) pri bolnikih, ki so predhodno prejemali vsaj eno zdravilo, ki potuje po krvnem obtoku.
English: In nonclinical studies, lymphoid depletion and reduced thymic weight were observed, consistent with the pharmacologic disruption of microtubules caused by MMAE derived from brentuximab vedotin.
Slovenian: V predkliničnih študijah so opazili limfoidno izginjanje in manjšo maso timusa, kar je skladno s farmakološko prekinitvijo mikrotubulnega omrežja, ki ga povzroči MMAE, presnovek brentuksimaba vedotina.
English: 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.
Slovenian: Razpon trajanja odziva je znašal od 0,1 meseca do 39,1+ meseca, mediani čas spremljanja od prvega odmerka za bolnike, ki so dosegli objektivni odziv (OR) po IRF, pa je bil 15,5 meseca.
English: Figure 4: Kaplan-Meier Plot of PFS per Investigator in Patients with ≥ 2 Risk Factors
Slovenian: Slika 4: Kaplan-Meierjeva krivulja preživetja za PFS po raziskovalcu pri bolnikih z ≥ 2 dejavnikoma tveganja
English: For safety information of chemotherapy agents given in combination with ADCETRIS (doxorubicin, vinblastine and dacarbazine) for newly diagnosed patients with HL, refer to their summary of product characteristics.
Slovenian: Za podatke o varnosti kemoterapevtikov (doksorubicin, vinblastin in dakarbazin), ki se uporabljajo v kombinaciji z zdravilom ADCETRIS za na novo diagnosticirane bolnike s HL, glejte ustrezne povzetke glavnih značilnosti zdravila.
English: ADCETRIS is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE).
Slovenian: Zdravilo ADCETRIS je konjugirano zdravilo iz protiteles, ki ga sestavlja monoklonsko protitelo, usmerjeno proti CD30 (rekombinantni himerni imunoglobulin G1 [IgG1], pridobljen s tehnologijo rekombinantne DNA v ovarijskih celicah kitajskega hrčka), ki se kovalentno veže na antimikrotubulno učinkovino monometil avristatin E (MMAE).
English: Population PK analysis showed that baseline serum albumin concentration was a significant covariate of MMAE clearance.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da je bila izhodiščna koncentracija albumina pomembna sospremenljivka očistka MMAE.
English: Adjusted p-value
Slovenian: Prilagojena p-vrednost
English: At the time of last evaluation, most of the patients (82-85%) who experienced peripheral neuropathy had resolution or improvement of their peripheral neuropathy symptoms.
Slovenian: Ob zadnji ocenitvi je pri večini bolnikov (82-85%), ki so imeli periferno nevropatijo, stanje izzvenelo ali pa so se simptomi periferne nevropatije izboljšali.
English: Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations (see section 5.2).
Slovenian: Razpoložljivi podatki kažejo, da lahko huda okvara ledvic, okvara jeter in nizke koncentracije albumina v serumu vplivajo na očistek MMAE (glejte poglavje 5.2).
English: The efficacy and safety of ADCETRIS were evaluated in a randomised, open-label, 2-arm, multicenter trial in 1334 patients with previously untreated advanced HL in combination with chemotherapy (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]).
Slovenian: Učinkovitost in varnost zdravila ADCETRIS sta bili ovrednoteni v randomizirani, odprti, multicentrični študiji z dvema krakoma, kjer je bilo vključenih 1334 bolnikov s predhodno nezdravljenim napredovalim HL v okviru zdravljenja v kombinaciji s kemoterapijo (doksorubicin [A], vinblastin [V] in dakarbazin [D] [AVD]).
English: John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in ADCETRIS-treated patients.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom ADCETRIS, se lahko ponovno aktivira John Cunningham virus (JCV), kar povzroči progresivno multifokalno levkoencefalopatijo (PML) in smrt.
English: Of the 35 patients (33%) who had B symptoms at baseline, 27 patients (77%) experienced resolution of all B symptoms at a median time of 0.7 months from initiation of ADCETRIS.
Slovenian: Med 35 bolniki (33%), ki so imeli ob izhodišču simptome B, so pri 27 bolnikih (77%) vsi simptomi B izzveneli ob medianem času 0,7 mesecev od začetka uporabe zdravila ADCETRIS.
English: Complete blood counts should be monitored prior to administration of each dose of this treatment (see section 4.4).
Slovenian: Pred aplikacijo vsakega odmerka zdravila je treba preveriti celotno krvno sliko bolnika (glejte poglavje 4.4).
English: If patient's weight is more than 100 kg, the dose calculation should use 100 kg. d. The maximal recommended dose is 180 mg.
Slovenian: Če je bolnikova telesna masa večja od 100 kg, je treba pri izračunu odmerka uporabiti 100 kg. d. Največji priporočeni odmerek je 180 mg.
English: After reconstitution each mL of solution contains 5 mg of Adcetris.
Slovenian: Po rekonstituciji en ml raztopine vsebuje 5 mg zdravila Adcetris.
English: Figure 2: Modified progression-free survival per IRF in patients with Stage IV disease (ADCETRIS + AVD vs. ABVD)
Slovenian: Slika 2: Modificirano preživetje brez napredovanja bolezni po IRF pri bolnikih z boleznijo stadija IV (ADCETRIS + AVD v primerjavi z ABVD)
English: There is limited experience in patients with renal and hepatic impairment.
Slovenian: Izkušnje pri bolnikih z okvaro ledvic in jeter so omejene.
English: Physician's Choice (Methotrexate or Bexarotene) n = 64
Slovenian: Po izbiri zdravnika (metotreksat ali beksaroten) n = 64
English: Adcetris is used to treat systemic anaplastic large cell lymphoma which is found in your lymph nodes and/or throughout other parts of your body that has: not responded to other types of anti-cancer treatments, or come back after previous anti-cancer treatment.
Slovenian: Zdravilo Adcetris uporabljamo za zdravljenje sistemskega anaplastičnega velikoceličnega limfoma, ki se nahaja v bezgavkah in/ali v vseh drugih delih telesa, in: - se ni odzval na druge oblike zdravljenja proti raku ali - se je ponovil po predhodnemu zdravljenju raka.
English: The safety profile of ADCETRIS is based on available clinical trial data, the Named Patient Program (NPP), and post-marketing experience to date.
Slovenian: Varnostni profil zdravila ADCETRIS temelji na razpoložljivih podatkih iz kliničnih preskušanj, programa uporabe zdravila pred pridobitvijo dovoljenja za promet pri bolnikih, ki so izčrpali vse druge možnosti zdravljenja (NPP, “Named Patient Program”) in spremljanja zdravila po pridobitvi dovoljenja za promet.
English: If patient's weight is more than 100 kg, the dose calculation should use 100 kg. d. The maximal recommended dose for combination therapy is 120 mg.
Slovenian: Če je bolnikova telesna masa večja od 100 kg, je treba pri izračunu odmerka uporabiti 100 kg. d. Največji priporočeni odmerek pri kombiniranem zdravljenju je 120 mg.
English: There are no data as to whether brentuximab vedotin or its metabolites are excreted in human milk.
Slovenian: Ni podatkov o tem, ali se brentuksimab vedotin ali njegovi presnovki izločajo v materino mleko.
English: The efficacy of retreatment in patients who had previously responded (CR or PR) to treatment with ADCETRIS was evaluated in a phase 2, open-label, multicenter trial.
Slovenian: Učinkovitost ponovne uvedbe zdravljenja pri bolnikih s predhodnim odzivom (CR ali PR) na zdravljenje z zdravilom ADCETRIS so vrednotili v odprtem, multicentričnem preskušanju 2. faze.
English: Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0; see Neutrophils/granulocytes; LLN = lower limit of normal b.
Slovenian: Razvrstitev v stopnje temelji na terminološko poenotenih kriterijih neželenih učinkov (CTCAE, “Common Terminology Criteria for Adverse Events”) nacionalnega onkološkega inštituta, različica 3.0; glejte nevtrofilci/granulociti; LLN = spodnja meja normalne vrednosti b.
English: Number of Risk Factors ≥ 3
Slovenian: Število dejavnikov tveganja ≥ 3
English: In the pooled dataset of ADCETRIS as monotherapy across HL, sALCL and CTCL studies (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 and C25007, see section 5.1) the most frequent adverse reactions (≥ 10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain.
Slovenian: V združenem naboru podatkov o zdravilu ADCETRIS, uporabljenem kot monoterapija v študijah HL, sALCL in CTCL (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 in C25007, glejte poglavje 5.1), so bili najpogostejši neželeni učinki (≥ 10%) okužbe, periferna senzorična nevropatija, navzea, utrujenost, driska, pireksija, okužba zgornjih dihal, nevtropenija, izpuščaj, kašelj, bruhanje, artralgija, periferna motorična nevropatija, reakcije, povezane z infundiranjem, pruritus, zaprtost, dispneja, zmanjšanje telesne mase, mialgija in bolečine v trebuhu.
English: Per IRF, the objective response rate (ORR) in the ITT population was 50% (95% CI, 37; 63%).
Slovenian: Po oceni IRF je znašal delež objektivnega odziva (ORR) pri populaciji bolnikov, ki so bili vključeni v študijo (ITT), 50% (95% IZ, 37, 63%).
English: However, any patient who experiences an event of hyperglycaemia should have their serum glucose closely monitored.
Slovenian: Pri bolnikih, pri katerih se pojavi hiperglikemija, je potrebno skrbno spremljanje glukoze v serumu.
English: The median number of cycles was 8.5 (range, 2 to 30 cycles).
Slovenian: Mediano število ciklov je bilo 8,5 (razpon od 2 do 30 ciklov).
English: The median number of cycles was approximately 12 cycles in the ADCETRIS arm.
Slovenian: Mediano število ciklov v skupini zdravila ADCETRIS je bilo približno 12.
English: Progression Free Survival per IRF
Slovenian: Preživetje brez napredovanja (PFS) po IRF
English: Systemic anaplastic large cell lymphoma
Slovenian: Sistemski anaplastični velikocelični limfom
English: CR was 59% (34 of 58 patients in the ITT set) and tumour reduction (of any degree) was achieved in 97% of patients.
Slovenian: Popolna remisija (CR) je bila dosežena pri 59% (34 od vseh 58 bolnikov, ki so bili vključeni v študijo [ITT]), zmanjšanje tumorja (kakršne koli stopnje) pa je bilo doseženo pri 97% bolnikov.
English: Patients with a diagnosis of mycosis fungoides [MF] or primary cutaneous anaplastic large cell lymphoma [pcALCL] were considered eligible for the study.
Slovenian: Bolniki z diagnozo fungoidnega granuloma [MF] ali primarnega kožnega anaplastičnega velikoceličnega limfoma [pcALCL] so bili primerni za vključitev v študijo.
English: Infection a, upper respiratory tract infection Infection a, upper respiratory tract infection
Slovenian: okužba a, okužba zgornjih dihal okužba a, okužba zgornjih dihal
English: 2.88 vials
Slovenian: 2,88 viale
English: At the time of the updated analysis (3 years of follow-up) for patients with 2 or more risk factors, the hazard ratio for PFS per IRF was 0.49 (95% CI [0.34, 0.71]) and the hazard ratio for PFS per investigator was 0.41 (95% CI [0.29, 0.58]) (see Figures 3 and 4).
Slovenian: V obdobju posodobljene analize (3 leta spremljanja) pri bolnikih z 2 ali več dejavniki tveganja je bilo razmerje ogroženosti za PFS po IRF 0,49 (95% IZ [0,34, 0,71]) in razmerje ogroženosti za PFS po raziskovalcu 0,41 (95% IZ [0,29, 0,58]) (glejte sliki 3 in 4).
English: Therefore, co-administration of brentuximab vedotin with strong CYP3A4 and P-gp inhibitors may increase the incidence of neutropenia.
Slovenian: Zato lahko sočasno dajanje brentuksimaba vedotina z močnimi zaviralci CYP3A4 in P-gp poveča incidenco nevtropenije.
English: If the patient's weight is more than 100 kg, the dose calculation should use 100 kg (see section 6.6).
Slovenian: Pri bolnikih s telesno maso, večjo od 100 kg, je treba pri izračunu odmerka uporabiti 100 kg (glejte poglavje 6.6).
English: Maximum concentrations of brentuximab vedotin ADC were typically observed at the end of infusion or the sampling timepoint closest to the end of infusion.
Slovenian: Največjo koncentracijo ADC brentuksimaba vedotina so običajno opazili ob koncu infundiranja ali ob točki vzorčenja, ki je bila najbližje koncu infundiranja.
English: Grade 3 neutropenia was reported in 18% and Grade 4 neutropenia was reported in 47% of patients.
Slovenian: O nevtropeniji 3. stopnje so poročali pri 18% bolnikov, o nevtropeniji 4. stopnje pa pri 47% bolnikov.
English: 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.
Slovenian: Varnostni podatki pri bolnikih s ponovitvijo ali z refraktarnim HL, brez opravljene presaditve avtolognih matičnih celic, ki so se zdravili s priporočenim odmerkom 1,8 mg/kg vsake tri tedne v študiji z enim krakom 4. faze (n = 60), študijah 1. faze z višanjem odmerkov in kliničnih farmakoloških študijah (n = 15 bolnikov) ter v NPP (n = 26 bolnikov) (glejte poglavje 5.1), so skladni z varnostnim profilom ključnih kliničnih študij.
English: Peripheral neuropathy led to treatment discontinuation in 7%, dose reductions in 21%, and dose delays in 1% of patients.
Slovenian: Periferna nevropatija je povzročila prekinitev zdravljenja pri 7%, zmanjšanje odmerka pri 21% in odložitev odmerka pri 1% bolnikov.
English: Objective response rate (CR + PR)
Slovenian: Objektivni odziv (CR + PR)
English: The results in the intent-to-treat (ITT) population showed a statistically significant improvement in modified PFS for ADCETRIS+ AVD, with a stratified hazard ratio of 0.770 (95% CI, 0.603; 0.983, p = 0.035), indicating a 23% reduction in the risk of modified PFS events for ADCETRIS+ AVD versus ABVD.
Slovenian: Rezultati v populaciji “z namenom zdravljenja” (ITT, “intent-to-treat”), so pokazali statistično pomembno izboljšanje modificiranega PFS za zdravilo ADCETRIS v kombinaciji z AVD; stratificirano razmerje ogroženosti je znašalo 0,770 (95% CI, 0,603; 0,983, p-vrednost = 0,035), kar kaže na 23-odstotno zmanjšanje tveganja dogodkov modificiranega PFS za zdravilo ADCETRIS v kombinaciji z AVD v primerjavi z ABVD.