FrancophonIA/ELRC3.0 huggingface dataset:
English: A pre-specified subgroup analysis of mPFS by disease stage showed that patients with Stage IV disease had a larger effect compared with the ITT population, with an unstratified hazard ratio of 0.71 (95% CI, 0.53; 0.96), compatible with a 29% reduction in the risk of modified PFS events for ADCETRIS+ AVD versus ABVD.
Maltese: Analiżi speċifikata minn qabel tal-mPFS skont l-istadju tal-marda wriet li l-pazjenti b'marda ta' Stadju IV esperjenzaw effett akbar meta mqabbla mal-popolazzjoni ITT, bi proporzjon ta' periklu mhux stratifikat ta' 0.71 (95% CI, 0.53; 0.96), kompatibbli ma' tnaqqis ta' 29% fir-riskju ta' avvenimenti PFS modifikati għal ADCETRIS+ AVD kontra ABVD.
English: Response assessments were performed at cycles 2, 4, 7, 10, 13, and 16 with PET at cycles 4 and 7.
Maltese: Valutazzjonijiet tar-rispons twettqu f'ċikli 2, 4, 7, 10, 13, u 16 u b'PET f'ċikli 4 u 7.
English: 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).
Maltese: Il-farmakokinetika ta' ADC u MMAE ta' brentuximab vedotin wara infużjoni ġol-vina ta' 30 minuta ta' BV mogħtija f'rata ta' 1.4 mg/kg jew 1.8 mg/kg, mogħtija kull 3 ġimgħat, ġiet evalwata fi prova klinika ta' fażi 1/2 li saret fuq 36 pazjent pedjatriku (li kellhom minn 7-17-il sena) b'r/r HL u b'sALCL (tfal li kellhom minn 7-11-il sena, n = 12 u adolexxenti li kellhom minn 12 sa 17-il sena, n = 24)
English: Figure 3: Kaplan-Meier Plot of PFS per IRF in Patients with ≥ 2 Risk Factors
Maltese: Figura 3: Plot ta' Kaplan-Meier tal-PFS kull IRF f'Pazjenti b'≥ 2 Fatturi ta' Riskju
English: Compared to patients with normal hepatic function, MMAE exposure increased approximately 2.3-fold (90% CI 1.27-4.12-fold) in patients with hepatic impairment.
Maltese: Imqabbla ma' pazjenti b'funzjoni normali tal-fwied, l-esponiment għal MMAE żdied b'madwar 2.3 darbiet (CI ta' 90% 1.27-4.12-il darba) f'pazjenti b'indeboliment epatiku.
English: The other chemotherapy medicines are doxorubicin, vinblastine and dacarbazine.
Maltese: Il-mediċini tal-kimoterapija l-oħra huma doxorubicin, vinblastine u dacarbazine.
English: Data in HL Patients Who Are Not Stem Cell Transplant (SCT) Candidates
Maltese: Dejta f'pazjenti b'HL Li Mhumiex Kandidati għal Trapjant ta' Ċelluli Staminali (SCT, Stem Cell Transplant)
English: Eighteen (18) patients (18%) received 16 cycles of ADCETRIS; and the median number of cycles received was 9 (ranging from 1 to 16).
Maltese: Tmintax-il (18) pazjent (18%) irċevew 16-il ċiklu ta' ADCETRIS; u n-numru medju ta' ċikli riċevuti kien ta' 9 (firxa minn 1 sa 16).
English: Combined use of bleomycin and ADCETRIS causes pulmonary toxicity (see section 4.5).
Maltese: L-użu flimkien ta' bleomycin u ADCETRIS jikkawża tossiċità pulmonari (ara sezzjoni 4.5).
English: Anaphylactic reactions have been reported (see section 4.4).
Maltese: Reazzjonijiet anafilattiċi ġew irrappurtati (ara sezzjoni 4.4).
English: Co-administration of brentuximab vedotin with ketoconazole, a strong CYP3A4 and P-gp inhibitor, increased the exposure to the antimicrotubule agent MMAE by approximately 73%, and did not alter the plasma exposure to brentuximab vedotin.
Maltese: L-għoti ta' brentuximab vedotin flimiken ma' ketoconazole, inibitur qawwi ta' CYP3A4 u P-gp, żied l-esponiment għas-sustanza kontra l-mikrotubule MMAE b'madwar 73%, u ma bidilx l-esponiment fil-plażma għal brentuximab vedotin.
English: Neutropenia a, anaemia, febrile neutropenia
Maltese: Newtropenija a, anemija, newtropenija bid-deni
English: Date of renewal: 10 September 2018
Maltese: Data ta' l-ewwel awtorizazzjoni: 25 ta' Ottubru, 2012 Data ta' l-aħħar tiġdid: 10 ta' Settembru 2018
English: Phase 1 included 3 r/r HL patients treated at 1.4 mg/kg and 9 patients (7 r/r HL and 2 sALCL) treated at 1.8 mg/kg.
Maltese: Fażi 1 kienet tinkludi 3 pazjenti b'r/r HL ittrattati b'doża ta' 1.4 mg/kg u 9 pazjenti (7 b'r/r HL u 2 b'sALCL) ittrattati b'doża ta' 1.8 mg/kg.
English: In vitro data indicate that the MMAE metabolism that occurs is primarily via oxidation by CYP3A4/5.
Maltese: Dejta in vitro tindika li l-metaboliżmu ta' MMAE li jseħħ huwa primarjament permezz ta' ossidazzjoni minn CYP3A4/5.
English: The median duration of response was 8.8 and 12.3 months in patients who achieved OR (CR+PR) and CR, respectively.
Maltese: It-tul medjan tar-rispons kien 8.8 u 12.3 xhur f'pazjenti li kisbu OR (CR+PR) u CR, rispettivament.
English: Best clinical response (n = 102 )
Maltese: L-aħjar rispons kliniku (N = 102)
English: Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage.
Maltese: Fi ħdan iċ-ċellula, speċi definita attiva waħda, MMAE, tintreħa permezz ta' qsim proteolitiku.
English: 27.9 months
Maltese: 27.9 xhur
English: Adverse events that led to treatment discontinuation in ≥ 2% of patients included peripheral sensory neuropathy, peripheral neuropathy, and peripheral motor neuropathy.
Maltese: L-avvenimenti avversi li wasslu għat-twaqqif tal-kura f' ≥ 2% tal-pazjenti, kienu jinkludu newropatija sensorjali periferali, newropatija periferali u newropatija motorja periferali
English: For further efficacy results see Table 10.
Maltese: Għall-aktar riżultati ta' effikaċja ara Tabella 10.
English: IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin (see section 4.8).
Maltese: IRRs huma aktar frekwenti u aktar severi f'pazjenti b'antikorpi għal brentuximab vedotin (ara sezzjoni 4.8).
English: • HL that was refractory to frontline treatment
Maltese: • HL li kien refrattorju għal trattament ippreferut
English: There is limited experience in patients with renal and hepatic impairment.
Maltese: Hemm esperjenza limitata f'pazjenti b'indeboliment renali u epatiku.
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.
Maltese: Esponimenti għal MMAE naqsu wara dożi multipli ta' brentuximab vedotin b'madwar 50% sa 80% tal-esponiment tal-ewwel doża tiġi osservata f'dożi sussegwenti.
English: Progression Free Survival per IRF
Maltese: Ħielsa minn Progressjoni kull IRF
English: At least one metabolite of MMAE has been shown to be active in vitro.
Maltese: Mill-inqas metabolit wieħed ta' MMAE intwera li huwa attiv in vitro.
English: A multiexponential decline in ADC serum concentrations was observed with a terminal half-life of approximately 4 to 6 days.
Maltese: Tnaqqis multiesponenzjali fil-konċentrazzjonijiet fis-serum ta' ADC kien osservat b'half-life terminali ta' madwar 4 sa 6 ijiem.
English: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS.
Maltese: Sindrome Stevens-Johnson (SSJ) u nekrożi tossika tal-epiderme (NTE) kienu rrapportati b'ADCETRIS.
English: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection with an absolute neutrophil count < 1.0 x 10
Maltese: Newtropenija bid-deni (deni ta' oriġini mhux magħrufa mingħajr infezzjoni klinikament jew mikrobijoloġikament dokumentata b'għadd assolut ta' newtrofili ta' < 1.0 x 10
English: A best overall response of CR was reported for 7 patients (12%); PR was reported for 23 patients (38%).
Maltese: L-aħjar rispons globali ta' CR ġie rrappurtat għal 7 pazjenti (12%); PR kienet irrappurtata għal 23 pazjent 23 (38%).
English: Relapsed or refractory sALCL
Maltese: Seba' pazjenti b'sALCL li
English: Nausea, constipation, vomiting, diarrhoea, abdominal pain, stomatitis
Maltese: Dardir, stitikezza, rimettar, dijarea, uġigħ addominali, stomatite
English: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 13.2 mg ta' sodium f'kull kunjett, ekwivalenti għal 0.7% tad-doża massima ta' kuljum rakkomandata mill-WHO ta' 2 g sodium għal persuna adulta.
English: There were no formal drug-drug interaction studies with brentuximab vedotin and bleomycin(B).
Maltese: Ma kien hemm l-ebda studji ta' interazzjoni bejn mediċina u oħra b'brentuximab vedotin u bleomycin (B).
English: Response assessments were performed at cycles 2, 4, 7, 10, 13 and 16 with PET at cycles 4 and 7.
Maltese: Valutazzjonijiet tar-rispons twettqu f'ċikli 2, 4, 7, 10, 13 u 16 b'PET f'ċikli 4 u 7.
English: Of the ITT population, 846 patients (64%) had Stage IV disease.
Maltese: Mill-popolazzjoni ITT, 846 pazjent (64%) kellhom marda ta' Stadju IV.
English: The recommended dose in combination with chemotherapy (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]) is 1.2 mg/kg administered as an intravenous infusion over 30 minutes on days 1 and 15 of each 28-day cycle for 6 cycles (see section 5.1).
Maltese: Id-doża rakkomandata flimkien mal-kimoterapija (doxorubicin [A], vinblastine [V] u dacarbazine [D] [AVD]) hija ta' 1.2 mg/kg mogħtija bħala infużjoni fil-vini għal 30 minuta f'jum 1 u 15 ta' kull ċiklu ta' 28 jum għal 6 ċikli (ara sezzjoni 5.1).
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.
Maltese: Studju evalwa l-PK ta' brentuximab vedotin u MMAE wara l-għoti ta' 1.2 mg/kg ta' ADCETRIS lil pazjenti b'indeboliment renali ħafif (n = 4), moderat (n = 3) u sever (n = 3).
English: MMAE does not inhibit other isoforms.
Maltese: MMAE ma jinibixxix isoformi oħra.
English: Stevens-Johnson syndrome and toxic epidermal necrolysis
Maltese: Sindrome Stevens-Johnson u nekrożi tossika tal-epiderme
English: The median duration of response was 9.2 and 9.4 months in patients who achieved OR (CR+PR) and CR, respectively.
Maltese: It-tul medjan tar-rispons kien 9.2 u 9.4 xhur f'pazjenti li kisbu OR (CR+PR) u CR, rispettivament.
English: Intent to Treat (ITT) Population
Maltese: Popolazzjoni b'Intenzjoni li Tiġi Kkurata (ITT, Intent-to-Treat)
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).
Maltese: Dejta disponibbli tindika li t-tneħħija ta' MMAE tista' tiġi affettwata minn indeboliment renali sever, indeboliment epatiku, u minn konċentrazzjonijiet baxxi ta' albumina fis-serum (ara sezzjoni 5.2).
English: 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).
Maltese: ADCETRIS huwa indikat għall-kura ta' pazjenti adulti b'CD30+ HL b'riskju mkabbar ta' rikaduta jew progressjoni wara trapjant ta' ċelluli staminali awtologi (ASCT, autologous stem cell transplant) (ara sezzjoni 5.1).
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.
Maltese: L-effikaċja u s-sigurtà ta' ADCETRIS ġew ivvalutati fi prova każwali, multiċentrika ta' żewġ gruppi, double-blind, bil-plaċebo bħala kontroll fuq 329 pazjent b'HL b'riskju ta' rikaduta jew progressjoni wara ASCT.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: In the pivotal phase 2 population (SG035-0003 and SG035-0004), the median duration of Grade 3 or Grade 4 neutropenia was limited (1 week); 2% of patients had Grade 4 neutropenia that lasted ≥ 7 days.
Maltese: Fil-popolazzjoni tal-istudji importanti ħafna ta' fażi 2 (SG035-0003 u SG035-0004), it-tul medjan ta' newtropenija ta' Grad 3 jew Grad 4 kien limitat (ġimgħa waħda); 2% tal-pazjenti kellhom newtropenija ta' Grad 4 li damet ≥ 7 ijiem.
English: 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).
Maltese: 35% inqas pazjenti trattati b'ADCETRIS + AVD irċevew kimoterapija ta' salvataġġ sussegwenti (n = 45) meta mqabbel ma' dawk ittrattati b'ABVD (n = 69) u 22% inqas pazjenti ttrattati b'ADCETRIS + AVD irċevew doża għolja ta' kimoterapija u trapjant (n = 29) meta mqabbel ma' dawk ittrattati b'ABVD (n = 37).
English: The recommended diluent volume is 150 mL.
Maltese: Il-volum ta' dilwent irrakkomandat huwa ta' 150 ml.
English: 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).
Maltese: ADCETRIS huwa indikat għat-trattament ta' pazjenti adulti b'limfoma taċ-ċelluli T tal-ġilda CD30+ (CTCL, CD30+ cutaneous T-cell lymphoma) wara mill-inqas 1 terapija sistematika fil-passat (ara sezzjoni 5.1).
English: Citric acid monohydrate (for pH-adjustment) Sodium citrate dihydrate (for pH-adjustment) α,α-Trehalose dihydrate Polysorbate 80
Maltese: Citric acid monohydrate (għal aġġustament tal-pH) Sodium citrate dihydrate (għal aġġustament tal-pH) α,α-Trehalose dihydrate
English: Common side effects (may affect up to 1 in 10 people) - an infection in the blood (sepsis) and/or septic shock (a life-threatening form of sepsis);
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) - infezzjoni fid-demm (sepsis) u/jew xokk settiku (forma ta' sepsis ta' periklu għall-ħajja);
English: Table 8: Summary of PFS per IRF and OS by number of risk factors in the phase 3 HL post-ASCT Study
Maltese: Tabella 8: Sommarju ta' PFS kull IRF u OS bl-Għadd ta' Fatturi ta' Riskju fl-Istudju HL ta' Fażi 3 wara ASCT Sopravivenza
English: Serious adverse drug reactions occurred in 12% of patients.
Maltese: Reazzjonijiet avversi serji tal-mediċina seħħew fi 12% tal-pazjenti.
English: Response to treatment with ADCETRIS was assessed by Independent Review Facility (IRF) using the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007).
Maltese: Rispons għall-kura b' ADCETRIS kien evalwat minn Faċilità ta' Valutazzjoni Indipendenti (IRF) bl-użu ta' Kriterji ta' Rispons Rivedut għal-Limfoma Malinna (Cheson, 2007).
English: ADC accumulation (as assessed by AUC14D between Cycle 1 and Cycle 3) was 1.27-fold.
Maltese: L-akkumulazzjoni ADC (kif ivvalutata minn AUC14D bejn Ċiklu 1 u Ċiklu 3) kienet ta' 1.27 darbiet.
English: • Extranodal involvement at time of pre-ASCT relapse, including extranodal extension of nodal masses into adjacent vital organs
Maltese: • Involviment ekstranodali fi żmien ir-rikaduta ta' qabel ASCT, li jinkludi estensjoni ekstranodali ta' massi nodali f'organi vitali tal-madwar
English: Hodgkin lymphoma
Maltese: Limfoma ta' Hodgkin
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu /
English: The ADC is eliminated by catabolism with a typical estimated CL and half life of 1.5 l/day and 4-6 days respectively.
Maltese: L-ADC huwa eliminat permezz ta' kataboliżmu b'CL tipika stmata u half life ta'1.5
English: Adcetris 50 mg powder for concentrate for solution for infusion brentuximab vedotin
Maltese: ADCETRIS 50 mg trab għal konċentrat għal soluzzjoni għall-infużjoni brentuximab vedotin
English: 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.
Maltese: L-effikaċja fil-pazjenti anzjani b'marda ta' Stadju IV fil-fergħa A + AVD (pazjenti bl-età ta' ≥ 60 sena [n = 118] [HR = 0.80, 95% CI (0.42, 1.53)] u bl-età ta' ≥ 65 sena [n = 78] [HR = 0.78, 95% CI (0.36, 1.67)]) wriet benefiċċju mtejjeb meta mqabbel mal-pazjenti anzjani fil-popolazzjoni ITT.
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).
Maltese: Aktar minn hekk, il-farmakokinetiċi tal-popolazzjoni ta' brentuximab vedotin flimkien ma' AVD ġew eżaminati, inkluż id-data minn 661 pazjent li kellhom sa 82 sena (42 pazjent li kellhom ≥ 65- < 75 sena, u 17-il pazjent li kellhom ≥ 75 sena).
English: (95% CI [0.36, 0.70])b
Maltese: (95% CI [0.36, 0.70])
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.
Maltese: Cmax, AUC u Tmax medjana ta' MMAE wara doża waħda ta' 1.8 mg/kg ta' ADC fi studju ta' fażi 1 kienu madwar 4.97 ng/ml, 37.03 ng/ml x jum u 2.09 jiem rispettivament.
English: Disease control rate (CR + PR + SD) Duration of response
Maltese: Rata ta' kontroll tal-marda (CR + PR + SD)
English: Of the 329 patients, 165 patients were randomised to the treatment arm and 164 patients were randomised to the placebo arm.
Maltese: Minn 329 pazjent, 165 pazjent kienu magħżula b'mod każwali mal-grupp tat-trattament u 164 pazjent kienu magħżula fil-grupp tal-plaċebo.
English: The median time from initial sALCL diagnosis to first dose with ADCETRIS was 16.8 months.
Maltese: Iż-żmien medjan mid-dijanjosi inizjali ta' sALCL sal-ewwel doża ta' ADCETRIS kien ta' 16.8 xhur.
English: 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.
Maltese: Cmax u AUC ta' ADC tipiċi wara doża waħda ta' 1.8 mg/kg fi studju ta' fażi 1 kienu madwar 31.98 μg/ml u 79.41 μg/ml x jum rispettivament.
English: Each vial contains 50 mg of brentuximab vedotin.
Maltese: Kull kunjett fih 50 mg ta' brentuximab vedotin.
English: Chills
Maltese: Sess
English: The pharmacokinetics of brentuximab vedotin were evaluated in phase 1 studies and in a population pharmacokinetic analysis of data from 314 patients.
Maltese: Il-farmakokinetika ta' brentuximab vedotin kienet evalwata fi studji ta' fażi 1 u f'analiżi farmakokinetika tal-popolazzjoni ta' dejta minn 314-il pazjent.
English: This is equivalent to 0.7% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 0.7% tal-ammont massimu rakkomandat ta' sodium li jista' jittieħed kuljum minn persuna adulta.
English: Safety was evaluated in a phase 1/2 study in paediatric patients aged 7-17 years of age (n = 36) with relapsed or refractory (r/r) HL and sALCL (see section 5.1).
Maltese: Is-sigurtà ġiet evalwata fi studju ta' fażi 1/2 f'pazjenti pedjatriċi li kellhom minn 7-17-il sena (n = 36) b'HL u sALCL ta' rikaduta jew refrattorja (r/r) (ara sezzjoni 5.1).
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.
Maltese: Minn 35 pazjenti (33%) li kellhom sintomi B fil-linja bażi, 27 pazjent (77%) kellhom riżoluzzjoni tas-sintomi B kollha fi żmien medjan ta' 0.7 xhur mill-bidu ta' ADCETRIS.
English: MMAE is not likely to displace or to be displaced by highly protein-bound medicines.
Maltese: MMAE mhux probabbli li jispostja jew li jiġi spostjat minn mediċini li jeħlu ħafna ma' proteini.
English: Grade 3 or Grade 4 anaemia, thrombocytopenia, and prolonged (≥ 1 week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS.
Maltese: Anemija, ta' Grad 3 jew Grad 4, tromboċitopenija, u newtropenija fit-tul (≥ 1 ġimgħa) ta' Grad 3 jew Grad 4 jistgħu jsseħħu b'ADCETRIS.
English: België/Belgique/Belgien Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
Maltese: +32 2 464 06 11 takeda-belgium@takeda.com
English: Symptoms of an anaphylactic reaction may include, but are not limited to, urticaria, angioedema, hypotension and bronchospasm.
Maltese: Sintomi ta' reazzjoni ananfilattika jistgħu jinkludu, iżda mhumiex limitati għal, urtikarja, anġjoedima, pressjoni baxxa u bronkospażmu.
English: Peripheral neuropathy led to treatment discontinuation in 15%, dose reductions in 15%, and dose delays in 17% of patients.
Maltese: Newropatija periferali wasslet għat-twaqqif tal-trattament fi 15% tal-pazjenti, tnaqqis fid-doża fi 15% tal-pazjenti, u dewmien fid-doża fi 17% tal-pazjenti.
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.
Maltese: Il-medjan tas-Cmax u l-AUC ta' ADC wara doża waħda ta' 1.8 mg/kg kienu 29.8 µg/mL, 67.9 µg*jum/mL, rispettivament, f'pazjenti li kellhom < 12-il sena, u 34.4 µg/mL u 77.8 µg*jum/mL, rispettivament, f'pazjenti li kellhom ≥ 12-il sena.
English: A multiexponential decline in ADC serum concentrations was observed with a terminal half-life of approximately 4 to 5 days.
Maltese: Tnaqqis multi-esponenzjali fil-konċentrazzjonijiet ta' ADC fis-serum ġie osservat b'half-life terminali ta' madwar 4 sa 5 ijiem.
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.
Maltese: Kumplikazzjonijiet gastrointestinali (GI) li jinkludu ostruzzjoni intestinali, ileus, enterokolite, kolite newtropenika, erożjoni, ulċera, perforazzjoni u emorraġija, xi wħud b'riżultati fatali, ġew irrappurtati f'pazjenti kkurati b'ADCETRIS.
English: 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.
Maltese: Fil-prova klinika ta' ADCETRIS bħala terapija kombinata, in-newropatija li toħroġ wara l-kura seħħet f'67% tal-populazzjoni; in-newropatija motorja periferali seħħet fi 11% tal-pazjenti.
English: Adcetris contains the active substance brentuximab vedotin, an anti-cancer agent, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells.
Maltese: Adcetris fih is-sustanza attiva brentuximab vedotin, sustanza kontra l-kanċer, li hija magħmula minn antikorp monoklonali marbuta ma' sustanza maħsuba biex toqtol ċelluli tal-kanċer.
English: 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.
Maltese: Analiżijiet ta' sottogrupp speċifikati minn qabel ta' ORR4 skont IRF twettqu skont is-sottotip ta' CTCL tal-pazjenti, l-għażla tat-trattament tat-tobba, stat ta' ECOG fil-linja bażi ECOG, età, sess, u reġjun ġeografiku.
English: In the ITT population, 33% fewer patients treated with ADCETRIS + AVD in the ITT population received subsequent salvage chemotherapy (n = 66) and high-dose chemotherapy and transplant (n = 36) compared with those treated with ABVD (n = 99 and n = 54, respectively).
Maltese: ITT irċevew kimoterapija ta' salvataġġ sussegwenti (n = 66) u doża għolja ta' kimoterapija u trapjant (n = 36) meta mqabbel ma' dawk ittrattati b'ABVD (n = 99 u n = 54, rispettivament).
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).
Maltese: Li jsir studju single-arm f' popolazzjoni ta' pazjenti simili għall-popolazzjoni ta' sALCL b'investigazzjoni tar-rata ta' rispons, tul tar-rispons, ir-rata ta' (tieni) ASCT u dejta f'subpopolazzjonijiet (inklużi iżda mhux neċessarjament ristretta għall-istatus ALK u letà) ibbażat fuq CHMP protokoll miftiehem (Studju C25006).