FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Pazjenti b'pcALCL kienu irċivew jew terapija ta' radjazzjoni fil-passat jew mill-inqas 1 terapija sistematika fil-passat, u pazjenti b'MF kienu rċivew mill-inqas 1 terapija sistematika filpassat.
English: Disease stage a at initial diagnosis of HL, n (%)
Maltese: Stadju tal-marda a fid-dijanjosi inizjali ta' HL, n (%)
English: Brentuximab vedotin caused embryo-foetal lethality in pregnant female rats.
Maltese: Brentuximab vedotin ikkawża mewt tal-embrijuni u feti f'firien nisa tqal.
English: Of the 17 patients (29%) who had B symptoms at baseline, 14 patients (82%) experienced resolution of all B symptoms in a median time from initiation of ADCETRIS of 0.7 months.
Maltese: Minn 17-il pazjenti (29%) li kellhom sintomi B fil-linja bażi, 14-il pazjent (82%) kellhom riżoluzzjoni tas-sintomi B kollha fi żmien medjan ta' 0.7 xhur mill-bidu ta' ADCETRIS.
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.
Maltese: M'hemm l-ebda esperjenza minn provi kliniċi li użaw ADCETRIS flimkien mal-kimoterapija f'pazjenti b'indeboliment renali, fejn il-krejatinina fis-serum hija ≥ 2.0 mg/dL u/jew it-tneħħija tal-krejatinina jew it-tneħħija tal-krejatinina kkalkulata hija ≤ 40 mL/minuta.
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]).
Maltese: L-effikaċja u s-sigurtà ta' ADCETRIS ġew evalwati fi prova każwali multiċentrika, open-label u b'2 fergħat, li fiha ntgħażlu 1334 pazjent b'HL avvanzata li qatt ma kienet ikkurata qabel flimkien mal-kimoterapija (doxorubicin [A], vinblastine [V] u dacarbazine [D] [AVD]).
English: ADCETRIS should be held for any suspected case of acute pancreatitis.
Maltese: ADCETRIS għandu jitwaqqaf jekk dijanjosi ta' pankrejatite akuta hija kkonfermata.
English: Hyperglycaemia
Maltese: Rispons Komplut
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.
Maltese: Mis-60 pazjent tal-istudju, 49 pazjent (82%) irċivew > 1 kura relatata mal-kanċer fil-passat, u 11-il pazjent (18%) irċivew 1 kura relatata mal-kanċer fil-passat.
English: 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.
Maltese: L-effikaċja u s-sigurtà ta' ADCETRIS bħala mediċina waħda ġew evalwati fi studju importanti ħafna ta' fażi 3, open-label, li fih il-parteċipanti ntgħażlu b'mod każwali, multiċentriku f'128 pazjent b'CD30+ CTCL istoloġikalment ikkonfermata.
English: Cases of pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), some with fatal outcomes, have been reported in patients receiving ADCETRIS.
Maltese: Każijiet ta' tossiċità pulmonari, li jinkludu pnewmonite, mard interstizjali tal-pulmun, u sindrome ta' problemi respiratorji akuti (ARDS), xi wħud b'riżultati fatali, kienu rrappurtati f'pazjenti li rċevew ADCETRIS.
English: The ORR per IRF assessment was 86% (50 of 58 patients in the ITT set).
Maltese: L-ORR għal kull valutazzjoni minn IRF kienet ta' 86% (50 minn 58 pazjent fil-grupp ITT). CR kienet ta' 59% (34 minn 58 pazjent fil-grupp ITT) u tnaqqis fit-tumur (ta' kwalunkwe grad) intlaħaq f'97% tal-pazjenti.
English: However, results of repeat-dose toxicity studies in rats indicate the potential for brentuximab vedotin to impair male reproductive function and fertility.
Maltese: Madankollu, riżultati ta' studji dwar l-effett tossiku minn dożi ripetuti fil-firien jindika l-potenzjal għal brentuximab vedotin biex itellef il-funzjoni riproduttiva u l-fertilità maskili.
English: DO NOT SHAKE.
Maltese: LMTD ma ntlaħqitx.
English: Table 1: Dosing recommendations for neutropenia
Maltese: Tabella 1: Rakkomandazzjonijiet ta' dożaġġ għal newtropenija
English: Refractory
Maltese: Pożoloġija
English: An excretion study was undertaken in patients who received a dose of 1.8 mg/kg of brentuximab vedotin.
Maltese: Studju ta' eskrezzjoni twettaq f'pazjenti li rċevew doża ta' 1.8 mg/kg ta' brentuximab vedotin.
English: An exploratory intra-patient analysis showed that approximately 69% of the sALCL patients treated with ADCETRIS as part of the SG035-0004 clinical study experienced an improvement in clinical benefit as measured by longer progression free survival (PFS) compared with their most recent prior line of therapy.
Maltese: Analiżi esploratorja intra-pazjenti uriet li madwar 69% tal-pazjenti b' sALCL kkurati b'ADCETRIS bħala parti mill-istudju kliniku SG035-0004, kellhom titjib fil-benefiċċju kliniku kif imkejjel minn sopravivenza mingħajr progressjoni (PFS) itwal meta mqabbel mal-aktar linja ta' kura riċenti minn qabel tagħhom.
English: Twenty-eight patients (47%) went on to receive SCT after a median of 7 cycles (range, 4 to 16 cycles) of ADCETRIS treatment.
Maltese: Tmienja u għoxrin pazjent (47%) komplew u rċivew SCT wara medjan ta' 7 ċikli (medda, 4 sa 16il ċiklu) ta' kura b'ADCETRIS.
English: Of the patients treated, 9 responding patients went on to receive an allogeneic stem cell transplant (SCT) and 9 responding patients went on to autologous SCT.
Maltese: Mill-pazjenti kkurati, 9 pazjenti li rrispondew komplew biex irċevew trapjant alloġeniku ta' ċelluli staminali SCT u 9 pazjenti li rrispondew komplew biex irċevew SCT awtologu.
English: • B symptoms at pre-ASCT relapse
Maltese: • Sintomi B f'rikaduta ta' qabel ASCT
English: Co-administration of midazolam, a CYP3A4 substrate, with brentuximab vedotin did not alter the metabolism of midazolam; therefore brentuximab vedotin is not expected to alter the exposure to medicines that are metabolized by CYP3A4 enzymes.
Maltese: L-għoti ta' midazolam, substrat ta' CYP3A4, flimkien ma' brentuximab vedotin ma bidilx il-metaboliżmu ta' midazolam; għalhekk brentuximab vedotin mhux mistenni li jbiddel l-esponiment għall-mediċini li huma metabolizzati minn enzimi ta' CYP3A4.
English: - Stevens-Johnson syndrome - a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin - new or recurring cytomegalovirus (CMV) infection
Maltese: - Sindrome ta' Stevens-Johnson - disturb rari u serju li fih tista' tesperjenza sintomi li jixbħu linfluwenza segwiti minn raxx aħmar jew vjola bl-uġigħ li jinfirex u jrabbi l-infafet li jinkludu l-istakkament estensiv tal-ġilda - infezzjoni ġdida jew rikorrenti taċ-ċitomegalovirus (CMV)
English: The median number of cycles was 7 (range 1 to 16 cycles).
Maltese: In-numru medjan ta' ċikli kien ta' 7 (medda minn 1 sa 16-il ċiklu).
English: Infusion-related reactions
Maltese: Reazzjonijiet relatati mal-infużjoni
English: Stratified Hazard Ratio and p-value
Maltese: Fatturi tar-riskju IPFP
English: Post-hoc subgroup analyses of modified PFS per IRF for patients with Stage IV disease were performed including age, region, baseline extranodal sites, number of IPFP risk factors, baseline B symptoms, baseline ECOG status and gender.
Maltese: Twettqu numru ta' analiżijiet tas-sottogrupp post-hoc tal-PFS immodifikat għal kull IRF għall-pazjenti b'marda ta' Stadju IV li jinkludu l-età, ir-reġjun, is-siti estranodali fil-linja bażi, in-numru ta' fatturi tar-riskju IPFP, is-sintomi tal-linja bażi B, l-istatus tal-ECOG fil-linja bażi u s-sess.
English: Number of events (%)
Maltese: N (%)
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)
Maltese: Riżultati tal-effikaċja għall-pazjenti HL li qatt ma kienet ikkurata qabel ittrattati b'1.2 mg/kg ta' ADCETRIS + AVD f'jum 1 u 15 ta' kull ċiklu ta' 28 jum (ITT u Stadju IV)
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli bħalissa hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus and cough were reported in 13% of patients.
Maltese: IRRs bħal uġigħ ta' ras, raxx, uġigħ fid-dahar, rimettar, tkexkix, dardir, qtugħ ta' nifs, ħakk u sogħla ġew irrappurtati fi 13% tal-pazjenti.
English: Fifty nine percent (59%) of patients had advanced stage disease (Stage III or IV) at initial diagnosis.
Maltese: Disa u ħamsin fil-mija (59%) tal-pazjenti kellhom marda fi stadju avvanzat (Stadju III jew IV) fid-dijanjosi inizjali.
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).
Maltese: Is-sopravivenza medjana globali (OS) hija ta' 40.5 xhur (iż-żmien medjan ta' osservazzjoni (żmien sa' l-mewt jew l-aħħar kuntatt) mill-ewwel doża kien ta' 35.1 xhur (medda 1.8 sa 72.9+ xhur).
English: One patient had a baseline ECOG status of 2, which was prohibited by protocol and is captured as Inclusion Criteria Not Met. b. Primary refractory sALCL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Maltese: b. sALCL primarja li ma rrispondietx għall-kura hija definita bħala falliment biex tintlaħaq remissjoni kompluta, jew progressjoni fi żmien 3 xhur wara li tkun tkompliet terapija primarja.
English: Pruritus
Maltese: POTAMITIS
English: Febrile neutropenia Immune system disorders Uncommon:
Maltese: Disturbi fis-sistema immuni Mhux komuni
English: Primary refractory HL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Maltese: HL li ma rrispondietx primarjament hija definita bħala in-nuqqas li tintlaħaq remissjoni kompluta, jew progressjoni fi żmien 3 xhur wara li tkun tkompliet terapija primarja.
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.
Maltese: Għall-informazzjoni ta' sigurtà tal-aġenti kimoterapewtiċi mogħtija flimkien ma' ADCETRIS (doxorubicin, vinblastine u dacarbazine) għall-pazjenti b'HL li kienu għadhom kif ġew iddijanjostikati, irreferi għas-sommarju tal-karatteristiċi tal-prodott tagħhom.
English: In clinical trials, serious infections and opportunistic infections occurred in 10% of patients, sepsis or septic shock occurred in < 1% of the patients.
Maltese: Fil-provi kliniċi, infezzjonijiet serji u infezzjonijiet opportunistiċi seħħew f'10% tal-pazjenti, sepsis jew xokk settiku seħħew f' < 1% tal-pazjenti.
English: Each vial contains approximately 13.2 mg of sodium.
Maltese: Kull kunjett fih madwar 13.2 mg ta' sodium.
English: Eligible patients were required to have at least one of the following risk factors:
Maltese: Pazjenti eleġibbli kienu meħtieġa li jkollhom tal-anqas waħda mill-fatturi ta' riskju li ġejjin:
English: Each vial contains 50 mg of brentuximab vedotin
Maltese: Kull kunjett fih 50 mg ta' brentuximab vedotin
English: Adcetris will be given to you together with doxorubicin, vinblastine and dacarbazine which are other chemotherapy medicines used to treat Hodgkin lymphoma.
Maltese: Adcetris se jingħata lilek flimkien ma' doxorubicin, vinblastine u dacarbazine li huma mediċini tal-kimoterapija oħra li jintużaw biex jikkuraw l-limfoma ta' Hodgkin.
English: An exploratory intra-patient analysis showed that approximately 64% of the HL patients treated with ADCETRIS as part of the SG035-0003 clinical study experienced an improvement in clinical benefit as measured by longer progression free survival (PFS) compared with their most recent prior line of therapy.
Maltese: Analiżi esploratorja intra-pazjenti uriet li madwar 64% tal-pazjenti b' HL kkurati b'ADCETRIS bħala parti mill-istudju kliniku SG035-0003, kellhom titjib fil-benefiċċju kliniku kif imkejjel minn sopravivenza mingħajr progressjoni (PFS) itwal meta mqabbel mal-aktar linja ta' kura riċenti minn qabel tagħhom.
English: Immediate and delayed infusion-related reactions (IRR), as well as anaphylactic reactions, have been reported.
Maltese: Kienu rrappurtati reazzjonijiet immedjati u ttardjati relatati mal-infużjoni (IRR), kif ukoll reazzjonijiet anafilattiċi.
English: A+AVD
Maltese: ITT (ADCETRIS + AVD vs.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: The safety and efficacy of ADCETRIS in children less than 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' ADCETRIS fi tfal b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Each pack of Adcetris consists of one vial.
Maltese: Kull pakkett ta' Adcetris fih kunjett wieħed.
English: Advanced (IIB-IVB pcALCL, n (%)
Maltese: a stmat għal kull IRF fit-2 Sena (%)
English: Each single use vial must be reconstituted with 10.5 mL of water for injections to a final concentration of 5 mg/mL.
Maltese: Kull kunjett għal użu ta' darba għandu jiġi rikostitwit b'10.5 ml ta' ilma għall-injezzjonijiet sa konċentrazzjoni finali ta' 5 mg/ml.
English: Common side effects (may affect up to1 in 10 people) pneumonia sore, creamy-yellow, raised patches in the mouth (thrush) decreased level of blood platelets dizziness blisters which may crust or scab increased level of blood sugar increased liver enzyme levels unusual hair loss or thinning
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - pulmonite - irqajja' mtellgħin fil-ħalq li jkunu bl-uġigħ, ta' kulur il-krema jew sofor (kundizzjoni li tissejjaħ
English: 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
Maltese: Kampjuni ta' kalkoli għall-pazjenti li qed jirċievu id-doża rrakkomandata ta' 1.8 mg/kg ta' ADCETRIS għall-piż li jvarja minn 60 kg sa 120 kg
English: Table 13: Summary of baseline patient and disease characteristics in the phase 3 CTCL Study (ITT Population)
Maltese: Tabella 13: Sommarju tal-karatteristiċi tal-pazjent u tal-marda fil-linja bażi fl-istudju ta' fażi 3 dwar CTCL (Popolazzjoni ITT)
English: These results were consistent with the pharmacological effect of MMAE on the mitotic apparatus (disruption of the microtubule network) in cells.
Maltese: Dawn ir-riżultati kienu konsistenti mal-effett farmakoloġiku ta' MMAE fuq l-apparat mitotiku (tfixkil tan-network ta' mikrotubuli) fiċ-ċelluli.
English: Table 14: Efficacy results in CTCL patients treated with 1.8 mg/kg of ADCETRIS every 3 weeks (ITT population)
Maltese: Riżultati tal-effikaċja f'pazjenti b'CTCL Ittrattati b'1.8 mg/kg ta' ADCETRIS kull 3 ġimgħat (Popolazzjoni ITT)
English: How to store Adcetris
Maltese: X'fih Adcetris
English: Best response to salvage therapy pre-ASCT Complete Response
Maltese: Ma rrispondietx primarjament għal terapija ppreferita
English: Calculation to determine the total number of ADCETRIS vials needed:
Maltese: Kalkolu biex jiġi stabbilit in-numru ta' kunjetti ta' ADCETRIS meħtieġa:
English: Prior chemotherapy Regimens (range) Histologically confirmed CD30-expressing disease Anaplastic lymphoma kinase (ALK)-negative disease Disease characteristics
Maltese: Korsijiet ta' kimoterapija preċedenti (firxa) Marda li għandha CD30 ikkonfermata b'mod istoloġiku Marda ta' limfoma anaplastika negattiva għal kinase (ALK) Karatteristiċi tal-marda
English: Partial Response
Maltese: RESPONSABBLI
English: Tabulated list of adverse reactions
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: The analysis indicated that MMAE clearance was 2-fold lower in patients with low serum albumin concentrations <3.0 g/dl compared with patients with serum albumin concentrations within the normal range.
Maltese: L-analiżi indikat li t-tneħħija ta' MMAE kienet 2 darbiet baxxa f'pazjenti b'konċentrazzjonijiet baxxi ta' albumina fis-serum < 3.0 g/dl meta mqabbel ma' pazjenti b'konċentrazzjonijiet ta' albumina fis-serum fil-firxa normali.
English: Thus, it is not likely to have any substantial contribution to the systemic effects of MMAE.
Maltese: Għalhekk, mhuwiex probabbli li se jkollu kwalunkwe kontribuzzjoni sostanzjali għall-effetti sistematiċi ta' MMAE.
English: Demyelinating polyneuropathy Respiratory, thoracic and mediastinal disorders Very common:
Maltese: Polinewropatija li tneħħi l-myelin Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna:
English: Bone pain, arthralgia, back pain, myalgia
Maltese: Uġigħ fl-għadam, artralġija, uġigħ tad-dahar, majalġja
English: The European Organization for Research and Treatment of Cancer Quality of Life 30-Item Questionnaire (EORTC-QLQ-C30) showed no clinically meaningful difference between the two arms in both the ITT and Stage IV population.
Maltese: Il-Kwestjonarju ta' 30 Mistoqsija tal-Organizzazzjoni Ewropea għar-Riċerka u t-Trattament tal-Kwalità tal-Ħajja bil-Kanċer (EORTC-QLQ-C30) ma wera l-ebda differenza klinikament sinifikanti bejn iż-żewġ fergħat kemm fil-popolazzjoni ITT u fi Stadju IV.
English: Eight HL patients and 9 sALCL patients went on to receive SCT following treatment with ADCETRIS.
Maltese: Tmien pazjenti b'HL u 9 pazjenti b'sALCL komplew biex irċivew SCT wara t-trattament b'ADCETRIS.
English: Patients with renal impairment should be closely monitored for adverse events.
Maltese: Pazjenti b'indeboliment epatiku għandhom jiġu mmonitorjati mill-qrib għal avvenimenti avversi.
English: Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures.
Maltese: Evalwazzjoni tal-pazjent jista' jinkludi eżami fiżiku, l-evalwazzjoni tal-laboratorju għall- amylase fis-serum u serum lipase, u immaġini addominali, bħal ultrasound u miżuri oħra dijanjostiċi xierqa.
English: b risk factors, n (%)
Maltese: b, n (%)
English: 6.3 Shelf life
Maltese: 6.7 xhur
English: The most commonly reported opportunistic infections were herpes viral infections.
Maltese: L-aktar infezzjonijiet opportunistiċi li ġew irrappurtati b'mod komuni kienu l-infezzjonijiet virali tal-herpes.
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.
Maltese: Karatteristiċi tal-pazjent fil-linja bażi wrew nuqqas ta' suċċess minn korsijiet ta' kimoterapija multipla preċedenti (medjan ta' 3 b' firxa ta' 1 sa 7) qabel l-ewwel amministrazzjoni ta' ADCETRIS.
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.
Maltese: Newropatija periferali indotta minn ADCETRIS tipikament hija effett ta' esponiment kumulattiv għal dan il-prodott mediċinali u fil-biċċa l-kbira hija riversibbli.
English: After reconstitution each vial contains 5 mg/ml of brentuximab vedotin
Maltese: Wara r-rikostituzzjoni kull kunjett fih 5 mg/ml ta' brentuximab vedotin
English: Grade 1 (paraesthesia and/or loss of reflexes, with no loss of function)
Maltese: Grad 1 (parasteżija u/jew telf ta' riflessi, bl-ebda telf ta' funzjoni)
English: Not estimable.
Maltese: U KWANTITATTIVA
English: ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following ASCT, or 2. following at least two prior therapies when ASCT or multi -agent chemotherapy is not a treatment option.
Maltese: ADCETRIS huwa indikat għall-kura ta' pazjenti adulti b'CD30+ Limfoma ta' Hodgkin (HL) li reġgħet ħarġet jew li ma rrispondietx għall-kura: 1. wara trapjant ta' ASCT jew 2. wara tal-inqas żewġ terapiji preċedenti meta ASCT jew kimoterapija b' mediċini multipli mhiex għażla għal trattament.
English: Number of Risk Factors ≥ 3
Maltese: Għadd ta' Fatturi ta' Riskju ≥ 3
English: There is no clinical trial experience using ADCETRIS in combination with chemotherapy in patients with hepatic impairment, where total bilirubin is > 1.5 times the upper limit of normal (ULN) (unless due to Gilbert syndrome), or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are > 3 times the ULN, or > 5 times the ULN if their elevation may be reasonably ascribed to the presence of HL in the liver.
Maltese: M'hemm l-ebda esperjenza minn provi kliniċi li jużaw ADCETRIS flimkien mal-kimoterapija f'pazjenti b'indeboliment epatiku, fejn il-bilirubina totali hija > 1.5 darbiet aktar mil-limitu normali tan-naħa ta' fuq (ULN, upper limit of normal) (sakemm mhux minħabba s-sindromu ta' Gilbert), jew l-aspartate aminotransferase (AST) jew l-alanine aminotransferase (ALT) huma > 3 darbiet aktar mill-ULN, jew > 5 darbiet aktar mill-ULN jekk l-elevazzjoni tagħhom tista' raġonevolment tiġi attribwita għall-preżenza ta' HL fil-fwied.
English: Population PK analysis showed that baseline serum albumin concentration was a significant covariate of MMAE clearance.
Maltese: Analiżi tal-PK tal-popolazzjoni wriet li l-konċentrazzjoni ta' albumin fis-serum fil-linja bażi kienet kovarjanti sinifikanti tat-tneħħija ta' MMAE.
English: This expression is independent of disease stage, line of therapy or transplant status.
Maltese: Din l-espressjoni hija indipendenti mill-istadju tal-marda, linja tat-terapija jew l-istatus tat-trapjant.
English: Population pharmacokinetic analysis indicated that the pharmacokinetics of ADCETRIS in combination with AVD were consistent to that in monotherapy.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni indikat li l-farmakokinetiċi ta' ADCETRIS flimkien ma' AVD kienu konsistenti għal dawk fil-monoterapija.
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.
Maltese: Jekk il-piż tal-pazjent huwa aktar minn 100 kg, il-kalkolu tad-doża għandu juża 100 kg. d. Id-doża massima rrakkomandata hija ta' 180 mg.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq ir-rikostituzzjoni u id-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Other secondary efficacy endpoints including CR rate and ORR at the end of randomisation regimen, CR rate at the end of first-line therapy, and the rate of PET negativity at the end of Cycle 2, duration of response (DOR), duration of complete remission (DOCR), disease-free survival (DFS,) and event-free survival (EFS) all trended in favour of ADCETRIS + AVD in both the ITT and Stage IV population.
Maltese: Punti ta' tmiem sekondarji oħra tal-effikaċja li jinkludu r-rata ta' CR u ORR fit-tmiem tal-kors tal-għażla każwali, ir-rata ta' CR fit-tmiem tat-terapija primarja, u r-rata ta' negattività tal-PET fit-tmiem ta' Ċiklu 2, it-tul tar-rispons (DOR), it-tul tar-remissjoni kompluta (DOCR), is-sopravivenza mingħajr mard (DFS), u s-sopravivenza mingħajr avveniment (EFS) kollha kienu favur ADCETRIS + AVD kemm fil-popolazzjoni
English: Number of deaths c
Maltese: Għadd ta' mwiet c
English: Indicates results from non-stratified analysis.
Maltese: Jindika riżultati minn analiżi mhux stratifikata.
English: The following side effects have been reported with Adcetris alone:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna: