FrancophonIA/ELRC3.0 huggingface dataset:
English: 9/L) or Grade 2 (< 1500-1000/mm < 1.5-1.0 x 10
Maltese: Grad 1 (< LLN - 1500/mm < LLN - 1.5 x 10 9/L) jew Grad 2 (< 1500 - 1000/mm < 1.5 - 1.0 x 10 9/L)
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal- ġestjoni tar-riskju (RMP)
English: In the clinical trial of ADCETRIS as combination therapy, neutropenia led to dose delays in 24% of patients.
Maltese: Fil-prova klinika ta' ADCETRIS bħala terapija kombinata, in-newtropenija wasslet għal dewmien fid-doża ta' 24% tal-pazjenti.
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.
Maltese: Il-punt aħħari primarju ta' PFS intlaħaq u wera differenza fil-PFS medjan ta' 18.8 xhur favur il-grupp ta' trattament.
English: Pre-specified subgroup analyses of PFS per IRF were performed by patients' best response to pre-ASCT salvage therapy, HL status after frontline therapy, age, gender, baseline weight, baseline ECOG performance status, number of treatments pre-ASCT, geographic region, pre-ASCT PET status, B symptom status after failure of frontline therapy, and pre-ASCT extranodal disease status.
Maltese: Analiżi tas-sottogrupp speċifikat qabel ta' PFS skont IRF saru fuq pazjenti li kellhom l-aħjar rispons għal terapija ta' salvataġġ qabel ASCT, stat ta' HL wara t-terapija preferenzjali, età, ġeneru, piż fillinja bażi, stat ta' prestazzjoni fil-linja bażi ta' ECOG, għadd ta' trattamenti qabel ASCT, reġjun ġeografiku, stat PET qabel ASCT, stat ta' sintomu B wara falliment tat-terapija preferenzjali, u l-istat tal-marda ekstranodali qabel ASCT.
English: Study SGN35-006 (Retreatment Study)
Maltese: Studju SGN35-006 (Studju tal-kura mill-ġdid)
English: Study SGN35-006 (Retreatment study)
Maltese: Studju SGN35-006 (Studju tal-Kura mill-Ġdid)
English: Best clinical response (n = 58 )
Maltese: L-aħjar rispons kliniku (n = 58)
English: Timing of the modified event was the date of the first PET scan post completion of first-line therapy demonstrating the absence of complete response (CR), defined as Deauville score of ≥3.
Maltese: Iż-żmien tal-avveniment immodifikat kien id-data tal-ewwel PET scan wara t-tlestija tat-terapija primarja li turi n-nuqqas ta' rispons komplut (CR, complete response), definit bħala punteġġ Deauville ta' ≥ 3.
English: Adverse events led to treatment discontinuation in 13% of patients.
Maltese: L-avvenimenti avversi wasslu għat-twaqqif tal-kura fi 13% tal-pazjenti.
English: ADCETRIS may cause peripheral neuropathy, both sensory and motor.
Maltese: ADCETRIS jista' jikkawża newropatija periferali, kemm sensorja kif ukoll motorja.
English: Among patients who experienced peripheral neuropathy in the pivotal phase 2 studies (SG035-0003 and SG035-0004) and randomised phase 3 monotherapy studies (SGN35-005 and C25001), the median follow up time from end of treatment until last evaluation ranged from 48.9 to 98 weeks.
Maltese: Fost il-pazjenti li kellhom esperjenza ta' newropatija periferali fl-istudji importanti ħafna ta' fażi 2 (SG035-0003 u SG035-0004) u studji ta' monoterapija ta' fażi 3 li fihom il-parteċipanti ntgħażlu b'mod każwali (SGN35-005 u C25001), iż-żmien medjan sal-vista ta' wara, mit-tmiem tal-kura sal-aħħar valutazzjoni varja minn 48.9 sa 98 ġimgħa.
English: Uncommon side effects (may affect up to 1 in 100 people) - Tumour lysis syndrome - a potentially-life threatening condition in which you may experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): - Sindrome tal-lisi tat-tumur - kundizzjoni potenzjalment ta' periklu għall-ħajja fejn tista' tesperjenza sturdament, tnaqqis fl-awrina, konfużjoni, rimettar, dardir, nefħa, qtugħ tan-nifs jew disturbi fir-ritmu tal-qalb.
English: Patients with renal impairment should be closely monitored for adverse events (see section 5.2).
Maltese: Pazjenti b'indeboliment epatiku għandhom jiġu mmonitorjati mill-qrib għal avvenimenti avversi (ara sezzjoni 5.2).
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.
Maltese: Ir-rata ta' rispons oġġettiv (ORR) għal kull valutazzjoni minn IRF kienet ta' 75% (76 minn 102 pazjenti fil-grupp b'intenzjoni li jiġu kkurati [ITT]) u tnaqqis fit-tumur intlaħaq f'94% tal-pazjenti.
English: Table 14 includes the results for ORR4 and other key secondary endpoints.
Maltese: Tabella 14 tinkludi r-riżultati għal ORR4 u punti aħħarin ewlenin oħrajn.
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.
Maltese: Riżultati minn dawn l-istudji ta' fażi 1 u mill-esperjenza NPP wrew li f 'pazjenti mingħajr ASCT preċedenti b' HL li reġgħet ħarget jew li ma rrispondietx għall-kura, response klinikament sinifikanti jistgħu jinkisbu kif jidher minn evalwazzjoni ta' investigatur, rata ta' rispons oġġettiv ta' 54% u rata ta' remissjoni kompleta ta' 22%,wara medja ta' 5 ċikli ta' ADCETRIS.
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.
Maltese: Jekk il-piż tal-pazjent ikun ta' aktar minn 100 kg, il-kalkolazzjoni tad-doża għandha tuża 100 kg. d. Id-doża massima rakkomandata għat-terapija kombinata hija ta' 120 mg.
English: Acute pancreatitis has been observed in patients treated with ADCETRIS.
Maltese: Pankrejatite akuta kienet osservata f'pazjenti kkurati b'ADCETRIS.
English: The effects of brentuximab vedotin on human male and female fertility have not been studied.
Maltese: L-effetti ta' brentuximab vedotin fuq il-fertilità maskili u femminili tal-bniedem ma ġewx studjati.
English: Classical HL, sALCL and subtypes of CTCL (including MF and pcALCL) express CD30 as an antigen on the surface of their malignant cells.
Maltese: HL klassika, sALCL u sottotipi ta' CTCL (li jinkludu MF u pcALCL) jesprimu CD30 bħala antiġen fuq il-wiċċ ta' ċelluli malinni tagħhom.
English: Of the 20 evaluable patients with HL, 6 patients (30%) achieved a CR and 6 patients (30%) achieved a PR with ADCETRIS retreatment, for an ORR of 60%.
Maltese: HL, 6 pazjenti (30%) kisbu CR u 6 pazjenti (30%) kisbu PR b'kura mill-ġdid b'ADCETRIS, għal ORR ta' 60%.
English: Patient weight (kg)
Maltese: Piż talpazjent (kg)
English: It is given by your doctor or nurse over 30 minutes.
Maltese: Tingħata mit-tabib jew mill-infermier tiegħek fuq perijodu ta' 30 minuta.
English: Pre-specified subgroup analyses of modified PFS per IRF were performed for the ITT population including age, region, cancer stage at baseline, baseline extranodal sites, number of IPFP risk factors, baseline B symptoms, Cycle 2 PET assessment, Cycle 2 PET Deauville score, and receipt of alternative first-line medication (AFM).
Maltese: Twettqu numru ta' analiżijiet tas-sottogrupp speċifikat minn qabel tal-PFS għal kull IRF għall-popolazzjoni ITT, li kienu jinkludu l-età, ir-reġjun, l-istadju tal-kanċer fil-linja bażi, is-siti estranodali fil-linja bażi, in-numru ta' fatturi tar-riskju IPFP, is-sintomi tal-linja bażi B, il-valutazzjoni PET ta' Ċiklu 2, il-punteġġ Deauville tal-PET f'Ċiklu 2, u għoti ta' medikazzjoni primarja alternattiva (AFM, alternative first-line medication).
English: Patients who discontinued due to peripheral neuropathy received a median of 8 doses of ADCETRIS+AVD (A+AVD) before discontinuation of one or more agents.
Maltese: Pazjenti li waqfu minħabba newropatija periferali rċevew medjan ta' 8 dożi ta' ADCETRIS+AVD (A+AVD) qabel ma waqqfu wieħed jew aktar mill-aġenti.
English: The pharmacokinetics of ADCETRIS in combination with AVD were evaluated in a single phase 3 study in 661 patients.
Maltese: Il-farmakokinetiċi ta' ADCETRIS flimkien ma' AVD kienu evalwati fi studju wieħed ta' fażi 3 f'661 pazjent.
English: Systemic anaplastic large cell lymphoma
Maltese: Limfoma sistemika ta' ċelluli kbar anaplastiċi
English: Median per Investigator
Maltese: Medjan kull Investigatur
English: Musculoskeletal and connective tissue disorders Very common:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna:
English: Table 5 provides the efficacy results for modified PFS and overall survival (OS) in the ITT population and patients with Stage IV disease.
Maltese: Tabella 5 tipprovdi r-riżultati tal-effikaċja għall-PFS modifikat u s-sopravivenza globali (OS, overall survival) fil-popolazzjoni ITT u l-pazjenti b'marda ta' Stadju IV.
English: The infusion line should be flushed following administration with sodium chloride 9 mg/ mL (0.9%) solution for injection, 5% dextrose for injection, or Lactated Ringer's for injection.
Maltese: Wara l-għoti, l-linja ta' infużjoni għandha titlaħlaħ b'soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, 5% dextrose għall-injezzjoni, jew Lactated Ringer għall-injezzjoni.
English: Toxic epidermal necrolysis was not reported in the combination therapy setting.
Maltese: In-nekrożi tossika tal-epiderme ma ġietx irrappurtata fl-ambitu tat-terapija kombinata.
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 (Child-Pugh A; n = 1), moderate (Child-Pugh B; n = 5) and severe (Child-Pugh C; n = 1) hepatic 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 epatiku ħafif (Child-Pugh A;
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.
Maltese: L-effikaċja u s-sigurtà ta' ADCETRIS ġew evalwati f'żewġ studji addizzjonali open-label li saru fuq 108 pazjenti b'CD30+ CTCL rikaduta (li jinkludu pazjenti b'MF u pcALCL kif ukoll SS, Lyp u istoloġija CTCL mħallta), irrispettivament mil-livell ta' espressjoni ta' CD30.
English: Approximately 24% of the total MMAE administered as part of the ADC during a brentuximab vedotin infusion was recovered in both urine and faeces over a 1-week period.
Maltese: Madwar 24% ta' MMAE totali mogħti bħala parti mill-ADC matul infużjoni ta' brentuximab vedotin kien irkuprat fl-awrina u fl-ippurgar fuq perijodu ta' ġimgħa waħda.
English: Calculation to determine the total ADCETRIS dose (mL) to be further diluted (see section 4.2):
Maltese: Kalkolu biex tiġi determinata d-doża totali ta' ADCETRIS (ml) li għandha tiġi dilwita aktar (ara sezzjoni 4.2:
English: Brentuximab vedotin is an antibody drug conjugate (ADC) that delivers an antineoplastic agent that results in apoptotic cell death selectively in CD30-expressing tumour cells.
Maltese: Brentuximab vedotin huwa konjugat ta' mediċina antikorp (ADC) li jwassal sustanza antineoplastika li tirriżulta f'mewt selettiv taċ-ċellula apoptotika f'ċelluli tat-tumur li jkollhom CD30.
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)]).
Maltese: Analiżi aġġornata li saret wara 3 snin ta' insegwiment uriet titjib sostnut fil-PFS skont IRF (HR = 0.58 [95% CI (0.41, 0.
English: For the patients who received 1 prior cancer-related treatment, CR was reported for 1 patient (9%) and PR was reported for 4 patients (36%).
Maltese: Għall-pazjenti li kienu rċivew 1 kura relatata mal-kanċer fil-passat, CR ġie rrappurtat għal 1 pazjent (9%); u PR kien irrappurtat għal 4 pazjenti (36%).
English: 11 retreatment experiences.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Combination therapy Note: Primary prophylaxis with G-CSF is recommended for all patients receiving combination therapy beginning with the first dose.
Maltese: Terapija kombinata Nota: Profilassi primarja b'G-CSF hija rakkomandata għall-pazjenti kollha li jirċievu terapija kombinata li tibda mill-ewwel doża.
English: Of these 33 patients who received the RP2D, 32 were evaluable for response.
Maltese: Minn dawn it-33 pazjent li rċivew l-RP2D, 32 setgħu jiġu evalwati għal rispons.
English: In humans, the mean steady state volume of distribution was approximately 6-10 l for ADC.
Maltese: Fil-bnedmin, il-volum ta' distribuzzjoni medju fi stat fiss kien madwar 6-10 l għal ADC.
English: Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (17%), pyrexia (6%), and neutropenia (3%).
Maltese: Ir-reazzjonijiet avversi serji li ġraw f' ≥ 3% tal-pazjenti kienu jinkludu newtropenija bid-deni (17%), deni (6%), u newtropenija (3%).
English: Each vial contains a 10% overfill giving 55 mg of Adcetris per vial and a total reconstituted volume of 11 mL.
Maltese: Kull kunjett fih ammont żejjed ta' 10% li jagħti 55 mg ta' ADCETRIS f'kull kunjett u volum totali rikostitwit ta' 11 ml.
English: Progression Free Survivala
Maltese: Sopravivenza mingħajr progressjoni
English: 0C; ref CTCAE v3) has been reported with treatment with ADCETRIS.
Maltese: CTCAE v3) kienet irrappurtata b'kura b'ADCETRIS.
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.
Maltese: (n = 60), f'fażi 1 ta' studji dwar żieda fid- doza u farmakoloġija klinika (n = 15 pazjenti) u fil-NPP (n = 26 pazjenti) (ara sezzjoni 5.1) kienu konsistenti mal-profil tas-sigurtà ta' l-istudji kliniċi pivitali.
English: Of the patients treated, 8 responding patients went on to receive an allogeneic SCT.
Maltese: Mill-pazjenti kkurati, 8 pazjenti li rrispondew komplew biex irċevew SCT alloġenika.
English: This medicine contains 13.2 mg sodium (main component of cooking/table salt) in each vial.
Maltese: Din il-mediċina fiha 13.2 mg ta' sodium (komponent ewlieni tal-melħ tat-tisjir) f'kull kunjett.
English: Of the recovered MMAE, approximately 72% was recovered in the faeces.
Maltese: Mill-MMAE irkuprat, madwar 72% kien irkuprat fl-ippurgar.
English: HL at increased risk of relapse or progression
Maltese: HL b'riskju mkabbar ta' rikaduta jew progressjoni
English: In clinical trials treatment emergent neuropathy occurred in 59% of the population, peripheral motor neuropathy occurred in 14% of patients.
Maltese: Fil-provi kliniċi seħħet newropatija li żviluppat mit-trattament fi 59% tal-popolazzjoni, newropatija motorja periferali seħħet f' < 14% tal-pazjenti.
English: Objective response (CR + PR) Complete remission (CR)
Maltese: Rispons oġġettiv (CR + PR) Remissjoni kompluta (CR)
English: ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.
Maltese: ADCETRIS għandhu jinżamm għal kwalunkwe każ suspettat ta' pankrejatite akuta.
English: Provision of the results of the ongoing Non-Interventional Post-Authorization Safety Study (PASS) conducted in HL and sALCL patient populations (Study MA25101).
Maltese: Id-dispożizzjoni ta' riżultati tal-Istudju dwar is-Sigurtà Bla Intervent wara l-Awtorizzazzjoni (PASSPost-Authorization Safety Study) għaddej li jkun sar fuq popolazzjonijiet ta' pazjenti b'HL u sALCL (Studju MA25101).
English: Post-hoc Risk Factor Analyses
Maltese: Analiżi ta' Fatturi ta' Riskju Post-hoc
English: After multiple-dose, IV infusion of 1.2 mg/kg brentuximab vedotin every two weeks, maximal serum concentrations of ADC were observed near the end of the infusion and elimination exhibited a multi-exponential decline with a t1/2z of approximately 4 to 5 days.
Maltese: Wara numru ta' dożi, b'infużjoni fil-vini ta' 1.2 mg/kg ta' brentuximab vedotin kull ġimagħtejn, ilkonċentrazzjonijiet massimi fis-serum ta' ADC kienu osservati fit-tmiem tal-infużjoni u leliminazzjoni wriet tnaqqis multi-esponenzjali b't1/2z ta' madwar 4 sa 5 ijiem.
English: A fever with a low white blood cell count may be a sign of serious infection experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (this may be a potentially life-threatening complication known as tumour lysis syndrome) experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin that may be life-threatening (this may be a serious skin reaction known as Stevens-Johnson syndrome and toxic epidermal necrolysis) have new or worsening stomach pain, nausea, vomiting, constipation as these may be symptoms of a serious and potentially fatal stomach or intestinal complication (gastrointestinal complications)
Maltese: Deni b'għadd baxx ta' ċelluli bojod tad-demm jista' jkun sinjal ta' infezzjoni serja - ikollok esperjenza ta' sturdament, tnaqqis fl-awrina, konfużjoni, rimettar, tqalligħ, nefħa, qtugħ ta' nifs, jew disturbi fir-ritmu tal-qalb (din tista' tkun kumplikazzjoni b'potenzjal ta' periklu għall-ħajja magħrufa bħala sindrome tal-lisi tat-tumur) - ikollok esperjenza ta' sintomi li jixbħu l-influwenza segwiti b'raxx aħmar jew fil-vjola li juġgħa u li jinfirex u nfafet inkluż distakkament estensiv tal-ġilda li jistgħa jkun fatali(din tista' tkun reazzjoni serja tal-ġilda magħrufa bħala sindrome Stevens-Johnson u nekrożi tossika talepiderme) - ikollok uġigħ ġdid jew li jmur għall-agħar fl-istonku, dardir, rimettar, stitikezza, għax dawn jistgħu jkunu sintomi ta' kumplikazzjoni serja u potenzjalment fatali fl-istonku u fl-imsaren (kumplikazzjonijiet gastrointestinali) - ikollok testijiet tal-fwied b'riżultati mhux normali, għax dan jista' jkun relatat ma' feriti serji u potenzjalment fatali tal-fwied (epatotossiċità).
English: In patients with Stage IV disease for whom no extranodal disease was reported, no benefit has been shown at time of analysis ([n = 85] [HR = 1.49, 95% CI (0.51, 4.31)]).
Maltese: Fil-pazjenti b'marda ta' Stadju IV li għalihom ma ġiet irrappurtata l-ebda marda ekstranodali, ma ntwera l-ebda benefiċċju fiż-żmien li saret l-analiżi ([n = 85] [HR = 1.49, 95% CI (0.51, 4.31)]).
English: Complete Response (CR) per IRF n (%)
Maltese: Rispons Komplet (CR) skont IRF
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji f‘annimali wrew tossiċità fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: The safety data in patients retreated with ADCETRIS (SGN35-006, see section 5.1) were consistent with those observed in the combined pivotal phase 2 studies, with the exception of peripheral motor neuropathy, which had a higher incidence (28% vs. 9% in the pivotal phase 2 studies) and was primarily Grade 2.
Maltese: Id-dejta dwar is-sigurtà f'pazjenti ttrattati mill-ġdid b'ADCETRIS (SGN35-006, ara sezzjoni 5.1) kienu konsistenti ma' dawk osservati fl-istudji importanti ħafna kombinati ta' fażi 2, bl-eċċezzjoni ta' newropatija periferali tal-moviment, li kellha inċidenza ogħla (28% kontra 9% fl-istudji importanti ħafna ta' fażi 2) u kienet l-aktar ta' grad 2.
English: Infusion-related reactions a, chills
Maltese: Reazzjonijiet relatati mal-infużjoni a, tertir ta' bard
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.
Maltese: Il-karatteristiċi farmakokinetiċi fis-serum u l-plażma tal-ADC u MMAE rispettivament wara l-għoti ta' brentuximab vedotin flimkien ma' AVD kienu simili għal dawk fil-monoterapija.
English: The ADC is expected to be catabolised as a protein with component amino acids recycled or eliminated.
Maltese: ADC huwa mistenni li jiġi kkatabolizzat bħala proteina bl-aċidi amminiċi komponenti tiegħu riċiklati jew eliminati.
English: MMAE is further metabolised mainly to an equally potent metabolite; however, its exposure is an order of magnitude lower than that of MMAE.
Maltese: MMAE jiġi mmetabolizzat b'mod ulterjuri l-aktar għal metabolit potenti ugwalment; madankollu, l-esponiment tiegħu hu ordni ta' kobor iktar baxxa minn dik ta' MMAE.
English: Fatigue, pyrexia, infusion-related reactions
Maltese: Għeja, deni, reazzjonijiet relatati mal-infużjoni
English: The investigator assessments were generally consistent with the independent review of the scans.
Maltese: Il-valutazzjonijiet mill-investigatur ġeneralment kienu konsistenti mal-valutazzjoni indipendenti tal-iskans.
English: Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out.
Maltese: Għalkemm ma ġietx stabbilita assoċjazzjoni kawżali ma' ADCETRIS, ir-riskju ta' tossiċità pulmonari ma jistax jiġi eskluż.
English: Calculated from a weighted Holm's procedure
Maltese: Ikkalkulat minn proċedura Holm ippiżata (weighted)
English: The primary endpoint in Study C25003 was modified PFS (mPFS) per independent review facility (IRF), defined as time from randomisation to disease progression, death, or evidence of non-complete response (non-CR) after completion of first-line therapy per IRF followed by subsequent anticancer therapy.
Maltese: Il-punt tat-tmiem primarju fl-Istudju C25003 kien PFS modifikat (mPFS) għal kull faċilità ta' reviżjoni indipendenti (IRF, independent review facility), definit bħala ż-żmien mill-għażla b'mod każwali sal-progressjoni tal-marda, il-mewt, jew l-evidenza ta' rispons mhux komplut (non-CR, non-complete response) wara t-tlestija tat-terapija primarja għal kull IRF segwita minn terapija sussegwenti ta' kontra l-kanċer.
English: Psychiatric Disorders Very common:
Maltese: Disturbi Psikjatriċi Komuni ħafna:
English: Older patients who received G-CSF primary prophylaxis had lower incidence of neutropenia and febrile neutropenia than those who did not receive G-CSF primary prophylaxis.
Maltese: Pazjenti aktar anzjani li rċevew profilassi primarja G-CSF kellhom inċidenza inqas ta' newtropenija u newtropenija bid-deni minn dawk li ma rċevewx profilassi primarja G-CSF.
English: Powder for concentrate for solution for infusion 1 vial
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett 1
English: IRRs, such as headache, rash, back pain, vomiting, chills, nausea, dyspnoea, pruritus, cough, infusion site pain and pyrexia were reported in 9% of patients.
Maltese: IRRs, bħal uġigħ ta' ras, raxx, uġigħ tad-dahar, rimettar, tertir ta' bard, dardir, qtugħ tan-nifs, ħakk, sogħla, uġigħ fis-sit tal-infużjoni u deni kienu rrappurtati f'9% tal-pazjenti.
English: Neutropenia
Maltese: Epatotossiċità
English: Across the study, a total of 16 patients with r/r HL and 17 patients with r/r sALCL, of whom 10 were in first relapse, were treated with 1.8 mg/kg of ADCETRIS.
Maltese: Matul l-istudju, total ta' 16-il pazjent b'r/r HL u 17-il pazjent b'r/r sALCL, li minnhom 10 kienu fl-ewwel rikaduta, ġew ittattati b'1.8 mg/kg ta' ADCETRIS.
English: If the patient's weight is more than 100 kg, the dose calculation should use 100 kg (see section 6.6).
Maltese: Jekk il-piż tal-pazjenti huwa ta' aktar minn 100 kg, il-kalkolu tad-doża għandu juża 100 kg (ara sezzjoni 6.6).
English: After reconstitution each mL of solution contains 5 mg of Adcetris.
Maltese: Wara r-rikostituzzjoni kull ml ta' soluzzjoni fih 5 mg ta' Adcetris.
English: Patients were treated with 1.8 mg/kg of ADCETRIS every 3 weeks.
Maltese: Il-pazjenti kienu kkurati b'1.8 mg/kg ta' ADCETRIS kull 3 ġimgħat.
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.
Maltese: [36%, 66%]) għall-pazjenti li kienu rċivew > 1 kura relatata mal-kanċer fil-passat, u 45% (95% CI [17%, 77%]) għall-pazjenti li kienu rċivew 1 kura relatata mal-kanċer fil-passat.
English: Hazard Ratio
Maltese: Rispons Parzjali