FrancophonIA/ELRC3.0 huggingface dataset:
English: p. Stomatitis includes the following reported PTs: Mucosal inflammation, Oropharyngeal pain, Stomatitis, Mouth ulceration, Oral pain, Oral mucosal blistering, Aphthous stomatitis, Tongue ulceration, Glossodynia, Oral mucosal erythema, Glossitis#, and Oropharyngeal blistering#.
Maltese: Infjammazzjoni mukożali, Uġigħ orofarinġeali, Stomatite, Ulċerazzjoni fil-ħalq, Uġigħ fil-ħalq, Infafet bil-mukuż fil-ħalq, Stomatite aftuża, Ulċerazzjoni fl-ilsien, Glossodinija, Eritema bilmukuż fil-ħalq, Glossite
English: ≤ 2.5 × ULN prior to each dose (see Table 4, sections 4.4 and 5.2).
Maltese: Ipposponi MYLOTRARG sal-irkupru tal-bilirubina totali għal ≤ 2 × ULN u AST u ALT sa ≤ 2.5 × ULN qabel kull doża (ara Tabella 4, sezzjonijiet 4.4 u 5.2).
English: Vascular disorders Very common
Maltese: Disturbi vaskulari Komuni ħafna
English: MYLOTARG must not to be used in children and adolescents under 15 years of age because limited data are available in this population.
Maltese: MYLOTARG m'għandux jintuża fit-tfal u fl-adolexxenti ta' età inqas minn 15-il sena għax hemm dejta limitata disponibbli f'din il-popolazzjoni.
English: In patients, the total volume of distribution of hP67.6 antibody (sum of V1 [10 L] and V2 [15 L]) was found to be approximately 25 L.
Maltese: (total ta' V1 [10 L] u V2 [15 L]) instab li kien madwar 25 L.
English: Reconstitute each 5 mg vial with 5 mL of water for injections to obtain a single-use solution of 1 mg/mL of gemtuzumab ozogamicin.
Maltese: Irrikostitwixxi kull kunjett ta' 5 mg b'5 mL ta' ilma għall-injezzjonijiet biex tikseb soluzzjoni li tintuża darba ta' 1 mg/mL ta' gemtuzumab ozogamicin.
English: Inductiona
Maltese: Stitikezza
English: The median time from the last gemtuzumab ozogamicin dose to onset of VOD was 9 days (range: 2-298 days).
Maltese: Iżżmien medjan mill-aħħar doża ta' gemtuzumab ozogamicin għall-bidu ta' VOD kien 9 ijiem (medda: 2-298 jum).
English: See also section 6.3 for dilution, storage, and infusion information.
Maltese: Ara wkoll sezzjoni 6.3 għal informazzjoni dwar id-dilwizzjoni, il-ħażna u l-infużjoni.
English: Several single agent studies measured target (CD33) saturation post-MYLOTARG dose in patients with relapsed and refractory AML.
Maltese: Diversi studji dwar mediċina waħda kejlu ssaturazzjoni fil-mira (CD33) wara doża ta' MYLOTARG f'pazjenti b'AML rikaduta u refrattorja.
English: Response rate (by Investigator)
Maltese: Rata ta' rispons (mill-Investigatur)
English: In vitro, the binding N-acetyl gamma calicheamicin dimethyl hydrazide to human plasma proteins is approximately 97%.
Maltese: In vitro, it-tagħqid ta' N-acetyl gamma calicheamicin dimethyl hydrazide mal-proteini tal-plażma talbniedem huwa madwar 97%.
English: 35 mg/m2/day on Day 1 to Day 2
Maltese: 35 mg/m 2/jum f'Jum 1 sa
English: In 23.5% of the studies the majority of patients received fractionated (3 mg/m2 on Day 1, 4, 7) doses of MYLOTARG, while in 35.3% of the studies doses higher than 3 mg/m2 were given.
Maltese: Fi 23.5% tal-istudji, ilmaġġoranza tal-pazjenti rċivew dożi frazzjonati (3 mg/m f'Jiem 1, 4, 7) ta' MYLOTARG, waqt li f'35.3% tal-istudji ngħataw dożi ogħla minn 3 mg/m 2.
English: Respiratory, thoracic and mediastinal disorders Very common Dyspnoean
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: The recommended dose of MYLOTARG is 3 mg/m2/dose (up to a maximum of one 5 mg vial) infused over a 2-hour period on Days 1, 4, and 7 in combination with DNR 60 mg/m2/day infused over 30 minutes on Day 1 to Day 3, and AraC 200 mg/m2/day by continuous infusion on Day 1 to Day 7.
Maltese: Id-doża rakkomandata ta' MYLOTARG hija 3 mg/m 2/doża (sa massimu ta' kunjett wieħed ta' 5 mg) li tiġi infuża għal perjodu ta' sagħtejn f'Jiem 1, 4 u 7 flimkien ma' DNR 60 mg/m 2/jum li tiġi infuża għal
English: Based on an analysis of potential risk factors, adult patients who received MYLOTARG as monotherapy, patients who had received an HSCT prior to gemtuzumab ozogamicin exposure were 2.6 times more likely (95% CI: 1.448, 4.769) to develop VOD compared to patients without HSCT prior to treatment with gemtuzumab ozogamicin; patients who had received an HSCT following treatment with gemtuzumab ozogamicin were 2.9 times more likely (95% CI: 1.502, 5.636) to develop VOD compared to patients without HSCT following treatment with gemtuzumab ozogamicin; and patients who had moderate/severe hepatic impairment at baseline were 8.7 times more likely (95% CI: 1.879, 39.862) to develop VOD compared to patients without moderate/severe hepatic impairment at baseline.
Maltese: Abbażi ta' analiżi ta' fatturi ta' riskju potenzjali, pazjenti adulti li rċivew MYLOTARG bħala monoterapija, pazjenti li rċivew HSCT qabel l-esponiment għal gemtuzumab ozogamicin kellhom probabbiltà ta' 2.6 darbiet aktar (CI ta' 95%: 1.448-4.769) li jiżviluppaw VOD meta mqabbel ma' pazjenti mingħajr HSCT qabel kura b'gemtuzumab ozogamicin; pazjenti li rċivew HSCT wara kura b'gemtuzumab ozogamicin kellhom probabbiltà ta' 2.9 darbiet aktar (CI ta' 95%: 1.502-5.636) li jiżviluppaw VOD meta mqabbel ma' pazjenti mingħajr HSCT qabel kura b'gemtuzumab ozogamicin; pazjenti li kellhom indeboliment tal-fwied moderat/sever fil-linja bażi kellhom probabbiltà ta' 8.7 darbiet aktar (CI ta' 95%: 1.879-39.
English: This is consistent with the known induction of DNA breaks by calicheamicin and other enediyne antitumour antibiotics.
Maltese: Dan huwa konsistenti mal-induzzjoni magħrufa tat-tkissir tad-DNA minn calicheamicin u antibijotiċi enediyne ta' kontra t-tumur oħra.
English: With MYLOTARG monotherapy, the response rate (CR/CRp/CRi; weighted average across studies) was 33.3% with fractionated dosing (1 study) and 24.3% with non-fractionated dosing (9 studies).
Maltese: Bil-monoterapija ta' MYLOTARG, ir-rata ta' rispons (CR/CRp/CRi; medja peżata fost l-istudji) kienet ta' 33.3% b'dożaġġ frazzjonat (studju wieħed) u 24.3% b'dożaġġ mhux frazzjonat (9 studji).
English: Therefore, coadministration of gemtuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) or uridine diphosphate glucuronosyltransferase (UGT) drug metabolising enzymes are unlikely to alter exposure to N-acetyl gamma calicheamicin dimethyl hydrazide.
Maltese: Għalhekk, l-għoti flimkien ta' gemtuzumab ozogamicin ma' inibituri jew indutturi taċ-ċitokromu P450 (CYP) jew uridine diphosphate glucuronosyltransferase (UGT) l-enzimi li jimmetabolizzaw il-mediċina x'aktarx li mhux se jbiddlu l-esponiment għal N-acetyl gamma calicheamicin dimethyl hydrazide.
English: q. Transaminases increased includes the following reported PTs: Transaminases increased, Hepatocellular injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, and Hepatic enzyme increased.
Maltese: Żieda fit-transaminases, Korriment epatoċellulari, Żieda flalanine aminotransferase, Żieda fl-aspartate aminotransferase u Żieda fl-enzimi tal-fwied.
English: In the combination therapy study, in patients with de novo AML treated with fractionated doses of gemtuzumab ozogamicin in combination with chemotherapy (N=131), 102 (77.9%) patients experienced all causality severe (Grade ≥ 3) infections.
Maltese: Fl-istudju ta' terapija kombinata f'pazjenti b'AML de novo li ma ġietx ikkurata preċedentement li ġew ikkurati b'dożi frazzjonati ta' gemtuzumab ozogamicin flimkien mal-kimoterapija (N=131), 102 (77.9%) pazjent esperjenzaw infezzjonijiet severi (Grad ≥ 3) tal-kawżalità kollha.
English: Gemtuzumab ozogamicin was found to be clastogenic.
Maltese: Gemtuzumab ozogamicin instab li huwa klastoġeniku.
English: Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' TLS u għandhom jiġu kkurati skont prassi medika standard.
English: In the completed randomised paediatric Phase 3 Study AAML0531 (see section 5.1) of gemtuzumab ozogamicin combined with intensive first-line therapy in 1,063 newly diagnosed children (93.7% of patients <18 years of age), and young adults (6.3% of patients) with de novo AML aged 0 to 29 years, the safety profile was similar with that observed in the other studies of gemtuzumab ozogamicin combined with intensive chemotherapy in adult patients with de novo AML.
Maltese: Fl-Istudju pedjatriku mitmum ta' Fażi 3 li fih il-parteċipanti ntgħażlu b'mod każwali, AAML0531 (ara sezzjoni 5.1) ta' gemtuzumab ozogamicin flimkien ma' terapija tal-ewwel linja intensiva f'1,063 tfal (93.7% tal-pazjenti ta' età ta' <18-il sena) u adulti żgħażagħ (6.3% tal-pazjenti) li kienu għadhom kif ġew dijanjostikati b'AML de novo ta' età ta' 0 sa 29 sena, il-profil tas-sigurtà kien simili għal dak osservat fl-istudji l-oħrajn ta' gemtuzumab ozogamicin flimkien ma' kimoterapija intensiva f'pazjenti adulti b'AML de novo.
English: The median times to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 were 22 and 27 days, respectively.
Maltese: 500/mm 3 u 1,000/mm 3 kien 22 u 27 jum, rispettivament.
English: Infusion lines made of PVC (DEHP- or non DEHP-containing), or polyethylene are recommended.
Maltese: Huma rakkomandati linji tal-infużjoni magħmula minn PVC (DEHP jew li ma jkunx fih DEHP), jew polyethylene.
English: Ascites
Maltese: Ipertensjoni
English: One VOD event occurred more than 28 days of last dose of gemtuzumab ozogamicin; with 1 of these events occurring a few days after having started an HSCT conditioning regimen.
Maltese: Avveniment wieħed ta' VOD seħħ aktar minn 28 jum mill-aħħar doża ta' gemtuzumab ozogamicin; b'1 minn dawn l-avvenimenti li seħħ ftit jiem wara li nbeda l-kors ta' kundizzjonament tal-HSCT.
English: (5.3%), Bacterial infection (9.2%), Gastrointestinal infection (8.4%), Skin infection (2.3%), and Other infections b. Haemorrhage includes Central nervous system haemorrhage (3.1%), Upper gastrointestinal haemorrhage (33.6%), Lower gastrointestinal haemorrhage (17.6%), Subcutaneous haemorrhage (60.3%), Other haemorrhage (64.9%), and Epistaxis (62.6%).
Maltese: Emorraġija tinkludi Emorraġija tas-sistema nervuża ċentrali (3.1%), Emorraġija gastrointestinali ta' fuq (33.6%), Emorraġija gastrointestinali t'isfel (17.6%), Emorraġija taħt il-ġilda (60.3%), Emorraġija oħra (64.9%), u Epistassi c.
English: Because of this limited data collection, laboratory data from the combination therapy study are included in Table 5.
Maltese: Minħabba din il-ġabra limitata ta' dejta, dejta tal-laboratorju mill-istudju ta' terapija kombinata hija inkluża f'Tabella 5.
English: Discontinuation of treatment should be strongly considered for patients who develop signs or symptoms of anaphylaxis, including severe respiratory symptoms or clinically significant hypotension (see section 4.2).
Maltese: It-twaqqif tal-kura għandu jiġi kkunsidrat ħafna għal pazjenti li jiżviluppaw sinjali jew sintomi ta' anafilassi, inkluż sintomi respiratorji severi jew ipotensjoni klinikament sinifikanti (ara sezzjoni 4.2).
English: Effects on the reproductive tract of female monkeys were observed in the 12-week study (atrophy of the ovary, oviduct, uterus, and cervix; approximately 193 times the human clinical exposure after the third dose of 3 mg/m2).
Maltese: Ġew osservati effetti fuq lapparat riproduttiv ta' xadini nisa fl-istudju ta' 12-il ġimgħa (atrofija tal-ovarju, utru, u ċerviċi; madwar 193 darba l-esponiment kliniku tal-bniedem wara t-tielet doża ta' 3 mg/m
English: Neutrophils decreased Hyperglycaemia Aspartate aminotransferase (AST) increas ed Prothrombin time increased Activated partial thromboplastin time prolonged Alkaline phosphatase increased
Maltese: Żieda fl-aspartate aminotransferase (AST) Żieda fil-ħin tal-prothrombin Ħin tat-tromboplastin parzjali attivat imdewwem
English: b. Based on the Cox Proportional Hazards Model Versus daunorubicin+cytarabine.
Maltese: b. Abbażi tal-Mudell ta' Riskji Proporzjonali Cox Kontra daunorubicin + cytarabine.
English: Schedule modification for hyperleukocytosis
Maltese: Modifikazzjoni fid-doża għal iperlewkoċitożi
English: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanised immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin.
Maltese: 6; immunoglobina umanizzata rikombinanti [Ig] G4, antikorp kappa prodott minn koltura taċ-ċelluli tal-mammiferi f'ċelluli NS0) li huwa marbut b'mod kovalenti mal-mediċina ċitotossiku N-acetyl gamma calicheamicin.
English: Additional findings included effects on the testes, epididymides and mammary gland as well as fertility.
Maltese: Sejbiet addizzjonali inkludew effetti fuq ittestikoli, l-epididimi u l-glandola mammarja kif ukoll il-fertilità.
English: In the combination therapy study, VOD and hepatic laboratory abnormalities were collected.
Maltese: Fl-istudju ta' terapija kombinata, inġabru anormalitajiet tal-laboratorju tal-VOD u tal-fwied.
English: The primary metabolic pathway of gemtuzumab ozogamicin is anticipated to be hydrolytic release of N acetyl gamma calicheamicin dimethyl hydrazide.
Maltese: Il-passaġġ metaboliku primarju ta' gemtuzumab ozogamicin huwa antiċipat li jkun ir-rilaxx idrolitiku ta' N acetyl gamma calicheamicin dimethyl hydrazide.
English: Management of patients with severe infection, bleeding/haemorrhage, or other effects of myelosuppression, including severe neutropenia or persistent thrombocytopenia, may require a dose delay or permanent discontinuation of MYLOTARG (see sections 4.2 and 4.4).
Maltese: Il-ġestjoni ta' pazjenti b'infezzjoni severa, ħruġ ta' demm/emorraġija, jew effetti oħra ta' majelosuppressjoni, inkluż newtropenija severa jew tromboċitopenija persistenti, tista' teħtieġ dewmien fid-doża jew twaqqif permanenti ta' MYLOTARG (ara s-sezzjonijiet 4.2 u 4.4).
English: The overall minimum and maximum ages range from 0 years to 22.3 years, with an overall median age of 8.7 years at the time of treatment.
Maltese: L-etajiet minimi u massimi globali varjaw minn 0 snin sa 22.3 snin, b'età medjana globali ta' 8.7 snin fiż-żmien tat-trattament.
English: SN
Maltese: nifs
English: Selected** adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)
Maltese: Reazzjonijiet avversi magħżula f'pazjenti li rċivew MYLOTARG fl-istudju ta' terapija kombinata (ALFA-0701)
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is primarily metabolised via nonenzymatic reduction.
Maltese: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide jiġi primarjament metabolizzat permezz ta' tnaqqis mhux enzimatiku.
English: The median times to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 were 21 and 25 days, respectively.
Maltese: 500/mm 3 u 1,000/mm 3 kien 21 u 25 jum, rispettivament.
English: Based on a population PK analysis, the clearance of gemtuzumab ozogamicin (hP67.6 antibody and unconjugated calicheamicin) is not expected to be affected by mild hepatic impairment status, as defined by National Cancer Institute Organ Dysfunction Working Group (NCI ODWG).
Maltese: Abbażi tal-analiżi PK tal-popolazzjoni, it-tneħħija ta' gemtuzumab ozogamicin (antikorp hP67.6 u calicheamicin mhux konjugat) mhix mistennija li tiġi affettwata minn status ta' indeboliment tal-fwied ħafif, kif definit mill-Grupp ta' Ħidma ta' Disfunzjoni tal-Organi tal-Istitut tal-Kanċer Nazzjonali (NCI ODWG, National Cancer Institute Organ Dysfunction Working Group).
English: Based on the primary definition of EFS: event dates (induction failure, relapse, or death) determined by investigator assessment.
Maltese: Abbażi tad-definizzjoni primarja ta' EFS: dati ta' avveniment (ma tibdiex l-induzzjoni, rikaduta jew mewt) determinati minn valutazzjoni tal-investigatur.
English: Given that the hP67.6 portion renders target selectivity on the intact molecule, and that gemtuzumab ozogamicin dosages are reported in terms of milligrams of protein (hP67.6), the hP67.6 concentration results are reported as the primary PK measures.
Maltese: Minħabba li l-proporzjon ta' hP67.6 irendi selettività fil-mira fuq il-molekula intatta, u minħabba li d-dożaġġi ta' gemtuzumab ozogamicin huma rrappurtati f'termini ta' milligrammi ta' proteina (hP67.6), ir-riżultati tal-konċentrazzjonijet ta' hP67.6 huma rrappurtati bħala kejl primarju tal-PK.
English: BATCH NUMBER
Maltese: Numru ta' studji
English: Cytogenetics (unfavourable), N Number of events, n (%) Median EFS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Maltese: Ċitoġenetiċi (Mhux favorevoli), N Numru ta' avvenimenti, n (%) EFS medjana f'xhur [CI ta' 95%] Proporzjon ta' Periklu [CI ta' 95%] valur-p
English: Abdominal paino
Maltese: Uġigħ addominali
English: However, the optimal dose of gemtuzumab ozogamicin for paediatric patients was not established, since in Study AAML0531 during the second intensification period after the second dose of gemtuzumab ozogamicin, a larger proportion of patients in the gemtuzumab ozogamicin arm experienced prolonged neutrophil recovery time (> 59 days) as compared with the comparator arm (21.0% versus 11.5%), and more patients died during remission (5.5% versus 2.8%).
Maltese: Madankollu, l-aħjar doża ta' gemtuzumab ozogamicin għal pazjenti pedjatriċi ma ġietx determinata, peress li fl-Istudju AAML0531 waqt it-tieni perjodu ta' intensifikazzjoni wara ttieni doża ta' gemtuzumab ozogamicin, proporzjon akbar ta' pazjenti fil-fergħa ta' emtuzumab ozogamicin esperjenzaw żmien ta' rkupru tan-newtrofili mdewwem (> 59 jum) meta mqabbel malfergħa tal-komparatur (21.0% kontra 11.5%), u aktar pazjenti mietu waqt ir-remissjoni (5.5% kontra
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 34 and 35 days, respectively.
Maltese: Iż-żmien medjan għal irkupru tal-plejtlits għal għadd ta' 50,000/mm 3 u 100,000/mm 3 kien 34 u 35 jum, rispettivament.
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 32 and 35 days, respectively.
Maltese: Iż-żmien medjan għal irkupru tal-plejtlits għal għadd ta' 50,000/mm 100,000/mm 3 kien 32 u 35 jum, rispettivament.
English: Across all studies, near maximal peripheral CD33 saturation was observed post-MYLOTARG dose at all dose levels of 2 mg/m² and above, suggesting that a low dose of gemtuzumab ozogamicin is sufficient to bind all available CD33 sites.
Maltese: Flistudji kollha, ġiet osservata kważi saturazzjoni tas-CD33 periferali massima wara doża ta' MYLOTARG fil-livelli kollha tad-doża ta' 2 mg/m² u aktar, li jissuġġerixxi li doża baxxa ta' gemtuzumab ozogamicin hija biżżejjed biex tgħaqqad is-siti tas-CD33 kollha disponibbli.
English: Gemtuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody which specifically recognises human CD33.
Maltese: Gemtuzumab ozogamicin huwa ADC immirat lejn CD33. Gemtuzumab huwa antikorp umanizzat talimmunoglobulina ta' klassi G sottotip 4 (IgG4) li jagħraf speċifikament is-CD33 tal-bniedem.
English: Event-free survival by investigator assessment by AML risk classifications from study ALFA-0701 (mITT Population)
Maltese: Sopravivenza globali skont il-klassifiki tar-riskju ta' AML mill-istudju ALFA0701 (Populazzjoni mITT)
English: For patients experiencing a complete remission (CR) following induction, defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count (ANC) of more than 1.0 × 109 cells/L with a platelet count of 100 × 109/L or more in the peripheral blood in the absence of transfusion, up to 2 consolidation courses of intravenous DNR (60 mg/m2 for 1 day [first course] or 2 days [second course]) in combination with intravenous AraC (1 g/m2 per 12 hours, infused over 2 hours on Day 1 to Day 4) with intravenous MYLOTARG (3 mg/m2/dose infused over 2 hours up to a maximum dose of one 5 mg vial on Day 1) are recommended.
Maltese: 9/L jew aktar fiddemm periferali fin-nuqqas ta' trasfużjoni, huma rakkomandati sa 2 korsijiet ta' konsolidazzjoni ta' DNR ġol-vini 60 mg/m 2 għal jum 1 [l-ewwel kors] jew jumejn [it-tieni kors]) flimkien ma' AraC ġol vini (1 g/m 2 kull 12-il siegħa, li tiġi infuża fuq perjodu ta' sagħtejn f'Jum 1 sa Jum 4) b'MYLOTARG ġol-vini (3 mg/m 2/doża li jiġi infuż għal perjodu ta' sagħtejn sa doża massima ta' kunjett wieħed ta'
English: The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection.
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti (≥ 1%) li wasslu għat-twaqqif permanenti fl-istudju ta' terapija kombinata kienu tromboċitopenija, VOD, emorraġija u infezzjoni.
English: Single doses higher than 9 mg/m2 in adults were not tested.
Maltese: Dożi waħdanin ogħla minn 9 mg/m2 f'adulti ma ġewx ittestjati.
English: Number of events, n (%) Median RFS in months [95% CI]a
Maltese: Numru ta' avvenimenti, n (%) RFS medjana f'xhur [CI ta' 95%]
English: Abbreviations: AML =acute myeloid leukaemia; CI=confidence interval; EFS=event-free survival; ELN=European LeukaemiaNet; mIT T =modified intent-to-treat; n=number; N=number; NE=not estimable.
Maltese: CI=intervall ta' fiduċja; ELN=LewkimjaNet Ewropea; mITT=intenzjonat biex jikkura modifikat; n=numru; N=numru; NE= ma jistax jiġi stmat;
English: Overall, 29 (5.5%) of patients in the MYLOTARG arm and 15 (2.8%) patients in the comparator arm died during remission.
Maltese: B'mod ġenerali, 29 (5.5%) tal-pazjenti fil-fergħa ta' MYLOTARG u 15-il pazjent (2.8%) fil-fergħa tal-komparatur mietu matul remissjoni.
English: The study showed that addition of MYLOTARG to intensive chemotherapy improved EFS (3 years: 50.6% versus 44.0%; HR 0.838; 95% CI: 0.706, 0.995; p=0.0431) in de novo AML owing to a reduced relapse risk, with a trend towards longer OS in the MYLOTARG arm which was not statistically significant (3 years: 72.4% versus 67.6%; HR 0.904; 95% CI: 0.721, 1.133; p=0.3799).
Maltese: HR 0.838; CI ta' 95%: 0.706, 0.995; p=0.0431) f'AML de novo dovuta għal riskju mnaqqas ta' rikaduta, b'tendenza lejn OS itwal fil-fergħa ta' MYLOTARG li ma kienx statistikament sinifikanti (3 snin:
English: Patients in the Phase 2 trials did not develop antidrug antibodies (ADAs) and only 2 patients in a Phase 1 trial developed antibodies against the calicheamicin-linker complex, 1 of whom had reduced hP67.6 plasma concentrations.
Maltese: 2 ma żviluppawx anitkorpi għal kontra l-mediċini (ADAs, antidrug antibodies) u 2 pazjenti fi prova ta' Fażi 1 biss żviluppaw antikorpi kontra l-kumpless li jorbot malcalicheamicin, 1 minnhom kellu konċentrazzjonijiet imnaqqsa fil-plażma hP67.6.
English: Thrombocytopeniab Neutropeniac
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: Safety results observed in a systematic literature review of studies evaluating MYLOTARG in paediatric patients (see section 5.1), are presented in Table 7.
Maltese: Ir-riżultati tas-sigurtà osservati f'rieżami sistemiku tal-letteratura tal-istudji li jevalwaw MYLOTARG f'pazjenti pedjatriċi (ara sezzjoni 5.1), huma ppreżentati fit-Tabella 7.
English: Amber Type 1 glass vial, with butyl rubber stopper and crimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin.
Maltese: Kunjett tal-ħġieġ tat-Tip 1 kulur l-ambra, b'tapp tal-gomma tal-butyl u siġill irbattut b'għatu tat-tip flip off li fih 5 mg gemtuzumab ozogamicin.
English: Information about adverse drug reactions from monotherapy studies and post-marketing experience is presented Table 6 in order to provide full characterisation of adverse reactions.
Maltese: Informazzjoni dwar reazzjonijiet avversi għal mediċini minn studji ta' monoterapija u esperjenza ta' wara t-tqegħid fis-suq hija ppreżentata f'Tabella 6 sabiex tipprovdi karatterizzazzjoni sħiħa tar-reazzjonijiet avversi.
English: In the consolidation 1 phase of therapy, 94 (96.9%) patients had neutrophil recovery to counts of 500/mm3, and 91 (94%) patients recovered to counts of 1,000/mm3.
Maltese: Fil-fażi ta' konsolidazzjoni 1 tat-terapija, 94 (96.9%) pazjent kellhom irkupru tan-newtrofili għal għadd ta' 500/mm 3, u 91 (94%) pazjent irkupraw għal għadd ta' 1,000/mm 3. Iż-żmien medjan għal irkupru tan-newtrofili għal ANC ta'