FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon Angioedema#, Hypersensitivity* Rare
Maltese: Anġjoedema#, Sensittività eċċessiva*
English: This is not considered clinically relevant.
Maltese: Dan mhuwiex ikkunsidrat klinikament rilevanti.
English: Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
Maltese: Kull kunjett fih 3.5 mg ta' bortezomib (bħala mannitol boronic ester).
English: N=130 (ITT population)
Maltese: N=130 (popolazzjoni ITT)
English: Antiviral prophylaxis was administered to 26% of the patients in the Bzmb+M+P arm.
Maltese: Profilassi antivirali ngħatat lil 26% tal-pazjenti fil-parti tal-istudju dwar Bzmb+M+P.
English: Intent to Treat Populationb n=74
Maltese: Popolazzjoni Maħsuba għatTrattamentb n=74
English: A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Maltese: Normali (CrCL ≥ 60 ml/min/1.73 m2, n=12), Ħafif (CrCL=40-59 ml/min/1.73 m2, n=10), Moderat (CrCL=20-39 ml/min/1.73 m2, n=9), u Sever (CrCL < 20 ml/min/1.73 m2, n=3).
English: Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration
Maltese: Disturb testikulari*, Prostatite, Disturb fis-sider tal-mara, Tenerezza epididimali, Epididimite, Uġigħ pelviku, Ulċerazzjoni vulvali
English: Fertility Fertility studies were not conducted with bortezomib (see section 5.3).
Maltese: Fertilità Ma sarux studji dwar il-fertilità b'bortezomib (ara sezzjoni 5.3).
English: RR (Post-induction) *CR+nCR
Maltese: RR (Wara linduzzjoni) *CR+nCR
English: Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
Maltese: Il-pazjenti kellhom IgG/IgA/majeloma ta' katina ħafifa f'istanzi ta' 63%/25%/8%, emoglobina medjana ta' 105 g/l, u għadd medjan ta' plejtlits ta' 221.5 x 109/l.
English: Phase II
Maltese: Fażi II
English: Acute diffuse infiltrative pulmonary and pericardial disease.
Maltese: Mard pulmonari u perikardijali akut diffuż u infiltrattiv.
English: Table 2: Recommended posology for Bortezomib SUN in combination with melphalan and prednisone Twice weekly Bortezomib SUN (cycles 1-4)
Maltese: Tabella 2: Pożologija rakkommandata għal Bortezomib SUN flimkien ma' melphalan u prednisone Bortezomib SUN darbtejn fil-ġimgħa (ċikli 1-4)
English: Table 7 has been generated using Version 14.1 of the MedDRA.
Maltese: Tabella 7 kienet iġġenerata bl-użu tal-MedDRA Verżjoni 14.1.
English: Incidence of PN (%) All GradePN ≥ Grade 2 PN ≥ Grade 3 PN Discontinuation due to PN (%)
Maltese: Inċidenza ta' PN (%) PN Gradi kollha PN Grad ≥ 2 PN Grad ≥ 3 Waqfien minħabba PN (%)
English: 19.9 mo
Maltese: 19.9 xahar
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Maltese: Meninġite (anki batterika), Infezzjoni bil-virus EpsteinBarr, Herpes ġenitali, Tonsillite, Mastojdite, Sindrome ta' għeja wara l-virus
English: Patients in the BzmbR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21), rituximab 375 mg/m2 IV on day 1; cyclophosphamide 750 mg/m2 IV on day 1; doxorubicin 50 mg/m2 IV on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day bortezomib treatment cycle.
Maltese: Il-pazjenti fil-parti tal-istudju dwar trattament b'BzmbR-CAP irċivew bortezomib (1.3 mg/m2; f'jiem 1, 4, 8, 11, perjodu ta' waqfien jiem 12-21), rituximab 375 mg/m2 IV f'jum 1; cyclophosphamide 750 mg/m2 IV f'jum 1; doxorubicin 50 mg/m2 IV f'jum 1; u prednisone 100 mg/m2 mill-ħalq minn jum 1 sa jum 5 taċ-ċiklu ta' trattament ta' 21 jum b'bortezomib.
English: A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Maltese: Differenza statistikament sinifikanti fis-CR+nCR kienet osservata favur il-grupp ta' bortezomib kkombinat ma' dexamethasone.
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzmbDx groups respectively; the majority of patients underwent one single transplant procedure.
Maltese: Trapjanti ta' ċelluli staminali awtologi ġew riċevuti f'198 (82%) u 208 (87%) tal-pazjenti fil-gruppi ta' VDDx u BzmbDx, rispettivament; il-maġġoranza tal-pazjenti saritilhom proċedura waħda għal trapjant singolu.
English: Peripheral neuropathy in combination regimens Multiple myeloma
Maltese: Newropatija periferali f'korsijiet kombinati Majeloma multipla
English: The incidence of herpes zoster among patients in the Bzmb+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Maltese: L-inċidenza ta' herpes zoster fost pazjenti fil-grupp tat-trattament b'Bzmb+M+P kienet ta' 17% għal pazjenti li ma ngħatawx profilassi antivirali meta mqabbel ma' 3% għal pazjenti li ngħataw profilassi antivirali.
English: > 1 prior line of therapy
Maltese: > 1 Linja waħda ta' terapija fil-passat
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BzmbR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Maltese: Reazzjonijiet avversi addizzjonali għall-mediċina li kienu identifikati u assoċjati mal-użu tat-terapija kombinata (BzmbR-CAP) kienu infezzjoni bl-epatite B (< 1%) u iskemija mijokardijaka (1.3%).
English: Geometric mean (%CV) clearance was 7.79 (25%) l/hr/m2, volume of distribution at steady-state was 834 (39%) l/m2, and the elimination half-life was 100 (44%) hours.
Maltese: It-tneħħija ġeometrika medja (%CV) kienet 7.79 (25%) l/siegħa/m2, il-volum ta' distribuzzjoni fl-istat fiss kien 834 (39%) l/m2, u l-half-life ta' eliminazzjoni kienet 100 (44%) siegħa.
English: Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Maltese: Punti finali sekondarji kienu jinkludu, iż-żmien għall-progressjoni (TTP- time to progression), iż-żmien għat-terapija li jmiss kontra l-limfoma (TNT - time to next anti-lymphoma treatment), it-tul ta' żmien tal-perjodu mingħajr trattament (TFI - duration of treatment free interval), ir-rata totali ta' rispons (ORR - overall response rate) u r-rata ta' rispons sħiħ (CR/CRu - complete response), is-sopravivenza globali (OS - overall survival) u t-tul ta' żmien tar-rispons.
English: disease.
Maltese: KLINIKU
English: In the BzmbR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Maltese: Fil-grupp ta' BzmbR-CAP, 22.5% tal-pazjenti rċivew trasfużjonijiet talplejtlits meta mqabbla ma' 2.9% tal-pazjenti fil-grupp ta' R-CHOP.
English: Response Rate at 8 cycles n (%) ORR (CR+PR) p-valuea
Maltese: Rata ta' Rispons wara 8 ċikli n (%) ORR (CR+PR) valur pa
English: Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Maltese: Neoplażmi malinni, Lewkimja plażmaċitika, Karċinoma taċ-ċelluli renali, Massa, Fungojdi mikożi, Neoplażma beninna*
English: Day -- -- Day
Maltese: Jum -- -- Jum
English: e Median duration of follow up is 11.8 months
Maltese: e Żmien medjan ta' follow hu 11.8 xhur
English: 20.7 mo
Maltese: 20.7 xahar
English: The incidence of herpes zoster among patients in the BzmbR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Maltese: 7% għallpazjenti li ma ngħatawx profilassi antivirali meta mqabbel ma' 3.6% għall-pazjenti li ngħataw profilassi antivirali (ara sezzjoni 4.4).
English: In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Maltese: Fil-provi li fihom bortezomib ingħata bħala trattament ta' induzzjoni f'kombinazzjoni ma' dexamethasome (studju IFM-2005-01), u dexamethasone-thalidomide (studju MMY-3010), linċidenza ta' newropatija periferali fil-korsijiet ta' trattament ikkombinat qed jiġu ppreżentati fittabella t'hawn isfel:
English: Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Maltese: Trattament mill-ġdid ta' pazjenti b'majeloma multipla rikaduta Fi studju li fih trattamenti konsekuttivi b'bortezomib ingħataw lil 130 pazjent b'majeloma multipla li rkadiet, li qabel kellhom tal-anqas rispons parzjali b'kors ta' trattament li kien fih bortezomib, l-aktar każijiet avversi ta' kull grad li seħħew b'mod komuni f'tal-anqas 25% tal-poazjenti kienu tromboċitopenija (55%), newropatija (40%), anemija (37%), dijarea (35%) u stitikezza (28%).
English: VDDx=vincristine, doxorubicin, dexamethasone; BzmbDx=bortezomib, dexamethasone; TDx=thalidomide, dexamethasone; BzmbTDx=bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
Maltese: TDx=thalidomide, dexamethasone BzmbDx=bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Nota: Newropatija periferali kienet tinkludi t-termini ppreferuti: newropatija periferali, newropatija motorea periferali, newropatija sensorjali periferali, u polinewropatija.
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were 80.18%-122.80%.
Maltese: Il-proporzjon ġeometriku medju tal- AUClast kien ta' 0.99 u l-intervalli ta' kunfidenza ta' 90% kienu 80.
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzmbR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzmbR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Maltese: Iż-żewġ gruppi ta' trattament kienu jixxiebhu f'dik li hija inċidenza totali ta' każijiet ta' emorraġija tal-gradi kollha (6.3% fil-grupp ta' BzmbR-CAP u 5.0% fil-grupp ta' RCHOP) kif ukoll każijiet ta' emorraġija ta' Grad 3 jew aktar (BzmbR-CAP: 4 pazjenti [1.7%]; RCHOP: 3 pazjenti [1.2%]).
English: Median PFS by investigator assessment was 30.7 months in the BzmbR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Maltese: Il-medjan ta' PFS skont il-valutazzjoni mill-investigatur kienet 30.7 xhur fil-grupp ta' BzmbR-CAP u 16.1 xhur fil-grupp ta' R-CHOP (Proporzjon ta' periklu [HR]=0.51; p < 0.001).
English: Subcutaneous use: Add 1.4 ml 0.9% sodium chloride to make 2.5 mg/ml final concentration.
Maltese: Żid 1.4 ml ta' 0.9% sodium chloride sabiex tagħmel konċentrazzjoni finali ta' 2.5 mg/ml.
English: 27.0 mo
Maltese: 27.0 xahar
English: N=242 (ITT population)
Maltese: N=242 (popolazzjoni ITT)
English: • different reconstitution requirements for Bortezomib SUN 3.5 mg IV or SC use
Maltese: • ħtiġijiet ta' rikostituzzjoni differenti għall-użu ta' Bortezomib SUN 3.5 mg IV jew SC
English: In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Maltese: Studji in vitro jindikaw li bortezomib huwa inibitur dgħajjef tal-isożimi 1A2, 2C9, 2C19, 2D6 u 3A4 taċ-ċitokrom P450 (CYP).
English: Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
Maltese: Fuq medda ta' konċentrazzjoni ta' bortezomib ta' bejn 0.01 u 1.0 μg/ml, ir-rabta mal-proteina in vitro kien medja ta' 82.9% fi plażma tal-bniedem.
English: NOS=not otherwise specified * Grouping of more than one MedDRA preferred term.
Maltese: NOS = mhux speċifikat mod ieħor (not otherwise specified) * Ġabra flimkien ta' iktar minn terminu wieħed ippreferut ta' MedDRA. #
English: - In cycles 1 to 4, Bortezomib SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29
Maltese: - F'ċikli minn 1 sa 4, Bortezomib SUN jingħata darbtejn fil-ġimgħa f'jiem 1, 4, 8, 11, 22, 25, 29
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Maltese: L-età medjana tal-pazjenti fl-istudju kienet ta' 57 sena, 55% kienu rġiel u 48% tal-pazjenti kellhom ċitoġenetiċi ta' riskju għoli.
English: 15.0 mo
Maltese: 15.0 xahar
English: A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Maltese: Differenza statistikament sinifikanti f'CR+nCR kienet osservata favur il-grupp ta' bortezomib ikkombinat ma' dexamethasone u thalidomide.
English: The majority of the patients in both groups completed treatment, 80% in the BzmbR-CAP group and 82% in the R-CHOP group.
Maltese: Il-maġġoranza tal-pazjenti fiż-żewġ gruppi temmew it-trattament, 80% fil-grupp ta' BzmbR-CAP u 82% fil-grupp ta' R-CHOP.
English: Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Maltese: Ibbażat fuq il-kontribuzzjoni limitata (7%) ta' CYP2DG għallmetaboliżmu ta' bortezomib, il-metabolizzatur batut b'fenotip CYP2D6 mhux mistenni li jaffettwa ddispożizzjoni ġenerali ta' bortezomib.
English: Uncommon Cardiac tamponade#, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Maltese: Tamponade kardijaka#, Waqfien kardjopulmonari*, Fibrillazzjoni kardijaka (anki atrijali), Insuffiċjenza kardijaka (li tinkludi l-ventrikulu tax-xellug u tallemin)*, Arritmija*, Takikardija*, Palpitazzjonijiet, Anġina pectoris, Perikardite (li tinkludi effużjoni perikardijali)*, Kardijomijopatija*, Disfunzjoni ventrikulari*, Bradikardija
English: Distribution The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
Maltese: Distribuzzjoni Il-volum medju ta' distribuzzjoni (Vd) ta' bortezomib kien mifrux minn 1,659 l sa 3,294 l wara li ngħatat doża waħda jew doża ripetuta ġol-vini ta' 1.0 mg/m2 jew 1.3 mg/m2 lil pazjenti b'majeloma multipla.
English: Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Maltese: L-inċidenza ta' mewt minn “Mard progressiv” kienet ta' 18% fil-grupp ta' taħt il-ġilda u 9% fil-grupp ġol-vini.
English: Surgical and medical procedures
Maltese: Proċeduri kirurġiċi u mediċi
English: The overall incidence of hepatitis B infections was similar in patients treated with BzmbR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Maltese: L-inċidenza totali ta' infezzjonijiet bl-epatite B kienet tixxiebah f'pazjenti ttrattati b'BzmbR-CAP jew b'R-CHOP (0.8% vs 1.2% rispettivament).
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Maltese: III f'pazjenti b'majeloma multipla li qatt ma kienu ttrattati qabel, l-inċidenza globali ta' attivazzjoni mill-ġdid ta' herpes zoster kien aktar komuni f'pazjenti ttrattati b'bortezomib+Melphalan+Prednisolone meta mqabbla ma' Melphalan+Prednisolone (14% kontra 4% rispettivament).
English: Of those, 121 cases reported chalazion, blepharitis, meibomianitis, and/or Meibomian gland dysfunction.
Maltese: Minn dawk, 121 każ irrappurtaw keleżjon, blefarite, meibomjanite, u/jew funzjoni ħażina tal-glandola Meibomjan.
English: The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Maltese: Eliminazzjoni Il-half-life medja ta' eliminazzjoni (t1/2) ta' bortezomib wara li ngħataw ħafna dożi kienet fuq medda minn 40-193 siegħa.
English: *RR (Post-induction) CR+nCR
Maltese: *RR (Wara linduzzjoni) CR+nCR
English: Caution should be exercised when bortezomib is combined with CYP3A4 or CYP2C19 substrates (see section 4.5).
Maltese: Għandu jkun hemm kawtela meta bortezomib jintuża ma' substrati ta' CYP3A4 jew CYP2C19 (ara sezzjoni 4.5).
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna < 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzmbR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Maltese: F'pazjenti b'MCL (studju LYM-3002), l-inċidenza ta' infezzjoni b'herpes zoster kienet 6.7% fil-parti tal-istudju dwar BzmbR-CAP u 1.2% fil-parti tal-istudju dwar R-CHOP (ara sezzjoni 4.8).
English: 43.1 mo
Maltese: 43.1 xahar
English: Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the Bortezomib SUN treatment cycle.
Maltese: Prednisone jingħata mill-ħalq bid-doża ta' 100 mg/m2 f'jiem 1, 2, 3, 4 u 5 taċ-ċiklu ta' trattament b'Bortezomib SUN.
English: Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Maltese: Attivazzjoni mill-ġdid u infezzjoni bil-Virus tal-Epatite B (HBV - Hepatitis B Virus) Limfoma taċ-ċelluli mantle
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BzmbR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Maltese: F'pazjenti b'MCL (studju LYM-3002), kien hemm inċidenza ogħla (56.7% versus 5.8%) ta' tromboċitopenija ta' Grad ≥ 3 fil-grupp ta' trattament b'bortezomib (BzmbR-CAP) meta mqabbla mal-grupp li ma kienx ittrattat b'bortezomib (rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone [R-CHOP]).
English: A statistically significant survival benefit in favour of the Bzmb+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Maltese: Kien osservat benefiċċju ta' sopravivenza sinifikanti b'mod statistiku favur il-grupp ta' trattament Bzmb+M+P (HR=0.695; p=0.00043) minkejja terapiji sussegwenti li kienu jinkludu korsijiet ta' trattament ibbażati fuq bortezomib.
English: 5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)d 29 (26)d 64 (34)b 27 (13)b CR+nCR+PR+M R Median duration Days (months) Time to response CR+PR(days)
Maltese: 5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)
English: OR=Odds Ratio; ITT=Intent to Treat
Maltese: ITT= Intenzjoni li Tittratta (Intent to Treat)
English: It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m2).
Maltese: Mhuwiex magħruf jekk il-farmakokinetika ta' bortezomib hijiex influwenzata f'pazjenti b'indeboliment sever tal-kliewi li mhumiex qegħdin fuq id-dijalisi (CrCL < 20 ml/min/1.73 m2).
English: 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Maltese: 2-36.5 xhur) għall-pazjenti b'monoterapija ta' bortezomib u 33.0 xahar (95% CI; 28.9-37.1 xahar) għall-pazjenti li qed jieħdu terapija kombinata ta' bortezomib flimkien ma' doxorubicin liposomali pegilat.
English: N=240 (ITT population)
Maltese: N=240 (popolazzjoni ITT)
English: Median survival for the Bzmb+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Maltese: Issopravivenza medjana fil-grupp ta' trattament Bzmb+M+P kienet 56.4 xhur meta mqabbla ma' 43.1 fil-grupp ta' trattament M+P.
English: Mantle cell lymphoma (MCL) The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Maltese: Il-profil ta' sigurtà ta' bortezomib f'240 pazjent b'MCL ittrattati b'bortezomib bid-doża ta' 1.3 mg/m2 flimkien ma' rituximab, cyclophosphamide, doxorubicin, u prednisone (BzmbR-CAP), kontra 242 pazjent ittrattati b'rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone [RCHOP] kien relattivament konsistenti ma' dak osservat f'pazjenti b'majeloma multipla bid-differenzi prinċipali deskritti hawn taħt.
English: Four treatment cycles of this combination therapy are administered.
Maltese: Disa' ċikli ta' trattament ta' din it-terapija kombinata jingħataw.
English: A Phase II, single arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
Maltese: II, b'fergħa waħda ta'attività, sigurtà u farmakokinetika li saret mill-Grupp ta'Onkoloġija tat-Tfal (Children's Oncology Group) ivvalutat l-attività taż-żieda ta' bortezomib ma'kimoterapija ta' induzzjoni mill-ġdid b'ħafna sustanzi f'pazjenti pedjatriċi u pazjenti adulti żgħar b'tumuri malinni tal-limfojd (lewkimja limfoblastika akuta ta' qabel iċ-ċelluli B [ALL] b'ALL
English: A minority of patients with orthostatic hypotension experienced syncopal events.
Maltese: Minoranza ta' pazjenti b'ipotensjoni ortostatika kellhom episodji fejn intilfu minn sensihom.
English: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Maltese: Sindrome ta' Cushing*, Ipertirojdiżmu*, Tnixxija mhux adattata tal-ormon antidijuretiku
English: Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m2) and prednisone (60 mg/m2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.
Maltese: III li fih il-pazjenti ntgħażlu b'mod każwali (1:1), open-label, (MMY-3002-VISTA) ta' 682 pazjent kien magħmul biex jiġi ddeterminat jekk bortezomib (1.3 mg/m2 injettat ġol-vini) flimkien ma' melphalan (9 mg/m2) u prednisone (60 mg/m2) jirriżultawx f'titjib fiż-żmien ta' progressjoni (TTP) meta mqabbel ma' melphalan (9 mg/m2) u prednisone (60 mg/m2) f'pazjenti b'majeloma multipla li qatt ma kienu ttrattati qabel.
English: Patients with renal impairment should be monitored closely (see sections 4.2 and 5.2).
Maltese: Pazjenti b'indeboliment tal-kliewi għandhom jiġu mmonitorjati mill-qrib (ara sezzjonijiet 4.2 u 5.2).
English: The Cmax after subcutaneous administration (20.4 ng/ml) was lower than intravenous (223 ng/ml).
Maltese: Is-Cmax wara l-għoti ta' taħt il-ġilda (20.4 ng/ml) kien aktar baxx minn ta' ġol-vini (223 ng/ml).