FrancophonIA/ELRC3.0 huggingface dataset:
English: 6 - 12 months (n = 202) Median
Maltese: 6 - 12-il xahar (n = 202)
English: A total of 116 patients were randomised to receive bevacizumab 3 mg/kg every 2 weeks (n = 39), 10 mg/kg every 2 weeks; (n = 37), or placebo (n = 40).
Maltese: Total ta' 116-il pazjent kienu randomised biex jirċievu bevacizumab 3 mg/kg kull ġimagħtejn (n = 39), 10 mg/kg kull ġimagħtejn; (n = 37), jew plaċebo (n = 40).
English: Bevacizumab in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Maltese: Bevacizumab flimkien ma' interferon alfa-2a għall-kura primarja ta' kanċer avanzat u/jew metastatiku taċ-ċelluli renali (BO17705)
English: Intestinal obstruction, Recto-vaginal fistulaec,d, Gastrointestinal disorder, Stomatitis, Proctalgia
Maltese: Ostruzzjoni filmusrana, Fistuli rektovaġinaliċ,d, Disturbi gastrointestinali, Stomatite, Proktalġja
English: The pharmacokinetics of bevacizumab was well characterised by the paediatric population PK model for 70 paediatric patients in study BO20924 (1.4 to 17.6 years; 11.6 to 77.5 kg) and 59 patients in study BO25041 (1 to 17 years; 11.2 to 82.3 kg).
Maltese: Il-farmakokinetika ta' bevacizumab kienet ikkaratterizzata tajjeb permezz tal-mudell tal-PK talpopolazzjoni pedjatrika f'70 pazjent pedjatriku fi studju BO20924 ((1.4 sa 17.6 snin; 11.6 sa 77.5 kg) u 59 pazjent fi studju BO25041 (1 sa 17-il sena; 11.2 sa 82.3 kg).
English: Placebo + C/G (n = 242)
Maltese: Plaċebo + C/G (n = 242)
English: Pulmonary haemorrhage/ Haemoptysisb,d,
Maltese: Emorraġija fil pulmun/ Emoptisib,d,
English: Osteonecrosis of the jaw (ONJ) (see section 4.8)
Maltese: Osteonekrosi tax-xedaq (ONJ - Osteonecrosis of the jaw) (ara sezzjoni 4.8)
English: No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of co-administered interferon alfa 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
Maltese: Ma kienet osservata l-ebda interazzjoni ta' rilevanza klinika ta' bevacizumab fuq il-farmakokinetika ta' interferon alfa 2a, erlotinib (u l-metabolit attiv tiegħu OSI-420), jew il-kimoterapiji irinotecan (u lmetabolit attiv tiegħu SN38), capecitabine, oxaliplatin (kif determinat mill-kejl ta' platinum ħieles u totali), u cisplatin mogħtija fl-istess waqt.
English: Efficacy results for trial BO17705
Maltese: Riżultati tal-effikaċja għall-prova BO17705
English: • AVF0780g: In combination with bolus 5-fluorouracil/folinic acid (5-FU/FA) for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen).
Maltese: • AVF0780g: F'taħlita ma' 5-fluorouracil/folinic acid (5-FU/FA) bħala bolus għal total ta' 6 ġimgħat ta' kull ċiklu ta' 8 ġimgħat (kors Roswell Park).
English: Congestive heart failure (CHF) (see section 4.8)
Maltese: Insuffiċjenza tal-qalb konġestiva (CHF - congestive heart failure) (ara sezzjoni 4.8)
English: • MVASI can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Maltese: • MVASI jista' jżid ir-riskju ta' fsada jew iżid ir-riskju ta' problemi bil-fejqan tal-ferita wara kirurġija.
English: Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg q 3 weeks
Maltese: Carboplatin/ Paclitaxel + Bevacizumab 15 mg/kg q 3 ġimgħat
English: (16.2 vs. 17.5 months; p = 0.3769)
Maltese: (16.2 vs. 17.5 xhur; p = 0.3769)
English: The incidence of adverse events, including grade ≥ 3 adverse events and serious adverse events, was similar between the two treatment arms.
Maltese: L-inċidenza ta' avvenimenti avversi, inklużi avvenimenti avversi u avvenimenti avversi serji ta' grad ≥ 3, kienet simili bejn iż-żewġ gruppi ta' trattament.
English: Difference in response rates 95% CI for difference in response rates4
Maltese: Differenza fir-rati ta' rispons CI ta' 95% għad-differenza fir-rati ta' Rispons4
English: Fluoropyrimidine/irinotecan or Fluoropyrimidine/oxaliplatin based chemotherapy + bevacizumaba
Maltese: Kimoterapija bbażata fuq fluoropyrimidine/irinotecan jew fluoropyrimidine/oxaliplatin + bevacizumaba
English: PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease2,3 CP (n = 368)
Maltese: Riżultati ta' PFS1 skont l-istadju tal-marda u l-istat ta' tneħħija minn studju BO17707 (ICON7) Pazjenti randomised b'marda ta' stadju III bi tneħħija ottimali2,3 CP (n = 368)
English: The overall mean age was 59.4 years; 56.6% of patients had an ECOG performance status of 0, 43% had a value of 1 and 0.4% had a value of 2.
Maltese: L-età medja globali kienet ta' 59.4 snin; 56.6% tal-pazjenti kellhom stat ta' ħila ta' ECOG ta' 0, 43% kellhom valur ta' 1 u 0.4% kellhom valur ta' 2. 15.
English: Overall survival3
Maltese: Sopravivenza globali3
English: An overall survival benefit has been demonstrated in trial E4599 with a 15 mg/kg/q3wk dose of bevacizumab.
Maltese: Intwera benefiċċju globali ta' sopravivenza fil-prova E4599 b'doża ta' 15 mg/kg/q3wk ta' bevacizumab.
English: 7.5 mg/kg IV 30-90 min Day 1, prior to XELOX, q 3 weeks
Maltese: 7.5 mg/kg IV 30-90 min Fl-ewwel ġurnata, qabel XELOX, q 3 ġimgħat
English: (17.5 vs.15.0 months; p = 0.0584)
Maltese: (17.5 vs.15.0 xhur; p = 0.0584)
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 hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2, iżda ma tista' ssir lebda rakkomandazzjoni dwar pożoloġija.
English: Proteinuria ranged in severity from clinically asymptomatic, transient, trace proteinuria to nephrotic syndrome, with the great majority as grade 1 proteinuria (NCI-CTCAE v.3).
Maltese: Proteina fl-awrina, varjat fis-severità minn klinikament bla sintomi, temporanja, traċċa ta' proteina flawrina għal sindrome nefrotika, bil-maġġoranza tkun proteina fl-awrina ta' grad 1 (NCI-CTCAE v.3).
English: Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of patients treated with bevacizumab.
Maltese: Proteina fl-awrina ta' grad 4 (sindrome nefrotiku) kienet osservata f'sa 1.4% tal-pazjenti ttrattati b'bevacizumab.
English: p-value Overall response rate Rate (n) p-value Overall survival* (months) Median HR (95% CI) p-value A total of 154 patients (ECOG Performance Status 0 or 1) were randomised.
Maltese: Rata (n) Valur p Sopravivenza globali* (xhur) Medjan HR (CI ta' 95%) Valur p Total ta' 154 pazjent (Stat ta' Ħila ta' ECOG ta' 0 jew 1) kienu randomised.
English: Best overall response - Primary analysis6
Maltese: L-Aħjar rispons globali - Analiżi primarja6
English: Hypertensiona,b Thromboembolism arteriala,b,
Maltese: Pressjoni għoljaa,b Tromboemboliżmu fl-arterjia,b,
English: Do not use MVASI if:
Maltese: Tużax MVASI:
English: There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving bevacizumab monotherapy compared to patients receiving bevacizumab in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).
Maltese: Ma kien hemm la differenzi statistikament sinifikanti u lanqas ta' rilevanza klinika fit-tneħħija ta' bevacizumab f'pazjenti li kienu qed jirċievu monoterapija ta' bevacizumab meta mqabbel ma' pazjenti li kienu qed jirċievu bevacizumab flimkien ma' interferon alfa-2a, erlotinib jew kimoterapiji (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin jew cisplatin/gemcitabine).
English: Thromboembolis m (arterial)b,d, Haemorrhageb,d, Deep vein thrombosis
Maltese: Tromboemboliżmu (arterjali)b,d, Emorraġijab,d, Trombożi fil-vini tal-fond
English: In a retrospective single institution series, 12 consecutive (2005 to 2008) children with relapsed or progressive high-grade glioma (3 with WHO grade IV, 9 with grade III) were treated with bevacizumab (10 mg/kg) and irinotecan (125 mg/m2) every 2 weeks.
Maltese: F'serje retrospettiva b'istituzzjoni waħda, 12-il tifel u ifla konsekuttivi (2005 sa 2008) bi glijoma ta' grad għoli li rkadat jew progressiva (3 b'WHO grad IV, 9 bi grad III) kienu kkurati b'bevacizumab (10 mg/kg) u irinotecan (125 mg/m2) kull ġimagħtejn.
English: p-value (Chi-squared test)
Maltese: Valur p (Test Chi-squared) Stimi Kaplan-Meier.
English: In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving bevacizumab.
Maltese: Fi provi kliniċi, proteina fl-awrina kienet irrappurtata fil-firxa ta' 0.7% sa 54.7% tal-pazjenti li kienu qed jirċievu bevacizumab.
English: Final analysis
Maltese: Analiżi finali.
English: The median age of patients was 61.0 (range: 25-84) years.
Maltese: L-età medjana tal-pazjenti kienet ta' 61.0 (firxa: 25−84) sena.
English: For further information please refer to table 3 “Adverse reactions reported in post-marketing setting”.
Maltese: Għal aktar informazzjoni jekk jogħġbok irreferi għal tabella 3 “Reazzjonijiet avversi rrappurtati flambjent ta' wara t-tqegħid fis-suq”.
English: Cisplatin/Gemcitabine + bevacizumab 7.5 mg/kg q 3 weeks
Maltese: Cisplatin/Gemcitabine + bevacizumab 7.5 mg/kg q 3 ġimgħat
English: Hypersensitivity, Infusion reactionsa,b,d
Maltese: Sensittività eċċessiva, reazzjonijiet għallinfużjonia,b,d
English: MVASI contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
Maltese: MVASI fih is-sustanza attiva bevacizumab, li hija antikorp monoklonali umanizzat (tip ta' proteina li normalment tiġi magħmula mis-sistema immuni biex tgħin tiddefendi lill-ġisem minn infezzjoni u kanċer).
English: In study BO25041, bevacizumab exposure was similar compared to a typical adult at the same dose.
Maltese: Fi studju BO25041, l-esponiment għal bevacizumab kien simili meta mqabbel ma' adult tipiku bl-istess doża.
English: Gallbladder perforationb,c
Maltese: Perforazzjoni talbużżieqa talmarrarab,c
English: (17.5 vs.14.3 months; p = 0.0609)
Maltese: (17.5 vs.14.3 xhur; p = 0.0609)
English: p = 0.6267)
Maltese: 0 xhur; p = 0.6267)
English: MVASI should be discontinued in patients with life-threatening (grade 4) thromboembolic reactions, including pulmonary embolism (NCI-CTCAE v.3).
Maltese: MVASI għandu jitwaqqaf f'pazjenti b'reazzjonijiet tromboemboliċi ta' periklu għall-ħajja (grad 4), inkluż emboliżmu pulmonari (NCI-CTCAE v.3).
English: In addition, in study AVF3694g the incidences of all grade CHF were similar between the anthracycline + bevacizumab (6.2%) and the anthracycline + placebo arms (6.0%).
Maltese: Barra dan, fi studju AVF3694g l-inċidenzi ta' CHF ta' kull grad kienet simili fil-gruppi ta' anthracycline + bevacizumab (6.2%) u anthracycline + plaċebo (6.0%).
English: Anorexia Hypomagnesae mia
Maltese: Anoressija Ipomanjesimja Iponatrimija
English: Metastatic breast cancer (mBC)
Maltese: Kanċer tas-sider li mmetastatizza (mBC - metastatic breast cancer)
English: In four phase III trials (AVF2119g, E2100, BO17708 and AVF3694g) in patients with metastatic breast cancer CHF grade 3 (NCI-CTCAE v.3) or higher was reported in up to 3.5% of patients treated with bevacizumab in combination with chemotherapy compared with up to 0.9% in the control arms.
Maltese: III (AVF2119g, E2100, BO17708 u AVF3694g) f'pazjenti b'kanċer tas-sider li mmetastatizza, CHF ta' grad 3 (NCI-CTCAE v.3) jew ogħla kienet irrappurtata f'sa 3.5% tal-pazjenti kkurati b'bevacizumab flimkien ma' kimoterapija meta mqabbla ma' mhux aktar minn 0.9% fil-gruppi ta' kontroll.
English: Tumour-associated haemorrhage was also seen rarely in other tumour types and locations, including cases of central nervous system (CNS) bleeding in patients with CNS metastases (see section 4.4).
Maltese: Emorraġija assocjata mat-tumur rarament dehret wkoll f'tipi u postijiet oħra ta' tumur, inkluż każijiet ta' fsada fis-sistema nervuża ċentrali (CNS - central nervous system) f'pazjenti b'metastasi fis-CNS (ara sezzjoni 4.4).
English: • Arterial thromboembolism (see section 4.4).
Maltese: • Tromboemboliżmu arterjali (ara sezzjoni 4.4).
English: Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis.
Maltese: Analiżi primarja twettqet b'data meta waqfet tinġabar id-dejta ta' 12 ta' Diċembru 2012 u hija meqjusa lanaliżi finali.
English: • CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration.
Maltese: • Grupp CP: Carboplatin (AUC 6) u paclitaxel (175 mg/m2) għal 6 ċikli ta' 3 ġimgħat.
English: The trial contained two parts: an initial unblinded 2-arm part (Part I) in which patients were randomised to two different treatment groups (XELOX and FOLFOX-4) and a subsequent 2 x 2 factorial 4-arm part (Part II) in which patients were randomised to four treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + bevacizumab, FOLFOX-4 + bevacizumab).
Maltese: Il-prova kien fiha żewġ partijiet: parti tal-bidu b'żewġ kategoriji unblinded (l-ewwel Parti) fejn il-pazjenti kienu randomised f'żewġ gruppi ta' kura differenti (XELOX u FOLFOX-4) u parti sussegwenti b'4 kategoriji 2 x 2 fattorjali (Parti II) fejn il-pazjenti kienu randomised f'erba' gruppi ta' kura (XELOX + plaċebo, FOLFOX-4 + plaċebo, XELOX + bevacizumab, FOLFOX-4 + bevacizumab).
English: Hypertensive encephalopathya
Maltese: Enċefalopatija ipertensivaa
English: Primary endpoint Median PFS** Hazard ratio (97.5% CI)a
Maltese: Punt finali primarju PFS medjan** Proporzjon ta' periklu (CI ta' 97.5% CI)
English: Gastrointestin al ulcera
Maltese: Ulċera gastrointestinalia
English: Of the 452 patients randomised at baseline, the majority of patients were white (80.0% in the chemo alone group and 75.3% in the chemo + bevacizumab group), had squamous cell carcinoma (67.1% in the chemo alone group and 69.6% in the chemo + bevacizumab group), had persistent/recurrent disease (83.6% in the chemo alone group and 82.8% in the chemo + bevacizumab group), had 1-2 metastatic sites (72.0% in the chemo alone group and 76.2% in the chemo + bevacizumab group), had lymph node involvement (50.2% in the chemo alone group and 56.4% in the chemo + bevacizumab group), and had a platinum free interval ≥ 6 months (72.5% in the chemo alone group and 64.4% in the chemo + bevacizumab group).
Maltese: Mill-452 pazjent randomised fil-linja bażi, il-maġġoranza tal-pazjenti kienu bojod (80.0% fil-grupp ta' kimo waħedha u 75.3% fil-grupp ta' kimo + bevacizumab), kellhom karċinoma taċ-ċellula skwamuża (67.1% fil-grupp ta' kimo waħedha u 69.6% fil-grupp ta' kimo + bevacizumab), kellhom marda persistenti/rikorrenti (83.6% fil-grupp ta' kimo waħedha u 82.8% fil-grupp ta' kimo + bevacizumab), kellhom 1-2 siti metastatiċi (72.0% fil-grupp ta' kimo waħedha u 76.2% fil-grupp ta' kimo + bevacizumab), kellhom involviment tal-glandoli limfatiċi (50.2% fil-grupp ta' kimo waħedha u 56.4% fil-grupp ta' kimo + bevacizumab), u kellhom intervall mingħajr platinu ta' ≥ 6 xhur (72.5% fil-grupp ta' kimo waħedha u 64.4% fil-grupp ta' kimo + bevacizumab).
English: Posterior Reversible Encephalopathy Syndrome (PRES) (rare) (see also section 4.4)
Maltese: Sindrome ta' Enċefalopatija Riversibbli Posterjuri (PRES - Posterior Reversible Encephalopathy Syndrome), (rari) (ara wkoll sezzjoni 4.4)
English: Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI) Topotecan n = 120
Maltese: PFS medjana (xhur) Proporzjon ta' periklu (CI ta' 95%) OS medjana (xhur) Proporzjon ta' periklu (CI ta' 95%) Topotecan n = 120
English: A third group of 110 patients received bolus 5-FU/FA + bevacizumab (Arm 3).
Maltese: It-tielet grupp ta' 110 pazjent irċieva 5-FU/FA + bevacizumab (Kategorija 3) bħala bolus.
English: Three additional studies with bevacizumab have been conducted in mCRC patients: first-line (NO16966), second-line with no previous bevacizumab treatment (E3200), and second-line with previous bevacizumab treatment following disease progression in first-line (ML18147).
Maltese: Saru tliet studji oħra b'bevacizumab f'pazjenti b'mCRC: -kura preferita (NO16966), kura sekondarja bl-ebda kura preċedenti b'bevacizumab (E3200), u kura sekondarja b'kura preċedenti b'bevacizumab wara progressjoni tal-marda b'kura preferita (ML18147).
English: Primary endpoint Overall survival (OS)
Maltese: Sopravivenza globali (OS)
English: Anti-tumour activity was not observed in two earlier studies among a total of 30 children aged > 3 years old with relapsed or progressive high-grade glioma when treated with bevacizumab and irinotecan (CPT 11).
Maltese: Attività kontra t-tumuri ma kienetx osservata f'żewġ studji aktar bikrija fost total ta' 30 tifel u tifla b'età ta' > 3 snin bi glijoma ta' grad għoli li rkadat jew progressiva meta kkurati b'bevacizumab u irinotecan (CPT 11).
English: MVASI will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Maltese: MVASI se jingħata flimkien ma' kura ta' kimoterapija li fiha mediċina fluoropyrimidine.
English: 1,000 mg/m2 oral bid
Maltese: 130 mg/m2 IV 2 h 1,000 mg/m2 orali bid
English: In one clinical trial evaluating bevacizumab in combination with 5-fluorouracil/folinic acid, AVF2192g, patients with metastatic colorectal cancer who were not candidates for treatment with irinotecan were included.
Maltese: Fi prova klinika li evalwat bevacizumab flimkien ma' 5-fluorouracil/folinic acid, AVF2192g, kienu inklużi pazjenti b'kanċer tal-kolorektum li mmetastatizza li ma kienux kandidati għall-kura b'irinotecan.
English: Intestinal obstruction, Recto-vaginal fistulaed,e, Gastrointestinal disorder, Proctalgia
Maltese: Sadd tal-musrana, Fistuli rektovaġinalid,e, Disturb gastrointestinali, Proktalġja
English: The majority of patients included in the study were white (87% in all three arms); the median age was 60 years in CPP and CPB15 arms and 59 years in CPB15+ arm; and 29% of patients in CPP or CPB15 and 26% in CPB15+ were over 65 years of age.
Maltese: Il-maġġoranza tal-pazjenti inklużi fl-istudju kienu bojod (87% fit-tliet gruppi kollha); l-età medjana kienet 60 sena fil-gruppi CPP u CPB15 u 59 sena fil-grupp CPB15+; u 29% tal-pazjenti f'CPP jew CPB15 u 26% f'CPB15+ kellhom età 'l fuq minn 65 sena.
English: Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4.8)
Maltese: Sindrome ta' Enċefalopatija Riversibbli Posterjuri (PRES - Posterior Reversible Encephalopathy Syndrome) (ara sezzjoni 4.8)
English: Observed in paediatric population only.
Maltese: Osservat fil-popolazzjoni pedjatrika biss.
English: Musculoskeleta l and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: Severe reactions are defined as adverse events with at least a 2% difference compared to the control arm in clinical studies for NCI-CTCAE grade 3-5 reactions.
Maltese: Reazzjonijiet severi huma definiti bħala avvenimenti avversi b'differenza ta' mill-inqas 2% meta mqabbel mal-grupp ta' kontroll fl-istudji kliniċi għal reazzjonijiet ta' NCI-CTCAE grad 3-5.
English: Hypersensitivity reactions/infusion reactions (see section 4.8)
Maltese: Reazzjonijiet ta' sensittività eċċessiva/relatati mal-infużjoni (ara sezzjoni 4.8)
English: In a single-arm study (PBTC-022), 18 children with recurrent or progressive non-pontine high-grade glioma (including 8 with glioblastoma [WHO grade IV], 9 with anaplastic astrocytoma [grade III] and 1 with anaplastic oligodendroglioma [grade III]) were treated with bevacizumab (10 mg/kg) two weeks apart and then with bevacizumab in combination with CPT-11 (125-350 mg/m2) once every two weeks until progression.
Maltese: Fi studju ta' grupp wieħed (PBTC-022), 18-il tifel u tifla bi glijoma ta' grad għoli rikorrenti jew progressiva mhux fil-pons (inkluż 8 bi glijoblastoma [WHO grad IV], 9 b'astroċitoma anaplastika [grad III] u wieħed jew waħda b'oligodendroglijoma anaplastika [grad III]) kienu kkurati b'bevacizumab (10 mg/kg) ġimagħtejn minn xulxin u wara b'bevacizumab flimkien ma' CPT-11 (125-350 mg/m2) darba kull ġimagħtejn sal-progressjoni.
English: The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab-treated patients in the FOLFOX treatment subgroup, HR = 0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Maltese: Il-medjan tas-sopravivenza globali kien 20.3 xhur fil-pazjenti kkurati bil-plaċebo u 21.2 xhur filpazjenti kkurati b'bevacizumab fis-sottogrupp ta' kura b'FOLFOX, HR = 0.94, CI ta' 97.5% = [0.75; 1.16]; valur p = 0.4937, ir-riżultati li jikkorrespondu fis-sottogrupp ta' kura b'XELOX, ikunu 19.2 kontra 21.4 xhur, HR = 0.84, CI ta' 97.5% = [0.68; 1.04]; valur p = 0.0698.
English: In two clinical trials of metastatic renal cell carcinoma, microangiopathic haemolytic anaemia (MAHA) was reported in 7 of 19 patients treated with bevacizumab (10 mg/kg every two weeks) and sunitinib malate (50 mg daily) combination.
Maltese: F'żewġ provi kliniċi ta' karċinoma metastatika taċ-ċellula renali, kienet irrappurtata anemija emolitika mikroanġjopatika (MAHA - microangiopathic haemolytic anaemia), f'7 minn 19-il pazjent ikkurati bit-taħlita ta' bevacizumab (10 mg/kg kull ġimagħtejn) u sunitinib malate (50 mg kuljum).
English: In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab-treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026.
Maltese: Fis-sottogrupp ta' kura b'FOLFOX, il-PFS medjana kienet 8.6 xhur fil-pazjenti kkurati bil-plaċebo u 9.4 xhur fil-pazjenti kkurati b'bevacizumab, HR = 0.89, CI ta' 97.5% = [0.73; 1.08]; valur p = 0.1871, ir-riżultati li jikkorrispondu fis-sottogrupp ta' kura b'XELOX ikunu 7.4 kontra 9.3 xhur, HR = 0.77, CI ta' 97.5% = [0.63; 0.94]; valur p = 0.0026.
English: The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p = 0.1789), duration of objective response (6.7 vs. 9.1 months) or time to symptom progression (HR = 1.172; p = 0.5076).
Maltese: p = 0.1789), tul tar-rispons oġġettiv (6.7 vs 9.1 xhur) jew ħin sal-progressjoni tas-sintomi (HR = 1.172; p = 0.5076).
English: Chemotherapy (n = 225)
Maltese: Kimoterapija (n = 225)
English: • Gastrointestinal perforations (see section 4.4).
Maltese: • Perforazzjonijiet gastro-intestinali (ara sezzjoni 4.4).
English: Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 weeks
Maltese: Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 ġimgħat
English: Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine, peripheral sensory neuropathy with paclitaxel or oxaliplatin, nail disorders or alopecia with paclitaxel and paronychia with erlotinib.
Maltese: Eżempji jinkludu is-sindrome ta' eritrodisasteżija palmari-plantari ma' doxorubicin liposomali pegilat jew capecitabine, newropatija periferali tas-sensi ma' paclitaxel jew oxaliplatin, disturbi fid-dwiefer jew alopeċja ma' paclitaxel, u paronikja ma' erlotinib.
English: difference compared to the control arm for NCI-CTCAE grade 3-5 reactions),
Maltese: NCI-CTCAE grad 3-5,
English: In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the bevacizumab-containing arms compared with up to 14% in the control arms.
Maltese: Fi provi kliniċi, bl-eċċezzjoni ta' studju JO25567, l-inċidenza globali ta' pressjoni għolja (kull grad) varjat sa 42.1% fil-gruppi li fihom bevacizumab meta mqabbla ma' sa 14% fil-gruppi ta' kontroll.
English: Uncommon (≥ 0.1% to < 1%) reports of fistulae that involve areas of the body other than the gastrointestinal tract (e.g. bronchopleural and biliary fistulae) were observed across various indications.
Maltese: Rapporti mhux komuni (≥ 0.1% sa < 1%) ta' fistuli li jinvolvu partijiet oħra tal-ġisem minbarra l-apparat gastro-intestinali (eż. fistuli bronkoplewrali u biljari) kienu osservati tul diversi ndikazzjonijiet.
English: MVASI is contraindicated in pregnancy (see section 4.3).
Maltese: MVASI huwa kontraindikat fit-tqala (ara sezzjoni 4.3).