FrancophonIA/ELRC3.0 huggingface dataset:
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 bleeding reactions have been reported in up to 8.3% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 4.6% of patients treated with paclitaxel and topotecan.
Maltese: Minn prova klinika f'pazjenti b'kanċer persistenti, rikorrenti jew metastatiku tal-għonq tal-utru (studju GOG-0240), kienu irrappurtati reazzjonijiet ta' fsada ta' grad 3-5 f'sa 8.3% tal-pazjenti kkurati b'bevacizumab flimkien ma' paclitaxel u topotecan meta mqabbel ma' sa 4.6% tal-pazjenti kkurati b'paclitaxel u topotecan.
English: Reactions consistent with CHF were reported in clinical trials.
Maltese: Kien osservat titjib klinikament u statistikament sinifikanti f'PFS.
English: • CP arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) every 3 weeks for 6 and up to
Maltese: • grupp ta' CP: Carboplatin (AUC5) u paclitaxel (175 mg/m2 IV) kull 3 ġimgħat għal 6 ċikli u sa 8 ċikli.
English: Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells.
Maltese: Bevacizumab jeħel ma' fattur tal-iżvilupp tal-endotelju vaskulari uman (VEGF - vascular endothelial growth factor), il-mutur kruċjali ta' vaskuloġenesi u ta' anġjoġenesi u b'hekk jimpedixxi lil VEGF milli jeħel mar-riċetturi tiegħu, Flt-1 (VEGFR-1) u KDR (VEGFR-2), fuq il-wiċċ taċ-ċelluli talendotelju.
English: This was a randomised, double-blind, phase II clinical trial investigating bevacizumab 10 mg/kg in a 2 weekly schedule with the same dose of bevacizumab in combination with 150 mg daily erlotinib, in patients with metastatic clear cell RCC. A total of 104 patients were randomised to treatment in this trial, 53 to bevacizumab 10 mg/kg every 2 weeks plus placebo and 51 to bevacizumab 10 mg/kg every 2 weeks plus erlotinib 150 mg daily.
Maltese: Total ta' 104 pazjent kienu randomised għall-kura f'din il-prova, 53 għal bevacizumab 10 mg/kg kull ġimagħtejn u plaċebo u 51 għal bevacizumab 10 mg/kg kull ġimagħtejn u erlotinib 150 mg kuljum.
English: • MVASI may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
Maltese: • MVASI jista' jikkawża infezzjonijiet u numru mnaqqas ta' newtrofili (tip ta' ċellula tad-demm importanti għall-protezzjoni tiegħek kontra l-batterja).
English: • hole in the gall bladder (symptoms and signs may include abdominal pain, fever, and nausea/vomiting),
Maltese: • toqba fil-bużżieqa tal-marrara (sintomi u sinjali jistgħu jinkludu uġigħ addominali, deni, u tqalligħ/rimettar),
English: MVASI in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Maltese: MVASI flimkien ma' interferon alfa-2a huwa indikat għall-kura primarja ta' pazjenti adulti b'kanċer taċ-ċelluli renali avanzat u/jew metastatiku.
English: Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI)
Maltese: PFS medjana (xhur) Proporzjon ta' periklu (CI ta' 95%) OS medjana (xhur) Proporzjon ta' periklu (CI ta' 95%)
English: Pre-specified PFS analyses were conducted, all with a cut-off date of 29 September 2009.
Maltese: Saru analiżi speċifikati minn qabel ta' PFS, kollha b'data meta waqfet tinġabar id-dejta ta' 29 ta' Settembru 2009.
English: Progression-free survival1
Maltese: Sopravivenza mingħajr progressjoni1
English: • AVF4095g evaluated the efficacy and safety of bevacizumab in combination with carboplatin and gemcitabine followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Maltese: • AVF4095g evalwa l-effikaċja u s-sigurtà ta' bevacizumab flimkien ma' carboplatin u gemcitabine, segwit minn bevacizumab bħala sustanza waħedha f'pazjenti b'kanċer rikorrenti tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew sensittivi għallplatinu.
English: Progression-free survival Median (months) Hazard ratio (95% confidence interval)
Maltese: Sopravivenza Mingħajr Progressjoni Medjan (xhur) Proporzjon ta' periklu (Intervall ta' kunfidenza ta' 95%)
English: Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by IV infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or PC in combination with bevacizumab at a dose of 15 mg/kg IV infusion day 1 of every 3-week cycle.
Maltese: Il-pazjenti kienu randomised għal kimoterapija bbażata fuq platinum (paclitaxel 200 mg/m2) u carboplatin AUC = 6.0, it-tnejn permezz ta' infużjoni IV (PC) fl-ewwel ġurnata ta' kull ċiklu ta' 3-ġimgħat sa 6 ċikli jew PC flimkien ma' bevacizumab b'doża ta' 15 mg/kg bħala infużjoni IV flewwel ġurnata ta' kull ċiklu ta' 3-ġimgħat.
English: An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Maltese: Analiżi interim uriet li kien hemm titwil sinifikanti tal-ħin sal-progressjoni tal-marda fil-grupp ta' 10 mg/kg kif imqabbel mal-grupp tal-plaċebo (proporzjon ta' periklu, 2.55; p < 0.001).
English: In study BO20924 of bevacizumab with current standard of care in metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma, the safety profile of bevacizumab-treated children was comparable with that observed in adults treated with bevacizumab.
Maltese: Fl-istudju BO20924 ta' bevacizumab flimkien ma' kura standard attwali f'rabdomijosarkoma metastatika u sarkoma tat-tessut l-artab mhux rabdomijosarkoma, il-profil tas-sigurtà ta' tfal ittrattati b'bevacizumab kien komparabbli ma' dak osservat f'adulti ttrattati b'bevacizumab.
English: Gastrointestinal perforations have been reported in clinical trials with an incidence of less than 1% in patients with non-squamous non-small cell lung cancer, up to 1.3% in patients with metastatic breast cancer, up to 2.0% in patients with metastatic renal cell cancer or in patients with ovarian cancer, and up to 2.7% (including gastrointestinal fistula and abscess) in patients with metastatic colorectal cancer.
Maltese: Fi provi kliniċi, perforazzjonijiet gastro-intestinali kienu irrappurtati b'inċidenza ta' anqas minn 1% f'pazjenti b'kanċer taċ-ċelluli mhux żgħar, mhux skwamuż tal-pulmun, sa 1.3% f'pazjenti b'kanċer tas-sider li mmetastatizza, sa 2.0% f'pazjenti b'kanċer metastatiku taċ-ċellula renali jew f'pazjenti b'kanċer tal-ovarji, u sa 2.7% (inkluż fistula u axxess gastro-intestinali) f'pazjenti b'kanċer talkolorektum li mmetastatizza.
English: Detailed information about these post-marketing reactions are provided in table 3.
Maltese: Informazzjoni dettaljata dwar dawn ir-reazzjonijiet ta' wara t-tqegħid fis-suq huma pprovduti f'tabella 3.
English: In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of postoperative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting bevacizumab.
Maltese: Fi provi klinċi dwar karċinoma metastatika tal-kolon jew rektum, ma kienux osservati l-ebda żieda firriskju ta' fsada wara l-operazzjoni jew komplikazzjonijiet fil-fejqan ta' feriti f'pazjenti li kellhom operazzjoni maġġuri 28-60 ġurnata qabel ma' nbeda bevacizumab.
English: The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, longer progression-free survival, and a trend in longer survival, compared with 5-FU/FA chemotherapy alone (see table 5).
Maltese: Iż-żieda ta' bevacizumab 5 mg/kg kull ġimagħtejn ma' 5-FU/FA wassal għal rata oġġettiva ta' rispons għola, sopravivenza bla progressjoni itwal, u tendenza ta' sopravivenza itwal, meta mqabbla ma' kimoterapija b'5-FU/FA waħedha (ara tabella 5).
English: The efficacy and safety of bevacizumab in combination with chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in the treatment for patients with persistent, recurrent or metastatic carcinoma of the cervix was evaluated in study GOG-0240, a randomised, four-arm, open label, multicentre phase III trial.
Maltese: L-effikaċja u s-sigurtà ta' bevacizumab flimkien ma' kimoterapija (paclitaxel u cisplatin jew paclitaxel u topotecan) fil-kura ta' pazjenti b'karċinoma persistenti, rikorrenti jew metastatika tal-għonq tal-utru kienu evalwati fi studju GOG-0240, prova randomised, b'erba' gruppi, open label, b'aktar minn ċentru wieħed ta' fażi
English: Patients included in analysis
Maltese: Investigazzjonijiet Tnaqqis fil-piż
English: The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/kg.
Maltese: Il-farmakokinetika ta' bevacizumab kienet lineari f'dożi li varjaw minn 1 sa' 10 mg/kg.
English: • CPB7.5+ arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks plus bevacizumab (7.5 mg/kg q3w) for up to 12 months (bevacizumab was started at cycle 2 of chemotherapy if treatment was initiated within 4 weeks of surgery or at cycle 1 if treatment was initiated more than 4 weeks after surgery).
Maltese: Carboplatin (AUC 6) u paclitaxel (175 mg/m2) għal 6 ċikli ta' 3 ġimgħat flimkien ma' bevacizumab (7.5 mg/kg q3w) għal mhux aktar minn 12-il xahar (bevacizumab inbeda f'ċiklu 2 tal-kimoterapija jekk il-kura inbdiet fi żmien 4 ġimgħat mill-kirurġija jew flewwel ċiklu jekk il-kura inbdiet aktar minn 4 ġimgħat wara l-kirurġija).
English: No incompatibilities between MVASI and polyvinyl chloride or polyolefin bags or infusion sets have been observed.
Maltese: Ma ġewx osservati l-ebda inkompatibilitajiet bejn MVASI u polyvinyl chloride jew boroż talpolyolefin jew settijiet tal-infużjoni.
English: These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.
Maltese: Dawn jinkludu tnaqqis fin-numru ta' ċelluli bojod tad-demm, speċjalment newtrofili (tip wieħed ta' ċelluli bojod tad-demm li jgħinu biex jipproteġu kontra nfezzjonijiet); preżenza ta' proteina fl-awrina; tnaqqis tal-pottassju, sodju jew fosforu (minerali) fid-demm; żieda tal-livel taz-zokkor fid-demm; żieda ta' alkaline phosphatase (enzima) fid-demm; żieda tal-krejatinina fis-serum (proteina imkejla permezz ta' test tad-demm jiġi determinat kemm qed jaħdmu tajjeb il-kliewi tiegħek); tnaqqis tal-emoglobina (jinstab fiċ-ċelluli l-ħomor tad-demm, li jġorru l-ossiġnu), li jista' jkun sever.
English: Each mL of concentrate contains 25 mg of bevacizumab, corresponding to 1.4 to 16.5 mg/mL when diluted as recommended.
Maltese: Kull mL ta' konċentrat fih 25 mg ta' bevacizumab, li jikkorrispondu għal 1.4 sa 16.5 mg/mL meta dilwit kif rakkomandat.
English: Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with bevacizumab (analyses shown in table 7), consistent with the statistically significant benefit observed in the pooled analysis.
Maltese: Analiżi sekondarja tal-PFS, ibbażata fuq valutazzjonijiet tar-rispons ta' ‘wara l-kura', ikkonfermat ilbenefiċċju kliniku ta' superjorità sinifikanti għall-pazjenti kkurati b'bevacizumab (analiżi mniżżla f'Tabella 7), konsistenti mal-benefiċċju statistikament sinifikanti osservat fl-analiżi miġbura.
English: In most clinical trials urine protein levels of ≥ 2g/24 hrs led to stopping treatment with bevacizumab until recovery to < 2g/24 hrs.
Maltese: Fil-biċċa l-kbira talprovi kliniċi livelli ta' proteina fl-awrina ta' ≥ 2 g/24 siegħa wasslu għal twaqqif tat-trattament b'bevacizumab sakemm irpiljaw għal < 2 g/24 siegħa.
English: Hazard ratio (95% CI) > 12 months (n = 282) Median
Maltese: > 12-il xahar (n = 282) Medjan
English: Trial E2100 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating bevacizumab in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease.
Maltese: Prova E2100 kienet prova klinika open-label, randomised, ikkontrollata b'mod attiv u multicentre li evalwat bevacizumab flimkien ma' paclitaxel għal kanċer tas-sider rikorrenti lokalment jew li mmetastatizza f'pazjenti li ma kienux irċievew kimoterapija minn qabel għall-mard metastatiku jew rikorrenti lokalment.
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only.
Maltese: Analiżi ta' segwitu twettqet b'data meta waqfet tinġabar id-dejta ta' 07 ta' Marzu 2014; il-valuri p kollha huma murija għal skop deskrittiv biss.
English: MVASI will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Maltese: MVASI se jingħata flimkien ma' paclitaxel u cisplatin jew, b'mod alternattiv, paclitaxel u topotecan lil pazjenti li ma jistgħux jirċievu terapija bi platinu.
English: Overall survival - Follow-up analysis7 Median (months)1
Maltese: Sopravivenza globali - Analiżi ta' segwitu7 Medjan (xhur)1
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014. p-value displayed for descriptive purpose only.
Maltese: Analiżi ta' segwitu twettqet b'data meta waqfet tinġabar id-dejta ta' 07 ta' Marzu 2014.
English: Gallbladder perforationa,b
Maltese: Perforazzjoni talbużżieqa talmarraraa,b
English: The primary endpoint was PFS based on investigator's assessment of disease progression based on radiological scans or CA-125 levels, or symptomatic deterioration per protocol.
Maltese: Il-punt finali primarju kien PFS ibbażata fuq valutazzjoni tal-investigatur tal-progressjoni tal-marda bbażata fuq skans radjuloġiċi jew livelli ta' CA 125, jew deterjorazzjoni sintomatika għal kull protokoll.
English: Median OS (months) Hazard ratio (95% CI) p-value
Maltese: Medjan (xhur) Proporzjon ta' periklu (CI ta' 95%) valur p
English: Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CP (n = 154)
Maltese: PFS Medjana (xhur) Proporzjon ta' periklu (CI ta' Pazjenti randomised b'marda ta' stadju III bi tneħħija mhux ottimali3 CP (n = 154)
English: Febrile neutropenia, Leucopenia, Neutropeniab Thrombocytope nia
Maltese: Lewkopenija, Newtropenijab, Tromboċitopenija
English: Adverse reactions reported in post-marketing setting
Maltese: KONDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: The incidence of each histologic sub-type of EOC was similar between the treatment arms; 69% of patients in each treatment arm had serous adenocarcinoma histologic type.
Maltese: L-inċidenza ta' kull sotto tip istoloġiku ta' EOC kienet simili bejn il-gruppi ta' kura; 69% tal-pazjenti f'kull grupp ta' kura kellhom tip istoloġiku ta' adenokarċinoma seruża.
English: There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurologic disorder, which can present with the following signs and symptoms among others: seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Maltese: Kien hemm rapporti rari ta' pazjenti kkurati b'bevacizumab li żviluppaw sinjali u sintomi li huma konsistenti ma' PRES, marda newroloġika rari, li tista' tippreżenta ruħa bis-sinjali u s-sintomi li ġejjin, fost oħrajn: eċċessjonijiet, uġigħ ta' ras, stat mentali alterat, problemi tal-vista, jew telf tal-vista kortikali, bi jew bla pressjoni għolja assoċjata.
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.8) Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with bevacizumab.
Maltese: Għalhekk, ir-riskju ta' emorraġija fisCNS f'pazjenti bħal dawn ma ġietx ivvalutata b'mod prospettiv fi provi kliniċi randomised (ara sezzjoni 4.8).
English: Exploratory analysis; OS updated analysis at clinical cut-off on 28 October 2015, approx. 45% patient had died and OS is therefore considered immature.
Maltese: * Analiżi esploratorja; analiżi aġġornata għal OS fil-cut-off kliniku fit-28 ta' Ottubru 2015, madwar 45% tal-pazjenti kienu mietu u għalhekk OS hija kkunsidrata bħala immatura.
English: Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Maltese: Mikroanġjopatija trombotika renali, li klinikament tista' tidher bħala proteina fl-awrina (mhux magħruf) b'użu fl-istess waqt ta' sunitinib jew mingħajru.
English: Median PFS (months) Hazard ratio (95% CI)
Maltese: PFS medjana (xhur) Proporzjon ta' periklu (CI ta' 95%)
English: The main secondary efficacy endpoint was progression-free survival (PFS).
Maltese: Il-punt finali ewlieni sekondarju tal-effikaċja kien is-sopravivenza mingħajr progressjoni (PFS - progression-free survival).
English: Lethargy
Maltese: Treddigħ
English: Some of these reactions have resulted in various degrees of visual loss, including permanent blindness.
Maltese: Uħud minn dawn ir-reazzjonijiet wasslu għal gradi varji ta' telf tal-vista, inkluż telf permanenti tal-vista.
English: Assessment of bevacizumab metabolism in rabbits following a single IV dose of 125I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Maltese: IV ta' 125I-bevacizumab indikat li l-profil metaboliku tiegħu kien simili għal dak mistenni minn molekola IgG nattiva li ma teħilx ma' VEGF.
English: For further information on proteinuria see section 4.4 and Proteinuria in section 4.8
Maltese: Għall-aktar tagħrif dwar proteina fl-awrina ara sezzjoni 4.4 u Proteina fl-awrina f'sezzjoni 4.8.
English: • CPB15 arm: Five cycles of bevacizumab (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Maltese: Ħames ċikli ta' bevacizumab (15 mg/kg q3w inbeda f'ċiklu 2) flimkien ma' carboplatin (AUC 6) u paclitaxel (175 mg/m2) għal 6 ċikli segwit minn plaċebo waħdu, għal total sa 15-il xahar ta' terapija
English: Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: Aneurysms and artery dissections
Maltese: Tromboemboliżmu arterjali:
English: Pulmonary hypertensiona, Nasal septum perforationa
Maltese: Tqalligħ, Rimettar, Uġigħ addominali
English: Aneurysms and artery dissections (see section 4.8)
Maltese: Anewriżmi u dissezzjonijiet tal-arterji (ara sezzjoni 4.8)
English: The overall rates of discontinuation due to adverse events were 8.8% in the CT arm and 43.6% in the CT + BV arm (mostly due to grade 2-3 adverse events) and the median time to discontinuation in the CT + BV arm was 5.2 months compared with 2.4 months in the CT arm.
Maltese: Ir-rati globali ta' waqfien minħabba avvenimenti avversi kienu ta' 8.8% fil-grupp ta' CT u 43.6% fil-grupp ta' CT + BV (il-biċċa l-kbira minħabba avvenimenti avversi ta' grad 2-3) u ż-żmien medjan sal-waqfien fil-grupp ta' CT + BV kien ta' 5.2 xhur meta mqabbel ma' 2.4 xhur fil-grupp ta' CT.
English: There is evidence suggesting that all grade (US National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Maltese: Hemm evidenza li tissuġġerixxi li proteina fl-awrina ta' kull grad (US National Cancer Institute-Common Terminology Criteria għall-Avvenimenti Avversi
English: 5-fluorouracil IV bolus/infusion, each on days 1 and 2
Maltese: Bolus/infużjoni ta' 5fluorouracil IV, kull wieħed flewwel u fit-tieni ġurnata
English: Both the 5 mg/kg/week and 2.5 mg/kg/week equivalent doses of bevacizumab provided a statistically significant benefit with regards to OS (HR 0.751 in study E3200; HR 0.81 in study ML18147) and PFS (HR 0.518 in study E3200; HR 0.68 in study ML18147).
Maltese: HR ta' 0.81 fl-istudju ML18147) u PFS (HR ta' 0.518 fl-istudju E3200;
English: Hypertensionb,d, Thromboemboli sm (venous)b,d
Maltese: Disturbi vaskulari Pressjoni għoljab,d, Tromboemboliżmu (fil-vini)b,d
English: Analyses of the clinical safety data suggest that the occurrence of hypertension and proteinuria with bevacizumab therapy are likely to be dose-dependent.
Maltese: Analiżi ta' tagħrif kliniku ta' sigurtà jissuġġerixxi li l-okkorrenza ta' pressjoni għolja u proteina fl-awrina waqt terapija b'bevacizumab huma wisq probabbli dipendenti fuq id-doża.
English: • Each 16 mL vial contains 400 mg of bevacizumab, corresponding to 16.5 mg/mL when diluted as recommended.
Maltese: - Kull kunjett ta' 16 mL fih 400 mg ta' bevacizumab, li jikkorrispondu għal 16.5 mg/mL meta dilwit kif rakkomandat.
English: A total of 1,528 patients were randomised in equal proportions to the following two arms:
Maltese: Total ta' 1,528 pazjent kienu randomised fi proporzjonijiet ugwali għaż-żewġ gruppi li ġejjin:
English: Foetal abnormalitiesa
Maltese: Kunjett wieħed
English: Study MO22224 evaluated the efficacy and safety of bevacizumab in combination with chemotherapy for platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Maltese: Studju MO22224 evalwa l-effikaċja u s-sigurtà ta' bevacizumab flimkien ma' kimoterapija għallkanċer rikorrenti tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew reżistenti għall-platinu.
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Maltese: Reazzjonijiet ta' sensittività eċċessiva/relatati mal-infużjoni (ara sezzjoni 4.4 u Esperjenza wara ttqegħid fis-suq taħt)
English: Infusion reactionsa,b,c
Maltese: Insuffiċjenza konġestiva talqalba,b,
English: • sickness,
Maltese: Letarġija,
English: This was a phase II randomised, double-blind, active-controlled clinical trial evaluating the efficacy and safety of bevacizumab in combination with 5-FU/FA as first-line treatment for metastatic colorectal cancer in patients who were not optimal candidates for first-line irinotecan treatment.
Maltese: II randomised, double-blind u active-controlled li stmat l-effikaċja u s-sigurtà ta' bevacizumab f'taħlita ma' kimoterapija b'5-FU/FA għall-kura primarja ta' kanċer metastatiku tal-kolon jew rektum f'pazjenti li ma kienux kandidati ideali għall-kura primarja b'irinotecan.
English: Haemorrhage (see section 4.4)
Maltese: Fistuli mhux GI (ara sezzjoni 4.4)
English: Overall survival Median (months) Hazard ratio 95% CI
Maltese: Numru ta' pazjenti Sopravivenza globali Medjan (xhur) CI ta' 95%
English: The addition of bevacizumab to IFN alfa-2a significantly increased PFS and objective tumour response rate.
Maltese: IFN alfa-2a waħdu bħala kura primarja f'mRCC.
English: Eligible patients had epithelial ovarian, fallopian tube or primary peritoneal cancer that progressed within < 6 months of previous platinum therapy consisting of a minimum of 4 platinum therapy cycles.
Maltese: Pazjenti eliġibbli kellhom kanċer tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju talperitonew li kellu progressjoni fi żmien < 6 xhur wara terapija preċedenti ta' platinu li kienet tikkonsisti minn minimu ta' 4 ċikli ta' terapija bi platinu.