FrancophonIA/ELRC3.0 huggingface dataset:
English: • Carboplatin (AUC 4, day 1) and gemcitabine (1,000 mg/m2 on days 1 and 8) and concurrent placebo every 3 weeks for 6 and up to 10 cycles followed by placebo (every 3 weeks) alone until disease progression or unacceptable toxicity.
Maltese: • Carboplatin (AUC 4, ġurnata 1) u gemcitabine (1,000 mg/m2 f'ġurnata 1 u 8) u plaċebo fl-istess waqt kull 3 ġimgħat għal 6 ċikli u sa 10 ċikli segwit minn plaċebo (kull 3 ġimgħat) waħdu salprogressjoni tal-marda jew tossiċità mhux aċċettabli.
English: MVASI is a concentrate for solution for infusion.
Maltese: MVASI huwa konċentrat għal soluzzjoni għall-infużjoni.
English: Renal thrombotic microangiopat hyb,c,
Maltese: Mikroanġjopatija trombotika filkliewib,ċ,
English: Other medicines and MVASI
Maltese: Mediċini oħra u MVASI
English: Thromboembolism (see section 4.4)
Maltese: Tromboemboliżmu (ara sezzjoni 4.4)
English: In study BO20924, bevacizumab exposure was generally lower compared to a typical adult patient at the same dose.
Maltese: Fi studju BO20924, l-esponiment għal bevacizumab ġeneralment kien inqas meta mqabbel ma' pazjent adult tipiku bl-istess doża.
English: • Paclitaxel 80 mg/m2 as a 1-hour IV infusion on days 1, 8, 15, and 22 every 4 weeks
Maltese: Paclitaxel 80 mg/m2 bħala infużjoni IV ta' siegħa fi ġranet 1, 8, 15, u 22 kull 4 ġimgħat.
English: The difference in ORR per independent central review was 18% (CI: 0.6%, 35.3%) between the two treatment arms in the few patients who had evaluable tumour at baseline and had a confirmed response prior to receiving any local therapy: 27/75 patients (36.0%, 95% CI: 25.2%, 47.9%) in the chemo arm and 34/63 patients (54.0%, 95% CI: 40.9%, 66.6%) in the BV + chemo arm.
Maltese: Id-differenza f'ORR għal kull analiżi ċentrali indipendenti kienet ta' 18% (CI: 0.6%, 35.3%) bejn iż-żewġ gruppi ta' trattament fil-ftit pazjenti li kellhom tumur li seta' jiġi evalwat fil-linja bażi u li kellhom rispons ikkonfermat qabel ma rċevew xi terapija lokali: 27/75 pazjent (36.0%, CI ta' 95%: 25.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 infections have been reported in up to 24% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 13% 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), infezzjonijiet ta' grad 3-5 kienu rrappurtati f'sa 24% tal-pazjenti kkurati b'bevacizumab flimkien ma' paclitaxel u topotecan meta mqabbel ma' sa 13% tal-pazjenti kkurati b'paclitaxel u topotecan.
English: • AVF2107g: A weekly schedule of irinotecan/bolus 5-fluorouracil/folinic acid (IFL) for a total of 4 weeks of each 6 week-cycle (Saltz regimen).
Maltese: Skeda ta' kull ġimgħa ta' irinotecan/bolus 5-fluorouracil/folinic acid (IFL) għal total ta' 4 ġimgħat ta' kull ċiklu ta' 6 ġimgħat (kors Saltz).
English: Grade 3 hypertension was 60.0% in patients treated with bevacizumab in combination with erlotinib compared to 11.7% in patients treated with erlotinib alone.
Maltese: Pressjoni għolja ta' grad 3 seħħet f'60.0% tal-pazjenti ttrattati b'bevacizumab flimkien ma' erlotinib meta mqabbel ma' 11.7% f'pazjenti ttrattati b'erlotinib waħdu.
English: Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Maltese: Effetti sekondarji severi ta' frekwenza mhux magħrufa (frekwenza ma tistax tiġi stmata mid-dejta disponibbli) jinkludu:
English: • The active substance is bevacizumab.
Maltese: - Is-sustanza attiva hi bevacizumab.
English: Eight hundred and thirteen patients were randomised to receive IFL + placebo (Arm 1) or IFL + bevacizumab (5 mg/kg every 2 weeks, Arm 2).
Maltese: Tmien mija u tlettax-il pazjent kienu randomised biex jirċievu IFL + plaċebo (Kategorija 1) jew IFL + bevacizumab (5 mg/kg kull ġimagħtejn, Kategorija 2).
English: In a study of platinum-resistant recurrent ovarian cancer patients, alopecia, mucosal inflammation, peripheral sensory neuropathy, proteinuria and hypertension were also reported and occurred at a rate at least 5% higher in the CT + BV arm for bevacizumab-treated patients ≥ 65 years of age compared with bevacizumab-treated patients aged < 65 years.
Maltese: Fi studju ta' pazjenti b'kanċer rikorrenti tal-ovarji reżistenti għall-platinu, kienu rrappurtati wkoll alopeċja, infjammazzjoni tal-mukuża, newropatija periferali tas-sensi, proteina fl-awrina u pressjoni għolja u seħħew b'rata mill-inqas 5% ogħla fil-grupp ta' CT + BV għal pazjenti kkurati b'bevacizumab b'età ta' ≥ 65 sena meta mqabbel ma' pazjenti kkurati b'bevacizumab b'età ta' < 65 snin.
English: A third group of 33 patients received bolus 5-FU/FA + bevacizumab (10 mg/kg every 2 weeks).
Maltese: It-tielet grupp ta' 33 pazjent irċevew 5-FU/FA + bevacizumab (10 mg/kg kull ġimagħtejn) bħala bolus.
English: Hazard ratio [95% CI]
Maltese: Proporzjon ta' periklu [CI ta' 95%]
English: Major or massive pulmonary haemorrhage/haemoptysis has been observed primarily in trials in patients with non-small cell lung cancer (NSCLC).
Maltese: Emorraġija fil-pulmun/emoptisi maġġuri jew massiva kienet osservata primarjament fi provi b'pazjenti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun (NSCLC - non-small cell lung cancer).
English: Rate
Maltese: Skeda
English: • PLD 40 mg/m2 as a 1 mg/min IV infusion on day 1 only every 4 weeks.
Maltese: PLD 40 mg/m2 bħala infużjoni IV ta' 1 mg/min f'ġurnata 1 biss kull 4 ġimgħat.
English: Efficacy results from study GOG-0240 by bevacizumab treatment
Maltese: Riżultati tal-effikaċja minn studju GOG-0240 skont il-kura b'bevacizumab
English: BO17707 was a phase III, two-arm, multicentre, randomised, controlled, open-label study comparing the effect of adding bevacizumab to carboplatin plus paclitaxel in patients with FIGO stage I or IIA (grade 3 or clear cell histology only; n = 142), or FIGO stage IIB-IV (all grades and all histological types, n = 1,386) epithelial ovarian, fallopian tube or primary peritoneal cancer following surgery (NCI-CTCAE v.3).
Maltese: III, b'żewġ gruppi, multiċentriku, randomised, ikkontrollat, open-label li qabbel l-effett taż-żieda ta' bevacizumab ma' carboplatin flimkien ma' paclitaxel f'pazjenti b'kanċer avanzat tal-epetilju tal-ovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew b'FIGO stadju I jew IIA (grad 3 jew istoloġija ta' ċelluli ċari biss; n = 142), jew FIGO stadju IIB - IV (kull grad u kull tip ta' istoloġija, n = 1,386) wara kirurġija (NCI-CTCAE v.3).
English: The GOG-0218 study was a phase III multicentre, randomised, double-blind, placebo-controlled, three arm study evaluating the effect of adding bevacizumab to an approved chemotherapy regimen (carboplatin and paclitaxel) in patients with advanced (stages IIIB, IIIC and IV according to FIGO staging version dated 1988) epithelial ovarian, fallopian tube or primary peritoneal cancer.
Maltese: III, multiċentriku, randomised, double-blind, ikkontrollat bilplaċebo u bi tliet gruppi li evalwa l-effett taż-żieda ta' bevacizumab ma' kors ta' kimoterapija pprovat (carboplatin u paclitaxel) f'pazjenti b'kanċer avanzat (stadji IIIB, IIIC u IV skont il-verżjoni tal-istadji ta' FIGO datata 1988) tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew.
English: Median PFS (months) Hazard ratio (95% CI)4
Maltese: PFS Medjana (xhur) Proporzjon ta' periklu (CI ta' 95%)4
English: One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression.
Maltese: Mija u ħames pażjent kienu randomised għall-kategorija 5-FU/FA + plaċebo u 104 pazjent għall-kategorija 5-FU/FA + bevacizumab (5 mg/kg kull ġimagħtejn).
English: Median PFS (months)
Maltese: PFS Medjana (xhur)
English: MVASI, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
Maltese: MVASI, flimkien ma' paclitaxel u cisplatin jew, b'mod alternattiv, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu terapija bi platinu, huwa indikat għat-trattament ta' pazjenti adulti b'karċinoma persistenti, rikorrenti, jew metastatika tal-għonq tal-utru (ara Sezzjoni 5.1).
English: MVASI is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Maltese: MVASI jingħata flimkien ma' wieħed mill-korsijiet ta' kimoterapija li ġejjin: paclitaxel u cisplatin jew paclitaxel u topotecan.
English: These reactions included infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitritis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular haemorrhage such as vitreous haemorrhage or retinal haemorrhage and conjunctival haemorrhage.
Maltese: Dawn ir-reazzjonijiet kienu jinkludu endoftalmite infettiva, infjammazzjoni fl-għajn bħal endoftalmite sterili, uveite, u vitrite, distakk tar-retina, tiċrita tal-epitelju tal-kulur tarretina, żieda tal-pressjoni fl-għajn, emorraġija fl-għajn bħal emorraġija fil-vitriju jew emorraġija fir-retina u emorraġija fil-konġuntiva.
English: Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
Maltese: Bevacizumab kien assoċjat ma' każijiet serji ta' perforazzjoni gastro-intestinali.
English: • high blood pressure.
Maltese: • għeja, • pressjoni għolja.
English: Efficacy results from study AVF4095g
Maltese: Riżultati tal-effikaċja mill-istudju AVF4095g
English: • The analysis of PFS as determined by the independent review committee (censoring for NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.50-0.77, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 13.1 in the CPP arm and 19.1 months in the CPB15+ arm.
Maltese: • L-analiżi ta' PFS kif determinata mill-kumitat ta' evalwazzjoni indipendenti (ċensura għal NPT) uriet proporzjon ta' periklu stratifikat ta' 0.62 (CI ta' 95%: 0.50-0.77, valur p log-rank ta' naħa waħda < 0.0001) meta CPB15+ huwa mqabbel ma' CPP, b'PFS medjana ta' 13.1 fil-grupp CPP u ta' 19.1 xahar fil-grupp CPB15+.
English: Most patients in both the CP arm (80.4%) and the CPB arm (78.9%) were white.
Maltese: 4%) kif ukoll fil-grupp ta' CPB (78.9%) kienu bojod.
English: Median OS (months) HR (95% CI) p-value
Maltese: HR (CI ta' 95%) Valur p
English: Exploratory PFS and OS analyses by chemotherapy cohort
Maltese: Analiżi esploratorja ta' PFS u OS skont il-koorti ta' kimoterapija
English: There was a small difference, of borderline significance, between the time to progression of disease in the 3 mg/kg group and that in the placebo group (hazard ratio, 1.26; p = 0.053).
Maltese: Kien hemm differenza żgħira, kemm kemm sinifikanti, bejn il-ħin sal-progressjoni tal-marda fil-grupp ta' 3 mg/kg u dak fil-grupp talplaċebo (proporzjon ta' periklu, 1.26; p = 0.053).
English: In addition, a pre-specified analysis of the data censoring for CA-125 progression events was conducted, as well as an independent review of PFS as determined by radiological scans.
Maltese: progressjoni ta' CA-125, kif ukoll valutazzjoni indipendenti ta' PFS kif determinat minn skans radjuloġiċi.
English: Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 mL of red blood) should not be treated with bevacizumab.
Maltese: Pazjenti b'emorraġija fil-pulmun/emoptisi reċenti (> 2.5 mL ta' demm aħmar) m'għandhomx jiġu kkurati b'bevacizumab.
English: Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and cisplatin 50 mg/m2 IV on day 2 (q3w); or Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and cisplatin 50 mg/m2 IV on day 1 (q3w)
Maltese: • Paclitaxel 135 mg/m2 IV fuq medda ta' 24 siegħa f'jum 1 u cisplatin 50 mg/m2 IV f'jum 2, kull 3 ġimgħat (q3w); jew Paclitaxel 175 mg/m2 IV fuq medda ta' 3 sigħat f'jum 1 u cisplatin 50 mg/m2 IV f'jum 2 (q3w); jew Paclitaxel 175 mg/m2 IV fuq medda ta' 3 sigħat f'jum 1 u cisplatin 50 mg/m2 IV f'jum 1 (q3w)
English: MVASI in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents (see section 5.1).
Maltese: MVASI flimkien ma' paclitaxel, topotecan, jew doxorubicin liposomali pegilat huwa indikat għallkura ta' pazjenti adulti b'kanċer rikorrenti tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew reżistenti għall-platinu li rċevew mhux aktar minn żewġ korsijiet ta' kimoterapija qabel u li ma rċevewx terapija b'bevacizumab jew b'inibituri ta' VEGF oħra jew sustanzi li jimmiraw riċettur ta' VEGF qabel (ara Sezzjoni 5.1).
English: Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of bevacizumabtreated patients.
Maltese: Tul il-provi kliniċi kollha, emorraġija mukokutanja dehret f'mhux aktar minn 50% tal-pazjenti kkurati b'bevacizumab.
English: Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients treated with bevacizumab across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Maltese: Żieda fir-reazzjonijiet tromboemboliċi arterjali kienet osservata f'pazjenti kkurati b'bevacizumab fil-firxa tal-indikazzjonijiet kollha, inkluż aċċidenti cerebrovaskulari, infart mijokardijaku, attakki iskemiċi li jgħaddu u reazzjonijiet tromboemboliċi arterjali oħrajn.
English: • you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Maltese: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għall-prodotti derivati minn ċelluli talovarju ta' ħamster ċiniż (CHO - Chinese hamster ovary) jew għal xi antikorpi rikombinati umani jew umanizzati oħra.
English: Paclitaxel/ bevacizumab (n = 229)
Maltese: Paclitaxel/bevac izumab (n = 229)
English: This was a phase III randomised, controlled, open-label trial investigating bevacizumab 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy versus fluoropyrimidine-based chemotherapy alone in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen.
Maltese: III randomised, ikkontrollata u open-label li nvestigat bevacizumab 5.0 mg/kg kull ġimagħtejn jew 7.5 mg/kg kull 3 ġimgħat flimkien ma' kimoterapija bbażata fuq fluoropyrimidine kontra kimoterapija bbażata fuq fluoropyrimidine waħedha f'pazjenti b'mCRC li kellhom progressjoni fuq kors ta' kura preferita li kien fih bevacizumab.
English: During the trial, of the patients who received trial treatment, 32.2% (136/422) of patients received 7-12 administrations of bevacizumab and 21.1% (89/422) of patients received 13 or more administrations of bevacizumab.
Maltese: Waqt il-prova, mill-pazjenti li rċevew il-kura ta' prova, 32.2% (136/422) tal-pazjenti rċevew 7-12-il għotja ta' bevacizumab u 21.1% (89/422) tal-pazjenti rċevew 13 jew aktar għotjiet ta' bevacizumab.
English: This leaflet was last revised in
Maltese: Numru ta' pazjenti Sopravivenza globali
English: The primary endpoint was overall survival, with secondary endpoints for the trial including progression-free survival.
Maltese: Il-punt finali primarju kien sopravivenza globali, b'punti finali sekondarji għall-prova inkluż sopravivenza mingħajr progressjoni.
English: The majority of patients included in the study were white (96%), the median age was 57 years in both treatment arms, 25% of patients in each treatment arm were 65 years of age or over, and approximately 50% of patients had an ECOG PS of 1; 7% of patients in each treatment arm had an ECOG PS of 2.
Maltese: Il-maġġoranza tal-pazjenti inklużi fl-istudju kienu bojod (96%), l-età medjana kienet ta' 57 sena fiżżewġ gruppi ta' kura, 25% tal-pazjenti f'kull grupp ta' kura kellhom età ta' 65 sena jew aktar, u madwar 50% tal-pazjenti kellhom ECOG PS ta' 1; 7% tal-pazjenti f'kull grupp ta' kura kellhom ECOG PS ta' 2.
English: In the majority of the occasions the necessary amount of MVASI can be diluted with 0.9% sodium chloride solution for injection to a total volume of 100 mL.
Maltese: Fil-maġġoranza talokkażjonijiet l-ammont neċessarju ta' MVASI jista' jiġi dilwit ma' soluzzjoni għall-injezzjoni ta' 0.9% sodium chloride sa volum totali ta' 100 mL.
English: No increase in the incidence of other reactions, including gastrointestinal perforation, wound healing complications, congestive heart failure, and haemorrhage was observed in elderly patients (> 65 years) receiving bevacizumab as compared to those aged ≤ 65 years treated with bevacizumab.
Maltese: L-ebda żieda fl-inċidenza ta' reazzjonijiet oħra, inkluż perforazzjoni gastro-intestinali, komplikazzjonijiet fil-fejqan tal-ferita, insuffiċjenza tal-qalb konġestiva u emorraġija, ma ġew osservati f'pazjenti anzjani (> 65 sena) li kienu qed jirċievu bevacizumab kif imqabbla ma' dawk b'età ≤ 65 sena kkurati b'bevacizumab.
English: Patients receiving bevacizumab plus chemotherapy, with a history of arterial thromboembolism, diabetes or age greater than 65 years have an increased risk of developing arterial thromboembolic reactions during therapy.
Maltese: Pazjenti li qed jirċievu bevacizumab flimkien ma' kimoterapija, b'passat ta' tromboemboliżmu arterjali, dijabete jew età aktar minn 65 sena għandhom riskju akbar ta' żvilupp ta' reazzjonijiet tromboemboliċi arterjali waqt it-terapija.
English: PFS1 results by disease stage and debulking status from study GOG-0218
Maltese: Riżultati tal-effikaċja minn studju GOG-0218
English: Addition of bevacizumab to standard of care did not demonstrate clinical benefit in clinical trial BO20924, in 71 evaluable children (from age 6 months to less than 18 years old) patients with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma (see section 4.2 for information on paediatric use).
Maltese: Iż-żieda ta' bevacizumab ma' kura standard ma wrietx benefiċċju kliniku fil-prova klinika BO20924, f'71 pazjenti tfal (b'età minn 6 xhur sa inqas minn 18-il sena) b'rabdomijosarkoma metastatika u sarkoma tat-tessut l-artab mhux rabdomijosarkoma li setgħu jiġu evalwati (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Leucovorin
Maltese: Erlotinib
English: Efficacy results for trial BO17704 Cisplatin/Gemcitabine + placebo
Maltese: Prova BO17704 kienet prova ta' fażi
English: Treatment with bevacizumab at 15 mg/kg every 3 weeks in combination with chemotherapy (carboplatin and paclitaxel) for 6 and up to 8 cycles, followed by bevacizumab until disease progression or unacceptable toxicity resulted, when data were derived from eCRF, in a clinically meaningful and statistically significant improvement in OS compared to treatment with carboplatin and paclitaxel alone.
Maltese: Trattament b'bevacizumab b'doża ta' 15 mg/kg kull 3 ġimgħat flimkien ma' kimoterapija (carboplatin u paclitaxel) għal 6 u sa 8 ċikli, segwit minn bevacizumab sal-progressjoni tal-marda jew sal-okkorrenza ta' tossiċità inaċċettabbli wassal, meta data kienet derivata minn eCRF, għal titjib klinikament sinifikanti u statistikament sinifikanti f'OS meta mqabbel ma' carboplatin u paclitaxel waħedhom.
English: Additional endpoints included objective response, duration of response, overall survival and safety.
Maltese: Punti finali addizzjonali kienu jinkludu rispons oġġettiv, tul tar-rispons, sopravivenza globali u sigurtà.
English: MVASI 25 mg/mL concentrate for solution for infusion bevacizumab
Maltese: MVASI 25 mg/mL konċentrat għal soluzzjoni għall-infużjoni bevacizumab
English: Overall approximately 34% of patients were FIGO stage III optimally debulked with gross residual disease, 40% stage III suboptimally debulked, and 26% were stage IV patients.
Maltese: Globalment madwar 34% tal-pazjenti kienu FIGO stadju III bi tneħħija ottimali b'marda residwa sostanzjali, 40% kienu stadju III bi tneħħija inqas minn ottimali, u 26% kienu pazjenti ta' stadju IV.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MVASI 25 mg/mL sterile concentrate bevacizumab
Maltese: MVASI 25 mg/mL konċentrat sterili bevacizumab
English: Hazard ratio (95% CI)
Maltese: Proporzjon ta' Periklu (CI ta' 95%)4
English: For patients in study AVF3694g who received anthracyclines concomitantly with bevacizumab, the incidences of grade 3 or higher CHF for the respective bevacizumab and control arms were similar to those in the other studies in metastatic breast cancer: 2.9% in the anthracycline + bevacizumab arm and 0% in the anthracycline + placebo arm.
Maltese: Għall-pazjenti fi studju AVF3694g li rċevew anthracyclines flimkien ma' bevacizumab, l-inċidenzi ta' CHF ta' grad 3 jew ogħla għallgruppi rispettivi ta' bevacizumab u kontroll kienu simili għal dawk fl-istudji l-oħra dwar kanċer metastatiku tas-sider: 2.9% fil-grupp ta' bevacizumab + anthracycline u 0% fil-grupp ta' anthracycline + plaċebo.
English: Deep vein thrombosis
Maltese: Trombożi fil-vini talfond
English: Results from the randomised phase III studies, PACCE and CAIRO-2, in patients with mCRC suggest that the use of anti-EGFR monoclonal antibodies panitumumab and cetuximab, respectively, in combination with bevacizumab plus chemotherapy, is associated with decreased PFS and/or OS, and with increased toxicity compared with bevacizumab plus chemotherapy alone.
Maltese: III, PACCE u CAIRO-2, f'pazjenti b'mCRC jissuġġerixxu li l-użu tal-antikorpi monoklonali kontra EGFR panitumumab u cetuximab, rispettivament, flimkien ma' bevacizumab u kimoterapija, huwa assoċjat ma' tnaqqis f'PFS u/jew OS, u ma' żieda fit-tossiċità meta mqabbel ma' kimoterapija u bevacizumab waħedhom.
English: These therapies in combination with MVASI may increase the risk of severe side effects.
Maltese: Dawn it-terapiji flimkien ma' MVASI jistgħu jżidu r-riskju ta' effetti sekondarji severi.
English: Patients with thromboembolic reactions ≤ grade 3 need to be closely monitored (NCI-CTCAE v.3).
Maltese: Pazjenti b'reazzjonijiet tromboemboliċi ta' ≤ grad 3 għandhom jiġu sorveljati mill-viċin (NCI-CTCAE v.3).
English: Hazard ratio was estimated from Cox proportional hazards models stratified by the duration of platinum free-interval prior to enrolling onto this study per eCRF (electronic case report form) and secondary surgical debulking status Yes/No (Yes = randomised to undergo cytoreduction or randomised to not undergo cytoreduction; No = not a candidate or did not consent to cytoreduction).
Maltese: Il-proporzjon ta' periklu kien stmat minn mudelli ta' perikli proporzjonali Cox stratifikati skont it-tul talintervall mingħajr platinu qabel ir-reġistrazzjoni f'dan l-istudju għal kull eCRF (formola elettronika tarrapport tal-każ - electronic case report form) u l-istat ta' tneħħija kirurġika sekondarja Iva/Le (Iva = randomised għal cytoreduction jew randomised biex ma ssirx cytoreduction; Le = mhux kandidat jew ma kkonsentiex għal cytoreduction).
English: Grade 3-5 (NCI-CTCAE v.3) venous thromboembolic reactions have been reported in up to 7.8% of patients treated with chemotherapy plus bevacizumab compared with up to 4.9% in patients treated with chemotherapy alone (across indications, excluding persistent, recurrent, or metastatic cervical cancer).
Maltese: Reazzjonijiet tromboemboliċi venużi ta' grad 3-5 (NCI-CTCAE v.3) ġew irrapportati f'sa 7.8% talpazjenti kkurati b'kimoterapija flimkien ma' bevacizumab meta mqabbla ma' sa 4.9% f'pazjenti kkurati b'kimoterapija waħidha (fl-indikazzjonijiet kollha, minbarra kanċer persistenti, rikorrenti jew metastatiku tal-għonq tal-utru).