FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with histologically confirmed mCRC and disease progression were randomised 1:1 within 3 months after discontinuation of bevacizumab first-line therapy to receive fluoropyrimidine/oxaliplatin- or fluoropyrimidine/irinotecan-based chemotherapy (chemotherapy switched depending on first-line chemotherapy) with or without bevacizumab.
Maltese: Pazjenti b'mCRC ikkonfermat istoloġikament u bi progressjoni tal-marda kienu randomised 1:1 fi żmien 3 xhur wara l-waqfien ta' terapija preferitata' bevacizumab biex jirċievu kimoterapija bbażata fuq fluoropyrimidine/oxaliplatin jew fluoropyrimidine/irinotecan (kimoterapija maqluba skont ilkimoterapija preferita) flimkien ma' bevacizumab jew mingħajru.
English: Proteinuria a,b
Maltese: Proteina flawrina a,b
English: Haemorrhage b,d
Maltese: Emorraġija b,d
English: Grade 3-5 reactions have been observed in up to 2.3% of patients treated with bevacizumab plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Maltese: Reazzjonijiet ta' Grad 3-5 kienu osservati f'sa 2.3% tal-pazjenti kkurati b'bevacizumab flimkien ma' kimoterapija meta mqabbel ma' < 1% b'kimoterapija biss (NCI-CTCAE v.3).
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 tumor 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 iżżewġ gruppi ta' trattament fil-ftit pazjenti li kellhom tumur li seta' jiġi evalwat fil-linja bażi u li kellhom rispons ikkonfermat qabel ma rċivew xi terapija lokali: 27/75 pazjent (36.0%, CI ta' 95%: 25.
English: Table 10 Trial E2100 efficacy results Progression-free survival
Maltese: Tabella 10 Riżultati tal-effikaċja tal-prova E2100
English: Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis 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 primarja twettqet b'data meta waqfet tinġabar id-dejta ta' 12 ta' Diċembru 2012 u hija meqjusa lanaliżi finali
English: This was a phase III randomised, active-controlled, open-label trial investigating bevacizumab 10 mg/kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second line) with advanced colorectal cancer.
Maltese: III, randomised, ikkontrollata b'mod attiv, open-label li nvestigat bevacizumab 10 mg/kg f'taħlita ma' leucovorin b'bolus ma' 5-fluorouracil u wara infużjoni ta' 5fluorouracil, b'oxaliplatin ġol-vini (FOLFOX-4), mogħti fuq skeda ta' kull ġimagħtejn f'pazjenti kkurati minn qabel (it-tieni linja) b'kanċer avvanzat tal-kolorektum.
English: Gastrointestinal ulcer a
Maltese: Ulċera gastrointestinali
English: ● It is possible that Zirabev can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
Maltese: ● Huwa possibbli li Zirabev jista' jikkawża sensittività eċċessiva u/jew reazzjonijiet għallinfużjoni (reazzjonijiet relatati mal-injezzjoni tiegħek tal-mediċina).
English: • Arterial thromboembolism (see section 4.4).
Maltese: Tromboemboliżmu arterjali (ara sezzjoni 4.4).
English: These clinically significant reactions have therefore been included in Table 2 within the column entitled “Frequency Not Known.”
Maltese: Dawn ir-reazzjonijiet klinikament sinifikanti għalhekk ġew inklużi f'Tabella 2 fil-kolonna intitolata “Frekwenza Mhux Magħrufa”.
English: A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
Maltese: Dijanjożi ta' PRES tinħtieġ li tiġi konfermata permezz ta' immaġni tal-moħħ, preferibbilment immaġni ta' reżonanza manjetika (MRI - magnetic resonance imaging).
English: Serious wound healing complications, including anastomotic complications, with a fatal outcome have been reported.
Maltese: Kienu rrappurtati kumplikazzjonijiet serji fil-fejqan tal-feriti, inkluż komplikazzjonijiet anastomiċi, b'riżultat fatali.
English: This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
Maltese: II li saret biex tqabbel l-effikaċja u s-sigurtà ta' bevacizumab kontra plaċebo.
English: The safety and efficacy of the recommended dose (5 mg/kg of body weight every two weeks) in metastatic carcinoma of the colon or rectum were studied in three randomised, active-controlled clinical trials in combination with fluoropyrimidine-based first-line chemotherapy.
Maltese: Is-sigurtà u l-effikaċja tad-doża rakkomandata (5 mg/kg ta' piż tal-ġisem kull ġimagħtejn) f'karċinoma metastatika tal-kolon jew rektum ġew studjati fi 3 provi kliniċi randomized u active-controlled f'taħlita ma' kimoterapija primarja fuq fluoropyrimidine.
English: In clinical trials, the overall incidence of arterial thromboembolic reactions ranged up to 3.8% in the bevacizumab containing arms compared with up to 2.1% in the chemotherapy control arms.
Maltese: Fi provi kliniċi, l-inċidenza globali ta' reazzjonijiet tromboemboliċi arterjali varjat sa 3.8% fil-grupp b'bevacizumab meta mqabbla ma' inċidenza sa 2.1% fil-gruppi ta' kontroll b'kimoterapija.
English: If this is well-tolerated the second infusion may be given over 60 minutes.
Maltese: Jekk din tiġi ttollerata tajjeb, it-tieni infużjoni tista' tingħatalek fuq medda ta' 60 minuta.
English: Zirabev 25 mg/ml concentrate for solution for infusion bevacizumab
Maltese: Zirabev 25 mg/ ml konċentrat għal soluzzjoni għall-infużjoni bevacizumab
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 ġol-għajnejn bħal endoftalmite sterili, uveite u vitrite, distakk tar-retina, tiċrita talepitelju tal-kulur tar-retina, żjieda fil-pressjoni ġol-għajn, emorraġija ġol-għajn bħal emorraġija filvitriju jew emorraġija fir-retina u emorraġija fil-konġuntiva.
English: • Superiority of the bevacizumab-containing arms versus the chemotherapy alone arms in the overall comparison was demonstrated in terms of progression-free survival in the ITT population (Table 7).
Maltese: ● Is-superjorità tal-kategoriji li fihom bevacizumab kontra l-kategorijib' kimoterapija biss filparagun totali ntweriet f'termini ta' sopravivenza mingħajr progressjoni fil-popolazzjoni ITT (Tabella 7).
English: Posterior reversible encephalopathy syndrome a,b,c
Maltese: Sindrome ta' enċefalopatija posterjuri riversibbli a,b,c
English: Treatment was given until progressive disease or unacceptable toxicity.
Maltese: Il-kura ngħatat sal-progressjoni tal-marda jew sa tossiċità inaċċettabbli.
English: The addition of bevacizumab to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Maltese: Iż-żjieda ta' bevacizumab ma' FOLFOX-4 wasslet f'titwil statistikament sinifikanti tas-sopravivenza.
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' kullġimgħa ta' irinotecan/bolus 5-fluorouracil/folinic acid (IFL) għal total ta' 4 ġimgħat ta' kull ċiklu ta' 6 ġimgħat (dożaġġ Saltz).
English: Detailed information about these post-marketing reactions are provided in Table 3.
Maltese: Informazzjoni ddettaljata dwar dawn ir-reazzjonijiet ta' wara t-tqegħid fis-suq hija pprovduta f'Tabella 3.
English: Wound healing complications (see section 4.8)
Maltese: Kumplikazzjonijiet fil-fejqan ta' feriti (ara sezzjoni 4.8)
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 anġjoġenesi, u b'hekk jimpedixxi lil VEGF milli jeħel mar-riċetturi tiegħu, Flt-1 (VEGFR-1) u KDR (VEGFR-2), fuq il-wiċċ taċċelluli tal-endotelju.
English: The clinical benefit, as measured by overall survival, was seen in all pre-specified patient subgroups, including those defined by age, sex, performance status, location of primary tumour, number of organs involved and duration of metastatic disease.
Maltese: Il-benefiċċju kliniku, hekk kif imkejjel missopravivenza totali, deher f'kull sottogrupp ta' pazjenti speċifikat minn qabel, inkluż dawk magħżula skont l-età, sess, performance status, post tat-tumur primarju, numru ta' organi involuti u t-tul talmarda metastatika.
English: In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of post-operative 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 żjieda fir-riskju ta' fsada wara l-operazzjoni jew kumplikazzjonijiet fil-fejqan ta' feriti f'pazjenti li kellhom operazzjoni maġġuri 28-60 jum qabel ma nbeda bevacizumab.
English: Osteonecrosis of the jaw a,b
Maltese: Osteonekrożi tax-xedaq a,b
English: Therapy should be permanently discontinued in patients who develop nephrotic syndrome (NCI-CTCAE v.3).
Maltese: It-terapija għandha titwaqqaf għal kollox f'pazjenti li żviluppaw sindrome nefrotiku (NCI-CTCAE v.3).
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: This group of medical terms may involve the same underlying pathophysiology (e.g. arterial thromboembolic reactions include cerebrovascular accident, myocardial infarction, transient ischaemic attack and other arterial thromboembolic reactions).
Maltese: Dan il-grupp ta' termini mediċi jista' jinvolvi l-istess patofiżjoloġija warajh (eż. reazzjonijiet tromboemboliċi fl-arterji jinkludu inċident ċerebrovaskulari, infart mijokardijaku, attakk iskemiku temporanju u reazzjonijiet tromboemboliċi fl-arterji oħrajn).
English: Prior hormonal therapy for the treatment of metastatic disease was allowed.
Maltese: Terapija ormonali minn qabel għall-kura ta' mard metastatika kienet permessa.
English: Do not use Zirabev
Maltese: X'fih Zirabev
English: Congenital, familial, and genetic disorder
Maltese: Disturb konġenitali, familjali u ġenetiku
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: 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 speriferali 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 ta' < 65 sena.
English: 85 mg/m2 intravenous 2 h
Maltese: 85 mg/m 2 ġol-vini 2 h 200 mg/m2 ġol-vini 2 h 400 mg/m 2 bolus ġol-vini, 600 mg/m 2 ġol-vini 22 h
English: ● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with bevacizumab treatment.
Maltese: ● Effett sekondarju newroloġiku rari msejjaħ sindrome ta' enċefalopatija riversibbli posterjuri (PRES, posterior reversible encephalopathy syndrome) ġie assoċjat ma' kura b'bevacizumab.
English: Study E3200 used a 5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-naïve patients, while study ML18147 used a 2.5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-pretreated patients.
Maltese: Fi studju E3200 intużat doża ekwivalenti għal 5 mg/kg/ġimgħa ta' bevacizumab f'pazjenti li qatt ma rċivew bevacizumab, waqt li fi studju ML18147 intużat doża ekwivalenti għal 2.5 mg/kg/ġimgħa ta' bevacizumab f'pazjenti li qabel kienu kkurati b'bevacizumab.
English: • spontaneous reporting,
Maltese: • perforazzjoni addominali,
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 irċievew 5-FU/FA + bevacizumab (10 mg/kg kull ġimagħtejn) bħala bolus.
English: After discontinuation of bevacizumab treatment, ovarian function recovered in 86.2% of these evaluable women.
Maltese: Wara l-waqfien tal-kura b'bevacizumab, il-funzjoni talovarji rkuprat f'86.2% ta' dawn in-nisa li setgħu jiġu evalwati.
English: Concentrate for solution for infusion 1 vial of 4 ml
Maltese: Konċentrat għal soluzzjoni għall-infużjoni Kunjett 1 ta' 164 ml
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 studji kliniċi, perforazzjonijiet gastrointestinali kienet irrappurtata b'inċidenza ta' inqas minn 1% f'pazjenti b'kanċer tal-pulmun b'ċelluli mhux żgħar, mhux skwamuż, sa 1.3% f'pazjenti b'kanċer metastatiku tas-sider, 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 gastrointestinali) f'pazjenti b'kanċer tal-kolon jew tar-rektum li mmetastatizza.
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, multi- centre phase III trial.
Maltese: L-effikaċja u s-sigurtà ta' bevacizumab flimkien mal-kimoterapija (paclitaxel u cisplatin jew paclitaxel u topotecan) fil-kura ta' pazjenti b'karċinoma persistenti, rikorrenti jew metastatika talgħonq tal-utrukienu evalwati fi studju GOG-0240, prova randomised, b'erba'gruppi, open label, b'aktar minn ċentru wieħed ta' fażi
English: Intestinal perforation, Ileus , Intes tinal obstruction, Recto-vaginal fistulae c,d
Maltese: Perforazzjoni talmusrana, Ileus, Sadd tal-musrana, Fistuli rektovaġinali d,e,
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 bil-kimoterapija waħidha (fl-indikazzjonijiet kollha, minbarra kanċer persistenti, rikorrenti, jew metastatiku tal-għonq tal-utru).
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, il-ħinijiet u l-kondizzjonijiet ta' ħażna ta' waqt l-użu huma r-responsabbilità ta' min qed jużah u normalment ma jkunx aktar minn 24 siegħa f'temperatura ta' 2°C sa 8°C, sakemm id-dilwizzjoni ma saritx taħt kondizzjonijiet ikkontrollati u asettiċi vvalidati.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA): http://www.ema.europa.eu
English: Pain, Lethargy, Mucosal inflammation
Maltese: Astenija, Għeja, Uġigħ, Letarġija, infjammazzjoni tal-mukuża
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 l-EGFR panitumumab u cetuximab, rispettivament, flimkien ma' bevacizumab u l-kimoterapija, huwa assoċjat ma' tnaqqis f'PFS u/jew OS, u ma' żjieda fit-tossiċità meta mqabbel ma' kimoterapija u bevacizumab waħdu.
English: Across clinical trials, the following Grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patients treated with bevacizumab with at least a 2% difference compared to the corresponding control groups: hyperglycaemia, decreased haemoglobin, hypokalaemia, hyponatraemia, decreased white blood cell count, increased international normalised ratio (INR).
Maltese: Tul il-provi kliniċi, l-anormalitajiet tal-laboratorju ta' Grad 3 u 4 (NCI-CTCAE v.3) li ġejjin seħħew f'pazjenti kkurati b'bevacizumab b'tal-inqas differenza ta' 2% meta mqabbel mal-gruppi ta' kontroll li jikkorrispondi: ipergliċemija, emoglobina mnaqqsa, ipokalimja, iponatremija, għadd taċċelluli bojod tad-demm imnaqqas, żjieda fil-proporzjon normalizzat internazzjonali (INR
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 7-12il għotja ta' bevacizumab u 21.1% (89/422) tal-pazjenti rċevew 13 jew aktar ta' bevacizumab.
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 multiċentre li evalwat bevacizumab flimkien ma' paclitaxel għal kanċer tas-sider rikorrenti lokalment jew li mmetastatizza f'pazjenti li ma kinux irċivew kimoterapija minn qabel għal marda metastatika jew rikorrenti lokalment.
English: Thrombocytopenia
Maltese: Kanċer ċervikali
English: In an exploratory retrospective analysis of data from 13 completed randomised trials in patients with various tumour types, 3 patients out of 91 (3.3%) with brain metastases experienced CNS bleeding (all Grade 4) when treated with bevacizumab, compared to 1 case (Grade 5) out of 96 patients (1%) that were not exposed to bevacizumab.
Maltese: F'analiżi retrospettiv esploratorju ta' tagħrif minn 13-il prova randomized mitmuma f'pazjenti b'diversi tipi tat-tumur, 3 pazjenti minn 91 (3.3%) b'metastasi fil-moħħ kellhom fsada fis-CNS (kollha ta' Grad 4) meta kkurati b'bevacizumab, imqabbel ma' każ 1 (Grad 5) minn 96 pazjent (1%) li ma kienux esposti għal 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-żjieda ta' bevacizumab 5 mg/kg kull ġimagħtejn ma' 5-FU/FA wassal għal rata oġġettiva ta' rispons ogħla, sopravivenza bla progressjoni itwal, u tendenza ta'sopravivenza itwal, meta mqabbla ma' kimoterapija b'5-FU/FA waħedha (ara Tabella 5).
English: The addition of bevacizumab to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see Table 4).
Maltese: Iż-żjieda ta' bevacizumab ma' IFL wassal għal żjiedet statistikament sinifikanti fis-sopravivenza totali, fis-sopravivenza mingħajr progressjoni u fir-rata ta' rispons totali (ara Tabella 4).
English: Long term effects of the treatment with bevacizumab on fertility are unknown.
Maltese: Mhux magħrufa l-effetti fit-tul talkura b'bevacizumab fuq il-fertilità.
English: If you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine.
Maltese: Jekk se tagħmel operazzjoni, jekk kellek operazzjoni maġġuri f'dawn laħħar 28 ġurnata jew jekk għad għandek ferita ta' wara operazzjoni, li għadha ma fieqitx, m'għandekx tingħata din il-mediċina.
English: There were no complete responses and 2 partial responses (MacDonald criteria).
Maltese: Ma kien hemm l-ebda rispons komplet u żewġ risponsi parzjali (kriterji ta' MacDonald).
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: 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: Żjieda fir-reazzjonijiet tromboemboliċi arterjali kienet osservata f'pazjenti kkurati b'bevacizumab fil-firxa tal-indikazzjonijiet kolha, inkluż aċċidenti ċerebrovaskulari, infart mijokardijaku, attakki iskemiċi li jgħaddu, u reazzjonijiet tromboemboliċi arterjali oħrajn.
English: Gallbladder perforation a,b
Maltese: Perforazzjoni filbużżieqa talmarrara a,b
English: Gastrointestinal disorder, Proctalgia
Maltese: Disturb gastrointestinali, Proktalġja