FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with recent pulmonary haemorrhage/ haemoptysis (> 2.5 ml of red blood) should not be treated with Avastin.
Maltese: Pazjenti b'emorraġija fil-pulmun/emoptisi reċenti (> 2.5 ml ta' demm aħmar) m'għandhomx jiġu kkurati b'Avastin.
English: • fistula: abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected, including connections between vagina and the gut in patients with cervical cancer.
Maltese: • fistula: konnessjoni mhux normali qisha pajp bejn l-organi interni u l-ġilda jew tessuti oħra li normalment ma jkunux konnessi, inklużi konnessjonijiet bejn il-vaġina u l-imsaren f'pazjenti b'kanċer tal-għonq tal-utru.
English: ● Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival and overall survival in the eligible per-protocol population.
Maltese: • In-nuqqas ta' inferjorità tal-kategoriji li fihom XELOX meta mqabbla mal-kategoriji li fihom FOLFOX-4 fil-paragun totali ntweriet f'termini ta' sopravivenza mingħajr progressjoni u sopravivenza totali fil-popolazzjoni eliġibbli ta' qabel il-protokoll.
English: Prior hormonal therapy for the treatment of metastatic disease was allowed.
Maltese: Terapija ormonali minn qabel għall-kura ta' mard metastatiku kienet permessa.
English: CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Maltese: Hemm informazzjoni dwar ir-razza għal 29.3% talpazjenti u kważi l-pazjenti kollha kienu bojod.
English: Long term effects of the treatment with bevacizumab on fertility are unknown.
Maltese: Mhux magħrufa l-effetti fit-tul ta' kura b'bevacizumab fuq il-fertilità.
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),
Maltese: Dawn jinkludu nuqqas fin-numru ta' ċelluli bojod tad-demm, speċjalment neutrofili (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; żjieda tal-livel taz-zokkor fid-demm; żjieda ta' l-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 ta' lemoglobina (jinstab fiċ-ċelluli l-ħomor tad-demm, li jġorru l-ossiġnu), li jista' jkun sever.
English: Arthralgia
Maltese: Letarġija
English: The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/kg.
Maltese: Il-farmakokinetika ta' bevacizumab kienet linejari f'dożi li varjaw minn 1 sa' 10 mg/kg.
English: Placebo + C/G (n = 242)
Maltese: Plaċebo+ C/G (n = 242)
English: Grade 3-5 reactions have been observed in up to 2.3% of patients treated with Avastin 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'Avastin flimkien ma' kimoterapija meta mqabbel ma' < 1% b'kimoterapija biss (NCI-CTCAE v.3).
English: NAME OF THE MEDICINAL PRODUCT Avastin 25 mg/ml concentrate for solution for infusion.
Maltese: Avastin 25 mg/ml konċentrat għal soluzzjoni għall-infużjoni.
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 talovarji 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.L-ebda żjieda 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 Avastin kif imqabbla ma' dawk b'età ≤ 65 sena kkurati b'Avastin.
English: There was no exclusion criterion for prior anti-angiogenic therapy.
Maltese: Ma kien hemm l-ebda kriterju ta' esklużjoni għal terapija anti-anġjoġenika minn qabel.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 4 ml
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni Kunjett ta' 4 ml
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 (dożaġġ Saltz).
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 warajħ (eż. reazzjonijiet tromboemboliċi fl-arterji jinkludu inċident ċerebrovaskulari, infart mijokardijaku, attakk iskemiku temporanju u reazzjonijiet tromboemboliċi fl-arterji oħrajn).
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG0240), grade 3-5 bleeding reactions have been reported in up to 8.3% of patients treated with Avastin 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'Avastin flimkien ma' paclitaxel u topotecan meta mqabbel ma' sa 4.6% tal-pazjenti kkurati b'paclitaxel u topotecan.
English: ● Superiority of the Avastin-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 Avastin kontra l-kategoriji b'kimoterapija biss fil-paragun totali ntweriet f'termini ta' sopravivenza mingħajr progressjoni fil-popolazzjoni ITT (Tabella 7).
English: This was a Phase III randomised, controlled, open-label trial investigating Avastin 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 firstline bevacizumab-containing regimen.
Maltese: III randomised, ikkontrollata u open-label li nvestigat Avastin 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: 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 ġo lgħajn bħal endoftalmite sterili, uveite, u vitrite, distakk tar-retina, tiċrita tal-epitelju tal-kulur tar-retina, żjieda fil-pressjoni ġo l-għajn, emorraġija ġo l-għajn bħal emorraġija fil-vitriju jew emorraġija firretina u emorraġija fil-konġuntiva.
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 Avastin.
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 komplikazzjonijiet fil-fejqan ta' feriti f'pazjenti li kellhom operazzjoni maġġuri 28-60 ġurnata qabel ma' nbeda Avastin.
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 sotto grupp ta' pazjenti speċifikat minn qabel, inkluż dawk magħżula skond l-età, sess, performance status, post tat-tumur primarju, numru ta' organi involuti u t-tul talmarda metastatika.
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 adenokarċinoma seruża tat-tip istoloġika.
English: Fistulab,d, Muscular weakness, Back pain
Maltese: Fistulab,d, Dgħufija fil-muskoli, Uġigħ ta' dahar
English: For further information please refer to Table 3 'Adverse reactions reported in post-marketing setting.'
Maltese: a Għal aktar informazzjoni jekk jogħġbok irreferi għal Tabella 3 'Reazzjonijiet avversi rrappurtati fl-ambjent ta'
English: • shortness of breath or low levels of oxygen in the blood,
Maltese: • tħossok debboli u bla enerġija,
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 trombo-embolitiċi 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).
English: Median OS (months) Hazard Ratio (95% CI) p-value All analyses presented in this table are stratified analyses.
Maltese: OS Medjan (xhur) Proporzjon ta' periklu (CI ta' 95%) valur p L-analiżi kollha ppreżentati f'din it-tabella huma analiżi stratifikati.
English: • The other ingredients are trehalose dihydrate, sodium phosphate, polysorbate 20 and water for injections.
Maltese: • Is-sustanzi l-oħra huma trehalose dihydrate, sodium phosphate, polysorbate 20 u ilma għallinjezzjoni.
English: • Haemorrhage, including pulmonary haemorrhage/haemoptysis, which is more common in non small cell lung cancer patients (see section 4.4).
Maltese: • Emorraġija, inkluż emorraġija fil-pulmun/emoptisi li hija aktar komuni f'pazjenti b'kanċer taċ ċelluli mhux żgħar tal-pulmun (ara sezzjoni 4.4).
English: A GOG PS of 2 at baseline was reported in 0.9% of patients in the CP arm and in 1.2% of patients in the CPB arm.“ The primary efficacy endpoint was overall survival (OS).
Maltese: GOG PS ta' 2 fil-linja bażi kien irrappurtat f'0.9% talpazjenti fil-grupp ta' CP u f'1.2% tal-pazjenti fil-grupp ta' CPB.
English: Osteonecrosis of the jaw (ONJ) (see section 4.8)
Maltese: Newtropenija u infezzjonijiet (ara sezzjoni 4.8)
English: Venous thromboembolism (see section 4.8)
Maltese: Tromboemboliżmu fil-vini (ara sezzjoni 4.8)
English: Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaec,d,
Maltese: Perforazzjoni talmusrana, Ileus, Ostruzzjoni filmusrana, Fistuli rektovaġinali ċ,d
English: Median (months) Hazard ratio [95% CI]
Maltese: Medjan (xhur) Proporzjon ta' periklu [95% CI]
English: Non-GI Fistulae (see section 4.8)
Maltese: Fistuli mhux GI (ara sezzjoni 4.8)
English: Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Nausea, Vomiting, Abdominal pain
Maltese: Emorraġija mirrektum, Stomatite, Stitikezza, Dijarea, T qalligħ, Rimettar, Uġigħ addominali
English: The addition of Avastin to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see Table 4).
Maltese: Iż-żjieda ta' Avastin ma' IFL wassal għal żjiediet statistikament sinnifikanti fis-sopravivenza totali, fis-sopravivenza mingħajr progressjoni u fir-rata ta' rispons totali (ara Tabella 4).
English: Hazard Ratio (95% CI) 2 p-value 3
Maltese: Proporzjon ta' periklu (95% CI) valur p
English: Avastin will be administered in combination with erlotinib.
Maltese: Avastin se jingħata flimkien ma' erlotinib.
English: Diluted medicinal product
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516)
Maltese: 0001, 95% CI 0.343 ; 0.516)
English: The primary endpoint was progression-free survival based on investigator assessment using modified RECIST 1.0.
Maltese: Il-mira primarja kienet sopravivenza mingħajr progressjoni bbażata fuq valutazzjoni tal-investigatur bl-użu ta' RECIST 1.0. modifikat.
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 ta' l-iżvilupp ta' l-endotelju vaskulari uman (VEGF), 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 ta' l-endotelju.
English: Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensin-converting enzyme inhibitors, diuretics and calcium-channel blockers.
Maltese: Il-pressjoni għolja ġeneralment kienet ikkontrollata b'mod xieraq permezz ta' anti-ipertensivi orali bħal inibituri ta' l-enżima li tibdel angiotensin, dijuretiċi u mblokkaturi tal-kanali tal-kalċju.
English: Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Maltese: Enċefalopatija ipertensiva (rari ħafna) (ara wkoll sezzjoni 4.4 u Pressjoni għolja f'sezzjoni 4.8)
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 Avastin 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' 3ġimgħat sa 6 ċikli jew PC flimkien ma' Avastin b'doża ta' 15 mg/kg bħala infużjoni IV fl-ewwel ġurnata ta' kull ċiklu ta' 3-ġimgħat.
English: The pharmacokinetics of bevacizumab was well characterized by the paediatric population PK model for 70 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: Fi Studju BO20924, il-farmakokinetika ta' bevacizumab kienet ikkaratterizzata tajjeb permezz talmudell tal-PK tal-popolazzjoni pedjatrika f'70 pazjent pedjatriku (1.4 sa 17.6 snin; 11.6 sa 77.5 kg).
English: During the trial, of the patients who received trial treatment, 32.2% (136/422) of patients received 7-12 administrations of Avastin and 21.1% (89/422) of patients received 13 or more administrations of Avastin.
Maltese: Waqt il-prova, mill-pazjenti li rċevew il-kura ta' prova, 32.2% (136/422) tal-pazjenti rċevew 7-12-il għotja ta' Avastin u 21.1% (89/422) tal-pazjenti rċevew 13 jew aktar għotjiet ta' Avastin.
English: The efficacy and safety of Avastin 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' Avastin 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: Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Maltese: Bevacizumab flimkien ma' interferon alfa-2a huwa indikat għall-kura primarja ta' pazjenti adulti b'kanċer taċ-ċelluli renali avanzat u/jew metastatiku.
English: Posterior reversible encephalopathy syndrome a,b,d
Maltese: Sindrome ta' enċefalopatija posterjuri riversibblia,b,d
English: Trial E2100 was an open-label, randomised, active controlled, multicentre clinical trial evaluating Avastin 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 Avastin 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: Therapy should be permanently discontinued in patients who develop nephrotic syndrome (NCI-CTCAE v.3).
Maltese: It-terapija għandha titwaqqf għal kollox f'pazjenti li żviluppaw sindrome nefrotiku (NCI-CTCAE v.3).
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
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: Neutropenia and infections (see section 4.8)
Maltese: Reazzjonijiet ta' sensittività eċċessiva/relatati mal-infużjoni (ara sezzjoni 4.8)
English: The addition of Avastin 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' Avastin 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 weħedha (ara Tabella 5).
English: One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + Avastin (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression.
Maltese: Mija u ħames pażjent magħżula bl-addoċċ għall-kategorija 5-FU/FA + plaċebo u 104 pazjent għall-kategorija 5-FU/FA + Avastin (5 mg/kg kull ġimagħtejn).
English: Across all clinical trials, mucocutaneous haemorrhage has been seen in up to 50% of Avastin-treated patients.
Maltese: Tul il-provi kliniċi kollha, emorraġija mukokutanja dehret f'mhux aktar minn 50% tal-pazjenti kkurati b'Avastin.
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: Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with Avastin through:
Maltese: Tabella 1 tipprovdi r-reazzjonijiet avversi kollha skont il-frekwenza li kienu determinati li huma kkawżati minn Avastin permezz ta':
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 talvista, inkluż telf permanenti tal-vista.
English: Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with Avastin (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'Avastin (analiżi mniżżla f'Tabella 7), konsistenti mal-benefiċċju statistikament sinifikanti osservat f'analiżi miġbura.
English: Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaed,e,
Maltese: Perforazzjoni gastrointestinalib,d, Perforazzjoni talmusrana, Ileus, Sadd talmusrana, Fistuli rektovaġinalid,e, Disturb gastro-intestinali, Proktalġja
English: Cardiac disorders
Maltese: Deidratazzjoni Iponatrimija
English: Avastin was combined with two chemotherapy regimens:
Maltese: Kura ta' marda rikorrenti reżistenti għall-platinu:
English: Avastin is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Maltese: Avastin jingħata flimkien ma' wieħed mill-korsijiet ta' kimoterapija li ġejjin: paclitaxel u cisplatin jew paclitaxel u topotecan.
English: If indicated, therapy should either be permanently discontinued or temporarily suspended as described in section 4.4.
Maltese: Jekk indikat, it-terapija għandha titwaqqaf b'mod permanenti jew temporanjament kif deskritt fis-sezzjoni 4.4.
English: Across clinical trials, 8 cases of PRES have been reported.
Maltese: Matul il-provi kliniċi, kienu rrappurtati 8 każijiet ta' PRES.
English: • CPB7.5+ arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks plus Avastin (7.5 mg/kg q3w) for up to 12 months (Avastin 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' Avastin (7.5 mg/kg q3w) għal mhux aktar minn 12-il xahar (Avastin inbeda f'ċiklu 2 tal-kimoterapija jekk il-kura inbdiet fi żmien 4 ġimgħat mill-kirurġija jew fl-ewwel ċiklu jekk il-kura inbdiet aktar minn 4 ġimgħat wara l-kirurġija).
English: • The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV every 2 weeks (or bevacizumab 15 mg/kg every 3 weeks if used in combination with topotecan 1.25 mg/m2 on Days 1-5 every 3 weeks).
Maltese: • Il-kimoterapija magħżula kienet ikkombinata ma' bevacizumab 10 mg/kg IV kull ġimagħtejn (jew bevacizumab 15 mg/kg kull 3 ġimgħat jekk użat flimkien ma' topotecan 1.25 mg/m2 fi Ġranet 1-5 kull 3 ġimgħat).
English: Hazard ratio (95% confidence interval)
Maltese: Proporzjon ta' periklu (Intervall ta' kunfidenza ta' 95%)