FrancophonIA/ELRC3.0 huggingface dataset:
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 IV 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 ta' 5-fluorouracil u wara infużjoni ta' 5fluorouracil, b'oxaliplatin IV (FOLFOX-4), mogħti fuq skeda ta' kull ġimagħtejn f'pazjenti kkurati minn qabel (it-tieni linja) b'kanċer avanzat tal-kolorektum.
English: EGFR mutation status was determined for each patient prior to patient screening and 154 patients were randomised to receive either erlotinib + bevacizumab (erlotinib 150 mg oral daily + bevacizumab [15 mg/kg IV every 3 weeks]) or erlotinib monotherapy (150 mg oral daily) until disease progression (PD) or unacceptable toxicity.
Maltese: L-istat ta' mutazzjoni ta' EGFR kien determinat għal kull pazjent qabel l-ittestjar tal-pazjent u 154 pazjent kienu randomised biex jirċievu erlotinib + bevacizumab (erlotinib 150 mg mill-ħalq kuljum + bevacizumab [15 mg/kg IV kull 3 ġimgħat]) jew monoterapija ta' erlotinib (150 mg mill-ħalq kuljum) sal-progressjoni tal-marda (PD - disease progression) jew sa tossiċità inaċċettabbli.
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab-treated patients.
Maltese: Riżultat fatali kien irrappurtat f'madwar terz tal-każijiet serji ta' perforazzjonijiet gastro-intestinali, li jirrappreżenta bejn 0.2%-1% tal-pazjenti kollha kkurati b'bevacizumab.
English: The primary endpoint was PFS as assessed by the investigator using RECIST.
Maltese: Il-punt finali primarju kien PFS kif evalwata mill-investigatur bl-użu ta' RECIST.
English: (p-value = 0.0036)
Maltese: (valur p = 0.0036)
English: Osteonecrosis of the jawb,c
Maltese: Osteonekrosi taxxedaqa,b
English: • Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and topotecan 0.75 mg/m2 IV over 30 minutes on days 1-3 (q3w)
Maltese: • Paclitaxel 175 mg/m2 IV fuq medda ta' 3 sigħat f'jum 1 u topotecan 0.75 mg/m2 IV fuq medda ta' 30 minuta fi granet 1-3 (q3w)
English: The metabolism and elimination of bevacizumab is similar to endogenous IgG i.e. primarily via proteolytic catabolism throughout the body, including endothelial cells, and does not rely primarily on elimination through the kidneys and liver.
Maltese: Il-metaboliżmu u l-eliminazzjoni ta' bevacizumab huma simili għal IgG endoġenu i.e. primarjament permezz ta' kataboliżmu proteolitiku mal-ġisem kollu, inkluż ċelluli tal-endotelju, u ma jiddependix primarjament minn eliminazzjoni mill-kliewi u l-fwied.
English: • Carboplatin (AUC 4, day 1) and gemcitabine (1,000 mg/m2 on days 1 and 8) and concurrent bevacizumab (15 mg/kg day 1) every 3 weeks for 6 and up to 10 cycles followed by bevacizumab (15 mg/kg 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 bevacizumab (15 mg/kg ġurnata 1) fl-istess waqt kull 3 ġimgħat għal 6 ċikli u sa 10 ċikli segwit minn bevacizumab (15 mg/kg kull 3 ġimgħat) waħdu sal-progressjoni tal-marda jew tossiċità mhux aċċettabli
English: In a randomised phase II study (BO20924) a total of 154 patients aged ≥ 6 months to < 18 years with newly diagnosed metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma were treated with standard of care (Induction IVADO/IVA+/- local therapy followed by maintenance vinorelbine and cyclophosphamide) with or without bevacizumab (2.5 mg/kg/week) for a total duration of treatment of approximately 18 months.
Maltese: Fi studju randomised ta' fażi II (BO20924) total ta' 154 pazjent ta' età minn ≥ 6 xhur sa < 18-il sena b'rabdomijosarkoma metastatika u sarkoma tat-tessut l-artab mhux rabdomijosarkoma li kienu għadhom kif ġew dijanjostikati kienu ttrattati b'kura standard (Induzzjoni b'IVADO/IVA +/- terapija lokali segwit minn vinorelbine u cyclophosphamide bħala manteniment) bi jew mingħajr bevacizumab (2.5 mg/kg/ġimgħa) għal perjodu totali ta' trattament ta' madwar 18-il xahar.
English: Cerebrovascular accidents (including transient ischaemic attacks) were reported in up to 2.7% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
Maltese: Aċċidenti cerebrovaskulari (inkluż attakki iskemiċi li jgħaddu) kienu rrappurtati f'mhux aktar minn 2.7% tal-pazjenti kkurati b'bevacizumab flimkien ma' kimoterapija meta mqabbla ma' mhux aktar minn 0.5% tal-pazjenti kkurati b'kimoterapija biss.
English: Addition of bevacizumab to RT/T did not demonstrate clinical benefit in study BO25041 in 60 evaluable children patients with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG) (see section 4.2 for information on paediatric use).
Maltese: Żieda ta' bevacizumab ma' RT/T ma wrietx benefiċċju kliniku fl-istudju BO25041 f'60 pazjent pedjatriku li setgħu jiġu evalwati bi glijoma ta' grad għoli (HGG - high-grade glioma) supratentorali jew infratentorali fiċ-ċerebellum jew fil-pedunkulu li għadha kif ġiet ddijanjostikati (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
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 nefrotika (NCI-CTCAE v.3).
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression-free survival was 8.8 months.
Maltese: Fost il-110 pazjent randomised għall-Kategorija 3 (5-FU/FA + bevacizumab) qabel it-twaqqif ta' din il-kategorija, is-sopravivenza medjana globali kienet ta' 18.3 xhur u s-sopravivenza bla progressjoni medjana kienet ta' 8.8 xhur.
English: This study was designed as an open-label, randomised, two-arm phase III evaluation of bevacizumab plus chemotherapy (CT + BV) versus chemotherapy alone (CT).
Maltese: III b'żewġ gruppi, open-label u randomised ta' bevacizumab flimkien ma' kimoterapija (CT + BV) kontra kimoterapija waħedha (CT).
English: Trial BO17704 has demonstrated that both 7.5 mg/kg/q3wk and 15 mg/kg/q3wk bevacizumab doses increase progression-free survival and response rate.
Maltese: Prova BO17704 uriet li kemm doża ta' 7.5 mg/kg/q3wk ta' bevacizumab, kif ukoll dik ta' 15 mg/kg/q3wk, jżidu s-sopravivenza bla progressjoni u r-rata ta' rispons.
English: Proteinuriaa,b
Maltese: Proteina fl-awrinaa,b
English: 5.8% of the overall randomised patient population had stage IIIB disease.
Maltese: 5.8% tal-popolazzjoni globali ta' pazjenti randomised kellhom marda ta' stadju IIIB.
English: Grade 3 proteinuria was reported in up to 10.9% of treated patients.
Maltese: Proteina fl-awrina ta' grad 3 kienet irrappurtata f'sa 10.9% tal-pazjenti kkurati.
English: In clinical trials across all indications the overall incidence of NCI-CTCAE v.3 grade 3-5 bleeding reactions ranged from 0.4% to 6.9% in bevacizumab-treated patients, compared with up to 4.5% of patients in the chemotherapy control group.
Maltese: Fi provi kliniċi bl-indikazzjonijiet kollha, l-inċidenza globali ta' reazzjonijiet ta' fsada ta' NCI-CTCAE v.3 grad 3-5 varjat minn 0.4% sa 6.9% fil-pazjenti kkurati b'bevacizumab, meta mqabbla ma' inċidenza sa 4.5% tal-pazjenti fil-grupp ta' kontroll b'kimoterapija.
English: Adjuvant taxane therapy was allowed only if it was completed at least 12 months prior to trial entry.
Maltese: Terapija awżiljarja b'taxane kienet permessa biss jekk intemmett tal-anqas 12-il xahar qabel il-bidu tal-prova.
English: Capecitabine
Maltese: Oxaliplatin Capecitabine
English: Combination with platinum- or taxane-based therapies (see sections 4.4 and 4.8)
Maltese: Taħlita ma' terapiji bbażati fuq platinum jew taxane (ara sezzjonijiet 4.4 u 4.8)
English: MVASI will be administered in combination with erlotinib.
Maltese: MVASI se jingħata flimkien ma' erlotinib.
English: There is no relevant use of bevacizumab in the paediatric population in the indications for treatment of cancers of the colon, rectum, breast, lung, ovarian, fallopian tube, peritoneum, cervix and kidney.
Maltese: M'hemm l-ebda użu rilevanti ta' bevacizumab fil-popolazzjoni pedjatrika għall-indikazzjonijiet ta' trattament ta' kanċers tal-kolon, tar-rektum, tas-sider, tal-pulmun, tal-ovarji, tat-tubu fallopjan, talperitonew, taċ-ċerviċi u tal-kliewi.
English: Results from the primary analysis and the follow-up analysis are presented by bevacizumab treatment and by trial treatment in table 24 and 25, respectively.
Maltese: Ir-riżultati mill-analiżi primarja u l-analiżi ta' segwitu huma ppreżentati skont il-kura b'bevacizumab u skont il-kura tal-Prova f'tabella 24 u 25, rispettivament.
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 globali ntweriet f'termini ta' sopravivenza mingħajr progressjoni u sopravivenza globali fil-popolazzjoni eliġibbli ta' qabel il-protokoll.
English: Gastrointestinal disorders Gastrointestinal ulcer (not known) Hepatobiliary disorders
Maltese: Ulċera gastro-intestinali (mhux magħruf)
English: Secondary endpoints Progression-free survival - Primary analysis6 Median PFS (months)1 Hazard ratio [95% CI]
Maltese: Sopravivenza mingħajr progressjoni - Analiżi primarja6 PFS Medjana (xhur)1
English: Paclitaxel/ bevacizumab (n = 252)
Maltese: Paclitaxel/bevaciz umab (n = 252)
English: Ovarian failureb,c,d
Maltese: Insuffiċjenza talovarjib,ċ,d
English: Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1,250 mg/m2 intravenous infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with bevacizumab at a dose of 7.5 or 15 mg/kg IV infusion day 1 of every 3-week cycle.
Maltese: L-pazjenti kienu randomised għal kimoterapija bbażata fuq platinum, cisplatin 80 mg/m2 infużjoni filvini fl-ewwel ġurnata u gemcitabine 1,250 mg/m2 infużjoni fil-vini fl-ewwel u fit-tmin ġurnata ta' kull ċiklu ta' 3 ġimgħat sa 6 ċikli (CG) ma' plaċebo jew CG ma' bevacizumab f'doża ta' 7.5 jew 15 mg/kg infużjoni IV fl-ewwel ġurnata ta' kull ċiklu ta' 3 ġimgħat.
English: In a randomised phase II study (BO25041) a total of 121 patients aged ≥ 3 years to < 18 years with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high-grade glioma (HGG) were treated with post-operative radiation therapy (RT) and adjuvant temozolomide (T) with and without bevacizumab: 10 mg/kg every 2 weeks IV.
Maltese: Fi studju randomised ta' fażi II (BO25041) total ta' 121 pazjent b'età ta' ≥ 3 snin sa <18-il sena bi glijoma ta' grad għoli (HGG - high-grade glioma) supratentorali jew infratentorali fiċ-ċerebellum, jew fil-pedunkulu li għadha kif ġiet ddijanjostikata kienu trattati b'terapija ta' radjazzjoni (RT - radiation therapy) wara l-operazzjoni u temozolomide (T) wara din it-terapija flimkien ma' jew mingħajr bevacizumab: 10 mg/kg kull ġimagħtejn IV.
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 fir-riżultati tal-laboratorju ta' grad 3 u 4 (NCI-CTCAE v.3) li ġejjin seħħew f'pazjenti kkurati b'bevacizumab b'differenza ta' mill-inqas 2% meta mqabbel malgruppi ta' kontroll li jikkorrispondu: ipergliċemija, emoglobina mnaqqsa, ipokalimja, iponatrimja, għadd ta' ċelluli bojod tad-demm imnaqqas, żieda fil-proporzjon normalizzat internazzjonali (INRinternational normalised ratio).
English: Overall survival - Primary analysis6 Median (months)1
Maltese: Punt finali primarju Sopravivenza globali - Analiżi primarja6 Medjan (xhur)1
English: *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Maltese: *Bevacizumab huwa antikorp monoklonali rikombinant umanizzat, prodott permezz ta' teknoloġija tad-DNA f'ċelluli tal-Ovarji tal-Ħamster Ċiniż.
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 varjaw sa 3.8% fil-grupp b'bevacizumab meta mqabbla ma' inċidenza sa 2.1% fil-gruppi ta' kontroll b'kimoterapija.
English: Metastatic carcinoma of the colon or rectum (mCRC)
Maltese: Karċinoma tal-kolon jew tar-rektum li mmetastatizzat (mCRC - Metastatic carcinoma of the colon or rectum)
English: The addition of bevacizumab to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Maltese: Iż-żieda ta' bevacizumab ma' FOLFOX-4 wasslet f'titwil statistikament sinifikanti tas-sopravivenza.
English: In two subsequent studies in patients with treated brain metastases (which included around 800 patients), one case of grade 2 CNS haemorrhage was reported in 83 subjects treated with bevacizumab (1.2%) at the time of interim safety analysis (NCI-CTCAE v.3).
Maltese: F'żewġ studji sussegwenti f'pazjenti b'metastasi kkurati fil-moħħ (li kienu jinkludu madwar 800 pazjent), kien irrappurtat każ wieħed ta' emorraġija fis-CNS ta' grad 2 minn 83 individwu kkurat b'bevacizumab (1.2%) fil-ħin tal-analiżi interim tas-sigurtà (NCI-CTCAE v.3).
English: The percentage of patients with an ECOG PS of 1 or ≥ 2 was 38.7% and 5.0% in the CT arm, and 29.8% and 9.0% in the CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Maltese: Il-persentaġġ ta' pazjenti b'ECOG PS ta' 1 jew ≥ 2 kien ta' 38.7% u 5.0% fil-grupp ta' CT, u 29.8% u 9.0% fil-grupp ta' CT + BV.
English: Responders (response rate2) 95% CI for response rates3
Maltese: Dawk li rrispondew (rata ta' rispons2) CI ta' 95% għal rati ta' rispons3
English: Gastrointestinal perforationb,d, Intestinal perforation, Ileus,
Maltese: Perforazzjoni gastrointestinalib,d, Perforazzjoni talmusrana,
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: Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensinconverting enzyme inhibitors, diuretics and calcium-channel blockers.
Maltese: Il-pressjoni għolja ġeneralment kienet ikkontrollata b'mod xieraq permezz ta' anti-ipertensivi orali bħal inibituri tal-enzima li tibdel angiotensin, dijuretiċi u mblokkaturi tal-kanali tal-kalċju.
English: In clinical trials of ovarian cancer, grade 3-5 wound healing complications were observed in up to 1.8% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3).
Maltese: Fi provi kliniċi dwar kanċer tal-ovarji, komplikazzjonijiet fil-fejqan tal-feriti ta' grad 3-5 kienu osservati f'sa 1.8% tal-pazjenti fil-grupp ta' bevacizumab kontra 0.1% fil-grupp ta' kontroll (NCI-CTCAE v.3).
English: Relative to control arm.
Maltese: Relattiv għall-kategorija ta' kontroll.
English: • The primary analysis of investigator assessed PFS (censoring for CA-125 progressions and NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.52-0.75, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 12.0 months in the CPP arm and 18.2 months in the CPB15+ arm.
Maltese: • L-analiżi primarja ta' PFS evalwata mill-investigatur (ċensura għall-progressjonijiet ta' CA-125 u NPT) uriet proporzjon ta' periklu stratifikat ta' 0.62 (CI ta' 95%: 0.52-0.75, valur p log-rank ta' naħa waħda < 0.0001) meta CPB15+ huwa mqabbel ma' CPP, b'PFS medjana ta' 12.0-ilxahar fil-grupp CPP u 18.2 xhur fil-grupp CPB15+.
English: • The protocol-specified analysis of investigator assessed PFS (without censoring for CA-125 progression or non-protocol therapy [NPT]) shows a stratified hazard ratio of 0.71 (95% CI: 0.61-0.83, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 10.4 months in the CPP arm and 14.1 months in the CPB15+ arm.
Maltese: • L-analiżi speċifikata mill-protokoll ta' PFS evalwata mill-investigatur (mingħajr ċensura għallprogressjoni ta' CA-125 jew terapija mhux tal-protokoll [NPT - non-protocol therapy]) uriet proporzjon ta' periklu stratifikat ta' 0.71 (CI ta' 95%: 0.61-0.83, valur p log-rank ta' naħa waħda < 0.0001) meta CPB15+ huwa mqabbel ma' CPP, b'PFS medjana ta' 10.4 xhur fil-grupp CPP u 14.1 xahar fil-grupp CPB15+.
English: A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Maltese: Kien osservat profil ta' degradazzjoni li jiddependi mill-konċentrazzjoni meta dilwit ma' soluzzjonijiet ta' glukosju (5%).
English: Randomised patients stage III optimally debulked disease2,3
Maltese: Pazjenti randomised b'marda ta' stadju III bi tneħħija ottimali2,3
English: • A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with MVASI treatment.
Maltese: • Effett sekondarju newroloġiku rari msejjaħ sindrome ta' enċefalopatija riversibbli posterjuri (PRES - posterior reversible encephalopathy syndrome) ġie assoċjata ma' kura b'MVASI.
English: MVASI is not approved for use in patients under the age of 18 years.
Maltese: MVASI mhux approvat għall-użu f'pazjenti b'età inqas minn 18-il sena.
English: • It is possible that MVASI can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
Maltese: • Huwa possibbli li MVASI jista' jikkawża sensittività eċċessiva u/jew reazzjonijiet għallinfużjoni (reazzjonijiet relatati mal-injezzjoni tiegħek tal-mediċina).
English: Tumour assessments and response evaluations were determined by the investigators using the GOG RECIST criteria (Revised RECIST guideline (version 1.1).
Maltese: Valutazzjonijiet tat-tumur u evalwazzjonijiet tar-rispons kienu determinati mill-investigaturi bl-użu talkriterji GOG RECIST (Linja gwida RECIST riveduta (verżjoni 1.1).
English: • ML18147: bevacizumab 5.0 mg/kg of body weight every 2 weeks or bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin in patients with disease progression following first-line treatment with bevacizumab.
Maltese: • ML18147: bevacizumab 5.0 mg/kg ta' piż tal-ġisem kull ġimagħtejn jew bevacizumab 7.5 mg/kg ta' piż tal-ġisem kull 3 ġimgħat flimkien ma' fluoropyrimidine/irinotecan jew fluoropyrimidine/oxaliplatin f'pazjenti bi progressjoni tal-marda wara kura preferita b'bevacizumab.
English: These results were consistent with those from various sensitivity analyses and in clinically relevant subgroups.
Maltese: Dawn ir-riżultati kienu konsistenti ma' dawk minn diversi analiżi tas-sensittività u f'sottogruppi klinikament rilevanti.
English: 878 patients were randomised to the two arms.
Maltese: 878 pazjent kienu randomised għaż-żewġ gruppi.
English: Efficacy results1,2 from study GOG-0213
Maltese: Riżultati tal-effikaċja1,2 mill-istudju GOG-0213 Punt finali primarju
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 continued use of bevacizumab (15 mg/kg q3w) as single agent for a total of up to 15 months of therapy.
Maltese: • Grupp CPB15+: 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 użu kontinwu ta' bevacizumab (15 mg/kg q3w) bħala sustanza waħedha għal total sa 15-il xahar ta' terapija.
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: Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, bevacizumab therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy.
Maltese: Fatturi ta' riskju possibli jinkludu istoloġija ta' ċelluli skwamużi, kura b'mediċini anti-rewmatiċi/antiinfjammatorji, kura b'sustanzi kontra l-koagulazzjoni tad-demm, radjuterapija minn qabel, terapija b'bevacizumab, passat mediku minn qabel ta' arterjosklerosi, tumur f'lok ċentrali u formazzjoni ta' ħofra fit-tumuri qabel jew waqt it-terapija.
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 preferita ta' bevacizumab biex jirċievu kimoterapija bbażata fuq fluoropyrimidine/oxaliplatin jew fluoropyrimidine/irinotecan (kimoterapija maqluba skont ilkimoterapija preferita) flimkien ma' bevacizumab jew mingħajru.
English: A high proportion of patients (approximately 63% IFN/placebo; 55% bevacizumab/IFN) received a variety of non-specified post-trial anti-cancer therapies, including antineoplastic agents, which may have impacted the analysis of overall survival.
Maltese: Proporzjon għoli ta' pazjenti (madwar 63% IFN/plaċebo; 55% bevacizumab/IFN) irċevew varjetà ta' terapiji mhux speċifikati kontra l-kanċer wara l-prova, inkluż sustanzi anti-neoplastiċi, li setgħu kellhom effett fuq l-analiżi tas-sopravivenza globali.
English: • E3200: bevacizumab 10 mg/kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4) in bevacizumab-naïve patients.
Maltese: • E3200: bevacizumab 10 mg/kg ta' piż tal-ġisem kull ġimagħtejn flimkien ma' leucovorin u bolus ta' 5-fluorouracil, seġwit minn infużjoni ta' 5-fluorouracil, b'oxaliplatin (FOLFOX-4) filvini f'pazjenti li qatt ma ħadu bevacizumab qabel.
English: Efficacy results from study BO17707 (ICON7) Progression-free survival
Maltese: Riżultati tal-effikaċja minn studju BO17707 (ICON7)
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-kategoriji b'kimoterapija biss filparagun globali ntweriet f'termini ta' sopravivenza mingħajr progressjoni fil-popolazzjoni ITT (Tabella 7).
English: Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.
Maltese: Reazzjonijiet avversi sistemiċi inkluż emorraġiji mhux okulari u reazzjonijiet arterjali tromboemboliċi kienu rrappurtati wara injezzjoni ġol-vitriju ta' inibituri ta' VEGF.
English: • Pregnancy (see section 4.6).
Maltese: • Tqala (ara sezzjoni 4.6).