FrancophonIA/ELRC3.0 huggingface dataset:
English: Information on foetal malformations observed in the post-marketing setting are provided in sections 4.6 and 4.8.
Maltese: Informazzjoni dwar malformazzjonijiet tal-fetu osservati fl-ambjent ta' wara t-tqegħid fis-suq huma pprovduti fis-sezzjonijiet 4.6 u 4.8.
English: Dyspnoea, Rhinitis, Epistaxis, Cough
Maltese: Stomatite, Stitikezza, Dijarea,
English: The efficacy data from trials AVF0780g and AVF2192g investigating bevacizumab in combination with 5-FU/FA chemotherapy are summarised in table 5.
Maltese: It-tagħrif dwar l-effikaċja mill-provi AVF0780g u AVF2192g li studjaw lil bevacizumab f'taħlita ma' kimoterapija b'5-FU/FA huma miġbura fil-qosor f'tabella 5.
English: Ninety-seven (97) patients in the IFN alfa-2a arm and 131 patients in the bevacizumab arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
Maltese: Sebgħa u disgħin (97) pazjent fil-grupp ta' IFN alfa-2a u 131 pazjent fil-grupp ta' bevacizumab naqqsu d-doża ta' IFN alfa-2a minn 9 MIU għal 6 jew 3 MIU tliet darbiet fil-ġimgħa kif speċifikat minn qabel fil-protokoll.
English: The European Medicines Agency has waived the obligation to submit the results of studies, in all subsets of the paediatric population, in breast carcinoma, adenocarcinoma of the colon and rectum, lung carcinoma (small cell and non-small cell carcinoma), kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney), ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours), fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours), peritoneal carcinoma (excluding blastomas and sarcomas) and cervix and corpus uteri carcinoma.
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji f'kull sett tal-popolazzjoni pedjatrika, b'karċinoma tas-sider, adenokarċinoma tal-kolon u r-rektum, karċinoma tal-pulmun (karċinoma taċ-ċellula żgħira u mhux taċ-ċellula żgħira), karċinoma tal-kliewi u tal-pelvi tal-kliewi (barra nefroblastoma, nefroblastomatosi, sarkoma b'ċelluli ċari, nefroma mesoblastika, karċinoma tal-medulla tal-kliewi u tumur rhabdoid tal-kliewi), karċinoma tal-ovarji (barra rabdomajosarkoma u tumuri taċ-ċelluli ġerminali), karċinoma tat-tubu fallopjan (barra rabdomajosarkoma u tumuri taċ-ċelluli ġerminali), karċinoma tal-peritonew (barra blastomi u sarkomi) u karċinoma tal-għonq u tal-corpus tal-utru.
English: The pharmacokinetics of bevacizumab were evaluated in 152 children, adolescents and young adults (7 months to 21 years, 5.9 to 125 kg) across 4 clinical studies in paediatrics using a population pharmacokinetic model.
Maltese: Il-farmakokinetika ta' bevacizumab ġiet evalwata f'152 tifel u tifla, adolexxenti u adulti żagħżagħ (7 xhur sa 21 sena, 5.9 sa 125kg) minn 4 studji kliniċi fil-pedjatrija bl-użu ta' mudell tal-farmakokinetika tal-popolazzjoni.
English: Combinations of MVASI with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Maltese: Kombinazzjonijiet ta' MVASI ma' mediċina oħra msejjħa sunitinib malate (preskritt għall-kanċer talkliewi u kanċer gastro-intestinali) jistgħu jikkawżaw effetti sekondarji severi.
English: The addition of bevacizumab to fluoropyrimidine-based chemotherapy resulted in a statistically significant prolongation of survival in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen (ITT = 819) (see table 9).
Maltese: Iż-żieda ta' bevacizumab ma' kimoterapija bbażata fuq fluoropyrimidine wasslet għal titwil statistikament sinifikanti fis-sopravivenza f'pazjenti b'mCRC li kellhom progressjoni fuq kors ta' kura preferita li kien fih bevacizumab (ITT = 819) (ara tabella 9).
English: (p-value5 < 0.0001)
Maltese: (valur p5 < 0.0001)
English: 5 mg/kg IV 30-90 min Day 1, prior to FOLFOX-4, every 2 weeks
Maltese: 5 mg/kg IV 30-90 min Fl-ewwel ġurnata, qabel FOLFOX-4, kull ġimagħtejn
English: Pain,
Maltese: Deni,
English: Venous thromboembolic reactions include deep venous thrombosis, pulmonary embolism and thrombophlebitis.
Maltese: Reazzjonijiet tromboemboliċi venużi jinkludu trombożi fil-vini tal-fond, emboliżmu fil-pulmun u tromboflebite.
English: ** Primary analysis at clinical cut-off 31 January 2006.
Maltese: * Analiżi tas-sopravivenza globali fit-twaqqif kliniku fil-31 ta' Jannar 2007. ** Analiżi primarja fit-twaqqif kliniku fil-31 ta' Jannar 2006.
English: The study did not meet its primary endpoint of demonstrating a significant improvement of event free survival (EFS) (Central Radiology Review Committee (CRRC)-assessed) when bevacizumab was added to the RT/T arm compared with RT/T alone (HR = 1.44; 95% CI: 0.90, 2.30).
Maltese: L-istudju ma ssodisfax il-punt finali primarju tiegħu li juri titjib sinifikanti ta' sopravivenza mingħajr avveniment (EFS - event free survival) (evalwat minn Kumitat Ċentrali ta' Analiżi tar-Radjoloġija (CRRC - Central Radiology Review Committee)) meta bevacizumab kien miżjud mal-grupp ta' RT/T meta mqabbel ma' RT/T waħedhom (HR  1.44; CI ta' 95%: 0.90, 2.30).
English: The primary endpoint was progression-free survival based on investigator assessment using modified RECIST 1.0.
Maltese: Il-punt finali primarju kien sopravivenza mingħajr progressjoni bbażata fuq valutazzjoni talinvestigatur bl-użu ta' RECIST 1.0. modifikat.
English: In the chemotherapy arms, the FOLFOX-4 regimen used the same doses and schedule as shown in table 6 for trial NO16966.
Maltese: Fil-kategoriji tal-kimoterapija, il-kors ta' FOLFOX-4 uża l-istess dożi u skeda kif muri f'tabella 6 għall-prova NO16966.
English: Endpoint (months)
Maltese: Punt finali (xhur)
English: Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of treated patients.
Maltese: Proteina fl-awrina ta' grad 4 (sindrome nefrotika) kienet osservata f'mhux aktar minn 1.4% tal-pazjenti kkurati.
English: The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarised in table 23.
Maltese: L-analiżi esploratorja ta' PFS u OS skont il-koorti ta' kimoterapija (paclitaxel, topotecan u PLD) huma miġbura fil-qosor f'tabella 23.
English: Investigator assessed GOG protocol-specified PFS analysis (neither censored for CA-125 progressions nor censored for NPT prior to disease progression) with data cut-off date of 25 February, 2010.
Maltese: Analiżi ta' PFS speċifikata mill-protokoll GOG evalwata mill-investigatur (la iċċensurata għallprogressjonijiet ta' CA-125 u lanqas iċċensurata għal NPT qabel il-progressjoni tal-marda) b'data meta waqfet tinġabar id-dejta ta' 25 ta' Frar, 2010.
English: The rates of discontinuation due to adverse events in the subgroup of patients > 65 years old were 8.8% in the CT arm and 50.0% in the CT + BV arm.
Maltese: Ir-rati ta' waqfien minħabba avvenimenti avversi fis-sottogrupp ta' pazjenti b'età ta' > 65 sena kienu ta' 8.8% fil-grupp ta' CT u 50.0% filgrupp ta' CT + BV.
English: Secondary endpoint Progression-free survival (PFS)
Maltese: Valur p Punt finali sekondarju Sopravivenza mingħajr progressjoni (PFS)
English: The population pharmacokinetics were analysed in adult and paediatric patients to evaluate the effects of demographic characteristics.
Maltese: Il-farmakokinetika tal-popolazzjoni ġiet analizzata f'pazjenti adulti u pedjatriċi sabiex jiġu evalwati leffetti ta' karatteristiċi demografiċi.
English: This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of bevacizumab in combination with interferon (IFN) alfa-2a versus IFN alfa-2a alone as first-line treatment in mRCC.
Maltese: III, randomised u double-blind imwettqa biex tivvaluta l-effikaċja u s-sigurtà ta' bevacizumab flimkien ma' interferon (IFN) alfa-2a kontra
English: The overall incidence of NCI-CTC grade 3 and 4 hypertension in patients receiving bevacizumab ranged from 0.4% to 17.9%.
Maltese: Linċidenza globali ta' pressjoni għolja ta' NCI-CTC grad 3 u 4 f'pazjenti li kienu qed jirċievu bevacizumab varjat minn 0.4% sa 17.9%.
English: Infections and infestations Necrotising fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation (rare) (see also section 4.4)
Maltese: Faxxite b'nekrosi, ġeneralment sekondarja għall-komplikazzjonijiet filfejqan ta' feriti, perforazzjoni gastro-intestinali jew formazzjoni ta' fistula (rari) (ara wkoll sezzjoni 4.4)
English: This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/ vincristine/prednisone (R-CHOP) plus bevacizumab to R-CHOP without bevacizumab.
Maltese: III qabblet rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) flimkien ma' bevacizumab ma' R-CHOP mingħajr bevacizumab.
English: Efficacy results for trial AVF2107g
Maltese: Riżultati ta' effikaċja għall-prova AVF2107g
English: Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CPP (n = 253)
Maltese: PFS Medjana (xhur) Proporzjon ta' periklu (CI ta' 95%)4 Pazjenti randomised b'marda ta' stadju III bi tneħħija mhux ottimali3 CPP (n = 253)
English: Hypoxia, Dysphoniaa
Maltese: Ipoxja, Disfonijaa
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating bevacizumab 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3-weekly schedule; or bevacizumab 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Maltese: III, randomised, double-blind (għal bevacizumab), li nvestigat bevacizumab 7.5 mg/kg f'taħlita ma' capecitabine orali u oxaliplatin IV (XELOX), mogħti fuq skeda ta' kull 3 ġimgħat; jew bevacizumab 5 mg/kg f'taħlita ma' leucovorin u bolus ta' 5-fluorouracil, segwit minn infużjoni ta' 5-fluorouracil, ma' oxaliplatin IV (FOLFOX-4), mogħti fuq skeda ta' kull ġimagħtejn.
English: Trial results show that 94% (277 / 296) of eligible patients went on to receive single agent bevacizumab at cycle 7.
Maltese: Riżultati tal-prova juru li 94% (277 / 296) tal-pazjenti eliġibbli komplew biex jirċievu bevacizumab bħala sustanża waħedha f'ċiklu 7.
English: MVASI should be discontinued permanently in patients who experience grade 3 or 4 bleeding during bevacizumab therapy (NCI-CTCAE v.3) (see section 4.8).
Maltese: MVASI għandu jitwaqqaf għal kollox f'pazjenti li jkollhom esperjenza ta' fsada ta' grad 3 jew 4 waqt terapija b'bevacizumab (NCI-CTCAE v.3) (ara sezzjoni 4.8).
English: Arterial thromboembolism (see section 4.8)
Maltese: Tromboemboliżmu arterjali (ara sezzjoni 4.8)
English: Advanced and/or metastatic renal cell cancer (mRCC)
Maltese: Kanċer avanzat u/jew metastatiku taċ-ċelluli renali (mRCC - metastatic renal cell cancer)
English: In locally recurrent and metastatic breast cancer trials, grade 3-5 wound healing complications were observed in up to 1.1% of patients receiving bevacizumab compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
Maltese: Fi provi b'kanċer tas-sider lokalizzat, rikorrenti u li mmetastatizza, kienu osservati komplikazzjonijiet ta' grad 3-5 fil-fejqan tal-feriti f'mhux aktar minn 1.1% tal-pazjenti li kienu qed jirċievu bevacizumab meta mqabbel ma' mhux aktar minn 0.9% tal-pazjenti fil-gruppi ta' kontroll (NCI-CTCAE v.3).
English: Topotecan + Paclitaxel vs. Cisplatin + Paclitaxel
Maltese: Topotecan + Paclitaxel vs.
English: The safety and efficacy of bevacizumab, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in trials E4599 and BO17704.
Maltese: Is-sigurtà u l-effikaċja ta' bevacizumab, flimkien ma' kimoterapija bbażata fuq platinum, fil-kura primarja ta' pazjenti b'kanċer fil-pulmun mhux skwamuż, taċ-ċelluli mhux żgħar (NSCLC), kienu nvestigati fil-provi E4599 u BO17704.
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.
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: The median age was 46.0 years (range: 20-83) in the chemo alone group and 48.0 years (range: 22-85) in the chemo + bevacizumab group; with 9.3% of patients in the chemo alone group and 7.5% of patients in the chemo + bevacizumab group over the age of 65 years.
Maltese: L-età medjana kienet ta' 46.0 sena (firxa: 20-83) fil-grupp ta' kimo waħedha u ta' 48.0 sena (firxa: 22-85) fil-grupp ta' kimo + bevacizumab; b'9.3% tal-pazjenti fil-grupp ta' kimo waħedha u 7.5% talpazjenti fil-grupp ta' kimo + bevacizumab b'età 'l fuq minn 65 sena.
English: • comparative incidences noted between clinical trial treatment arms (with at least a 10%
Maltese: • inċidenza komparattiva innutata bejn il-gruppi ta' kura tal-prova klinika (b'differenza ta'
English: Each vial contains 100 mg bevacizumab in 4 mL of solution or 400 mg bevacizumab in 16 mL of solution.
Maltese: Kull kunjett fih 100 mg bevacizumab f'4 mL ta' soluzzjoni jew 400 mg bevacizumab f'16 mL ta' soluzzjoni.
English: However, somnolence and syncope have been reported with bevacizumab use (see table 1 in section 4.8).
Maltese: Madankollu, ngħas u sinkope kienu irrappurtati bl-użu ta' bevacizumab (ara tabella 1 f'sezzjoni 4.8).
English: In study BO25041 of bevacizumab added to post-operative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with bevacizumab.
Maltese: Fl-istudju BO25041 ta' bevacizumab flimkien ma' terapija ta' radjazzjoni (RT - radiation therapy) wara l-operazzjoni b'temozolomide fl-istess waqt u wara dan it-trattament f'pazjenti pedjatriċi bi glijoma ta' grad għoli supratentorali, infratentorali, fiċ-ċerebellum, jew fil-pedunkulu li għadhom kif ġew ddijanjostikati, il-profil ta' sigurtà kien komparabbli ma' dak osservat b'tipi oħra ta' tumuri f'adulti ttrattati b'bevacizumab.
English: Efficacy results from study MO22224 Primary endpoint
Maltese: Riżultati tal-effikaċja minn studju MO22224
English: Other reactions with a higher frequency seen in patients over 65 were grade 3-4 leucopenia and thrombocytopenia (NCI-CTCAE v.3); and all grade neutropenia, diarrhoea, nausea, headache and fatigue as compared to those aged ≤ 65 years when treated with bevacizumab (see sections 4.4 and 4.8 under Thromboembolism).
Maltese: Reazzjonijiet oħra bi frekwenza ogħla li kienu osservati f'pazjenti b'età ta' aktar minn 65 kienu lewkopenija u tromboċitopenija ta' grad 3-4 (NCI-CTCAE v.3); u newtropenija ta' kull grad, dijarea, tqalligħ, uġigħ ta' ras u għeja meta mqabbla ma' dawk b'età ≤ 65 sena meta kkurati b'bevacizumab (ara sezzjonijiet 4.4 u 4.8 taħt Tromboemboliżmu).
English: The primary efficacy endpoint was overall survival (OS).
Maltese: Il-punt finali primarju tal-effikaċja kien is-sopravivenza globali (OS - overall survival).
English: In study JO25567, all grade hypertension was observed in 77.3% of the patients who received bevacizumab in combination with erlotinib as first-line treatment for non-squamous NSCLC with EGFR activating mutations, compared to 14.3% of patients treated with erlotinib alone.
Maltese: Fi studju JO25567, pressjoni għolja ta' kull grad kienet osservata f'77.3% tal-pazjenti li rċevew bevacizumab flimkien ma' erlotinib bħala trattament ippreferut għal NSCLC mhux skwamuż b'mutazzjonijiet li jattivaw EGFR, meta mqabbel ma' 14.3% tal-pazjenti ttrattati b'erlotinib waħdu.
English: The primary analysis of investigator assessed PFS with a data cut-off date of 28 February 2010 shows an unstratified hazard ratio of 0.79 (95% CI: 0.68-0.91, 2-sided log-rank p-value 0.0010) with a median PFS of 16.0 months in the CP arm and 18.3 months in the CPB7.5+ arm.
Maltese: L-analiżi primarja ta' PFS evalwata mill-investigatur b'data meta waqqfet tinġabar id-dejta ta' 28 ta' Frar 2010 uriet proporzjon ta' periklu mhux stratifikat ta' 0.79 (CI ta' 95%: 0.68-0.91, valur p log-rank ta' żewġ naħat 0.0010) b'PFS medjana ta' 16.0 il-xahar fil-grupp CP u ta' 18.3 xhur fil-grupp CPB7.5+.
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.4)
Maltese: Perforazzjonijiet gastro-intestinali (GI - gastrointestinal) u Fistuli (ara sezzjoni 4.8)
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-0240), 1.8% of bevacizumab-treated patients and 1.4% of control patients were reported to have had nongastrointestinal vaginal, vesical, or female genital tract fistulae.
Maltese: Minn prova klinika f'pazjenti b'kanċer persistenti, rikorrenti jew metastatiku tal-għonq tal-utru (GOG0240), 1.8% tal-pazjenti kkurati b'bevacizumab u 1.4% tal-pazjenti fuq kontroll kien irrappurtat li kellhom fistuli mhux gastro-intestinali vaġinali, tal-bużżieqa tal-awrina, jew tal-apparat ġenitali femminili.
English: Efficacy results for trial E3200
Maltese: Riżultati tal-effikaċja għall-prova E3200
English: There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder.
Maltese: Kien hemm rapporti rari ta' pazjenti kkurati b'bevacizumab li żviluppaw sinjali u sintomi li huma konsistenti ma' PRES, disturb newroloġiku rari.
English: Alternatively, a 1.25 mg/m2 dose could be administered over 30 minutes on days 1-5 every 3 weeks.
Maltese: B'mod alternattiv, doża ta' 1.25 mg/m2 tista' tingħata fuq 30 minuta fi ġranet 1-5 kull 3 ġimgħat.
English: In clinical trials, the incidence of arterial thromboembolic reactions including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs) was higher in patients receiving bevacizumab in combination with chemotherapy compared to those who received chemotherapy alone.
Maltese: Fi provi kliniċi randomised, l-inċidenza ta' reazzjonijiet tromboemboliċi arterjali, inkluż aċċidenti ċerebrovaskulari (CVAs - cerebrovascular accidents), attakki iskemiċi temporanji (TIAs - transient ischaemic attacks) u infarti mijokardiċi (Mis - myocardial infarctions), kienet għola f'pazjenti li qed jirċievu bevacizumab flimkien ma' kimoterapija meta mqabbla ma' pazjenti li ħadu kimoterapija biss.
English: A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
Maltese: Dijanjosi ta' PRES tinħtieġ li tiġi kkonfermata permezz ta' immaġini tal-moħħ, preferibbilment immaġini ta' reżonanza manjetika (MRI - magnetic resonance imaging).
English: • NO16966: bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or bevacizumab 5 mg/kg every 2 weeks in combination with leucovorin plus 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
Maltese: • NO16966: bevacizumab 7.5 mg/kg ta' piż tal-ġisem kull 3 ġimgħat flimkien ma' capecitabine orali u oxaliplatin (XELOX) fil-vini jew bevacizumab 5 mg/kg kull ġimagħtejn flimkien ma' leucovorin u bolus ta' 5-fluorouracil, seġwit minn infużjoni ta' 5-fluorouracil, b'oxaliplatin (FOLFOX-4) fil-vini.
English: In clinical trials across indications, the overall incidence of venous thromboembolic reactions ranged from 2.8% to 17.3% of bevacizumab-treated patients compared with 3.2% to 15.6% in the control arms.
Maltese: Fi provi kliniċi fil-firxa tal-indikazzjonijiet kollha, l-inċidenza globali ta' reazzjonijiet tromboemboliċi venużi varjaw minn 2.8% sa 17.3% fil-pazjenti kkurati b'bevacizumab meta mqabbla ma' 3.2% sa 15.
English: Adjustment for these baseline factors resulted in a treatment hazard ratio of 0.78 (95% CI [0.63; 0.96], p = 0.0219), indicating a 22% reduction in the risk of death for patients in the bevacizumab + IFN alfa-2a arm compared to IFN alfa-2a arm.
Maltese: Aġġustament għal dawn il-fatturi fil-linja bażi irriżulta fi proporzjon ta' periklu tal-kura ta' 0.78 (CI ta' 95% [0.63; 0.96], p = 0.0219), li jindika tnaqqis ta' 22% fir-riskju ta' mewt għall-pazjenti fil-grupp ta' bevacizumab + IFN alfa-2a meta mqabbel mal-grupp ta' IFN alfa-2a.
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-żieda ta' bevacizumab ma' IFL wassal għal żiediet statistikament sinifikanti fis-sopravivenza globali , fis-sopravivenza mingħajr progressjoni u fir-rata ta' rispons totali (ara tabella 4).
English: E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating bevacizumab as first-line treatment of patients with locally advanced (stage IIIB with malignant pleural effusion), metastatic or recurrent NSCLC other than predominantly squamous cell histology.
Maltese: E4599 kienet prova klinika open-label, randomised, ikkontrollata b'mod attiv, li saret f'ħafna ċentri li vvalutat bevacizumab bħala kura primarja ta' pazjenti b'NSCLC avanzat lokalment (stadju IIIB b'effużjoni plewrali malinna), metastatiku jew rikorrenti minbarra istoloġija bi predominanza ta' ċelluli skwamużi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1246/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1246/002
English: 3.7% of the overall randomised patient population had stage IIIB disease.
Maltese: 3.7% tal-popolazzjoni globali ta' pazjenti randomised kellhom marda ta' stadju IIIB.
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 plus bevacizumab 15 mg/kg IV on day 1 (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 ġranet 1-3 flimkien ma' bevacizumab 15 mg/kg IV f'jum 1 (q3w)
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 randomised mitmuma f'pazjenti b'diversi tipi ta' tumuri, 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 wieħed (grad 5) minn 96 pazjent (1%) li ma kienux esposti għal bevacizumab.
English: Fatal outcome was reported in 0.8% of patients receiving bevacizumab compared to 0.5% in patients receiving chemotherapy alone.
Maltese: Riżultat fatali kien irrappurtat f'0.8% tal-pazjenti li ngħataw bevacizumab, meta mqabbla ma' 0.5% fil-pazjenti li rċievew kimoterapija biss.
English: Immune system disorders Hypersensitivity reactions and infusion reactions (not known); with the following possible co-manifestations: dyspnoea/difficulty breathing, flushing/redness/rash, hypotension or hypertension, oxygen desaturation, chest pain, rigors and nausea/vomiting (see also section 4.4 and Hypersensitivity reactions/infusion reactions above)
Maltese: Reazzjonijiet ta' sensittività eċċessiva u reazzjonijiet għall-infużjoni (mhux magħrufa); bil-possibbiltà tal-manifestazzjonijiet li ġejjin flistess waqt: qtugħ ta' nifs/diffikultà biex tieħu n-nifs, fwawar/ħmura/raxx, pressjoni baxxa jew pressjoni għolja, desaturazzjoni ta' ossiġnu, uġigħ fis-sider, tertir u tqalligħ/rimettar (ara wkoll sezzjoni 4.4 u Reazzjonijiet ta' sensittività eċċessiva/relatati malinfużjoni fuq)