FrancophonIA/ELRC3.0 huggingface dataset:
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 iż-żewġ gruppi ta' trattament fil-ftit pazjenti li kellhom tumur li seta' jiġi evalwat fil-linja bażi u li kellhom rispons ikkonfermat qabel ma rċevew xi terapija lokali: 27/75
English: Table 21 Progression-free survival by time from last platinum therapy to recurrence Investigator Assessment
Maltese: Tabella 21 Sopravivienza mingħajr progressjoni skont iż-żmien mill-aħħar terapija ta' platinu sa rikorrenza
English: In clinical trials, the overall incidence of arterial thromboembolic reactions ranged up to 3.8% in the Avastin containing arms compared with up to 2.1% in the chemotherapy control arms.
Maltese: Fi provi kliniċi, l-inċidenza globali ta' reazzjonijiet trombo-embolitiċi arterjali varjaw sa 3.8% filgrupp b'Avastin meta mqabbla ma' inċidenza sa 1.7% fil-gruppi ta' kontroll b'kimoterapija.
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 Kajr-2, f'pazjenti b'mCRC jissuġġerixxu li l-użu tal-antikorpi monoklonali kontra EGFR panitumumab u cetuximab, rispettivament, flimkien ma' bevacizumab u kimoterapija, huwa assoċjat ma' tnaqqis f'PFS u/jew OS , u ma' żjieda fit-tossiċità meta mqabbel ma' kimoterapija u bevacizumab waħdu.
English: Advanced and/or metastatic renal cell cancer (mRCC)
Maltese: Kanċer taċ-ċelluli renali avanzat u/jew matastatiku (mRCC)
English: Chemotherapy was chosen at the investigator's discretion prior to randomisation in a 2:1 ratio to receive either chemotherapy plus Avastin or chemotherapy plus placebo.
Maltese: Kimoterapija kienet magħżul skont id-diskrezzjoni tal-investigatur qabel randomisation f'proporzjon ta' 2:1 biex jirċievu kimoterapija u Avastin jew kimoterapija u plaċebo.
English: • perforation of the gut,
Maltese: • perforazzjoni addominali,
English: 3 95% CI for one sample binomial using Pearson-Clopper method Approximate 95% CI for difference of two rates using Hauck-Anderson method 5 log-rank test (stratified)
Maltese: Dawk li rrispondew (Rata ta' rispons CI ta' 95% għal Rati ta' Rispons Differenza fir-Rati ta' Rispons CI ta' 95% għad-Differenza fir-Rati ta' Rispons Valur p (Test Chi-squared) Stimi Kaplan-Meier Pazjenti u persentaġġ ta' pazjenti bl-aħjar rispons globali ta' CR jew PR ikkonfermat; persentaġġ ikkalkulat fuq pazjenti b'marda li setgħet titkejjel fil-linja bażi 3 CI ta' 95% għal binomjali ta' kampjum wieħed bl-użu tal-metodu Pearson-Clopper 4 CI ta' madwar 95% għad-differenza ta' żewġ rati bl-użu tal-metodu Hauck-Anderson test log-rank (stratifikat) Analiżi primarja twettqet b'data meta waqfet tinġabar id-data ta' 12 ta' Diċembru 2012 u hija meqjusa l-analiżi finali
English: Progression-free survival (PFS)
Maltese: Punt Aħħari Sekondarju Sopravivenza Mingħajr Progressjoni (PFS)
English: • inflammation of the moist lining of mouth and gut, lungs and air passages, reproductive, and urinary tracts,
Maltese: • infjammazzjoni tal-kisja niedja tal-ħalq u l-musrana, pulmun u passaġġi tal-arja, apparat riproduttiv u tal-awrina,
English: • CPB15 arm: Five cycles of Avastin (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Maltese: Ħames ċikli ta' Avastin (15 mg/kg q3w inbeda f'ċiklu 2) flimkien ma' carboplatin (AUC 6) u paclitaxel (175 mg/m2) għal 6 ċikli segwit minn plaċebo waħdu, għal total sa 15-il xahar ta' terapija
English: Each ml of concentrate contains 25 mg of bevacizumab, corresponding to 1.4 to 16.5 mg/ml when diluted as recommended.
Maltese: Kull ml ta' konċentrat fih 25 mg ta' bevacizumab, li jikkorrispondu għal 1.4 sa 16.5 mg/ml meta dilwit kif irrakkomandat.
English: Vascular disorders Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Maltese: Mikroanġjopatija trombotika renali, li klinikament tista' tidher bħala proteina fl-awrina (mhux magħruf) b'użu fl-istess waqt ta' sunitinib jew mingħajru.
English: Testing for proteinuria is recommended prior to start of Avastin therapy.
Maltese: Ittestjar għall-proteina fl-awrina huwa rakkomandat qabel tinbeda terapija b'Avastin.
English: Statistical analyses were performed independently for 1) patients who received capecitabine in combination with Avastin or placebo; 2) patients who received taxane-based or anthracycline-based chemotherapy in combination with Avastin or placebo.
Maltese: Saret analiżi statisitka indipendenti għal 1) pazjenti li rċevew capecitabine flimkien ma' Avastin jew plaċebo; 2) pazjenti li rċevew terapija ibbażata fuq taxane jew terapija bbażata fuq anthracycline flimkien ma' Avastin jew plaċebo.
English: (p-value = 0.0188)
Maltese: (valur p = 0.8910)
English: • lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),
Maltese: • feriti fil-ħanek bl-għadma tax-xedaq mikxufa li ma jfiequx u li jistgħu jkunu assoċjati ma' uġigħ u infjammazzjoni tat-tessut tal-madwar (ara l-paragrafi taħt il-lista ta' effetti sekondarji għal rakkomandazzjonijiet oħra),
English: Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 7.5 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab for up to 18 cycles had a statistically significant improvement in PFS.
Maltese: Imqabbla ma' pazjenti kkurati b'kimoterapija (carboplatin u paclitaxel) waħedha fl-isfond ta' kura primarja, il-pazjenti li rċevew bevacizumab b'doża ta' 7.5 mg/kg q3w flimkien ma' kimoterapija u komplew jirċievu bevacizumab sa 18-il ċikli kellhom titjib statistikament sinifikanti f'PFS.
English: Addition of Avastin to standard of care did not demonstrate clinical benefit in clinical trial BO20924, in 71 evaluable children (from age 6 months to less than 18 years old) patients with metastatic Rhabdomyosarcoma and non-Rhabdomyosarcoma Soft Tissue Sarcoma.
Maltese: Iż-żieda ta' Avastin ma' kura standard ma wrietx benefiċċju kliniku fil-prova klinika BO20924, f'71 pazjenti tfal (b'età minn 6 xhur sa inqas minn 18-il sena) b'Rabdomijosarkoma metastatika u Sarkoma tat-Tessut l-Artab mhux Rabdomijosarkoma li setgħu jiġu evalwati (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • hole in the gall bladder (symptoms and signs may include abdominal pain, fever, and nausea/vomiting).
Maltese: • toqba fil-bużżieqa tal-marrara (sintomi u sinjali jistgħu jinkludu uġigħ addominali, deni, u tqalligħ/rimettar).
English: Pregnancy, breast feeding and fertility
Maltese: Tqala, treddigħ u fertilità
English: • NO16966: Avastin 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or Avastin 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: Avastin 7.5 mg/kg ta' piż tal-ġisem kull 3 ġimgħat flimkien ma' capecitabine orali u oxaliplatin (XELOX) ġol-vini jew Avastin 5 mg/kg kull ġimagħtejn flimkien ma' leucovorin u bolus ta' 5-fluorouracil, seġwit minn infużjoni ta' 5-fluorouracil, b'oxaliplatin (FOLFOX-4) ġolvini.
English: Treatment with Avastin at 15 mg/kg every 3 weeks in combination with chemotherapy (carboplatin and paclitaxel) for 6 and up to 8 cycles, followed by Avastin until disease progression or unacceptable toxicity resulted, when data were derived from eCRF, in a clinically meaningful and statistically significant improvement in OS compared to treatment with carboplatin and paclitaxel alone.
Maltese: Trattament b'Avastin b'doża ta' 15 mg/kg kull 3 ġimgħat flimkien ma' kimoterapija (carboplatin u paclitaxel) għal 6 u sa 8 ċikli, segwit minn Avastin sal-progressjoni tal-marda jew sal-okkorrenza ta' tossiċità inaċċettabbli wassal, meta data kienet derivata minn eCRF, għal titjib klinikament sinifikanti u statistikament sinifikanti f'OS meta mqabbel ma' carboplatin u paclitaxel waħedhom.
English: Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, Avastin 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/anti-infjammatorji, kura b'sustanzi kontra l-koagulazzjoni tad-demm, radjuterapija minn qabel, terapija b'Avastin, passat mediku minn qabel ta' arterjosklerożi, tumur f'lok ċentrali u formazzjoni ta' ħofra fir-tumuri qabel jew waqt itterapija.
English: including pulmonary embolism (NCI-CTCAE v.3).
Maltese: Pazjenti b'reazzjonijiet tromboemboliċi ta' ≤ Grad 3 għandhom jiġu sorveljati mill-viċin (NCI-CTCAE v.3).
English: Relative to control arm
Maltese: Relattiv għall-kategorija ta' kontroll
English: 5 mg/kg every 2 weeks.
Maltese: 5 mg/kg kull ġimagħtejn.
English: The initial dose should be delivered over 90 minutes as an intravenous infusion.
Maltese: Id-doża tal-bidu għandha tingħata fuq medda ta' 90 minuta bħala infużjoni fil-vini.
English: Patients receiving Avastin plus chemotherapy, with a history of arterial thromboembolism, diabetes or age greater than 65 years have an increased risk of developing arterial thromboembolic reactions during therapy.
Maltese: Pazjenti li qed jirċievu Avastin flimkien ma' kimoterapija, b'passat ta' trombo-emboliżmu arterjali, dijabete jew età aktar minn 65 sena għandhom riskju akbar ta' żvilupp ta' reazzjonijiet tromboembolitiċi arterjali waqt il-kura.
English: Overall survival Median (months) Hazard ratio 95% CI
Maltese: Numru ta' pazjenti Sopravivenza totali Ħin medjan (xhur) 95% CI Hazard ratio c
English: Avastin 10 mg/kg was given every 2 weeks until disease progression.
Maltese: Avastin 10 mg/kg ingħata kull ġimagħtejn salprogressjoni tal-marda.
English: Detailed information about these post-marketing reactions are provided in Table 3.
Maltese: Informazzjoni dettaljata dwar dawn ir-reazzjonijiet ta' wara t-tqegħid fis-suq huma pprovduti f'Tabella 3.
English: The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with Avastin.
Maltese: Iżżieda osservata fil-krejatinina fis-serum ma kinitx assoċjata ma' inċidenza ogħla ta' manifestazzjonijiet kliniċi ta' indeboliment renali f'pazjenti ttrattati b'Avastin.
English: Study MO22224 evaluated the efficacy and safety of bevacizumab in combination with chemotherapy for platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Maltese: Studju MO22224 evalwa l-effikaċja u s-sigurtà ta' bevacizumab flimkien ma' kimoterapija għallkanċer tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew reżistenti għallplatinu.
English: Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 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: • pain, including headache, back pain and pain in the pelvis and anal regions,
Maltese: • uġigħ, inkluż uġigħ ta' ras, uġigħ ta' dahar u uġigħ fil-pelvi u l-partijiet anali,
English: In trial E2100, patients were treated until disease progression.
Maltese: Fil-prova E2100, il-pazjenti kienu kkurati sal-progressjoni tal-marda.
English: Each 16 ml vial contains 400 mg of bevacizumab, corresponding to 16.5 mg/ml when diluted as recommended
Maltese: Kull kunjett ta' 16 ml fih 400 mg ta' bevacizumab, li jikkorrispondu għal 16.5 mg/ml meta dilwit kif irrakkomandat.
English: Relative to the control arm.
Maltese: Relattiv għall-kategorija ta' kontroll.
English: The results of this study are summarised in Table 16.
Maltese: Lista ta' reazzjonijiet avversi f'tabella
English: Lethargy
Maltese: Erlotinib
English: ● It is possible that Avastin may increase the risk of developing holes in the gut wall.
Maltese: • Avastin jista' jżid ir-riskju li tiżviluppa qalb dgħajfa.
English: Myalgia
Maltese: Emorraġija
English: ● This medicine can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Maltese: • Din il-mediċina tista' żżid ir-riskju ta' fsada jew iżżid ir-riskju ta' problemi bil-fejqan tal-ferita wara kirurġija.
English: Placebo or Avastin
Maltese: Paclitaxel/Avasti
English: Febrile neutropenia, Leucopenia, Neutropeniab, Thrombo-cytopenia
Maltese: Newtropenija biddeni, Lewkopenija, Newtropenijab, T romboċit openija
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, perforazzjoni gastro-intestinali kienet irrappurtata b'inċidenza ta' anqas minn 1% f'pazjenti b'kanċer tas-sider li mmetastatizza jew kanċer taċ-ċelluli mhux żgħar, mhux skwamuż tal pulmun, sa 2.0% f'pazjenti b'kanċer metastatiku taċ-ċellula renali jew f'pazjenti b'kanċer tal-ovarji, usa 2.7% (inkluż fistula u axxess gastro-intestinali) f'pazjenti b'kanċer tal-kolon jew tar-rektum li mmetastatizza.
English: There is evidence suggesting that all Grade (US National Cancer InstituteCommon Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Maltese: Hemm evidenza li tissuġġerixxi li proteina fl-awrina ta' kull Grad (US National Cancer Institute-Common Terminology Criteria għall-Avvenimenti Avversi
English: Tumour-associated haemorrhage (see section 4.4)
Maltese: Fejqan tal-feriti (ara sezzjoni 4.4)
English: Based on a substudy from NSABP C-08 with 295 patients d For additional information refer below within section "Further information on selected serious adverse reactions."
Maltese: Ibbażat fuq sottostudju minn NSABP C-08 b'295 pazjent.
English: MAHA is a haemolytic disorder which can present with red cell fragmentation, anaemia, and thrombocytopenia.
Maltese: MAHA hija disturb emolitiku li tista' tidher bi frammentazzjoni taċ-ċelluli l-ħomor, anemija u tromboċitopenja.
English: Median OS (months) Hazard Ratio (95% CI) p-value
Maltese: Medjan (xhur) Proporzjon ta' periklu (CI ta' 95%) valur p
English: Avastin will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Maltese: Avastin se jingħata flimkien ma' paclitaxel u cisplatin jew, b'mod alternattiv, paclitaxel u topotecan lil pazjenti li ma jistgħux jirċievu terapija bi platinu.
English: According to the two-compartmental model, the elimination half-life is 18 days for a typical female patient and 20 days for a typical male patient.
Maltese: Skond il-mudell ta' żewġ kompartimenti, il-half-life ta' leliminazzjoni hija ta' 18-il ġurnata għall-pazjenta femminili tipika u ta' 20 ġurnata għall-pazjent maskili tipiku.
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 minnufih, il-ħin u l-kondizzjonijiet ta' ħażna ta' waqt l-użu huma rresponsabbilita ta' min qed jużah u normalment ma jkunx aktar minn 24 siegħa f'2°C sa' 8°C, sakemm id-dilwazzjoni ma saritx taħt kondizzjonijiet ikkontrollati u assettiċi ivvalidati.
English: Reactions consistent with CHF were reported in clinical trials.
Maltese: Titjib klinikament u statistikament sinifikanti f'PFS kien osservata fiż-żewġ provi.
English: p-value 3, 4 Objective response Rate
Maltese: Valur p muri għal skop deskrittiv biss
English: Hypomagnesaemia Hyponatraemia
Maltese: Artralġja Majalġja
English: The majority of patients (CP: 64.6%; CPB: 68.8%) were in the age category < 65 years.
Maltese: L-età medjana kienet ta' 60.0 sena fil-grupp ta' CP u 59.0 sena fil-grupp ta' CPB. Ilmaġġoranza tal-pazjenti (CP: 64.6%; CPB: 68.8%) kienu fil-kategorija ta' età ta' < 65 sena.
English: Eligible patients had epithelial ovarian, fallopian tube or primary peritoneal cancer that progressed within <6 months of previous platinum therapy consisting of a minimum of 4 platinum therapy cycles.
Maltese: Pazjenti eliġibbli kellhom kanċer tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju talperitonew li kellu progressjoni fi żmien <6 xhur wara terapija preċedenti ta' platinu li kienet tikkonsisti minn minimu ta' 4 ċikli ta' terapija bi platinu.
English: Posterior Reversible Encephalopathy Syndrome (see section 4.4) There have been rare reports of Avastin-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder.
Maltese: Kien hemm rapporti rari ta' pazjenti kkurati b'Avastin li żviluppaw sinjali u sintomi li huma konsistenti ma' PRES, disturb newroloġiku rari.
English: For dilution and other handling recommendations, see section 6.6.
Maltese: Għad-dilwizzjoni u rakkomandazzjonijiet oħra dwar l-immaniġġar, ara sezzjoni 6.6.
English: A total of 484 patients with measurable disease were randomised 1:1 to either: • Carboplatin (AUC4, Day 1) and gemcitabine (1000 mg/m2 on Days 1 and 8) and concurrent placebo every 3 weeks for 6 and up to 10 cycles followed by placebo (every 3 weeks) alone until disease progression or unacceptable toxicity
Maltese: • Carboplatin (AUC4, Ġurnata 1) u gemcitabine (1000 mg/m2 f'Ġurnata 1 u 8) u plaċebo fl-istess waqt kull 3 ġimgħat għal 6 ċikli u sa 10 ċikli segwit minn plaċebo (kull 3 ġimgħat) waħdu salprogressjoni tal-marda jew tossiċità mhux aċċettabli
English: Number of patients Overall survival Median time (months) 95% CI Hazard ratioc p-value
Maltese: Numru ta' pazjenti Sopravivenza totali Ħin medjan (xhur) 95% CI Hazard ratio b
English: Each 4 ml vial contains 100 mg of bevacizumab, corresponding to 1.4 mg/ml when diluted as recommended.
Maltese: Kull kunjett ta' 4 ml fih 100 mg ta' bevacizumab, li jikkorrispondu għal 1.4 mg/ml meta dilwit kif irrakkomandat.
English: In one clinical trial, the incidence of hypertension of grade ≥ 3 was two fold higher in patients aged > 65 years than in the younger age group (<65 years).
Maltese: Fi prova klinika waħda, l-inċidenza ta' pressjoni għolja ta' grad ≥ 3 kienet ogħla d-doppju f'pazjenti b'età > 65 sena meta mqabbel mal-grupp ta' età iżgħar (<65 sena).
English: Table 7 Key efficacy results for the superiority analysis (ITT population, trial NO16966) Endpoint (months)
Maltese: Tabella 7 Riżultati importanti tal-effikaċja għall-analiżi tas-superjorità (popolazzjoni
English: Hazard ratio Best overall response ratea
Maltese: Hazard ratio Valur p
English: HR (95% CI) p-value # A total of 154 patients (ECOG Performance Status 0 or 1) were randomized.
Maltese: PFS Medjana (xhur) Proporzjon ta' periklu (95% CI) 1 Analiżi ta' PFS evalwata mill-investigatur b'data cut-off ta' 30 ta' Novembru 2010.
English: • CT Arm (chemotherapy alone):
Maltese: • Grupp CT (kimoterapija waħedha):
English: Overall Response Rate
Maltese: Rata ta' Rispons Globali
English: This was a phase II randomised, double-blind, active-controlled clinical trial evaluating the efficacy and safety of Avastin in combination with 5-FU/FA as first-line treatment for metastatic colorectal cancer in patients who were not optimal candidates for first-line irinotecan treatment.
Maltese: II randomised, double-blind u active-controlled li stmat l-effikaċja u s-sigurtà ta' Avastin f'taħlita ma' kimoterapija b'5-FU/FA għall-kura primarja ta' kanċer metastatiku tal-kolon jew rektum f'pazjenti li ma kienux kandidati idejali għall-kura primarja b'irinotecan.
English: Pulmonary hypertensionc, Nasal septum perforationc
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Wound healing complications a,b
Maltese: Komplikazzjonijiet fil-fejqan talferiti a,b
English: 1 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 2 With gross residual disease.
Maltese: Analiżi ta' PFS speċifikata mill-protokoll GOG evalwata mill-investigatur (la iċċensurata għall-progressjonijiet ta' CA-125 u lanqas iċċensurata għal NPT qabel il-progressjoni tal-marda) b'data cut-off tad-data ta' 25 ta' Frar,
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 Avastin + IFN alfa-2a arm compared to IFN alfa-2a arm.
Maltese: 0219), li jindika tnaqqis ta' 22% fir-riskju ta' mewt għall-pazjenti filgrupp ta' Avastin+ IFN alfa-2a meta mqabbel mal-grupp ta' IFN alfa-2a.
English: • CPP arm: Five cycles of placebo (started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Maltese: • Grupp CPP: Ħames ċikli ta' plaċebo (inbeda f'ċiklu 2) flimkien ma' carboplatin (AUC 6) u paclitaxel (175 mg/m2) għal 6 ċikli segwit minn plaċebo waħdu, għal total sa 15-il xahar ta' terapija
English: • ML18147: Avastin 5.0 mg/kg of body weight every 2 weeks or Avastin 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: Avastin 5.0 mg/kg ta' piż tal-ġisem kull ġimagħtejn jew Avastin 7.5 mg/kg ta' piż talġisem kull 3 ġimgħat flimkien ma' fluoropyrimidine/irinotecan jew fluoropyrimidine/oxaliplatin f'pazjenti bi progressjoni tal-marda wara kura preferita b'bevacizumab.
English: Gastrointestinal haemorrhages, including rectal bleeding and melaena have been reported in colorectal cancer patients, and have been assessed as tumour-associated haemorrhages.
Maltese: Emorraġiji gastro-intestinali, inkluż fsada mir-rektum u melaena kienu rrappurtati f'pazjenti b'kanċer tal-kolorektum, u kienu stmati bħala emorraġiji assoċjati mat-tumur.
English: Non-GI Fistulae (see section 4.4) Avastin use has been associated with serious cases of fistulae including reactions resulting in death.
Maltese: Fistuli mhux GI (ara sezzjoni 4.4) L-użu ta' Avastin kien assoċjat ma' każijiet serji ta' fistuli inkluż reazzjonijiet li rriżultaw f'mewt.
English: 4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
Maltese: 4 ml ta' soluzzjoni f'kunjett (ħġieġ ta' Tip I) b'tapp (lasktu butyl) li fih 100 mg ta' bevacizumab. 16 ml ta' soluzzjoni f'kunjett (ħġieġ ta' Tip I) b'tapp (lasktu butyl) li fih 400 mg ta' bevacizumab.