FrancophonIA/ELRC3.0 huggingface dataset:
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + Avastin) 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 + Avastin) qabel it-twaqqif ta' din ilkategorija, is-sopravivenza medjana totali kienet ta' 18.3 xhur u s-sopravivenza bla progressjoni medjana kienet ta' 8.8 xhur.
English: Binding of the IgG to the FcRn receptor results in protection from cellular metabolism and the long terminal half-life.
Maltese: Twaħħil ta' IgG mar-riċettur ta' FcRn jirriżulta fi protezzjoni mill-metaboliżmu ċellulari u half-life terminali twila.
English: Table 26 Overall survival results from study GOG-0240 by Trial Treatment Treatment
Maltese: Tabella 26 Riżultati ta' sopravivenza globali mill-istudju GOG-0240 skont il-Kura tal-prova
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: Serious wound healing complications, including anastomotic complications, with a fatal outcome have been reported.
Maltese: Kienu rrappurtati komplikazzjonijiet serji fil-fejqan tal-feriti, inkluż komplikazzjonijiet anastomiċi, b'riżultat fatali.
English: A total of 361 patients were enrolled into this study and administered either chemotherapy (paclitaxel, topotecan, or pegylated liposomal doxorubicin (PLD) alone or in combination with bevacizumab:
Maltese: Total ta' 361 pazjent kienu rreġistrati f'dan l-istudju u ngħataw kimoterapija (paclitaxel, topotecan, jew doxorubicin liposomali pegilat (PLD - pegylated liposomal doxorubicin) waħedha jew flimkien ma' bevacizumab:
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: 7.5 mg/kg q 3 weeks
Maltese: 7.5 mg/kg q 3 ġimgħat
English: The incidence of AEs, including Grade ≥ 3 AEs and SAEs, was similar between the two treatment arms.
Maltese: L-inċidenza ta' AEs, inklużi AEs u SAEs ta' Grad ≥ 3, kienet simili bejn iż-żewġ gruppi ta' trattament.
English: Dyspnoea, Rhinitis
Maltese: Ipoxja, Disfonijaa
English: Final overall survival analysis performed when 46.9% of the patients had died.
Maltese: Analiżi finali tas-sopravivenza globali mwettqa meta 46.9% tal-pazjenti kienu mietu.
English: (p-value = 0.0062)
Maltese: (valur p = 0.0062)
English: Topotecan+ Paclitaxel vs. Cisplatin+ Paclitaxel
Maltese: Topotecan+Paclitaxel vs.
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating Avastin 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3weekly schedule; or Avastin 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 Avastin 7.5 mg/kg f'taħlita ma' capecitabine orali u oxaliplatin IV (XELOX), mogħti fuq skeda ta' kull 3 ġimgħat; jew Avastin 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: 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 Avastin (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 għejja meta mqabbla ma' dawk b'età ≤ 65 sena meta kkurati b'Avastin (ara sezzjoni 4.4 u 4.8 taħt Trombo-emboliżmu).
English: Venous thromboembolic reactions include deep venous thrombosis, pulmonary embolism and thrombophlebitis.
Maltese: Reazzjonijiet trombo-embolitiċi venużi jinkludu trombożi fil-vini l-kbar, emboliżmu fil-pulmun u tromboflebite.
English: The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarized in Table 24.
Maltese: L-analiżi esploratorja ta' PFS u OS skont il-koorti ta' kimoterapija (paclitaxel, topotecan u PLD) huma miġbura fil-qosor f'Tabella 24.
English: ● you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Maltese: • Sensittività eċċessiva għall-prodotti taċ-ċelluli tal-Ovarji tal-Ħamster Ċiniż (CHO) jew għall antikorpi oħra umani rikombinanti jew umanizzati.
English: Both the 5 mg/kg/week and 2.5 mg/kg/week equivalent doses of bevacizumab provided a statistically significant benefit with regards to OS (HR 0.751 in study E3200;
Maltese: Iddożi ekwivalenti għal 5 mg/kg/ġimgħa u 2.5 mg/kg/ġimgħa ta' bevacizumab it-tnejn ipprovdew benefiċċju statistikament sinifikanti rigward OS (HR ta' 0.751 fl-istudju E3200;
English: This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of Avastin 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' Avastin flimkien ma' interferon (IFN) alfa-2a kontra
English: IFN alfa-2a was given up to 52 weeks or until disease progression at a recommended starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
Maltese: IFN alfa-2a ingħata sat-52 ġimgħa jew sal-progressjoni tal-marda f'doża rakkomandata tal-bidu ta' 9 MIU tliet darbiet fil-ġimgħa, li tippermetti tnaqqis fid-doża għal 3 MIU tliet darbiet fil-ġimgħa f'2 passi.
English: Pelvic Pain
Maltese: Uġigħ fil-pelvi
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: 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 ta' l-anqas 12-il xahar qabel il-bidu tal-prova.
English: weeks (n=39), 10 mg/kg every 2 weeks; (n=37), or placebo (n=40).
Maltese: Total ta' 116-il pazjent kienu randomised biex jirċievu bevacizumab 3 mg/kg kull ġimagħtejn (n=39), 10 mg/kg kull ġimagħtejn; (n=37), jew plaċebo (n=40).
English: 3.7% of the overall randomised patient population had Stage IIIB disease.
Maltese: 3 3.7% tal-popolazzjoni globali ta' pazjenti randomised kellhom marda ta' Stadju IIIB.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea (EMA) għall-Mediċini http://www.ema.europa.eu
English: This study was designed as an open-label, randomized, 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: Alternatively, a 1.25 mg/m2 dose could be administered over 30 minutes on Days 1-5
Maltese: B'mod alternattiv, doża ta' 1.25 mg/m2 tista' tingħata fuq 30 minuta fi Ġranet 1-5 kull 3 ġimgħat.
English: In a randomized 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: Arterial thromboembolism (see section 4.8)
Maltese: Trombo-emboliżmu arterjali (ara sezzjoni 4.8)
English: * Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm
Maltese: Sopravivenza totali medjana* Hazard ratio (97.5% CI) * Analiżi tas-sopravivenza totali fit-twaqqif kliniku fil-31 ta' Jannar 2007 ** Analiżi primarja fit-twaqqif kliniku fil-31 ta' Jannar 2006
English: In study JO25567, all grade hypertension was observed in 77.3% of the patients who received Avastin 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 Avastin 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: However, somnolence and syncope have been reported with Avastin use (see table 1 in section 4.8).
Maltese: Madankollu, ngħas u sinkope kienu irrappurtati bl-użu ta' Avastin (ara tabella 1 f'sezzjoni 4.8).
English: Erlotinib N = 77#
Maltese: N = 77
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.8) Patients may be at an increased risk for the development of gastrointestinal perforation and gall bladder perforation when treated with Avastin.
Maltese: Perforazzjonijiet gastro-intestinali (GI - gastrointestinal) u Fistuli (ara sezzjoni 4.8) Il-pazjenti jistgħu jkunu f'risku akbar li jiżviluppaw perforazzjoni gastro-intestinali u perforazzjoni tal-marrara meta kkurati b'Avastin.
English: Progression-free survival - Primary analysis6 Median PFS (months)1
Maltese: Sopravivenza mingħajr progressjoni - Analiżi primarja PFS Medjana (xhur)
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 cut-off ta' 28 ta' Frar 2010 uriet proporzjon ta' periklu mhux stratifikat ta' 0.79 (95% CI: 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: E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating Avastin 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 Avastin bħala kura primarja ta' pazjenti b'NSCLC avvanzat lokalment (stadju IIIb b'effużjoni plewrali malinni), metastatiku jew rikorrenti minbarra istoloġija bi predominanza ta' ċelluli skwamużi.
English: Later infusions may be given to you over 30 minutes.
Maltese: Infużjonijiet oħra jistgħu jingħatawlek fuq medda ta' 30 minuta.
English: Results from the primary analysis and the follow-up analysis are presented by Avastin Treatment and by Trial Treatment in Table 25 and Table 26, respectively.
Maltese: Ir-riżultati mill-analiżi primarja u l-analiżi ta' segwitu huma ppreżentati skont il-Kura b'Avastin u skont il-Kura tal-Prova f'Tabella 25 u Tabella 26, rispettivament.
English: • a negative effect on a woman's ability to have children (see the paragraphs below the list of side effects for further recommendations),
Maltese: • effett negattiv fuq il-ħila ta' mara li jkollha t-tfal (ara l-paragrafi taħt il-lista ta' effetti sekondarji għal aktar rakkomandazzjonijiet),
English: Arm 2 IFL + Avastina
Maltese: IFL +Avastina
English: This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation.
Maltese: Din il-kondizzjoni normalment hija sekondarja għall-komplikazzjonijiet fil-fejqan ta' feriti, perforazzjoni gastro-intestinali jew formazzjoni ta' fistula.
English: 3 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: This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) plus bevacizumab to RCHOP without bevacizumab.
Maltese: III qabblet rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) flimkien ma' bevacizumab ma' R-CHOP mingħajr bevacizumab.
English: Avastin is a concentrate for solution for infusion.
Maltese: Avastin huwa konċentrat għal soluzzjoni għall-infużjoni.
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' CA125 u NPT) uriet proporzjon ta' periklu stratifikat ta' 0.62 (95% CI: 0.52-0.75, valur p logrank ta' naħa waħda < 0.0001) meta CPB15+ huwa mqabbel ma' CPP, b'PFS medjana ta' 12.0-il-xahar fil-grupp CPP u 18.2 xhur fil-grupp CPB15+.
English: Hypersensitivity, infusion reactions a,b,c
Maltese: Sensittività eċċessiva, Reazzjonijiet għallinfużjoni a,b,ċ
English: High-grade glioma
Maltese: GĦAMLA KWALITATTIVA
English: Other medicines and Avastin
Maltese: Mediċini oħra u Avastin
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 Avastin 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 Avastin meta mqabbel ma' mhux aktar minn 0.9% tal-pazjenti fil-gruppi ta' kontroll (NCI-CTCAE v.3).
English: Table 2: Severe Adverse Reactions by Frequency System organ class
Maltese: Tabella 1: Reazzjonijiet Avversi skont il-Frekwenza Klassi tas-sistemi u tal-organi
English: Table 24: Exploratory PFS and OS analyses by chemotherapy cohort CT
Maltese: Analiżi esploratorja ta' PFS u OS skont il-koorti ta' kimoterapija 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: Across clinical trials, the following Grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patients treated with Avastin 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'Avastin b'ta' mill-inqas differenza ta' 2% meta mqabbel mal-gruppi ta' kontroll li jikkorrispondu: ipergliċemija, emoglobina mnaqqsa, ipokalimja, iponatrimja, għadd ta' ċelluli bojod tad-demm imnaqqas, żjieda fil-proporzjon normalizzat internazzjonali (INRinternational normalised ratio).
English: Hypertensive encephalopathyc
Maltese: Enċefalopatija ipertensivaa
English: Gastrointestinal disorder, Stomatitis, Proctalgia
Maltese: , Disturbi gastro-intestinali, Stomatite, Proktalġja
English: ● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with Avastin treatment.
Maltese: • Effett sekondarju newroloġiku rari msejjaħ sindrome ta' enċefalopatija riversibbli posterjuri (PRES - posterior reversible encephalopathy syndrome) ġie assoċjata ma' kura b'Avastin.
English: EGFR mutation status was determined for each patient prior to patient screening and 154 patients were randomised to receive either erlotinib + Avastin (erlotinib 150 mg oral daily + Avastin [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 + Avastin (erlotinib 150 mg mill-ħalq kuljum + Avastin [15 mg/kg IV kull 3 ġimgħat]) jew monoterapija ta' erlotinib (150 mg mill-ħalq kuljum) salprogressjoni tal-marda (PD - disease progression) jew sa tossiċità inaċċettabbli.
English: (p-value = 0.0012)
Maltese: (valur p = 0.0012)
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: 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 ta' l-endotilju, u ma jiddependix primarjament minn eliminazzjoni mill-kliewi u l-fwied.
English: Myalgia, Arthralgia, Muscular weakness, Back Pain
Maltese: Mijalġja, Artralġja, Dgħufija fil-muskoli, Uġigħ ta' dahar
English: • AVF4095g evaluated the efficacy and safety of bevacizumab in combination with carboplatin and gemcitabine, followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Maltese: • AVF4095g evalwa l-effikaċja u s-sigurtà ta' bevacizumab flimkien ma' carboplatin u gemcitabine, segwit minn bevacizumab bħala sustanza waħedha f'pazjenti b'kanċer rikorrenti tal-epitelju talovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew sensittivi għall-platinu.
English: • problems with wound healing after surgery,
Maltese: • problemi bil-fejqan tal-ferita wara operazzjoni,
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 irrapportat każ wieħed ta' emorraġija fis-CNS ta' Grad 2 minn 83 individwu kkurat b'bevacizumab (1.2%) fil-ħin ta' l-analiżi interim tas-sigurtà (NCI-CTCAE v.3).
English: Pain, Lethargy, Mucosal Inflammation
Maltese: Uġigħ, Letarġija, Infjammazzjoni tal-mukuża
English: Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Maltese: Emboliżmu pulmonari, Epistassi, Qtugħ ta' nifs, Ipoxja
English: Each 4 ml vial contains 100 mg of bevacizumab.
Maltese: Kull kunjett fih 100 mg bevacizumab.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/300/002
English: Overall approximately 34% of patients were FIGO Stage III optimally debulked with gross residual disease, 40% Stage III sub-optimally debulked, and 26% were Stage IV patients.
Maltese: Globalment madwar 34% ta' pazjenti kienu FIGO Stadju III bi tneħħija ottimali b'marda residwa sostanzjali, 40% kienu Stadju III bi tneħħija inqas minn ottimali, u 26% kienu pazjenti ta' Stadju IV.
English: This was a phase III randomised, active-controlled, open-label trial investigating Avastin 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 Avastin 10 mg/kg f'taħlita ma' leucovorin b'bolus ta' 5-fluorouracil u wara infużjoni ta' 5-fluorouracil, b'oxaliplatin IV (FOLFOX-4), mogħti fuq skeda ta' kull ġimagħtejn f'pazjenti kkurati minn qabel (ittieni linja) b'kanċer avvanzat tal-kolorektum.
English: Laboratory abnormalities
Maltese: Anormalitajiet fir-riżultati tal-laboratorju
English: Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
Maltese: Fistuli rekto-vaġinali huma l-aktar fistuli komuni fil-kategorija fistula GI-vaġinali.
English: A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Maltese: Kien osservat profil ta' degradazzjoni li jiddependi mil-konċentrazzjoni meta dilwit ma' soluzzjonijiet ta' glukosju (5%).
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014 8 p-value displayed for descriptive purpose only
Maltese: Analiżi ta' segwitu twettqet b'data meta waqfet tinġabar id-data ta' 07 ta' Marzu 2014; il-valuri p kollha huma murija għal skop deskrittiv biss
English: • The analysis of PFS as determined by the independent review committee (censoring for NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.50-0.77, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 13.1 in the CPP arm and 19.1 months in the CPB15+ arm.
Maltese: • L-analiżi ta' PFS kif determinata mill-kumitat ta' evalwazzjoni indipendenti (ċensura għal NPT) uriet proporzjon ta' periklu stratifikat ta' 0.62 (95% CI: 0.50-0.77, valur p log-rank ta' naħa waħda < 0.0001) meta CPB15+ huwa mqabbel ma' CPP, b'PFS medjana ta' 13.1 filgrupp CPP u ta' 19.1 xahar fil-grupp CPB15+.
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/oxaliplatinor 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: Do not use Avastin if:
Maltese: Tużax Avastin:
English: Gallbladder perforation b,c
Maltese: Perforazzjoni tal-bużżieqa talmarrarab,c
English: Progression-free survivalb Investigator Assessment
Maltese: Sopravivenza mingħajr progressjoni Valutazzjoni tal-Investigatur