FrancophonIA/ELRC3.0 huggingface dataset:
English: The HR for PFS was 0.47 (95% CI: 0.35, 0.62) and 0.45 (95% CI: 0.31, 0.67) for the < 65 and ≥ 65 subgroups, respectively.
Maltese: L-HR għal PFS kien ta' 0.47 (CI ta' 95%: 0.35, 0.62) u 0.45 (CI ta' 95%: 0.31, 0.67) għas-sottogruppi ta' < 65 u ≥ 65, rispettivament.
English: Anaemia, Lymphopenia
Maltese: Anemija, Limfopenija
English: Table 23 Efficacy Results from Study MO22224
Maltese: Tabella 23 Riżultati tal-Effikaċja minn Studju MO22224
English: • localised pus collection,
Maltese: • ġabra lokalizzata ta' materja,
English: Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
Maltese: Hoffmann-La Roche Pharma AG Tel: +49 (0) 7624 140
English: • abnormal urine test (protein in the urine),
Maltese: • test ta' l-awrina mhux normali (proteina fl-awrina),
English: FOLFOX-4 or XELOX + bevacizumab (n=699)
Maltese: jew XELOX + bevacizumab (n=699)
English: 2 Investigator assessed PFS analysis with data cut-off date of 30 November 2010.
Maltese: 2 Analiżi ta' PFS evalwata mill-investigatur b'data meta waqqfet tinġabar id-data ta' 30 ta' Novembru 2010.
English: fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy + Avastina
Maltese: kimoterapija bbażata fuq fluoropyrimidine/irinotecan jew fluoropyrimidine/oxaliplatin kimoterapija bbażata fuq fluoropyrimidine/irinotecan jew fluoropyrimidine/oxaliplatin + Avastina
English: 3 One-sided log-rank p-value Subject to a p-value boundary of 0.0116.
Maltese: Suġġett għal-limitu ta' valur p ta' 0.0116.
English: System organ class
Maltese: Klassi tas sistemi u talorgani
English: Avastin vs. No Avastin
Maltese: Avastin vs.
English: Overall response rate Rate (%)
Maltese: Rata ta' Rispons totali Rata (%)
English: (p-value
Maltese: (valur p
English: Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 Avastin + FOLFOX-4 and 244 Avastin monotherapy).
Maltese: Tmin mija u disgħa u għoxrin pazjent kienu randomised (292 FOLFOX-4, 293 Avastin + FOLFOX-4 u 244 b'monoterapija ta' Avastin).
English: Most patients had EOC (82% in CPP and CPB15, 85% in CPB15+) followed by PPC (16% in CPP, 15% in CPB15, 13% in CPB15+) and FTC (1% in CPP, 3% in CPB15, 2% in CPB15+).
Maltese: Ilmaġġoranza tal-pazjenti kellhom EOC (82% f'CPP u CPB15, 85% f'CPB15+) segwit minn PPC (16% f'CPP, 15% f'CPB15, 13% f'CPB15+) u FTC (1% f'CPP, 3% f'CPB15, 2% f'CPB15+).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/001 - 100 mg/4 ml vial EU/1/04/300/002 - 400 mg/16 ml vial
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/300/001 - kunjett ta' 100 mg/4 ml EU/1/04/300/002 - kunjett ta' 400 mg/16 ml
English: Gastrointestinal perforation a,b
Maltese: Perforazzjoni gastrointestinali a,b
English: • spontaneous reporting,
Maltese: • rappurtar spontanju,
English: (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: IRC Assessment
Maltese: Valutazzjoni IRC
English: The majority of patients in both arms had an ECOG Performance Status (PS) of 0 (CT: 56.4% vs. CT + BV: 61.2%).
Maltese: Il-maġġoranza tal-pazjenti fiż-żewġ gruppi kellhom Stat ta' Ħila (PS - Performance Status) ECOG ta' 0 (CT: 56.4% kontra CT + BV: 61.2%).
English: Table 18 Efficacy results from study BO17707 (ICON7)
Maltese: Tabella 18 Riżultati tal-effikaċja minn studju BO17707 (ICON7)
English: A total of 16 patients (4.4%) were > 75 years old.
Maltese: Total ta' 16-il pazjent (4.4%) kellhom età ta' > 75 sena.
English: Hazard ratio (95% CI) > 12 months (n=282) Median
Maltese: Proporzjon ta' periklu (95% CI) > 12-il xahar (n=282)
English: The recommended dose is 5 mg, 7.5 mg, 10 mg or 15 mg per kilogram of your body weight.
Maltese: Id-doża rakkomandata hija ta' 5 mg, 7.5 mg, 10 mg jew 15 mg għal kull kilogramma tal-piż tiegħek.
English: PFS^ (months)
Maltese: PFS^ (xhur)
English: HR 0.81 in study ML18147) and PFS (HR 0.518 in study E3200; HR 0.68 in study ML18147).
Maltese: HR ta' 0.81 fl-istudju ML18147) u PFS (HR ta' 0.518 fl-istudju E3200;
English: (p-value 0.3360)
Maltese: (valur p 0.3360)
English: • lack of energy,
Maltese: • nuqqas ta' enerġija,
English: Avastin may impair female fertility (see sections 4.6 and 4.8).
Maltese: Avastin jista' jtellef il-fertilità femminili (ara sezzjonijiet 4.6 u 4.8).
English: Arm 1 IFL + placebo
Maltese: Kategorija 1 IFL + plaċebo
English: (16.2 vs 17.5 months; p = 0.3769)
Maltese: (16.2 vs 17.5 xhur; p = 0.3769)
English: The majority of patients had EOC (87.7%) followed by PPC (6.9%) and FTC (3.7%) or a mixture of the three origins (1.7%).
Maltese: Il-maġġoranza tal-pazjenti kellhom EOC (87.7%) segwit minn PPC (6.9%) u FTC (3.7%) jew taħlita tat-tliet oriġini (1.7%).
English: Best Overall Response - Primary analysis6
Maltese: Sopravivenza globali - Analiżi primarja1
English: F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 CH-4070 Basel Switzerland
Maltese: Hoffmann-La Roche Ltd Grenzacherstrasse 124
English: An overall survival benefit has been demonstrated in trial E4599 with a 15 mg/kg/q3wk dose of bevacizumab.
Maltese: Intwera benefiċċju globali ta' sopravvivenza fil-prova E4599 b'doża ta' 15 mg/kg/q3wk ta' bevacizumab.
English: Posterior Reversible Encephalopathy Syndrome (PRES), (rare) (see also section 4.4)
Maltese: Sindrome ta' Enċefalopatija Riversibbli Posterjuri (PRES - Posterior Reversible Encephalopathy Syndrome), (rari) (ara wkoll sezzjoni 4.4)
English: Objective Response Rate (ORR) Patients included in analysis Rate
Maltese: Rata ta' Rispons Oġġettiv (ORR) Pazjenti inklużi fl-analiżi
English: The majority of patients had serous adenocarcinoma histologic type (85% in CPP and CPB15, 86% in CPB15+).
Maltese: Ilmaġġoranza tal-pazjenti kellhom adenokarċinoma seruża tat-tip istoloġika (85% f'CPP u CPB15, 86% f'CPB15+).
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Stabilità kimika u fiżika ta' waqt l-użu ntweriet għal 48 siegħa f'2°C sa' 30°C f'soluzzjoni għallinjezzjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/ml to 16.5 mg/ml.
Maltese: Il-konċentrazzjoni tas-soluzzjoni finali ta' bevacizumab għandha tinżamm fil-firxa ta' 1.4 mg/ml sa 16.5 mg/ml.
English: FOLFOX-4 or XELOX + placebo (n=701)
Maltese: jew XELOX + plaċebo (n=701)
English: • Study AVF3694g (capecitabine) • Median PFS increase 2.9 months, HR 0.69 (p = 0.0002, 95% CI 0.56; 0.84)
Maltese: • Żjieda medjana f'PFS 2.9 xhur, HR 0.69 (p = 0.0002, 95% CI 0.56 ; 0.84)
English: Leucovorin 200 mg/m2 IV 2 h 5-Fluorouracil
Maltese: Leucovorin 200 mg/m2 IV 2 h 5-Fluorouracil 400 mg/m2 IV bolus,
English: Cisplatin/Gemcitabine + placebo
Maltese: Cisplatin/Gemcitabine + plaċebo
English: Table 12 Efficacy results for trial E4599
Maltese: Tabella 12 Riżultati ta' l-effikaċja għall-prova E4599
English: Arm 2
Maltese: Kategorija 2
English: (p-value = 0.3113)
Maltese: (valur p = 0.3113)
English: • high blood pressure.
Maltese: • pressjoni għolja.
English: (11.9 vs.14.3 months; p = 0.4825)
Maltese: (11.9 vs.14.3 xhur; p = 0.4825)
English: Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01X C07
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi u immunomodulaturi, sustanzi antineoplastiċi, sustanzi antineoplastiċi oħra, antikorpi monoklonali, Kodiċi ATC:
English: Table 22 Efficacy results1,2 from study GOG-0213 Primary Endpoint
Maltese: Tabella 22 Riżultati tal-effikaċja1,2 mill-istudju GOG-0213 Punt Aħħari Primarju
English: The 131 patients in the Avastin + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the trial, exhibited at 6, 12 and 18 months PFS event free rates of 73, 52 and 21% respectively, as compared to 61, 43 and 17% in the total population of patients receiving Avastin + IFN alfa-2a.
Maltese: Il-131 pazjent fil-grupp ta' Avastin + IFN alfa-2a li naqqsu u żammew id-doża ta' IFN alfa-2a f'6 jew 3 MIU waqt il-prova, wrew rati ta' PFS mingħajr avvenimenti wara 6, 12 u 18-il xahar ta' 73, 52 u 21% rispettivament, meta mqabbel ma' 61, 43 u 17% fil-popolazzjoni totali ta' pazjenti li kienu qed jirċievu Avastin + IFN alfa-2a.
English: 5-Fluorouracil: IV bolus injection immediately after leucovorin
Maltese: 5-Fluorouracil: injezzjoni bolus IV minnufih wara leucovorin
English: IRF assessment
Maltese: valutazzjoni IRF
English: <2D barcode carrying the unique identifier included.>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: XELOX or XELOX + Avastin
Maltese: jew XELOX+
English: Table 5 Efficacy results for trials AVF0780g and AVF2192g AVF0780g
Maltese: Riżultati dwar l-effikaċja għall-provi AVF0780g u AVF2192g
English: The rate of infusion was based on tolerability, with an initial infusion duration of 90 minutes.
Maltese: Ir-rata ta' infużjoni kienet ibbażata fuq it-tollerabilità, b'rata ta' infużjoni fil-bidu ta' 90 minuta.
English: 6 - 12 months (n=202) Median
Maltese: 6 - 12-il xahar (n=202)
English: • Topotecan 4 mg/m2 as a 30-minute IV infusion on Days 1, 8, and 15 every 4 weeks.
Maltese: • Topotecan 4 mg/m2 bħala infużjoni IV ta' 30 minuta fi Ġranet 1, 8, u 15 kull 4 ġimgħat.
English: Table 4 Efficacy results for trial AVF2107g
Maltese: Tabella 4 Riżultati ta' effikaċja għall-prova AVF2107g
English: Most patients were FIGO Stage III (both 68%) followed by FIGO Stage IV (13% and 14%), FIGO Stage II (10% and 11%) and FIGO Stage I (9% and 7%).
Maltese: Il-biċċa l-kbira tal-pazjenti kienu FIGO Stadju III (it-tnejn 68%) segwit minn FIGO Stadju IV (13% u 14%), FIGO Stadju II (10% u 11%) u FIGO Stadju I (9% u 7%).
English: Due date the MAH should discuss any further outcome data on the combination of bevacizumab + erlotinib in this indication (e.g. data from the ongoing ACCRU study, NCT number NCT01532089) (due date: Q2 2019)
Maltese: L-MAH għandu jiddiskuti kwalunkwe data oħra dwar riżultati tal-kombinazzjoni ta' bevacizumab + erlotinib f'din l-indikazzjoni (eż. data mill-istudju li għadu għaddej tal-ACCRU, numru tal-NCT NCT01532089) (data mistennija:
English: It is recommended that treatment be continued until disease progression or unacceptable toxicity (see section 5.1, study MO22224).
Maltese: Huwa rakkomandat li l-kura titkompla sa progressjoni tal-marda jew tossiċità mhux aċċettabbli (ara sezzjoni 5.1, studju MO22224).
English: Gastrointestinal ulcera
Maltese: Ulċera gastrointestinalia
English: Proteinuriab,d
Maltese: Proteina flawrinab,d
English: At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72).
Maltese: Fiż-żmien tal-analiżi primarju finali, il-punt finali primarju ta' EFS minn analiżi ċentrali indipendenti ma weriex differenza statistikament sinifikanti bejn iż-żewġ gruppi ta' trattament, b'HR ta' 0.93 (CI ta' 95%: 0.61, 1.41; valur p = 0.72).
English: Congestive heart failure (CHF)
Maltese: Insuffiċjenza tal-qalb konġestiva (CHF)
English: Very Rare
Maltese: Rari
English: Avastin may impair female fertility.
Maltese: Avastin jista' jnaqqas il-fertilità femminili.
English: difference compared to the control arm for NCI-CTCAE Grade 3-5 reactions,
Maltese: NCI-CTCAE Grad 3-5,
English: Bevacizumab 10 mg/kg q 2 wk
Maltese: Bevacizumab 10 mg/kg q ġimagħtejn
English: Overall approximately 50% of patients had a GOG PS of 0 at baseline, 43% a GOG PS score of 1, and 7% a GOG PS score of 2.
Maltese: Globalment madwar 50% tal-pazjenti kellhom GOG PS ta' 0 fil-linja bażi, 43% punteġġ GOG PS ta' 1, u 7% punteġġ GOG PS ta' 2.
English: Oxaliplatin 85 mg/m2 IV 2 h Oxaliplatin on day 1 Leucovorin on day 1 and 2
Maltese: Oxaliplatin 85 mg/m2 IV 2 h Oxaliplatin fl-Ewwel ġurnata Leucovorin fl-ewwel u fit-tieni ġurnata
English: FOLFOX-4 or FOLFOX-4 + Avastin
Maltese: FOLFOX-4 + Avastin
English: Table 8 Efficacy results for trial E3200
Maltese: Tabella 8 Riżultati ta' l-effikaċja għall-prova E3200
English: Pulmonary haemorrhage/ Haemoptysisb,d,
Maltese: Emorraġija pulmonari/ Emoptisia,b,
English: In randomised clinical trials, age > 65 years was associated with an increased risk of developing arterial thromboembolic reactions, including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs).
Maltese: Fi provi kliniċi randomised, età > 65 sena kienet assoċjata ma' żjieda fir-riskju ta' żvilupp ta' reazzjonijiet trombo-embolitiċi arterjali, inkluż aċcidenti ċerebrovaskulari (CVAs), attakki iskemiċi temporanji (TIAs) u infarti mijokardiċi (MIs).
English: • AVF0780g: In combination with bolus 5-fluorouracil/folinic acid (5-FU/FA) for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen).
Maltese: • AVF0780g: F'taħlita ma' 5-fluorouracil/folinic acid (5-FU/FA) bħala bolus għal total ta' 6 ġimgħat ta' kull ċiklu ta' 8 ġimgħat (dożaġġ Roswell Park).
English: Uncommon Rare Very Rare
Maltese: Rari ħafna Ħafna
English: CI, confidence interval; HR, Hazard ratio from unstratified Cox regression analysis; NR, not reached.
Maltese: HR, Proporzjon ta' periklu minn analiżi ta' regressjoni Cox mhux stratifikata; NR, ma ntlaħaqx.
English: In terms of safety, there was a higher overall incidence of Grade 3-5 AEs in study E3200 relative to study ML18147.
Maltese: F'termini ta' sigurtà, kien hemm inċidenza globali ogħla ta' AEs ta' Grad 3-5 fl-istudju E3200 meta mqabbel malistudju ML18147.
English: Тел: +359 2 818 44 44
Maltese: Рош България ЕООД Тел: +359 2 818 44 44
English: The percentage of patients who received Avastin in the open-label phase was 62.1% in the capecitabine + placebo arm and 49.9% in the capecitabine + Avastin arm.
Maltese: Il-persentaġġ ta' pazjenti li rċevew Avastin fil-fażi open-label kien ta' 62.1% fil-grupp ta' capecitabine + plaċebo u 49.9% fil-grupp ta' capecitabine + Avastin.
English: • Gastrointestinal perforations (see section 4.4).
Maltese: • Perforazzjoni gastro-intestinali (ara sezzjoni 4.4).
English: Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of patients treated with Avastin.
Maltese: Proteina fl-awrina ta' Grad 4 (sindrome nefrotiku) kienet osservata f'sa 1.4% tal-pazjenti ttrattati b'Avastin.
English: The choices of chemotherapy included capecitabine, taxane (protein-bound paclitaxel, docetaxel), and anthracycline-based agents (doxorubicin/ cyclophosphamide, epirubicin/ cyclophosphamide, 5-fluorouracil/ doxorubicin/ cyclophosphamide, 5-fluorouracil/epirubicin/cyclophosphamide) given every three weeks (q3w).
Maltese: L-għażliet ta' kimoterapija kienu jinkludu, capecitabine, taxane (paclitaxel imwaħħal mal-proteini, docetaxel), sustanzi bbażati fuq anthracycline (doxorubicin/ cyclophosphamide, epirubicin/ cyclophosphamide, 5-fluorouracil/ doxorubicin/ cyclophosphamide, 5-fluorouracil/epirubicin/cyclophosphamide) mogħtija kull tliet ġimgħat (q3w).
English: Effect of bevacizumab on the pharmacokinetics of other antineoplastic agents No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of coadministered interferon alpha 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
Maltese: Effett ta' bevacizumab fuq il-farmakokinetika ta' sustanzi antineoplastiċi oħra Ma kienet osservata l-ebda interazzjoni ta' rilevanza klinika ta' bevacizumab fuq il-farmakokinetika ta' interferon alpha 2a, erlotinib (u l-metabolit attiv tiegħu OSI-420), jew il-kimoterapiji irinotecan (u l-metabolit attiv tiegħu SN38), capecitabine, oxaliplatin (kif determinat mill-kejl ta' platinum ħieles u totali), u cisplatin mogħtija fl-istess waqt.
English: In this trial arterial thromboembolic reactions were observed in 11% (11/100) of patients compared to 5.8% (6/104) in the chemotherapy control group.
Maltese: F'din il-prova reazzjonijiet trombo-embolitiċi arterjali kienu osservati f'11% (11/100) tal-pazjenti meta mqabbla ma' 5.8% (6/104) fil-grupp ta' kontroll b'kimoterapija.
English: Table 6 Treatment regimens in trial NO16966 (mCRC) Treatment
Maltese: Tabella 6 Korsijiet ta' kura fi prova NO16966 (mCRC)
English: The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p=0.1789), duration of objective response (6.7 vs 9.1 months) or time to symptom progression (HR = 1.172; p=0.5076).
Maltese: Iż-żjieda ta' erlotinib ma' bevacizumab ma wasslitx għal titjib f'OS (HR = 1.764; p=0.1789), tul tar-rispons oġġettiv (6.7 vs 9.1 xhur) jew ħin sal-progressjoni tas-sintomi (HR = 1.172; p = 0.5076).
English: • In a retrospective single institution series, 12 consecutive (2005 to 2008) children with relapsed or progressive high-grade glioma (3 with WHO Grade IV, 9 with Grade III) were treated with bevacizumab (10 mg/kg) and irinotecan (125 mg/m²) every 2 weeks.
Maltese: • F'serje retrospettiva b'istituzzjoni waħda, 12-il tifel u ifla konsekuttivi (2005 sa 2008) bi glijoma ta' grad għoli li rkadat jew progressiva (3 b'WHO Grad IV, 9 bi Grad III) kienu kkurati b'bevacizumab (10 mg/kg) u irinotecan (125 mg/m²) kull ġimagħtejn.
English: The overall incidence of NCI-CTC Grade 3 and 4 hypertension in patients receiving Avastin ranged from 0.4% to 17.9%.
Maltese: Grad 3 u 4 f'pazjenti li kienu qed jirċievu Avastin varjat minn 0.4% sa 17.9%.
English: The median age of patients was 61.0 (range: 25−84) years.
Maltese: L-età medjana tal-pazjenti kienet ta' 61.0 (firxa: 25−84) sena.
English: Table 16 Efficacy results from study GOG-0218
Maltese: Tabella 16 Riżultati tal-effikaċja minn studju GOG-0218
English: Efficacy Results for Study ML18147 (ITT population)
Maltese: Tabella 9 Riżultati tal-Effikaċja għal Studju ML18147 (popolazzjoni ITT)
English: The population pharmacokinetics were analysed in adult and pediatric patients to evaluate the effects of demographic characteristics.
Maltese: Il-farmakokinetika tal-popolazzjoni ġiet analizzata sabiex jiġu evalwati l-effetti ta' karatteristiċi demografiċi.
English: Sepsis, Abscessb,d,
Maltese: Sepsi, Axxessb,d, Ċellulite,
English: 400 mg/m2 IV bolus, 600 mg/m2 IV 22 h
Maltese: 600 mg/ m2 IV 22 h
English: New cases of ovarian failure were reported in 2.6% patients in the mFOLFOX-6 group compared to 39% in the mFOLFOX-6 + bevacizumab group.
Maltese: Każijiet ġodda ta' insuffiċjenza tal-ovarji kienu rrappurtati f'2.6% tal-pazjenti fil-grupp ta' mFOLFOX-6 meta mqabbel ma' 39% fil-grupp ta' mFOLFOX-6 + bevacizumab.
English: Supraventricular tachycardia
Maltese: Takikardija supraventrikolari
English: Hypersensitivity, infusion reactionsa,b,d
Maltese: Sensittività eċċessiva, reazzjonijiet għallinfużjonia,b,d
English: Avastin in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Maltese: Avastin flimkien ma' interferon alfa-2a għall-kura primarja ta' kanċer avvanzat u/jew metastatiku taċċelluli renali (BO17705)
English: For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.
Maltese: (EGFR - Epidermal Growth Factor Receptor) (ara Sezzjoni 5.1).
English: In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving Avastin.
Maltese: Fi provi kliniċi, proteina fl-awrina kienet irrappurtata fil-firxa ta' 0.7% sa 54.7% tal-pazjenti li kienu qed jirċievu Avastin.
English: The 649 randomised patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%,
Maltese: Is-649 pazjent randomised (641 ikkurati) kellhom Karnofsky Performance Status (KPS) ta' ≥70%, l-ebda metastasi fis-CNS u funzjoni ta' l-organi adegwata.
English: Proteinuria ranged in severity from clinically asymptomatic, transient, trace proteinuria to nephrotic syndrome, with the great majority as Grade 1 proteinuria (NCI-CTCAE v.3).
Maltese: Proteina fl-awrina, varjat fis-severità minn klinikament bla sintomi, temporanja, traċċa ta' proteina flawrina għal sindrome nefrotika, bil-maġġoranza tkun proteina fl-awrina ta' Grad 1 (NCI-CTCAE v.3).
English: In four phase III trials (AVF2119g, E2100, BO17708 and AVF3694g) in patients with metastatic breast cancer CHF Grade 3 (NCI-CTCAE v.3) or higher was reported in up to 3.5% of patients treated with Avastin in combination with chemotherapy compared with up to 0.9% in the control arms.
Maltese: III (AVF2119g, E2100, BO17708 u AVF3694g) f'pazjenti b'kanċer tassider li mmetastatizza, CHF ta' Grad 3 (NCI-CTCAE v.3) jew ogħla kienet irrapportata f'sa 3.5% talpazjenti kkurati b'Avastin flimkien ma' kimoterapija meta mqabbla ma' mhux aktar minn 0.9% filgruppi ta' kontroll.
English: 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: (14.9 vs. 17.5 months; p = 0.4146)
Maltese: (14.9 vs. 17.5 xhur; p = 0.4146)
English: Median OS (months) Hazard ratio (95% CI) (eCRF)a
Maltese: OS medjana (xhur) Proporzjon ta' periklu (CI ta' 95%) (eCRF)a
English: A third group of 110 patients received bolus 5-FU/FA + Avastin (Arm 3).
Maltese: It-tielet grupp ta' 110 pazjent irċieva 5-FU/FA+Avastin (Kategorija 3) bħala bolus.
English: The trial contained two parts: an initial unblinded 2-arm part (Part I) in which patients were randomised to two different treatment groups (XELOX and FOLFOX-4) and a subsequent 2 x 2 factorial 4-arm part (Part II) in which patients were randomised to four treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + Avastin, FOLFOX-4 + Avastin).
Maltese: Ilprova kien fiha żewġ partijiet: parti tal-bidu b'żewġ kategoriji unblinded (l-ewwel Parti) fejn ilpazjenti kienu randomised f'żewġ gruppi ta' kura differenti (XELOX u FOLFOX-4) u parti sussegwenti b'4 kategoriji 2 x 2 fattorjali (Parti II) fejn il-pazjenti kienu randomised f'erba' gruppi ta' kura (XELOX + plaċebo, FOLFOX-4 + plaċebo, XELOX + Avastin, FOLFOX-4 + Avastin).
English: Information on foetal malformations observed in the post marketing setting are provided in section 4.6 Fertility, Pregnancy and Lactation and 4.8 Undesirable Effects.
Maltese: Informazzjoni dwar malformazzjonijiet tal-fetu osservati fl-ambjent ta' wara t-tqegħid fis-suq huma pprovduti f'sezzjoni 4.6 Fertilità, tqala u treddigħ u 4.8 Effetti mhux mixtieqa.
English: • CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration
Maltese: • Grupp CP: Carboplatin (AUC 6) u paclitaxel (175 mg/m2) għal 6 ċikli ta' 3 ġimgħat
English: (17.5 vs.14.3 months; p = 0.0609)
Maltese: (17.5 vs. 14.3 xhur; p = 0.0609)
English: Three additional studies with bevacizumab have been conducted in mCRC patients: first-line (NO16966), second-line with no previous bevacizumab treatment (E3200), and second-line with previous bevacizumab treatment following disease progression in first-line (ML18147).
Maltese: Saru tliet studji oħra b'bevacizumab f'pazjenti b'mCRC: -kura preferita (NO16966), kura sekondarja bl-ebda kura preċedenti b'bevacizumab (E3200) , u kura sekondarja b'kura preċedenti b'bevacizumab wara progressjoni tal-marda b'kura preferita (ML18147).
English: Tumour-associated haemorrhage was also seen rarely in other tumour types and locations, including cases of central nervous system (CNS) bleeding in patients with CNS metastases (see section 4.4).
Maltese: Emorraġija assocjata mat-tumur rarament dehret wkoll f'tipi u postijiet oħra ta' tumur, inkluż każijiet ta' fsada fis-sistema nervuża ċentrali (CNS) f'pazjenti b'metastażi fis-CNS (ara sezzjoni 4.4).
English: Carboplatin/ Paclitaxel
Maltese: Grupp 1 Carboplatin/ Paclitaxel