FrancophonIA/ELRC3.0 huggingface dataset:
English: LIST OF EXCIPIENTS Trehalose dihydrate, sodium phosphate, polysorbate 20, water for injections.
Maltese: TA' EĊĊIPJENTI Trehalose dihydrate, sodium phosphate, polysorbate 20, ilma għall-injezzjoni.
English: Congenital, familial, and genetic disorder
Maltese: Disturbi konġenitali, familjali u ġenetiċi
English: At baseline, most patients in both treatment arms had a GOG PS of 0 (CP: 82.4%: CPB; 80.7%) or 1 (CP: 16.7%: CPB; 18.1%).
Maltese: 7%) jew 1 (CP: 16.7%: CPB; 18.1%).
English: However two of the randomized patients discontinued the study before receiving any study treatment ^ Blinded independent review (protocol-defined primary analysis) * Exploratory analysis: final OS analysis at clinical cut off on 31 October 2017, approx. 59% of patients had died.
Maltese: Madankollu tnejn mill-pazjenti randomised waqfu mill-istudju qabel ma rċevew kwalunkwe trattament tal-istudju ^ Analiżi indipendenti u blinded (analiżi primarja definita mill-protokoll) * Analiżi esploratorja: analiżi finali ta' OS fil-cut-off kliniku fil-31 ta' Ottubru 2017, madwar 59% tal-pazjenti kienu mietu.
English: The corresponding frequencies in the control group receiving chemotherapy alone were 1.1% vs. 0.8%, respectively.
Maltese: Il-frekwenzi korrispondenti fil-grupp ta' kontroll li rċevew kimoterapija waħedha kienu ta' 1.1% kontra 0.8%, rispettivament.
English: • tiredness,
Maltese: • stitikezza,
English: There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving Avastin monotherapy compared to patients receiving Avastin in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).
Maltese: Ma kien hemm la differenzi statistikament sinifikanti u lanqas ta' rilevanza klinika fittneħħija ta' bevacizumab f'pazjenti li kienu qed jirċievu monoterapija ta' Avastin meta mqabbel ma' pazjenti li kienu qed jirċievu Avastin flimkien ma' interferon alfa-2a, erlotinib jew kimoterapiji (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin jew cisplatin/gemcitabine).
English: The percentage of patients with an ECOG PS of 1 or ≥ 2 was 38.7% and 5.0% in the CT arm, and 29.8% and 9.0% in the
Maltese: Il-persentaġġ ta' pazjenti b'ECOG PS ta' 1 jew ≥ 2 kien ta' 38.7% u 5.0% fil-grupp ta' CT, u 29.8% u 9.0% fil-grupp ta' CT + BV.
English: In addition, in study AVF3694g the incidences of all Grade CHF were similar between the anthracycline + Avastin (6.2%) and the anthracycline + placebo arms (6.0%).
Maltese: Barra dan, fi studju AVF3694g l-inċidenzi ta' CHF ta' kull Grad kienet simili fil-gruppi ta' anthracycline + Avastin (6.2%) u anthracycline + plaċebo (6.0%).
English: Table 13 Efficacy results for trial BO17704
Maltese: Tabella 13 Riżultati ta' l-effikaċja għall-prova BO17704
English: Of the 452 patients randomized at baseline, the majority of patients were white (80.0% in the Chemo alone group and 75.3% in the Chemo+Avastin group), had squamous cell carcinoma (67.1% in the Chemo alone group and 69.6% in the Chemo+Avastin group), had persistent/recurrent disease (83.6% in the Chemo alone group and 82.8% in the Chemo+Avastin group), had 1-2 metastatic sites (72.0% in the Chemo alone group and 76.2% in the Chemo+Avastin group), had lymph node involvement (50.2% in the Chemo alone group and 56.4% in the Chemo+Avastin group), and had a platinum free interval ≥ 6 months (72.5% in the Chemo alone group and 64.4% in the Chemo+Avastin group).
Maltese: Mill-452 pazjent randomised fil-linja bażi, il-maġġoranza tal-pazjenti kienu bojod (80.0% fil-grupp ta' Kimo waħedha u 75.3% fil-grupp ta' Kimo+Avastin), kellhom karċinoma taċ-ċellula skwamuża (67.1% fil-grupp ta' Kimo waħedha u 69.6% fil-grupp ta' Kimo+Avastin), kellhom marda persistenti/rikorrenti (83.6% fil-grupp ta' Kimo waħedha u 82.8% fil-grupp ta' Kimo+Avastin), kellhom 1-2 siti metastatiċi (72.0% fil-grupp ta' Kimo waħedha u 76.2% fil-grupp ta' Kimo+Avastin), kellhom involviment tal-glandoli limfatiċi (50.2% fil-grupp ta' Kimo waħedha u 56.4% fil-grupp ta' Kimo+Avastin), u kellhom intervall mingħajr platinu ta' ≥ 6 xhur (72.5% fil-grupp ta' Kimo waħedha u 64.4% fil-grupp ta' Kimo+Avastin).
English: Table 9
Maltese: Tabella 20
English: Avastin 25 mg/ml concentrate for solution for infusion Bevacizumab
Maltese: Avastin 25 mg/ml konċentrat għal soluzzjoni għall-infużjoni Bevacizumab
English: 5-FU/FA + placebo
Maltese: 5-FU/FA + plaċebo
English: Tabulated list of adverse reactions
Maltese: Tabella 2: Reazzjonijiet Avversi
English: Secondary endpoints included overall survival, response rate, disease control rate, duration of response, and safety.
Maltese: Punti finali sekondarji kienu jinkludu sopravivenza globali, rata ta' rispons, rata ta' kontroll tal-marda, tul tar-rispons u sigurtà.
English: In one clinical trial evaluating Avastin in combination with 5-fluorouracil/folinic acid, AVF2192g, patients with metastatic colorectal cancer who were not candidates for treatment with irinotecan were included.
Maltese: Fi prova klinika li evalwat Avastin flimkien ma' 5-fluorouracil/folinic acid, AVF2192g, kienu inklużi pazjenti b'kanċer tal-kolorektum li mmetastatizza li ma kienux kandidati għall-kura b'irinotecan.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 4.8, 5.1, 5.2 u 5.3.
English: Avastin contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
Maltese: Avastin fih is-sustanza attiva bevacizumab, li hija antikorp monoklonali umanizzat (tip ta' proteina li normalment tiġi magħmula mis-sistema immuni biex tgħin tiddefendi lill-ġisem minn infezzjoni u kanċer).
English: 95% CI (0.69; 0.93)
Maltese: 0.80 (p=0.003) 95% CI (0.69; 0.93)
English: • Arterial thromboembolism (see section 4.4).
Maltese: • Trombo-emboliżmu Arterjali (ara sezzjoni 4.4).
English: Fatal outcome was reported in 0.8% of patients receiving Avastin compared to 0.5% in patients receiving chemotherapy alone.
Maltese: Riżultat fatali kien irrappurtat f'0.8% tal-pazjenti li ngħataw Avastin, meta mqabbla ma' 0.5% fil-pazjenti li rċievew kimoterapija biss.
English: Non-small cell lung cancer (NSCLC)
Maltese: Kanċer fil-pulmun taċ-ċelluli mhux żgħar (NSCLC)
English: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Maltese: Termini jirrappreżentaw grupp ta' avvenimenti li jiddeskrivu kunċett mediku minflok kondizzjoni waħda jew terminu ppreferut MedDRA (Medical Dictionary for Regulatory Activities).
English: The analysis of the primary endpoint showed no difference between the Avastin + Placebo arm and the Avastin + Erlotinib arm (median PFS 8.5 versus 9.9 months).
Maltese: L-analiżi tal-mira primarja ma wriet l-ebda differenza bejn il-grupp b'Avastin + Placebo u l-grupp b'Avastin + Erlotinib (PFS medjan 8.5 kontra 9.9 xhur).
English: • CP arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) every 3 weeks for 6 and up to 8 cycles.
Maltese: • grupp ta' CP: Carboplatin (AUC5) u paclitaxel (175 mg/m2 IV) kull 3 ġimgħat għal 6 ċikli u sa 8 ċikli.
English: Day 1, prior to XELOX, q 3 weeks
Maltese: Fl-ewwel ġurnata, qabel XELOX, q 3 ġimgħat
English: Table 25 Efficacy results from study GOG-0240 by Avastin Treatment
Maltese: Tabella 25 Riżultati tal-effikaċja minn studju GOG-0240 skont il-Kura b'Avastin
English: Common Uncommon Rare
Maltese: Komuni Ħafna
English: Hypertension a,b
Maltese: Emorraġija a,b
English: Gastrointestinal ulcer (not known)
Maltese: Ulċera gastro-intestinali (mhux magħruf)
English: Combination of bevacizumab and sunitinib malate In two clinical trials of metastatic renal cell carcinoma, microangiopathic haemolytic anaemia (MAHA) was reported in 7 of 19 patients treated with bevacizumab (10 mg/kg every two weeks) and sunitinib malate (50 mg daily) combination.
Maltese: F'żewġ provi kliniċi ta' karċinoma metastatika taċ-ċellula renali, kienet irrapportata anemija emolitika mikroanġjopatika (MAHA), f'7 minn 19-il pazjent ikkurati bit-taħlita ta' bevacizumab (10 mg/kg kull ġimagħtejn) u sunitinib malate (50 mg kuljum).
English: Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines.
Maltese: Barra minn hekk, 65% tal-pazjenti kienu rċievew kimoterapija awżiljarja, inkluż 19% b'taxanes minn qabel u 49% b'anthracyclines minn qabel.
English: Oxaliplatin 130 mg/m2 IV 2 h Oxaliplatin on day 1 Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
Maltese: Oxaliplatin 130 mg/m2 IV 2 h Oxaliplatin fl-ewwel ġurnata Capecitabine orali bid għal ġimagħtejn (segwit b'ġimgħa mingħajr kura)
English: The secondary endpoint of Overall Survival (OS) was not mature .
Maltese: Il-punt finali sekondarju ta' Sopravivenza Globali (OSOverall Survival) ma kienx matur.
English: In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026.
Maltese: Fis-sottogrupp ta' kura b'FOLFOX, il-PFS medjan kien 8.6 xhur fil-pazjenti kkurati bil-plaċebo u 9.4 xhur fil-pazjenti kkurati b'bevacizumab, HR = 0.89, 97.5% CI = [0.73 ; 1.08]; valur p = 0.1871, irriżultati li jikkorrispondu fis-sottogrupp ta' kura b'XELOX ikunu 7.4 kontra 9.3 xhur, HR = 0.77, 97.5% CI = [0.63; 0.94]; valur p = 0.0026.
English: Efficacy results for study JO25567
Maltese: Riżultati tal-effikaċja għall-istudju JO25567
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.4) Avastin has been associated with serious cases of gastrointestinal perforation.
Maltese: Perforazzjonijiet gastro-intestinali (GI) u Fistuli (ara sezzjoni 4.4) Avastin kien assoċjat ma' każijiet serji ta' perforazzjoni gastro-intestinali.
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: Thromboembolism (arterial)b,d, Haemorrhageb,d,
Maltese: T romboemboliżmu (arterjali)b,d, Emorraġijab,d, Trombożi fil-vini talfond
English: Chemotherapy (n=225)
Maltese: Kimoterapija (n=225)
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 jirċievu bevacizumab bħala sustanża waħedha f'ċiklu 7.
English: Table 10 Trial E2100 efficacy results
Maltese: Tabella 10 Riżultati ta' l-effikaċja fil-prova E2100:
English: HR (95% CI) p-value
Maltese: (95% CI) Valur p
English: Avastin or placebo was administered at a dose of 15 mg/kg q3w.
Maltese: Avastin jew plaċebo ingħata f'doża ta' 15 mg/kg q3w.
English: Osteonecrosis of the jaw b,c
Maltese: Osteonekrosi tax-xedaqa,b
English: In these studies, bevacizumab was administered at the following dosing regimens in combination with FOLFOX-4 (5-FU/LV/oxaliplatin), XELOX (capecitabine/oxaliplatin), and fluoropyrimidine/irinotecan and fluoropyrimidine/oxaliplatin:
Maltese: F'dawn l-istudji, bevacizumab kien mogħti fil-korsijiet ta' dożaġġ li gejjin, flimkien ma' FOLFOX-4 (5-FU/LV/oxaliplatin), XELOX (capecitabine/oxaliplatin), u fluoropyrimidine/irinotecan u fluoropyrimidine/oxaliplatin:
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: • PLD 40 mg/m2 as a 1 mg/min IV infusion on Day 1 only every 4 weeks.
Maltese: • PLD 40 mg/m2 bħala infużjoni IV ta' 1 mg/min f'Ġurnata 1 biss kull 4 ġimgħat.
English: The primary endpoint was progression-free survival (PFS) based on independent review assessment.
Maltese: Il-punt finali primarju kien sopravivenza mingħajr progressjoni (PFS - progression-free survival) ibbażat fuq valutazzjoni ta' analiżi indipendenti.
English: Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Maltese: Effetti sekondarji severi ta' frekwenza mhux magħrufa (frekwenza ma tistax tiġi stmata mid-data disponibbli) jinkludu:
English: Uncommon (≥ 0.1% to < 1%) reports of fistulae that involve areas of the body other than the gastrointestinal tract (e.g. bronchopleural and biliary fistulae) were observed across various indications.
Maltese: Rapporti mhux komuni (≥ 0.1% sa < 1%) ta' fistuli li jinvolvu partijiet oħra tal-ġisem minbarra lapparat gastro-intestinali (eż. fistuli bronkoplewrali u biljari) kienu osservati tul diversi ndikazzjonijiet.
English: • In a single-arm study (PBTC-022), 18 children with recurrent or progressive non-pontine high-grade glioma (including 8 with glioblastoma [WHO Grade IV], 9 with anaplastic astrocytoma [Grade III] and 1 with anaplastic oligodendroglioma [Grade III]) were treated with bevacizumab (10 mg/kg) two weeks apart and then with bevacizumab in combination with CPT-11 (125-350 mg/m²) once every two weeks until progression.
Maltese: Fi studju ta' grupp wieħed (PBTC-022), 18-il tifel u tifla bi glijoma ta' grad għoli rikorrenti jew progressiva mhux fil-pons (inkluż 8 bi glijoblastoma [WHO Grad IV], 9 b'astroċitoma anaplastika [Grad III] u wieħed jew waħda b'oligodendroglijoma anaplastika [Grad III]) kienu kkurati b'bevacizumab (10 mg/kg) ġimagħtejn minn xulxin u wara b'bevacizumab flimkien ma' CPT-11 (125-350 mg/m²) darba kull ġimagħtejn sal-progressjoni.
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 Avastin in combination with chemotherapy compared to those who received chemotherapy alone.
Maltese: Fi provi kliniċi randomised, l-inċidenza ta' reazzjonijiet trombo-embolitiċi arterjali, inkluż aċċidenti ċerebrovaskulari (CVAs), attakki iskemiċi temporanji (TIAs) u infarti mijokardiċi (MIs), kienet għola f'pazjenti li qed jirċievu Avastin flimkien ma' kimoterapija meta mqabbla ma' pazjenti li ħadu kimoterapija biss.
English: Renal thrombotic microangiopathya,b,
Maltese: Mikroanġjopatija trombotika filkliewi b,ċ
English: An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Maltese: Analiżi interim uriet li kien hemm titwil sinifikanti tal-ħin sal-progressjoni tal-marda fil-grupp ta' 10 mg/kg kif mqabbel malgrupp tal-plaċebo (hazard ratio, 2.55; p<0.001).
English: Pulmonary haemorrhage/haemoptysis
Maltese: Emorraġija fil-pulmun/emoptisi
English: Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the Avastin 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' Avastin naqqsu ddoża ta' IFN alfa-2a minn 9 MIU għal 6 jew 3 MIU tliet darbiet fil-ġimgħa kif speċifikat minn qabel fil-protokoll.
English: Combinations of Avastin with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Maltese: Kombinazzjonijiet ta' Avastin ma' mediċina oħra msejjħa sunitinib malate (preskritt għall-kanċer talkliewi u kanċer gastro-intestinali) jistgħu jikkawżaw effetti sekondarji severi.
English: Thromboembolism arteriala,b, Haemorrhage a,b
Maltese: Tromboemboliżmu fl-arterji a,b
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: Metastatic carcinoma of the colon or rectum (mCRC)
Maltese: Karċinoma tal-kolon jew tar-rektum li mmetastatizzat (mCRC)
English: In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the Avastin containing arms compared with up to 14% in the control arms.
Maltese: Fi provi kliniċi, bl-eċċezzjoni ta' studju JO25567, l-inċidenza globali ta' pressjoni għolja (kull grad) varjat sa 42.1% fil-gruppi li fihom Avastin meta mqabbla ma' sa 14% fil-gruppi ta' kontroll.
English: Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1).
Maltese: Benefiċċju kliniku f'pazjenti b'NSCLC intwera kemm b'doża ta' 7.5 mg/kg kif ukoll b'15 mg/kg (ara sezzjoni 5.1).
English: 15 mg/kg q 3 weeks
Maltese: 15 mg/kg q 3 ġimgħat
English: The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
Maltese: Il-valur tipiku tal-volum periferali (Vp) kien ta' 1.69 L u 2.35 L għall-pazjenti nisa u rġiel rispettivament, meta bevacizumab jingħata flimkien ma' sustanzi anti-neoplastiċi.
English: Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine, peripheral sensory neuropathy with paclitaxel or oxaliplatin, nail disorders or alopecia with paclitaxel, and paronychia with erlotinib.
Maltese: Eżempji jinkludu is-sindrome ta' eritrodisasteżija palmari-plantari ma' doxorubicin liposomali pegilat jew capecitabine, newropatija periferali tas-sensi ma' paclitaxel jew oxaliplatin, disturbi fid-dwiefer jew alopeċja ma' paclitaxel, u paronikja ma' erlotinib.
English: The addition of Avastin to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Maltese: Iż-żjieda ta' Avastin ma' FOLFOX-4 wasslet f'titwil statistikament sinifikanti tas-sopravivenza.
English: (p-value = 0.00004)
Maltese: (valur p = 0.00004)
English: The efficacy results are presented in Table 15 Table 15 Efficacy results for trial BO17705
Maltese: Tabella 15 Riżultati ta' l-effikaċja għall-prova BO17705
English: Peripheral sensory neuropathyb, Dysarthria, Headache, Dysguesia
Maltese: Newropatija periferali tassensib, Disartrija, Uġigħ ta' ras, Disġewżja
English: Epithelial ovarian, fallopian tube and primary peritoneal cancer
Maltese: Kanċer tal-epitelju tal-ovarji, tat-tubu fallopjan, u kanċer primarju tal-peritonew
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 using a population pharmacokinetic model.
Maltese: Il-farmakokinetika ta' bevacizumab ġiet evalwata f'152 pazjent pedjatriku (7 xhur sa 21 sena, 5.9 sa 125kg) minn 4 studji kliniċi fit-tfal bl-użu ta' mudell tal-farmakokinetika tal-popolazzjoni.
English: The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab treated patients in the FOLFOX treatment subgroup, HR=0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Maltese: Il-medjan tas-sopravivenza globali kien 20.3 xahar fil-pazjenti kkurati bil-plaċebo u 21.2 xahar filpazjenti kkurati b'bevacizumab fis-sottogrupp ta' kura b'FOLFOX, HR=0.94, 97.5% CI = [0.75 ; 1.16]; valur p = 0.4937, ir-riżultati li jikkorrespondu fis-sottogrupp ta' kura b'XELOX, ikunu 19.2 kontra 21.4 xahar, HR = 0.84, 97.5% CI = [0.68 ; 1.04]; valur p = 0.0698.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-240), 1.8% of Avastin-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 (GOG-240), 1.8% tal-pazjenti kkurati b'Avastin u 1.4% tal-pazjenti fuq kontroll kien irrappurtat li kellhom fistuli mhux gastrointestinali vaġinali, tal-bużżieqa tal-awrina, jew tal-apparat ġenitali femminili.
English: Progression-Free Survival*
Maltese: Sopravivenza Mingħajr Progressjoni*
English: • MO22224 evaluated the efficacy and safety of bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Maltese: • MO22224 evalwa l-effikaċja u s-sigurtà ta' bevacizumab flimkien ma' paclitaxel, topotecan, jew doxorubicin liposomali pegilat f'pazjenti b'kanċer rikorrenti tal-epitelju tal-ovarji, tat-tubu fallopjan jew kanċer primarju tal-peritonew reżistenti għall-platinu.
English: % pts with objective response p-value * primary analysis Overall survival
Maltese: % ta' pazjenti b'rispons oġġettiv Valur p * analiżi primarja Sopravivenza globali
English: Severe reactions are defined as adverse events with at least a 2% difference compared to the control arm in clinical studies for NCI-CTCAE Grade 3-5 reactions.
Maltese: Reazzjonijiet severi huma definiti bħala avvenimenti avversi b'differenza ta' mill-inqas 2% meta mqabbel mal-grupp ta' kontroll flistudji kliniċi għal reazzjonijiet ta' NCI-CTCAE Grad 3-5.
English: Chemotherapy + Avastin (n=227)
Maltese: Kimoterapija + Avastin (n=227)
English: Table 2 provides the frequency of severe adverse reactions.
Maltese: Tabella 2 tipprovdi l-frekwenza ta' reazzjonijiet avversi severi.
English: Investigator assessment
Maltese: Investigazzjonijiet
English: Anti-tumour activity was not observed in two earlier studies among a total of 30 children aged > 3 years old with relapsed or progressive high-grade glioma when treated with bevacizumab and irinotecan (CPT-11).
Maltese: Attività kontra t-tumuri ma kienetx osservata f'żewġ studji fost total ta' 30 tifel u tifla b'età ta' > 3 snin bi glijoma ta' grad għoli li rkadat jew progressiva meta kkurati b'bevacizumab u irinotecan.
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.