FrancophonIA/ELRC3.0 huggingface dataset:
English: Grange Castle Business Park
Maltese: Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin
English: Gastrointestinal perforation a,b
Maltese: Perforazzjoni gastrointestinali a,b,
English: Paclitaxel 135 mg/m2 intravenous over 24 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m intravenous over 3 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 1 plus bevacizumab 15 mg/kg intravenous on Day 1 (q3w)
Maltese: Paclitaxel 135 mg/m 2 ġol-vini fuq medda ta' 24 siegħa f'Jum 1 u cisplatin 50 mg/m 2 ġol-vini f'Jum 2 flimkien ma' bevacizumab 15 mg/kg ġol-vini f'Jum 2 (q3w); jew Paclitaxel 175 mg/m 2 ġol-vini fuq medda ta' 3 sigħat f'Jum 1 u cisplatin 50 mg/m 2 ġol-vini f'Jum 2 flimkien ma' bevacizumab 15 mg/kg ġol-vini f'Jum 2 (q3w); jew Paclitaxel 175 mg/m 2 ġol-vini fuq medda ta' 3 sigħat f'Jum 1 u cisplatin 50 mg/m 2 ġol-vini f'Jum 1 flimkien ma' bevacizumab 15 mg/kg ġol-vini f'Jum 1 (q3w)
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 ġol-vini], 9 b'astroċitoma anaplastika [Grad III] u 1 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: The efficacy results are presented in Table 13 Table 13 Efficacy results for trial BO17705
Maltese: Tabella 13 Riżultati tal-effikaċja għall-prova BO17705
English: Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Maltese: , Emboliżmu pulmonari, Ipossija, Disfonija
English: • problems with wound healing after surgery,
Maltese: • problemi bil-fejqan tal-feriti wara operazzjoni,
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 tal-karatteristiċi demografiċi.
English: Arthralgia, Myalgia
Maltese: Artralġja, Majalġja
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 assoċjata 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: Median OS (months) HR (95% CI) p-value
Maltese: HR (95% CI) valur p
English: The analysis of the primary endpoint showed no difference between the bevacizumab + Placebo arm and the bevacizumab + 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' bevacizumab + Plaċebo u l-grupp ta' bevacizumab + Erlotinib (PFS medjan 8.5 kontra 9.9 xhur).
English: In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving bevacizumab.
Maltese: Fi provi kliniċi, proteina fl-awrina ġiet irrappurtata fil-firxa ta' 0.7% sa 54.7% tal-pazjenti li kienu jirċievu bevacizumab.
English: Thromboemboli sm arterial a,b
Maltese: Tromboemboliż mu fl-arterji a,b
English: Anorexia, Hypomagnesaemia, Hyponatraemia
Maltese: Anoressija, Ipomagneżemija, Iponatremija
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 bevacizumab 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 tas-sider li mmetastatizza, CHF ta' Grad 3 (NCI-CTCAE v.3) jew ogħla kienet irrapportata f'sa 3.5% tal-pazjenti kkurati b'bevacizumab flimkien ma' kimoterapija meta mqabbla ma' mhux aktar minn 0.9% fil-gruppi ta' kontroll.
English: FOLFOX-4 + bevacizumab a
Maltese: FOLFOX-4 + bevacizumab
English: Arterial thromboembolism
Maltese: Tromboemboliżmu arterjali
English: * if specified, the frequency has been derived from clinical trial data
Maltese: * jekk speċifikata, il-frekwenza ġiet derivata minn dejta tal-provi kliniċi
English: For further information please refer to Table 3 ‘Adverse reactions reported in post-marketing setting.'
Maltese: Għal aktar informazzjoni, jekk jogħġbok irreferi għal Tabella 3 ‘Reazzjonijiet avversi rrappurtati fl-ambjent ta' wara t-tqegħid fis-suq.'
English: Bvb + IFNa
Maltese: Bv b + IFN
English: The overall incidence of NCI-CTC Grade 3 and 4 hypertension in patients receiving bevacizumab ranged from 0.4% to 17.9%.
Maltese: Grad 3 u 4 f'pazjenti li kienu qed jirċievu bevacizumab varjat minn 0.4% sa 17.9%.
English: The incidence of AEs, including Grade ≥3 AEs and SAEs, was similar between the two treatment arms.
Maltese: L-inċidenza tal-AEs, inkluż AEs u SAEs ta' Grad ≥3, kienet simili bejn iż-żewġ gruppi ta' trattament.
English: The other ingredients are sucrose, succinic acid, disodium edetate, polysorbate 80, sodium hydroxide (for pH adjustment), and water for injections.
Maltese: L-ingredjenti l-oħra huma sucrose, succinic acid, disodium edetate, polysorbate 80, sodium hydroxide (għall-aġġustament tal-pH), u ilma għall-injezzjonijiet.
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 għal komplikazzjonijiet fil-fejqan ta' feriti, perforazzjoni gastrointestinali jew formazzjoni ta' fistula (rari) (ara wkoll sezzjoni 4.4)
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 preċedenti b'kura preċedenti b'bevacizumab wara progressjoni tal-marda b'kura preferita (ML18147).
English: A third group of 110 patients received bolus 5-FU/FA + bevacizumab (Arm 3).
Maltese: It-tielet grupp ta' 110 pazjenti rċieva 5-FU/FA + bevacizumab (Kategorija 3) bħala bolus.
English: In addition, in study AVF3694g the incidences of all Grade CHF were similar between the anthracycline + bevacizumab (6.2%) and the anthracycline + placebo arms (6.0%).
Maltese: Barra dan, fi studju AVF3694g, l-inċidenza ta' CHF ta' kull Grad kienet simili fil-gruppi ta' anthracycline + bevacizumab (6.2%) u tanthracycline + plaċebo (6.0%).
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 tal-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, ir-riżultati 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: 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 s-sindrome ta' eritrodisasteżija palmari-plantari ma' doxorubicin liposomali pegilat jew capecitabine, newropatija periferali tas-sensi ma' paclitaxel jew oxaliplatin, disturbi tad-dwiefer jew alopeċja ma' paclitaxel, u paronikja ma' erlotinib.
English: Hypersensitivity reactions/infusion reactions (see section 4.8)
Maltese: Reazzjonijiet ta' sensittività eċċessiva/reazzjonijiet tal-infużjoni (ara sezzjoni 4.8)
English: Gallbladder perforation b,c
Maltese: Perforazzjoni tal-bużżieqa talmarrara b,c
English: Hypersensitivity, Infusion reactions a,b,d
Maltese: Sensittività eċċessiva, Reazzjonijiet talinfużjoni a,b,d
English: In study JO25567, all grade hypertension was observed in 77.3% of the patients who received bevacizumab in combination with erlotinib as first-line treatment for non-squamous NSCLC with EGFR activating mutations, compared to 14.3% of patients treated with erlotinib alone.
Maltese: Fl-istudju JO25567, pressjoni għolja ta' kull grad kienet osservata f'77.3% tal-pazjenti li rċivew bevacizumab flimkien ma' erlotinib bħala trattament ippreferut NSCLC mhux skwamuż b'mutazzjonijiet li jattivaw EFGR, meta mqabbel ma' 14.3% tal-pazjenti trattati b'erlotinib waħdu.
English: Overall response rate Rate (percent) 95% CI
Maltese: Rata ta' rispons totali Rata (perċentwali) 95% CI
English: Ovarian failure b,c,d
Maltese: Insuffiċjenza tal-ovarji b,c,d
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 jigu ppreżentati r-riżultati tal-istudji, f'kull sett tal-popolazzjoni pedjatrika, b'karċinoma tas-sider, adenokarċinoma tal-kolon u r-rektum, karinċoma tal-pulmun (karċinoma taċ-ċelluli żgħira u mhux taċ-ċellula żgħira), karċinoma tal-kliewi u tal-pelvi tal-kliewi (barra nefrobalstoma, nefroblastomatożi, sarkoma taċ-ċelluli ċari, nefroma meżoblastika, karċinoma tal-mudella tal-kliewi u tumur rhabdoid tal-kliewi), karċinoma tal-ovarji (barra rabdomijosarkoma u tumuri taċ-ċelluli ġerminali), karċinoma tat-tubu fallopjan (barra rabdomijosarkoma u tumuri taċ-ċelluli ġerminali), karċinoma tal-peritonew (barra blastomi u sarkomi) u karċinoma tal-għonq u tal-corpus tal-utru.
English: Zirabev may impair female fertility.
Maltese: Zirabev jista' jnaqqas il-fertilità feminili.
English: Gastrointestinal (GI) perforations and fistulae (see section 4.8)
Maltese: Perforazzjonijiet gastrointestinali (GI - gastrointestinal) u fistuli (ara sezzjoni 4.8)
English: Osteonecrosis of the jaw (ONJ) (see section 4.8)
Maltese: Osteonekrożi tax-xedaq (ONJ - Osteonecrosis of the jaw ara sezzjoni 4.8)
English: Osteonecrosis of the jaw b,c
Maltese: Osteonekrożi tax-xedaq b,c
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 bil-korsijiet ta' dożaġġ li ġejjin flimkien ma' FOLFOX-4 (5- FU/LV/oxaliplatin), XELOX (capecitabine/oxaliplatin), u fluoropyrimidine/irinotecan u fluoropyrimidine/oxaliplatin:
English: The study did not meet its primary endpoint of demonstrating a significant improvement of EFS (Central Radiology Review Committee (CRRC)-assessed) when bevacizumab was added to the RT/T arm compared with RT/T alone (HR = 1.44; 95% CI: 0.90, 2.30).
Maltese: L-istudju ma ssodisfax l-punt ta' tmiem primarju tiegħu li juri titjib sinifikanti tal-EFS (ivvalutat mill-Kumitat ta' Reviżjoni tar-Radjoloġija Ċentrali (CRRC)) meta bevacizumab żdied mal-fergħa ta' RT/T meta mqabbel ma' RT/T waħidha (HR = 1.44; 95% CI: 0.90, 2.30).
English: Venous thromboembolic reactions include deep venous thrombosis, pulmonary embolism and thrombophlebitis.
Maltese: Reazzjonijiet tromboemboliċi venużi jinkludu trombożi fil-vini l-kbar, emboliżmu fil-pulmun u tromboflebite.
English: This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of bevacizumab in combination with interferon (IFN) alfa-2a versus IFN alfa-2a alone as first-line treatment in mRCC.
Maltese: III randomized u double-blind biex tivvaluta l-effikaċja u s-sigurtà ta' bevacizumab flimkien ma' interferon (IFN) alfa-2a kontra
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 huwa simili għal IgG endoġenu i,e. primarjament permezz ta' kataboliżmu proteolitiku mal-ġisem kollu, inkluż ċelluli tal-endotilju, u ma jiddependix primarjament minn eliminazzjoni mill-kliewi u l-fwied.
English: This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation.
Maltese: Din il-kondizzjoni normalment hija sekondarja għal komplikazzjonijiet fil-fejqan ta' feriti, perforazzjoni gastrointestinali jew formazzjoni ta' fistula.
English: Peripheral s ensory neuropathy b,
Maltese: Newropatija periferali sensorjali b,
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 matastatika taċ-ċellula renali, kienet irrapportata anemija emolitika mikroanġjopatika (MAHA - microangiopathic haemolytic anaemia) f'7 minn 19il pazjent ikkurati bil-taħlita ta' bevacizumab (10 mg/kg kull ġimagħtejn) u sunitinib malate (50 mg kuljum)
English: Zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
Maltese: Zirabev, flimkien ma' paclitaxel u cisplatin jew, b'mod alternattiv, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu terapija bil-platinu, huwa indikat għat-trattament ta' pazjenti adulti b'karċinoma persistenti, rikorrenti, jew metastatika tal-għonq tal-utru (ara sezzjoni 5.1).
English: Median PFS (months) Hazard ratio [95% CI]
Maltese: PFS medjana (xhur) Proporzjon ta' periklu [95% CI]
English: In one clinical trial evaluating bevacizumab 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 bevacizumab flimkien ma' 5-fluorouracil/folinic acid, AVF2192g, kienu inklużi pazjenti b'kanċer tal-kolorektum li mmetastatizza li ma kinux kandidati għall-kura b'irinotecan.
English: Metastatic breast cancer (mBC)
Maltese: Kanċer tas-sider li mmetastatizza (mBC - Metastatic breast cancer)
English: In most clinical trials urine protein levels of ≥ 2 g/24 hrs led to the holding of bevacizumab until recovery to < 2 g/24 hrs.
Maltese: Filbiċċa l-kbira tal-provi kliniċi, livelli ta' proteina fl-awrina ta' ≥ 2 g/24 siegħa wasslu għal twaqqif ta' bevacizumab sakemm irpiljaw għal < 2 g/24 siegħa.
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 fiż-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: Pulmonary haemorrhage/ Haemoptysis a,b
Maltese: Emorraġija pulmonari/Emo ptiżi a,b
English: Placebo or bevacizumab
Maltese: + bevacizumab
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 + bevacizumab, FOLFOX-4 + bevacizumab).
Maltese: Il-prova kien fiha żewġ partijiet: parti tal-bidu b'żewġ partijiet: parti tal-bidu b'żewġ kategoriji unblinded (l-ewwel Parti) fejn il-pazjenti kienu randomized 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 randomized f'erba' gruppi ta' kura (XELOX + plaċebo, FOLFOX-4 + plaċebo, XELOX + bevacizumab, FOLFOX-4 + bevacizumab).
English: Posterior Reversible Encephalopathy Syndrome (PRES), (rare) (see also section 4.4)
Maltese: Sindrome ta' Enċefalopatija Posterjuri Riversibbli (PRESPosterior Reversible Encephalopathy Syndrome), (rari) (ara wkoll sezzjoni 4.4)
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+bevacizumab group), had squamous cell carcinoma (67.1% in the Chemo alone group and 69.6% in the Chemo+bevacizumab group), had persistent/recurrent disease (83.6% in the Chemo alone group and 82.8% in the Chemo+bevacizumab group), had 1-2 metastatic sites (72.0% in the Chemo alone group and 76.2% in the Chemo+bevacizumab group), had lymph node involvement (50.2% in the Chemo alone group and 56.4% in the
Maltese: Mill-452 pazjent randomised fil-linja bażi, il-maġġoranza tal-pazjenti kienu bojod (80.0% fil-grupp tal-Kimo waħidha u 75.3% fil-grupp ta' Kimo+bevacizumab), kellhom karċinoma taċ-ċellula skwamuża (67.1% fil-grupp tal-Kimo waħedha u 69.6% fil-grupp ta' Kimo+bevacizumab), kellhom marda persistenti/rikorrenti (83.6% fil-grupp tal-Kimo waħidha u 82.8% fil-grupp ta' Kimo+bevacizumab), kellhom 1-2 siti metastatiċi (72.0% fil-grupp tal-Kimo waħedha u 76.2% filgrupp ta' Kimo+bevacizumab), kellhom involviment tal-glandoli limfatiċi (50.2% fil-grupp talKimo waħedha u 56.4% fil-grupp ta' Kimo+bevacizumab), u kellhom intervall mingħajr platinum ta' ≥ 6 xhur (72.5% fil-grupp tal-Kimo waħidha u 64.4% fil-grupp ta' Kimo+bevacizumab).
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 125 kg) f'4 studji kliniċi fit-tfal bl-użu ta'mudell tal-farmakokinetika tal-popolazzjoni.
English: In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the bevacizumab 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 bevacizumab meta mqabbel ma' sa 14% fil-gruppi ta' kontroll.
English: Zirabev should be discontinued permanently in patients who experience Grade 3 or 4 bleeding during Zirabev therapy (NCI-CTCAE v.3) (see section 4.8).
Maltese: Zirabev għandu jitwaqqaf għal kollox f'pazjenti li jkollhom esperjenza ta' fsada ta' Grad 3 jew 4 waqt kura b'Zirabev (NCI-CTCAE v.3) (ara sezzjoni 4.8).
English: Aneurysms and artery dissections, Renal thrombotic microangiopathy b,c
Maltese: Anewriżmi u dissezzjonijiet tal-arterji, Mikroanġjopatij a trombotika fil-kliewi b,c
English: Aneurysms and artery dissections, Renal thrombotic microangiopathy a,b
Maltese: Anewriżmi u dissezzjonijiet tal-arterji, Mikroanġjopatij a trombotika talkliewi a,b
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 intemmet talanqas 12-il xahar qabel il-bidu tal-prova.
English: Adjustment for these baseline factors resulted in a treatment hazard ratio of 0.78 (95% CI [0.63; 0.96], p=0.0219), indicating a 22% reduction in the risk of death for patients in the bevacizumab + IFN alfa-2a arm compared to IFN alfa-2a arm.
Maltese: Aġġustament għal dawn il-fatturi fil-linja bażi rriżulta f'hazard ratio tal-kura ta' 0.78 (95% CI [0.63; 0.96], p=0.0219), li jindika tnaqqis ta' 22% fir-riskju ta' mewt għal pazjenti fil-grupp ta' bevacizumab + IFN alfa-2a meta mqabbel mal-grupp ta' IFN alfa-2a.
English: Gastrointestinal ulcer (not known)
Maltese: Ulċera gastrointestinali (mhux magħruf)
English: 1000 mg/m2 oral bid
Maltese: 130 mg/m 2 ġol-vini 2 h 1000 mg/m 2 orali bid
English: Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the bevacizumab arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
Maltese: Sebgħa u disgħin (97) pazjent fil-grupp ta' IFN alfa-2a u 131 pazjent fil-fergħa ta' bevacizumab naqqsu d-doża ta' IFN alfa-2a minn 9 MIU għal jew 6 jew 3 MIU tliet darbiet fil-ġimgħa kif speċifikat minn qabel fil-protokoll.
English: • Gastrointestinal perforations (see section 4.4).
Maltese: Perforazzjonijiet gastrointestinali (ara sezzjoni 4.4).
English: Zirabev should be discontinued in patients with life-threatening (Grade 4) thromboembolic reactions, including pulmonary embolism (NCI-CTCAE v.3).
Maltese: Zirabev għandu jitwaqqaf f'pazjenti b'reazzjonijiet tromboemboliċi ta' periklu għall-ħajja (Grad 4), inkluż emboliżmu pulmonari (NCI-CTCAE v.3).
English: Bevacizumab in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Maltese: Bevacizumab flimkien ma' interferon alfa-2a għall-kura prinarja ta' kanċer avvanzat u/jew matastatiku taċ-ċelluli renali (BO17705)
English: In clinical trials across indications, the overall incidence of venous thromboembolic reactions ranged from 2.8% to 17.3% of bevacizumab-treated patients compared with 3.2% to 15.6% in the control arms.
Maltese: Fil-provi kliniċi fil-firxa tal-indikazzjonijiet kollha, l-inċidenza globali ta' reazzjonijiet tromboemboliċi venużi varjaw minn 2.8% sa 17.3% fil-pazjenti kkurati b'bevacizumab mqabbla ma' 3.2% sa 15.
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 ngħata sat-52 ġimgħa jew sal-progressjoni tal-marda f'doża rakkomandata tal-bidu ta' 9 MIU tliet darbiet fil-ġimgħa, li tipppermetti tnaqqis fid-doża għal 3 MIU tliet darbiet fil-ġimgħa f'2 passi.
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, iżidu s-sopravivenza bla progressjoni u r-rata ta' rispons.
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab treated patients.
Maltese: Riżultat fatali kien irrappurtat f'madwar terz tal-każijiet serji ta' perforazzjoni gastrointestinali, li jirrappreżenta bejn 0.2%-1% tal-pazjenti kollha kkurati b'bevacizumab.