FrancophonIA/ELRC3.0 huggingface dataset:
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 bid-doża ta' 7.5 mg/kg kif ukoll b'15 mg/kg (ara sezzjoni 5.1).
English: This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) plus bevacizumab to R-CHOP without bevacizumab.
Maltese: III qabblet rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) flimkien ma' bevacizumab ma' R- CHOP mingħajr bevacizumab.
English: Secondary endpoints Progression-free survival - Primary analysis 6
Maltese: Sopravivenza mingħajr progressjoni - Analiżi primarja
English: Placebo + IFNa
Maltese: Plaċebo + IFN
English: Overall survival - primary analysis Hazard ratio (95% CI)
Maltese: Sopravivenza globali - analiżi primarja Proporzjon ta' periklu (CI ta' 95%)
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 jikkorrispondu 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: Table 14 Efficacy results from study GOG-0240 by bevacizumab treatment
Maltese: Tabella 14 Riżultati tal-effikaċja mill-istudju GOG-0240 skont kura b'bevacizumab
English: Hypersensitivity, Infusion reactions a,b,c
Maltese: Sensittività eċċessiva, Reazzjonijiet għallinfużjoni a,b,c
English: Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
Maltese: Bevacizumab kien assoċjat ma' każijiet serji ta' perforazzjoni gastrointestinali.
English: In study BO25041 of bevacizumab added to postoperative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with bevacizumab.
Maltese: Fl-istudju BO25041 ta' bevacizumab miżjud ma' terapija ta' radjazzjoni (RT - radiation therapy) ta' wara operazzjoni ma' temozolomide konkomitanti u aġġuvanti fil-pazjenti pedjatriċi bi glijoma ta' grad għoli supratentorjali, infratentorjali, ċerebellari, jew pedunkulari li tkun għadha kif ġiet iddijanjostikata, il-profil tas-sigurtà kien komparabbli ma' dak osservat f'tipi tat-tumur oħra fl-adulti kkurati b'bevacizumab.
English: Each vial contains 400 mg bevacizumab.
Maltese: Kull kunjett fih 400 mg bevacizumab.
English: However, somnolence and syncope have been reported with bevacizumab use (see table 1 in section 4.8).
Maltese: Madankollu, ngħas u sinkope kienu irrapurtati bl-użu ta' bevacizumab (ara tabella 1 f'sezzjoni 4.8).
English: Table 15 Overall survival results from study GOG-0240 by trial treatment
Maltese: Tabella 15 Riżultati ta' sopravivenza globali mill-istudju GOG-0240 skont il-kura tal-prova
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 rċivew kimoterapija awżiljarja inkluż 19% b'taxanes minn qabel u 49% b'anthracycline minn qabel.
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 bevacizumab (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 tromboċitopenja ta' Grad 3-4 (NCI-CTCAE v.3); u newtropenija ta' kull grad, dijarea, tqalligħ, uġigħ ta' ras u għeja meta mqabbal ma' dawk b' ≤ 65 sena meta meta kkurati b'bevacizumab (ara sezzjonijiet 4.4 u 4.8 taħt Tromboemboliżmu).
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 sustanza waħedha f'ċiklu 7.
English: Advanced and/or metastatic renal cell cancer (mRCC)
Maltese: Kanċer taċ-ċelluli renali avanzat u/jew metastatiku (mRCC - metastatic renal cell cancer)
English: Patients and percentage of patients with best overall response of confirmed CR or PR; percentage calculated on patients with measurable disease at baseline 95% CI for one sample binomial using Pearson-Clopper method Approximate 95% CI for difference of two rates using Hauck-Anderson method log-rank test (stratified) Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis
Maltese: CI ta' 95% għal binomjali ta' kampjun wieħed bl-użu tal-metodu ta' Pearson-Clopper CI ta' madwar 95% għad-differenza ta' żewġ rati bl-użu tal-metodu Hauck-Anderson test log-rank (stratifikat)
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 1.69 L u 2.35 L għall-pazjenti nisa u rġiel rispettivament, meta bevacizumab jingħata flimkien ma' sustanzi antineoplastiċi.
English: The safety and efficacy of bevacizumab, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in trials E4599 and BO17704.
Maltese: Is-sigurtà u l-effikaċja ta' bevacizumab, flimkien ma' kimoterapija bbażata fuq il-platinum, fil-kura primarja ta' pazjenti b'kanċer fil-pulmun mhux skwamuż, taċ-ċelluli mhux żgħar (NSCLC), kienu nvestigati fil-provi E4599 u BO17704.
English: Grade 3 proteinuria was reported in up to 10.9% of treated patients.
Maltese: Proteina fl-awrina ta' Grad 3 kienet irrrappurtata f'sa 10.9% tal-pazjenti kkurati.
English: Patients with thromboembolic reactions ≤ Grade 3 need to be closely monitored (NCI-CTCAE v.3).
Maltese: Pazjenti b'reazzjonijiet tromboemboliċi ta' ≤ Grad 3 għandhom jiġu sorveljati mill-qrib (NCI-CTCAE v.3).
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014 p-value displayed for descriptive purpose only
Maltese: Analiżi ta' segwitu twettqet b'data meta waqfet tinġabar id-dejta ta' 07 ta' Marzu 2014; il-valuri p kollha huma murija għal skop deskrittiv biss
English: Addition of bevacizumab to RT/T did not demonstrate clinical benefit in study BO25041 in 60 evaluable children patients with newly diagnosed supratentorial or infratentorial cerebellar or peduncular high- grade glioma (HGG) (see section 4.2 for information on paediatric use).
Maltese: Iż-żieda ta' bevacizumab ma' RT/T ma wrietx benefiċċju kliniku fl-istudju BO25041 f'60 pazjent tfal evalwabbli bi glijoma ta' grad għoli (HGG) supratentorjali jew ċerebellari infrantentorjali jew pedunkulari li kienet għadha kif ġiet dijanjostikata (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The median age was 46.0 years (range: 20-83) in the Chemo alone group and 48.0 years (range: 22-85) in the Chemo+bevacizumab group; with 9.3% of patients in the Chemo alone group and 7.5% of patients in the Chemo+bevacizumab group over the age of 65 years.
Maltese: L-età medjana kienet ta' 46.0 sena (medda: 20-83) fil-grupp tal-Kimo waħidha u 48.0 sena (firxa: 2285) fil-grupp ta' Kimo+bevacizumab; b'9.3% tal-pazjenti fil-grupp tal-Kimo waħidha u 7.5% talpazjenti fil-grupp ta' Kimo+bevacizumab b'età 'l fuq minn 65 sena.
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 bevacizumab 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 bevacizumab meta mqabbel ma' mhux aktar minn 0.9% tal-pazjenti fil-gruppi ta' kontroll (NCI-CTCAE v.3).
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-240), 1.8% of bevacizumab-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'bevacizumab u 1.4% tal-pazjenti fuq kontroll kien irrappurtat li kellhom fistuli mhux gastrointestinali vaġinali, tal-bużżieqa tal-awrin jew fl-apparat ġenitali femminili.
English: If indicated, therapy should either be permanently discontinued or temporarily suspended as described in section 4.4.
Maltese: Jekk indikat, it-terapija għandha titwaqqaf b'mod permanenti jew temporanjament kif deskritt f'sezzjoni 4.4.
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 tal-progressjoni tal-marda fil-grupp ta' 10 mg/kg kif imqabbel mal-grupp tal-plaċebo (hazard ratio, 2.55; p < 0.001).
English: These results were consistent with those from various sensitivity analyses and in clinically relevant subgroups.
Maltese: Dawn ir-riżultati kienu konsistenti ma' dawk minn diversi analiżijiet tas-sensittività u f'sottogruppi klinikament rilevanti.
English: When Zirabev is injected directly into the eye (unapproved use), the following side effects may occur:
Maltese: Meta Zirabev jiġi injettat direttament fil-għajn (użu mhux approvat), jistgħu jseħħu l-effetti sekondarji li ġejjin:
English: Combinations of Zirabev with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Maltese: Kombinazzjonijiet ta' Zirabev ma' mediċina oħra msejħa sunitinib malate (preskritta għall-kanċer tal-kliewi u kanċer gastrointestinali) jistgħu jikkawżaw effetti sekondarji severi.
English: E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating bevacizumab 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 bevacizumab bħala kura primarja ta' pazjenti b'NSCLC avvanzat lokalment (stadju IIIb b'effużjoni plewrali malinna), metastatiku jew rikorrenti minbarra istoloġija bi predominanza ta' ċelluli skwamużi.
English: Grade 3 hypertension was 60.0% in patients treated with bevacizumab in combination with erlotinib compared to 11.7% in patients treated with erlotinib alone.
Maltese: Pressjoni għolja ta' Grad 3 seħħet f'60.0% fil-pazjenti trattati b'bevacizumab flimkien ma' erlotinib meta mqabbel ma' 11.7% f'pazjenti trattati b'erlotinib waħdu.
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating bevacizumab 7.5 mg/kg in combination with oral capecitabine and intravenous oxaliplatin (XELOX), administered on a 3- weekly schedule; or bevacizumab 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Maltese: III, randomized, double-blind (għal bevacizumab), li investigat bevacizumab 7.5 mg/kg f'taħlita ma' capecitabine orali u oxaliplatin ġol-vini (XELOX), mogħti fuq skeda ta' kull ġimgħat; jew bevacizumab 5 mg/kg f'taħlita ma' leucovorin u bolus ta' 5fluorouracil , segwit minn infużjoni ta' 5-fluorouracil, ma' oxaliplatin ġol-vini (FOLFOX-4), mogħti fuq skeda ta' kull ġimgħatejn.
English: Cases of non-mandibular osteonecrosis have been observed in bevacizumab treated paediatric patients (see section 4.8, Paediatric population).
Maltese: Każijiet ta' osteonekrożi mhux tax-xedaq kienu osservati f'pazjenti pedjatriċi kkurati b'bevacizumab (ara sezzjoni 4.8, Popolazzjoni pedjatrika).
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 talkimoterapija, il-kors b'FOLFOX-4 uża l-istess dożi u skeda kif muri f'Tabella 6 għall-prova NO16966.
English: The rate of infusion was based on tolerability, with an initial infusion duration of 90 minutes.
Maltese: Ir-rata ta' infużjoni ġiet ibbażata fuq it-tollerabbiltà, b'rata ta' infużjoni fil-bidu ta' 90 minuta.
English: Pulmonary hypertension a,
Maltese: Pressjoni pulmonari għolja a,
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 bevacizumab in combination with chemotherapy compared to those who received chemotherapy alone.
Maltese: Fil-provi kliniċi, randomized, l-inċidenza ta' reazzjonijiet tromboemboliċi arterjali, inkluż aċċidenti ċerebrovaskulari (CVAs - cerebrovascular accidents), attakki iskemiċi temporanji (TIAs - transient ischaemic attacks) u infarti mijokardijaċi (MIs - myocardial infarctions) kienet ogħla f'pazjenti li qed jirċievu bevacizumab flimkien ma' kimoterapija meta mqabbla ma' pazjenti li ħadu kimoterapija biss.
English: For further information on proteinuria see section 4.4 and Proteinuria in section 4.8.
Maltese: Għal aktar tagħrif dwar proteina fl-awrina ara sezzjoni 4.4 u Proteina fl-awrina f'sezzjoni 4.8.
English: The efficacy data from trials AVF0780g and AVF2192g investigating bevacizumab in combination with 5-FU/FA-chemotherapy are summarised in Table 5.
Maltese: It-tagħrif dwar l-effikaċja mill-provi AVF0780g u AVF2192g li studjaw lil bevacizumab f'taħlita ma' kimoterapija b'5-FU/FA humamiġbura f'Tabella 5.
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 artab mhux rabdomijosarkoma li kienu għadhom kif ġewt dijanjostikati kienu ttrattati b'kura standard (Induzzjoni ġol-viniADO/ġolviniA+/- 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: There is no relevant use of bevacizumab in the paediatric population in the indications for treatment of cancers of the colon, rectum, breast, lung, ovarian, fallopian tube, peritoneum, cervix and kidney.
Maltese: M'hemm l-ebda użu rilevanti ta' bevacizumab fil-popolazzjoni pedjatrika fl-indikazzjonijiet għallkura ta' kanċers tal-kolon, tar-rektum, tas-sider, tal-pulmun, tal-ovarji, tat-tubu fallopjan, talperitonew, taċ-ċerviċi u tal-kliewi.
English: There is evidence suggesting that all Grade (US National Cancer Institute- Common Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Maltese: Hemm evidenza li tissuġġerixxi li proteina fl-awrina ta' kull Grad (Kriterji tat-Terminoloġija Komuni għall-Avvenimenti Avversi tal-Istitut Nazzjonali talKanċer tal-Istati Uniti [NCI-CTCAE v.3]) tista' tkun relatata mad-doża.
English: Objective response rate (ORR) Patients included in analysis Rate
Maltese: Rata ta' rispons oġġettiv (ORRobjective response rate)
English: Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensin-converting enzyme inhibitors, diuretics and calcium-channel blockers.
Maltese: Il-pressjoni għolja ġeneralment kienet ikkontrollata b'mod xieraq permezz ta' anti-ipertensivi orali bħal inibituri tal-enzima li tibdel angiotensin, dijuretiċi u imblokkaturi tal-kanal tal-kalċju.
English: Gastrointestinal (GI) perforations and fistulae (see section 4.4)
Maltese: Perforazzjonijiet gastrointestinali (GI) u fistuli (ara sezzjoni 4.4)
English: *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Maltese: *Bevacizumab huwa antikorp monoklonali rikombinanti umanizzat prodott permezz ta' teknoloġija tad-DNA f'ċelluli tal-Ovarju tal-Ħamster Ċiniż.
English: Proteinuria b,d
Maltese: Proteina flawrina b,d
English: Haemorrhage a,b
Maltese: Emorraġija a,b
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) 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 pazjenti randomized għall-Kategorija 3 (5-FU/FA + bevacizumab) qabel it-twaqqif ta' din il-kategorija, is-sopravivenza medjana totali kienet ta' 18.3 xhur u s-sopravivenza bla progressjoni medjana ta' 8.8 xhur.
English: In clinical trials across all indications the overall incidence of NCI-CTCAE v.3 Grade 3-5 bleeding reactions ranged from 0.4% to 6.9% in bevacizumab treated patients, compared with up to 4.5% of patients in the chemotherapy control group.
Maltese: Fi provi kliniċi fl-indikazzjonijiet kollha, l-inċidenza globali ta' reazzjonijiet ta' fsada ta' NCICTCAE v.3 Grad 3-5 varjat minn 0.4% sa 6.9% fil-pazjenti kkurati b'bevacizumab, meta mqabbla ma' inċidenza sa 4.5% tal-pazjenti fil-grupp ta' kontroll b'kimoterapija.
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 marriċettur ta' FcRn jirriżulta fi protezzjoni mill-metaboliżmu ċellulari u l-half-life terminali twila.
English: Results from the primary analysis and the follow-up analysis are presented by bevacizumab Treatment and by Trial Treatment in Table 14 and Table 15, respectively.
Maltese: Ir-riżultati millanaliżi primarja u l-analiżi ta' segwitu huma ppreżentati skont il-Kura b'bevacizumab u skont ilKura tal-Prova f'Tabella 14 u Tabella 15, rispettivament.
English: Posology Metastatic carcinoma of the colon or rectum (mCRC)
Maltese: Karċinoma tal-kolon jew tar-rektum li mmetastatizzat (mCRC - Metastatic carcinoma of the colon or rectum)
English: Dysarthria, Headache, Dysguesia
Maltese: Stomatite, Stitikezza, Dijarea, Nawsja,
English: ● if you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Maltese: ● jekk inti allerġiku (tbati minn sensittività eċċessiva) għal prodotti derivati minn ċelluli tal-ovarju tal-ħamster ċiniż (CHO, Chinese hamster ovary) jew għal antikorpi umani jew umanizzati rikombinanti oħra.
English: The typical value for central volume (Vc) was 2.73 L and 3.28 L for female and male patients respectively, which is in the range that has been described for IgGs and other monoclonal antibodies.
Maltese: Il-valur tipiku għal volum ċentrali (Vc) kien 2.73 L u 3.28 L għall-pazjenti nisa u rġiel rispettivament, li huwa fil-firxa li kienet deskritta għal IgGs u antikorpi monoklonali oħra.
English: 95% CI for difference in response rates p-value (Chi-squared test)
Maltese: Valur p (Test chi-squared)
English: Dyspnoea, Rhinitis, Epis taxis , Cough
Maltese: Qtugħ ta' nifs, Rinite, Epistassi, Sogħla
English: Hypersensitivity reactions and infusion reactions (not known); with the following possible co-manifestations: dyspnoea/difficulty breathing, flushing/redness/rash, hypotension or hypertension, oxygen desaturation, chest pain, rigors and nausea/vomiting (see also section 4.4 and Hypersensitivity reactions/infusion reactions above)
Maltese: Reazzjonijiet ta' sensittività eċċessiva u reazzjonijiet għall-infużjoni (mhux magħrufa); bil-possibbiltà ta' manifestazzjonijiet li ġejjin fl-istess waqt: qtugħ ta' nifs/diffikultà biex tieħu n-nifs, fwawar/ħmura/raxx, pressjoni baxxa jew pressjoni għolja, desaturazzjoni ta'ossiġnu, uġigħ fis-sider, tertir u tqalligħ/rimettar (ara wkoll sezzjoni 4.4
English: d Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
Maltese: Fistuli rektovaġinali huma l-aktar fistuli komuni fil-kategorija fistula GI-vaġinali.
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 fil-moħħ (li kienu jinkudu madwar 800 pazjent), kien irrapportat każ wieħed ta' emorraġija fis-CNS ta' Grad 2 minn 83 individwu kkurati b'bevacizumab (1.2%) fil-ħin tal-analiżi interim tas-sigurtà (NCI-CTCAE v.3).
English: Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 ml of red blood) should not be treated with Zirabev.
Maltese: Pazjenti b'emorraġija fil-pulmun/emoptiżi riċenti (> 2.5 ml ta' demm aħmar) m'għandhomx jiġu kkurati b'Zirabev.
English: Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, bevacizumab therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy.
Maltese: Fatturi ta' riskju possibbli jinkludu istoloġija ta' ċelluli skwamużi, kura b'mediċini anti-rewmatiċi/anti-infjammatorji, kura b'sustanzi kontra l-koagulazzjoni tad-demm, radjuterapija minn qabel, terapija b'bevacizumab, passat mediku minn qabel ta' arterosklerożi, tumur f'lok ċentrali u formazzjoni ta' ħofra fit-tumuri qabel jew waqt it-terapija.
English: • fistula: abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected, including connections between vagina and the gut in patients with cervical cancer.
Maltese: • fistula: konnessjoni mhux normali qisha pajp bejn l-organi interni u l-ġilda, jew tessuti oħra li normalment ma jkunux konnessi, inklużi konnessjonijiet bejn il-vaġina u l-musrana f'pazjenti b'kanċer tal-għonq tal-utru.
English: There was a small difference, of borderline significance, between the time to progression of disease in the 3 mg/kg group and that in the placebo group (hazard ratio, 1.26; p=0.053).
Maltese: Kien hemm differenza żgħira, kemm kemm sinifikat, bejn il-ħin sal-progressjoni tal-marda fil-grupp ta' 3 mg/kg u dak fil-grupp ta' plaċebo (hazard ratio, 1.26; p=0.053).
English: Other medicines and Zirabev
Maltese: Mediċini oħra u Zirabev
English: Severe reactions are defined as adverse reactions 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 reazzjonijiet avversi b'differenza ta' mill-inqas 2% meta mqabbel mal-grupp ta' kontroll fl-istudji kliniċi għal reazzjonijiet ta' NCI-CTCAE Grad 3-5.