FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the results of the population pharmacokinetic analysis, pertuzumab exposure in patients with mild (creatinine clearance [CLcr] 60 to 90 ml/min, N=200) and moderate renal impairment (CLcr 30 to 60 ml/min, N=71) was similar to that in patients with normal renal function (CLcr greater than 90 ml/min, N=200).
Maltese: Ibbażat fuq ir-riżultati tal-analiżi talfarmakokinetika tal-popolazzjoni, l-esponiment għal pertuzumab f'pazjenti b'indeboliment renali ħafif (tneħħija tal-krejatinina [CLcr] ta' 60 sa 90 ml/min, N=200) u moderat (CLcr ta' 30 sa 60 ml/min, N=71) kien simili għal dak f'pazjenti b'funzjoni renali normali (CLcr aktar minn 90 ml/min, N=200).
English: Patients in the pivotal trial CLEOPATRA were tested at multiple time-points for anti-drug antibodies (ADA) to Perjeta.
Maltese: CLEOPATRA ġew ittestjati f'punti ta' ħin multipli għall-antikorpi kontra l-mediċina (ADA - anti-drug antibodies) għal Perjeta.
English: The most common NCI-CTCAE Grade 3-4 ADRs (≥10%) were neutropenia and febrile neutropenia.
Maltese: L-aktar ADRs komuni ta' NCI-CTCAE Grad 3-4 (≥10%) kienu newtropenija u newtropenija bid-deni.
English: • 6 cycles of docetaxel in combination with carboplatin
Maltese: • 6 ċikli ta' docetaxel flimkien ma' carboplatin
English: This absence of drug-drug interaction was confirmed by pharmacokinetic data from the NEOSPHERE and APHINITY studies.
Maltese: Dan in-nuqqas ta' interazzjoni bejn mediċina u oħra kien ikkonfermat minn data farmakokinetika mill-istudji NEOSPHERE u APHINITY.
English: The statistically significant OS benefit in favour of the Perjetatreated group, previously observed at an interim analysis of OS (performed one year after the primary analysis), was maintained (HR 0.68, p = 0.0002 log-rank test).
Maltese: Il-benefiċċju statistikament sinifikanti f'OS favur il-grupp ikkurat b'Perjeta, osservat qabel f'analiżi interim ta' OS (imwettqa sena wara l-analiżi primarja), inżamm (HR 0.68, p = 0.0002 test log-rank).
English: Vial (Type I glass) with a stopper (butyl rubber) containing 14 ml of solution.
Maltese: Kunjett (Ħġieġ Tip I) b'tapp (lastku butyl) fih 14 ml ta' soluzzjoni.
English: Left ventricular dysfunction (including congestive heart failure)
Maltese: Disfunzjoni tal-ventriklu tax-xellug (inkluż insuffiċjenza konġestiva tal-qalb)
English: • Trastuzumab plus docetaxel
Maltese: Trastuzumab Docetaxel
English: In the neoadjuvant and adjuvant trials, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA.
Maltese: Fil-provi neoadjuvant u adjuvant, avvenimenti ta' sensittività eċċessiva/anafilassi kienu konsistenti ma' dawk osservati f'CLEOPATRA.
English: Perjeta has not been studied in patients with: a pre-treatment LVEF value of < 50%; a prior history of congestive heart failure (CHF); LVEF declines to < 50% during prior trastuzumab adjuvant therapy; or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to > 360 mg/m2 of doxorubicin or its equivalent.
Maltese: Perjeta ma ġiex studjat f'pazjenti b': valur ta' LVEF ta' qabel il-kura ta' < 50%; passat mediku ta' insuffiċjenza konġestiva tal-qalb (CHF); tnaqqis fl-LVEF ta' < 50% matul terapija awżiljarja ta' qabel b'trastuzumab; jew kondizzjonijiet li jistgħu jtellfu l-funzjoni tal-ventriklu tax-xellug bħal pressjoni għolja mhux ikkontrollata, infart mijokardijaku reċenti, arritmija kardijaka serja li teħtieġ kura jew esponiment kumulattiv minn qabel għal anthracycline għal > 360 mg/m ta' doxorubicin jew l ekwivalenti tiegħu.
English: Secondary efficacy endpoints were pCR rate in the breast (ypT0/is), DFS, PFS and OS.
Maltese: Punti finali sekondarji tal-effikaċja kienu r-rata ta' pCR fis-sider (ypT0/is), DFS, PFS u OS.
English: Key to abbreviations (Table 5): HR: Hazard Ratio; CI: Confidence Interval
Maltese: Tifsira għat-taqsiriet (Tabella 5): HR: Proporzjon ta' Periklu; CI: Intervall ta' Kunfidenza 1.
English: The median clearance (CL) of pertuzumab was 0.235 litres/day and the median half-life was 18 days.
Maltese: It-tneħħija (CL) medjana ta' pertuzumab kienet ta' 0.235 litri/kuljum u l-half-life medjana kienet ta' 18-il ġurnata.
English: After dilution, one ml of solution contains approximately 3.02 mg of pertuzumab for the initial dose and approximately 1.59 mg of pertuzumab for the maintenance dose (see section 6.6).
Maltese: Wara d-dilwizzjoni, 1 ml ta' soluzzjoni fih madwar 3.02 mg ta' pertuzumab għad-doża inizjali u madwar 1.59 mg ta' pertuzumab għad-doża ta' manteniment (ara sezzjoni 6.6).
English: Data available for Infusion Related Reactions (IRR) and anaphylaxis/hypersensitivity with fatal outcome for patients treated with Perjeta in clinical trials, data from published literature, and relevant data from the Roche global safety database showed that there were no cases of confirmed IRRs or anaphylaxis/hypersensitivity with a fatal outcome in pivotal clinical trials in patients treated with pertuzumab.
Maltese: Data disponibbli għal Reazzjonijiet Relatati mal-Infużjoni (IRR - Infusion Related Reactions) u anafilassi/sensittività eċċessiva b'eżitu fatali għal pazjenti ttrattati b'Perjeta fi provi kliniċi, data minn letteratura ppubblikata, u data rilevanti mid-database dwar is-sigurtà globali ta' Roche wrew li ma kienx hemm każijiet ta' IRRs jew anafilassi/sensittività eċċessiva kkonfermati b'eżitu fatali fi provi kliniċi pivitali f'pazjenti ttrattati b'pertuzumab.
English: • CLEOPATRA, in which Perjeta was given in combination with docetaxel and trastuzumab to patients with metastatic breast cancer (n=453)
Maltese: • CLEOPATRA, fejn Perjeta ingħata flimkien ma' docetaxel u trastuzumab lill-pazjenti b'kanċer metastatiku tas-sider (n=453)
English: Severe hypersensitivity, including anaphylaxis and events with a fatal outcome, has been observed with Perjeta (see section 4.8).
Maltese: Sensittività eċċessiva severa, inklużi anafilassi u avvenimenti b'riżultat fatali, kienet osservata b'Perjeta (ara sezzjoni 4.8).
English: Name and address of the manufacturer responsible for batch release Roche Pharma AG
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Roche Pharma AG
English: The difference in pCR rate is considered likely to translate into a clinically meaningful difference in long term outcomes and is supported by positive trends in PFS (HR 0.69, 95% CI 0.34, 1.40) and DFS (HR 0.60, 95% CI 0.28, 1.27).
Maltese: Id-differenza fir-rata ta' pCR hija meqjusa li x'aktarx tittraduċi f'differenza klinikament sinifikanti fir-riżultati fit-tul u hija appoġġjata minn xejriet pożittivi f'PFS (HR 0.69, CI ta' 95% 0.34, 1.40) u DFS (HR 0.60, CI ta' 95%
English: Intravenous administration of pertuzumab from GD19 through GD50 (period of organogenesis) was embryotoxic, with dose-dependent increases in embryo-foetal death between GD25 to GD70.
Maltese: Għoti ta' pertuzumab fil-vini minn GD19 sa GD50 (perijodu ta' organoġenesi) kien tossiku għall-embriju, b'żidiet dipendenti mid-doża fl-imwiet tal-embriju jew tal-fetu minn GD25 sa GD70.
English: Vas cular dis orders
Maltese: DATA TA' SKADENZA
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 420 mg/14 ml
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni 420 mg/14 ml
English: Hypersensitivity reactions/anaphylaxis
Maltese: Reazzjonijiet ta' sensittività eċċessiva/anafilassi
English: A population pharmacokinetic analysis was performed with data from 481 patients across different clinical trials (phase I, II and III) with various types of advanced malignancies who had received Perjeta as a single agent or in combination at pertuzumab doses ranging from 2 to 25 mg/kg administered every 3 weeks as a 30-60 minutes intravenous infusion.
Maltese: Analiżi farmakokinetika tal-popolazzjoni saret b'data minn 481 pazjent minn provi kliniċi differenti (fażi I, II u III), b'diversi tipi ta' tumuri malinni avanzati li kienu rċevew Perjeta bħala sustanza waħedha jew flimkien ma' sustanzi oħra, b'dożi li varjaw minn 2 sa 25 mg/kg mogħtija kull 3 ġimgħat bħala infużjoni fil-vini fuq medda ta' 30-60 minuta.
English: Perjeta has been associated with infusion reactions, including events with a fatal outcome (see section 4.8).
Maltese: Perjeta kien assoċjat ma' reazzjonijiet għall-infużjoni, inklużi avvenimenti b'riżultat fatali (ara sezzjoni 4.8).
English: The incidences of embryo-foetal loss were 33, 50, and 85% for pregnant female monkeys treated with bi-weekly pertuzumab doses of 10, 30, and 100 mg/kg, respectively (2.5 to 20-fold greater than the recommended human dose, based on Cmax).
Maltese: L-inċidenza ta' telf tal-embriju jew fetu kienet ta' 33, 50, u 85% għal xadini femminili tqal ikkurati b'dożi ta' pertuzumab darbtejn fil-ġimgħa ta' 10, 30, u 100 mg/kg, rispettivament (2.5 sa 20-darba akbar mid-doża rrakkomandata fil-bniedem, ibbażat fuq Cmax).
English: Docetaxel was given intravenously at an initial dose of 75 mg/ m2 followed by 75 mg/ m2 or 100 mg/ m2 (if tolerated) every 3 weeks.
Maltese: Docetaxel ingħata fil-vini b'doża inizjali ta' 75 mg/m segwit minn 75 mg/m jew 100 mg/m
English: Left ventricular dysfunction (LVD)
Maltese: Disfunzjoni tal-ventriklu tax-xellug (LVD - Left ventricular dysfunction) Fil-prova pivitali
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 420 mg/14 ml
Maltese: INDIVIDWALI 420 mg/14 ml
English: Perjeta+ Trastuzumab+ FEC Perjeta+ Trastuzumab
Maltese: Perjeta + trastuzumab + Kimoterapija
English: Treatment Perjeta+Trastuzumab+Docetaxel and Perjeta+Trastuzumab are compared to Trastuzumab+ Docetaxel while Perjeta+Docetaxel is compared to Perjeta+Trastuzumab+Docetaxel.
Maltese: Kura ta' Perjeta+Trastuzumab+Docetaxel u Perjeta+Trastuzumab huma mqabbla ma' Trastuzumab+ Docetaxel waqt li Perjeta+Docetaxel hija mqabbla ma' Perjeta+Trastuzumab+Docetaxel.
English: Simes corr. for CMH test)
Maltese: Valur p (b'korrezzj oni Simes għat-test CMH)
English: Perjeta 420 mg concentrate for solution for infusion pertuzumab
Maltese: Perjeta 420 mg konċentrat għal soluzzjoni għall-infużjoni pertuzumab
English: As a result, pertuzumab inhibits ligand-initiated intracellular signalling through two major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K).
Maltese: B'riżultat ta' dan, pertuzumab jinibixxi is-sinjalar intraċellulari mibdija mil-ligand permezz ta' żewġ rotot ta' sinjalar ewlenin, kinase tal-proteina attivat minn mitoġen (MAP) u phosphoinositide 3-kinase (PI3K).
English: Gastrointestinal disorders Diarrhoea Vomiting
Maltese: Disturbi gastro-intestinali Dijarea
English: No relationship between CLcr and pertuzumab exposure was observed over the range of CLcr (27 to 244 ml/min).
Maltese: Ma kienet osservata l-ebda relazzjoni bejn CLcr u l-esponiment għal pertuzumab fil-firxa ta' CLcr (27 sa 244 ml/min).
English: Perjeta does not contain any antimicrobial preservative.
Maltese: Perjeta ma fih l-ebda preservattiv kontra l-mikrobi.
English: Perjeta must be permanently discontinued in case of NCI-CTCAE Grade 4 hypersensitivity reactions (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.2).
Maltese: Perjeta għandu jitwaqqaf b'mod permanenti f'każ ta' reazzjonijiet ta' sensittività eċċesiva (anafilassi) ta' NCI-CTCAE Grad 4, bronkospażmu jew sindrome ta' distress respiratorju akut (ara sezzjoni 4.2).
English: Overall 7% of patients had inflammatory breast cancer, 32% had locally advanced breast cancer and 61% had operable breast cancer.
Maltese: Globalment 7% tal-pazjenti kellhom kanċer tas-sider infjammatorju, 32% kellhom kanċer tas-sider avanzat lokalment u 61% kellhom kanċer tas-sider operabbli.
English: A post hoc exploratory analysis revealed that for patients who had received prior trastuzumab (n = 88), the hazard ratio for IRF-assessed PFS was 0.62 (95% CI 0.35, 1.07), compared with 0.60 (95% CI 0.43, 0.83) for patients who had received prior therapy which did not include trastuzumab (n = 288).
Maltese: Analiżi esploratorja post hoc uriet li għall-pazjenti li kienu rċevew trastuzumab qabel (n = 88), il-proporzjon ta' periklu għal PFS evalwat minn IRF kien ta' 0.62 (95% CI 0.35, 1.07), meta mqabbel ma' 0.60 (95% CI 0.43, 0.83) għall-pazjenti li kienu rċevew terapija minn qabel li ma kinetx tinkludi trastuzumab (n = 288).
English: • Perjeta plus docetaxel.
Maltese: +Docetaxel
English: The estimate of IDFS at 4-years was 92.3% in the Perjeta-treated group versus 90.6% in the placebo treated group.
Maltese: L-estimu ta' IDFS wara 4 snin kien ta' 92.3% fil-grupp ittrattat b'Perjeta kontra 90.6% fil-grupp ittrattat bil-plaċebo.
English: D-79639 Grenzach-Whylen
Maltese: D-79639 Grenzach-Whylen Il-Ġermanja
English: The other ingredients are glacial acetic acid, L-histidine, sucrose, polysorbate 20 and water for injections
Maltese: • Is-sustanzi l-oħra huma glacial acetic acid, L-histidine, sucrose, polysorbate 20 u ilma għall injezzjonijiet.
English: In clinical trials, single doses higher than 25 mg/kg (1727 mg) have not been tested.
Maltese: Fi provi kliniċi, dożi waħdanin ogħla minn 25 mg/kg (1727 mg) ma ġewx ittestjati.
English: After dilution, one ml of solution should contain approximately 3.02 mg of pertuzumab (840 mg/278 ml) for the initial dose where two vials are required and approximately 1.59 mg of pertuzumab (420 mg/264 ml) for the maintenance dose where one vial is required.
Maltese: Wara d-dilwazzjoni, ml wieħed ta' soluzzjoni għandu jkun fih madwar 3.02 mg ta' pertuzumab (840 mg/278 ml) għad-doża tal-bidu li għalija huma meħtieġa żewġ kunjetti u madwar 1.59 mg ta' pertuzumab (420 mg/264 ml) għad-doża ta' manteniment fejn huwa meħtieġ kunjett wieħed.
English: The results for investigator-assessed PFS were similar to those observed for IRF-assessed PFS.
Maltese: Ir-riżultati ta' PFS evalwata mill-investigatur kienu simili għal dawk osservati għal PFS evalwata minn IRF.
English: Table 5 Overall Efficacy: ITT Population
Maltese: Tabella 5 Effikaċja Globali:
English: Treatment should include standard anthracycline- and/or taxane-based chemotherapy.
Maltese: It-trattament għandu jinkludi kimoterapija standard ibbażata fuq anthracycline u/jew taxane.
English: Docetaxel N=75
Maltese: N=75
English: The diarrhoea was managed (with the exception of euthanasia of one animal, 50 mg/kg/dose) with supportive care including intravenous fluid replacement therapy.
Maltese: Id-dijarea kienet immaniġġata (bl-eċċezzjoni ta' ewtanażja ta' annimal wieħed, 50 mg/kg/doża) b'kura ta' sapport inkluż terapija fil-vini ta' sostituzzjoni ta' fluwidi.
English: Five studies evaluated the effects of pertuzumab on the PK of co-administered cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin and erlotinib.
Maltese: Ħames studji evalwaw l-effetti ta' pertuzumab fuq il-PK ta' sustanzi ċitotossiċi, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin, u erlotinib mogħtija miegħu.
English: 21.0, 23.6) in the Perjeta arm versus +9.2 (95% CI 8.2, 10.2) in the placebo arm.
Maltese: +9.2 (CI ta' 95% 8.2, 10.2) fil-grupp tal-plaċebo.
English: • a drop in LVEF to less than 40% • a LVEF of 40%-45% associated with a fall of ≥ 10% points below pre-treatment value.
Maltese: • LVEF ta' 40%-45% assoċjat ma' tnaqqis ta' > 10% punti taħt il-valur ta' qabel il-kura.
English: Consistent results were observed across pre-specified patient subgroups including the subgroups based on stratification factors of geographic region and prior adjuvant/neoadjuvant therapy or de novo metastatic breast cancer (see Figure 1).
Maltese: Riżultati konsistenti kienu osservati fost is-sottogruppi ta' pazjenti speċifikati minn qabel kollha inkluż is-sottogruppi bbażati fuq fatturi ta' stratifikazzjoni ta' reġjun ġeografiku u terapija awżiljarja/ neoadjuvant minn qabel jew kanċer metastatiku tas-sider de novo (ara Figura 1).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsquent updates published on the European medicines web-portal.
Maltese: Sussegwentement, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Reproductive toxicology studies have been conducted in pregnant cynomolgus monkeys (Gestational Day (GD) 19 through to GD 50) at initial doses of 30 to 150 mg/kg followed by bi-weekly doses of 10 to 100 mg/kg.
Maltese: Saru studji dwar l-effett tossiku fuq is-sistema riproduttiva f'xadini cynomolgus tqal (Jum ta' Tqala (GD) 19 sa GD 50) b'dożi tal-bidu ta' 30 sa 150 mg/kg segwit minn dożi darbtejn fil-ġimgħa ta' 10 sa 100 mg/kg.
English: The mean decrease from baseline at that time for physical function was -10.7 (95% CI-11.4, -10.0) in the Perjeta arm and -10.6 (95% CI -11.4, -9.9) in the placebo arm; global health status was -11.2 (95% CI -12.2, -10.2) in the Perjeta arm and -10.2
Maltese: (CI ta' 95% -11.4, -9.9) fil-grupp tal-plaċebo; l-istat tas-saħħa globali kien -11.2 (CI ta' 95%12.2, -10.2) fil-grupp ta' Perjeta u -10.
English: 14 ml of Perjeta concentrate should be withdrawn from the vial and diluted into a 250 ml PVC or non-PVC polyolefin infusion bag of sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Il-kunjett m'għandux jitħawwad. 14 ml ta' konċentrat ta' Perjeta għandhom jittelgħu mill-kunjett u jiġu dilwiti f'borża għall-infużjoni ta' 250 ml, tal-PVC jew tal-polyolefin mingħajr PVC ta' soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: pCR rate in the breast and lymph node (ypT0/is N0)
Maltese: Rati esploratorji addizzjonali ta' pCR kienu jinkludu listat tal-glandoli (ypT0/isN0 u ypT0N0).
English: Table 3 Summary of efficacy from CLEOPATRA study Parameter
Maltese: Tabella 3 Sommarju tal-effikaċja mill-istudju CLEOPATRA
English: Elderly patients (> 65 years) may have a higher risk of diarrhoea compared with younger patients (< 65 years).
Maltese: Pazjenti anzjani (> 65 sena) jista' jkollhom riskju ogħla ta' dijarea meta mqabbla ma' pazjenti iżgħar (< 65 sena).
English: Overall 6% of patients had inflammatory breast cancer, 25% had locally advanced breast cancer and 69% had operable breast cancer.
Maltese: Globalment 6% tal-pazjenti kellhom kanċer tas-sider infjammatorju, 25% kellhom kanċer tas-sider avanzat lokalment u 69% kellhom kanċer tas-sider operabbli.
English: BO17929 - single-arm trial in metastatic breast cancer
Maltese: BO17929 - prova bi grupp wieħed dwar kanċer metastatiku tas-sider
English: < 6 weeks
Maltese: 4 snin
English: The incidence of symptomatic LVD was also lower in the Perjeta-treated group (1.8% in the placebo-treated group vs. 1.5% in the Perjeta-treated group) (see section 4.4).
Maltese: L-inċidenza ta' LVD sintomatika kienet ukoll aktar baxxa fil-grupp ikkurat b'Perjeta (1.8% fil-grupp ikkurat bi plaċebo vs. 1.5% fil-grupp ikkurat b'Perjeta) (ara sezzjoni 4.4).
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, the overall frequency of investigator reported hypersensitivity/anaphylaxis events during the entire treatment period was 9.3% in the placebo-treated group and 11.3% in the Perjeta-treated group, of which 2.5% and 2.0% were NCI-CTCAE Grade 3-4, respectively.
Maltese: CLEOPATRA f'kanċer metastatiku tas-sider, il-frekwenza globali ta' avvenimenti ta' sensittività eċċessiva/anafilassi rrappurtata mill-investigatur waqt il-perijodu kollu tal-kura kienet ta' 9.3% fil-grupp ikkurat bil-plaċebo u ta' 11.3% fil-grupp ikkurat b'Perjeta, li minnhom 2.5% u 2.0% kienu ta' NCI-CTCAE Grad 3-4, rispettivament.
English: 2 years.
Maltese: 3 snin
English: Results of Subgroup Analysis
Maltese: Riżultati tal-Analiżi tas-Sottogrupp
English: The majority of cases of symptomatic heart failure reported in the adjuvant setting were in patients who received anthracyclinebased chemotherapy (see section 4.8).
Maltese: Il-maġġoranza tal-każijiet ta' insuffiċjenza sintomatika tal-qalb irrappurtati fl-ambjent adjuvant kienu f'pazjenti li rċevew kimoterapija bbażata fuq anthracycline (ara sezzjoni 4.8).
English: [95% CI]
Maltese: [CI ta' 95%] 93.5
English: • APHINITY, in which adjuvant Perjeta was given in combination with trastuzumab and anthracycline-based or non-anthracycline-based, taxane-containing chemotherapy to patients with early breast cancer (n=2364)
Maltese: • APHINITY, fejn Perjeta adjuvant ingħata flimkien ma' trastuzumab u kimoterapija li fiha ttaxane bbażata fuq anthracycline jew mhux ibbażata fuq anthracycline lil pazjenti b'kanċer bikri tas-sider (n=2364)
English: See section 4 “Serious side effects” for more details about signs of heart problems to look out for.
Maltese: Ara sezzjoni 4 “Effetti sekondarji serji” għal aktar dettalji dwar sinjali ta' problemi fil-qalb li għandek toqgħod attent għalihom.
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Maltese: Il-Manifattur Roche Pharma AG
English: In the hormone receptor-negative subgroup, estimates of IDFS rates were 92.8% versus 91.2% at 3 years and 91.0% versus 88.7% at 4 years in Perjeta-treated patients versus placebo-treated patients,
Maltese: Fis-sottogrupp negattiv għar-riċettur tal-ormoni, l-estimi tar-rati ta' IDFS kienu 92.8% kontra 91.2% wara 3 snin u 91.0% kontra 88.7% wara 4 snin f'pazjenti ttrattati b'Perjeta kontra pazjenti ttrattati bi plaċebo, rispettivament.
English: The primary endpoint of cardiac safety, i.e. the incidence of NYHA Class III/IV LVD and LVEF declines, was consistent with previous data in the neoadjuvant setting (see section 4.4. and 4.8).
Maltese: III/IV u t-tnaqqis f'LVEF, kien konsistenti mad-data preċedenti fl-ambjent neadjuvant (ara sezzjoni 4.4 u 4.8).
English: In the neoadjuvant setting, locally advanced and inflammatory breast cancers are considered as highrisk irrespective of hormone receptor status.
Maltese: Fl-ambjent neoadjuvant, kanċers tas-sider avanzati lokalment u infjammatorji huma kkunsidrati bħala ta' riskju għoli irrispettivament mill-istat tar-riċettur tal-ormoni.
English: As in the CLEOPATRA, TRYPHAENA, and NEOSPHERE trials, a higher incidence of febrile neutropenia was observed among Perjeta-treated Asian patients compared with other races in the APHINITY trial (15.9% of Perjeta-treated patients and 9.9% of placebo-treated patients).
Maltese: Bħal fil-provi CLEOPATRA, TRYPHAENA, u NEOSPHERE, filprova APHINITY kienet osservata inċidenza ogħla ta' newtropenija bid-deni f'pazjenti Asjatiċi ttrattati b'Perjeta meta mqabbla ma' razez oħra (15.9% tal-pazjenti ttrattati b'Perjeta u 9.9% talpazjenti ttrattati bil-plaċebo).
English: Responders***
Maltese: NUMRU(I)
English: In the APHINITY trial, the incidence of NCI-CTCAE v.4 Grade 3-4 neutropenia was 40.6% in patients treated with Perjeta, trastuzumab and chemotherapy compared with 39.1% in patients treated with placebo, trastuzumab and chemotherapy, including 28.3% and 26.5% Grade 4 neutropenia,
Maltese: Fil-prova APHINITY, l-inċidenza ta' newtropenija ta' NCI-CTCAE v.4 Grad 3-4 kienet ta' 40.6% f'pazjenti ttrattati b'Perjeta, trastuzumab u kimoterapija meta mqabbla ma' 39.1% f'pazjenti ttrattati bi plaċebo, trastuzumab u kimoterapija, inkluż 28.3% u 26.
English: Secondary efficacy endpoints were clinical response rate, breast conserving surgery rate (T2-3 tumours only), disease-free survival (DFS), and PFS. Additional exploratory pCR rates included nodal status (ypT0/isN0 and ypT0N0).
Maltese: Punti finali sekondarji tal-effikaċja kienu r-rata ta' rispons kliniku, ir-rata ta' kirurġija ta' konservazzjoni tas-sider (tumuri T2-3 biss), sopravivenza mingħajr ilmarda (DFS - disease-free survival), u PFS.