FrancophonIA/ELRC3.0 huggingface dataset:
English: In the neoadjuvant period of the BERENICE trial, the incidence of NYHA Class III/IV symptomatic LVD (congestive heart failure according to NCI-CTCAE v.4) was 1.5% in the group treated with dose dense doxorubicin and cyclophosphamide (AC) followed by Perjeta plus trastuzumab and paclitaxel and none of the patients (0%) experienced symptomatic LVD in the group treated with FEC followed by Perjeta in combination with trastuzumab and docetaxel.
Maltese: III/IV (insuffiċjenza konġestiva tal-qalb skont NCI-CTCAE v.4) kienet ta' 1.5% fil-grupp ittrattat b'dose dense doxorubicin u cyclophosphamide (AC) segwit minn Perjeta flimkien ma' trastuzumab u paclitaxel u l-ebda pazjent (0%) ma kellu LVD sintomatika fil-grupp ittrattat b'FEC segwit minn Perjeta flimkien ma' trastuzumab u docetaxel.
English: Patients with clinically important cardiac risk factors were not included (see section 4.4).
Maltese: Pazjenti b'fatturi ta' riskju kardijaċi ta' importanza klinika ma kienux inklużi (ara sezzjoni 4.4).
English: An observation period of 30 - 60 minutes is recommended after completion of each infusion.
Maltese: Perjodu ta' osservazzjoni ta' 30-60 minuta huwa rakkomandat wara t-tlestija ta' kull infużjoni ta' Perjeta.
English: If the first infusion is well tolerated, subsequent infusions may be administered over a period of 30 minutes to 60 minutes (see section 4.4).
Maltese: Jekk l-ewwel infużjoni tkun ittollerata tajjeb, infużjonijiet sussegwenti jistgħu jingħataw fuq perijodu ta' 30 minuta sa 60 minuta (ara sezzjoni 4.4).
English: The median time to death was 40.8 months in the placebo-treated group and 56.5 months in the Perjeta-treated group (see Table 3, Figure 2).
Maltese: Il-ħin medjan sal-mewt kien ta' 40.8 xhur fil-grupp ikkurat bil-plaċebo u 56.5 xhur fil-grupp ikkurat b'Perjeta (ara Tabella 3, Figura 2).
English: Figure 3 Kaplan-Meier Curve of Invasive Disease Free Survival
Maltese: Kaplan-Meier ta' Sopravivenza Mingħajr Marda Invażiva
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, rash occurred in 51.7% of Perjeta-treated patients, compared with 38.9% of placebo-treated patients.
Maltese: CLEOPATRA f'kanċer metastatiku tas-sider, raxx seħħ f'51.7% tal-pazjenti kkurati b'Perjeta, meta mqabbel ma' 38.9% ta' pazjenti kkurati bil-plaċebo.
English: • an IV infusion with an initial loading dose of trastuzumab 8 mg/kg body weight followed every 3 weeks thereafter by a maintenance dose of 6 mg/kg body weight or
Maltese: • infużjoni IV b'doża għolja tal-bidu (initial loading dose) ta' trastuzumab 8 mg/kg ta' piż talġisem segwita kull 3 ġimgħat minn hemm 'il quddiem b'doża ta' manteniment ta' 6 mg/kg ta' piż tal-ġisem jew
English: A consistent pattern of results was observed regardless of pCR definition used.
Maltese: Kien osservat disinn konsistenti ta' riżultati rrispettivament mid-definizzjoni tal-pCR użata.
English: The median age was 51 years, and over 99% of patients were female.
Maltese: L-età medjana kienet ta' 51 sena, u aktar minn 99% tal-pazjenti kienu nisa.
English: declines in LVEF of at least 10% points from baseline and to <50% were reported in 2.7% of Perjetatreated patients and 2.8% of placebo-treated patients, of whom 79.7% of Perjeta-treated patients and
Maltese: Tnaqqis bla sintomi jew bi ftit sintomi (NYHA klassi II) f'LVEF ta' mill-inqas 10% mil-linja bażi u għal <50% kien irrappurtat fi 2.7% tal-pazjenti ttrattati b'Perjeta u fi 2.8% tal-pazjenti ttrattati bil-plaċebo, li minnhom 79.7% tal-pazjenti ttrattati b'Perjeta u 80.
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was balanced in the two treatment groups (86.3% of Perjeta-treated patients and 86.6% of placebo-treated patients, including 60.7% and 64.8% Grade 4 neutropenia, respectively).
Maltese: CLEOPATRA f'kanċer metastatiku tas-sider, l-inċidenza ta' newtropenija ta' NCICTCAE v.3 Grad 3-4 kienet ibbilanċjata fiż-żewġ gruppi ta' kura (86.3% tal-pazjenti kkurati b'Perjeta u 86.6% tal-pazjenti kkurati bil-plaċebo, inkluż 60.7% u 64.8% newtropenija ta' Grad 4, rispettivament).
English: p-value (Log-Rank test, stratified1) 3 year event-free rate3 [95% CI] Secondary Endpoints1
Maltese: Valur p (Test Log-Rank, stratifikat Rata ta' 3 snin mingħajr avveniment
English: The pCR rates were lower in the subgroup of patients with hormone receptor positive tumours (range 46.2% to 50.0%) than in patients with hormone receptor-negative tumours (range 65.0% to 83.8%).
Maltese: Ir-rati tal-pCR kienu aktar baxxi fis-sottogrupp ta' pazjenti b'tumuri pożittivi għar-riċettur tal-ormon (firxa 46.2% sa 50.0%) milli f'pazjenti b'tumuri negattivi għar-riċettur tal-ormon (firxa 65.0% sa 83.8%).
English: Docetaxel N=73
Maltese: N=73
English: Additional supportive clinical trial information
Maltese: Informazzjoni addizzjonali ta' appoġġ mill-prova klinika
English: The safety and efficacy of Perjeta in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Perjeta fi tfal u adolexxenti b'età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: In the TRYPHAENA trial, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was 85.3% in patients treated with neoadjuvant Perjeta + TCH and 77.0% in patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC, including 66.7% and 59.5% Grade 4 neutropenia,
Maltese: 3% f'pazjenti kkurati b'Perjeta + TCH neoadjuvant u 77.0% f'pazjenti kkurati b'Perjeta, trastuzumab u docetaxel neoadjuvant wara FEC, inkluż 66.7% u 59.5% newtropenija ta' Grad 4, rispettivament.
English: AUTHORISATION
Maltese: Perjeta
English: • Cohort A - 4 cycles of two weekly dose-dense doxorubicin and cyclophosphamide followed by 4 cycles of Perjeta in combination with trastuzumab and paclitaxel.
Maltese: • Grupp A - 4 ċikli ta' dose dense doxorubicin u cyclophosphamide darbtejn fil-ġimgħa segwiti minn 4 ċikli ta' Perjeta flimkien ma' trastuzumab u paclitaxel
English: Pertuzumab displayed linear pharmacokinetics within the recommended dose range.
Maltese: Linearità/nuqqas ta' linearità Pertuzumab wera farmakokinetika lineari fil-firxa tad-doża rakkomandata.
English: Following surgery all patients received 3 cycles of 5fluorouracil (600 mg/m2), epirubicin (90 mg/m2), cyclophosphamide (600 mg/m2) (FEC) given intravenously every three weeks, and trastuzumab administered intravenously every three weeks to complete one year of therapy.
Maltese: (90 mg/m2), cyclophosphamide (600 mg/m2) (FEC) mogħtija fil-vini kull tliet ġimgħat, u trastuzumab mogħti fil-vini kull tliet ġimgħat biex tintemm sena waħda ta' terapija.
English: A consistent pattern of results was observed regardless of pCR definition.
Maltese: Kien osservat disinn konsistenti ta' riżultati rrispettivament mid-definizzjoni tal-pCR.
English: n (%) [95% CI]
Maltese: n (%) [CI ta'
English: In the hormone receptor-positive subgroup estimates of IDFS rates were 94.8% versus 94.4% at 3 years and 93.0% versus 91.6% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Maltese: 8% kontra 94.4% wara 3 snin u 93.0% kontra 91.6% wara 4 snin f'pazjenti ttrattati b'Perjeta kontra pazjenti ttrattati bi plaċebo, rispettivament.
English: no. of patients with an event Median months Overall Survival - secondary endpoint**
Maltese: Sopravivenza globali - punt finali sekondarju**
English: Secondary efficacy endpoints were IDFS including second primary non-breast cancer, overall survival (OS), disease-free survival (DFS), recurrence-free interval (RFI) and distant recurrence-free interval (DRFI).
Maltese: Punti finali sekondarji tal-effikaċja kienu IDFS inkluż it-tieni kanċer primarju mhux tas-sider, sopravivenza globali (OS - overall survival), sopravivenza mingħajr il-marda (DFS - disease-free survival), intervall mingħajr rikorrenza (RFIrecurrence-free interval) u intervall mingħajr rikorrenza f'postijiet oħra (DRFI - distant recurrencefree interval).
English: Antibodies are cleared principally by catabolism.
Maltese: Antikorpi jiġu mneħħija prinċipalment minn kataboliżmu.
English: The pCR rates as well as the magnitude of benefit with Perjeta (Perjeta plus trastuzumab and docetaxel compared to patients receiving trastuzumab and docetaxel) were lower in the subgroup of patients with hormone receptor-positive tumours (difference of 6% in pCR in the breast) than in patients with hormone receptor-negative tumours (difference of 26.4% in pCR in the breast).
Maltese: Ir-rati ta' pCR kif ukoll id-daqs tal-benefiċċju b'Perjeta (Perjeta flimkien ma' trastuzumab u docetaxel imqabbel ma' patients li kienu qed jirċievu trastuzumab u docetaxel) kienu aktar baxxi fis-sottogrupp ta' pazjenti b'tumuri pożittivi għar-riċettur tal-ormon (differenza ta' 6% f'pCR fis-sider) milli f'pazjenti b'tumuri negattivi għar-riċettur tal-ormon (differenza ta' 26.4% f'pCR fis-sider).
English: In the APHINITY trial, febrile neutropenia occurred in 12.1% of Perjeta-treated patients and 11.1% of placebo-treated patients.
Maltese: Fil-prova APHINITY, newtropenija bid-deni seħħet fi 12.1% tal-pazjenti ttrattati b'Perjeta u fi 11.1% tal-pazjenti ttrattati bil-plaċebo.
English: The incidence of NCI-CTCAE Grade 3-4 diarrhoea was 9.3% in Perjeta-treated patients vs 5.1% in placebo-treated patients.
Maltese: L-inċidenza ta' dijarea ta' NCICTCAE Grad 3-4 kienet ta' 9.3% fil-pazjenti kkurati b'Perjeta kontra 5.1% fil-pazjenti kkurati bilplaċebo.
English: In the TRYPHAENA trial, rash occurred in 36.8% of patients treated with neoadjuvant Perjeta + TCH and 20.0% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Maltese: Fil-prova TRYPHAENA, raxx seħħ f'36.8% tal-pazjenti kkurati b'Perjeta + TCH neoadjuvant u f'20.0% talpazjenti kkurati b'Perjeta, trastuzumab u docetaxel neoadjuvant wara FEC.
English: The primary endpoint of the study was pathological complete response (pCR) rate in the breast (ypT0/is).
Maltese: Il-punt finali primarju tal-istudju kien ir-rata ta' rispons patoloġiku komplut (pCR - pathological complete response) fis-sider (ypT0/is).
English: Close observation of the patient during and for 60 minutes after the first infusion and during and for 30-60 minutes after subsequent infusions of Perjeta is recommended.
Maltese: Osservazzjoni mill-qrib tal-pazjent matul u għal 60 minuta wara l-ewwel infużjoni u matul u għal 30-60 minuta wara infużjonijiet sussegwenti ta' Perjeta hija rrakkomandata.
English: The recommended initial loading dose of pertuzumab is 840 mg administered as a 60 minute intravenous infusion, followed every 3 weeks thereafter by a maintenance dose of 420 mg administered over a period of 30 to 60 minutes.
Maltese: Id-doża għolja tal-bidu rrakkomandata ta' Perjeta hija ta' 840 mg mogħtija bħala infużjoni fil-vini fuq medda ta' 60 minuta, segwit kull 3 ġimgħat minn hemm 'l quddiem b'doża ta' manteniment ta' 420 mg mogħtija fuq perijodu ta' 30 sa 60 minuta.
English: Trastuzumab was given intravenously at an initial dose of 8 mg/kg, followed by 6 mg/kg every three weeks.
Maltese: Trastuzumab ingħata fil-vini b'doża inizjali ta' 8 mg/kg, segwit minn 6 mg/kg kull tliet ġimgħat.
English: Medical review of these 15 reports showed that in 8/15 cases, the reported events were not indicative of IRR/hypersensitivity/anaphylaxis.
Maltese: Analiżi medika ta' dawn il-15-il rapport uriet li fi 8/15-il każ, l-avvenimenti rrappurtati ma kinux jindikaw IRR/sensittività eċċessiva/anafilassi.
English: From the global safety database of the MAH a total of 15 case reports were retrieved inculding MedDRA PTs potentially indicative of an IRR or hypersensitivity/anaphylaxis which were associated with fatal outcome.
Maltese: Mid-database dwar is-sigurtà globali talMAH, inġabru total ta' 15-il rapport ta' każijiet inklużi PTs tal-MedDRA li potenzjalment jindikaw IRR jew sensittività eċċessiva/anafilassi li kienu assoċjati ma' eżitu fatali.
English: The most common ADRs (≥30%) from this pooled data were diarrhoea, alopecia, nausea, fatigue,
Maltese: L-aktar ADRs komuni (≥30%) minn din id-data miġbura kienu dijarea, alopeċja, tqalligħ, għeja, newtropenija u rimettar.
English: Leucopenia
Maltese: Pożoloġija
English: • 3 or 4 cycles of FEC or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel
Maltese: • 3 jew 4 ċikli ta' FEC jew 5-fluorouracil, doxorubicin u cyclophosphamide (FAC), segwiti minn 3 jew 4 ċikli ta' docetaxel jew 12-il ċiklu ta' paclitaxel fil-ġimgħa
English: Grade ≥ 3 diarrhoea was reported in 9.8% of patients in the Perjeta arm vs. 3.7% in the placebo arm.
Maltese: Dijarea ta' Grad ≥ 3 kienet irrappurtata f'9.8% tal-pazjenti fil-grupp ta' Perjeta vs. 3.7% fil-grupp tal-plaċebo.
English: IDFS= invasive disease free survival; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab.
Maltese: IDFS= Sopravivenza mingħajr marda invażiva; CI= intervall ta' kunfidenza; Pla= plaċebo; Ptz= pertuzumab (Perjeta); T= trastuzumab.
English: In the NEOSPHERE trial, diarrhoea occurred in 45.8% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel compared with 33.6% of patients treated with trastuzumab and docetaxel.
Maltese: Fil-prova NEOSPHERE, dijarea seħħet f'45.8% tal-pazjenti kkurati b'Perjeta, trastuzumab u docetaxel neoadjuvant meta mqabbel ma' 33.6% tal-pazjenti kkurati b'trastuzumab u docetaxel.
English: The loading dose of 8 mg/kg of trastuzumab IV should be readministered over approximately 90 minutes, followed by a maintenance dose of 6 mg/kg IV administered every 3 weeks thereafter.
Maltese: Id-doża għolja tal-bidu ta' 8 mg/kg ta' trastuzumab IV għandha terġa' tingħata fuq madwar 90 minuta, segwita minn doża ta' manteniment ta' 6 mg/kg IV mogħtija kull 3 ġimgħat minn hemm 'il quddiem.
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of LVD during study treatment was higher in the placebo-treated group than in the Perjeta-treated group (8.6% and 6.6%, respectively).
Maltese: CLEOPATRA f'kanċer metastatiku tas-sider, l-inċidenza ta' LVD waqt il-kura talistudju kienet ogħla fil-grupp ikkurat bil-plaċebo milli fil-grupp ikkurat b'Perjeta (8.6% u 6.6%, rispettivament).
English: was 8.3% in the group treated with Perjeta plus trastuzumab and FEC (5-fluorouracil, epirubicin, cyclophosphamide) followed by Perjeta plus trastuzumab and docetaxel; 9.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC; and 6.6% in the group treated with
Maltese: Fil-prova neoadjuvant TRYPHAENA, l-inċidenza ta' LVD (matul il-perijodu kollu tal-kura) kienet ta' 8.3% fil-grupp ikkurat b'Perjeta flimkien ma' trastuzumab u FEC (5-fluorouracil, epirubicin, cyclophosphamide) segwit minn Perjeta flimkien ma' trastuzumab u docetaxel; 9.3% fil-grupp ikkurat b'Perjeta flimkien ma' trastuzumab u docetaxel wara FEC;. u 6.6% fil-grupp ikkurat b'Perjeta flimkien ma' TCH (docetaxel, carboplatin u trastuzumab).
English: Diarrhoea is most frequent during concurrent administration with taxane therapy.
Maltese: Id-dijarea hija l-aktar frekwenti waqt għoti flimkien ma' terapija b'taxane.
English: In the TRYPHAENA trial, diarrhoea occurred in 72.3% of patients treated with neoadjuvant Perjeta+TCH and 61.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Maltese: Fil-prova TRYPHAENA, dijarea seħħet f'72.3% tal-pazjenti kkurati b'Perjeta+TCH neoadjuvant u f'61.4% talpazjenti kkurati b'Perjeta, trastuzumab u docetaxel neoadjuvant wara FEC.
English: Alopecia Rash
Maltese: TAGĦRIF
English: These dose levels resulted in clinically relevant exposures of 2.5 to 20-fold greater than the recommended human dose, based on Cmax.
Maltese: Dawn il-livelli ta' doża rriżultaw f'esponimenti klinikament relevanti ta' 2.5 sa 20 darba aktar mid-doża rrakkomandata fil-bniedem, ibbażata fuq Cmax.
English: Mucosal inflammation Oedema peripheral Pyrexia
Maltese: Marda talinterstizju talpulmun Effużjoni filplewra
English: Roche
Maltese: Sucrose
English: Asymptomatic or mildly symptomatic (NYHA class II)
Maltese: F'APHINITY, l-inċidenza ta' insuffiċjenza sintomatika tal-qalb (NYHA klassi
English: Respiratory, thoracic and medias tinal dis orders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: In the APHINITY trial, the adverse event of rash occurred in 25.8% of patients in Perjeta arm vs. 20.3% of patients in placebo arm.
Maltese: Fil-prova APHINITY, l-avveniment avvers ta' raxx seħħ f'25.8% tal-pazjenti fil-grupp ta' Perjeta vs. 20.3% tal-pazjenti fil-grupp tal-plaċebo.
English: In both the TRYPHAENA and APHINITY trials, the overall frequency of hypersensitivity/anaphylaxis was highest in the Perjeta and TCH treated group (13.2% and 7.6%, respectively), of which 2.6% and 1.3% of events, respectively, were NCI-CTCAE Grade 3-4.
Maltese: 7.6% rispettivament), li fosthom 2.6% u 1.3% tal-avvenimenti, rispettivament, kienu NCI-CTCAE Grad 3-4.
English: in severity.
Maltese: U L-UŻU
English: Pertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
Maltese: IgG1 umanizzat magħmul f'ċelluli mammiferi (ovarju talħamster Ċiniż) permeżż ta' teknoloġija tat-tfassil tad-DNA.
English: In addition, pertuzumab mediates antibody-dependent cell-mediated cytotoxicity (ADCC).
Maltese: Barra minn hekk, pertuzumab jikkawża ċitototossiċità medjata miċ-ċellula dipendenti mill-antikorp (ADCC).
English: Cochran-Mantel-Haenszel
Maltese: Kanċer metastatiku tas-sider
English: A feeling of numbness, prickling or tingling in feet or hands; sharp jabbing, throbbing, freezing or burning pain; feeling pain from something which should not be painful such as a light touch; less able to feel changes in heat or cold; loss of balance or coordination
Maltese: Sensazzjoni ta' tirżiħ, tingiż jew tnemnin fis-saqajn jew fl-idejn; uġigħ qawwi jixbah daqqiet ta' sikkina, itektek, b'sensazzjoni ta' ffriżar jew ta' ħruq; sensazzjoni ta' wġigħ minn xi ħaġa li m'għandhiex tkun ta' wġigħ bħal mess ħafif; tnaqqis fil-kapaċità li tħoss bidliet fis-sħana jew fil-kesħa; telf ta' bilanċ jew ta' koordinazzjoni
English: • Cohort B - 4 cycles of FEC followed by 4 cycles of Perjeta in combination with trastuzumab and docetaxel.
Maltese: • Grupp B - 4 ċikli ta' FEC segwiti minn 4 ċikli ta' Perjeta flimkien ma' trastuzumab u docetaxel.
English: Perjeta in combination with TCH (docetaxel, carboplatin and trastuzumab).
Maltese: TCH: docetaxel, carboplatin u trastuzumab, CMH: Cochran-Mantel-Haenszel
English: NEOSPHERE is a phase II, multicentre, multinational randomised controlled trial with Perjeta and was conducted in 417 adult female patients with newly diagnosed, early, inflammatory or locally advanced HER2-positive breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy.
Maltese: II, b'aktar minn ċentru wieħed, multinazzjonali, randomised u kkontrollata b'Perjeta li twettaq fuq 417-il pazjenta femminili adulta b'kanċer tas-sider pożittiv għal HER2, li kien għadu kif ġie ddijanjostikat, bikri, infjammatorju jew lokalment avanzat (T2-4d; tumur primarju b'dijametru ta' > 2ċm) li ma kienux irċevew terapija b'trastuzumab, kimoterapija jew radjuterapija minn qabel.
English: Pertuzumab was given intravenously at an initial dose of 840 mg, followed by 420 mg every three weeks.
Maltese: Perjeta ingħata fil-vini b'doża inizjali ta' 840 mg, segwit minn 420 mg kull tliet ġimgħat.
English: The metabolism of pertuzumab has not been directly studied.
Maltese: Il-metaboliżmu ta' pertuzumab ma ġiex studjat b'mod dirett.
English: The PK results of pertuzumab in the NEOSPHERE and APHINITY studies were consistent with the predictions from the previous population PK model.
Maltese: Ir-riżultati PK ta' pertuzumab fl-istudji NEOSPHERE u APHINITY kienu konsistenti malpreviżjonijiet mill-mudell preċedenti tal-PK tal-popolazzjoni.
English: The population PK analysis suggested no PK differences based on age, gender and ethnicity (Japanese versus non-Japanese).
Maltese: L-analiżi PK tal-popolazzjoni ma ssuġġerit l-ebda differenza PK ibbażata fuq l-età, sess u etniċità (Ġappuniżi kontra dawk mhux Ġappuniżi).
English: No definitive conclusion on adverse effects can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Maltese: Wieħed ma jistgħax jasal għall-konklużjoni definittiva dwar l-effetti avversi fuq l-organi riproduttivi maskili minn studju dwar l-effett tossiku minn dożi ripetuti f'xadini cynomolgus .
English: During the second cycle when all medicinal products were administered on the same day, the most common infusion reactions in the Perjeta-treated group (≥ 1.0%) were fatigue, dysgeusia, drug hypersensitivity, myalgia and vomiting (see section 4.4).
Maltese: Matul it-tieni ċiklu meta l-prodotti mediċinali kollha ngħataw fl-istess jum, l-aktar reazzjonijiet għallinfużjoni komuni fil-grupp ikkurat b'Perjeta (≥ 1.0%) kienu għeja, disġewżja, sensittività eċċessiva għall-mediċina, mijalġja u rimettar (ara sezzjoni 4.4).
English: TRYPHAENA is a multicentre, randomised phase II clinical trial conducted in 225 adult female patients with HER2-positive locally advanced, operable, or inflammatory breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy.
Maltese: II, b'aktar minn ċentru wieħed u randomised li twettqet fuq 225 pazjenta femminili adulta b'kanċer tas-sider pożittiv għal HER2 avanzat lokalment, operabbli jew infjammatorju (T2-4d; tumur primarju b'dijamtru ta' > 2cm) li ma kienux irċevew trastuzumab, kimoterapija jew radjuterapija minn qabel.
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Roche Registration GmbH
English: • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)
Maltese: • kura neoadjuvant ta' pazjenti adulti b'kanċer tas-sider pożittiv għal HER2, avanzat lokalment, infjammatorju, jew ta' stadju bikri li għandu riskju għoli ta' rikorrenza (ara sezzjoni 5.1).
English: Estimates of IDFS rates in the lymph node- positive subgroup were 92.0% versus 90.2% at 3 years and 89.9% vs. 86.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Maltese: L-estimi tar-rati ta' IDFS fis-sottogrupp bi glandoli limfatiċi pożittivi kienu 92.0% kontra 90.2% wara 3 snin u 89.9% vs. 86.7% wara 4 snin f'pazjenti ttrattati b'Perjeta kontra pazjenti ttrattati bi plaċebo, rispettivament.
English: Patients treated with Perjeta, trastuzumab and docetaxel are at increased risk of febrile neutropenia compared with patients treated with placebo, trastuzumab and docetaxel, especially during the first 3 cycles of treatment (see section 4.8).
Maltese: Pazjenti kkurati b'Perjeta, trastuzumab u docetaxel huma f'riskju akbar ta' newtropenija bid-deni meta mqabbla ma' pazjenti kkurati bil-plaċebo, trastuzumab u docetaxel, speċjalment matul l-ewwel 3 ċikli ta' kura (ara sezzjoni 4.8).
English: ° Hypersensitivity/anaphylactic reaction is based on a group of terms.
Maltese: ° Reazzjoni ta' sensittività eċċessiva/anafilattika hija bbażata fuq grupp ta' termini.
English: pCR rates were similar in patients with operable versus locally advanced disease.
Maltese: Ir-rati ta' pCR kienu simili f'pazjenti b'marda operabbli kontra marda avanzata lokalment.
English: Heartburn
Maltese: Docetaxel
English: Each vial contains a total of 420 mg pertuzumab at a concentration of 30 mg/ml
Maltese: Kull kunjett fih total ta' 420 mg pertuzumab f'konċentrazzjoni ta' 30 mg/ml.
English: Patients treated with Perjeta must have HER2-positive tumour status, defined as a score of 3+ by immunohistochemistry (IHC) and/or a ratio of ≥ 2.0 by in situ hybridisation (ISH) assessed by a validated test.
Maltese: Pazjenti kkurati b'Perjeta irid ikollhom l-istat tat-tumur pożittiv għal HER2, definit bħala punteġġ ta' 3+ minn immunoistokimika (IHC) u/jew proporzjoni ta' ≥ 2.0 minn ibridazzjoni in situ (ISH) evalwat permezz ta' test validat.