FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of trastuzumab emtansine and DM1-containing catabolites were evaluated after the administration of 3.6 mg/kg of trastuzumab emtansine to metastatic HER2+ breast cancer patients with normal hepatic function (n=10), mild (Child-Pugh A; n=10) and moderate (Child-Pugh B; n=8) hepatic impairment.
Maltese: Il-farmakokinetika ta' trastuzumab emtansine u ta' kataboliti li fihom DM1 ġiet evalwata wara l-għoti ta' 3.6 mg/kg ta' trastuzumab emtansine lill-pazjenti b'kanċer metastatiku tas-sider HER2+ b'funzjoni epatika normali (n=10), u b'indeboliment epatiku ħafif (Child-Pugh A; n=10) u moderat (Child-Pugh B; n=8).
English: A change of 5 points in the TOI-B is considered clinically significant.
Maltese: Bidla ta' 5 punti fit-TOI-B hija meqjusa klinikament sinifikanti.
English: Figure 3 Kaplan-meier curve of overall survival
Maltese: Kaplan-meier tas-sopravivenza globali
English: Table 3 shows pooled data from the overall treatment period in the MBC studies (N= 1871; median number of cycles of trastuzumab emtansine was 10) and in KATHERINE (N=740; median number of cycles was 14).
Maltese: It-Tabella 3 turi data miġbura mill-perjodu globali tat-trattament fl-istudji dwar MBC (N=1871; innumru medjan ta' ċikli ta' trastuzumab emtansine kien ta' 10) u f'KATHERINE (N=740; in-numru medjan ta' ċikli kien ta' 14).
English: Serum transaminases > 3 x ULN and concomitant total bilirubin > 2´ ULN
Maltese: Transaminases fis-serum > 3 x ULN u bilirubin totali fl-istess waqt > 2 ×
English: Rash, Pruritus, Alopecia, Nail disorder, Palmarplantar erythrodysaesthesia syndrome, Urticaria
Maltese: Raxx, Ħakk, Alopeċja, Disturb fid-dwiefer, Sindrome ta' eritrodisestesija palmari-plantari, Urtikarja
English: It is essentially ‘sodium- free'.
Maltese: Hija essenzjalment ‘mingħajr sodium'.
English: Patients in Study TDM4370g/BO21977 and Study BO29738 who received 3.6 mg/kg of trastuzumab emtansine intravenously every 3 weeks had a mean Cycle 1 maximum serum concentration (Cmax) of trastuzumab emtansine of 83.4 (± 16.5) mg/mL and 72.6 (± 24.3) mg/mL, respectively.
Maltese: Pazjenti fl-Istudju TDM4370g/BO21977 u fl-Istudju BO29738 li rċevew 3.6 mg/kg ta' trastuzumab emtansine fil-vini kull 3 ġimgħat kellhom konċentrazzjoni massima fis-serum (Cmax) fiċ-Ċiklu 1 medja ta' trastuzumab emtansine ta' 83.4 (± 16.5) µg/mL u 72.6 (± 24.3) µg/mL, rispettivament.
English: Events of LVEF drop of >10% from baseline and/or CHF were observed in an observational study (BO39807) of MBC patients with baseline LVEF of 40-49% in a real world setting.
Maltese: Ġew osservati avvenimenti ta' tnaqqis fl-LVEF ta' >10% mil-linja bażi u/jew CHF fi studju ta' osservazzjoni (BO39807) ta' pazjenti b'MBC b'LVEF fil-linja bażi ta' 40-49% f'ambjent mhux kliniku.
English: The median age was approximately 49 years (range 23-80 years), 72.8% were White, 8.7% were Asian and 2.7% were Black or African American.
Maltese: L-età medjana kienet ta' madwar 49 sena (medda 23-80 sena), 72.8% kienu Bojod, 8.7% kienu Asjatiċi u 2.7% kienu Suwed jew Amerikani Afrikani.
English: In patients with EBC, the overall incidence was 32.3% and 10.3% for
Maltese: F'pazjenti b'EBC, l-inċidenza globali kienet ta' 32.3% u 10.
English: Tables 4 and 5 displays laboratory abnormalities observed in patients treated with trastuzumab emtansine in clinical study TDM4370g/BO21977/EMILIA and study BO27938/KATHERINE.
Maltese: It-Tabelli 4 u 5 juru anormalitajiet tal-laboratorju osservati f'pazjenti ttrattati b'trastuzumab emtansine fl-istudju kliniku TDM4370g/BO21977/EMILIA u l-istudju BO27938/KATHERINE.
English: Figure 2 Kaplan-meier curve of IRC-assessed progression-free survival
Maltese: Kaplan-meier tas-sopravivenza mingħajr progressjoni stmata minn IRC
English: Pharmacokinetic data in patients with severe renal impairment (CLcr 15 to 29 mL/min) are limited (n = 1), therefore no dosage recommendations can be made.
Maltese: Data farmakokinetika dwar pazjenti b'indeboliment renali sever (CLcr 15 sa 29 mL/min) hija limitata (n = 1), għalhekk ma jistgħux isiru rakkomandazzjonijiet ta' dożaġġ.
English: For dose modifications in the event of LVEF decrease, see Table 2 in section 4.2 and section 4.4.
Maltese: Għall-modifikazzjonijiet fid-doża f'każ ta' tnaqqis fl-LVEF, ara Tabella 2 f'sezzjoni 4.2 u sezzjoni 4.4.
English: - Systemic exposures (AUC) of trastuzumab emtansine at Cycle 1 in patients with mild and moderate hepatic impairment were approximately 38% and 67% lower than that of patients with normal hepatic function, respectively.
Maltese: - Esponimenti sistemiċi (AUC) għal trastuzumab emtansine f'Ċiklu 1 f'pazjenti b'indeboliment epatiku ħafif u moderat kienu bejn wieħed u ieħor 38% u 67% inqas minn dawk ta' pazjenti b'funzjoni epatika normali, rispettivament.
English: In human plasma, trastuzumab emtansine catabolites MCC-DM1, Lys-MCC-DM1, and DM1 were detected at low levels.
Maltese: Fil-plażma umana, kataboliti ta' trastuzumab emtansine MCC-DM1, Lys-MCC-DM1, u DM1 instabu f'livelli baxxi.
English: If LVEF < 45% is confirmed, discontinue trastuzumab emtansine.
Maltese: LVEF < 45% Tagħtix trastuzumab emtansine.
English: Grade 2 (> 2.5 to ≤ 5´ the ULN)
Maltese: Grad 2 (> 2.5 sa ≤ 5 × l-ULN)
English: Increased transaminases were reported in 32.4% of patients with EBC.
Maltese: Żieda fit-transaminases kienet irrappurtata fi 32.4% tal-pazjenti b'EBC.
English: Signs and symptoms include dyspnoea, cough, fatigue, and pulmonary infiltrates.
Maltese: Sinjali u sintomi jinkludu qtugħ ta' nifs, sogħla, għeja, u infiltrati pulmonari.
English: Grade 3
Maltese: Grad 4
English: The safety of trastuzumab emtansine has been evaluated in 2,611 breast cancer patients in clinical studies.
Maltese: Is-sigurtà ta' trastuzumab emtansine kienet evalwata f'2,611-il pazjent b'kanċer tas-sider fi studji kliniċi.
English: Decreased potassium
Maltese: Tnaqqis fil-potassium
English: The co-primary efficacy endpoints of the study were progression-free survival (PFS) as assessed by an independent review committee (IRC) and overall survival (OS) (see Table 7 and Figures 2 to 3).
Maltese: Il-punti finali koprimarji tal-effikaċja tal-istudju kienu sopravivenza mingħajr progressjoni (PFSprogression-free survival) kif evalwata minn kumitat ta' analiżi indipendenti (IRC - independent review committee) u sopravivenza globali (OS - overall survival) (ara Tabella 7 u Figuri 2 sa 3).
English: In patients 65 to 74 years old (n=113), based on IRC assessments, the hazard ratios for PFS and OS were 0.88 (95% CI: 0.53, 1.45) and 0.74 (95% CI: 0.37, 1.47), respectively.
Maltese: F'pazjenti b'età minn 65 sa 74 sena (n=113), ibbażat fuq valutazzjonijiet minn IRC, il-proporzjonijiet ta' periklu għal PFS u għal OS kienu ta' 0.88 (CI ta' 95%: 0.53, 1.45) u 0.74 (CI ta' 95%: 0.37, 1.47), rispettivament.
English: Epistaxis, Cough, Dyspnoea
Maltese: Epistassi, Sogħla, Qtugħ ta' nifs
English: Table 7 Summary of efficacy from study TDM4370g/BO21977 (EMILIA)
Maltese: Tabella 7 Sommarju tal-effikaċja minn studju TDM4370g/BO21977 (EMILIA)
English: In the EMILIA study (TDM4370g/BO21977), 5.2% (24/466) of patients tested positive for anti-trastuzumab emtansine antibodies, of which 13 were also positive for neutralizing antibodies.
Maltese: Fl-istudju EMILIA (TDM4370g/BO21977), 5.2% (24/466) tal-pazjenti kellhom test pożittiv għall-antikorpi kontra trastuzumab emtansine, li 13 minnhom kienu pożittivi wkoll għal antikorpi newtralizzanti.
English: In patients ≥ 65 years old (n=138 across both treatment arms) the hazard ratios for progression-free survival (PFS) and Overall Survival (OS) were 1.06 (95% CI: 0.68, 1.66) and 1.05 (95% CI: 0.58, 1.91), respectively.
Maltese: F'pazjenti b'età ta' ≥ 65 sena (n=138 fiż-żewġ gruppi ta' trattament) il-proporzjonijiet ta' periklu għal sopravivenza mingħajr progressjoni (PFS - progressionfree survival) u Sopravivenza Globali (OS - Overall Survival) kienu ta' 1.06 (CI ta' 95%: 0.68, 1.66) u 1.05 (CI ta' 95%: 0.58, 1.91), rispettivament.
English: Table 3 Tabulated list of ADRs in patients treated with trastuzumab emtansine in clinical trials
Maltese: Tabella 3 Lista f'tabella tal-ADRs f'pazjenti ttrattati b'trastuzumab emtansine fi provi kliniċi
English: Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) with trastuzumab emtansine should be avoided due to the potential for an increase in DM1 exposure and toxicity.
Maltese: (eż., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, u voriconazole) flimkien ma' trastuzumab emtansine għandu jiġi evitat minħabba l-potenzjal ta' żieda fl-esponiment għal DM1 u fit-tossiċità.
English: · the most common National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≥ 3 ADRs (> 2%) were thrombocytopenia, increased transaminases, anaemia, neutropenia, fatigue and hypokalaemia.
Maltese: ● l-aktar ADRs komuni ta' Grad ≥ 3 skont il-Kriterji ta' Terminoloġija Komuni ta' Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kanċer (NCI-CTCAE - National Cancer Institute - Common Terminology Criteria for Adverse Events) (> 2%) kienu tromboċitopenija, żieda fittransaminases, anemija, newtropenija, għeja u ipokalimja.
English: Transaminases increased (AST/ALT)
Maltese: Żieda fit-Transaminase (AST/ALT)
English: Grade 3 or 4 events were reported in 0.4% of patients with MBC.
Maltese: Avvenimenti ta' Grad 3 jew 4 kienu rrappurtati f'0.4% tal-pazjenti b'MBC.
English: Emtansine refers to the MCC-DM1 complex.
Maltese: Emtansine jirreferi għall-kumpless MCCDM1.
English: In clinical studies, patients had a LVEF ³ 50% at baseline.
Maltese: Fi studji kliniċi, il-pazjenti kellhom LVEF ta' ≥ 50% fil-linja bażi.
English: · Risk Management Plan (RMP)
Maltese: ● Pjan tal-Ġestjoni tar-Riskju (RMP)
English: DM1 was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
Maltese: DM1 ma kienx mutaġeniku f'analiżi in vitro dwar mutazzjoni riversibbli fil-batterji (Ames).
English: Hepatic
Maltese: Epatiku
English: In study TDM4370g/BO21977, consistent treatment benefit of trastuzumab emtansine was seen in the majority of pre-specified subgroups evaluated, supporting the robustness of the overall result.
Maltese: Fl-istudju TDM4370g/BO21977, benefiċċju konsistenti tat-trattament ta' trastuzumab emtansine kien osservat fil-maġġoranza tas-sottogruppi speċifikati minn qabel evalwati, li jappoġġa r-robustezza tarriżultat globali.
English: Grade 4 (> 20´ the ULN)
Maltese: Grad 4 (> 20 × l-ULN)
English: Based on population PK analysis, body weight, albumin, sum of longest diameter of target lesions by Response Evaluation Criteria In Solid Tumors (RECIST), HER2 shed extracellular domain (ECD), baseline trastuzumab concentrations, and aspartate aminotransferase (AST) were identified as statistically significant covariates for trastuzumab emtansine PK parameters.
Maltese: Evaluation Criteria In Solid Tumors), reħa ta' HER2 fid-dominju ekstraċellulari (ECD - extracellular domain), konċentrazzjonijiet fil-linja bażi ta' trastuzumab, u aspartate aminotransferase (AST), kienu identifikati bħala kovarjanti statistikament sinifikanti għall-parametri PK ta' trastuzumab emtansine.
English: Grade 3 (> 3 to ≤ 10´ the ULN)
Maltese: Grad 3 (> 3 sa ≤ 10 × l-ULN)
English: Pulmonary Toxicity Interstitial lung disease (ILD) or pneumonitis
Maltese: interstitial lung disease) jew pulmonite
English: The primary endpoint was investigator assessed Progression-Free Survival (PFS).
Maltese: Il-punt finali primarju kien is-Sopravivenza Mingħajr Progressjoni (PFS - Progression-Free Survival) evalwata mill-investigatur.
English: Cases of haemorrhagic events, including central nervous system, respiratory and gastrointestinal haemorrhage, have been reported with trastuzumab emtansine treatment.
Maltese: Każijiet ta' avvenimenti emorraġiċi, li jinkludu emorraġija fis-sistema nervuża ċentrali, respiratorja u gastrointestinali, ġew irrappurtati bi trattament bi trastuzumab emtansine.
English: TDM4370g/BO21977(EMILIA)
Maltese: Kanċer Metastatiku tas-Sider TDM4370g/BO21977(EMILIA)
English: Dose reduction schedule (Starting dose is 3.6 mg/kg)
Maltese: Tabella 1 Skeda ta' tnaqqis fid-doża Skeda ta' tnaqqis fid-doża (Doża tal-bidu hija 3.6 mg/kg)
English: In the GLP toxicity studies, with the exception of irreversible peripheral axonal toxicity (observed only in monkeys at ³ 10 mg/kg) and reproductive organ toxicity (observed only in rats at 60 mg/kg), partially or completely reversible dose dependent toxicities were identified in both animal models.
Maltese: Fl-istudji ta' GLP dwar ittossiċità, bl-eċċezzjoni ta' tossiċità axxonali periferali irriversibbli (osservata biss fix-xadini b'≥ 10 mg/kg) u tossiċità fuq l-organi riproduttivi (osservata biss fil-firien b'60 mg/kg), tossiċitajiet dipendenti mid-doża parzjalment jew kompletament riversibbli kienu identifikati fiż-żewġ mudelli ta' annimali.
English: Table 2 Dose Modification Guidelines Dose Modifications for Patients with EBC Adverse reaction Severity
Maltese: Waqqaf it-trattament Tabella 2 Linji Gwida għall-Modifikazzjoni fid-Doża Modifikazzjonijiet fid-Doża għal Pazjenti b'EBC Reazzjoni avversa Severità
English: Data from first interim analysis 25 July 2018
Maltese: Data mill-ewwel analiżi interim tal-25 ta' Lulju 2018
English: Population pharmacokinetic analysis indicates that age does not have a clinically meaningful effect on the pharmacokinetics of trastuzumab emtansine (see sections 5.1 and 5.2).
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni tindika li l-età m'għandhiex effett klinikament sinifikanti fuq il-farmakokinetika ta' trastuzumab emtansine (ara sezzjonijiet 5.1 u 5.2).
English: An average of 3.5 DM1 molecules are conjugated to each molecule of trastuzumab.
Maltese: Medja ta' 3.5 molekuli ta' DM1 huma kkonjugati għal kull molekula ta' trastuzumab.
English: · the most common adverse drug reactions (ADRs) (≥25%) with trastuzumab emtansine were nausea, fatigue, musculoskeletal pain, haemorrhage, headache, transaminases increased, thrombocytopenia, and peripheral neuropathy.
Maltese: ● l-aktar reazzjonijiet avversi tal-mediċina (ADRs - adverse drug reactions) komuni (≥ 25%) b'trastuzumab emtansine kienu dardir, għeja, uġigħ muskoluskeletriku, emorraġija, uġigħ ta' ras, żieda fit-transaminases, tromboċitopenija, u newropatija periferali.
English: General risk factors for a cardiac event and those identified in adjuvant breast cancer studies with trastuzumab therapy include advancing age (> 50 years), low baseline LVEF values (< 55%), low LVEF levels prior to or following the use of paclitaxel in the adjuvant setting, prior or concomitant use of antihypertensive medicinal products, previous therapy with an anthracycline and high BMI (> 25 kg/m2).
Maltese: Fatturi ġenerali ta' riskju għal avveniment kardijaku u dawk identifikati fi studji awżiljarji ta' kanċer tas-sider b'terapija bi trastuzumab jinkludu età li qed tavvanza (> 50 sena), valuri baxxi ta' LVEF fil-linja bażi (< 55%), livelli baxxi ta' LVEF qabel jew wara l-użu ta' paclitaxel flambjent awżiljarju, użu minn qabel jew fl-istess waqt ta' prodotti mediċinali kontra l-pressjoni għolja, terapija preċedenti b'anthracycline u BMI għoli (> 25 kg/m
English: Hierarchical testing applied for IDFS and OS 2.
Maltese: Ittestjar ġerarkiku applikat għal IDFS u OS
English: Grade 3 or 4 increased AST and ALT were reported in 4.2% and 2.7% of patients with MBC respectively and usually occurred in the early treatment cycles (1-6).
Maltese: Żidiet ta' Grad 3 jew 4 f'AST u ALT kienu rrappurtati f'4.2% u 2.7% tal-pazjenti b'MBC rispettivament u normalment seħħew fiċ-ċikli bikrija tat-trattament (1-6).
English: These symptoms may indicate nerve damage.
Maltese: Dawn is-sintomi jistgħu jindikaw ħsara fin-nervituri.
English: In an observational study (BO39807), approximately 22% (7 out of 32) of MBC patients initiating trastuzumab emtansine with LVEF of 40-49% at baseline, experienced a LVEF drop of >10% from baseline and/or CHF; most of these patients had other cardiovascular risk factors.
Maltese: Fi studju ta' osservazzjoni (BO39807), madwar 22% (7 minn 32) tal-pazjenti b'MBC li bdew trastuzumab emtansine b'LVEF ta' 40-49% fil-linja bażi, kellhom tnaqqis fl-LVEF ta' >10% mil-linja bażi u/jew CHF; ħafna minn dawn il-pazjenti kellhom fatturi ta' riskju kardjovaskulari oħrajn.
English: Glucose (5%) solution should not be used (see section 6.2).
Maltese: M'għandhiex tintuża soluzzjoni ta' glucose (5%) (ara sezzjoni 6.2).
English: · Store in a refrigerator at (2°C - 8°C).
Maltese: ● Aħżen fi friġġ f'temperatura ta' (2°C - 8°C).
English: Additional endpoints included IDFS including second primary non-breast cancer, disease-free survival (DFS), overall survival (OS), and distant recurrence-free interval (DRFI).
Maltese: Punti finali addizzjonali kienu jinkludu IDFS inklużi t-tieni kanċer primarju mhux tas-sider, sopravivenza mingħajr marda (DFS - disease-free survival), sopravivenza globali (OS - overall survival), u intervall mingħajr rikorrenza distanti (DRFI - distant recurrence-free interval).
English: The primary efficacy endpoint of the study was Invasive Disease-Free Survival (IDFS).
Maltese: Invasive Disease-Free Survival)
English: Hypersensitivity was reported in 2.7% of patients with EBC, with Grade 3 or 4 in 0.4% of patients.
Maltese: Sensittività eċċessiva kienet irrappurtata fi 2.7% tal-pazjenti b'EBC, bi Grad 3 jew 4 f'0.4% tal-pazjenti.
English: Volume (mL) = Total dose to be administered =(body weight (kg) x dose (mg/kg)) 20 (mg/mL, concentration of reconstituted solution)
Maltese: Volum (mL) = Doża totali li għandha tingħata =(piż tal-ġisem (kg) x doża (mg/kg)) 20 (mg/mL, konċentrazzjoni tas-soluzzjoni rikostitwita)
English: Volume (mL) = Total dose to be administered (body weight (kg) x dose (mg/kg)) 20 (mg/mL, concentration of reconstituted solution)
Maltese: Volum (mL) = Doża totali li għandha tingħata (piż tal-ġisem (kg) x doża (mg/kg)) 20 (mg/mL, konċentrazzjoni tas-soluzzjoni rikostitwita)
English: Grade 3 (> 5 to ≤ 20´ the ULN)
Maltese: Grad 3 (> 5 sa ≤ 20 × l-ULN)
English: Figure 1 Kaplan-Meier Curve of Invasive Disease-Free Survival in KATHERINE
Maltese: Kaplan-Meier ta' Sopravivenza Mingħajr Marda Invażiva f'KATHERINE
English: In the descriptive follow-up overall survival analysis, the hazard ratio was 0.75 (95% CI 0.64, 0.88).
Maltese: Fl-analiżi deskrittiva ta' segwitu ta' sopravivenza globali, il-proporzjon ta' periklu kien ta' 0.75 (CI ta' 95% 0.64, 0.88).
English: Patients (n = 110) received 3.6 mg/kg of trastuzumab emtansine intravenously every 3 weeks until disease progression or unacceptable toxicity.
Maltese: Il-pazjenti (n = 110) irċevew 3.6 mg/kg ta' trastuzumab emtansine fil-vini kull 3 ġimgħat sa progressjoni tal-marda jew tossiċità mhux aċċettabbli.
English: No relationship was observed between trastuzumab emtansine exposure (AUC), trastuzumab emtansine maximum serum concentration (Cmax), total trastuzumab exposure (AUC), or Cmax of DM1 and increases in transaminase.
Maltese: Ma kinitx osservata relazzjoni bejn l-esponiment għal trastuzumab emtansine (AUC), il-konċentrazzjoni massima ta' trastuzumab emtansine fis-serum (Cmax), l-esponiment totali għal trastuzumab (AUC), jew C max ta' DM1 u żidiet fit-transaminase.
English: · Trastuzumab emtansine arm: trastuzumab emtansine 3.6 mg/kg intravenously over 30-90 minutes on Day 1 of a 21-day cycle · Control arm (lapatinib plus capecitabine): lapatinib 1250 mg/day orally once per day of a 21-day cycle plus capecitabine 1000 mg/m2 orally twice daily on Days 1-14 of a 21-day cycle
Maltese: ● Grupp ta' kontroll (lapatinib flimkien ma' capecitabine): lapatinib 1,250 mg/jum mill-ħalq darba kuljum ta' ċiklu ta' 21 ġurnata flimkien ma' capecitabine 1,000 mg/m mill-ħalq darbtejn kuljum f'Jum 1-14 ta' ċiklu ta' 21 ġurnata
English: Table 4 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study TDM4370g/BO21977/EMILIA
Maltese: Tabella 4 Anormalitajiet tal-laboratorju osservati f'pazjenti ttrattati b'trastuzumab emtansine fl-istudju TDM4370g/BO21977/EMILIA
English: · Breathing problems: Kadcyla can cause serious breathing problems such as shortness of breath (either at rest or while performing any type of activity) and cough.
Maltese: ● Problemi bin-nifs: Kadcyla jista' jikkawża problemi serji bin-nifs bħal qtugħ ta' nifs (waqt ilmistrieħ jew waqt li wieħed ikun qed iwettaq xi tip ta' attività) u sogħla.
English: In the subgroup of patients with hormone receptor-negative disease (n=426), the hazard ratios for PFS and OS were 0.56 (95% CI: 0.44, 0.72) and 0.75 (95% CI: 0.54, 1.03), respectively.
Maltese: Fis-sottogrupp ta' pazjenti b'marda negattiva għar-riċettur tal-ormon (n=426), ilproporzjonijiet ta' periklu għal PFS u għal OS kienu ta' 0.56 (CI ta' 95%: 0.44, 0.72) u 0.75 (CI ta' 95%: 0.54, 1.03), rispettivament.
English: Due to the low incidence of ADA, conclusions cannot be made on the impact of anti- trastuzumab emtansine antibodies on the pharmacokinetics, safety, and efficacy of trastuzumab emtansine.
Maltese: Minħabba l-inċidenza baxxa ta' ADA, ma jistgħux isiru konklużjonijiet dwar l-impatt ta' antikorpi kontra trastuzumab emtansine fuq il-farmakokinetika, is-sigurtà, u l-effikaċja ta' trastuzumab emtansine.
English: The reconstituted Kadcyla solution diluted in infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for infusion, or sodium chloride 4.5 mg/mL (0.45%) solution for infusion, is stable for up to 24 hours at 2°C to 8°C, provided it was prepared under controlled and validated aseptic conditions.
Maltese: Is-soluzzjoni rikostitwita ta' Kadcyla dilwita f'boroż għall-infużjoni li fihom soluzzjoni għal infużjoni ta' 9 mg/mL (0.9%) sodium chloride, jew soluzzjoni għal infużjoni ta' 4.5 mg/mL (0.45%) sodium chloride, hija stabbli għal 24 siegħa f'temperatura ta' 2°C sa 8°C, jekk kienet ippreparata f'kondizzjonijiet asettiċi kkontrollati u validati.
English: BO27938 (KATHERINE)
Maltese: Kanċer Bikri tas-Sider BO27938 (KATHERINE)
English: A total of 1243 patients from seven clinical studies were tested at multiple time points for anti-drug antibody (ADA) responses to trastuzumab emtansine.
Maltese: Total ta' 1,243 pazjent minn seba' studji kliniċi kienu ttestjati f'punti ta' żmien multipli għal risponsi tal-antikorpi kontra l-mediċina (ADA - anti-drug antibody) għal trastuzumab emtansine.
English: In the Phase I and Phase II studies, 6.4% (24/376) of patients tested positive for anti- trastuzumab emtansine antibodies.
Maltese: II, 6.4% (24/376) tal-pazjenti kellhom test pożittiv għall-antikorpi kontra trastuzumab emtansine.
English: Kadcyla can make some existing conditions worse, or cause side effects.
Maltese: Kadcyla jista' jaggrava xi kondizzjonijiet eżistenti, jew jikkawża effetti sekondarji.
English: TBILI > 2´ ULN at any time
Maltese: TBILI > 2 × ULN fi kwalunkwe ħin
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC)
Maltese: Aħżen fi friġġ (2ºC - 8ºC)
English: Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight (see section 4.2):
Maltese: Iddetermina l-volum tas-soluzzjoni rikostitwita meħtieġ ibbażat fuq doża ta' 3.6 mg trastuzumab emtansine/kg ta' piż tal-ġisem (ara sezzjoni 4.2):
English: Increased transaminases were reported in 24.2% of patients in MBC clinical studies.
Maltese: Żieda fit-transaminases kienet irrappurtata f'24.2% tal-pazjenti fl-istudji kliniċi dwar MBC.
English: Overall Survival (OS) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 5 year survival rate2,% [95% CI] IDFS including second primary non-breast cancer
Maltese: Sopravivenza Globali (OS - Overall Survival) Numru (%) ta' pazjenti b'avveniment HR [CI ta' 95%] valur p (test Log-Rank, mhux stratifikat) rata ta' sopravivenza ta' 5 snin2,% [CI ta' 95%] IDFS li tinkludi t-tieni kanċer primarju mhux tas-sider
English: Thrombocytopenia Grade 3 (25,000 to < 50,000/mm3)
Maltese: Grad 2-3 fil-jum tattrattament skedat (25,000 sa < 75,000/mm