FrancophonIA/ELRC3.0 huggingface dataset:
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with zidovudine or abacavir, results in a significant decrease in plasma concentration of these nucleoside reverse transcriptase inhibitors (NRTIs).
Maltese: L-użu konġunt ta' Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, ma' zidovudine jew abacavir, jirriżulta fi tnaqqis sinifikanti fil-konċentrazzjoni tal-plażma ta' dawn l-impedituri tat-tip nucleoside reverse transcriptase (NRTIs).
English: Phenobarbital and phenytoin should be used with caution in combination with Aptivus, co-administered with low dose ritonavir (see section 4.4).
Maltese: Emorraġija intrakranjali (ICH) ġiet osservata biss fl-esperjenza ta' wara t-tqegħid fis-suq (ara sezzjoni 4.4).
English: Due to their metabolic profile and inherent risk of inducing torsades de pointes, administration of halofantrine and lumefantrine with Aptivus, co-administered with low dose ritonavir, is not recommended (see section 4.4).
Maltese: Minħabba l-profil metaboliku tagħhom u r-riskju inerenti talinduzzjoni ta' torsades de pointes, lgħoti ta' halofantrine u lumefantrine ma' Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Common: may affect up to 1 in 10 people - Vomiting - Abdominal pain (tummy pain) - Flatulence (breaking wind more often) - Tiredness - Headache - Mild rashes e.g. with hives or with flat or raised small red spots - Increases in blood lipid (fat) levels - Dyspepsia
Maltese: Rari: jistgħu jaffettwaw sa 1 persuna minn kull 1000 - Insuffiċjenza tal-fwied (li tinkludi mewt) - Epatite - Xaħam fil-fwied - Żieda fil-livelli ta' bilirubina fid-demm (prodott li jirriżulta mit-tkissir tal-emoglobina) - Deidrattazzjoni - Il-wiċċ jirqaq - Emorraġija fil-moħħ* (ara hawn fuq) - Żieda fil-livelli tal-enzima tal-frixa lipase fid-demm
English: Patients had baseline HIV-1 isolates with a median of 16 HIV-1 protease gene mutations, including a median of 3 primary protease gene mutations D30N, L33F/I, V46I/L, G48V, I50V, V82A/F/T/L, I84V, and L90M.
Maltese: D30N, L33F/I, V46I/L, G48V, I50V, V82A/F/T/L, I84V, u L90M.
English: Aptivus, co-administered with low dose ritonavir, should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other medical conditions, or who are receiving medicinal products known to increase the risk of bleeding such as antiplatelet agents and anticoagulants or who are taking supplemental vitamin E. Patients taking Aptivus oral solution should be advised not to take any supplemental vitamin E.
Maltese: Aptivus, mogħti flimkien ma' doża baxxa ta' ritonavir, għandu jintuża b'attenzjoni f'pazjenti li jinsabu f'riskju ta' aktar fsada minħabba trawmiet, kirurġiji, jew kundizzjonijiet mediċi oħra, jew li qed jirċievu prodotti mediċinali magħrufa li jgħollu r-riskju ta' fsada bħal mediċini kontra l-plejtlets u anti-koagulanti jew li qed jieħdu vitamina supplimentali E.
English: Co-administration of Aptivus and agents that induce CYP3A and/or P-gp may decrease tipranavir concentrations and reduce its therapeutic effect (see list and details of considered agents, below).
Maltese: L-għoti konġunt ta' Aptivus u mediċini li jissensitizzaw CYP3A u/jew P-gp jistgħu jnaqqsu lkonċentrazzjonijiet ta' tipranavir u jnaqqsu l-effett terapewtiku tiegħu (ara lista u dettalji ta' mediċini kkonsidrati, hawn isfel).
English: This indication is based on the results of two phase III studies, performed in highly pre-treated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.
Maltese: II li investiga lfarmakokinetika, is-sigurtà u l-effikaċja ta' Aptivus f'pazjenti adolexxenti li fil-biċċa l-kbira tagħhom kienu rċivew kura fil-passat, li kellhom bejn 12 sa 18-il sena.
English: The recommended dose for an adult or an adolescent 12 years and above is:
Maltese: Adulti u adolexxenti (minn 12 - 18-il sena)
English: Increased CPK, myalgia, myositis and, rarely, rhabdomyolysis, have been reported with protease inhibitors, particularly in combination with nucleoside reverse transcriptase inhibitors.
Maltese: Żjieda fis-CPK, majalġja, mijosite, u rarament, rabdomajoliżi, kienu ġew rapportati ma' l-użu ta' impedituri ta' l-enżima protease, b'mod partikolari meta ntużaw flimkien ma' impedituri ta' l-enżima reverse transcriptase.
English: Co-administration of colchicine with Aptivus/ritonavir in patients with renal or hepatic impairment (see section 4.5).
Maltese: Il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħu jiżdiedu matul it-terapija antiretrovirali (ara sezzjoni 4.4).
English: CYP 3A4 inhibition by tipranavir/r co-administered with low dose ritonavir, with alfuzosin is contraindicated.
Maltese: Xorta tista' tgħaddi l-HIV meta tkun qiegħed tieħu din il-mediċina, għalkemm ir-riskju jonqos b'terapija antiretrovirali effettiva.
English: The paediatric dose should not exceed the 500 mg/200 mg dose.
Maltese: Id-doża fi tfal m'għanhiex taqbeż id-doża ta' 500 mg/200 mg.
English: Inhibition of CYP 3A4 by tipranavir/r.
Maltese: Inibizzjoni ta' CYP 3A4 minn tipranavir/r.
English: The mean Cmax reduction observed with food ranges from 21% to 69%.
Maltese: It-tnaqqis medju tas-Cmax osservat bl-ikel ivarja minn 21% għal 69%.
English: According to Desjardins et al (2015)1, there was 60% decrease in Cmax for a diclofenac acid capsule, compared to a 43% decrease in Cmax for a potassium tablet, in the fed state vs fasted.
Maltese: Skont Desjardins et al (2015)1, kien hemm tnaqqis ta' 60% fis-Cmax għal kapsula ta' aċidu diclofenac, meta mqabbel ma' tnaqqis ta' 43% fis-Cmax għal pillola tal-potassju, meta wieħed ikun kiel u meta jibqa' sajjem. Chen et al (2015
English: Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis via inhibition of both COX-1 and COX-2 isoenzymes of the arachidonic acid pathway.
Maltese: Diclofenac huwa mediċina antiinfjammatorja nonsterojdali (NSAID) li tinibixxi s-sinteżi tal-prostaglandina permezz tal-inibizzjoni kemm ta' isoenzimi COX-1 kif ukoll dawk COX-2 tar-rotta tal-aċidu arakidoniku.
English: Diclofenac 50 mg Tablets contain diclofenac epolamine, a salt of diclofenac, formed by the combination of diclofenamic acid with the tertiary amine N-(2-hydroxyethyl)-pyrrolidine.
Maltese: Il-pilloli Diclofenac ta' 50 mg fihom diclofenac epolamine, melħ ta' diclofenac, ifformati bit-taħlita ta' aċidu diklofenamiku mal-amina terzjarja N-(2-idrossietil)-pirrolidina.
English: Limited within study comparisons are available.
Maltese: Hemm disponibbli tqabbil limitat fl-istudji.
English: This was a single-dose openlabel randomised 2x2 crossover study of acceptable design.
Maltese: Dan kien studju b'doża waħda open-label randomizzat 2x2 crossover ta' disinn aċċettabbli.
English: Section 4.2 of the proposed SmPC for Diclofenac (epolamine) 50 mg immediate release tablets is in line with the reference product, and recommends that: '… tablets should be swallowed whole with a glass of water, preferably during or after meals.
Maltese: Is-Sezzjoni 4.2 tal-SmPC propost għall-pilloli Diclofenac (epolamine) ta' 50 mg li jerħu l-mediċina minnufih hija konformi mal-prodott ta' referenza, u tirrakkomanda li: "… il-pilloli għandhom jinbelgħu sħaħ ma' tazza ilma, preferibbilment waqt jew wara l-ikel.
English: The marketing authorisation application (MAA) for Diclofenac (epolamine) 50 mg immediate release tablets was submitted according to Article 10(1) of Directive 2001/83/EC.
Maltese: L-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq (MAA) għal pilloli Diclofenac (epolamina) ta' 50 mg li jerħu l-mediċina minnufih ġiet ippreżentata skont l-Artikolu 10(1) tad-Direttiva 2001/83/KE.
English: In summary, the view of the PKWP was that under fed conditions the Cmax is highly variable; Cmax ratio fed/fasted ranged from 26-73% for the different formulations, and formulations that are bioequivalent in the fasted state may not be bioequivalent in the fed state, especially if the dosage form is different.
Maltese: Fil-qosor, il-PKWP kien tal-opinjoni li f'kundizzjonijiet fejn il-pazjent kien kiel, is-Cmax huwa varjabbli ħafna; il-proporzjon tas-Cmax malikel/fis-sawm varja bejn 26 u 73% għad-diversi formulazzjonijiet, u l-formulazzjonijiet li huma bijoekwivalenti fi stat ta' sawm mhux bilfors ikunu bijoekwivalenti mal-ikel, speċjalment jekk il-forma tad-dożaġġ tkun differenti.
English: • The Committee reviewed the data submitted by the applicant in support of this particular medicinal product Diclofenac (Altergon) 50mg tablets;
Maltese: • Il-Kumitat eżamina d-data ppreżentata mill-applikant insostenn ta' dan il-prodott mediċinali partikolari, il-pilloli Diclofenac (Altergon)ta' 50mg;
English: • The Committee therefore concluded that there was a lack of appropriate data to support the positive benefit-risk of this medicinal product Diclofenac 50mg tablets.
Maltese: • Għaldaqstant il-Kumitat ikkonkluda li kien hemm nuqqas ta' data xierqa insostenn tal-bilanċ pożittiv bejn il-benefiċċju u r-riskju ta' dan il-prodott mediċinali, il-pilloli Diclofenac ta' 50mg.
English: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of Directive 2001/83/EC where France and the Slovakia raised objections that were considered to be a potential serious risk to public health;
Maltese: Direttiva 2001/83/KE fejn Franza u s-Slovakkja qajmu oġġezzjonijiet li kienu kkunsidrati bħala riskju potenzjalment serju għas-saħħa pubblika;
English: Chen et al (2015)2 reported a 69% reduction in Cmax for a buffered potassium solution vs a 28% reduction for a potassium tablet, in the fed state vs. fasted state.
Maltese: )2 irrapportaw tnaqqis ta' 69% fis-Cmax għal soluzzjoni buffered ta' potassju meta mqabbel ma' tnaqqis ta' 28% għal pillola tal-potassju, meta wieħed ikun kiel u meta jibqa' sajjem.
English: The CMDh therefore referred the matter to the CHMP through an Article 29(4) referral procedure.
Maltese: Is-CMDh għalhekk irrefera lkwistjoni lis-CHMP permezz ta' proċedura ta' riferiment tal-Artikolu 29(4).
English: • The Committee was of the view that in this case bioequivalence of Diclofenac 50 mg tablets vs. the reference product Flector granules for oral solution should be demonstrated in fed conditions as well, in view of the available literature demonstrating that the Cmax of different formulations of diclofenac is affected differently in fed conditions;
Maltese: • Il-Kumitat kien tal-fehma li f'dan il-każ, il-bijoekwivalenza tal-pilloli Diclofenac ta' 50 mg meta mqabbla mal-prodott ta' referenza grani għal soluzzjoni orali Flector għandha tintwera wkoll f'kundizzjonijiet fejn il-pazjent ikun kiel, fid-dawl tal-letteratura disponibbli li turi li s-Cmax ta' formulazzjonijiet differenti ta' diclofenac huwa affettwat b'mod differenti f'kundizzjonijiet fejn ilpazjent ikun kiel;
English: However the objecting EU Member States argued that the effect of food on Cmax may be formulationdependent in the case of diclofenac, and that from the available evidence the potential difference in bioavailability (Cmax decrease of up to 70%) may reach such a high level so as to compromise the safe and effective use of the drug.
Maltese: Madankollu l-Istati Membri tal-UE li oġġezzjonaw argumentaw li l-effett tal-ikel fuq is-Cmax jista' jiddependi mill-formulazzjoni fil-każ ta' diclofenac, u li, mill-evidenza disponibbli, id-differenza potenzjali fil-bijodisponibbiltà (sa 70% tnaqqis tas-Cmax) tista' tilħaq livell tant għoli li tista' tikkomprometti l-użu sigur u effettiv tal-mediċina.
English: Therefore as Diclofenac epolamine tablets and the reference product diclofenac epolamine granules for solution are different oral pharmaceutical formulations, and because literature data show that the food effect on Cmax of diclofenac is not only dependent on the drug substance but also on the formulation, in this case, bioequivalence can only be concluded if bioequivalence is shown under fed as well as fasted conditions.
Maltese: Għaldaqstant, peress li l-pilloli Diclofenac epolamine u l-prodott ta' referenza granuli ta' diclofenac epolamine għal soluzzjoni huma formulazzjonijiet farmaċewtiċi orali differenti, u peress li d-data mil-letteratura turi li l-effett tal-ikel fuq is-Cmax ta' diclofenac ma jiddependix biss mis-sustanza tal-mediċina iżda wkoll mill-formulazzjoni, f'dan il-każ, il-konklużjoni ta' bijoekwivalenza tista' tintlaħaq biss jekk il-bijoekwivalenza tintwera f'kundizzjonijiet fejn il-pazjent ikun kiel kif ukoll meta jkun sajjem.
English: Although it was argued by the applicant that a failure of bioequivalence under fasting state is predictive of a failure of bioequivalence under fed state based on the submitted literature, the CHMP was of the view that the reverse argument could not be upheld i.e that bioequivalence under fasting state is predictive of bioequivalence under fed state, without any evidence to support it.
Maltese: Għalkemm l-applikant argumenta li nuqqas ta' bijoekwivalenza fi stat ta' sawm jista' jfisser nuqqas ta' bijoekwivalenza f'każ li l-pazjent ikun kiel skont il-letteratura ppreżentata, is-CHMP kien tal-fehma li ma setax jaċċetta l-argument bil-kontra, jiġifieri li l-bijoekwivalenza fi stat ta' sawm tista' tfisser bijoekwivalenza meta l-pazjent ikun kiel, mingħajr ebda evidenza insostenn ta' dan.
English: During the CHMP meeting the applicant presented their view in an oral explanation.
Maltese: Waqt il-laqgħa tas-CHMP l-applikant ippreżenta l-opinjoni tiegħu fi spjegazzjoni orali.
English: Furthermore, comparative dissolution testing at pH 5.5 demonstrated immediate release from test and reference product, which was used to support the comparative rate and extent of absorption in vivo in the fed state.
Maltese: Barra minn hekk, test ta' dissoluzzjoni komparattiv f'pH ta' 5.5 wera li kemm il-prodott ittestjat kif ukoll il-prodott ta' referenza rħew il-mediċina minnufih, u dan intuża bħala appoġġ tar-rata komparattiva u l-grad ta' assorbiment in vivo wara l-ikel.
English: One study demonstrating the bioequivalence of diclofenac epolamine tablets vs. Flector (diclofenac epolamine) granules for oral solution in healthy volunteers in the fasted state was submitted by the applicant in support of this MAA.
Maltese: Studju li wera l-bijoekwivalenza tal-pilloli diclofenac epolamine meta mqabblin mal-granuli Flector (diclofenac epolamine) għal soluzzjoni orali f'voluntiera b'saħħithom fi stat ta' sawm ġie ppreżentat mill-applikant b'appoġġ għal din l-MAA.
English: In summary this review of literature by the applicant about the magnitude of the food-effect on the rate of absorption with diclofenac immediate release formulations, allowed to conclude that it reached on average, 50% decrease on Cmax and various delays on tmax, without any loss in the amount of systemic exposure.
Maltese: Fil-qosor, din ir-reviżjoni tal-letteratura mill-applikant dwar id-daqs tal-effett tal-ikel fuq ir-rata ta' assorbiment b'formulazzjonijiet li jerħu l-mediċina diclofenac minnufih, wasslet għall-konklużjoni li laħqet medja ta' tnaqqis ta' 50% fuq is-Cmax u diversi dewmien fuq it-tmax, mingħajr ebda telf flammont ta' espożizzjoni sistemika.
English: However no data was submitted to show the food effect between test and reference product to support this application, given that the SmPC recommendation in section 4.2 is that Diclofenac epolamine tablets should be swallowed whole with a glass of water, preferably during or after meals.
Maltese: Madankollu ma ġiet ippreżentata ebda data li turi l-effett tal-ikel bejn il-prodott ittestjat u l-prodott ta' referenza insostenn ta' din l-applikazzjoni, peress li r-rakkomandazzjoni fis-Sezzjoni 4.2 tal-SmPC hija li l-pilloli Diclofenac epolamine għandhom jinbelgħu sħaħ ma' tazza ilma, preferibbilment waqt jew wara l-ikel.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata Il-pakkett li jmiss malprodott
English: Favourable effects
Maltese: Effetti favorevoli
English: Whereas
Maltese: II.
English: The therapeutic indication of Lartruvo is:
Maltese: Lindikazzjoni terapewtika ta' Lartruvo hija:
English: Lartruvo was granted a conditional marketing authorisation under Article 14(7) of Regulation (EC) No. 726/2004, valid throughout the European Union, on 9 November 2016.
Maltese: Lartruvo ngħata awtorizzazzjoni għat-tqegħid fis-suq kondizzjonali skont l-Artikolu 14(7) tarRegolament (KE) Nru. 726/2004, valida fl-Unjoni Ewropea kollha, fid-9 ta' Novembru 2016.
English: Cardiac arrhythmia events were more commonly reported in the investigational arm (any grade 12.8% vs 9.6%; grade >=3 2.7% vs 0.8%).
Maltese: Avvenimenti ta' arritmija kardijaka ġew irrappurtati b'mod aktar komuni fil-fergħa investigattiva (kwalunkwe grad 12.8% kontra 9.6%; grad >=3 2.7% kontra 0.8%).
English: The rate of TEAE was overall similar in both treatment arms (98.1% vs 99.2%).
Maltese: Ir-rata ta' TEAE kienet globalment simili fiż-żewġ fergħat ta' kura (98.1% kontra 99.2%).
English: Infusion related reactions, cardiac arrhythmia and cardiac dysfunction are considered events of special interest for olaratumab.
Maltese: Reazzjonijiet relatati mal-infużjoni, arritmija kardijaka u disfunzjoni kardijaka jitqiesu bħala avvenimenti ta' interess speċjali għal olaratumab.
English: Overall, 509 adult patients with advanced or metastatic soft tissue sarcoma not amenable to treatment with surgery or radiotherapy with curative intent (of those 234 were leiomiosarcoma, LMS) were randomized 1:1, stratified by number of prior systemic therapies for advanced/metastatic disease, histological tumour type, and ECOG PS, to the investigational arm (n=258; LMS n=119) with olaratumab plus doxorubicin or the control arm (n=251; LMS n=114) with placebo plus doxorubicin.
Maltese: B'kollox, 509 pazjenti adulti b'sarkoma tat-tessut artab avvanzata jew metastatika mhux emenabbli għal kura b'kirurġija jew radjoterapija b'intenzjoni kurattiva (li minnhom 234 kienu lejomijosarkoma, LMS) ġew randomizzati 1:1, stratifikati skont in-numru ta' terapiji sistemiċi preċedenti għal marda avvanzata/metastatika, tip ta' tumur istoloġiku, u ECOG PS, għall-fergħa investigattiva (n=258; LMS n=119) b'olaratumab u doxorubicin jew il-fergħa tal-kontroll (n=251; LMS n=114) bi plaċebo u doxorubicin.
English: The median PFS was 5.42 months in the investigational arm and 6.77 months in the control arm (HR=1.231 [95% CI: 1.009, 1.502]; p=0.042).
Maltese: Il-PFS medjana kienet 5.42 xhur fil-fergħa investigattiva u 6.77 xhur filfergħa tal-kontroll (HR=1.231 [95% CI: 1.009, 1.502]; p=0.042).
English: Deaths due to adverse events were overall similar in both arms (7[2.7%] vs 6 [2.4%]).
Maltese: L-imwiet minħabba avvenimenti avversi kienu globalment simili fiż-żewġ fergħat (7[2.7%] kontra 6 [2.4%]).
English: ANNOUNCE (I5B-MC-JGDJ) was a randomized, double-blind, placebo-controlled, phase 3 trial of olaratumab plus doxorubicin versus placebo plus doxorubicin in patients with locally advanced or metastatic soft tissue sarcoma.
Maltese: ANNOUNCE (I5B-MC-JGDJ) kienet prova randomizzata, double-blind, ikkontrollata bi plaċebo, ta' fażi 3 ta' olaratumab u doxorubicin kontra plaċebo u doxorubicin f'pazjenti b'sarkoma tat-tessut artab lokalment avvanzata jew metastatika.
English: However, the median duration of doxorubicin treatment was 18 weeks and 23 weeks for the investigational and control groups, respectively.
Maltese: Madankollu, id-durata medja ta' kura b'doxorubicin keinet 18il ġimgħa u 23 ġimgħa għall-gruppi investigattivi u tal-kontroll, rispettivament.
English: The incidence for all grades of events in the cardiac dysfunction AESI category was 18.3% in the investigational arm and 13.7% in the control arm, the majority being events of peripheral oedema (13.2 vs 9.2%) and oedema (1.2% vs 0%).
Maltese: L-inċidenza għall-gradi kollha ta' avvenimenti fil-kategorija AESI ta' disfunzjoni kardijaka kienet 18.3 % fil-fergħa investigattiva u 13.7 % fil-fergħa tal-kontroll, il-maġġoranza tal-avvenimenti kienu ta' edema periferali (13.2 kontra 9.2%) u edema (1.2% kontra 0%).
English: According to the protocol, doxorubicin 75 mg/m2 was to be administered (after olaratumab or placebo) on day 1 of cycles 1 to 8 (of 3 weeks each).
Maltese: Skont il-protokoll, doxorubicin 75 mg/m2 kellu jingħata (wara olaratumab jew plaċebo) f'jum 1 taċ-ċikli 1 sa 8 (ta' 3 ġimgħat kull wieħed).
English: The rate of haematological toxicities (neutropenia, thrombocytopenia, anaemia and febrile neutropenia) and gastrointestinal toxicities (nausea, vomiting and diarrhoea) was balanced between the treatment arms.
Maltese: Ir-rata ta' tossiċitajiet ematoloġiċi (newtropenja, tromboċitopenja, anemija, u newtropenja bid-deni) u tossiċitajiet gastrointestinali (nawsja, rimettar u dijarea) kienu bbilanċjati bejn il-fergħat ta' kura.
English: Benefit-risk assessment and discussion
Maltese: Valutazzjoni tal-benefiċċju u r-riskju u diskussjoni
English: Frequency of patients with TEAE leading to treatment discontinuation was similar in both arms (4.3% vs 4.4%).
Maltese: Il-frekwenza ta' pazjenti b'TEAE li wassal għat-twaqqif tal-kura kienet simili fiż-żewġ fergħat (4.3% kontra 4.4%).
English: A total of 170 (66.1%) vs 158 (63.5%) of patients died in the investigational vs control arm, respectively, mostly attributed to study disease (63.4% vs 61%).
Maltese: Total ta' 170 (66.1%) kontra 158 (63.5%) tal-pazjenti mietu fil-fergħa investigattiva meta mqabbla mal-fergħa tal-kontroll, rispettivament, li l-aktar ġew attribwiti għall-marda tal-istudju (63.4% kontra 61%).
English: In the ITT population, the median OS was 20.37 months in the investigational arm and 19.75 months in the control arm (HR=1.047 [95% CI: 0.841, 1.303]; p=0.69), and the OS KM curves are completely overlapping, indicating that adding Lartruvo to doxorubicin had no favourable effect on OS. Further OS analyses showed that in most subgroups HR estimates ranged from 0.9 to 1.1, consistent with the overall OS results.
Maltese: 37 xhur fil-fergħa investigattiva u 19.75 xhur fil-fergħa talkontroll (HR=1.047 [95% CI: 0.841, 1.303]; p=0.69), u l-kurvi ta' OS KM huma kompletament imrikkba fuq xulxin, li jindikaw li ż-żieda ta' Lartruvo ma' doxorubicin ma kellha l-ebda effett favorevoli fuq l-OS. Analiżijiet oħra tal-OS urew li f'ħafna mis-sottogruppi, l-istimi tal-HR varjaw minn 0.9 sa 1.1, b'mod konsistenti mar-riżultati globali tal-OS.
English: Compared to the currently recommended posology of olaratumab (15 mg/kg on days 1 and 8 of each 3 week cycle), a loading cycle of 20 mg/kg on day 1 and day 8 of cycle 1 was used, to minimize the number of patients exposed to sub-therapeutic olaratumab serum levels without an increased risk of toxicity, based on PK and matched case-control analysis by exposure quartiles results.
Maltese: Meta mqabbel mal-pożoloġija rakkomandata attwalment ta' olaratumab (15 mg/kg f'jiem 1 u 8 ta' kull ċiklu ta' 3 ġimgħat), intuża ċiklu ta' tagħbija ta' 20 mg/kg f'jum 1 u jum 8 ta' ċiklu 1, biex jiġi mminimizzat in-numru ta' pazjenti esposti għal livelli fis-seru subterapewtiċi ta' olaratumab mingħajr riskju miżjud ta' tossiċità, abbażi ta' PK u analiżi ta' kontroll tal-każ imqabbla skont riżultati ta' kwartili ta' esponiment.
English: The rate of potential immediate (i.e. occurring on the day of infusion) hypersensitivity reactions was higher in the investigational arm for all grade events (11.7% vs. 7.2%) and Grade ≥3 events (2.3% vs 0.8%) but no fatal events were reported.
Maltese: Ir-rata ta' reazzjonijiet ta' sensittività eċċessiva immedjati potenzjali (jiġifieri li seħħew fil-jum tal-infużjoni) kienet ogħla fil-fergħa investigattiva għallavvenimenti tal-gradi kollha (11.7% kontra 7.2%) u avvenimenti ta' Grad ≥3 (2.3% kontra 0.8%), iżda ma ġie rrappurtat l-ebda avveniment fatali.
English: Immediate non-anaphylactic reactions were reported in 9.3% patients and were grade 1/2 in severity.
Maltese: Ġew irrappurtati reazzjonijiet mhux anafilattiċi immedjati f'9.3 % pazjenti u dawn kienu ta' grad 1/2 fis-severità.