FrancophonIA/ELRC3.0 huggingface dataset:
English: GIOTRIF 40 mg film-coated tablets afatinib
Maltese: GIOTRIF 40 mg pilloli miksija b'rita afatinib
English: Dermatitis acneiform
Maltese: Dermatite qisha akne
English: GIOTRIF 20 mg film-coated tablets
Maltese: GIOTRIF 20 mg pilloli miksija b'rita
English: The tablets should be swallowed whole with water.
Maltese: Pazjenti bi storja medika ta' ILD ma ġewx studjati.
English: GIOTRIF 30 mg film-coated tablets afatinib
Maltese: GIOTRIF 30 mg pilloli miksija b'rita afatinib
English: Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see section 5.2).
Maltese: Esponiment għal afatinib instab li huwa miżjud f'pazjenti b'indeboliment tal-kliewi moderat jew sever (ara sezzjoni 5.2).
English: The efficacy and safety of GIOTRIF in Asian patients with Stage IIIB/IV EGFR mutation-positive locally advanced or metastatic adenocarcinoma of the lung was evaluated in a randomised, multicentre, open-label trial.
Maltese: L-effikaċja u s-sigurtà ta' GIOTRIF f'pazjenti Ażjatiċi li għandhom adenokarċinoma tal-pulmun lokalment avvanzata jew metastatika b'mutazzjoni pożittiva tal-EGFR tal-Istadju IIIB/IV ġew evalwati fi prova multiċentrika u open-label, li fiha l-parteċipanti ntgħażlu b'mod każwali.
English: • Itching
Maltese: • Rimettar
English: Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
Maltese: Pillola miksija b'rita, tonda, bikonvessa u b'tarf illixxat, ta' lewn blu ċar, imnaqqxa bil-kodiċi “T40” fuq naħa waħda u l-Logo ta' Boehringer Ingelheim fuq in-naħa l-oħra.
English: Other information on drug-drug interactions
Maltese: Informazzjoni oħra dwar interazzjonijiet bejn mediċina u oħra
English: EGFR mutation status should be established prior to initiation of GIOTRIF therapy (see section 4.4).
Maltese: L-istat tal-mutazzjoni ta' EGFR għandu jiġi stabbilit qabel ma tinbeda t-terapija b'GIOTRIF (ara sezzjoni 4.4).
English: Breast-feeding Do not breast-feed while taking this medicine as a risk to the breast-fed child cannot be excluded.
Maltese: Treddax waqt li tkun qed tieħu din il-mediċina għax riskju lit-tarbija li tkun terda' ma jistax jiġi eskluż.
English: Analysis of GIOTRIF's efficacy in EGFR TKI naïve patients with tumours harbouring uncommon EGFR Mutations (LUX-Lung 2, -3, and -6)
Maltese: Dan il-prodott mediċinali għandu jingħata mingħajr ikel (ara sezzjonijiet 4.2 u 5.2).
English: What GIOTRIF looks like and contents of the pack GIOTRIF 50 mg film-coated tablets are dark blue and oval shaped.
Maltese: GIOTRIF 50 mg pilloli miksija b'rita huma ta' lewn blu skur u b'forma ovali.
English: Progression-free survival Months (median) Hazard Ratio (HR) (95%CI) p-value
Maltese: Xhur (medjan) Proporzjon ta' Periklu (HR) (95%CI) valur p
English: Pruritus
Maltese: Uġigħ
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 20 mg
Maltese: Ż-ŻGĦAR EWLENIN POUCH TAL-ALUMINJU għal 20 mg
English: There have been reports of ILD or ILD-like adverse reactions (such as lung infiltration, pneumonitis, acute respiratory distress syndrome, allergic alveolitis), including fatalities, in patients receiving GIOTRIF for treatment of NSCLC.
Maltese: Mard interstizjali tal-pulmun (ILD - Interstitial Lung Disease) Kien hemm rapporti ta' ILD jew reazzjonijiet avversi li jixbhu lil ILD (bħal infiltrazzjoni tal-pulmun, pnewmonite, sindrome ta' diffikultà respiratorja akuta, alveolite allerġika), li jinkludu fatalitajiet, f'pazjenti li kienu qed jirċievu GIOTRIF għall-kura ta' NSCLC.
English: Each blister contains 7 x 1 film-coated tablets and is packed in an aluminium pouch together with a desiccant sachet that should not be swallowed.
Maltese: Jekk ikollok diffikultajiet biex tibla' l-pillola, ħollha f'tazza ilma mingħajr gass (still water).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 50 mg
Maltese: Ż-ŻGĦAR EWLENIN POUCH TAL-ALUMINJU għal 50 mg
English: Hazard Ratio/ Odds Ratio (95%CI) p-value
Maltese: Proporzjon ta' Periklu/ Proporzjon talProbabbiltajiet (95%CI) Valur-p
English: Table 2 summarises the frequencies of ADRs from all NSCLC trials and from post-marketing experience with daily GIOTRIF doses of 40 mg or 50 mg as monotherapy.
Maltese: Tabella 2 turi fil-qosor il-frekwenzi ta' ADRs mill-provi kollha NSCLC u mill-esperjenza ta' wara ttqegħid fis-suq b'dożi ta' kuljum ta' GIOTRIF ta' 40 mg jew 50 mg mogħti waħdu.
English: Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka
Maltese: Boehringer Ingelheim Pharma GmbH & Co.
English: 7 x 1 tablet (unit dose)s
Maltese: Il-pakkett li jmiss mal-prodott
English: MA (EU)Number
Maltese: Numru tal-MA
English: (Invented) name
Maltese: Isem (ivvintat)
English: Events (%)
Maltese: Avvenimenti (%)
English: 30th January 2020
Maltese: 30 ta' Jannar 2020
English: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Maltese: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey L-Isvizzera
English: Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands
Maltese: Merck Europe B.V. Gustav Mahlerplein 102 1082 MA Amsterdam L-Olanda
English: BICR: Blinded Independent Central Review; CI: Confidence interval; NE: Not estimable.
Maltese: BICR: Analiżi Ċentrali Indipendenti Blinded; CI: Intervall ta' kunfidenza; NE:
English: Avelumab ORR (95% CI)
Maltese: Avelumab ORR (CI ta' 95%)
English: Guillain-Barré Syndrome*
Maltese: Sindrome ta' Guillain-Barré*
English: Duration of response (DOR)a
Maltese: Tul tar-rispons (DOR)a
English: Merkel cell carcinoma (study EMR100070-003)
Maltese: Karċinoma taċ-ċelluli Merkel (studju EMR100070-003)
English: • infusion-related reactions;
Maltese: • reazzjonijiet relatati mal-infużjoni;
English: # At Risk
Maltese: F'Riskju
English: Date of first authorisation: 18 September 2017 Date of latest renewal: 20 June 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Settembru 2017 Data tal-aħħar tiġdid: 20 ta' Ġunju 2019
English: PD-L1 expression at cut-off of 1%
Maltese: Espressjoni ta' PD-L1 waqt cut-off ta' 1%
English: Colitis*, autoimmune colitis*, enterocolitis*, ileus
Maltese: Kolite*, kolite awtoimmuni*, enterokolite*, ileus
English: • you have had an organ transplant.
Maltese: • kellek trapjant ta' organu.
English: (10.2, not estimable)
Maltese: (10.2, ma jistax jiġi stmat)
English: Sodium content
Maltese: Kontenut ta' Sodium
English: Conditional approval
Maltese: Approvazzjoni kondizzjonali
English: (18, not estimable)
Maltese: (18, ma jistax jiġi stmat)
English: Renal cell carcinoma (study B9991003)
Maltese: Karċinoma taċ-ċelluli renali (studju B9991003)
English: PD-L1 expression at cut-off of 5%
Maltese: Espressjoni ta' PD-L1 waqt cut-off ta' 5%
English: * Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.03)
Maltese: Avvenimenti Avversi Verżjoni 4.0 (NCI-CTCAE v4.03 - National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0)
English: Avelumab plus axitinib
Maltese: Avelumab + Axitinib:
English: 2.3 months).
Maltese: 2.5 xhur).
English: Response rate, CR+PR** n (%) (95% CI)
Maltese: Rata ta' rispons, CR+PR** n (%) (CI ta' 95%)
English: Positive (n=58) Negative (n=16)
Maltese: Pożittivi (n=58) Negattivi (n=16)
English: The solution pH is in the range of 5.0 - 5.6 and the osmolality is between 270 and 330 mOsm/kg.
Maltese: Il-pH tas-soluzzjoni hija fil-medda ta' 5.0 - 5.6 u losmolalità hija bejn 270 u 330 mOsm/kg.
English: Weight decreased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased
Maltese: Tnaqqis fil-piż, żieda ta' alanine aminotransferase (ALT), żieda ta' aspartate aminotransferase (AST)
English: The active substance is avelumab.
Maltese: Is-sustanza attiva hi avelumab.
English: Excipients: Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections.
Maltese: Eċċipjenti: Mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, ilma għall-injezzjonijiet.
English: Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1).
Maltese: Avelumab huwa antikorp monoklonali ta' immunoglobulina G1 (IgG1 - immunoglobulin G1) uman immirat kontra ligand ta' mewt ipprogrammata 1 (PD-L1 - programmed death ligand 1).
English: The volume of distribution at steady state was 4.72 L.
Maltese: Il-volum ta' distribuzzjoni fl-istat fiss kien ta' 4.72 L.
English: Serum creatinine more than 1.5 and up to 6 times ULN
Maltese: Kreatinina fis-serum ta' aktar minn 1.5 darbiet u sa 6 darbiet tal-ULN
English: Severity*
Maltese: Severità*
English: Table 3: Adverse reactions in patients treated with avelumab in combination with axitinib in clinical studies B9991002 and B9991003
Maltese: Tabella 3: Reazzjonijiet avversi f'pazjenti ttrattati b'avelumab flimkien ma' axitinib fl-istudji kliniċi B9991002 u B9991003
English: Efficacy endpoints (Part A) (per RECIST v1.1, IERC)
Maltese: Punti finali tal-effikaċja (Parti A) (skont RECIST v1.1, IERC)
English: Tubulo-interstitial nephritis*
Maltese: Nefrite tubulointerstizjali*
English: IHC-MCV tumour status
Maltese: Stat ta' IHC-MCV tat-tumur
English: No clinically important differences in the clearance of avelumab were found between patients with mild (glomerular filtration rate (GFR) 60 to 89 mL/min, Cockcroft-Gault Creatinine Clearance (CrCL); n=623), moderate (GFR 30 to 59 mL/min, n=320) and patients with normal (GFR ≥ 90 mL/min, n=671) renal function.
Maltese: Ma nstabet l-ebda differenza klinikament importanti fit-tneħħija ta' avelumab bejn pazjenti b'indeboliment tal-kliewi ħafif (rata ta' filtrazzjoni mill-glomeruli (GFR - glomerular filtration rate) ta' 60 sa 89 mL/min, Tneħħija tal-Kreatinina (CrCL - Creatinine Clearance) Cockcroft-Gault; n=623), moderat (GFR 30 sa 59 mL/min, n=320) u f'pazjenti li għandhom funzjoni tal-kliewi normali (GFR ≥ 90 mL/min, n=671).
English: Pancreatitis*
Maltese: Pankreatite*
English: Grade 2 pneumonitis
Maltese: Pulmonite ta' Grad 2
English: Myocarditis*
Maltese: Mijokardite*
English: Bavencio is compatible with polyethylene, polypropylene, and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 micrometre.
Maltese: Bavencio huwa kompatibbli ma' boroż tal-infużjoni tal-polyethylene, polypropylene, u ethylene vinyl acetate, ma' fliexken tal-ħġieġ, settijiet tal-infużjoni tal-polyvinyl chloride u filtri fil-pajp b'membrani tal-polyethersulfone b'daqsijiet tal-pori ta' 0.2 mikrometri.
English: Figure 2: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part B, N=116)
Maltese: Figura 2: Stimi Kaplan-Meier ta' sopravivenza mingħajr progressjoni (PFS - progression-free survival) skont RECIST v1.1, IERC (Parti B, N=116)
English: • inflammation of your pancreas (pancreatitis);
Maltese: • infjammazzjoni tal-frixa tiegħek (pankreatite);
English: Results (N=88)
Maltese: (N=88)
English: Additional secondary endpoints included objective response (OR), time to response (TTR) and duration of response (DOR).
Maltese: Punti finali sekondarji addizzjonali jinkludu rispons oġġettiv (OR - objective response), żmien għal rispons (TTR - time to response) u tul ta' żmien tar-rispons (DOR - duration of response).
English: Autoimmune colitis, autoimmune pancreatitis, enterocolitis, ileus, pancreatitis necrotizing
Maltese: Kolite awtoimmuni, pankreatite awtoimmuni, enterokolite, ileus, pankreatite b'nekrożi
English: Patient distribution by Memorial Sloan-Kettering Cancer Center (MSKCC) risk groups was 22% favourable, 65% intermediate, and 11% poor.
Maltese: Id-distribuzzjoni talpazjenti skont iċ-Ċentru tal-Kanċer Memorial Sloan-Kettering (MSKCC - Memorial Sloan-Kettering Cancer Center) kienet ta' 22% favorevoli, 65% intermedju, u 11% batut.
English: Avelumab has not been studied in patients with severe renal impairment (GFR 15 to 29 mL/min).
Maltese: Avelumab ma ġiex studjat f'pazjenti b'indeboliment tal-kliewi sever (GFR 15 sa 29 mL/min).
English: Results (N=116)
Maltese: (N=116)
English: Bavencio 20 mg/mL sterile concentrate avelumab
Maltese: Bavencio 20 mg/mL konċentrat sterili avelumab
English: Type 1 diabetes mellitus Avelumab can cause Type 1 diabetes mellitus, including diabetic ketoacidosis (see section 4.8).
Maltese: Dijabete mellitus ta' Tip 1 Avelumab jista' jikkawża dijabete mellitus ta' Tip 1, inkluż ketoaċidożi dijabetika (ara sezzjoni 4.8).
English: Myocarditis
Maltese: Mijokardite
English: Positive (n=46)
Maltese: Pożittivi (n=46)
English: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN
Maltese: Aspartate aminotransferase (AST) jew alanine aminotransferase (ALT) 3 darbiet u sa 5 darbiet akbar mill-ogħla limitu tan normal (ULN - upper limit of normal)
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Maltese: (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: Patient distribution by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups was 21% favourable, 62% intermediate, and 16% poor.
Maltese: Database Consortium) kienet ta' 21% favorevoli, 62% intermedju, u 16% batut.
English: In patients with ALT ≥ 3 times ULN (Grades 2-4, n=82), ALT resolved to Grades 0-1 in 92%.
Maltese: F'pazjenti b'ALT ≥ 3 darbiet l-ULN (Gradi 2-4, n=82), l-ALT irkuprat għal Gradi 0-1 fi 92%.
English: Withhold until adverse reactions recover to Grade 0-1
Maltese: Waqqaf sakemm irreazzjonijiet avversi jirkupraw għal Grad 0-1
English: • you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS);
Maltese: • għandek infezzjoni bil-virus tal-immunodefiċjenza umana (HIV - human immunodeficiency virus) jew sindrome akkwistat tal-immunodefiċjenza (AIDS - acquired immune deficiency syndrome);
English: Bavencio has not been studied in children and adolescents below 18 years of age.
Maltese: Bavencio ma ġiex studjat fi tfal u adolexxenti taħt it-18-il sena.
English: Uveitis*
Maltese: Uveite*
English: Neuropathy peripheral
Maltese: Newropatija periferali
English: Figure 1: Kaplan-Meier estimates of progression-free survival (PFS) per RECIST v1.1, IERC (Part A, minimum follow-up of 36 months)
Maltese: Figura 1: Stimi Kaplan-Meier ta' sopravivenza mingħajr progressjoni (PFS - progression-free survival) skont RECIST v1.1, IERC (Parti A, segwitu minimu ta' 36 xahar)
English: Adrenal insufficiency
Maltese: insuffiċjenza adrenali)
English: Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
Maltese: Avelumab intwera wkoll li jinduċi l-lisi diretta taċ-ċelluli tat-tumur medjata permezz ta' ċelluli natural killer (NK) permezz ta' ċitotossiċità medjata miċ-ċelluli dipendenti mill-antikorpi (ADCCantibody-dependent cell-mediated cytotoxicity).
English: In patients treated with avelumab in combination with axitinib, 24.7% (121/489) of patients developed immune-related thyroid disorders, including 111 (22.7%) patients with hypothyroidism, 17 (3.5%) with hyperthyroidism, and 7 (1.4%) with thyroiditis.
Maltese: F'pazjenti ttrattati b'avelumab flimkien ma' axitinib, 24.7% (121/489) tal-pazjenti żviluppaw disturbi tat-tirojde relatati mal-immunità, inklużi 111-il pazjent (22.7%) b'ipotirojdiżmu, 17 (3.5%) b'ipertirojdiżmu, u 7 (1.4%) b'tirojdite.
English: Rash pruritic, rash maculo-papular, pruritus generalized, dermatitis acneiform, erythema, rash macular, rash papular, rash erythematous, dermatitis, eczema, rash generalized
Maltese: Raxx bil-ħakk, raxx makulo-papulari, ħakk ġeneralizzat, dermatite akneiform, eritema, raxx makulari, raxx bil-ponot, raxx eritematuż, dermatite, ekżema, raxx ġeneralizzat
English: Suspected pancreatitis
Maltese: Pankreatite suspettata
English: The most common Grade ≥ 3 adverse reactions were anaemia (6.0%), dyspnoea (3.9%), and abdominal pain (3.0%).
Maltese: Ir-reazzjonijiet avversi ta' Grad ≥ 3 l-aktar komuni kienu anemija (6.0%), qtugħ ta' nifs (3.9%), u wġigħ addominali (3.0%).
English: Data for immune-related adverse reactions for avelumab as a monotherapy are based on 1,650 patients in the phase I study EMR100070-001 in solid tumours and 88 patients in study EMR100070-003, and for avelumab in combination with axitinib are based on 489 patients in study B9991002 and B9991003 (see section 5.1).
Maltese: Dejta dwar reazzjonijiet avversi relatati mal-immunità għal avelumab bħala monoterapija hija bbażata fuq 1,650 pazjent fl-istudju ta' fażi I EMR100070-001 dwar tumuri solidi u 88 pazjent fi studju EMR100070-003, u għal avelumab flimkien ma' axitinib hija bbażata fuq 489 pazjent fl-istudju B9991002 u B9991003 (ara sezzjoni 5.1).
English: Alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood creatine phosphokinase increased*, transaminases increased*
Maltese: Żieda ta' alanine aminotransferase (ALT)*, żieda ta' aspartate aminotransferase (AST)*, żieda ta' creatine phosphokinase fid-demm*, żieda ta' transaminases*
English: One vial of 10 mL contains 200 mg of avelumab.
Maltese: Kunjett wieħed ta' 10 mL fih 200 mg ta' avelumab.
English: Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Maltese: Bavencio huwa indikat bħala monoterapija għat-trattament ta' pazjenti adulti b'karċinoma metastatika taċ-ċelluli Merkel (MCC - Merkel cell carcinoma).
English: • inflammation of your heart (myocarditis);
Maltese: • infjammazzjoni tal-qalb tiegħek (mijokardite);
English: The Kaplan-Meier curve of PFS of the 88 patients (Part A) with metastatic MCC is presented in Figure 1.
Maltese: Il-kurva Kaplan-Meier ta' PFS tat-88 pazjent (Parti A) b'MCC metastatika hija ppreżentata f'Figura 1.
English: Pneumonitis
Maltese: Pulmonite
English: The median duration was 2.8 months (range: 3 days to more than 15.5 months).
Maltese: It-tul medjan kien ta' 2.8 xhur (medda: 3 ijiem sa aktar minn 15.5 xhur).
English: PD-L1 status was determined by immunohistochemistry.
Maltese: L-istat ta' PD-L1 ġie determinat permezz ta' immunoistokimika.
English: Patients with prior systemic therapy directed at advanced or metastatic RCC; prior systemic immunotherapy treatment with IL-2, IFN-α, anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or active brain metastasis; active autoimmune disease that might deteriorate when receiving an immunostimulatory agents; a history of other malignancies within the last 5 years; organ transplant were ineligible.
Maltese: RCC avvanzata jew metastatika; trattament b'immunoterapija sistemika minn qabel b'Il-2, IFN-α, antikorpi kontra PD-1, kontra PD-L1, jew kontra CTLA-4, jew metastasi attiva fil-moħħ; marda awtoimmuni attiva li tista' tiddeterjora meta jingħataw sustanzi immunostimulanti; storja ta' tumuri malinni oħra fl-aħħar 5 snin; trapjant ta' organu ma kinux eliġibbli.
English: Sodium hydroxide Water for injections
Maltese: Sodium hydroxide Ilma għall-injezzjonijiet
English: • problems due to inflammation of your lungs (pneumonitis);
Maltese: • problemi minħabba infjammazzjoni tal-pulmun tiegħek (pulmonite);
English: Avelumab has not been studied in patients with moderate hepatic impairment (bilirubin between 1.5 and 3 times ULN) or severe hepatic impairment (bilirubin > 3 times ULN).
Maltese: Avelumab ma ġiex studjat f'pazjenti b'indeboliment tal-fwied moderat (bilirubina bejn 1.5 u 3 darbiet l-ULN) jew b'indeboliment tal-fwied sever (bilirubina > 3 darbiet tal-ULN).
English: Median, months (range)
Maltese: Medjan, xhur (firxa)
English: Other clinically important immune-related adverse reactions were reported in less than 1% of patients: myositis, hypopituitarism, uveitis, and Guillain-Barré syndrome (see section 4.8).
Maltese: Reazzjonijiet avversi oħra relatati mal-immunità ta' importanza klinika kienu rrappurtati f'inqas minn 1% tal-pazjenti: mijosite, ipopitwitariżmu, uveite, u sindrome ta' Guillain-Barré (ara sezzjoni 4.8).
English: ** CIs are derived using the log-log transformation with back transformation to untransformed scale.
Maltese: ** CIs huma derivati bl-użu ta' trasformazzjoni log-log bi trasformazzjoni b'lura għal skala mhux trasformata.
English: The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy.
Maltese: Ir-rotta PD-1/PD-L1 huwa maħsub li hija involuta fiż-żamma ta' tolleranza għall-fetu matul it-tqala.
English: The majority (n=160, 71.4%) of the patients with progressive disease continued treatment with both medicinal products after progression.
Maltese: Il-maġġoranza (n=160, 71.4%) tal-pazjenti b'marda progressiva komplew it-trattament biż-żewġ prodotti mediċinali wara l-progressjoni.
English: • inflammation of your muscles (myositis).
Maltese: • infjammazzjoni tal-muskoli tiegħek (mijosite).
English: Immune-related myocarditis
Maltese: Mijokardite relatata mal-immunità
English: In the supplemental analysis, avelumab CL was found to decrease over time: the largest mean maximal reduction (% coefficient of variation [CV%]) from baseline value with different tumour types was approximately 32.1% (CV 36.2%).
Maltese: coefficient of variation]) mill-valur fil-linja bażi b'tipi ta' tumuri differenti kien madwar 32.1% (CV 36.2%).
English: In this patient population, the most common adverse reactions with avelumab were fatigue (32.4%), nausea (25.1%), diarrhoea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight decreased (16.6%), and vomiting (16.2%).
Maltese: 1%), dijarea (18.9%), tnaqqis fl-aptit (18.4%), stitikezza (18.4%), reazzjonijiet relatati mal infużjoni (17.1 %), tnaqqis fil-piż (16.6%), u rimettar (16.2%).
English: • Recurrent Grade 3 immune-related adverse reaction
Maltese: • Reazzjoni avversa relatata malimmunità rikorrenti ta' Grad 3
English: Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).
Maltese: Bavencio flimkien ma' axitinib huwa indikat għat-trattament tal-ewwel għazla ta' pazjenti adulti b'karċinoma taċ-ċelluli renali (RCC - renal cell carcinoma) avvanzata (ara sezzjoni 5.1).
English: Pneumonitis*
Maltese: Pulmonite*
English: Immune-related endocrinopathies
Maltese: Endokrinopatiji relatati mal-immunità
English: Progression-free survival (PFS)
Maltese: Sopravivenza Mingħajr Progressjoni (PFS - progression-free survival)
English: Tumour response assessments were performed every 6 weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Maltese: Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST - Response Evaluation Criteria in Solid Tumours) v1.1.
English: The observed hazard ratio (HR) for OS was 0.80 (95% CI: 0.616, 1.027) for avelumab in combination with axitinib compared to sunitinib.
Maltese: Il-proporzjon ta' periklu (HR - hazard ratio) osservat għal OS kien ta' 0.80 (CI ta' 95%: 0.616, 1.027) għal avelumab flimkien ma' axitinib meta mqabbel ma' sunitinib.
English: Table 2: Adverse reactions in patients treated with avelumab as monotherapy in clinical study EMR100070-003 and adverse reactions from a phase I study (EMR100070-001) in solid tumours
Maltese: Tabella 2: Reazzjonijiet avversi f'pazjenti ttrattati b'avelumab bħala monoterapija fi studju kliniku EMR100070-003 u reazzjonijiet avversi minn studju ta' fażi I (EMR100070-001) dwar tumuri solidi
English: • Avelumab 10 mg/kg intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily orally (N=442).
Maltese: • Infużjoni ġol-vini ta' avelumab 10 mg/kg kull ġimagħtejn flimkien ma' axitinib 5 mg darbtejn kuljum mill-ħalq (N=442).
English: Diabetes mellitus*, Type 1 diabetes mellitus*
Maltese: Dijabete mellitus*, dijabete mellitus ta' Tip 1*