FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 2 with serum creatinine > 1.5-3 x (ULN or baseline)
Maltese: Grad 2 bi kreatinina fisseru >1.5-3 x (ULN jew linja bażi)
English: Manufacturer AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sweden
Maltese: Il-Manifattur AstraZeneca AB Gärtunavägen SE-151 85 Södertälje L-Iżvezja
English: IMFINZI 50 mg/ml sterile concentrate durvalumab
Maltese: IMFINZI 50 mg/ml konċentrat sterili durvalumab
English: • IMFINZI is single-dose.
Maltese: • IMFINZI huwa doża waħda.
English: The following immune-related adverse reactions were reported in less than 1% of patients treated with IMFINZI monotherapy in clinical trials (n = 1889): Myasthenia gravis, myocarditis, myositis, polymyositis.
Maltese: Ir-reazzjonijiet avversi medjati mis-sistema immuni li ġejjin ġew irrappurtati f'inqas minn 1 % tal-pazjenti kkurati b'monoterapija b'IMFINZI fil-provi kliniċi (n = 1889): Mijastenija gravi, mijokardite, mijożite, polimijożite.
English: Baseline demographics of the overall study population were as follows: male (70%), age ≥ 65 years (45%), age ≥ 75 years (8%), White (69%), Asian (27%), other (4%), current smoker (16%), past-smoker (75%), never smoker (9%), ECOG Performance Status 0 (49%), ECOG Performance Status 1 (51%).
Maltese: Id-demografiċi tal-linja bażi tal-popolazzjoni globali tal-istudju kienu kif ġej: irġiel (70%), età ≤65 sena (45%), età ≤75 sena (8%), Bojod (69%), Asjatiċi (27%), oħra (4%), ipejjep bħalissa (16%), kien ipejjep fil-passat (75%), qatt ma pejjep (9%), Status tal-Prestazzjoni ECOG0 0 (49%), Status talPrestazzjoni ECOG 1 (51%).
English: Patient-reported symptoms, function and health-related quality of life (HRQoL) were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Maltese: Inġabru sintomi, funzjoni u kwalità tal-ħajja relatata mas-saħħa (HRQoL, healthrelated quality of life) irrappurtati mill-pazjenti, permezz ta' EORTC QLQC30 u l-modulu tiegħu tal-kanċer tal-pulmun (EORTC QLQLC13).
English: Permanently discontinue a
Maltese: Waqqaf b'mod permanenti
English: The efficacy of IMFINZI was evaluated in the PACIFIC Study, a randomised, double-blind, placebo-controlled, multicentre study in 713 patients with locally advanced, unresectable NSCLC.
Maltese: L-effikaċja ta' IMFINZI ġiet evalwata fl-Istudju PACIFIC, studju randomizzat, double blind, ikkontrollat bil-plaċebo, multiċentriku f'713-il pazjent b'NSCLC lokalment avvanzat li ma jistax jitneħħa.
English: Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated
Maltese: Ibda 1 sa 2 mg/kg/jum prednisone jew ekwivalenti segwit bi tnaqqis gradwali u sostituzzjoni tal-ormon kif indikat klinikament
English: • inflammation of the lungs (pneumonitis)
Maltese: • infjammazzjoni tal-pulmuni (pulmonite)
English: • muscle pain (myalgia)
Maltese: • ugigħ fil-muskoli (mijalġija)
English: c fatal pneumonitis and fatal pneumonia were reported at similar rate between the IMFINZI-treated group and placebo group in the PACIFIC Study; fatal hepatitis and fatal polymyositis were reported in other clinical trials.
Maltese: c pulmonite fatali u pnewmonja fatali ġew irrapportati b'rata simili bejn il-grupp ikkurat b'IMFINZI u l-grupp tal-plaċebo fl-Istudju PACIFIC; epatite fatali u polimijosite fatali ġew irrapportati fi provi kliniċi oħrajn.
English: The solution has a pH of approximately 6.0 and an osmolality of approximately 400 mOsm/kg.
Maltese: Is-soluzzjoni għandha pH ta' madwar 6.0 u ożmolalità ta' madwar 400 mOsm/kg.
English: The study demonstrated a statistically significant improvement in PFS in the IMFINZI-treated group compared with the placebo group [hazard ratio (HR) = 0.52 (95% CI: 0.42, 0.65), p < 0.0001].
Maltese: L-istudju wera titjib statistikament sinifikanti fil-PFS meta mqabbel mal-grupp tal-plaċebo [proporzjon ta' periklu (HR, hazard ratio) = 0.52 (95% CI: 0.42, 0.65), p < 0.0001].
English: The corresponding frequency category for each ADR is defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Maltese: Ilkategorija ta' frekwenza korrispondenti għal kull ADR hija definita kif ġej: komuni ħafna (≤1/10); komuni (≤1/100 sa <1/10); mhux komuni (≤1/1,000 sa <1/100); rari (≤1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
Maltese: Eċċipjenti: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polisorbat 80, ilma għall-injezzjonijiet.
English: Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system.
Maltese: L-espressjoni tal-proteina “programmed cell death ligand1” (PDL1) hija rispons immuni adattiv li jgħin lit-tumuri jevitaw identifikazzjoni u eliminazzjoni mis-sistema immuni.
English: • abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased)
Maltese: • testijet anormali tal-fwied (żieda fl-aspartataminotransferażi, żieda fl-aspartataminotransferażi)
English: In the combined safety database with IMFINZI monotherapy, (n = 1889 multiple tumour types), immune-mediated pneumonitis occurred in 79 (4.2%) patients, including Grade 3 in 12 (0.6%) patients, Grade 4 in 1 (< 0.1%) patient, and Grade 5 in 5 (0.3%) patients.
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata ma' monoterapija ta' IMFINZI, (n = 1889 tipi ta' tumuri multipli), pulmonite medjata mis-sistema immuni seħħet f'79 (4.2%) pazjent, inkluż Grad 3 fi 12-il pazjent (0.6%), Grad 4 f'pazjent 1 (< 0.1%), u Grad 5 f'5 (0.3%) pazjenti.
English: Grade 2 or 3 Withhold dose
Maltese: Grad 2 jew 3 Issospendi d-doża
English: Kaplan-Meier curve of PFS for PD-L1 TC ≥ 1%
Maltese: Il-kurva Kaplan-Meier ta' PFS għal PD-L1 TC ≥ 1%
English: includes lung infection, pneumocystis jirovecii pneumonia, pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia haemophilus, pneumonia klebsiella, pneumonia necrotising, pneumonia pneumococcal and pneumonia streptococcal.
Maltese: tinkludi infezzjoni fil-pulmun, pulmonite kkawżata minn pneumocystis jirovecii, pulmonite, pulmonite adenovirali, pulmonite batterika, pulmonite ċitomegalovirali, pulmonite haemophilus, pulmonite klebsiella, pulmonite nekrotizzanti, pulmonite pnewmokokkali u pulmonite streptokokkali.
English: Overall the safety profile of durvalumab in PD-L1 TC ≥ 1% subgroup was consistent with the intent to treat population, as was the PD-L1 TC < 1% subgroup.
Maltese: B'mod ġenerali, il-profil tas-sigurtà ta' durvalumab f'subgrupp PD-L1 TC ≥ 1% kien konsistenti malpopolazzjoni b'intenzjoni li tiġi kkurata, kif kien is-subgrupp PD-L1 TC < 1%.
English: Data from NSCLC patients 75 years of age or older are limited.
Maltese: Dejta minn pazjenti b'NSCLC ta' 75 sena jew aktar hija limitata.
English: Placebo Hazard ratio (95% CI):
Maltese: Plaċebo Proporzjon ta' periklu (95% CI):
English: Median PFS (95% CI)
Maltese: PFS medjana (95% CI)
English: PFS2 is defined as the time from the date of randomisation until the date of second progression (defined by local standard clinical practice) or death.
Maltese: PFS hija definita bħala ż-żmien mid-data tar-randomizzazzjoni sad-data ta' tieni progressjoni (definita bi prattika klinika standard lokali) jew mewt.
English: Where available, archival tumour tissue specimens taken prior to chemoradiation therapy were retrospectively tested for PD-L1 expression on tumour cells (TC) using the VENTANA PD-L1 (SP263) IHC assay.
Maltese: Fejn disponibbli, kampjuni ta' tessut tat-tumur arkivjali meħudin qabel it-terapija b'kemoradjazzjoni ġew ittestjati retrospettivament għal espressjoni PD-L1 fuq ċelloli tat-tumur (TC) permezz tal-assaġġ IHC VENTANA PD-L1 (SP263).
English: Data on patients aged 75 years of age or older are limited.
Maltese: Dejta dwar pazjenti li għandhom 75 sena jew aktar hija limitata.
English: Forest plot of PFS by PD-L1 expression
Maltese: Forest plot ta' PFS skont l-espressjoni PD-L1
English: Mild (creatinine clearance (CrCL) 60 to 89 mL/min) and moderate renal impairment (creatinine clearance (CrCL) 30 to 59 mL/min) had no clinically significant effect on the PK of durvalumab.The effect of severe renal impairment (CrCL 15 to 29 mL/min) on the PK of durvalumab is unknown.
Maltese: Indeboliment tal-kliewi ħafif (tneħħija tal-kreatinina (CrCL) 60 sa 89 ml/min) u moderat (tneħħija talkreatinina (CrCL) 30 sa 59 ml/min) ma kellu l-ebda effett klinikament sinifikanti fuq il-PK ta' durvalumab.
English: The presence of ADAs did not have a clinically relevant effect on safety.
Maltese: Il-preżenza ta' ADAs ma kellhiex effett klinikament rilevanti fuq is-sigurtà.
English: Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1).
Maltese: G1 kappa (IgG1κ) sħiħ tal-bniedem li selettivament jimblokka l-interazzjoni ta' PDL1 ma' PD1 u CD80 (B7.1).
English: 60 minutes, every 2 weeks.
Maltese: 60 minuta, kull ġimagħtejn.
English: Diabetes insipidus
Maltese: Dijabete insipidus
English: What IMFINZI contains The active substance is durvalumab.
Maltese: X'fih IMFINZI Is-sustanza attiva hi durvalumab.
English: Grade 2 with ALT or AST > 3-5 x ULN and/or total bilirubin > 1.5-3 x ULN
Maltese: Grade 2 b'ALT jew AST >35 x ULN u/jew bilirubina totali >1.53 x ULN
English: 2.4 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a gray flip-off aluminium seal containing 120 mg durvalumab.
Maltese: 2.4 ml ta' konċentrat f'kunjett tal-ħġieġ tat-Tip 1 b'tapp elastomeriku u siġill tal-aluminju griż tat-tip flip off li fih 120 mg durvalumab.
English: p includes autoimmune nephritis, tubulointerstitial nephritis, nephritis, glomerulonephritis and glomerulonephritis membranous.
Maltese: p tinkludi nefrite awtoimmuni, nefrite tubulointerstizjali, nefrite, glomerulonefrite u glomerulonefrite membranuża.
English: n includes rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, erythema, eczema and rash.
Maltese: n tinkludi raxx eritematuż, raxx ġeneralizzat, raxx makulari, raxx makulopapulari, raxx papulari, raxx pruritiku, praxx pustulari, eritema, ekżema u raxx.
English: Fertility There are no data on the potential effects of durvalumab on fertility in humans or animals.
Maltese: Fertilità M'hemmx dejta dwar l-effetti potenzjali ta' durvalumab fuq il-fertilità fil-bnedmin jew fl-annimali.
English: Median OS (95% CI)
Maltese: OS medjana (95% CI)
English: Administer the infusion solution intravenously over 60 minutes using a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Maltese: Agħti s-soluzzjoni tal-infużjoni ġolvini fuq 60 minuta permezz ta' filtru f'linja sterili ta' rbit baxx mal-proteini ta' 0.2 jew 0.22 micron.
English: AstraZeneca AB SE-151 85 Södertälje Sweden
Maltese: AstraZeneca AB SE151 85 Södertälje L-Iżvezja
English: • Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous (IV) bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or glucose 50 mg/mL (5%) solution for injection.
Maltese: • Iġbed il-volum meħtieġ mill-kunjett(i) ta' IMFINZI u poġġih f'borża intravenuża (IV) li fiha klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni, jew glukożju 50 mg/ml (5%) soluzzjoni għall-injezzjoni.
English: Of the 1570 patients who were treated with IMFINZI 10 mg/kg every 2 weeks and evaluable for the presence of anti-drug antibodies (ADAs), 2.9% (45/1570) of patients tested positive for treatment-emergent ADAs.
Maltese: Mill-1570 pazjent li ġew ikkurati b'IMFINZI 10 mg/kg kull ġimagħtejn u evalwabbli għall-preżenza ta' antikorpi kontra d-droga (ADAs), 2.9 % (45/1570) tal-pazjenti ttestjaw pożittivi għal ADAs emerġenti mill-kura.
English: Forest plot of OS by PD-L1 expression
Maltese: Forest plot ta' OS skont l-espressjoni PD-L1
English: b (months)
Maltese: b (xhur)
English: Compliance was similar between the IMFINZI and placebo treatment groups (83% vs 85.1% overall of evaluable forms completed).
Maltese: Il-konformità kienet simili bejn il-grupp ta' kura ta' IMFINZI u plaċebo (83% kontra 85.
English: Other medicines and IMFINZI
Maltese: Mediċini oħra u IMFINZI
English: IMFINZI was discontinued in 26 patients.
Maltese: IMFINZI twaqqaf f'26 pazjent.
English: Secondary efficacy endpoints included PFS at 12 months (PFS 12) and 18 months (PFS 18) from randomisation and Time from Randomisation to Second Progression (PFS2).
Maltese: L-end-points tal-effikaċja sekondarji kienu jinkludu PFS wara 12-il xahar (PFS 12) u 18-il xahar (PFS 18) mir-randomizzazzjoni, u Ħin mirRandomizzazzjoni għal Tieni Progressjoni (PFS2).
English: In the PACIFIC Study, in patients who had completed treatment with at least 2 cycles of concurrent chemoradiation within 1 to 42 days prior to initiation of the trial, pneumonitis or radiation pneumonitis occurred in 161 (33.9%) patients in the IMFINZI-treated group and 58 (24.8%) in the placebo group, including Grade 3 (3.4% vs 3.0%) and Grade 5 (1.1% vs 1.7%) (see section 4.8).
Maltese: FlIstudju PACIFIC, f'pazjenti li temmew il-kura b'mill-inqas 2 ċikli ta' kimoradjazzjoni konkurrenti fi żmien 1 sa 42 jum qabel il-bidu tal-prova, pulmonite jew pulmonite minn radjazzjoni seħħet f'161 (33.9%) pazjent fil-grupp ikkurat b'IMFINZI u fi 58 (24.8%) fil-grupp tal-plaċebo, inkluż Grad 3 (3.4% kontra 3.0%) u Grad 5 (1.1% kontra 1.7%) (ara sezzjoni 4.8).
English: Name and address of the manufacturers responsible for batch release AstraZeneca AB
Maltese: Isem u indirizz tal-manifatturi responsabbli għall-ħruġ tal-lott AstraZeneca AB
English: • Administer the infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Maltese: • Agħti s-soluzzjoni tal-infużjoni ġol-vini fuq 60 minuta permezz ta' linja ġol-vini li fiha filtru f'linja sterili ta' rbit baxx mal-proteini ta' 0.2 jew 0.22 micron.
English: Patients with the following were excluded from the PACIFIC Study: a baseline ECOG performance score ≥ 2; active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent); active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI.
Maltese: Il-pazjenti b'dawn li ġejjin ġew esklużi mill-Istudju PACIFIC: punteġġ tal-prestazzjoni ECOG fil-linja bażi ≤2; marda awtoimmuni ddokumentata attiva jew preċedenti fi żmien sentejn mill-bidu tal-istudju; storja ta' immunodefiċjenza; storja ta' reazzjonijiet avversi severi medjati mis-sistema immuni; kondizzjonijiet mediċi li jeħtieġu immunosoppressjoni sistemika, ħlief doża fiżjoloġika ta' kortikosterojdi sistemiċi (10 mg/jum prednisone jew ekwivalenti); tuberkulożi attiva jew epatite B jew C jew infezzjoni tal-HIV jew pazjenti li jirċievu vaċċin ħaj attenwat fi żmien 30 jum qabel jew wara lbidu ta' IMFINZI.
English: Common Musculoskeletal and connective tissue disorders Myalgia
Maltese: Komuni Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Mijalġija
English: Kaplan-Meier curve of PFS
Maltese: 2 Kurva ta' KaplanMeier tal-PFS
English: Mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin > 1.0 to 1.5 × ULN and any AST) had no clinically significant effect on the PK of durvalumab.
Maltese: Indeboliment tal-fwied ħafif (bilirubina ≥ULN u AST >ULN jew bilirubina >1.0 sa 1.5 × ULN u kwalunkwe AST) ma kellu l-ebda effett klinikament sinifikanti fuq il-PK ta' durvalumab.
English: Patients excluded from clinical trials
Maltese: Pazjenti esklużi mill-provi kliniċi
English: Resolution occurred in 2 patients.
Maltese: IMFINZI twaqqaf f'2 pazjenti.
English: Hepatobiliary disorders Aspartate aminotransferase increased or Alanine aminotransferase increased
Maltese: Disturbi fil-fwied u fil-marrara Żieda fl-aspartataminotransferażi jew żieda fl-alanina aminotransferażi
English: The data for the following immune-mediated adverse reactions reflect the combined safety database of 1889 patients which includes the PACIFIC Study and two additional studies (a multi-cohort, open-label clinical trial in patients with advanced solid tumours, and an open-label study in patients with locally advanced or metastatic NSCLC).
Maltese: Id-dejta għarreazzjonijiet avversi medjati mis-sistema immuni li ġejjin tirrifletti d-dejtabejż dwar is-sigurtà kombinata ta' 1889 pazjent li tinkludi l-Istudju PACIFIC u żewġ studji addizzjonali (prova klinika ta' bosta koorti open label f'pazjenti b'tumuri solidi avvanzati, u studju open label f'pazjenti b'NSCLC lokalment avvanzat jew metastatiku).
English: Patients were randomised 2:1 to receive 10 mg/kg IMFINZI (n = 476) or 10 mg/kg placebo (n = 237) via intravenous infusion every 2 weeks for up to 12 months or until unacceptable toxicity or confirmed disease progression.
Maltese: Il-pazjenti ġew randomizzati 2:1 biex jirċievu 10 mg/kg IMFINZI (n = 476) jew 10 mg/kg plaċebo (n = 237) permezz ta' infużjoni ġol-vini kull ġimagħtejn sa 12-il xahar jew sakemm isseħħ tossiċità mhux aċċettabbli jew tiġi kkonfermata progressjoni tal-marda.
English: The median time to onset was 95 days (range: 28-239 days).
Maltese: Iż-żmien medjan għall-bidu kien ta' 95 jum (medda: 28239 jum).
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: The use of systemic corticosteroids or immunosuppressants before starting durvalumab, except physiological dose of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent), is not recommended because of their potential interference with the pharmacodynamic activity and efficacy of durvalumab.
Maltese: L-użu ta' kortikosterojdi sistemiċi jew immunosoppressanti qabel il-bidu ta' durvalumab, għajr doża fiżjoloġika ta' kortikosterojdi sistemiċi (≤10 mg/jum prednisone jew ekwivalenti), mhuwiex irrakkomandat minħabba l-interferenza potenzjali tagħhom mal-attività farmakodinamika u l-effikaċja ta' durvalumab.
English: In the PACIFIC Study, (n = 475 in the IMFINZI arm, and n = 234 in the placebo arm) immune-mediated pneumonitis occurred in 51 (10.7%) patients in the IMFINZI-treated group and 16 (6.8%) patients in the placebo group, including Grade 3 in 8 (1.7%) patients on IMFINZI vs. 6 (2.6%) patients on placebo and Grade 5 (fatal) in 4 (0.8%) patients on IMFINZI vs. 3 (1.3%) patients on placebo.
Maltese: 7%) pazjent fil-grupp ikkurat b'IMFINZI u 16 (6.8%)il pazjent fil-grupp tal-plaċebo, inkluż Grad 3 fi 8 (1.7%) pazjenti fuq IMFINZI kontra 6 (2.6%) pazjenti fuq il-plaċebo u Grad 5 (fatali) f'4 (0.8%) pazjenti fuq IMFINZI kontra 3 (1.3%) pazjenti fuq il-plaċebo.
English: When you are given IMFINZI, you can have some serious side effects.
Maltese: Meta tingħata IMFINZI, jista' jkollok xi effetti sekondarji serji.
English: Common includes laryngitis, nasopharyngitis, peritonsillar abscess, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheobronchitis and upper respiratory tract infection.
Maltese: Komuni tinkludi larinġite, nażofarinġite, axxess peritonsillari, farinġite, rinite, sinusite, tonsillite, traċeobronkite u infezzjoni fil-parti ta' fuq tal-apparat respiratorju.
English: • inflammation of the muscle
Maltese: • infjammazzjoni tal-muskolu
English: Immune-mediated adrenal insufficiency or hypophysitis/hypopituitarism
Maltese: Insuffiċjenza adrenali immunomedjata jew ipofisite/ipopitwitariżmu
English: The terminal half-life (t1/2), based on baseline CL, was approximately 18 days.
Maltese: In-nofs ħajja terminali (t1/2), ibbażata fuq CL fil-linja bażi, kienet madwar 18-il jum.
English: The study excluded patients who had progressed following chemoradiation therapy, patients with prior exposure to any anti-PD-1 or anti-PD-L1 antibody, patients with active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids; active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI.
Maltese: L-istudju eskluda pazjenti li pproggressaw wara terapija b'kimoradjazzjoni, pazjenti b'esponiment preċedenti għal xi antikorp kontra PD-1 jew PD-L1, pazjenti b'marda awtoimmuni attiva jew iddokumentata preċedentement fi żmien sentejn mill-bidu tal-istudju; storja ta' immunodefiċjenza; storja ta' reazzjonijiet avversi medjati mis-sistema immuni severi; kondizzjonijiet mediċi li kienu jeħtieġu immunosoppressjoni sistemika, ħlief doża fiżjoloġika ta' kortikosterojdi sistemiċi; tuberkulożi attiva jew infezzjoni tal-epatite B jew C jew HIV jew pazjenti li jirċievu vaċċin ħaj attenwat fi żmien 30 jum qabel jew wara l-bidu ta' IMFINZI.
English: Rare (may affect up to 1 in 1000 people)
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1000)
English: In this patient population, the most frequent adverse reactions were cough (40.2% vs 30.3% in placebo), upper respiratory tract infections (26.1% vs 11.5% in placebo) and rash (21.7% vs 12.0% in placebo).
Maltese: F'din il-popolazzjoni ta' pazjenti, l-aktar reazzjonijiet avversi frekwenti kienu sogħla (40.2% vs 30.3% fi plaċebo), infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju (26.
English: PFS and OS results are summarised in Figures 3, 4, 5 and 6.
Maltese: Ir-riżultati PFS u OS huma mogħtija fil-qosor fil-Figuri 3, 4, 5 u 6.
English: Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation.
Maltese: Imblukkar selettiv tal-interazzjonijiet ta' PDL1/PD1 u PDL1/CD80 itejjeb ir-rispons immuni kontra t-tumur u jżid l-attivazzjoni taċ-ċelloli-T.
English: For symptomatic adrenal insufficiency, patients should be managed as recommended in section 4.2.
Maltese: Għal insuffiċjenza adrenali sintomatika, il-pazjenti għandhom jiġu mmaniġġjati kif irrakkomandat f'sezzjoni 4.2.
English: IMFINZI should be discontinued for Grade 4 adverse reactions (with the exception of Grade 4 laboratory abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms and clinical judgment).
Maltese: IMFINZI għandu jitwaqqaf għal reazzjonijiet avversi ta' Grad 4 (bl-eċċezzjoni ta' abnormalitajiet tal-laboratorju, li għalihom, iddeċiżjoni ta' waqfien għandha tkun ibbażata fuq sinjali/sintomi kliniċi li jiġu magħhom u ġudizzju kliniku).
English: • inflammation of the gut or intestine (colitis)
Maltese: • infjammazzjoni tal-musrana jew tal-intestini (kolite)
English: Grade 1 or 2 Interrupt or slow the rate of infusion
Maltese: Grad 1 jew 2 Interrompi jew dewwem ir-rata tal-infużjoni
English: IMFINZI is most commonly associated with immune-mediated adverse reactions.
Maltese: IMFINZI jiġi assoċjat bl-aktar mod komuni ma' reazzjonijiet avversi medjati mis-sistema immuni.
English: Grade 3 with serum creatinine > 3 x baseline or > 3-6 x ULN; Grade 4 with serum creatinine > 6 x ULN
Maltese: Grad 3 bi kreatinina fisseru > 3 x linja bażi jew > 3-6 x ULN ;
English: Of the 713 patients randomised, 63% of patients provided a tissue sample of sufficient quality and quantity to determine PD-L1 expression and 37% were unknown.
Maltese: tessut ta' kwalità u ta' kwantità suffiċjenti biex tiġi ddeterminata l-espressjoni PD-L1 u 37% ma kinux magħrufa.