FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used for tumours that are severe in character (grade 2 or 3), have come back, and cannot be removed with surgery.
Maltese: Jintuża għal tumuri severi (grad 2 jew 3), li ġew lura u ma jistgħux jitneħħew b'operazzjoni kirurġika.
English: Palladia is used to treat dogs with mast-cell tumours (a type of skin cancer).
Maltese: Palladia jintuża sabiex jittratta klieb b'tumuri tat-tip mast-cell (tip ta' kanċer tal-ġilda).
English: Other information about Palladia:
Maltese: Aktar tagħrif dwar Palladia:
English: What is the risk associated with Palladia?
Maltese: X'inhu r-riskju assoċjat ma' Palladia?
English: The main study was carried out in two phases in 151 dogs with mast cell tumours.
Maltese: L-istudju prinċipali sar f'żewġ fażijiet fuq 151 kelb bit-tumuri tat-tip mast-cell.
English: This summary was last updated in 06.2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 06.2013.
English: In case of side effects, the veterinarian might decide to lower the dose of Palladia or to stop treatment, either temporarily or permanently.
Maltese: F'każ ta' effetti sekondarji, il-veterinarju jista' jiddeċiedi li jbaxxi d-doża ta' Palladia jew li jnaqqas it-trattament, jew temporanjament jew b'mod permanenti.
English: How has Palladia been studied?
Maltese: Kif ġie studjat Palladia?
English: The main measures of effectiveness were the ‘objective response' (an evaluation by the veterinarian of the way the tumour changed during treatment) and the time taken until the tumour started to get worse.
Maltese: Il-miżuri prinċipali ta' effikaċja kienu r-‘rispons oġġettiv' (evalwazzjoni minn veterinarju dwar il-mod it-tumur inbidel matul it-trattament) u ż-żmien sakemm it-tumur beda jaqleb għall-agħar.
English: If Palladia is taken accidentally, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Maltese: Jekk Palladia jiġi meħud aċċidentalment itlob parir mediku immedjatament u uri l-Fuljett ta' Tagħrif jew it-tikketta lit-tabib.
English: A number of studies with Palladia were carried out either in laboratory dogs or in animal patients in veterinary practices or hospitals.
Maltese: Numru ta' studji b'Palladia saru jew fuq klieb tal-laboratorju jew fuq annimali pazjenti fi prattiċi jew sptarijiet veterinarji.
English: Nanostring RNA gene signature)
Maltese: (eż. Nanostring RNA gene signature)
English: Frederick, Maryland (MD) 21703 United States (USA)
Maltese: Frederick, Maryland (MD) 21703
English: AstraZeneca Pharmaceuticals LP, Frederick Manufacturing Center (FMC) 633 Research Court
Maltese: LP, Frederick Manufacturing Center (FMC) 633 Research Court
English: Manufacturer Schering-Plough Labo NV Industriepark 30
Maltese: Schering-Plough Labo NV Industriepark 30
English: Treatment modification
Maltese: Modifika fit-trattament
English: ATC code: L01XC18
Maltese: L01XC18
English: 28.0 (14, not available)
Maltese: 28.0 (14, mhux disponibbli)
English: Favourable
Maltese: Favorevoli
English: Schering-Plough Labo NV Industriepark 30, Heist-op-den-Berg B-2220, Belgium
Maltese: Schering-Plough Labo NV Industriepark 30, Heist-op-den-Berg B-2220, Il-Belġju
English: Placebo n=505
Maltese: Plaċebo n=505
English: Table 15
Maltese: Tabella 15:
English: Immune-related adverse reactions (see section 4.4)
Maltese: Reazzjonijiet avversi marbuta mal-immunità (ara sezzjoni 4.4)
English: * Cetuximab, platinum, and 5-FU
Maltese: * Cetuximab, platinum, u 5-FU
English: 18.9 (11, not available)
Maltese: 18.9 (11, mhux disponibbli)
English: The potential risk of gastrointestinal perforation should be taken into consideration.
Maltese: Għandu jitqies r-riskju possibbli ta' perforazzjoni gastrointestinali.
English: *p-Value is nominal.
Maltese: *Il-Valur p huwa nominali.
English: Grade 2 with creatinine > 1.5 to ≤ 3 times upper limit of normal (ULN)
Maltese: Grad 2 bi kreatinina > 1.5 sa ≤ 3 darbiet iktar mil-limitu ta' fuq tan normal (ULN - upper limit of normal)
English: Uncommon epilepsy epilepsy myasthenic syndrome
Maltese: Mhux komuni epilessija epilessija sindrome mijastenikuh
English: Table 18: Efficacy results in KEYNOTE-087 and KEYNOTE-013
Maltese: Tabella 18: Riżultati tal-effikaċja f'KEYNOTE-087 u KEYNOTE-013
English: Endocrinopathies
Maltese: Endokrinopatiji
English: Methotrexate, docetaxel, or cetuximab
Maltese: * Methotrexate, docetaxel, jew cetuximab †
English: Placebo Carboplatin Paclitaxel/Nab-paclitaxel n=281
Maltese: Plaċebo Carboplatin Paclitaxel/Nab-paclitaxel n=281
English: Patient-reported outcomes (PROs) were assessed using EORTC QLQ-C30.
Maltese: Riżultati rrappurtati mill-pazjenti (PROs - Patient-reported outcomes) ġew evalwati bl-użu ta' EORTC QLQ-C30.
English: The most common tumour types by histology were Hodgkin lymphoma (11.7%), glioblastoma multiforme (9.1%), neuroblastoma (6.5%), osteosarcoma (6.5%) and melanoma (5.2%).
Maltese: L-aktar tipi ta' tumuri komuni skont l-istoloġija kienu limfoma ta' Hodgkin (11.7%), glioblastoma multiforme (9.1%), newroblastoma (6.5%), osteosarkoma (6.5%) u melanoma (5.2%).
English: BRAF mutation positive
Maltese: negattiv għall-mutazzjoni BRAF
English: Infections and infestations Common pneumonia pneumonia pneumonia
Maltese: Infezzjonijiet u infestazzjonijiet Komuni pulmonite pulmonite pulmonite
English: Assessed by blinded independent central review (BICR) using RECIST 1.1
Maltese: Stmat permezz ta' reviżjoni indipendenti ċentrali blinded (BICR - blinded independent central review) bl-użu ta' RECIST 1.1 §
English: Docetaxel 75 mg/m2 every 3 weeks
Maltese: Docetaxel 75 mg/m2 kull
English: * BICR using RECIST 1.1
Maltese: * BICR bl-użu ta' RECIST 1.1
English: Table 22: ORR and OS by PD-L1 Expression
Maltese: Tabella 22: ORR u OS skont l-Espressoni ta' PD-L1 Punt finali
English: KEYNOTE-013
Maltese: KEYNOTE-013b
English: Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN
Maltese: Grad 2 b'aspartate aminotransferase (AST) jew alanine aminotransferase (ALT) > 3 sa 5 darbiet ogħla millULN jew bilirubin totali > 1.5 sa 3 darbiet ogħla mill-ULN
English: cardiac arrhythmia (including atrial fibrillation)
Maltese: (inkluża fibrillazzjoni tal-atriju)
English: Grades 3 or 4 myocarditis Grades 3 or 4 encephalitis Grades 3 or 4 Guillain-Barré syndrome
Maltese: Mijokardite ta' Gradi 3 jew 4 Enċefalite ta' Gradi 3 jew 4 Sindrom ta' Guillain-Barré ta' Gradi 3 jew 4
English: Number (%
Maltese: Numru (%) ta' pazjenti
English: Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4).
Maltese: Nota: il-gradi ta' tossiċità huma skont il-Kriterji tal-Istitut Nazzjonali tal-Kanċer għal Terminoloġija Komuni għall-Avvenimenti Avversi Verżjoni 4.0 (NCI-CTCAE v.4).
English: Psychiatric disorders Common insomnia insomnia insomnia
Maltese: Disturbi psikjatriċi Komuni insomnja insomnja insomnja
English: Chemotherapy n=151
Maltese: Kimoterapija n=151
English: Standard Treatment* n=110
Maltese: Standard* n=110
English: Withhold until adverse reactions recover to Grades 0-1*
Maltese: Tagħtihx sakemm irreazzjonijiet avversi jirkupraw għal Gradi 0-1 *
English: KEYNOTE-087
Maltese: KEYNOTE-087a
English: NA = not available
Maltese: NA = mhux disponibbli (not available)
English: Participants were enrolled across 28 tumour types by primary diagnosis.
Maltese: Ilparteċipanti ġew irreġistrati minn 28 tip ta' tumur skont id-dijanjosi primarja.
English: Uncommon uveitis uveitis
Maltese: Mhux komuni uveitej uveitej
English: Grades 3 or 4
Maltese: Gradi 3 jew 4
English: The geometric mean value (CV%) for the terminal half-life is 22 days (32%) at steady-state.
Maltese: Il-valur ġeometriku medju (CV%) għal half-life terminali huwa 22 jum (32%) fl-istat fiss.
English: Nephritis
Maltese: nefritez
English: KEYTRUDA contains the active substance pembrolizumab, which is a monoclonal antibody.
Maltese: KEYTRUDA fih is-sustanza attiva pembrolizumab, li huwa antikorp monoklonali.
English: • Aseptically add 2.3 mL of water for injections to yield a 25 mg/mL (pH 5.2-5.8) solution of KEYTRUDA.
Maltese: • B'mod asettiku żid 2.3 mL ta' ilma għall-injezzjonijiet biex tipproduċi soluzzjoni ta' 25 mg/mL (pH 5.2-5.8) ta' KEYTRUDA.
English: Pembrolizumab + Axitinib vs. Sunitinib
Maltese: Pembrolizumab + Axitinib vs.
English: Chemotherapy OS by PD-L1 Expression Number of Events (number of patients)*
Maltese: Kimoterapija OS skont l-Espressjoni ta' PD-L1 Numru ta' Avvenimenti (numru ta'
English: 5347 JN Oss The Netherlands
Maltese: N.V. Organon Veersemeer 4 5347 JN Oss L-Olanda
English: tenosynovitis
Maltese: tenosinovitey
English: Disease subtypes were 97% nodular sclerosis and 3% mixed cellularity.
Maltese: Is-sottotipi tal-marda kienu 97% sklerosi nodulari u 3% ċellularità mħallta.
English: Number at Risk Pembrolizumab + Axitinib:
Maltese: Numru f'Riskju Pembrolizumab + Axitinib:
English: Boehringer Ingelheim (BIB) Pharma GmbH & Co. KG Birkendorfer Straße 65 88397 Biberach an der Riss Germany
Maltese: KG Birkendorfer Straße 65 88397 Biberach an der Riss Il-Ġermanja
English: Classical Hodgkin lymphoma
Maltese: Limfoma klassika ta' Hodgkin
English: The same scoring system was used for metastatic melanoma (MEL score).
Maltese: L-istess sistema ta' punteġġ intużat għal melanoma metastatika (punteġġ MEL).
English: Endpoint n=370
Maltese: Skop finali n=370
English: At the time of this analysis, the hazard ratio in the overall population (95% CI) was 0.59 (0.45, 0.78) with 84/432 (19.4%) events in the combination arm and 122/429 (28.4%) events in the sunitinib arm.
Maltese: Fiż-żmien ta' din l-analiżi, il-proporzjon ta' periklu fil-popolazzjoni globali (CI ta' 95%) kien 0.59 (0.45, 0.78) b'84/432 (19.4%) avveniment fil-grupp ta' kombinazzjoni u 122/429 (28.4%) avveniment fl-grupp ta' sunitinib.
English: Grade ≥ 3 with creatinine > 3 times ULN
Maltese: Grad ≥ 3 bi kreatinina > 3 darbiet iktar mill-ULN
English: Table 28: Efficacy Results in KEYNOTE-426
Maltese: Tabella 28: Riżultati tal-Effikaċja f'KEYNOTE-426
English: Standard Treatment* n=133
Maltese: Standard* n=133
English: Complications of allogeneic HSCT in classical Hodgkin lymphoma
Maltese: Komplikazzjonijiet ta' HSCT alloġenejku f'limfoma klassika ta' Hodgkin
English: Pneumonitis led to discontinuation of pembrolizumab in 98 (1.7%) patients.
Maltese: Il-pulmonite wasslet għat-twaqqif ta' pembrolizumab f'98 (1.7%) pazjent.
English: In patients with NSCLC, pneumonitis occurred in 107 (4.9%), including Grade 2, 3, 4 or 5 cases in 39 (1.8%), 30 (1.4%), 10 (0.5%) and 9 (0.4%), respectively.
Maltese: F'pazjenti b'NSCLC, pulmonite seħħet f'107 (4.9%), inklużi każijiet ta' Grad 2, 3, 4 jew 5 f'39 (1.8%), 30 (1.4%), 10 (0.5%) u 9 (0.4%), rispettivament.
English: Uncommon neutropaenia, leukopaenia, eosinophilia lymphopaenia, eosinophilia
Maltese: Mhux komuni newtropenija, lewkopenija, eosinofilja limfopenija, eosinofilja
English: Chemotherapy (n=137)
Maltese: Kimoterapija (n=137)
English: BRAF mutation status in melanoma
Maltese: L-istat ta' mutazzjoni BRAF f'melanoma
English: Based on Kaplan-Meier estimation
Maltese: Abbażi tal-istima Kaplan-Meier
English: OS HR (95% CI)
Maltese: HR (95% CI)
English: The study population characteristics were: median age of 62 years (range: 26 to 90); 38% age 65 or older; 73% male; 79% White and 16% Asian; 80% had a Karnofsky Performance Score (KPS) 90-100 and 20% had KPS 70-80; patient distribution by IMDC risk categories was 31% favourable, 56% intermediate and 13% poor.
Maltese: Il-karatteristiċi tal-popolazzjoni tal-istudju kienu: età medjana ta' 62 sena (firxa: 26 sa 90); 38% b'età ta' 65 jew aktar; 73% irġiel; 79% Bojod u 16% Asjatiċi; 80% kellhom Punteġġ ta' Eżekuzzjoni ta' Karnofsky (KPS - Karnofsky Performance Score) ta' 90-100 u 20% kellhom KPS ta' 70-80; id-distribuzzjoni tal-pazjenti skont il-kategoriji ta' riskju IMDC kienet 31% favorevoli, 56% intermedja u 13% batuta.
English: Safety data of pembrolizumab in the adjuvant melanoma setting in patients ≥ 75 years are limited.
Maltese: Data dwar sigurtà ta' pembrolizumab fl-ambjent ta' trattament addizzjonali ta' melanoma f'pazjenti ≥ 75 sena hija limitata.
English: The 18-month OS rate was 81.0% (95% CI 76.7, 84.6) for pembrolizumab in combination with axitinib and 70.7% (95% CI 65.8, 75.1) for sunitinib.
Maltese: 0% (CI ta' 95% 76.7, 84.6) għal pembrolizumab flimkien ma' axitinib u 70.7% (CI ta' 95% 65.8, 75.1) għal sunitinib.
English: A prolonged time to deterioration in EORTC QLQ-C30 global health status/QoL was observed for patients treated with pembrolizumab compared to investigator's choice chemotherapy (HR 0.70; 95% CI 0.55-0.90).
Maltese: Ġie osservat żmien imdewwem għal deterjorament fl-istat ta' saħħa globali/QoL ta' EORTC QLQ-C30 għall-pazjenti ttrattati b'pembrolizumab meta mqabbel mal-kimoterapija magħżula mill-investigatur (HR 0.70; CI ta' 95% 0.55-0.90).
English: Incidences of Grades 3-5 adverse reactions were 76% for pembrolizumab combination therapy and 71% for sunitinib alone.
Maltese: Inċidenzi ta' reazzjonijiet avversi ta' Gradi 3-5 kienu 76% għal terapija ta' kombinazzjoni b'pembrolizumab u 71% għal sunitinib waħdu.
English: Table 1: Recommended treatment modifications for KEYTRUDA
Maltese: Tabella 1: Modifikazzjonijiet fit-trattament rakkomandati għall-KEYTRUDA
English: Standard Treatment* n=125
Maltese: Standard* n=125
English: Patients with ECOG performance status score ≥ 2 were excluded from the clinical trials of melanoma, NSCLC, cHL, and HNSCC (see sections 4.4 and 5.1).
Maltese: Pazjenti b'punteġġ tal-istat ta' eżekuzzjoni ta' ECOG ta' ≥ 2 ġew esklużi mill-provi kliniċi ta' melanoma, NSCLC, cHL, u HNSCC (ara sezzjonijiet 4.4 u 5.1).
English: Disease characteristics were: 21% HPV positive and 95% had Stage IV disease (Stage IVa 21%, Stage IVb 6%, and Stage IVc 69%).
Maltese: Il-karatteristiċi tal-marda kienu: 21% pożittivi għal HPV u 95% kellhom il-marda fi Stadju IV (Stadju IVa 21%, Stadju IVb 6%, u Stadju IVc 69%).
English: BRAF mutant with prior BRAF treatment
Maltese: Mutazzjoni fi BRAF bi trattament preċedenti għal BRAF
English: A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were PD-L1 positive (n=671; 80%) vs. PD-L1 negative (n=150; 18%).
Maltese: Bħala parti mill-analiżi finali saret analiżi ta' sottogrupp minn KEYNOTE-006 f'pazjenti li kienu pożittivi għal PD-L1 (n=671; 80%) vs. negattivi għal PD-L1 (n=150; 18%).
English: Rare immune thrombocytopenic purpura, haemolytic anaemia, pure red cell aplasia, haemophagocytic lymphohistiocytosis eosinophilia
Maltese: Rari purpura tromboċitopenika immuni, anemija emolitika, aplażja pura taċ-ċelluli ħomor, limfoistjoċitożi emofagoċitika eosinofilja
English: Placebo + Pemetrexed + Platinum Chemotherapy n=206
Maltese: Plaċebo + Kimoterapija b'Pemetrexed + Platinum n=206
English: Rare toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema nodosum hair colour changes, lichenoid keratosis, papule
Maltese: Rari nekrolisi tossika talepidermide, sindrome ta' Stevens-Johnson, eritema nodosum bidliet fil-kulur taxxagħar, keratożi likenuża,
English: Combination with axitinib
Maltese: axitinib
English: Disease subtypes were 80% nodular sclerosis, 11% mixed cellularity, 4% lymphocyte-rich and 2% lymphocyte-depleted.
Maltese: Is-sottotipi tal-marda kienu 80% sklerosi nodulari, 11% ċellularità mħallta, 4% mgħobbija bil-limfoċiti u 2% bi tnaqqis fil-kwantità ta' limfoċiti.
English: Hypothyroidism resolved in 153 (23.7%) patients, 10 with sequelae.
Maltese: L-ipotirojdiżmu għadda f'153 (23.7%) pazjenti, 10 minnhom b'konsegwenzi.
English: Not reached (0.0+, 45.6+)
Maltese: Ma ntlaħaqx (0.0+, 45.6+)e
English: Uncommon pancreatitis pancreatitis pancreatitis
Maltese: Mhux komuni pankreatiteo pankreatiteo pankreatiteo
English: Chemotherapy n=179
Maltese: Kimoterapija n=179
English: The initial analysis resulted in a HR for OS of 0.82 (95% CI: 0.67, 1.01) with a one-sided p-value of 0.0316.
Maltese: 82 (CI ta' 95%: 0.67, 1.01) b'valur p one-sided ta' 0.0316.
English: Based on stratified Log rank test
Maltese: Ibbażat fuq test Log rank stratifikat ‡
English: • Data on RNA and proteomic serum profiling
Maltese: • Tilwin b'IHC għal PD-L2 • Data dwar RNA u profil tas-serum proteomiku
English: Randomization was stratified by tumour PD-L1 expression (TPS ≥ 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1).
Maltese: L-għażla arbitrarja ġiet stratifikata mill-espressjoni ta' PD-L1 mit-tumur (TPS ≥ 50% jew < 50%), l-istat tal-HPV (pożittiv jew negattiv), u l-PS ta' ECOG (0 vs. 1).
English: Number at Risk Pembrolizumab 2 mg/kg: Pembrolizumab 10 mg/kg: Docetaxel:
Maltese: Numru f'Riskju Pembrolizumab 2 mg/kg: Pembrolizumab 10 mg/kg: Docetaxel:
English: Subgroup analyses by enrollment were performed in KEYNOTE-426 in patients with PD-L1 CPS ≥ 1 [pembrolizumab/axitinib combination: n=243 (56%) vs. sunitinib: n=254 (59%)]; CPS < 1 [pembrolizumab/axitinib combination: n=167 (39%) vs. sunitinib: n=158 (37%)], and in patients with IMDC risk categories of favourable [pembrolizumab/axitinib combination: n=138 (32%) vs. sunitinib: n=131 (31%)]; intermediate [pembrolizumab/axitinib combination: n=238 (55%) vs. sunitinib: n=246 (57%)]; and poor [pembrolizumab/axitinib combination: n=56 (13%) vs. sunitinib: n=52 (12%)].
Maltese: Saru analiżi ta' sottogrup b'reġistrazzjoni f'KEYNOTE-426 f'pazjenti b'PD-L1 CPS ≥ 1 [kombinazzjoni ta' pembrolizumab/axitinib: n=243 (56%) vs. sunitinib: n=254 (59%)]; CPS < 1 [kombinazzjoni ta' pembrolizumab/axitinib: n=167 (39%) vs. sunitinib: n=158 (37%)], u f'pazjenti b'kategoriji ta' riskju tal-IMDC ta' favorevoli [kombinazzjoni ta' pembrolizumab/axitinib: n=138 (32%) vs. sunitinib: n=131 (31%)]; intermedju [kombinazzjoni ta' pembrolizumab/axitinib: n=238 (55%) vs. sunitinib: n=246 (57%)]; u dgħajjef [kombinazzjoni ta' pembrolizumab/axitinib: n=56 (13%) vs. sunitinib: n=52 (12%)].
English: Date of first authorisation: 17 July 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 Lulju 2015
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); and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma ddefiniti bħala: 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); u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: For the IMDC risk category, the OS hazard ratio for the favourable risk group was 0.94 (95% CI 0.43, 2.07), for the intermediate risk group the OS hazard ratio was 0.52 (95% CI 0.36, 0.75), and for the poor risk group the OS hazard ratio was 0.50 (95% CI 0.29, 0.87).
Maltese: Għall-kategorija ta' riskju tal-IMDC, il-proporzjon ta' periklu ta' OS għall-grupp ta' riskju favorevoli kien 0.94 (CI ta' 95% 0.43, 2.07) il-proporzjon ta' periklu ta' OS għall-grupp ta' riskju intermedju kien 0.52 (CI ta' 95% 0.36, 0.75), u għall-grupp ta' riskju dgħajjef il-proporzjon ta' periklu ta' OS kien 0.50
English: In the Hodgkin lymphoma population, the ORR was 50.0%, 2 patients (11.1%) had a complete response and 7 patients (38.9%) had a partial response.
Maltese: Fil-popolazzjoni tal-limfoma ta' Hodgkin, l-ORR kien ta' 50.0%, 2 pazjenti (11.1%) kellhom rispons sħiħ u 7 pazjenti (38.9%) kellhom rispons parzjali.
English: • Description of the main signs or symptoms of the irARs and the importance of notifying their treating physician immediately if symptoms occur
Maltese: • Deskrizzjoni tas-sinjali u s-sintomi prinċipali tal-irARs u l-importanza li t-tabib li qed jittrathom jiġi infurmat immedjatament jekk iseħħu s-sintomi
English: Among patients with BRAF mutant tumours, 139 (46%) were previously treated with a BRAF inhibitor.
Maltese: Fost pazjenti b'tumuri b'mutazzjoni BRAF, 139 (46%) kienu ttrattati b'inibitur ta' BRAF qabel.
English: Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilising sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology.
Maltese: Pembrolizumab huwa antikorp monoklonali umanizzat kontra mewt iprogrammat taċ-ċellula-1 (PD-1programmed cell death-1) (isotip IgG4/kappa b'modifikazzjoni fis-sekwenza biex tistabilizza fiż-żona Fc) magħmul f'ċelluli tal-ovarju tal-ħamster Ċiniż permezz ta' teknoloġija tad-DNA rikombinanti.
English: Chemotherapy n=272
Maltese: Kimoterapija n=272
English: Incidences of Grades 3-5 adverse reactions in patients with NSCLC were 67% for pembrolizumab combination therapy and 66% for chemotherapy alone and in patients with HNSCC were 85% for pembrolizumab combination therapy and 84% for chemotherapy plus cetuximab.
Maltese: Inċidenzi ta' reazzjonijiet avversi ta' Gradi 3-5 f'pazjenti b'NSCLC kienu 67% għal terapija ta' kombinazzjoni ma' pembrolizumab u 66% għal kimoterapija waħedha u f'pazjenti b'HNSCC kienu 85% għal terapija ta' kombinazzjoni b'pembrolizumab u 84% għal kimoterapija flimkien ma' cetuximab.
English: • Genomic analyses using whole exome sequencing and/or RNAseq (e.g.
Maltese: • Analiżi ġenomika bl-użu ta' sekwenzar sħiħ tal-eksom u/jew RNAseq
English: Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel).
Maltese: Il-pazjenti ntgħażlu b'mod każwali (1:1:1) biex jirċievu pembrolizumab bid-doża ta' 2 (n=180) jew 10 mg/kg (n=181) kull 3 ġimgħat jew kimoterapija (n=179; inkluż dacarbazine, temozolomide, carboplatin, paclitaxel, jew carboplatin+paclitaxel).
English: PD-L1 expression was tested retrospectively by immunohistochemistry assay with the 22C3 anti-PD-L1 antibody; 84% of patients had PD-L1-positive melanoma (PD-L1 expression in ≥ 1% of tumour and tumour-associated immune cells relative to all viable tumour cells).
Maltese: L-espressjoni ta' PD-L1 ġiet ittestjata retrospettivament permezz ta' assaġġ immunoistokimiku bl-antikorp 22C3 kontra PD-L1; 84% talpazjenti kellhom melanoma pożittiva għal PD-L1 (espressjoni ta' PD-L1 f'≥ 1% tat-tumur u taċ-ċelluli immuni assoċjati mat-tumur mqabbla maċ-ċelluli vijabbli kollha tat-tumur).
English: In patients with non-squamous NSCLC treated with pembrolizumab in combination with pemetrexed and platinum chemotherapy (n=488), the incidence of nephritis was 1.4% (all Grades) with 0.8% Grade 3 and 0.4% Grade 4.
Maltese: F'pazjenti b'NSCLC mhux skwamuża ttrattati b'pembrolizumab flimkien ma' kimoterapija b'pemetrexed u platinum (n=488), l-inċidenza ta' nefrite kienet ta' 1.4% (il-Gradi kollha) b'0.8% ta' Grad 3 u 0.4% ta' Grad 4.
English: In this patient population, the most frequent adverse reactions were anaemia (50%), nausea (50%), fatigue (37%), constipation (35%), diarrhoea (30%), neutropaenia (30%), decreased appetite (28%) and vomiting (25%).
Maltese: F'din il-popolazzjoni ta' pazjenti, ir-reazzjonijiet avversi l-aktar frekwenti kienu anemija (50%), nawsja (50%), għeja (37%), stitikezza (35%), dijarea (30%), newtropenija (30%), tnaqqis fl-aptit (28%) u rimettar (25%).
English: Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment.
Maltese: Endokrinopatiji severi, inkluż insuffiċjenza tal-glandoli adrenali, ipofisite, dijabete mellitus tat-tip 1, ketoaċidożi tad-dijabete, ipotirojdiżmu, u ipertirojdiżmu ġew osservati bi trattament b'pembrolizumab.
English: Among patients who were evaluable for PD-L1 expression (79%), 69% (n=294) were PD-L1 positive and 31% (n=134) were PD-L1 negative.
Maltese: Fost il-pazjenti li setgħu jiġu vvalutati għal espressjoni ta' PD-L1 (79%), 69% (n=294) kienu pożittivi għal PD-L1 u 31% ( n=134) kienu negattivi għal PD-L1.
English: PD L1 negative
Maltese: negattivi għal PD L1
English: BRAF mutations were reported in 302 (36%) patients.
Maltese: Mutazzjonijiet BRAF kienu rrappurtati fi 302 (36%) pazjenti.