FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of pembrolizumab in combination with axitinib has been evaluated in a clinical study of 429 patients with advanced RCC receiving 200 mg pembrolizumab every 3 weeks and 5 mg axitinib twice daily.
Maltese: Is-sigurtà ta' pembrolizumab flimkien ma' axitinib ġiet evalwata fi studju kliniku ta' 429 pazjent b'RCC avvanzata li kienu qed jirċievu 200 mg pembrolizumab kull 3 ġimgħat u 5 mg axitinib darbtejn kuljum.
English: Urothelial Carcinoma
Maltese: Karċinoma taċ-Ċelluli
English: Common aspartate aminotransferase increased, alanine aminotransferase increased, hypercalcaemia, blood alkaline phosphatase increased, blood bilirubin increased, blood creatinine increased hypercalcaemia, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased
Maltese: Komuni żieda fl-aspartate aminotransferase, żieda flalanine aminotransferase, iperkalċimja, żieda flalkaline phosphatase fiddemm, żieda fil-bilirubina fid-demm, żieda filkreatinina fid-demm iperkalċimija, żieda flalanine aminotransferase, żieda fl-aspartate aminotransferase, żieda fl-alkaline phosphatase fid-demm żieda fl-alkaline phosphatase fid-demm, iperkalċimija, żieda filbilirubina fid-demm
English: Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors.
Maltese: F'sitwazzjonijiet wara t-tqegħid fis-suq ġie rrapportat rifjut ta' trapjant ta' organu solidu f'pazjenti li kienu ngħataw trattament b'inibituri ta' PD-1.
English: Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8).
Maltese: Każijiet tas-sindrome ta' Stevens-Johnson (SJS - Stevens-Johnson syndrome) u nekrolisi tossika talepidermide (TEN - toxic epidermal necrolysis) ġew irrappurtati f'pazjenti li kienu qed jirċievu pembrolizumab (ara sezzjoni 4.8).
English: Patients had PD-L1 expression with a  50% tumour proportion score (TPS) based on the PD-L1 IHC 22C3 pharmDx
Maltese: Il-pazjenti kellhom espressjoni ta' PD-L1 b'punteġġ ta' proporzjon tat-tumur (TPS - tumour proportion score) ta' ≥ 50% ibbażat fuq is-Sett PD-L1 IHC 22C3 pharmDxTM.
English: A total of 65 NSCLC patients aged ≥ 75 years were enrolled in study KEYNOTE-407 (34 in the pembrolizumab combination and 31 in the control).
Maltese: Total ta' 65 pazjenti b'NSCLC b'età ta' ≥ 75 sena ġew irreġistrati fl-istudju KEYNOTE-407 (34 filfergħa tal-kombinazzjoni b'pembrolizumab u 31 fil-fergħa ta' kontroll).
English: Renal cell carcinoma KEYNOTE-426: Controlled trial of combination therapy in RCC patients naïve to treatment The efficacy of pembrolizumab in combination with axitinib was investigated in KEYNOTE-426, a randomised, multicentre, open-label, active-controlled trial conducted in patients with advanced RCC with clear cell component, regardless of PD-L1 tumour expression status and International Metastatic RCC Database Consortium (IMDC) risk group categories.
Maltese: L-effikaċja ta' pembrolizumab flimkien ma' axitinib ġiet investigata f'KEYNOTE-426, prova arbitrarja, b'ħafna ċentri, ikkontrollata b'mod attiv fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża f'pazjenti b'RCC avvanzata b'komponent ta' ċelluli b'ċitoplasmu ċar, irrispettivament mill-istat ta' espressjoni PD-L1 tat-tumur u l-kategoriji tal-gruppi ta' riskju talKonsorzju tad-Database Internazzjonali ta' RCC Metastatika (IMDC - International Metastatic RCC Database Consortium).
English: No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was ≥ 200 mg/kg, which produced exposure multiples of 19 and 94 times the exposure in humans at doses of 10 and 2 mg/kg, respectively.
Maltese: Ma ġew osservati l-ebda sejbiet ta' sinifikat tossikoloġiku u l-livell fejn ma ġie osservat l-ebda effett avvers (NOAEL - no observed adverse effect level) fiż-żewġ studji kien ≥200 mg/kg, li pproduċa multipli ta' esponiment ta' 19-il darba u 94 darba aktar mill-esponiment filbnedmin bid-dożi ta' 10 u 2 mg/kg, rispettivament.
English: In patients treated with pembrolizumab monotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 10.9% for lymphocytes decreased, 8.2% for sodium decreased, 6.3% for haemoglobin decreased, 5.2% for phosphate decreased, 4.8% for glucose increased, 2.8% for AST increased, 2.7% for alkaline phosphatase increased, 2.7% for ALT increased, 2.2% for potassium decreased, 1.8% for calcium increased, 1.8% for neutrophils decreased, 1.8% for potassium increased, 1.7% for bilirubin increased, 1.7% for platelets decreased, 1.6% for albumin decreased, 1.5% for calcium decreased, 1.3% for creatinine increased, 0.8% for leucocytes decreased, 0.7% for magnesium increased, 0.6% for glucose decreased, 0.2% for magnesium decreased, and 0.2% for sodium increased.
Maltese: F'pazjenti ttrattati b'monoterapija ta' pembrolizumab, il-proporzjon ta' pazjenti li kellhom bidla millinja bażi għal anormalità tal-laboratorju ta' Grad 3 jew 4 kien kif ġej: 10.9% għal tnaqqis fil-limfoċiti, 8.2% għal tnaqqis fis-sodium, 6.3% għal tnaqqis fl-emoglobina, 5.2% għal tnaqqis fil-phosphate, 4.8% għal żieda fil-glucose, 2.8% għal żieda fl-AST, 2.7% għal żieda fl-alkaline phosphatase, 2.7% għal żieda fl-ALT, 2.2% għal tnaqqis fil-potassium, 1.8% għal żieda fil-calcium, 1.8% għal tnaqqis finnewtrofili, 1.8% għal żieda fil-potassium, 1.7% għal żieda fil-bilirubin, 1.7% għal tnaqqis fil-plejtlits, 1.6% għal tnaqqis fl-albumina, 1.5% għal tnaqqis fil-kalċju, 1.3% għal żieda fil-kreatinina, 0.8% għal tnaqqis fil-lewkoċiti, 0.7% għal żieda fil-magnesium, 0.6% għal tnaqqis fil-glucose, 0.2% għal tnaqqis fil-magnesium, u 0.2% għal żieda fis-sodium.
English: Pembrolizumab 200 mg every 3 weeks n=154
Maltese: Pembrolizumab 200 mg kull 3 ġimgħat n=154
English: A total of 559 patients were randomised.
Maltese: Total ta' 559 pazjent intagħżlu b'mod arbitrarju.
English: An updated OS analysis was performed when patients had a median follow-up of 16.6 months (range: 0.1 to 26.3 months).
Maltese: Saret analiżi aġġornata ta' OS meta l-pazjenti kellhom medjan ta' segwitu ta' 16.6 xhur (firxa: 0.1 sa 26.3 xhur).
English: Severe skin reactions resolved in 64 patients.
Maltese: Reazzjonijiet severi fil-ġilda fiequ f'64 pazjent.
English: vomiting (26%), headache (22%), abdominal pain (21%), anaemia (21%) and constipation (20%).
Maltese: L-aktar reazzjonijiet avversi komuni (irrappurtati f'mill-inqas 20% tal-pazjenti pedjatriċi) kienu deni (31%), rimettar (26%), uġigħ ta' ras (22%), uġigħ fl-addome (21%), anemija (21%) u stitikezza (20%).
English: Kaplan Meier curves for OS based on the final analysis are shown in Figures 13 and 14.
Maltese: Kaplan Meier għal OS abbażi tal-analiżi finali qed jintwerew fil-Figuri 13 u 14.
English: Patients with clinically significant renal (creatinine > 1.5 x ULN) or hepatic (bilirubin > 1.5 x ULN, ALT, AST > 2.5 x ULN in the absence of liver metastases) abnormalities at baseline were excluded from clinical trials, therefore information is limited in patients with severe renal and moderate to severe hepatic impairment.
Maltese: Pazjenti b'anormalitajiet tal-kliewi (kreatinina > 1.5 x ULN) jew tal-fwied (bilirubin > 1.5 x ULN, ALT, AST > 2.5 x ULN meta ma jkunx hemm metastasi fil-fwied) sinifkanti b'mod kliniku fil-linja bażi ġew esklużi mill-provi kliniċi, għalhekk l-informazzjoni hija limitata f'pazjenti b'indeboliment sever tal-kliewi u b'indeboliment minn moderat sa sever tal-fwied.
English: Hypophysitis led to discontinuation of pembrolizumab in 8 (0.1%) patients.
Maltese: L-ipofisite wasslet għat-twaqqif ta' pembrolizumab fi 8 (0.1%) pazjenti.
English: The median number of prior lines of therapy administered for the treatment of cHL was 4 (range 1 to 12).
Maltese: In-numru medjan ta' linji preċedenti ta' terapija mogħtija għat-trattament ta' cHL kien ta' 4 (firxa minn 1 sa 12).
English: In patients with solid tumours and other lymphomas, the ORR was 5.9%, no patient had a complete response and 8 patients (5.9%) had a partial response.
Maltese: F'pazjenti b'tumuri solidi u limfomi oħra, l-ORR kien ta' 5.9%, l-ebda pazjent ma kellu rispons sħiħ u 8 pazjenti (5.9%) kellhom rispons parzjali.
English: Ipilimumab
Maltese: Kimoterapija
English: There were no Grade 5 hepatic events.
Maltese: Ma kien hemm l-ebda avvenimenti epatiċi ta' Grad 5.
English: An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or ≥ 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDx
Maltese: Saret analiżi f'KEYNOTE-052 f'pazjenti li kellhom tumuri li jesprimu PD-L1 b'CPS ta' < 10 (n=251; 68%) jew ≥ 10 (n=110; 30%) abbażi tal-Kitt PD-L1 IHC 22C3 pharmDxTM (ara Tabella 22).
English: Preliminary data from an early review showed a reduced survival with pembrolizumab monotherapy in patients whose tumours express PD-L1 with a CPS < 10 compared with standard chemotherapy.
Maltese: Data preliminari minn analiżi bikrija wriet tnaqqis fis-sopravivenza b'monoterapija b'pembrolizumab f'pazjenti li t-tumuri tagħhom jesprimu PD-L1 b'CPS < 10 meta mqabbla ma' kimoterapija standard.
English: Patients who tolerated axitinib 5 mg twice daily for 2 consecutive treatment cycles (i.e. 6 weeks) with no > Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to ≤ 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily.
Maltese: Pazjenti li ttolleraw axitinib 5 mg darbtejn kuljum għal 2 ċikli konsekuttivi ta' trattament (i.e. 6 ġimgħat) mingħajr l-ebda avvenimenti avversi ta' > Grad 2 marbuta mat-trattament għal axitinib u bi pressjoni ikkontrollata tajjeb sa ≤ 150/90 mm Hg tħallew iżidu d-doża ta' axitinib għal 7 mg darbtejn kuljum.
English: Hypothyroidism occurred in 645 (11.0%) patients, including Grade 2 or 3 cases in 475 (8.1%) and 8 (0.1%) patients, respectively, receiving pembrolizumab.
Maltese: Ipotirojdiżmu seħħ f'645 (11.0%) pazjent, inkluż każijiet ta' Grad 2 jew 3 f'475 (8.1%) pazjent u 8 (0.1%) pazjenti, rispettivament, li kienu qed jirċievu pembrolizumab.
English: KEYTRUDA has not been studied in patients with severe renal impairment (see sections 4.4 and 5.2).
Maltese: KEYTRUDA ma ġiex studjat f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjonijiet 4.4 u 5.2).
English: * Based on the stratified Cox proportional hazard model NR = not reached
Maltese: * Abbażi tal-mudell ta' periklu proporzjonali stratifikat Cox NR (not reached) = Ma ntlaħaqx
English: In patients treated with pembrolizumab in combination with axitinib, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 20.1% for ALT increased, 13.2% for AST increased, 10.8% for lymphocytes decreased, 8.9% for glucose increased, 7.8% for sodium decreased, 6.4% for phosphate decreased, 6.2% for potassium increased, 4.3% for creatinine increased, 3.6% for potassium decreased, 2.1% for bilirubin increased, 2.1% for haemoglobin decreased, 1.7% for alkaline phosphatase increased, 1.5% for prothrombin INR increased, 1.4% for leukocytes decreased, 1.4% for platelets decreased, 1.2% for activated partial thromboplastin time prolonged, 1.2% for neutrophils decreased, 1.2% for sodium increased, 0.7% for calcium decreased, 0.7% for calcium increased, 0.5% for albumin decreased, and 0.2% for glucose decreased.
Maltese: 8% għal tnaqqis fil-limfoċiti, 8.9% għal żieda fil-glucose, 7.8% għal tnaqqis fis-sodium, 6.4% għal tnaqqis fil-phosphate, 6.2% għal żieda fil-potassium, 4.3% għal żieda fil-kreatinina, 3.6% għal tnaqqis fil-potassium, 2.1% għal żieda fil-bilirubin, 2.1% għal tnaqqis fl emoglobina, 1.7% għal żieda fl-alkaline phosphatase, 1.5% għal żieda fl-INR tal-prothrombin, 1.4%għal tnaqqis fil-lewkoċiti, 1.4% għal tnaqqis fil-plejtlets, 1.2% għal ħin parzjali ta' thromboplastin attivat imtawwal, 1.2% għal tnaqqis fin-newtrofili, 1.2% għal żieda fis-sodium, 0.7% għal tnaqqis filcalcium, 0.7% għal żieda fil-calcium, 0.5% għal tnaqqis fl-albumina, u 0.2% għal tnaqqis fil-glucose.
English: Investigations Very common blood creatinine increased alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased
Maltese: Investigazzjonijiet Komuni ħafna żieda fil-kreatinina fiddemm żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, żieda fil-kreatinina fid-demm
English: Efficacy and safety data from patients ≥ 75 years are limited.
Maltese: Data dwar l-effikaċja u s-sigurtà minn pazjenti ta' ≥ 75 sena hija limitata.
English: Key eligibility criteria were metastatic non-squamous NSCLC, no prior systemic treatment for metastatic NSCLC, and no EGFR or ALK genomic tumour aberrations.
Maltese: Il-kriterji l-aktar importanti għal eliġibiltà kienu NSCLC mhux skwamuża metastatika, l-ebda trattament sistemiku preċedenti għal NSCLC metastatika, u l-ebda aberrazzjoni ġenomika EGFR jew ALK fit-tumur.
English: No clinical data are available on the possible effects of pembrolizumab on fertility.
Maltese: Mhemmx data klinika disponibbli dwar l-effetti li jista' jkollu pembrolizumab fuq il-fertilità.
English: When you get KEYTRUDA, you can have some serious side effects.
Maltese: Meta jingħatalek KEYTRUDA, jista' jkollok xi effetti sekondarji serji.
English: Blood and lymphatic system disorders Very common anaemia anaemia, neutropaenia, thrombocytopaenia
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni ħafna anemija anemija, newtropenija, tromboċitopenija
English: Among KEYNOTE-087 patients, the baseline characteristics were median age 35 years (9% age 65 or older); 54% male; 88% White; and 49% and 51% had an ECOG performance status 0 and 1, respectively.
Maltese: Fost il-pazjenti ta' KEYNOTE-087, il-karatteristiċi tal-linja bażi kienu età medjana ta' 35 sena (9% ta' 65 sena jew aktar); 54% irġiel; 88% Bojod; u 49% u 51% kellhom stat ta' esekuzzjoni ta' ECOG ta' 0 u 1, rispettivament.
English: Table 3: Efficacy results in KEYNOTE-006
Maltese: Tabella 3: Riżultati ta' effikaċja f'KEYNOTE-006 Skop finali
English: Pembrolizumab 10 mg/kg every 3 weeks n=277
Maltese: Pembrolizumab 10 mg/kg kull 3 ġimgħat n=277
English: • Pembrolizumab 200 mg with pemetrexed 500 mg/m2 and investigator's choice of cisplatin
Maltese: • Pembrolizumab 200 mg ma' pemetrexed 500 mg/m2 u cisplatin 75 mg/m2 jew carboplatin AUC
English: Reasons for cisplatin ineligibility included: baseline creatinine clearance of < 60 mL/min (50%), ECOG performance status of 2 (32%), ECOG performance status of 2 and baseline creatinine clearance of < 60 mL/min (9%), and other (Class III heart failure, Grade 2 or greater peripheral neuropathy, and Grade 2 or greater hearing loss; 9%).
Maltese: Ir-raġunijiet għall-ineliġibbiltà għal cisplatin kienu jinkludu: tneħħija tal-kreatinina fil-linja bażi ta' <60 mL/min (50%), stat ta' eżekuzzjoni ta' ECOG ta' 2 (32%), stat ta' eżekuzzjoni ta' ECOG ta' 2 u tneħħija tal-kreatinina fil-linja bażi ta' <60 mL/min (9%), u oħrajn (insuffiċjenza tal-qalb Klassi
English: What KEYTRUDA contains The active substance is pembrolizumab.
Maltese: X'fih KEYTRUDA Is-sustanza attiva hija pembrolizumab.
English: Rare myocarditis myocarditis k, pericarditis
Maltese: Rari mijokarditek mijokarditek, perikardite
English: Table 8: Efficacy results by PD-L1 expression in KEYNOTE-002
Maltese: Tabella 8: Riżultati ta' effikaċja skont l-espressjoni ta' PD-L1 f'KEYNOTE-002 Skop finali
English: Pembrolizumab 200 mg every 3 weeks n=64
Maltese: Pembrolizumab 200 mg kull 3 ġimgħat n=64
English: Clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 - 5.8.
Maltese: Soluzzjoni ċara sa ftit tkanġi, minn bla kulur sa kemxejn safra, pH 5.2 - 5
English: Number at Risk Pembrolizumab + Chemo:
Maltese: Numru f'Riskju Pembrolizumab + Kimo:
English: Both studies included patients regardless of PD-L1 expression.
Maltese: Iż-żewġ studji inkludew pazjenti irrispettivament mill-espressjoni ta' PD-L1.
English: • Equilibrate the vial to room temperature (at or below 25°C).
Maltese: • Ekwilibra l-kunjett għat-temperatura tal-kamra (f'temperatura ta' 25°C jew anqas).
English: Treatment with pembrolizumab continued until RECIST 1.1-defined progression of disease as determined by the investigator, unacceptable toxicity, or a maximum of 24 months.
Maltese: Trattament b'pembrolizumab kompla sakemm kien hemm progressjoni tal-marda definita minn RECIST 1.1 iddeterminata mill-investigatur, tossiċità inaċċettabbli, jew sa massimu ta' 24 xahar.
English: The Kaplan-Meier curves for OS and PFS are shown in Figures 9 and 10.
Maltese: Il-kurvi Kaplan-Meier għal OS u PFS qed jintwerew fil-Figuri 9 u 10.
English: TM
Maltese: M0.
English: KEYTRUDA has not been studied in patients with moderate or severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: KEYTRUDA ma ġiex studjat f'pazjenti b'indeboliment moderat jew sever tal-fwied (ara sezzjonijiet 4.4 u 5.2).
English: Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=344) or 10 mg/kg (n=346) every 3 weeks or docetaxel at a dose of 75 mg/m2 every 3 weeks (n=343) until disease progression or unacceptable toxicity.
Maltese: Il-pazjenti ntgħażlu b'mod każwali (1:1:1) biex jirċievu pembrolizumab b'doża ta' 2 (n=344) jew 10 mg/kg (n=346) kull 3 ġimgħat jew docetaxel b'doża ta' 75 mg/m2 kull 3 ġimgħat (n=343) sakemm kien hemm progressjoni tal-marda jew tossiċità mhux aċċettabbli.
English: Patients without disease progression could be treated for up to 24 months.
Maltese: Il-pazjenti mingħajr progressjoni tal-marda setgħu jiġu trattati sa 24 xahar.
English: Use of pembrolizumab for adjuvant treatment of patients with melanoma A trend toward increased frequency of severe and serious adverse reactions in patients ≥ 75 years was observed.
Maltese: L-użu ta' pembrolizumab għal trattament addizzjonali ta' pazjenti b'melanoma Ġiet osservata tendenza ġenerali ta' żieda fil-frekwenza ta' reazzjonijiet avversi severi u serji f'pazjenti ≥ 75 sena.
English: The median follow-up time was 12.8 months (range: 0.1 to 21.5 months).
Maltese: Iż-żmien medjan ta' segwitu kien ta' 12.8 xhur (firxa: 0.1 sa 21.5 xhur).
English: powder for concentrate for solution for infusion 1 vial
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni kunjett 1
English: The median time to onset of hepatitis was 3.6 months (range 8 days to 21.4 months).
Maltese: Il-medjan ta' żmien għall-bidu ta' epatite kien 3.6 xhur (firxa minn 8 ijiem sa 21.4 xhur).
English: One vial of 4 mL contains 100 mg of pembrolizumab.
Maltese: Kunjett wieħed ta' 4 mL fih 100 mg ta' pembrolizumab.
English: Among the 542 randomised patients in KEYNOTE-045, baseline characteristics were: median age 66 years (range: 26 to 88), 58% age 65 or older; 74% male; 72% White and 23% Asian; 56% ECOG performance status of 1 and 1% ECOG performance status of 2; and 96% M1 disease and 4% M0 disease.
Maltese: Fost il-542 pazjent magħżula b'mod arbitrarju f'KEYNOTE-045, il-karattersistiċi fil-linja bażi kienu: età medjana ta' 66 sena (firxa: 26 sa 88), 58% kellhom età ta' 65 sena jew aktar; 74% kienu rġiel; 72% kienu Bojod u 23% kienu Asjatiċi; 56% kellhom stat ta' eżekuzzjoni ta' ECOG ta' 1 u 1% kellhom stat ta' eżekuzzjoni ta' ECOG ta' 2; u 96% kellhom marda
English: The median number of prior lines of therapy administered for the treatment of cHL was 5 (range 2 to 15).
Maltese: In-numru medjan ta' linji preċedenti ta' terapija mogħtija għat-trattament ta' cHL kien ta' 5 (firxa minn 2 sa 15).
English: Patients with the following conditions were excluded from clinical trials: active CNS metastases; ECOG PS ≥ 2 (except for urothelial carcinoma and RCC); HIV, hepatitis B or hepatitis C infection; active systemic autoimmune disease; interstitial lung disease; prior pneumonitis requiring systemic corticosteroid therapy; a history of severe hypersensitivity to another monoclonal antibody; receiving immunosuppressive therapy and a history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for greater than 12 weeks.
Maltese: ECOG PS ≥ 2 (ħlief għal karċinoma uroteljali u RCC); pazjenti b'infezzjoni tal-HIV, tal-epatite B jew tal-epatite C; mard awtoimmuni sistemiku attiv; mard tal-interstizju tal-pulmun; pulmonite preċedenti li tkun teħtieġ terapija sistemika b'kortikosterojdi; bi storja ta' sensittività eċċessiva severa għal antikorp monoklonali ieħor; li kienu qed jirċievu terapija immunosoppressiva u bi storja ta' reazzjonijiet avversi severi marbuta mal-immunità minn trattament b'ipilimumab, ddefiniti bħala kwalunkwe tossiċità ta' Grad 4 jew Grad 3 li tkun teħtieġ trattament bil-kortikosterojdi (> 10 mg/jum prednisone jew doża ekwivalenti) għal aktar minn 12-il ġimgħa.
English: A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were BRAF wild type (n=525; 63%), BRAF mutant without prior BRAF treatment (n=163; 20%) and BRAF mutant with prior BRAF treatment (n=139; 17%) as summarised in Table 7.
Maltese: Bħala parti mill-analiżi finali saret analiżi ta' sottogrupp ta' KEYNOTE-006 f'pazjenti bit-tip BRAF li jinstab fin-natura (n=525; 63%), bil-mutazzjoni fi BRAF mingħajr trattament preċedenti għal BRAF (n=163; 20%) u bil-mutazzjoni fi BRAF bi trattament għal BRAF qabel (n=139; 17%) kif miġbura filqosor f'Tabella 7.
English: Pembrolizumab Axitinib n=432
Maltese: Axitinib n=432
English: Common hypertension hypertension
Maltese: GĦAMLA KWALITATTIVA
English: Grades 3 or 4, or recurrent Grade 2 Permanently discontinue
Maltese: Gradi 3 jew 4, jew Grad 2 rikurrenti
English: Based on the stratified Cox proportional hazard model Based on stratified log-rank test
Maltese: Abbażi tal-mudell ta' periklu proporzjonali stratifikat ta' Cox Abbażi tat-test log-rank stratifikat
English: KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).
Maltese: KEYTRUDA bħala monoterapija jew flimkien ma' kimoterapija bi platinum u 5-fluorouracil (5-FU), huwa indikat għat-trattament tal-ewwel għażla ta' karċinoma taċ-ċelluli skwamużi fir-ras u fl-għonq (HNSCC - head and neck squamous cell carcinoma) metastatika jew rikurrenti li ma tistax titneħħa b'operazzjoni f'adulti li t-tumuri tagħhom jesprimu PD-L1 b'CPS ≥ 1 (ara sezzjoni 5.1).
English: Data from patients ≥ 65 years are too limited to draw conclusions on cHL population (see section 5.1).
Maltese: Data minn pazjenti ta' ≥ 65 sena hija limitata wisq biex jinġibdu konklużjonijiet dwar il-popolazzjoni b'cHL (ara sezzjoni 5.1).
English: Efficacy results based on an additional seven months of follow-up are summarized in Table 10 and Figure 4.
Maltese: Riżultati ta' effikaċja abbażi ta' seba' xhur addizzjonali ta' segwitu huma miġbura filqosor f'Tabella 10 u Figura 4.
English: An exploratory subgroup analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 1 to < 20 [pembrolizumab plus chemotherapy: n=116 (45%) vs. standard treatment: n=125 (49%) and pembrolizumab monotherapy: n=124 (48%) vs. standard treatment: n=133 (52%)] (see Table 26).
Maltese: Saret analiżi esploratorja ta' sottogrupp f'KEYNOTE-048 f'pazjenit li t-tumuri tagħhom kienu jesprimu PD-L1 b'CPS ≥ 1 sa < 20 [pembrolizumab flimkien ma' kimoterapija: n=116 (45%) vs. trattament standard: n=125 (49%) u monoterapija b'pembrolizumab: n=124 (48%) vs. trattament standard: n=133 (52%)] (ara Tabella 26).