FrancophonIA/ELRC3.0 huggingface dataset:
English: A HR=2.09 [95% CI 0.84,5.23] in OS and HR=1.73 [95% CI 0.77,3.90] in PFS for pembrolizumab combination vs chemotherapy was reported within this study subgroup.
Maltese: 23] f'OS u HR=1.73 [CI ta' 95% 0.77,3.90] f'PFS għal kombinazzjoni b'pembrolizumab kontra kimoterapija.
English: KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2.
Maltese: KEYTRUDA huwa antikorp monoklonali umanizzat li jintrabat mar-riċettur ta' mewt ipprogrammata taċ-ċellula 1 (PD-1 - programmed cell death-1) u jimblokka l-interazzjoni tiegħu mal-ligands PD-L1 u PD-L2.
English: In this patient population, the most frequent adverse reactions were diarrhoea (54%), hypertension (45%), fatigue (38%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysaesthesia syndrome (28%), nausea (28%), ALT increased (27%), AST increased (26%), dysphonia (25%), cough (21%), and constipation (21%).
Maltese: F'din il-popolazzjoni ta' pazjenti, l-aktar reazzjonijiet avversi frekwenti kienu dijarea (54%), pressjoni għolja (45%), għeja (38%), ipotirojdiżmu (35%), tnaqqis fl-aptit (30%), sindrome ta' eritrodisestesija tal-keff tal-id u tal-qiegħ tas-sieq (28%), nawsja (28%), żieda fl-ALT (27%), żieda flAST (26%), disfonja (25%), sogħla (21%), u stitikezza (21%).
English: Patients were randomised (1:1) to receive pembrolizumab at a dose of 200 mg every 3 weeks (n=154) or investigator's choice platinum-containing chemotherapy (n=151; including pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, or paclitaxel+carboplatin.
Maltese: Il-pazjenti ntagħżlu b'mod każwali (1:1) biex jirċievu pembrolizumab b'doża ta' 200 mg kull 3 ġimghat (n=154) jew kimoterapija li fiha l-platinum li jagħżel l-investigatur (n=151; inkluż pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, jew paclitaxel+carboplatin.
English: Ipilimumab 3 mg/kg every 3 weeks n=278
Maltese: Ipilimumab 3 mg/kg kull 3 ġimgħat n=278
English: The exposure multiple between the NOAEL and a human dose of 200 mg was 74.
Maltese: Il-multiplu tal-epsoniment bejn in-NOAEL u ddoża tal-bniedem ta' 200 mg kien 74.
English: The 12-month OS rate was 89.5% (95% CI 86.2, 92.1) for pembrolizumab in combination with axitinib and 78.8% (95% CI 74.7, 82.4) for sunitinib.
Maltese: Ir-rata ta' OS ta' 12-il xahar kienet 89.5% (CI ta' 95% 86.2, 92.1) għal pembrolizumab flimkien ma' axitinib u 78.8% (CI ta' 95% 74.7, 82.4) għal sunitinib.
English: Pembrolizumab has not been studied in patients with moderate or severe hepatic impairment (see section 4.2).
Maltese: Pembrolizumab ma ġiex studjat f'pazjenti b'indeboliment moderat jew sever tal-fwied (ara sezzjoni 4.2).
English: Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Maltese: Grad 3 jew suspett ta' sindrome ta' Stevens-Johnson (SJS - StevensJohnson syndrome) jew nekrolisi tossika tal-epidermide (TEN - toxic epidermal necrolysis)
English: In patients with NSCLC whose tumours have high PD-L1 expression, the risk of adverse reactions with combination therapy relative to pembrolizumab monotherapy should be considered and the benefit/risk ratio of the combined therapy evaluated on an individual basis (see sections 4.1, 4.4, 4.8 and 5.1).
Maltese: F'pazjenti b'NSCLC li t-tumuri tagħhom jesprimu ħafna PD-L1, għandu jitqies ir-riskju ta' reazzjonijiet avversi b'terapija kombinata meta mqabbla ma' monoterapija b'pembrolizumab u lproporzjon tal-benefiċċju/riskju tat-terapija kkombinata għandu jiġi evalwat fuq bażi individwali (ara sezzjonijiet 4.1, 4.4, 4.8 u 5.1).
English: PD-L1 status in melanoma
Maltese: L-istat ta' PD-L1 f'melanoma
English: Common pain in extremity, myositis w, arthritis myositis w, pain in extremity, arthritis myositis w, arthritis x,
Maltese: Komuni uġigħ fl-idejn u s-saqajn, mijositew, artritex mijositew, uġigħ fl-idejn u s-saqajn, artritex mijositew, artritex,
English: Table 2: Adverse reactions in patients treated with pembrolizumab*
Maltese: Tabella 2: Reazzjonijiet avversi f'pazjenti ttrattati b'pembrolizumab*
English: Pembrolizumab + Pemetrexed + Platinum Chemotherapy n=410
Maltese: Pembrolizumab + Kimoterapija b'Pemetrexed + Platinum n=410
English: Overall, 20 cHL patients ≥ 65 years were treated with pembrolizumab in studies KEYNOTE-087 and KEYNOTE-013.
Maltese: Globalment, 20 pazjent ta' ≥ 65 sena b'cHL ġew ittrattati b'pembrolizumab fl-istudji KEYNOTE-087 u KEYNOTE-013.
English: Table 29: Efficacy Results in KEYNOTE-426 by IMDC Risk Category
Maltese: Riżultati tal-effikaċja f'KEYNOTE-426 skont il-Kategorija ta' Riskju tal-IMDC
English: Pembrolizumab Monotherapy n=124
Maltese: Monoterapija b'Pembrolizumab n=124
English: Grades 2 or 3
Maltese: Gradi 2 jew 3
English: Standard Treatment* n=122
Maltese: Standard* n=122
English: Corticosteroid therapy may be considered.
Maltese: Tista' titqies terapija bil-kortikosterojdi.
English: Common thrombocytopaenia, lymphopaenia febrile neutropaenia, leukopaenia, lymphopaenia anaemia, neutropaenia, leukopaenia, thrombocytopaenia
Maltese: Komuni tromboċitopenija, limfopenija newtropenija bid-deni, lewkopenija, limfopenija anemija, newtropenija, lewkopenija, tromboċitopenija
English: Figure 10: Kaplan-Meier Curve for Progression-Free Survival in KEYNOTE-407
Maltese: Kaplan-Meier Għal Sopravivenza Mingħajr Progressjoni f'KEYNOTE-407
English: Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2
Maltese: Punteġġ tal-istat ta' eżekuzzjoni tal-Kooperattiva tal-Grupp ta' Onkoloġija tal-Lvant (ECOG - Eastern Cooperative Oncology Group) ta' ≥ 2
English: Immune system disorders Common infusion related reaction infusion related reaction a infusion related reaction
Maltese: Disturbi fis-sistema immuni Komuni reazzjoni relatata malinfużjonia reazzjoni relatata malinfużjonia reazzjoni relatata malinfużjonia
English: • Withdraw the required volume up to 2 mL (50 mg) of KEYTRUDA and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
Maltese: • Iġbed il-volum meħtieġ sa 2 mL (50 mg) ta' KEYTRUDA u ttrasferixxi ġo borża għal għoti filvini li fiha 9 mg/mL (0.9%) sodium chloride jew 50 mg/mL (5%) glucose biex tipprepara soluzzjoni dilwita b'konċentrazzjoni finali li tvarja minn 1 sa 10 mg/mL.
English: Among the 882 patients in KEYNOTE-048, 754 (85%) had tumours that expressed PD-L1 with a CPS ≥ 1 based on the PD-L1 IHC 22C3 pharmDx
Maltese: Fost it-882 pazjent f'KEYNOTE-048, 754 (85%) kellhom tumuri li jesprimu PD-L1 b'CPS ≥ 1 abbażi tal-Kitt PD-L1 IHC 22C3 pharmDx™.
English: Table 12: Efficacy results in KEYNOTE-024
Maltese: Tabella 12: Riżultati tal-effikaċja f'KEYNOTE-024
English: Patients received pembrolizumab 200 mg every 3 weeks (n=210; KEYNOTE-087) or 10 mg/kg every 2 weeks (n=31; KEYNOTE-013) until unacceptable toxicity or documented disease progression.
Maltese: Il-pazjenti rċivew pembrolizumab 200 mg kull 3 ġimgħat (n=210; KEYNOTE-087) jew 10 mg/kg kull ġimagħtejn (n=31; KEYNOTE-013) sakemm kien hemm tossiċità mhux aċċettabbli jew progressjoni ddokumentata tal-marda.
English: ORR difference, % (95% CI)
Maltese: Differenza fl-ORR, % (CI ta' 95%)
English: Based on method by Miettinen and Nurminen
Maltese: Abbażi ta' metodu ta' Miettinen u Nurminen #
English: Standard Treatment* n=235
Maltese: Standard* n=235
English: Due date
Maltese: data)
English: KEYTRUDA in combination with axitinib in RCC
Maltese: KEYTRUDA flimkien ma' axitinib f'RCC
English: Table 13: Efficacy results in KEYNOTE-189
Maltese: Tabella 13: Riżultati ta' effikaċja f'KEYNOTE-189 Skop finali
English: * Includes patients without measurable disease at baseline by independent radiology IRO = Integrated radiology and oncologist assessment using RECIST 1.1
Maltese: IRO = Stima radjuloġika u ta' onkoloġista integrata bl-użu ta' RECIST 1.1
English: KEYTRUDA 200 mg every 3 weeks n=514
Maltese: 200 mg kull 3 ġimgħat n=514
English: A total of 57 NSCLC patients aged ≥ 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control).
Maltese: Total ta' 57 pazjent b'NSCLC li kellhom ≥ 75 sena ġew irreġistrati fl-istudju KEYNOTE-189 (35 filkombinazzjoni b'pembrolizumab u 22 fil-kontroll).
English: Preparation and administration of the infusion
Maltese: Preparazzjoni u amministrazzjoni tal-infużjoni
English: Hyperthyroidism resolved in 191 (78.3%) patients, 5 with sequelae.
Maltese: L-ipertirojdiżmu għadda f'191 (78.3%) pazjent, 5 minnhom b'konsegwenzi.
English: Colitis led to discontinuation of pembrolizumab in 29 (0.5%) patients.
Maltese: Il-kolite wasslet għat-twaqqif ta' pembrolizumab f'29 (0.5%) pazjent.
English: Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies.
Maltese: Tista' tkun meħtieġa terapija ta' sostituzzjoni tal-ormoni fit-tul f'każijiet ta' endokrinopatiji marbuta mal-immunità.
English: Of the patients who recovered, 92 (84%) were rechallenged with either pembrolizumab (3%) or axitinib (31%) monotherapy or with both (50%).
Maltese: Mill-pazjenti li rkupraw, 92 (84%) reġgħu ngħataw monoterapija b'pembrolizumab (3%) jew b'axitinib (31%) jew bit-tnejn li huma (50%).
English: • Placebo with pemetrexed 500 mg/m 2 and investigator's choice of cisplatin 75 mg/m or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by placebo and pemetrexed 500 mg/m intravenously every 3 weeks (n=206)
Maltese: • Plaċebo ma' pemetrexed 500 mg/m2 u cisplatin 75 mg/m2 jew carboplatin AUC 5 mg/mL/min fil-vini, skont l-għażla tal-investigatur, kull 3 ġimgħat għal 4 ċikli segwiti minn plaċebo u pemetrexed 500 mg/m2 fil-vini kull 3 ġimgħat (n=206)
English: Pembrolizumab Monotherapy n=133
Maltese: Monoterapija b'Pembrolizumab n=133
English: Chemotherapy (n=42)
Maltese: Kimoterapija (n=42)
English: PFS Hazard ratio* (95% CI) OS Hazard ratio* (95% CI) ORR %
Maltese: Proporzjon ta' periklu għal PFS* (95% CI) Proporzjon ta' periklu għal OS* (95% CI) ORR %
English: Among patients who were evaluable for PD-L1 expression (98%), 82% were PD-L1 positive and 18% were PD-L1 negative.
Maltese: Fost il-pazjenti li setgħu jiġu vvalutati għal espressjoni ta' PD-L1 (98%), 82% kienu pożittivi għal PD-L1 u 18% kienu negattivi għal PD-L1.
English: Allogeneic HSCT prior to treatment with pembrolizumab In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab.
Maltese: HSCT alloġenejku qabel it-trattament b'pembrolizumab F'pazjenti bi storja ta' HSCT alloġenejku, ġew irrappurtati GVHD akuta, inkluż GVHD fatali, wara trattament b'pembrolizumab.
English: ORR % 38%
Maltese: 80%g
English: Among the 305 patients in KEYNOTE-024, baseline characteristics were: median age 65 years (54% age 65 or older); 61% male; 82% White, 15% Asian; and ECOG performance status 0 and 1 in 35% and 65%, respectively.
Maltese: Fost it-305 pazjenti f'KEYNOTE-024, il-karatteristiċi fil-linja bażi kienu: età medjana ta' 65 sena (54% b'età ta' 65 sena jew aktar); 61% kienu rġiel; 82% Bojod, 15% Asjatiċi; u 35% u 65% kellhom stat ta' esekuzzjoni ta' ECOG ta' 0 u 1, rispettivament.
English: Pneumonitis occurred in 253 (4.3%) patients, including Grade 2, 3, 4 or 5 cases in 106 (1.8%), 69 (1.2%), 13 (0.2%) and 9 (0.2%) patients, respectively, receiving pembrolizumab.
Maltese: Il-pulmonite seħħet f'253 (4.3%) pazjent, inkluż każijiet ta' Grad 2, 3, 4 jew 5 fi 106 (1.8%) pazjent, 69 (1.2%) pazjent, 13 (0.2%) pazjenti u 9 (0.2%) pazjenti, rispettivament, li kienu qed jirċievu pembrolizumab.
English: In patients with ALT ≥ 3 times ULN (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%.
Maltese: F'pazjenti b'ALT ≥ 3 darbiet aktar mill-ULN (Gradi 2-4, n=116), l-ALT irkupra għal Gradi 0-1 f'94%.
English: • Pembrolizumab 200 mg and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for 4 cycles, and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for 4 cycles or nab paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by pembrolizumab 200 mg every 3 weeks.
Maltese: • Pembrolizumab 200 mg u carboplatin AUC 6 mg/mL/min f'Jum 1 ta' kull ċiklu ta' 21 jum għal 4 ċikli, u paclitaxel 200 mg/m2 f'Jum 1 ta' kull ċiklu ta' 21 jum għal 4 ċikli jew nab paclitaxel 100 mg/m2 fil-Jiem 1, 8 u 15 ta' kull ċiklu ta' 21 jum għal 4 ċikli, segwit minn pembrolizumab 200 mg kull 3 ġimgħat.
English: • Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
Maltese: • Iġbed il-volum meħtieġ sa 4 mL (100 mg) ta' konċentrat u ttrasferixxi ġo borża għal għoti filvini li fiha 9 mg/mL (0.9%) sodium chloride jew 50 mg/mL (5%) glucose biex tipprepara soluzzjoni dilwita b'konċentrazzjoni finali li tvarja minn 1 sa 10 mg/mL.
English: Based on severity and type of reaction (Grade 2 or Grade 3)
Maltese: Abbażi tas-severità u t-tip ta' reazzjoni (Grad 2 jew Grad 3)
English: Among the 495 patients in KEYNOTE-040, 129 (26%) had tumours that expressed PD-L1 with a TPS ≥ 50% based on the PD-L1 IHC 22C3 pharmDx
Maltese: Fost l-495 pazjent f'KEYNOTE-040, 129 (26%) kellhom tumuri li kienu jesprimu PD-L1 b'TPS ≥ 50% abbażi tal-Kitt PD-L1 IHC 22C3 pharmDxTM.
English: th edition classification, a total of 82 subjects were classified as stage IIIA; 42 in the pembrolizumab arm and 40 in the placebo arm; with a total of 13 RFS events; 6 in the pembrolizumab arm and 7 in the placebo arm.
Maltese: Skont il-klassifikazzjoni tat-8n edizzjoni tal-AJCC, total ta' 82 individwu ġew ikklassifikati fl-istadju IIIA; 42 fil-fergħa ta' pembrolizumab u 40 fil-fergħa tal-plaċebo; b'total ta' 13-il avveniment RFS; 6 fil-fergħa ta' pembrolizumab u 7 fil-fergħa tal-plaċebo.
English: Pembrolizumab 10 mg/kg every 3 weeks n=181
Maltese: Pembrolizumab 10 mg/kg kull 3 ġimgħat n=181
English: KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Maltese: KEYTRUDA 25 mg/mL konċentrat għal soluzzjoni għall-infużjoni.
English: The Kaplan-Meier curve for OS for the TPS ≥ 50% population is shown in Figure 15.
Maltese: Il-kurva Kaplan-Meier għal OS għall-popolazzjoni ta' TPS ≥ 50% qed tintwera f'Figura 15.
English: Not reached (1.4+, 18.2+)
Maltese: Ma ntlaħaqx (1.4+, 18.2+)
English: Pembrolizumab 2 mg/kg every 3 weeks n=180
Maltese: Pembrolizumab 2 mg/kg kull 3 ġimgħat n=180
English: PFS rate at 18 months HR (95% CI)
Maltese: Rata ta' PFS wara 18-il xahar HR (95% CI)
English: The primary efficacy outcome measures were progression free survival (PFS; as assessed by Integrated Radiology and Oncology Assessment [IRO] review using Response Evaluation Criteria in Solid Tumours [RECIST], version 1.1) and overall survival (OS).
Maltese: Il-miżuri tar-riżultat tal-effikaċja primarja kienu sopravivenza ħielsa minn progressjoni (PFSprogression free survival; kif stmat permezz tar-reviżjoni tal-Analiżi Integrata ta' Radjuloġija u Onkoloġija [IRO - Integrated Radiology and Oncology Assessment] bl-użu tal-Kriterji ta' Valutazzjoni tar-Rispons f'Tumuri Solidi [RECIST - Response Evaluation Criteria in Solid Tumors], verżjoni 1.1) u sopravivenza totali (OS - overall survival).
English: Of the 154 patients, 134 were enrolled with solid tumours, 18 with Hodgkin lymphoma, and 2 with other lymphomas.
Maltese: Mill-154 pazjent, 134 ġew irreġistrati b'tumuri solidi, 18 b'limfoma ta' Hodgkin, u 2 b'limfomi oħra.
English: An analysis was performed in KEYNOTE-189 in patients who had PD-L1 TPS < 1% [pembrolizumab combination: n=127 (31%) vs. chemotherapy: n=63 (31%)], TPS 1-49% [pembrolizumab combination: n=128 (31%) vs. chemotherapy: n=58 (28%)] or ≥ 50% [pembrolizumab combination: n=132 (32%) vs. chemotherapy: n=70 (34%)] (see Table 14).
Maltese: Saret analiżi f'KEYNOTE-189 f'pazjenti li kellhom TPS ta' PD-L1 < 1% [kombinazzjoni ta' pembrolizumab: n=127 (31%) vs. kimoterapija: n=63 (31%)], TPS 1-49% [kombinazzjoni ta' pembrolizumab: n=128 (31%) vs. kimoterapija: n=58 (28%)] jew ≥ 50% [kombinazzjoni ta' pembrolizumab: n=132 (32%) vs. kimoterapija: n=70 (34%)] (ara Tabella 14).
English: Standard Treatment* n=255
Maltese: Standard* n=255
English: Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT) Allogeneic HSCT after treatment with pembrolizumab Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with classical Hodgkin lymphoma undergoing allogeneic HSCT after previous exposure to pembrolizumab.
Maltese: HSCT alloġenejku wara t-trattament b'pembrolizumab Każijiet ta' marda tal-graft kontra l-persuna li tirċiviha (GVHD - graft-versus-host-disease) u marda okklussiva tal-vini (VOD - veno-occlusive disease) epatiċi ġew osservati f'pazjenti b'limfoma ta' Hodgkin klassika li kien qed isirilhom HSCT alloġenejku wara esponiment preċedenti għal pembrolizumab.
English: Thirty-five percent had tumour PD-L1 expression TPS < 1% [negative]; 19% were East Asian; and 60% received paclitaxel.
Maltese: Ħamsa u tletin fil-mija kellhom espressjoni ta' PD-L1 tat-tumur b'TPS ta' < 1% [negattiv]; 19% kienu mill-Asja tal-Lvant; u 60% irċivew paclitaxel.
English: Based upon a standard query including bradyarrhythmias and tachyarrhythmias.
Maltese: †Abbażi ta' mistoqsija standard li tinkludi bradijarritmiji u takijarritmiji.
English: The following additional clinically significant, immune-related adverse reactions have been reported in clinical trials or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barré syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis and encephalitis (see sections 4.2 and 4.8).
Maltese: Ir-reazzjonijiet avversi addizzjonali marbuta mal-immunità, sinifikanti b'mod kliniku, li ġejjin ġew irrappurtati fi provi kliniċi jew mill-esperjenza ta' wara t-tqegħid fis-suq: uveite, artrite, mijosite, mijokardite, pankreatite, sindrome ta' Guillain-Barré, sindromu mijasteniku, anemija emolitika, sarkojdożi u enċefalite (ara sezzjonijiet 4.2 u 4.8).
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80.
Maltese: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80.
English: The safety of pembrolizumab as monotherapy has been evaluated in 5,884 patients with advanced melanoma, resected Stage III melanoma (adjuvant therapy), NSCLC, cHL, urothelial carcinoma, or HNSCC across four doses (2 mg/kg every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg every 2 or 3 weeks) in clinical studies.
Maltese: Is-sigurtà ta' pembrolizumab bħala monoterapija ġiet ivvalutata f'5,884 pazjent b'melanoma avvanzata, melanoma imneħħija b'operazzjoni ta' Stadju III (terapija addizzjonali), NSCLC, cHL, karċinoma uroteljali, jew HNSCC f'kull waħda minn erba' dożi (2 mg/kg kull 3 ġimgħat, 200 mg kull 3 ġimgħat, jew 10 mg/kg kull ġimgħatejn jew 3 ġimgħat) fi studji kliniċi.
English: Pembrolizumab 2mg/kg every 3 weeks (n=44)
Maltese: Pembrolizumab 2mg/kg kull 3 ġimgħat (n=44)
English: BRAF mutations were reported in 20 (39%) patients.
Maltese: rrappurtati f'20 (39%) pazjent.
English: The safety of pembrolizumab in combination with chemotherapy has been evaluated in 1,067 patients with NSCLC or HNSCC receiving 200 mg, 2 mg/kg or 10 mg/kg pembrolizumab every 3 weeks, in clinical studies.
Maltese: Is-sigurtà ta' pembrolizumab flimkien ma' kimoterapija ġiet evalwata f'1,067 pazjent b'NSCLC jew HNSCC li rċivew 200 mg, 2 mg/kg jew 10 mg/kg pembrolizumab kull 3 ġimgħat, fi studji kliniċi.
English: th edition stage (IIIA vs. IIIB vs. IIIC 1-3 positive lymph nodes vs.
Maltese: IIIC 1-3 għoqiedi tal-limfa pożittivi vs.
English: KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.
Maltese: KEYTRUDA, flimkien ma' carboplatin u paclitaxel jew nab-paclitaxel, huwa indikat bħala ttrattament preferut ta' NSCLC skwamuża metastatika fl-adulti.
English: • Cetuximab 400 mg/m 2 load then 250 mg/m 2 once weekly, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m 2 every 3 weeks, and 5-FU 1,000 mg/m 2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU)
Maltese: • KEYTRUDA 200 mg kull 3 ġimgħat, AUC ta' carboplatin 5 mg/mL/min kull 3 ġimgħat jew cisplatin 100 mg/m2 kull 3 ġimgħat, u 5-FU 1,000 mg/m2/jum għal 4 ijiem kontinwi kull 3 ġimgħat (massimu ta' 6 ċikli ta' platinum u 5-FU)
English: ‡ (95% CI) 29.3 (21.2, 38.5)
Maltese: (CI ta' 95% 0.29, 0.87).
English: KEYTRUDA 25 mg/mL concentrate for solution for infusion pembrolizumab
Maltese: KEYTRUDA 25 mg/mL konċentrat għal soluzzjoni għall-infużjoni pembrolizumab
English: Randomisation was stratified by risk categories (favourable versus intermediate versus poor) and geographic region (North America versus Western Europe versus “Rest of the World”).
Maltese: L-għażla arbitrarja ġiet stratifikata skont il-kategoriji ta' riskju (favorevoli versus intermedju versus dgħajjef) u r-reġjun ġeografiku (L-Amerika ta' Fuq versus LEwropa tal-Punent versus “Il-Kumplament tad-Dinja”).
English: KEYNOTE-087 and KEYNOTE-013: Open-label studies in patients with relapsed or refractory classical Hodgkin lymphoma (cHL)
Maltese: KEYNOTE-087 u KEYNOTE-013: Studji fejn kemm l-investigaturi kif ukoll il-pazjenti kienu jafu liema sustanza qed tintuża f'pazjenti b'limfoma klassika ta' Hodgkin (cHL) li reġgħet tfaċċat mill-ġdid jew li ma rrispondietx għat-trattament
English: BRAF mutations were reported in 13% of the study population.
Maltese: Ilmutazzjonijiet BRAF kienu rrappurtati fi 13% tal-popolazzjoni tal-istudju.
English: Number (%) of patients with event
Maltese: Numru (%) ta' pazjenti b'avveniment
English: Adrenal insufficiency Symptomatic hypophysitis Type 1 diabetes associated with Grade ≥ 3 hyperglycaemia (glucose > 250 mg/dL or > 13.9 mmol/L) or associated with ketoacidosis Hyperthyroidism Grade ≥ 3
Maltese: Insuffiċjenza tal-glandoli adrenali Ipofisite bis-sintomi Dijabete tat-tip 1 assoċjata ma' ipergliċemija ta' Grad ≥ 3 (glukosju > 250 mg/dL jew > 13.9 mmol/L) jew assoċjata ma' ketoaċidożi Ipertirojdżmu ta' Grad ≥ 3
English: The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline.
Maltese: Il-karatteristiċi tal-popolazzjoni tal-istudju kienu: età medjana ta' 65 sena (medda: 29 sa 88); 55% b'età ta' 65 sena jew aktar; 81% irġiel; 77% Bojod; stat ta' eżekuzzjoni ta' ECOG ta' 0 (29%) u 1 (71%); u 8% b'metastasi fil-moħħ ittrattata fil-linja bażi.
English: Grade ≥ 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN
Maltese: Grad ≥ 3 b'AST jew ALT > 5 darbiet ogħla mill-ULN jew bilirubin totali > 3 darbiet ogħla mill-ULN
English: Severe skin reactions led to discontinuation of pembrolizumab in 9 (0.2%) patients.
Maltese: Reazzjonijiet severi fil-ġilda wasslu għal twaqqif ta' pembrolizumab f'9 (0.2%) pazjenti.
English: Patients were randomised (1:1:1) to receive pembrolizumab 10 mg/kg every 2 (n=279) or 3 weeks (n=277) or ipilimumab 3 mg/kg every 3 weeks (n=278).
Maltese: Il-pazjenti ntagħżlu b'mod każwali (1:1:1) biex jirċievu pembrolizumab 10 mg/kg kull ġimagħtejn (n=279) jew kull 3 ġimgħat (n=277) jew ipilimumab 3 mg/kg kull 3 ġimgħat (n=278).
English: PD-L1 negative
Maltese: negattiv għal PD-L1
English: Sub-population analyses
Maltese: Analiżi ta' sottopopolazzjoni
English: In KEYNOTE-051, 154 paediatric patients (60 children aged 6 months to less than 12 years and 94 adolescents aged 12 years to 18 years) with advanced melanoma or PD-L1 positive advanced, relapsed, or refractory solid tumours or lymphoma were administered pembrolizumab 2 mg/kg every 3 weeks.
Maltese: F'KEYNOTE-051, 154 pazjent pedjatriku (60 tifel u tifla b'età minn 6 xhur sa inqas minn 12-il sena u 94 adolexxent b'età minn 12-il sena sa 18-il sena) b'melanoma avvanzata jew tumuri solidi pożittivi għal PD-L1, avvanzati, li rkadew, jew li ma rrispondewx għat-trattament jew limfoma ngħataw pembrolizumab 2 mg/kg kull 3 ġimgħat.