FrancophonIA/ELRC3.0 huggingface dataset:
English: See Table 28 for p-Value for inferential test of PFS based on the pre-specified interim analysis, where statistical significance has been reached.
Maltese: Ara Tabella 28 għal Valur p għat-test inferenzjali ta' PFS ibbażat fuq lanaliżi interim speċifikata minn qabel, fejn intlaħaq sinifikat statistiku.
English: KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults (see section 5.1).
Maltese: KEYTRUDA, flimkien ma' axitinib, huwa indikat bħala t-trattament tal-ewwel għażla ta' karċinoma avvanzata taċ-ċelluli renali (RCC - renal cell carcinoma) fl-adulti (ara sezzjoni 5.1).
English: In patients treated with pembrolizumab in combination with chemotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 26.7% for neutrophils decreased, 23.9% for lymphocytes decreased, 19.1% for haemoglobin decreased, 17.9% for leucocytes decreased, 12.2% for platelets decreased, 10.2% for sodium decreased, 8.9% for phosphate decreased, 7.4% for glucose increased, 6.5% for potassium decreased, 3.3 for creatinine increased, 3.1% for ALT increased, 3.1% for AST increased, 3.1% for calcium decreased, 3.0% for potassium increased, 2.9% for albumin decreased, 2.3% for calcium increased, 1.2% for alkaline phosphatase increased, 0.8% for glucose decreased, 0.7% for bilirubin increased, and 0.3% for sodium increased.
Maltese: 2% għal tnaqqis fis-sodium, 8.9% għal tnaqqis filphosphate, 7.4% għal żieda fil-glucose, 6.5% għal tnaqqis fil-potassium, 3.3% għal żieda filkreatinina, 3.1% għal żieda fl-ALT, 3.1% għal żieda fl-AST, 3.1% għal tnaqqis fil-calcium, 3.0% għal żieda fil-potassium, 2.9% għal tnaqqis fl-albumina, 2.3% għal żieda fil-kalċju, 1.2% għal żieda flalkaline phosphatase, 0.8% għal tnaqqis fil-glucose, 0.7% għal żieda fil-bilirubina, u 0.3% għal żieda fis-sodium.
English: pruritus
Maltese: ponot
English: Nephritis occurred in 22 (0.4%) patients, including Grade 2, 3 or 4 cases in 5 (0.1%), 14 (0.2%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab as monotherapy.
Maltese: Nefrite seħħet fi 22 (0.4%) pazjent, inkluż każijiet ta' Grad 2, 3 jew 4 f'5 (0.1%) pazjenti, 14-il (0.2%) pazjent u f'pazjent wieħed (<0.
English: The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively.
Maltese: Il-karatteristiċi tal-linja bażi għal din il-popolazzjoni kienu jinkludu: età medjana ta' 63 sena (42% b'età ta' 65 sena jew aktar); 61% kienu rġiel; 72% kienu Bojod u 21% kienu Asjatiċi u 34% u 66% kellhom stat ta' esekuzzjoni ta' ECOG ta' 0 u 1, rispettivament.
English: KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Maltese: KEYTRUDA bħala monoterapija huwa indikat bħala t-trattament preferut ta' karċinoma tal-pulmun mhux taċ-ċelluli ż-żgħar (NSCLC - non-small cell lung carcinoma) metastatika f'adulti li t-tumuri tagħhom jesprimu PD-L1 b'punteġġ ta' proporzjon tat-tumur (TPS - tumour proportion score) ta' ≥50% mingħajr tumuri pożittivi għall-mutazzjonijiet EGFR jew ALK.
English: Table 14: Efficacy results by PD-L1 Expression in KEYNOTE-189
Maltese: Riżultati ta' effikaċja skont l-Espressjoni ta' PD-L1 f'KEYNOTE-189
English: PFS Hazard ratio* (95% CI)
Maltese: Proporzjon ta' periklu għal PFS* (95% CI)
English: The median follow-up time was 10.5 months (range: 0.2 to 20.4 months).
Maltese: 5 xhur (firxa: minn 0.2 sa 20.4 xhur).
English: Common dizziness, neuropathy peripheral, lethargy, dysgeusia lethargy dizziness, lethargy, neuropathy peripheral
Maltese: disgewżja letarġija sturdament, letarġija, newropatija periferali
English: Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P087, A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects with Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL) - Final Study Report
Maltese: II ta' MK-3475 (Pembrolizumab) f'Individwi b'Limfoma Klassika ta' Hodgkin (cHL - Classical Hodgkin Lymphoma) li Reġgħet tfaċċat mill-ġdid jew li Ma Rrispondietx għat-Trattament (R/R - Relapsed or Refractory)- Rapport Finali tal-Istudju
English: BRAF wild type
Maltese: Rata ta' PFs
English: Of the 540 patients, 61% were male, 43% were ≥ 65 years (median age was 62 years [range 15-89]) and 98% were white.
Maltese: Mill-540 pazjent, 61% kienu rġiel, 43% kellhom ≥65 sena (medjan tal-età kien 62 sena [firxa minn 15-89]) u 98% kienu bojod.
English: Figure 17: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Maltese: Kaplan-Meier għal sopravivenza mingħajr progressjoni skont il-grupp tattrattament f'KEYNOTE-426 (popolazzjoni bl-intenzjoni li tiġi ttrattata)*
English: Common pneumonitis pneumonitis pneumonitis
Maltese: pulmonitel pulmonitel
English: Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction toxicity, except for endocrinopathies that are controlled with replacement hormones (see sections 4.2 and 4.8).
Maltese: Pembrolizumab għandu jitwaqqaf għalkollox għal kwalunkwe reazzjoni avversa marbuta malimmunità ta' Grad 3 li tfiġġ mill-ġdid u għal kwalunkwe tossiċità ta' Grad 4 minn reazzjoni avversa marbuta mal-immunità, ħlief għal endokrinopatiji li huma kkontrollati b'ormoni ta' sostituzzjoni (ara sezzjonijiet 4.2 u 4.8).
English: - The recommended dose of KEYTRUDA is either 200 mg every 3 weeks or 400 mg every
Maltese: - Id-doża rrakkomandata ta' KEYTRUDA hija 200 mg kull 3 ġimgħat jew 400 mg kull
English: This 96 hour hold may include up to 6 hours at room temperature (at or below 25°C).
Maltese: Din iżżamma ta' 96 siegħa tista' tinkludi sa 6 sigħat f'temperatura tal-kamra (ta' 25°C jew anqas).
English: PFS HR (95% CI)
Maltese: Medjan f'xhur (95% CI)
English: Table 27 summarises the key efficacy measures for the TPS ≥ 50% population.
Maltese: Tabella 27 tiġbor fil-qosor il-kejl ta' effikaċja l-aktar importanti għall-popolazzjoni ta' TPS ≥ 50%.
English: Data from pembrolizumab monotherapy in patients with resected Stage III melanoma, from pembrolizumab in combination with axitinib in patients with advanced RCC, from chemotherapy combination in patients with metastatic NSCLC, and from pembrolizumab (with or without chemotherapy) in patients receiving first-line treatment for metastatic or unresectable recurrent HNSCC ≥ 75 years are limited (see sections 4.4 and
Maltese: Data minn monoterapija b'pembrolizumab f'pazjenti b'melanoma ta' Stadju III mneħħija b'operazzjoni, minn pembrolizumab flimkien ma' axitinib f'pazjenti b'RCC avvanzata, minn kombinazzjoni ma' kimoterapija f'pazjenti b'NSCLC metastatika, u minn pembrolizumab (flimkien ma' kimoterapija jew mingħajrha) f'pazjenti li jkunu qed jirċievu trattament tal-ewwel għażla għal HNSCC metastatika jew rikurrenti li ma tistax titneħħa b'operazzjoni ta' ≥ 75 sena hija limitata (ara sezzjonijiet 4.4 u 5.1).
English: Patients excluded from clinical trials
Maltese: Pazjenti li ġew esklużi mill-provi kliniċi
English: • IHC staining for PD-L2
Maltese: Kimoterapija pożittivi għal PD-L1
English: KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinumcontaining chemotherapy (see section 5.1).
Maltese: KEYTRUDA bħala monoterapija huwa indikat għat-trattament ta' HNSCC rikurrenti jew metastatika f'adulti li t-tumuri tagħhom jesprimu PD-L1 b'TPS ta' ≥ 50% u li tiprogressa waqt jew wara kimoterapija li jkun fiha l-platinum (ara sezzjoni 5.1).
English: Complete response Partial response p-Value
Maltese: Rispons parzjali Valur p¶
English: p-Value Median in months (95% CI) Rate (%) at 6 months (95% CI) Overall response rate ORR% (95% CI) p-Value Complete response Partial response Stable disease Response duration Median in months (range)
Maltese: (CI ta' 95%) Valur p‡ Medjan f'xhur (CI ta' 95%) Rata (%) wara 6 xhur (CI ta' 95%) Rata ta' rispons totali§ ORR% (CI ta' 95%) Valur p¶ Rispons sħiħ Rispons parzjali Marda stabbli
English: The safety and efficacy of pembrolizumab were evaluated in KEYNOTE-045, a multicentre, randomised (1:1), controlled study for the treatment of locally advanced or metastatic urothelial carcinoma in patients with disease progression on or after platinum-containing chemotherapy.
Maltese: Is-sigurtà u l-effikaċja ta' pembrolizumab ġew evalwati f'KEYNOTE-045, studju kkontrollat, b'ħafna ċentri, arbitrarju (1:1), għat-trattament ta' karċinoma uroteljali avvanzata lokalment jew metastatika f'pazjenti bi progressjoni tal-marda waqt jew wara kimoterapija li fiha l-platinum.
English: Factors associated with early deaths were fast progressive disease on prior platinum therapy and liver metastases.
Maltese: Il-fatturi assoċjati ma' mwiet bikrija kienu marda progressiva mgħaġġla waqt terapija preċedenti bilplatinum u metastasi fil-fwied.
English: Sixtynine (44.8%) patients had 1 or more Grades 3 to 5 adverse reactions of which 6 (3.9%) patients had 1 or more adverse reactions that resulted in death.
Maltese: Disgħa u sittin (44.8%) pazjent kellhom reazzjoni avversa waħda jew aktar ta' Gradi 3 sa 5 li minnhom 6 (3.9%) pazjenti kellhom reazzjoni avversa waħda jew aktar li wasslet għall-mewt.
English: PD-L1 IHC 22C3 pharmDx
Maltese: fit-12-il xahar fl-24 xahar
English: Chemotherapy
Maltese: FARMAĊEWTIKU
English: The study excluded patients with autoimmune disease or those receiving immunosuppression; further exclusion criteria were a history of severe or life-threatening immunerelated 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 dose) for greater than 12 weeks; ongoing adverse reactions ≥ Grade 2 from previous treatment with ipilimumab; previous severe hypersensitivity to other monoclonal antibodies; a history of pneumonitis or interstitial lung disease; HIV, hepatitis B or hepatitis C infection and ECOG Performance Status ≥ 2.
Maltese: L-istudju eskluda pazjenti b'mard awtoimmuni jew dawk li kienu qed jirċievu immunosoppressjoni; kriterji oħra ta' esklużjoni kienu storja ta' reazzjonijiet avversi severi jew ta' periklu għall-ħajja marbuta mal-immunità minn trattament b'ipilimumab, ddefinita bħala kwalunkwe tossiċità ta' Grad 4 jew Grad 3 li tkun teħtieġ trattament b'kortikosterojdi (> 10 mg/jum prednisone jew doża ekwivalenti) għal aktar minn 12-il ġimgħa; reazzjonijiet avversi ta' ≥Grad 2 li jkunu għadhom għaddejjin minn trattament preċedenti b'ipilimumab; sensittività eċċessiva severa preċedenti għal antikorpi monoklonali oħra; storja ta' pulmonite jew mard tal-interstizju talpulmun; HIV, infezzjoni b'epatite B jew epatite Ċ u Stat ta' Eżekuzzjoni ta' ECOG ta' ≥ 2.
English: Kaplan-Meier curves for OS and PFS based on the final analysis are shown in Figures 1 and 2.
Maltese: Il-kurvi Kaplan-Meier għal OS u PFS abbażi talanaliżi finali qed jintwerew f'Figuri 1 u 2.
English: Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful.
Maltese: Abbażi tad-data ta' sigurtà disponibbli f'cHL u tipi ta' tumuri oħra, dawn id-differenzi mhumiex klinikament sinifikanti.
English: Hyperthyroidism may be managed symptomatically.
Maltese: L-ipertirojdiżmu jista' jiġi mmaniġġjat abbażi tas-sintomi.
English: Table 10: Efficacy results in KEYNOTE-054
Maltese: Riżultati ta' effikaċja f'KEYNOTE-054
English: Hepatitis led to discontinuation of pembrolizumab in 19 (0.3%) patients.
Maltese: L-epatite wasslet għat-twaqqif ta' pembrolizumab f'19-il (0.3%) pazjent.
English: Figure 13: Kaplan-Meier curve for overall survival for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
Maltese: Kaplan-Meier għal sopravivenza globali għal pembrolizumab flimkien ma' kimoterapija f'KEYNOTE-048 b'espressjoni ta' PD-L1 (CPS ≥ 1)
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1).
Maltese: KEYTRUDA bħala monoterapija huwa indikat għat-trattament ta' karċinoma uroteljali avvanzata lokalment jew metastatika f'adulti li jkunu rċivew kimoterapija preċedenti li fiha l-platinum (ara sezzjoni 5.1).
English: Nephritis led to discontinuation of pembrolizumab in 10 (0.2%) patients.
Maltese: In-nefrite wasslet għat-twaqqif ta' pembrolizumab f'10 (0.2%) pazjenti.
English: PD-L1 Expression Pembrolizumab
Maltese: Terapija ta' kombinazzjoni b'Pembrolizumab
English: Table 17 summarises key efficacy measures for the entire population (TPS  1%) and for the patients with TPS  50%, and Figure 11 shows the Kaplan-Meier curve for OS (TPS  1%), based on a final analysis with median follow up of 42.6 months.
Maltese: Tabella 17 tiġbor fil-qosor ilmiżuri ta' effikaċja l-aktar importanti għall-popolazzjoni kollha kemm hi (TPS ≥ 1%) u għall-pazjenti b'TPS ≥ 50%, u l-Figura 11 turi l-kurva Kaplan-Meier għal OS (TPS ≥ 1%), abbażi tal-analiżi finali b'segwitu medjan ta' 42.6 xhur.
English: KEYTRUDA in combination with axitinib in RCC For RCC patients treated with KEYTRUDA in combination with axitinib, see the Summary of Product Characteristics (SmPC) regarding dosing of axitinib.
Maltese: Għal pazjenti b'RCC ittrattati b'KEYTRUDA flimkien ma' axitinib, ara s-Sommarju tal-Karatteristiċi tal-Prodott (SmPC - Summary of Product Characteristics) dwar l-għoti tad-doża ta' axitinib.
English: Hazard ratio* (95% CI) p-Value
Maltese: Proporzjon ta' periklu*(95% CI) RFS
English: The safety of pembrolizumab as monotherapy has been evaluated in 154 paediatric patients with advanced melanoma, lymphoma, or PD-L1 positive advanced, relapsed, or refractory solid tumours at 2 mg/kg every 3 weeks in the Phase I/II study KEYNOTE-051.
Maltese: Is-sigurtà ta' pembrolizumab bħala monoterapija ġiet evalwata f'154 pazjent pedjatriku b'melanoma avvanzata, limfoma jew tumuri solidi pożittivi għal PD-L1, avvanzati, li rkadew jew ma rrispondewx għat-trattament bid-doża ta' 2 mg/kg kull 3 ġimgħat fl-istudju ta' Fażi I/II KEYNOTE-051.
English: The trial demonstrated a statistically significant improvement in OS for all patients randomised to pembrolizumab in combination with chemotherapy compared to standard treatment (HR 0.72; 95% CI 0.60-0.87) and in patients whose tumours expressed PD-L1 CPS ≥ 1 randomised to pembrolizumab monotherapy compared to standard treatment.
Maltese: Il-prova uriet titjib sinifkanti b'mod statistiku f'OS għall-pazjenti kollha magħżula b'mod arbitrarju għal pembrolizumab flimkien ma' kimoterapija meta mqabbla ma' trattament standard (HR 0.72; CI ta' 95% 0.60-0.87) u f'pazjenti li t-tumuri tagħhom kienu jesprimu PD-L1 b'CPS ≥ 1 li ntagħżlu b'mod arbitrarju għal monoterapija b'pembrolizumab meta mqabbla ma' trattament standard.
English: Uncommon lichenoid keratosis u, psoriasis, dermatitis, papule, hair colour changes psoriasis, dermatitis acneiform, dermatitis, vitiligo t, eczema hair colour changes, lichenoid keratosis, papule, psoriasis, vitiligo
Maltese: Komuni ħafna uġigħ muskoluskeletrikuv, artralġja uġigħ muskoluskeletrikuv, artralġja uġigħ muskoluskeletrikuv, artralġja, uġigħ flestremitajiet
English: The pharmacokinetics of pembrolizumab was studied in 2,993 patients with metastatic or unresectable melanoma, NSCLC, or carcinoma who received doses in the range of 1 to 10 mg/kg every 2 weeks, 2 to 10 mg/kg every 3 weeks, or 200 mg every 3 weeks.
Maltese: Il-farmakokinetika ta' pembrolizumab ġiet studjata f'2,993 pazjent b'melanoma li ma setgħetx titneħħa b'operazzjoni jew li kienet metastatika, NSCLC, jew karċinoma li rċivew dożi li varjaw minn 1 sa 10 mg/kg kull ġimagħtejn, 2 sa 10 mg/kg kull 3 ġimgħat jew 200 mg kull 3 ġimgħat.
English: 3Q 2021
Maltese: L-ewwel kwart tal-2021
English: Table 26: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 Expression in KEYNOTE 048 (CPS ≥ 1 to < 20)
Maltese: Riżultati tal-effikaċja għal pembrolizumab flimkien ma' kimoterapija u pembrolizumab bħala monoterapija skont l-Espressjoni ta' PD-L1 f'KEYNOTE 048 (CPS ≥ 20)
English: Assessment of tumour status was performed every 6 weeks through Week 18, every 9 weeks through Week 45 and every 12 weeks thereafter.
Maltese: Stima tal-istat tat-tumur saret kull 6 ġimgħat sa Ġimgħa 18, kull 9 ġimgħat sa Ġimgħa 45 u kull 12-il ġimgħa wara dan.
English: Figure 8: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-189 (intent to treat population)
Maltese: Kaplan-Meier għas-sopravivenza mingħajr progressjoni skont il-fergħa ta' trattament f'KEYNOTE-189 (popolazzjoni bl-intenzjoni li tiġi ttrattata)
English: Common hyponatraemia, hypokalaemia, hypocalcaemia hyponatraemia, hypocalcaemia hypokalaemia, hyponatraemia, hypocalcaemia
Maltese: Komuni iponatremija, ipokalimja, ipokalċimja iponatremija, ipokalċimja ipokalimja, iponatremija, ipokalċimja
English: A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were BRAF wild type (n=414; 77%) or BRAF mutant with prior BRAF treatment (n=126; 23%) as summarised in Table 6.
Maltese: Bħala parti mill-analiżi finali saret analiżi ta' sottogrupp minn KEYNOTE-002 f'pazjenti bit-tip BRAF li jinstab fin-natura (n=414; 77%) jew b'mutazzjoni fi BRAF li ħadu trattament għal BRAF qabel (n=126; 23%) kif miġbura fil-qosor f'Tabella 6.
English: The recommended dose of KEYTRUDA as part of combination therapy is 200 mg every 3 weeks administered as an intravenous infusion over 30 minutes.
Maltese: Id-doża rakkomandata ta' KEYTRUDA bħala parti minn terapija kombinata hija 200 mg kull 3 ġimgħat mogħtija bħala infużjoni fil-vini fuq perjodu ta' 30 minuta.
English: Table 17: Response to pembrolizumab 2 or 10 mg/kg every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010
Maltese: Tabella 17: Rispons għal pembrolizumab 2 jew 10 mg/kg kull 3 ġimgħat f'pazjenti li kienu ttrattati qabel b'NSCLC f'KEYNOTE-010
English: EU/1/15/1024/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1024/001
English: Nephritis resolved in 13 patients, 3 with sequelae.
Maltese: In-nefrite għaddiet fi 13-il pazjent, 3 minnhom b'konsegwenzi.
English: Pembrolizumab + Platinum Chemotherapy + 5-FU n=242
Maltese: Pembrolizumab + Kimoterapija bi platinum + 5-FU
English: Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%).
Maltese: Il-karatteristiċi tal-marda kienu skwamuża (18%) u mhux skwamuża (82%);
English: Poor
Maltese: Limited
English: OS rate at 24 months HR (95% CI)
Maltese: Rata ta' OS wara 24 xahar HR (95% CI)
English: Figure 2: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-006 (intent to treat population)
Maltese: Kaplan-Meier għal sopravivenza mingħajr progressjoni skont il-fergħa ta' trattament f'KEYNOTE-006 (popolazzjoni bl-intenzjoni li tiġi ttrattata)
English: Common (may affect up to 1 in 10 people) - lung infection - decreased number of white blood cells (neutrophils) with a fever - reaction related to the infusion of the medicine - thyroid gland problems - decreased sodium or calcium in the blood - trouble sleeping - dry eye - abnormal heart rhythm - high blood pressure - inflammation of the lungs - inflammation of the intestines; dry mouth - red raised rash, sometimes with blisters - muscle pain, aches or tenderness; joint pain with swelling; pain in arms or legs - inflammation of the kidneys; sudden kidney damage - chills; influenza like illness - increased calcium in the blood; increased liver enzyme levels in the blood
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - infezzjoni fil-pulmun - tnaqqis fin-numru ta' ċelluli bojod tad-demm (newtrofili) bid-deni - reazzjoni marbuta mal-infużjoni tal-mediċina - problemi bil-glandola tat-tirojde - tnaqqis ta' sodium jew calcium fid-demm - problemi bl-irqad - għajnejn xotti - ritmu ta' taħbit tal-qalb mhux normali - pressjoni għolja - infjammazzjoni tal-pulmuni - infjammazzjoni tal-intestini; ħalq xott - raxx aħmar u mqabbeż fil-ġilda xi drabi bl-infafet - uġigħ, weġgħat jew sensittività fil-muskoli; uġigħ fil-ġogi flimkien ma' nefħa; uġigħ fid dirgħajn jew fir-riġlejn - infjammazzjoni tal-kliewi; ħsara f'daqqa fil-kliewi - tkexkix ta' bard; mard jixbah lill-influwenza - żieda tal-calcium fid-demm; żieda fil-livelli ta' enzimi tal-fwied fid-demm
English: Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving pembrolizumab (see section 4.8).
Maltese: Ġiet irrappurtata dijabete mellitus tat-Tip 1, inkluż ketoaċidożi tad-dijabete, f'pazjenti li kienu qed jirċievu pembrolizumab (ara sezzjoni 4.8).
English: Corticosteroids should be administered (initial dose of 0.5-1 mg/kg/day (for Grade 2 events) and 1-2 mg/kg/day (for Grade ≥ 3 events) prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued (see section 4.2).
Maltese: Għandhom jingħataw il-kortikosterojdi (doża tal-bidu ta' 0.5-1 mg/kg/jum (għall-każijiet ta' Grad 2) u 1-2 mg/kg/jum (għall-każijiet ta' Grad ≥ 3) prednisone jew ekwivalenti segwit bi tnaqqis bil-ftit il-ftit għal xejn) u, abbażi tas-severità ta' kemm huma għoljin il-livelli tal-enzimi tal-fwied, pembrolizumab m'għandux jingħata jew għandu jitwaqqaf għalkollox (ara sezzjoni 4.2).
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Maltese: Data disponibbli bħalissa hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5
English: No dose adjustment is necessary in patients ≥ 65 years (see section 5.1).
Maltese: Ma huwa meħtieg l-ebda aġġustament fid-doża f'pazjenti ta' ≥ 65 sena (ara sezzjoni 5.1).
English: arthralgia, pain in extremity
Maltese: psorijażi, vitiligot
English: PFS and ORR results are reported from an interim analysis at a median follow-up of 11 months.
Maltese: Irriżultati ta' PFS u ORR huma rrappurtati minn analiżi interim b'segwitu medjan ta' 11-il xahar.
English: s.
Maltese: A.
English: A total of 861 patients were randomised.
Maltese: Total ta' 861 pazjent intagħżlu b'mod arbitrarju.
English: • Placebo 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/m on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by placebo every 3 weeks.
Maltese: • Plaċebo 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
English: The management guidelines for these adverse reactions are described in section 4.4.
Maltese: Il-linji gwida għall-immaniġġjar ta' dawn irreazzjonijiet avversi huma deskritti f'sezzjoni 4.4.
English: *Based on the stratified Cox proportional hazard model
Maltese: * Abbażi tal-mudell ta' periklu proporzjonali stratifikat Cox
English: The Kaplan-Meier curves for OS and PFS based on an additional four months of follow up are shown in Figures 16 and 17.
Maltese: Il-kurvi Kaplan-Meier għal OS u PFS abbażi ta' erba' xhur addizzjonali ta' segwitu qed jintwerew fil-Figuri 16 u 17.
English: Immune-related severe skin reactions occurred in 89 (1.5%) patients, including Grade 2, 3 or 5 cases in 10 (0.2%), 65 (1.1%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab.
Maltese: Reazzjonijiet avversi fil-ġilda marbuta mas-sistema immmuni Reazzjonijiet severi fil-ġilda marbuta mas-sistema immuni seħħew f'89 (1.5%) pazjent, inklużi każijiet ta' Grad 2, 3 jew 5 f'10 (0.2%) pazjenti, 65 (1.1%) pazjent u pazjent wieħed (< 0.1%), rispettivament, li kienu qed jirċievu pembrolizumab.