FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 12: Objective response (CA209067)
Maltese: Tabella 12: Rispons oġġettiv (CA209067)
English: The frequency of adverse events in the cardiac disorders system organ class regardless of causality was higher in the nivolumab group than in the chemotherapy group in post-CTLA4/BRAF inhibitor metastatic melanoma population.
Maltese: Il-frekwenza ta' każijiet avversi fil-klassi tas-sistema tal-organi ta' disturbi fil-qalb irrispettivament ta' kaswalità kienet ogħla fil-grupp ta' nivolumab fil-grupp ta' kimoterapija filpopolazzjoni ta' impeditur post-CTLA4/BRAF b'melanoma metastatika.
English: No Grade 3-5 cases were reported.
Maltese: Ma ġie rrappurtat lebda każ ta' Grad 3-5.
English: Grade 2 and Grade 3 hypophysitis (including lymphocytic hypophysitis) occurred in 5.8% (26/448) and 2.0% (9/448) of patients, respectively.
Maltese: Ipofiżite (inkluż ipofiżite limfoċitika) ta' Grad 2 u 3 seħħet f'5.8% (26/448) u f'2.0% (9/448) tal-pazjenti, rispettivament.
English: Objective response (95% CI) Odds ratio (vs. ipilimumab) (99.5% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Duration of response Median (range), months
Maltese: Rispons oġġettiv (95% CI) Proporzjon ta' probabbiltà (vs. ipilimumab) (99.5% CI) Rispons sħiħ (CR) Rispons parzjali (PR) Marda stabbli (SD) Tul għar-rispons
English: The median OS was 17.3 months (95% CI: 12.5, 37.8), and the estimated OS rates were 42% (95% CI: 32, 51) at 3 years, 35% (95% CI: 26, 44) at 4 years, and 34% (95% CI: 25, 43) at 5 years (minimum follow-up of 45 months).
Maltese: L-OS medjan kien ta' 17.3 xhur (95% CI: 12.5, 37.8), u r-rati OS stmati kienu 42% (95% CI: 32, 51) wara 3 snin, 35% (95% CI: 26, 44) wara 4 snin, u 34% (95% CI: 25, 43) wara 5 snin (segwitu minimu ta' 45 xahar).
English: Uncommon tachycardia, pericardial disordersj Rare arrhythmia (including ventricular arrhythmia)d, atrial fibrillation, myocarditisa,f Vascular disorders
Maltese: Rari arritmija (inkluż arritmija ventrikulari)d, fibrillazzjoni atrijali, mijokarditea,f
English: Nivolumab+ipilimumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: < 0.0001 Nivolumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.55 (0.42, 0.73); p-value: < 0.0001
Maltese: Nivolumab vs. ipilimumab (analiżi primarja) - HR (99.5% CI): 0.55 (0.42, 0.73); valur-p: < 0.0001 Nivolumab+ipilimumab vs. nivolumab (analiżi deskrittiva) - HR (95% CI): 0.76 (0.62, 0.95)
English: Patients with baseline performance score of 2, treated leptomeningeal metastases, ocular/uveal melanoma, autoimmune disease and patients who have had a Grade 3-4 adverse reaction that was related to prior anti-CTLA-4 therapy were included in study CA209172 (see section 5.1).
Maltese: Pazjenti b'punteġġ tal-prestazzjoni tal-linja bażi 2, b'metastasi leptomeninġeali kkurata, b'melanoma okulari/uveali, b'marda awtoimmuni u pazjenti li kellhom reazzjoni avversa ta' Grad 3-4 li kienet relatata ma' terapija kontra CTLA-4 preċedenti ġew inklużi fl-istudju CA209172 (ara sezzjoni 5.1).
English: In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Maltese: Filtri fil-pajp b'riti tal-polyethersulfone b'daqsijiet tal-pori ta' 0.2 μm sa 1.2 μm.
English: Seventy-four percent of patients had cutaneous melanoma, and 11% had mucosal melanoma; 35% of patients had PD-L1 positive melanoma (≥ 5% tumour cell membrane expression).
Maltese: Erba' u sebgħin fil-mija tal-pazjenti kellhom melanoma kutanja, u 11% kellhom melanoma mukosali; 35% tal-pazjenti kellhom melanoma pożittiva għal PD-L1 (≥ 5% espressjoni tal-rita ċellulari tat-tumur).
English: Median durations of response were 31.9 months (range: 1.4+-31.9) and 12.8 months (range: 1.3+-13.6+), respectively.
Maltese: Iż-żmien medju tar-rispons kien ta' 31.9 xhur (medda: 1.4+-31.9) u 12.8 xhur (medda: 1.3+-13.6+), rispettivament.
English: Hypophysitis occurred in 4.0% (22/547) of patients.
Maltese: Ipofiżite seħħet f'4.0% (22/547) tal-pazjenti.
English: Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
Maltese: KullmL tal-konċentrat fih 0.1 mmol (jew 2.5 mg) sodju.
English: 240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes
Maltese: 240 mg kull ġimagħtejn għal 30 minuta jew 480 mg kull 4 ġimgħat għal 60 minuta
English: Common stomatitis, pancreatitis, constipation, dry mouth colitis, stomatitis, pancreatitis, abdominal pain, constipation, dry mouth
Maltese: Komuni stomatite, pankreatite, stitikezza, ħalq xott kolite, stomatite, pankreatite, uġigħ addominali, stitikezza, ħalq xott
English: Complications of allogeneic HSCT in classical Hodgkin Lymphoma
Maltese: Kumplikazzjonijiet ta' HSCT alloġeniku fil-Limfoma ta' Hodgkin klassika
English: The median age was 65 years (range: 18-87), 59% were men, and 99.5% were white.
Maltese: L-età medjana kienet ta' 65 sena (firxa: 18-87), 59% kienu rġiel, u 99.5% kienu bojod.
English: ORR (95% CI) by tumour PD-L1 expression n=210
Maltese: ORR (95% CI) minn espressjoni tat-tumur ta' PD-L1
English: Median OS for tumour PD-L1 expression ≥ 1% was not reached for nivolumab in combination with ipilimumab, and was 19.61 months in the sunitinib arm (HR = 0.52; 95% CI: 0.34, 0.78).
Maltese: L-OS medjana għall-espressjoni PD-L1 tat-tumur ≥ 1% ma ntlaħqitx għal nivolumab mogħti flimkien ma' ipilimumab, u kienet 19.61 xhur fil-fergħa ta' sunitinib (HR = 0.52; 95% CI: 0.34, 0.78).
English: Adverse reactions reported in the pooled dataset for patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg (n = 448) and for patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg (n = 547) are presented in Table 6.
Maltese: Ir-reazzjonijiet avversi rrapportati fis-sett ta' data kondiviż għal pazjenti kkurati b'nivolumab 1 mg/kg mogħti flimkien ma' ipilimumab 3 mg/kg (n = 448) u għal pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg (n = 547) huma ppreżentati fit-Tabella 6.
English: The number of prior systemic regimen received was 1 for 27% of patients, 2 for 51% of patients, and > 2 for 21% of patients.
Maltese: In-numru ta' programmi ta' kura preċedenti riċevuti kien 1 għal 27% tal-pazjenti, 2 għal 51% tal-pazjenti u > 2 għal 21% tal-pazjenti.
English: This medicine contains 2.5 mg sodium per mL of concentrate.
Maltese: Din il-mediċina fiha 2.5 mg sodju għal kull mL ta' konċentrat.
English: The OS HRs for nivolumab vs. chemotherapy were 0.69 (95% CI: 0.49, 0.96) in patients with tumour PD-L1 expression ≥1% and 1.52 (95% CI: 0.89, 2.57) in patients with tumour PD-L1 expression <1%.
Maltese: L-OS HRs għal nivolumab vs. kimoterapija kienu 0.69 (95% CI: 0.49, 0.96) f'pazjenti b'espressjoni tat-tumur ta' PD-L1 ≥1% u 1.52 (95% CI: 0.89, 2.57) f'pazjenti b'espressjoni tat-tumur ta' PDL1 <1%.
English: Not reached (0+-12.5+)
Maltese: Mhux milħuq (0+ -12.5+)
English: Nivolumab+ipilimumab (events: 139/314), median and 95% CI: N.A. (38.18, N.A.) OS rate and 95% CI at 12 months: 73% (68, 78), 24 months: 64% (59, 69), and 36 months: 58% (52, 63) ──Δ─── Nivolumab (events: 158/316), median and 95% CI: 37.59 months (29.08, N.A.) OS rate and 95% CI at 12 months: 74% (69, 79), 24 months: 59% (53, 64), and 36 months: 52% (46, 57) Ipilimumab (events: 206/315), median and 95% CI: 19.94 months (16.85, 24.61) OS rate and 95% CI at 12 months: 67% (61, 72), 24 months: 45% (39, 50), and 36 months: 34% (29, 39)
Maltese: Rata tal-OS u 95% CI wara 12-il xahar: 73% (68, 78), 24 xahar: 64% (59, 69), u 36 xahar: 58% (52, 63) ──Δ─── Nivolumab (eventi: 158/316), medjan u 95% CI: 37.59 xhur (29.08, N.A.) Rata tal-OS u 95% CI wara 12-il xahar: 74% (69, 79), 24 xahar: 59% (53, 64), u 36 xahar: 52% (46, 57) - - -- - - Ipilimumab (eventi: 206/315), medjan u 95% CI: 19.94 xhur (16.
English: In patients treated with nivolumab monotherapy, the incidence of liver function test abnormalities was 6.7% (173/2578).
Maltese: F'pazjenti kkurati bil-monoterapija ta' nivolumab, l-inċidenza ta' abnormalitajiet fit-testijiet talfunzjoni tal-fwied kienet ta' 6.7% (173/2578).
English: Randomised phase 3 study vs. docetaxel (CA209057)
Maltese: Studju ta' fażi 3 randomizzat vs. docetaxel (CA209057)
English: Grade 2 and Grade 3 cases were reported in 13.7% (75/547) and 3.7% (20/547) of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2, Grad 3 fi 13.7% (75/547) u 3.7% (20/547) tal-pazjenti, rispettivament.
English: Median duration of response was 13.2 months (95% CI: 8.2, NE)
Maltese: Id-durata medjana għar-rispons kienet 13.2 -il xahar (95% CI: 8.2, NE)
English: Grade 4 hypothyroidism Grade 4 hyperthyroidism Grade 4 hypophysitis Grade 3 or 4 adrenal insufficiency Grade 4 diabetes
Maltese: Ipotirojdiżmu ta' Grad 4 Ipertirojdiżmu ta' Grad 4 Ipofiżite ta' Grad 4
English: Squamous Cell Cancer of the Head and Neck
Maltese: Skawmuż tar-Ras u tal-Għonq (SCCHN, Squamous Cell Cancer of the Head and Neck)
English: Time to resolution ranged from 0.4 to 144.1+ weeks.
Maltese: Iż-żmien għal riżoluzzjoni varja minn 0.4 sa 144.1+ ġimgħat.
English: PD-L1 expression ≥ 1%
Maltese: Espressjoni PD-L1 ≥ 1%
English: Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg**
Maltese: Nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg**
English: Nivolumab+Ipilimumab (events: 111/210), median and 95% CI: 11.10 (7.98, 22.18) ──Δ─── Nivolumab (events: 125/208), median and 95% CI: 5.32 (2.83, 7.06) Ipilimumab (events: 159/202), median and 95% CI: 2.83 (2.76, 3.09)
Maltese: - - -*- - - - Nivolumab+Ipilimumab (eventi: 111/210), medjan u 95% CI: 11.10 (7.98, 22.18) ──Δ─── Nivolumab (eventi: 125/208), medjan u 95% CI: 5.32 (2.83, 7.06) - - -- - - Ipilimumab (eventi: 159/202), medjan u 95% CI: 2.83 (2.76, 3.09)
English: Median (95% CI)
Maltese: Medjan (95% CI)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Uncommon spondyloarthropathy, Sjogren's syndrome, arthritis, myopathy, myositis (including polymyositis)a,e, rhabdomyolysisa,f polymyalgia rheumatica, myositis (including polymyositis), rhabdomyolysis
Maltese: Mhux komuni spondiloartropatija, sindromu ta' Sjogren, artrite, mijopatija, mijożite (inkluż polimijożite)a,e, rabdomijolożia,f polimijalġija rewmatika, mijożite (inkluż polimijożite), rabdomijolożi
English: Chronic diseases associated with a build-up of inflammatory cells in various organs and tissues, most commonly the lungs (sarcoidosis)
Maltese: Mard kroniku assoċjat ma' akkumulazzjoni ta' ċelluli infjammatorji f'diversi organi u tessuti, laktar komuni l-pulmun (sarkojdożi)
English: Apparently meaningful symptom improvement (MID = 2 point change in FKSI-DRS score; p < 0.001) and time to improvement (HR = 1.66 (1.33,2.08), p < 0.001) were significantly better for patients on the nivolumab arm.
Maltese: It-titjib apparentament sinifikanti tas-sintomi (MID = 2 bidla fil-punt fil-punteġġ FKSI-DRS; p < 0.001) u l-ħin għat-titjib (HR = 1.66 (1.33, 2.08), p < 0.001) kienu aħjar b'mod sinifikanti għall-pazjenti fil-fergħa nivolumab.
English: nivolumab + ipilimumab Median OS (95% CI)
Maltese: nivolumab + ipilimumab OS medjana (95% CI)
English: Efficacy assessments included investigator-assessed ORR, retrospectively evaluated by an IRRC, and duration of response.
Maltese: Il-valutazzjonijiet tal-effikaċja inkludew ORR ivvalutata minn investigatur, investigata b'mod retrospettiv minn IRRC, u żmien tarrispons.
English: A total of 405 patients were randomised to receive either nivolumab (n = 272) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or chemotherapy (n = 133) which consisted of the investigator's choice of either dacarbazine (1000 mg/m2 every 3 weeks) or carboplatin (AUC 6 every 3 weeks) and paclitaxel (175 mg/m2 every 3 weeks).
Maltese: Total ta' 405 pazjenti kienu magħżula b'mod każwali sabiex jirċievu jew 3 mg/kg nivolumab (n = 272) mogħti ġol-vina għal 60 minuta kull ġimagħtejn jew inkella kimoterapija (n = 133) li kienet tikkonsisti fl-għażla mill-investigatur jew ta' dacarbazine (1000 mg/m2 kull 3 ġimgħat) jew ta' carboplatin (AUC 6 kull 3 ġimgħat) u paclitaxel (175 mg/m2 kull 3 ġimgħat).
English: In patients treated with nivolumab monotherapy, the incidence of nephritis or renal dysfunction was 2.8% (71/2578).
Maltese: F'pazjenti kkurati bil-monoterapija ta' nivolumab, l-inċidenza ta' nefrite jew ta' disfunzjoni renali kienet ta' 2.8% (71/2578).
English: Grade 2, Grade 3, and Grade 4 cases were reported in 0.5% (3/547), 2.4% (13/547), and 0.4% (2/547) of patients, respectively.
Maltese: Każijiet ta' Grad 2, Grad 3, u Grad 4 ġew irrappurtati f'0.5% (3/547), 2.4% (13/547), u 0.4% (2/547) tal-pazjenti, rispettivament.
English: OPDIVO in combination with ipilimumab: When nivolumab 1 mg/kg was administered in combination with ipilimumab 3 mg/kg, the CL of nivolumab was increased by 29% and the CL of ipilimumab was increased by 9%, which was not considered clinically relevant.
Maltese: 3 mg/kg, is-CL ta' nivolumab żdied b'29% u s-CL ta' ipilimumab żdied b'9 %, li ma tqiesx bħala klinikament rilevanti.
English: • Physician educational material • Patient alert card
Maltese: • Materjal edukattiv għat-tabib • Kard ta' allert għall-pazjent
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 10 mg of nivolumab.
Maltese: U KWANTITATTIVA Kull mL konċentrat fih 10 mg nivolumab.
English: Grade 2 or 3 creatinine elevation
Maltese: Elevazzjoni tal-kreatinina ta' Grad 2 jew 3
English: Table 24: OS by tumour PD-L1 expression (CA209141)
Maltese: OS skont l-espressjoni PD-L1 tat-tumur(CA209141) Espressjoni PD-L1
English: It includes 243 patients who had ASCT; Cohort A included 63 (26%) patients who were brentuximab vedotin naïve; Cohort B included 80 (33%) patients who had received brentuximab vedotin after ASCT failure; and Cohort C included 100 (41%) patients who had received brentuximab vedotin before and/or after ASCT out of which 33 (14%) patients received brentuximab vedotin only prior to ASCT.
Maltese: Jinkludi 243 pazjent li kellhom ASCT; Koorti A inkludiet 63 (26%) pazjent li qatt ma kienu ħadu brentuximab vedotin qabel; Koorti B inkluda 80 (33%) pazjent li kienu rċievew brentuximab vedotin wara li ASCT ma rnexxietx;
English: Strata adjusted difference.
Maltese: Differenza aġġustata mill-istrati.
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+49 (0)89 121 42-350)
Maltese: KGaA Tel: 0800 0752002 (+49 (0)89 121 42-350)
English: Figure 1: Kaplan-Meier curves of OS (CA209066)
Maltese: Kaplan-Meier tal-OS (CA209066)
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of pneumonitis including interstitial lung disease, was 7.8% (35/448).
Maltese: F'pazjenti kkurati b'nivolumab 1 mg/kg mogħti flimkien ma' ipilimumab 3 mg/kg fil-melanoma, linċidenza ta' pulmonite inkluż il-mard tal-pulmun interstizjali, kienet, 7.8% (35/448).
English: The median age was 62 years (range: 18-88) with 40% ≥ 65 years of age and 9% ≥ 75 years of age.
Maltese: L-età medjana kienet ta' 62 sena (firxa: 18-88) b'40%  65 sena u 9%  75 sena.
English: - - -*- - - - Nivolumab+ipilimumab (events: 161/314), median and 95% CI: 11.50 (8.90, 22.18).
Maltese: - - -*- - - - Nivolumab+ipilimumab (eventi: 161/314), medjan u 95% CI: 11.50
English: CA209205 Cohort Ba
Maltese: CA209205 Koorti Ba
English: 99.79% CI 95% CI
Maltese: Sopravivenza globali Każijiet Proporzjon ta' periklu 99.79% CI 95% CI valur p
English: Hazard ratio 96.85% CI p-value
Maltese: Sopravivenza totali Avvenimenti Proporzjon ta' periklu 96.85% CI valur-p
English: Results from post-hoc, exploratory analyses indicate that in patients with low (e.g. <1%) to no tumour PD-L1 expression, other patient characteristics (e.g. liver metastases, visceral metastases, baseline haemoglobin <10g/dL and ECOG performance status = 1) might contribute to the clinical outcome.
Maltese: Ir-riżultati minn analiżi post-hoc, esploratorja, jindikaw li f'pazjenti b'espressjoni tat-tumur ta' PD-L1 baxxa (eż. < 1%) sa bla espressjoni tat-tumur ta' PD-L1, karatteristiċi oħrajn tal-pazjent (eż. metastasi fil-fwied, metastasi vixxerali, emoglobina tal-linja bażi < 10 g/dL u status ta' prestazzjoni ECOG = 1) jistgħu jagħtu kontribut għall-eżitu kliniku.
English: Inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica), inflammation of the joints (arthritis)
Maltese: Infjammazzjoni tal-muskoli li tikkawża uġigħ jew ebusija (polymyalgia rheumatica), infjammazzjoni tal-ġogi (artrite)
English: Among 131 patients who discontinued the combination due to adverse reaction after 28 months of follow-up, the ORR was 71% (93/131) with 20% (26/131) achieving a complete response and median OS was not reached.
Maltese: Fost 131 pazjent li waqqfu l-kombinazzjoni minħabba reazzjoni avversa wara 28 xahar ta' segwitu, l-ORR kien 71% (93/131) bi 20% (26/131) li kisbu rispons sħiħ u l-OS medjana ma ntlaħqitx.
English: The majority of patients were male (73%) and white (87%), and 31% and 69% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively.
Maltese: Il-maġġoranza tal-pazjenti kienu rġiel (73%) u bojod (87%), u 31% u 69% tal-pazjenti kellhom KPS fil-linja bażi ta' 70 sa 80% u 90 sa 100%, rispettivament.
English: OPDIVO is a medicine used to treat: advanced melanoma (a type of skin cancer) in adults melanoma after complete resection in adults (treatment after surgery is called adjuvant therapy) advanced non-small cell lung cancer (a type of lung cancer) in adults advanced renal cell carcinoma (advanced kidney cancer) in adults classical Hodgkin lymphoma that has come back after or has not responded to previous therapies, including an autologous stem-cell transplant (a transplant of your own blood-producing cells) in adults advanced cancer of the head and neck in adults advanced urothelial carcinoma (bladder and urinary tract cancer) in adults.
Maltese: OPDIVO hu mediċina li jintuża għat-trattament ta': melanoma avvanzata (tip ta' kanċer tal-ġilda) fl-adulti melanoma wara risezzjoni kompleta fl-adulti (kura wara kirurġija hija msejħa terapija aġġuvanti) kanċer avvanzat tal-pulmun mhux b'ċelloli żgħar (tip ta' kanċer tal-pulmun) fl-adulti karċinoma taċ-ċelloli tal-kliewi avvanzata (kanċer tal-kliewi avvanzat) fl-adulti limfoma ta' Hodgkin klassika li reġgħet tfaċċat wara jew li ma rrispondietx għat-terapiji minn qabel, inkluż trapjant awtologu ta' ċelluli staminali (trapjant taċ-ċelluli li jipproduċu d-demm tiegħek stess) fl-adulti kanċer avvanzat tar-ras u tal-għonq fl-adulti karċinoma tal-apparat tal-awrina avvanzata (kanċer tal-bużżieqa tal-awrina u tal-apparat talawrina) fl-adulti.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.4% (24/547), 0.7% (4/547), and 0.5% (3/547) of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2, Grad 3 u Grad 4 f'4.4% (24/547), 0.7% (4/547), u 0.5% (3/547) tal-pazjenti, rispettivament.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of liver function test abnormalities was 29.5% (132/448).
Maltese: F'pazjenti kkurati b'nivolumab 1 mg/kg mogħti flimkien ma' ipilimumab 3 mg/kg fil-melanoma, linċidenza ta' testijiet tal-funzjoni tal-fwied abnormali kienet, 29.5% (132/448).
English: Patients with baseline performance score of 2 were included in study CA209171 (see section 5.1).
Maltese: Pazjenti b'punteġġ tal-prestazzjoni tal-linja bażi ta' 2 ġew inklużi fl-istudju CA209171 (ara sezzjoni 5.1).
English: The primary efficacy population included those intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the International Metastatic RCC Database Consortium (IMDC) criteria (less than one year from time of initial renal cell carcinoma diagnosis to randomisation, Karnofsky performance status <80%, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, platelet count greater than the upper limit of normal, and absolute neutrophil count greater than the upper limit of normal).
Maltese: Il-popolazzjoni tal-effikaċja primarja inkludiet dawk il-pazjenti ta' riskju intermedju/baxx b'tal-inqas fattur ta' riskju pronjostiku 1 jew aktar minn 6 skont il-kriterji tal-Konsorzju tal-Bażi tad-Data ta' RCC Metastatika Internazzjonali (IMDC) (inqas minn sena mid-dijanjożi inizjali tal-karċinoma taċ-ċellola tal-kliewi għarrandomizzazzjoni, status tal-prestazzjoni ta' Karnofsky <80%, emoglobina inqas mil-limitu aktar baxx tan-normal, kalċju kkoreġut ta' akbar minn 10 mg/dL, għadd ta' pjastrini akbar mil-limitu ta' fuq tannormal, u għadd ta' newtrofili assolut akbar mil-limitu ta' fuq tan-normal).
English: Of the 1008 treated patients, 103 (10%) had ocular/uveal melanoma, 66 (7%) had an ECOG performance score of 2, 165 (16%) had asymptomatic treated and untreated CNS metastases, 13 (1.3%) had treated leptomeningeal metastases, 25 (2%) had autoimmune disease, and 84 (8%) had Grade 3-4 immune-related AEs with prior anti-CTLA-4 therapy.
Maltese: Mill-1008 pazjent ikkurat, 103 (10%) kellhom melanoma okulari/uveali, 66 (7%) kellhom punteġġ tal-prestazzjoni ECOG ta' 2, 165 (16%) kellhom metastasi tas-CNS asintomatika ikkurata u mhux ikkurata, 13 (1.3%) kellhom metastasi leptomeninġeali kkurata, 25 (2%) kellhom marda awtoimmuni, u 84 (8%) kellhom Reazzjonijiet avversi (Aes) relatati mal-immunità ta' Grad 3-4 b'terapija kontra CTLA-4 preċedenti.
English: In patients treated with nivolumab monotherapy, the incidence of diarrhoea, colitis, or frequent bowel movements was 13.1% (339/2578).
Maltese: F'pazjenti kkurati bil-monoterapija ta' nivolumab, l-inċidenza ta' dijarea, kolite, jew ippurgar frekwenti kienet ta' 13.1% (339/2578).
English: Nivolumab in combination with ipilimumab (see section 4.2)
Maltese: Nivolumab flimkien ma' ipilimumab (ara sezzjoni 4.2)
English: Hazard ratio 95% CI p-value Median (95% CI) “+” denotes a censored observation.
Maltese: Sopravivenza ħielsa millprogressjoni Avvenimenti Proporzjon ta' periklu 95% CI valur-p Medjan (95% CI) “+” Tfisser osservazzjoni ċċensurata.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare histiocytic necrotising lymphadenitis (Kikuchi lymphadenitis) Blood and lymphatic system disorders Very common neutropaeniaa,b Uncommon eosinophilia Immune system disorders
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Rari limfadenite nekrotika istjosistika (limfadenite Kikuchi) Disturbi tad-demm u tas-sistema limfatika Komuni ħafna newtropenijaa,b
English: Study CA209069 was a randomised, Phase 2, double-blind study comparing the combination of nivolumab and ipilimumab with ipilimumab alone in 142 patients with advanced (unresectable or metastatic) melanoma with similar inclusion criteria to study CA209067 and the primary analysis in patients with BRAF wild-type melanoma (77% of patients).
Maltese: L-istudju CA209069 kien studju double-blind, ta' Fażi 2, randomizzat li jevalwa ssigurtà u l-effikaċja ta' nivolumab mogħti flimkien ma' iplimumab mqabbla ma' ipilimumab mogħti waħdu f'142 pazjenti b'melanoma avvanzata (ma tistax titneħħa jew metastatika) bi kriterji ta' inklużjoni simili għall-istudju CA209067 u l-analizi primarja f'pazjenti b'melanoma tat-tip salvaġġ (77% tal-pazjenti).
English: Randomisation was stratified by tumour PD-L1 expression (≥ 5% vs. < 5%/indeterminate), and stage of disease per the AJCC staging system.
Maltese: Ir-randomizzazzjoni ġiet stratifikata skont l-espressjoni PD-L1 tat-tumur (≥ 5% vs. < 5%/indeterminat), u fażi tal-marda skont is-sistema ta' fażi ta' AJCC.