FrancophonIA/ELRC3.0 huggingface dataset:
English: In murine syngeneic tumour models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumour activity.
Maltese: F'mudelli ta' tumur ġenetikament identiku tal-ġrieden, l-imblokk doppju ta' PD-1 u CTLA-4 irriżulta f'attività kontra t-tumur sinerġestika.
English: The median age was 61 years (range: 21-85) with 38% ≥ 65 years of age and 8% ≥ 75 years of age.
Maltese: L-età medjana kienet ta' 61 sena (firxa: 21-85) bi 38%  65 sena u 8%  75 sena.
English: Common vitiligo, dry skin, erythema, alopecia, urticaria dry skin, erythema, urticaria
Maltese: Komuni vitiligo, ġilda niexfa, eritema, alopeċja, urtikarja ġilda niexfa, eritema, urtikarja
English: Transfer the concentrate into a sterile, evacuated glass bottle or intravenous container (PVC or polyolefin).
Maltese: Ittrasferixxi l-konċentrat fi flixkun tal-ħġieġ, evakwat u sterili jew f'kontenitur intravenuż (PVC jew poliolefina).
English: Efficacy results are shown in Table 18.
Maltese: (Tabella 18 u Figura 10).
English: 0.5% with nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks and 4.6% with nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks.
Maltese: L-inċidenza ta' antikorpi newtralizzanti kontra nivolumab kienet 0.5% b'nivolumab 3 mg/kg u ipilimumab 1 mg/kg kull 3 ġimgħat u 4.6% b'nivolumab 1 mg/kg u ipilimumab 3 mg/kg kull 3 ġimgħat.
English: Events Hazard ratio 95% CI Rate (95% CI) at 60 months
Maltese: Avvenimenti Proporzjon ta' periklu 95% CI Rata (95% CI) wara 60 xahar
English: Table 17 summarises results of ORR and OS by tumour PD-L1 expression.
Maltese: It-Tabella 17 tagħmel sommarju tar-riżultati ta' ORR u OS permezz tal-espressjoni PD-L1 tat-tumur.
English: Severe hepatitis has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Maltese: Ġiet osservata epatite severa b'monoterapija ta' nivolumab jew nivolumab mogħti flimkien ma' ipilimumab (ara sezzjoni 4.8).
English: c p-value is compared to alpha 0.002 in order to achieve statistical significance.
Maltese: Il-valur p jitqabbel ma' alpha 0.002 sabiex tinkiseb sinifikanza statistika.
English: Years from most recent transplant to first dose of study therapy, median (min-max) a 18/80 (22.5%) of the patients in CA209205 Cohort B presented B-Symptoms at baseline.
Maltese: Snin mill-aktar trapjant riċenti għall-ewwel doża tatterapija tal-istudju, medjana (min-mass) a 18/80 (22.5%) tal-pazjenti f'CA209205 Koorti B ippreżentaw is-Sintomi-B fil-linja bażi.
English: Grade 1, Grade 2, Grade 3, and Grade 4 diabetes mellitus and Grade 4 diabetic ketoacidosis were each reported in 0.2% (1/448) of patients.
Maltese: Kemm dijabete mellitus ta' Grad 1, Grad 2, Grad 3 u Grad 4 kif ukoll ketaċidożi dijabetika ta' Grad 4 kienu rrappurtati f'0.2% (1/448) tal-pazjenti.
English: The median duration of response was not reached (range: 4.4-16.6+ months).
Maltese: Iddurata medjana tar-rispons ma ntlaħqitx (medda: 4.4-16.6+ xhur).
English: For tumour PD-L1 expression < 1%, the median OS was 34.7 months for the nivolumab in combination with ipilimumab, and was 32.2 months in the sunitinib arm (HR = 0.70; 95% CI: 0.54, 0.92).
Maltese: Għallespressjoni PD-L1 tat-tumur ≥ 1%, l-OS medjana kienet 34.7 xhur għal nivolumab mogħti flimkien ma' ipilimumab, u kienet 32.2 xhur fil-fergħa ta' sunitinib (HR = 0.70; 95% CI: 0.54, 0.92).
English: The majority of cases were Grade 1 or 2 in severity reported in 4.2% (107/2578) and 5.4% (139/2578) of patients, respectively.
Maltese: Il-maġġoranza tal-każijiet kienu ta' Grad 1 jew 2 fis-severità rrappurtata fi 4.2% (107/2578) u 5.4% (139/2578) tal-pazjenti rispettivament.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of nephritis or renal dysfunction was 8.8% (48/547).
Maltese: F'pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg f'RCC, l-inċidenza ta' nefrite jew disfunzjoni tal-kliewi kienet 8.8% (48/547).
English: Median time to onset was 1.5 months (range: 0.0-30.1).
Maltese: Il-ħin medjan sal-bidu kien 1.5 xhur (firxa: 0.0-30.1).
English: The volume of OPDIVO concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the OPDIVO concentrate strength is 10 mg/mL).
Maltese: Il-volum tal-konċentrat ta' OPDIVO biex titħejja d-doża (mL) = id-doża totali f'mg, diviż b'10 (il-qawwa tal-konċentrat ta' OPDIVO hija ta' 10 mg/mL).
English: At 24 months, the OS rate was 66.5 (95% CI 61.8-70.9) for nivolumab in combination with ipilimumab and 52.9 (95% CI 47.9- 57.7) for sunitinib.
Maltese: Wara 24 xahar, ir-rata ta' OS kienet 66.5 (95% CI 61.8-70.9) għal nivolumab flimkien ma' ipilimumab u 52.9 (95% CI 47.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 6.7% (30/448), 15.4% (69/448), and 1.8% (8/448) of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2, Grad 3 u Grad 4 f'6.7% (30/448), 15.4% (69/448), u 1.8% (8/448) tal-pazjenti, rispettivament.
English: Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).
Maltese: Relattiva għall-monoterapija ta' nivolumab, żieda fis-sopravivenza mingħajr progressjoni (progression-free survival, PFS) u fis-sopravivenza globali (overall survival, OS) għall-kombinazzjoni ta' nivolumab ma' ipilimumab hija stabbilita biss f'pazjenti b'espressjoni baxxa ta' PD-L1 tat-tumur (ara sezzjonijiet 4.4 u 5.1).
English: The median age was 60 years (range: 28-83) with 31% ≥ 65 years of age and 5% ≥ 75 years of age, 83% were male, and 83% were white.
Maltese: L-età medjana kienet ta' 60 sena (medda: 28-83) b'31 % li għandhom 65 sena u 5 % li għandhom 75 sena, 83 % kienu rġiel u 83 % kienu bojod.
English: Randomised phase 3 study vs. chemotherapy (CA209037)
Maltese: Studju każwali ta' fażi 3 vs. kemoterapija (CA209037)
English: A total of 1096 patients were randomised in the trial, of which 847 patients had intermediate/poor-risk RCC and received either nivolumab 3 mg/kg (n = 425) administered intravenously over 60 minutes in combination with ipilimumab 1 mg/kg administered intravenously over 30 minutes every 3 weeks for 4 doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks or sunitinib (n = 422) 50 mg daily, administered orally for 4 weeks followed by 2 weeks off, every cycle.
Maltese: Total ta' 1096 pazjent kienu magħżula b'mod każwali fil-prova, li minnhom 847 pazjent kellhom RCC ta' riskju intermedju/baxx u rċivew jew nivolumab 3 mg/kg (n = 425) mogħti minn ġol-vina fuq 60 minuta flimkien ma' ipilimumab 1 mg/kg mogħti minn ġol-vina fuq 30 minuta kull 3 ġimgħat għal 4 dożi segwit minn monoterapija ta' nivolumab 3 mg/kg kull ġimagħtejn jew sunitinib (n = 422) 50 mg kuljum, mogħti mill-ħalq għal 4 ġimgħat segwit minn ġimagħtejn mingħajr terapija, kull ċiklu.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg, the incidence of hypersensitivity/infusion reactions was 3.8% (17/448); all were Grade 1 or 2 in severity.
Maltese: F'pazjenti kkurati b'nivolumab 1 mg/kg mogħti flimkien ma' ipilimumab 3 mg/kg, l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva/infużjoni kienet 3.8% (17/448); kollha kienu ta' Grad 1 jew 2 fis-sensittività.
English: Hypophysitis (1 Grade 1, 2 Grade 2, 5 Grade 3, and 1 Grade 4), hypopituitarism (4 Grade 2 and 1 Grade 3), adrenal insufficiency (including secondary adrenocortical insufficiency) (1 Grade 1, 9 Grade 2, and 5 Grade 3), diabetes mellitus (including Type 1 diabetes mellitus) (3 Grade 2 and 1 Grade 3), and diabetic ketoacidosis (2 Grade 3) were reported.
Maltese: Grad 2 u 1 Grad 3), insuffiċjenza adrenali (inkluż insuffiċjenza adrenokortikali sekondarja) (1 Grad 1, 9 Grad 2, u 5
English: Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Maltese: Nivolumab huwa prodott fiċ-ċelloli tal-ovarji tal-ħamster Ċiniż b'teknoloġija rikombinanti tad-DNA.
English: As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of nivolumab.
Maltese: Peress li l-antikorpi monoklonali mhumiex metabolizzati minn enzimi taċ-ċitokroma P450 (CYP) jew enzimi oħrajn li jimmetabolizzaw il-mediċini, l-inibizzjoni jew l-induzzjoni ta' dawn l-enzimi minn prodotti mediċinali koamministrati oħrajn mhix antiċipata li jaffettwa l-farmakokinetika ta' nivolumab.
English: Grade 3 diarrhoea or colitis - OPDIVO monotherapy
Maltese: Dijarea jew kolite ta' Grad 3 - Monoterapija b'OPDIVO
English: Median time to onset was 3.6 months (range: 0.2-19.6).
Maltese: Ħin medjan sal-bidu kien ta' 3.6 xhur (firxa: 0.2-19.6).
English: Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
Maltese: Nivolumab isaħħaħ ir-risponsi taċ-ċelloli-T, inkluż ir-risponsi kontra t-tumuri, permezz ta' mblokk ta' PD-1 li jeħel ma' ligandi PD-L1 u PD-L2.
English: Uncommon adrenal insufficiency, hypopituitarism, hypophysitis, thyroiditis, diabetes mellitus Rare diabetic ketoacidosis
Maltese: Mhux komuni insuffiċjenza adrenali, ipopitwitariżmu, ipofiżite, tirojdite, dijabete mellitus
English: Clinical activity was observed regardless of tumour PD-L1 expression status.
Maltese: Ġiet osservata attività klinika, kien x'kien l-istatus tal-espressjoni ta' PD-L1 tat-tumur.
English: For Grade 2 (symptomatic) pneumonitis, nivolumab or nivolumab in combination with ipilimumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Maltese: Għal pulmonite (sintomatika) tal-Grad 2, nivolumab jew nivolumab mogħti flimkien ma' ipilimumab għandhom jitwaqqfu u l-kortikosterojdi għandhom jibdew f'doża ta' 1 mg/kg/kuljum ta' ekwivalenti ta' methylprednisolone.
English: Median (95% CI) months Rate (95% CI) at 6 months Overall survivalc
Maltese: Medjan (95% CI) xhur Rata (95% CI) wara 6 xhur Sopravivenza globalic
English: b 25/100 (25%) of the patients in CA209205 Cohort C presented B-Symptoms at baseline.
Maltese: b 25/100 (25%) tal-pazjenti f'CA209205
English: Grade 3 and 4 cases were reported in 0.7% (19/2578) and <0.1% (1/2578) of patients respectively.
Maltese: Każijiet ta' Grad 3 u 4 kienu rrapportati f'0.7% (19/2578) u < 0.1% (1/2578) ta' pazjenti rispettivament.
English: Endocrinopathies Skin
Maltese: IL-PRODOTT MEDIĊINALI
English: Figure 7: Recurrence-free Survival (CA209238)
Maltese: Figura 7: Sopravivenza mingħajr rikorrenza (CA209238)
English: Ulcer of the small intestines
Maltese: Ulċera tal-intestini ż-żgħar
English: If myocarditis is suspected, prompt initiation of a high dose of steroids (prednisone 1 to 2 mg/kg/day or methylprednisolone 1 to 2 mg/kg/day) and prompt cardiology consultation with diagnostic workup according to current clinical guidelines should be initiated.
Maltese: Jekk ikun hemm suspett ta' mijokardite, għandha ssir inizjazzjoni minnufih ta' doża għolja ta' sterojdi (prednisone 1 sa 2 mg/kg/kuljum jew methylprednisolone 1 sa 2 mg/kg/kuljum) u għandha tinbeda konsultazzjoni kardjoloġika minnufih b'workup dijanjostiku skont il-linji gwida kliniċi attwali.
English: Additional efficacy measures included duration of response, PFS and OS.
Maltese: Miżuri addizzjonali tal-effikaċja inkludew iż-żmien tar-rispons, PFS u OS.
English: Grade 2 and Grade 3 cases were reported in 20.3% (91/448) and 7.6% (34/448) of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2, Grad 3 f'20.3% (91/448) u 7.6% (34/448), tal-pazjenti, rispettivament.
English: The magnitude of OS benefit was consistent for ≥ 1%, ≥ 5% or ≥ 10% tumour PD-L1 expression levels (see Table 24).
Maltese: Id-daqs tal-benefiċċju tal-OS kien konsistenti għal livelli ta' espressjoni PD-L1 tat-tumur ta' ≥ 1 %, ≥ 5 % jew ≥ 10 % (ara Tabella 24).
English: Overall survival Events Hazard ratioa (95% CI) p-valueb Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Rate (95% CI) at 18 months Progression-free survival Events Hazard ratio 95% CI p-value Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Confirmed objective responsec (95% CI) Odds ratio (95% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Median time to response Months (range) Median duration of response Months (range)
Maltese: Soprvaivenza globalid Avvenimenti Proporzjon ta' periklua 95% CI Rata (95% CI) wara 60 xahar Rispons oġġettiv ikkonfermat (95% CI) Tul medjan tar-rispons Xhur (medda) Sopravivenza ħielsa mill-progressjoni Rata (95% CI) wara 60 xahar
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency.
Maltese: Nivolumab jew nivolumab mogħti flimkien ma' ipilimumab għandhom jitwaqqfu b'mod permanenti għal insuffiċjenza adrenali severa (Grad 3) jew ta' theddida għal ħajja (Grad 4).
English: Median time to onset of these endocrinopathies was 1.9 months (range: 0.0-28.1).
Maltese: Ilħin medjan sal-bidu ta' dawn l-endokrinopatiji kien 1.9 xhur (firxa: 0.0-28.1).
English: CA209205 Cohort Cb
Maltese: CA209039 CA209205 Koorti Cb
English: The median age was 63 years (range: 39-85) with 44% ≥65 years of age and 11% ≥75 years of age.
Maltese: L-età medjana kienet ta' 63 sena (medda: 39-85) b'44% li għandhom 65 sena u 11% li għandhom 75 sena.
English: Grade 3 or 4 pneumonitis
Maltese: Pulmonite ta' Grad 3 jew 4
English: Grade 2 cases were reported in 2.2% (10/448) of patients.
Maltese: Kienu rrappurtati każijiet ta' Grad 2 f'2.2% (10/448) tal-pazjenti.
English: A total of 418 patients were randomised to receive either nivolumab (n = 210) administered intravenously over 60 minutes at 3 mg/kg every 2 weeks or dacarbazine (n = 208) at 1000 mg/m2 every
Maltese: Total ta' 418-il-pazjenti kienu magħżula b'mod każwali biex jew jingħataw nivolumab (n = 210) filvina fuq 60 minuta f'doża ta' 3 mg/kg kull ġimgħatejn jew dacarbazine (n = 208) f'doża ta' 1000 mg/m2 kull 3 ġimgħat.
English: Progression-free survival Median (95% CI) months Rate (95% CI) at 6 months
Maltese: Sopravivenza mingħajr progressjoni Medjan (95% CI) xhur Rata (95% CI) wara 6 xhur
English: Median time to onset was 2.3 months (range: 0.0-18.2).
Maltese: Ħin medjan sal-bidu kien ta' 2.3 xhur (firxa: 0.0-18.2).
English: PFS results (with minimum follow up of 18 months) are shown in Figure 2 (all randomised population), Figure 3 (at the tumour PD-L1 5% cut off), and Figure 4 (at the tumour PD-L1 1% cut off).
Maltese: Ir-riżultati tal-PFS (b'segwitu minimu ta' 18-il xahar) huma murija fil-Figura 2 (il-popolazzjoni randomizzata kollha), Figura 3 (fit-tumur ta' PD-L1 ta' 5% cut off), u Figura 4 (fit-tumur ta' PD-L1 ta' 1% cut off).
English: Hazard ratio 95% CI Rate (95% CI) at 24 months
Maltese: Avvenimenti Proporzjon ta' periklu 95% CI Rata (95% CI) wara 24 xahar
English: • patients with prior autoimmune disease, and any condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications,
Maltese: • pazjenti b'marda awtoimmuni preċedenti, u bi kwalunkwe kundizzjoni li teħtieġ kura sistemika b'jew kortikosterojdi (≥ 10 mg prednisone kuljum jew ekwivalenti) jew b'medikazzjonijiet immunosuppressivi oħrajn,
English: Very common increased AST, increased ALT, increased alkaline phosphatase, increased lipase, increased amylase, hypocalcaemia, increased creatinine, hyperglycaemiac, lymphopaenia, leucopoenia, thrombocytopaenia, anaemiak, hypercalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia
Maltese: Investigazzjonijietb Komuni ħafna żieda fl-AST, żieda fl-ALT, żieda f'alkaline phosphatase, żieda fil-lipase, żieda fl-amylase, ipokalċemija, żieda filkreatinina, ipergliċemijac, limfopenija, lewkopenija, tromboċitopenija, anemijak, iperkalċemija, iperkalemija, ipokalemija, ipomanjesimja, iponatremja
English: Seventy-three percent of patients had cutaneous melanoma and 10% had mucosal melanoma.
Maltese: Tlieta u sebgħin fil-mija kellhom melanoma fil-ġilda u 10% kellhom melanoma tal-mukus.
English: Figure 5 Overall survival (CA209067) - Minimum follow-up of 36 months
Maltese: Sopravivenza globali (CA209067) - Segwitu minimu ta' 36 xahar
English: Classical Hodgkin Lymphoma
Maltese: Limfoma ta' Hodgkin Klassika
English: ECOG performance scores were 0 for 61% of patients and 1 for 39% of patients.
Maltese: Il-punteġġi tal-prestazzjoni tal-ECOG kienu 0 għal 61% tal-pazjenti u 1 għal 39% talpazjenti.
English: Adverse reactions reported in the pooled dataset for patients treated with nivolumab monotherapy (n = 2578) are presented in Table 5.
Maltese: Ir-reazzjonijiet avversi rrapportati fis-sett ta' data kondiviż għal pazjenti kkurati bil-monoterapija ta' nivolumab (n = 2578) huma ppreżentati fit-Tabella 5.
English: There was no statistically significant difference between nivolumab and chemotherapy in the final OS analysis.
Maltese: Ma kienx hemm differenza statistikament sinifikanti bejn nivolumab u l-kimoterapija fl-analiżi finali ta' OS.
English: Nephritis and Renal Dysfunction
Maltese: Nefrite u disfunzjoni renali relatati mas-sistema immunitarja
English: In this patient population, objective response was reported in 33 patients (31%) with a median duration of response of 22.9 months (95% CI: 17.0, NR).
Maltese: F'din il-popolazzjoni ta' pazjenti, rispons oġġettiv kien irrappurtat fi 33 pazjent (31%) bi żmien medjan ta' rispons ta' 22.9 xhur (95% CI: 17.0, NR).
English: Updated analysis Minimum follow-up: 62.6 months
Maltese: Analiżi aġġornata Segwitu minimu: 62.6 xhur
English: f p-value is compared to alpha 0.001 in order to achieve statistical significance.
Maltese: Il-valur p jitqabbel ma' alpha 0.001 sabiex tinkiseb sinifikanza statistika.
English: The majority of patients were white (92%) and male (55%).
Maltese: Il-maġġoranza tal-pazjenti kienu bojod (92%) u rġiel (55%).
English: In patients treated with nivolumab monotherapy, the incidence of hypersensitivity/infusion reactions was 4.7% (121/2578), including 6 Grade 3 and 2 Grade 4 cases.
Maltese: F'pazjenti kkurati bil-monoterapija ta' nivolumab, l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva/infużjoni kienet ta' 4.7% (121/2578), li kienu jinkludu 6 każijiet ta' Grad 3 u 2 każijiet ta' Grad 4.
English: Tumour PD-L1 expression levels were balanced between the two treatment groups (nivolumab vs. docetaxel) at each of the predefined tumour PD-L1 expression levels of ≥ 1% (53% vs. 55%), ≥ 5% (41% vs. 38%), or ≥ 10% (37% vs. 35%).
Maltese: Il-livelli tal-espressjoni PD-L1 tat-tumur kienu bbilanċjati bejn iż-żewġ gruppi ta' kura (nivolumab vs. docetaxel) f'kull livell tal-espressjoni PD-L1 tat-tumur definit minn qabel ta'≥ 1% (53% vs. 55%), ≥ 5% (41% vs.
English: Nivolumab+ipilimumab vs ipilimumab (primary analysis) - HR (95% CI): 0.55 (0.45, 0.69); p-value: < 0.0001 Nivolumab vs ipilimumab (primary analysis) - HR (95% CI): 0.65 (0.53, 0.80); p-value: < 0.0001
Maltese: Nivolumab vs ipilimumab (analiżi primarja) - HR (95% CI): 0.65 (0.53, 0.80); valur-p: < 0.0001
English: Hazard ratioa 99.1% CI p-valueb,h Median (95% CI)
Maltese: 99.1% CI valur pb,h
English: In the nivolumab group there were two patients with CRs and seven patients with PRs who had tumour PD-L1 expression < 1%.
Maltese: Fil-grupp nivolumab kien hemm żewġ pazjenti b'CRs u seba' pazjenti b'PRs li kellhom espressjoni PD-L1 tat-tumur ta' < 1%.
English: Figure 9: Kaplan-Meier curves of OS (CA209057)
Maltese: Kaplan-Meier tal-OS (CA209057)
English: The 49 patients had a median follow-up from subsequent allogeneic HSCT of 5.6 months (range: 0-19 months).
Maltese: Id-49 pazjent kellhom segwitu medjan minn HSCT alloġeniku sussegwenti ta' 5.6 xhur (firxa: 0-19-il xahar).
English: Additional safety and descriptive efficacy data are available from study CA209374, an open-label Phase 3b/4 safety study of nivolumab monotherapy (treated with 240 mg every 2 weeks) for the treatment of patients with advanced or metastatic RCC (n = 142), including 44 patients with non-clear cell histology.
Maltese: Data dwar is-sigurtà addizzjonali u dwar l-effikaċja deskrittiva hija disponibbli minn studju CA209374, studju tas-sigurtà ta' Fażi 3b/4 bit-tikketta mikxufa ta' monoterapija ta' nivolumab (ikkurati b'240 mg kull ġimagħtejn) għall-kura ta' pazjenti b'RCC avvanzat jew metastatiku (n = 142), inkluż 44 pazjent b'istoloġija taċ-ċelloli mhux ċara.
English: Reporting of suspected adverse reactions
Maltese: Reazzjonijiet avversi relatati mal-immunità
English: Grade 3 thyroid disorders were reported in < 0.1% (2/2578) of patients.
Maltese: Disturbi tat-tirojde ta' Grad 3 kienu rrappurtati f'< 0.1% (2/2578) ta' pazjenti.
English: Months (range)
Maltese: Xhur (firxa)
English: The majority of patients had AJCC Stage III disease (81%), and 19% had Stage IV disease.
Maltese: III tal-AJCC (81%), u 19% kellhom marda ta' Fażi
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.7% (21/448), 1.1% (5/448), and 0.2% (1/448) of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2, Grad 3 u Grad 4 f'4.7% (21/448), 1.1% (5/448), u 0.2% (1/448) talpazjenti, rispettivament.
English: The ORRs in the BRAF mutation-positive subgroup were 17% (95% CI: 8.4, 29.0) for nivolumab and 11% (95% CI: 2.4, 29.2) for chemotherapy, and in the BRAF wild-type subgroup were 30% (95% CI: 24.0, 36.7) and 9% (95% CI: 4.6, 16.7), respectively.
Maltese: LORRs fis-sottogrupp ta' mutanti pożittivi tal-BRAF kienu 17% (95% CI: 8.4, 29.0) għal nivolumab u 11% (95% CI: 2.4, 29.2) għall-kimoterapija, u fis-sottogrupp tat-tip salvaġġ tal-BRAF kienu 30% (95% CI: 24
English: 10 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a grey flip-off seal (aluminium).
Maltese: 10 mL ta' konċentrat f'kunjett tal-10 mL (ħġieġ tat-Tip I) b'tapp (lasktu tal-butyl miksi) u siġill griż li jinqala' bis-seba' (aluminju).
English: Rate (95% CI) at 12 months “+” denotes a censored observation.
Maltese: Rata (95% CI) wara 12il xahar “+”tfisser osservazzjoni ċċensurata.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 3.0% for anaemia (all Grade 3), 0.7% for thrombocytopaenia, 0.6% for leucopoenia, 5.1% for lymphopaenia, 1.1% for neutropaenia, 2.0% for increased alkaline phosphatase, 4.8% for increased AST, 6.5% for increased ALT, 1.1% for increased total bilirubin, 2.1% for increased creatinine, 7.2% for hyperglycaemia, 1.8% for hypoglycemia, 12.2% for increased amylase, 20.1% for increased lipase, 0.4% for hypocalcaemia, 1.3% for hypercalcaemia, 2.4% for hyperkalemia, 1.1% for hypermagnesaemia, 0.4% for hypomagnesaemia 1.9% for hypokalaemia, and 9.9% for hyponatraemia.
Maltese: F'pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg f'RCC, ilproporzjon ta' pazjenti li esperjenzaw aggravar mil-linja bażi sa Grad 3 jew 4 l-anormalità tallaboratorju kienet kif ġej: 3.0% għall-anemija (kollha Grad 3), 0.7% għat-tromboċitopenja, 0.6% għallewkopenja, 5.1% għal-limfopenija, 1.1% għan-newtropenija, 2.0% għall-alkaline phosphatase, 4.8% għaż-żieda tal-AST, 6.5% għaż-żieda tal-ALT, 1.1% għaż-żieda tal-bilirubin totali, 2.1% għaż-żieda tal-kreatinina, 7.2% għal ipergliċemija, 1.8% għall-ipogliċemija, 12.2% għaż-żieda tal-amylase, 20.
English: Patients were enrolled regardless of their tumour PD-L1 or human papilloma virus (HPV) status.
Maltese: Il-pazjenti ġew irreġistrati irrispettivament mill-istatus PD-L1 tat-tumur jew talvajrus tal-papilloma uman (HPV, human papilloma virus) tagħhom.
English: 24 mL of concentrate in a 25 mL vial (Type I glass) with a stopper (coated butyl rubber) and a red matte flip-off seal (aluminium).
Maltese: 24 mL ta' konċentrat f'kunjett tal-25 mL (ħġieġ tat-Tip I) b'tapp (lasktu tal-butyl miksi) u siġill aħmar matt li jinqala' bis-seba' (aluminju).