FrancophonIA/ELRC3.0 huggingface dataset:
English: OS in favourable risk patients receiving nivolumab plus ipilimumab compared to sunitinib had a hazard ratio of 1.13 (95% CI: 0.64, 1.99; p = 0.6710).
Maltese: L-OS f'pazjenti b'riskju favorevoli li rċivew nivolumab u ipilimumab meta mqabbel ma' sunitinib kellhom proporzjon ta' riskju ta' 1.13 (95% CI: 0.64, 1.99; p = 0.6710).
English: ≥ 10% to < 50%a
Maltese: ≥ 10% sa < 50%a
English: PHARMACEUTICAL FORM AND CONTENTS Sterile concentrate
Maltese: U KONTENUT Konċentrat sterili
English: with Stage IIIB/C or Stage IV American Joint Committee on Cancer (AJCC), 7th edition, histologically confirmed melanoma that is completely surgically resected.
Maltese: Committee on Cancer (AJCC), is-7 edizzjoni, li ġiet maqtugħa kompletament.
English: The majority of patients were male (75%) and white (88%), all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups were represented, and 34% and 66% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively.
Maltese: Il-maġġoranza tal-pazjenti kienu rġiel (75%) u bojod (88%), il-gruppi ta' riskju ta' Memorial Sloan Kettering Cancer Center (MSKCC) kienu rappreżentati, u 34% u 66% tal-pazjenti kellhom KPS fil-linja bażi ta' 70 sa 80% u 90 sa 100%, rispettivament.
English: Nivolumab showed numerically less effect on OS (HR 1.85; 95% CI: 0.76, 4.51), PFS (HR=1.76; 95%-CI: 0.77, 4.05) and ORR (9.1% vs. 16.7%).
Maltese: Nivolumab wera, numerikament, effett inqas fuq l-OS (HR 1.85; 95% CI: 0.76, 4.51), PFS (HR=1.76; 95%-CI: 0.77, 4.05) u l-ORR (9.1% vs. 16.
English: Uncommon bronchitis bronchitis, aseptic meningitis
Maltese: Mhux komuni Bronkite bronkite, meninġite asettika
English: Sunitinib (events: 209/422), median and 95.0% CI: 26.97 (22.08, 34.83)
Maltese: Sunitinib (avvenimenti: 209/422), medjan u 95.0% CI: 26.
English: Post-marketing event (also see section 4.4).
Maltese: Avveniment ta' wara t-tqegħid fis-suq (ara wkoll sezzjoni 4.4).
English: Each vial contains either 40 mg (in 4 mL), 100 mg (in 10 mL) or 240 mg (in 24 mL) of nivolumab.
Maltese: Kull kunjett fih 40 mg (f'4 mL), 100 mg (f'10 mL) jew 240 mg (f'24 mL) nivolumab.
English: The other ingredients are sodium citrate dihydrate, sodium chloride (see section 2 "OPDIVO contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: Is-sustanzi l-oħra huma sodium citrate dihydrate, sodium chloride (ara sezzjoni 2 ”OPDIVO fih sodium”), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid u ilma għall-injezzjonijiet.
English: PD-L1 Expression nivolumab docetaxel ORR by tumour PD-L1 expression Minimum follow-up: 13.2 months
Maltese: Docetaxel ORR permezz tal-espressjoni PD-L1 tat-tumur Segwitu minimu: 13.2 xhur
English: Rapid onset of GVHD has been reported with nivolumab use before and after allogeneic HSCT (see section 4.4).
Maltese: Feġġa rapida ta' GVHD ġiet irrapportata bl-użu ta' nivolumab qabel u wara HSCT alloġeneika (ara sezzjoni 4.4).
English: 30th September 2021
Maltese: 30 ta' Settembru 2021
English: The estimated 2 and 3 year OS rates were 68% (95% CI: 56, 78) and 61% (95% CI: 49, 71), respectively, for the combination (n = 73) and 53% (95% CI: 36, 68) and 44% (95% CI: 28, 60), respectively, for ipilimumab (n = 37).
Maltese: Ir-rati OS stmati ta' sentejn u 3 snin kienu 68% (95% CI: 56, 78) and 61% (95% CI: 49, 71), rispettivament għall-kombinazzjoni (n = 73) u 53% (95% CI: 36, 68) u 44% (95% CI: 28, 60), rispettivament għal ipilimumab (n = 37).
English: CA209032 was a Phase 1/2 open-label multi-cohort study which included a cohort of 78 patients (including 18 subjects who received planned crossover treatment with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg combination) with similar inclusion criteria to study CA209275 treated with nivolumab monotherapy 3 mg/kg for urothelial carcinoma.
Maltese: CA209032 kien studju multi-koorti open-label ta' Fażi 1/2 li inkluda koorti ta' 78 pazjent (inkluż 18il individwu li rċivew kura crossover (crossover treatment) ippjanata b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg) bi kriterji ta' inklużjoni simili għall-istudju CA209275 ikkurati b'monoterapija b'nivolumab 3 mg/kg għall-kanċer tal-apparat tal-awrina.
English: Respiratory, thoracic and mediastinal disorders Very common dyspnoea Common pneumonitisa,c, pulmonary embolisma, cough pneumonitis, dyspnoea, pleural effusion, cough
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna Dispnea Komuni pulmonitea,c, emboliżmu pulmonaria, tqaħqiħ pulmonite, dispnea, effużjoni plewrali, tqaħqiħ
English: PFS rate at 12 months and 95% CI: 42% (36, 47) - - -- - - Ipilimumab (events: 245/315), median and 95% CI: 2.89 (2.79, 3.42).
Maltese: Ir-rata PFS fi 12-il xahar u 95% CI: 42% (36, 47) - - -- - - Ipilimumab (eventi: 245/315), medjan u 95% CI: 2.89 (2.79, 3.42).
English: No Grade 5 endocrinopathy was reported.
Maltese: Ma ġiet irrappurtata l-ebda endokrinopatija ta' Grad 5.
English: Grade 2, Grade 3, and Grade 4 adrenal insufficiency (including secondary adrenocortical insufficiency) occurred in 2.9% (16/547), 2.2% (12/547) and 0.4% (2/547) of patients, respectively.
Maltese: Insuffiċjenza adrenali (inkluż insuffiċjenza adrenokortikali sekondarja) ta' Grad 2, Grad 3, u Grad 4 seħħet fi 2.9% (16/547), 2.2% (12/547) u 0.4% (2/547) tal-pazjenti, rispettivament.
English: It is to be administered as an intravenous infusion over a period of 30 or 60 minutes depending on the dose (see Tables 1, 2 and 3).
Maltese: Għandu jingħata bħala infużjoni tul perjodu ta' 30 jew 60 minuta skont id-doża (ara t-Tabelli 1, 2 u 3).
English: Quantifiable tumour PD-L1 expression was measured in 79% of patients in the nivolumab group and 77% of patients in the docetaxel group.
Maltese: L-espressjoni kwantifikabbli PD-L1 tat-tumur kienet imkejla f'79% tal-pazjenti fil-grupp nivolumab u 77% tal-pazjenti fil-grupp docetaxel.
English: The following immune-related adverse reactions were reported in less than 1% of patients treated with nivolumab monotherapy or nivolumab in combination with ipilimumab in clinical trials across doses and tumour types: pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barré syndrome, myasthenia gravis, myasthenic syndrome, aseptic meningitis, encephalitis, gastritis, sarcoidosis, duodenitis, myositis, myocarditis, and rhabdomyolysis.
Maltese: Reazzjonijiet avversi oħra relatati mas-sistema immuni Ir-reazzjonijiet avversi relatati mal-immunità li ġejjin kienu rrappurtati f'inqas minn 1% tal-pazjenti ttrattati b'monoterapija ta' Nivolumab jew nivolumab flimkien ma' ipilimumab fi provi kliniċi f'dożi differenti u tipi ta' tumur: pankreatite, uveite, demajelinazzjoni, newropatija awtoimmuni (li tinkludi paresi tan-nerv tal-wiċċ u abducens), sindrome ta' Guillain-Barré, mijastenija gravis, sindrome mijasteniku, meninġite asettika, enċefalite, gastrite, sarkojdożi, duwodenite, mijożite, mijokardite, u rabdomijoliżi.
English: Tumour PD-L1 expression was determined using the PD-L1 IHC 28-8 pharmDx assay.
Maltese: L-espressjoni PD-L1 ta' tumur ġiet determinata permezz tal-assaġġ PDL1 IHC 28-8 pharmDx.
English: Samsung Biologics Co. Ltd. 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon, 21987 Korea
Maltese: Yeonsu-gu, Incheon, 21987 Korea
English: Baseline ECOG performance status was 0 (54%) or 1 (46%).
Maltese: L-istatus talprestazzjoni ECOG fil-Linja Bażi kien 0 (54%) jew 1 (46%).
English: Vogt-Koyanagi-Harada syndromeh Cardiac disorders
Maltese: Sindrome ta' Vogt-Koyanagi-Haradah
English: The primary endpoint was recurrence-free survival (RFS).
Maltese: Il-punt ta' tmiem primarju kien sopravivenza mingħajr rikorrenza (RFS, recurrence-free survival).
English: Recommendation for the use of hormone replacement therapy is provided in section 4.4.
Maltese: Rakkomandazzjoni għall-użu ta' terapija ta' sostituzzjoni ormonali hi pprovduta f'sezzjoni 4.4
English: For tumour PD-L1 expression, 34% of patients had PD-L1 expression ≥ 5% and 62% had < 5% as determined by clinical trial assay.
Maltese: Għal espressjoni ta' PD-L1 ta' tumur, 34% tal-pazjenti kellhom espressjoni PD-L1 ≥ 5% u 62% kellhom <5% stabbilita b'assaġġ ta' prova klinika.
English: Primary analysis Minimum follow-up: 10.6 months
Maltese: Analiżi primarja Segwitu minimu: 10.6 xhur
English: The median PFS was 3.7 months (95% CI: 1.9, 9.3).
Maltese: Il-PFS medjan kien ta' 3.7 xhur (95% CI: 1.9, 9.3).
English: Uncommon Guillain-Barré syndrome, polyneuropathy, neuritis, peroneal nerve palsy, autoimmune neuropathy (including facial and abducens nerve paresis), encephalitisc polyneuropathy, autoimmune neuropathy (including facial and abducens nerve paresis), myasthenia gravisc
Maltese: Mhux komuni is-sindrome ta' Guillain-Barré, polinewropatija, nervite, paraliżi tan-nerv peroneali, newropatija awtoimmuni (inkluż pareżi tal-wiċċ u tan-nervituri abduċeni), enċefalitec polinewropatija, newropatija awtoimmuni (inkluż pareżi tal-wiċċ u tan-nevituri abduċeni), mijastenija gravisc
English: In patients treated with nivolumab monotherapy, the incidence of pneumonitis, including interstitial lung disease and lung infiltration, was 3.4% (87/2578).
Maltese: F'pazjenti kkurati bil-monoterapija ta' nivolumab, l-inċidenza ta' pulmonite, inkluż mard pulmonari intersitzjali u infiltrazzjoni tal-pulmun, kienet ta' 3.4% (87/2578).
English: Cases of Vogt-Koyanagi-Harada syndrome and hypoparathyroidism have been reported postmarketing (see section 4.8).
Maltese: Ġew irrappurtati każijiet ta' sindrome ta' Vogt-Koyanagi-Harada u ta' ipoparatirojdiżmu wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: These changes were not considered clinically relevant.
Maltese: Dan it-tibdil ma tqiesx bħala klinikament rilevanti.
English: Longer follow-up data from Cohort B (minimum 20.5 months) and efficacy of Cohort C from CA209205 are presented below in Table 22.
Maltese: Data ta' segwitu itwal minn Koorti B (minimu 20.5 xhur) u effikaċja ta' Koorti C minn CA209205 huma ppreżentati hawn taħt fit-Tabella 22.
English: Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Bristol-Myers Squibb Pharma EEIG Plaza 254
English: Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT) in classical Hodgkin Lymphoma
Maltese: Kumplikazzjonijiet ta' Trapjant alloġeniku b'Ċelluli Staminali Ematopojetiċi (Haematopoietic Stem Cell Transplant, HSCT) fil-Limfoma ta' Hodgkin klassika
English: Overall survivald
Maltese: Soprvaivenza globalia
English: In patients with tumour PD-L1 expression ≥1%, ORR was 33.5% for nivolumab (n=179; 95% CI: 26.7, 40.9) and 13.5% for chemotherapy (n=74; 95% CI: 6.7, 23.5).
Maltese: F'pazjenti b'espressjoni tat-tumur ta' PD-L1 ≥1%, l-ORR kien ta' 33.5% għal nivolumab (n = 179; 95% CI: 26.7, 40.9) u ta' 13.5% għall-kimoterapija (n = 74; 95% CI: 6.7, 23.5).
English: Among all randomised patients, the ORR was 27.2% (95% CI: 22.0, 32.9) in the nivolumab group and 9.8% (95% CI: 5.3, 16.1) in the chemotherapy group.
Maltese: Fost il-pazjenti randomizzati kollha, l-ORR kien ta' 27.2% (95% CI: 22.0, 32.9) fil-grupp nivolumab u 9.8% (95% CI: 5.3, 16.1) fil-grupp tal-kimoterapija.
English: PFS rate at 12 months and 95% CI: 49% (44, 55) ──Δ─── Nivolumab (events: 183/316), median and 95% CI: 6.87 (4.34, 9.46).
Maltese: Ir-rata PFS fi 12-il xahar u 95% CI: 49% (44, 55) ──Δ─── Nivolumab (eventi: 183/316), medjan u 95% CI: 6.87 (4.34, 9.46).
English: See “Description of selected adverse reactions; laboratory abnormalities” below.
Maltese: Ara “Deskrizzjoni ta' reazzjonijiet avversi partikolari; anormalitajiet tal-laboratorju” iktar ‘il quddiem.
English: The PFS was measured by RECIST, version 1.1.
Maltese: Il-PFS tkejjel b'RECIST, verżjoni 1.1.
English: Rash is a composite term which includes maculopapular rash, rash erythematous, rash pruritic, rash follicular, rash macular, rash morbilliform, rash papular, rash pustular, rash papulosquamous, rash vesicular, rash generalised, exfoliative rash, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, dermatitis exfoliative, dermatitis psoriasiform, drug eruption and pemphigoid.
Maltese: Raxx huwa terminu kompost li jinkludi raxx makulopaulari, raxx eritematuż, raxx pruritiku, raxx follikulari, raxx makulari, raxx bl-infafet, raxx papulari, raxx pustulari, raxx papuloskawmuż, raxx vesikulari, raxx ġeneralizzat, raxx esfoljattiv, dermatite, dermatite akneiform, dermatite allerġika, dermatite atopika, dermatite bulloża, dermatite esfoljattiva, dermatite psorjasiforme, eruzzjoni tal-mediċina u l-formazzjoni ta' nfafet bl-ilma jew qsim talġilda (pemfigojde).
English: Patients had to have a Karnofsky Performance Score (KPS) ≥ 70%.
Maltese: Il-pazjenti kellu jkollhom punteġġ tal-prestazzjoni ta' Karnofsky (KPS)  70%.
English: Not reached (2.9-20.5+)
Maltese: Ma ntlaħaqx (2.9-20.5+)
English: Figure 12: Kaplan-Meier curves of OS (CA209141)
Maltese: Kaplan-Meier ta' OS (CA209141)
English: A total of 361 patients were randomised to receive either nivolumab 3 mg/kg (n = 240) administered intravenously over 60 minutes every 2 weeks or investigator's choice of either cetuximab (n = 15), 400 mg/m2 loading dose followed by 250 mg/m2 weekly or methotrexate (n = 52) 40 to 60 mg/m2 weekly, or docetaxel (n = 54) 30 to 40 mg/m2 weekly.
Maltese: Total ta' 361 pazjent ġew randomizzati sabiex jirċievu jew nivolumab 3 mg/kg (n = 240) mogħti ġolvina għal 60 minuta kull ġimagħtejn jew l-għażla tal-investigatur ta' jew cetuximab (n = 15), 400 mg/m2 doża tat-tagħbija segwita minn 250 mg/m2 kull ġimgħa jew methotrexate (n = 52) 40 sa 60 mg/m2 kull ġimgħa, jew docetaxel (n = 54) 30 sa 40 mg/m2 kull ġimgħa.
English: Confirmed objective response
Maltese: complete response)
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.8% (26/547), 6.6% (36/547), and 1.6% (9/547) of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2, Grad 3 u Grad 4 f'4.8% (26/547), 6.6% (36/547), u 1.6% (9/547) tal-pazjenti, rispettivament.
English: The median age was 60 years (range: 23-88).
Maltese: L-età medjana kienet ta' 60 sena (medda: 23-88).
English: CA209039 is a Phase 1b open-label, multi-centre, dose-escalation, and multidose study of nivolumab in relapsed/refractory hematologic malignancies, including 23 patients with cHL treated with nivolumab 3 mg/kg monotherapy; amongst which, 15 patients received prior brentuximab vedotin treatment as a salvage therapy following ASCT, similar to Cohort B of study CA209205.
Maltese: CA209039 huwa studju ta' Fażi 1b, open-label, multi-ċentriku, b'doża li togħla, u b'ħafna dożi ta' nivolumab f'tumuri ematoloġiċi li reġgħu ħarġu/refrattarji, inkluż 23 pazjent bis-cHL ikkurati b'monoterapija ta' nivolumab 3 mg/kg; fejn fosthom, 15-il pazjent irċevew kura minn qabel bi brentuximab vedotin bħala terapija tas-salvataġġ wara ASCT, b'mod simili għal Koorti B tal-istudju CA209205.
English: Patients with active autoimmune disease and symptomatic interstitial lung disease were excluded from clinical trials of cHL (see section 5.1).
Maltese: Pazjenti b'mard awtoimmuni attiv u mard pulmonari intersitzjali sintomatiku kienu esklużi mill-provi kliniċi tas-cHL (ara sezzjoni 5.1).
English: Investigator assessed ORR was 61% (95% CI: 48.9, 72.4) in the combination arm (n = 72) versus 11% (95% CI: 3.0, 25.4) for the ipilimumab arm (n = 37).
Maltese: L-investigatur evalwa li l-ORR kienet 61% (95% CI: 48.9, 72.4) fil-fergħa ta' kombinazzjoni (n = 72) kontra 11% (95% CI: 3.0, 25.4) għall-fergħa ta' ipilimumab (n = 37).
English: Grade 4 rash
Maltese: Raxx ta' Grad 4
English: Data unstable due to the limited duration of response.
Maltese: Data mhux stabbli minħabba żmien limitat ta' rispons.
English: Figure 6: Overall survival by PD-L1 expression: 1% cut off (CA209067) - Minimum follow-up of 36 months
Maltese: Figura 6: Sopravivenza globali skont l-espressjoni PD-L1: 1% cut off (CA209067) - Segwitu minimu ta' 36 xahar
English: Randomised phase 3 study vs. dacarbazine (CA209066)
Maltese: Studju każwali ta' fażi 3 vs. dacarbazine (CA209066)
English: Immune-related nephritis and renal dysfunction
Maltese: Nefrite relatata malimmunità u disfunzjoni tal-kliewi
English: Squamous NSCLC
Maltese: NSCLC skwamuż
English: Grade 4 creatinine elevation
Maltese: Elevazzjoni tal-kreatinina ta' Grad4
English: Table 15: ORR based on response evaluable patients - total and by subgroup (CA209171) Results
Maltese: ORR abbażi tal-pazjenti evalwabbli fuq ir-rispons - total u skont is-subgroup (CA209171)
English: Incidence rates per 100 person-years of exposure were 9.3 vs. 0; serious cardiac events were reported by 4.9% patients in the nivolumab group vs. 0 in the investigator´s choice group.
Maltese: Rati ta' inċidenza għal kull 100 sena ta' persuna ta' esponiment kienu ta' 9.3 vs 0; każijiet kardijaċi serji kienu rrappurtati f'4.9% tal-pazjenti fil-grupp ta' nivolumab vs 0 fil-grupp ta' għażla tal-investigatur.
English: Confirmed objective response (IRRC) (95% CI)
Maltese: Rispons oġġettiv ikkonfermat (IRRC) (95% CI)
English: Of patients evaluable for the presence of antiipilimumab antibodies, the incidence of anti-ipilimumab antibodies ranged from 6.3 to 8.4% and neutralising antibodies against ipilimumab ranged from 0 to 0.3%.
Maltese: Mill-pazjenti evalwabbli għall-preżenza ta' antikorpi kontra ipilimumab, l-inċidenza ta' antikorpi kontra ipilimumab varjat minn 6.3 sa 8.4% u ta' antikorpi newtralizzanti kontra ipilimumab varjat minn 0 sa 0.3%.
English: Other medicines and OPDIVO
Maltese: Mediċini oħra u OPDIVO
English: Hazard ratio 98.52% CI p-value
Maltese: Sopravivenza globali Avvenimenti Proporzjon ta' periklu 98.52% CI valur-p
English: Median age, years (range) Gender
Maltese: Età medjana, snin (firxa) Sess
English: Uncommon polyneuropathy, autoimmune neuropathy (including facial and abducens nerve paresis)
Maltese: Mhux komuni polinewropatija, newropatija awtoimmuni (inkluż pareżi tal-wiċċ u tan-nervituri abduċeni)
English: Table 6: Adverse reactions with nivolumab in combination with ipilimumab Nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg*
Maltese: Tabella 6: Reazzjonijiet avversi b'nivolumab mogħti flimkien ma' ipilimumab Nivolumab 1 mg/kg mogħti flimkien ma' ipilimumab 3 mg/kg*
English: The differences between the two nivolumab-containing groups were evaluated descriptively.
Maltese: Id-differenzi bejn iż-żewġ gruppi li fihom nivolumab ġew evalwati b'mod deskrittiv.
English: CA209205 is an ongoing Phase 2, open-label, multi-cohort, single-arm study of nivolumab in cHL.
Maltese: CA209205 huwa studju li għadu għaddej ta' Fażi 2, open-label, multi-koorti, ta' fergħa waħda ta' nivolumab fis-cHL.
English: NAME OF THE MEDICINAL PRODUCT OPDIVO 10 mg/mL sterile concentrate nivolumab
Maltese: OPDIVO 10 mg/mL konċentrat sterili nivolumab
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għall-aġġusament tal-pH) Hydrochloric acid (għall-aġġusament tal-pH)
English: Fluid in the lungs
Maltese: Fluwidu fil-pulmun
English: Grade 2 adrenal insufficiency Grade 3 diabetes
Maltese: Insuffiċjenza adrenali ta' Grad 2 Dijabete ta' Grad 3
English: Open-label phase 1 dose-escalation study (MDX1106-03)
Maltese: Studju b'doża li togħla ta' Fażi 1 open-label (MDX106-03)
English: PD-L1 Expression nivolumab investigator's choice OS by tumour PD-L1 expression Number of events (number of patients)
Maltese: nivolumab għażla tal-investigatur OS skont l-espressjoni PD-L1 tat-tumur Numru ta' avvenimenti (numru ta' pazjenti)
English: Nivolumab has not been studied in patients with moderate (total bilirubin > 1.5 × to 3 × ULN and any AST) or severe hepatic impairment (total bilirubin > 3 × ULN and any AST) (see section 4.2).
Maltese: Nivolumab ma ġiex studjat f'pazjenti b'indeboliment talfwied moderat (bilirubina totali > 1.5 × sa 3 × ULN u kwalunkwe AST) jew sever (bilirubina totali > 3 × ULN u kwalunkwe AST) (ara sezzjoni 4.2).
English: ──Δ─── Nivolumab (events: 50/210), median and 95% CI: N.A. - - -- - - Dacarbazine (events: 96/208), median and 95% CI: 10.84 (9.33, 12.09)
Maltese: ──Δ─── Nivolumab (avvenimenti: 50/210), medjan u 95% CI: Mhux Disponibbli - - -- - - Dacarbazine (avvenimenti: 96/208), medjan u 95% CI: 10.
English: The Kaplan-Meier curves for OS are shown in Figure 12.
Maltese: Il-kurvi Kaplan-Meier għal OS qed jintwerew fil-Figura 12.
English: CA209205 Cohort Ba CA209039
Maltese: CA209205 Koorti Ba u CA209039
English: Immune system disorders Common infusion related reaction, hypersensitivity infusion-related reaction, hypersensitivity
Maltese: Disturbi fis-sistema immuni Komuni reazzjoni marbuta mal-infużjoni, sensittività eċċessivac reazzjoni marbuta mal-infużjoni, sensittività eċċessiva
English: Objective response (95% CI) Odds ratio (95% CI) p-value
Maltese: Rispons tal-oġġettiv (95% CI) Odds ratio (95% CI) valur p
English: Very common increased AST, increased ALT, increased total bilirubin, increased alkaline phosphatase, increased lipase, increased amylase, increased creatinine, hyperglycaemiac, hypoglycaemia, lymphopaenia, leucopoenia, neutropaenia, thrombocytopaenia, anaemiak, hypocalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia increased AST, increased ALT, increased total bilirubin, increased alkaline phosphatase, increased lipase, increased amylase, increased creatinine, hyperglycaemiac, hypoglycaemia, lymphopaenia, leucopoenia, neutropaeniac, thrombocytopaenia, anaemiak, hypercalcaemia, hypocalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia
Maltese: Komuni ħafna żieda fl-AST, żieda fl-ALT, żieda filbilirubina totali, żieda f'alkaline phosphatase, żieda fil-lipase, żieda flamylase, żieda fil-kreatinina, ipergliċemijac, ipogliċemija, limfopenija, lewkopenija, newtropenija, tromboċitopenija, anemijak, ipokalċemija, iperkalemija, ipokalemija, ipomanjesimja, iponatremja żieda fl-AST, żieda fl-ALT, żieda filbilirubina totali, żieda f'alkaline phosphatase, żieda fil-lipase, żieda flamylase, żieda fil-kreatinina, ipergliċemijac, ipogliċemija, limfopenija, lewkopenija, newtropenijac, tromboċitopenija, anemijak, iperkalċemija, ipokalċemija, iperkalemija, ipokalemija, ipomanjesimja, iponatremja
English: Renal and urinary disorders Common renal failure (including acute kidney injury)a,c renal failure (including acute kidney injury)c
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Komuni indeboliment tal-kliewi (inkluż ħsara akuta fil-kliewi)a,c indeboliment tal-kliewi (inkluż ħsara akuta fil-kliewi)c
English: To further investigate the value of biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other genomic-based methods/ assays, and associated cut offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1, PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, expression of components of antigen-presentation complexes and/or other inhibitory checkpoint receptors/ligands within tumour, etc.) as predictive of nivolumab + ipilimumab combination therapy efficacy in the context of melanoma studies CA209038, CA209067, or CA209069.
Maltese: Sabiex jiġi mistħarreġ aktar il-valur ta' bijomarkaturi li mhumiex ta' stat ta' espressjoni PD-L1 f'livell ta' membrana ta' rita ta' ċellola ta' tumur minn IHC (eż., metodi/assaġġi oħrajn ibbażati fuq il-ġenomika, u cut offs assoċjati, li jistgħu jkunu aktar sensittivi u speċifiċi biex jipprevedu rispons għal trattament abbażi ta' PD-L1, PD-L2, limfoċiti infiltranti tat-tumur b'kejl ta' densità ta' CD8+T, firma RNA, espressjoni ta' komponenti ta' kumplessi ta' prestazzjoni ta' antiġen u/jew riċetturi/liganti talpunt ta' kontroll inibitorji fit-tumur, eċċ.) bħala previżjoni taleffikaċja ta' terapija kombinata ta' nivolumab + ipilimumab filkuntest tal-istudji dwar il-melanoma CA209038, CA209067, jew CA209069.
English: Table 17: ORR and OS by tumour PD-L1 expression (CA209057)
Maltese: ORR u OS permezz tal-espressjoni PD-L1 tat-tumur (CA209057) Espressjoni PD-L1
English: Nivolumab+ipilimumab vs nivolumab (descriptive analysis) - HR (95% CI): 0.85 (0.68, 1.07)
Maltese: Nivolumab+ipilimumab vs nivolumab (analiżi deskrittiva) - HR (95% CI): 0.85