FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored for signs and symptoms of hepatitis such as transaminase and total bilirubin elevations.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' epatite bħal żieda fit-transaminasi u fil-bilirubina totali.
English: Nivolumab 3 mg/kg (events: 184/240), median and 95% CI: 7.72 (5.68,8.77) Investigator's choice (events: 105/121), median and 95% CI: 5.06 (4.04, 6.24)
Maltese: 72 (5.68,8.77) L-għażla tal-investigatur (avvenimenti: 105/121), medjan u 95 % CI: 5.06 (4.04, 6.24) Tabella 23: Riżultati tal-effikaċja (CA209141)
English: Intestinal perforation, inflammation of the stomach (gastritis), inflammation of the duodenum Skin disease with thickened patches of red skin, often with silvery scales (psoriasis), severe condition of the skin that causes red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body (erythema multiforme) Severe and possibly fatal peeling of the skin (Stevens-Johnson syndrome) Chronic disease of joints (spondyloarthropathy), disease in which the immune system attacks the glands that make moisture for the body, such as tears and saliva (Sjogren's syndrome), aching muscles, muscle tenderness of weakness, not caused by exercise (myopathy), inflammation of the muscles (myositis), stiffness in muscles and joints, muscle spasm (rhabdomyolysis), inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica) Inflammation of the kidney
Maltese: Perforazzjoni intestinali, infjammazzjoni tal-istonku (gastrite), infjammazzjoni tad-duwodenu Marda tal-ġilda b'irqajja' magħquda ta' ġilda ħamra, ħafna drabi bi skali lewn il-fidda (psorjasi), kondizzjoni severa tal-ġilda li tikkawża ponot ħomor, ħafna drabi bil-ħakk, simili għar-raxx talħosba, li jibdew fuq ir-riġlejn u xi drabi fuq il-wiċċ u l-bqija tal-ġisem (eritema multiforme) Tqaxxir sever u possibbilment fatali tal-ġilda (sindrome ta' Stevens-Johnson)
English: If diagnosis of corticosteroidrefractory immune-related colitis is confirmed addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered.
Maltese: Jekk id-dijanjosi tal-kolite relatata mas-sistema immunitarja li tirreżisti l-kortikosterojdi hija kkonfermata, għandha tiġi kkunsidrata ż-żieda ta' aġent immunosoppressiv alternattiv fit-terapija tal-kortikosterojdi, jew is-sostituzzjoni tat-terapija tal-kortikosterojdi.
English: A total of 272 patients were randomised to receive either nivolumab 3 mg/kg (n = 135) administered intravenously over 60 minutes every 2 weeks or docetaxel (n = 137) 75 mg/m2 every 3 weeks.
Maltese: Total ta' 272 pazjenti ntgħażlu b'mod każwali sabiex jirċievew jew 3 mg/kg nivolumab (n = 135) mogħti ġol-vina għal 60 minuta kull ġimagħtejn jew docetaxel (n = 137) 75 mg/m2 kull 3 ġimgħat.
English: Grade 5 cases were reported in < 0.1% (2/2578) of patients in these studies.
Maltese: Każijiet ta' Grad 5 ġew irrapportati f'< 0.1% (2/2578) tal-pazjenti f'dawn listudji.
English: Table 8: Efficacy Results (CA209066)
Maltese: Tabella 8: Riżultati ta' effikaċja (CA209066) nivolumab (n = 210)
English: Grade 2 hypopituitarism occurred in 0.4% (2/547) of patients.
Maltese: Seħħ ipopitwitariżmu ta' Grad 2 f'0.4% (2/547) tal-pazjent.
English: ipilimumab Median OS (95% CI)
Maltese: ipilimumab OS medjana (95% CI)
English: Common hypothyroidism, hyperthyroidism
Maltese: Mhux komuni polymyalgia rheumatica, artrite
English: Randomised phase 3 study of nivolumab as monotherapy vs. everolimus (CA209025)
Maltese: Karċinoma taċ-Ċellola tal-Kliewi Studju ta' fażi 3 randomizzat ta' nivolumab bħala monoterapija vs. everolimus (CA209025)
English: n ipilimumab Median OS (95% CI)
Maltese: n ipilimumab OS medjana (95% CI)
English: N responders/ N evaluablea 95% CIb a includes confirmed and unconfirmed responses, scans were mandatory only at week 8/9 and week 52.
Maltese: 95% CIb a jinkludu risponsi kkonfermati u mhux ikkonfermati, l-iskenns kienu obbligatorji biss fil-ġimgħa 8/9 u filġimgħa 52.
English: Grade 3 diarrhoea or colitis observed with nivolumab in combination with ipilimumab requires permanent discontinuation of treatment and initiation of corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Dijarea jew kolite tal-Grad 3 osservati b'nivolumab mogħti flimkien ma' ipilimumab jeħtieġu twaqqif permanenti tal-kura u għandhom jinbdew il-kortikosterojdi f'doża ta' 1 sa 2 mg/kg/kuljum f'ekwivalenti ta' methylprednisolone.
English: The improvement in OS was similar between nivolumab in combination with ipilimumab and nivolumab monotherapy in patients with high tumour PD-L1 expression (PD-L1 ≥ 1%).
Maltese: It-titjib fl-OS kien simili bejn nivolumab flimkien ma' ipilimumab u monoterapija ta' nivolumab f'pazjenti b'espressjoni għolja ta' PD-L1 tat-tumur (PD-L1 ≥ 1%).
English: Grade 2, Grade 3, and Grade 4 cases were reported in 1.6% (7/448), 0.9% (4/448), and 0.7% (3/448) of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2, Grad 3 u Grad 4 f'1.6% (7/448), 0.9% (4/448), u 0.7% (3/448) tal-pazjenti, rispettivament.
English: In addition, levels of myeloid-derived suppressor cells in circulation will be explored in study CA209038.
Maltese: Barra minn hekk, il-livelli taċ-ċelluli li jrażżnu derivati millmajelojde fiċ-ċirkolazzjoni sejrin jiġu esplorati fl-istudju CA209038.
English: Median time to onset was 1.2 months (range: 0.0-22.6).
Maltese: Il-ħin medjan sal-bidu kien ta' 1.2 xhur (firxa: 0.0-22.6).
English: Nivolumab+Ipilimumab (events: 77/155), median and 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (events: 86/171), median and 95% CI: 14.00 (7.03, N.A.) Ipilimumab (events: 129/164), median and 95% CI: 3.91 (2.83, 4.17)
Maltese: - - -*- - - - Nivolumab+Ipilimumab (eventi: 77/155), medjan u 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (eventi: 86/171), medjan u 95% CI: 14.
English: Rare cases of SJS and TEN some of them with fatal outcome have been observed (see sections 4.2 and 4.4).
Maltese: Ġew osservati każijiet rari ta' SJS u TEN b'xi wħud minnhom b'riżultat fatali (ara sezzjonijiet 4.2 u 4.4).
English: 4 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a dark blue flip-off seal (aluminium).
Maltese: 4 mL konċentrat f'kunjett tal-10 mL (ħġieġ tat-Tip I) b'tapp (lasktu tal-butyl miksi) u siġill blu skur li jinqala' mis-seba' (aluminju).
English: Duration of response in CR (months) Median (95% CI)
Maltese: Durata tar-rispons f'CR (xhur) Medjana (95% CI)
English: Median (95% CI) (months) Rate (95% CI) at 12 months
Maltese: Medjan (95% CI) xhur Rata (95% CI) wara 12-il xahar
English: Classical Hodgkin Lymphoma (cHL)
Maltese: PFS medjanaa (xhur)
English: The majority of cases were Grade 1 or 2 in severity reported in 1.6% (41/2578) and 0.7% (18/2578) of patients respectively.
Maltese: Il-maġġoranza tal-każijiet kienu ta' Grad 1 jew 2 fis-severità rrapportata f'1.6% (41/2578) u 0.7% (18/2578) tal-pazjenti rispettivament.
English: Median time to onset was 2.1 months (range: 0.0-16.1).
Maltese: Il-ħin medjan sal-bidu kien 2.1 xhur (firxa: 0.0-16.1).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION OPDIVO 10 mg/mL sterile concentrate nivolumab
Maltese: U MNEJN GĦANDU JINGĦATA OPDIVO 10 mg/mL konċentrat sterili nivolumab
English: Median time to onset of these endocrinopathies was 1.9 months (range: 0.0-22.3).
Maltese: Il-ħin medjan sal-bidu ta' dawn l-endokrinopatiji kien 1.9 xhur (firxa: 0.0-22.3).
English: In patients treated with nivolumab after allogeneic HSCT, rapid-onset and severe GVHD, some with fatal outcome, have been reported in the post-marketing setting.
Maltese: F'pazjenti kkurati b'nivolumab wara HSCT alloġeneika, GVHD b'feġġa rapida u severa, uħud b'riżultat fatali ġew irrapportati fl-ambjent ta' wara t-tqegħid fis-suq.
English: Common adrenal insufficiency, hypopituitarism, hypophysitis, hyperthyroidism, thyroiditis adrenal insufficiencyc, hypophysitisc, thyroiditis, diabetes mellitusc
Maltese: Disturbi fis-sistema endokrinarja Komuni ħafna Ipotirojdiżmu Komuni insuffiċjenza adrenali, ipotirojdiżmu, ipofiżite, ipertirojdiżmu, titrojdite insuffiċjenza adrenalic, ipofiżitec, titrojdite, dijabete mellitusc
English: • patients treated with prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways),
Maltese: • pazjenti kkurati b'terapija preċedenti b'antikorp anti-PD-1, anti-PD-L1, anti-PD-L2, anti
English: Unstratified Hazard Ratio (95% CI)
Maltese: Rispons oġġettiv ikkonfermat (95% CI)
English: To further investigate the value of biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other methods / assays, and associated cut offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1 (on tumour- and tumour associated immune cells), PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, Tumour mutational burden) as predictive of nivolumab adjuvant therapy efficacy.
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, u cut offs assoċjati, li jistgħu jkunu aktar sensittivi u speċifiċi biex jipprevedu rispons għal trattament abbażi ta' PD-L1 (fuq ċelloli immuni ta' tumur jew assoċjati ma' tumur), PD-L2, limfoċiti infiltranti tat-tumur b'kejl ta' densità ta' CD8+T, firma RNA, piż mutazzjonali ta' tumur) bħala previżjoni ta' effikaċja ta' terapija aġġuvanti ta' nivolumab.
English: Median time to onset was 1.8 months (range: 0.0-26.6).
Maltese: Il-ħin medjan sal-bidu kien ta' 1.8 xhur (firxa: 0.0-26.6).
English: Infections and infestations Common pneumonia, upper respiratory tract infection pneumonia, upper respiratory tract infection, conjunctivitis
Maltese: Infezzjonijiet u Infestazzjonijiet Komuni pulmonite, infezzjoni fil-parti ta' fuq talapparat respiratorju pulmonite, infezzjoni fil-parti ta' fuq talapparat respiratorju, konġuntivite
English: Patients with tumour PD-L1 expression by all predefined expression levels in the nivolumab group demonstrated greater likelihood of improved survival compared to docetaxel, whereas survival was similar to docetaxel in patients with low or no tumour PD-L1 expression.
Maltese: Il-pazjenti b'espressjoni PD-L1 tat-tumur mil-livelli kollha tal-espressjoni definiti minn qabel filgrupp nivolumab urew probabilità akbar ta' sopravivenza mtejba meta mqabbla ma' docetaxel, mentri s-sopravivenza f'pazjenti b'espressjoni PD-L1 tat-tumur baxxa jew mingħajra kienet simili għal docetaxel.
English: Table 13: Efficacy results (CA209238)
Maltese: Tabella 13: Riżultati tal-effikaċja (CA209238) nivolumab (n = 453)
English: Post authorisation efficacy study (PAES): The MAH should submit the addendum to the CA209205 Final CSR reporting the OS data and data from the discontinuation schedule in Cohort C.
Maltese: Il-MAH għandu jissottometti l-addendum għasCSR Finali ta' CA209205 fejn fih jirrapporta d-data OS u data milliskeda ta' waqfien fil-Koorti C.
English: Efficacy results based on investigator-assessed ORR are presented in Table 15 below.
Maltese: Ir-riżultati tal-effikaċja abbażi tal-ORR ivvalutat minn investigatur huma ppreżentati fit-Tabella 15 hawn taħt.
English: Immune-related colitis
Maltese: Kolite relatata massistema immunitarja
English: Table 7: Immune-related adverse reactions leading to permanent discontinuation or requiring high-dose corticosteroids by dosing regimen Nivolumab 3 mg/kg monotherapy
Maltese: Reazzjonijiet avversi relatati mas-sistema immunitarja li wasslu għal twaqqif permanenti jew li kienu jeħtieġu kortikosterojdi ta' doża għolja b'reġimen tad-dożaġġ Monoterapija ta' nivolumab 3 mg/kg
English: Uncommon metabolic acidosis
Maltese: Mhux komuni aċidożi metabolika
English: If not used immediately, chemical and physical in-use stability of OPDIVO has been demonstrated for 24 hours at 2ºC to 8ºC protected from light and a maximum of 8 hours at 20°C-25°C and room light (this 8-hour period of the total 24 hours should be inclusive of the product administration period).
Maltese: Jekk ma jintużax minnufih, l-istabilità kimika u fiżika ta' OPDIVO waqt l-użu ġew murija għal 24 siegħa f'temperatura ta' 2 ºC sa 8 ºC protett mid-dawl u massimu ta' 8 sigħat f'temperatura ta' 20 °C-25
English: Derived from a stratified proportional hazards model.
Maltese: Meħud minn mudell ta' perikli proporzjonali stratifikati.
English: Uncommon tubulointerstitial nephritis, renal failure (including acute kidney injury)a,c General disorders and administration site conditions Very common fatigue
Maltese: Mhux komuni nefrite tubulointerstizjali, indeboliment tal-kliewi (inkluż ħsara akuta fil-kliewi)a,c Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna għeja
English: How to use OPDIVO 4.
Maltese: Effetti sekondarji possibbli 5.
English: Baseline ECOG performance status score was 0 (90%) or 1 (10%).
Maltese: Il-punteġġ tal-istatus tal-prestazzjoni tal-ECOG ta' linja bażi kien 0 (90%) jew 1 (10%).
English: Nivolumab+Ipilimumab (events: 29/68), median and 95% CI: N.A. (9.72, N.A.) ──Δ─── Nivolumab (events: 38/80), median and 95% CI: 21.95 (8.90, N.A.) Ipilimumab (events: 57/75), median and 95% CI: 3.94 (2.79, 4.21)
Maltese: 38/80), medjan u 95% CI: 21.95 (8.90, N.A.) - - -- - - Ipilimumab (eventi: 57/75), medjan u 95% CI: 3.94
English: All were considered not related to nivolumab by investigators except arrhythmia (atrial fibrillation, tachycardia and ventricular arrhythmia).
Maltese: Kollha kienu kkunsidrati mhux relatati ma' nivolumab mill-investigaturi ħlief arritmija (fibrillazzjoni atrijali, takikardja u arritmija ventrikulari).
English: A total of 906 patients were randomised to receive either nivolumab 3 mg/kg (n = 453) administered every 2 weeks or ipilimumab 10 mg/kg (n = 453) administered every 3 weeks for 4 doses then every 12 weeks beginning at week 24 for up to 1 year.
Maltese: Total ta' 906 pazjenti ġew randomizzati biex jirċievu jew nivolumab 3 mg/kg (n = 453) mogħti kull ġimagħtejn jew ipilimumab 10 mg/kg (n = 453) mogħti kull 3 ġimgħat għal 4 dożi, imbagħad kull 12il ġimgħa li jibdew minn ġimgħa 24 għal massimu ta' sena.
English: PD-L1 < 1%, PD-L1+ TAIC abundantd
Maltese: PD-L1  1%, PD-L1+ TAIC abbundanti (61 nivolumab, 47 għażla talinvestigatur)
English: The PFS HRs for nivolumab vs. chemotherapy were 1.58 (95% CI: 0.87, 2.87) for BRAF mutationpositive patients and 0.82 (95% CI: 0.60, 1.12) for BRAF wild-type patients.
Maltese: Il-PFS HRs għal nivolumab vs. kimoterapija kienu ta' 1.58 (95% CI: 0.87, 2.87) għall-pazjenti mutanti pożittivi tal-BRAF u 0.
English: Patients with a baseline performance score ≥ 2, active brain metastases or autoimmune disease, symptomatic interstitial lung disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of NSCLC (see sections 4.5 and 5.1).
Maltese: Pazjenti b'punteġġ tal-prestazzjoni fil-linja bażi ta' ≥ 2, b'metastasi attiva fil-moħħ jew b'mard awtoimmuni, mard interstizjali sintomatiku tal-pulmun, u pazjenti li kienu qegħdin jirċievu immunosuppressanti sistemiċi qabel ma daħlu fl-istudju ġew esklużi mill-provi kliniċi pivotali ta' NSCLC (ara sezzjonijiet 4.5 u 5.1).
English: Grade 4 or recurrent Grade 3 ; persistent Grade 2 or 3 despite treatment modification; inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day
Maltese: Grad 4 jew Grad 3 rikorrenti: presistenti Grad 2 jew 3 minkejja ttibdil fil-kura; inabbiltà biex id-doża ta' konkosterojde titnaqqas għal 10 mg prednisone jew ekwivalenti kuljum
English: Uncommon (may affect up to 1 in 100 people) Bronchitis
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn 100)
English: Data from SCCHN, adjuvant melanoma and first-line RCC patients 75 years of age or older are too limited to draw conclusions on this population (see sections 4.8 and 5.1).
Maltese: Data minn pazjenti b'SCCHN, b'melanoma aġġuvanti u RCC tal-ewwel linja ta' 75 sena jew aktar hi limitata wisq biex wieħed jasal għal konklużjonijiet dwar din il-popolazzjoni (ara sezzjonijiet 4.8 u 5.1).
English: The majority of patients (72%) were treated with one prior anti-angiogenic therapy.
Maltese: Ilmaġġoranza tal-pazjenti (72%) kienu kkurati b'terapija anti-anġjoġenika minn qabel waħda.
English: For Grade 2 or 3 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Maltese: Għal elevazzjoni tal-kreatinina fis-serum ta' Grad 2 jew 3, nivolumab jew nivolumab mogħti flimkien ma' ipilimumab għandhom jiġu interrotti u għandhom jinbdew il-kortikosterojdi b'doża ta' 0.5 sa 1 mg/kg/jum ta' ekwivalenti għall-methylprednisolone.
English: Table 22: Updated efficacy results in patients with relapsed/refractory classical Hodgkin lymphoma from longer follow up of study CA209205
Maltese: Tabella 22: Riżultati tal-effikaċja aġġornati f'pazjenti b'limfoma ta' Hodgkin klassika rikaduta/rifrattarja minn segwitu itwal ta' studju CA209205 CA209205 Koorti Ba
English: ** nivolumab in combination with ipilimumab for the first 4 doses then followed by nivolumab monotherapy in RCC.
Maltese: ** nivolumab mogħti flimkien ma' ipilimumab għall-ewwel 4 dożi mbagħad segwit minn monoterapija ta' nivolumab f'RCC.
English: Grade 2 cases were reported in 2.4% (13/547) of patients.
Maltese: Kienu rrappurtati każijiet ta' Grad 2 f'2.4% (13/547) tal-pazjenti.
English: Grade 2 and Grade 3 hypopituitarism occurred in 0.4% (2/448) and 0.7% (3/448) of patients, respectively.
Maltese: Seħħ ipopitwitariżmu ta' Grad 2 u Grad 3 f'0.4% (2/448) u 0.7% (3/448) tal-pazjenti, rispettivament.
English: Administer the OPDIVO infusion intravenously over a period of 30 or 60 minutes depending on the dose.
Maltese: Agħti l-infużjoni ta' OPDIVO ġol-vina fuq 30 jew 60 minuta skont id-doża.
English: Common infusion related reactionc, hypersensitivityc
Maltese: Disturbi fis-sistema immuni Komuni reazzjoni marbuta mal-infużjonic, sensittività eċċessivac
English: Withhold dose(s)
Maltese: Waqqaf id-doża(i)
English: Symptomatic Grade 2 or 3 hypothyroidism, hyperthyroidism, hypophysitis,
Maltese: Ipotirojdiżmu, ipertirojdiżmu, ipofiżite ta' Grad 2 jew 3 simptomatiċi
English: Hazard ratio 95% CI p-value
Maltese: Proporzjon ta' periklu 95% CI valur-p
English: Table 1: Recommended dose and infusion time for intravenous administration of nivolumab monotherapy
Maltese: Tabella 1: Doża u żmien ta' infużjoni rakkomandati għal għoti ġol-vini ta' monoterapija b'nivolumab
English: Confirmed objective response (BICR)
Maltese: Rispons oġġettiv ikkonfermat (BICR)
English: In patients treated with nivolumab monotherapy, the incidence of thyroid disorders, including hypothyroidism or hyperthyroidism, was 9.6% (248/2578).
Maltese: F'pazjenti kkurati bil-monoterapija ta' nivolumab, l-inċidenza ta' disturbi tat-tirojde, fosthom ipotirojdiżmu jew ipertirojdiżmu, kienet ta' 9.6% (248/2578).
English: Shortness of breath (dyspnoea)
Maltese: Qtugħ ta' nifs (dispnea)
English: Immune-related hepatitis
Maltese: Epatite relatata massistema immunitarja
English: Grade 2 diarrhoea or colitis
Maltese: Rari ketoaċidożi dijabetika
English: A total of 582 patients were randomised to receive either nivolumab 3 mg/kg administered intravenously over 60 minutes every 2 weeks (n = 292) or docetaxel 75 mg/m2 every 3 weeks
Maltese: Total ta' 582 pazjenti ntgħażlu b'mod każwali sabiex jirċievew jew 3 mg/kg nivolumab (n = 292) mogħti ġol-vina għal 60 minuta kull ġimagħtejn jew docetaxel (n = 290) 75 mg/m2 kull 3 ġimgħat.
English: A total of 821 patients were randomised to receive either nivolumab 3 mg/kg (n = 410) administered intravenously over 60 minutes every 2 weeks or everolimus (n = 411) 10 mg daily, administered orally.
Maltese: Total ta' 821 pazjent kienu magħżula b'mod każwali sabiex jirċievew jew nivolumab 3 mg/kg (n = 410) mogħti minn ġol-vina fuq 60 minuta kull ġimagħtejn jew everolimus (n = 411) 10 mg kuljum, mogħti minn ġol-ħalq.
English: Median
Maltese: Komuni
English: Uncommon uveitis
Maltese: Mhux komuni
English: The majority of cases were Grade 1 or 2 in severity reported in 0.8% (21/2578) and 1.7% (44/2578) of patients respectively.
Maltese: Il-maġġoranza ta' dawn il-każijiet kellhom severità ta' Grad 1 jew 2 rapportati f'0.8% (21/2578) u 1.7% (44/2578) ta' pazjenti rispettivament.
English: After administration of the nivolumab dose, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Maltese: Jekk applikabbli, iddilwa mal-volum meħtieġ ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride jew soluzzjoni għall-injezzjoni ta' 50 mg/mL (5%) glukożju.
English: All patients received nivolumab 3 mg/kg monotherapy intravenously over 60 minutes every 2 weeks.
Maltese: Il-pazjenti kollha rċevew monoterapija ta' nivolumab 3 mg/kg ġol-vina għal perjodu ta' 60 minuta kull ġimagħtejn.
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.39 (0.28, 0.54) Nivolumab vs. Ipilimumab - hazard ratio: 0.65 (0.48, 0.88) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.60 (0.43, 0.84)
Maltese: Ipilimumab - proporzjon ta' periklu: 0.65 (0.48, 0.88) Nivolumab+Ipilimumab vs.
English: Prior radiation therapy Prior ASCT
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Fourty-nine (47.6%) responders had ongoing responses with a duration ranging from 0.0-27.6+ months.
Maltese: Disgħa u erbgħin (47.6%) ta' dawk li rrispondew kellhom risponsi li għadhom għaddejin b'tul li jvarja minn 0.0-27.6+ xhur.
English: Single-arm phase 2 study (CA209171)
Maltese: Studju ta' fergħa waħda ta' fażi 2 (CA209171)
English: Data from cHL patients 65 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Maltese: Id-data minn pazjenti tas-cHL li għandhom 65 sena jew aktar hija wisq limitata sabiex jinstiltu konklużjonijiet minn din il-popolazzjoni (ara sezzjoni 5.1).
English: Median time to onset was 0.9 months (range: 0.0-17.9).
Maltese: Nivolumab - proporzjon ta' periklu: 0.70 (0.49, 0.99)
English: Severe rash has been observed with nivolumab in combination with ipilimumab and, less commonly, with nivolumab as monotherapy (see section 4.8).
Maltese: Raxx sever ġie osservat b'nivolumab mogħti flimkien ma' ipilimumab jew, inqas komuni, b'nivolumab bħala monoterapija (ara sezzjoni 4.8).
English: Skin and subcutaneous tissue disorders Very common rashe, pruritus Common vitiligo, dry skin, erythema, alopecia Uncommon erythema multiforme, psoriasis, rosacea, urticaria Rare toxic epidermal necrolysisa,f, Stevens-Johnson syndromea,f Musculoskeletal and connective tissue disorders Common musculoskeletal paing, arthralgia Uncommon polymyalgia rheumatica, arthritis Rare
Maltese: Uġigħ muskoluskelettriku huwa terminu kompost li jinkludi uġigħ fid-dahar, uġigħ fl-għadam, uġigħ fis-sider muskuloskelettriku, skumdità muskoloskelettrika, mijalġija, uġigħ fl-għonq, uġigħ fl-estremitajiet, u uġigħ spinali.
English: It is available in packs containing either 1 vial of 4 mL, 1 vial of 10 mL or 1 vial of 24 mL.
Maltese: Huwa disponibbli f'pakketti li jkun fihom jew kunjett 1 ta' 4 mL, kunjett 1 ta' 10 mL jew kunjett 1 ta' 24 mL.
English: RFS, assessed by investigator, was defined as the time between the date of randomisation and the date of first recurrence (local, regional, or distant metastasis), new primary melanoma, or death due to any cause, whichever occurred first.
Maltese: RFS, ivvalutata minn investigatur, ġiet definita bħala ż-żmien bejn iddata tar-randomizzazzjoni u d-data tal-ewwel rikorrenza (metastażi lokali, reġjonali, jew distanti), melanoma primarja ġdida, jew mewta dovuta għal kwalunkwe każ, ikun li jkun liema jseħħ l-ewwel.
English: There are no data on adjuvant treatment in patients with melanoma with the following risk factors (see sections 4.5 and 5.1
Maltese: Ma hemm ebda data dwar kura aġġuvanti f'pazjenti b'melanoma bil-fatturi ta' riskju li ġejjin (ara sezzjonijiet 4.5 u 5.1