FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours, malignant neoplasms of lymphoid tissue and malignant neoplasms of the central nervous system (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'nivolumab f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-kura ta' tumuri solidi malinni, neoplażmi malinni tat-tessuti limfojdi u neoplażmi malinni tas-sistema nervuża ċentrali (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Updated analysis Minimum follow-up: 24.2 months
Maltese: Analiżi aġġornata Segwitu minimu: 24.2 xhur
English: In patients treated with nivolumab monotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 5.2% for anaemia (all Grade 3), 1.0% for thrombocytopaenia, 1.0% for leucopoenia, 10.0% for lymphopaenia, 1.1% for neutropaenia, 2.1% for increased alkaline phosphatase, 2.7% for increased AST, 2.2% for increased ALT, 1.2% for increased total bilirubin, 0.9% for increased creatinine, 3.8% for hyperglycaemia, 1.0% for hypoglycaemia, 3.5% for increased amylase, 7.9% for increased lipase, 6.4% for hyponatraemia, 1.8% for hyperkalaemia, 1.5% for hypokalaemia, 1.2% for hypercalcaemia, 0.7% for hypermagnesaemia, 0.5% for hypomagnesaemia, 0.7% for hypocalcaemia, and 0.1% for hypernatraemia.
Maltese: 0% għal limfopenija, 1.1% għal newtropenija, 2.1% għal żieda f'alkaline phosphatase, 2.7% għal żieda fl-AST, 2.2% għal żieda flALT, 1.2% għal żieda fil-bilirubina totali, 0.9% għal żieda fil-kreatinina, 3.8% għal ipergliċemija, 1.0% għal ipogliċemija, 3.5% żieda tal-amylase, 7.9% għal żieda fil-lipase, 6.4% għal iponatremja, 1.8% għal iperkalemija, 1.5% għal ipokalimja, 1.2% għal iperkalċemija, 0.7% għal ipermanjesimja, 0.5% għal ipomanjesimja, 0.7% għal ipokalċemija, u 0.1% għal ipernatremja.
English: In addition, symptom improvement and overall health status were assessed using the Lung Cancer Symptom Score (LCSS) average symptom burden index and the EQ-5D Visual Analogue Scale (EQ-VAS), respectively.
Maltese: Barra minn hekk, it-titjib fis-sintomi u l-istatus globali tas-saħħa kienu vvalutati permezz tal-medja tal-indiċi tal-piż tas-sintomi tal-Punteġġ tas-Sintomi tal-Kanċer tal-Pulmun (LCSS - Lung Cancer Symptom Score) u l-Iskala Analoga Viżwali EQ-5D (EQ-VAS - EQ-5D Visual Analogue Scale), rispettivament.
English: Forty-eight percent of patients had macroscopic lymph nodes and 32% had tumour ulceration.
Maltese: Tmienja u erbgħin fil-mija tal-pazjenti kellhom nodi limfatiċi makroskopiċi u 32% kellhom ulċerazzjoni ta' tumur.
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, as well as patients with prior therapy for melanoma (except patients with surgery, adjuvant radiotherapy after neurosurgical resection for lesions of the central nervous system, and prior adjuvant interferon completed ≥6 months prior to randomisation) 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), were excluded from the study.
Maltese: Il-pazjenti b'marda awtoimmuni preċedenti, u bi kwalunkwe kundizzjoni li teħtieġ kura sistemika b'jew kortikosterodji (≥ 10 mg prednisone kuljum jew ekwivalenti) jew b'medikazzjonijiet immunosuppressivi oħrajn, kif ukoll pazjenti b'terapija preċedenti għal melanoma (għajr pazjenti b'kirurġija, radjoterapija aġġuvanti wara risezzjoni newroloġika għal leżjonijiet tas-sistema nervuża ċentrali, u interferon aġġuvanti preċedenti mlesti ≥ 6 xhur qabel ir-randomizzazzjoni) terapija preċedenti b'antikorp, anti-PD-1, anti-PD-L1, antiPD-L2, anti-CD137, jew anti CTLA-4
English: Safety was the primary endpoint and efficacy was a secondary endpoint.
Maltese: Is-sigurtà kienet punt ta' tmiem primarju u l-effikaċja kienet punt ta' tmiem sekondarju.
English: Tumour PD-L1 expression levels were balanced between the two treatment groups (nivolumab vs. investigator's choice) at each of the predefined tumour PD-L1 expression levels of ≥ 1% (55% vs. 62%), ≥ 5% (34% vs. 43%), or ≥ 10% (27% vs.
Maltese: Il-livelli tal-espressjoni PD-L1 tat-tumur kienu bbilanċjati bejn iż-żewġ gruppi ta' kura (nivolumab vs. l-għażla tal-investigatur) f'kull wieħed millivelli tal-espressjoni PD-L1 definiti minn qabel ta' ≥ 1 % (55 % vs. 62 %), ≥ 5 % (34 % vs.
English: The majority of cases were Grade 1 or 2 in severity reported in 8.5% (220/2578) and 3.0% (78/2578) of patients respectively.
Maltese: Il-maġġoranza tal-każijiet kienu ta' Grad 1 jew 2 fis-severità rrapportata f'8.5% (220/2578) u 3.0% (78/2578) tal-pazjenti rispettivament.
English: 240 mg every 2 weeks over 30 minutes
Maltese: 240 mg kull ġimagħtejn għal 30 minuta
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 2.8% for anaemia (all Grade 3), 1.2% for thrombocytopaenia, 0.5% for leucopoenia, 6.7% for lymphopaenia, 0.7% for neutropaenia, 4.3% for increased alkaline phosphatase, 12.4% for increased AST, 15.3% for increased ALT, 1.2% for increased total bilirubin, 2.4% for increased creatinine, 5.3% for hyperglycaemia, 8.7% for increased amylase, 19.5% for increased lipase, 1.2% for hypocalcaemia, 0.2% each for hypernatraemia and hypercalcaemia, 0.5% for hyperkalemia, 0.3% for hypermagnesaemia, 4.8% for hypokalaemia, and 9.5% for hyponatraemia.
Maltese: 2.8% għall-anemija (kollha Grad 3), 1.2% għat-tromboċitopenja, 0.5% għallewkopenja, 6.7% għal-limfopenija, 0.7% għan-newtropenija, 4.3% għall-alkaline phosphatase, 12.4% għaż-żieda tal-AST, 15.3% għaż-żieda tal-ALT, 1.2% għaż-żieda tal-bilirubin totali, 2.4% għaż-żieda tal-kreatina, 5.3% għal ipergliċemija, 8.7% għaż-żieda tal-amylase, 19.5% għaż-żieda tal-lipażi, 1.2% għall-ipokalċemija, 0.2% għall-ipernatremija u għall-iperklaċemija, 0.5% għall-iperkalemija, 0.3% għall-ipermagnesmija, 4.8% għall-ipokalimja, u 9.5% għall-iponatremija.
English: The majority of cases were Grade 1 or 2 in severity reported in 3.5% (91/2578) and 1.2% (32/2578) of patients respectively.
Maltese: Il-maġġoranza tal-każijiet kienu ta' Grad 1 jew 2 fisseverità rrapportata fi 3.5% (91/2578) u 1.2% (32/2578) tal-pazjenti rispettivament.
English: Anaemia is a composite term which includes, among other causes, haemolytic anaemia and autoimmune anaemia.
Maltese: Anemija huwa terminu kompost li jinkludi, fost kawżi oħra, anemija emolitika u anemija awtoimmuni.
English: Median time to onset was 2.0 months (range: 0.4-26.8).
Maltese: Il-ħin medjan sal-bidu kien 2.0 xhur (firxa: 0.4-26.8).
English: PD-L1 expression ≥ 5%
Maltese: Espressjoni ta' PD-L1 ≥ 5%
English: Randomised phase 3 study of nivolumab in combination with ipilimumab vs. sunitinib (CA209214)
Maltese: Studju każwali ta' fażi 3 ta' nivolumab mogħti flimkien ma' ipilimumab vs. sunitinib (CA209214)
English: At the time of this analysis, the hazard ratio was 0.66; (99.8% CI 0.48-0.91) with 166/425 events in the combination arm and 209/422 events in the sunitinib arm. At 18 months, the OS rate was 74.3 (95% CI 69.8-78.2) for nivolumab in combination with ipilimumab and 59.9 (95% CI 54.9-64.5) for sunitinib.
Maltese: Meta saret l-analiżi, il-proporzjon ta' periklu kien 0.66; (99.8% CI 0.48-0.91) b'166/425 avveniment fil-fergħa ta' kombinazzjoni u 209/422 avveniment fil-fergħa ta' sunitinib.
English: The Kaplan-Meier curves for OS are shown in Figure 9.
Maltese: Il-kurvi Kaplan-Meier għal OS qed jintwerew f'Figura 9.
English: PD-L1 expression < 5%
Maltese: Espressjoni ta' PD-L1 < 5%
English: The total dose of OPDIVO required can be infused directly as a 10 mg/mL solution or can be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection (see section 6.6).
Maltese: Id-doża totali meħtieġa ta' OPDIVO tista' tiġi infuża direttament bħala soluzzjoni ta' 10 mg/mL jew tista' tiġi dilwita b'9 mg/mL (0.9%) sodium chloride jew soluzzjoni għall-injezzjoni ta' 50 mg/mL (5%) glukożju (ara sezzjoni 6.6).
English: After 28 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to nivolumab in combination with ipilimumab had an ORR of 67.6% (95% CI: 57.7, 76.6; n = 102) and 54.7% (95% CI: 47.8, 61.5; n = 212), while those in the nivolumab monotherapy arm had an ORR of 36.7% (95% CI: 27.2, 47.1; n = 98) and 48.2% (95% CI: 41.4, 55.0; n = 218), respectively.
Maltese: Wara 28 xahar ta' segwitu, pazjenti bi BRAF tat-tip selvaġġ u pożittivi għall-mutazzjoni BRAF[V600] randomizzati għal nivolumab mogħti flimkien ma' ipilimumab kellhom ORR ta'67.6% (95% CI: 57.7, 76.6; n = 102) u 54.7% (95% CI: 47.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg//kg, the incidence of hypersensitivity/infusion reactions was 4.0% (22/547); all were Grade 1 or 2 in severity.
Maltese: F'pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg//kg, l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva/infużjoni kienet 4.0% (22/547); kollha kienu ta' Grad 1 jew 2 fis-sensittività.
English: Severe nephritis and renal dysfunction have been observed with monotherapy treatment or nivolumab in combination with ipilimumab (see section 4.8).
Maltese: Nefrite jew disfunzjoni renali relatata mas-sistema immuni Ġew osservati nefrite severa u disfunzjoni renali b'kura monoterapewtika jew b'nivolumab mogħti flimkien ma' ipilimumab (ara sezzjoni 4.8).
English: OPDIVO concentrate may be diluted with either: sodium chloride 9 mg/mL (0.9%) solution for injection; or 50 mg/mL (5%) glucose solution for injection.
Maltese: Il-konċentrat ta' OPDIVO jista' jiġi dilwit b': sodium chloride 9 mg/mL (0.9%) soluzzjoni għal injezzjoni; jew 50 mg/mL (5%) soluzzjoni tal-glukożju għal injezzjoni.
English: Teл.
Maltese: IV.
English: Duration of response in PR (months) Median (95% CI)
Maltese: Durata tar-rispons f'PR (xhur) Medjana (95% CI)
English: Nivolumab monotherapy should be withheld for Grade 3 diarrhoea or colitis, and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Monoterapija ta' Nivolumab għandha titwaqqaf għal dijarea jew kolite tal-Grad 3, u għandhom jinbdew il-kortikosterojdi f'doża ta' 1 sa 2 mg/kg/kuljum f'ekwivalenti ta' methylprednisolone.
English: Nivolumab+Ipilimumab (events: 59/123), median and 95% CI: N.A. (26.45, N.A.) ──Δ─── Nivolumab (events: 71/117), median and 95% CI: 23.46 months (13.01, 36.53) Ipilimumab (events: 77/113), median and 95% CI: 18.56 months (13.67, 23.20)
Maltese: (26.45, N.A.) ──Δ─── Nivolumab (eventi: 71/117), medjan u 95% CI: 23.46 xhur (13.01, 36.53) - - -- - - Ipilimumab (eventi: 77/113), medjan u 95% CI: 18.56 xhur (13.67, 23.20)
English: Median time to onset was 1.2 months (range: 0.0-24.7).
Maltese: Il-ħin medjan sal-bidu kien 1.2 xhur (firxa: 0.0-24.7).
English: Nivolumab monotherapy:
Maltese: Monoterapija b'nivolumab:
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
Maltese: F'pazjenti kkurati b'nivolumab 1 mg/kg mogħti flimkien ma' ipilimumab 3 mg/kg fil-melanoma, linċidenza ta' nefrite jew disfunzjoni tal-kliewi kienet ta' 5.1% (23/448).
English: The Kaplan-Meier curves for OS are shown in Figure 10.
Maltese: Il-kurvi Kaplan-Meier għal OS qed jintwerew f'Figura 10.
English: 8.7,22.2%), a median OS of 8.21 months (95% CI: 6.05,10.9), and a median PFS of 1.87 months (95% CI 1.77,3.15).
Maltese: Nivolumab 3 mg/kg wera ORR ta' 14.5% (95% CI: 8.7-22.2%), OS medjan ta' 8.21 xhur (95% CI: 6.05-10.9 xhur), u PFS medjana ta' 1.87 xhur (95% CI 1.77-3.15 xhur.
English: For Grade 4 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Għal elevazzjoni tal-kreatinina fis-serum ta' Grad 4, nivolumab jew nivolumab mogħti flimkien ma' ipilimumab għandhom jitwaqqfu b'mod permanenti, u għandhom jinbdew il-kortikosterojdi b'doża ta' 1 sa 2 mg/kg/jum ta' ekwivalenti għall-methylprednisolone.
English: Thirty-two percent of patients had BRAF mutation-positive melanoma; 26.5% of patients had PD-L1 ≥ 5% tumour cell membrane expression.
Maltese: Tnejn u tletin fil-mija tal-pazjenti kellhom melanoma pożittiva għal mutazzjoni BRAF; 26.5% tal-pazjenti kellhom PD-L1 ≥ 5% espressjoni tal-membrana taċ-ċelloli tat-tumur.
English: - Keep this leaflet.
Maltese: Reazzjonijiet ta' infużjoni
English: Median time to onset of these endocrinopathies was 2.8 months (range: 0.3-29.1).
Maltese: Ħin medjan sal-bidu kien f'dawn ittliet endokrinopatiji kien ta' 2.8 xhur (firxa: 0.3-29.1).
English: Figure 8: Kaplan-Meier curves of OS (CA209017)
Maltese: Kaplan-Meier tal-OS (CA209017)
English: Patients with tumour PD-L1 expression by all predefined expression levels in the nivolumab group demonstrated greater likelihood of improved survival compared to investigator's choice.
Maltese: Il-pazjenti b'espressjoni PD-L1 tat-tumur mil-livelli tal-espressjoni kollha definiti minn qabel filgrupp nivolumab urew probabbiltà akbar ta' sopravivenza mtejba meta mqabbel mal-għażla talinvestigatur.
English: Monotherapy phase
Maltese: Monoterapija ta' Nivolumab
English: The Kaplan-Meier curves for OS are shown in Figure 8.
Maltese: Il-kurvi Kaplan-Meier għal OS qed jintwerew f'Figura 8.
English: Forty-two percent of patients were BRAF V600 mutation positive while 45% were BRAF wild type and 13% BRAF were status unknown.
Maltese: Tnejn u erbgħin fil-mija tal-pazjenti kienu BRAF V600 pożittivi għall-mutazzjoni filwaqt li 45% kienu BRAF tip selvaġġ u 13% kienu status BRAF mhux magħruf.
English: Median time to onset was 2.6 months (range: 0.2520.6).
Maltese: Il-ħin medjan sal-bidu kien 2.6 xhur (firxa: 0.25-20.6).
English: Figure 10: Kaplan-Meier curves of OS (CA209025)
Maltese: Kaplan-Meier tal-OS (CA209025)
English: Severe rash should be managed with high-dose corticosteroid at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Raxx sever għandu jiġi ġestit b'kortikosterojdi ta' doża għolja f'doża ta' 1 sa 2 mg/kg/jum ekwivalenti ta' methylprednisolone.
English: Updated analysis Minimum follow-up: 62.7 months
Maltese: Analiżi aġġornata Segwitu minimu: 62.7 xhur
English: Hyperacute GVHD, defined as acute GVHD occurring within 14 days after stem cell infusion, was reported in three patients (6%).
Maltese: GCHD akut ħafna, definit bħala GVHD akut seħħ fi żmien 14-il jum wara l-infużjoni taċ-ċelluli staminali, kien irrapportat fi tliet pazjenti (6%).
English: Preliminary results from the follow-up of patients with cHL undergoing allogeneic HSCT after previous exposure to nivolumab showed a higher than expected number of cases of acute graft-versus-host disease (GVHD) and transplant related mortality (TRM).
Maltese: Ir-riżultati preliminari mill-visti ta' wara tal-pazjenti b'cHL sottoposti għal HSCT alloġeniku wara lesponiment preċedenti għal nivolumab urew numru ikbar milli kien mistenni ta' każijiet tal-marda “graft-versus-host” (acute graft-versus-host-disease, aGVHD) u mortalità relatata mat-trapjant (transplant related mortality, TRM).
English: In the non-squamous NSCLC study (CA209057), the safety profile in patients with baseline renal or hepatic impairment was comparable to that in the overall population.
Maltese: Fl-istudju tal-NSCLC mhux skwamuż (CA209057), il-profil tas-sigurtà f'pazjenti b'indeboliment talkliewi jew tal-fwied fil-linja bażi kien komparabbli ma' dak tal-popolazzjoni ġenerali.
English: Inflammation of the muscles such as myocarditis (inflammation of the heart muscle), myositis (inflammation of the muscles) and rhabdomyolysis (stiffness in muscles and joints, muscle spasm).
Maltese: Infjammazzjoni tal-muskoli bħal mijokardite (infjammazzjoni tal-muskolu tal-qalb), mijożite (infjammazzjoni tal-muskoli) u rabdomijolożi (ebusija fil-muskoli u l-ġogi, spażmi fil-muskoli).
English: Randomised phase 3 study of nivolumab in combination with ipilimumab or nivolumab as monotherapy vs. ipilimumab as monotherapy (CA209067)
Maltese: Studju ta' Fażi 3 Randomizzat ta' nivolumab mogħti flimkien ma' ipilimumab jew nivolumab bħala monterapija kontra ipilimumab bħala monoterapija (CA209067)
English: The safety and efficacy of nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg or nivolumab 3 mg/kg vs. ipilimumab 3 mg/kg monotherapy for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, double-blind study (CA209067).
Maltese: Is-sigurtà u l-effikaċja ta' nivolumab 3 mg/kg għall-kura ta' melanoma (metastatika jew li ma tistax titneħħa bil-kirurġija) avvanzata ġew evalwati fi studju każwali ta' fażi 3, bit-tikketta tingħaraf (CA209037).
English: OPDIVO must be administered with caution in patients with moderate (total bilirubin > 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment.
Maltese: OPDIVO jrid jingħata bir-reqqa f'pazjenti b'indeboliment tal-fwied moderat (bilirubina totali > 1.5 × sa 3 × il-limitu superjuri tan-normal [ULN] u kwalunkwe AST) jew sever (bilirubina totali > 3 × ULN u kwalunkwe AST).
English: One vial of 24 mL contains 240 mg of nivolumab.
Maltese: Kunjett tal-24 mL fih 240 mg nivolumab.
English: The median age was 66 years (range: 38 to 90) with 55% ≥65 years of age and 14% ≥75 years of age.
Maltese: L-età medjana kienet ta' 66 sena (medda: 38 sa 90) b'55% li għandhom ≥65 sena u 14% li għandhom ≥75 sena.
English: For symptomatic Grade 2 adrenal insufficiency, nivolumab or nivolumab in combination with ipilimumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Maltese: Għal insuffiċjenza adrenali sintomatika ta' Grad 2, nivolumab jew nivolumab mogħti flimkien ma' ipilimumab għandhom jitwaqqfu, u għandha tinbeda sostituzzjoni fiżjoloġika tal-kortikosterojdi skont kif ikun meħtieġ.
English: In the pooled dataset of nivolumab 3 mg/kg as monotherapy across tumour types (n = 2578) with minimum follow-up ranging from 2.3 to 28 months, the most frequent adverse reactions (≥ 10%) were fatigue (30%), rash (17%), pruritus (13%), diarrhoea (13%), and nausea (12%).
Maltese: Fis-sett ta' data kondiviż ta' nivolumab 3 mg/kg bħala monoterapija fit-tipi ta' tumuri (n = 2578) b'segwitu minimu li jvarja minn 2.3 sa 28 xhur, l-iktar reazzjonijiet avversi spissi (≥ 10%) kienu għeja (30%), raxx (17%), ħakk (13%), dijarea (13%), u dardir (12%).
English: Anaemia is a composite term which includes, among other causes, haemolytic anaemia and autoimmune anaemia
Maltese: Anemija huwa terminu kompost li jinkludi, fost kawżi oħra, anemija emolitika u anemija awtoimmuni
English: The majority of patients were white (86%) and male (78%).
Maltese: Il-maġġoranza tal-pazjenti kienu bojod (86%) u rġiel (78%).
English: The prescribed dose for the patient is 240 mg or 480 mg given regardless of body weight depending on indication (see section 4.2).
Maltese: Id-doża preskritta għall-pazjent hija ta' 240 mg jew 480 mg mogħtija irrispettivament mill-piż talġisem skont l-indikazzjoni (ara sezzjoni 4.2).
English: Patients in Cohort C (n = 33) who have received brentuximab vedotin only prior to ASCT had ORR of 70% (95% CI: 51, 84), CR of 15% (95% CI: 5, 32), PR of 55% (95% CI: 36, 72).
Maltese: ORR ta' 70% (95% CI: 51, 84), CR ta' 15% (95% CI: 5, 32), PR ta' 55% (95% CI: 36, 72).
English: Unless an alternate aetiology has been identified, signs or symptoms of endocrinopathies should be considered immune-related.
Maltese: Għajr meta etjoloġija alternattiva tkun ġiet identifikata, sinjali jew sintomi ta' endokrinopatiji għandhom jiġu kkunsidrati relatati mas-sistema immuni.
English: Prior to launch of OPDIVO in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' OPDIVO f'kull Stat Membru d-Detentur ta;Awtorizzazzjoni għat-Tqegħid fis-Suq (Marketing Authorization Holder, MAH) għandu jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi l-midja komunikattiva, modalitajiet ta' tqassim, u kull aspett tal-programm malAwtorità Kompetenti Nazzjonali.
English: Progression Free Survival per Investigator (Months) Number of Subjects at Risk Nivolumab + Ipilimumab
Maltese: Sopravivenza mingħajr progressjoni (Xhur) Numru ta' Individwi f'Riskju Nivolumab + Ipilimumab Nivolumab
English: Common hypertension
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Reported in clinical studies and in the post-marketing setting.
Maltese: Rapportati fi studji kliniċi u f'ambjent ta' wara t-tqegħid fis-suq.
English: Table 16: Efficacy results (CA209057)
Maltese: Riżultati tal-effikaċja (CA209057)
English: OS benefit was observed regardless of HPV status (HPV-positive: HR = 0.63; 95% CI: 0.38, 1.04, HPV-negative: HR = 0.64; 95% CI: 0.40, 1.03, and HPV-unknown: HR = 0.78; 95% CI: 0.55, 1.10).
Maltese: HR = 0.63; 95% CI: 0.38, 1.04, negattiv għal HPV:
English: A group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour lysis syndrome) An inflammatory disorder (most likely of autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt-Koyanagi-Harada syndrome) Inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial disorders)
Maltese: Rifjut ta' trapjant ta' organu solidu Grupp ta' kumplikazzjonijiet metaboliċi li seħħew wara kura għall-kanċer ikkaratterizzati minn livelli għoljin ta' potassju u fosfati fid-demm, u minn livelli baxxi ta' kalċju fid-demm (sindrome ta' lisi ta' tumur) Disturb infjammatorju (wisq probabbli ta' oriġini awtoimmuni) li jaffettwa l-għajnejn, il-ġilda u l-membrani tal-widnejn, il-moħħ u l-korda spinali (is-sindrome ta' Vogt-Koyanagi-Harada)
English: Prior platinum-based therapy was administered in either the adjuvant, neo-adjuvant, primary, recurrent, or metastatic setting.
Maltese: Terapija preċedenti bbażata fuq platinum ingħatat jew f'ambjent aġġuvanti, neoaġġuvanti, primarju, rikorrenti jew metastatiku.
English: Signs and symptoms may include abnormal kidney function tests, or decreased volume of urine.
Maltese: Sinjali u sintomi jistgħu jinkludu testijiet tal-funzjoni tal-kliewi mhux normali jew tnaqqis fil-volum ta' awrina.
English: Vogt-Koyanagi-Harada syndromeh Cardiac disorders Common tachycardia tachycardia
Maltese: Mhux magħruf Sindrome ta' Vogt-Koyanagi-Haradah Disturbi fil-qalb
English: Allergic reaction, reactions related to the infusion of the medicine Decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes Dehydration
Maltese: Reazzjoni allerġika, reazzjonijiet relatati mal-infużjoni tal-mediċina Tnaqqis fis-sekrezzjoni ta' ormoni prodotti mill-glandoli adrenali (glandoli li jinsabu fuq ilkliewi), attività baxxa fil-funzjoni tal-glandola pitwitarja (ipopitwitariżmu) jew infjammazzjoni (hypophysitis) tal-glandola pitwitarja li tinsab fil-bażi tal-moħħnefħa tal-glandola tat-tirojde, dijabete
English: BRAF and tumour PD-L1 status and best response to prior ipilimumab.
Maltese: Il-każwalità ġiet stratifikata skont status BRAF u PD-L1 tat-tumur u l-aqwa rispons għal ipilimumab preċedenti.