FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients without liver metastasis who had a baseline AST > 2.5 x ULN, patients with liver metastasis who had a baseline AST > 5 x ULN, and patients with a baseline total bilirubin ≥ 3 x ULN were also excluded.
Maltese: Pazjenti mingħajr metastasi fil-fwied li kellhom AST fil-linja bażi ta' > 2.5 x ULN, pazjenti b'metastasi fil-fwied li kellhom AST fil-linja bażi ta' > 5 x ULN, u pazjenti b'total ta' bilirubina fil-linja bażi ta' ≥ 3 x ULN ġew esklużi.
English: In the two observational studies, 12.1% and 33.1% of the patients had brain metastases at the time of advanced melanoma diagnosis.
Maltese: Fiż-żewġ studji ta' osservazzjoni, 12.1% u 33.1% tal-pazjenti kellhom metastasi f'moħħhom fil-ħin tad-dijanjożi tal-melanoma avvanzata.
English: Rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported in clinical trials and during post-marketing use (see section 4.8).
Maltese: Ġew irrappurtati wkoll każijiet rari ta' Reazzjoni għal Mediċina b'Eosinofilja u Sintomi Sistemiċi (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) fil-provi kliniċi u waqt l-użu ta' wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: If pituitary imaging or laboratory tests of endocrine function are abnormal, a short course of high-dose corticosteroid therapy (e.g. dexamethasone 4 mg every 6 hrs or equivalent) is recommended to treat the inflammation of the affected gland, and the scheduled dose of ipilimumab should be withheld (see section 4.2).
Maltese: Jekk l-immaġni tal-pitwitarja jew it-testijiet tal-laboratorju tal-funzjoni endokrinali jkunu anormali, kors qasir ta' terapija b'doża għolja ta' kortikosterojde (eż. dexamethasone 4 mg kull 6 sigħat jew ekwivalenti) hu rrakkomandat biex jikkura l-infjammazzjoni tal-glandola affettwata, u d-doża skedata ta' ipilimumab għandha tinżamm (ara sezzjoni 4.2).
English: Immune-related adverse reaction leading to permanent discontinuation Pneumonitis
Maltese: Reazzjoni avversa relatata mal-immunità li wasslet għal twaqqif permanenti Pulmonite
English: Uncommon eosinophilia
Maltese: Jekk il-pazjent żviluppa
English: • List of important immune-related adverse reactions (irARs) and their symptoms, as outlined in section 4.4 of the Summary of Product Characteristics (SmPC): o Inflammation of the gastrointestinal tract, such as colitis, which can lead to bowel perforation o Inflammation of the liver, such as hepatitis, which can lead to liver failure o Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis) o Inflammation of the nerves that can lead to neuropathy o Inflammation of the endocrine system.
Maltese: • Lista ta' reazzjonijiet avversi relatati mal-immunità importanti (irARs) u s-sintomi tagħhom, kif deskritti fis-sezzjoni 4.4 tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC): o Infjammazzjoni tal-passaġġ gastrointestinali bħal kolite, li tista' twassal għal perforazzjoni tal-musrana o Infjammazzjoni tal-fwied, bħal epatite, li tista' twassal għal ħsara fil-fwied o Infjammazzjoni tal-ġilda li tista' twassal għal reazzjoni severa tal-ġilda (nekroliżi epidermali tossika) o Infjammazzjoni tan-nervituri li tista' twassal għal newropatija o Infjammazzjoni tas-sistema endokrinali, inkluż il-glandoli adrenali, pitwitarji jew tat tirojde o Infjammazzjoni tal-għajnejn o irARs relatati oħrajn (eż. pulmonite, glomerulonefrite, ħsara f'aktar minn organu wieħed…) o Reazzjoni severa relatata mal-infużjoni
English: Myasthenia gravis-like symptoms have also been reported (see section 4.8).
Maltese: Sintomi bħal ta' mijastenja gravis ġew irrapportati wkoll (ara sezzjoni 4.8).
English: Cardiac disorders Common tachycardia tachycardia
Maltese: Disturbi fil-qalb Komuni takikardja takkikardija
English: ≥ Grade 2 for immune-related eye disorders NOT responding to topical immunosuppressive therapy a
Maltese: ≥ grad 2 għal disturbi fl-għajnejn relatati mal-immunità LI MA JKUNUX qed jirrispondu għal terapija immunosoppressiva topika a
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.42 (0.33, 0.54) Nivolumab vs. Ipilimumab - hazard ratio: 0.57 (0.45, 0.72) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.74 (0.58, 0.96)
Maltese: Ipilimumab - proporzjon ta' periklu: 0.57 (0.45, 0.72) Nivolumab+Ipilimumab vs.
English: Overall survival (OS) advantage of ipilimumab at the recommended dose of 3 mg/kg in patients with previously-treated advanced (unresectable or metastatic) melanoma was demonstrated in a Phase 3 study (MDX010-20).
Maltese: Il-vantaġġ ta' sopravivenza globali (Overall survival, OS) ta' ipilimumab fid-doża rakkomandata ta' 3 mg/kg f'pazjenti li kienu kkurati fil-passat għal melanoma avvanzata (li ma tistax tinqata' jew metastatika), intwera fi studju ta' Fażi 3 (MDX010-20).
English: For Grade 4 serum creatinine elevation, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Għal żieda fil-kreatinina fis-seru ta' Grad 4, ipilimumab flimkien ma' nivolumab għandu jitwaqqaf b'mod permanenti, u għandhom jinbdew il-kortikosterojdi b'doża ta' 1 sa 2 mg/kg/jum ta' ekwivalenti għal methylprednisolone.
English: Ipilimumab was administered every 3 weeks for 4 doses and then every 12 weeks thereafter in the absence of dose limiting toxicity (DLT) and disease progression.
Maltese: Ipilimumab ingħata kull 3 ġimgħat għal 4 dożi u mbagħad kull 12-il ġimgħa minn dak inhar 'il quddiem fin-nuqqas ta' tossiċità ta' limitazzjoni tad-doża (DLT, dose limiting toxicity) u progressjoni tal-marda.
English: Of patients 12 years of age and older with advanced melanoma, ipilimumab 5 mg/kg was administered to three patients and ipilimumab 10 mg/kg was administered to two patients.
Maltese: Il-punti tattmiem primarji kienu s-sigurtà u l-farmakokinetika (PK). Minn pazjenti ta' 12-il sena jew aktar b'melanoma avvanzata, ipilimumab 5 mg/kg ingħata lil 3 pazjenti u ipilimumab 10 mg/kg ingħata lil 2 pazjenti.
English: Common (may affect up to 1 in 10 people) serious lung infection (pneumonia), infections of the upper respiratory tract, inflammation of the eye (conjunctivitis) increase of eosinophils (type of white blood cells) 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 inflammation of the liver inflammation of the nerves (causing numbness, weakness, tingling or burning pain of the arms and legs), dizziness inflammation of the eye which causes redness or pain, blurred vision rapid heart beat high blood pressure (hypertension) inflammation of the lungs (pneumonitis, characterised by coughing and difficulty breathing), blood clots, fluid around the lungs, cough mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), constipation, dry mouth skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning, hives (itchy, bumpy rash)
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10) infezzjoni serja fil-pulmun (pulmonite), infezzjonijiet tal-passaġġ respiratorju ta' fuq, infjammazzjoni tal-għajnejn (konġuntivite) żieda fl-eosinofili (tip ta' ċelluli tad-demm bojod) reazzjoni allerġika, reazzjonijiet relatati mal-infużjoni tal-mediċina sekrezzjoni mnaqqsa ta' ormoni prodotti mill-glandoli adrenali (glandoli li jinsabu fuq il-kliewi), tnaqqis fil-funzjoni (ipopitwitariżmu) jew infjammazzjoni (ipofiżite) tal-glandola pitwitarja li tinsab fil-bażi tal-moħħ, nefħa tal-glandola tat-tirojde, dijabete deidratazzjoni infjammazzjoni tal-fwied infjammazzjoni tan-nervituri (li tikkawża tmewwit, dgħufija, tnemnim jew uġigħ bi ħruq taddirgħajn u tar-riġlejn), sturdament infjammazzjoni tal-għajn li tikkawża ħmura jew uġigħ, vista mċajpra taħbit tal-qalb mgħaġġel pressjoni għolja tad-demm (ipertensjoni) infjammazzjoni tal-pulmun (pulmonite, ikkaratterizzata minn sogħla u diffikultà fit-teħid tan-nifs), emboli tad-demm, fluwidu madwar il-pulmun, sogħla ulċeri fil-ħalq jew feriti (stomatite), infjammazzjoni tal-frixa (pankreatite), stitikezza, ħalq xott bidla fil-kulur tal-ġilda fi rqajja' (vitiligo), ġilda xotta, ħmura tal-ġilda, twaqqigħ jew tnaqqis taxxagħar mhux tas-soltu, ħorriqija (raxx imqabbeż, li jieklok) Infjammazzjoni tal-ġogi (artrite), spażmi fil-muskoli, dgħjufija fil-muskoli insuffiċjenza tal-kliewi (inkluż telf f'daqqa tal-funzjoni tal-kliewi) edema (nefħa), uġigħ, uġigħ fis-sider, tkexkix ta' bard
English: Ipilimumab must be permanently discontinued in patients with severe (Grade 3 or 4) motor neuropathy regardless of causality (see section 4.2).
Maltese: Ipilimumab għandu jitwaqqaf b'mod permanenti f'pazjenti b'newropatija severa tal-moviment (Grad 3 jew 4) irrispettivament mill-kawża tagħha (ara sezzjoni 4.2).
English: In the population pharmacokinetic analysis of data from clinical studies in patients with metastatic melanoma, pre-existing mild and moderate renal impairment did not influence the CL of ipilimumab.
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni ta' data minn studji kliniċi f'pazjenti b'melanoma metastatika, indeboliment tal-kliewi ħafif u moderat li kien jeżisti minn qabel ma influwenzax is-CL ta' ipilimumab.
English: Responses are summarised in Table 11.
Maltese: Tabella 11.
English: decreased blood gonadotrophin, leukopenia, polycythaemia, lymphocytosis, ocular myositis, and neurosensory hypoacusis.
Maltese: Minn perspettiva mikrobijoloġika, ladarba tinfetaħ, il-mediċina għandha tiġi infuża jew dilwita u infuża mill-ewwel.
English: For patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, time to onset of moderate to very severe (Grade 2-4) immune-related endocrinopathy ranged from 7 to nearly 20 weeks from the start of treatment.
Maltese: F'pazjenti li rċivew ipilimumab 3 mg/kg waħdu fi studju MDX010-20, iż-żmien għal bidu ta' endokrinopatija moderata sa severa ħafna relatata mal-immunità (Grad 2-4) varja minn 7 sa kważi
English: Common (may affect up to 1 in 10 people) tumour pain underactive function of the thyroid gland which can cause tiredness or weight gain, underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain dehydration confusion damage to the nerves (causing pain, weakness and cramps), dizziness, headache, blurred vision, pain in the eye low blood pressure, temporary redness of the face and neck, feeling of intense heat with sweating and rapid heart beat shortness of breath (dyspnoea), cough bleeding in the stomach or intestine, inflammation of the intestines (colitis), constipation, heartburn, stomach pain abnormal function of the liver inflammation of the inner surface lining of a particular organ inflammation and redness of the skin, skin colour change in patches (vitiligo), hives (itchy, bumpy rash), hair loss or thinning, excessive sweating at night, dry skin pain in muscles and joints(arthralgia), muscle spasms shivering, lack of energy, oedema (swelling), pain flu-like illness weight loss
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) uġigħ minħabba tumur funzjoni inqas attiva milli suppost tal-glandola tat-tirojde li tista' tikkawża għeja jew żieda filpiż, funzjoni inqas attiva milli suppost (ipopitwitariżmu) jew infjamazzjoni (ipofiżite) talglandola pitwitarja li tinsab fil-bażi tal-moħħ deidratazzjoni konfużjoni ħsara fin-nervituri (li tikkawża uġigħ, dgħufija u bugħawwieġ), sturdament, uġigħ ta' ras vista mċajpra, uġigħ fl-għajnejn pressjoni baxxa tad-demm, ħmura temporanja fil-wiċċ u l-għonq, sensazzjoni ta' sħana qawwija b'għaraq u taħbit mgħaġġel tal-qalb qtugħ ta' nifs (dispnea), sogħla ħruġ ta' demm fl-istonku jew fl-imsaren, infjammazzjoni tal-imsaren (kolite), stitikezza, qrusa fl-istonku, uġigħ fl-istonku funzjoni abnormali tal-fwied infjammazzjoni tar-rita tal-wiċċ tal-ġewwa ta' organu partikolari infjammazzjoni u ħmura fil-ġilda, bidla fil-kulur tal-ġilda f'irqajja' (vitiligo), ħorriqija (raxx imqabbeż, li jieklok), twaqqigħ jew tnaqqis tax-xagħar, għaraq eċċessiv matul il-lejl, ġilda xotta uġigħ fil-muskoli u l-ġogi (artralġja), spażmi fil-muskoli rogħda, nuqqas ta' enerġija, edema (nefħa), uġigħ mard simili għall-influwenza telf ta' piż
English: Stable disease was achieved for 260 days in one patient on ipilimumab 3 mg/kg and approximately 14 months in one patient on ipilimumab 10 mg/kg.
Maltese: Inkisbet marda stabbli għal 260 ġurnata f'pazjent wieħed fuq ipilimumab 3 mg/kg u għal madwar 14-il xahar f'pazjent wieħed fuq ipilimumab 10 mg/kg.
English: Blood and lymphatic system disorders Common eosinophilia
Maltese: Disturbi fis-sistema immuni Mhux komuni sensittività eċċessiva
English: Laboratory abnormalities with ipilimumab in combination with nivolumab
Maltese: Anormalitajiet tal-laboratorju b'ipilimumab flimkien ma' nivolumab
English: Post-marketing cases of cytomegalovirus (CMV) infection/reactivation have been reported in patients with corticosteroid-refractory immune-related colitis.
Maltese: F'pazjenti b'kolite relatata mal-immunità rifrattarja għall-kortikosterojdi ġew irrapportati każijiet ta' infezzjoni/riattivazzjoni tal-infezzjoni biċ-ċitomegalovirus (CMV) wara t-tqegħid fis-suq.
English: The Kaplan-Meier curves for OS (with a minimum follow-up of 24 months) in intermediate/poor risk patients are shown in Figure 7.
Maltese: Il-Kurvi Kaplan-Meier għall-OS (b'segwitu minimu ta' 24 xahar) f'pazjenti b'riskju intermedju/fqir huma murija fil-Figura 7.
English: Severe infusion reactions have been reported in clinical trials of ipilimumab or ipilimumab in combination with nivolumab (see section 4.8).
Maltese: Ġew irrappurtati diversi reazzjonijiet għall-infużjoni fil-provi kliniċi ta' ipilimumab jew ipilimumab flimkien ma' nivolumab (ara sezzjoni 4.8).
English: For symptomatic diabetes, ipilimumab in combination with nivolumab should be withheld, and insulin replacement should be initiated as needed.
Maltese: Għal dijabete sintomatika, ipilimumab flimkien ma' nivolumab għandu jitwaqqaf, u għandha tinbeda sostituzzjoni tal-insulina skont kif ikun meħtieġ.
English: Yervoy in combination with nivolumab: When ipilimumab 3 mg/kg was administered in combination with nivolumab 1 mg/kg, there was no effect of nivolumab on the CL of ipilimumab.
Maltese: Meta ipilimumab 3 mg/kg ingħata flimkien ma' nivolumab 1 mg/kg, ma kien hemm l-ebda effett ta' nivolumab fuq is-CL ta' ipilimumab.
English: In the population pharmacokinetic analysis of data from clinical studies in patients with metastatic melanoma, pre-existing mild hepatic impairment did not influence the CL of ipilimumab.
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni ta' data minn studji kliniċi f'pazjenti b'melanoma metastatika, indeboliment epatiku ħafif li kien jeżisti minn qabel ma influwenzax is-CL ta' ipilimumab.
English: If mild to moderate symptoms recur or persist for 5-7 days, the scheduled dose of ipilimumab should be withheld and corticosteroid therapy (e.g. prednisone 1 mg/kg orally once daily or equivalent) should be initiated.
Maltese: Jekk sintomi minn ħfief sa moderati jerġgħu jseħħu jew jippersistu għal 5-7 ijiem, id-doża skedata ta' ipilimumab għandha tinżamm u għandha tinbeda terapija b'kortikosterojde (eż. prednisone 1 mg/kg orali darba kuljum jew ekwivalenti).
English: For Grade 4 diarrhoea or colitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Għal dijarea jew kolite ta' Grad 4, ipilimumab flimkien ma' nivolumab għandu jitwaqqaf b'mod permanenti, u għandhom jinbdew il-kortikosterojdi b'doża ta' 1 sa 2 mg/kg/jum ta' ekwivalenti għal methylprednisolone.
English: The frequency of cardiac adverse events was lower in the nivolumab group than in the dacarbazine group in the metastatic melanoma without prior treatment population.
Maltese: Il-frekwenza talavvenimenti avversi kardijaċi kienet iktar baxxa fil-grupp ta' nivolumab milli fil-grupp ta' dacarbazine filmelanoma metastatika mingħajr popolazzjoni ta' kura preċedenti.
English: No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Maltese: L-ebda differenza ġenerali fis-sigurtà u l-effikaċja ma ġiet osservata bejn pazjenti anzjani (≥ 65 sena) u pazjenti iżgħar (< 65 sena).
English: How to use YERVOY 4.
Maltese: Użu IV.
English: Ipilimumab must be permanently discontinued in patients with severe (Grade 3 or 4) sensory neuropathy suspected to be related to ipilimumab (see section 4.2).
Maltese: Ipilimumab għandu jitwaqqaf b'mod permanenti f'pazjenti b'newropatija sensorjali severa (Grad 3 jew 4) li hi ssuspettata li tkun relatata ma' ipilimumab (ara sezzjoni 4.2).
English: If initial symptoms improve to mild (Grade 1) or resolve, ipilimumab therapy may be resumed (see section 4.2).
Maltese: Jekk is-sintomi inizjali jitjiebu għal ħfief (Grad 1) jew ifiequ, it-terapija b' ipilimumab tista' titkompla (ara sezzjoni 4.2).
English: Median OS in the subgroup with brain metastases at baseline was 5.67 months at the recommended dose of 3 mg/kg.
Maltese: L-OS medjana fis-subgrupp b'metastażi fil-moħħ fil-linja bażi kienet ta' 5.67 xhur bid-doża rakkomandata ta' 3 mg/kg.
English: Administration:
Maltese: Sími:
English: Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a key regulator of T-cell activity.
Maltese: It-twaqqif tal-kura jista' jwaqqaf l-effett tal-mediċina.
English: A Phase 3, double-blind study enrolled patients with previously treated or untreated unresectable Stage III or Stage IV melanoma.
Maltese: Studju ta' Fażi 3, double-blind irreġistra pazjenti b'melanoma ta' Stadju III jew Stadju IV li ma tistax tinqata' li ġiet ikkurata qabel jew li ma ġietx ikkurata.
English: Ipilimumab-induced rash and pruritus were predominantly mild (Grade 1) or moderate (Grade 2) and responsive to symptomatic therapy.
Maltese: Raxx u ħakk ikkawżati minn ipilimumab kienu fil-biċċa l-kbira tagħhom ħfief (Grad 1) jew moderati (Grad 2) u rrispondew għal terapija sintomatika.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been rarely reported with Ipilimumab in clinical studies and during postmarketing use.
Maltese: Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS) ġiet irrappurtata b'mod rari b'Ipilimumab fi studji kliniċi u waqt l-użu wara ttqegħid fis-suq.
English: Children younger than 12 years of age
Maltese: Tfal ta' inqas minn 12-il sena
English: Clinical trials with ipilimumab monotherapy
Maltese: Provi kliniċi b'monoterapija ta' ipilimumab
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 fl-apparat respiratorju ta' fuq, konġuntivite
English: Skin: Moderate to severe (Grade 3)b skin rash or (Grade 2)
Maltese: Raxx tal-ġilda moderat sa sever (Grad 3)b raxx tal-ġilda jew ħakk mifrux/intens (Grad 2) irrispettivament mill-etjoloġija
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.42 (0.31, 0.55) Nivolumab vs. Ipilimumab - hazard ratio: 0.44 (0.34, 0.58) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.94 (0.69, 1.28)
Maltese: Ipilimumab - proporzjon ta' periklu: 0.44 (0.34, 0.58) Nivolumab+Ipilimumab vs.
English: The final OS analysis occurred when all patients had a minimum follow-up of 28 months.
Maltese: L-analiżi finali ta' OS seħħet meta l-pazjenti kollha kellhom follow-up minimu ta' 28 xahar.
English: Uncommon psoriasis
Maltese: TWISSIJA(IET) SPEĊJALI
English: Sunitinib
Maltese: L-Italja
English: Grade 4 rash or Grade 3 pruritus
Maltese: Raxx ta' grad 4 jew ħakk ta' Grad 3
English: Grade 2 or 3 creatinine elevation Withhold dose(s) until creatinine returns to baseline and management with corticosteroids is complete
Maltese: Żieda ta' Grad 2 jew 3 fil-kreatinina Żomm id-doża(i) sakemm il-kreatinina tirritorna għal-linja bażi u l-immaniġġjar bil-kortikosterojdi jkun komplet
English: Not known solid organ transplant rejectionh Endocrine disorders Very common hypothyroidism hypothyroidism, hyperthyroidism
Maltese: Mhux magħrif rifjut ta' trapjant ta' organu soliduh Disturbi fis-sistema endokrinarja Komuni ħafna ipotirojdiżmu ipotirojdiżmu, ipertirojdiżmu
English: Resolution occurred in 86 patients (85.1%) with a median time to resolution of 6.1 weeks (range: 0.1+-82.9+).
Maltese: Fejqan seħħ f'86 pazjent (85.1 %) bi żmien medjan għall-fejqan ta' 6.1 ġimgħat (medda: 0.1+-82.9+).
English: In the ipilimumab 3 mg/kg monotherapy group, median OS was 22 months and 8 months for patients with SD and those with PD, respectively.
Maltese: Fil-grupp ta' ipilimumab 3 mg/kg mogħti waħdu, il-medjan tal-OS kien ta' 22 xahar u 8 xhur għallpazjenti b'SD u dawk b'PD, rispettivament.
English: YERVOY as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older (see section 4.4).
Maltese: YERVOY bħala monoterapija hu indikat għall-kura ta' melanoma avvanzata (li ma tistax tinqata' jew metastatika) f'persuni adulti, u f'adolexxenti minn 12-il sena 'il fuq (ara sezzjoni 4.4).
English: Median OS (95% CI)
Maltese: OS medjana (xhur) (95% CI)
English: Median time to onset was 0.5 months (range: 0.0-19.4).
Maltese: Iż-żmien medjan għall-bidu kien 0.5 xhur (medda: 0.0-19.4).
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 (avvenimenti: 71/117), medjan u 95 % CI: 23.46 xhur(13.01, 36.53)
English: Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells.
Maltese: Antiġen-4 ċitotossiku ta' limfoċiti T (CTLA-4) hu regolatur ewlieni tal-attività taċ-ċelluli T. Ipilimumab hu inibitur tal-punt ta' kontroll immuni ta' CTLA-4 li jimblokka s-sinjali inibitorji ta' ċelluli T indotti mill-mogħdija ta' CTLA-4, u dan iżid in-numru ta' ċelluli affettwaturi-T reattivi li jimmobolizzaw sabiex jiftħu attakk immuni dirett taċ-ċellula T kontra ċelluli ta' tumur.
English: Fatalities due to gastrointestinal perforation have been reported in < 1% of patients who received ipilimumab 3 mg/kg in combination with gp100.
Maltese: Fatalitajiet minħabba perforazzjoni gastrointestinali ġew irrapportati f'< 1% tal-pazjenti li rċivew ipilimumab 3 mg/kg flimkien ma' gp100.
English: No clear cut off for PD-L1 expression can reliably be established when considering the relevant endpoints of tumour response and PFS and OS.
Maltese: Ma jista' jiġi stabbilit b'mod ċar l-ebda cut off għall-espressjoni ta' PD-L1 meta jiġu kkunsidrati l-endpoints rilevanti tar-rispons tat-tumur u PFS U OS.
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Maltese: Ilpunt aħħari primarju tal-effikaċja kien ta' rata ta' sopravivenza ta' sena.
English: For patients with significant LFT elevations that are refractory to corticosteroid therapy, addition of an alternative immunosuppressive agent to the corticosteroid regimen may be considered.
Maltese: Għal pazjenti b'żidiet sinifikanti f'LFT li jkunu refrattarji għal terapija b'kortikosterojdi, iż-żieda ta' sustanza immunosoppressiva alternattiva mal-kors tal-kortikosterojde tista' tiġi kkunsidrata.
English: Patients with brain metastases in study CA184338 had a median OS of 6.3 months (95% CI: 3.2 - 12.0) and patients without brain metastases had a median OS of 17.7 months (95% CI: 13.6 - 12.1).
Maltese: Il-pazjenti b'metastasi f'moħħhom fi studju CA184338 kellhom OS medjana ta' 6.3 xhur (95 % CI: 3.2 - 12.0) u l-pazjenti mingħajr metastasi f'moħħhom kellhom OS medjana ta' 17.7 xhur (95 % CI: 13.6 - 12.1).