FrancophonIA/ELRC3.0 huggingface dataset:
English: Median OS for tumour PD-L1 expression ≥ 1% was not reached for ipilimumab in combination with nivolumab, and was 19.61 months in the sunitinib arm (HR = 0.52; 95% CI: 0.34, 0.78).
Maltese: LOS medjana għall-espressjoni PD-L1 tat-tumur ≥ 1% ma ntlaħqitx għal ipilimumab f'kombinazzjoni ma' nivolumab, u kienet ta' 19.61 xahar fil-fergħa ta' sunitinib (HR = 0.52; 95% CI: 0.34, 0.78).
English: By subgroup analysis, the observed OS benefit was consistent within most of the subgroups of patients (M [metastases]-stage, prior interleukin-2, baseline LDH, age, sex, and the type and number of prior therapy).
Maltese: Permezz ta' analiżi ta' subgrupp, -l-OS osservat kien wieħed konsistenti fi ħdan ħafna mis-subgruppi ta' pazjenti (fażi M [metastasi], qabel interleukin-2, LDH tal-linja bażi, età, sess, u t-tip u l-għadd ta' terapiji ta' qabel).
English: YERVOY in combination with nivolumab should be permanently discontinued for:
Maltese: YERVOY flimkien ma' nivolumab għandu jitwaqqaf b'mod permanenti għal:
English: Figure 3: Progression-free survival by PD-L1 expression: 5% cut off (CA209067)
Maltese: Figura 3: Sopravivenza mingħajr progressjoni skont l-espressjoni ta' PD-L1: cut off ta' 5% (CA209067)
English: The observed PFS results at 18 months of follow-up and ORR and OS results at 28 months of follow-up were consistently demonstrated across subgroups of patients including baseline ECOG performance status, BRAF status, M stage, age, history of brain metastases, and baseline LDH level.
Maltese: Ir-riżultati ta' OS osservati wara 18-il xahar ta' follow-up u r-riżultati ta' ORR u OR wara 28 xahar ta' follow-up intwerew b'mod konsistenti fost is-sottogruppi ta' pazjenti inkluż l-istatus tal-prestazzjoni ECOG fil-linja bażi, status BRAF, stadju M, età, storja ta' metastasi talmoħħ u livell ta' LDH fil-linja bażi.
English: In a Phase 1 trial, asymptomatic grade 3 increases in transaminases (ALT/AST > 5 × ULN) and bilirubin (total bilirubin > 3 × ULN) were reported with concurrent administration of ipilimumab (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID).
Maltese: Fi prova ta' Fażi 1, żidiet asintomatiċi ta' grad 3 fit-transaminases (ALT/AST > 5 x ULN) u bilirubina (bilirubina totali > 3 x ULN) kienu rrappurtati bl-għoti fl-istess ħin ta' ipilimumab (3 mg/kg) u vemurafenib (960 mg BID jew 720 mg BID).
English: Immune-related endocrinopathy
Maltese: Endokrinopatiji relatati mal-immunità
English: Severe elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin or symptoms of hepatotoxicity
Maltese: Żidiet severi fil-livelli ta' aspartate aminotransferase (AST), alanine aminotransferase (ALT), jew bilirubina totali jew sintomi ta' epatotossiċità
English: The frequency of severe (Grade 3 or 4) hypopituitarism was reported in 3% of patients.
Maltese: Il-frekwenza ta' ipopitwitariżmu gravi (Grad 3 jew 4) ġiet irrapportata fi 3% tal-pazjenti.
English: Post-marketing event (also see section 4.4)
Maltese: Avveniment wara t-tqegħid fis-suq (ara wkoll sezzjoni 4.4)
English: YERVOY 5 mg/ml concentrate for solution for infusion ipilimumab
Maltese: YERVOY 5 mg/ml konċentrat għal soluzzjoni għall-infużjoni Ipilimumab
English: Ipilimumab as monotherapy
Maltese: Ipilimumab bħala monoterapija
English: Grade 2 and Grade 3 thyroid disorders were reported in 14.5% (65/448) and 1.3% (6/448) of patients, respectively.
Maltese: Ġew irrappurtati disturbi tat-tirojde ta' Grad 2 u Grad 3 f'14.5% (65/448) u 1.3% (6/448) tal-pazjenti, rispettivament.
English: The final concentration should range from 1 to 4 mg/ml.
Maltese: Il-konċentrazzjoni finali għandha tvarja minn 1 sa 4 mg/ml.
English: All were considered not related to nivolumab by investigators except arrhythmia (atrial fibrillation, tachycardia and ventricular arrhythmia).
Maltese: Kollha tqiesu li mhumiex relatati ma' nivolumab mill-investigaturi ħlief aritmija (fibrilazzjoni atrijali, takkikardija u aritmija ventrikulari).
English: Secondary efficacy endpoints of best overall response rate (BORR), stable disease (SD), disease control rate (DCR), and progression free survival (PFS) were based on mWHO criteria and determined by the investigator's assessment.
Maltese: Il-punti aħħarin sekondarji tal-effikaċja tal-aqwa rata ta' rispons globali (BORR, best overall response rate), tal-marda stabbli (SD, stable disease), tar-rata ta' kontroll tal-mard (DCR, disease control rate) u tas-sopravivenza mingħajr progressjoni (PFS, progression free survival) kienu bbażati fuq kriterji tal-mWHO u ddeterminati mill-valutazzjoni tal-investigatur.
English: Uncommon paraneoplastic syndrome Blood and lymphatic system disorders Common anaemia, lymphopenia
Maltese: Mhux komuni sindrome paraneoplastiku Disturbi tad-demm u tas-sistema limfatika Komuni anemija, limfopenija
English: This observation was maintained with the OS results with a minimum followup of 36 months.
Maltese: Din l-osservazzjoni nżammet mar-riżultati ta' OS b'follow-up minimu ta' 36 xahar.
English: Management recommendations for diarrhoea or colitis are based on severity of symptoms (per NCI-CTCAE v4 severity grading classification).
Maltese: Rakkomandazzjonijiet ta' mmaniġġjar għal dijarea jew kolite huma bbażati fuq is-severità tas-sintomi (skont il-klassifikazzjoni tal-grad tas-severità ta' NCI-CTCAE v4).
English: 40 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium).
Maltese: 40 ml ta' konċentrat f'kunjett (ħġieġ ta' Tip I) b'tapp (lastku tal-butyl miksi) u siġill flip-off (aluminju).
English: Table 10: Summary of overall survival by PD-L1 expression: 5% cut off - CA209067 - Minimum follow-up of 36 months
Maltese: Sommarju ta' sopravivenza globali skont l-espressjoni ta' PD-L1: cut off ta' 5%CA209067 - Follow-up minimu ta' 36 xahar
English: Nivolumab+ipilimumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: < 0.0001 Nivolumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.55 (0.42, 0.73); p-value: < 0.0001
Maltese: 42 (0.32, 0.56); valur p: < 0.0001 Nivolumab vs. ipilimumab (analiżi primarja) - HR (99.5% CI): 0.55 (0.42, 0.73); valur p: < 0.0001
English: The OS HRs for ipilimumab in combination with nivolumab vs. nivolumab monotherapy were 0.71 (95% CI: 0.45, 1.13) for BRAF[V600] mutation-positive patients and 0.97 (95% CI: 0.74, 1.28) for BRAF wild-type patients.
Maltese: L-HRs ta' OR għal ipilimumab flimkien ma' nivolumab kontra monoterapija b'nivolumab kienu 0.71 (95% CI: 0.45, 1.13) għal pazjenti pożittivi għall-mutazzjoni BRAF[V600] u 0.97 (95% CI: 0.74, 1.28) għal pazjenti b'BRAF tat-tip selvaġġ.
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of pneumonitis including interstitial lung disease, was 7.8% (35/448).
Maltese: F'pazjenti kkurati b'ipilimumab 3 mg/kg flimkien ma' nivolumab 1 mg/kg fil-melanoma, l-inċidenza ta' pulmonite inkluż marda interstizjali tal-pulmun kienet 7.8% (35/448).
English: The safety and efficacy of ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg 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' ipilimumab 3 mg/kg flimkien ma' nivolumab 1 mg/kg nivolumab 3 mg/kg kontra monoterapija b'ipilimumab 3 mg/kg għall-kura ta' melanoma avvanzata (li ma tistax tinqata' jew metastatika) ġew evalwati fi studju ta' fażi 3, randomizzat, double-blind (CA209067).
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 għall-mutazzjoni BRAF; 26.5 % tal-pazjenti kellhom espressjoni tal-memrana ta-ċellula tattumur PD-L1 ≥ 5%.
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of diarrhoea or colitis was 46.7% (209/448).
Maltese: F'pazjenti kkurati b'ipilimumab 3 mg/kg flimkien ma' nivolumab 1 mg/kg fil-melanoma, l-inċidenza ta' dijarea jew kolite kienet46.7% (209/448).
English: Uncommon vasculitis, angiopathyb, peripheral ischaemia, orthostatic hypotension Rare temporal arteritisd
Maltese: Mhux komuni vaskulite, anġjopatijab, iskemija periferali, pressjoni ortostatika baxxa Rari arterite temporalid
English: Grade 2 and Grade 3 cases were reported in 13.7% (75/547) and 3.7% (20/547) of patients, respectively.
Maltese: Ġew irrapportati każijiet tal-Grad 2 u tal-Grad 3 f'13.7% (75/547) u f'3.7% (20/547) tal-pazjenti, rispettivament.
English: Nivolumab+Ipilimumab (events: 63/123), median and 95% CI: 11.24 (6.93, 23.03) ──Δ─── Nivolumab (events: 77/117), median and 95% CI: 2.83 (2.76, 5.13) Ipilimumab (events: 87/113), median and 95% CI: 2.79 (2.66, 2.96)
Maltese: Nivolumab+Ipilimumab (avvenimenti: 63/123), medjan u 95 % CI: 11.24 (6.93, 23.03) ──Δ─── Nivolumab (avvenimenti: 77/117), medjan u 95 % CI: 2.83 (2.76, 5.13) Ipilimumab (avvenimenti: 87/113), medjan u 95% CI: 2.79 (2.66, 2.96)
English: Grade 2 cases were reported in 2.2% (10/448) of patients.
Maltese: Ġew irrappurtati każijiet ta' Grad 2 f'2.2% (10/448) tal-pazjenti.
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 ta' PD-L1: cut off ta' 1% (CA209067)Follow-up minimu ta' 36 xahar
English: 10 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium).
Maltese: 10 ml ta' konċentrat f'kunjett (ħġieġ ta' Tip I) b'tapp (lastku tal-butyl miksi) u siġill flip-off (aluminju).
English: Immune-related hepatitis
Maltese: Epatite relatata malimmunità
English: Figure 5 Overall survival (CA209067) - Minimum follow-up of 36 months
Maltese: Sopravivenza globali (CA209067) - Follow-up minimu ta' 36 xahar
English: Summary of Adverse Events after up to Four Doses of 3, 5 and 10 mg/kg, All Treated Patients
Maltese: Sommarju tal-Avvenimenti Avversi wara massimu ta' Erba' Dożi ta' 3, 5 u 10 mg/kg, Il-Pazjenti Kkurati Kollha
English: The majority of patients were male (73%) and white (87%), and 31% and 69% of patients had a baseline KPS of 70 to 80% and 90 to 100%, respectively.
Maltese: Il-maġġoranza tal-pazjenti kienu rġiel (73%) u bojod (87%), u 31% u 69% tal-pazjenti kellhom KPS fil-linja bażi ta' 70 sa 80% u ta' 90 sa 100%, rispettivament.
English: Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Maltese: Uża sett tal-infużjoni u filtru in-line, sterili, mhux piroġeniku, li ma tantx jeħel mal-proteini tad-demm (daqs tal-pori ta' 0.2 μm sa 1.2 μm).
English: In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with YERVOY (see Tables 3A, 3B, and section 4.4).
Maltese: Barra minn hekk, kwalunkwe sinjal jew sintomu ta' reazzjonijiet avversi relatati mal-immunità, inklużi dijarea u kolite, għandu jiġi vvalutat waqt il-kura b'YERVOY (ara t-Tabelli 3A, 3B, u s-sezzjoni 4.4).
English: Grade 2 cases were reported in 2.4% (13/547) of patients.
Maltese: Ġew irrapportati każijiet tal-Grad 2 f'2.4% (13/547) talpazjenti.
English: Common peripheral sensory neuropathy, dizziness, headache, lethargy Uncommon Guillain-Barré syndromeb,c, meningitis (aseptic), autoimmune central neuropathy (encephalitis)d, syncope, cranial neuropathy, brain oedema, peripheral neuropathy, ataxia, tremor, myoclonus, dysarthria
Maltese: Komuni newropatija sensorjali periferali, sturdament, uġigħ ta' ras, letarġija Mhux komuni Sindrome ta' Guillain-Barréb,ċ, meniniġite (asettika), newropatija ċentrali awtoimmuni (enċefalite)d, sinkope, newropatija kranjali, edema fil-moħħ, newropatija periferali, atassija, rogħda, mijoklonus, disartrija
English: Rates of immune-related adverse reactions in HLA-A2*0201 positive patients who received ipilimumab in MDX010-20 were similar to those observed in the overall clinical program.
Maltese: Ir-rati ta' reazzjonijiet avversi relatati mal-immunità f'pazjenti pożittivi għal HLA-A2*0201 li rċivew ipilimumab fi studju MDX010-20 kienu simili għal dawk osservati fil-programm kliniku ġenerali.
English: In peripheral blood of patients with melanoma, a mean increase in the percent of activated HLA-DR+ CD4+ and CD8+ T cells was observed after treatment with ipilimumab, consistent with its mechanism of action.
Maltese: Fid-demm periferali ta' pazjenti b'melanoma, żieda medja fil-perċentwali ta' ċelluli T attivati HLA-DR+ CD4+ u CD8+ ġiet osservata wara l-kura b' ipilimumab, u dan hu konsistenti malmekkaniżmu ta' azzjoni tiegħu.
English: Among the patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in CA209067, 154/313 (49%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Maltese: Fost il-pazjenti kkurati b'ipilimumab 3 mg/kg flimkien ma' nivolumab 1 mg/kg f'CA209067, 154/313 (49%) kellhom l-ewwel bidu ta' reazzjonijiet avversi ta' Grad 3 jew 4 waqt il-fażi tal-kombinazzjoni inizjali.
English: Based on population pharmacokinetic analysis, the following mean (percent coefficient of variation) parameters of ipilimumab were obtained: terminal half-life of 15.4 days (34.4%); systemic CL of 16.8 ml/h (38.1%); and volume of distribution at steady-state of 7.47 l (10.1%).
Maltese: jiem (34.4%); CL sistemika ta' 16.8 ml/h (38.1%); u volum ta' distribuzzjoni fi stat fiss ta' 7.47 l (10.
English: Study CA184070 was a multi-center, Phase 1, open-label, dose-escalation study of ipilimumab in paediatric patients ≥1 year to ≤ 21 years of age with measurable/evaluable, untreatable, relapsed or refractory solid malignant tumors without a curative option with standard therapy.
Maltese: L-istudju CA184070 kien studju b'ħafna ċentri, ta' Fażi 1, bit-tikketta mikxufa, b'eskalazzjoni tad-doża ta' ipilimumab f'pazjenti pedjatriċi minn età ta' ≥1 sena sa ≤ 21 sena b'tumuri malinni solidi, li jistgħu jitkejlu/evalwabbli, mhux trattabbli, rikaduti jew refrattorji mingħajr opzjoni kurattiva b'terapija standard.
English: Grade 2 and Grade 3 cases were reported in 20.3% (91/448) and 7.6% (34/448) of patients, respectively.
Maltese: Ġew irrappurtati każijiet ta' Grad 2 u Grad 3 f'20.3% (91/448) u 7.6% (34/448) tal-pazjenti, rispettivament.
English: Number of Patients (%)
Maltese: Numru ta' pazjenti (%)
English: The estimated geometric mean CL is 8.72 mL/h in adolescent patients aged ≥12 to <18 years.
Maltese: Il-medja ġeometrika stmata tas-CL hija ta' 8.72 mL/siegħa f'pazjenti adolexxenti ta' bejn ≥12 u <18-il sena.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.4% (24/547), 0.7% (4/547), and 0.5% (3/547) of patients, respectively.
Maltese: Ġew irrapportati każijiet tal-Grad 2, tal-Grad 3, u tal-Grad 4 f'4.4 % (24/547), f'0.7 % (4/547), u f'0.5 % (3/547) tal-pazjenti, rispettivament.
English: Randomised phase 3 study of ipilimumab in combination with nivolumab vs. sunitinib (CA209214)
Maltese: Studju randomizzat tal-fażi 3 ta' ipilimumab f'kombinazzjoni ma' nivolumab kontra sunitinib (CA209214)
English: Hazard ratioa 99.8% CI p-valueb, c
Maltese: 99.1 % CI valur-pb,h
English: OS of ipilimumab 3 mg/kg monotherapy in chemotherapy-naive patients pooled across Phase 2 and 3 clinical trials (N= 78; randomised) and in treatment-naive patients in two retrospective observational studies (N= 273 and N= 157) were generally consistent.
Maltese: L-OS b'monoterapija ta' ipilimumab 3 mg/kg f'pazjenti li qatt ma ħadu kimoterapija, miġbura minn provi kliniċi ta' Fażi 2 u 3 (N = 78; magħżula b'mod każwali) u f'pazjenti li qatt ma ġew ikkurati qabel f'żewġ studji osservazzjonali retrospettivi (N = 273 u N = 157) kien ġeneralment konsistenti.
English: Grade 2 and Grade 3 cases were reported in 3.1% (17/547) and 1.1% (6/547), of patients, respectively.
Maltese: Każijiet tal-Grad 2 u tal-Grad 3 kienu rrapportati f'3.1 % (17/547) u f'1.1 % (6/547) tal-pazjenti, rispettivament.
English: Grade 2 and Grade 3 thyroid disorders were reported in 15.7% (86/547) and 1.3% (7/547) of patients, respectively.
Maltese: Ġew irrapportati disturbi tat-tirojde tal-Grad 2 u tal-Grad 3 f'15.7% (86/547) u f'1.3% (7/547) tal-pazjenti, rispettivament.
English: Data outside the 9 completed clinical trials in melanoma were included in frequency determinations.
Maltese: Dejta barra mid-9 provi kliniċi li tlestew dwar il-melanoma ġiet inkluża f'determinazzjonijiet tal-frekwenza.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC11.
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali Kodiċi ATC:
English: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events.
Maltese: Il-gradi ta' tossiċità huma skont il-Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kanċer.
English: Additional information about these potentially inflammatory adverse reactions is provided in “Description of selected adverse reactions” and section 4.4.
Maltese: Informazzjoni addizzjonali dwar dawn ir-reazzjonijiet avversi potenzjalment infjammatorji qed tingħata fis-sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” u sezzjoni 4.4.
English: Grade 2 and Grade 3 cases were reported in 10.4% (57/547) and 4.9% (27/547) of patients, respectively.
Maltese: Każijiet tal-Grad 2 u tal-Grad 3 kienu rrapportati f'10.4% (57/547) u f'4.9% (27/547) tal-pazjenti, rispettivament.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 3.0% for anaemia (all Grade 3), 0.7% for thrombocytopaenia, 0.6% for leucopoenia, 5.1% for lymphopaenia, 1.1% for neutropaenia, 2.0% for increased alkaline phosphatase, 4.8% for increased AST, 6.5% for increased ALT, 1.1% for increased total bilirubin, 2.1% for increased creatinine, 7.2% for hyperglycaemia, 1.8% for hypoglycemia,12.2% for increased amylase, 20.1% for increased lipase, 0.4% for hypocalcaemia, 1.3% for hypercalcaemia, 2.4% for hyperkalemia, 1.1% for hypermagnesaemia, 0.4% for hypomagnesaemia 1.9% for hypokalaemia, and 9.9% for hyponatraemia.
Maltese: F'pazjenti li ngħataw kura b'ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg f'RCC, ilproporzjon ta' pazjenti li esperjenzaw deterjorament mil-linja bażi għal anormalità tal-laboratorju talGrad 3 jew 4 kien kif ġej: 3.0% għal anemija (kollha tal-Grad 3), 0.7% għal tromboċitopenja, 0.6% għal lewkopenja, 5.1% għal limfopenja, 1.1% għal newtropenja, 2.0% għal żieda fil-fosfatażi alkalina, 4.8% għal żieda fl-AST, 6.5% għal żieda fl-ALT, 1.1% għal żieda fil-bilirubina totali, 2.1% għal żieda fil-kreatinina, 7.2% għal ipergliċemija, 1.8% għal ipergliċemija, 12.2% għal żieda flamilażi, 20.
English: Probability of Progression Free Survival
Maltese: Probabilità ta' Sopravivenza Mingħajr Progressjoni
English: OS results from this follow-up analysis are shown in Figure 5 (all randomised), Figure 6 (at the tumour PD-L1 1% cut off), and Table 10 (at the tumour PD-L1 5% cut off).
Maltese: Ir-riżultati tal-OS minn din l-analiżi ta' segwitu huma murija fil-Figura 5 (kollha randomizzati), fil-Figura 6 (bil-cut off ta' PD-L1 1% tat-tumur), u fit-Tabella 10 (bil-cut off ta' PD-L1 5% tat-tumur).
English: The median age was 57 years.
Maltese: L-età medjana kienet ta' 57 sena.
English: Results from exploratory multivariate analyses identified patient and tumour characteristics (ECOG performance status, M stage, baseline LDH, BRAF mutation status, PD-L1 status, and gender) which might contribute to the survival outcome.
Maltese: Ir-riżultati minn analiżijiet multivarjati esploratorji identifikaw karatteristiċi tal-pazjent u tat-tumur (status tal-prestazzjoni ECOG, stadju M, LDH fil-linja bażi, status tal-mutazzjoni BRAF, status ta' PD-L1 u s-sess) li jistgħu jikkontribwixxu għar-riżultat tas-sopravivenza.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 0.5% (3/547), 2.4% (13/547), and 0.4% (2/547) of patients, respectively.
Maltese: Ġew irrapportati każijiet tal-Grad 2, talGrad 3, u tal-Grad 4 f'0.5 % (3/547), f'2.4 % (13/547), u f'0.4 % (2/547) tal-pazjenti, rispettivament.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of rash was 48.8% (267/547).
Maltese: F'pazjenti li kienu qed jingħataw kura b'ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg f'RCC, l-inċidenza ta' raxx kienet ta' 48.8 % (267/547).
English: PFS results (with minimum follow up of 18 months) are shown in Figure 2 (all randomised population), Figure 3 (at the tumour PD-L1 5% cut off), and Figure 4 (at the tumour PD-L1 1% cut off).
Maltese: Ir-riżultati tal-PFS (b'follow up minimu ta' 18-il xahar) jidhru f'Figura 2 (il-popolazzjoni randomizzata kollha), Figura 3 (bil-cut off ta' PD-L1 5% tat-tumur), u Figura 4 (bil-cut off ta' PD-L1 1% tat-tumur).
English: The frequency of adverse events in the cardiac disorders system organ class regardless of causality was higher in the nivolumab group than in the chemotherapy group in post-CTLA4/BRAF inhibitor metastatic melanoma population.
Maltese: Il-frekwenza ta' avvenimenti avversi fis-sistema tal-klassifika tal-organi tad-disturbi fil-qalb irrispettivament mill-kawżalità kienet ogħla fil-grupp ta' nivolumab milli fil-grupp tal-kimoterapija f'popolazzjoni ta' melanoma metastatika ta' wara inibitur CTLA4/BRAF.
English: Flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection at the end of the infusion.
Maltese: Laħlaħ il-linja bis-sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni jew 50 mg/ml (5%) glucose soluzzjoni għall-injezzjoni fit-tmiem tal-infużjoni.
English: Nivolumab+Ipilimumab (events: 63/155), median and 95% CI: N.A. (39.06, N.A.) ──Δ─── Nivolumab (events: 71/171), median and 95% CI: N.A. (40.21, N.A.) Ipilimumab (events: 103/164), median and 95% CI: 21.49 months (16.85, 29.08)
Maltese: Nivolumab+Ipilimumab (avvenimenti: 63/155), medjan u 95% CI: N.A. (39.06, N.A.) ──Δ─── Nivolumab (avvenimenti: 71/171), medjan u 95% CI: N.A. (40.21, N.A.) Ipilimumab (avvenimenti: 103/164), medjan u 95% CI: 21.49 xahar (16.
English: Except where noted, data relating to ipilimumab monotherapy are based on patients who received either ipilimumab 3 mg/kg monotherapy (n= 131) or ipilimumab 3 mg/kg in combination with gp100 (n= 380) in a Phase 3 study of advanced (unresectable or metastatic) melanoma (MDX010-20, see section 5.1).
Maltese: Ħlief kif innutat, dejta relatata ma' monoterapija b'ipilimumab hija bbażata fuq pazjenti li rċivew jew monoterapija b'ipilimumab 3 mg/kg (n= 131) jew ipilimumab 3 mg/kg flimkien ma' gp100 (n= 380) fi studju ta' Fażi 3 ta' melanoma avvanzata (li ma tistax tinqata' jew metastatika) (MDX010-20, ara sezzjoni 5.1).
English: Nivolumab+ipilimumab vs ipilimumab (primary analysis) - HR (95% CI): 0.55 (0.45, 0.69); p-value: <0.0001 Nivolumab vs ipilimumab (primary analysis) - HR (95% CI): 0.65 (0.53, 0.80); p-value: <0.0001
Maltese: 0001 Nivolumab vs ipilimumab (analiżi primarja) - HR (95% CI): 0.65 (0.53, 0.80); valur p: <0.0001
English: s r.o.
Maltese: Wara l-ftuħ
English: Pregnant monkeys received ipilimumab every 3 weeks from the onset of organogenesis in the first trimester through delivery, at exposure (AUC) levels either similar to or higher than those associated with the clinical dose of 3 mg/kg of ipilimumab.
Maltese: Xadini tqal ingħataw ipilimumab kull 3 ġimgħat mill-bidu tal-organoġenesi fl-ewwel simestru sal-ħlas, f'livelli ta' esponiment (AUC) simili jew ogħla minn dawk assoċjati mad-doża klinika ta' 3 mg/kg ta' ipilimumab.
English: The incidence of neutralising antibodies against nivolumab was 0.5% with nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks and 4.6% with nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks.
Maltese: L-inċidenza ta' antikorpi newtralizzanti kontra nivolumab kienet ta' 0.5% b'nivolumab 3 mg/kg u ipilimumab 1 mg/kg kull 3 ġimgħat u 4.6% b'nivolumab 1 mg/kg u ipilimumab 3 mg/kg kull 3 ġimgħat.
English: Investigationsb
Maltese: Investigazzjonijiet