FrancophonIA/ELRC3.0 huggingface dataset:
English: rhabdomyolysisa,f
Maltese: F'dan il-fuljett:
English: Number of Subjects at Risk Nivolumab + Ipilimumab
Maltese: Numru ta' Individwi f'Riskju Nivolumab + Ipilimumab
English: The primary efficacy outcome measures were OS, ORR and PFS as determined by a Blinded Independent Central Review (BICR) in intermediate/poor risk patients.
Maltese: Ċentrali Indipendenti Blinded (BICR) f'pazjenti b'riskju intermedju/baxx.
English: Patients with a baseline performance score ≥ 2, active brain or leptomeningeal metastases, active autoimmune disease, medical conditions requiring systemic immunosuppression, or carcinoma of the nasopharynx or salivary gland as the primary tumour sites were excluded from the SCCHN clinical trial (see sections 4.5 and 5.1).
Maltese: Il-pazjenti b'punteġġ ta' prestazzjoni tal-linja bażi ≥ 2, b'metastasi fil-moħħ jew leptomeninġeali attivi, b'mard awtoimmuni attiv, jew b'kundizzjonijiet mediċi li jeħtieġu immunosuppressjoni sistemika ġew esklużi mill-provi kliniċi tal-karċinoma tal-apparat tal-awrina (ara sezzjonijiet 4.5 u 5.1).
English: Inflammation of the intestines (colitis), mouth ulcers and cold sores (stomatitis), vomiting, stomach pain, constipation, dry mouth
Maltese: Infjamazzjoni tal-imsaren (kolite), ulċeri tal-ħalq u infafet tad-deni (stomatite), rimettar, uġigħ fl-istonku, stitikezza, ħalq xott
English: The majority of the patients had AJCC Stage IV disease (93%); 58% had M1c disease at study entry.
Maltese: Il-maġġoranza tal-pazjenti kellhom il-marda AJCC ta' Stadju IV (93%); 58% kellhom il-marda M1c meta bdew l-istudju.
English: Single-arm phase 2 study (CA209172)
Maltese: Studju ta' fergħa waħda ta' fażi 2 (CA209172)
English: Post authorisation efficacy study (PAES): In order to further elucidate the contribution of ipilimumab to the efficacy and toxicity of the combination regimen of nivolumab and ipilimumab, the MAH should conduct and submit the results of a randomised, clinical study comparing the efficacy and safety of the combination of nivolumab and ipilimumab to nivolumab monotherapy in previously untreated adult patients with intermediate/poorrisk advanced renal cell carcinoma and with an appropriate spectrum of PDL1 expression levels.
Maltese: Sabiex tkompli tiġi ċċarata l-kontribuzzjoni ta' ipilimumab għall-effikaċja u għattossiċità tar-reġimen ta' kombinazzjoni ta' nivolumab u ipilimumab, ilMAH għandu jwettaq u jippreżenta r-riżultati ta' studju kliniku każwali li jqabbel l-effikaċja u s-sigurtà tal-kombinazzjoni ta' nivolumab u ipilimumab ma' monoterapija ta' nivolumab f'pazjenti adulti b'karċinoma taċ-ċellola tal-kliewi avvanzata b'riskju intermedju/baxx li ma kinux ingħataw kura preċedenti u bi spettru xieraq tal-livelli ta' espressjoni ta' PD-L1.
English: (n = 15/12.0)
Maltese: CA209039 (n = 15/12.0)
English: OPDIVO as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
Maltese: Limfoma ta' Hodgkin Klassika (classical Hodgkin lymphoma, cHL) OPDIVO bħala monoterapija huwa indikat għall-kura ta' pazjenti adulti b'limfoma ta' Hodgkin klassika li reġgħet ħarġet jew refrattarja wara trapjant awtologu ta' ċelluli staminali (autologous stem cell transplant, ASCT) u kura bi brentuximab vedotin.
English: Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the treatment groups.
Maltese: Fost pazjenti b'espressjoni PD-L1 ta' tumur kwantifikabbli, id-distribuzzjoni tal-pazjenti kienet ibbilanċjata tul il-gruppi ta' kura kollha.
English: The safety and efficacy of nivolumab 3 mg/kg for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, double-blind study (CA209066).
Maltese: Is-sigurtà u l-effikaċja ta' nivolumab 3 mg/kg għall-kura ta' melanoma avvanzata (li ma tistax titneħħa kirurġikament jew metastatika) kienu evalwati fi studju randomizzat, bi blindaġġ doppju, tal-fażi 3 (CA209066).
English: Squamous Cell Cancer of the Head and Neck (SCCHN) OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1).
Maltese: OPDIVO bħala monoterapija huwa indikat għall-kura tal-kanċer rikorrenti jew metastatiku taċ-ċelloli skawmużi tar-ras u tal-għonq f'adulti li jkunu qed javvanzaw fuq jew wara terapija bbażata fuq ilplatinu (ara sezzjoni 5.1).
English: The trial demonstrated a statistically significant improvement in RFS for patients randomised to the nivolumab arm compared with the ipilimumab 10 mg/kg arm. RFS benefit was consistently demonstrated across subgroups, including tumour PD-L1 expression, BRAF status, and stage of disease.
Maltese: Il-benefiċċju ta' RFS intwera b'mod konsistenti tul is-subgruppi, inkluż espressjoni ta' PD-L1 ta' tumur, l-istatus ta' BRAF, u l-fażi talmarda.
English: In intermediate/poor-risk patients, OS benefit was observed in the nivolumab in combination with ipilimumab arm vs. sunitinib regardless of tumour PD-L1 expression.
Maltese: F'pazjenti b'riskju intermedju/baxx, il-benefiċċju tal-OS ġie osservat fil-fergħa ta' nivolumab flimkien ma' ipilimumab kontra sunitinib irrispettivament mill-espressjoni PD-L1 tat-tumur.
English: Figure 2: Progression-free survival (CA209067)
Maltese: Figura 2: Sopravivenza mingħajr progessjoni (CA209067)
English: Uncommon psoriasis
Maltese: Mhux komuni effużjoni plewrali
English: Prespecified interim analysis Minimum follow-up: 13.2 months
Maltese: Analiżi interim speċifikata minn qabel Segwitu minimu: 13.2 xhur
English: following nivolumab therapy' o Potential risk of ‘Risk of GVHD with nivolumab after allogeneic HSCT'
Maltese: graft-versus-host disease) u mortalità relatata mat-trapjant ta' Trapjant alloġeniku b'Ċelluli Staminali Ematopojetiċi (HSCT, Haematopoietic Stem Cell Transplant) wara l-kura b'nivolumab” o Riskju potenzjali ta' “Riskju ta' GVHD b'nivolumab wara HSCT alloġeneiku”
English: Uncommon tubulointerstitial nephritis tubulointerstitial nephritis
Maltese: nefrite tubulointerstizjali
English: Nivolumab attaches to a target protein called programmed death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body's natural defences).
Maltese: Nivolumab jeħel ma' proteina fil-mira msejħa riċettur programmat tal-mewt-1 (programmed death-1, PD-1) li tista titfi l-attività ta' ċelloli T (tip ta' ċelloli tad-demm bojod li jiffurmaw parti mis-sistema immuni, id-difiża naturali tal-ġisem).
English: The co-primary efficacy outcome measures were confirmed ORR in the first 120 patients treated with nivolumab, as measured by independent radiology review committee (IRRC) using RECIST, version 1.1, and comparison of OS of nivolumab to chemotherapy.
Maltese: Il-kejl koprimarju tal-eżitu tal-effikaċja kien ORR ikkonfermata fl-ewwel 120 pazjenti ttrattati b'nivolumab, kif imkejla minn kumitat indipendenti ta' analiżi tar-radjoloġija (independent radiology review committee, IRRC) bl-użu tal-Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST, verżjoni 1.1), u paragun tas-sopravvivenza ġenerali (OS) ta' nivolumab mal-kemoterapija.
English: The median duration of treatment was 7.9 months (range: 1 day- 21.4+ months) in nivolumab with ipilimumab- treated patients and was 7.8 months (range: 1 days- 20.2+ months) in sunitinib treated patients.
Maltese: It-tul medjan tal-kura kien 7.9 xhur (firxa: jum 1 - 21.4+ xhur) f'pazjenti kkurati b'nivolumab ma' ipilimumab u kien 7.8 xhur (firxa: jum 1 - 20.2+ xhur) f'pazjenti kkurati b'sunitinib.
English: The median age was 62 years (range: 21 to 85) with 34% ≥65 years of age and 7% ≥75 years of age.
Maltese: L-età medjana kienet ta' 62 sena (medda: 21 sa 85) bi 34% li għandhom 65 sena u 7% li għandhom 75 sena.
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.55 (0.40, 0.75) Nivolumab vs. Ipilimumab - hazard ratio: 0.54 (0.40, 0.73) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 1.02 (0.73, 1.43)
Maltese: Ipilimumab - proporzjon ta' periklu: 0.54 (0.40, 0.73) Nivolumab+Ipilimumab vs.
English: Each mL of concentrate contains 10 mg of nivolumab.
Maltese: Kull mL konċentrat fih 10 mg nivolumab.
English: (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) and who have experienced disease progression during or within 6 months of receiving platinum-based therapy regimen and had an ECOG performance status score of 0 or 1.
Maltese: III/IV u mhux amenabbli għal terapija lokali b'intenzjoni kurattiva (kirurġija jew terapija ta' radjazzjoni bi jew mingħajr kemoterapija) u li kellhom progressjoni tal-marda waqt jew fi żmien 6 xhur minn meta rċivew reġim ta' terapija bbażata fuq platinum u punteġġ ta' status ta' prestazzjoni ECOG ta' 0 jew 1.
English: Baseline characteristics were balanced between groups except for the proportions of patients who had a history of brain metastasis (19% and 13% in the nivolumab group and chemotherapy group, respectively) and patients with LDH greater than ULN at baseline (51% and 35%, respectively).
Maltese: Ilkaratteristiċi bażi kienu bbilanċjati bejn il-gruppi ħlief għall-proporzjonijiet tal-pazjenti li fl-imgħoddi kellhom metastasi fil-moħħ (19% u 13% fil-grupp ta' nivolumab u l-grupp tal-kimoterapija, rispettivament) u l-pazjenti b'LDH ogħla mill-ULN fil-linja bażi (51% u 35%, rispetivament).
English: Median (95% CI) Rate (95% CI) At 6 months At 12 months
Maltese: Medjan (95% CI) Rata (95% CI) Wara 6 xhur Wara 12-il xahar
English: Patients should be monitored for signs and symptoms of nephritis or renal dysfunction.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' nefrite jew disfunzjoni renali.
English: The effect of hepatic impairment on the CL of nivolumab was evaluated in patients with mild hepatic impairment (total bilirubin 1.0 × to 1.5 × ULN or AST > ULN as defined using the National Cancer Institute criteria of hepatic dysfunction; n = 92) compared to patients with normal hepatic function (total bilirubin and AST ≤ ULN; n = 804) in the population PK analyses.
Maltese: L-analiżi primarja OS ma ġietx aġġustata biex tikkunsidra t-terapiji sussegwenti, b'54 (40.6%) pazjent fil-grupp kimoterapewtiku li sussegwentement irċivew trattament kontra PD1. LOS tista' titħawwad minn persuni li jirtiraw, żbilanċ ta' terapiji sussegwenti u differenzi fil-fatturi tallinja bażi.
English: Unopened vial 3 years
Maltese: Kunjett mhux miftuħ 3 snin
English: The following side effects have been reported with nivolumab in combination with ipilimumab:
Maltese: L-effetti sekondarji li ġejjin ġew irrappurtati b'nivolumab mogħti flimkien ma' iplimumab:
English: Grade 2, Grade 3, and Grade 4 cases were reported in 13.6% (61/448), 15.8% (71/448), and 0.4% (2/448) of patients, respectively.
Maltese: Grad 3, u Grad 4 seħħet f'1.6% (7/448), 1.3% (6/448) u 0.2% (1/448) tal-pazjenti, rispettivament.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/4 mL
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 40 mg/4 mL
English: Docetaxel ──Δ─── Nivolumab 3 mg/kg (events: 190/292), median and 95% CI: 12.19 (9.66, 14.98) - - -- - - Docetaxel (events: 223/290), median and 95% CI: 9.36 (8.05, 10.68) The trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with docetaxel at the prespecified interim analysis when 413 events were observed (93% of the planned number of events for final analysis).
Maltese: ──Δ─── Nivolumab 3 mg/kg (avvenimenti: 190/292), medjan u 95% CI: 12.19 (9.66, 14.98) - - -- - - Docetaxel (avvenimenti: 223/290), medjan u 95% CI: 9.
English: After 28 months of follow-up, median durations of response for patients with tumour PD-L1 expression level ≥5% were not reached (range: 0+-31.6+) in the combination arm, not reached (range: 2.8-30.6+) in the nivolumab monotherapy arm and not reached (range: 1.4-30.6+) in the ipilimumab arm. At tumour PD-L1 expression <5%, median durations of response were not reached (range: 0+-33.3+) in the combination arm, not reached (range: 0+-32.3+) in the nivolumab monotherapy arm and 18.2 months (range: 0.0+-31.5+) in the ipilimumab monotherapy arm.
Maltese: Wara 28 xahar ta' segwitu, it-tul taż-żmien medjan tar-rispons għal pazjenti b'livell ta' espressjoni tattumur ta' PD-L1 ≥ 5% ma ntleħaqx (firxa: 0+-31.6+) fil-fergħa ta' kombinazzjoni, ma ntleħaqx (firxa: 2.8-30.6+) fil-fergħa tal-monoterapija ta' nivolumab u ma ntlaħaqx (firxa: 1.4-30.6+) fil-fergħa ta' ipilimumab.
English: OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1).
Maltese: OPDIVO bħala monoterapija huwa indikat għall-kura aġġuvanti ta' adulti b'melanoma bl-involviment ta' nodi limfatiċi jew b'marda metastatika li jkunu għaddew minn risezzjoni kompleta (ara sezzjoni 5.1).
English: Severe infusion reactions have been reported in clinical trials of nivolumab or nivolumab in combination with ipilimumab (see section 4.8).
Maltese: Reazzjonijiet severi ta' infużjoni ġew rrappurtati fil-provi kliniċi ta' nivolumab jew ta' nivolumab mogħti flimkien ma' ipilimumab (ara sezzjoni 4.8).
English: (95% CI) Rate (95% CI) at 60 months
Maltese: (95% CI) Rata (95% CI) wara 24 xahar
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of relapsed or refractory cHL following ASCT was evaluated in two multi-centre, open-label, single-arm studies (CA209205 and CA209039).
Maltese: Is-sigurtà u l-effikaċja ta' nivolumab 3 mg/kg bħala sustanza waħedha għall-kura ta' cHL li reġgħet ħarġet jew refrattarja wara ASCT kienu evalwati f'żewġ studji multiċentriċi, open-label, ta' fergħa waħda (CA209205 u CA209039).
English: Hypersensitivity/Infusion Reaction a at least 40 mg daily prednisone equivalents b frequency is based on the number of patients who experienced the immune-related adverse reaction
Maltese: Endokrinopatiji Ġilda a tal-inqas 40 mg kuljum ta' prednisone ekwivalenti b il-frekwenza hija bbażata fuq in-numru ta' pazjenti li esperjenzaw ir-reazzjoni avversa relatata mas-sistema immunitarja
English: For Grade 4 diarrhoea or colitis, 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 dijarea jew kolite tal-Grad 4, nivolumab jew nivolumab mogħti flimkien ma' ipilimumab għandhom jitwaqqfu b'mod permanenti, u għandhom jinbdew kortikosterojdi f'doża ta' 1 sa 2 mg/kg/kuljum f'ekwivalenti ta' methylprednisolone.
English: Severe diarrhoea or colitis has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Maltese: Dijarea jew kolite severa ġew osservati b'monoterapija ta' Nivolumab jew b'nivolumab mogħti flimkien ma' ipilimumab (ara sezzjoni 4.8).
English: Minimum follow-up for the analysis of ORR was 28 months.
Maltese: Is-segwitu minimu għall-analiżi tal-ORR kien ta' 28 xahar.
English: The median age was 61 years (range: 18 to 90 years), 65% of patients were men, and 97% were white.
Maltese: L-età medjana kienet 61 sena (firxa ta':18 sa 90 sena), 65% tal-pazjenti kienu rġiel, u 97% kienu bojod.
English: Skin and subcutaneous tissue disorders Very common rashe, pruritus rashe, pruritus
Maltese: Disturbi fis-sistema nervuża Komuni newropatija periferika, uġigħ ta' ras, sturdament
English: For Grade 3 or 4 pneumonitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Maltese: Għal pulmonite ta' Grad 3 jew 4, nivolumab jew nivolumab mogħti flimkien ma' ipilimumab għandhom jitwaqqfu b'mod permanenti u l-kortikosterojdi għandhom jinbdew b'doża ta' 2 sa 4 mg/kg/jum ta' ekwivalenti għall-methylprednisolone.
English: In the absence of data for patients with autoimmune disease, symptomatic interstitial lung disease, active brain metastases and patients who had been receiving systemic immunosuppressants prior to study entry, nivolumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with poorer prognostic features and/or aggressive disease.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott mediċinali.
English: Check with your doctor or nurse before you are given OPDIVO if: you have an autoimmune disease (a condition where the body attacks its own cells); you have melanoma of the eye; you were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine; you have been told that your cancer has spread to your brain; you have any history of inflammation of the lungs; you have been taken medicines to suppress your immune system.
Maltese: Ivverifika mat-tabib jew mal-infirmier tiegħek qabel tingħata OPDIVO jekk: għandek marda awtoimmuni (kundizzjoni li fiha l-ġisem jattakka ċ-ċelloli tiegħu stess); għandek melanoma tal-għajn; qabel ingħatajt ipilimumab, mediċina oħra għall-kura tal-melanoma, u esperjenzajt effetti sekondarji serji minħabba dik il-mediċina; qalulek li l-kanċer tiegħek infirex għal moħħok; għandek xi storja ta' infjamazzjoni tal-pulmuni; kont qed tieħu mediċini biex trażżan is-sistema immuni tiegħek.
English: Odds Ratio (95% CI)
Maltese: Proporzjon ta' Periklu (95% CI)
English: Progression- free survival Rate (95% CI) at 12 months Rate (95% CI) at 18 months Overall survival
Maltese: Sopravivenza ħielsa minn progressjoni Rata (95% CI) wara 12-il xahar Rata (95% CI) wara 18-il xahar Sopravivenza globali Medjana
English: OPDIVO 10 mg/mL concentrate for solution for infusion nivolumab
Maltese: OPDIVO 10 mg/mL konċentrat għal soluzzjoni għall-infużjoni.
English: The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed ORR and PFS. Additional prespecified subgroup analyses were conducted to evaluate the efficacy of tumour PD-L1 expression at predefined levels of 1%, 5% and 10%.
Maltese: Twettqu analiżijiet addizzjonali ta' sottogrupp definit minn qabel biex tiġi vvalutata l-effikaċja mill-espressjoni PD-L1 tat-tumur f'livelli definiti minn qabel ta' 1 %, 5 %, u 10 %.
English: The safety and efficacy of nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg for the treatment of advanced/metastatic RCC was evaluated in a phase 3, randomised, open-label study (CA209214).
Maltese: Is-sigurtà u l-effikaċja ta' nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg għall-kura ta' RCC avvanzata/metastatika kienu evalwati fi studju ta' fażi 3, każwali, open-label (CA209214).
English: Grade 2 and Grade 3 thyroid disorders were reported in 15.7% (86/547) and 1.3% (7/547) of patients, respectively.
Maltese: 7% (86/547) u 1.3% (7/547) tal-pazjenti, rispettivament.
English: PD-L1 ≥ 1%, PD-L1+ TAIC rared
Maltese: (43 nivolumab, 25 għażla talinvestigatur) PD-L1 < 1%, PD-L1+ TAIC rarid
English: The Kaplan-Meier curves for OS are shown in Figure 1.
Maltese: Il-kurvi Kaplan-Meier għall-OS qed jintwerew fil-Figura 1.
English: Data from SCCHN and adjuvant melanoma patients 75 years of age or older are too limited to draw conclusions on this population.
Maltese: Tagħrif minn pazjenti b'SCCHN u melanoma aġġuvanti ta' 75 sena jew aktar huwa limitat wisq biex jinstiltu konklużjonijiet dwar din il-popolazzjoni.
English: Not known aseptic meningitish
Maltese: Pulmonite relatata mas-sistema immunitarja
English: The study included patients (18 years or older) who have experienced disease progression during or after 1 or 2 prior anti-angiogenic therapy regimens and no more than 3 total prior systemic treatment regimens.
Maltese: Listudju inkluda pazjenti (18-il sena jew akbar) li esperjenzaw progressjoni tal-marda matul jew wara 1 jew 2 korsijiet ta' terapija anti-anġjoġenika u mhux aktar minn 3 korsijiet ta' kura sistemika minn qabel.
English: Nivolumab in combination with ipilimumab:
Maltese: Nivolumab flimkien ma' ipilimumab:
English: Range Median time to response Months (range) Median duration of follow-up Months (range) Progression-free survival Rate (95% CI) at 12 months “+” denotes a censored observation.
Maltese: Sopravivenza ħielsa minn progressjoni Rata (95% CI) wara 12-il xahar “+” ifisser osservazzjoni ċċensurata.
English: Study CA209172 was a single-arm, open label study of nivolumab monotherapy in patients with stage III (unresectable) or stage IV metastatic melanoma after prior treatment containing an antiCTLA-4 monoclonal antibody.
Maltese: Barra minn hekk, f'CA209037 ġew esklużi pazjenti li kellhom reazzjoni avversa tal-Grad 4 li kienet relatata ma' terapija anti-CTLA4
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 - proprozjon ta' periklu: 0.57 (0.45, 0.72) Nivolumab+Ipilimumab vs.
English: Median time to onset was 2.1 months (range: 0.0-27.6).
Maltese: Il-ħin medjan sal-bidu kien ta' 2.1 xhur (firxa: 0.0-27.6).
English: OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).
Maltese: OPDIVO flimkien ma' ipilimumab huwa indikat għall-kura tal-ewwel linja ta' pazjenti adulti b'riskju intermedju/baxx ta' karċinoma taċ-ċellola tal-kliewi avvanzata (ara sezzjoni 5.1).
English: Acid in the blood produced from diabetes (diabetic ketoacidosis) A temporary inflammation of the nerves that causes pain, weakness and paralysis in the extremities (Guillain-Barré syndrome); damage to nerves causing numbness and weakness (polyneuropathy); inflammation of the nerves; foot drop (peroneal nerve palsy); inflammation of the nerves caused by the body attacking itself, causing numbness, weakness, tingling or burning pain (autoimmune neuropathy); muscle weakness and tiredness without atrophy (myasthenia gravis)
Maltese: Infjammazzjoni temporanja tan-nervituri li tikkawża uġigħ, dgħjufija u paraliżi fl-estremitajiet (sindromu ta' Guillain-Barré), telf tar-rita protettiva madwar in-nervituri (demajelinazzjoni), kundizzjoni fejn il-muskoli jiddagħjfu u jgħejjew faċilment (sindromu mijasteniku) Infjammazzjoni tal-moħħ
English: This observation was maintained with the OS results with a minimum followup of 36 months.
Maltese: Din l-osservazzjoni nżammet bir-riżultati ta' OS b'segwitu minimu ta' 36 xahar.
English: Table 25: Efficacy by tumour cell and TAIC PD-L1 expression (CA209141)
Maltese: L-effikaċja skont l-espressjoni PD-L1 taċ-ċelloli tat-tumur u dik TAIC (CA209141) OS medjanaa(xhur)
English: With a minimum of 63 months follow-up in NSCLC, no new safety signals were identified.
Maltese: B'minimu ta' 63 xahar ta' segwitu fl-NSCLC, ma ġie identifikat l-ebda sinjal ġdid ta' sigurtà.
English: Not known solid organ transplant rejectionh, sarcoidosish Endocrine disorders
Maltese: Vaskulite Disturbi respiratorji, toraċiċi u medjastinali
English: Immune-related adverse reaction
Maltese: Epatite relatata mas-sistema immuni
English: Hazard Ratio (95% CI)
Maltese: Proporzjon talProbabilità (95% CI)
English: If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up to 24 hours [a maximum of 8 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light].
Maltese: [massimu ta' 8 sigħat mill-24 siegħa totali jistgħu jkunu f'temperatura ambjentali (20°C-25°C) u dawl tal-kamra].