FrancophonIA/ELRC3.0 huggingface dataset:
English: When Zonisamide Mylan is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
Maltese: Meta Zonisamide Mylan jintuża bħala ‘żieda' għall-kura eżistenti fl-adulti, id-doża tal-bidu rakkomandata hija 25 mg darbtejn kuljum.
English: Epileptic fits are caused by abnormal electrical activity in the brain.
Maltese: L-attakki ta' epilessija huma kkawżati minn attività elettrika anormali fil-moħħ.
English: When Zonisamide Mylan is used as an ‘add-on' to existing treatment in children aged six years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Maltese: Meta Zonisamide Mylan jintuża bħala kura ta' 'żieda' ma' kura eżistenti fit-tfal minn sitt snin ‘il fuq, iddoża tiddependi mill-piż tal-ġisem; id-doża tal-bidu rakkomandata hija 1 mg għal kull kg tal-piż talġisem kuljum.
English: A risk management plan has been developed to ensure that Zonisamide Mylan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zonisamide Mylan jintuża bl-aktar mod sigur possibbli.
English: Zonisamide Mylan is a medicine used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain).
Maltese: Zonisamide Mylan huwa mediċina li tintuża biex tikkura pazjenti li jbatu minn epilessija parzjali (attakki ta' epilessija li jibdew minn parti speċifika tal-moħħ), inklużi dawk li għandhom ġeneralizzazzjoni sekondarja (fejn l-epilessija mbagħad tinfirex mal-moħħ kollu).
English: Zonisamide Mylan zonisamide
Maltese: Kif ġie studjat Zonisamide Mylan?
English: It is used on its own in newly diagnosed adults and as an ‘add-on' therapy in adults and children aged six years and above already receiving other anti-epilepsy medicines.
Maltese: Jintuża waħdu f'adulti li għadhom kemm ingħataw dijanjożi u bħala 'żieda' għat-terapija fl-adulti u t-tfal li għandhom minn sitt snin ‘il fuq li diġà qed jieħdu mediċini oħra kontra l-epilessija.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zonisamide Mylan has been shown to have comparable quality and to be bioequivalent to Zonegran.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Zonisamide Mylan wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Zonegran.
English: The Committee recommended that Zonisamide Mylan be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Zonisamide Mylan ikun approvat għall-użu fl-UE.
English: By blocking these channels, zonisamide is expected to prevent abnormal electrical activity spreading through the brain, thereby reducing the chances of an epileptic fit.
Maltese: Billi timblokka dawn il-kanali, iz-zonisamide hija mistennija li tipprevjeni attività elettrika anormali li qed tinfirex mal-moħħ, b'hekk tnaqqas iċ-ċansijiet ta' attakki ta' epilessija.
English: When calcium and sodium enter nerve cells, electrical impulses can be transmitted between the nerve cells.
Maltese: Meta l-kalċju u s-sodju jidħlu fiċ-ċelluli tan-nervituri, jistgħu jiġu trażmessi impulsi elettriċi bejn iċ-ċelluli tan-nervituri.
English: When Zonisamide Mylan is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Maltese: Meta Zonisamide Mylan jintuża waħdu f'pazjenti li jkunu għadhom kemm ingħataw dijanjożi, id-doża tal-bidu rakkomandata hija 100 mg darba kuljum għal ġimagħtejn, li tista' tiżdied b'100 mg f'intervalli ta' ġimagħtejn.
English: How is Zonisamide Mylan used?
Maltese: Kif jintuża Zonisamide Mylan?
English: 1 bottle + 1 bottle adaptor + 1 dosing syringe 10 ml
Maltese: Flixkun 1 + adapter talflixkun 1 + siringa taddożaġġ 1 10ml
English: (Invented) name Strength Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa Għamla Farmaċewtika
English: ATC code: L01XC17.
Maltese: L01XC17.
English: Indication*
Maltese: Indikazzjoni*
English: 101 International Drive Portsmouth, New Hampshire 03801 USA
Maltese: 101 International Drive Portsmouth, New Hampshire 03801 L-Istati Uniti tal-Amerika
English: ECOG PS 2 < 75 years
Maltese: ECOG PS 2 < 75 sena
English: 31st March 2019
Maltese: 31 ta' Marzu 2019
English: ECOG PS 2 CNS Metastasis
Maltese: ECOG PS 2 Metastasi tas-CNS
English: c included 4 drug-related deaths: 1 pneumonitis, 1 acute respiratory failure, 1 respiratory failure, and 1 cardiovascular failure.
Maltese: c inkludiet 4 imwiet relatati mal-mediċini: 1 pnewmonite, 1 falliment respiratorju akut, 1 falliment respiratorju, u 1 falliment kardjovaskulari.
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
Maltese: Nota: Il-gradi tat-tossiċità huma konformi man-National Cancer Institute Common Terminology Criteria for Adverse Events (Kriterji tat-Terminoloġija Komuni tal-Istitut Nazzjonali tal-Kanċer) Verżjoni 4.0 (NCI-CTCAE v4).
English: Events (%)
Maltese: Każijiet (%)
English: ≥ 75 years
Maltese: ≥ 75 sena
English: CR+PR, confidence interval based on the Clopper and Pearson method
Maltese: CR+PR, intervall ta' fiduċja abbażi tal-metodu Clopper and Pearson
English: (27 nivolumab, 10 investigator's choice)
Maltese: (27 nivolumab, 10 għażla talinvestigatur)
English: PVC containers
Maltese: Kontenituri tal-PVC
English: Grade 2 elevation in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin
Maltese: Elevazzjoni ta' Grad 2 fl-aspartate aminotransferase (AST), alanine aminotransferase (ALT), jew ilbilirubina totali
English: 3.6 (Not available)
Maltese: 3.6 (Mhux disponibbli)
English: ≥ 1% to < 10%a ≥ 10% to < 50%a ≥ 50%a
Maltese: ≥ 1% to < 10%a ≥ 10% sa < 50%a ≥ 50%a
English: Based on a stratified log-rank test.
Maltese: Ibbażat fuq test log-rank stratifikat.
English: The active substance is nivolumab.
Maltese: Is-sustanza attiva hija nivolumab.
English: chemotherapy (n = 47)
Maltese: kemoterapija (n = 47)
English: Preparation and administration
Maltese: Preparazzjoni u amministrazzjoni
English: (95% CI) Difference in ORR (95% CI)d p-valuee,f
Maltese: (95% CI) Differenza fl-ORR (95% CI)d valur pe,f
English: Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Maltese: Sindrome ta' Stevens-Johnson (Stevens-Johnson syndrome, SJS) jew nekroliżi epidermali tossika (toxic epidermal necrolysis, TEN)
English: EU/1/15/1014/001 40 mg vial EU/1/15/1014/002 100 mg vial EU/1/15/1014/003 240 mg vial
Maltese: EU/1/15/1014/001 kunjett tal-40 mg EU/1/15/1014/002 kunjett tal-100 mg EU/1/15/1014/003 kunjett tal-240 mg
English: Patient-reported outcomes (PROs) were assessed using the EORTC QLQ-C30, EORTC QLQ-H&N35, and 3-level EQ-5D.
Maltese: L-eżiti rrappurtati mill-pazjenti (PROs, patient reported outcomes) ġew ivvalutati bl-użu ta' EORTC QLQ-C30, EORTC QLQ-H&N35, u EQ-5D ta' 3 livelli.
English: Nivolumab + Ipilimumab
Maltese: Nivolumab+Ipilimumab vs.
English: Randomised phase 3 study of nivolumab vs ipilimumab 10 mg/kg (CA209238)
Maltese: Studju ta' fażi 3 randomizzat ta' nivolumab vs ipilimumab 10 mg/kg (CA209238)
English: ECOG status
Maltese: Status tal-ECOG
English: Sixteen percent of patients had received prior adjuvant therapy; the most common adjuvant treatment was interferon (9%).
Maltese: Sittax fil-mija ta' pazjenti kellhom terapija adjuvanti preċedentement; l-aktar trattament adjuvanti komuni kien interferon (9%).
English: Progression Free Survival Events (%)
Maltese: Sopravivenza mingħajr progressjoni Każijiet (%)
English: investigator's choice (n = 121)
Maltese: għażla tal-investigatur (n = 121)
English: Nivolumab + ipilimumab (events: 166/425), median and 95.0% CI: NA (32.49, NA)
Maltese: Nivolumab + ipilimumab (avvenimenti: 166/425), medjan u 95.0% CI: NA (32.49, NA)
English: • Grade 4 or recurrent Grade 3 adverse reactions;
Maltese: • Reazzjonijiet avversi ta' Grad 4 jew rikorrenti ta' Grad 3;
English: Stevens-Johnson syndrome, vitiligo, erythema multiforme, alopecia, psoriasis
Maltese: Mhux komuni Psrojażi sindrome ta' Stevens-Johnson, vitiligo, eritema multiforme, alopeċja, psorjażi
English: Phase 3b/4 safety study (CA209374)
Maltese: 3b/4 (CA209374)
English: Ocular/ Uveal melanoma
Maltese: Melanoma okulari/ Uveali
English: Hazard ratioa 95% CI p-value p<0.0001
Maltese: 95% CI Valur-p p<0.0001
English: 95% CI: 1.4, 17.9 OS by tumour PD-L1 expression Minimum follow-up: 13.2 months Number of events (number of patients)
Maltese: 95% CI: 1.4, 17.9 OS permezz tal-espressjoni PD-L1 tat-tumur Segwitu minimu: 13.2 xhur Numru ta' avvenimenti (numru ta' pazjenti)
English: Everolimus 10 mg (events: 215/411), median and 95% CI: 19.55 (17.64, 23.06)
Maltese: Everolimus (avvenimenti: 215/411), medjan u 95% CI: 19.55 (17.64, 23.06)
English: Table 4:
Maltese: Tabella 4:
English: Randomisation was stratified by tumour PD-L1 status and M stage (M0/M1a/M1b versus M1c).
Maltese: L-għażla każwali kienet stratifikata skont l-istatus PD-L1 tat-tumur u l-istadju M (M0/M1a/M1b kontra M1c).
English: OS and PFS were estimated using Kaplan-Meier method.
Maltese: L-OS u l-PFS ġew stmati bl-użu tal-metodu Kaplan-Meier.
English: Pericardial disorders is a composite term which includes pericarditis, pericardial effusion, cardiac tamponade, and Dressler's syndrome.
Maltese: Disturbi perikardijaċi huwa terminu kompost li jinkludi perikardite, effużjoni perikardijaka, taponade kardijaku, u sindrome ta' Dressler.
English: • subjects under the age of 18 years.
Maltese: • individwi li għandhom inqas minn 18-il sena.
English: 95% CI p-value
Maltese: 95% CI valur p
English: Subsequent systemic therapy was received by 31.8%, 44.3%, and 62.2% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Maltese: It-terapija sistemika sussegwenti ġiet riċevuta minn 31.8%, 44.3%, u 62.2% tal-pazjenti fil-kombinazzjoni, ilfergħat ta' monoterapija ta' nivolumab, u ipilimumab, rispettivament.
English: (95% CI)c nivolumab investigator's choice nivolumab investigator's choice nivolumab investigator's choice
Maltese: (95% CI)c nivolum ab għażla talinvestigatu nivolum ab għażla talinvestigatu nivoluma b għażla talinvestigatur
English: Computed using Kaplan-Meier method.
Maltese: Ikkalkulat permezz tal-metodu ta' Kaplan-Meier.
English: Grade 3 or 4 elevation in AST, ALT, or total bilirubin
Maltese: Elevazzjoni ta' Grad 3 jew 4 fl-AST, ALT, jew il-bilirubina totali
English: Solid organ transplant rejection.
Maltese: Rifjut ta' trapjant ta' organu solidu.
English: Nine of 49 patients (18.4%) died from complications of allogeneic HSCT after nivolumab.
Maltese: Disgħa minn 49 pazjent (18.4%) mietu minn kumplikazzjonijiet ta' HSCT alloġeniku wara nivolumab.
English: Hazard ratioa 99.8% CI p-valueb, c
Maltese: 99.8% CI valur pb, c
English: Ipilimumab 3 mg/kg over 90 minutes
Maltese: Ipilimumab 3 mg/kg għal 90 minuta
English: CA209214 also randomised 249 favourable risk patients as per IMDC criteria to nivolumab plus ipilimumab (n = 125) or to sunitinib (n = 124).
Maltese: CA209214 għażlet b'mod każwali wkoll 249 pazjent b'riskju favorevoli skont il-kriterji IMDC għal nivolumab u ipilimumab (n = 125) jew għal sunitinib (n = 124).
English: Melanoma (advanced or adjuvant treatment)
Maltese: Melanoma (trattament avvanzat jew aġġuvanti)
English: A total of 945 patients were randomised to receive nivolumab in combination with ipilimumab (n = 314), nivolumab monotherapy (n = 316), or ipilimumab monotherapy (n = 315).
Maltese: Total ta' 945 pazjent kienu randomizzati biex jirċievew nivolumab flimkien ma' ipilimumab (n=314), nivolumab bħala monoterapija (n=316), jew ipilumab bħala monoterapija (n=315).
English: Open-label phase 1/2 study (CA209032)
Maltese: Studju ta' Fażi 1/2 open-label (CA209032)
English: (95.92% CI) p-valueb
Maltese: (95.92% CI) valur-pb
English: PD-L1 < 1%, PD-L1+ TAIC rared
Maltese: PD-L1  1%, PD-L1+ TAIC rarid
English: PD-L1+ TAIC in the tumour microenvironment were qualitatively assessed, and characterised as “numerous”, “intermediate”, and “rare” based on pathologist assessments.
Maltese: PD-L1+ TAIC fil-mikroambjent tat-tumuri ġew ivvalutati b'mod kwalitattiv u ġew ikkaratterizzati bħala “numerużi”, “intermedji” u “rari” abbażi ta' valutazzjonijiet patoloġisti.
English: PFS rate at 12 months and 95% CI: 18% (14, 23)
Maltese: Ir-rata PFS fi 12-il xahar u 95% CI: 18% (14, 23)
English: ≥ 5 prior lines of systemic therapy
Maltese: ≥ 5 linji minn qabel ta' terapija sistemika Terapija b'radjazzjoni preċedenti
English: B-symptoms were present in 22% (53/243) of the patients in CA209205 at baseline.
Maltese: Sintomi-B kienu preżenti fi 22% (53/243) tal-pazjenti f'CA209205 fil-linja bażi.
English: Guillain-Barré syndrome, demyelination, myasthenic syndrome, encephalitisa,c
Maltese: Rari is-sindrome ta' Guillain-Barré, demajelinazzjoni, sindrome majesteniku, enċefalitea,c
English: Uncommon arrhythmia (including ventricular arrhythmia)a,d, atrial fibrillation, myocarditisa,f arrhythmia (including ventricular arrhythmia), myocarditisc
Maltese: Mhux komuni arritmija (inkluż arritmija ventrikulari)a,d, fibrillazzjoni atrijali, mijokarditea,f arritmija (inkluż arritmija ventrikulari), mijokarditec
English: Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 USA
Maltese: Thompson Road East Syracuse, New York 13057 L-Istati Uniti tal-Amerika
English: Table 26: Efficacy results (CA209275)a nivolumab (n = 270)
Maltese: Riżultati ta' effikaċja (CA209275)a nivolumab (n = 270)
English: Uncommon pleural effusion Gastrointestinal disorders
Maltese: Mhux komuni effużjoni plewrali Disturbi gastro-intestinali
English: ≥ 1% to < 10%a
Maltese: ≥ 1% sa < 10%a
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency (including secondary adrenocortical insufficiency), hypophysitis (including hypopituitarism), diabetes mellitus, and diabetic ketoacidosis have been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Maltese: Endokrinopatiji severi, inkluż ipotirojdiżmu, ipertirojdiżmu, insuffiċjenza adrenali (inkluż insuffiċjenza adrenokortikali sekondarja), ipofiżite (inkluż ipopitwitariżmu), dijabete mellitus, u ketoaċidożi dijabetika ġew osservati b'monoterapija b'nivolumab jew nivolumab mogħti flimkien ma' ipilimumab (ara sezzjoni 4.8).
English: The overall safety profile of nivolumab 3 mg/kg for the adjuvant treatment of melanoma (n = 452) was consistent with that established across tumour types for nivolumab monotherapy.
Maltese: Il-profil ġenerali tas-sigurtà ta' nivolumab 3 mg/kg għall-kura aġġuvanti ta' melanoma (n = 452) kien konsistenti ma' dak stabbilit għal tipi ta' tumuri differenti għal monoterapija ta' nivolumab.
English: P-value is derived from a log-rank test stratified by prior maintenance therapy and line of therapy; the corresponding O'Brien-Fleming efficacy boundary significance level is 0.0408.
Maltese: Il-valur-p huwa meħud minn test log-rank stratifikat permezz ta' terapija ta' manteniment u linja ta' terapija; il-livell corrispondenti O'Brien-Fleming ta' sinifikanza tal-livell tal-effikaċja huwa ta' 0.0408.
English: Grade 2 myocarditis
Maltese: Mijokardite ta' Grad 2
English: Date of first authorisation: 19 June 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Ġunju 2015
English: • That OPDIVO treatment may increase the risk of: o Immune-related pneumonitis o Immune-related colitis o Immune-related hepatitis o Immune-related nephritis and renal dysfunction o Immune-related endocrinopathies o Immune-related skin adverse reactions o Other immune-related ARs
Maltese: • It-trattament b'OPDIVO jista' jżid ir-riskju ta': o Pnewmonite relatata mal-immunità o Kolite relatata mal-immunità o Epatite relatata mal-immunità o Nefrite u diżfunzjoni tal-kliewi relatati mal-immunità o Endokrinopatiji relatati mal-immunità o Reazzjonijiet avversi tal-ġilda relatati mal-immunità o Reazzjonijiet avversi oħra relatati mal-immunità
English: Uncommon intestinal perforationa, gastritis, duodenitis gastritis
Maltese: Mhux komuni perforazzjoni intestinalia, gastrite, duwodenite
English: The ORR and PFS were assessed by IRRC per RECIST version 1.1.
Maltese: L-ORR u l-PFS ġew ivvalutati minn IRRC għal kull RECIST verżjoni 1.1.
English: How to store OPDIVO 6.
Maltese: Kif taħżen OPDIVO 6.
English: Number (n)/ minimum follow-up (months)
Maltese: Numru (n)/segwitu minimu (xhur)
English: OPDIVO infusion is compatible with PVC and polyolefin containers, glass bottles, PVC infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Maltese: L-infużjoni ta' OPDIVO hija kompatibbli ma' kontenituri tal-PVC u polyolefin, fliexken tal-ħġieġ, settijiet tal-infużjoni tal-PVC, u filtri fil-pajp b'riti tal-polyethersulfone b'daqsijiet tal-pori ta' 0.2 μm sa 1.2 μm.
English: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2.
Maltese: Nivolumab huwa antikorp monoklonali tal-immunoglobulina umana G4 (IgG4) (HuMAb), li jeħel mar-riċettur ta' mewt ipprogrammata-1 (PD-1) u jimblokka l-interazzjoni tiegħu ma' PD-L1 u PD-L2.
English: Store in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2 °C-8 °C).
English: Objective response, n (%); (95% CI) Complete remission (CR), n (%); (95% CI) Partial remission (PR), n (%); (95% CI)
Maltese: Rispons oġġettiv, n (%); (95% CI) Remissjoni kompleta (CR), n (%); (95% CI)
English: Cardiac and pulmonary adverse events including pulmonary embolism have also been reported with combination therapy.
Maltese: Kienu rrappurtati wkoll każijiet avversi kardijaċi u pulmonari inkluż emboliżmu pulmonari b'terapija kkombinata.
English: Minimum follow-up was approximately 24 months.
Maltese: Il-follow-up minimu kien ta' bejn wieħed u ieħor 24 xahar.
English: Grade 3-4 irAEs with Anti-CTLA-4
Maltese: Marda awtoimmuni irAEs ta' Grad 3-4 b'kontra CTLA-4
English: At a minimum follow-up of 9 months, investigator-assessed confirmed ORR was 24.4% (95% CI: 15.3, 35.4).
Maltese: B'segwitu minimu ta' 9 xhur, l-ORR ikkonfermata u vvalutata mill-investigatur kienet ta' 24.4% (95% CI: 15.3, 35.4).
English: Based on the stratified DerSimonian-Laird test.
Maltese: Ibbażat fuq it-test ta' DerSimonian-Laird stratifikat.
English: Median duration of responseb
Maltese: Durata medjana tar-risponsg
English: In patients treated with nivolumab monotherapy, the incidence of rash was 26.4% (680/2578).
Maltese: F'pazjenti kkurati bil-monoterapija ta' nivolumab, l-inċidenza ta' raxx kienet ta' 26.4% (680/2578).
English: Common oedema (including peripheral oedema), pain oedema (including peripheral oedema), pain, chest pain, chills
Maltese: Komuni edema (inkluż edema periferali), uġigħ edema (inkluż edema periferali), uġigħ, uġigħ fis-sider, sirdat
English: Nivolumab as monotherapy (see section 4.2)
Maltese: Nivolumab bħala monoterapija (ara sezzjoni 4.2)
English: Nivolumab 3 mg/kg (events: 183/410), median and 95% CI: 25.00 (21.75, N.A.)
Maltese: Nivolumab 3 mg/kg (avvenimenti: 183/410), medjan u 95% CI: 25.
English: Confidence interval for ORR calculated using the Clopper-Pearson method.
Maltese: L-intervall ta' kunfidenza għal ORR huwa kkalkulat bl-użu tal-metodu Clopper-Pearson.
English: Rare toxic epidermal necrolysisa,f, StevensJohnson syndromef Musculoskeletal and connective tissue disorders Very common arthralgia musculoskeletal paing, arthralgia
Maltese: Rari nekroliżi epidermali tossikaa,f, sindrome ta' Stevens-Johnsonf Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna Artralġija uġigħ muskoluskeletrikug, artralġija
English: • Relevant information (e.g., seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns: o Immune-related pneumonitis o Immune-related colitis o Immune-related hepatitis o Immune-related nephritis and renal dysfunction o Immune-related endocrinopathies o Immune-related skin adverse reactions o Other immune-related ARs o Potential risk of ‘Complications including acute graft-versus-host disease (GVHD) and transplant related mortality of allogeneic Haematopoietic Stem Cell Transplant (HSCT)
Maltese: • Informazzjoni rilevanti (eż., serjetà, severità, frekwenza, iż-żmien tal-bidu, riversibilità tarreazzjoni avversa jekk applikabbli) għat-tħassib dwar is-sigurtà li ġej: o Pnewmonite relatata mal-immunità o Kolite relatata mal-immunità o Epatite relatata mal-immunità o Nefrite u disfunzjoni tal-kliewi relatati mal-immunità o Endokrinopatiji relatati mal-immunità o Reazzjonijiet avversi tal-ġilda relatati mal-immunità o Reazzjonijiet avversi oħra relatati mal-immunità o Riskju potenzjali ta' “Kumplikazzjonijiet inkluż il-marda “graft-versus-host” (GVHD,
English: The PFS HR for nivolumab vs. chemotherapy was 1.03 (95% CI: 0.78, 1.36).
Maltese: Il-PFS HR għal nivolumab vs. kimoterapija kien ta' 1.03 (95% CI: 0.78, 1.36).
English: Ipilimumab 1 mg/kg over 30 minutes
Maltese: Ipilimumab 1 mg/kg għal 30 minuta
English: Uncommon eosinophilia
Maltese: Eosinofilja
English: Urothelial Carcinoma Open-label phase 2 study (CA209275)
Maltese: Karċinoma tal-Apparat tal-Awrina Studju ta' Fażi 2 open-label (CA209275)
English: The effect of renal impairment on the CL of nivolumab was evaluated in patients with mild (GFR < 90 and ≥ 60 mL/min/1.73 m2; n = 379), moderate (GFR < 60 and ≥ 30 mL/min/1.73 m2; n = 179), or severe (GFR < 30 and ≥ 15 mL/min/1.73 m2; n = 2) renal impairment compared to patients with normal renal function (GFR ≥ 90 mL/min/1.73 m2; n = 342) in population PK analyses.
Maltese: L-effett tal-indeboliment tal-kliewi fuq is-CL ta' nivolumab ġie evalwat f'pazjenti b'indeboliment talkliewi ħafif (GFR < 90 u ≥ 60 mL/min/1.73 m2; n = 379), moderat (GFR < 60 u ≥ 30 mL/min/1.73 m2; n = 179), jew sever (GFR < 30 u ≥ 15 mL/min/1.73 m2; n = 2) meta mqabblin ma' pazjenti b'funzjoni normali tal-kliewi (GFR ≥ 90 mL/min/1.73 m2; n = 342) fl-analiżijiet PK tal-popolazzjoni.
English: RFS results are shown in Table 13 and Figure 7 (all randomised population).
Maltese: Ir-riżultati tal-RFS huma murija fit-Tabella 13 u fil-Figura 7 (popolazzjoni kollha randomizzata).
English: Randomisation was stratified by PD-L1 expression (≥ 5% vs. < 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system.
Maltese: Irrandomizzazzjoni ġiet stratifikata mill-espressjoni PD-L1 (≥ 5% kontra < 5% espressjoni membrana taċ-ċellula tat-tumur), l-istatus BRAF, u l-istadju M skont is-sistema ta' waqfien tal-Kumitat Konġunt Amerikan fuq il-Kanċer (American Joint Committee on Cancer) (AJCC).
English: ──Δ─── Nivolumab 3 mg/kg (events: 86/135), median and 95% CI: 9.23 (7.33, 13.27) - - -- - - Docetaxel (events: 113/137), median and 95% CI: 6.01 (5.13, 7.33)
Maltese: ──Δ─── Nivolumab 3 mg/kg (avvenimenti: 86/135), medjan u 95% CI: 9.23 (7.33, 13.27) - - -- - - Docetaxel (avvenimenti: 113/137), medjan u 95% CI: 6.01 (5.13, 7.33)
English: In patients with tumour PD-L1 expression <1%, ORR per IRRC was 13.0% (n=69; 95% CI: 6.1, 23.3) and 12.0% (n=25; 95% CI: 2.5, 31.2), respectively.
Maltese: F'pazjenti b'espressjoni tat-tumur ta' PD-L1 <1%, l-ORR għal kull IRRC kien 13.0% (n = 69; 95% CI: 6.1, 23.3) u 12.0% (n = 25; 95% CI: 2.5, 31.2), rispettivament.
English: PVC infusion sets
Maltese: Settijiet tal-infużjoni tal-PVC
English: Not Availableb
Maltese: Mhux disponibblib
English: Grade 3 rash
Maltese: Raxx ta' Grad 3
English: CA209205 Cohort Ca
Maltese: CA209205 Koorti Ca
English: Patients with investigator-assessed primary site of oropharyngeal cancer were tested for HPV (determined by p16 immunohistochemistry [IHC]).
Maltese: Il-pazjenti b'sit primarju vvalutat mill-investigatur ta' kanċer orofarinġeali ġew ittestjati għal HPV (determinati minn immunoistokimika p16 [IHC]).
English: Nivolumab was continued beyond progression in 44% of patients.
Maltese: Nivolumab tkompla wara l-progressjoni f'44% tal-pazjenti.