FrancophonIA/ELRC3.0 huggingface dataset:
English: referral for Vasotop P
Maltese: Il-konklużjonijiet xjentifiċi huma pprovduti fl-Anness
English: Symptoms (DRESS)d
Maltese: Sistemiċi (DRESS)d
English: Gastrointestinal:
Maltese: Gastrointestinali:
English: Rare proteinuriad
Maltese: Rari proteinurjad
English: Age ≥ 12 to 21 years
Maltese: Età ≥ minn 12 sa 21 sena
English: Abbreviations: SAEs = serious adverse events; AEs = adverse events; irAEs = immune-related adverse events
Maltese: SAEs = avvenimenti avversi serji; AEs = avvenimenti avversi; irAEs = avvenimenti avversi relatati malimmunità
English: No. at Risk mg/kg 965 429 127 73 41 29 28 12 8 4 0
Maltese: Nru. f'Riskju mg/kg 965 429 127 73 41 29 28 12 8 4 0
English: Table 3C:
Maltese: Tabella 3C:
English: Endocrine:
Maltese: Endokrinali:
English: Table 3A
Maltese: Tabella 3A
English: Computed using Kaplan-Meier method.
Maltese: Ikkalkulat permezz tal-metodu Kaplan-Meier.
English: Version 4.0 (NCI-CTCAE v4).
Maltese: Verżjoni 4.0 (NCI-CTCAE v4).
English: a gp100 peptide vaccine is an experimental control.
Maltese: a it-tilqima b'gp100 peptide hi kontroll sperimentali.
English: Based on the stratified DerSimonian-Laird test.
Maltese: Abbażi tat-test DerSimonian-Laird stratifikat.
English: Based on a stratified log-rank test.
Maltese: Abbażi ta' test log-rank stratifikat.
English: NCI-CTCAE v4 Gradea
Maltese: NCI-CTCAE v4 Grada
English: (HR 0.89 with a 95% CI of 0.76, 1.04 and log-rank test P-value = 0.1548).
Maltese: (HR 0.89 b'95% CI of 0.76, 1.04 u valur-P tat-test log-rank = 0.1548).
English: Overall Survival (proportion)
Maltese: Sopravivenza Globali (proporzjon)
English: Age 12 to < 18 years
Maltese: Età 12 sa < 18-il sena
English: Table 3B
Maltese: Tabella 3B
English: Rare proctitisd
Maltese: Rari proktited
English: Very limited data are available.
Maltese: Hemm biss dejta limitata ħafna disponibbli.
English: 1-year OS (%) (95% CI) BORR (%) (95% CI) SD (n/N)a
Maltese: Sena OS (%) (95% CI) BORR (%) (95% CI) SD (n/N)a
English: (In clinical trials, methylprednisolone 2 mg/kg/day has been used).
Maltese: (Fil-provi kliniċi, intuża methylprednisolone 2 mg/kg/kuljum).
English: 50 mg/ml (5%) glucose solution for injection
Maltese: 50 mg/ml (5%) glucose soluzzjoni għall-injezzjoni
English: CA184332 and CA184338
Maltese: CA184332 u CA184338
English: MedDRA v.17.0 for CA184070, v.19.0 for CA184178, and V.12.1 for Adult Safety Pool.
Maltese: MedDRA v.17.0 għal CA184070, v.19.0 għal CA184178, u V.12.1 għall-Aggregazzjoni tal-Effikaċja fl-Adulti.
English: - inflammation of the nerves that can lead to paralysis.
Maltese: - infjammazzjoni tan-nervituri li tista' twassal għal paraliżi.
English: Uncommon arrhythmia (including ventricular arrhythmia)a,d, atrial fibrillation, myocarditisa,f arrhythmia (including ventricular arrhythmia), myocarditisc
Maltese: Mhux komuni aritmija (inkluż aritmija ventrikulari)a,d, fibrillazzjoni atrijali, mijokarditea,f arritmija (inkluż arritmija ventrikulari), mijokarditec
English: Table 13:
Maltese: Tabella 13:
English: a. Summary of safety profile
Maltese: Sommarju tal-profil tas-sigurtà
English: Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Maltese: Sindrome ta' Stevens-Johnson (SJS, Stevens-Johnson syndrome) jew nekrolisi epidermali tossika (TEN, toxic epidermal necrolysis)
English: Date of first authorisation: 13 July 2011 Date of latest renewal: 21 April 2016
Maltese: Data tal-aħħar tiġdid: 21 ta' April 2016
English: CA184004/ 022Pooled
Maltese: CA184004/ 022Aggregati
English: Common confusional state
Maltese: Komuni stat ta' konfużjoni
English: Uncommon intestinal perforationa, gastritis, duodenitis gastritis
Maltese: Mhux komuni perforazzjoni intestinalia, gastrite, duodenite gastrite
English: Neutralising antibodies against ipilimumab ranged from 0 to 0.3%.
Maltese: Antikorpi newtralizzanti kontra ipilimumab varjaw minn 0 sa 0.3%.
English: Efficacy Results in CA184178 Ipilimumab 3 mg/kg N= 4
Maltese: Riżultati tal-Effikaċja f'CA184178 Ipilimumab 3 mg/kg N= 4
English: The types of irARs were consistent with the adult experience, with the most commonly reported irARs across all groups in the categories of gastrointestinal (0 [3 mg/kg], 62.5% [5 mg/kg], and 44.4% [10 mg/kg]), hepatic function (0 [3 mg/kg], 75.0% [5 mg/kg], 33.3% [10 mg/kg]), and skin (0 [3 mg/kg], 25.0% [5 mg/kg], 33.3% [10 mg/kg]) events.
Maltese: It-tipi ta' irARs kienu konsistenti mal-esperjenza fl-adulti, bl-aktar irARs li kienu rappurtati b'mod komuni filgruppi kollha fil-kategoriji ta' avvenimenti gastrointestinali (0 [3 mg/kg], 62.5% [5 mg/kg], u 44.4% [10 mg/kg]), tal-funzjoni epatika (0 [3 mg/kg], 75.0% [5 mg/kg], 33.3% [10 mg/kg]), tal-ġilda (0 [3 mg/kg], 25.0%
English: Grade 2 elevation in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin
Maltese: Żieda ta' Grad 2 fl-aminotransferase (AST), alanine aminotransferase (ALT), jew bilirubina totali
English: - - -*- - - - Nivolumab+ipilimumab (events: 161/314), median and 95% CI: 11.50 (8.90, 22.18).
Maltese: - - -*- - - - Nivolumab+ipilimumab (avvenimenti: 161/314), medjan u 95% CI: 11.50 (8.90, 22.18).
English: No clinically relevant pharmacokinetic drug-drug interaction was observed between ipilimumab and paclitaxel/carboplatin, dacarbazine or its metabolite, 5-aminoimidazole-4-carboxamide (AIC).
Maltese: Ma ġiet osservata l-ebda interazzjoni bejn mediċina u oħra li hija klinikament rilevanti bejn ipilimumab u paclitaxel/carboplatin, dacarbazine jew il-metabolit tiegħu, 5-aminoimidazole-4-carboxamide (AIC).
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 f'konformità mal-Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kanċer Verżjoni 4.0 (NCI-CTCAE v4).
English: ECOG performance status score was 0 (73%) or 1 (27%).
Maltese: Il-punteġġ tal-istatus talprestazzjoni ECOG kien 0 (73%) jew 1 (27%).
English: Other organ systemsb: (e.g. nephritis, pneumonitis, pancreatitis, non-infectious myocarditis)
Maltese: Sistemi tal-organi oħrab: (eż. nefrite, pnewmonite, pankreatite, mijokardite mhux infettiva)
English: Elevations in LFTs may develop in the absence of clinical symptoms.
Maltese: Żidiet f'LFTs jistgħu jiżviluppaw fl-assenza ta' sintomi kliniċi.
English: Stevens-Johnson syndrome, vitiligo, erythema multiforme, alopecia, psoriasis
Maltese: Mhux komuni psorjasi sindrome ta' Stevens-Johnson, vitiligo, eritema multiforme, alopeċja, psorjasi
English: Advanced Melanoma
Maltese: Melanoma avvanzata
English: Nivolumab 1 mg/kg over 30 minutes
Maltese: Nivolumab 1 mg/kg għal 30 minuta
English: sodium chloride 9 mg/ml (0.9%) solution for injection; or
Maltese: sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni; jew
English: Treatment-Related Deaths, n
Maltese: AEs relatati mal-mediċina, n
English: Table 9: Overall survival in observational studies
Maltese: Tabella 9: Sopravivenza globali fi studji ta' osservazzjoni
English: Increases in AST and ALT of any severity were reported in 1% and 2% of patients, respectively.
Maltese: Żidiet fl-AST u ALT ta' kwalunkwe severità ġew irrapportati f'1% u 2% tal-pazjenti, rispettivament.
English: BORR was similar in the 10 mg/kg and 3 mg/kg groups.
Maltese: Il-BORR kien simili fil-gruppi ta' 10 mg/kg u 3 mg/kg.
English: Excipients: Tris hydrochloride, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Maltese: Tris hydrochloride, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, ilma għall-injezzjonijiet.
English: CA184004/007 Pooled
Maltese: CA184004/007 Aggregati
English: Patients with ocular melanoma were not included in the CA184-169 clinical trial.
Maltese: Pazjenti b'melanoma okulari ma ġewx inklużi fil-prova klinika CA184-169.
English: The differences between the two nivolumab-containing groups were evaluated descriptively.
Maltese: Iddifferenzi bejn iż-żewġ gruppi li fihom nivolumab ġew evalwati b'mod deskrittiv.
English: See “Description of selected adverse reactions; laboratory abnormalities” below.
Maltese: Ara “Deskrizzjoni ta' reazzjonijiet avversi; anormalitajiet tal‑laboratorju” hawn taħt.
English: Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 United States
Maltese: Thompson Road East Syracuse, New York 13057 L-Istati Uniti
English: A total of 945 patients were randomised to receive ipilimumab in combination with nivolumab (n = 314), nivolumab monotherapy (n = 316), or ipilimumab monotherapy (n = 315).
Maltese: Ġew randomizzati total ta' 945 pazjent biex jirċievu ipilimumab flimkien ma' nivolumab (n = 314), monoterapija b'nivolumab (n = 316), jew monoterapija b'ipilimumab (n = 315).
English: Rare cases of toxic epidermal necrolysis (TEN) (including Steven Johnson Syndrome) have been observed, some with fatal outcome.
Maltese: Ġew osservati każijiet rari ta' nekrolisi epidermali tossika (TEN, toxic epidermal necrolysis) (inkluż Sindrome ta' Steven Johnson), xi wħud b'riżultat fatali.
English: Uncommon arrhythmia, atrial fibrillation Vascular disorders
Maltese: Mhux komuni arritmija, fibrillazzjoni atrijali Disturbi vaskulari
English: DCR (%) (95% CI) Median PFS (months) (95% CI)
Maltese: DCR (%) (95% CI) PFS medjana (xhur) (95% CI)
English: • Persistent Grade 2 or 3 adverse reactions despite management.
Maltese: • Reazzjonijiet avversi ta' Grad 2 jew 3 persistenti minkejja mmaniġġjar.
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency (including secondary adrenocortical insufficiency), hypophysitis (including hypopituitarism), diabetes mellitus, and diabetic ketoacidosis have been observed with ipilimumab in combination with nivolumab (see section 4.8).
Maltese: Ġew osservati endokrinopatiji severi, inkluż ipotirojdiżmu, ipertirojdiżmu, insuffiċjenza adrenali (inkluż insuffiċjenza adrenokortikali sekondarja), ipofiżite (inkluż ipopitwitariżmu), dijabete mellitus, u ketoaċidożi dijabetika b'ipilimumab flimkien ma' nivolumab (ara sezzjoni 4.8).
English: Table 11: Objective response (CA209067)
Maltese: Tabella 11: Rispons oġġettiv (CA209067)
English: Nephritis and Renal Dysfunction Endocrinopathies
Maltese: Nefrite u Disfunzjoni tal-Kliewi Endokrinopatiji
English: Pericardial disorders is a composite term which includes pericarditis, pericardial effusion, cardiac tamponade, and Dressler's syndrome.
Maltese: Disturbi perikardijaċi huwa term kompost li jinkludi perikardite, effużjoni perikardijaka, tamponaġġ kardijaku, u s-sindrome ta' Dressler.
English: Table 4: Adverse reactions in patients with advanced melanoma treated with ipilimumab 3 mg/kg (n= 767)a
Maltese: Tabella 4: Reazzjonijiet avversi f'pazjenti b'melanoma avvanzata kkurati b' ipilimumab 3 mg/kg (n=767)a
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 irrandomizza wkoll 249 pazjent b'riskju favorevoli skont il-kriterji tal-IMDC għal nivolumab flimkien ma' ipilimumab (n = 125) jew għal sunitinib (n = 124).
English: Common pneumonitisa,c, pulmonary embolisma, cough pneumonitis, dyspnoea, pleural effusion, cough
Maltese: Komuni pulmonitea,c, emboliżmu pulmonaria, sogħla pulmonite, dispnea, effużjoni plewrali, sogħla
English: The use of anticoagulants is known to increase the risk of gastrointestinal haemorrhage.
Maltese: L-użu ta' antikoagulanti huwa magħruf li jżid ir-riskju ta' emorraġija gastrointestinali.
English: Uncommon bronchitis bronchitis, aseptic meningitis
Maltese: Mhux komuni bronkite bronkite, meninġite asettika
English: Uncommon (may affect up to 1 in 100 people) bronchitis
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100) bronkite
English: Other moderate adverse reactionsc a
Maltese: Reazzjonijiet avversi moderati oħrajnċ a
English: Nivolumab+ipilimumab vs nivolumab (descriptive analysis) - HR (95% CI): 0.85 (0.68, 1.07)
Maltese: Nivolumab+ipilimumab vs nivolumab (analiżi deskrittiva) - HR (95% CI): 0.85 (0.68, 1.07)
English: The overall safety profile of ipilimumab 3 mg/kg in clinical trial CA184-169 (N=362) was consistent with that established for ipilimumb in patients treated for advanced melanoma.
Maltese: Il-profil tas-sigurtà globali ta' ipilimumab 3 mg/kg fil-prova klinika CA184-169 (N=362) kien konsistenti ma' dak stabbilit għal ipilimumb f'pazjenti kkurati għal melanoma avvanzata.
English: Age (2-87 years) had no clinically important effect on the CL of ipilimumab.
Maltese: L-età (2-87 sena) ma kellha l-ebda effett klinikament importanti fuq is-CL ta' ipilimumab.
English: Nivolumab+ipilimumab vs. nivolumab (descriptive analysis) - HR (95% CI): 0.76 (0.62, 0.95)
Maltese: Nivolumab+ipilimumab vs. nivolumab (analiżi deskrittiva) - HR (95% CI): 0.76 (0.62, 0.95)
English: Fatal Guillain-Barré syndrome has been reported in clinical trials.
Maltese: Sindromu fatali ta' Guillain-Barré ġie rrapportat fil-provi kliniċi.
English: Clinical trials excluded patients with ECOG performance status > 1 and mucosal melanoma.
Maltese: Provi kliniċi eskludew pazjenti bi stat ta' prestazzjoni ECOG > 1 u melanoma mukożali.
English: Overall survival compared between Ipilimumab 10 mg/kg and 3 mg/kg groups showed HR = 0.84 (95% CI: 0.70, 0.99; P-value = 0.04).
Maltese: Issopravivenza globali mqabbla bejn il-gruppi ta' Ipilimumab 10 mg/kg u 3 mg/kg uriet HR = 0.84 (95% CI: 0.70, 0.99; valur-P = 0.04).
English: PFS rate at 12 months and 95% CI: 18% (14, 23)
Maltese: Rata tal-PFS wara 12-il xahar u 95% CI: 18% (14, 23)
English: No statistically significant difference in progression free survival (PFS) was observed between the 10 mg/kg and the 3 mg/kg groups.
Maltese: Ma ġiet osservata l-ebda differenza statistikament sinifikanti fissopravivenza mingħajr progressjoni (PFS, progression free survival) bejn il-gruppi ta' 10 mg/kg u 3 mg/kg.
English: A summary of adverse events in adolescents 12 years of age and older, as well as adults, is presented in Table 7.
Maltese: Sommarju ta' avvenimenti avversi f'adolexxenti ta' aktar minn 12-il sena, kif ukoll fl-adulti, huwa ppreżentat fit-Tabella 7.
English: Neutralising antibodies against ipilimumab were not detected.
Maltese: Ma ġewx identifikati antikorpi newtralizzanti kontra ipilimumab.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available post-marketing data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli ta' wara t-tqegħid fis-suq).
English: Cases of Vogt-Koyanagi-Harada syndrome and serous retinal detachment have been reported post-marketing (see section 4.8).
Maltese: Każijiet tas-sindrome ta' Vogt-Koyanagi-Harada u stakkament retinali serju ġew irrapportati wara t-tqegħid fis-suq (ara s-sezzjoni 4.8).
English: A total of 676 patients were randomized: 137 to the ipilimumab monotherapy group, 403 to the ipilimumab + gp100 group, and 136 to the gp100 alone group.
Maltese: Total ta' 676 pazjent ġew randomizzati: 137 għall-grupp tal-monoterapija ta' ipilimumab, 403 għallgrupp ta' ipilimumab + gp100, u 136 għall-grupp ta' gp100 waħdu.
English: Cardiac and pulmonary adverse events including pulmonary embolism have also been reported with combination therapy.
Maltese: Bit-terapija kombinata, ġew irrappurtati wkoll avvenimenti avversi kardijaċi u pulmonari inkluż emboliżmu pulmonari.
English: Incidence rates per 100 person-years of exposure were 9.3 vs. 0; serious cardiac events were reported by 4.9% patients in the nivolumab group vs. 0 in the investigator´s choice group.
Maltese: Ir-rati ta' inċidenza għal kull 100 sena ta' persuna ta' esponiment kienu 9.3 kontra 0; avvenimenti kardijaċi serji ġew irrappurtati minn 4.9 % pazjenti fil-grupp ta' nivolumab kontra 0 fil-grupp tal-għażla tal-investigatur.
English: Use a separate infusion line for the infusion.
Maltese: Uża linja tal-infużjoni separata għall-infużjoni.
English: Rare toxic epidermal necrolysisa,f, StevensJohnson syndromef Musculoskeletal and connective tissue disorders Very common arthralgia musculoskeletal paing, arthralgia
Maltese: Rari nekrolisi epidermali tossikaa,f, sindrome ta' Stevens-Johnsonf Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna artralġja uġigħ muskoloskeletalig, artralġja
English: Tumour PD-L1 expression was determined using the PD-L1 IHC 288 pharmDx assay.
Maltese: L-espressjoni ta' PD-L1 tat-tumur ġiet determinata permezz tal-assaġġ PDL1 IHC 28-8 pharmDx.
English: Grade 4 creatinine elevation
Maltese: Żieda ta' Grad 4 fil-kreatinina
English: Fatal toxic epidermal necrolysis (including SJS) has been reported in < 1% of patients who received ipilimumab in combination with gp100 (see section 5.1).
Maltese: Nekrolisi epidermali tossika fatali (inkluż SJS) ġiet irrapportata f'< 1% tal-pazjenti li rċivew ipilimumab flimkien ma' gp100 (ara sezzjoni 5.1).
English: Including fatal outcome.
Maltese: Tinkludi riżultat fatali.
English: Figure 2: Progression-free survival (CA209067)
Maltese: Figura 2: Sopravivenza mingħajr progressjoni (CA209067)
English: OS at 1 year % (95% CI) OS at 2 years % (95% CI) OS at 3 years % (95% CI) OS at 4 years % (95% CI)
Maltese: OS wara sena % (95 % CI) OS wara sentejn % (95 % CI) OS wara 3 snin % (95 % CI) OS wara 4 snin % (95 % CI)
English: In clinical trials, patients received up to 20 mg/kg without apparent toxic effects.
Maltese: Fil-provi kliniċi, il-pazjenti rċivew sa 20 mg/kg mingħajr effetti tossiċi apparenti.
English: Hepatic:
Maltese: Epatiċi:
English: “+” denotes a censored observation.
Maltese: “+” tfisser osservazzjoni ċċensurata.
English: The frequencies of serious adverse reactions in the 10 mg/kg and 3 mg/kg groups were 37% and 18%, with the 3 most common serious adverse reactions being diarrhea (10.7% vs 5.5%), colitis (8.0% vs 3.0%), and hypophysitis (4.4% vs 1.9%).
Maltese: Il-frekwenzi ta' reazzjonijiet avversi serji fil-gruppi ta' 10 mg/kg u 3 mg/kg kienu ta' 37 % u 18 %, bl-aktar 3 reazzjonijiet avversi serji komuni li kienu dijarea (10.7% vs 5.5%), kollite (8.0% vs 3.0%), u ipofiżite (4.4% vs 1.9%).
English: Withhold dose(s)
Maltese: Żomm id-doża(i)
English: Rash is a composite term which includes maculopapular rash, rash erythematous, rash pruritic, rash follicular, rash macular, rash morbilliform, rash papular, rash pustular, rash papulosquamous, rash vesicular, rash generalised, exfoliative rash, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, dermatitis exfoliative, dermatitis psoriasiform, drug eruption and pemphigoid.
Maltese: Raxx huwa terminu kompost li jinkludi raxx makulopapulari, raxx eritematuż, raxx pruritiku, raxx follikulari, raxx makulari, raxx morbilliform, raxx papulari, raxx pustulari, raxx papuloskwamuż, raxx veskikulari, raxx ġeneralizzat, raxx esfoljattiv, dermatite, dermatite aknieforma, dermatite allerġika, dermatite atopika, dermatite bulluża, dermatite esfoljattiva, dermatite psorjasiforma, raxx mill-mediċina u pemfigojd.
English: The median age was 61 years (range: 21-85) with 38% ≥ 65 years of age and 8% ≥ 75 years of age.
Maltese: L-età medjana kienet ta' 61 sena (medda: 21-85) bi 38% ≥ li kellhom 65 sena u 8% ≥ ta' 75 sena.
English: Patients with ocular melanoma, primary CNS melanoma, active brain metastases, human immunodeficiency virus (HIV), hepatitis B, and hepatitis C were not included in the MDX010-20 clinical trial.
Maltese: Pazjenti b'melanoma okulari, b'melanoma tas-CNS primarja, b'metastasi tal-moħħ attiva, b'virus tal-immunodefiċjenza uman (HIV), b'epatite B u b'epatite Ċ ma ġewx inklużi fil-prova klinika MDX010-20.
English: The primary endpoint was OS in the ipilimumab+ gp100 group vs. the gp100 group.
Maltese: Il-punt aħħari primarju kienet -l-OS fil-grupp ta' ipilimumab + gp100 vs. ilgrupp ta' gp100.
English: Patients were randomized in a 3:1:1 ratio to receive ipilimumab 3 mg/kg + an investigational gp100 peptide vaccine (gp100), ipilimumab 3 mg/kg monotherapy, or gp100 alone.
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 3:1:1 biex jirċievu ipilimumab 3 mg/kg + tilqima investigattiva b'gp100 peptide (gp100), ipilimumab 3 mg/kg mogħti waħdu, jew gp100 waħdu.
English: In addition, iritis, haemolytic anaemia, amylase elevations, multi-organ failure, and pneumonitis have been reported in patients treated with ipilimumab 3 mg/kg + gp100 peptide vaccine in MDX010-20.
Maltese: Flimkien ma' dan, irite, anemija emolitika, żidiet f'amylase, insuffiċjenza ta' diversi organi, u pnewmonite ġew irrapportati f'pazjenti kkurati b' ipilimumab 3 mg/kg + tilqima b'gp100 peptide fi studju MDX010-20.
English: Immune-related endocrinopathy observed in clinical trials was generally controlled with hormone replacement therapy.
Maltese: Endokrinopatija relatata mal-immunità osservata fil-provi kliniċi, ġeneralment ġiet ikkontrollata b'terapija tas-sostituzzjoni tal-ormoni.
English: Resolution occurred in 64 patients (45.4%).
Maltese: Il-fejqan seħħ f'64 pazjent (45.4%).
English: Uncommon gastrointestinal perforationb,c, large intestine perforationb,c, intestinal perforationb,c, peritonitisb, gastroenteritis, diverticulitis, pancreatitis, enterocolitis, gastric ulcer, large intestinal ulcer, stomatitis, oesophagitis, ileusd
Maltese: Mhux komuni perforazzjoni gastrointestinalib,ċ, perforazzjoni tal-musrana l-kbirab,ċ, perforazzjoni intestinalib,ċ, peritoniteb, gastroenterite, divertikulite, pankreatite, enterokolite, ulċera gastrika, ulċera fil-musrana l-kbira, esofaġite, stomatite, ileusd
English: Study CA209069 was a randomised, Phase 2, double-blind study comparing the combination of nivolumab and ipilimumab with ipilimumab alone in 142 patients with advanced (unresectable or metastatic) melanoma with similar inclusion criteria to study CA209067 and the primary analysis in patients with BRAF wild-type melanoma (77% of patients).
Maltese: Studju CA209069 kien studju randomizzat, ta' Fażi 2, double-blind li qabbel il-kombinazzjoni ta' nivolumab u ipilimumab ma' ipilimumab waħdu f'142 pazjent b'melanoma avvanzata (li ma tistax tinqata' jew metastatika) bi kriterji ta' inklużjoni simili għall-istudju CA209067 u l-analiżi primarja f'pazjenti b'melanoma ta' BRAF tat-tip selvaġġ (77% tal- pazjenti).
English: Attribution to ipilimumab reported as Possible, Probable, Definite, or Missing for CA184178 and Adult Safety Pool, and Related or Missing for CA184070.
Maltese: Attribuzzjoni għal ipilimumab irrappurtata bħala Possibbli, Probabbli, Definita jew Nieqsa għal CA184178 u Ġabra tal-Istudju f'Adulti, u Relatata jew Nieqsa għal CA184070.
English: Other medicines and YERVOY
Maltese: Mediċini oħra u YERVOY
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, tkexkix ta' bard
English: Duration of follow-up ranged up to 55 months.
Maltese: It-tul ta' żmien ta' follow-up varja sa 55 xahar.
English: Use separate infusion bags and filters for each infusion.
Maltese: Uża boroż tal-infużjoni u filtri separati għal kull infużjoni.
English: • Patient Information Brochures including Alert Cards
Maltese: • Fuljetti ta' Informazzjoni għall-Pazjent inkluż Kards ta' Twissija
English: Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italy
Maltese: Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso IT-03012 Anagni (FR)
English: Polyethersulfone (0.2 μm to 1.2 μm) and nylon (0.2 μm) in-line filters
Maltese: L-infużjoni b'YERVOY hija kompatibbli ma': settijiet tal-infużjoni tal-PVC filters in-line tal-polyetherfulfone (0.2 μm sa 1.2 μm) u tan-nylon (0.2 μm)
English: Investigator assessed ORR was 61% (95% CI: 48.9, 72.4) in the combination arm (n = 72) versus 11% (95% CI: 3.0, 25.4) for the ipilimumab arm (n = 37).
Maltese: L-ORR ivvalutat mill-investigatur kien 61% (95% CI: 48.9, 72.4) fil-fergħa tal-kombinazzjoni (n = 72) kontra 11% (95% CI: 3.0, 25.4) għall-fergħa ta' ipilimumab (n = 37).