FrancophonIA/ELRC3.0 huggingface dataset:
English: In the dataset of nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC (n = 547), with a minimum follow-up of 17.5 months, the most frequent adverse reactions (≥ 10%) were fatigue (48%), rash (34%), pruritus (28%), diarrhoea (27%), nausea (20%), hypothyroidism (16%), musculoskeletal pain (15%), arthralgia (14%), decreased appetite (14%), pyrexia (14%), vomiting (11%), hyperthyroidism (11%).
Maltese: Fis-sett ta' data ta' nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg f'RCC (n = 547), b'segwitu minimu ta' 17.5 xhur, l-aktar reazzjonijiet avversi frekwenti (≥ 10%) kienu għeja (48%), raxx (34%), prurite (28%), dijarea (27%), dardir (20%), ipotirojdiżmu (16%), uġigħ muskoluskeletriku (15%), artralġija (14%), tnaqqis fl-aptit (14%), piressija (14%), rimettar (11%), ipertirojdiżmu (11%).
English: Efficacy by tumour PD-L1 expression: Objective responses to nivolumab were observed regardless of tumour PD-L1 expression.
Maltese: Ġew osservati risponsi oġġettivi għal nivolumab irrispettivament mill-espressjoni tat-tumur ta' PD-L1.
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 ddefiniti 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 ta' wara ttqegħid fis-suq disponibbli).
English: Nivolumab CL in cHL patients was approximately 32% lower relative to NSCLC.
Maltese: Is-CL ta' Nivolumab f'pazjenti cHL kienet madwar 32% iktar baxxa meta mqabbla ma' NSCLC.
English: Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis or Stevens-Johnson syndrome)
Maltese: Tqaxxir sever u possibilment fatali tal-ġilda (nekroliżi epidermali tossika jew sindrome ta' Stevens-Johnson)
English: Common musculoskeletal paing arthritis, muscle spasms, muscular weakness
Maltese: Komuni uġigħ muskoluskeletrikug artrite, spażmi tal-muskolu, dgħufija muskolari
English: Diabetes mellitus including Type 1 diabetes mellitus (3 Grade 2, 2 Grade 3, and 3
Maltese: Ġew irrappurtati dijabete mellitus inkluż dijabete mellitus tat-tip I (3 Grad 2, 2 Grad 3, u 3 Grad 4), u ketoaċidożi dijabetika (1 Grad 4).
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of diarrhoea or colitis was 46.7% (209/448).
Maltese: F'pazjenti kkurati b'nivolumab 1 mg/kg mogħti flimkien ma' ipilimumab 3 mg/kg fil-melanoma, linċidenza ta' dijarea jew kolite, kienet 46.7% (209/448).
English: The unopened vial can be stored at controlled room temperature up to 25°C with room light for up to 48 hours.
Maltese: Il-kunjett mhux miftuħ jista' jinħażen f'temperatura ambjentali kkontrollata sa 25°C b'dawl fil-kamra sa massimu ta' 48 siegħa.
English: Study CA209063 was a single-arm, open-label study conducted in 117 patients with locally advanced or metastatic squamous NSCLC after two or more lines of therapy; otherwise similar inclusion criteria as study CA209017 were applied.
Maltese: Studju CA209063 kien studju b'fergħa waħda, open-label li sar fuq 117-il pazjent b'NSCLC skwamuż lokalment avvanzat jew metastatiku wara żewġ linji ta' terapija jew aktar; inkella ġew applikati kriterji ta' inklużjoni simili għal dawk tal-istudju CA209017.
English: Of the 811 treated patients, 103 (13%) had an ECOG performance score of 2, 686 (85%) were < 75 years old and 125 (15%) were ≥ 75 years old.
Maltese: Mit-811-il pazjent ikkurat, 103 (13%) kellhom punteġġ ta' prestazzjoni tal-ECOG ta' 2, 686 (85%) kellhom < 75 sena 125 (15%) kellhom ≥ 75 sena.
English: The OS HRs for nivolumab vs. chemotherapy were 1.32 (95% CI: 0.75, 2.32) for BRAF mutation-positive patients and 0.83 (95% CI: 0.62, 1.11) for BRAF wild-type patients.
Maltese: L-OS HRs għal nivolumab vs. kimoterapija kienu ta' 1.32 (95% CI: 0.75, 2.32) għall-pazjenti mutanti pożittivi tal-BRAF u 0.83 (95% CI: 0.62, 1.11) għall-pazjenti tat-tip salvaġġ tal-BRAF.
English: Use separate infusion bags and filters for each infusion.
Maltese: Uża boroż u filtri ta' infużjoni separati għal kull infużjoni.
English: Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumour responses in metastatic melanoma.
Maltese: Inibizzjoni medjata kkombinata ta' nivolumab (anti-PD-1) u ipilimumab (anti-CTLA-4) tirriżulta f'risponsi mtejba ta' kontra t-tumur fil-melanoma metastatika.
English: Baseline ECOG performance status score was 0 (20%) or 1 (78%), 77% were former/current smokers, 90% had Stage IV disease, 66% had two or more lesions, 45%, 34% and 20% received 1, 2, or 3 or more prior lines of systemic therapy, respectively, and 25% were HPV-16 status positive.
Maltese: Il-punteġġ tal-istatus tal-prestazzjoni ECOG fil-linja bażi kien 0 (20 %) jew 1 (78 %), 77 % kienu/għadhom ipejpu, 90 % kellhom marda fi Stadju IV, 66 % kellhom żewġ leżjonijiet jew aktar, 45 %, 34 % u 20 % rċivew linja 1, 2 jew 3 jew aktar ta' terapija sistemika preċedenti, rispettivament, u 25 % kellhom status pożittiv għal HPV-16.
English: Baseline ECOG performance status was 0 (31%) or 1 (69%).
Maltese: L-istatus talprestazzjoni ECOG fil-Linja Bażi kien 0 (31%) jew 1 (69%).
English: ECOG performance status score was 0 (73%) or 1 (27%).
Maltese: Il-punteġġ tal-istat ta' prestazzjoni ta' ECOG kien 0 (73%) jew 1 (27%).
English: Renal Cell Carcinoma (RCC)
Maltese: Rispons komplet (CR
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of rash was 48.8% (267/547).
Maltese: F'pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg f'RCC, l-inċidenza ta' raxx kienet, 48.8% (267/547).
English: Among the patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 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'nivolumab 1 mg/kg mogħti flimkien ma' ipilimumab 3 mg/kg f'CA209067, 154/313 (49%) kellhom l-ewwel bidu ta' reazzjonijiet avversi ta' Grad 3 jew 4 matul il-fażi ta' kombinazzjoni inizjali.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of rash was 65.0% (291/448).
Maltese: F'pazjenti kkurati b'nivolumab 1 mg/kg mogħti flimkien ma' ipilimumab 3 mg/kg fil-melanoma, linċidenza ta' raxx kienet, 65.0% (291/448).
English: Most patients had ECOG performance score of 0 (64%) or 1 (34%).
Maltese: Ħafna mill-pazjenti kellhom punteġġ ta' prestazzjoni ECOG ta' 0 (64%) jew 1 (34%).
English: Figure 3: Progression-free survival by PD-L1 expression: 5% cut off (CA209067)
Maltese: Figura 3: Sopravivenza mingħajr progessjoni mill-espressjoni ta' PD-L1: cut off ta' 5% (CA209067)
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 11 (at the tumour PD-L1 5% cut off).
Maltese: Riżultati tal-OS minn din l-analiżi ta' follow-up huma murija fil-Figura 5 (kollha randomizzati), Figura 6 (bil-cut off tal-PD-L1 1% tat-tumur), u Tabella 11 (bil-cut off tal-PD-L1 5% tat-tumur).
English: Grade 3 and 4 cases were reported in 1.6% (41/2578) and 0.3% (9/2578) of patients, respectively.
Maltese: Każijiet ta' Grad 3 u 4 ġew irrapportati f'1.6% (41/2578), u 0.3% (9/2578) ta' pazjenti rispettivament.
English: • Persistent Grade 2 or 3 adverse reactions despite management.
Maltese: • Reazzjonijiet avversi persistenti ta' Grad 2 jew 3 minkejja l-ġestjoni tagħhom.
English: The PFS HRs for nivolumab vs. chemotherapy were 0.76 (95% CI: 0.54, 1.07) in patients with tumour PD-L1 expression ≥1% and 1.92 (95% CI: 1.05, 3.5) in patients with tumour PD-L1 expression <1%.
Maltese: Il-PFS HRs għal nivolumab vs. kimoterapija kienu 0.76 (95% CI: 0.54, 1.07) f'pazjenti b'espressjoni tat-tumur ta' PD-L1 ≥1% u 1.92 (95% CI: 1.05, 3.5) f'pazjenti b'espressjoni tat-tumur ta' PD-L1 <1%.
English: Not known hypoparathyroidismh Metabolism and nutrition disorders Common decreased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna nuqqas ta' aptit nuqqas ta' aptit
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of pneumonitis including interstitial lung disease was 6.2% (34/547).
Maltese: F'pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg f'RCC, l-inċidenza ta' pulmonite inkluż il-mard tal-pulmun interstizjali, kienet 6.2% (34/547).
English: • patients with prior therapy for melanoma (except patients with surgery, adjuvant radiotherapy after neurosurgical resection for lesions of the central nervous system, and prior adjuvant interferon completed ≥ 6 months prior to randomisation),
Maltese: • pazjenti b'terapija preċedenti għal melanoma (għajr pazjenti b'kirurġija, radjoterapija aġġuvanti wara risezzjoni newrokirurġika għal leżjonijiet tas-sistema nervuża ċentrali, u interferon aġġuvanti preċedenti mwettqa ≥ 6 xhur qabel ir-randomizzazzjoni),
English: Quantifiable tumour PD-L1 expression was measured in 67% of patients in the nivolumab group and 82% of patients in the investigator's choice group.
Maltese: L-espressjoni PD-L1 tat-tumur kwantifikabbli tkejlet f'67 % tal-pazjenti fil-grupp nivolumab u fi 82 % tal-pazjenti fil-grupp tal-għażla tal-investigatur.
English: Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg
Maltese: Nivolumab 1 mg/kg Flimkien ma' Ipilimumab 3 mg/kg
English: Median time to onset was 2.6 months (range: 0.7-12.6).
Maltese: Il-ħin medjan sal-bidu kien 2.6 xhur (firxa: 0.7-12.6).
English: Number of Subjects at Risk Nivolumab 3 mg/kg
Maltese: Għadd ta' Individwi f'Riskju Nivolumab 3 mg/kg
English: Grade 2 and Grade 3 cases were reported in 3.1% (17/547) and 1.1% (6/547), of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2 u Grad 3 fi 3.1% (17/547) u 1.1% (6/547), 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 (eventi: 63/123), medjan u 95% CI: 11.24 (6.93, 23.03) ──Δ─── Nivolumab (eventi: 77/117), medjan u 95% CI: 2.83 (2.76, 5.13) - - -- - - Ipilimumab (eventi: 87/113), medjan u 95% CI: 2.79 (2.66, 2.96)
English: Figure 11: Kaplan-Meier curves of OS in intermediate/poor risk patients (CA209214)
Maltese: Kaplan-Meier tal-OS f'pazjenti b'riskju intermedju/baxx (CA209214)
English: Grade 2 and Grade 3 cases were reported in 5.1% (131/2578) and 1.2% (31/2578) of patients respectively.
Maltese: Każijiet ta' Grad 2 u Grad 3 kienu rrappurtati f'5.1% (131/2578) u 1.2% (31/2578) tal-pazjenti rispettivament.
English: When administered in combination with ipilimumab, the CL of nivolumab increased by 20% in the presence of anti-nivolumab antibodies and the CL of ipilimumab increased by 5.7% in the presence of anti-ipilimumab antibodies.
Maltese: Meta jingħata f'kombinazzjoni ma' ipilimumab, is-CL ta' nivolumab żdied b'20% fil-preżenza ta' antikorpi ta' kontra nivolumab u s-CL ta' ipilimumab żdied b'5.7 % fil-preżenza ta' antikorpi ta' kontra ipilimumab.
English: Infections of the upper respiratory tract
Maltese: Infezzjonijiet fl-apparat respiratorju superjuri
English: When nivolumab 3 mg/kg was administered in combination with ipilimumab 1 mg/kg, the CL of nivolumab was increased by 1% and the CL of ipilimumab was decreased by 1.5%, which were not considered clinically relevant.
Maltese: Meta nivolumab 3 mg/kg ingħata flimkien ma' ipilimumab 1 mg/kg, is-CL ta' nivolumab żdied b'1 % u s-CL ta' ipilimumab żdied b'1.5 %, li ma tqiesx bħala klinikament rilevanti.
English: Grade 3 and 4 cases were reported in 0.4% (11/2578) and <0.1% (1/2578) of patients, respectively.
Maltese: Każijiet ta' Grad 3 u 4 ġew irrapportati f'0.4% (11/2578) u < 0.1 (1/2578) ta' pazjenti rispettivament.
English: Figure 4: Progression-free survival by PD-L1 expression: 1% cut off (CA209067)
Maltese: Figura 4: Sopravivenza mingħajr progessjoni mill-espressjoni ta' PD-L1: cut off ta' 1% (CA209067)
English: “+” Denotes a censored observation.
Maltese: “+” tfisser osservazzjoni ċċensurata.
English: 16.16) and the estimated OS rates were 69.2% (CI: 57.7, 78.2) at 6 months and 45.6% (CI: 34.2, 56.3) at 12 months.
Maltese: (95% CI: 7.26, 16.16) u r-rati OS stmati kienu ta' 69.2% (CI: 57.7, 78.2) wara 6 xhur u 45.6% (CI: 34.2, 56.3) wara 12-il xahar.
English: Complete response (CR) Partial response (PR) Stable disease (SD)
Maltese: Rispons komplut (complete rispons, CR) Rispons parzjali (partial response, PR) Mard stabbli (stable disease (SD)
English: Efficacy by BRAF status: After18 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to nivolumab in combination with ipilimumab had a median PFS of 15.5 months (95% CI: 8.0, NA) and 11.3 months (95% CI: 8.3, 22.2), while those in the nivolumab monotherapy arm had a median PFS of 5.6 months (95% CI: 2.8, 9.3) and 7.1 months (95% CI: 4.9, 14.3), respectively.
Maltese: Wara 18-il xahar ta' segwitu, pazjenti bi BRAF tat-tip selvaġġ u pożittivi għall-mutazzjoni BRAF[V600] randomizzati għal nivolumab mogħti flimkien ma' ipilimumab kellhom PFS medjan ta' 15.5 xhur (95% CI: 8.0, NA) u 11.3 xhur (95% CI: 8.3, 22.2), waqt li dawk fil-fergħa ta' monoterapija b'nivolumab kellhom PFS medjana ta' 5.6 xhur (95% CI: 2.8, 9.3) u 7.1 xhur (95% CI: 4.9, 14.3), rispettivament.
English: Grade 2 and Grade 3 cases were reported in 10.4% (57/547) and 4.9% (27/547) of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2 u Grad 3 f'10.4% (57/547) u 4.9% (27/547) tal-pazjenti, rispettivament.
English: The effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis in the first trimester through delivery, at exposure levels either 8 or 35 times higher than those observed at the clinical dose of 3 mg/kg of nivolumab (based on AUC).
Maltese: L-effetti ta' nivolumab fuq l-iżvilupp qabel u wara t-twelid fix-xadini ġew evalwati wara li ngħataw nivolumab darbtejn fil-ġimgħa malli feġġet l-organoġenesi fl-ewwel trimestru salħlas, b'livelli ta' esponiment ta' 8 jew 35 darba ogħla minn dawk osservati bid-doża klinika ta' 3 mg/kg ta' nivolumab (fuq il-bażi tal-AUC).
English: Rate (95% CI) at 12 months Rate (95% CI) at 18 months Rate (95% CI) at 24 months a
Maltese: Rata (95% CI) fi 12-il xahar Rata (95% CI) fi 18-il xahar Rata (95% CI) f'24 xahar a
English: Grade 3 cases were reported in 1.6% (41/2578) of patients.
Maltese: Każijiet ta' Grad 3 ġew irrapportati f'1.6% (41/2578) tal-pazjenti.
English: Patients with ocular/uveal melanoma were excluded from pivotal clinical trials of melanoma.
Maltese: Pazjenti b'melanoma okulari/uveali kienu esklużi mill-provi kliniċi pivotali tal-melanoma.
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 osservati ta' PFS fi 18-il xahar ta' segwitu u r-riżultati ta' ORR u ta' OS fi 28 xahar ta' segwitu ntwerew b'mod konsistenti fis-sottogruppi tal-pazjenti inkluż listatus ta' prestazzjoni tal-ECOG fil-linja bażi,l-istatus BRAF, l-istadju M, l-età, il-passat ta' metastasi tal-moħħ, u l-livell LDH tal-linja bażi.
English: Changes in test results
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Nivolumab with ipilimumab was continued beyond progression in 29% of patients.
Maltese: ipilimumab tkompla wara l-progressjoni f'29% tal-pazjenti.
English: OPDIVO infusion is compatible with:
Maltese: L-infużjoni ta' OPDIVO hija kompatibbli ma':
English: The OS HRs for nivolumab in combination with ipilimumab 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 tal-OS għal nivolumab mogħti flimkien ma' monoterapija ipilimumab vs. 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 bi BRAF tat-tip selvaġġ.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of liver function test abnormalities was 18.5% (101/547).
Maltese: F'pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg f'RCC, l-inċidenza ta' testijiet tal-funzjoni tal-fwied abnormali, kienet, 18.5% (101/547).
English: Data from the 80 patients from CA209205 Cohort B and from the 15 patients from CA209039 who received prior brentuximab vedotin treatment following ASCT were integrated.
Maltese: Id-data minn 80 pazjent minn CA209205 Koorti B u mill-15-il pazjent minn CA209039 li rċevew kura minn qabel bi brentuximab vedotin wara ASCT kienet integrata.
English: A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, solid tumour type, tumour size, and hepatic impairment.
Maltese: Analiżi PK tal-popolazzjoni ma ssuġġerixxiet ebda differenza fis-CL ta' nivolumab fuq il-bażi ta' età, sess, razza, tip ta' tumur solidu, daqs tat-tumur, u indeboliment tal-fwied.
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of diarrhoea or colitis was 28.2% (154/547).
Maltese: F'pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg f'RCC, l-inċidenza ta' dijarea jew kolite, kienet 28.2% (154/547).
English: Patients in the combination arm received nivolumab 1 mg/kg over 60 minutes and ipilimumab 3 mg/kg over 90 minutes administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab 3 mg/kg as monotherapy every 2 weeks.
Maltese: Il-pazjenti filfergħa kkombinata rċevew nivolumab 1 mg/kg għal 60 minuta u ipilimumab 3 mg/kg għal 90 minuta mogħti fil-vina kull 3 ġimgħat għall-ewwel 4 dożi, segwit minn nivolumab 3/mg bħala monoterapija kull ġimagħtejn.
English: Among the patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Maltese: Fost il-pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg f'CA209214, 169/547 (31%) kellhom l-ewwel bidu ta' reazzjonijiet avversi ta' Grad 3 jew 4 matul il-fażi ta' kombinazzjoni inizjali.
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 (eventi: 63/155), medjan u 95% CI: N.A. (39.06, N.A.) ──Δ─── Nivolumab (eventi: 71/171), medjan u 95% CI: N.A. (40.21, N.A.) - - -- - - Ipilimumab (eventi: 103/164), medjan u 95% CI: 21.49 xhur (16.
English: Grade 2 and Grade 3 thyroid disorders were reported in 14.5% (65/448) and 1.3% (6/448) of patients, respectively.
Maltese: Kienu rrappurtati każijiet ta' Grad 2, Grad 3 ta' disturbi tat-tirojde f'14.5% (65/448) u 1.3% (6/448) tal-pazjenti, rispettivament.
English: Table 2:
Maltese: Tabella 24:
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of thyroid disorders was 27.2% (149/547).
Maltese: F'pazjenti kkurati b'nivolumab 3 mg/kg mogħti flimkien ma' ipilimumab 1 mg/kg f'RCC, l-inċidenza tad-disturbi tat-tirojde kienet 27.2% (149/547).
English: P-value is derived from a log-rank test stratified by prior cetuximab; the corresponding O'Brien-Fleming efficacy boundary significance level is 0.0227.
Maltese: Il-valur-p huwa meħud minn test log-rank stratifikat permezz ta' cetuximab preċedenti; il-livell korrispondenti O'Brien-Fleming ta' sinifikanza tal-livell tal-effikaċja huwa ta' 0.0227.
English: Median time to onset was 2.6 months (range: 0.5-21.8).
Maltese: Il-ħin medjan sal-bidu kien 2.6 xhur (firxa: 0.5-21.8).
English: Table 20: Baseline patient characteristics in CA209205 Cohort B, Cohort C and CA209039
Maltese: Karatteristiċi tal-linja bażi tal-pazjent f'CA209205 Koorti B, Koorti C u CA209039 CA209205
English: Not Reached (1.9+, 12.0+)
Maltese: Mhux Milħuq (1.9+, 12.0+)
English: PD-L1 expression < 1%
Maltese: Espressjoni PD-L1 < 1%
English: ORRs were higher for the combination of nivolumab and ipilimumab relative to nivolumab monotherapy across tumour PD-L1 expression levels (Table 12) after 28 months of follow-up, with a best overall response of complete response correlating to an improved survival rate.
Maltese: L-ORRs kienu ogħla għall-kombinazzjoni ta' nivolumab u ta' ipilimumab mqabbla mal-monoterapija ta' nivolumab fil-livelli ta' espressjoni tattumur ta' PD-L1 (Tabella 12) wara 28 xahar ta' segwitu, bl-aħjar rispons globali sħiħ li jikkorrelata ma' rata ta' sopravivenza mtejba.
English: Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg
Maltese: Nivolumab 3 mg/kg Flimkien ma' Ipilimumab 1 mg/kg
English: In the dataset of nivolumab 3 mg/kg as monotherapy for the adjuvant treatment of melanoma (n = 452), the most frequent adverse reactions (≥ 10%) were fatigue (46%), rash (29%), diarrhoea (24%), pruritus (23%), nausea (15%), arthralgia (13%), musculoskeletal pain (11%), and hypothyroidism (11%).
Maltese: Fis-sett ta' data ta' nivolumab 3 mg/kg bħala monoterapija għall-kura aġġuvanti ta' melanoma (n = 452), l-aktar reazzjonijiet avversi frekwenti (≥ 10%) kienu għeja (46%), raxx (29%), dijarea (24%), ħakk (23%), dardir (15%), artralġija (13%), uġigħ muskuloskeletali (11%), u ipotirojdiżmu (11%).
English: The median age was 55 years (range: 18-86), 58% were men, and 95% were white.
Maltese: L-età medjana kienet 55 sena (medda: 18-86), 58% kienu rġiel, u 95% kienu bojod.
English: Baseline characteristics were similar across the two studies and cohorts (see Table 20 below).
Maltese: Il-karatteristiċi tal-linja bażi kienu simili fiż-żewġ studji u koorti (ara Tabella 20 hawn taħt).
English: In the pooled dataset of nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma (n = 448) with minimum follow-up ranging from 6 to 28 months, the most frequent adverse reactions (≥ 10%) were rash (52%), fatigue (46%), diarrhoea (43%), pruritus (36%), nausea (26%), pyrexia (19%), decreased appetite (16%), hypothyroidism (16%), colitis (15%), vomiting (14%), arthralgia (13%), abdominal pain (13%), headache (11%), and dyspnoea (10%).
Maltese: (n = 448) b'segwitu minimu li jvarja minn 6 sa 28 xahar, l-iktar reazzjonijiet avversi frekwenti (≥ 10%) kienu raxx (52%), għeja (46%), dijarea (43%), prurite (36%), dardir (26%), piressija (19%), tnaqqis fl-aptit (16%), ipotirojdiżmu (16%), kolite (15 %), rimettar (14%), artralġija (13%), uġigħ addominali (13%), uġigħ ta' ras (11%), u dispnea (10%).
English: Grade 3 or 4 myocarditis
Maltese: Mijokardite ta' Grad 3 jew 4
English: In 49 evaluated patients from two cHL studies who underwent allogeneic HSCT after discontinuing nivolumab monotherapy, Grade 3 or 4 acute GVHD was reported in 13/49 patients (26.5%).
Maltese: F'49 pazjent evalwat minn żewġ studji tas-cHL li sarilhom HSCT alloġeniku wara li waqqfu lmonoterapija ta' nivolumab, GVHD akut ta' Grad 3 jew 4 kien irrapportat fi 13/49 pazjent (26.5%).
English: nivolumab Median OS (95% CI)
Maltese: nivolumab OS medjana (95% CI)
English: At the time of this final ORR analysis, results from 120 nivolumab-treated patients and 47 chemotherapy-treated patients who had a minimum of 6 months of follow-up were analysed.
Maltese: Fi żmien din l-analiżi finali tal-ORR, ġew analizzati r-riżultati minn 120 pazjent ikkurati b'nivolumab u 47 pazjent ikkurat bil-kemoterapija kellhom minimu ta' 6 xhur ta' segwitu.