FrancophonIA/ELRC3.0 huggingface dataset:
English: Pneumonitis requiring the use of corticosteroids occurred in 1.6% (51/3,178) of patients receiving atezolizumab monotherapy.
Maltese: Pulmonite li teħtieġ l-użu ta' kortikosterojdi seħħet f'1.6% (51/3,178) tal-pazjenti li kienu qed jirċievu atezolizumab bħala monoterapija.
English: For each 28-day cycle, Tecentriq is administered on days 1 and 15, and nab-paclitaxel is administered on days 1, 8, and 15.
Maltese: Għal kull ċiklu ta' 28 jum, Tecentriq jingħata fil-jiem 1 u 15, u nab-paclitaxel jingħata fil-jiem 1, 8 u 15.
English: Nausea, diarrhoea, stomatitis, fatigue, pyrexia, mucosal inflammation, decreased appetite, weight decreased, hypertension and proteinuria were reported higher (≥5% difference) in patients receiving atezolizumab in combination with bevacizumab,
Maltese: Dardir, dijarea, stomatite, għeja kbira, deni, infjammazzjoni talmukuża, tnaqqis fl-aptit, tnaqqis fil-piż, pressjoni għolja u proteina fl-awrina kienu rrappurtati bi frekwenza ogħla (differenza ta' ≥5%) f'pazjenti li jirċievu atezolizumab flimkien ma' bevacizumab, paclitaxel u carboplatin.
English: Patients with event (%) Median (months) (95% CI)
Maltese: Pazjenti b'avveniment (%) Medjan (xhur) (CI ta' 95%)
English: The management guidelines for these adverse reactions are described in sections 4.2 and 4.4.
Maltese: Il-linji gwida ta' mmaniġġjar għal dawn ir-reazzjonijiet avversi huma deskritti fis-sezzjonijiet 4.2 u 4.4.
English: Nephritis occurred in < 0.1% (3/3,178) of patients who received atezolizumab.
Maltese: Nefrite seħħet f'< 0.1% (3/3,178) tal-pazjenti li rċevew atezolizumab.
English: In study IMpower150, there are no data on the efficacy of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in EGFR+ patients who have progressed previously on erlotinib+bevacizumab.
Maltese: Fl-istudju IMpower150, m'hemmx data dwar l-effikaċja ta' atezolizumab flimkien ma' bevacizumab, paclitaxel u carboplatin f'pazjenti EGFR+ li fil-passat għamlu progress fuq erlotinib+bevacizumab.
English: Investigator-assessed Overall Best Response3* (RECIST 1.1)
Maltese: L-Aqwa Rispons Globali stmat millinvestigatur3* (RECIST 1.1)
English: A phase III, double-blind, two-arm, multi-center, international, randomised, placebo-controlled study, IMpassion130, was conducted to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel, in patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease.
Maltese: III, double-blind, b'żewġ gruppi, b'aktar minn ċentru wieħed, internazzjonali, randomised u kkontrollat bil-plaċebo, IMpassion130, twettaq biex jiġu evalwati l-effikaċja u s-sigurtà ta' atezolizumab flimkien ma' nab-paclitaxel, f'pazjenti b'TNBC avvanzat lokalment jew metastatiku li ma jistax jitneħħa permezz ta' kirurġija li ma rċevewx kimoterapija qabel għal mard metastatiku.
English: Other endpoints Investigator-assessed ORR (RECIST v1.1)^
Maltese: ORR stmata mill-investigatur (RECIST v1.1)^
English: b Includes reports of pneumonia, bronchitis, lung infection, lower respiratory tract infection, infective exacerbation of COPD, infectious pleural effusion, tracheobronchitis, atypical pneumonia, lung abscess, pyopneumothorax.
Maltese: b Tinkludi rapporti ta' pulmonite, bronkite, infezzjoni fil-pulmun, infezzjoni fl-apparat respiratorju t'isfel, aggravar infettiv ta' COPD, effużjoni infettiva fil-plewra, trakeobronkite, pulmonite atipika, axxess fil-pulmun, pyopneumothorax.
English: Patients had to be eligible for taxane monotherapy (i.e. absence of rapid clinical progression, life-threatening visceral metastases, or need for rapid symptom and/or disease control) and were excluded if they had received prior chemotherapy in the neoadjuvant or adjuvant setting within the last 12 months, a history of autoimmune disease; administration of a live, attenuated vaccine within 4 weeks prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomisation; untreated, symptomatic or corticosteroid-dependent brain metastases.
Maltese: Ilpazjenti kellhom ikunu eliġibbli għal taxane bħala monoterapija (jiġifieri nuqqas ta' progressjoni klinika mgħaġġla, metastasi fil-vixxri ta' periklu għall-ħajja, jew ħtieġa ta' kontroll rapidu tas-sintomi u/jew tal-marda) u kienu esklużi jekk kienu rċevew kimoterapija qabel fl-ambjent neoawżiljarju jew awżiljarju fl-aħħar 12-il xahar, kellhom passat ta' mard awtoimmuni; għoti ta' vaċċin ħaj u attenwat fi żmien 4 ġimgħat qabel ir-randomisation, għoti ta' sustanzi immunostimulatorji sistemiċi fi żmien 4 ġimgħat jew medikazzjonijiet immunosoppressivi sistemiċi fi żmien ġimagħtejn qabel irrandomisation; metastasi fil-moħħ mhux ittrattata, sintomatika jew dipendenti fuq il-kortikosterojdi.
English: The median number of treatment cycles was 7 for atezolizumab and 6 for nab-paclitaxel in each treatment arm.
Maltese: In-numru medjan ta' ċikli ta' trattament kien ta' 7 għal atezolizumab u ta' 6 għal nab-paclitaxel f'kull grupp ta' trattament.
English: • prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Maltese: • tiġi ppreparata f'kabinett ta' fluss laminari jew f'armarju ta' sigurtà bijoloġika bl-użu tal prekawzjonijiet standard għall-immaniġġjar sigur ta' sustanzi għall-użu fil-vini.
English: Figure 8: Kaplan-Meier curves for progression free survival (IMpower130)
Maltese: Kaplan-Meier għas-sopravivenza mingħajr progressjoni (IMpower130)
English: Guillain-Barré syndrome led to discontinuation of atezolizumab in 1 patient (< 0.1%).
Maltese: Is-sindrome ta' Guillain-Barré wasslet għal twaqqif ta' atezolizumab f'pazjent wieħed (< 0.1%).
English: Investigator-assessed ORR (RECIST v1.1)
Maltese: ORR stmata mill-investigatur (RECIST v1.1)
English: SWITZERLAND
Maltese: Sverige
English: Adrenal insufficiency occurred in 0.4% (12/3,178) of patients who received atezolizumab monotherapy.
Maltese: Insuffiċjenza adrenali seħħet f'0.4% (12/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: Vinflunine was administered 320 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Maltese: Vinflunine ngħata bħala 320 mg/m permezz ta' infużjoni fil-vini f'Jum 1 ta' kull ċiklu ta' 21 jum sal-progressjoni tal-marda jew sa tossiċità mhux aċċettabbli.
English: Colitis led to discontinuation of atezolizumab in 8 (0.3%) patients.
Maltese: Kolite wasslet għal twaqqif ta' atezolizumab fi 8 (0.3%) pazjenti.
English: Myocarditis has been observed in clinical trials with atezolizumab (see section 4.8).
Maltese: Mijokardite kienet osservata fi provi kliniċi b'atezolizumab (ara sezzjoni 4.8).
English: Includes reports of encephalitis, meningitis, photophobia.
Maltese: Tinkludi rapporti ta' enċefalite, meninġite u fotofobija.
English: Treatment with atezolizumab should be withheld if Grade 2 event (ALT or AST > 3 to 5 x ULN or blood bilirubin > 1.5 to 3 x ULN) persists for more than 5 to 7 days, and 1 to 2 mg/kg/day of prednisone or equivalent should be started.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf jekk avveniment ta' Grad 2 (ALT jew AST > 3 sa 5 x ULN jew bilirubina fid-demm > 1.5 sa 3 x ULN) jippersisti għal aktar minn 5 sa 7 ijiem, u għandu jinbeda 1 sa 2 mg/kg/jum ta' prednisone jew ekwivalenti.
English: PD-L1 testing for patients with UC or TNBC
Maltese: Ittestjar ta' PD-L1 għal pazjenti b'UC jew TNBC
English: Table 3: Summary of efficacy in all comers (IMvigor211)
Maltese: Tabella 3: Sommarju tal-effikaċja fil-pazjenti kollha rreġistrati (IMvigor211)
English: The median time to onset was 5.4 months (range: 0.7 to 11.0 months).
Maltese: Iż-żmien medjan sal-bidu kien ta' 5.4 xhur (medda: 0.7 sa 11.0 xhur).
English: PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumours v1.1.
Maltese: PFS = sopravivenza mingħajr progressjoni; RECIST = Kriterji ta' Evalwazzjoni tarRispons f'Tumuri Solidi v1.1.
English: Since atezolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected.
Maltese: Peress li atezolizumab jitneħħa miċ-ċirkolazzjoni permezz ta' kataboliżmu, mhux mistennija interazzjonijiet metaboliċi bejn mediċina u oħra.
English: • Absence of symptoms and signs (including worsening of laboratory values [e.g., new or worsening hypercalcaemia]) indicating unequivocal progression of disease
Maltese: • Nuqqas ta' sintomi u sinjali (li jinkludu aggravar tal-valuri tal-laboratorju [eż., iperkalċimija ġdida jew li qed tmur għall-agħar]) li jindikaw progressjoni ċara tal-marda
English: Human immunoglobulins G1 (IgG1) are known to cross the placental barrier and atezolizumab is an IgG1; therefore, atezolizumab has the potential to be transmitted from the mother to the developing foetus.
Maltese: Immunoglobulini G1 (IgG1 - immunoglobulins G1) umani huma magħrufa li jgħaddu mill-barriera talplaċenta u atezolizumab huwa
English: Withhold Tecentriq Treatment may be resumed when metabolic control is achieved on insulin replacement therapy
Maltese: It-trattament jista' jinbeda mill-ġdid meta jinkiseb kontroll metaboliku b'terapija ta' sostituzzjoni tal-insulina
English: Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with systemic corticosteroid use, administration of other systemic immunosuppressants may be considered.
Maltese: Abbażi ta' data limitata minn studji kliniċi f'pazjenti li r-reazzjonijiet avversi tagħhom relatati mal-immunità ma setgħux jiġu kkontrollati bl-użu ta' kortikosterojdi sistemiċi, jista' jitqies l-għoti ta' immunosoppressanti sistemiċi oħra.
English: • Evidence of clinical benefit as assessed by the investigator
Maltese: • Evidenza ta' benefiċċju kliniku kif stmat mill-investigatur
English: Stratifiedǂ hazard ratio (95% CI) 12-month OS (%)**
Maltese: PFS ta' 12-il xahar (%) Analiżi interim ta' OS*
English: Nephritis has been observed in clinical trials with atezolizumab (see section 4.8).
Maltese: Nefrite kienet osservata fi provi kliniċi b'atezolizumab (ara sezzjoni 4.8).
English: Adrenal insufficiency requiring the use of corticosteroids occurred in 0.3% (9/3,178) of patients receiving atezolizumab monotherapy.
Maltese: Insuffiċjenza adrenali li kienet teħtieġ l-użu ta' kortikosterojdi seħħet f'0.3% (9/3,178) tal-pazjenti li kienu qed jirċievu atezolizumab bħala monoterapija.
English: No formal pharmacokinetic drug interaction studies have been conducted with atezolizumab.
Maltese: Ma twettaq l-ebda studju farmakokinetiku formali ta' interazzjoni tal-mediċina b'atezolizumab.
English: (HR of 0.71, 95% CI: 0.47, 1.08; median OS of 16.3 vs. 12.6 months for atezolizumab and docetaxel,
Maltese: 11.9 xhur għal atezolizumab u docetaxel, rispettivament) u pazjenti li qatt ma pejpu (HR ta' 0.71, CI ta' 95%: 0.47, 1.08; OS medjana ta' 16.3 vs. 12.6 xhur għal atezolizumab u docetaxel, rispettivament).
English: The time to deterioration (a sustained ≥ 10-point decline from baseline score) of patient-reported global health status/health-related quality of life as measured by the EORTC QLQ-C30 was similar in each treatment group indicating that all patients maintained their baseline HRQoL for a comparable duration of time.
Maltese: Iż-żmien sa deterjorament (tnaqqis sostnut ta' ≥ 10 punti mill-punteġġ fil-linja bażi) tal-istat tas-saħħa globali/kwalità tal-ħajja relatata mas-saħħa rrappurtati mill-pazjenti kif imkejla mill-EORTC QLQC30 kien simili f'kull grupp ta' trattament u dan jindika li l-pazjenti kollha żammew l-HRQoL fil-linja bażi tagħhom għal tul ta' żmien komparabbli.
English: However, patients with EGFR mutations did not show improved OS with atezolizumab compared to docetaxel (HR of 1.24, 95% CI: 0.71, 2.18; median OS of 10.5 vs. 16.2 months for atezolizumab and docetaxel, respectively).
Maltese: Madankollu, pazjenti b'mutazzjonijiet ta' EGFR ma wrewx OS imtejba b'atezolizumab meta mqabbla ma' docetaxel (HR ta' 1.24, CI ta' 95%: 0.71, 2.18; OS medjana ta' 10.
English: If you have not received anticancer medicines before for advanced lung cancer, Tecentriq will be given to you in combination with or without bevacizumab and anticancer medicines (chemotherapies called carboplatin and paclitaxel or nab paclitaxel).
Maltese: Jekk inti ma rċevejtx mediċini kontra l-kanċer fil-passat għal kanċer avvanzat tal-pulmun, Tecentriq se jingħatalek flimkien ma' jew mingħajr bevacizumab u mediċini kontra l-kanċer (kimoterapiji msejħa carboplatin u paclitaxel jew nab-paclitaxel).
English: Tumour assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, Day 1 and then every 9 weeks thereafter.
Maltese: Valutazzjonijiet tat-tumur twettqu kull 6 ġimgħat għall-ewwel 48 ġimgħa wara Ċiklu 1, Jum 1 u mbagħad kull 9 ġimgħat wara dan.
English: • hoarse voice (dysphonia)
Maltese: • leħen maħnuq (disfonja)
English: Atezolizumaba (1,200 mg) + bevacizumab d
Maltese: Atezolizumaba (1,200 mg) + bevacizumabd (15 mg/kg)
English: Hyperthyroidism occurred in 0.9% (30/3,178) of patients who received atezolizumab monotherapy.
Maltese: Ipertirojdiżmu seħħ f'0.9% (30/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: Each vial contains 1,200 mg of atezolizumab (in 20 mL).
Maltese: Kull kunjett fih 1,200 mg ta' atezolizumab (f'20 mL).
English: 9.3, 40.0) in patients with PD-L1 expression ≥ 5%, 18.8% (95% CI: 10.9, 29.0) in patients with PD-L1 expression ≥ 1%, and 19.3% (95% CI: 12.7, 27.6) in all comers.
Maltese: .4, 38.9) f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 5%, 23.7% (CI ta' 95%: 18.1, 30.1) f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1%, u 19.7% (CI ta' 95%: 15.4, 24.6) fil-pazjenti kollha rreġistrati.
English: There were 24.2% of patients who received only prior platinum-containing adjuvant or neoadjuvant therapy and progressed within 12 months.
Maltese: Kien hemm 24.2% tal-pazjenti li rċevew biss terapija awżiljarja jew neoawżiljarja li kien fiha platinum u kellhom progressjoni fi żmien 12-il xahar.
English: Atezolizumab is administered as an intravenous infusion.
Maltese: Tinkludi rapporti ta' insuffiċjenza adrenali u insuffiċjenza adrenali primarja.
English: A phase II, multi-centre, international, two-cohort, single-arm clinical trial, IMvigor210, was conducted in patients with locally advanced or metastatic UC (also known as urothelial bladder cancer).
Maltese: II, b'aktar minn ċentru wieħed, internazzjonali, b'żewġ koorti u bi grupp wieħed, IMvigor210, twettqet f'pazjenti b'UC avvanzata lokalment jew metastatika (magħrufa ukoll bħala kanċer tal-epitelju tal-apparat urinarju u tal-bużżieqa tal-awrina).
English: Docetaxel was administered 75 mg/m by intravenous infusion on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Maltese: Docetaxel ingħata bħala 75 mg/m permezz ta' infużjoni fil-vini f'Jum 1 ta' kull ċiklu ta' 21 jum sal-progressjoni tal-marda jew sa tossiċità mhux aċċettabbli.
English: Patients received treatment until radiographic disease progression per RECIST v1.1, or unacceptable toxicity.
Maltese: Il-pazjenti rċevew trattament sal-progressjoni radjugrafika tal-marda skont RECIST v1.1, jew sa tossiċità mhux aċċettabbli.
English: (25.5%), nausea (23.5%), cough (20.8%), dyspnoea (20.5%), pyrexia (20.1%), diarrhoea (19.7%), rash (19.5%), back pain (15.3%), vomiting (15.0%), asthenia (14.5%), arthralgia (13.9%), musculoskeletal pain (13.0%), pruritus (12.6%) and urinary tract infection (11.6%).
Maltese: 0%), astenja (14.5%), artralġja (13.9%), uġigħ muskoluskeletriku (13.0%), ħakk (12.6%) u infezzjoni fl-apparat tal-awrina (11.6%).
English: No overall differences in safety were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Maltese: Ma ġiet osservata l-ebda differenza globali fis-sigurtà bejn pazjenti b'età ta' ≥ 65 sena u pazjenti iżgħar li jirċievu atezolizumab bħala monoterapija.
English: Mutagenicity studies have not been performed to establish the mutagenic potential of atezolizumab.
Maltese: Ma twettqux studji dwar mutaġeniċità biex jiġi stabbilit il-potenzjal mutaġeniku ta' atezolizumab.
English: The use of in-line filter membranes is optional.
Maltese: L-użu ta' riti tal-filtru fil-pajp huwa fakultattiv.
English: Colitis requiring the use of corticosteroids occurred in 0.6% (19/3,178) of patients receiving atezolizumab monotherapy.
Maltese: Kolite li teħtieġ l-użu ta' kortikosterojdi seħħet f'0.6% (19/3,178) tal-pazjenti li kienu qed jirċievu atezolizumab bħala monoterapija.
English: Investigator-assessed DOR (RECIST v1.1)
Maltese: DOR stmata mill-investigatur (RECIST v1.1)
English: Grade 4 or any grade of recurrent pancreatitis
Maltese: Pankreatite rikorrenti ta' Grad 4 jew ta' kwalunkwe grad
English: Investigator-assessed PFS (RECIST v1.1) - Primary analysis
Maltese: PFS stmata mill-investigatur (RECIST v1.1) - Analiżi primarja Nru ta' avvenimenti (%)
English: Figure 13: Kaplan-Meier curve for progression-free survival (IMpower133)
Maltese: Kaplan-Meier għal sopravivenza mingħajr progressjoni (IMpower133)
English: • infection of the lung
Maltese: • infezzjoni fil-pulmun
English: Diabetes mellitus occurred in 0.3% (11/3,178) of patients who received atezolizumab monotherapy.
Maltese: Dijabete mellitus seħħet f'0.3% (11/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: • Brief introduction to atezolizumab (indication and purpose of this tool)
Maltese: • Introduzzjoni qasira għal atezolizumab (l-indikazzjoni u l-għan ta' din l-għodda)
English: Treatment with atezolizumab may be resumed when symptoms are controlled and thyroid function is improving.
Maltese: It-trattament b'atezolizumab jista' jitkompla meta s-sintomi jiġu kkontrollati u l-funzjoni tat-tirojde tkun qed titjieb.
English: 10.0 vs. 6.1 months) and liver metastases (HR of 0.41, 95% CI: 0.26, 0.62; median PFS 8.2 vs. 5.4
Maltese: Titjib fil-PFS intwera wkoll f'pazjenti b'mutazzjonijiet ta' EGFR jew arranġamenti mill-ġdid ta' ALK (HR ta' 0.55, CI ta' 95%: 0.35, 0.87; PFS medjana ta' 10.0 vs. 6.1 xhur) u metastasi fil-fwied (HR ta' 0.41, CI ta' 95%: 0.26, 0.62; PFS medjana ta' 8.2 vs. 5.4 xhur).
English: y Includes reports of myositis, rhabdomyolysis, polymyalgia rheumatica, dermatomyositis, muscle abscess, myoglobin urine present.
Maltese: Tinkludi rapporti ta' mijosite, rabdomijoliżi, polimijalġja rewmatika, dermatomijosite, axxess fil-muskoli, mijoglobina preżenti fl-awrina.
English: Includes reports of oropharyngeal pain, oropharyngeal discomfort, throat irritation.
Maltese: Jinkludi rapporti ta' wġigħ orofarinġali, skumdità orofarinġali, irritazzjoni fil-gerżuma.
English: It is important that you also read the package leaflet for nab-paclitaxel.
Maltese: Huwa importanti li inti taqra wkoll il-fuljett ta' tagħrif għal nab-paclitaxel.
English: Programmed death-ligand 1 (PD-L1) may be expressed on tumour cells and/or tumour-infiltrating immune cells, and can contribute to the inhibition of the antitumour immune response in the tumour microenvironment.
Maltese: Death-ligand 1 ipprogrammat (PD-L1 - programmed death-ligand 1) jista' jiġi espress fuq ċelluli tattumur u/jew ċelluli immuni li jinfiltraw it-tumur, u jistgħu jikkontribwixxu għall-inibizzjoni tarrispons immuni kontra t-tumur fil-mikroambjent tat-tumur.
English: No. of responders (%) 95% CI
Maltese: Numru ta' persuni li rrispondew (%) CI ta' 95%
English: A phase III, open-label, multicenter, international, randomised study, IMpower150, was conducted to evaluate the efficacy and safety of atezolizumab in combination with paclitaxel and carboplatin, with or without bevacizumab, in chemotherapy-naïve patients with metastatic non-squamous NSCLC.
Maltese: III, open-label, b'aktar minn ċentru wieħed, internazzjonali u randomised, IMpower150, twettaq biex jiġu evalwati l-effikaċja u s-sigurtà ta' atezolizumab flimkien ma' paclitaxel u carboplatin, b'bevacizumab jew mingħajru, f'pazjenti li ma ngħatawx kimoterapija filpassat b'NSCLC metastatiku u mhux skwamuż.
English: Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 nephritis.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf b'mod permanenti għal nefrite ta' Grad 3 jew 4.
English: Treatment with atezolizumab may be resumed if metabolic control is achieved on insulin replacement therapy.
Maltese: Ittrattament b'atezolizumab jista' jinbeda mill-ġdid jekk jinkiseb kontroll metaboliku b'terapija ta' sostituzzjoni tal-insulina.
English: For TNBC, it is recommended that patients are treated with Tecentriq until disease progression or unmanageable toxicity (see section 5.1).
Maltese: Għal TNBC, huwa rakkomandat li l-pazjenti jiġu ttrattati b'Tecentriq sal-progressjoni tal-marda jew sa tossiċità li ma tistax tiġi mmaniġġjata (ara sezzjoni 5.1).
English: Patients should be monitored for symptoms of motor and sensory neuropathy.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sintomi ta' newropatija motorja u tas-sensi.
English: Patients with EGFR mutant or ALK-positive NSCLC
Maltese: • uġigħ fil-muskoli u fl-għadam
English: For Grade 3 diarrhoea or colitis, treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Maltese: Għal dijarea jew kolite ta' Grad 3, għandu jinbeda trattament b'kortikosterojdi fil-vini (1 sa 2 mg/kg/jum methylprednisolone jew ekwivalenti).
English: A total of 1,225 patients were enrolled and per the analysis plan the first 850 randomised patients were included in the primary efficacy analysis.
Maltese: Kienu rreġistrati total ta' 1,225 pazjent, bil-popolazzjoni tal-analiżi primarja li kienet tikkonsisti millewwel 850 pazjent randomised.
English: • joint pain
Maltese: • riħ komuni
English: Neutropenia and peripheral neuropathies occurring during treatment with atezolizumab and nabpaclitaxel may be reversible with interruptions of atezolizumab and/or nab-paclitaxel.
Maltese: Newtropenija u newropatiji periferali li jseħħu matul it-trattament b'atezolizumab u nab-paclitaxel jistgħu jkunu riversibbli b'interruzzjonijiet ta' atezolizumab u/jew nab-paclitaxel.
English: CI = confidence interval; DOR = duration of response; OS = overall survival.
Maltese: DOR = tul tar-rispons; OS = sopravivenza globali.
English: Tecentriq used alone The following side effects have been reported in clinical trials with Tecentriq used alone:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati fi provi kliniċi b'Tecentriq użat waħdu:
English: Hypophysitis Hypophysitis occurred in < 0.1% (2/3,178) of patients who received atezolizumab monotherapy.
Maltese: Ipofisite seħħet f'< 0.1% (2/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: Common hypothyroidismg
Maltese: Komuni ipotirojdiżmu g
English: • underactive thyroid gland (hypothyroidism)
Maltese: • glandola tat-tirojde mhux attiva biżżejjed (ipotirojdiżmu)
English: Investigator-assessed PFS (RECIST v1.1) - Updated exploratory analysis4
Maltese: valur p PFS ta' 12-il xahar (%) PFS stmata mill-investigatur (RECIST v1.1) - Analiżi esploratorja aġġornata4
English: A population pharmacokinetic analysis suggests that steady-state is obtained after 6 to 9 weeks (2 to 3 cycles) of repeated dosing.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tissuġġerixxi li stat fiss jintlaħaq wara 6 sa 9 ġimgħat (2 sa 3 ċikli) ta' dożaġġ ripetut.
English: Nederland Roche Nederland B.V.
Maltese: Roche Nederland B.V. Tel: +31 (0)
English: Meningoencephalitis occurred in 0.4% (13/3,178) of patients who received atezolizumab monotherapy.
Maltese: Meningoenċefalite seħħet f'0.4% (13/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin in metastatic non squamous non small cell lung cancer
Maltese: • b'kanċer li jaffettwa l-pulmuni, imsejjaħ kanċer taċ-ċelluli żgħar tal-pulmun (SCLC - small cell lung cancer).
English: You must not be given Tecentriq if:
Maltese: M'għandekx tingħata Tecentriq jekk:
English: Hypersensitivity to atezolizumab or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal atezolizumab jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Latvija Roche Latvija SIA
Maltese: Magyarország Roche (Magyarország)