FrancophonIA/ELRC3.0 huggingface dataset:
English: Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).
Maltese: Tecentriq, flimkien ma' carboplatin u etoposide, huwa indikat għat-trattament tal-ewwel għażla ta' pazjenti adulti b'kanċer taċ-ċelluli żgħar tal-pulmun fi stadju estensiv (ES-SCLC - extensive-stage small cell lung cancer) (ara sezzjoni 5.1).
English: The median age was 64 years (range: 33 to 85), and 61% of patients were male.
Maltese: L-età medjana kienet ta' 64 sena (medda: 33 sa 85), u 61% tal-pazjenti kienu rġiel.
English: • blocked nose (nasal congestion)
Maltese: • imnieħer imblokkat (konġestjoni fl-imnieħer)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,200 mg/20 mL
Maltese: INDIVIDWALI 1,200 mg/20 mL
English: The confirmed ORRs per IRF-RECIST v1.1 were 28.0% (95% CI: 19.5, 37.9) in patients with PD-L1 expression ≥ 5%, 19.3% (95% CI: 14.2, 25.4) in patients with PD-L1 expression ≥ 1%, and 15.8% (95% CI: 11.9, 20.4) in all comers.
Maltese: L-ORRs ikkonfermati skont l-IRF-RECIST v1.1 kienu ta' 28.0 % (CI ta' 95%: 19.5, 37.9) f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 5%, 19.3% (CI ta' 95%: 14.2, 25.4) f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1%, u 15.
English: Patients with the following conditions were excluded from clinical trials: a history of autoimmune disease, history of pneumonitis, active brain metastasis, HIV, hepatitis B or hepatitis C infection, significant cardiovascular disease and patients with inadequate hematologic and end-organ function.
Maltese: Pazjenti bil-kundizzjonijiet li ġejjin kienu esklużi mill-provi kliniċi: storja ta' mard awtoimmuni, storja ta' pulmonite, metastasi attiv fil-moħħ, infezzjoni bl-HIV, bl-epatite B jew bl-epatite Ċ, mard kardjovaskulari sinifikanti u pazjenti b'funzjoni ematoloġika u tal-organu finali inadegwata.
English: Co-primary endpoints OS
Maltese: Punti finali koprimarji
English: Figure 2: Kaplan-Meier curve for overall survival in the ITT population (IMpower150)
Maltese: Kaplan-Meier għal sopravivenza globali fil-popolazzjoni ITT (IMpower150)
English: Approximately half the patients had received a taxane (51%) or anthracycline (54%) in the (neo)adjuvant setting.
Maltese: Madwar nofs il-pazjenti kienu rċevew taxane (51%) jew anthracycline (54%) fl-ambjent (neo)awżiljarju.
English: Common abdominal pain, colitiss, dysphagia, oropharyngeal paint stomatitis, dysgeusia
Maltese: Komuni uġigħ addominali, kolite s, diffikultà biex tibla', uġigħ orofarinġalit stomatite, disgewżja
English: Includes reports of musculoskeletal pain and myalgia.
Maltese: Jinkludi rapporti ta' wġigħ muskoluskeletriku u mijalġja.
English: Pneumonitis occurred in 2.7% (87/3,178) of patients who received atezolizumab monotherapy.
Maltese: Pulmonite seħħet fi 2.7% (87/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: • inflammation of the intestines (colitis): symptoms may include diarrhoea (watery, loose or soft stools), blood in stools, and stomach pain
Maltese: • infjammazzjoni tal-intestini (kolite): sintomi jistgħu jinkludu dijarea (purgar maħlul jew artab),
English: Fifty-nine percent of patients in the nab-paclitaxel and carboplatin arm received any cancer immunotherapy after disease progression, which includes atezolizumab as crossover treatment (41% of all patients), compared to 7.3% of patients in the atezolizumab, nab paclitaxel and carboplatin arm.
Maltese: Disgħa u ħamsin fil-mija tal-pazjenti fil-grupp ta' nab-paclitaxel u carboplatin irċevew kwalunkwe immunoterapija kontra l-kanċer wara progressjoni tal-marda, li tinkludi atezolizumab bħala trattament ta' qlib (41% tal-pazjenti kollha), meta mqabbla ma' 7.3% tal-pazjenti fil-grupp ta' atezolizumab, nab-paclitaxel u carboplatin.
English: GERMANY
Maltese: Portugal
English: A total of 1,202 patients were enrolled and were randomised (1:1:1) to receive one of the treatment regimens described in Table 5.
Maltese: Ġew irreġistrati total ta' 1,202 pazjent u kienu randomised (1:1:1) biex jirċievu wieħed mill-korsijiet ta' trattament deskritti fit-Tabella 5.
English: 87 patients, one experienced a fatal event.
Maltese: Mis-87 pazjent, persuna waħda kellha avveniment fatali.
English: EU/1/17/1220/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1220/001
English: In study IMpower150, age ≥ 65 was associated with an increased risk of developing adverse events in patients receiving atezolizumab in combination with bevacizumab, carboplatin and paclitaxel.
Maltese: Fl-istudju IMpower150, età ta' ≥ 65 kienet assoċjata ma' żieda fir-riskju li jiġu żviluppati avvenimenti avversi f'pazjenti li jirċievu atezolizumab flimkien ma' bevacizumab, carboplatin u paclitaxel.
English: Figure 12: Kaplan-Meier curve for overall survival (IMpower133)
Maltese: Kaplan-Meier għal sopravivenza globali (IMpower133)
English: In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section
Maltese: F'pazjenti b'NSCLC b'mutazzjoni ta' EGFR jew pożittiv għal ALK, Tecentriq, flimkien ma' bevacizumab, paclitaxel u carboplatin, huwa indikat biss wara falliment ta' terapiji mmirati xierqa (ara sezzjoni 5.1).
English: Randomisation was stratified by sex, presence of liver metastases and PD-L1 expression on TC and IC.
Maltese: Randomisation ġiet stratifikata skont is-sess, il-preżenza ta' metastasi fil-fwied u l-espressjoni ta' PD-L1 fuq TC u IC.
English: PFS (IRF-assessed; RECIST v1.1)
Maltese: PFS (stmata minn IRF; RECIST v1.1)
English: Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 pneumonitis.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf b'mod permanenti għal pulmonite ta' Grad 3 jew 4.
English: Baseline ECOG performance status was 0 (35%) or 1 (65%).
Maltese: L-istat ta' eżekuzzjoni ta' ECOG fil-linja bażi kien ta' 0 (35%) jew 1 (65%).
English: q Includes reports of pneumonitis, lung infiltration, bronchiolitis, interstitial lung disease, radiation pneumonitis.
Maltese: q Tinkludi rapporti ta' pulmonite, infiltrazzjoni fil-pulmun, bronkjolite, marda tal-interstizju tal-pulmun,
English: Investigator-assessed PFS (RECIST v1.1)*
Maltese: PFS stmata mill-investigatur (RECIST v1.1)*
English: No. of responders (%) 95% CI No. of complete response (%) No. of partial response (%)
Maltese: Nru ta' persuni li rrispondew (%) CI ta' 95% Nru b'rispons komplet (%) Nru b'rispons parzjali (%)
English: Table 5: Intravenous treatment regimens (IMpower150) Treatment regimen
Maltese: Korsijiet ta' trattament fil-vini (IMpower150) Kors ta' trattament
English: Investigator-assessed confirmed DOR (RECIST 1.1)^
Maltese: DOR ikkonfermat stmat mill-investigatur (RECIST 1.1)^
English: Immune-related nephritis
Maltese: Nefrite relatata mal-immunità
English: The primary efficacy endpoint for Cohort 1 was confirmed objective response rate (ORR) as assessed by an independent review facility (IRF) using RECIST v1.1.
Maltese: Il-punt finali primarju tal-effikaċja għal Koorti 1 kien ir-rata ta' rispons oġġettiv (ORR - objective response rate) ikkonfermata kif stmata minn faċilità ta' analiżi indipendenti (IRF - independent review facility) bl-użu ta' RECIST v1.1.
English: Hypothyroidism occurred in 5.2% (164/3,178) of patients who received atezolizumab monotherapy.
Maltese: Ipotirojdiżmu seħħ f'5.2% (164/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: 51% of patients' tumours had PD-L1 expression of ≥ 1% TC or ≥ 1% IC and 49% of patients' tumours had PD-L1 expression of < 1% TC and < 1% IC.
Maltese: L-istat ta' eżekuzzjoni ta' ECOG fil-linja bażi kien ta' 0 (43%) jew 1 (57%). 51% tat-tumuri tal-pazjenti kellhom espressjoni ta' PD-L1 ta' ≥ 1% TC jew ≥ 1% IC u 49% tat-tumuri tal-pazjenti kellhom espressjoni ta' PD-L1 ta' < 1% TC u < 1% IC.
English: of 0.52, 95% CI: 0.33, 0.82; median OS 13.3 vs. 9.4 months).
Maltese: 17.5 xhur), u metastasi fil-fwied (HR ta' 0.52, CI ta' 95%: 0.33, 0.82; OS medjana ta' 13.3 vs. 9.4 xhur).
English: v Includes reports of ascites, autoimmune hepatitis, hepatocellular injury, hepatitis, hepatitis acute, hepatotoxicity, liver disorder, drug-induced liver injury, hepatic failure, hepatic steatosis, hepatic lesion, oesophageal varices haemorrhage, varices oesophageal.
Maltese: Tinkludi rapporti ta' axxite, epatite awtoimmuni, ħsara epatoċellulari, epatite, epatite akuta, epatotossiċità, disturb fil-fwied, ħsara fil-fwied ikkawżata mill-mediċina, insuffiċjenza epatika, steatożi epatika, leżjoni epatika, emorraġija tal-variċi tal-esofagu, variċi fl-esofagu.
English: Myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome and Meningoencephalitis
Maltese: Sindrome majastenika/majastenja gravis, sindrome ta' Guillain-Barré u Meningoenċefalite
English: No. of complete response (%) 95% CI
Maltese: Nru ta' rispons komplet (%) CI ta' 95%
English: The median duration was 26 days (range 6 days to 14.5+ months; + denotes a censored value).
Maltese: It-tul ta' żmien medjan kien ta' 26 jum (medda minn 6 ijiem sa' 14.5+ xhur; + jindika valur iċċensurat).
English: Myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome, which may be life threatening, were observed in patients receiving atezolizumab.
Maltese: Sindrome majastenika/majastenja gravis jew is-sindrome ta' Guillain-Barré, li jistgħu jkunu ta' periklu għall-ħajja, kienu osservati f'pazjenti li kienu qed jirċievu atezolizumab.
English: The median duration was 24 days (range 3 days to 12.0+ months; + denotes a censored value).
Maltese: It-tul ta' żmien medjan kien ta' 24 jum (medda minn 3 ijiem sa 12.0+ xhur; + jindika valur iċċensurat).
English: Includes reports of cytokine release syndrome, hypersensitivity, anaphylaxis.
Maltese: Tinkludi rapporti ta' sindrome ta' rilaxx ta' ċitokina, sensittività eċċessiva, anafilassi.
English: The data below reflect information for significant adverse reactions for atezolizumab as monotherapy in clinical studies (see section 5.1).
Maltese: Id-data ta' hawn taħt tirrifletti l-informazzjoni għal reazzjonijiet avversi sinifikanti għal atezolizumab bħala monoterapija fi studji kliniċi (ara sezzjoni 5.1).
English: Based on population PK and exposure-response analyses age (21-89 years), region, ethnicity, renal impairment, mild hepatic impairment, level of PD-L1 expression, or ECOG performance status have no effect on atezolizumab pharmacokinetics.
Maltese: Abbażi tal-PK tal-popolazzjoni u l-analiżi dwar ir-rispons għall-esponiment, l-età (21-89 sena), irreġjun, l-etniċità, l-indeboliment tal-kliewi, l-indeboliment ħafif tal-fwied, il-livell ta' espressjoni ta' PD-L1, jew l-istat ta' eżekuzzjoni ta' ECOG m'għandhom l-ebda effett fuq il-farmakokinetika ta' atezolizumab.
English: The metabolism of atezolizumab has not been directly studied.
Maltese: Il-metaboliżmu ta' atezolizumab ma ġiex studjat b'mod dirett.
English: Guillain-Barré syndrome requiring the use of corticosteroids occurred in < 0.1% (2/3,178) of patients receiving atezolizumab monotherapy.
Maltese: Sindrome ta' Guillain-Barré li teħtieġ l-użu ta' kortikosterojdi seħħet f'< 0.1% (2/3,178) tal-pazjenti li kienu qed jirċievu atezolizumab bħala monoterapija.
English: There were 310 patients treated with atezolizumab 1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit.
Maltese: Kien hemm 310 pazjenti ttrattati b'atezolizumab, 1,200 mg permezz ta' infużjoni fil-vini kull 3 ġimgħat sat-telf tal-benefiċċju kliniku.
English: For the recommended dose of 1680 mg: twenty-eight mL of Tecentriq concentrate should be withdrawn from two vials of Tecentriq 840 mg and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride
Maltese: Għad-doża rakkomandata ta' 1,680 mg: għandhom jinġibdu tmienja u għoxrin mL ta' konċentrat ta' Tecentriq minn żewġ kunjetti ta' Tecentriq 840 mg u dawn għandhom jiġu dilwiti f'borża tal-infużjoni ta' 250 mL tal-polyvinyl chloride (PVC), tal-polyolefin (PO), tal-polyethylene (PE), jew talpolypropylene (PP) li fiha soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: Nervous system disorders Very Common peripheral neuropathyl , dizziness, headache
Maltese: Disturbi fis-sistema nervuża Komuni ħafna newropatija periferalil, sturdament, uġigħ ta' ras
English: Table 8: Intravenous treatment regimens (IMpower130) Treatment
Maltese: Tabella 8: Korsijiet ta' trattament fil-vini (IMpower130)
English: Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
Maltese: Tecentriq, flimkien ma' bevacizumab, paclitaxel u carboplatin, huwa indikat għat-trattament tal-ewwel għażla ta' pazjenti adulti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun (NSCLC - non small cell lung cancer) metastatiku u mhux skwamuż.
English: A phase III, open-label, multi-center, international, randomised study, (IMvigor211), was conducted to evaluate the efficacy and safety of atezolizumab compared with chemotherapy (investigator's choice of vinflunine, docetaxel, or paclitaxel) in patients with locally advanced or metastatic UC who progressed during or following a platinum-containing regimen.
Maltese: III, open-label, b'aktar minn ċentru wieħed, internazzjonali u randomised, (IMvigor211), twettaq biex jiġu evalwati l-effikaċja u s-sigurtà ta' atezolizumab imqabbla ma' kimoterapija (għażla tal-investigatur ta' vinflunine, docetaxel, jew paclitaxel) f'pazjenti b'UC lokalment avvanzata jew metastatika li kellhom progressjoni waqt jew wara kors li kien fih il-platinum.
English: Tecentriq works by attaching to a specific protein in your body called programmed death-ligand 1 (PD-L1).
Maltese: Tecentriq jaħdem billi jeħel ma' proteina speċifika fil-ġisem tiegħek imsejħa death-ligand 1 ipprogrammat (PD-L1 - programmed death-ligand 1).
English: In study IMpower150, age ≥ 65 was associated with a diminished effect of atezolizumab in patients receiving atezolizumab in combination with carboplatin and paclitaxel.
Maltese: Fl-istudju IMpower150, età ta' ≥ 65 kienet assoċjata ma' tnaqqis fl-effett ta' atezolizumab f'pazjenti li kienu qed jirċievu atezolizumab flimkien ma' carboplatin u paclitaxel.
English: Hepatitis occurred in 2.0% (62/3,178) of patients who received atezolizumab monotherapy.
Maltese: Epatite seħħet fi 2.0% (62/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: A population pharmacokinetic analysis indicates that the clearance of atezolizumab is 0.200 L/day and the typical terminal elimination half-life is 27 days.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tindika li t-tneħħija ta' atezolizumab hija 0.200
English: Based on an independent Data Monitoring Committee (iDMC) recommendation following an early review of survival data, accrual of patients on the atezolizumab monotherapy treatment arm whose tumours have a low PD-L1 expression (less than 5% of immune cells staining positive for PD-L1 by immunohistochemistry) was stopped after observing decreased overall survival for this subgroup.
Maltese: Abbażi ta' rakkomandazzjoni minn Kumitat għall-Monitoraġġ tad-Data indipendenti (iDMCindependent Data Monitoring Committee) wara analiżi bikrija tad-data tas-sopravivenza, iż-żieda ta' pazjenti fil-grupp ta' trattament b'monoterapija ta' atezolizumab li t-tumuri tagħhom għandhom espressjoni baxxa ta' PD-L1 (inqas minn 5% taċ-ċelluli immuni li jieħdu kulur li juri li huma pożittivi għal PD-L1 permezz ta' immunoistokimika) twaqqfet wara li ġie osservat tnaqqis fis-sopravivenza globali għal dan is-sottogrupp.
English: Secondary efficacy endpoints included objective response rate (ORR) and duration of response (DOR) per RECIST v1.1.
Maltese: Il-punti finali sekondarji tal-effikaċja kienu jinkludu rata ta' rispons oġġettiv (ORR - objective response rate) u tul tar-rispons (DORduration of response) skont RECIST v1.1.
English: Pneumonitis led to discontinuation of atezolizumab in 12 (0.4%) patients.
Maltese: Pulmonite wasslet għal twaqqif ta' atezolizumab fi 12-il (0.4%) pazjent.
English: At the time of the updated OS analysis, an exploratory PFS analysis was performed as presented in Table 6.
Maltese: Fiż-żmien tal-analiżi aġġornata ta' OS, analiżi esploratorja ta' PFS twettqet kif ippreżentat fit-Tabella 6.
English: Of the
Maltese: (CI ta'
English: CI = confidence interval; DOR = duration of response; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Maltese: PFS=progression-free survival (sopravivenza mingħajr progressjoni); RECIST=Response Evaluation Criteria in Solid Tumours (Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi) v1.1.; CI=confidence interval (intervall ta' kunfidenza); ORR=objective response rate (rata ta' rispons oġġettiv); DOR=duration of response (tul tarrispons);
English: The median age was 67 years (range: 31 to 88), and 77.1% of patients were male.
Maltese: L-età medjana kienet ta' 67 sena (medda: 31 sa 88), u 77.1% tal-pazjenti kienu rġiel.
English: CI = confidence interval; DOR=duration of response; IC = tumour-infiltrating immune cells; IRF = independent review facility; NE = not estimable; ORR = objective response rate; OS = overall survival;
Maltese: IC = ċelluli immuni li jinfiltraw it-tumur; IRF = faċilità ta' analiżi indipendenti; NE = ma jistax jiġi stmat;
English: Investigator-assessed DOR* (RECIST v1.1)
Maltese: DOR stmat mill-investigatur* (RECIST v1.1)
English: Hypothyroidism:
Maltese: Kodiċi ATC:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 mL vial of concentrate contains 840 mg of atezolizumab*.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' 14 mL ta' konċentrat fih 840 mg ta' atezolizumab*.
English: The baseline and prognostic disease characteristics of the IMvigor210 Cohort 1 study population were overall comparable to patients in the clinic who would be considered cisplatin ineligible but would be eligible for a carboplatin-based combination chemotherapy.
Maltese: Koorti 1 kienu globalment komparabbli għall-pazjenti fil-klinika li jiġu kkunsidrati mhux eliġibbli biex jirċievu cisplatin iżda li jkunu eliġibbli għal kimoterapija ta' kombinazzjoni bbażata fuq carboplatin.
English: The median time to onset was 7.7 months (range: 5.0 to 8.8 months).
Maltese: Iż-żmien medjan sal-bidu kien ta' 7.7 xhur (medda: 5.0 sa 8.8 xhur).
English: Refer to the full prescribing information for the combination product (see also section 5.1).
Maltese: Irreferi għall-informazzjoni sħiħa dwar il-preskrizzjoni għallprodott kombinat (ara wkoll sezzjoni 5.1).
English: PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Maltese: PFS = sopravivenza mingħajr progressjoni; RECIST = Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi v1.1.
English: Grade 4 Diarrhoea or Colitis (life threatening; urgent intervention indicated)
Maltese: Dijarea jew Kolite ta' Grad 4 (ta' periklu għall-ħajja; intervent urġenti indikat)
English: The median age was 73 years.
Maltese: L-età medjana kienet ta' 73 sena.
English: and PFS by PD-L1 expression are summarised in Figures 7 and 9, respectively.
Maltese: Ir-riżultati esploratorji ta' OS u PFS skont l-espressjoni ta' PD-L1 huma miġbura fil-qosor fil-Figuri 7 u 9, rispettivament.
English: Meningoencephalitis has been observed in clinical trials with atezolizumab (see section 4.8).
Maltese: Meningoenċefalite kienet osservata fi provi kliniċi b'atezolizumab (ara sezzjoni 4.8).
English: Colitis occurred in 1.1% (34/3,178) of patients who received atezolizumab monotherapy.
Maltese: Kolite seħħet f'1.1% (34/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: 95% CI Stratifiedǂ hazard ratio (95% CI)
Maltese: Proporzjon ta' periklu stratifikat (CI ta' 95%)
English: Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).
Maltese: Tecentriq, flimkien ma' nab-paclitaxel u carboplatin, huwa indikat għat-trattament tal-ewwel għażla ta' pazjenti adulti b'NSCLC metastatiku u mhux skwamuż li m'għandhomx NSCLC b'mutazzjoni ta' EGFR jew pożittiv għal ALK (ara sezzjoni 5.1).
English: and 0.82 for OS while in patients who had not received prior (neo)adjuvant treatment (n=127), the hazard ratio for PFS was 0.44 and 0.53 for OS.
Maltese: 82 għal OS filwaqt li f'pazjenti li ma kinux irċevew trattament (neo)awżiljarju minn qabel (n=127), il-proporzjon ta' periklu għal PFS kien ta' 0.44 u 0.53 għal OS.
English: Table 4: Summary of updated efficacy (IMvigor210 Cohort 1)
Maltese: Tabella 4: Sommarju tal-effikaċja aġġornata (IMvigor210
English: • Information that atezolizumab can cause serious side effects during or after treatment, that need to be treated right away
Maltese: • Informazzjoni li atezolizumab jista' jikkawża effetti sekondarji serji waqt jew wara t-trattament,
English: Kaplan-Meier curves for OS in the ITT population are presented in Figure 2.
Maltese: Kurvi Kaplan-Meier għal OS filpopolazzjoni ITT huma ppreżentati fil-Figura 2.
English: It belongs to a group of medicines called monoclonal antibodies.
Maltese: Din tagħmel parti minn grupp ta' mediċini msejħa antikorpi monoklonali.
English: CI = confidence interval; DOR = duration of response; NE = not estimable; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
Maltese: PFS=progression-free survival (sopravivenza mingħajr progressjoni); RECIST=Response Evaluation Criteria in Solid Tumours (Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi ) v1.1.; CI=confidence interval (intervall ta' kunfidenza); ORR=objective response rate (rata ta' rispons oġġettiv); DOR=duration of response (tul tar-rispons); OS=overall survival (sopravivenza globali), NE=not estimable (ma jistax jiġi stmat)
English: Median in months ***
Maltese: Medjan f'xhur ***
English: Investigator-assessed PFS (RECIST v1.1)
Maltese: PFS stmata mill-investigatur (RECIST v1.1)
English: Other medicines and Tecentriq
Maltese: Mediċini oħra u Tecentriq
English: A Phase I/III, randomised, multicentre, double-blind, placebo-controlled study, IMpower133, was conducted to evaluate the efficacy and safety of atezolizumab in combination with carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).
Maltese: Studju ta' Fażi I/III, randomised, b'aktar minn ċentru wieħed, double-blind u kkontrollat bil-plaċebo, IMpower133, twettaq biex jiġu evalwati l-effikaċja u s-sigurtà ta' atezolizumab flimkien ma' carboplatin u etoposide f'pazjenti b'kanċer taċ-ċelluli żgħar tal-pulmun fi stadju estensiv (ES-SCLCextensive-stage small cell lung cancer) li ma ngħatawx kimoterapija fil-passat.
English: For Grade 2 or Grade 3 hypophysitis, atezolizumab should be withheld and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started, and hormone replacement should be initiated as needed.
Maltese: Għal ipofisite ta' Grad 2 jew Grad 3, atezolizumab għandu jitwaqqaf u għandu jinbeda trattament b'kortikosterojdi fil-vini (1 sa 2 mg/kg/jum methylprednisolone jew ekwivalenti), u għandha tinbeda sostituzzjoni tal-ormoni kif meħtieġ.
English: Nab-paclitaxel (100 mg/m2)b,c + carboplatin (AUC 6)c
Maltese: Nab-paclitaxel (100 mg/m2)b,c
English: Myasthenia gravis occurred in < 0.1% (1/3,178) of patients who received atezolizumab monotherapy.
Maltese: Majastenja gravis seħħet f'< 0.1% (1/3,178) tal-pazjenti li kienu qed jirċievu atezolizumab bħala monoterapija.
English: The median time to onset 7.2 months (range: 24 days to 13.7 months).
Maltese: Iż-żmien medjan sal-bidu kien ta' 7.2 xhur (medda: 24 jum sa 13.7 xhur).
English: Hypophysitis occurred in 0.4% (2/473) of patients who received atezolizumab in combination with nab-paclitaxel and carboplatin.
Maltese: Ipofisite seħħet f'0.4% (2/473) tal-pazjenti li rċevew atezolizumab flimkien ma' nab-paclitaxel u carboplatin.
English: • 840 milligrams (mg) every two weeks, or
Maltese: • 840 milligramma (mg) kull ġimagħtejn, jew