FrancophonIA/ELRC3.0 huggingface dataset:
English: After dilution (see section 6.6), one mL of solution contains approximately 4.4 mg of atezolizumab.
Maltese: Wara d-dilwizzjoni (ara sezzjoni 6.6), mL wieħed ta' soluzzjoni fih madwar 4.4 mg ta' atezolizumab.
English: 2,759 patients across multiple tumour types.
Maltese: Is-sigurtà ta' atezolizumab mogħti flimkien ma' prodotti mediċinali oħra, ġiet evalwata f'2,759 pazjent b'tipi multipli ta' tumuri.
English: Tecentriq is an anti-cancer medicine that contains the active substance atezolizumab.
Maltese: Tecentriq huwa mediċina kontra l-kanċer li fih is-sustanza attiva atezolizumab.
English: Includes reports of diabetes mellitus, type 1 diabetes mellitus, diabetic ketoacidosis, ketoacidosis.
Maltese: i Tinkludi rapporti ta' dijabete mellitus, dijabete mellitus tip 1, ketoaċidożi dijabetika, ketoaċidożi.
English: Pancreatitis, including amylase increased and lipase increased, occurred in 0.6% (18/3,178) of patients who received atezolizumab monotherapy.
Maltese: Pankreatite, inkluż żieda ta' amylase u żieda ta' lipase, seħħet f'0.6% (18/3,178) tal-pazjenti li rċevew atezolizumab bħala monoterapija.
English: Grade 3 and 4
Maltese: Grad 3 u 4
English: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin should be monitored prior to initiation of treatment, periodically during treatment with atezolizumab and as indicated based on clinical evaluation.
Maltese: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) u bilirubina għandhom jiġu mmonitorjati qabel jinbeda t-trattament, kull tant żmien waqt it-trattament b'atezolizumab u kif indikat abbażi tal-evalwazzjoni klinika.
English: Other clinically significant adverse events which were observed more frequently in the atezolizumab, bevacizumab, paclitaxel, and carboplatin arm were epistaxis, haemoptysis, cerebrovascular accident, including fatal events.
Maltese: Avvenimenti avversi klinikament sinifikanti oħra li ġew osservati b'mod aktar frekwenti fil-grupp ta' atezolizumab, bevacizumab, paclitaxel, u carboplatin kienu epistassi, emoptisi, inċident ċerebrovaskulari, inklużi avvenimenti fatali.
English: Treatment with atezolizumab until loss of clinical benefit was permitted as defined by the following criteria:
Maltese: Trattament b'atezolizumab sa telf tal-benefiċċju kliniku kien permess kif definit mill-kriterji li ġejjin:
English: Arm A Atezolizumab + nab-paclitaxel + carboplatin
Maltese: Grupp A Atezolizumab + nab-paclitaxel + carboplatin
English: The confirmed ORR per investigator-assessed mRECIST was 29.0% (95% CI: 20.4, 38.9) in patients with PD-L1 expression ≥ 5%, 23.7% (95% CI: 18.1, 30.1) in patients with PD-L1 expression ≥ 1%, and 19.7% (95% CI: 15.4, 24.6) in all comers.
Maltese: L-ORR ikkonfermata skont mRECIST stmati mill-investigatur kienet ta' 29.0% (CI ta' 95%: 20.4, 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: A total of 287 patients were randomised 1:1 to receive either atezolizumab (1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit) or docetaxel (75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression).
Maltese: Total ta' 287 pazjent kienu randomised 1:1 biex jirċievu atezolizumab (1,200 mg permezz ta' infużjoni fil-vini kull 3 ġimgħat sa telf tal-benefiċċju kliniku) jew docetaxel (75 mg/m permezz ta' infużjoni fil-vini f'jum 1 ta' kull ċiklu ta' 21 jum sal-progressjoni tal-marda).
English: Per second interim analysis for OS and exploratory PFS analysis at clinical cut off January 2
Maltese: Skont it-tieni analiżi interim għal OS u analiżi esploratorja għal PFS fiż-żmien tal-waqfien kliniku fit-2 ta'
English: • who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).
Maltese: • li huma kkunsidrati mhux eliġibbli biex jirċievu cisplatin, u li t-tumuri tagħhom għandhom espressjoni ta' PD-L1 ta' ≥ 5% (ara sezzjoni 5.1).
English: Median OS for all patient subgroups (PD-L1 expression ≥ 5 % and ≥ 1 %) and in all comers was 10.6 months.
Maltese: OS medjana għassottogruppi kollha tal-pazjent (espressjoni ta' PD-L1 ta' ≥ 5 % u ≥ 1 %) u fil-pazjenti kollha rreġistrati kienet ta' 10.6 xhur.
English: Hepatitis led to discontinuation of atezolizumab in 6 (< 0.2%) patients.
Maltese: Epatite wasslet għal twaqqif ta' atezolizumab f'6 (< 0.2%) pazjenti.
English: • After dilution, one mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose.
Maltese: • Wara d-dilwizzjoni, millilitru wieħed ta' soluzzjoni fih madwar 3.2 mg ta' atezolizumab għal doża ta' 840 mg u 6.0 mg ta' atezolizumab għal doża ta' 1,680 mg.
English: After dilution, one mL of solution should contain approximately 3.2 mg of Tecentriq (840 mg/264 mL).
Maltese: Wara d-dilwizzjoni, mL wieħed ta' soluzzjoni għandu jkun fih bejn wieħed u ieħor 3.2 mg ta' Tecentriq (840 mg/264 mL).
English: Arm C (Bevacizumab + Paclitaxel + Carboplatin)
Maltese: Grupp C (Bevacizumab + Paclitaxel + Carboplatin)
English: Paclitaxel was administered 175 mg/m2 by intravenous infusion over 3 hours on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Maltese: Paclitaxel ingħata bħala 175 mg/m permezz ta' infużjoni fil-vini fuq 3 sigħat f'Jum 1 ta' kull ċiklu ta' 21 jum sal-progressjoni tal-marda jew sa tossiċità mhux aċċettabbli.
English: Atezolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reactions, except for endocrinopathies that are controlled with replacement hormones (see sections 4.2 and 4.8).
Maltese: Atezolizumab għandu jitwaqqaf b'mod permanenti għal kwalunkwe reazzjoni avversa relatata malimmunità ta' Grad 3 li terġa' sseħħ u għal kwalunkwe reazzjoni avversa relatata mal-immunità ta' Grad 4, minbarra għal endokrinopatiji li huma kkontrollati b'ormoni ta' sostituzzjoni (ara sezzjonijiet 4.2 u 4.8).
English: Arm B (Atezolizumab + Bevacizumab + Paclitaxel + Carboplatin)
Maltese: Grupp B (Atezolizumab + Bevacizumab + Paclitaxel + Carboplatin)
English: Infusion-related reactions have been observed with atezolizumab (see section 4.8).
Maltese: Reazzjonijiet relatati mal-infużjoni ġew osservati b'atezolizumab (ara sezzjoni 4.8).
English: Tecentriq has not been studied in patients with moderate or severe hepatic impairment (see section 5.2).
Maltese: Tecentriq ma ġiex studjat f'pazjenti b'indeboliment moderat jew sever tal-fwied (ara sezzjoni 5.2).
English: Figure 3: Forest plot of overall survival by PD-L1 expression in the primary analysis population (OAK)
Maltese: Figura 3: Forest plot tas-sopravivenza globali skont l-espressjoni ta' PD-L1 fil-popolazzjoni talanaliżi primarja (OAK)
English: For each 21-day cycle, Tecentriq, nab-paclitaxel, and carboplatin are administered on day 1.
Maltese: Għal kull ċiklu ta' 21 jum, Tecentriq, nab-paclitaxel, u carboplatin jingħataw fil-jum 1.
English: Updated PFS results are also presented in Figures 4 and 5.
Maltese: Riżultati aġġornati tal-PFS huma ppreżentati wkoll fil-Figuri 4 u 5.
English: • blood tests showing low levels of potassium (hypokalaemia) or sodium (hyponatremia)
Maltese: • testijiet tad-demm li juru livelli baxxi ta' potassium (ipokalimja) jew ta' sodium (iponatrimija)
English: The initial dose of Tecentriq must be administered over 60 minutes.
Maltese: Id-doża inizjali ta' Tecentriq għandha tingħata fuq medda ta' 60 minuta.
English: The safety of atezolizumab as monotherapy is based on pooled data in 3,178 patients across multiple tumour types.
Maltese: Is-sigurtà ta' atezolizumab bħala monoterapija hija bbażata fuq data miġbura minn 3,178 pazjent b'tipi multipli ta' tumuri.
English: The majority of the patients were male (59%) and white (90%).
Maltese: Il-maġġoranza tal-pazjenti kienu rġiel (59%) u bojod (90%).
English: 12-month PFS (%)
Maltese: PFS ta' 6 xhur (%)
English: Figure 5: Forest plot of progression free survival by PD-L1 expression in the ITT population, Arm B vs. C (IMpower150)
Maltese: Forest plot ta' sopravivenza mingħajr progressjoni skont l-espressjoni ta' PD-L1 filpopolazzjoni ITT, Grupp B vs. C (IMpower150)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One 20 mL vial of concentrate contains 1,200 mg atezolizumab*.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' 20 mL ta' konċentrat fih 1,200 mg atezolizumab*.
English: The study enrolled a total of 438 patients and had two patient cohorts.
Maltese: L-istudju rreġistra total ta' 438 pazjent u kellu żewġ koorti ta' pazjenti.
English: 31 July 2021
Maltese: Jannar 2019
English: Patients were staged according to the American Joint Committee on Cancer (AJCC) 7th edition.
Maltese: Il-pazjenti ġew allokati stadju skont is-7 edizzjoni tal-Kumitat Amerikan Konġunt għall-Kanċer (AJCC - American Joint Committee on Cancer).
English: Roche a/s c/o Icepharma hf
Maltese: Roche a/s c/o Icepharma hf Sími: +354 540 8000
English: 6-month OS (%) 12-month OS (%)
Maltese: OS ta' 6 xhur (%) OS ta' 12-il xahar (%)
English: There was no evidence of efficacy in patients with asymptomatic brain metastases at baseline, although the number of patients treated was small; the median PFS was 2.2 months in the atezolizumab plus nab-paclitaxel arm (n=15) compared to 5.6 months in the placebo plus nabpaclitaxel arm (n=11) (HR 1.40; 95% CI 0.57, 3.44).
Maltese: Ma kienx hemm evidenza ta' effikaċja f'pazjenti b'metastasi asintomatika fil-moħħ fil-linja bażi, għalkemm in-numru ta' pazjenti ttrattati kien żgħir; il-PFS medjana kienet ta' 2.2 xhur fil-grupp ta' atezolizumab flimkien ma' nab-paclitaxel (n=15) meta mqabbla ma' 5.6 xhur fil-grupp ta' plaċebo flimkien ma' nab-paclitaxel (n=11) (HR 1.40; CI ta' 95% 0.57, 3.44).
English: Figure 4: Kaplan-Meier Curve for Progression Free Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
Maltese: Kaplan-Meier għas-Sopravivenza Mingħajr Progressjoni f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1% (IMpassion130)
English: The co-primary efficacy endpoints included investigator-assessed progression free survival (PFS) in the ITT population and in patients with PD-L1 expression ≥ 1% per RECIST v1.1 as well as overall survival (OS) in the ITT population and in patients with PD-L1 expression ≥ 1%.
Maltese: ITT u f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1% skont RECIST v1.1 kif ukoll sopravivenza globali (OS - overall survival) filpopolazzjoni ITT u f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1%.
English: Bevacizumabd (15 mg/kg) + paclitaxel
Maltese: Bevacizumabd (15 mg/kg) + paclitaxel (200 mg/m2)b,c
English: The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of atezolizumab, including immunerelated pneumonitis, hepatitis, colitis, hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, neuropathies, meningoencephalitis, pancreatitis, and infusion related reactions, and how to manage them.
Maltese: Il-programm edukattiv huwa mmirat biex iżid l-għarfien u jipprovdi informazzjoni dwar is-sinjali u ssintomi ta' ċerti riskji identifikati importanti ta' atezolizumab, inklużi pulmonite, epatite, kolite, ipotirojdiżmu, ipertirojdiżmu, insuffiċjenza adrenali, ipofisite, dijabete mellitus tat-tip 1, newropatiji, meningoenċefalite, pankreatite relatati mal-immunità, u reazzjonijiet relatati mal-infużjoni, u kif għandhom jiġu mmaniġġjati.
English: This medicine should not be given to children or adolescents below 18 years of age.
Maltese: Din il-mediċina m'għandhiex tingħata lil tfal jew adolexxenti ta' età inqas minn 18-il sena.
English: Withhold Tecentriq
Maltese: Kif jaħdem Tecentriq
English: Stratified hazard ratio‡ (95% CI) p-value
Maltese: Proporzjon ta' periklu stratifikatǂ (CI ta' 95%) Valur p**
English: Treatment with atezolizumab should be withheld for ≥ Grade 3 serum amylase or lipase levels increased (> 2 x ULN), or Grade 2 or 3 pancreatitis, and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf għal żieda tal-livelli ta' amylase jew lipase fis-serum għal ≥ Grad 3 (> 2 x ULN), jew pankreatite ta' Grad 2 jew 3, u għandu jinbeda trattament b'kortikosterojdi fil-vini (1 sa 2 mg/kg/jum ta' methylprednisolone jew ekwivalenti).
English: Secondary efficacy endpoints evaluated per investigator-assessed Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 are objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR).
Maltese: Il-punti finali sekondarji evalwati skont Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST - Response Evaluation Criteria in Solid Tumours) v1.1 stmati mill-investigatur huma rata ta' rispons oġġettiv (ORR - objective response rate), sopravivenza mingħajr progressjoni (PFS - progression-free survival), u tul tar-rispons (DOR - duration of response).
English: Arm A (Atezolizumab + Paclitaxel + Carboplatin)
Maltese: Grupp A (Atezolizumab + Paclitaxel + Carboplatin)
English: Figure 5: Kaplan-Meier Curve for Overall Survival in patients with PD-L1 expression ≥ 1% (IMpassion130)
Maltese: Kaplan-Meier għas-Sopravivenza Globali f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1% (IMpassion130)
English: Tel: + 372 - 6 177 380
Maltese: Roche Eesti OÜ Tel: + 372 - 6 177 380
English: In addition, nab-paclitaxel is administered on days 8 and 15.
Maltese: Barra minn hekk, nab-paclitaxel jingħata fil-jiem 8 u 15.
English: Secondary endpoints Investigator-assessed PFS (RECIST v1.1)
Maltese: Punti finali sekondarji PFS stmata mill-investigatur (RECIST v1.1)
English: Figure 6: Kaplan-Meier curves for overall survival (IMpower130)
Maltese: Kaplan-Meier għas-sopravivenza globali (IMpower130)
English: The key results are summarised in Table 9 and Kaplan-Meier curves for OS and PFS are presented in Figures 6 and 8, respectively.
Maltese: Ir-riżultati ewlenin huma mogħtija fil-qosor fit-Tabella 9 u l-kurvi Kaplan-Meier għal OS u PFS huma ppreżentati fil-Figuri 6 u 8, rispettivament.
English: Arm B in the ITT population (IMpower150)
Maltese: ITT (IMpower150)
English: Uncommon myositisy Renal and urinary disorders Common proteinuriaz
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Komuni proteinurja z
English: Physicians should carefully consider the combined risks of the four-drug regimen of atezolizumab bevacizumab, paclitaxel, and carboplatin before initiating treatment (see section 4.8).
Maltese: It-tobba għandhom jikkunsidraw bir-reqqa r-riskji kkombinati tal-kors ta' erba' mediċini ta' atezolizumab, bevacizumab, paclitaxel, u carboplatin qabel ma jibdew it-trattament (ara sezzjoni 4.8).
English: Tel: +370 5 2546799
Maltese: UAB “Roche Lietuva” Tel: +370 5 2546799
English: Common hypokalaemia, hyponatraemia, hyperglycaemia hypokalaemia, hyponatraemia, hypomagnesaemia
Maltese: Komuni ipokalimja, iponatrimija, ipergliċemija ipokalimja, iponatrimija, ipomanjesimja
English: Figure 2: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK)
Maltese: Kaplan-Meier għas-sopravivenza globali fil-popolazzjoni tal-analiżi primarja (il-pazjenti kollha rreġistrati) (OAK)
English: IMvigor210 (GO29293): Single-arm trial in previously untreated urothelial carcinoma patients who are ineligible for cisplatin therapy and in urothelial carcinoma patients previously treated with chemotherapy
Maltese: IMvigor210 (GO29293): Prova bi grupp wieħed f'pazjenti b'karċinoma tal-epitelju tal-apparat urinarju li ma kinux ittrattati fil-passat li mhumiex eliġibbli għal terapija b'cisplatin u f'pazjenti b'karċinoma tal-epitelju tal-apparat urinarju li fil-passat kienu ttrattati b'kimoterapija
English: No fertility studies have been conducted with atezolizumab; however assessment of the cynomolgus monkey male and female reproductive organs was included in the chronic toxicity study.
Maltese: Ma twettqux studji dwar il-fertilità b'atezolizumab; madankollu, valutazzjoni ta' organi riproduttivi ta' xadini cynomolgus irġiel u nisa kienet inkluża fl-istudju dwar tossiċità kronika.
English: Exposure to atezolizumab increased dose proportionally over the dose range 1 mg/kg to 20 mg/kg including the fixed dose 1,200 mg administered every 3 weeks.
Maltese: Esponiment għal atezolizumab żdied b'mod proporzjonali mad-doża fuq il-firxa tad-doża minn 1 mg/kg sa 20 mg/kg inkluż id-doża fissa ta' 1,200 mg mogħtija kull 3 ġimgħat.
English: OAK (GO28915): Randomised phase III trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
Maltese: OAK (GO28915): Prova randomised ta' fażi
English: Kaplan-Meier curves for OS in the ITT population are presented in Figure 10.
Maltese: Kurvi Kaplan-Meier għal OS filpopolazzjoni ITT huma ppreżentati fil-Figura 10.
English: In studies IMpower150 and IMpower133, data for patients ≥75 years of age are too limited to draw conclusions on this population.
Maltese: Fl-istudji IMpower150 u IMpower133, id-data għall-pazjenti b'età ta' ≥75 sena hija wisq limitata biex jinsiltu konklużjonijiet dwar din il-popolazzjoni.
English: Unopened vial
Maltese: Kollha Rreġistrati
English: ORR (IRF-assessed; RECIST v1.1)
Maltese: ORR (stmata minn IRF; RECIST v1.1)
English: paclitaxel and carboplatin.
Maltese: + carboplatin
English: 22 months showed a median OS of 12.6 months in patients treated with atezolizumab, vs. 9.7 months in patients treated with docetaxel (HR of 0.69, 95% CI: 0.52, 0.92).
Maltese: Analiżi aġġornata b'total ta' 200 mewt osservati u segwitu medjan ta' sopravivenza ta' 22 xahar uriet OS medjana ta' 12.6 xhur f'pazjenti ttrattati b'atezolizumab, vs. 9.7 xhur f'pazjenti ttrattati b'docetaxel (HR ta' 0.69, CI ta' 95%: 0.52, 0.92).
English: p-value1
Maltese: valur p1,2
English: A phase II, multi-centre, international, randomised, open-label, controlled study, POPLAR, was conducted in patients with locally advanced or metastatic NSCLC who progressed during or following a platinum-containing regimen, regardless of PD-L1 expression.
Maltese: II, b'aktar minn ċentru wieħed, internazzjonali, randomised, open-label, POPLAR, twettaq f'pazjenti b'NSCLC avvanzat lokalment jew metastatiku li kellhom progressjoni matul jew wara kors li fih platinum, irrispettivament mill-espressjoni ta' PD-L1.
English: For the recommended dose of 840 mg: fourteen mL of Tecentriq concentrate should be withdrawn from the vial and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Għad-doża rakkomandata ta' 840 mg: għandhom jinġibdu erbatax-il mL ta' konċentrat ta' Tecentriq mill-kunjett u dawn għandhom jiġu dilwiti f'borża tal-infużjoni ta' 250 mL tal-polyvinyl chloride (PVC), tal-polyolefin (PO), tal-polyethylene (PE), jew tal-polypropylene (PP) li fiha soluzzjoni għallinjezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: u Includes reports of autoimmune pancreatitis, pancreatitis, pancreatitis acute, lipase increased, amylase increased.
Maltese: u Tinkludi rapporti ta' pankreatite awtoimmuni, pankreatite, pankreatite akuta, żieda fil-lipase, żieda fl-amylase.
English: l Includes reports of neuropathy peripheral, autoimmune neuropathy, peripheral sensory neuropathy, polyneuropathy, herpes zoster, peripheral motor neuropathy, neuralgic amyotrophy, peripheral sensorimotor neuropathy, toxic neuropathy, axonal neuropathy, lumbosacral plexopathy, neuropathic arthropathy, peripheral nerve infection.
Maltese: Tinkludi rapporti ta' newropatija periferali, newropatija awtoimmuni, newropatija sensorja periferali, polinewropatija, herpes zoster, newropatija motorja periferali, amjotrofija newralġika, newropatija sensorjamotorja periferali, newropatija tossika, newropatija assonali, plessopatija lumbosakrali, artropatija newropatika, infezzjoni fin-nerv periferali.
English: Age was not identified as a significant covariate influencing atezolizumab pharmacokinetics based on patients of age range of 21-89 years (n=472), and median of 62 years of age.
Maltese: L-età ma kienitx identifikata bħala kovarjat sinifikanti li jinfluwenza l-farmakokinetika ta' atezolizumab abbażi ta' pazjenti b'firxa ta' età ta' 21-89 sena (n=472), u medjan ta' età ta' 62 sena.
English: Tecentriq used in combination with anticancer medicines The following side effects have been reported in clinical trials when Tecentriq is given in combination with anticancer medicines:
Maltese: Tecentriq użat flimkien ma' mediċini kontra l-kanċer L-effetti sekondarji li ġejjin kienu rrappurtati fi provi kliniċi meta Tecentriq jingħata flimkien ma' mediċini kontra l-kanċer:
English: Most patients were women (99.6%), 67.5% were white and 17.8% Asian.
Maltese: Il-biċċa l-kbira tal-pazjenti kienu nisa (99.6%), 67.5% kienu bojod u 17.8% Asjatiċi.
English: For symptomatic adrenal insufficiency, atezolizumab should be withheld and treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Maltese: Għal insuffiċjenza adrenali sintomatika, atezolizumab għandu jitwaqqaf u għandu jinbeda trattament b'kortikosterojdi fil-vini (1 sa 2 mg/kg/jum ta' methylprednisolone jew ekwivalenti).
English: Treatment with atezolizumab should be withheld for Grade 2 or 3 myositis and corticosteroid therapy (1-2 mg/kg/day prednisone or equivalent) should be initiated.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf għal mijosite ta' Grad 2 jew 3 u għandha tinbeda terapija b'kortikosterojdi (1-2 mg/kg/jum ta' prednisone jew ekwivalenti).
English: ORR was 15.3% vs. 14.7% and median DOR was 18.6 months vs. 7.2 months for atezolizumab vs. docetaxel, respectively.
Maltese: 3% vs. 14.7% u DOR medjan kien ta' 18.6 xhur vs.
English: The effect of age on the pharmacokinetics of atezolizumab was assessed in a population pharmacokinetic analysis.
Maltese: L-effett tal-età fuq il-farmakokinetika ta' atezolizumab kien evalwat f'analiżi farmakokinetika tal-popolazzjoni.
English: Hypophysitis occurred in 0.8% (3/393) of patients who received atezolizumab with bevacizumab, paclitaxel, and carboplatin.
Maltese: Ipofisite seħħet f'0.8% (3/393) tal-pazjenti li rċevew atezolizumab ma' bevacizumab, paclitaxel, u carboplatin.
English: DOR (IRF-assessed; RECIST v1.1)
Maltese: DOR (stmat minn IRF; RECIST v1.1)
English: IMpassion130 (WO29522): Randomised phase III trial in locally advanced or metastatic TNBC patients previously untreated for metastatic disease
Maltese: IMpassion130 (WO29522): Prova randomised ta' fażi
English: Treatment may be resumed when the event is resolved
Maltese: Probabilità ta' sopravivenza
English: Immune-Related Endocrinopathies (Type 1 Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Adrenal Insufficiency and Hypophysitis) Immune-Related Neuropathies (Guillain-Barre Syndrome, Myasthenic Syndrome / Myasthenia Gravis) Immune-Related Meningoencephalitis Immune-Related Myocarditis Immune-Related Nephritis Immune-Related Myositis Infusion-Related Reactions
Maltese: - Epatite Relatata mal-Immunità - Pulmonite Relatata mal-Immunità - Kolite Relatata mal-Immunità - Pankreatite Relatata mal-Immunità - Endokrinopatiji Relatati mal-Immunità (Dijabete Mellitus tat-Tip 1, Ipotirojdiżmu, Ipertirojdiżmu, Insuffiċjenza Adrenali u Ipofisite) - Newropatiji Relatati mal-Immunità (Sindrome ta' Guillain-Barre, Sindrome Majastenika/Majastenja Gravis) Meningoenċefalite Relatata mal-Immunità Mijokardite Relatata mal-Immunità Nefrite Relatata mal-Immunità Mijosite Relatata mal-Immunità Reazzjonijiet Relatati mal-Infużjoni - Deskrizzjoni tas-sinjali u tas-sintomi tar-reazzjonijiet avversi relatati mal-immunità.
English: Guillain-Barré syndrome and demyelinating polyneuropathy occurred in 0.2% (5/3,178) of patients who received atezolizumab monotherapy.
Maltese: Is-sindrome ta' Guillain-Barré u polinewropatija bi ħsara fil-majlin seħħew f'0.2% (5/3,178) talpazjenti li rċevew atezolizumab bħala monoterapija.
English: Rare myasthenic syndrome o
Maltese: Rari sindrome majastenikao
English: The time to onset was 18 and 33 days.
Maltese: Iż-żmien biex tibda kien ta' 18 u 33 jum.