FrancophonIA/ELRC3.0 huggingface dataset:
English: QLQ-LC13 was observed with atezolizumab compared to docetaxel (HR of 0.71, 95% CI: 0.49, 1.05;
Maltese: Iż-żmien medjan sal-bidu kien ta' 13.1 xhur (medda: 9.0 sa 17.5 xhur).
English: • inflammation of the heart muscle (myocarditis): symptoms may include shortness of breath, decreased exercise tolerance, feeling tired, chest pain, swelling of the ankles or legs, irregular heartbeat, and fainting
Maltese: • infjammazzjoni tal-muskolu tal-qalb (mijokardite): sintomi jistgħu jinkludu qtugħ ta' nifs, tnaqqis fit-tolleranza tal-eżerċizzju, tħossok għajjien, uġigħ fis-sider, nefħa fl-għekiesi jew fissaqajn, taħbit tal-qalb irregolari, u ħass ħażin
English: Secondary and exploratory endpoints Investigator-assessed ORR (RECIST 1.1)
Maltese: ORR stmata mill-investigatur (RECIST 1.1)
English: Table 5: Summary of efficacy in the primary analysis population (all comers)* (OAK)
Maltese: Sommarju tal-effikaċja fil-popolazzjoni tal-analiżi primarja (il-pazjenti kollha rreġistrati)* (OAK)
English: PFS, ORR and DOR results of IMpassion130 for patients with PD-L1 expression ≥ 1% at the time of the final analysis for PFS with a median survival follow up of 13 months are summarized in Table 6 with Kaplan-Meier curves for PFS in Figure 4.
Maltese: Ir-riżultati ta' PFS, ORR u DOR ta' IMpassion130 għal pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1% fiżżmien tal-analiżi finali għal PFS b'segwitu medjan tas-sopravivenza ta' 13-il xahar huma mogħtija filqosor fit-Tabella 6 b'kurvi
English: Treatment with intravenous corticosteroids (1 to 2 mg/kg/day methylprednisolone or equivalent) should be started.
Maltese: Għandu jinbeda trattament b'kortikosterojdi fil-vini (1 sa 2 mg/kg/jum ta' methylprednisolone jew ekwivalenti).
English: After dilution (see section 6.6), one mL of solution contains approximately 3.2 mg of atezolizumab for the 840 mg dose and approximately 6.0 mg of atezolizumab for the 1680 mg dose.
Maltese: Wara d-dilwizzjoni (ara sezzjoni 6.6), mL wieħed ta' soluzzjoni fih madwar 3.2 mg ta' atezolizumab għad-doża ta' 840 mg u madwar 6.0 mg ta' atezolizumab għad-doża ta' 1,680 mg. *Atezolizumab huwa antikorp monoklonali
English: • constipation
Maltese: Nefrite
English: Cases of pneumonitis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8).
Maltese: Każijiet ta' pulmonite, inklużi każijiet fatali, kienu osservati fi provi kliniċi b'atezolizumab (ara sezzjoni 4.8).
English: Tecentriq is a concentrate for solution for infusion.
Maltese: Tecentriq huwa konċentrat għal soluzzjoni għall-infużjoni.
English: Median duration of PFS (months)
Maltese: Tul medjan ta' PFS (xhur)
English: Uncommon hyperthyroidismh, diabetes mellitusi, adrenal insufficiencyj
Maltese: Mhux komuni ipertirojdiżmu h, dijabete mellitusi, insuffiċjenza adrenali j
English: Withhold until adverse reactions recovers to Grade 0-1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Maltese: Waqqaf sakemm ir-reazzjonijiet avversi jitjiebu għal Grad 0 jew Grad 1 fi żmien 12-il ġimgħa u l-kortikosterojdi jkunu tnaqqsu għal ≤ 10 mg prednisone jew ekwivalenti kuljum.
English: • you are allergic to atezolizumab or any of the other ingredients of this medicine (listed in section 6).
Maltese: • inti allerġiku għal atezolizumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: For ≥ Grade 3 hyperglycaemia (fasting glucose > 250 mg/dL or 13.9 mmol/L), atezolizumab should be withheld.
Maltese: Għal ipergliċemija ta' ≥ Grad 3 (livell ta' glucose meta l-pazjent ikun sajjem > 250 sa 500 mg/dL), atezolizumab għandu jitwaqqaf.
English: Tel: +49 (0) 7624 140
Maltese: Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
English: • urinary tract infection
Maltese: Disturbi gastro-intestinali
English: The PFS, ORR and DOR results from the primary analysis as well as the exploratory OS final analysis results are summarized in Table 12.
Maltese: Ir-riżultati ta' PFS, ORR u DOR mill-analiżi primarja kif ukoll mill-analiżi finali esploratorja ta' OS huma miġbura fil-qosor fit-Tabella 12.
English: The demographics and baseline disease characteristics of the study population defined as ITT-WT (n=679) were well balanced between the treatment arms.
Maltese: Il-karatteristiċi demografiċi u tal-marda fil-linja bażi tal-popolazzjoni tal-istudju ddefinita bħala ITTWT (n=679) kienu bbilanċjati tajjeb bejn il-gruppi ta' trattament.
English: Cases of myositis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8).
Maltese: Każijiet ta' mijosite, inklużi każijiet fatali, ġew osservati fi provi kliniċi b'atezolizumab (ara sezzjoni 4.8).
English: Approximately three-quarters of patients had non-squamous histology (74%), 10% had known EGFR mutation, 0.2% had known ALK rearrangements, 10% had CNS metastases at baseline, and most patients were current or previous smokers (82%).
Maltese: Madwar tliet kwarti tal-pazjenti kellhom istoloġija mhux skwamuża (74%), 10% kellhom mutazzjoni magħrufa ta' EGFR, 0.2% kellhom arranġamenti mill-ġdid magħrufa ta' ALK, 10% kellhom metastasi fis-CNS fillinja bażi, u l-biċċa l-kbira tal-pazjenti kienu jpejpu attwalment jew qabel (82%).
English: Pancreatitis requiring the use of corticosteroids occurred in 0.1% (4/3,178) of patients receiving atezolizumab monotherapy.
Maltese: Pankreatite li teħtieġ l-użu ta' kortikosterojdi seħħet f' 0.1% (4/3,178) tal-pazjenti li kienu qed jirċievu atezolizumab bħala monoterapija.
English: The median time to onset was 3.6 months (range 3 days to 9.9 months).
Maltese: Iżżmien medjan sal-bidu kien ta' 3.6 xhur (medda minn 3 ijiem sa 9.9 xhur).
English: Grade 2 or Grade 3
Maltese: Grad 2 jew 3
English: Symptomatic Colitis
Maltese: Kull Gradi
English: Grade 3 or 4 serum amylase or lipase levels increased (> 2 x ULN) or Grade 2 or 3 pancreatitis
Maltese: Żieda tal-livelli ta' amylase jew lipase fis-serum għal Grad 3 jew 4 (> 2 x ULN) jew pankreatite ta' Grad 2 jew 3
English: Treatment with atezolizumab should be withheld for Grade 2 pneumonitis, and 1 to 2 mg/kg/day prednisone or equivalent should be started.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf għal pulmonite ta' Grad 2, u għandu jinbeda 1 sa 2 mg/kg/jum prednisone jew ekwivalenti.
English: The median duration was 1.4 months (range 0 day to 21.2+ months; + denotes a censored value).
Maltese: It-tul ta' żmien medjan kien ta' 1.4 xhur (medda minn 0 jiem sa 21.2+ xhur; + jindika valur iċċensurat).
English: Patients were excluded if they had history of autoimmune disease, administration of a live, attenuated vaccine within 28 days prior to randomisation, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to randomisation, active or untreated CNS metastases, clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions, as seen on imaging.
Maltese: Dan l-istudju eskluda pazjenti li kellhom storja ta' mard awtoimmuni; metastasi tal-moħħ attiv jew dipendenti fuq il-kortikosterojdi; għoti ta' vaċċin ħaj u attenwat fi żmien 28 jum qabel irreġistrazzjoni; u għoti ta' sustanzi immunostimulatorji sistemiċi fi żmien 4 ġimgħat jew prodott mediċinali immunosoppressiv sistemiku fi żmien ġimagħtejn qabel ir-reġistrazzjoni.
English: Isolated hypothyroidism may be managed with replacement therapy and without corticosteroids.
Maltese: Ipotirojdiżmu iżolat jista' jiġi mmaniġġjat b'terapija ta' sostituzzjoni u mingħajr kortikosterojdi.
English: No overall differences in efficacy were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Maltese: Ma ġiet osservata l-ebda differenza globali fl-effikaċja bejn pazjenti b'età ta' ≥ 65 sena u pazjenti iżgħar li kienu qed jirċievu atezolizumab bħala monoterapija.
English: 6-month PFS (%) 12-month PFS (%)
Maltese: valur p PFS ta' 12-il xahar (%)
English: Tecentriq is used in combination with anticancer medicine (chemotherapy called nab-paclitaxel): if your doctor tested your cancer and found high levels of a specific protein in your body called program death ligand (PD-L1) when the cancer has spread to other parts of the body and has not been treated with anticancer medicines (chemotherapy) or else when the cancer has come back in the breast after previous treatment.
Maltese: Tecentriq jintuża flimkien ma' mediċina kontra l-kanċer (kimoterapija msejħa nab-paclitaxel): jekk it-tabib tiegħek ittestja l-kanċer tiegħek u sab livelli għolja ta' proteina speċifika f'ġismek imsejħa program death ligand (PD-L1 - program death ligand)
English: No. of partial response (%) 95% CI
Maltese: Nru ta' rispons parzjali (%) CI ta' 95%
English: No studies have been conducted to investigate the pharmacokinetics of atezolizumab in children or adolescents.
Maltese: Ma twettqux studji biex jinvestigaw il-farmakokinetika ta' atezolizumab fit-tfal jew fl-adolexxenti.
English: Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment; systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal products within 2 weeks prior to study entry were excluded from clinical trials.
Maltese: Pazjenti li kienu ngħataw vaċċin ħaj u attenwat fi żmien 28 jum qabel ir-reġistrazzjoni; sustanzi immunostimulatorji sistemiċi fi żmien 4 ġimgħat jew prodotti mediċinali immunosoppressivi sistemiċi fi żmien ġimagħtejn qabel id-dħul fl-istudju kienu esklużi mill-provi kliniċi.
English: Post-authorisation efficacy study (PAES): In order to evaluate the efficacy of atezolizumab monotherapy versus atezolizumab plus carboplatin/gemcitabine versus placebo plus cisplatin/gemcitabine in patients with locally advanced or metastatic urothelial cancer who are platinum -ineligible and -eligible patients, the MAH should submit the final CSR of study IMvigor130.
Maltese: Sabiex tiġi evalwata leffikaċja ta' atezolizumab bħala monoterapija kontra atezolizumab flimkien ma' carboplatin/gemcitabine kontra plaċebo flimkien ma' cisplatin/gemcitabine f'pazjenti b'kanċer tal-epitelju tal-apparat urinarju avvanzat lokalment jew metastatiku li huma pazjenti mhux eliġibbli u eliġibbli għall-platinum, l-MAH għandu jissottometti s-CSR finali tal-studju IMvigor130.
English: Baseline ECOG performance status was 0 (58.4%)
Maltese: L-istat ta' eżekuzzjoni ta' ECOG fil-linja bażi kien ta' 0 (58.4%) jew 1 (41.3%).
English: Common thrombocytopeniac lymphocyte count decreased
Maltese: Kif jidher Tecentriq u l-kontenut tal-pakkett
English: polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE) or polypropylene (PP) infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Għandhom jinġibdu għoxrin 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), talpolyethylene (PE), jew tal-polypropylene (PP) li fiha soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: Treatment beyond disease progression was permitted at the discretion of the physician.
Maltese: Trattament wara lprogressjoni tal-marda kien permess skont id-diskrezzjoni tat-tabib.
English: No. of complete response (%) No. of partial response (%) No. of stable disease (%)
Maltese: Nru ta' rispons komplet (%) Nru ta' rispons parzjali (%) Nru ta' marda stabbli (%)
English: Cohort 2.
Maltese: Grad 1 jew 2
English: Patients should be closely monitored for signs and symptoms that are suggestive of acute pancreatitis.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi li jindikaw pankreatite akuta.
English: The majority of patients were white (82%).
Maltese: Il-maġġoranza tal-pazjenti kienu bojod (82%).
English: Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin In the first-line NSCLC study (IMpower150), an overall higher frequency of adverse events was observed in the four-drug regimen of atezolizumab, bevacizumab, paclitaxel, and carboplatin compared to atezolizumab, paclitaxel and carboplatin, including Grade 3 and 4 events (63.6%
Maltese: Fl-istudju dwar trattament tal-ewwel għażla għal NSCLC (IMpower150), ġiet osservata frekwenza ogħla b'mod globali ta' avvenimenti avversi fil-kors ta' erba' mediċini ta' atezolizumab, bevacizumab, paclitaxel, u carboplatin meta mqabbla ma' atezolizumab, paclitaxel u carboplatin, inklużi avvenimenti ta' Grad 3 u 4 (63.6% meta mqabbla ma' 57.5%), avvenimenti ta' Grad 5 (6.1% meta mqabbla ma' 2.5%), avvenimenti avversi ta' interess speċjali għal atezolizumab (52.4% meta mqabbla ma' 48.0%), kif ukoll avvenimenti avversi li wasslu għal irtirar ta' kwalunkwe trattament ta' studju (33.8% meta imqabbel ma' 13.3%).
English: months).
Maltese: 2 xhur).
English: Patients with ECOG performance status ≥ 2 were excluded from the clinical trials in NSCLC, TNBC
Maltese: Pazjenti bi stat ta' eżekuzzjoni ta' ECOG ta' ≥ 2 kienu esklużi mill-provi kliniċi f'NSCLC, TNBC u UC tat-tieni linja (ara sezzjonijiet 4.4 u 5.1).
English: Treatment may be resumed when rash is resolved and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day
Maltese: It-trattament jista' jinbeda mill-ġdid meta r-raxx jgħaddi u l-kortikosterojdi jkunu tnaqqsu għal ≤ 10 mg prednisone jew ekwivalenti kuljum
English: How to store Tecentriq
Maltese: X'fih Tecentriq
English: Talk to your doctor or nurse before you are given Tecentriq if you:
Maltese: Id-doża rakkomandata ta' Tecentriq hija ta':
English: • inflammation of the brain (encephalitis) or inflammation of the membrane around the spinal cord and brain (meningitis): symptoms may include neck stiffness, headache, fever, chills, vomiting, eye sensitivity to light, confusion and sleepiness
Maltese: • infjammazzjoni tal-pulmun (pulmonite): sintomi jistgħu jinkludu sogħla ġdida jew li qed taggrava, qtugħ ta' nifs, u uġigħ fis-sider
English: Each 14 mL vial contains 840 mg of atezolizumab.
Maltese: Kull kunjett ta' 14 mL fih 840 mg ta' atezolizumab.
English: 1L ES-SCLC
Maltese: L-IŻVIZZERA
English: BATCH NUMBER Batch
Maltese: • pressjoni baxxa
English: Approximately three-quarters of patients had non-squamous histology (74%), 10% had known EGFR mutation, 0.2% had known ALK
Maltese: Madwar tliet kwarti tal-pazjenti kellhom istoloġija mhux skwamuża (74%), 10% kellhom mutazzjoni magħrufa ta'
English: 95% CI Stratified hazard ratio‡ (95% CI)
Maltese: Numru ta' mwiet (%) Żmien medjan sal-avvenimenti (xhur) CI ta' 95%
English: The European Medicines Agency has deferred the obligation to submit the results of studies with atezolizumab in all subsets of the paediatric population in the treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jigu ppreżentati r-riżultati tal-istudji b'atezolizumab f'kull sett tal-popolazzjoni pedjatrika fit-trattament ta' neoplażmi malinni (minbarra tumuri tas-sistema nervuża ċentrali, neoplażmi ematopoetiċi u tat-tessut limfojd) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: No. of deaths (%)
Maltese: Numru ta' mwiet (%)
English: The median duration was 2.1 months (range 0 day to 22.0+ months; + denotes a censored value).
Maltese: It-tul ta' żmien medjan kien ta' 2.1 xhur (medda minn 0 jiem sa 22.0+ xhur; + jindika valur iċċensurat).
English: Treatment with atezolizumab should be permanently discontinued for Grade 4 or grade 3 recurrent myositis, or when unable to reduce the corticosteroid dose to the equivalent of ≤ 10 mg prednisone per day within 12 weeks after onset.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf b'mod permanenti għal mijosite rikorrenti ta' Grad 4 jew Grad 3, jew meta d-doża ta' kortikosterojdi ma tkunx tista' titnaqqas għad-doża ekwivalenti ta' ≤ 10 mg ta' prednisone kuljum fi żmien 12-il ġimgħa wara l-bidu.
English: Myasthenia Gravis) - Immune-Related Meningoencephalitis - Immune-Related Myocarditis - Immune-Related Nephritis - Immune-Related Myositis - Infusion-Related Reactions
Maltese: Madankollu, kortikosterojdi sistemiċi jew immunosoppressanti oħra jistgħu jintużaw biex jittrattaw reazzjonijiet avversi relatati mal-immunità wara li jinbeda atezolizumab (ara sezzjoni
English: IMvigor211 (GO29294): Randomised trial in locally advanced or metastatic UC patients previously treated with chemotherapy
Maltese: IMpower130 (GO29537): Prova randomised ta' fażi
English: Hepatitis requiring the use of corticosteroids occurred in 0.6% (18/3,178) of patients receiving atezolizumab monotherapy.
Maltese: Epatite li teħtieġ l-użu ta' kortikosterojdi seħħet f'0.6% (18/3,178) tal-pazjenti li kienu qed jirċievu atezolizumab bħala monoterapija.
English: NAME OF THE MEDICINAL PRODUCT Tecentriq 840 mg concentrate for solution for infusion.
Maltese: Tecentriq 840 mg konċentrat għal soluzzjoni għall-infużjoni.
English: 18.1, 30.1) in patients with PD-L1 expression ≥ 1%, and 19.7% (95% CI: 15.4, 24.6) in all comers.
Maltese: 9, 29.0) f'pazjenti b'espressjoni ta' PD-L1 ta' ≥ 1%, u 19.3% (CI ta' 95%: 12.7, 27.6) għall-pazjenti kollha rreġistrati.
English: The effect of moderate or severe hepatic impairment (bilirubin > 1.5 × to 3 × ULN and any AST or bilirubin > 3 × ULN and any AST) on the pharmacokinetics of atezolizumab is unknown.
Maltese: L-effett ta' indeboliment moderat jew sever tal-fwied (bilirubina > 1.5 × sa 3 × ULN u kwalunkwe AST jew bilirubina > 3 × ULN u kwalunkwe AST) fuq il-farmakokinetika ta' atezolizumab mhux magħruf.
English: Hepatobiliary disorders Common
Maltese: • diffikultà biex tibla'
English: • No decline in ECOG performance status
Maltese: • L-ebda tnaqqis fl-istat ta' eżekuzzjoni ta' ECOG
English: In the population pharmacokinetic analysis, no clinically important differences in the clearance of atezolizumab were found in patients with mild (estimated glomerular filtration rate [eGFR] 60 to
Maltese: Fl-analiżi talfarmakokinetika tal-popolazzjoni, ma nstabux differenzi klinikament importanti fit-tneħħija ta' atezolizumab f'pazjenti b'indeboliment tal-kliewi ħafif (rata stmata ta' filtrazzjoni mill-glomeruli
English: Figure 11 summarises the results of OS in the ITT and PD-L1 subgroups, demonstrating OS benefit with atezolizumab in all subgroups, including those with PD-L1
Maltese: Figura 11 tiġbor fil-qosor ir-riżultati ta' OS fissottogruppi ta' ITT u PD-L1, u dan juri benefiċċju ta' OS b'atezolizumab fis-sottogruppi kollha, inklużi dawk b'espressjoni ta' PD-L1 ta' < 1% f'TC u IC.
English: 12-month OS (%)
Maltese: OS ta' 12-il xahar (%)
English: or
Maltese: y
English: IMpower133 (GO30081): Randomised phase I/III trial in patients with chemotherapy-naïve extensivestage SCLC, in combination with carboplatin and etoposide
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 (ara sezzjoni 5.1).
English: (fasting glucose > 250 mg/dL or 13.9 mmol/L), atezolizumab should be withheld.
Maltese: [GFR - glomerular filtration rate] < 60 mL/min), u 25 pazjent (21%) b'metastasi fil-fwied.
English: No data are available in patients with either moderate or severe hepatic impairment.
Maltese: M'hemmx data disponibbli f'pazjenti b'indeboliment moderat jew sever talfwied.
English: • inflammation of the thyroid, adrenal glands and the pituitary gland (hypothyroidism, hyperthyroidism, adrenal insufficiency or hypophysitis): symptoms may include tiredness, weight loss, weight gain, change in mood, hair loss, constipation, dizziness, headaches, increased thirst, increased urination and changes in vision.
Maltese: • infjammazzjoni tat-tirojde, tal-glandoli adrenali u tal-glandola pitwitarja (ipotirojdiżmu, ipertirojdiżmu, insuffiċjenza adrenali jew ipofisite): sintomi jistgħu jinkludu għeja, telf ta' piż, żieda fil-piż, bidla fil-burdata, telf ta' xagħar, stitikezza, sturdament, uġigħ ta' ras, żieda fl-għatx, żieda fil-mogħdija tal-awrina u bidliet fil-viżjoni.
English: Immune-related neuropathies
Maltese: Ilma għall-injezzjonijiet
English: The use of systemic corticosteroids or immunosuppressants before starting atezolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of atezolizumab.
Maltese: L-użu ta' kortikosterojdi jew immunosoppressanti sistemiċi qabel ma jinbeda atezolizumab għandu jiġi evitat minħabba l-potenzjal tagħhom li jfixklu l-attività farmakodinamika u l-effikaċja ta' atezolizumab.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 20 mL vial of concentrate contains 1,200 mg atezolizumab After dilution, 1 mL of solution contains approximately 4.4 mg of atezolizumab
Maltese: Kull kunjett ta' 20 mL ta' konċentrat fih 1,200 mg atezolizumab Wara d-dilwizzjoni, 1 ml ta' soluzzjoni fih madwar 4.4 mg ta' atezolizumab.
English: Treatment with atezolizumab may be resumed when serum amylase and lipase levels improve to ≤ Grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
Maltese: Ittrattament b'atezolizumab jista' jinbeda mill-ġdid meta l-livelli ta' amylase u lipase fis-serum jitjiebu għal ≤ Grad 1 fi żmien 12-il ġimgħa, jew is-sintomi ta' pankreatite jgħaddu, u l-kortikosterojdi jkunu tnaqqsu għal ≤ 10 mg prednisone jew ekwivalenti kuljum.
English: The median time to onset was 1.5 months (range 6 days to 18.8
Maltese: Iż-żmien medjan sal-bidu kien ta' 1.5 xhur (medda minn 6 ijiem sa 18.8 xhur).
English: Polska Roche Polska Sp.z o.o.
Maltese: Česká republika Roche s. r. O.
English: Type I glass vial with a butyl rubber stopper and an aluminium seal with a plastic aqua flip-off cap containing 20 mL of concentrate solution for infusion.
Maltese: Kunjett tal-ħġieġ Tip I b'tapp tal-lastku butyl u siġill tal-aluminju b'għatu tal-plastik aqua flip-off li jkun fih 20 mL ta' konċentrat għal soluzzjoni għall-infużjoni.
English: Patient demographics and baseline tumour disease in patients with PD-L1 expression ≥1% were generally representative of the broader study population.
Maltese: Id-demografika tal-pazjenti u l-marda tat-tumur fil-linja bażi f'pazjent b'espressjoni ta' PD-L1 ta' ≥ 1% ġeneralment kienu rappreżentattivi tal-popolazzjoni usa' tal-istudju.
English: Atezolizumaba (1,200 mg) + paclitaxel (200 mg/m2)b,c + carboplatinc (AUC 6)
Maltese: atezolizumab (1,200 mg)a + carboplatin (AUC 5)
English: Treatment with atezolizumab should be permanently discontinued for Grade 4 hypophysitis.
Maltese: It-trattament b'atezolizumab għandu jitwaqqaf b'mod permanenti għal ipofisite ta' Grad 4.
English: For the description of studies with Tecentriq administered every 3 weeks at 1,200 mg, refer to the Tecentriq 1,200 mg concentrate for solution for infusion SmPC.
Maltese: Għad-deskrizzjoni ta' studji b'Tecentriq mogħti kull 3 ġimgħat b'doża ta' 1,200 mg, irreferi għallSmPC ta' Tecentriq 1,200 mg konċentrat għal soluzzjoni għall-infużjoni.
English: Body weight, gender, positive ADA status, albumin levels and tumour burden have a statistically significant, but not clinically relevant effect on atezolizumab pharmacokinetics.
Maltese: Il-piż tal-ġisem, is-sess, l-istat ta' ADA pożittiv, il-livelli ta' albumina u l-piż tat-tumur għandhom effett statistikament sinifikanti iżda mhux klinikament rilevanti fuq il-farmakokinetika ta' atezolizumab.
English: There were no effects on the male reproductive organs.
Maltese: Ma kienx hemm effett fuq l-organi riproduttivi maskili.
English: A total of 403 patients were enrolled and randomised (1:1) to receive one of the treatment regimens described in Table 11.
Maltese: Ġew irreġistrati total ta' 403 pazjenti u kienu randomised (1:1) biex jirċievu wieħed mill-korsijiet ta' trattament deskritti fit-Tabella 11.
English: However, monoclonal antibodies are not expected to alter DNA or chromosomes.
Maltese: Madankollu, antikorpi monoklonali mhumiex mistennija li jibdlu d-DNA jew kromożomi.