FrancophonIA/ELRC3.0 huggingface dataset:
English: Erythema multiforme
Maltese: Eritema multiforme
English: Hepatic impairment (see sections 5.1 and 5.2).
Maltese: Insuffiċjenza epatika (ara sezzjonijiet 5.1 u 5.2).
English: Pfizer Ελλάς Α.Ε.
Maltese: Pfizer Ελλάς A.E.
English: This medicine has been given “conditional approval”.
Maltese: Din il-mediċina ingħatat “approvazzjoni kondizzjonali”.
English: Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free)
Maltese: Pfizer Healthcare Ireland Tel: 1800 633 363 (mingħajr ħlas)
English: Cytochrome P-450 (CYP)3A inhibitors
Maltese: Inibituri ta' ċitokrom P-450 (CYP)3A
English: (Cyprus Branch) Tηλ+357 22 817690
Maltese: Tηλ+357 22 817690
English: Date of first authorisation: 27 March 2013 Date of latest renewal: 18 February 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 27 ta' Marzu 2013 Data tal-aħħar tiġdid: 18 ta' Frar 2019
English: Pfizer ApS Tlf: +45 44 20 11 00
Maltese: Danmark Pfizer ApS Tlf: +45 44 20 11 00
English: Tel.: +420 283 004 111
Maltese: s r.o. Tel.: +420 283 004 111
English: Number (%) of subjects with MMR
Maltese: Numru (%) ta' individwi b'MMR
English: 1-sided p-value
Maltese: valur p 1-sided
English: Treatment with bosutinib is associated with elevations in serum transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]).
Maltese: Trattament b'bosutinib huwa assoċjat ma' żidiet fil-livelli tat-transaminases fis-serum (alanine aminotransferase [ALT], aspartate aminotransferase [AST]).
English: Elderly patients (≥ 65 years)
Maltese: Anzjani (≥ 65 sena)
English: Incidence at baseline n (%)
Maltese: Inċidenza fil-linja bażi n (%)
English: In vitro testing indicated that bosutinib had limited activity against the T315I or the V299L mutation.
Maltese: Ittestjar in vitro indika li bosutinib kellu attività limitata kontra l-mutazzjoni T315I jew V299L.
English: The tablet film-coating contains polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b) and iron oxide yellow (E172, for Bosulif 100 mg and 400 mg) or iron oxide red (E172, for Bosulif 400 mg and 500 mg).
Maltese: Il-kisi b'rita tal-pillola fih polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b) u iron oxide yellow (E172, għal Bosulif ta' 100 mg u 400 mg) jew iron oxide red (E172, għal Bosulif ta' 400 mg u 500 mg).
English: Abbreviations: BCR-ABL=breakpoint cluster region-Abelson; CI=confidence interval;
Maltese: BCR-ABL=breakpoint cluster region-Abelson;
English: The systemic exposure of N-desmethylated metabolite was 25% of the parent compound, while the oxydechlorinated metabolite was 19% of the parent compound.
Maltese: Lesponiment sistemiku tal-metabolit N-desmethylated kien 25% tal-kompost prinċipali, filwaqt li dak tal-metabolit oxydechlorinated kien 19% tal-kompost prinċipali.
English: Maximal exposure Cmax increased by 28% and 34% in the moderate and severe groups, respectively.
Maltese: L-esponiment massimu Cmax żdied bi 28% u 34% fi gruppi b'indeboliment moderat u sever tal-kliewi, rispettivament.
English: Cmax of bosutinib in plasma increased 2.4-fold, 2-fold, and 1.5-fold, respectively, in Child-Pugh classes A, B, and C; and bosutinib AUC in plasma increased 2.3-fold, 2-fold, and 1.9-fold, respectively.
Maltese: Is-Cmax ta' bosutinib fil-plasma żdied b'2.4, 2, u 1.5 darbiet, rispettivament, fil-kategoriji Child-Pugh A, B, u C; u l-AUC ta' bosutinib fil-plasma żdied b'2.3, 2, u 1.9 darbiet, rispettivament.
English: Urticaria, Acne, Pruritus
Maltese: Urtikarja, Akne, Ħakk
English: No metabolism of bosutinib was observed with CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A5.
Maltese: Ma kienx osservat metaboliżmu ta' bosutinib b'CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, jew 3A5.
English: Hepatitis B reactivation
Maltese: Riattivazzjoni tal-epatite B
English: - haloperidol, used to treat psychotic disease such as schizophrenia.
Maltese: - haloperidol, użat biex jittratta mard psikotiku bħal skizofrenija.
English: Bosulif is indicated for the treatment of adult patients with:
Maltese: Bosulif hu indikat għat-trattament ta' pazjenti adulti:
English: - The other ingredients are: microcrystalline cellulose (E460), croscarmellose sodium (E468), poloxamer 188, povidone (E1201) and magnesium stearate (E470b).
Maltese: L-ingredjenti l-oħra huma: microcrystalline cellulose (E460), croscarmellose sodium (E468), poloxamer 188, povidone (E1201) u magnesium stearate (E470b).
English: Overall, % (95% CI) Major, % (95% CI) Complete, % (95% CI)
Maltese: Globali, % (95% CI) Maġġuri, % (95% CI) Komplet, % (95% CI)
English: The median duration of therapy was 13.8 months (range: 0.03 to 123.3 months).
Maltese: It-tul medjan tat-terapija kien ta' 13.8 xhur (medda: 0.03 sa 123.3 xhur).
English: Serum lipase
Maltese: Lipase fis-serum
English: Bosulif contains the active substance bosutinib.
Maltese: - Is-sustanza attiva hi bosutinib.
English: All 3 metabolites exhibited activity that was  5% that of bosutinib in a Src-transformed fibroblast anchorage-independent proliferation assay.
Maltese: It-3 metaboliti wrew attività li kienet 5% ta' bosutinib fl-analiżi tal-proliferazzjoni tal-Src fibroblast trasformat indipendenti mill-ankoraġġ.
English: 9/L and less than 1.0×10
Maltese: 9 /L u anqas minn 1.0 x 10
English: The following active substances may increase the risk of side effects with Bosulif: - ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole, used to treat fungal infections.
Maltese: Is-sustanzi attivi li ġejjin jistgħu jżidu r-riskju tal-effetti avversi b'Bosulif: - ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, użati għall-infezzjonijiet fungali.
English: Y253H E255K/V F359C/I/V
Maltese: F359C/V
English: Pfizer Ελλάς A.E. Τλ: +30 210 6785 800
Maltese: Τλ: +30 210 6785 800
English: Frequency categories are defined as: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenza huma definiti bħala: komuni ħafna ( 1/10), komuni ( 1/100 sa < 1/10), mhux komuni ( 1/1000 sa < 1/100), rari (1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħrufa (ma tistax tiġi stmata mit-tagħrif disponibbli.
English: The concomitant use of bosutinib with strong CYP3A inhibitors (including, but not limited to itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, nefazodone, mibefradil, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir, grapefruit products including grapefruit juice) or moderate CYP3A inhibitors (including, but not limited to fluconazole, ciprofloxacin, erythromycin, diltiazem, verapamil, amprenavir, atazanavir, darunavir/ritonavir, fosamprenavir, aprepitant, crizotinib, imatinib) should be avoided, as an increase in bosutinib plasma concentration will occur.
Maltese: L-użu ta' bosutinib flimkien ma' inibituri ta' CYP3A b'saħħithom (inkluż, iżda mhux limitati għal itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, nefazodone, mibefradil, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir, prodotti tal-grejpfrut inkluż meraq tal-grejpfrut) jew inibituri ta' CYP3A moderati (inkluż, iżda mhux limitati għal fluconazole, ciprofloxacin, erythromycin, diltiazem, verapamil, amprenavir, atazanavir, darunavir/ritonavir, fosamprenavir, aprepitant, crizotinib, imatinib) għandu jkun evitat, għaliex ikun hemm żieda fil-konċentrazzjoni ta' bosunitib fil-plażma.
English: Of the 445 (35%) patients with reports of adverse reactions of thrombocytopenia, 41 (9%) patients discontinued treatment with bosutinib due to thrombocytopenia.
Maltese: Mill-445 (35%) pazjent b'avvenimenti avversi ta' trombocitopenija, 41 (9%) individwu waqqfu trattament b' bosutinib minħabba trombocitopenija.
English: Safety pharmacology
Maltese: Sigurtà farmakoloġika
English: Bosutinib did not have effects on respiratory functions.
Maltese: Bosutinib ma kellux effetti fuq il-funzjonijiet respiratorji.
English: Table 2 - Adverse reactions for bosutinib
Maltese: Tabella 2 - Reazzjonijiet avversi għal bosutinib
English: - clarithromycin and moxifloxacin antibiotics used to treat bacterial infections.
Maltese: - antibijotiċi clarithromycin u moxifloxacin użati biex jittrattaw infezzjonijiet batteriċi.
English: fosamprenavir and darunavir, used to treat human immunodeficiency virus (HIV)/AIDS.
Maltese: fosamprenavir u darunavir, użati biex jittrattaw il-virus tal-immunodefiċjenza umana
English: Bosutinib can induce severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
Maltese: Bosutinib jista' jinduċi reazzjonijiet severi tal-ġilda bħas-Sindrome ta' Stevens-Johnson u Nekrolisi Epidermali Tossika.
English: The Kaplan-Meier estimates of OS at 48 weeks for bosutinib and imatinib patients in the mITT population were 99.6% (95% CI: 97.1%, 99.9%) and 97.9% (95% CI: 95.0%, 99.1%), respectively.
Maltese: L-istimi Kaplan-Meier ta' OS wara 48 ġimgħa għal pazjenti fuq bosutinib u imatinib fil-popolazzjoni mITT, kienu ta' 99.6% (95% CI: 97.1%, 99.9%) u 97.9% (95% CI: 95.0%, 99.1%), rispettivament.
English: Stomach/intestinal disorders.
Maltese: Disturbi gastro-intestinali
English: Ph+ CP CML with prior treatment with imatinib and dasatinib or nilotinib
Maltese: Ph+ CP CML b'trattament preċedenti b'imatinib u dasatinib jew nilotinib
English: C] radiolabelled bosutinib to lactating
Maltese: Studju ta' radiolabelled bosutinib [
English: - clarithromycin, telithromycin, erythromycin, and ciprofloxacin, used to treat bacterial infections.
Maltese: - clarithromycin, telithromyciin, erythromycin, u ciprofloxacin użati għall-infezzjonijiet batteriċi.
English: The Grade 3 or Grade 4 adverse reactions reported for  5% of patients were thrombocytopenia (20.3%), anaemia (10.2%), neutropenia (10.5%), ALT increased (12.7%), diarrhoea (9.6%), rash (5.0%), lipase increased (8.2%), and AST increased (5.8%).
Maltese: Ir-reazzjonijiet avversi ta' Grad 3 jew ta' Grad 4 irrapportati f' 5% tal-pazjenti kienu trombocitopenija (20.3%), anemija (10.2%), newtropenja (10.5%), żieda fl-ALT (12.7%), dijarea (9.6%), raxx (5.0%), żieda fil-livell ta' lipase (8.2%) u żieda fl-AST (5.8%).
English: Abbreviations: AP=accelerated phase; BP=blast phase; Ph+=Philadelphia chromosome-positive; CP=chronic phase; CML=chronic myelogenous leukaemia; K-M=Kaplan-Meier; N/n=number of patients; N/A=not applicable; N/R=not reached as of minimum follow-up; N/E=not estimable; CI=confidence interval; MCyR=major cytogenetic response; CCyR=complete cytogenetic response; OHR=overall haematological response; CHR=complete haematological response.
Maltese: K-M=Kaplan-Meier; N/n=numru ta' pazjenti; N/A=not applicable (mhux applikabbli); N/R=not reached (ma ntlaħaqx); N/E=not estimable (ma jistax jiġi stmat); CI=confidence interval (intervall ta' kunfidenza); MCyR=major cytogenetic response (rispons ċitoġeniku maġġuri); CCyR=complete cytogenetic response (rispons ċitoġeniku komplet); OHR=overall haematological response (rispons ematoloġiku globali); CHR=complete haematological response (rispons ematoloġiku komplet).
English: Concomitant medicinal products were given to treat diarrhoea in 662 (66%) patients.
Maltese: Prodotti mediċinali konkomitanti ngħataw għat-trattament tad-dijarea f'662 (66%) tal-pazjenti.
English: BCR-ABL mutation status at baseline
Maltese: Status tal-mutazzjoni ta' BCR-ABL fillinja bażi
English: The maximum toxicity of thrombocytopenia of Grade 3 was experienced in 161 (36%) patients and Grade 4 in 98 (22%) patients.
Maltese: It-tossiċità massima ta' trombocitopenija ta' Grad 3 kienet esperjenzata f'161 (36%) pazjent u ta' Grad 4 f'98 (22%) pazjent.
English: Ph+ CP CML with prior imatinib treatment only
Maltese: Ph+ CP CML b'trattament preċedenti b'imatinib biss
English: Based on the limited clinical information from the Phase 1/2 study, some evidence of clinical activity was observed in patients with BCR-ABL mutations (see Table 6).
Maltese: Abbażi tal-informazzjoni klinika limitata mill-istudju tal-Fażi 1/2, xi evidenza ta' attività klinika kienet osservata f'pazjenti b'mutazzjonijiet ta' BCR-ABL (ara Tabella 6).
English: The secondary efficacy endpoints included MMR by 18 months, duration of MMR, CCyR by 12 months, duration of CCyR, event-free survival (EFS), and overall survival (OS).
Maltese: Il-punti aħħarin tal-effikaċja sekondarja kienu jinkludu MMR sa 18-il xahar, it-tul tal-MMR, CCyR sa 12-il xahar, it-tul tas-CCyR, sopravivenza mingħajr avvenimenti (EFS, event-free survival), u sopravivenza globali (OS, overall survival).
English: Bosutinib activity in vitro in hERG assays suggested a potential for prolongation of cardiac ventricular repolarisation (QTc).
Maltese: L-attività ta' bosutinib in vitro fl-analiżi hERG tissuġġerixxi potenzjal ta' titwil ta' ripolarizzjoni ventrikulari tal-qalb (QTc).
English: At least 1 adverse reaction of any toxicity grade was reported for 1,240 (97.5%) patients.
Maltese: Kienet irrapportata tal-inqas reazzjoni avversa waħda minn kull grad ta' tossiċità f'1,240 (97.5%) pazjent.
English: - respiratory tract infection.
Maltese: - infezzjoni fil-passaġġ respiratorju.
English: The most frequent adverse reactions reported for  20% of patients were diarrhoea (78.1%), nausea (40.8%), thrombocytopenia (34.9%), abdominal pain (34.0%), vomiting (33.0%), rash (31.5%), anaemia (25.6%), pyrexia (21.8%), fatigue (21.4%), and ALT increased (25.0%).
Maltese: L-aktar reazzjonijiet avversi frekwenti rapportata għal 20% tal-pazjenti kienu dijarea (78.1%); nawseja (40.8%), trombocitopenija (34.9%), uġigħ addominali (34.0%), rimettar (33.0%), raxx (31.5%), anemija (25.6%), deni (21.8%), għeja (21.4%), u żieda fl-ALT (25.0%).
English: Bosutinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity, reproductive toxicity, and photoxicity studies.
Maltese: Bosutinib kien evalwat fuq sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, effett tossiku fuq is-sistema riproduttiva, u studji fototossiċi.
English: Stevens-Johnson Syndrome**, Toxic epidermal necrolysis** Musculoskeletal and connective tissue disorders Very common Arthralgia, Back pain Common
Maltese: Mhux magħrufa Sindrome ta' Stevens-Johnson**, Nekrolisi epidermali tossika** Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna Artralġija, Uġigħ fid-dahar Komuni
English: Four patients (0.3%) experienced QTcF interval prolongation (greater than 500 ms).
Maltese: Erba' pazjenti (0.3%) esperjenzaw titwil tal-intervall tal-QTcF (aktar minn 500 ms).
English: In vitro studies indicate that bosutinib has a low potential to inhibit breast cancer resistance protein (BCRP, systemically), organic anion transporting polypeptide (OATP)1B1, OATP1B3, organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2 at clinically relevant concentrations, but may have the potential to inhibit BCRP in the gastrointestinal tract and OCT1.
Maltese: Studji in vitro jindikaw li bosutinib għandu potenzjal baxx li jinibixxi proteina ta' reżistenza għallkanċer tas-sider (BCRP, breast cancer resistance protein, sistemikament), organic anion transporting polypeptide (OATP)1B1, OATP1B3, organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2, f'konċentrazzjonijiet klinikament rilevanti, iżda jista' jkollu l-potenzjal li jinibixxi BCRP fil-passaġġ gastrointestinali u OCT1.
English: Of the 297 (23%) patients with reports of adverse reactions of anaemia, 3 patients discontinued bosutinib due to anaemia.
Maltese: Mill-297 (23%) pazjent b'rapporti ta' avvenimenti avversi ta' anemija, 3 pazjenti waqqfu bosutinib minħabba anemija.
English: Rare side effects (may affect up to 1 in 1,000 people): - severe skin disorder (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative (scaly, peeling) rash.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna): - disturb serju tal-ġilda (eritema multiforme, sindrome ta' Stevens-Johnson, nekrolisi epidermali tossika) minħabba reazzjoni allerġika, raxx bil-qxur.
English: Complete cytogenetic response by Month 12 (n, %) CCyR (95% CI)
Maltese: Rispons ċitoġenetiku komplet sa Xahar 12 (n, %) CCyR (95% CI)
English: EU/1/13/818/001 (28 film-coated tablets) EU/1/13/818/002 (30 film-coated tablets) EU/1/13/818/005 (112 film-coated tablets)
Maltese: EU/1/13/818/001 (28 pillola miksijin b'rita) EU/1/13/818/002 (30 pillola miksijin b'rita) EU/1/13/818/005 (112 pillola miksijin b'rita)
English: The following adverse reactions were reported in patients in bosutinib clinical studies (Table 2).
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati f'pazjenti fi studji kliniċi ta' bosutinib (Tabella 2).
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE14.
Maltese: Aġenti anti-neoplastiċi, inibituri tal-proteina kinasi, Kodiċi ATC:
English: Orange oval (width: 8.8 mm; length: 16.9 mm) biconvex, film-coated tablet debossed with “Pfizer” on one side and “400” on the other side.
Maltese: Pillola oranġjo, b'forma ovali (wisa': 8.8 mm; tul: 16.9 mm), bikonvessa, miksija b'rita, imnaqqxa b'“Pfizer” fuq naħa waħda u “400” fuq in-naħa l-oħra.
English: The maximum toxicity of diarrhoea was Grade 1 or 2 in 88% of patients, Grade 3 in 12% of patients; 1 patient (< 1%) experienced a Grade 4 event.
Maltese: Ittossiċità massima ta' dijarea kienet ta' Grad 1 jew 2 f'88% tal-pazjenti, ta' Grad 3 fi 12% tal-pazjenti; pazjent 1 (< 1%) esperjenza avveniment ta' Grad 4.
English: Renal impairment was based on CLCr (calculated by the Cockcroft-Gault formula) of < 30 mL/min (severe renal impairment), 30  CLCr  50 mL/min (moderate renal impairment), or 50 < CLCr  80 mL/min (mild renal impairment).
Maltese: L-indeboliment tal-kliewi kien ibbażat fuq (is-CLCr) (ikkalkulata skont il-formula Cockcroft-Gault) ta' <30 mL/min (indeboliment sever tal-kliewi), 30  CLCr  50 mL/min (indeboliment moderat tal-kliewi), jew 50 < CLCr  80 mL/min (indeboliment ħafif tal-kliewi).
English: The median duration of therapy was 14.1 months (range: 0.3 to 24.7 months), 61.6 months (0.03 to 99.6 months), 11.1 months (range: 0.03 to 123.3 months), 30.2 months (range: 0.3 to 85.6 months), and 5.7 months (range: 0.07 to 17.8 months), respectively.
Maltese: It-tul medjan tat-terapija kien ta' 14.1 xhur (medda: 0.3 sa 24.7 xhur), 61.6 xhur (0.03 sa 99.6 xhur), 11.1 xhur (firxa: 0.03 sa 123.3 xhur), 30.2 xhur (medda: 0.3 sa 85.6 xhur), u 5.7 xhur(firxa: 0.07 sa 17.8 xhur), rispettivament.
English: After 500 mg bosutinib daily with food, Cmax was 200 (6) ng/mL and AUCss was 3,640 (12) ng•h/mL.
Maltese: Wara doża ta' 500 mg ta' bosutinib kuljum mal-ikel, is-Cmax kien ta' 200 (6) ng/ml, u lAUCss medju kien 3,640 (12) ng•h/mL.
English: Bosutinib was highly bound to human plasma proteins in vitro (94%) and ex vivo in healthy subjects (96%), and binding was not concentration-dependent.
Maltese: Bosutinib jeħel b'mod estensiv mal-proteini fil-plasma tal-bniedem in vitro (94%) u ex vivo f'pazjenti b'saħħithom (96%), u t-twaħħil mhuwiex dipendenti mill-konċentrazzjoni.
English: Maximum Grade 1 or 2 events were experienced by 186 (42%) patients.
Maltese: Avvenimenti massimi ta' Grad 1 jew 2 kienu esperjenzati minn 186 (42%) pazjent.
English: After a minimum of 12 months of follow-up in the mITT population, 77.6% of patients treated with bosutinib (N=241) and 72.4% of patients treated with imatinib (N=239) were still receiving first-line treatment.
Maltese: Wara minimu ta' 12-il xahar ta' segwitu fil-popolazzjoni mITT, 77.6% tal-pazjenti ttrattati bi bosutinib (N=241), u 72.4% tal-pazjenti ttrattati b'imatinib (N=239), kienu għadhom jirċievu trattament primarju (first-line).
English: Blood creatinine increased, Amylase increased, Blood creatine phosphokinase increased
Maltese: Żieda tal-kreatinina fid-demm, Żieda f'amylase, Żieda ta' creatine phosphokinase fid-demm
English: MMR at Month 18 (95% CI)
Maltese: MMR f'Xahar 18 (95% CI)
English: - methadone, used to treat pain.
Maltese: - methadone, użat biex jittratta l-uġigħ.
English: The cumulative incidence of MMR adjusting for competing risk of treatment discontinuation without MMR was higher in the bosutinib treatment group compared to the imatinib treatment group in the mITT population (45.1% [95% CI: 38.8%, 51.2%] versus 33.7% [95% CI: 27.8%, 39.6%] at Week 48; hazard ratio [HR] from a stratified proportional subdistributional hazards model: 1.35 [95% CI: 1.07, 1.70], 1-sided p-value = 0.0086).
Maltese: L-inċidenza kumulattiva ta' MMR meta wieħed jaġġusta għar-riskju li jikkompeti tat-twaqqif tattrattament mingħajr MMR, kienet ogħla fil-grupp ta' trattament ta' bosutinib meta mqabbla mal-grupp ta' trattament ta' imatinib fil-popolazzjoni mITT (45.1% [95% CI: 38.8%, 51.2%] kontra 33.7% [95% CI: 27.8%, 39.6%] f'Ġimgħa 48; proporzjon ta' periklu [HR, hazard ratio] minn mudell ta' perikli subdistribuzzjonali proporzjonali stratifikat: 1.35 [95% CI: 1.07, 1.70], valur p 1-sided = 0.0086).
English: Maximum Grade 1 or 2 events were experienced by 63 (32%) patients.
Maltese: Avvenimenti massimi ta' grad 1 jew 2 kienu esperjenzati minn 63 (32%) pazjent.
English: Platelets < 50 × 109/L
Maltese: Plejtlits <50 x 10
English: In vitro and in vivo studies indicated that bosutinib (parent compound) undergoes predominantly hepatic metabolism in humans.
Maltese: Studji in vitro u in vivo indikaw li bosutinib (kompost prinċipali) jgħaddi b'mod predominanti minn metaboliżmu epatiku fil-bnedmin.
English: Cumulative cytogenetic responsea MCyR, % (95% CI) CCyR, % (95% CI)
Maltese: MCyR, % (95% CI) CCyR, % (95% CI)
English: In the Phase 1/2 clinical study in patients with previously treated Ph+ leukaemias, QTcF interval changes > 60 ms from baseline were observed in 6 (1.1%) of 562 patients.
Maltese: Fl-istudju kliniku tal-Fażi 1/2 f'pazjenti li kienu trattati qabel għal lewċemiji Ph+, bidliet fl-intervall tal-QTcF ta' >60 ms mil-linja bażi kienu osservati f'6 (1.1%) minn 562 pazjent.
English: Dehydration, Hyperkalaemia, Hypophosphataemia Nervous system disorders Very common Headache Common
Maltese: Deidratazzjoni, Iperkalemija, Ipofosfatemija Disturbi fis-sistema nervuża Komuni ħafna Uġigħ ta' ras Komuni
English: ANC = absolute neutrophil count
Maltese: ANC = għadd assolut tan-newtrofili
English: 9/L, no blasts or promyelocytes in peripheral blood, less than 5% myelocytes + metamyelocytes in bone marrow, less than 20% basophils in peripheral blood, and no extramedullary involvement.
Maltese: 9 /L, l-ebda blasts jew promajeloċiti fid-demm periferali, anqas minn 5% majeloċiti + metamajeloċiti fil-mudullun, anqas minn 20% bażofili fid-demm periferali, u l-ebda involviment ekstramedullari.
English: Subjects with moderate and severe renal impairment had an increase in AUC over healthy volunteers of 35% and 60%, respectively.
Maltese: Individwi b'indeboliment moderat u sever tal-kliewi kellhom żieda fl-AUC meta mqabbla ma' voluntiera b'saħħithom, ta' 35% u 60%, rispettivament.
English: • newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
Maltese: • lewkimja majeloġena kronika pożittiva għall-kromosoma ta' Filadelfja (Ph+ CML, Philadelphia chromosome-positive chronic myelogenous leukaemia) bil-fażi kronika (CP, chronic phase) li tkun ġiet iddijanjostikata għall-ewwel darba.
English: Treatment with bosutinib is associated with myelosuppression, defined as anaemia, neutropenia, and thrombocytopenia.
Maltese: Trattament b'bosutinib huwa assoċjat ma' majelosuppressjoni, definita bħala anemija, newtropenja, u tromboċitopenja.
English: Bosulif 400 mg film-coated tablets EU/1/13/818/006
Maltese: Bosulif 400 mg pilloli miksijin b'rita EU/1/13/818/006
English: The maximum toxicity of Grade 3 neutropenia was experienced in 90 (46%) patients and of Grade 4 in 44 (22%) patients.
Maltese: Newtropenja f'tossiċità massima ta' Grad 3 kienet esperjenzata f'90 (46%) pazjent u ta' Grad 4 f'44 (22%) pazjent.