FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence rate of hematologic malignancies, most notably AML, MDS and B-cell malignancies (including Hodgkin's lymphoma), was 1.31 per 100 person-years for the lenalidomide arms and 0.58 per 100 person-years for the placebo arms (1.02 per 100 person-years for patients exposed to lenalidomide after ASCT and 0.60 per 100 person-years for patients not-exposed to lenalidomide after ASCT).
Maltese: AML, MDS u tumuri malinni ta' ċelluli B, (jinkludu limfoma ta' Hodgkin), kienet ta' 1.31 għal kull 100 sena ta' persuna għall-partijiet tal-istudju dwar lenalidomide u 0.58 għal kull 100 sena ta' persuna għall-partijiet tal-istudju dwar ilplaċebo (1.02 għal kull 100 sena ta' persuna esposti għal lenalidomide wara ASCT, u 0.60 għal kull 100 sena ta' persuna għal pazjenti mhux esposti għal lenalidomide wara ASCT).
English: Viral infections, including herpes zoster and hepatitis B virus reactivation
Maltese: Infezzjonijiet virali, li jinkludu herpes zoster u l-attivazzjoni mill-ġdid tal-virus tal-epatite B
English: Very Common Pneumonias◊,a, Upper respiratory tract infection, Neutropenic infection, Bronchitis◊, Influenza◊, Gastroenteritis◊, Sinusitis, Nasopharyngitis, Rhinitis
Maltese: Komuni Ħafna Pnewmonji◊,a, Infezzjoni fin naħa ta' fuq tal-passaġġ respiratorju, Infezzjoni newtropenika, Bronikite◊, Influwenza◊, Gastroenterite◊, Sinusite, Nażofarinġite, Rinite
English: Despite the fact that 170 out of the 351 patients randomised to placebo/dex received lenalidomide after disease progression or after the studies were unblinded, the pooled analysis of overall survival demonstrated a statistically significant survival advantage for len/dex relative to placebo/dex (HR = 0.833, 95% CI = [0.687, 1.009], p=0.045).
Maltese: Minkejja l-fatt li 170 minn 351 pazjent li kienu randomised għall-plaċebo/dex, irċivew lenalidomide wara l-progressjoni tal-marda jew wara li listudji kienu unblinded, l-analiżi miġbura ta' sopravivenza totali wriet vantaġġ tas-sopravivenza li kien statistikament sinifikanti għal len/dex meta mqabbel mal-kura bil-plaċebo/dex (HR = 0.833, 95% CI = [0.687, 1.009], p = 0.045).
English: The observed adverse reactions which occurred more frequently with lenalidomide and dexamethasone than placebo and dexamethasone in pooled multiple myeloma clinical trials (MM-009 and MM-010) were fatigue (43.9%), neutropenia (42.2%), constipation (40.5%), diarrhoea (38.5%), muscle cramp (33.4%), anaemia (31.4%), thrombocytopenia (21.5%), and rash (21.2%).
Maltese: L-iktar reazzjonijiet avversi li seħħew b'mod aktar frekwenti b'lenalidomide u dexamethasone milli minn plaċebo u dexamethasone fil-provi kliniċi multipli miġbura li saru b'lenalidomide dwar ilmajeloma (MM-009 u MM-010) kienu għeja kbira (43.9%), newtropenija (42.2%), stitikezza (40.5%), dijarea (38.5%), bugħawwieġ fil-muskoli (33.4%), anemija (31.4%), tromboċitopenija (21.5%), u raxx
English: Lenalidomide Accord as combination therapy (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Maltese: Lenalidomide Accord bħala terapija kombinata (ara sezzjoni 4.2) hu indikat għall-kura ta' pazjenti adulti b'majeloma multipla li ma kinitx ikkurata fil-passat U li mhumiex eliġibbli għal trapjant.
English: • Multiple myeloma: patients with at least one prior therapy The combination of lenalidomide with dexamethasone in multiple myeloma patients with at least one prior therapy is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients; see section 4.8).
Maltese: • Majeloma multipla: pazjenti b'mill-inqas terapija waħda fil-passat Il-kumbinazzjoni ta' lenalidomide ma' dexamethasone f'pazjenti b'majeloma multipla b'mill-inqas terapija waħda fil-passat hi marbuta ma' inċidenza ogħla ta' newtropenija ta' grad 4 (5.1% f'pazjenti kkurati b'lenalidomide/dexamethasone meta mqabbla ma' 0.6% ta' pazjenti kkurati bilplaċebo/dexamethasone; ara sezzjoni 4.8).
English: 0.25 mg/kg ª If neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide
Maltese: 0.25 mg/kg ª Jekk in-newtropenija tkun l-unika tossiċità fi kwalunkwe livell ta' doża, żid fattur li jistimula l-kolonji tal-granuloċiti (G-CSF - granulocyte colony stimulating factor) u żomm il-livell ta' doża ta' lenalidomide
English: The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients; see section 4.8).
Maltese: Il-kumbinazzjoni ta' lenalidomide ma' dexamethasone f'pazjenti b'majeloma multipla hi marbuta ma' inċidenza ogħla ta' tromboċitopenija ta' grad 3 u grad 4 (9.9% u 1.4%, rispettivament, f'pazjenti kkurati b'lenalidomide/dexamethasone meta mqabbla ma' 2.3% u 0.0% f'pazjenti kkurati bilplaċebo/dexamethasone; ara sezzjoni 4.8).
English: The maintenance dose was 10 mg once daily on days 1-28 of repeated 28-day cycles (increased up to 15 mg once daily after 3 months in the absence of dose-limiting toxicity), and treatment was continued until disease progression.
Maltese: Id-doża ta' manteniment kienet ta' 10 mg darba kuljum f'jiem 1-28 ta' ċikli ripetuti ta' 28 jum (li tiżdied sa 15-il mg darba kuljum wara 3 xhur fl-assenza ta' tossiċità li tillimita d-doża), u t-trattament tkompla sal-progressjoni tal-marda.
English: Each capsule contains 25 mg of lenalidomide.
Maltese: Kull kapsula fiha 25 mg ta' lenalidomide.
English: Hepatic failure, including fatal cases, has been reported in patients treated with lenalidomide in combination therapy: acute hepatic failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, and mixed cytolytic/cholestatic hepatitis have been reported.
Maltese: Insuffiċjenza tal-fwied, li tinkudi każijiet fatali, ġiet irrappurtata f'pazjenti kkurati b'lenalidomide f'terapija kombinata: insuffiċjenza akuta tal-fwied, epatite tossika, epatite ċitolitika, epatite kolestatika u epatite mħallta/kolestatika ġew irrappurtati.
English: • Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Maltese: • Raxx mifrux, temperatura tal-ġisem għolja, żieda fl-enzimi tal-fwied, anormalitajiet fid-demm (eosinofilja), għoqod tal-limfa mkabbra u involviment ta' organi oħrajn tal-ġisem (Reazzjoni talMediċina b'Eosinofilja u Sintomi Sistemiċi magħrufa wkoll bħala DRESS jew sindrome ta' sensittività eċċessiva għall-mediċina).
English: Grade 3 or 4 thrombocytopenia was observed to a lesser extent in the Rd and Rd18 arms than in the comparator arm (8.1% vs 11.1%, respectively).
Maltese: Tromboċitopenija ta' grad 3 jew 4 ġiet osservata fi grad inqas milli fil-partijiet tal-istudju dwar Rd u Rd18 milli fil-parti tal-istudju dwar il-komparatur (8.1% vs 11.1%, rispettivament).
English: The adverse reactions observed more frequently with Rd or Rd18 than MPT were: diarrhoea (45.5%), fatigue (32.8%), back pain (32.0%), asthenia (28.2%), insomnia (27.6%), rash (24.3%), decreased appetite (23.1%), cough (22.7%), pyrexia (21.4%), and muscle spasms (20.5%).
Maltese: Ir-reazzjonijiet avversi osservati b'mod aktar frekwenti b'Rd jew Rd18 milli b'MPT kienu: dijarea (45.5%), għeja kbira (32.8%), uġigħ fid-dahar (32.0%), astenja (28.2%), nuqqas ta' rqad (27.6%), raxx (24.3%), nuqqas ta' aptit (23.1%), sogħla (22.7%), deni (21.4%), u spażmi tal-muskoli (20.5%).
English: Patients were randomised 1:1 to receive either lenalidomide or placebo maintenance (10 mg once daily on days 1-28 of repeated 28day cycles increased up to 15 mg once daily after 3 months in the absence of dose-limiting toxicity) following 2 courses of lenalidomide consolidation (25 mg/day, days 1-21 of a 28-day cycle).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew lenalidomide jew kura ta' manteniment bi plaċebo (10 mg darba kuljum f'jiem 1-28 ta' ċiklu ripetut ta' 28 jum li żdiedu għal sa 15-il mg darba kuljum wara 3 xhur flassenza ta' tossiċità li tillimita d-doża) wara 2 korsijiet ta' konsolidazzjoni b'lenalidomide (25 mg/jum, jiem 1-21 ta' ċiklu ta' 28 jum).
English: The median overall PFS was 33.9 months (95% CI NE, NE) in the lenalidomide arm versus 19.0 months (95% CI 16.2, 25.6) in the placebo arm.
Maltese: 001). Il-PFS medjan globali tas-sopravivenza kien ta' 33.9 xhur (95% CI NE, NE) fil-parti tal-istudju dwar lenalidomide, kontra 19.0 xhur (95% CI 16.2, 25.6) fil-parti tal-istudju dwar il-plaċebo.
English: The no observed adverse effect level (NOAEL) was considered to be less than 75 mg/kg/day, and is approximately 25-fold greater than the human daily exposure based on AUC exposure.
Maltese: In-no observed adverse effect level (NOAEL) kien ikkunsidrat li kien inqas minn 75 mg/kg/kuljum, u hu madwar 25 darba iktar mill-espożizzjoni ta' kuljum fil-bniedem ibbażata fuq l-AUC.
English: Anaemia ◊, Haemorrhagic disorder^, Leucopenias
Maltese: Tromboċitopenija^,◊, Anemija, Lewkopenija◊, Limfopenija Komuni
English: Leukocytoclastic vasculitis, Drug Reaction with Eosinophilia and Systemic Symptoms^
Maltese: Jekk il-pazjent ikollu kwalunkwe avvenimenti tromboemboliċi, il-kura trid titwaqqaf u tinbeda terapija standard kontra l-koagulazzjoni.
English: The percentage of multiple myeloma patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups.
Maltese: Il-perċentwali ta' pazjenti b'majeloma multipla li kellhom 65 sena jew iktar ma kienx differenti b'mod sinifikattiv bejn il-gruppi ta' lenalidomide/dexamethasone u tal-plaċebo/dexamethasone.
English: Lenalidomide Accord 15 mg hard capsules lenalidomide
Maltese: Lenalidomide Accord 15 mg kapsuli ibsin lenalidomide
English: At doses of 5 to 25 mg/day, half-life in plasma is approximately 3 hours in healthy volunteers and ranges from 3 to 5 hours in patients with multiple myeloma,.
Maltese: Fid-dożi ta' minn 5 sa 25 mg/kuljum, il-half-life fil-plażma hi ta' madwar 3 sigħat f'voluntiera b'saħħithom u tvarja minn 3 sa 5 sigħat f'pazjenti b'majeloma multipla.
English: In this pooled extended follow-up analysis, the median TTP was 60.1 weeks (95% CI: 44.3, 73.1) in patients treated with len/dex (N = 353) versus 20.1 weeks (95% CI: 17.7, 20.3) in patients treated with placebo/dex (N = 351).
Maltese: F'din l-analiżi follow-up estiża tal-istudji miġbura, it-TTP medjan kien ta' 60.1 ġimgħat (95% CI: 44.3, 73.1) f'pazjenti kkurati b' len/dex (N = 353) kontra 20.1 ġimgħat (95% CI: 17.7, 20.3) f'pazjenti kkurati bil-plaċebo/dex (N = 351).
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Maltese: Għal pazjenti li jkunu pożittivi għal infezzjoni bl-HBV, konsultazzjoni ma' tabib b'kompetenza filkura tal-epatite B hi rakkomandata.
English: • That Lenalidomide Accord may cause neutropenia and thrombocytopenia and the need for regular blood tests
Maltese: • Li Lenalidomide Accord jista' jikkawża newtropenja u tromboċitopenja u l-ħtieġa ta' testijiet tad-demm regolari
English: Each capsule contains 10 mg of lenalidomide.
Maltese: Kull kapsula fiha 10 mg ta' lenalidomide.
English: CI = confidence interval; HR = hazard ratio; max = maximum; min = minimum; NE = not estimable; OS = overall survival; PFS = progression-free survival;
Maltese: HR = proporzjon ta' periklu; max = massimu; min = minimu; NE = ma tistax issir stima; OS = sopravivenza globali;
English: Lenalidomide Accord 7.5 mg hard capsules Gelatin
Maltese: Lenalidomide Accord 7.5 mg kapsuli ibsin Gelatin
English: Population pharmacokinetic analyses indicate that body weight (33- 135 kg), gender, race and type of haematological malignancy do not have a clinically relevant effect on lenalidomide clearance in adult patients.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tindika li l-piż tal-ġisem (33 -135 kg), is-sess tal-persuna, irrazza u t-tip ta' tumuri malinni ematoloġiċi, m'għandhomx effett klinikament rilevanti fuq it-tneħħija ta' lenalidomide f'pazjenti adulti.
English: a The median is based on the Kaplan-Meier estimate.
Maltese: ª Il-medjan hu bbażat fuq stima ta' Kaplan-Meier.
English: Each capsule contains 7.5 mg of lenalidomide.
Maltese: Kull kapsula fiha 7.5 mg ta' lenalidomide.
English: An open-label, randomised, multicenter, phase III study (ECOG E4A03) was conducted in 445 patients with newly diagnosed multiple myeloma; 222 patients were randomised to the lenalidomide/low dose dexamethasone arm, and 223 were randomised to the lenalidomide/standard dose dexamethasone arm.
Maltese: Studju ta' fażi 3 (ECOG E4A03), miftuħ, li fih il-parteċipanti ntgħażlu b'mod każwali, multiċentriku, sar fuq 445 pazjenti li kienu ddijanjostikati għall-ewwel darba b'majeloma multipla; 222 pazjent intgħażlu b'mod każwali fil-parti tal-istudju fejn il-parteċipanti rċivew lenalidomide/doża baxxa ta' dexamethasone, u 223 ntgħażlu b'mod każwali fil-parti tal-istudju fejn il-parteċipanti rċivew lenalidomide/doża standard ta' dexamethasone.
English: There was a higher frequency of grade 4 febrile neutropenia observed (1.7% in MPR+R/MPR+p compared to 0.0% in MPp+p).
Maltese: Kien hemm frekwenza ogħla ta' newtropenija bid-deni ta' grad 4 (1.7% f'MPR+R/MPR+p meta mqabbla ma' 0.0% f'MPp+p).
English: Respiratory, Thoracic and Mediastinal Disorders
Maltese: Disturbi Respiratorji, Toraċiċi u Medjastinali
English: Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients; see section 4.8).
Maltese: Episodji ta' newtropenija bid-deni ta' grad 4 kienu osservati b'mod mhux frekwenti (0.6% f'pazjenti kkurati b'lenalidomide/dexamethasone meta mqabbla ma' 0.0% f'pazjenti kkurati bil-placebo/dexamethasone; ara sezzjoni 4.8).
English: In both studies, the baseline demographic and disease-related characteristics were comparable between the len/dex and placebo/dex groups.
Maltese: Fiż-żewġ studji, il-linja bażi demografika u l-karatteristiċi relatati mal-marda kienu komparabbli bejn il-gruppi ta' len/dex u tal-plaċebo/dex.
English: In general, study subjects had advanced-stage disease: of the total study population, 41% had ISS stage III, 9% had severe renal insufficiency (creatinine clearance [CLcr] < 30 mL/min).
Maltese: B'mod ġenerali, individwi fl-istudju kellhom marda fi stat avvanzat: millpopolazzjoni totali fl-istudju, 41% kellhom ISS fi stadju III, 9% kellhom insuffiċjenza severa tal kliewi (tneħħija tal-krejatinina [CLcr] ta' < 30 mL/min).
English: • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Maltese: • Kopulazzjoni sesswali li tkun biss ma' raġel li kellu vasektomija; il-vasektomija trid tkun ikkonfermata minn żewġ analiżi negattivi tas-semen
English: Fall to < 0.5 x 109/L
Maltese: Jaqgħu għal < 0.5 x 109/L
English: The combination of lenalidomide with low dose dexamethasone in newly diagnosed multiple myeloma patients is associated with a lower frequency of grade 4 neutropenia (8.5% in Rd and Rd18, compared with MPT (15%).
Maltese: Il-kombinazzjoni ta' lenalidomide ma' doża baxxa ta' dexamethasone f'pazjenti b'majeloma multipla ddijanjostikata għall-ewwel darba hi assoċjata ma' frekwenza aktar baxxa ta' newtropenija ta' grad 4 (8.5% f'Rd u Rd18) meta mqabbla ma' MPT (15%).
English: In vitro (bacterial mutation, human lymphocytes, mouse lymphoma, Syrian Hamster Embryo cell transformation) and in vivo (rat micronucleus) mutagenicity studies revealed no drug related effects at either the gene or chromosomal level.
Maltese: In vitro (mutazzjoni batterjali, limfoċiti umani, limfoma fil-ġrieden, trasformazzjoni taċ-ċelluli tasSyrian Hamster Embryo) u in vivo (mikronukleu tal-firien) studji dwar il-mutaġeniċità dwar dawn ilfatturi ma żvelaw l-ebda effetti marbuta mal-mediċina, la fuq livell ta' ġeni u lanqas fuq livell kromosomali.
English: Dose level -5
Maltese: Livell tad-doża -5
English: In patients with multiple myeloma, the combination of lenalidomide with dexamethasone is associated with an increased risk of venous thromboembolism (predominantly deep vein thrombosis and pulmonary embolism) and was seen to a lesser extent with lenalidomide in combination with melphalan and prednisone.
Maltese: F'pazjenti b'majeloma multipla, il-kombinazzjoni ta' leanlidomide ma' dexamethasone hi assoċjata ma' żieda fir-riskju ta' tromboemboliżmu venuż (il-biċċa l-kbira trombożi fonda tal-vini u emboliżmu pulmonari) u ġie osservat fi grad inqas b'lenalidomide flimkien ma' melphalan u prednisone.
English: Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants.
Maltese: Immunosoppressanti, immunosoppressanti oħrajn.
English: In patients with multiple myeloma, , treatment with lenalidomide monotherapy was associated with a lower risk of venous thromboembolism (predominantly deep vein thrombosis and pulmonary embolism) than in patients with multiple myeloma treated with lenalidomide in combination therapy (see sections 4.5 and 4.8).
Maltese: F'pazjenti majeloma multipla, il-kura b'lenalidomide mogħti waħdu kienet assoċjata ma' riskju aktar baxx ta' tromboemboliżmu venuż (il-biċċa l-kbira trombożi tal-vini profondi u emboliżmu pulmonari), milli minn pazjenti b'majeloma multipla kkurati b'lenalidomide f'terapija kombinata (ara sezzjonijiet 4.5 u 4.8).
English: Resume lenalidomide at dose level -1
Maltese: Erġa' ibda lenalidomide u melphalan fillivell tad-doża - 1
English: Cases of allergic reaction/hypersensitivity reactions have been reported in patients treated with lenalidomide (see section 4.8).
Maltese: Każijiet ta' reazzjonijiet allerġiċi/sensittività eċċessiva kienu rrappurtati f'pazjenti kkurati b'lenalidomide (ara sezzjoni 4.8).
English: Each capsule contains 2.5 mg of lenalidomide.
Maltese: Kull kapsula fiha 2.5 mg ta' lenalidomide.
English: Dose level -2
Maltese: Livell tad-doża -2
English: In the CALGB 100104 study, the adverse reactions observed more frequently with lenalidomide maintenance than placebo were neutropenia (79.0% [71.9% after the start of maintenance treatment]), thrombocytopenia (72.3% [61.6%]), diarrhoea (54.5% [46.4%]), rash (31.7% [25.0%]), upper respiratory tract infection (26.8% [26.8%]), fatigue (22.8% [17.9%]), leucopenia (22.8% [18.8%]) and anaemia (21.0% [13.8%]).
Maltese: Fl-istudju CALGB 100104, ir-reazzjonijiet avversi osservati aktar ta' spiss bid-doża ta' manteniment ta' lenalidomide milli bi plaċebo kienu newtropenija (79.0% [71.9% wara l-bidu tal-kura ta' manteniment]), tromboċitopenija (72.3% [61.6%), dijarea (54.5% [46.4%]), raxx (31.7% [25.
English: Fall to < 30 x 109/L
Maltese: Jaqgħu għal < 30 x 109/L
English: Treatment-emergent AEs of neutropenia leading to lenalidomide discontinuation were reported in 2.2% of patients in CALGB 100104 and 2.4% of patients in IFM 2005-02, respectively.
Maltese: AEs ta' newtropenija li jiżviluppaw mill-kura li jwasslu għat-twaqqif ta' lenalidomide ġew irrappurtati f'2.2% tal-pazjenti f'CALGB 100104 u 2.4% tal-pazjenti f'IFM 2005-02, rispettivament.
English: Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients).
Maltese: Episodji ta' newtropenija bid-deni ta' grad 4 kienu osservati b'mod mhux frekwenti (0.6% f'pazjenti kkurati b'lenalidomide/dexamethasone meta mqabbla ma' 0.0% f'pazjenti kkurati bilplacebo/dexamethasone).
English: Various visceral effects (discoloration, red foci at different organs, small colourless mass above atrioventricular valve, small gall bladder, malformed diaphragm) were also observed in single foetuses.
Maltese: Diversi effetti vixxerali (tibdil fil-kulur, foci ħomor f'organi differenti, massa żgħira bla kulur fuq ilvalv atrijo-ventrikulari, bużżieqa tal-marrara żgħira, dijaframma malformata) kienu wkoll osservati f'feti singoli.
English: 10 mg once daily1
Maltese: 10 mg darba kuljum1
English: Pancreatitis, Gastrointestinal perforation (including diverticular, intestinal and large intestine perforations)^
Maltese: Mhux Magħrufa Pankreatite, Perforazzjoni gastrointestinali (li tinkludi perforazzjonijiet divertikulari, intestinali u tal-musrana lkbira)^
English: The incidence rate of solid tumour SPMs was 1.36 per 100 person-years for the lenalidomide arms and 1.05 per 100 person-years for the placebo arms (1.26 per 100 person-years for patients exposed to lenalidomide after ASCT and 0.60 per 100 person-years for patients not-exposed to lenalidomide after ASCT).
Maltese: Ir-rata ta' inċidenza ta' tumuri solidi SPMs kienet ta' 1.36 għal kull 100 sena ta' persuna għall-partijiet tal-istudju dwar lenalidomide u ta' 1.05 għal kull 100 sena ta' persuna għall-partijiet tal-istudju dwar il-plaċebo (1.26 għal kull 100 sena ta' persuna esposti għal lenalidomide wara ASCT, u 0.60 għal kull 100 sena ta' persuna għal pazjenti mhux esposti għal lenalidomide wara ASCT).
English: The combination of lenalidomide with melphalan and prednisone in newly diagnosed multiple myeloma patients is associated with a higher frequency of grade 3 and grade 4 thrombocytopenia (40.4% in MPR+R/MPR+p) compared with MPp+p (13.7%).
Maltese: Il-kombinazzjoni ta' lenalidomide ma' melphalan u prednisone f'pazjenti b'majeloma multipla ddijanjostikata għall-ewwel darba hi assoċjata ma' frekwenza ogħla ta' tromboċitopenija ta' grad 3 u grad 4 (40.4% f'MPR+R/MPR+p) meta mqabbla ma' MPp+p (13.7%).
English: The results of PFS at unblinding, following a preplanned interim analysis, using a cut-off of 7 July 2010 (31.4 months follow up) showed a 48% reduction in risk of disease progression or death favoring lenalidomide (HR = 0.52; 95% CI 0.41, 0.66; p <0.001).
Maltese: (31.4 xhur ta' follow-up), urew tnaqqis ta' 48% fir-riskju tal-progressjoni talmarda jew il-mewt, favur lenalidomide (HR = 0.52; 95% CI 0.41, 0.66;
English: Lenalidomide maintenance after ASCT is associated with a higher frequency of grade 4 neutropenia compared to placebo maintenance (32.1% vs 26.7% [16.1% vs 1.8% after the start of maintenance treatment] in CALGB 100104 and 16.4% vs 0.7% in IFM 2005-02, respectively).
Maltese: Manteniment b'lenalidomide wara ASCT hu assoċjat ma' frekwenza ogħla ta' newtropenija ta' grad 4 meta mqabbla mal-partijiet tal-istudju dwar il-manteniment bi plaċebo (32.1% vs 26.7% [16.1% kontra 1.8% wara l-bidu tal-kura ta' manteniment] f'CALGB 100104 u 16.4% vs 0.7% f'IFM 200502, rispettivament).
English: How to store Lenalidomide Accord 6.
Maltese: Kif taħżen Lenalidomide Accord 6.
English: The median overall survival in the extended follow-up analysis of the pooled studies is 164.3 weeks (95% CI: 145.1, 192.6) in patients treated with len/dex versus 136.4 weeks (95% CI: 113.1, 161.7) in patients treated with placebo/dex.
Maltese: Il-medjan tas-sopravivenza totali fl-analiżi follow-up estiża tal-istudji miġbura hi ta' 164.3 ġimgħat (95% CI: 145.1, 192.6) f'pazjenti kkurati b'len/dex kontra 136.4 ġimgħat (95% CI: 113.1, 161.7) f'pazjenti kkurati bil-plaċebo/dex.
English: Each capsule contains 15 mg of lenalidomide.
Maltese: Kull kapsula fiha 15 mg ta' lenalidomide.
English: All patients received prophylactic anticoagulation (low molecular weight heparin, warfarin, heparin, low-dose acetylsalicylic acid during the study.
Maltese: Il-pazjenti kollha rċivew antikoagulazzjoni profilattika (eparina b'piż molekulari baxx, WARFARINA, eparina, doża baxxa ta' acetylsalicylic acid) matul l-istudju.
English: Lenalidomide Accord 10 mg hard capsules:
Maltese: Lenalidomide Accord 10 mg kapsuli ibsin: