natgillin/translations-raw huggingface dataset:
Frequencies are defined as very common (≥ 1/ 10) and common (≥ 1/ 100 to < 1/ 10).
Pogostnost je navedena kot zelo pogosta (≥ 1/ 10) ali pogosta (≥ 1/ 100 do < 1/ 10).
The most frequent adverse reactions considered due to receipt of 2x1000 mg MabThera in Phase II and III studies were acute infusion reactions.
Najpogostejši neželeni učinki, za katere so menili, da so nastali zaradi prejetja 2 x 1000 mg zdravila MabThera v študijah faze II in III, so bile akutne reakcije, povezane z infuzijo.
Infusion reactions occurred in 15% patients following the first infusion of rituximab and 5% in placebo patients.
Reakcije, povezane z infuzijo, so se pojavile pri 15% bolnikov po prvi infuziji rituksimaba in pri 5% bolnikov, ki so prejemali placebo.
Infusion reactions decreased to 2% following the second infusion in both rituximab and placebo groups.
Pojavnost reakcij, povezanih z infuzijo, se je zmanjšala na 2% po drugi infuziji v skupini, ki je prejemala rituksimab, in skupini, ki je prejemala placebo.
The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for MabThera (see section 4.4).
15 trg odražajo pričakovani profil neželenih učinkov iz kliničnih preskušanj zdravila MabThera (glejte poglavje 4. 4).
Summary of Adverse Drug Reactions Reported in Clinical Trials or During Postmarketing Surveillance Occurring in Patients with Rheumatoid Arthritis receiving MabThera
Povzetek neželeni učinkov, o katerih so poročali med kliničnimi študijami ali po prihodu zdravila na trg pri bolnikih z revmatoidnim artritisom, ki so prejemali zdravilo MabThera.
System Organ Infections and Infestations
Organski sistem Infekcijske in parazitske bolezni
Class Very Common Common any infection, upper urinary tract respiratory tract infections infection
Zelo pogosti Pogosti okužbe sečil katera koli okužba, okužba zgornjih dihal
Immune System Disorders General disorders and administration site conditions
Glejte tudi spodnji odstavek o reakcijah, povezanih z infuzijo.
*Infusion related reactions (nausea, chills, rhinitis, urticaria hot flush) hypertension, rash, pyrexia, pruritus, throat irritation and hypotension
O neželenih dogodkih, katerih incidenca je bila v skupinah, ki so prejemale samo zdravilo MabThera, podobna incidenci v kontrolnih skupinah, so v kliničnih preskušanjih poročali z uporabo naslednjih terminov: okužbe spodnjih dihal/ pljučnica, bolečina v zgornjem delu trebuha, mišični krči in splošna oslabelost.
*Infusion related reactions (generalized oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalized pruritis, anaphylaxis, anaphylactoid reaction)
Poleg dogodkov v zgornji preglednici so med možne neželene učinke vključili naslednje klinično pomembne dogodke, o katerih so občasno poročali v populaciji, zdravljeni z rituksimabom:
Metabolism and Nutritional Disorders
Bolezni dihal:
hypercholesterolemia
Bolezni kože in podkožja:
Nervous System disorders Gastrointestinal Disorders
Bolezni imunskega sistema:
Paraesthesia, migraine dyspepsia
generalizirani edem bronhospazem, sopenje, edem grla angionevrotični edem, generalizirani pruritus anafilaksa, anafilaktoidna reakcija
Musculo skeletal disorders
Večkratno zdravljenje
See also infusion-related reactions below.
Omejeni podatki iz kliničnih preskušanj z večkratnim zdravljenjem bolnikov z revmatoidnim artritisom nakazujejo, da je profil neželenih učinkov podoben tistemu, ki so ga opazili ob prvem zdravljenju.
Infusion related reactions may occur as a result of hypersensitivity and/ or to the mechanism of action.
Pri ponovnem zdravljenju HACA pozitivnih bolnikov pa na osnovi podatkov, ki so na voljo, po dajanju rituksimaba ne moremo izključiti intenzivnejših z infuzijo povezanih ali alergijskih reakcij in nezmožnosti zmanjšanja števila celic B.
The following terms have been reported as adverse events during clinical trials, however, were reported at a similar incidence in the MabThera-arms compared to control arms: lower respiratory tract infections/ pneumonia, abdominal pain upper, muscle spasms and asthenia.
Incidenca akutnih reakcij, povezanih z infuzijo, je bila po nadaljnjih ciklih zdravljenja navadno manjša od incidence po prvi infuziji zdravila MabThera.
However, worsening of infusion or allergic reactions and failure to B cell deplete following rituximab cannot be excluded in HACA positive patients after repeated exposure to rituximab on the basis of available data.
Reakcije, povezane z infuzijo Simptome, ki nakazujejo na akutno reakcijo, povezano z infuzijo (npr. pruritus, zvišana telesna temperatura, urtikarija/ kožni izpuščaj, mrazenje, pireksija, okorelost, kihanje, angionevrotični edem, vnetje žrela, kašelj in bronhospazem, s sočasno hipotenzijo ali hipertenzijo ali brez ene ali druge) so opazili pri 79 od 540 (15%) bolnikov pri prvem zdravljenju z zdravilom MabThera.
The incidence of acute infusion reactions following subsequent treatment courses was generally lower than the incidence following the first infusion of MabThera.
V študiji, ki je ocenjevala dodatek
15 Infusion-related reactions Symptoms suggesting an acute infusion reaction (e. g. pruritis, fever, urticaria/ rash, chills, pyrexia, rigors, sneezing, angioneurotic edema, throat irritation, cough and bronchospasm, with or without associated hypotension or hypertension) were observed in 79/ 540 (15%) patients following their first exposure to MabThera; In a study comparing the effect of glucocorticoid regimen, these events were observed in 5/ 149 (3%) of patients following their first rituximab placebo infusion and 42/ 192 (22%) of patients receiving their first infusion of 1000 mg rituximab.
16 glukokortikoidnega zdravljenja, so te dogodke opazili pri 5 od 149 (3%) bolnikov po prvi injekciji placeba in pri 42 od 192 (22%) bolnikov, ki so prejeli prvo infuzijo 1000 mg rituksimaba.
Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of these events.
Premedikacija z intravenskimi glukokortikoidi je pomembno znižala incidenco in resnost teh dogodkov.
Of the patients who received 1000 mg rituximab without premedication with glucocorticoids, 18/ 65 (28%) experienced an acute infusion reaction, compared with 24/ 127 (19%) in patients given intravenous glucocorticoid premedication, respectively.
Od bolnikov, ki so prejeli 1000 mg rituksimaba brez premedikacije z glukokortikoidi, jih je 18 od 65 (28%) imelo akutno reakcijo, povezano z infuzijo, v primerjavi s 24 od 127 (19%) pri bolnikih, ki so dobili premedikacijo z intravenskimi glukokortikoidi.
Infections The rate of infection was approximately 0.9 per patient year in MabThera treated patients.
Okužbe Pri bolnikih, ki so se zdravili z zdravilom MabThera, je bil delež okužb približno 0, 9 na bolnik- leto.
The infections consisted mostly of upper respiratory tract infections and urinary tract infections.
Večinoma je šlo za okužbe zgornjih dihal in sečil.
The incidence of clinically significant infection, some of which were fatal, was 0.05 per patient year in MabThera treated patients.
Incidenca klinično pomembnih okužb, od katerih je bilo nekaj smrtnih, je bila pri bolnikih, ki so se zdravili z zdravilom MabThera 0, 05 na bolnik- leto.
This includes Rheumatoid Arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and Vasculitis.
Pri uporabi zdravila MabThera za zdravljenje avtoimunskih bolezni so poročali o smrtnih primerih progresivne multifokalne levkoencefalopatije, in sicer pri revmatoidnem artritisu in avtoimunskih boleznih, za katere zdravilo ni odobreno, sistemskem eritematoznem lupusu (SLE) in vaskulitisu.
All the reported cases had multiple risk factors for PML, including either the underlying disease and or long-term immunosuppressive therapy or chemotherapy.
Vsi primeri, o katerih so poročali, so imeli več dejavnikov tveganja za PML, vključno z obstoječo boleznijo in/ ali dolgotrajnim imunosupresivnim zdravljenjem ali kemoterapijo.
Malignancies The clinical data, particularly the number of repeated courses, are too limited to assess the potential incidence of malignancies following exposure to rituximab, although present data do not seem to suggest any increased risk.
Maligne bolezni Klinični podatki, predvsem število ponovnih zdravljenj, so preveč omejeni, da bi lahko ocenili možnost pojava malignih bolezni po zdravljenju z rituksimabom, čeprav sedanji podatki ne kažejo kakršnegakoli povečanega tveganja.
Long-term safety evaluations are ongoing.
Dolgoročno vrednotenje varnosti je v teku.
Cardiovascular Cardiac events were observed in 11% patients in clinical studies with MabThera.
Kardiovaskularni neželeni dogodki Neželene dogodke, povezane s srcem, so opazili pri 11% bolnikov v kliničnih študijah z zdravilom MabThera.
In placebo controlled studies, serious cardiac events were reported equally in MabThera and placebo treated patients (2%).
V s placebom primerjanih študijah so v skupini, ki je prejemala zdravilo MabThera, in skupini, ki je prejemala placebo, enako pogosto poročali o resnih neželenih dogodkih, povezanih s srcem (2%).
There has been no experience of overdose in human clinical trials.
Pri kliničnih preskušanjih pri človeku ni nobenih izkušenj v zvezi s prevelikim odmerjanjem zdravila MabThera.
However, single doses higher than 1000 mg have not been tested in controlled clinical trials.
Vendar pa večjih enkratnih odmerkov od 1000 mg niso preskušali.
Pharmacotherapeutic group: monoclonal antibodies, ATC code:
Farmakoterapevtska skupina: monoklonska protitelesa, oznaka ATC:
Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Rituksimab se veže specifično na transmembranski antigen, CD20, neglikoziliran fosfoprotein, ki se nahaja na limfocitih pre- B in dozorelih limfocitih B.
The antigen is expressed on > 95% of all B cell non-Hodgkin’ s lymphomas.
Antigen je izražen pri > 95% vseh B- celičnih ne- Hodgkinovih limfomov.
CD20 is found on both normal and malignant B cells, but not on haematopoietic stem cells, pro- B cells, normal plasma cells or other normal tissue.
CD20 najdemo tako na običajnih kot na malignih celicah B, vendar ne na matičnih hematopoetskih celicah, pro- B- celicah, normalnih plazemskih celicah ali drugem normalnem tkivu.
16 The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis.
Domena rituksimaba Fab se veže na antigen CD20 na B- limfocitih in prek domene Fc sproži imunska dogajanja, ki privedejo do razgradnje celic B.
Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells.
Mogoča mehanizma celične razgradnje vsebujeta od komplementa odvisno citotoksičnost (CDC), ki je posledica vezave Clq in od protiteles odvisno celično citotoksičnost (ADCC), ki jo posreduje eden ali več receptorjev Fcγ na površini granulocitov, makrofagov ali naravnih celic ubijalk.
Rituximab binding to CD 20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.
Vezava rituksimaba na antigen CD20 na limfocitih B povzroči celično smrt z apoptozo.
Peripheral B cell counts declined below normal following completion of the first dose of MabThera.
Število perifernih celic B se je po zaključku prvega odmerka zdravila MabThera zmanjšalo pod
In patients treated for hematological malignancies, B cell repletion began within 6 months of treatment returning to normal levels between 9 and 12 months after completion of therapy.
Pri bolnikih, ki so se zdravili zaradi hematoloških malignih bolezni, se je število B celic začelo popravljati v 6 mesecih zdravljenja, normaliziralo se je po 9 do 12 mesecih po končanem zdravljenju.
In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg MabThera separated by a 14 day interval.
Pri bolnikih z revmatodnim artritisom so takojšen upad števila celic B v periferni krvi opazili po dveh infuzijah 1000 mg zdravila MabThera v razmiku 14 dni.
Clinical Experience in Non-Hodgkin’ s lymphoma and in chronic lymphocytic leukaemia
Klinične izkušnje pri ne- Hodgkinovem limfomu in kronični limfocitni levkemiji
Monotherapy Initial treatment, weekly for 4 doses In the pivotal study, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/ m2 of MabThera as an intravenous infusion once weekly for four weeks.
Samostojno zdravljenje Začetno zdravljenje, 4 odmerki, enkrat na teden V ključnem preskušanju je 166 bolnikov, pri katerih se je nizko maligni ne- Hodgkinov limfom ali folikularni B- celični ne- Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo, 4 tedne prejemalo po 375 mg/ m2 zdravila MabThera v obliki intravenske infuzije enkrat na teden.
The overall response rate (ORR) in the intent-to-treat (ITT) population was 48% (CI95% 41% - 56%) with a 6% complete response (CR) and a 42% partial response (PR) rate.
Celokupen odgovor (ORR, overal response rate) v populaciji z namenom zdraviti (ITT, the intent- to - treat) je bil 48% (95 -% interval zaupanja 41−56%), od tega popoln odgovor (CR, complete response) pri 6%, delni odgovor (PR, partial response) pa pri 42%.
The projected median time to progression (TTP) for responding patients was 13.0 months.
Mediana časa do napredovanja bolezni (TTP, time to progression) je pri odzivnih bolnikih znašala 13, 0 mesecev.
12%), higher in patients whose largest lesion was< 5 cm vs. > 7 cm in greatest diameter (53% vs.
V analizi podskupin je bil celokupen odgovor boljši pri bolnikih s histološkimi podtipi IWF B, C in D (58%) v primerjavi s podtipom IWF A (12%); boljši pri bolnikih, katerih največje lezije so bile v največjem premeru manjše od 5 centimetrov (53%) kot pri bolnikih, katerih lezije so bile v največjem premeru večje kot 7 centimetrov (38%).
22%).
Celokupen odgovor pri bolnikih, pri katerih je prišlo do ponovitve bolezni, je bil boljši pri bolnikih, občutljivih za kemoterapijo (50%), kot pa pri bolnikih, neodzivnih na kemoterapijo (opredeljeno kot trajanje odgovora < 3 mesece) (22%).
Neither age, sex, lymphoma grade, initial diagnosis, presence or absence of bulky disease, normal or high LDH nor presence of extranodal disease had a statistically significant effect (Fisher’ s exact test) on response to MabThera.
Na odgovor na zdravilo MabThera naslednji dejavniki niso imeli statistično značilnega vpliva (Fisherjev natančni test): starost, spol, gradus limfoma, začetna diagnoza, prisotnost ali odsotnost obsežne bolezni, normalna ali visoka koncentracija LDH ali ekstranodalna bolezen.
40% of patients with bone marrow involvement responded compared to 59% of patients with no bone marrow involvement (p=0.0186).
Na zdravljenje se je odzvalo 40% bolnikov z infiltracijo kostnega mozga v primerjavi z 59% bolnikov brez infiltracije kostnega mozga (p = 0, 0186).
This finding was not supported by a stepwise logistic regression analysis in which the following factors were identified as prognostic factors: histological type, bcl-2 positivity at baseline, resistance to last chemotherapy and bulky disease.
Te ugotovitve niso podprli s stopenjsko logistično regresijsko analizo, s katero so ugotovili naslednje prognostične dejavnike: histološki tip, izraženost bcl- 2 na začetku zdravljenja, neodzivnost na zadnjo kemoterapijo in obsežna bolezen.
Initial treatment, weekly for 8 doses In a multi-centre, single-arm study, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/ m2 of MabThera as intravenous infusion weekly for eight doses.
Začetno zdravljenje, 8 odmerkov, enkrat na teden V multicentrični študiji brez primerjalne skupine je 37 bolnikov, pri katerih se je nizko maligni ne - Hodgkinov limfom ali folikularni B- celični ne- Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo, prejemalo osem odmerkov po 375 mg/ m2 zdravila MabThera v obliki intravenske infuzije enkrat na teden.
The ORR was 57% (95% Confidence interval (CI); 41% – 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Celokupen odgovor je znašal 57% (95 -% interval zaupanja 41% – 73%; popoln odgovor 14%, delni odgovor 43%), mediana časa do napredovanja bolezni je bila pri odzivnih bolnikih 19, 4 meseca (razpon 5, 3 do 38, 9 meseca).
Initial treatment, bulky disease, weekly for 4 doses In pooled data from three studies, 39 patients with relapsed or chemoresistant, bulky disease (single lesion ≥ 10 cm in diameter), low grade or follicular B cell NHL received 375 mg/ m2 of MabThera as intravenous infusion weekly for four doses.
Začetno zdravljenje, obsežna bolezen, 4 odmerki, enkrat na teden Združeni podatki treh študij navajajo, da je 39 bolnikov, pri katerih se je nizko maligni ali folikularni B- celični ne- Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo in so imeli obsežno bolezen (ena lezija ≥ 10 cm v premeru), prejelo štiri odmerke po 375 mg/ m2 zdravila MabThera v obliki intravenske infuzije enkrat na teden.
The ORR was 36% (CI95% 21% – 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Celokupen odgovor je znašal 36% (95 -% interval zaupanja 21– 51%; popoln odgovor 3%, delni odgovor 33%); mediana časa do napredovanja bolezni je za odzivne bolnike znašala 9, 6 meseca (razpon 4, 5 do 26, 8 meseca).
Re-treatment, weekly for 4 doses In a multi-centre, single-arm study, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of MabThera, were re- treated with 375 mg/ m2 of MabThera as intravenous infusion weekly for four doses.
18 so dosegli objektivni klinični odgovor na predhodno zdravljenje z zdravilom MabThera, ponovno prejelo štiri odmerke po 375 mg/ m2 zdravila MabThera v obliki intravenske infuzije enkrat na teden.
Three of the patients had received two courses of MabThera before enrollment and thus were given a third course
Trije od teh bolnikov so bili dvakrat zdravljeni z zdravilom MabThera pred vključitvijo, tako so v študiji prejeli tretje zdravljenje z zdravilom MabThera.
For the 60 re-treatments on study, the ORR was 38% (CI95% 26% – 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 – 26.6).
Za 60 ponovnih zdravljenj je bil celokupen odgovor na zdravljenje 38% (95 -% interval zaupanja 26– 51%; 10% popoln odgovor, 28% delni odgovor).
This compares favourably with the TTP achieved after the prior course of MabThera (12.4 months).
To je lepo primerljivo s časom do napredovanja bolezni, ki je bil dosežen po predhodnem zdravljenju z zdravilom MabThera (12, 4 meseca).
Initial treatment, in combination with chemotherapy In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/ m2, vincristine 1.4 mg/ m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/ m2/ day on days 1 -5) every 3 weeks for 8 cycles or MabThera 375 mg/ m2 in combination with CVP (R-CVP).
Začetno zdravljenje, v kombinaciji s kemoterapijo V randomiziranem odprtem preskušanju je skupno 322 predhodno nezdravljenih bolnikov s folikularnimi limfomi randomizirano prejelo ali 8 ciklov kemoterapije CVP (ciklofosfamid 750 mg/ m2, vinkristin 1, 4 mg/ m2 do največ 2 mg na prvi dan, in prednizolon 40 mg/ m2/ dan od 1. – 5. dne) vsake 3 tedne ali zdravilo MabThera v odmerku 375 mg/ m2 v kombinaciji s CVP (R- CVP).
MabThera was administered on the first day of each treatment cycle.
Zdravilo MabThera so prejeli prvi dan vsakega cikla zdravljenja.
A total of 321 patients (162 R-CVP, 159 CVP) received therapy and were analysed for efficacy.
Skupno so zdravili ter glede na učinkovitost analizirali 321 bolnikov (162 R- CVP, 159 CVP).
6.6 months, p < 0.0001, log-rank test).
Skupina R- CVP je imela glede primarnega cilja raziskave, to je časa do prenehanja učinkovitosti zdravljenja, značilno prednost pred skupino CVP (27 mesecev proti 6, 6 meseca, p < 0, 0001, test log- rank).
The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p < 0.0001 Chi-Square test) in the R-CVP group (80.9%) than the CVP group (57.2%).
Delež bolnikov z odgovorom na zdravljenje (CR, CRu – nepotrjeni popoln odgovor (complete response/ uncomfirmed), PR) je bil značilno večji (p < 0, 0001, test hi- kvadrat) v skupini R- CVP (80, 9%) kot pa v skupini CVP (57, 2%).
Treatment with R-CVP significantly prolonged the time to disease progression or death compared to CVP, 33.6 months and 14.7 months, respectively (p < 0.0001, log-rank test).
Zdravljenje z R- CVP je značilno podaljšalo čas do napredovanja bolezni ali smrti v primerjavi s CVP (33, 6 meseca proti 14, 7 meseca, p < 0, 0001, test log- rank).
The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test).
Mediana trajanja odgovora je bila v skupini R- CVP 37, 7 meseca, v skupini CVP pa 13, 5 meseca (p < 0, 0001, test log- rank).
The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by center): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group
Razlika med zdravljenima skupinama glede na celokupno preživetje je pokazala pomembno klinično razliko (p = 0, 029, test log- rank, stratifikacija s strani centra): preživetje po 53 mesecih je bilo 80, 9% za bolnike v R- CVP skupini v primerjavi z 71, 1% za bolnike v CVP skupini.
Results from three other randomized trials using MabThera in combination with chemotherapy regimen other than CVP (CHOP, MCP, CHVP/ Interferon-α) have also demonstrated significant improvements in response rates, time-dependent parameters as well as in overall survival.
Rezultati treh drugih randomiziranih preskušanj z uporabo zdravila MabThera/ Rituxan v kombinaciji z drugimi kemoterapijami, poleg CVP (CHOP, MCP, CHVP/ interferon- α), so prav tako pokazali pomembno izboljšanje v odgovoru, od časa odvisnih parametrih in celokupnem preživetju.
Key results from all four studies are summarized in table 3.
Ključni rezultati iz vseh štirih študij so povzeti v preglednici 3.
18 Table 3
19 Preglednica 3.
Summary of key results from four phase III randomized studies evaluating the benefit of MabThera with different chemotherapy regimens in follicular lymphoma
Povzetek ključnih rezultatov iz štirih študij faze III, s katerimi so ocenjevali korist zdravila MabThera z različnimi shemami kemoterapije pri zdravljenju folikularnih limfomov.
Median Median Treatment, CR,
Mediana Mediana
Study
CR (%)
FU, ORR,% TTF/ PFS/ EFS N%
TTF/ PFS/ EFS (meseci) mediana TTP:
rates,
(%) 53 mesecev
months mo Median TTP:
159
80.9
41
P < 0.0001
80, 9 p = 0, 029
p=0.029
18 mesecev
Not reached p < 0.001
nedoseženo
48-months
p < 0, 001
Median PFS:
p = 0, 016
28.8 OSHO-39
48 mesecev mediana PFS:
MCP, 96
96
Not reached
28, 8
p < 0.0001
nedoseženo
0.0096
p < 0, 0001
CHVP-IFN,
p =
Median EFS:
0, 0096
42-months
42 mesecev
FL2000
CHVP- IFN:
Not reached
mediana EFS:
EFS – Event Free Survival TTP – Time to progression or death PFS – Progression-Free Survival TTF – Time to Treatment Failure OS rates – survival rates at the time of the analyses
EFS: preživetje brez dogodka (Event Free Survival) TTP: čas do napredovanja bolezni ali smrti (Time to progression or death) PFS: preživetje brez napredovanja bolezni (Progression- Free survival) TTF: čas do prenehanja učinkovitosti zdravljenja (Time to Treatment Failure) OS: celokupno preživetje v času analize (survival rates at the time of the analyses)