natgillin/translations-raw huggingface dataset:
• with unresolved Neisseria meningitidis infection. • who are not currently vaccinated against Neisseria meningitidis. • who have known or suspected hereditary complement deficiencies.
• z neozdravljeno okužbo z Neisseria meningitidis • ki niso bili nedavno cepljeni proti Neisseria meningitidis • z znanimi prirojenimi pomanjkljivostmi komplementa ali sumom nanje.
Meningococcal Infection:
Meningokokna okužba:
These patients might be at risk of disease by uncommon serogroups (particularly Y, W135 and X), although meningococcal disease due to any serogroup may occur.
Pri teh bolnikih utegne obstajati tveganje za bolezen, pogojeno z manj pogostimi serološkimi skupinami (zlasti Y, W135 in X), čeprav je meningokokna bolezen možna zaradi katerekoli serološke skupine.
To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving Soliris and must be re-vaccinated according to current medical guidelines for vaccination use.
Za zmanjšanje tveganja okužbe morajo biti vsi bolniki cepljeni najmanj 2 tedna pred pričetkom jemanja zdravila Soliris ter prejeti obnovitveno cepljenje v skladu z veljavnimi medicinskimi smernicami za cepljenje.
Tetravalent vaccines against serotypes A, C, Y and W135 are strongly recommended, preferably conjugated ones.
Zelo priporočljiva so štirivalentna cepiva proti serotipom A, C, Y in W135, in sicer po možnosti konjugirana.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.There have been 3 reported cases of meningococcal infection in Soliris treated patients: two in vaccinated PNH patients and one in an unvaccinated patient with idiopathic membranous glomerulonephropathy.
Pri bolnikih, ki so bili zdravljeni z zdravilom Soliris, so v 3 primerih poročali o meningokokni okužbi: dvakrat pri cepljenih bolnikih s PNH in enkrat pri necepljenem bolniku z idiopatsko membransko glomerulonefropatijo.
All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with antibiotics if necessary.
Vse bolnike je treba nadzorovati glede zgodnjih znakov meningokokne okužbe, jih nemudoma ovrednotiti v primeru suma na okužbo ter jih po potrebi zdraviti z antibiotiki.
Patients should be informed of these signs and symptoms and steps taken to seek medical care immediately (see Patient Information Leaflet for a description).
Bolnike je treba obvestiti o teh znakih in simptomih ter ustreznih ukrepih, da bi lahko nemudoma poiskali medicinsko pomoč (opis najdete v Navodilih za uporabo).
Other Systemic Infections:
Druge sistemske okužbe:
The overall severity and frequency of infections in Soliris treated patients was similar to placebo treated patients in clinical studies, although an increase in the number and severity of infections, particularly due to encapsulated bacteria, cannot
Bolnike je treba seznaniti z informacijami, ki so v Navodilih
Patients should be provided with information from the Patient Information Leaflet to increase their awareness of potential serious infections and the signs and symptoms of them.
3 za uporabo, da bi tako povečali njihovo pozornost za potencialno resne okužbe ter njihove znake in simptome.
Infusion Reactions:
Reakcije na infuzijo:
As with all therapeutic proteins, administration of Soliris may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis), though immune system disorders within 48 hours of Soliris administration did not differ from placebo treatment in PNH and non-PNH studies conducted with Soliris.
Tako kot vse terapevtske beljakovine lahko tudi aplikacija zdravila Soliris privede do reakcije na infuzijo ali imunogenosti, ki lahko povzroči alergijske ali preobčutljivostne reakcije (vključno z anafilakso), čeprav se motnje imunskega sistema v 48 urah po uporabi zdravila Soliris pri študijah z bolniki s PNH in brez PNH, ki so bile izvedene z zdravilom Soliris, niso razlikovale od tistih pri zdravljenju s placebom.
In clinical trials, no PNH patients experienced an infusion reaction which required discontinuation of Soliris.
V kliničnih preskušanjih ni imel noben bolnik s PNH takšne reakcije na infuzijo, ki bi zahtevala prekinitev zdravljenja z zdravilom Soliris.
Infrequent, low titre antibody responses have been detected in Soliris treated patients across all PNH and non-PNH studies with a frequency (3.4%) similar to that of placebo (4.8%).
V vseh študijah z bolniki s PNH ali brez PNH so se pri bolnikih, zdravljenih z zdravilom Soliris, odzivi na nizek titer protiteles pojavljali redko, in sicer s podobno pogostostjo (3, 4%) kot pri placebu (4, 8%).
No patients have been reported to develop neutralizing antibodies following therapy with Soliris, and there has been no observed correlation of antibody development to clinical response or adverse events.
Pri nobenem bolniku se po zdravljenju z zdravilom Soliris niso razvila nevtralizirajoča protitelesa, prav tako ni bilo opažene korelacije med razvojem protiteles in kliničnim odzivom ali neželenimi učinki.
Immunization:
Imunizacija:
Prior to initiating Soliris therapy, it is recommended that PNH patients should receive immunizations according to current immunization guidelines.
Pred začetkom zdravljenja z zdravilom Soliris je priporočljivo, da bolniki s PNH prejmejo imunizacije v skladu z veljavnimi smernicami o imunizaciji.
Additionally, all patients must be vaccinated against meningococcus at least 2 weeks prior to receiving Soliris.
Poleg tega morajo biti vsi bolniki cepljeni proti meningokokom najmanj 2 tedna pred prejemanjem zdravila Soliris.
If available, tetravalent, conjugated vaccines are recommended (see meningococcal disease).
Če so na voljo, so priporočljiva štirivalentna konjugirana cepiva (glejte Meningokokna bolezen).
Anticoagulant therapy:
Antikoagulantna terapija:
Laboratory Monitoring:
Laboratorijsko spremljanje:
PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels.
Bolnike s PNH je treba nadzirati glede znakov in simptomov intravaskularne hemolize, vključno z ravnmi laktat- dehidrogenaze (LDH) v serumu.
PNH patients receiving Soliris therapy should be similarly monitored for intravascular haemolysis by measuring LDH levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).
Podobno je treba bolnike s PNH, ki prejemajo zdravilo Soliris, nadzirati glede intravaskularne hemolize z merjenjem ravni LDH ter po potrebi prilagoditi odmerek v okviru priporočene sheme odmerjanja 14+ / - 2 dni med fazo vzdrževanja (največ vsakih 12 dni).
Treatment Discontinuation:
Prekinitev zdravljenja:
Patients who discontinue treatment with Soliris should be monitored for signs and symptoms of serious intravascular haemolysis.
Pri bolnikih, ki prekinejo zdravljenje z zdravilom Soliris, je treba nadzirati znake in simptome resne intravaskularne hemolize.
Serious haemolysis is identified by serum LDH levels greater than the pre-treatment level, along with any of the following: greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in one week or less; a haemoglobin level of < 5 gm/dL or a decrease of > 4 gm/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis.
Resno hemolizo označujejo ravni LDH v serumu, višje od ravni pred zdravljenjem, v povezavi s katerimkoli od naslednjih znakov: absolutno zmanjšanje velikosti klona PNH za več kot 25% (ob odsotnosti razredčenja zaradi transfuzije) v času enega tedna ali manj; raven hemoglobina < 5 gm/ dl ali zmanjšanje za > 4 gm/ dl v času enega tedna ali manj; angina; sprememba duševnega stanja; 50% povečanje ravni serumskega kreatinina; ali tromboza.
If serious haemolysis occurs after Soliris discontinuation, consider the following procedures/treatments: blood transfusion (packed RBCs), or exchange transfusion if the PNH RBCs are > 50% of the total RBCs by flow cytometry; anticoagulation; corticosteroids; or reinstitution of Soliris.
V primeru resne hemolize po prekinitvi zdravljenja z zdravilom Soliris razmislite o naslednjih postopkih/ načinih zdravljenja: transfuzija krvi (koncentriranih eritrocitov) ali izmenjalna transfuzija, če je eritrocitov PNH > 50% vseh eritrocitov (izmerjeno s pretočno citometrijo); antikoagulacija; kortikosteroidi; ali ponovna uvedba zdravila Soliris.
In PNH clinical studies, 16 patients discontinued the Soliris treatment regimen.
V kliničnih študijah PNH je 16 bolnikov prekinilo režim zdravljenja z zdravilom Soliris.
This medicinal product contains 5.00 mmol sodium per dose (1 vial).
To zdravilo vsebuje 5, 00 mmol natrija na odmerek (1 viala).
To be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih na nadzorovani natrijevi dieti.
For Soliris, no clinical data on exposed pregnancies are available.
4 Za zdravilo Soliris ni kliničnih podatkov o njegovi uporabi med nosečnostjo.
Animal reproduction studies have not been conducted with eculizumab (see section 5.3).
Z ekulizumabom niso bile izvedene nobene reprodukcijske študije na živalih (glejte poglavje 5. 3).
4 Human IgG are known to cross human placental barrier, and thus eculizumab may potentially cause terminal complement inhibition in the foetal circulation.
Za humane IgG je znano, da prehajajo preko humane placentalne bariere, iz česar sledi, da utegne ekulizumab povzročiti zaviranje terminalnega komplementa v obtoku ploda.
Woman of childbearing potential have to use adequate contraception methods during treatment and up to 5 months after treatment.
Ženske v rodni dobi morajo med zdravljenjem in do 5 mesecev po zdravljenju uporabljati ustrezne kontracepcijske metode.
It is not known whether eculizumab is secreted into human milk.
Ni znano, ali se ekulizumab izloča v materino mleko.
Since many medicinal products and immunoglobulins are secreted into human milk, and because of the potential for serious adverse reactions in nursing infants, lactation should be discontinued during treatment and up to 5 months after treatment.
Ker pa se številna zdravila in imunoglobulini izločajo v materino mleko in ker obstaja možnost resnih neželenih reakcij pri dojenčkih, je treba med zdravljenjem in do 5 mesecev po zdravljenju dojenje prekiniti.
4.8 Undesirable effects Eculizumab for the treatment of PNH was studied in three clinical studies that included 195 eculizumab-treated patients and most of these patients have been enrolled in the E05-001 extension study.
Večina med njimi je bila vključena v razširitveno študijo E05- 001.
There was one pivotal trial comparing the eculizumab-treatment arm to a placebo-treatment arm.
Izvedeno je bilo eno osrednje preskušanje, v okviru katerega so primerjali krak z ekulizumabom s krakom s placebom.
The most commonly reported adverse reactions are headache, nasopharyngitis, nausea, pyrexia, myalgia, fatigue, and herpes simplex, each occurring in 5 or more out of 100 patients.
Neželeni učinki, o katerih so najpogosteje poročali, so glavobol, nazofaringitis, navzeja, pireksija, mialgija, utrujenost in herpes simpleks, ki so se pojavljali pri 5 ali več bolnikih od 100 bolnikov.
Adverse events reported at a very common (≥1/10) or common (> 5/100 and < 10/100) frequency with eculizumab in a total of 140 patients in C04-001 and C04-002 are listed by system organ class and preferred term in Table 1.
Neželeni dogodki, o katerih so pri uporabi ekulizumaba poročali zelo pogosto (≥1/ 10) ali pogosto (od > 5/ 100 do < 10/ 100) pri skupno 140 bolnikih v študijah C04- 001 in C04- 002, so navedeni v tabeli 1 glede na organski sistem in priporočeni izraz.
Adverse events were mostly mild to moderate in severity.
Neželeni dogodki so bili večinoma blagi do zmerni.
Uncommon or rare events cannot be estimated due to limited patient exposure (195 PNH patients).
Občasnih ali redkih dogodkov ni mogoče oceniti zaradi omejenega števila izpostavljenih bolnikov (195 bolnikov s PNH).
Adverse Events Reported in Studies C04-001 and C04-002 Adverse Event
Neželeni dogodki, o katerih so poročali v študijah C04- 001 in C04- 002 Neželeni dogodek
Very Common (> 1/10) Urinary tract infection Nasopharyngitis Upper Respiratory Tract Infection
Zelo pogosto (> 1/ 10) Okužbe sečil Nazofaringitis Okužbe zgornjih dihal
Common (5/100 – 1/10) Respiratory Tract Infection Herpes Simplex Sinusitis Viral Infection Gastroenteritis
Pogosto (5/ 100 – 1/ 10) Okužbe dihal Herpes simpleks Sinuzitis
Psychiatric disorders Nervous System Disorders
Psihiatrične motnje Bolezni živčevja
Dizziness Headache
Omotica Glavobol
Epistaxis Pharyngolaryngeal pain Cough
Epistaksa Faringolaringealna bolečina Kašelj
5 Gastrointestinal Disorders
5 Bolezni prebavil
Diarrhoea Nausea
Driska Navzeja
Vomiting Abdominal Pain Abdominal Pain Upper Constipation
Bruhanje Bolečine v trebuhu Bolečine v zgornjem delu trebuha Zaprtje
Rash Pruritis
Izpuščaji Pruritus
Back Pain Arthralgia
Bolečine v hrbtu Artralgija
Myalgia Pain in extremity Muscle cramp
Mialgija Bolečine v okončinah Mišični krči
Influenza-Like Illness Fatigue
Gripi podobna bolezen Utrujenost
In the C04-001 study, headache was the most common adverse event observed with eculizumab.
V študiji C04- 001 je bil najpogosteje opažen neželeni dogodek pri uporabi ekulizumaba glavobol.
Headaches were observed in 44.2% (19/43 patients) of patients treated with eculizumab and 27.3% (12/44 patients) in placebo-treated patients and were mild/moderate in all but 1 eculizumab treated and 1 placebo-treated patients.
Glavobol je bil šibek/ zmeren pri vseh opaženih primerih, razen pri 1 bolniku, zdravljenem z ekulizumabom, in 1 bolniku, zdravljenem s placebom.
Most headaches were mild and did not persist after the initial administration phase of Soliris.
Večina glavobolov je bilo blagih in je prenehalo po začetni fazi dajanja zdravila Soliris.
In addition, the following adverse events were increased in frequency by 5% or more with Soliris as compared to placebo: nasopharyngitis (25.0%), nausea (17.1%), pyrexia (14.3%), myalgia (7.9%), fatigue (7.9%), and herpes simplex (5.7%).
Poleg tega so pri uporabi zdravila Soliris s 5 ali več odstotkov povečano pogostostjo kot pri placebu nastopali naslednji neželeni dogodki: nazofaringitis (25, 0%), navzeja (17, 1%), pireksija (14, 3%), mialgija (7, 9%), utrujenost (7, 9%) in herpes simpleks (5, 7%).
There was no evidence of an increased incidence of infection across PNH studies with eculizumab as compared to placebo, including serious infections, severe infections or multiple infections.
V okviru PNH študij ni bilo dokazov za povečanje pogostosti okužb pri uporabi ekulizumaba v primerjavi s placebom, vključno z resnimi okužbami, hudimi okužbami ali večkratnimi okužbami.
The most serious adverse event was meningococcal septicaemia in two vaccinated PNH patients (see section 4.4).
Najresnejši neželeni dogodek je bila meningokokna sepsa pri dveh cepljenih bolnikih s PNH (glejte poglavje 4. 4).
Low titres of antibodies were detected in 2% patients with PNH treated with Soliris.
Pri uporabi zdravila Soliris so bili nizki titri protiteles ugotovljeni pri 2% bolnikov s PNH.
Safety Data From Other Clinical Studies Supportive safety data were obtained in 11 clinical studies that included 716 patients exposed to eculizumab in six disease populations other than PNH.
Podatki o varnosti iz drugih kliničnih študij Podporni podatki o varnosti so bili pridobljeni v 11 kliničnih študijah, v katerih je bilo ekulizumabu izpostavljeno 716 bolnikov iz šestih skupin bolezni, drugačnih od PNH.
With regard to other AEs and considering all double-blind, placebo-controlled studies in patients diagnosed with diseases other than PNH (N=526 patients with Soliris; N=221 patients with placebo), AEs reported with Soliris at a frequency of 2% or greater than the frequency reported with placebo were: upper respiratory tract infection, rash, and injury.
V zvezi z drugimi neželenimi dogodki in ob upoštevanju vseh dvojno slepih, s placebom kontroliranih študij so pri bolnikih, pri katerih so bile poleg PNH diagnosticirane druge bolezni (n = 526 bolnikov, zdravljenih z zdravilom Soliris; n = 221 bolnikov, zdravljenih s placebom), pri jemanju zdravila Soliris poročali o naslednjih neželenih dogodkih s pogostostjo, večjo za 2% ali več kot pri placebu: okužbe zgornjih dihal, izpuščaji in poškodbe.
Immunomodulators, ATC code:
Imunomodulatorji, oznaka ATC:
Soliris is a recombinant humanised monoclonal IgG2/4k antibody that binds to the human C5 complement protein and inhibits the activation of terminal complement.
Zdravilo Soliris je rekombinantno humanizirano monoklonsko protitelo IgG2/ 4k, ki se veže na beljakovino humanega komplementa C5 in s tem zavira aktiviranje terminalnega komplementa.
The Soliris antibody contains human constant regions and murine complementarity-determining regions grafted onto the human
Protitelo zdravila Soliris vsebuje humane konstantne regije in murinske komplementarnost določajoče
6 framework light- and heavy-chain variable regions.
6 regije, presajene na humani okvir lahkih in težkih verig z variabilnimi regijami.
Soliris is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148kDa.
Zdravilo Soliris je sestavljeno iz dveh težkih verig s 448 aminokislinami in dveh lahkih verig s 214 aminokislinami ter ima molekulsko maso približno 148 kDa.
Mechanism of Action Eculizumab, the active ingredient in Soliris, is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9.
Ekulizumab, zdravilna učinkovina zdravila Soliris, je zaviralec terminalnega komplementa, ki se specifično veže na beljakovino komplementa C5 z visoko afiniteto in s tem zavira njeno cepitev na C5a in C5b ter preprečuje nastanek terminalnega kompleksa komplementa C5b- 9.
Soliris therefore restores terminal complement regulation in the blood of PNH patients and inhibits terminal complement mediated intravascular haemolysis in PNH patients.
Zdravilo Soliris torej ponovno vzpostavi regulacijo terminalnega komplementa v krvi bolnikov s PNH in pri njih zavira intravaskularno hemolizo, pogojeno s terminalnim komplementom.
Administration of Soliris results in a rapid and sustained reduction in terminal complement activity.
Uporaba zdravila Soliris povzroči hitro in trajnostno zmanjšanje aktivnosti terminalnega komplementa.
Eculizumab serum concentrations of approximately 35 microgram/ml are sufficient for essentially complete inhibition of terminal complement-mediated intravascular haemolysis in most PNH patients.
Koncentracije ekulizumaba v serumu približno 35 mikrogramov/ ml zadoščajo za dejansko popolno zavrtje intravaskularne hemolize, pogojene s terminalnim komplementom, pri večini bolnikov s PNH.
resulted in a rapid and sustained reduction in complement-mediated
Uporaba zdravila Soliris je povzročila hitro in trajnostno zmanjšanje hemolize, pogojene s komplementom.
The safety and efficacy of Soliris in PNH patients with haemolysis were assessed in a randomized, double-blind, placebo-controlled 26 week study (C04-001); PNH patients were also treated with Soliris in a single arm 52 week study (C04-002); and in a long term extension study (E05-001).
Bolniki s PNH so bili z zdravilom Soliris zdravljeni tudi v okviru 52- tedenske študije z enim krakom (C04- 002) ter v okviru dolgoročne razširitvene študije (E05- 001).
In all studies, the dose of Soliris was 600 mg study drug every 7 ± 2 days for 4 weeks, followed by 900 mg 7 ± 2 days later, then 900 mg every 14 ± 2 days for the study duration.
V vseh študijah je bil odmerek zdravila Soliris 600 mg preučevane učinkovine vsakih 7 ± 2 dni v obdobju 4 tednov, čemur je sledil odmerek 900 mg 7 ± 2 dni kasneje in nato odmerek 900 mg vsakih 14 ± 2 dni tekom celotnega trajanja študije.
Soliris was administered as an intravenous infusion over 25 – 45 minutes.
Zdravilo Soliris je bilo aplicirano v obliki 25 – 45- minutne intravenske infuzije.
In study C04-001 (TRIUMPH) PNH patients with at least 4 transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either Soliris (n = 43) or placebo (n = 44).
V študiji C04- 001 (TRIUMPH) so bili bolniki s PNH z vsaj 4 transfuzijami v preteklih 12 mesecih, z najmanj 10% celic PNH, kar je bilo potrjeno s pretočno citometrijo, ter najmanj 100. 000 trombociti na mikroliter randomizirani na bodisi zdravljenje z zdravilom Soliris (n = 43) ali na zdravljenje s placebom (n = 44).
Prior to randomization, all patients underwent an initial observation period to confirm the need for RBC transfusion and to identify the haemoglobin concentration (the "set-point") which would define each patient’s haemoglobin stabilization and transfusion outcomes.
Pred randomizacijo so bili vsi bolniki na uvodnem opazovanju, da bi tako lahko potrdili potrebo po transfuziji eritrocitov in ugotovili koncentracijo hemoglobina („ nastavitveno točko “), ki bi naj določila stabilizacijo hemoglobina pri posameznem bolniku ter rezultate transfuzije.
The haemoglobin set-point was less than or equal to 9 g/dL in patients with symptoms and was less than or equal to 7 g/dL in patients without symptoms.
Nastavitvena točka za hemoglobin je bila manj ali enako 9 g/ dl pri bolnikih s simptomi oziroma manj ali enako 7 g/ dL pri bolnikih brez simptomov.
Primary efficacy endpoints were haemoglobin stabilization (patients who maintained a haemoglobin concentration above the haemoglobin set-point and avoid any RBC transfusion for the entire 26 week period) and blood transfusion requirement.
Primarni končni točki sta bili stabilizacija hemoglobina (bolniki, pri katerih se je koncentracija hemoglobina vzdrževala nad nastavitveno točko za hemoglobin ter pri katerih se transfuzija eritrocitov ni izvajala v celotnem 26- tedenskem obdobju) ter potreba po transfuziji krvi.
Fatigue and health-related quality of life were relevant secondary endpoints.
Utrujenost in z zdravjem povezana kakovost življenja sta bili relevantni sekundarni končni točki.
Major baseline characteristics were balanced (see table 2).
Glavne izhodiščne karakteristike so bile uravnotežene (glejte tabelo 2).
In the non-controlled study C04-002 (SHEPHERD), PNH patients with at least one transfusion in the prior 24 months and at least 30,000 platelets/microliter received Soliris over a 52-week period.
V nekontrolirani študiji C04- 002 (SHEPHERD) so bolniki s PNH, ki so imeli najmanj eno transfuzijo v zadnjih 24 mesecih in najmanj 30. 000 trombocitov na mikroliter, prejemali zdravilo Soliris
Concomitant medications included anti-thrombotic agents in 63% of the patients and systemic corticosteroids in 40% of the patients.
Sočasno uporabljana zdravila so vključevala antitrombotike pri 63% bolnikov in sistemske kortikosteroide pri 40% bolnikov.
Baseline characteristics are shown in Table 2.
Tabela 2:
C04-001
Demografske in druge značilnosti bolnikov v študijah C04- 001 in C04- 002
N = 44
n = 44
N = 43
n = 43
N = 97
n = 97
History of Aplastic Anemia or MDS (%)
Anamneza aplastične anemije ali MDS (%)
Concomitant Steroids/Immunosuppressant
Sočasno zdrav. s steroidi/ imunosupresivi (%)
18.0 (12.0, PRBC in previous 12 months (median (Q1,Q3))
Koncentrirani eritrociti v preteklih 12 mesecih
24.0)
8, 0
8.0 (4.0, 24.0)4
(mediana (Q1, Q3))
Mean Hgb level (g/dL) at setpoint (SD)
Povprečna raven Hgb (g/ dl) v nastavitveni točki (SD)
Pre-treatment LDH levels (median, U/L) Free Haemoglobin at baseline (median, mg/dL)
Raven LDH pred zdravljenjem (mediana, e. / l) Prosti hemoglobin, izhodiščna vrednost (mediana, mg/ dl)
2,234.5 46.2
2. 234, 5 46, 2
2,032.0 40.5
2. 032, 0 40, 5
2,051.0 34.9
2. 051, 0 34, 9