natgillin/translations-raw huggingface dataset:
The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p < 0.0001) Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response 
Okrajšave: NA: ni na voljo; ORR: celokupni odgovor (overall response rate); CR: popolni odgovor (complete response); PR: delni odgovor (partial response).
In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to < 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point. 
Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom se je število perifernih celic B zmanjšalo na < 10 celic/µl po dveh infundiranjih 375 mg/m2 rituksimaba (po enem na teden) in je na tej ravni ostalo do 6 mesecev.
• Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any 
• podrobne podatke o tveganju za okužbe in PML, • informacije o znakih in simptomih okužb, še posebno PML, in informacije o nujnosti, da nemudoma obvestijo svojega zdravnika, če izkusijo katerega od znakov ali simptomov,
PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Ritemvia (Rituximab) Alert Card for patients with non-oncology diseases Why have I been given this card? 
BESEDILO OPOZORILNE KARTICE ZA BOLNIKA Z NEONKOLOŠKO INDIKACIJO Opozorilna kartica za bolnike, ki prejemajo zdravilo Ritemvia (rituksimab) za neonkološke bolezni
Pack of 1 vial. 
Pakiranje vsebuje eno vialo.
In clinical trials fewer than 1% (17/3189) of patients experienced a serious IRR. 
V kliničnih preskušanjih se je resna z infuzijo povezana reakcija pojavila pri manj kot 1% bolnikov (17/3189).
The most common infections in the rituximab arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster. 
Med najpogostejšimi okužbami v skupini z zdravilom rituksimab so bile okužbe zgornjih dihal, gastroenteritis, okužbe sečil in herpes zoster.
Among the 3189 patients treated with rituximab, 1135 (36%) experienced at least one IRR with 733/3189 (23%) of patients experiencing an IRR following first infusion of the first exposure to rituximab. 
Med 3189 bolniki, ki so prejeli rituksimab, se je vsaj ena z infuzijo povezana reakcija pojavila pri 1135 bolnikih (36%), od tega pa se je pri 733 od 3.189 bolnikov (23%) reakcija pojavila po prejemu prve infuzije rituksimaba.
Metabolism and nutrition disorders hyperglycaemia , weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia 
Presnovne in prehranske motnje hiperglikemija, zmanjšanje telesne mase, periferni edem, edem obraza, zvišanje LDH, hipokalciemija
b) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis 
b) Če se zdravite zaradi granulomatoze s poliangiitisom ali mikroskopskega poliangiitisa
Inhibition of the rate of progressive joint damage was also observed long term. 
Dolgoročno so opazili tudi zavrtje hitrosti napredovanja okvar sklepov.
At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, patients were randomly assigned to receive either rituximab (two 500 mg IV infusions separated by two weeks (on Day 1 and Day 15) followed by 500 mg IV every 6 months for 18 months) or azathioprine (administered orally at a dose of 2 mg/kg/day for 12 months, then 1.5 mg/kg/day for 6 months, and finally 1 mg/kg/day for 4 months (treatment discontinuation after these 22 months)). 
Takrat in znotraj največ 1 meseca po zadnjem pulzu ciklofosfamida so bolnike randomizirali ali na prejemanje rituksimab (dve 500-mg intravenski infuziji v presledku dveh tednov (1. in 15. dan) in nato 500 mg intravensko vsakih 6 mesecev v obdobju 18 mesecev) ali na prejemanje azatioprina (peroralno v odmerku 2 mg/kg/dan 12 mesecev, nato 1,5 mg/kg/dan 6 mesecev in nazadnje 1 mg/kg/dan 4 mesece (prenehanje zdravljenja po teh 22 mesecih)).
a) Non-Hodgkin's Lymphoma 
a) ne-Hodgkinovega limfoma
Infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections, herpes zoster and urinary tract infections. 
Okužbe so bile pretežno blage do zmerne; v glavnem je šlo za okužbe zgornjih dihal, herpes zoster in okužbe sečil.
No patients were withdrawn from treatment due to infusion-related reactions. 
Zaradi reakcij, povezanih z infundiranjem, niso zdravljenja prenehali pri nobenem bolniku.
In a randomised trial, patients with rheumatoid arthritis treated with rituximab and methotrexate had comparable response rates to tetanus recall antigen (39% vs. 42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs. 82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs. 93%), when given 6 months after rituximab as compared to patients only receiving methotrexate. 
V randomizirani študiji so imeli bolniki z revmatoidnim artritisom, ki so se zdravili z rituksimabom in metotreksatom, v primerjavi z bolniki, ki so dobivali samo metotreksat, podoben delež odgovorov na cepivo proti tetanusu (recall antigen) (39 % v primerjavi z 42 %), nižji delež odgovorov na polisaharidno cepivo proti pnevmokoku (43 % v primerjavi z 82 % na vsaj 2 serotipa) in neoantigen KLH (47 % v primerjavi s 93 %).
These symptoms are usually reversible with interruption of rituximab infusion and administration of an anti-pyretic, an antihistaminic, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required. 
Ti simptomi običajno izginejo po prekinitvi infuzije rituksimaba in uporabi antipiretika, antihistaminika in v nekaterih primerih kisika, fiziološke raztopine intravensko ali bronhodilatatorja ter po potrebi glukokortikoidov.
In the clinical trial on induction of remission, the incidence of malignancy in rituximab-treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period). 
Incidenca malignih bolezni med bolniki, ki so v klinični študiji pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom prejemali rituksimab, je bila v kliničnem preskušanju indukcije remisije ob končnem zaključnem datumu študije (tj. ko je zadnji bolnik dokončal obdobje spremljanja) 2,00 na 100 bolnik-let.
In patients treated for haematological malignancies, B cell recovery began within 6 months of treatment and generally returned to normal levels within 12 months after completion of therapy, although in some patients this may take longer (up to a median recovery time of 23 months post-induction therapy). 
Pri bolnikih, ki so se zdravili zaradi hematoloških malignih bolezni, so se celice B začele obnavljati v 6 mesecih zdravljenja, njihovo število pa se je v splošnem vrnilo v normalno stanje v 12
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 popolni odgovor (complete response/uncomfirmed), PR) je bil značilno večji (p < 0,0001, test hi-kvadrat) v skupini R-CVP (80,9 %) kot v skupini CVP (57,2 %).
tachycardia, +cardiac disorder tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia 
+popuščanje levega prekata, +supraventriku larna tahikardija, +ventrikularna tahikardija, +angina pektoris, +ishemija miokarda, bradikardija hude srčne bolezni4 in 6
Metabolism and nutritional disorders hypercholesterolemia 
Presnovne in prehranske motnje hiperholesterolemija
These symptoms mainly comprised fever, chills and rigors. 
Ti simptomi so bili navadno zvišana telesna temperatura, mrzlica in drgetanje.
Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p< 0.0001 log-rank test). 
Vzdrževalno zdravljenje z rituksimabom je klinično pomembno in statistično značilno izboljšalo primarni cilj - preživetje brez napredovanja bolezni (progression free survival - PFS) (čas od randomizacije v vzdrževalno zdravljenje do ponovitve bolezni, napredovanja bolezni ali smrti) v primerjavi z opazovano skupino (p < 0,0001, test log-rang).
1 mL contains 10 mg of rituximab. 
1 ml vsebuje 10 mg rituksimaba.
This is because Ritemvia can affect the way some other medicines work. 
Zdravilo Ritemvia namreč lahko vpliva na delovanje nekaterih drugih zdravil in obratno - tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Ritemvia.
Cytokine release syndrome 
Bolezni imunskega sistema sindrom sproščanja citokinov
The efficacy and safety of rituximab in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study. 
V randomizirani, odprti, kontrolirani multicentrični študiji so učinkovitost in varnost zdravila rituksimab v kombinaciji s kratkotrajnim zdravljenjem z majhnim odmerkom glukokortikoida (prednizon) ocenili pri novodiagnosticiranih bolnikih z zmernim do hudim pemfigusom (74 z navadnim pemfigusom [pemphigus vulgaris] in 16 z luščečim se pemfigusom [pemphigus foliaceus]).
A total of 19/34 (56%) patients with PV, who were treated with rituximab, tested positive for ADA antibodies by 18 months. 
Po 18 mesecih je imelo skupno 19 od 34 (56%) bolnikov z navadnim pemfigusom, zdravljenih z rituksimab, pozitiven izvid za ADA.
See also infusion-related reactions below. 
Glejte tudi spodnji odstavek o reakcijah, povezanih z infuzijo.
Significant reductions in disability index (HAQ-DI) and fatigue (FACIT-Fatigue) were observed in patients treated with rituximab compared to patients treated with methotrexate alone. 
Health Assessment Questionnaire Disability Index) in utrujenosti (FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy) v primerjavi z bolniki, ki so se zdravili le z metotreksatom.
Infusion-related reactions in the pemphigus vulgaris clinical study were common (58%). 
Z infundiranjem povezane reakcije V klinični študiji pri navadnem pemfigusu so bile z infundiranjem povezane reakcije pogoste (58%).
Kaplan-Meier estimated progression-free rates at 12 months were 78% in the rituximab maintenance group vs. 57% in the observation group. 
Delež bolnikov brez napredovanja bolezni, ocenjen po Kaplan-Meierju, je bil pri 12 mesecih 78 % v skupini, ki je prejemala vzdrževalno zdravljenje z rituksimabom, in 57 % v opazovani skupini.
Patients treated with rituximab in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12). 
V vseh študijah je bilo pri bolnikih, ki so se zdravili z rituksimabom in metotreksatom, zmanjšanje aktivnosti bolezni (DAS28, Disease Activity Score) pomembno večje kot pri bolnikih, ki so se zdravili samo z metotreksatom (preglednica 12).
Progression of Kaposi's sarcoma has been observed in rituximab-exposed patients with preexisting Kaposi's sarcoma. 
Pri bolnikih s Kaposijevim sarkomom, ki so se zdravili z rituksimabom, so opazili napredovanje Kaposijevega sarkoma.
Alopecia Pruritus Urticaria Skin disorder 
Bolezni kože in podkožja alopecija pruritus urtikarija bolezni kože
There are no data on the safety of rituximab in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease. 
Podatkov o varnosti zdravila rituksimab pri bolnikih z zmernim srčnim popuščanjem (III. razred NYHA)
Maintenance and relapse 
žrela in spolovil.
In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of rituximab. 
Tudi fludarabin in ciklofosfamid nista imela opaznega učinka na farmakokinetiko rituksimaba.
Clinical experience in granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis 
Klinične izkušnje pri granulomatozi s poliangiitisom (Wegenerjevi granulomatozi) in mikroskopskem poliangiitisu
Ritemvia monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy. 
Zdravilo Ritemvia je indicirano za samostojno zdravljenje bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila.
The recommended dose of Ritemvia used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 infusions in total). 
Priporočeni odmerek zdravila Ritemvia za vzdrževalno zdravljenje bolnikov s predhodno nezdravljenimi folikularnimi limfomi, ki so se odzvali na indukcijsko zdravljenje, je: 375 mg/m2 telesne površine enkrat na 2 meseca (z začetkom 2 meseca po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 12 infuzij).
Table 12 Clinical response outcomes at primary endpoint in Trial 1 (ITT population) 
Klinični odzivi ob času primarnega cilja preskušanja 1 (populacija, ki so jo nameravali zdraviti).
Ritemvia 
Rituksimab
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless dilution has taken place in controlled and validated aseptic conditions. 
Če je ne uporabimo takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; čas običajno ne sme presegati
All patients Newly diagnosed n=99 n=48 n=51 
Vsi bolniki n = 99
In the maintenance therapy clinical trial, 7/57 (12%) patients in the rituximab arm experienced at least one infusion-related reaction. 
V kliničnem preskušanju vzdrževalnega zdravljenja se je vsaj ena z infuzijo povezana reakcija pojavila pri 7 od 57 (12%) bolnikov v skupini z rituksimab.
Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 μg/mL for 2 × 500 mg dose and ranged from 298 to 341 μg/mL for 2 × 1000 mg dose. 
Povprečna serumska Cmax rituksimaba po prvi infuziji je bila 157 do 171 μg/ml za 2 x 500 mg odmerek ter 298 do 341 μg/ml za 2 x 1.000 mg odmerek.
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).
IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with those seen for rheumatoid arthritis patients in clinical trials (see section 4.8). 
V kliničnih preskušanjih so bile z infuzijo povezane reakcije pri bolnikih z granulomatozo s poliangiitisom, mikroskopskim poliangiitisom in navadnim pemfigusom podobne istim pri bolnikih z revmatoidnim artritisom (glejte poglavje 4.8).
In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC). 
Pri KLL je bila celokupna incidenca srčnih bolezni stopnje 3 ali 4 nizka, tako v študiji v prvi liniji zdravljenja (4% R-FC, 3% FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (4% R-FC, 4% FC).
All patients treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris must be given the patient alert card with each infusion. 
Vsem bolnikom, ki se z zdravilom rituksimab zdravijo za revmatoidni artritis, granulomatozo s poliangiitisom, mikroskopski poliangiitis ali navadnega pemfigusa, je treba ob vsaki infuziji dati opozorilno kartico za bolnike (glejte Dodatek IIIA - Označevanje).
It is recommended that immunoglobulin levels are determined prior to initiating treatment with rituximab. 
Pred začetkom zdravljenja z zdravilom rituksimab je priporočljivo določiti koncentracije imunoglobulinov.
If you have heart disease or angina, these reactions might get worse. 
Obstoječa bolezen srca in angina pektoris se lahko poslabšata.
Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171 - 1177 µg/mL) after the eighth infusion. 
Pri 37 bolnikih z ne-Hodgkinovim limfomom, ki so prejeli 375 mg/m2 rituksimaba z intravensko infuzijo v osmih odmerkih enkrat na teden, se je povprečna Cmax povečala z vsako naslednjo infuzijo, tako da se je iz povprečne vrednosti 243 µg/ml (od 16 do 582 µg/ml) po prvi infuziji povečala na 550 µg/ml (171 do 1.177 µg/ml) po osmi infuziji.
However, a large component of inter-individual variability remained for CL2 after correction for CD19-positive cell counts and tumour lesion size. 
Bolniki z večjim številom CD19 pozitivnih celic ali večjimi tumorskimi lezijami so imeli večji Cl2, vseeno pa je precejšnja variabilnost Cl2 med posamezniki ostala tudi po prilagoditvi števila CD19 pozitivnih celic in velikosti tumorskih lezij.
albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively. 
V vseh podskupinah bolnikov (spol, starost, starosti prilagojen mednarodni prognostični indeks, stadij po klasifikaciji Ann Arbor, ECOG (Eastern Cooperative Oncology Group), koncentracija mikroglobulina ß2, koncentracija LDH, koncentracija albumina, B simptomi, obsežna bolezen, ekstranodalne lokalizacije, infiltracija kostnega mozga) je bilo razmerje tveganj za preživetje brez dogodkov za R-CHOP v primerjavi s CHOP manjše kot 0,83, za skupno preživetje pa manjše kot 0,95.
In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC). 
Pri KLL je bila celokupna incidenca bolezni živčevja stopnje 3 ali 4 nizka, tako v študiji v prvi liniji zdravljenja (4% R-FC, 4% FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (3% R-FC, 3% FC).
Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the rituximab infusion. 
Ker se med infuzijo rituksimaba lahko pojavi hipotenzija, je treba premisliti o tem, da bi 12 ur pred infuzijo zdravila rituksimab bolnik prenehal jemati zdravila proti visokemu krvnemu tlaku.
• high or low blood pressure (low blood pressure especially when standing upright) 
težave s srcem - na primer srčni infarkt, neredno ali hitro bitje srca, visok ali nizek krvni tlak (nizek krvni tlak zlasti po hitrem vstajanju),
• If you are having Ritemvia alone 
Če prejemate samo zdravilo Ritemvia,
Rituximab was administered as two IV infusions separated by an interval of 15 days. 
Rituksimab so bolniki prejeli v dveh intravenskih infuzijah v razmiku 15 dni.
Following second infusion, mean Cmax ranged from 183 to 198 μg/mL for the 2 × 500 mg dose and ranged from 355 to 404 μg/mL for the 2 × 1000 mg dose. 
Po drugi infuziji je bila povprečna Cmax 183 do 198 μg/ml za 2 x 500 mg odmerek ter 355 do 404 μg/ml za 2 x 1.000 mg odmerek.
Physician information 
KLINIČNI PODATKI
Rituximab N=505 
n = 505
You might get infections more easily during your treatment with Ritemvia. 
Med zdravljenjem z zdravilom Ritemvia ste lahko bolj nagnjeni k okužbam.
Mean change in HAQ‐DI 
Povprečna sprememba HAQ-DI
Previously untreated follicular lymphoma 
Predhodno nezdravljeni folikularni limfomi
Contents of the pack and other information 
Shranjevanje zdravila Ritemvia Vsebina pakiranja in dodatne informacije
Median EFS: 36 Not reached p < 0.0001 
mediana EFS: ni doseženo p < 0,0001
Co-administration with methotrexate had no effect on the pharmacokinetics of rituximab in rheumatoid arthritis patients. 
Sočasna uporaba metotreksata pri bolnikih z revmatoidnim artritisom ni vplivala na farmakokinetiko rituksimaba.
Rituximab (N=167) 
Rituksimab (n = 167)
Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. 
Je glikoziliran imunoglobulin s humanim IgG1 konstantnim delom in mišjo lahko in težko verigo v variabilnem delu.
Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of rituximab for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis. 
Pri uporabi rituksimaba 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, vključno s sistemskim eritematoznim lupusom (SLE) in vaskulitisom.
9.25 years log-rank p value hazard ratio (95% CI) risk reduction TNLT (median) 
9,25 let vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja TNLT (mediana)
• loss of hair 
• izguba telesne mase,
There was no apparent negative impact of the presence of ADA on safety or efficacy in the maintenance therapy clinical trial. 
V kliničnem preskušanju vzdrževalnega zdravljenja prisotnost ADA ni imela opaznega negativnega vpliva na varnost ali učinkovitost.
Ear and labyrinth disorders tinnitus, ear pain hearing loss5 
vključno z motnjami labirinta tinitus, bolečine v ušesu izguba sluha5
Uncommon side effects (may affect up to 1 in 100 people): 
Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 bolnikov):
• low number of white blood cells, with or without fever or blood cells called “platelets” 
bakterijske ali virusne okužbe, bronhitis, majhno število belih krvnih celic (z zvišano telesno temperaturo ali zmanjšanje brez nje) ali krvnih celic, ki jih imenujemo trombociti (krvne ploščice),
R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI. 
Zdravljenje z R-CHOP je bilo glede na starost prilagojen mednarodni prognostični indeks ugodno za bolnike z majhnim in velikim tveganjem.
Very rare myocardial infarction 
miokardni infarkt atrijska undulacija
In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximab-treated patients vs. 5% for azathioprine treated patients. 
V kliničnem preskušanju vzdrževalnega zdravljenja je bila pojavnost nevtropenije vseh stopenj v skupini z zdravilom rituksimab 0% in v skupini z azatioprinom 5%.
Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with rituximab. 
Zato morajo ženske v rodni dobi med zdravljenjem z zdravilom rituksimab in še 12 mesecev po njem uporabljati učinkovita kontracepcijska sredstva.
b) Granulomatosis with polyangiitis or microscopic polyangiitis 
b) granulomatoze s poliangiitisom ali mikroskopskega poliangiitisa
Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001 MCID HAQ-DI ≥0.22, MCID SF-36 PHS >5.42, MCID SF-36 MHS >6.33 
Značilna razlika v primerjavi s placebom ob času primarnega cilja študije: * p < 0,05; **p < 0,001; ***p ≤ 0,0001 MCID HAQ