natgillin/translations-raw huggingface dataset:
ADRs reported in clinical trials or during postmarketing surveillance in patients with NHL and CLL disease treated with MabThera monotherapy/ maintenance or in combination with chemotherapy
Neželeni učinki, ki so jih opazili med kliničnimi preskušanji ali med nadzorom v obdobju trženja pri bolnikih z ne- Hodgkinovim limfomom in KLL, ki so se zdravili z zdravilom MabThera kot samostojnim/ vzdrževalnim zdravljenjem ali v kombinaciji s kemoterapijo.
Class
sepsa,
Common
+pljučnica,
Infections and
Infekcijske
bacterial
bakterijske
sepsis, +
+
serious viral
resna virusna okužba1, reaktivacija
infestations
in
infections,
okužbe,
pneumonia, +
+
infection1,
febrilne okužbe,
viral
virusne
febrile infection, +
herpes zoster,
hepatitis B
bolezni
infections, + bronchitis
okužbe, +
herpes zoster, + respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, + sinusitis
okužba dihal,
reactivation1
bronhitis
10
glivične okužbe, okužbe neznanega izvora, +akutni bronhitis, +sinuzitis
System Organ
pozna nevtropenija2,
Very
Bolezni krvi
Common
nevtropenija,
Uncommon
anemija,
Unknown
motnje koagulacije,
Class
in
Common
levkopenija,
Blood and lymphatic system disorders
trompocitopenija,
neutropenia, anaemia, leucopenia, thrombocytopenia, +febrile +
aplastična anemija,
coagulation disorders, aplastic anaemia,
prehodno zvišanje
Late neutropenia2, transient increase
hemolitična anemija,
pancytopenia neutropenia
limfatičnega sistema
haemolytic anaemia, lymphadenopathy
febrilna nevtropenija
in serum IgM levels2
koncentracije IgM v serumu2
infusion hypersensitivity related reactions, angioedema
reakcije, povezane z
tumour lysis syndrome3, cytokine release syndrome3, serum sickness, anaphylaxis
sindrom razpada tumorja3, sindrom
Metabolism and nutrition disorders
sistema Presnovne in prehranske motnje
hyperglycaemia, weight decrease, peripheral oedema, face
infuzijo, angioedem
oedema, increased LDH, hypocalcaemia Psychiatric disorders
hiperglikemija, zmanjšanje telesne mase, periferni edem, edem obraza, zvečana koncentracija LDH, hipokalciemija
depression, nervousness,
sproščanja citokinov3, serumska bolezen, anafilaksa
Nervous system disorders
11 Organski sistem
paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety
Pogosti
Dysgeusia
Občasni
cranial neuropathy, peripheral neuropathy facial nerve palsy4, loss of other senses4
depresija, nervoza Psihiatrične motnje
Eye disorders
Bolezni
lacrimation disorder, conjunctivitis
parestezija,
severe vision loss4
sprememba okusa
Ear and labyrinth disorders
hipestezija, agitacija,
tinnitus, ear pain
nevropatija, periferna
hearing loss4
nevropatija, paraliza obraznega živca4, izguba drugih čutil4 huda izguba vida4 izguba sluha4
myocardial infarction3 and 5,
srčno popuščanje3 in 5,
left ventricular failure, + supraventricular
popuščanje levega
heart failure3 and 5, severe cardiac
infarkt3 in 5, aritmija,
arrhythmia, +atrial
ventrikla,
tachycardia, +
hudi dogodki,
events 3 and 5
povezani s srcem3 in 5
fibrillation, tachycardia, + cardiac disorder
atrijska fibrilacija, tahikardija, +srčne
ventricular tachycardia, +angina, + myocardial ischaemia, bradycardia,
supraventrikularna tahikardija, +
hypertension, orthostatic hypotension, hypotension
bolezni hipertenzija, ortostatska hipotenzija, hipotenzija
vasculitis (predominately cutaneous), leukocytoclastic vasculitis
ventrikularna tahikardija, +angina pektoris, +miokardna ishemija, bradikardija
Respiratory, thoracic and mediastinal disorders
vaskulitis (pretežno kožni), levkocitoklastični vaskulitis odpoved dihal3,
bronchospasm3, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis
Bolezni
asthma, bronchiolitis obliterans, lung disorder, hypoxia
bronhospazem3,
respiratory failure3, pulmonary infiltrates, interstitial pneumonitis
astma, bronhiolitis
11
dihal,
System Organ
bolezen dihal,
Very
obliterans, bolezen
Common
prsnega
Uncommon
bolečina v prsnem
Unknown
pljuč, hipoksija
Class
intersticijska
Common
povečanje trebuha
Gastrointestinal disorders
pljučnica perforacija prebavil6
vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation
bruhanje, driska, bolečina v trebuhu, disfagija, stomatitis, zaprtje, dispepsija, anoreksija, vnetje žrela
abdominal enlargement
Bolezni kože
gastro-intestinal perforation6
pruritus,
Skin and subcutaneous
urtikarija, znojenje,
pruritis, rash, +
nočno znojenje, +
urticaria, sweating, night
izpuščaj, + alopecija
severe bullous skin reactions,
bolezni kože hipertonija, bolečina v mišicah, bolečina v sklepih, bolečina v hrbtu, bolečina v vratu, bolečina
tissue disorders Musculoskeletal, connective tissue and bone disorders
spremembami, toksična epidermalna nekroliza6 ledvična odpoved3
alopecia
zvišana
sweats, +skin disorder hypertonia, myalgia, arthralgia, back pain, neck pain, pain
tumorska bolečina,
toxic epidermal necrolysis6
bolečina na mestu
Renal and urinary disorders
12 Organski sistem
renal failure3
Zelo pogosti
General disorders and administration
težave in
fever, chills, asthenia,
telesna
tumour pain, flushing, malaise, cold syndrome, +
temperatura, mrazenje,
pain at the infusion site
slabosti, sindrom prehlada, +utrujenost, +
headache
splošna
fatigue, + shivering, + multi-organ failure3
drgetanje, +
decreased IgG levels
oslabelost, glavobol zmanjšane koncentracije IgG
For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+" where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
1 Glejte tudi poglavje okužbe spodaj.
Only the highest frequency observed in the trials is reported 1 see also section infection below 2 see also section haematologic adverse reactions below 3 see also section infusion-related reactions below.
3 Glejte tudi poglavje reakcije, povezane z infuzijo, spodaj.
Rarely fatal cases reported 4 signs and symptoms of cranial neuropathy.
4 Znaki in simptomi kranialne nevropatije.
Occurred at various times up to several months after completion of MabThera therapy 5 observed mainly in patients with prior cardiac condition and/ or cardiotoxic chemotherapy and were mostly associated with infusion-related reactions 6 includes fatal cases
6 Vključujejo smrtne primere.
The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the MabThera-arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
O neželenih dogodkih med kliničnimi preskušanji, katerih incidenca je bila v skupinah, ki so prejemale samo zdravilo MabThera, nižja ali podobna incidenci v kontrolnih skupinah, so poročali z uporabo naslednjih terminov: hematotoksičnost, nevtropenična okužba, okužba sečil, motnje senzorike, pireksija.
Infusion-related reactions Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of patients in clinical trials, and were predominantly seen during the first infusion, usually in the first one to two hours.
Reakcije, povezane z infuzijo O znakih in simptomih, ki bi lahko nakazovali na reakcije, povezane z infuzijo, so poročali pri več kot 50% bolnikov v kliničnih preskušanjih in so jih večinoma opazili med prvo infuzijo, ponavadi v prvih dveh urah.
These symptoms mainly comprised fever, chills and rigors.
Ti simptomi so bili navadno zvišana telesna temperatura, mrazenje in okorelost.
Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/ rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumor lysis syndrome.
Drugi simptomi so bili rdečica, angioedem, bronhospazem, bruhanje, navzea, urtikarija/ kožni izpuščaj, utrujenost, glavobol, vnetje žrela, rinitis, pruritus, bolečina, tahikardija, hipertenzija, hipotenzija, dispneja, dispepsija, astenija in značilnosti sindroma razpada tumorja.
Severe infusion-related reactions (such as bronchospasm, hypotension) occurred in about 10% of the cases.
Hude reakcije, povezane z infuzijo (kot npr. bronhospazem, hipotenzija), so se pojavile v približno 10% primerov.
Additional reactions reported in some cases were myocardial infarction, atrial fibrillation and pulmonary oedema.
V nekaterih primerih so poročali tudi o miokardnem infarktu, atrijski fibrilaciji in pljučnem edemu.
12 events (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
Poslabšanje obstoječih bolezenskih stanj srca, kot je angina pektoris ali kongestivno srčno popuščanje, ali hudi neželeni dogodki, povezani s srcem (srčno popuščanje, miokardni infarkt, atrijska fibrilacija), pljučni edem, večorganska odpoved, sindrom razpada tumorja, sindrom sproščanja citokinov, ledvična odpoved in odpoved dihal so se pri bolnikih pojavili z nižjo ali neznano pogostnostjo.
The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is < 1% of patients by the eighth cycle of MabThera(-containing) treatment.
Incidenca simptomov, povezanih z infuzijo, se z nadaljnjimi infuzijami precej znižuje, do osmega cikla zdravljenja z zdravilom MabThera se tovrstni simptomi pojavijo pri < 1% bolnikov.
Infections MabThera induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Okužbe Zdravilo MabThera je pri 70 do 80% bolnikov povzročilo zmanjšanje števila celic B, vendar pa je bilo povezano z zmanjšanjem koncentracij serumskih imunoglobulinov le pri manjšem številu bolnikov.
Localized candida infections as well as Herpes zoster was reported at a higher incidence in the MabThera-containing arm of randomized studies.
V randomiziranih študijah so pri bolnikih, ki so jemali zdravilo MabThera, poročali o višji incidenci lokaliziranih okužb s kandido in herpes zostrom.
Severe infections were reported in about 4% of patients.
Pri 4% bolnikov so opazili hude okužbe.
Higher frequencies of infections overall, including grade 3 or 4 infections, were observed during MabThera maintenance treatment up to 2 years when compared to observation. There was no cumulative toxicity in terms of infections reported over a 2-year treatment period.
V primerjavi z opazovano skupino so med največ dveletnim vzdrževalnim zdravljenjem z zdravilom MabThera opazili večjo pogostnost okužb na splošno, vključno z okužbami stopnje 3 ali 4.
In addition, other serious viral infections either new, reactivated or exacerbated, some of which were fatal, have been reported with MabThera treatment.
Med njimi so bile nekatere tudi smrtne.
The majority of patients had received MabThera in combination with chemotherapy or as part of a hematopoetic stem cell transplant.
Večina bolnikov je prejela rituksimab v kombinaciji s kemoterapijo ali v okviru presaditve krvotvornih matičnih celic.
Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy (PML)) and hepatitis C virus.
Primeri teh resnih virusnih okužb so okužbe, ki jih povzročajo herpesvirusi (citomegalovirus, virus herpesa zostra in virus herpesa simpleksa), virus JC (progresivna multifokalna
Cases of hepatitis B reactivation, have been reported, the majority of which were in subjects receiving MabThera in combination with cytotoxic chemotherapy.
Poročali so o reaktivaciji virusa hepatitisa B, v večini teh primerov so bolniki prejemali rituksimab hkrati s citotoksično kemoterapijo.
Progression of Kaposi’ s sarcoma has been observed in rituximab-exposed patients with pre-existing Kaposi’ s sarcoma.
Pri bolnikih s Kaposijevim sarkomom, ki so se zdravili z rituksimabom, so opazili napredovanje Kaposijevega sarkoma.
These cases occurred in non-approved indications and the majority of patients were HIV positive.
Ti primeri so se pojavili pri neodobrenih indikacijah, večina bolnikov je bila HIV pozitivna.
Haematologic Adverse Reactions In clinical trials with MabThera monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
Hematološki neželeni učinki V kliničnih preskušanjih z zdravilom MabThera kot samostojnim zdravilom, ki so ga bolniki prejemali 4 tedne, so se pri manjšem številu bolnikov pojavile hematološke nepravilnosti, ki pa so bile običajno blage in reverzibilne.
Severe (grade 3/ 4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Huda nevtropenija (stopnje 3 ali 4) se je pojavila pri 4, 2% bolnikov, anemija pri 1, 1% in trombocitopenija pri 1, 7% bolnikov.
During MabThera maintenance treatment for up to 2 years, leucopenia (5% vs.
5%, nevtropenija:
2%, grade 3/ 4) and neutropenia (10% vs.
10%) kot v opazovani skupini (levkopenija:
4%, grade 3/ 4) were reported at a higher incidence when compared to observation.
4%).
The incidence of thrombocytopenia was low (< 1, grade 3/ 4%) and was not different between treatment arms.
Incidenca trombocitopenije je bila nizka (stopnja 3 ali 4 < 1%), med zdravljenima skupinama pa ni bilo razlik.
In studies with MabThera in combination with chemotherapy, grade 3/ 4 leucopenia (R-CHOP 88% vs.
V študijah z zdravilom MabThera v kombinaciji s kemoterapijo so bile incidence levkopenije, nevtropenije in pancitopenije stopenj 3 ali 4 višje pri bolnikih, ki so prejemali zdravilo MabThera skupaj s kemoterapijo, v primerjavi z bolniki, ki so prejemali samo kemoterapijo (levkopenija:
CHOP 79%, R-FC 23% vs.
88% proti CHOP:
FC 12%), neutropenia (R-CVP 24% vs.
12%; nevtropenija:
CVP 14%; R-CHOP 97% vs.
97% proti CHOP:
CHOP 88%, R-FC 30% vs.
88%, R- FC:
FC 19%), pancytopenia (R-FC 3% vs.
19%; pancitopenija:
FC 1%) were reported higher frequencies when compared to chemotherapy alone.
3% proti FC 1%).
However, the higher incidence of neutropenia in patients treated with MabThera and chemotherapy was not associated with a higher incidence of infections and infestations compared to patients treated with chemotherapy alone and the neutropenia was not prolonged in the MabThera group.
Vendar pa višja incidenca nevtropenije pri bolnikih, ki so prejemali zdravilo MabThera v kombinaciji s kemoterapijo, ni bila povezana z višjo incidenco infekcijskih in parazitskih bolezni kot pri bolnikih, zdravljenih samo s kemoterapijo.
There were no differences reported for the incidence of thrombocytopenia or anaemia.
V skupini, ki je prejemala zdravilo MabThera, nevtropenija ni bila podaljšana.
Some cases of late neutropenia occurring more than four weeks after the last infusion of MabThera were reported.
Poročali so o posameznih primerih pozne nevtropenije, ki se je pojavila več kot štiri tedne po zadnji infuziji zdravila MabThera.
FC 71%).
V študiji pri bolnikih s KLL v prvi liniji zdravljenja so imeli bolniki s stopnjo C po Binetu več neželenih dogodkov v skupini R- FC v primerjavi s skupino FC (R- FC 83% proti FC 71%).
In studies of MabThera in patients with Waldenstrom’ s macroglobulinaemia, transient increases in serum IgM levels have been observed following treatment initiation, which may be associated with hyperviscosity and related symptoms.
Pri bolnikih z Waldenstromovo makroglobulinemijo so v študijah z zdravilom MabThera po začetku zdravljenja opazili prehodna zvišanja koncentracij IgM v serumu, kar pa je lahko povezano s hiperviskoznostjo in sorodnimi simptomi.
Cardiovascular reactions Cardiovascular reactions during clinical trials with MabThera monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Kardiovaskularni neželeni učinki O kardiovaskularnih neželenih učinkih so med kliničnimi preskušanji zdravila MabThera kot samostojnega zdravila poročali pri 18, 8% bolnikov.
Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported.
Najpogosteje so poročali o hipotenziji in hipertenziji.
During maintenance treatment, the incidence of grade 3/ 4 cardiac disorders was comparable between patients treated with MabThera and observation.
Med infuzijo sta se pojavili tudi aritmija stopnje 3 ali 4 (vključno z ventrikularno in supraventrikularno tahikardijo) in angina pektoris.
Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischemia) in 3% of patients treated with MabThera compared to < 1% on observation.
Med vzdrževalnim zdravljenjem je bila incidenca srčnih bolezni stopnje 3 ali 4 med bolniki, zdravljenimi z zdravilom MabThera, in opazovano skupino primerljiva.
In studies evaluating MabThera in combination with chemotherapy, the incidence of
O resnih neželenih dogodkih, povezanih s srcem (vključno z atrijsko fibrilacijo, miokardnim infarktom, popuščanjem levega ventrikla, miokardno ishemijo), so poročali pri 3% bolnikov, ki so prejemali zdravilo MabThera in pri manj kot 1% bolnikov v opazovani skupini.
13 grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/ fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
V študijah z zdravilom MabThera v kombinaciji s kemoterapijo je bila incidenca srčnih aritmij stopnje 3 ali 4, predvsem supraventrikularnih aritmij, kot sta tahikardija in atrijska fibrilacija/ undulacija, višja v skupini R- CHOP (14 bolnikov, 6, 9%) kot pa v skupini CHOP (3 bolniki, 1, 5%).
All of these arrhythmias either occurred in the context of a MabThera infusion or were associated with predisposing conditions such as fever, infection, acute myocardial infarction or pre-existing respiratory and cardiovascular disease.
Vse aritmije so se pojavile v povezavi z infuzijo zdravila MabThera ali pa so bile povezane s predisponiranimi stanji, kot so zvišana telesna temperatura, okužba, akutni miokardni infarkt ali predhodna respiratorna ali kardiovaskularna bolezen.
No difference between the R-CHOP and CHOP group was observed in the incidence of other grade 3 and 4 cardiac events including heart failure, myocardial disease and manifestations of coronary artery disease.
V incidenci ostalih s srcem povezanih dogodkov stopnje 3 in 4, vključno s srčnim popuščanjem, miokardno boleznijo in manifestacijami koronarne bolezni, med skupinama R - CHOP in CHOP ni bilo razlik.
In the CLL first-line study, the overall incidence of grade 3 or 4 cardiac disorders was low (4% R-FC, 3% FC).
V študiji pri KLL v prvi liniji zdravljenja je bila celokupna incidenca srčnih bolezni stopnje 3 ali 4 nizka (4% R- FC, 3% FC).
Neurologic events During the treatment period, four patients (2%) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Nevrološki dogodki V obdobju zdravljenja so se med prvim ciklom pri 4 bolnikih (2%) v skupini R- CHOP, ki so imeli kardiovaskularne dejavnike tveganja, pojavili trombembolični cerebrovaskularni zapleti.
There was no difference between the treatment groups in the incidence of other thromboembolic events.
Med zdravljenima skupinama ni bilo razlik v incidenci drugih trombemboličnih dogodkov.
In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Nasprotno pa so se pri treh bolnikih (1, 5%) v skupini CHOP pojavili cerebrovaskularni neželeni dogodki, vsi v
In the CLL first-line study, the overall incidence of grade 3 or 4 nervous system disorders was low (4% R-FC, 4% FC).
V študiji pri KLL v prvi liniji zdravljenja je bila celokupna incidenca bolezni živčevja stopnje 3 ali 4 nizka (4% R- FC, 4% FC).
In the majority of these cases, MabThera was administered with chemotherapy.
Bolezni prebavil Perforacijo prebavil, ki je v nekaterih primerih vodila v smrt, so opazili pri bolnikih, ki so prejemali zdravilo MabThera za zdravljenje ne- Hodgkinovega limfoma, v večini teh primerov skupaj s kemoterapijo.
IgG levels In the clinical trial evaluating MabThera maintenance treatment, median IgG levels were below the lower limit of normal (LLN) (< 7 g/ L) after induction treatment in both the observation and the MabThera groups.
Koncentracija IgG V kliničnem preskušanju vzdrževalnega zdravljenja z zdravilom MabThera je bila mediana koncentracije IgG po indukcijskem zdravljenju pod spodnjo mejo normale (< 7 g/ l) v opazovani skupini in skupini, ki je prejemala zdravilo MabThera.
In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the MabThera group.
V opazovani skupini se je mediana koncentracije IgG postopno povečevala nad spodnjo mejo normale, v skupini, ki je prejemala zdravilo MabThera pa je ostala nespremenjena.
The proportion of patients with IgG levels below the LLN was about 60% in the MabThera group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Delež bolnikov s koncentracijo IgG pod spodnjo mejo normale je bil približno 60% v dveletnem obdobju zdravljenja z zdravilom MabThera, v opazovani skupini pa se je zmanjšal (36% po dveh letih).
Patient subpopulations (MabThera monotherapy) Elderly patients(≥ 65 years):
Podskupine bolnikov (samostojno zdravljenje z zdravilom MabThera)
The incidence of ADRs of all grades and grade 3 / 4 ADR was similar in elderly patients compared to younger patients (< 65 years).
Starejši bolniki (≥ 65 let) Incidenci neželenih učinkov vseh stopenj in učinkov stopnje 3 ali 4 sta bili pri starejših in mlajših bolnikih (< 65 let) podobni.
15.4%).
Obsežna bolezen Bolniki z obsežno boleznijo so imeli višjo incidenco neželenih učinkov stopnje 3 ali 4 kot bolniki brez obsežne bolezni (25, 6% v primerjavi s 15, 4%).
Re-treatment The percentage of patients reporting ADRs upon re-treatment with further courses of MabThera was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/ 4 ADRs).
Ponovno zdravljenje Odstotek bolnikov, pri katerih so se po ponovnem zdravljenju z zdravilom MabThera pojavili neželeni učinki, je bil podoben kakor po prvem zdravljenju (za neželene učinke katere koli stopnje in stopnje 3 ali 4).
The clinical efficacy of MabThera, given together with methotrexate was studied in three double blind controlled clinical trials (one phase III two phase II trials) in patients with rheumatoid arthritis.
Klinično učinkovitost zdravila MabThera so ob sočasni uporabi metotreksata proučevali v treh dvojno slepih, kontroliranih kliničnih preskušanjih (eno faze III in dve faze II) pri bolnikih z revmatoidnim artritisom.
More than 1000 patients received at least one treatment course and were followed for periods ranging from 6 months to over 3 years; nearly 600 patients received two or more courses of treatment during the follow up period.
Več kot 1000 bolnikov je prejelo najmanj en cikel zdravljenja, po tem so jih spremljali od 6 mesecev do več kot 3 leta; skoraj 600 bolnikov je v obdobju spremljanja prejelo dva ali več ciklov zdravljenja.
14 Patients received 2 x 1000 mg of MabThera separated by an interval of two weeks; in addition to methotrexate (10-25 mg/ week).
Bolniki so prejeli 2 x 1000 mg zdravila MabThera v razmiku dveh tednov in metotreksat (10 do 25 mg/ teden).
ADRs, which occurred with at least a 2% difference compared to the control arm and more frequently by patients who had received at least one infusion of MabThera than among patients that had received placebo in the phase III trial and the combined population included in phase II studies, are listed in the Table below.
V spodnji preglednici so navedeni neželeni učinki, o katerih so poročali v preskušanju faze III in združeni populaciji, ki je bila vključena v študije faze II, ki so se pojavili z vsaj 2 -% razliko v primerjavi s kontrolno skupino in pogosteje pri bolnikih, ki so prejeli najmanj eno infuzijo zdravila MabThera, kot pri bolnikih, ki so dobili placebo.