natgillin/translations-raw huggingface dataset:
Based on modifications made to the study treatment, most reactions were assessed as secondary to docetaxel infusions.
Na podlagi prilagoditev raziskovanega zdravljenja so večino reakcij ocenili kot posledico infuzij docetaksela.
Feeling sick or being tired
• slabost ali utrujenost
Those studies included the pivotal trials CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225), and APHINITY (n=4804) [pooled in Table 2].
Te študije vključujejo ključna preskušanja CLEOPATRA (n = 808), NEOSPHERE (n = 417), TRYPHAENA (n = 225) in APHINITY (n = 4804)
For the initial dose, the recommended infusion period is 60 minutes.
Priporočeni čas infundiranja začetnega odmerka je 60 minut.
Before starting treatment, you must tell your doctor or nurse if you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby.
Pred začetkom zdravljenja morate zdravniku ali medicinski sestri povedati, če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev.
Interruption of treatment with pertuzumab should be considered if no improvement in the patient's condition is achieved.
Razmisliti je treba o prekinitvi zdravljenja s pertuzumabom, če ne dosežemo izboljšanja bolnikovega stanja.
In both treatment groups, the proportion of patients experiencing febrile neutropenia was highest in the first cycle of therapy and declined steadily thereafter.
V obeh zdravljenih skupinah je bil delež bolnikov, pri katerih se je pojavila febrilna nevtropenija, največji med prvim ciklom zdravljenja, nato pa se je postopoma znižal.
Most of these patients had received prior anthracycline therapy and 11% of all patients had received prior trastuzumab.
Večina teh bolnikov je predhodno prejela zdravljenje z antraciklini, 11 % vseh bolnikov pa je predhodno prejemalo trastuzumab.
The median clearance (CL) of pertuzumab was 0.235 litres/day and the median half-life was 18 days.
Mediani očistek (Cl) pertuzumaba je bil 0,235 litra/dan, mediani razpolovni čas je bil 18 dni.
Number of IDFS events/Total N (%)
Število dogodkov IDFS / Skupaj n (%)
In a subset of monkeys, chronic dosing (7 to 26 weekly doses) resulted in episodes of severe secretory diarrhoea.
V podskupini opic je kronična uporaba (od 7 do 26 tedenskih odmerkov) povzročila pojavljanje hude sekretorne driske.
Compared with published data for similar regimens without pertuzumab, high pCR rates were observed in all 3 treatment arms (see Table 4).
V primerjavi z objavljenimi podatki za podobne sheme brez pertuzumaba so bili visoki deleži pCR opaženi v vseh treh zdravljenih skupinah (glejte Preglednico 4).
This clinical assessment should be based on the severity of the preceding reaction and response to administered treatment for the adverse reaction (see section 4.2).
Ta klinična ocena mora temeljiti na tem, kako huda je bila prejšnja reakcija in odzivu na zdravljenje neželenega učinka (glejte poglavje 4.2).
Clinical response represents patients with a best overall response of CR or PR during the neoadjuvant period (in the primary breast lesion).
Klinični odgovor predstavlja bolnike z najboljšim celokupnim odgovorom CR ali PR med neoadjuvantnim obdobjem (v primarni prsni leziji).
No statistically significant differences were found between the two treatment groups in Health Related Quality of Life as assessed by FACT-B TOI-PFB scores.
Med terapevtskima skupinama niso ugotovili statistično značilnih razlik v z zdravjem povezani kakovosti življenja, ocenjeni s FACT-B TOI-PFB.
Patients should have a pre-treatment LVEF of ≥ 55% (≥ 50% after completion of the anthracycline component of chemotherapy, if given).
Bolniki morajo imeti LVEF pred zdravljenjem ≥ 55 % (≥ 50 % po koncu antraciklinske komponente kemoterapije, če je uporabljena).
Some of the side effects which you get may be due to your breast cancer.
Nekateri neželeni učinki, ki se vam lahko pojavijo, so lahko posledica raka dojk.
Simes corr. for CMH test)
(Simesova korekcija za test CMH)
Approximate 95% CI for difference of two response rates using Hauck-Anderson method.
Približno 95-% interval zaupanja za razliko med deležema odgovora z uporabo Hauck-Andersonove metode.
There is limited amount of data from the use of pertuzumab in pregnant women.
Podatkov o uporabi pertuzumaba pri nosečnicah je malo.
° Hypersensitivity/anaphylactic reaction is based on a group of terms.
° Preobčutljivost/anafilaktična reakcija je osnovana na skupini izrazov.
The breast cancer has been identified to be of the “HER2-positive” form - your doctor will test you for this.
• če so rak dojke označili kot “HER2-pozitivna oblika” - zdravnik vas bo napotil na te preiskave;
For all following infusions, if the first infusion was well tolerated:
Nadaljnje infuzije, če ste prvo infuzijo dobro prenesli:
Treatment should include standard anthracycline- and/or taxane-based chemotherapy.
Zdravljenje mora vključevati standardno kemoterapijo na osnovi antraciklina in/ali taksana.
Infusion reactions, allergic or anaphylactic (more severe allergic) reactions can happen.
Pojavijo se lahko infuzijske reakcije, alergijske ali anafilaktične (hujše alergijske) reakcije.
After completion of chemotherapy, patients received radiotherapy and/or hormone therapy as per local clinical standard.
Po dokončanju kemoterapije so bolniki prejemali obsevanje in/ali hormonsko zdravljenje v skladu z lokalnim kliničnim standardom.
The number of infusions you will be given depends on how you respond to treatment and whether you are receiving treatment before or after surgery (neoadjuvant or adjuvant therapy) or for disease which has spread.
• Število infuzij, ki jih boste dobili, je odvisno od tega, kako se boste odzvali na zdravljenje in tega, ali se boste zdravili pred ali po operaciji (neoadjuvantno ali adjuvantno) ali za razsejano bolezen.
Perjeta will be stored by the health professionals at the hospital or clinic.
Zdravilo Perjeta bodo shranjevali zdravstveni delavci v bolnišnici ali ambulanti.
Table 3 Summary of efficacy from CLEOPATRA study Parameter
Povzetek učinkovitosti iz študije CLEOPATRA
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreeed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Patients may continue therapy during periods of reversible chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Bolniki lahko med obdobji reverzibilne mielosupresije, povzročene s kemoterapijo, nadaljujejo z zdravljenjem, vendar jih je v tem času treba skrbno spremljati zaradi zapletov, ki jih lahko povzroči nevtropenija.
Treatment with Perjeta may affect the heart.
Zdravljenje z zdravilom Perjeta lahko vpliva na srce.
In the analyses of patient-reported outcomes, a 10-point difference was considered clinically meaningful.
V analizah rezultatov samoocene bolnikov je kot klinično pomembna veljala razlika 10 točk.
If it has been 6 weeks or more since your last visit a higher Perjeta dose of 840 mg will be given to you.
Če je od vašega zadnjega obiska minilo 6 tednov ali več, boste prejeli večji odmerek
Duration of Response †^ n=
Trajanje odgovora †^
Patients should be observed closely for hypersensitivity reactions.
Bolnike je treba skrbno opazovati glede preobčutljivostnih reakcij.
Perjeta may harm the unborn baby.
Zdravilo Perjeta lahko škoduje nerojenemu otroku.
It is supplied in a glass vial containing 14 ml concentrate.
Na voljo je v stekleni viali, ki vsebuje 14 ml koncentrata.
Medical review of these 15 reports showed that in 8/15 cases, the reported events were not indicative of IRR/hypersensitivity/anaphylaxis.
Medicinski pregled teh 15 poročil je pokazal, da v 8/15 primerov poročani dogodki niso nakazovali na infuzijsko reakcijo/preobčutljivost/anafilaksijo.
4. p-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.
Vrednost p iz Cochran-Mantel-Haenszelovega testa s Simesovo korekcijo za večkratne primerjave.
Perjeta will be given to you by a doctor or nurse in a hospital or clinic.
Zdravilo Perjeta vam bo dal zdravnik ali medicinska sestra v bolnišnici ali ambulanti.
A decrease in the number or low amount of white blood cells (shown in a blood test), with or without fever, which may increase the risk of an infection.
• zmanjšanje števila ali majhno količino belih krvnih celic (to pokaže preiskava krvi) z zvišano telesno temperaturo ali brez nje, kar lahko poveča tveganje za okužbo;
Demographics were well balanced between the two treatment arms.
Demografske značilnosti so bile med terapevtskima skupinama dobro uravnotežene.
The incidence of left ventricular dysfunction and cardiac failure congestive reflect the MedDRA Preferred Terms reported in the individual studies.
Incidenca disfunkcije levega ventrikla in kongestivnega srčnega popuščanja odraža preferenčne izraze po MedDRA, o katerih so poročali pri posameznih študijah.
The final analysis of OS was performed when 389 patients had died (221 in the placebo-treated group and 168 in the Perjeta-treated group).
Končna analiza celokupnega preživetja je bila izvedena, ko je umrlo 389 bolnikov (221 v skupini, ki je prejemala placebo, in 168 v skupini, ki je prejemala zdravilo Perjeta).
The indication in the neoadjuvant treatment of breast cancer is based on demonstration of an improvement in pathological complete response rate, and trends to improvement in disease-free survival that nevertheless do not establish or precisely measure a benefit with regard to long-term outcomes, such as overall survival or disease-free survival.
Indikacija za neoadjuvantno zdravljenje raka dojk temelji na dokazanem izboljšanju deleža patološkega popolnega odgovora in težnjah k izboljšanju preživetja brez bolezni, ki pa ne dokazujejo ali natančno merijo koristi glede na dolgoročne izide, kot sta celokupno preživetje ali preživetje brez bolezni.
If you are allergic to pertuzumab, or to any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na pertuzumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
For instructions on dilution of Perjeta prior to administration, see sections 6.2 and 6.6.
Za navodila o razredčenju zdravila Perjeta pred uporabo glejte poglavji 6.2 in 6.6.
If a significant infusion reaction occurs, the infusion should be slowed down or interrupted and appropriate medical therapies should be administered.
Če se pojavi pomembna infuzijska reakcija, je treba hitrost infuzije zmanjšati ali jo prekiniti in uporabiti ustrezna zdravila.
The diarrhoea was managed (with the exception of euthanasia of one animal, 50 mg/kg/dose) with supportive care including intravenous fluid replacement therapy.
Drisko so obvladali (razen pri eni živali, ki je prejela evtanazijo, odmerek 50 mg/kg) s podpornimi zdravili, vključno z intravenskim nadomeščanjem tekočine.
Secondary efficacy endpoints were overall survival (OS), PFS (investigator-assessed), objective response rate (ORR), duration of response, and time to symptom progression according to the FACT B Quality of Life questionnaire.
Sekundarni cilji učinkovitosti so bili celokupno preživetje (OS - overall survival), PFS (ocenjeno s strani raziskovalca), delež objektivnega odgovora (ORR - objective response rate), trajanje odgovora in čas do napredovanja simptomov glede na Vprašalnik o kakovosti življenja FACT B.
*** Patients with best overall response of confirmed CR or PR by RECIST.
*** Bolniki z najboljšim celokupnim odgovorom ali potrjenim CR ali PR po RECIST.
Left ventricular dysfunction (including congestive heart failure)
Disfunkcija levega prekata (vključno s kongestivnim srčnim popuščanjem)
* ADRs with a fatal outcome have been reported.
* Poročali so o neželenih učinkih s smrtnim izidom.
All analyses stratified by nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen.
Vse analize so bile stratificirane po stanju bezgavk, verziji protokola, stanju centralnih hormonskih receptorjev in shemi adjuvantne kemoterapije.
Because human IgG is secreted in human milk and the potential for absorption and harm to the infant is unknown, a decision should be made to discontinue breast-feeding or to discontinue treatment, taking into account the benefit of breast-feeding for the child and the benefit of Perjeta therapy for the woman (see section 5.2).
Ker se protitelesa IgG pri ljudeh izločajo v materino mleko in možnost absorpcije ter škodljivih vplivov na dojene otroke ni znana, se je treba odločiti med prenehanjem dojenja ali prenehanjem zdravljenja, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z zdravilom Perjeta za mater (glejte poglavje 5.2).
Do not use this medicine if you notice any particles in the liquid or it is the wrong colour (please see section 6).
• Ne uporabljajte tega zdravila, če opazite v tekočini kakšne delce ali če je tekočina spremenjene barve (glejte poglavje 6).
The majority of the reported events were Grade 1 or 2
Večina zabeleženih dogodkov je bila 1. ali 2. stopnje.
BO17929 was a phase II, non-randomised study in patients with metastatic breast cancer whose tumours had progressed during treatment with trastuzumab.
Študija BO17929 je bila nerandomizirana študija faze II pri bolnikih z metastatskim rakom dojk, katerih tumorji so napredovali med zdravljenjem s trastuzumabom.
A statistically significant improvement in IRF-assessed PFS was demonstrated in the Perjeta-treated group compared with the placebo-treated group.
Statistično značilno izboljšanje PFS po oceni IRF je bilo dokazano v skupini, zdravljeni z zdravilom Perjeta, v primerjavi s skupino, zdravljeno s placebom.
The majority of patients had node-positive (63%) and/or hormone receptor-positive disease (64%), and were Caucasian (71%).
Večina bolnikov je imela bolezen s pozitivnimi bezgavkami (63 %) in/ali pozitivnimi hormonskimi receptorji (64 %) ter so bili belci (71 %).
Patients experiencing infusion reactions should be advised not to drive and use machines until symptoms abate.
Bolnikom, pri katerih se pojavi infuzijska reakcija, je treba svetovati, naj ne vozijo ali upravljajo strojev, dokler simptomi infuzijske reakcije ne izzvenijo.
Adjuvant Treatment
Adjuvantno zdravljenje
You will also be given trastuzumab and chemotherapy.
• Dobili boste tudi trastuzumab in kemoterapijo.
Perjeta and trastuzumab should be administered sequentially and not mixed in the same infusion bag.
Zdravilo Perjeta in trastuzumab je treba dati zaporedoma in se ju ne sme mešati v isti infuzijski vrečki.
If you experience any of the above symptoms after treatment with Perjeta has been stopped, you should consult your doctor immediately and inform him or her that you have previously been treated with Perjeta.
Če se vam kateri od omenjenih simptomov pojavi po koncu zdravljenja z zdravilom Perjeta, se morate takoj posvetovati z zdravnikom in ga obvestiti, da ste pred tem dobivali zdravilo Perjeta.
Immune system disorders Infusion reaction°°, * Hypersensitivity°, *
Bolezni imunskega sistema infuzijska reakcija°°, * preobčutljivost°, *
In neoadjuvant and adjuvant trials, Perjeta was administered on the same day as other study treatments in all cycles.
V preskušanjih neoadjuvantnega in adjuvantnega zdravljenja so zdravilo Perjeta dajali isti dan kot druga študijska zdravljenja v vseh ciklih.
Infusion reactions occurred in 18.6% - 25.0% of patients on the first day of Perjeta administration (in combination with trastuzumab and chemotherapy).
Infuzijske reakcije so se pojavile pri 18,6-25,0 % bolnikov prvi dan aplikacije zdravila Perjeta (v kombinaciji s trastuzumabom in kemoterapijo).
Prespecified subgroup analyses without adjusting for multiple comparisons, therefore, results are considered descriptive.
Stanje hormonskih receptorjev negativno pozitivno Analize vnaprej opredeljenih podskupin brez prilagoditve za večkratne primerjave; rezultati se zato štejejo kot opisni.
Do not throw away any medicines via wastewater or household waste.
• Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
As a result, pertuzumab inhibits ligand-initiated intracellular signalling through two major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K).
Posledica je, da pertuzumab zavre z ligandom sproženo znotrajcelično signaliziranje po dveh pomembnih signalnih poteh, in sicer prek z mitogenom aktivirane protein (MAP) kinaze in fosfoinozitidne 3-kinaze (PI3K).
Table 4 NEOSPHERE (WO20697) and TRYPHAENA (BO22280): Overview of efficacy (Intent to Treat Population)
NEOSPHERE (WO20697) in TRYPHAENA (BO22280): Pregled učinkovitosti (populacija z namenom zdravljenja)
A total of 43% of patients in both treatment groups had previously received radiotherapy.
Skupno 43 % bolnikov iz obeh skupin je bilo predhodno zdravljenih z obsevanjem.
Common (≥ 1/100 to < 1/10) Uncommon( ≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000)
zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana pogostnost (ni je mogoče oceniti iz razpoložljivih podatkov).
If you forget or miss your appointment to receive Perjeta make another appointment as soon as possible.
Če ste pozabili ali zgrešili termin, ob katerem bi morali prejeti zdravilo Perjeta, se čim prej dogovorite za obisk.
Figure 2 Kaplan-Meier Curve of Overall Survival
Kaplan-Meierjeva krivulja celokupnega preživetja
Diarrhoea is most frequent during concurrent administration with taxane therapy.
Driska je najpogostejša med sočasnim prejemanjem terapije s taksanom.
Perjeta is not recommended during pregnancy and in women of childbearing potential not using contraception.
Uporaba zdravila Perjeta med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, ni priporočljiva.
This absence of drug-drug interaction was confirmed by pharmacokinetic data from the NEOSPHERE and APHINITY studies.
Odsotnost medsebojnega delovanja med zdravili je bila potrjena s farmakokinetičnimi podatki študij NEOSPHERE in APHINITY.
The amount of medicine you are given and how long the infusion will last are different for the first dose and following doses.
• Količina zdravila, ki jo boste dobili, in trajanje infuzije se pri prvem in naslednjih odmerkih razlikujeta.
There is very limited data available in patients with unresectable locally recurrent disease.
Pri bolnikih z neoperabilno lokalno ponovitvijo bolezni je na voljo le zelo malo podatkov.
Perjeta is compatible with polyvinylchloride (PVC) or non-PVC polyolefin bags including polyethylene.
Zdravilo Perjeta je kompatibilno s polivinilkloridnimi (PVC) ali ne-PVC poliolefinskimi vrečkami,
Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms.
Bolnike je treba pregledati in jih natančno nadzirati, dokler znaki in simptomi povsem ne izginejo.
Most events were mild to moderate in severity and occurred in the first few cycles of treatment.
Večina dogodkov je bila blagih do zmernih in se je pojavila v prvih nekaj ciklih zdravljenja.
IDFS including second primary non-breast cancer
IDFS vključno z drugim primarnim rakom, ki ni bil rak dojk
The efficacy results from the APHINITY trial are summarised in Table 5 and in Figure 3.
Rezultati učinkovitosti iz preskušanja APHINITY so povzeti v preglednici 5 in na sliki 3.
Limited data are available in patients > 75 years of age.
Za bolnike, starejše od 75 let, je na voljo le malo podatkov.
In addition, pertuzumab mediates antibody-dependent cell-mediated cytotoxicity (ADCC).
Poleg tega pertuzumab posreduje od protiteles odvisno, celično posredovano citotoksičnost (ADCC - antibody-dependent cell-mediated cytotoxicity).
In this study, cardiac safety was similar to that observed in patients given the same regimen but with Perjeta administered sequentially (following FEC chemotherapy).
V tej študiji je bila kardiološka varnost podobna kot pri bolnikih, ki so prejemali enako shemo, le da je bilo zdravilo Perjeta uporabljeno zaporedno (po kemoterapiji FEC).
The population PK analysis suggested no PK differences based on age, gender and ethnicity (Japanese versus non-Japanese).
Populacijska farmakokinetična analiza ni pokazala farmakokinetičnih razlik glede na starost, spol ali etnično pripadnost (Japonci v primerjavi z nejaponci).
14 ml of Perjeta concentrate should be withdrawn from the vial and diluted into a 250 ml PVC or non-PVC polyolefin infusion bag of sodium chloride 9 mg/ml (0.9%) solution for infusion.
14 ml koncentrata zdravila Perjeta je treba povleči iz viale in razredčiti v 250-ml PVC ali ne-PVC poliolefinsko infuzijsko vrečko, ki vsebuje 9 mg/ml (0,9-%) raztopino natrijevega klorida za infundiranje.
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC13
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa, oznaka ATC: L01XC13.
The PK results of pertuzumab in the NEOSPHERE and APHINITY studies were consistent with the predictions from the previous population PK model.
Farmakokinetični rezultati pertuzumaba v študijah NEOSPHERE in APHINITY so skladni z napovedmi prejšnjega populacijskega farmakokinetičnega modela.
These dose levels resulted in clinically relevant exposures of 2.5 to 20-fold greater than the recommended human dose, based on Cmax.
S temi odmerki so dosegli klinično pomembno izpostavljenost, ki je bila 2,5 do 20-krat večja kot pri priporočenem odmerku za ljudi (na osnovi Cmax).
Secondary endpoints included the assessment of patient-reported global health status, role and physical function, and treatment symptoms using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires.
Sekundarni opazovani dogodki so obsegali oceno splošnega zdravstvenega stanja, družbene in družinske vloge, telesne zmožnosti ter simptomov zdravljenja z uporabo vprašalnikov EORTC QLQ-C30 in EORTC QLQ-BR23, ki so jih izpolnjevali bolniki.
• a fixed subcutaneous dose of trastuzumab by injection (600 mg) every 3 weeks irrespective of the patient's body weight.
• kot fiksni subkutani odmerek, apliciran z injekcijo trastuzumaba (600 mg) vsake 3 tedne ne glede na bolnikovo telesno maso.
The statistically significant OS benefit in favour of the Perjetatreated group, previously observed at an interim analysis of OS (performed one year after the primary analysis), was maintained (HR 0.68, p = 0.0002 log-rank test).
Statistično signifikantna dobrobit za celokupno preživetje v korist skupine, ki je prejemala zdravilo Perjeta, predhodno opažena pri vmesni analizi celokupnega preživetja (izvedeni eno leto po primarni analizi), se je ohranila (razmerje ogroženosti 0,68; p = 0,0002, test log-rang).
A feeling of numbness, prickling or tingling in feet or hands; sharp jabbing, throbbing, freezing or burning pain; feeling pain from something which should not be painful such as a light touch; less able to feel changes in heat or cold; loss of balance or coordination
• občutek otrplosti, žgečkanje ali mravljinčenje v stopalih ali dlaneh; ostro zbadajoča, utripajoča ali pekoča bolečina; občutek bolečine zaradi nečesa, kar ne bi smelo biti boleče, kot je rahel dotik; manjša zmožnost občutenja temperaturnih sprememb; izguba ravnotežja ali koordinacije
Progression-Free Survival (independent review) - primary endpoint*
Preživetje brez napredovanja bolezni (neodvisen pregled)primarni končni cilj*
In patients receiving a taxane, Perjeta and trastuzumab should be administered prior to the taxane.
Bolniki, ki prejemajo taksan, morajo zdravilo Perjeta in trastuzumab dobiti pred taksanom.
None of these patients experienced anaphylactic/hypersensitivity reactions that were clearly related to ADA.
Pri nobenem od teh bolnikov se ni pojavila anafilaktična/preobčutljivostna reakcija, ki bi bila jasno povezana z ADA. Pediatrična populacija
The most common NCI-CTCAE Grade 3-4 ADRs (≥10%) were neutropenia and febrile neutropenia.
Najpogostejša neželena učinka 3. do 4. stopnje po merilih NCI-CTCAE (≥ 10 %) sta bila nevtropenija in febrilna nevtropenija.