natgillin/translations-raw huggingface dataset:
In the pivotal trial CLEOPATRA, ADRs were reported less frequently after discontinuation of docetaxel treatment.
V ključnem preskušanju CLEOPATRA so po ukinitvi zdravljenja z docetakselom o neželenih učinkih poročali redkeje.
In the pivotal trial CLEOPATRA, the initial dose of Perjeta was given the day before trastuzumab and docetaxel to allow for the examination of Perjeta-associated reactions.
V ključnem preskušanju CLEOPATRA je bil začetni odmerek zdravila Perjeta uporabljen 24 ur pred trastuzumabom in docetakselom; to je omogočilo ovrednotenje reakcij, povezanih z zdravilom Perjeta.
In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events.
V ključnem preskušanju CLEOPATRA je večina bolnikov v obeh zdravljenih skupinah vsaj enkrat doživela levkopenijo (63,0 % bolnikov v skupini, ki je prejemala zdravilo Perjeta, in 58,3 % bolnikov v skupini, ki je prejemala placebo); od tega največkrat nevtropenijo.
In the pivotal trial in patients with ovarian cancer treated at a dose of 50 mg/m2, myelosuppression was generally mild to moderate, reversible, and was not associated with episodes of neutropaenic infection or sepsis.
V osrednji raziskavi pri bolnicah z rakom jajčnikov, zdravljenih z odmerkom 50 mg/m2, je bila mielosupresija na splošno blaga do zmerna in reverzibilna ter ni bila povezana z epizodami okužb zaradi nevtropenije ali sepso.
In the pivotal trial MO16432, Herceptin was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2 ).
V ključnem preskušanju MO16432 so zdravilo Herceptin dajali sočasno z neoadjuvantno kemoterapijo, ki je vključevala tri cikle doksorubicina (kumulativni odmerek 180 mg/m2).
In the pivotal trial MO16432, Herceptin was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2) .
V ključnem preskušanju MO16432 so zdravilo Herceptin dajali sočasno z neoadjuvantno kemoterapijo, ki je vključevala tri cikle doksorubicina (kumulativni odmerek 180 mg/m2).
In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of Herceptin (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of Herceptin if the preceding dose of Herceptin was well tolerated.
V ključnih študijah (H0648g, M77001) so paklitaksel ali docetaksel dali en dan po uvajalnem odmerku zdravila Herceptin (za odmerek glejte Povzetek glavnih značilnosti zdravila za paklitaksel ali docetaksel) in takoj po nadaljnjih odmerkih zdravila Herceptin, če je bolnik predhoden odmerek zdravila Herceptin dobro prenašal.
In the pivotal trials Grade 3 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations were observed in 2.4% (LUX- Lung-3) and 1.6% (LUX-Lung 8) of patients with normal baseline liver tests treated with 40 mg/day.
V ključnih raziskavah so med bolniki z normalnimi izhodiščnimi izvidi jetrnih preiskav, ki so se zdravili z odmerki po 40 mg na dan, opazili povečanje vrednosti alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (ALT) stopnje 3 pri 2,4 % (LUX-Lung 3) in 1,6 % bolnikov (LUX-Lung 8).
In the pivotal trials with 3 times a week dosing, the most frequently reported adverse drug reactions judged to be probably or possibly related to imiquimod cream treatment were application site reactions at the wart treatment site (33.7% of imiquimod treated patients).
V treh preskušanjih z odmerjanjem trikrat tedensko so bili najpogosteje poročani neželeni učinki, za katere je bilo presojeno, da so verjetno oz. možno povezani z zdravljenjem z imikvimod kremo, reakcije na mestu nanašanja na zdravljenem področju z bradavicami (33,7% bolnikov, zdravljenih z imikvimodom).
In the pivotal trials, anti-adalimumab antibodies were identified in 5.5% (58/1053) of patients treated with adalimumab, compared to 0.5% (2/370) on placebo.
V preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, so protitelesa proti adalimumabu odkrili pri 5,5 % (58/1053) bolnikov, zdravljenih z adalimumabom, in pri 0,5 % (2/370) bolnikov, ki so dobivali placebo.
In the pivotal trials, anti-adalimumab antibodies were identified in 5.5% (58/1053) of patients treated with adalimumab, compared to 0.5% (2/370) on placebo.
V preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, so protitelesa proti adalimumabu odkrili pri 5,5 % (58/1053) bolnikov, zdravljenih z adalimumabom, in pri 0,5 % (2/370), ki so dobivali placebo.
In the pivotal, randomised, observer-blind study V59P20, in which participants were stratified by age (2 through 5 years and 6 through 10 years), the immunogenicity of a single dose of Menveo one month post vaccination was compared with the single dose of ACWY-D.
V osrednji, randomizirani, opazovalni slepi študiji V59P20, v kateri so bili sodelujoči stratificirani po starosti (2 do vključno 5 let in 6 do vključno 10 let), so imunogenost enega odmerka cepiva Menveo en mesec po cepljenju primerjali z enim odmerkom ACWY-D.
In the pJIA study, children who received golimumab 30 mg/m2 (maximum 50 mg) subcutaneously every 4 weeks, had median steady-state trough golimumab concentrations which were similar across different age groups, and which were also similar to or slightly higher than those seen in adult RA patients who received 50 mg golimumab every 4 weeks.
V študiji pJIA so otroci, ki so prejeli 30 mg/m2 (največ 50 mg) golimumaba subkutano vsake 4 tedne, dosegli mediane najnižje koncentracije golimumaba v stanju dinamičnega ravnovesja, ki so bile podobne v vseh starostnih skupinah in so bile prav tako podobne ali rahlo zvišane v primerjavi s koncentracijami pri odraslih bolnikih z revmatoidnim artritisom, ki so prejeli 50 mg golimumaba vsake 4 tedne.
In the placebo group, 0% to 7% of patients were able achieve a platelet count response during the 6 months of treatment.
V skupini s placebom je med 6-mesečno uporabo doseglo odziv števila trombocitov od 0% do 7% bolnikov.
In the placebo group, there were 4 cases of 6-month persistent infection and 1 case of 12-month persistent infection.
V skupini s placebom so bili 4 primeri 6-mesečne persistentne okužbe in 1 primer 12-mesečne persistentne okužbe.
In the placebo- controlled clinical trials, abatacept treatment did not lead to increased autoantibody formation, such as antinuclear and anti-dsDNA antibodies, relative to placebo treatment (see sections 4.8 and 5.3).
V s placebom nadzorovanih kliničnih preskušanjih pri zdravljenju z abataceptom tvorba avtoprotiteles, kot so protijedrna in anti-dsDNA protitelesa, ni bila večja kot pri placebu (glejte poglavji 4.8 in 5.3).
In the placebo-controlled clinical trials with intravenous abatacept, infections at least possibly related to treatment were reported in 23.1% of abatacept-treated patients and 20.7% of placebo-treated patients.
V s placebom nadzorovanih kliničnih preskušanjih intravenske uporabe abatacepta so o okužbah, ki bi lahko bile povezane z zdravljenjem, poročali pri 23,1% bolnikov, ki so prejemali abatacept, in 20,7% bolnikov, ki so prejemali placebo.
In the placebo-controlled clinical trials, abatacept treatment did not lead to increased autoantibody formation, such as antinuclear and anti-dsDNA antibodies, relative to placebo treatment (see sections 4.8 and 5.3).
V s placebom nadzorovanih kliničnih preskušanjih pri zdravljenju z abataceptom tvorba avtoprotiteles, kot so protijedrna in anti-dsDNA protitelesa, ni bila večja kot pri placebu (glejte poglavji 4.8 in 5.3).
In the placebo-controlled clinical trials, infections at least possibly related to treatment were reported in 23.1% of abatacept-treated patients and 20.7% of placebo-treated patients.
V s placebom nadzorovanih kliničnih preskušanjih so o okužbah, ki bi lahko bile povezane z zdravljenjem, poročali pri 23,1% bolnikov, ki so prejemali abatacept, in 20,7% bolnikov, ki so prejemali placebo.
In the placebo-controlled clinical trials, the frequencies of malignancies in abatacept- and placebo- treated patients were 1.4% and 1.1%, respectively (see section 4.8).
V s placebom nadzorovanih kliničnih preskušanjih je bila pogostnost novotvorb pri uporabi abatacepta 1,4%, pri uporabi placeba pa 1,1% (glejte poglavje 4.8).
In the placebo-controlled GIST phase III trial, the overall incidence of hand-foot skin reaction was 66.7% in patients treated with Stivarga as compared to 15.2% in patients receiving placebo.
V s placebom nadzorovanem preskušanju III. faze pri bolnikih z GIST je bila celokupna incidenca kožnih reakcij na dlaneh in podplatih 66,7 % pri bolnikih, zdravljenih z zdravilom Stivarga, v primerjavi s 15,2 % pri bolnikih, ki so prejemali placebo.
In the placebo-controlled GIST phase III trial, the overall incidence of proteinuria was 6.8% in patients treated with Stivarga compared to 1.5% in patients receiving placebo.
V s placebom nadzorovanem preskušanju III. faze pri bolnikih z GIST je bila celokupna incidenca proteinurije 6,8 % pri bolnikih, zdravljenih z zdravilom Stivarga, v primerjavi z 1,5 % pri bolnikih, ki so prejemali placebo.
In the placebo-controlled metastatic CRC phase III trial the overall incidence of hypertension was 30.4% in patients treated with Stivarga as compared to 7.9% in patients receiving placebo.
V s placebom nadzorovanem preskušanju III. faze pri bolnikih z metastatskim kolorektalnim rakom je bila celokupna incidenca hipertenzije 30,4 % pri bolnikih, zdravljenih z zdravilom Stivarga, v primerjavi s 7,9 % pri bolnikih, ki so prejemali placebo.
In the placebo-controlled metastatic CRC phase III trial, the overall incidence of hand-foot skin reaction was 45.2% in patients treated with Stivarga as compared to 7.1% in patients receiving placebo.
V s placebom nadzorovanem preskušanju III. faze pri bolnikih z metastatskim kolorektalnim rakom je bila celokupna incidenca kožnih reakcij na dlaneh in podplatih 45,2 % pri bolnikih, zdravljenih z zdravilom Stivarga, v primerjavi s 7,1 % pri bolnikih, ki so prejemali placebo.
In the placebo-controlled period of clinical studies in plaque psoriasis (a total of 1,382 patients treated with Cosentyx and 694 patients treated with placebo for up to 12 weeks), infections were reported in 28.7% of patients treated with Cosentyx compared with 18.9% of patients treated with placebo.
V s placebom kontroliranih obdobjih kliničnih študij psoriaze s plaki (s skupno 1.382 bolniki, ki so do 12 tednov prejemali zdravilo Cosentyx, in 694 bolniki, ki so prejemali placebo) so o okužbah poročali pri 28,7% bolnikov, ki so prejemali zdravilo Cosentyx, v primerjavi z 18,9% bolnikov, ki so prejemali placebo.
In the placebo-controlled period of clinical studies of patients with psoriasis, patients with psoriatic arthritis and patients with Crohn’s disease, the rate of infection was 1.38 per patient-year of follow-up in ustekinumab-treated patients, and 1.35 in placebo-treated patients.
V s placebom nadzorovanem obdobju kliničnih študij pri bolnikih s psoriazo in psoriatičnim artritisom je bila pogostnost okužb 1,27 na bolnikov-let spremljanja pri bolnikih, zdravljenih z ustekinumabom, oziroma 1,17 pri bolnikih, zdravljenih s placebom.
In the placebo-controlled phase III trial in patients with metastatic CRC, the overall incidence of treatment emergent proteinuria was 7.4% in patients treated with Stivarga as compared to 2.4% in patients receiving placebo.
V s placebom nadzorovanem preskušanju III. faze pri bolnikih z metastatskim kolorektalnim rakom je bila celokupna incidenca proteinurije, ki jo je bilo nujno potrebno zdraviti, 7,4 % pri bolnikih, zdravljenih z zdravilom Stivarga, v primerjavi z 2,4 % pri bolnikih, ki so prejemali placebo.
In the placebo-controlled studies 6.2% of patients experienced “hypoglycaemia” as an adverse reaction under linagliptin.
Neželeni učinek hipoglikemijo je v s placebom nadzorovanih študijah med zdravljenjem z linagliptinom imelo 6,2 % bolnikov.
In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis and Crohn’s disease, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.
V s placebom nadzorovanih študijah pri bolnikih s psoriazo in/ali s psoriatičnim artritisom so bile pogostnosti okužb in resnih okužb pri bolnikih, zdravljenih z ustekinumabom, podobne kot pri tistih, ki so prejemali placebo.
In the placebo-controlled studies, fold increase in peripheral blood CD34+ cell count (cells/l) over the 24-hour period from the day prior to the first apheresis to just before the first apheresis was evaluated (Table 6).
V s placebom kontroliranih študijah so ocenili n-kratno povečanje celic CD34+ (celic/l) v periferni krvi v razdobju 24 ur od dneva pred prvo aferezo do tik pred prvo aferezo (Preglednica 6).
In the placebo-controlled studies, most patients (>98%) had normal lymphocyte values prior to initiating treatment.
V s placebom kontroliranih študijah je imela večina bolnikov (> 98 %) pred začetkom zdravljenja normalne vrednosti limfocitov.
In the placebo-controlled trials, 15/260 (6%) of subjects treated with 100 mg dose subcutaneously developed anti-mepolizumab antibodies after having received at least one dose of mepolizumab.
V preskušanjih, kontroliranih s placebom, so se protitelesa proti mepolizumabu pojavila pri 15 od 250 (6 %) preiskovancev, zdravljenih z odmerkom 100 mg subkutano, potem ko so dobili vsaj en odmerek mepolizumaba.
In the pooled adolescent schizophrenia population (13-17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (<3 ng/ml) and males (< 2 ng/ml) was 29.5 % and
V populaciji mladostnikov s shizofrenijo (13-17 let), ki so se zdravili do 2 leti, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 29,5 % in pri moških (< 2 ng/ml) 48,3 %.
In the pooled analysis for C209 and C215 of patients who received a background regimen of emtricitabine/tenofovir disoproxil fumarate, demographic and baseline characteristics were balanced between the rilpivirine and efavirenz arm.
V skupni analizi za C209 in C215 za bolnike, ki so prejemali osnovno shemo zdravljenja z emtricitabinom/dizoproksiltenofovirijevim fumaratom, so demografske in začetne značilnosti uravnotežili med krakoma rilpivirina in efavirenza.
In the pooled analysis for DUET-1 and DUET-2, the incidence of hepatic events tended to be higher in co-infected subjects treated with INTELENCE compared to co-infected subjects in the placebo group.
V združeni analizi izsledkov preskušanj DUET-1 in DUET-2 je bila pojavnost jetrnih neželenih učinkov pri sočasno okuženih bolnikih, ki so jih zdravili z zdravilom INTELENCE, večja v primerjavi s sočasno okuženimi bolniki, ki so prejemali placebo.
In the pooled analysis for TMC278-C209 and TMC278-C215 of 1096 patients who received a background regimen (BR) of FTC/TDF, demographic and baseline characteristics were balanced between the rilpivirine and efavirenz (EFV) arms.
V združeni analizi za TMC278-C209 in TMC278-C215 1096 bolnikov, ki so prejemali osnovno shemo zdravljenja (BR-background regimen) s FTC/TDF, so demografske in začetne značilnosti uravnotežili med krakoma rilpivirina in efavirenza (EFV).
In the pooled analysis from NV-02B-007 (GLOBE) and NV-02B-015, by 104 weeks of treatment grade 3 or4 CK elevations (> 7x ULN) occurred in 12.6% of telbivudine-treated patients (n = 847) and 4.0% of lamivudine-treated patients (n = 846).
V združeni analizi podatkov iz študij NV-02B-007 (GLOBE) in NV-02B-015 je v 104 tednih zdravljenja prišlo do zvišanja CK stopnje 3 ali 4 (>7x ULN (upper limit of normal) – zgornje meje normalnih vrednosti) pri 12,6% bolnikov, zdravljenih s telbivudinom, (n = 847) in pri 4,0% bolnikov, zdravljenih z lamivudinom (n = 846).
In the pooled analysis of 100 PAH patients from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, elevations in liver aminotransferases ≥ 3  ULN were observed in 2% of patients.
V skupni analizi 100 bolnikov s PAH iz nenadzorovanih pediatričnih študij FUTURE 1/2 in FUTURE 3/podaljšanje, so povišane vrednosti jetrnih aminotransferaz ≥ 3  ULN opazili pri 2 % bolnikov.
In the pooled analysis of studies where patients switched from sodium phenylbutyrate to glycerol phenylbutyrate, ammonia AUC0-24h was 774.11 and 991.19 [(micromol/L)*hour] during treatment with glycerol phenylbutyrate and sodium phenylbutyrate, respectively (n = 80, ratio of geometric means 0.84; 95% confidence intervals 0.740, 0.949).
Analiza združenih podatkov iz študij, kjer so bolniki prešli z natrijevega fenilbutirata na glicerol fenilbutirat, je bila površina pod krivuljo plazemskih koncentracij amoniaka (AUC0–24h) 774,11 [(mikromol/l)*h] med zdravljenjem z glicerol fenilbutiratom in in 991,19 med zdravljenjem z natrijevim fenilbutiratom (n = 80, razmerje geometričnih sredin 0,84; 95-odstotni interval zaupanja 0,740, 0,949).
In the pooled analysis of the INPULSIS trials, the estimated mean change from baseline to week 52 in SGRQ total score was smaller in the nintedanib group (3.53) than in the placebo group (4.96), with a difference between the treatment groups of -1.43 (95% CI: -3.09, 0.23; p=0.0923).
V združeni analizi preskušanj INPULSIS je bila ocenjena povprečna sprememba skupnega seštevka SGRQ od izhodišča do 52. tedna manjša v skupini z nintedanibom (3,53), kot v skupini s placebom (4,96), z razliko med skupinama zdravljenja -1,43 (95 % IZ: -3,09; 0,23; p=0,0923).
In the pooled analysis of the Phase 3 studies, 380/1,023 (37%) patients’ virus had baseline NS5A RAVs.
V združeni analizi študij 3. faze je imelo 380/1.023 (37 %) virusov pri bolnikih izhodiščne RAV NS5A.
In the pooled analysis of the placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to linagliptin 5 mg (63.1% versus 60.3%).
Pri analizi zbranih podatkov s placebom nadzorovanih preskušanjih je bila pojavnost neželenih učinkov pri bolnikih, ki so jemali placebo, podobna kot pri tistih, ki so jemali po 5 mg linagliptina (63,1 % v primerjavi s 60,3 %).
In the pooled analysis of treatment-experienced patients, the rates of discontinuation of therapy due to adverse reactions were 3.9 % in patients receiving ISENTRESS + OBT and 4.6 % in patients receiving placebo + OBT.
Pri združeni analizi predhodno že zdravljenih bolnikov je bilo zdravljenje zaradi neželenih učinkov prekinjeno pri 3,9 % bolnikov, ki so prejemali zdravilo ISENTRESS + OBT, in pri 4,6 % bolnikov, ki so prejemali placebo + OBT.
In the pooled analysis, the rate ratio of exacerbations through week 24 in subjects treated with lumacaftor/ivacaftor (lumacaftor 400 mg/ivacaftor 250 mg q12h; n=369) was 0.61 (P<0.0001), representing a reduction of 39% relative to placebo.
V združeni analizi je bilo razmerje pogostnosti poslabšanj do 24. tedna pri bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem (lumakaftor 400 mg/ivakaftor 250 mg na 12 ur; n=369) 0,61 (P<0,0001), kar predstavlja zmanjšanje za 39 % glede na placebo.
In the pooled data from these two studies the most serious adverse reactions on Gilenya 0.5 mg were infections, macular oedema and transient atrioventricular block at treatment initiation.
V analizi združenih podatkov iz obeh študij so bili najbolj resni neželeni učinki zdravila Gilenya 0,5 mg okužbe, makularni edem in prehoden atrioventrikularni blok na začetku zdravljenja.
In the pooled dataset of nivolumab 3 mg/kg as monotherapy across tumour types (CA209066, CA209037, CA209067 (monotherapy group), CA209017, CA209057, CA209063 and CA209025), the most frequent adverse reactions (≥ 10%) were fatigue (34%), rash (19%), pruritus (14%), diarrhoea (13%), nausea (13%), and decreased appetite (10%).
Zbrani podatki iz študij uporabe nivolumaba v odmerku 3 mg/kg v obliki monoterapije pri različnih vrstah tumorjev (CA209066, CA209037, CA209067 (skupina z monoterapijo), CA209017, CA209057, CA209063 in CA209025) kažejo, da so najpogostejši neželeni učinki (≥ 10 %) bili naslednji: utrujenost (34 %), izpuščaj (19 %), srbenje (14 %), driska (13 %), navzea (13 %) in zmanjšanje apetita (10 %).
In the pooled dataset of two studies in squamous NSCLC (CA209017 and CA209063), the most frequent adverse reactions (≥ 10% of patients) were fatigue (33%), decreased appetite (15%), and nausea (12%).
Zbrani podatki iz dveh študij, izvedenih pri ploščatoceličnem NSCLC (študija CA209017 in študija CA209063), kažejo, da so najpogostejši neželeni učinki ( ≥ 10 % bolnikov) bili utrujenost (33 %), zmanjšanje apetita (15 %) in navzea (12 %).
In the pooled efficacy analysis from the two Phase III clinical studies (C209 [ECHO] and C215 [THRIVE]) through 96 weeks, patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/mL had a greater risk of virologic failure (17.6% with rilpivirine versus 7.6% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL (5.9% with rilpivirine versus 2.4% with efavirenz).
V skupni analizi učinkovitosti iz dveh kliničnih študij faze III (C209 [ECHO] in C215 [THRIVE]) do vključno 96. tedna je bilo pri bolnikih, zdravljenih z emtricitabinom/dizoproksiltenofovirijevim fumaratom + rilpivirinom z začetno virusno obremenitvijo > 100.000 HIV-1 RNA kopij/ml tveganje za virološki neuspeh (17,6 % z rilpivirinom v primerjavi s 7,6 % z efavirenzom) v primerjavi z bolniki z začetno virusno obremenitvijo ≤ 100.000 HIV-1 RNA kopij/ml (5,9 % z rilpivirinom v primerjavi z 2,4 % z efavirenzom) večje.
In the pooled RE-COVER and RE-COVER II studies, a total of 5,153 patients were randomized and 5,107 were treated.
V združenih študijah RE-COVER in RE-COVER II je bilo skupno naključno razvrščenih 5153 bolnikov, zdravljenih bolnikov pa 5107.
In the population pharmacokinetic analyses of the phase III studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored.
V analizi populacijske farmakokinetike na podlagi študij faze III so raziskovali vpliv zdravil, ki jih najpogosteje sočasno uporabljamo pri bolnikih s psoriazo (vključno s paracetamolom, ibuprofenom, acetilsalicilno kislino, metforminom, atorvastatinom in levotiroksinom), na farmakokinetiko ustekinumaba.
In the population pharmacokinetic analysis in patients with ONIVYDE using the results of a subset with UGT1A1*28 genotypic testing, in which the analysis adjusted for the lower dose administered to patients homozygous for the UGT1A1*28 allele, patients homozygous (N=14) and non-homozygous (N=244) for this allele had total SN-38 average steady-state concentrations of 1.06 and 0.95 ng/ml, respectively.
V populacijski farmakokinetični analizi pri bolnikih, ki so prejemali zdravilo ONIVYDE, pri kateri so uporabili rezultate podskupine z genotipskim testiranjem za UGT1A1*28, kjer so analizo prilagodili glede na manjši odmerek, dan bolnikom s homozigotnostjo za alel UGT1A1*28, so imeli bolniki s homozigotnostjo (N=14) in brez homozigotnosti (N=244) za ta alel povprečno koncentracijo skupnega SN-38 v dinamičnem ravnovesju 1,06 oziroma 0,95 ng/ml.
In the population pharmacokinetic analysis of data from clinical studies in patients with metastatic melanoma, pre-existing mild and moderate renal impairment did not influence the clearance of ipilimumab.
Analiza podatkov populacijske farmakokinetike iz kliničnih študij pri bolnikih z metastatskim melanomom je pokazala, da predhodna blaga in zmerna okvara ledvic nista vplivali na očistek ipilimumaba.
In the population pharmacokinetic analysis of data from clinical studies in patients with metastatic melanoma, pre-existing mild hepatic impairment did not influence the clearance of ipilimumab.
Analiza podatkov populacijske farmakokinetike iz kliničnih študij pri bolnikih z metastatskim melanomom je pokazala, da predhodna blaga okvara jeter ni vplivala na očistek ipilimumaba.