natgillin/translations-raw huggingface dataset:
In studies in treatment-naïve patients, increases from baseline were observed in both the tenofovir alafenamide fumarate and tenofovir disoproxil fumarate containing treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 96.
V študijah pri predhodno nezdravljenih bolnikih so v 96. tednu opazili povečanje od začetne vrednosti v obeh skupinah zdravljenja, v skupini z alafenamidtenofoviratom in skupini z dizoproksiltenofovirat fumaratom, pri parametrih maščob na tešče za skupni holesterol, direktni holesterol lipoproteinov nizke gostote (low-density lipoprotein, LDL) ali LDL holesterol, holesterol lipoproteinov visoke gostote (high-density lipoprotein, HDL) ali HDL holesterol in trigliceride.
In studies in treatment-naïve patients, increases from baseline were observed in both treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 96.
V študijah pri predhodno nezdravljenih bolnikih so v 96. tednu povečanje od začetne vrednosti opazili v obeh skupinah zdravljenja pri parametrih maščob na tešče za skupni holesterol, direktni holesterol lipoproteinov nizke gostote (low-density lipoprotein, LDL) ali LDL holesterol, holesterol lipoproteinov visoke gostote (high-density lipoprotein, HDL) ali HDL holesterol in trigliceride.
In studies in treatment-naïve patients, increases from baseline were observed in both treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 96.
V študijah pri predhodno nezdravljenih bolnikih so v 96. tednu povečanje od začetne vrednosti opazili v obeh skupinah zdravljenja, pri parametrih maščob na tešče za skupni holesterol, direktni LDL holesterol in HDL holesterol, ter trigliceride.
In studies in vitro, alogliptin was found to be neither a substrate nor an inhibitor of key transporters associated with drug disposition in the kidney: organic anion transporter-1, organic anion transporter-3 or organic cationic transporter-2 (OCT2).
V študijah in vitro je bilo ugotovljeno, da alogliptin ni niti substrat niti zaviralec ključnih prenašalcev, povezanih z odlaganjem zdravil v ledvicah: organskega anionskega prenašalca-1, organskega anionskega prenašalca-3 ali organskega kationskega prenašalca-2 (OCT2; “organic cationic transporter-2”).
In studies of clinically-relevant duration (14-28 days), daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog.
V študijah s klinično relevantnim trajanjem (14-28 dni) je bilo dajanje daptomicina povezano z minimalnimi do blagimi degenerativnimi/regenerativnim spremembami skeletnih mišic pri podganah in psih.
In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).
V predkliničnih raziskavah uporabe interferona pri nečloveških primatih so opažali motnje menstrualnega ciklusa (glejte točko poglavje 4.4).
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.
In studies of sepsis, 1015 patients received Kineret at doses up to 2 mg/kg/hour i.v. (~35 times the recommended dose in RA) over a 72 hour treatment period.
V študijah sepse je 1015 bolnikov dobivalo zdravilo Kineret v odmerkih do 2 mg/kg/uro i.v. (~35-krat priporočeni odmerek pri RA) skozi 72 urno obdobje zdravljenja.
In studies of up to 9 months an overall mean decrease of 1% in height percentile (decrease of 2% in children (7-11 years) and increase of 0.3% in adolescents (12-17 years)) was observed in duloxetine- treated paediatric patients (see section 4.4).
V študijah, ki so trajale do 9 mesecev, so pri pediatričnih bolnikih, zdravljenih z duloksetinom, opazili skupno povprečno zmanjšanje za 1 % višinskega percentila (zmanjšanje za 2 % pri otrocih (7-11 let) in povečanje za 0,3 % pri mladostnikih (12-17 let)) (glejte poglavje 4.4).
In studies performed with spinosad only, the primary biliary, faecal and urinary metabolites in both rat and dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and to a lesser extent in the urine.
V študijah, opravljenih s samim spinosadom, so glavne presnovke v žolču, blatu in urinu pri podganah in psih opredelili kot demetilirane spinosine, glutationske konjugate starševskih spojin in N- demetilirana spinosina A in D. Glavna pot izločanja je z žolčem in blatom, v manjši meri pa z urinom.
In studies performed with the individual active substances, both sitagliptin and metformin are excreted in the milk of lactating rats.
V študijah, opravljenih s posameznima zdravilnima učinkovinama, sta se sitagliptin in metformin izločala v mleko doječih podgan.
In studies using the Arizona Sexual Experience Scale (ASEX), the incidence of treatment-emergent sexual dysfunction (TESD) and the ASEX total score showed no clinically relevant difference to placebo in symptoms of sexual dysfunction at the 5 to
V študijah z arizonsko lestvico spolne izkušnje (ASEX), incidenca spolne disfunkcije zaradi zdravljenja (TESD) in skupno število točk po lestvici ASEX ni pokazalo klinično pomembnih razlik v primerjavi s placebom glede simptomov spolne disfunkcije pri odmerkih 5 do
In studies using the criteria- based up-titration regimen, a majority of patients achieved the pre-defined target LDL-C (based on their level of CV risk) on the 75 mg Q2W dose, and a majority of patients maintained treatment on the 75 mg Q2W dose.
V študijah, v katerih so povečevanje odmerka izvajali na podlagi meril, je večina bolnikov dosegla vnaprej opredeljeni ciljni LDL-H (na podlagi svojega KV tveganja) z odmerkom 75 mg na 2 tedna in večina bolnikov je tudi vzdrževala zdravljenje z odmerkom 75 mg na 2 tedna.
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count  1000/ mm3).
V študijah, v katerih so odrasli bolniki sočasno prejemali zdravilo Enbrel in anakinro, so opažali večjo stopnjo resnih okužb v primerjavi s samim zdravilom Enbrel in pri 2 % bolnikov (3/139) se je pojavila nevtropenija (absolutna koncentracija nevtrofilcev < 1.000/mm3).
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count  1000/mm3).
V študijah, v katerih so odrasli bolniki sočasno prejemali zdravilo Enbrel in anakinro, so opažali večjo stopnjo resnih okužb v primerjavi s samim zdravilom Enbrel in pri 2 % bolnikov (3/139) se je pojavila nevtropenija (absolutna koncentracija nevtrofilcev < 1.000/mm3).
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed, and 2% of patients (3/139) developed neutropenia (absolute neutrophil count  1000/mm3).
V študijah, v katerih so odrasli bolniki sočasno prejemali zdravilo Enbrel in anakinro, so opažali večjo stopnjo resnih okužb v primerjavi s samim zdravilom Enbrel in pri 2 % bolnikov (3/139) se je pojavila nevtropenija (absolutna koncentracija nevtrofilcev < 1.000/mm3).
In studies where tipranavir co- administered with low-dose ritonavir was used with or without enfuvirtide, it has been observed that the steady-state plasma tipranavir trough concentration of patients receiving enfuvirtide were 45% higher as compared to patients not receiving enfuvirtide.
V raziskavah, v katerih so uporabili tipranavir s hkratnimi majhnimi odmerki ritonavirja v kombinaciji z enfuvirtidom ali brez njega, je bila najmanjša koncentracija tipranavirja v plazmi v ravnovesnem stanju pri bolnikih, ki so prejemali enfuvirtid, za 45% večja kot pri bolnikih, ki niso prejemali enfuvirtida.
In studies with adults, data were obtained after two doses of Bexsero with a one month or two month interval between doses (see Table 7).
V študijah pri odraslih so podatki pridobljeni po dveh odmerkih cepiva Bexsero z eno- ali dvomesečnim presledkom med odmerkoma (glejte preglednico 7).
In studies with daily i.v. dosing regimen, there was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in rats and rabbits.
V študijah z dnevnim intravenskim odmerjanjem pri podganah in kuncih, niso opazili neposrednih škodljivih vplivov na plod ali teratogenega delovanja ibandronske kisline.
In studies with rats a reduction in fertility indices was observed at parentally toxic doses (see section 5.3).
V študijah na podganah so pri parenteralni aplikaciji toksičnih odmerkov opazili zmanjšano plodnost (glejte poglavje 5.3).
In studies with VPRIV additional side effects have also been reported: Very common side effects are:
V študijah z zdravilom VPRIV so poročali tudi o dodatnih neželenih učinkih: Zelo pogosti neželeni učinki so:
In studies without antibacterial soaking, pyrexia or hyperthermia was reported in 35.6% of NexoBrid- treated patients compared with 18.6% in control patients.
V študijah brez antibakterijskega namakanja so o pireksiji ali hipertermiji poročali pri 35,6 % bolnikov, zdravljenih z zdravilom NexoBrid, v primerjavi z 18,6 % bolnikov iz kontrolne skupine.
In studies, Aubagio was shown to reduce relapses and delay the progression of disability in patients with relapsing- remitting MS.
V študijah je zdravilo Aubagio pri bolnikih z recidivno remitentno multiplo sklerozo zmanjšalo število recidivov in upočasnilo napredovanje njihove nezmožnosti.
In studies, Cresemba’s effect was comparable to that of voriconazole in treating invasive aspergillosis.
V študijah je bil učinek zdravila Cresemba pri zdravljenju invazivne aspergiloze primerljiv z učinkom vorikonazola.
In studies, rats given high doses showed an increased incidence of incomplete foetal ossification.
Študijah pri podganah, ki so prejemale velike odmerke, so pokazal zvišano pojavnost nepopolne osifikacije pri plodu.
In studies, the most common side effects with Sprycel (seen in more than 1 patient in 10) were infection, suppression of the bone marrow (decreasing numbers of blood cells), headache, haemorrhage (bleeding), pleural effusion (fluid around the lungs), dyspnoea (difficulty breathing),, diarrhoea, vomiting, nausea (feeling sick), abdominal pain (stomach ache), skin rash, musculoskeletal pain, fatigue (tiredness), swelling in the extremities and the face, pyrexia (fever), neutropenia (low levels of neutrophils), thrombocytopenia (low blood platelet counts) and anaemia (low red blood cell counts).
Najpogostejši neželeni učinki zdravila Sprycel v študijah (opaženi pri več kot 1 bolniku od 10) so bili okužbe, supresija kostnega mozga (zmanjšana tvorba krvnih celic), glavobol, krvavitve, plevralni izliv (tekočina okoli pljuč), dispneja (zasoplost), driska, bruhanje, navzeja (slabost), bolečine v trebuhu, kožni izpuščaji, bolečine v mišicah in sklepih, utrujenost, otekanje okončin in obraza, pireksija (povišana telesna temperatura), nevtropenija (nizko število nevtrofilcev), trombocitopenija (nizko število trombocitov) in anemija (nizko število rdečih krvnih celic).
In studies, the most common side effects with Tarceva when used as monotherapy for lung cancer were rash (seen in 75% of patients), diarrhoea (seen in 54% of patients), loss of appetite and tiredness (each seen in 52% of patients).
V študijah so bili najpogostejši neželeni učinki zdravila Tarceva, kadar je bilo uporabljeno kot samostojno zdravilo za zdravljenje pljučnega raka, izpuščaji (opaženi pri 75 % bolnikov), driska (opažena pri 54 % bolnikov) in izguba teka (opažena pri 52 % bolnikov).
In studies, the most common side effects with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infection of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (itchy rash), headache, dizziness, vomiting, nausea (feeling sick), arthralgia (joint pain), rigors (shaking chills), pyrexia (fever) and fatigue (tiredness).
V študijah so bili najpogostejši neželeni učinki zdravila Tysabri (opaženi pri 1 do 10 bolnikih od 100) okužbe sečil (okužbe struktur za odvajanje urina), nazofaringitis (okužbe nosu in žrela), urtikarija (srbeči izpuščaji), glavobol, omotica, bruhanje, navzeja (slabost), artralgija (bolečine v sklepih), mrzlica (drgetanje), pireksija (povišana telesna temperatura) in utrujenost.
In studies,some eye-related side-effects have been reported both in patients using Strensiq and those who were not, probably associated with hypophosphatasia.
V študijah so pri bolnikih, ki so uporabljali zdravilo Strensiq, in pri tistih, ki ga niso, poročali o nekaterih neželenih učinkih, povezanih z očesom, ki so verjetno povezani s hipofosfatazijo.
In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/18 infection was 100% (95% CI: 80.5; 100).
V študiji 007 je bila učinkovitost cepiva Cervarix proti 12-mesečni persistentni okužbi s HPV- 16/18 100 % (95 % interval zaupanja: 80,5; 100).
In study 008, immunogenicity up to month 48 was similar to the response observed in study 001.
V študiji 008 je bila imunogenost v do 48. meseca podobna odzivu, opaženem v študiji 001.
In study 0102 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5 % and no extramedullary disease]
V študiji 0102 [ANC  1,5 x 109/l, trombociti  100 x 109/l, brez blastov v krvi, BM blasti < 5 % in brez obolelosti zunaj kostnega mozga]
In study 024 (a subset of study 001/007), a challenge dose of Cervarix was administered to 65 subjects at a mean interval of 6.8 years after the administration of the first vaccine dose.
V študiji 024 (podštudiji študije 001/007) je bil provokacijski odmerek cepiva Cervarix uporabljen pri 65 osebah povprečno 6,8 let po prvem odmerku cepiva.
In Study 02507, the total Bone Marrow Burden (BMB) score as assessed by MRI in lumbar spine and femur in Cerdelga-treated patients decreased by a mean of 1.1 points after 9 months (n=20) and 2.15 points after 18 months (n=18).
V študiji 02507 se je ocena celokupne obremenitve kostnega mozga (BMB, Bone Marrow Burden), izvedena s slikanjem ledvene hrbtenice in stegnenice z magnetno resonanco (MRI) pri bolnikih, ki so prejemali zdravilo Cerdelga, po 9 mesecih (n=20) zmanjšala povprečno za 1,1 točke in po 18 mesecih (n=18) za 2,15 točke.
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4 % (8/194) of patients receiving PegIntron in combination with ribavirin.
V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm3 pri 4 % (8/194) bolnikov in zmanjšanje števila trombocitov pod 50.000/mm3 pri 4 % (8/194) bolnikov, ki so prejemali zdravilo PegIntron v kombinaciji z ribavirinom.
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4 % (8/194) of patients receiving ViraferonPeg in combination with ribavirin.
V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm3 pri 4 % (8/194) bolnikov in zmanjšanje števila trombocitov pod 50.000/mm3 pri 4 % (8/194) bolnikov, ki so prejemali zdravilo ViraferonPeg v kombinaciji z ribavirinom.
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4% (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4% (8/194) of patients receiving ribavirin capsules in combination with peginterferon alfa-2b.
V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm3 pri 4 % (8/194) bolnikov in zmanjšanje števila trombocitov pod 50.000/mm3 pri 4 % (8/194) bolnikov, ki so prejemali ribavirin v kombinaciji s peginterferonom alfa- 2b.
In Study 1 previous treatment with anti-tumour necrosis factor (TNF)α agent was not allowed.
V 1. študiji predhodno zdravljenje z zaviralcem tumorske nekroze (TNF-anti-tumour necrosos factor) α ni bilo dovoljeno.
In Study 1, 11/39 belatacept and
6. mesecu pa so bile redke.
In Study 1, 5/39 belatacept patients versus 1/21 ciclosporin patients with AR had experienced graft loss, and 5/39 belatacept patients and no ciclosporin patients with AR had died by Year 3.
V Študiji 1 je do 3. leta prišlo do izgube presadka pri 5 od 39 bolnikov z AZ, ki so prejemali belatacept, in pri 1 od 21 bolnikov z AZ, ki so prejemali ciklosporin.
In Study 1, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at the time of cortical clean-up, and 3% of patients in the Omidria group compared to 28% of patients in the placebo group had a pupil constriction ≥2.5 mm (P<0.0001 in both instances, Chi-Square test).
V študiji 1 so imeli med čiščenjem lečne skorje premer zenice < 6 mm samo 4 % bolnikov v skupini z zdravilom Omidria, medtem ko je bilo v skupini s placebom takih bolnikov 23 %, zoženje zenice za ≥ 2,5 mm pa so opazili pri 3 % bolnikov v skupini z zdravilom Omidria in 28 % bolnikov v skupini s placebom (p < 0,0001 v obeh primerih, hi-kvadratni preskus).
In Study 1, patients had the following median baseline characteristics: age 39 years, disease duration
V študiji 1 so imeli bolniki naslednje mediane vrednosti za izhodiščne karakteristike: starost 39 let, trajanje bolezni 7,0 let, rezultat po EDSS 2,0.
In Study 1, pharmacodynamics was assessed in 57 newly diagnosed paediatric patients with standard-risk ALL who received three intramuscular doses of Oncaspar (2500 Units/m2), one each during induction and two delayed intensification treatment phases.
V 1. študiji so ocenili farmakodinamiko pri 57 pediatričnih bolnikih z novo diagnozo ALL s standardnim tveganjem, ki so prejeli tri intramuskularne odmerke zdravila Oncaspar (2.500 enot/m2), po eno injekcijo med indukcijo in dvema fazama pozne intenzifikacije zdravljenja.
In Study 1, the most common adverse reactions were infections, including two life-threatening infections (1 patient in each arm).
V študiji 1 so bili najpogostejši neželeni učinki okužbe, vključno z dvema smrtno nevarnima okužbama (po 1 bolnik v vsaki skupini).
In Study 1, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (50% versus 32%, respectively).
V študiji 1 je bil delež bolnikov, ki so prekinili sodelovanje v študiji večji v Selincro skupini kot v placebo skupini (50 % proti 32 %, glede na vrstni red).
In Study 1007, the median duration of study treatment was
V Študiji 1007 je bila mediana trajanja preiskovanega zdravljenja pri bolnikih v skupini s krizotinibom (n = 172)
In Study 1014, the median duration of study treatment was 47 weeks for patients in the crizotinib arm (N=171); the median duration of treatment was 23 weeks for patients who crossed over from the chemotherapy arm to receive crizotinib treatment (N=109).
V Študiji 1014 je bila mediana trajanja preiskovanega zdravljenja pri bolnikih v skupini s krizotinibom (n = 171) 47 tednov, pri bolnikih, ki so prešli iz skupine s kemoterapijo v skupino, ki je prejemala krizotinib (n = 109), pa 23 tednov.
In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3 %) than patients on nevirapine (2.5 %).
V študiji 1100.1090, iz katere izvira večina podatkov o povezanih neželenih dogodkih (n=28), je bila pojavnost granulocitopenije večja pri bolnikih, ki so prejemali placebo (3,3 %), kot pri bolnikih, ki so prejemali nevirapin (2,5 %).
In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3%) than patients on nevirapine (2.5%).
V študiji 1100.1090, iz katere izvira večina podatkov o povezanih neželenih dogodkih (n=28), je bila pojavnost granulocitopenije večja pri bolnikih, ki so prejemali placebo (3,3 %), kot pri bolnikih, ki so prejemali nevirapin (2,5 %).
In study 1118, 44 patients with genotype 1 infection, including 12 cirrhotic patients, who had previously failed treatment with sofosbuvir + ribavirin + PEG-IFN or with sofosbuvir + ribavirin were treated with ledipasvir/sofosbuvir + ribavirin for 12 weeks; the SVR was 100% (44/44).
V študiji 1118 so 44 bolnikov z okužbo genotipa 1, vključno z 12 bolniki s cirozo, pri katerih predhodno zdravljenje s sofobuvirjem + ribavirinom ± PEG-IFN ali s sofobuvirjem + ribavirinom ni bilo uspešno, so 12 tednov zdravili z ledipasvirjem/sofosbuvirjem + ribavirinom; SVR je bil 100 % (44/44).
In Study 1899, a significant decrease in all cause mortality in favour of posaconazole was observed [POS 49/304 (16 %) vs.
V študiji 1899 so opazili bistveno zmanjšanje umrljivosti iz vseh vzrokov v prid posakonazolu
In Study 19, 18 patients were identified with a somatic tumour BRCA mutation (a mutation in the tumour but wildtype in the germline).
V študiji 19 so pri 18 bolnicah ugotovili somatsko tumorsko mutacijo gena BRCA (mutacijo v tumorju, a divji tip v klični liniji).
In Study 2, a Phase 1 study, 16 of 37 patients with CD were treated with siltuximab, at the recommended dose of 11 mg/kg every 3 weeks
V študiji 2, ki je bila študija pri bolnikih s Castlemanovo boleznijo faze I, je 16 od 37 bolnikov prejemalo siltuksimab v priporočenem odmerku 11 mg/kg vsake 3 tedne.
In Study 2, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at cortical clean-up, and 1% of patients in the Omidria group compared to 27% of patients in the placebo group had a pupil constriction ≥2.5 mm (P<0.0001, Chi-Square test).
V študiji 2 so imeli med čiščenjem lečne skorje premer zenice < 6 mm samo 4 % bolnikov v skupini z zdravilom Omidria, medtem ko je bilo v skupini s placebom takih bolnikov 23 %, zoženje zenice za ≥ 2,5 mm pa so opazili pri 1 % bolnikov v skupini z zdravilom Omidria in 27 % bolnikov v skupini s placebom (p < 0,0001, hi-kvadratni preskus).
In Study 2, the CMH weighted mean difference (Omidria – placebo) in the mean AUC was 0.59 mm [95% confidence interval: 0.49, 0.69] (P < 0.0001).
V študiji 2 je tehtana sredina (Omidria–placebo) povprečne AUC po CMH znašala 0,59 mm [95-odstotni interval zaupanja: 0,49, 0,69] (p < 0,0001).
In study 2011 003 the incidence of venous thromboembolic events was 10.6% in the Kd arm and 3.1% in the bortezomib plus dexamethasone (Vd) arm.
V študiji 2011 003 je bila incidenca venskih tromboemboličnih dogodkov 10,6 % v skupini Kd in 3,1 % v skupini z bortezomibom in deksametazonom (Vd).
In study 301, overall the most frequently reported events during the MTT were cough in 18 (4.8%) subjects, wheezing/bronchospasm in eight (2.1%) subjects and chest discomfort in six (1.6%) subjects.
V študiji 301 so bili med MTT najpogosteje ugotovljeni neželeni učinki kašelj pri 18 (4,8 %) preiskovancih, piskajoče dihanje/bronhospazem pri osmih (2,1 %) preiskovancih in nelagoden občutek v prsnem košu pri šestih (1,6 %) preiskovancih.
In study 302 patients with atrial fibrillation, or other cardiac arrhythmia requiring medical therapy were excluded.
Bolniki z atrijsko fibrilacijo ali z drugimi srčnimi aritmijami, ki so zahtevale zdravljenje, niso bilo vključeni v študijo 302.