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randomizirana kontrolirana študija
1 Prevajalska redakcija
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Z zdravljenjem povezani neželeni učinki v randomiziranih kontroliranih študijah 3. faze Preiskave
Treatment related adverse reactions in phase 3 randomized controlled studies Investigations
2 Prevajalska redakcija
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Študija 1 (študija 11213) je bila multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija III. faze, v katero so bili vključeni 903 bolniki.
Study 1 (study 11213) was a Phase III, multi-centre, randomised, double blind, placebo-controlled study in 903 patients.
3 Prevajalska redakcija
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Druga študija je bila randomizirana, kontrolirana, multicentrična študija, v kateri so primerjali terapevtsko shemo zdravljenja z Zevalinom z rituksimabom.
9 Study 2 was a randomized, controlled, multicenter study comparing the Zevalin therapeutic regimen to treatment with rituximab.
4 Prevajalska redakcija
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Pri bolnikih s cervikalno distonijo so izvedli dve randomizirani, multicentrični, dvojno slepi študiji III faze, kontrolirani s placebom.
Two Phase III randomised, multicentre, double-blind, placebo-controlled studies were conducted in patients with cervical dystonia.
5 Prevajalska redakcija
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Ker pa to ni bila prospektvina, randomizirana in kontrolirana študija, morate vse primerjave z zunanjo kontrolno skupino pazljivo vrednotiti.
However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
6 Prevajalska redakcija
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Z alopurinolom kontrolirana študija s febuksostatom (Febuxostat Allopurinol Controlled Trial - FACT) je bila randomizirana, dvojno slepa, multicentrična, 52- tedenska študija
The Febuxostat Allopurinol Controlled Trial (FACT) Study was a Phase 3, randomized, double-blind, multicenter, 52-week study. Seven hundred sixty (760) patients were randomized:
7 Prevajalska redakcija
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Učinkovitost in varnost Humire za zdravljenje revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
The efficacy and safety of Humira for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
8 Prevajalska redakcija
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Učinkovitost in varnost Trudexe za zdravljenje revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
The efficacy and safety of Trudexa for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
9 Prevajalska redakcija
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10 Karcinom jetrnih celic Študija 3 (študija 100554) je bila mednarodna, multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija III. faze pri 602 bolnikih s karcinomom jetrnih celic.
Hepatocellular carcinoma Study 3 (study 100554) was a Phase III, international, multi-centre, randomised, double blind, placebo-controlled study in 602 patients with hepatocellular carcinoma.
10 Prevajalska redakcija
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za Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [ CDAI ] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
au The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
11 Prevajalska redakcija
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Eno randomizirano kontrolirano preskušanje in epidemiološke študije so pri uporabnicah ugotovile dva - do trikrat večje tveganje kot pri neuporabnicah.
One randomised controlled trial and epidemiological studies found a two- to threefold higher risk for users compared with non-users.
12 Prevajalska redakcija
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Učinkovitost zdravila Enbrel je bila ocenjena v randomizirani, dvojno slepi in s placebom kontrolirani študiji pri 205 bolnikih s psoriatičnim artritisom.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
13 Prevajalska redakcija
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Pegaptanib so pri bolnikih z neovaskularno AMD raziskali v dveh kontroliranih, dvojno slepih in enako zasnovanih randomiziranih študijah (EOP1003, EOP1004).
Pegaptanib was studied in two controlled, double-masked, and identically designed randomised studies (EOP1003; EOP1004) in patients with neovascular AMD.
14 Prevajalska redakcija
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Učinkovitost in varnost Trudexe za zdravljenje za revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
The efficacy and safety of Trudexa for the treatment of lon rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
15 Prevajalska redakcija
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Psoriatični artritis Učinkovitost zdravila Arava je dokazala kontrolirana, randomizirana dvojno slepa študija 3L01 pri 188 bolnikih s psoriatičnim artritisom.
The efficacy of Arava was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20mg/ day.
16 Prevajalska redakcija
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Študija je randomizirana, dvojno slepa s placebom kontrolirana študija za ugotavljanje odmerka zdravila za indikacijo pridobljenega pomanjkanja proteina C zaradi meningokokne sepse (IMAG 112).
The study is a randomized, double-blind, placebo- controlled dose-finding study, in the indication of acquired protein C deficiency due to meningococcal sepsis (IMAG 112).
17 Prevajalska redakcija
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Profilaksa invazivnih glivičnih okužb (IFI) (študiji 316 in 1899) Opravljeni sta bili dve randomizirani, kontrolirani študiji profilakse pri bolnikih z velikim tveganjem za nastanek invazivnih glivičnih okužb.
Prophylaxis of Invasive Fungal Infections (IFIs) (Studies 316 and 1899) Two randomised, controlled prophylaxis studies were conducted among patients at high risk for developing invasive fungal infections.
18 Prevajalska redakcija
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V kontrolirane, randomizirane dvojno slepe klinične študije III. faze (program RECORD) je bilo vključenih več kot 9500 bolnikov (7050 z zamenjavo kolka in 2531 z zamenjavo kolena).
Over 9,500 patients (7,050 in total hip replacement surgery and 2,531 in total knee replacement surgery) were studied in controlled randomised double-blind phase III clinical studies, the RECORD-programme.
19 Prevajalska redakcija
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Učinkovitost in varnost zdravila MabThera v lajšanju simptomov in znakov revmatoidnega artritisa sta bili dokazani v treh randomiziranih, kontroliranih, dvojno slepih, multicentričnih študijah.
The efficacy and safety of MabThera in alleviating the symptoms and signs of rheumatoid arthritis was demonstrated in three randomized, controlled, double-blind, multicenter studies.
20 Prevajalska redakcija
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Učinkovitost duloksetina kot zdravila za bolečino pri diabetični nevropatiji so ugotavljali v 2 randomiziranih 12- tedenskih dvojno slepih s placebom kontroliranih študijah z določenim odmerkom
The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
21 Prevajalska redakcija
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Zdravilo ORACEA so vrednotili v dveh randomiziranih, dvojno slepih, s placebom kontroliranih, 16 - tedenskih študijah pri 537 bolnikih z rozaceo (10 do 40 papul in pustul, in dva ali manj nodulov).
ORACEA has been evaluated in two pivotal randomised, double-blind, placebo-controlled, 16-week studies in 537 patients with rosacea (10 to 40 papules and pustules, and two or fewer nodules).
22 Prevajalska redakcija
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Neželene učinke so ugotavljali na podlagi kumulativnih podatkov sedmih randomiziranih, dvojno slepih, s placebom kontroliranih študij Aranespa pri skupaj 2112 bolnikih (Aranesp 1200, placebo 912).
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients (Aranesp 1200, placebo 912).
23 Prevajalska redakcija
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Podatki o varnosti temeljijo na izsledkih, dobljenih pri 650 bolnikih s hematološkimi malignomi, vključenih v 3 randomizirane, s placebom kontrolirane klinične študije in v študijo farmakokinetike.
Safety data are based upon 650 patients with haematological malignancies enrolled in 3 randomised, placebo-controlled clinical studies and a pharmacokinetic study.
24 Prevajalska redakcija
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V randomizirani, dvojno slepi in s placebom kontrolirani študiji na odraslih bolnikih so primerjali kombinacijo abakavirja, lamivudina in zidovudina s kombinacijo indinavirja, lamivudina in zidovudina.
One randomised, double blind, placebo controlled clinical study in adults has compared the combination of abacavir, lamivudine and zidovudine to the combination of indinavir, lamivudine and zidovudine.
25 Prevajalska redakcija
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Z alopurinolom in s placebom kontrolirana študija učinkovitosti febuksostata (Allopurinol and Placebo- Controlled Efficacy Study of Febuxostat - APEX) je bila randomizirana, dvojno slepa, multicentrična, 28- tedenska študija 3. faze.
The Allopurinol and Placebo-Controlled Efficacy Study of Febuxostat (APEX) was a Phase 3, randomized, double-blind, multicenter, 28-week study.
26 Prevajalska redakcija
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Elektrofiziologija srca V randomizirani, dvojno slepi, s placebom in aktivno kontrolirani študiji, v kateri so uporabljali standardno in Holter elektrokardiografijo, niso opažali učinka na QT interval.
Cardiac electrophysiology No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
27 Prevajalska redakcija
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Na skupno 248 bolnikih s PBB in karcinomom, ki so povprečno imeli 1 do 4 epizode PBB dnevno med jemanjem opioidne terapije, so izvedli dve dvojno slepi, randomizirani, s placebom kontrolirani križni študiji.
Two double-blind, randomized, placebo-controlled crossover studies have been conducted involving a total of 248 patients with BTP and cancer who experienced on average 1 to 4 episodes of BTP per day while taking maintenance opioid therapy.
28 Prevajalska redakcija
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Varnost zdravila FABLYN za zdravljenje osteoporoze so ocenjevali v veliki (8. 556 bolnic), dvojno slepi, randomizirani multinacionalni študiji kostnih zlomov faze III, kontrolirani s placebom (študija PEARL).
The safety of FABLYN in the treatment of osteoporosis was assessed in a large (8,556 patients) double-blind, randomized, placebo-controlled multinational Phase 3 fracture trial (the PEARL study).
29 Prevajalska redakcija
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V prospektivni, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 314 bolnikih z rakom na pljučih, ki so dobivali kemoterapijo s platino, so ugotovili značilno zmanjšanje potreb po transfuziji ra
In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).
30 Prevajalska redakcija
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Rezultati potrditvene študije faze III Učinkovitost in varnost degareliksa so ovrednotili v odprti, multicentrični, randomizirani študiji s paralelnimi skupinami, kontrolirani z aktivnim primerjalnim zdravilom.
Results of the confirmatory Phase III study The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study.
31 Prevajalska redakcija
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Pri bolnikih z akutnim miokardnim infarktom z elevacijo ST spojnice sta bili varnost in učinkovitost klopidogrela vrednoteni v dveh randomiziranih, s placebom kontroliranih, dvojno slepih študijah, CLARITY in COMMIT.
In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
32 Prevajalska redakcija
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Interval QTcF so ocenili v randomizirani, s placebom in zdravilno učinkovino (moksifloksacin 400 mg enkrat na dan) kontrolirani navzkrižni študiji pri 45 zdravih odraslih, ki so jim 3. dan v 12 urah naredili 10 meritev.
QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 45 healthy adults, with 10 measurements over 12 hours on Day 3.
33 Prevajalska redakcija
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V dveh kontroliranih, multicentričnih, randomiziranih, dvojno slepih študijah faze III s paralelnimi skupinami, so ugotavljali učinkovitost Panretin gela za zdravljenje indeksiranih kožnih lezij KS- a (razpredelnica 3).
Two controlled, multicentre, randomised, double blind parallel group, Phase III studies provided the data for Panretin gel in the treatment of index cutaneous lesions of KS (Table 3).
34 Prevajalska redakcija
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Učinek atorvastatina na koronarno bolezen s smrtnim izidom in brez njega so ocenili v randomiziranem, dvojno slepi, s placebom kontrolirani študiji ASCOT- LLA (Anglo- Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm).
The effect of atorvastatin on fatal and non-fatal coronary heart disease was assessed in a randomized, double-blind, placebo-controlled study, the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA).
35 Prevajalska redakcija
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Varnost in učinkovitost zdravila Replagal so ovrednotili v dveh randomiziranih dvojno slepih, s placebom kontroliranih študijah in odprtih nadaljevalnih študijah, pri 40 bolnikih z diagnozo Fabryjeve bolezni, ki je temeljila na kliničnih in biokemičnih dokazih.
The safety and efficacy of Replagal was assessed in two randomised, double blind, placebo controlled studies and open label extension studies, in a total of forty patients with a diagnosis of Fabry Disease based on clinical and biochemical evidence.
36 Prevajalska redakcija
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Zdravljenje z zdravilom Emselex v odmerkih po 7, 5 mg in 15 mg na dan so raziskovali v štirih dvojno slepih, randomiziranih, kontroliranih kliničnih študijah faze III pri bolnikih in bolnicah s simptomi čezmerno aktivnega mehurja.
Treatment with Emselex administered at dosages of 7.5 mg and 15 mg daily has been investigated in four double-blind, Phase III, randomised, controlled clinical studies in male and female patients with symptoms of overactive bladder.
37 Prevajalska redakcija
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Učinkovitost pri odraslih bolnikih s PAH (uporabljen v kombinaciji z epoprostenolom) Randomizirana, dvojno slepa, s placebom kontrolirana študija je bila narejena pri 267 bolnikih s PAH, stabiliziranih na intravenskem epoprostenolu.
Efficacy in adult patients with PAH (when used in combination with epoprostenol) A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol.
38 Prevajalska redakcija
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V randomizirano, dvojno slepo, multicentrično, s placebom kontrolirano preskušanje faze III (študija RRA02997) so bili vključeni 203 odrasli bolniki (inhalacijski iloprost: n = 101, placebo: n = 102) s stabilno pljučno hipertenzijo.
8 A randomised, double-blind, multi-centre, placebo-controlled phase III trial (study RRA02997) has been conducted in 203 adult patients (inhaled iloprost: N=101; placebo n=102) with stable pulmonary hypertension.
39 Prevajalska redakcija
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Različna preskušanja so zajela manjše število otrok, vendar pa obstaja tudi ena randomizirana, kontrolirana (v primerjavi z mikroemulzijo ciklosporina ter v kombinaciji s kortikosteroidi in aztioprinom) šestmesečna pediatrična študija.
Small numbers of children were included in various trials; however, there also exists one randomised controlled (vs. cyclosporine micro-emulsion and in combination with corticosteroids and azthioprine) 6-months paediatric study.
40 Prevajalska redakcija
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Zdravilo ARICLAIM in trening mišic medeničnega dna (Pelvic Floor Muscle Training, PFMT): v 12 - tedenski slepi, randomizirani, kontrolirani študiji je zdravilo ARICLAIM pokazalo večja znižanja IEF v primerjavi ali s placebom ali s samim PFMT.
ARICLAIM and Pelvic Floor Muscle Training (PFMT): during a 12-week blinded, randomised, controlled study, ARICLAIM demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
41 Prevajalska redakcija
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Varnost in učinkovitost Humire so ocenili pri več kot 1400 bolnikih z zmerno do zelo aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [ CDAI ] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
The safety and efficacy of Humira were assessed in over 1400 patients with moderately to severely active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
42 Prevajalska redakcija
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Zdravilo YENTREVE in trening mišic medeničnega dna (Pelvic Floor Muscle Training, PFMT): v 12 - tedenski slepi, randomizirani, kontrolirani študiji je zdravilo YENTREVE pokazalo večja znižanja IEF v primerjavi ali s placebom ali s samim PFMT.
YENTREVE and Pelvic Floor Muscle Training (PFMT): during a 12-week blinded, randomised, controlled study, YENTREVE demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
43 Prevajalska redakcija
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Začetno zdravljenje pri aktivni Crohnovi bolezni s fistulami Učinkovitost zdravila so ocenjevali tudi v randomizirani, dvojno slepi s placebom kontrolirani študiji pri 94 bolnikih s Crohnovo boleznijo s fistulami, ki so trajale najmanj 3 mesece.
21 The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn’ s disease who had fistulae that were of at least 3 months’ duration.
44 Prevajalska redakcija
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Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri ankilozirajočem spondilitisu II pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
45 Prevajalska redakcija
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Podatki iz randomizirane, kontrolirane študije faze III (CAIRO) podpirajo uporabo zdravila Xeloda v začetnem odmerku 1000 mg/ m2 2 tedna vsake 3 tedne v kombinaciji z irinotekanom v prvi liniji zdravljenja bolnikov z metastatskim kolorektalnim rakom.
Data from a randomised, controlled phase III study (CAIRO) support the use of Xeloda at a starting dose of 1000 mg/ m2 for 2 weeks every 3 weeks in combination with irinotecan for the first-line treatment of patients with metastatic colorectal cancer.
46 Prevajalska redakcija
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Izvedenih je bilo pet randomiziranih, dvojno slepih kontroliranih študij, ki so vkljucevale elektivno endoskopijo zgornjih prebavil, pri približno 4. 500 bolnikih, ki uvodoma niso imeli ulkusov (odmerki celekoksiba od 50 mg do 400 mg dvakrat na dan).
Five randomised double-blind controlled studies have been conducted including scheduled upper gastrointestinal endoscopy in approximately 4500 patients free from initial ulceration (celecoxib doses from 50 mg-400 mg BID).
47 Prevajalska redakcija
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Varnost in učinkovitost Trudexe so ocenili pri več kot 1400 bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [ CDAI ] ≥ 220 in ≤ 450) v randomiziranih, lje dvojno slepih, s placebom kontroliranih študijah.
ge Crohn’ s Disease lon The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
48 Prevajalska redakcija
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Podatki o učinkovitosti so bili pridobljeni iz začetne odprte študije faze II in iz dveh randomiziranih, dvojno slepih, kontroliranih multicentričnih študij faze III (v eni je bilo zdravilo primerjano s peroralno traneksamično kislino in v drugi s placebom).
Efficacy data were obtained from an initial open-label Phase II study and from two randomised, double blind controlled multi centre Phase III studies (one with oral tranexamic acid as the comparator and one placebo controlled).
49 Prevajalska redakcija
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7 Bolezenska kratkovidnost Ena multicentrična dvojno maskirana s placebom kontrolirana randomizirana študija (BPD OCR 003 PM [ VIP- PM ]) je bila opravljena pri bolnikih s subfovealno horioidalno neovaskularizacijo, ki jo je povzročila bolezenska kratkovidnost.
Pathological myopia One multicentre, double-masked, placebo-controlled, randomised study (BPD OCR 003 PM [ VIP- PM ]) was conducted in patients with subfoveal choroidal neovascularisation caused by pathological myopia.
50 Prevajalska redakcija
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Varnost in učinkovitost zdravila Soliris pri bolnikih s PNH s hemolizo so preučevali v okviru 26 - tedenske randomizirane dvojno slepe, s placebom kontrolirane študije (C04- 001). Bolniki s PNH so bili z zdravilom Soliris zdravljeni tudi v okviru 52- tedenske študije z enim krakom (C04- 002) ter v okviru dolgoročne razširitvene študije (E05- 001).
The safety and efficacy of Soliris in PNH patients with haemolysis were assessed in a randomized, double-blind, placebo-controlled 26 week study (C04-001); PNH patients were also treated with Soliris in a single arm 52 week study (C04-002); and in a long term extension study (E05-001).
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randomizirana kontrolirana študija