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randomised controlled trial
1 Pravna redakcija
finance
CELEX: 32003L0063
In general, clinical trials shall be done as "controlled clinical trials" if possible, randomised and as appropriate versus placebo and versus an established medicinal product of proven therapeutic value;
Na splošno se klinična preskušanja, če je mogoče, opravljajo kot "kontrolirana klinična preskušanja", naključna in kot primerna, proti placebu in proti že uveljavljenemu zdravilu z dokazano terapevtsko vrednostjo;
2 Prevajalska redakcija
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One randomised controlled trial and epidemiological studies found a two- to threefold higher risk for users compared with non-users.
Eno randomizirano kontrolirano preskušanje in epidemiološke študije so pri uporabnicah ugotovile dva - do trikrat večje tveganje kot pri neuporabnicah.
3 Prevajalska redakcija
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If this trial will not start or otherwise fail to address the relevant issues, the applicant commits to re-discuss and agree with CHMP the possibility to conduct a randomised controlled trial (or agreed alternative design) in patients with amyloidosis.
Če se to preskušanje ne bo začelo ali ne bo odgovorilo na postavljena vprašanja, se vlagatelj zavezuje, da se bo ponovno posvetoval in strinjal s CPMP o možnosti izvedbe randomiziranega nadzorovanega preskušanja (ali se strinja z drugačno zasnovo preskušanja) pri bolnikih z amiloidozo.
4 Prevajalska redakcija
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7 A multinational, randomised, controlled trial was conducted in 463 patients with EGFR-expressing metastatic carcinoma of the colon or rectum after confirmed failure of oxaliplatin and irinotecan- containing regimens.
7 Narejeno je bilo multinacionalno, randomizirano, kontrolirano preskušanje 463 bolnikov z metastatskim karcinomom na kolonu ali rektumu in eksprimiranim EGFR, po potrjenem neuspehu shem z oksaliplatinom in irinotekanom.
5 Prevajalska redakcija
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A multicentre randomised controlled trial comparing topiramate, stiripentol and clobazam as adjunctive therapy to valproate and clobazam in paediatric patients with Dravet’ s syndrome (SMEI) not adequately controlled with clobazam and valproate, and auxiliary pharmacogenetic study by 2010 (STP 167).
Multicentrično, randomizirano in nadzorovano študijo za primerjavo dodatnega zdravljenja s topiramatom, stiripentolom in klobazamom in zdravljenja z valproatom in klobazamom pri pediatričnih bolnikih s sindromom Dravet (SMEI – huda mioklonična epilepsija v otroštvu), ki s klobazamom in valproatom niso ustrezno kontrolirani, ter pomožno farmakogenetsko študijo do leta 2010 (STP 167).
6 Prevajalska redakcija
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The efficacy of Vectibix in patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior chemotherapy was studied in a randomised controlled trial (463 patients) and open-label, single-arm trials (384 patients).
Učinkovitost Vectibixa pri bolnikih z metastatskim kolorektalnim rakom (mKRR), ki jim je bolezen napredovala med predhodno kemoterapijo ali po njej, so raziskali v randomiziranem kontroliranem preskušanju (463 bolnikov) in odprtih preskušanjih z enim krakom (384 bolnikov).
7 Prevajalska redakcija
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41 children with SMEI were included in a randomised, placebo-controlled, add-on trial.
V randomizirano, s placebom nadzorovano preskušanje z dodatkom zdravila k obstoječemu zdravljenju so vključili 41 otrok s SMEI.
8 Prevajalska redakcija
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Over 4,400 allergic asthma patients were randomised in controlled efficacy trials with Xolair.
V kontroliranih preskušanjih učinkovitosti zdravila Xolair so randomizirali več kot 4. 400 bolnikov z alergijsko astmo.
9 Prevajalska redakcija
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The EUROPA study was a multicentre, international, randomised, double-blind, placebo-controlled clinical trial lasting 4 years.
Študija EUROPA je bila multicentrično, mednarodno, randomizirano, dvojno slepo, s placebom nadzorovano klinično preskušanje, ki je trajalo 4 leta.
10 Prevajalska redakcija
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For other HRT products there are only limited data from randomised controlled trials examining effects in cardiovascular morbidity or mortality.
O drugih zdravilih za HNZ je le malo podatkov iz randomiziranih kontroliranih preskušanj, ki so proučevala učinke na srčnožilno obolevnost ali umrljivost.
11 Prevajalska redakcija
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The efficacy and safety of paclitaxel were evaluated in two major, randomised, controlled trials (vs. cyclophosphamide 750 mg/ m2/ cisplatin 75 mg/ m2).
Učinkovitost in varnost paklitaksela so ocenili v dveh večjih randomiziranih, nadzorovanih preskušanjih (v primerjavi s 750 mg/ m2 ciklofosfamida/ 75 mg/ m2 cisplatina).
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A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih s placebom nadzorovanih kliničnih preskušanj antiepileptikov.
13 Prevajalska redakcija
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In randomised, placebo-controlled clinical trials, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
V randomiziranih, s placebom nadzorovanih kliničnih študijah, filgrastim ni povzročil zvečanja števila neželenih učinkov, povezanih s citotoksično kemoterapijo.
14 Prevajalska redakcija
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Efficacy of paclitaxel/ cisplatin combination has been demonstrated in two randomised, controlled trials in patients with locally advanced or metastatic NSCLC.
Učinkovitost kombinacije paklitaksela in cisplatina so pokazali pri bolnikih z lokalno napredovalimi ali metastaziranimi nedrobnoceličnim karcinomom pljuč v dveh randomiziranih, nadzorovanih preskušanjih.
15 Prevajalska redakcija
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The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years.
Učinkovitost cepiva Cervarix je bila ovrednotena v dveh nadzorovanih, dvojno slepih, randomiziranih kliničnih študijah II. in III. faze, v kateri je bilo skupaj vključenih 19. 778 žensk, starih od 15 do 25 let.
16 Prevajalska redakcija
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Patients with stable coronary artery disease: The EUROPA study was a multicentre, international, randomised, double-blind, placebo-controlled clinical trial lasting 4 years.
Bolniki s stabilno koronarno arterijsko boleznijo Študija EUROPA je bila multicentrično, mednarodno, randomizirano, dvojno slepo, s placebom nadzorovano klinično preskušanje, ki je trajalo 4 leta.
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The effect of palonosetron on QTc interval was evaluated in a double blind, randomised, parallel, placebo and positive (moxifloxacin) controlled trial in adult men and women.
Učinek palonosetrona na interval QTc so ocenili v dvojno slepem, randomiziranem, paralelnem, s placebom in pozitivno (moksifloksacin) kontroliranem preskušanju na odraslih moških in ženskah.
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POWER 1 and POWER 2 are randomised, controlled trials consisting of an initial dose-finding part and a second long-term part in which all patients randomised to PREZISTA co-administered with 100 mg ritonavir received the recommended dose of 600/100 mg b.i.d.
POWER 1 in POWER 2 sta randomizirani, kontrolirani preskušanji, ki sta sestavljeni iz: začetnega dela za ugotavljanje odmerka in iz drugega dolgoročnega dela, v katerem so vsi bolniki, randomizirani v skupino za zdravilo PREZISTA s 100 mg ritonavirja, prejeli priporočeni odmerek 600/ 100 mg dvakrat na dan.
19 Prevajalska redakcija
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Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Na lestvici EORTC- QLQ- C30 oziroma CLAS drugi, manjši, randomizirani, s placebom nadzorovani študiji nista pokazali pomembnega izboljšanja parametrov kakovosti življenja.
20 Prevajalska redakcija
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Clinical Efficacy Xigris was studied in one Phase 3 international, multi-centre, randomised, double-blind, placebo- controlled trial (PROWESS) in 1690 patients with severe sepsis.
Klinična učinkovitost Zdravilo Xigris so preučevali v mednarodnem multicentričnem randomiziranem dvojno slepem s placebom kontroliranim preskušanju faze 3 (PROWESS) pri 1690 bolnikih s hudo sepso.
21 Prevajalska redakcija
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In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months.
V študiji, kontrolirani s placebom, so bili bolniki z nezadostnim nadzorom glikemije, kljub trimesečnemu obdobju optimizacije insulina, 12 mesecev naključno zdravljeni s pioglitazonom ali placebom.
22 Prevajalska redakcija
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Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet in this population was comparable to that observed in patients less than 65 years old.
Podatki iz randomiziranega kontroliranega kliničnega preskušanja kažejo, da sta učinkovitost Myoceta in njegova varnost za srce v tej populaciji primerljivi s tistima pri bolnicah, mlajših od 65 let.
23 Prevajalska redakcija
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Aldara Cream has been evaluated in four randomised, vehicle controlled, double-blind trials in children aged 2 to 15 years with molluscum contagiosum (imiquimod n = 576, vehicle n = 313).
Aldara kremo so ocenjevali v štirih randomiziranih, z vehiklom kontroliranih dvojno slepih poskusih pri otrocih, starih od 2 do 15 let, ki so imeli molluscum contagiosum (imikvimod n=576, vehikel n=313).
24 Prevajalska redakcija
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Data in adult humans are conflicting, and there has been no increase in bleeding complications in randomised controlled trials in term and near-term neonates with hypoxic respiratory failure.
Podatki pri odraslih ljudeh so si nasprotujoči, pri randomiziranih nadzorovanih kliničnih preizkušanjih na novorojenčkih s hipoksično respiratorno odpovedjo, rojenih v roku ali blizu roka, pa ni bilo povečanja zapletov pri krvavitvah.
25 Prevajalska redakcija
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This was a phase III randomised, double-blind, active-controlled clinical trial evaluating Avastin in combination with IFL as first-line treatment for metastatic carcinoma of the colon or rectum.
To je bilo randomizirano, dvojno slepo, aktivno kontrolirano klinino preskušanje faze III, ki je proučevalo zdravilo Avastin v kombinaciji z IFL v prvi liniji zdravljenja metastatskega raka debelega črevesa in danke.
26 Prevajalska redakcija
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5 The Phase 3 international, multi-centre, randomised, double-blind, placebo-controlled clinical trial (PROWESS) involved 850 drotrecogin alfa (activated)-treated and 840 placebo-treated patients.
V mednarodnemu multicentričnemu randomiziranemu dvojno slepemu s placebom kontroliranemu kliničnemu preskušanju faze 3 (PROWESS) je sodelovalo 850 bolnikov, ki so prejemali drotrekogin alfa (aktiviran) in 840 bolnikov, ki so prejemali placebo.
27 Prevajalska redakcija
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Coronary artery disease (CAD) There is no evidence from randomised controlled trials of cardiovascular benefit with continuous combined conjugated oestrogens and medroxyprogesterone acetate (MPA).
Randomizirana kontrolirana preskušanja stalne kombinacije konjugiranih estrogenov in medroksiprogesteronacetata (MPA) niso pokazala srčnožilnih koristi.
28 Prevajalska redakcija
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AVF0780g: This was a phase II randomised, active-controlled, open-labelled clinical trial investigating Avastin in combination with 5-FU/ FA as first-line treatment of metastatic colorectal cancer.
AVF0780g: to je bilo randomizirano, aktivno kontrolirano, odprto klinično preskušanje faze II, v katerem so proučevali kombinacijo zdravila Avastin s 5- FU/ FA kot prvo linijo zdravljenja metastatskega raka debelega črevesa in danke.
29 Prevajalska redakcija
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Fixed Dose Combination The overall incidence of adverse events reported with Kinzalkomb was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Fiksna kombinacija Poročila z randomiziranih, nadzorovanih kliničnih preskušanj kažejo, da je celokupna pogostnost neželenih učinkov Kinzalkomba primerljiva s pogostnostjo neželenih učinkov samega telmisartana. V kliničnih preskušanjih je sodelovalo 1471 bolnikov, ki so bili naključno razvrščeni v skupini, od katerih je ena prejemala telmisartan in hidroklorotiazid (835), druga pa samo telmisartan (636).
30 Prevajalska redakcija
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Fixed Dose Combination The overall incidence of adverse events reported with PritorPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Fiksna kombinacija Poročila z randomiziranih, nadzorovanih kliničnih preskušanj kažejo, da je celokupna pogostnost neželenih učinkov PritorPlusa primerljiva s pogostnostjo neželenih učinkov samega telmisartana. V kliničnih preskušanjih je sodelovalo 1471 bolnikov, ki so bili naključno razvrščeni v skupini, od katerih je ena prejemala telmisartan in hidroklorotiazid (835), druga pa samo telmisartan (636).
31 Prevajalska redakcija
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Fixed Dose Combination The overall incidence of adverse events reported with MicardisPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Fiksna kombinacija Poročila z randomiziranih, nadzorovanih kliničnih preskušanj kažejo, da je celokupna pogostnost neželenih učinkov zdravila MicardisPlus primerljiva s pogostnostjo neželenih učinkov samega telmisartana. V kliničnih preskušanjih je sodelovalo 1471 bolnikov, ki so bili naključno razvrščeni v skupini, od katerih je ena prejemala telmisartan in hidroklorotiazid (835), druga pa samo telmisartan (636).
32 Prevajalska redakcija
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One was a non-comparative trial in 138 patients (29 % received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs procarbazine in a total of 225 patients (67 % received prior treatment with nitrosourea based chemotherapy).
Eno je bilo neprimerjalno preskušanje pri 138 bolnikih (29 % jih je pred tem že prejemalo kemoterapijo), drugo pa randomizirano, z učinkovino nadzorovano kontrolirano preskušanje TMZ in prokarbazina pri skupaj 225 bolnikih (67 % jih je pred tem že prejemalo kemoterapijo na osnovi nitrozouree).
33 Prevajalska redakcija
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Data from one multicenter, randomised, controlled phase III clinical trial support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast
Podatki multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja III. faze podpirajo uporabo docetaksela v kombinaciji s kapecitabinom za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije, ki je vključevala antraciklin.
34 Prevajalska redakcija
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ESPRIT (Enhanced Suppression of the Platelet IIb/ IIIa Receptor with eptifibatide Therapy) was a double- blind, randomised, placebo-controlled trial (n= 2,064) for nonurgent PCI with intracoronary stenting.
Raziskava ESPRIT (Enhanced Suppression of the Platelet IIb/ IIIa Receptor with eptifibatide Therapy, t. j. raziskava okrepljenega zaviranja trombocitnih receptorjev IIb/ IIIa z eptifibatidom) je bila dvojno slepa, randomizirana in s placebom kontrolirana raziskava (n = 2. 064) neurgentnega perkutanega koronarnega posega (PCI) z vstavitvijo intrakoronarne opornice.
35 Prevajalska redakcija
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6 Efficacy against cholera Efficacy against cholera was assessed in three randomised double-blind placebo-controlled clinical trials conducted in Bangladesh (endemic region) and in Peru (non-endemic region).
Učinkovitost proti koleri Učinkovitost proti koleri so ocenili v treh naključnih, dvojno slepih kliničnih preskušanjih, nadzorovanih s placebom, ki so jih opravili v Bangladešu (endemsko področje) in Peruju (neendemsko področje).
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Data from a multicentre, randomised, controlled phase III clinical trial in patients with advanced gastric cancer supports the use of Xeloda for the first-line treatment of advanced gastric cancer (ML17032).
Podatki iz multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja faze III pri bolnikih z napredovalim rakom želodca podpirajo uporabo zdravila Xeloda v prvi liniji zdravljenja napredovalega raka želodca (ML17032).
37 Prevajalska redakcija
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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.
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.
38 Prevajalska redakcija
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The safety and efficacy of Vaniqa was evaluated in two double-blind, randomised, vehicle- controlled clinical trials involving 594 women of skin types I-VI (393 on Vaniqa, 201 on vehicle) treated for up to 24 weeks.
Sodelovalo je 594 žensk s tipom kože I- VI (393 jih je prejemalo zdravilo Vaniqa, 201 pa le vehikel). Zdravljenje je trajalo do 24 tednov.
39 Prevajalska redakcija
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The objective of this double-blind, randomised, placebo controlled trial was to determine whether inhaled nitric oxide would reduce the occurrence of death and/ or initiation of extracorporeal membrane oxygenation (ECMO).
Namen tega dvojno slepega, randomiziranega, s placebom nadzorovanega preizkusa je bil določiti, ali vdihani dušikov oksid zniža smrtnost in/ ali potrebo po zdravljenju z zunajtelesno membransko oksigenacijo (ECMO – » extracorporeal membrane oxygenation «).
40 Prevajalska redakcija
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The efficacy and safety of Tarceva was demonstrated in a randomised, double-blind, placebo-controlled trial (BR.21), in 731 patients with locally advanced or metastatic NSCLC after failure of at least one chemotherapy regimen.
Učinkovitost in varnost zdravila Tarceva je bila dokazana v randomiziranem, dvojno slepem, s placebom primerjanem preskušanju (BR. 21), ki je vključevalo 731 bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč po neuspehu vsaj ene predhodne kemoterapije. Bolniki so bili randomizirani v razmerju 2:
41 Prevajalska redakcija
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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.
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.
42 Prevajalska redakcija
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In this randomised, open label, controlled clinical trial, chemotherapy (oxaliplatin or irinotecan) and bevacizumab were given with and without panitumumab in the first line treatment of patients with metastatic colorectal cancer.
V tem randomiziranem, odprtem, kontroliranem kliničnem preskušanju so v terapiji prve izbire pri bolnikih z metastatskim kolorektalnim rakom uporabljali kemoterapijo (oksaliplatin ali irinotekan) in bevacizumab s panitumumabom ali brez njega.
43 Prevajalska redakcija
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Clinical trials The efficacy and safety of lenalidomide were evaluated in two Phase III multi-centre, randomised, double-blind, placebo-controlled, parallel-group controlled studies (MM-009 and MM-010) of lenalidomide plus dexamethasone therapy versus dexamethasone alone in previously treated patients
Klinične študije Učinkovitost in varnost lenalidomida so ocenili v dveh multicentričnih, randomiziranih, dvojno slepih, s placebom nadzorovanih, paralelnih študijah III. faze (MM- 009 in MM- 010), v katerih so primerjali zdravljenje z lenalidomidom in deksametazonom v primerjavi z zdravljenjem samo z deksametazonom pri bolnikih z multiplim mielomom, ki so se že zdravili.
44 Prevajalska redakcija
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In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in Japanese patients, 204 patients were randomised to riluzole 100 mg/ day (50 mg twice daily) or placebo and were followed-up for 18 months.
V dvojno slepem, s placebom kontroliranem preskušanju za oceno učinkovitosti in varnosti riluzola pri japonskih bolnikih so 204 bolnike randomizirali na riluzol 100 mg/ dan (50 mg dvakrat na dan) ali placebo in jih spremljali 18 mesecev.
45 Prevajalska redakcija
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Infantile-onset Pompe disease; clinical trial in patients aged 6 months or less The safety and efficacy of Myozyme was assessed in a pivotal, randomised, open-label, historically- controlled clinical trial of 18 non-ventilated infantile-onset patients aged 6 months or less at the onset of treatment.
Zgodnji nastop Pompejeve bolezni; klinično preskušanje pri bolnikih starih 6 mesecev ali manj Varnost in učinkovitost zdravila Myozyme so ocenili v osrednji, randomizirani, odprti, sledeni klinični študiji 18 bolnikov brez predihavanja z zgodnjim nastopom bolezni, starih 6 mesecev ali manj ob začetku zdravljenja.
46 Prevajalska redakcija
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Three large long-term prospective randomised controlled clinical trials (mean duration 41 months; 14,067 patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk.
Tri obsežna, dolgotrajna, prospektivna, randomizirana in nadzorovana klinična preskušanja (srednji čas trajanja 41 mesecev; 14. 067 bolnikov), ki so primerjala rosiglitazon z nekaterimi drugimi odobrenimi peroralnimi antidiabetiki ali s placebom, tega tveganja niso ne potrdila ne ovrgla.
47 Prevajalska redakcija
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The efficacy and safety of Tarceva in combination with gemcitabine as a first-line treatment was assessed in a randomised, double-blind, placebo-controlled trial in patients with locally advanced, unresectable or metastatic pancreatic cancer.
Učinkovitost in varnost zdravila Tarceva v kombinaciji z gemcitabinom za zdravljenje v prvi liniji so ocenjevali v randomiziranem, dvojno slepem, s placebom primerjanem preskušanju pri bolnikih z lokalno napredovalim, neoperabilnim ali metastatskim rakom trebušne slinavke.
48 Prevajalska redakcija
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A total of 2640 adult patients with severe sepsis who were at low risk of death (e. g. patients with APACHE II < 25 or with only one sepsis-induced organ failure) were enrolled in a randomised, double- blind, placebo-controlled trial (ADDRESS).
V randomiziranemu dvojno slepemu s placebom kontroliranemu preskušanju (ADDRESS) je sodelovalo skupno 2640 odraslih bolnikov s hudo sepso z nizkim tveganjem za smrt (denimo, bolniki s številom točk po lestvici APACHE II < 25 ali s sepso povzročenim okvarjenim delovanjem samo enega organa).
49 Prevajalska redakcija
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The efficacy of venlafaxine immediate-release as a treatment for major depressive episodes was demonstrated in five randomised, double-blind, placebo-controlled, short-term trials ranging from 4 to 6 weeks duration, for doses up to 375 mg/ day.
Učinkovitost venlafaksina s takojšnjim sproščanjem pri zdravljenju hudih depresivnih epizod je bila dokazana v petih randomiziranih, dvojno slepih, s placebom nadzorovanih kratkoročnih raziskavah, ki so trajale od 4 do 6 tednov, za odmerke do 375 mg/ dan.
50 Prevajalska redakcija
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EMEA
In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21 % vs 8 %, respectively – chi-square p = 0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p = 0.0063).
V randomiziranem, z učinkovino nadzorovanem preskušanju je bil PFS po 6 mesecih statistično značilno daljši pri TMZ kot pri prokarbazinu (21 % v primerjavi z 8 %, hi- kvadrat, p = 0, 008), z mediano vrednostjo PFS 2, 89 meseca za temozolomid in 1, 88 meseca za prokarbazin (test log. ranga p = 0, 0063).
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1–50/94
randomised controlled trial