ライフサイエンスコーパス: phase III trial

1 of several studies (including two randomized phase III trials).

2 lase for Intracerebral Hemorrhage Evacuation Phase III trial.

3 vanced melanoma who received ipilimumab in a phase III trial.

4 IB to IV melanoma in a randomized open-label phase III trial.

5 ouble-masked, active-controlled, randomized, phase III trial.

6 patients treated in a randomized, controlled phase III trial.

7 onducted this randomized, placebo-controlled phase III trial.

8 compare the efficacy of these regimens in a phase III trial.

9 mains to be defined by an ongoing randomized phase III trial.

10 e and inform the feasibility and design of a phase III trial.

11 e in patients with hypercholesterolemia in a phase III trial.

12 andomized, double-blind, placebo-controlled, phase III trial.

13 can be used as a surrogate in a confirmatory phase III trial.

14 between WP and XT as used in this randomized phase III trial.

15 cinoma in situ were enrolled in a randomized phase III trial.

16 against a control treatment in a randomized phase III trial.

17 currently being evaluated in a further large phase III trial.

18 ient to justify further study within a large phase III trial.

19 ducted a double-blind multicenter controlled phase III trial.

20 ate is anticipated based on the results of a phase III trial.

21 This was a randomized, open-label, phase III trial.

22 le of IFN-alpha monotherapy in a multicenter phase III trial.

23 stigated in a three-arm, placebo-controlled, phase III trial.

24 this approach need to be established with a phase III trial.

25 ided the need for a much larger conventional Phase III trial.

26 mised, multicentre, double-blind, controlled phase III trial.

27 ntrolled series, although was not in a small phase III trial.

28 vorable HL for this international randomized phase III trial.

29 the FDA for refractory MG on the basis of a phase III trial.

30 umab (arm B) in a 1:1 randomized, controlled phase III trial.

31 ently randomized stratified subgroup of this phase III trial.

32 inating event to clinically definite MS in a phase III trial.

33 mains unclear and should be evaluated within phase III trials.

34 l measures of clinical utility and data from phase III trials.

35 d provides baseline data for planning future phase III trials.

36 pective studies of ipilimumab, including two phase III trials.

37 s of sustained virological response (SVR) in phase III trials.

38 for combination with the MAGE-A3 protein in phase III trials.

39 overall survival (OS) benefit in randomized phase III trials.

40 new agents are currently being evaluated in phase III trials.

41 in up to 5% of phase II and up to 7% of all phase III trials.

42 p to 25% of phase II trials and up to 42% of phase III trials.

43 cently, belimumab has been successful in two phase III trials.

44 accrual experience of the Cooperative Group phase III trials.

45 ications on the basis of interim analyses of phase III trials.

46 ble formulation for HIV PrEP being tested in Phase III trials.

47 s) of action and enhance planning of pivotal Phase III trials.

48 sting that MDT should be explored further in phase III trials.

49 t vaccine Butantan-DV, which is currently in phase III trials.

50 finitions were chosen in accordance with the Phase III trials.

51 sentative of the participating sites in both Phase III trials.

52 vaccine candidates, and many have moved into phase III trials.

53 onary embolism, were underrepresented in the Phase III trials.

54 e as that observed in the three EV71 vaccine phase III trials.

55 lacebo-controlled, randomized, multinational phase III trial, 1,144 patients with human epidermal gro

56 and Methods In this multicenter, open-label, phase III trial, 2,012 women with early TOP2A-normal bre

57 Any COI were disclosed in 103 phase III trials (68.7%) and in 71 editorials (47.3%).

58 Among the phase III trials, 82 (54.7%) had positive results, and 7

59 b monotherapy in clinical studies, including phase III trials; 86 (10%) had mucosal melanoma and 665

60 ernational, double-blind, placebo-controlled phase III trial, 913 patients were randomly assigned to

61 The prospective phase III trial ABCSG-28 (POSYTIVE) could not demonstrat

62 Large Phase III trials across Asia and Latin America have rece

63 All Cooperative Group phase III trials activated from 2000 to 2007 were examin

64 east 296 distinct processes are required for phase III trial activation: at least 239 working steps,

65 ive probability of success in a hypothetical phase III trial, adjusting for biomarker covariates.

66 ompliant secondary analysis of a prospective phase III trial, adult patients with digital CT images a

67 This article provides an overview of the phase III trial and delineates the different study arms

68 ber 2011, 1,485 articles were retrieved: 150 phase III trials and 150 editorials were eligible.

69 ults from recent elderly specific randomized phase III trials and retrospective subgroup analyses of

70 patient data from a large colorectal cancer phase III trials and statistical models, which take into

71 n of outbreaks are problematic for designing phase III trials and ultimate licensure.

72 inform go/no-go decisions for proceeding to phase III trials, and appropriate end points in phase II

73 cell trophic factor BAFF, was ineffective in phase III trials, and efgartigimod, which depletes antib

74 sensitivity analyses were rarely included in phase III trials, and they remain poorly understood by m

75 and YM150) and three are being evaluated in phase III trials (apixaban, edoxaban, and rivaroxaban) f

76 isation for Research and Treatment of Cancer phase III trial assesses whether adjuvant whole-brain ra

77 We performed a randomized phase III trial assessing dose intensification.

78 itorial authors was a positive conclusion by phase III trial authors (OR, 36.3; 95% CI, 6.8 to 194.2;

79 A phase III trial based on these data will further define

80 was recommended as the optimal dose for the phase III trial because of its good safety profile and h

81 s retrospective, correlative analysis of the phase III trial BMS099 of cetuximab in advanced non-smal

82 There are only 2 phase III trials, both on remote ischemic conditioning i

83 type-I repeat (TSR) of CS is efficacious in phase III trials but gives only a 35% reduction in sever

84 gher in lung/head and neck trials as well as phase III trials, but there was no difference according

85 specimens collected as part of the Alliance phase III trial, C9581.

86 Successful phase III trials can lead to approval of a new biologica

87 A phase III trial (Cancer and Leukemia Group B CALGB-49907

88 This phase III trial compared adjuvant whole-brain radiothera

89 The NCIC CTG PR3/MRC PR07 randomized phase III trial compared androgen-deprivation therapy (A

90 This blinded phase III trial compared cabozantinib with prednisone in

91 This randomized phase III trial compared lenalidomide as maintenance the

92 Our phase III trial compared neoadjuvant versus concurrent i

93 This randomized phase III trial compared overall survival (OS) for preop

94 This phase III trial compared the efficacy and safety of albu

95 This multicenter, randomized, open-label, phase III trial compared the efficacy and safety of deci

96 This phase III trial compared the safety and efficacy of amru

97 This phase III trial compared tivozanib with sorafenib as ini

98 ated in an ongoing international, randomized phase III trial comparing alisertib with investigator's

99 d to select patients enrolled onto the MA.27 phase III trial comparing anastrozole with exemestane.

100 10, the patient was enrolled in a randomized phase III trial comparing different lenalidomide-based t

101 or LOX in 306 of 1,113 patients treated on a phase III trial comparing four radiation fractionation s

102 TAX 324 was a phase III trial comparing induction chemotherapy (IC) wi

103 d Bowel Project (NSABP) B-32 is a randomized phase III trial comparing SNR immediately followed by AD

104 We performed a randomized phase III trial comparing sunitinib plus capecitabine (2

105 Phase III trials comparing non-vitamin K antagonist oral

106 prospective, randomized, placebo-controlled phase III trial conducted by SWOG was planned to define

107 randomized, double-blind, placebo-controlled phase III trial conducted in 12 European countries inclu

108 double-blind, randomized, placebo-controlled Phase III trial conducted in a university hospital.

109 stablished superiority based on a randomized phase III trial conducted through the Gynecologic Oncolo

110 act of TILs in primary TNBCs in two adjuvant phase III trials conducted by the Eastern Cooperative On

111 Data from 18,449 patients enrolled onto 21 phase III trials conducted from 1978 to 2002 were evalua

112 ents using patient-level data merged from 11 phase III trials conducted from 1994 to 2010.

113 However, randomized phase III trials conducted to date have failed to show a

114 More recently, a phase III trial confirmed the high activity of crizotini

115 om 22,654 patients enrolled in 28 randomized phase III trials contained in the ARCAD (Aide et Recherc

116 A randomized, phase III trial demonstrated superiority of sunitinib ov

117 works well in providing recommendations for phase III trial design.

118 Various randomized phase III trial designs have been proposed for definitiv

119 rly in the setting of mCRPC in which several phase III trials, each incorporating agents with differe

120 In a multicenter, open-label, phase III trial, elderly patients >/= 70 years old with

121 A randomized phase III trial ended prematurely, without a definitive

122 This phase III trial enrolled adult patients with brain metas

123 This open-label phase III trial evaluated efficacy and tolerability of l

124 ENGOT-ov14/PENELOPE prospectively randomized phase III trial evaluated the addition of pertuzumab to

125 This large randomized placebo-controlled phase III trial evaluated the mTOR inhibitor ridaforolim

126 ndomized, double-blinded, placebo-controlled phase III trial evaluating omalizumab for the treatment

127 reatment Group) N9831 is the only randomized phase III trial evaluating trastuzumab added sequentiall

128 This prospective, randomized phase III trial examined the effect of prophylactic trea

129 Institute (NCI) -sponsored Cooperative Group phase III trials failed to achieve their accrual goals.

130 study group (GCLLSG) initiated a multicenter phase III trial for CLL patients older than 65 years com

131 C435) is an oral NS3/4 protease inhibitor in phase III trials for chronic hepatitis C virus (HCV) inf

132 enylamino}acetate (ON 01910.Na), which is in phase III trials for myelodysplastic syndromes (MDS) ass

133 Apixaban and rivaroxaban were evaluated in phase III trials for prevention of recurrent ischemia in

134 nstrate their efficacy and safety in pivotal phase III trials for registration.

135 htly lower as compared to the results of the phase III trials for telaprevir or boceprevir.

136 e prospectively designed and conducted three phase III trials (Four-Arm Cooperative Study, LC00-03, a

137 mor, and only four randomized trials and one phase III trial have been completed so far, all in the f

138 Several phase II trials and a single, large phase III trial have explored chemotherapeutic regimens

139 r of early phase trials and three definitive Phase III trials have been conducted in the field of pro

140 Two ongoing phase III trials have been designed to address the optim

141 Prior phase III trials have demonstrated that dose escalation

142 olled in two independent European randomized phase III trials (IFM/DFCI2009 and EMN02/HO95).

143 In this randomized phase III trial in 16 centers, patients with resectable

144 In PARADIGMS, a double-blind phase III trial in 215 paediatric patients with multiple

145 thout a leukotriene receptor antagonist in a phase III trial in adolescent patients with moderate sym

146 Initial clinical evaluation led to a phase III trial in advanced HER2-positive breast cancer

147 trials and is currently being evaluated in a phase III trial in Africa.

148 ivity in early-phase studies, which led to a phase III trial in combination with oxaliplatin, fluorou

149 An ongoing phase III trial in patients who are eligible for therapy

150 dary outcomes in clinical trials, an ongoing phase III trial in patients with diabetic kidney disease

151 E1609 was a phase III trial in patients with resected cutaneous mela

152 In this randomized, controlled phase III trial in patients with vasopressor-dependent d

153 f research required to justify undertaking a phase III trial in the critically ill population has not

154 ch was shown to have an efficacy of 94% in a phase III trial in the Indian subcontinent.

155 same domains that had at least one completed phase III trial in the same time frame, but failed to re

156 atient-reported outcomes were evaluated in a phase III trial in which premenopausal women were random

157 odium falciparum malaria infection completed phase III trials in 2014 and demonstrated efficacy again

158 Two phase III trials in adult patients with non-small-cell l

159 decades in the design and interpretation of phase III trials in advanced NSCLC.

160 In phase III trials in atrial fibrillation, compared with w

161 , identified eligible randomized, controlled phase III trials in metastatic solid malignancies.

162 le-blind, placebo-controlled, multinational, phase III trial included adults with a history of modera

163 Methods This randomized, double-blind, phase III trial included AI-treated postmenopausal women

164 The multicenter randomized phase III trial included patients with cutaneous melanom

165 This phase III trial investigated overall survival (OS) for s

166 The NORDIC-VII multicenter phase III trial investigated the efficacy of cetuximab w

167 With the initiation of large phase III trials investigating immunomodulatory drugs fo

168 of RNP on fluorescein angiograms (FAs) in 2 phase III trials investigating the effect of ranibizumab

169 colorectal cancer led to several multicenter phase III trials investigating the efficacy of these age

170 ducted a post hoc analysis of the vandetanib phase III trial involving patients with advanced medulla

171 ide information as to what type of biomarker phase III trial is appropriate.

172 A phase III trial is now underway to formally determine wh

173 A randomized phase III trial is under way, comparing BV+CHP with CHOP

174 A phase III trial is underway comparing P-CAP with CAP in

175 A phase III trial is underway comparing perifosine-bortezo

176 Further investigation in a phase III trial is underway.

177 The primary endpoint in the Phase III trials is a composite outcome of failure at th

178 irreproducibility of results across pilot to Phase-III trials is population stratification bias cause

179 ly developed to target GBM, when tested in a phase III trial it failed to achieve clinical endpoints

180 double-blind, randomized, placebo-controlled phase III trial, ketamine or placebo was delivered subcu

181 b (substudy of a larger GSK sponsored global phase III trial, MEA115575) where subjects received mepo

182 remains the most common primary end point of phase III trials, more trials from the last decade have

183 of severe PH patients from the phase II and phase III trials (n = 13), compared with their pooled ma

184 ta from North Central Cancer Treatment Group Phase III Trial N0147, a randomized adjuvant trial of pa

185 The SAKK trial 75/08 was a multicenter phase III trial (NCT01107639) comparing induction chemot

186 In a recent phase III trial (NCT02020889) 53% of mepolizumab-treated

187 enotype 2/3-infected patients, enrolled in a phase III trial (NORDynamIC), were genotyped for ITPA (r

188 Data from a phase III trial of 1,050 patients with mCRPC were used (

189 In a Phase III trial of [(123)I]ioflupane in patients with in

190 1, a multinational, randomized, double-blind phase III trial of abiraterone acetate plus prednisone v

191 ernational, open-label randomized controlled phase III trial of adjuvant combination chemotherapy com

192 The Thai Phase III Trial of ALVAC-HIV and AIDSVAX B/E showed an e

193 ected adults who developed tuberculosis in a phase III trial of an investigational tuberculosis vacci

194 A prospective, randomized, phase III trial of bevacizumab plus IFN-alpha versus IFN

195 resampling patients from N9741, a randomized phase III trial of chemotherapy regimens for metastatic

196 rvival (OS) and disease response in S0421, a phase III trial of docetaxel plus prednisone with or wit

197 double-blind, placebo-controlled, randomized phase III trial of gemcitabine/bevacizumab versus gemcit

198 and target population were identified for a phase III trial of IMGN853 monotherapy in patients with

199 EGF30001, a phase III trial of lapatinib and paclitaxel versus pacli

200 y assigned 1:1 in a multicenter, open-label, phase III trial of letrozole (2.5 mg orally per day) wit

201 Data from a phase III trial of patients with mCRPC randomly assigned

202 ction adenocarcinoma, Intergroup Trial 0116 (Phase III trial of postoperative adjuvant radiochemother

203 We performed a randomized phase III trial of postoperative radiochemotherapy in th

204 A phase III trial of regorafenib versus placebo is ongoing

205 dose escalation by post hoc analysis of the phase III trial of rupatadine for Japanese patients with

206 There is a pressing need for a phase III trial of thyroid hormone that is of sufficient

207 or more controller medications, in the first phase III trial of tiotropium in children with severe sy

208 Results of the first phase III trial of VEGF-targeted therapy (sorafenib) in

209 Randomized, phase III trials of abiraterone acetate are underway to

210 controversy has become critical as multiple phase III trials of anti-VEGF agents combined with cytot

211 Recent therapeutic interventional phase III trials of antisense oligodeoxyribonucleotides

212 The phase III trials of apixaban and rivaroxaban have comple

213 Phase III trials of buparlisib and endocrine therapy in

214 , and those with ankylosing spondylitis from phase III trials of golimumab.

215 e glutamatergic hypothesis go from theory to phase III trials of novel mechanism antipsychotics.

216 igh SVR12 rates, equivalent to those seen in Phase III trials of other pangenotypic options, and has

217 s for HCC and ICC safely, supporting ongoing phase III trials of radiation in HCC and ICC.

218 ith HER2-positive EBC, providing support for phase III trials of T-DM1 in this setting.

219 mplete and reliable follow-up data from four phase III trials of the European Organisation for Resear

220 Recent placebo-controlled phase III trials of the mammalian target of rapamycin (m

221 logy of dengue viruses (DENV) in two pivotal phase III trials of the tetravalent dengue vaccine, CYD-

222 s with mCRPC and bone metastases; definitive phase III trials of this agent are underway.

223 However, Phase III trials of this combination in other genotypes

224 amework successfully predicted survival in a phase III trial on the basis of capecitabine phase II da

225 Most randomized phase III trials on which level-one evidence has been bu

226 d Methods In this multicenter, double-blind, phase III trial, patients were randomly assigned (2:1) t

227 In this randomized phase III trial, patients who had local treatment of one

228 In a prospective, multicenter, randomized phase III trial, patients with cN0 early breast cancer o

229 In this international phase III trial, patients with stage IIIB or IV adenocar

230 port final results of the largest randomized phase III trial performed to date among patients with lo

231 ior clinical benefit versus clopidogrel in a phase III trial (PLATO [Platelet Inhibition and Patient

232 -term survival but needs validation in large phase III trials powered for survival outcomes.

233 Editorials and related phase III trials published in six clinical oncology jour

234 Multivariable analysis showed that phase III trial results were the only significant predic

235 hin the prospectively randomized EORTC 62961 phase-III trial, RHT and systemic chemotherapy significa

236 In Phase III trials, rivaroxaban, apixaban, edoxaban (antif

237 rvival results reported for the predecessor, phase III trial S9321 by 50%.

238 io 1), phase II trials (scenario 2A/2B), and phase III trials (scenario 3A/3B).

239 A separate phase III trial served as an independent validation set.

240 therapy of cancer, since a recent randomized phase III trial showed a survival benefit for immunother

241 Twin phase III trials showed significantly improved survival

242 Negative results from multiple phase III trials suggest that the existing paradigm for

243 ed, multicenter, blinded, placebo-controlled phase III trial tested the efficacy and safety of bevaci

244 A randomized phase III trial testing chemotherapy with/without radiat

245 However, phase III trials testing continuous androgen deprivation

246 Phase II trials) and pivotal, confirmatory (Phase III trials) testing.

247 pective, multicenter, open-label, randomized phase III trial that compared a busulfan-based RIC with

248 CALGB/SWOG 80405 is a phase III trial that compared the addition of bevacizuma

249 ng Patients With Melanoma) was an Intergroup phase III trial that enrolled high-risk patients (stage

250 nt to show improved survival in a randomized phase III trial that enrolled patients with metastatic m

251 CALGB/SWOG 80405 was a randomized phase III trial that found no statistically significant

252 As compared to the phase III trial that led to registration of the drug a d

253 ical trials compared with large multi-center Phase III trials that are more likely to be representati

254 se end points in five prospective randomized phase III trials that enrolled a total of 6,081 patients

255 We included patients enrolled onto three phase III trials that randomly assigned patients to nove

256 One large phase III trial (the Iressa Pan-Asia Study [IPASS] trial

257 In another phase III trial, the oral combination of netupitant and

258 In one phase III trial, the oral combination of netupitant and

259 In the ESTIMABL phase III trial, the thyroid ablation rate was equivalen

260 Pooled data from 2 phase III trials, the Study of Belimumab in Subjects wit

261 Two phase III trials-the Trial Assigning Individualized Opti

262 LDL-C reduction and that, if proven safe in phase III trials, they will be as important to LDL-C con

263 ch, after completion, recommends the type of phase III trial to be used for the definitive testing of

264 We therefore did this phase III trial to compare concurrent chemotherapy and r

265 address this point, we designed a randomized phase III trial to compare rituximab plus cyclophosphami

266 center study, to our knowledge, is the first phase III trial to compare trabectedin versus dacarbazin

267 mRNA-1273 is currently in a phase III trial to evaluate its efficacy.

268 We report a prospective, double-blind phase III trial to investigate the effect of ATLG (Neovi

269 AURELIA is the first randomized phase III trial to our knowledge combining bevacizumab w

270 Radiation Therapy Oncology Group launched a phase III trial to test the hypothesis that adding cetux

271 hemotherapy and TME (PROSPECT), a randomized phase III trial to validate this experience, is now open

272 Further testing in phase III trials to accurately define the safety and eff

273 tcomes, fueling calls for the need for large phase III trials to definitively test this question.

274 820 men with mCRPC randomly assigned in nine phase III trials to DP or a DP-containing regimen were c

275 se II trials were simulated from four actual phase III trials (two positive for OS and two negative f

276 lticenter, double-blind, placebo-controlled, phase III trial was conducted across 39 centers in 13 co

277 This phase III trial was conducted to test whether the novel

278 ng results in phase II studies, a randomized phase III trial was designed to assess the efficacy of a

279 CPP FAP-310, a randomized, double-blind, Phase III trial was designed to examine the safety and e

280 A randomized phase III trial was designed to test whether first-line

281 This phase III trial was performed to assess the potential be

282 The aim of this multicenter randomized phase III trial was to assess whether NCRT improves outc

283 The aim of this pivotal phase III trial was to demonstrate the efficacy and safe

284 The goal of this phase III trial was to determine whether IC before chemo

285 Public availability of phase III trials was 15% (95% CI, 7% to 23%) at 12 month

286 In this randomised, double-blind-phase III trial, we evaluated the efficacy of budesonide

287 In this open-label phase III trial, we evaluated the safety, tolerability,

288 s in Ewing's sarcoma (ES) phase I/II trials, phase III trials were discouraging, requiring bedside-to

289 Seven published phase III trials were examined for prespecified design a

290 Two randomized phase III trials were identified, and individual patient

291 gression, and death obtained from randomized phase III trials were used to determine the likelihood o

292 tivity over 2 years compared with placebo in phase III trials when administered as monotherapy in AFF

293 This review reports the results of recent phase III trials which have attempted to improve upon th

294 ulations but ideally need to be confirmed in phase III trials, which are unfortunately often hindered

295 Ongoing phase III trials will provide critical insight into the

296 The VISION (phase III) trial will provide data of critical value to

297 dy was an open-label, randomized, controlled phase III trial with a 2 x 2 factorial design.

298 ival as the primary end point, and one small phase III trial with OS as the primary end point, all in

299 in DTC were presented in June 2013, and two phase III trials with VEGF and rearranged during transfe

300 were pooled from four studies, including two phase III trials, with patients who received nivolumab 3