ライフサイエンスコーパス: phase III trial

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

18 dependent predictive factors of success in a phase III trial.

19 es to determine whether a basis exists for a phase III trial.

20 ictive factors for success of the subsequent phase III trial.

21 schedule of IFN monotherapy in a multicenter phase III trial.

22 ndependent predictive factors for a positive phase III trial.

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

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

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

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

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

28 ently randomized stratified subgroup of this phase III trial.

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

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

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

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

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

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

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

36 accrual experience of the Cooperative Group phase III trials.

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

38 oped and a few are currently being tested in phase III trials.

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

40 decision aids in proceeding from phase II to phase III trials.

41 factors in phase II studies before designing phase III trials.

42 need to be validated prospectively in future phase III trials.

43 dronic acid) or are currently in (denosumab) phase III trials.

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

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

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

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

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

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

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

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

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

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

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

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

56 lts were more likely to lead to a successful phase III trial (50.8% v 22.5%; P = .003).

57 In this open-label phase III trial, 670 patients with imatinib-resistant or

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

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

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

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

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

66 period of approximately 40 months, during a phase III trial and safety extension study.

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

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

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

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

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

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

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

74 chnique that assesses whether the results of phase III trials are robust and likely to be generalizab

75 mising results in early clinical trials, and phase III trials are underway.

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 Dual-stage, multiarm, phase III trials can efficiently evaluate multiple exper

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

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

89 This phase III trial compared adjuvant whole-brain radiothera

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

91 This blinded phase III trial compared cabozantinib with prednisone in

92 This randomized phase III trial compared lenalidomide as maintenance the

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 is a randomized, double-blind, multicenter, phase III trial comparing ZA (4 mg intravenously every 3

106 Phase III trials comparing non-vitamin K antagonist oral

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

108 E2100, an open-label, randomized, phase III trial conducted by the Eastern Cooperative Onc

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

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

111 Based on these results, an ongoing phase III trial conducted within the Children's Oncology

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

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

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

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

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

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

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

119 mbination with capecitabine in a randomized, phase III trial demonstrating a benefit for the combinat

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

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

122 Phase III trials do not recruit representative treatment

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

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

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

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

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

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

129 This randomized phase III trial evaluated whether consolidation docetaxe

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

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

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

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

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

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

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

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

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

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

140 Recently, a randomized phase III trial has confirmed the benefit of temozolomid

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

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

143 tastatic melanoma, and meta-analyses and one phase III trial have suggested a survival benefit.

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

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

146 Prior phase III trials have demonstrated that dose escalation

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

148 The phase III trial in advanced gastrointestinal stromal tum

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

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

151 s with metastatic breast cancer as well as a phase III trial in combination with capecitabine have re

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

153 double-blind, randomised, placebo-controlled phase III trial in HIV-negative, HSV-2 seropositive wome

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

155 We conducted a phase III trial in patients with previously untreated me

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

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

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

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

160 standard dose of TRT in a planned randomized phase III trial in the United States cooperative groups.

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

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

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

164 mes, as was tried unsuccessfully in multiple phase III trials in cancer patients, is likely unwise gi

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

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

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

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

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

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

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

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

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

174 Further evaluation of this strategy in a phase III trial is proposed.

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

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

177 A phase III trial is underway comparing perifosine-bortezo

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

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

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

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

188 1, a multinational, randomized, double-blind phase III trial of abiraterone acetate plus prednisone v

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

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

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

192 A prospective, randomized phase III trial of bevacizumab plus IFN versus IFN monot

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

194 S0003 was a phase III trial of carboplatin/paclitaxel with or withou

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 rdiovascular mortality in a large randomized phase III trial of men treated with or without adjuvant

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

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

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

205 A phase III trial of regorafenib versus placebo is ongoing

206 ristics of bacteremic patients enrolled in a phase III trial of S. aureus bacteremia and endocarditis

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

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

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

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

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

212 Recent therapeutic interventional phase III trials of antisense oligodeoxyribonucleotides

213 The phase III trials of apixaban and rivaroxaban have comple

214 Phase III trials of buparlisib and endocrine therapy in

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

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

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

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

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

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

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

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

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

230 This Phase III trial randomly assigned 304 patients with CKD

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

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

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

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

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

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

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

238 Twin phase III trials showed significantly improved survival

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

240 In an international, randomized phase III trial, sunitinib demonstrated statistically si

241 Phase III trials supported efficacy for 75% of regular-a

242 A multinational, phase III trial (SYMMETRY) of E + P compared with paclit

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

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

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

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

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

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

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

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

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

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

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

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

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

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

260 A randomized, phase III trial to compare axitinib with sorafenib in pa

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

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

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

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

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

266 To our knowledge, this is the first phase III trial to perform prospective analysis of CA 19

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

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

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

270 uman experimental medicine strategies before phase III trials to assess blood-brain barrier penetrati

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

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

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

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

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

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

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

278 y of BCT compared with chemotherapy alone, a phase III trial was performed within the United States I

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

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

281 The primary goal of this multicenter phase III trial was to determine whether overall surviva

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

283 subset analysis of BR patients in alvimopan phase III trials was performed.

284 The objective of this phase-III trial was to assess the effect of a potent ant

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

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

287 Seven PH patients in the phase III trial were identified as severe PH.

288 me period between publication of phase II to phase III trial were independent predictive factors of s

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

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

291 351 phase II studies, 167 (47.6%) subsequent phase III trials were positive and 184 (52.4%) negative.

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

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

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

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

296 Ongoing phase III trials will provide critical insight into the

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