ライフサイエンスコーパス: central review

1 hese, 44 (30%) were deemed ineligible (43 by central review).

2 all response rate (ORR) (blinded independent central review).

3 RECIST version 1.1, assessed by independent central review).

4 at baseline according to blinded independent central review).

5 Hip fractures were confirmed by central review.

6 urvival, assessed via a blinded, independent central review.

7 es were reported by centers and confirmed by central review.

8 r whom cytogenetic data were not accepted on central review.

9 nge: 1-8) according to blinded, independent, central review.

10 artial responses, as assessed by independent central review.

11 artial responses, as assessed by independent central review.

12 ion 1.1 (RECIST v1.1) by blinded independent central review.

13 e, and were evaluated by blinded independent central review.

14 ized), as evaluated by blinded, independent, central review.

15 assessed by dual-reader, blinded independent central review.

16 clear communication during tumor boards and central review.

17 al [IC] and systemic) by blinded independent central review.

18 val (PFS) as assessed by Blinded Independent Central Review.

19 al response, assessed by blinded independent central review.

20 response) as assessed by blinded independent central review.

21 response rate (cORR) per blinded independent central review.

22 RECIST 1.1, assessed by blinded independent central review.

23 was event-free survival according to blinded central review.

24 ive response assessed by blinded independent central review.

25 e response rate (ORR) by blinded independent central review.

26 objective response rate (ORR) by independent central review.

27 ORR) per RECIST, version 1.1, by independent central review.

28 point was objective response rate (ORR) per central review.

29 s overall response rate (ORR) by independent central review.

30 n-free survival (PFS) by blinded independent central review.

31 survival as assessed by blinded independent central review.

32 ive fungal disease as adjudicated by blinded central review.

33 ib group, as assessed by blinded independent central review.

34 irmed objective response rate by independent central review.

35 (RECIST) version 1.1 by blinded independent central review.

36 rate in cohort 1 as assessed by independent central review.

37 version 1.1 assessed by blinded independent central review.

38 ponse per RECIST 1.1, by blinded independent central review.

39 response) as assessed by blinded independent central review.

40 dpoint was objective response by independent central review.

41 t was objective response rate by independent central review.

42 dpoint was overall response rate assessed by central review.

43 n-free survival (PFS) by blinded independent central review.

44 ression-free survival by blinded independent central review.

45 umours (version 1.1) assessed by independent central review.

46 ysis set (all randomised patients) by masked central review.

47 ew, whereas analysis of outcome was based on central review.

48 rossover were allowed if PD was confirmed by central review.

49 ial tumour response, assessed by independent central review.

50 ree survival assessed by blinded independent central review.

51 , which were assessed by blinded independent central review.

52 n 1.1), as assessed by a masked, independent central review.

53 eight of these patients were excluded after central review.

54 in cohort A according to blinded independent central review.

55 ors, version 1.1, as assessed by independent central review.

56 in Solid Tumors (RECIST) v1.1 by independent central review.

57 asurable disease at baseline per independent central review.

58 e disease at baseline by blinded independent central review.

59 e survival, according to blinded independent central review.

60 Pathologic responses were confirmed by central review.

61 T examinations were evaluated locally and by central review.

62 Response was assessed every 9 weeks by central review.

63 ssion-free survival (PFS) assessed by masked central review.

64 n Solid Tumours (version 1.1) by independent central review.

65 Tumors (RECIST, version 1.1) by independent central review.

66 lected all available detailed RT records for central review.

67 s complete response rate (CRR), evaluated by central review.

68 had a CRR of 52% (P = .08) when evaluated by central review.

69 was progression-free survival by independent central review.

70 r the biopsy or the treatment specimen after central review.

71 ed, 130 had histologically confirmed PTCL by central review.

72 ive response rate as assessed by independent central review.

73 d with tumor-node (TN) substage confirmed on central review: 18, T4N0/1; 12, T4N2; and 20, N3.

74 After central review, 47 of 48 relapses (98%) were detected by

75 pathological responses (13% per independent central review, a secondary endpoint) to neoadjuvant cem

76 assessed on the basis of blinded independent central review according to the Response Evaluation Crit

77 to 4 courses and at the end of therapy with central reviewing according to visual dichotomous criter

78 objective (complete or partial) response by central review after six cycles of treatment, analysed b

79 jaw have been reported, with 26 confirmed on central review, all in the zoledronic acid group (1.7%,

80 re judged to have had an overall response at central review; all responses were partial.

81 rvival (as determined by blinded independent central review) among patients without brain metastases.

82 e survival (according to blinded independent central review) among the patients with HER2-low disease

83 as assessed by means of blinded independent central review, among patients with a PD-L1 expression l

84 ncing tumour <2 cm(2) post-chemoradiation by central review), analysed by modified intention to treat

85 ogression-free survival (PFS) by independent central review, analysed by intention to treat after 714

86 GVHD diagnosis according to the NIH-CC using central review and a study adjudication committee.

87 Discordance between central review and contributing institutions occurred in

88 primary language; and (6) periodic, blinded central review and feedback on investigator efficacy sco

89 ression-free survival by blinded independent central review and has been reported previously.

90 gression-free survival (PFS) per independent central review and improvements in overall survival vers

91 Primary end points were PFS by central review and OS.

92 e response rate (ORR) by blinded independent central review and overall survival (OS) in patients wit

93 (PFS) per RECIST v1.1 by blinded independent central review and overall survival (OS).

94 n-free survival (PFS) by blinded independent central review and overall survival (OS).

95 ression-free survival by blinded independent central review and overall survival in all randomly assi

96 sessed per RECIST version 1.1 by independent central review and overall survival were secondary endpo

97 ession-free survival per blinded independent central review and overall survival.

98 No correlation between CD30 expression per central review and response was observed.

99 l response rate (ORR) by blinded independent central review and safety.

100 OR), and progression-free survival (PFS) per central review and safety.

101 These children should undergo central review and should be surgically managed at cente

102 By using central review and the Deauville criteria, 2-year EFS wa

103 irmed objective response rate by independent central review and was assessed in the full analysis set

104 n-free survival (PFS) by blinded independent central review and was previously reported.

105 sion 1.1 and assessed by blinded independent central review) and safety.

106 se Evaluation Criteria in Solid Tumors v1.1, central review) and safety.

107 se (DOR; all assessed by blinded independent central review), and safety.

108 survival as assessed by blinded independent central review, and overall survival (not analysed at th

109 ary 0.0019), assessed by masked, independent central review, and overall survival (p value boundary 0

110 progressive disease) by blinded independent central review, and overall survival (threshold one-side

111 hever occurred first) by blinded independent central review, and overall survival (time from randomis

112 ary endpoint was rPFS by blinded independent central review, and overall survival (time from randomis

113 DOR) and progression-free survival (PFS) per central review, and safety.

114 Optimal, standardized techniques and central review are essential if chest CT is to be used f

115 r partial response, according to independent central review as per Response Evaluation Criteria in So

116 artial response (PR), by blinded independent central review as per Response Evaluation Criteria in So

117 se rate (ORR) assessed by masked independent central review as per Response Evaluation Criteria in So

118 GFR TKI and PBC, cORR by blinded independent central review (as per RECIST v1.1) was 41.0% [95% confi

119 se had an objective response, as assessed by central review, as did four (17%, 5-39) of 23 with metas

120 uation Criteria in Solid Tumors version 1.1 (central review), assessed in prespecified subgroups base

121 jective response rate by blinded independent central review, assessed in all patients for whom treatm

122 n-free survival (PFS) by blinded independent central review assessment (n = 228; hazard ratio [HR], 0

123 n-free survival (PFS) by blinded independent central review assessment in the hormone receptor-positi

124 was assessed per RECIST v1.1 by independent central review at week 12, then every 6 weeks up to week

125 graded by the testing audiologist and by two central review audiologists using the American Speech-La

126 confirmed response per (blinded) independent central review [(B)ICR] using RECIST v1.1, progression-f

127 ive response rate by the blinded independent central review (BICR) and a pharmacokinetic analysis of

128 e response rate (ORR) by blinded independent central review (BICR) and by investigator as per RECIST

129 er RECIST version 1.1 by blinded independent central review (BICR) and overall survival.

130 sponse in the brain) per blinded independent central review (BICR) by RECIST version 1.1, time to int

131 ective response rate per blinded independent central review (BICR) for cohorts A and B combined and w

132 ry end point was DFS per blinded independent central review (BICR) for nivolumab versus placebo; safe

133 free survival (rPFS) per blinded independent central review (BICR) in Cohort 1 (all-comers) and in th

134 n-free survival (PFS) by blinded independent central review (BICR) in the HER2-low population of 13.2

135 Blinded independent central review (BICR) of progression in randomized clini

136 tment phase) assessed by blinded independent central review (BICR) of volumetric magnetic resonance i

137 rvival, as assessed by a blinded independent central review (BICR) per Response Evaluation Criteria i

138 ent allocation until the blinded independent central review (BICR) showed progressive disease for the

139 jective response rate by blinded independent central review (BICR) using 2014 Lugano response criteri

140 n-free survival (PFS) by blinded independent central review (BICR) with the trophoblast cell-surface

141 sease per RECIST v1.1 by blinded independent central review (BICR), and an Eastern Cooperative Oncolo

142 ession-free survival, by blinded independent central review (BICR), and per RECIST version 1.1, with

143 The primary endpoint was blinded independent central review (BICR)-assessed progression-free survival

144 by neuroradiologist CNS blinded independent central review (BICR).

145 e response rate (ORR) by blinded independent central review (BICR).

146 s PFS per RECIST v1.1 by blinded independent central review (BICR).

147 n-free survival (PFS) by blinded independent central review (BICR); additional assessments included o

148 bo until progression [by blinded independent central review (BICR)] or discontinuation.

149 jective response, PFS by blinded independent central review (BICR-PFS), safety, and time to deteriora

150 (ORR; per RECIST v1.1 by blinded independent central review [BICR]) in patients whose tumors had LAG-

151 tion treatment and its appropriateness after central review by a panel of 4 cardiologists.

152 nt was 6-month ORR assessed with independent central review by using modified Response Evaluation Cri

153 A central review committee evaluated one target tumor and

154 The central review committee, EDSS raters, laboratory person

155 ree survival assessed by blinded independent central review compared with those receiving nab-paclita

156 Blinded central review, conducted by three independent readers,

157 an objective response by blinded independent central review: confirmed complete responses were achiev

158 hy at diagnosis, will be integrated into the central review determination of staging of FHWT by commi

159 t [Dako Corp, Carpinteria, CA], confirmed by central review), Eastern Cooperative Oncology Group PS 0

160 -free survival (rPFS) by blinded independent central review, evaluated in the intention-to-treat popu

161 Response was assessed by independent central review every 9 weeks per RECIST v1.1.

162 e intervals) for PFS per blinded independent central review favored pembrolizumab (mismatch repair-pr

163 sponse rate assessed per blinded independent central review for dMMR solid tumors was 44.0% (95% CI,

164 us system metastases per blinded independent central review for etirinotecan pegol vs chemotherapy wa

165 n-free survival based on blinded independent central review, has previously been reported.

166 y, was progression-free survival assessed by central review; HRQOL was a prespecified secondary endpo

167 .4 months, the ORR was 50.0% per independent central review (ICR) (DOR not reached), and median PFS p

168 objective response rate (ORR) by independent central review (ICR).

169 objective response rate (ORR) by independent central review (ICR).

170 Conventional histopathological techniques at central review identified 2 undiagnosed primary tumors a

171 A consensus central review identified foci of radiotracer uptake con

172 ree survival assessed by blinded independent central review in all randomised patients (intention-to-

173 (ORR) per RECIST v1.1 by blinded independent central review in all randomized participants (excluding

174 ree survival assessed by blinded independent central review in all randomly assigned patients (analys

175 objective response rate (ORR) by independent central review in cohort A.

176 8wk-PFR)-assessed with a blinded independent central review in phase 2.

177 ponse, were evaluated by blinded independent central review in the efficacy-evaluable population (ie,

178 n-free survival based on blinded independent central review in the full analysis set.

179 which was assessed by a blinded, independent central review in the intention-to-treat population.

180 rogression-free survival assessed by blinded central review in the intention-to-treat population.

181 ival (PFS) assessed by a blinded independent central review in the PD-L1-positive and intention-to-tr

182 n-free survival (PFS) by blinded independent central review, in patients whose tumours had a PD-L1 co

183 version 1.1 assessed by masked, independent central review, in the intention-to-treat population, de

184 rs (RECIST) version 1.1, blinded independent central review] in the intention-to-treat (ITT) populati

185 ession-free survival assessed by independent central review (intention-to-treat population).

186 After central review, interim PET (n = 111) was negative in 76

187 high frequency audiometry, and to evaluate a central review mechanism for audiologic results for cisp

188 ion-free survival {rPFS; blinded independent central review; median rPFS 19.5 versus 10.9 months; haz

189 ical Disorders and Stroke (NINDS) to adopt a central review model.

190 Methods: Real-time central review of (18)F-FDG PET/CT was performed in 581

191 Masked central review of bone marrow pathology was done if avai

192 in the resection cavity, assessed by blinded central review of brain MRI scans by the study neuroradi

193 rtified vascular neurologists with secondary central review of clinically obtained brain images.

194 nalysis of the primary endpoint, including a central review of CT scans.

195 some elements (1%-25%) of SCU identified on central review of diagnostic specimens.

196 After central review of discordant cases, we estimated the rat

197 Central review of endoscopic images is critical to the c

198 tive response rate determined by independent central review of gadolinium-enhanced magnetic resonance

199 Central review of HER2 status showed that only 2490 (79%

200 xylin and eosin-stained slides were used for central review of histologic subtype, grade, and lymphov

201 Blinded central review of imaging provides improved specificity

202 obtained during surgery, analysed by masked central review of local histopathology reports.

203 is of Wilms tumor rupture was established by central review of notes from surgery and/or pathologic e

204 o were aged 0-16 years at diagnosis, and had central review of pathology and comprehensive clinical d

205 with very low-risk Wilms tumor confirmed by central review of pathology, diagnostic imaging, and sur

206 October 2006 and October 2013; all underwent central review of pathology, surgical reports, and imagi

207 rospectively enrolled, 115 were eligible for central review of PET/CT scans at the completion of stan

208 ears, a subset of 331 eligible patients with central review of PET2 was analyzed.

209 This proposal, possibly combined with central review of progression scans for these two time p

210 ence of metastasis determined by independent central review of radiographic imaging every 16 weeks.

211 Hip fracture was adjudicated by a central review of radiology reports.

212 Expert panel central review of sPET and iPET scans were evaluated for

213 firmed by review of pathology reports and/or central review of surgical pathology materials.

214 Central review of the endpoints was not done.

215 Central review of the interim PET2 scan was performed in

216 nrolled patients, 72 remained eligible after central review of their angiograms.

217 After mandatory central review of tumor blocks, if the DDLPS diagnosis w

218 tudy closure; however, after a retrospective central review, only disease in eight of 66 (12.1%) pati

219 ing cabozantinib had disease progression per central review or died.

220 occurred (as assessed by blinded independent central review) or the regimen was discontinued.

221 objective response rate (blinded independent central review); other end points included progression-f

222 survival as assessed by blinded independent central review, overall survival, safety, and a reductio

223 cell astrocytoma, as assessed on independent central review (P<0.001 for baseline vs. 6 months), with

224 f the 145 V/Q SPECT/CT scans included in the central review, PE could be excluded using only perfusio

225 ree survival assessed by blinded independent central review per Response Evaluation Criteria in Solid

226 overall response rate by blinded independent central review per Response Evaluation Criteria in Solid

227 response) established by use of independent central review per Response Evaluation in Neurofibromato

228 osed according to the 2001 WHO criteria by a central review process consisting of panels of expert he

229 ree survival according to masked independent central review; safety was a secondary endpoint.

230 point was objective response rate (ORR) per central review; secondary end points were clinical benef

231 dpoint was objective response rate (ORR) per central review; secondary endpoints included progression

232 esponses (51% [95% CI 39-62] per independent central review, the primary endpoint) and major patholog

233 CI, 4.9 to 10.8); as assessed by independent central review, these values were 34.3% and 9.1 months,

234 ndary end points included ORR by independent central review, time to response (TTR), duration of resp

235 ere progression-free survival by independent central review, time-to-treatment failure, and overall s

236 ponse rate (ORR) was assessed by independent central review using Response Evaluation Criteria in Sol

237 ith dMMR solid tumors by blinded independent central review using Response Evaluation Criteria in Sol

238 an objective response by blinded independent central review using Response Evaluation Criteria in Sol

239 sessment of response was made by independent central review using the International Workshop Criteria

240 ee survival, assessed by blinded independent central review, versus the chemotherapy TPC arm (5.7 vs

241 The median PFS by blinded independent central review was 12.5 months [95% confidence interval

242 The median PFS by central review was 16.6 months (95% CI, 12.9 to 19.6 mon

243 ression-free survival by blinded independent central review was 17.8 months (95% CI 14.3-20.8) in the

244 irmed objective response rate by independent central review was 18.2% (95% CI, 8.2% to 32.7%; five co

245 irmed objective response rate by independent central review was 26.5% (95% CI 15.0-41.1; 13 of 49, al

246 ression-free survival by blinded independent central review was 28.8 months (95% CI 22.4-37.9) with t

247 The objective response rate by independent central review was 29.4% (95% CI 20.8-39.3; 30 of 102 pa

248 ression-free survival by blinded independent central review was 3.7 months (95% CI 3.3-5.1) in the co

249 jective response rate by blinded independent central review was 37.8% (31/82 [95% CI 27.3-49.2]) in t

250 Median PFS per independent blinded central review was 4.8 months (IQR 1.4-9.2) for regorafe

251 therapy group, the ORR by masked independent central review was 54.6% (95% CI 45.2-63.8%) with iza-br

252 Estimated median rPFS by central review was 7.0 months (95% CI, 5.8 to 8.2 months

253 Median PFS by central review was 7.7 months with PTK/ZK versus 7.6 mon

254 PFS per RECIST v.1.1 by blinded independent central review was an exploratory endpoint.

255 Response rate by blinded independent central review was assessed in the phase 2 portion only.

256 Blinded independent central review was consistent: confirmed ORR 55.0% (95%

257 ent in PFS assessed by a blinded independent central review was demonstrated in the experimental arm

258 e response rate (ORR) by blinded independent central review was met with an ORR of 61.0% (75/123); 35

259 ogic diagnosis of ACT was required, although central review was not mandatory.

260 An objective response per independent central review was observed in 26 (31%; 95% CI 21-42) of

261 Central review was then compared with institutional poin

262 Central review was to be performed for all tissue sample

263 rom prostate cancer, as assessed by means of central review, was 5.8% in the bicalutamide group, as c

264 ee survival according to blinded independent central review, was analysed by intent-to-treat.

265 igible peripheral T-cell lymphoma subtype on central review were included in the efficacy analysis.

266 Confirmed objective responses by independent central review were observed in 33 patients in cohort 1

267 ereas those only identified by retrospective central review were treated per the local institution as

268 hieved an objective response, as assessed by central review, were noted among the 42 with locally adv

269 ive response rate in cohort A by independent central review which was assessed in the full analysis s

270 ression-free survival by blinded independent central review with nivolumab plus ipilimumab versus che

271 ression-free survival by blinded independent central review with nivolumab plus ipilimumab versus niv