ライフサイエンスコーパス: prespecified

1 PROMUS Element Plus Post-Approval Study was prespecified.

2 o 33%; lower bound of 1-sided 95% CI, 0.73%; prespecified 1-sided P = .04), while high sensitivity (9

3 We report the results of the prespecified 12-month analysis of the REVASCAT trial.

4 A prespecified (18)F-FDG PET analysis was conducted to ass

5 We prespecified a cutoff of 14% or more genomic LOH for LOH

6 using the coverage probability index with a prespecified acceptable echocardiography-catheterization

7 difference between groups was more than the prespecified acceptable margin of -5 letters at both 12

8 ALI was a prespecified adjudicated end point using a formal defini

9 Prespecified adjudicated severe hypoglycemia occurred in

10 Cardiovascular death or heart failure was a prespecified, adjudicated secondary end point.

11 We blindly adjudicated all reports of four prespecified AEs of interest-muscle-related, erectile dy

12 derived algorithm outperformed the 5 simple prespecified algorithms and performed well in both commu

13 We had prespecified an analysis censoring follow-up at oral pol

14 e du Myelome 2005-02) that met the following prespecified an RCT in patients with NDMM receiving ASCT

15 pooled and in each trial individually, with prespecified analyses by 10-year age group based on age

16 We conducted prespecified analyses of data from the FLAME (Effect of

17 This prespecified analysis compared outcomes in patients stra

18 The current study was a prespecified analysis in a separate cohort that initiall

19 A prespecified analysis of death from ovarian cancer of MM

20 In the prespecified analysis of EGFR FISH-positive subpopulatio

21 In this prespecified analysis of FOURIER, we investigated the ef

22 Prespecified analysis of PVR in the Placement of Aortic

23 time of initial VTE with recurrent VTE in a prespecified analysis of the CATCH (Comparison of Acute

24 A prespecified analysis of the end point of ATE was conduc

25 The primary outcome of this prespecified analysis was 1-year mortality.

26 lidated in a separate multicenter cohort via prespecified analysis, blinded per prospective-specimen-

27 In this prespecified analysis, we investigated the effect of evo

28 Dual Antiplatelet Therapy (DAPT) Study as a prespecified analysis.

29 ort and lipid compartment separately using a prespecified analytic plan for exposures, covariates, ef

30 In this analysis of prespecified and post hoc objectives from the trial, we

31 with mixed-model repeated measures including prespecified and post-hoc tests.

32 The prespecified and standardised primary outcomes were kidn

33 er outcomes and fewer symptoms), equivalence prespecified as +/-6 points.

34 The non-inferiority margin was prespecified as -5 Early Treatment Diabetic Retinopathy

35 significant excess of serious adverse events prespecified as being of special interest.

36 rence in time to onset of asthma, defined by prespecified asthma criteria relying on documented rever

37 Interim analyses were prespecified at 5 years of follow-up.

38 ment and baseline values (principal efficacy prespecified at 8 months).

39 All outcomes and analyses were prespecified before study initiation.

40 vity, continuity, epileptiform features, and prespecified "benign" or "highly malignant" patterns bas

41 Methods A prespecified, blinded molecular analysis of Cancer Esoph

42 e to 12-month follow-up, and equivalence was prespecified by a CI margin of +/-0.4% based on the inte

43 al WHAE were prospectively collected using a prespecified case report form in all study visits.

44 Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency,

45 es Outcomes (U-BIOPRED) adult cohort using 8 prespecified clinic-physiologic variables.

46 rized as nonpneumonia (due to the absence of prespecified clinical and laboratory signs and absence o

47 The prespecified clinical triggers, captured in the natural

48 -0.25 to 0.80; P = 0.30), which excluded the prespecified, clinically important difference of -1.2.

49 Based on a prespecified Cochrane protocol, we did a systematic lite

50 cts of empagliflozin, an analysis that was a prespecified component of the secondary microvascular ou

51 In a multivariable analysis controlling for prespecified confounders, preadmission oral corticostero

52 basis, adjusting for facility clustering and prespecified covariates.

53 model to determine the relative influence of prespecified criminal history and sociodemographic and c

54 uorescent in situ hybridization (FISH) using prespecified criteria and EGFR FISH-positive status was

55 Findings: Fifteen studies (n = 13914) met prespecified criteria and were reviewed in December 2015

56 ent injections at subsequent visits based on prespecified criteria for active wet AMD.

57 ence -2.0%, 95% CI -8.3 to 4.3), meeting the prespecified criteria for non-inferiority.

58 d inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with z

59 Prespecified criteria for surrogacy required either R(2)

60 e interval, 10 to 47; P=0.006) and satisfied prespecified criteria for the primary noninferiority ana

61 y withdrew from study drug (20 vs 32) or met prespecified criteria for treatment failure (zero vs two

62 starting at week 24 was initiated on meeting prespecified criteria of at least a 10-letter visual acu

63 ans through medical record reviews using the prespecified criteria of recurrent MI and stroke and the

64 y selected relevant incident reports meeting prespecified criteria, and then descriptively analyzed t

65 olled food challenge either upon achieving 4 prespecified criteria, or after 3 maintenance years.

66 ive disease (treatment failure)-according to prespecified criteria.

67 ndicated after cardiac surgery, according to prespecified criteria.

68 ailure -1.7, 95% CI -3.0, -0.5), meeting the prespecified criterion for non-inferiority.

69 , 2014, 348 deaths had occurred, meeting the prespecified cutoff for final analysis.

70 Using various prespecified cutoffs for the SpO2/FiO2 ratio resulted in

71 than 10% (denoted comparable) according to a prespecified decision rule (ie, posterior probability fo

72 luating symptomatic adults with KSHV using a prespecified definition.

73 published phase III trials were examined for prespecified design and outcomes.

74 Antibiotic treatment was started when prespecified diagnostic criteria were met (temperature >

75 2.5 mg twice daily with stratification to a prespecified duration of DAPT of 1, 6, or 12 months (gro

76 Prespecified effect modifiers were tested using multivar

77 Neratinib reached the prespecified efficacy threshold with regard to the HER2-

78 ped early in the arms containing SQ109 since prespecified efficacy thresholds were not met at the pla

79 by binomial proportional estimate using the prespecified end point (LRF or alive without LRF and fol

80 by binomial proportional estimate using the prespecified end point and 21% (95% CI, 7% to 26%) by Ka

81 ndovascular therapy and day 5 (which was the prespecified end point for infarct volume in the Diffusi

82 of 101 (17.8%) patients with LGE reached the prespecified end point, compared with 7 of 298 (2.3%) wi

83 LTBI treatments and recorded at least 1 of 2 prespecified end points (hepatotoxicity and prevention o

84 Prespecified end points included left ventricular mass i

85 tudies were included if SSI assessment was a prespecified endpoint.

86 Prespecified endpoints were to assess, in each treatment

87 The prespecified equivalence margin was 7% or less.

88 ducted on an intention-to-treat basis with a prespecified equivalence range of 20%.

89 However, prespecified exploratory analyses provided evidence sugg

90 INTERPRETATION: In this prespecified exploratory analysis, ticagrelor was superi

91 Here we report the prespecified exploratory endpoint of pembrolizumab versu

92 Overall survival was a prespecified exploratory endpoint.

93 The prespecified exploratory secondary outcome of neurodevel

94 rotic and non-atherosclerotic groups for the prespecified, exploratory analysis reported in this stud

95 rential response and assessment of whether 3 prespecified features (aeroallergen sensitization, previ

96 In this study, we report the prespecified final analysis of the primary objectives, O

97 e (secondary versus primary prevention) were prespecified for evaluation.

98 Data were extracted in prespecified forms and we then did a meta-analysis using

99 ted when the second interim analysis met the prespecified futility stopping criteria in the intention

100 Bayesian analyses were prespecified given the anticipated limited sample size.

101 placebo group, with 13% versus 25% having a prespecified good outcome (odds ratio, 0.42; 95% CI, 0.2

102 Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes

103 Although on the basis of the prespecified hypothesis testing sequence the renal outco

104 According to a prespecified hypothesis, ASL images were graded for the

105 In one of the three prespecified hypothesis-based subgroups, participants in

106 s, these efforts have relied on a variety of prespecified image features.

107 The methodology was prespecified in a rigorous protocol using the Systematic

108 All analyses were prespecified in the protocol and the statistical analysi

109 All analyses were prespecified in the study protocol.

110 ear follow-up of the TWENTE participants was prespecified in the trial protocol; that of the nonenrol

111 Primary and secondary outcomes are prespecified in trial registries, thus allowing the asse

112 stimated with a linear mixed-effects model), prespecified incident CKD (defined as a >30% decrease in

113 Of 2567 citations, 20 primary studies met prespecified inclusion criteria.

114 3 791 pregnant women across 37 countries met prespecified inclusion criteria.

115 this level of improvement did not cross the prespecified interim analysis boundary of P=0.000019.

116 n the future as specified in the protocol; a prespecified interim analysis of overall survival was co

117 The cutoff date for this prespecified interim analysis was Jan 3, 2017.

118 The sponsor stopped the trial after a prespecified interim analysis.

119 rial was stopped because of the results of a prespecified interim analysis.

120 the first primary end point was tested in a prespecified interim analysis.

121 The prespecified interim monitoring plan was to report for f

122 In our secondary analysis, we investigated prespecified intermediate renal outcomes of transitions

123 These effects did not reach a prespecified level of "clinically significant benefit."

124 y be applicable to geofencing other types of prespecified locations to facilitate healthcare research

125 The prespecified main kidney outcome, defined as the composi

126 ortions for determining equivalency of a 10% prespecified margin were evaluated by 95% CIs.

127 The prespecified minimal clinically important difference was

128 endpoint was objective response following a prespecified minimum follow-up period of 6 months, asses

129 282 (93%) participants were included in the prespecified, modified intention-to-treat analysis.

130 y the American Diabetes Association, was the prespecified, multiplicity-adjusted secondary outcome.

131 We did prespecified multivariable analyses to assess the indepe

132 ed at time of study design, translating into prespecified NIMs or hazard ratios that reflected larger

133 -2.4 (SD 1.5), with a difference within the prespecified non-inferiority margin of -0.19 (95% CI -0.

134 ug Administration snapshot algorithm, with a prespecified non-inferiority margin of -12%.

135 g Administration snapshot algorithm), with a prespecified non-inferiority margin of -12%.

136 and Drug Administration snapshot algorithm (prespecified non-inferiority margin of 12%).

137 g Administration snapshot algorithm), with a prespecified non-inferiority margin of 8%.

138 g Administration snapshot algorithm), with a prespecified non-inferiority margin of 8%.

139 primary outcome measure result includes the prespecified non-inferiority margin, the combination of

140 AIV against moderate-to-severe LCI and other prespecified non-LCI clinical outcomes including all-cau

141 This upper limit exceeded the prespecified noninferiority limit of 0.5 lines.

142 CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%.

143 preserved 7 days or less with respect to the prespecified noninferiority limit.

144 -0.80% (95% CI, -7.1% to 5.5%), meeting the prespecified noninferiority margin and allowing for stat

145 Given the prespecified noninferiority margin of -15%, the null hyp

146 5% CI, 0.988 to 1.200); upper bound exceeded prespecified noninferiority margin of 1.15.

147 rdial infarction, or nonfatal stroke) with a prespecified noninferiority margin of 1.3.

148 he difference in event rates fell within the prespecified noninferiority margin of 3.2 percentage poi

149 fference was 8.9%, which is greater than the prespecified noninferiority margin of 6.6%.

150 he upper bound of the HR 95% CI exceeded the prespecified noninferiority margin.

151 Prespecified noninferiority margins were 1.5 (RMDQ) and

152 ) and adults (95% CI, .9%-2.7%) excluded the prespecified noninferiority threshold of 6% (P = .003 an

153 24 weeks for at least 120 weeks and until a prespecified number of confirmed disability progression

154 dpoint was progression-free survival using a prespecified one-sided stratified log rank test at a sig

155 or first heart failure hospitalization was a prespecified outcome (median follow-up, 845 days).

156 Prespecified outcome measures included low-grade CIN (gr

157 The prespecified outcome was alpha-diversity (inverse Simpso

158 For each prespecified outcome, IPD were analysed using a 1-stage

159 An additional 56 prespecified outcomes measured maternal health-care use,

160 Prespecified outcomes were incident MCI and MCI progress

161 not inferior to in-person follow-up for the prespecified outcomes.

162 nterim overall survival analysis crossed the prespecified overall survival efficacy boundary.

163 three cycles of PEb was less than that of a prespecified parametric model, particularly for patients

164 Prespecified patient outcomes were pain severity, functi

165 as compared with the placebo regimen, in all prespecified patient subgroups, including in patients wi

166 Results were consistent across the prespecified patient subgroups.

167 None of the prespecified patient-level or study-level moderators was

168 Analysis was by intention-to-treat (ITT); prespecified per-protocol (PP) analyses were also done.

169 y the rate of attacks of angioedema during a prespecified period (day 8 to day 50) in the 300-mg and

170 In prespecified pooled analyses, the percentage of patients

171 verall survival was tested hierarchically in prespecified populations: IC2/3, followed by IC1/2/3, fo

172 results suggest the need for a study using a prespecified portal flow modulation protocol with define

173 betes were not significantly modified by any prespecified potential sources of heterogeneity (ie, age

174 However, results from the prespecified PP population suggest that enhancing remyel

175 der cancer (1990-2012) with information on 7 prespecified predictors at the time of diagnosis of the

176 The prespecified primary analyses did not show any treatment

177 We present the prespecified primary analysis results in the intention-t

178 etween the two treatment groups based on the prespecified primary analysis using a joint model (p=0.2

179 the association between midwall LGE and the prespecified primary composite outcome of SCD or aborted

180 The prespecified primary efficacy outcome was cardiovascular

181 and a standard regimen of enoxaparin in the prespecified primary efficacy outcome.

182 (1.5 mg) combination therapy regimen met the prespecified primary end point of superiority in mean VA

183 The prespecified primary end point was the mean change in vi

184 proof-of-concept was not established as per prespecified primary endpoint of proposed efficacy.

185 rences favouring the experimental group in a prespecified primary or secondary outcome were reported

186 The prespecified primary outcome was a composite measure of

187 The prespecified primary outcome was a laboratory confirmed

188 The prespecified primary outcome was cardiovascular disease

189 The prespecified primary outcome was each treatment group's

190 Our prespecified primary outcomes were self-report of any HI

191 The prespecified primary QOL measures were the Duke Activity

192 re triggered for review by the occurrence of prespecified procedural events.

193 rammed during serial visits as dictated by a prespecified programming algorithm.

194 We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients

195 tween Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for be

196 e device reprogrammed in accordance with the prespecified protocol.

197 l region, and randomly assigned (1:1) with a prespecified randomisation sequence (block size of four)

198 eyes received grid laser at baseline and, if prespecified rescue criteria were met, 1 additional lase

199 Other prespecified research questions were addressed qualitati

200 erivation model to determine the strength of prespecified, routinely obtained criminal history, socio

201 This prespecified safety analysis describes investigator-asse

202 Key prespecified safety endpoints were bone and renal parame

203 d a primary endpoint event or one of the ten prespecified safety events before the week-4 visit.

204 h, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over

205 en the achieved LDL-C level and any of the 9 prespecified safety events.

206 ious adverse events or any of the other nine prespecified safety events.

207 e safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a

208 Prespecified secondary analyses compared the effect on h

209 In a prespecified secondary analysis designed to address the

210 In this prespecified secondary analysis of 25 982 patients from

211 patients with diplopia were analyzed in this prespecified secondary analysis of National Ambulatory M

212 This prespecified secondary analysis shows that, when added t

213 In a prespecified secondary analysis, no difference in mortal

214 effects were found in analyses of the trial prespecified secondary cardiovascular endpoint (which ad

215 Prespecified secondary end point analysis did not show s

216 Prespecified secondary end points included all-cause mor

217 Of the other 8 reported prespecified secondary end points, including intraoperat

218 ival assessed by central review; HRQOL was a prespecified secondary endpoint.

219 Most of the prespecified secondary measures showed no significant be

220 The prespecified secondary outcome measure was time to defin

221 Additional prespecified secondary outcome measures included health-

222 The rates of other prespecified secondary outcome measures--self-reported c

223 Of 47 prespecified secondary outcomes analyzed, 41 showed no s

224 mains of cognitive function were assessed as prespecified secondary outcomes by use of standardised t

225 Among 20 prespecified secondary outcomes not adjusted for multipl

226 ary outcome was serum retinol concentration; prespecified secondary outcomes were hemoglobin concentr

227 Prespecified secondary outcomes were length of stay in t

228 HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV

229 Included among 10 prespecified secondary outcomes were the PHQ-9 score at

230 Prespecified secondary outcomes were the proportions of

231 There were no significant differences in any prespecified secondary outcomes, including adiposity, li

232 We report the prespecified secondary renal outcomes of that randomized

233 analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing-to under

234 In the prespecified sensitivity analysis restricted to data fro

235 he intention-to-treat (ITT) group and in the prespecified sepsis subgroup (ITT group: 23 days in ganc

236 gram (EGM) was systematically measured at 10 prespecified sites, as well as on a standard catheter an

237 If participants met prespecified specimen collection criteria, we collected

238 h targeted temperature management, receiving prespecified standardized clinical, neurophysiologic (pa

239 inded intention-to-treat analysis based on a prespecified statistical analysis plan included all part

240 o be beneficial, the result did not meet the prespecified statistical threshold for efficacy.

241 e interval [CI], 0.12 to 0.49; P<0.0001 [the prespecified stopping boundary]).

242 The prespecified stopping criteria were met after the enroll

243 This prespecified subanalysis investigated the effect of age

244 Sex differences were studied as a prespecified subanalysis.

245 A number of prespecified subgroup analyses and meta-regression analy

246 In prespecified subgroup analyses comparing treatment effec

247 Prespecified subgroup analyses in patients with diabetes

248 Prespecified subgroup analyses of children younger and o

249 We report prespecified subgroup analyses of outcomes in participan

250 is study did not meet its primary endpoints, prespecified subgroup analyses of patients with EGFR FIS

251 Prespecified subgroup analyses of postdural-puncture hea

252 Although differences existed in prespecified subgroup analyses, intubation was not assoc

253 In prespecified subgroup analyses, outcomes were reevaluate

254 This prespecified subgroup analysis focuses on the included p

255 nts with incident CVD and death, including a prespecified subgroup analysis in participants with vita

256 In this prespecified subgroup analysis of a multicenter, double-

257 Prespecified subgroup analysis of a randomized clinical

258 In the prespecified subgroup analysis of the influence of age,

259 We additionally did a prespecified subgroup analysis of the primary endpoint,

260 However, the prespecified subgroup analysis suggested a possible age-

261 In this prespecified subgroup analysis, we evaluated the effect

262 from the DANISH study were included in this prespecified subgroup analysis.

263 s were enrolled from the United States for a prespecified subgroup analysis.

264 In a prespecified subgroup of 120 patients with QRS 120 to 14

265 We sought to determine the outcomes in the prespecified subgroup of patients >/=75 years old (n=201

266 rded a significant effect of ataluren in the prespecified subgroup of patients with a baseline 6MWD o

267 nd 0.49 (95% CI, 0.20-1.17; P = 0.10) in the prespecified subgroup of patients with a baseline PaO2/F

268 The acOR was 3.1 (CI, 1.7 to 5.8) in the prespecified subgroup of patients with ECD versus 1.3 (C

269 DM was a prespecified subgroup.

270 n-hospital mortality between the 2 groups in prespecified subgroups after adjusting for multiple comp

271 rs version 1.1 (central review), assessed in prespecified subgroups based on PD-L1 expression and in

272 no heterogeneity of treatment effect across prespecified subgroups for reduced disability (pinteract

273 bizumab compared with PRP evaluated within 2 prespecified subgroups for the study eye: with baseline

274 Although all prespecified subgroups had lower cost with ezetimibe the

275 ood pressure [BP] treatment among the 6 key, prespecified subgroups in SPRINT: age >/=75 years, prior

276 We evaluated the primary outcome in prespecified subgroups stratified by age, sex, time of s

277 an change for ataluren versus placebo in the prespecified subgroups was -7.7 m (SE 24.1, 95% CI -54.9

278 the intention-to-treat population nor in the prespecified subgroups with a baseline 6MWD of less than

279 and the benefit was similar across all key, prespecified subgroups.

280 fference in risk was similar across multiple prespecified subgroups.

281 n on incident ADHF was consistent across all prespecified subgroups.

282 rction and stroke in all participants and in prespecified subgroups.

283 ause death composite outcomes overall and in prespecified subgroups.

284 ty was assessed and examined across multiple prespecified subgroups.

285 a surrogate measure of research impact in a prespecified subset of studies, stratified by individual

286 nt effect (for any of the treatments) across prespecified subsets.

287 2.6], P value < .0001); both results met the prespecified success criterion.

288 In a non-prespecified superiority analysis, we observed a 43% red

289 The prespecified surrogacy threshold was met, with an R(2)WL

290 The prespecified survival analysis method was competing risk

291 o 0.002; p=0.1664), although maximal cIMT (a prespecified tertiary outcome) was significantly reduced

292 Building on prior qualitative work, we prespecified that measures achieving agreement among at

293 ase 3 trial of neoadjuvant therapy reached a prespecified threshold for any biomarker signature ("gra

294 No genetic variant met the prespecified threshold for statistical significance.

295 f care alone was 91.2%, falling short of the prespecified threshold of 97.5%.

296 ge, and P-wave and R-wave amplitude exceeded prespecified thresholds in a small number of cases.

297 n intensity, and quality-of-life measures at prespecified time points over the course of 1 year.

298 Women who had vaccine exposure during the prespecified time windows were matched for propensity sc

299 re measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 da

300 To determine whether prespecified vascular risk factors and cardiac abnormali