ライフサイエンスコーパス: interim analysis

1 n-to-treat population (alpha=0.00111 at this interim analysis).

2 d points, including overall survival (at the interim analysis).

3 The lottery arm was dropped at interim analysis.

4 oved progression-free survival at the second interim analysis.

5 protocol-defined efficacy threshold for the interim analysis.

6 s terminated for futility after a preplanned interim analysis.

7 icacy thresholds were not met at the planned interim analysis.

8 concluded early for futility after a planned interim analysis.

9 related deaths were reported since the first interim analysis.

10 onsor stopped the trial after a prespecified interim analysis.

11 ped because of the results of a prespecified interim analysis.

12 Data reported are from the interim analysis.

13 imary end point was tested in a prespecified interim analysis.

14 groups for this prospectively planned second interim analysis.

15 urrence of 2 deaths in the placebo arm in an interim analysis.

16 than with bortezomib and dexamethasone in an interim analysis.

17 tical comparisons were done post hoc in this interim analysis.

18 test for paired binary data in a preplanned interim analysis.

19 from this study based on an unplanned second interim analysis.

20 nts and was discontinued for futility at the interim analysis.

21 275) were closed for futility at the second interim analysis.

22 nts after washout; after 12 weeks, we did an interim analysis.

23 We report on a planned interim analysis.

24 ed over from placebo to pertuzumab after the interim analysis.

25 vival was not reached in either group at the interim analysis.

26 of 7651 people were included in the planned interim analysis.

27 minated based on the results of this planned interim analysis.

28 nded by the safety committee after a planned interim analysis.

29 pped the study for futility after the second interim analysis.

30 We report results from the preplanned interim analysis.

31 This was a prespecified interim analysis.

32 n of the trial after the second prespecified interim analysis.

33 for futility in April, 2011, after a planned interim analysis.

34 d early as a result of futility at a planned interim analysis.

35 trial was stopped for benefit at the second interim analysis.

36 opped per protocol after the last designated interim analysis.

37 This is a 1-year-interim analysis.

38 essment, and this is the report of a planned interim analysis.

39 We report the results of a planned interim analysis.

40 d not cross the significance boundary at the interim analysis.

41 data were not available at the time of this interim analysis.

42 alysis and 24 months at the overall survival interim analysis.

43 the platinum-etoposide group from a planned interim analysis.

44 After an interim analysis, 10 additional patients received the se

45 Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to th

46 At the time of the interim analysis, 142 participants were evaluable.

47 At the time of interim analysis, 286 (21%) of 1343 enrolled patients ha

48 nation for futility at the second preplanned interim analysis (382 PFS events).

49 en the study was stopped after a pre-planned interim analysis, 396 patients were randomly assigned (1

50 In this 5-year interim analysis, 4821 patients were enrolled.

51 At the time of the interim analysis, 745 (99%) of the planned 748 patients

52 At the interim analysis, 80 mg telmisartan was taken forward in

53 At the prespecified interim analysis, 82 participants progressed to CNV, 51

54 In the interim analysis, a significantly higher percentage of i

55 We did a planned interim analysis after 219 (41%) deaths had occurred to

56 free survival at day 56 was met at a planned interim analysis after 235 patients (of 372) were enroll

57 The trial was stopped upon predefined interim analysis after 30 patients because of significan

58 the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-u

59 d when the trial was closed after the second interim analysis after 46 events occurred in 68 patients

60 stopping criterion for noninferiority at the interim analysis after 827 of planned 1200 patients were

61 trial was stopped for efficacy at the third interim analysis after a median of 5.1 years of follow-u

62 ter 378 expected events, with a confidential interim analysis after approximately 87 events (25% inte

63 Interim analysis after inclusion of 53 patients (50%) wi

64 The study was terminated at the interim analysis after randomizing 30 patients.

65 We report the results of a prespecified interim analysis after two-thirds of the planned study e

66 In this 3-year interim analysis, ALP concentrations were significantly

67 val, with an overall survival benefit at the interim analysis, among patients with newly diagnosed mu

68 g committee reviewed the data at the planned interim analysis and declared overall survival superiori

69 ly improved progression-free survival at the interim analysis and had a favorable risk-benefit profil

70 [95% CI 0.63-0.93], p=0.0034) at the second interim analysis and in the CPS of 20 or more population

71 due to futility for efficacy at an unplanned interim analysis and increased rates of safety end point

72 and the study sponsor (except members of the interim analysis and primary endpoint analysis data moni

73 fety monitoring board requested an unplanned interim analysis and subsequently recommended the termin

74 11 (last patient visit July, 2011), after an interim analysis, and suggested a change in primary outc

75 nrolled before the study was closed early at interim analysis (arm A, n = 136; arm B, n = 134).

76 The results of a preplanned interim analysis as of September 5, 2020, are reported h

77 present the findings of an unplanned, ad-hoc interim analysis at the request of the US Food and Drug

78 A prespecified interim analysis at week 8 showed a greater than expecte

79 stopped early by the funder after the second interim analysis because of futility.

80 ed termination of the study after the second interim analysis because of safety concerns and low effi

81 trial was closed after the second scheduled interim analysis because of slow accrual and the end of

82 The trial was stopped for futility after the interim analysis, because the results in the experimenta

83 f improvement did not cross the prespecified interim analysis boundary of P=0.000019.

84 e unmasking took place at age 2 years for an interim analysis, but participants and nearly all invest

85 study was terminated at the first preplanned interim analysis by the National Heart, Lung, and Blood

86 In this interim analysis, children aged 6 months to 17 years wer

87 The study was stopped after a planned interim analysis, conducted when 540 deaths had been rep

88 f an overall survival benefit was seen in an interim analysis; confirmation will be required in the p

89 s stopped for futility based on prespecified interim analysis criteria.

90 At the third interim analysis, criteria for futility were met and the

91 ched, the month 18 visit by the prespecified interim analysis cutoff date.

92 After the results of the first interim analysis (cutoff date Oct 31, 2016), the study w

93 At the time of the interim analysis (data cutoff April 29, 2016), median fo

94 At the second interim analysis (data cutoff Jan 2, 2019), median follo

95 At the second interim analysis (data cutoff, Dec 11, 2019), median fol

96 of overall survival was met at a preplanned interim analysis; data cutoff was on July 21, 2011.

97 Since the TOP 5-year interim analysis (December 2012), cohort size (6148 vs 4

98 e group was closed on June 5, 2020, after an interim analysis determined that there was a lack of eff

99 The pre-planned interim analysis done by intention to treat was done aft

100 and July 9, 2014, and assessed through to an interim analysis done on Jan 26, 2016.

101 Here, we present the results of an unplanned interim analysis done to assess the benefit-risk of the

102 nts by study group was observed at the first interim analysis; enrollment was stopped based on recomm

103 closed to accrual on Oct 14, 2019, after the interim analysis failed to meet the predefined criteria.

104 Positive interim analysis findings from four large adjuvant trial

105 The study was stopped after the second interim analysis; follow-up for safety is ongoing.

106 f progression-free survival was done at this interim analysis; follow-up to assess overall survival i

107 that hypothesis; this occurred at the second interim analysis for 11 hypotheses and at final analysis

108 8 years, the trial was stopped at the second interim analysis for futility regarding RFS (hazard rati

109 The trial was stopped at the fourth interim analysis for futility with a sample size of 479

110 The trial was stopped at the second interim analysis for futility.

111 tion, based on the results of a prespecified interim analysis for futility.

112 A prespecified interim analysis for overall survival was conducted at t

113 Results presented are from a prespecified interim analysis for overall survival.

114 The first interim analysis from EMPRISE showed that compared with

115 This 10-year interim analysis further supports the robust real-world

116 Interim analysis halfway through the trial had a Lan-DeM

117 0.4) in the bortezomib group at a preplanned interim analysis (hazard ratio [HR] 0.53 [95% CI 0.44-0.

118 At the interim analysis, HRQoL was assessed with the Functional

119 The study was stopped early at the planned interim analysis in July, 2015, because the study met it

120 The first interim analysis in October 2009, with 46% of the projec

121 roved overall survival (OS) after the second interim analysis (in 2012) of 271 deaths in the Gynecolo

122 The interim analysis included 210 patients randomized to TTF

123 This interim analysis included 90 patients who received idaru

124 This interim analysis includes adult WLWH randomized and enro

125 At a prespecified interim analysis, including 212 primary end point events

126 The results of this interim analysis indicate that rVSV-ZEBOV might be highl

127 This is an interim analysis, initiated after all enrolled patients

128 An interim analysis is scheduled after the first 30 patient

129 signed to an arm of the study at the time of interim analysis (January 20, 2016).

130 pre-specified stopping rule for futility at interim analysis led the trial to be stopped.

131 e drug to be superior or inferior, a planned interim analysis led to the trial being stopped.

132 For the 25% interim analysis, MACE occurred in 59 placebo-treated pa

133 e primary endpoint was met at the preplanned interim analysis (March 10, 2015).

134 At the first preplanned interim analysis (March, 2016), the independent data mon

135 At the time of the second prespecified interim analysis, median follow-up was 22.2 months (IQR

136 nded the trial be closed to accrual after an interim analysis met prespecified criteria for early sto

137 A preplanned interim analysis met the efficacy criterion for early cl

138 The study was terminated when the second interim analysis met the prespecified futility stopping

139 nitoring board because the second preplanned interim analysis met the prespecified stopping rule for

140 Arm C was closed for futility at the first interim analysis (n = 241), and arm A (n = 267) and arm

141 Study was terminated after interim analysis (n = 98); 90 patients were available fo

142 Results of the preplanned interim analysis (n=15 in each group) of the primary end

143 from available DNA samples from PANTHER-IPF (interim analysis, n = 79; final analysis, n = 118).

144 At the first scheduled interim analysis, non-inferiority was shown and the spon

145 At the second preplanned interim analysis (Nov 9, 2016), the primary endpoint was

146 At the pre-planned interim analysis (Oct 14, 2013), the IDMC selected trast

147 In this interim analysis of 315 patients with glioblastoma who h

148 We present herein the results of an interim analysis of 316 patients enrolled at Houston Met

149 Anderson Cancer Center, and before a planned interim analysis of 44 events.

150 In this interim analysis of a multicentre, open-label, non-rando

151 We previously reported the interim analysis of a multicentre, randomised, double-bl

152 We did this interim analysis of a non-randomised, phase 2 trial at 2

153 In this interim analysis of a phase 2 trial, one of three doses

154 d pain and functional status in a preplanned interim analysis of a phase 3 trial.

155 We recently reported results from interim analysis of a propensity score-matched study sug

156 wever, trial sequential analyses (similar to interim analysis of a randomized trial) powered for a 25

157 ata monitoring committee report of a planned interim analysis of a trial in second-line SQ NSCLC (CM0

158 We report the results of an interim analysis of a trial of rVSV-ZEBOV in Guinea, wes

159 ascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a d

160 This is a planned interim analysis of an on-going trial that will run for

161 G, AND PARTICIPANTS: Preliminary exploratory interim analysis of an ongoing randomized trial.

162 Here we report results from a planned interim analysis of an ongoing, phase 3 study of obetich

163 A planned interim analysis of change in alanine aminotransferase a

164 l to cohort 2 was stopped after an unplanned interim analysis of cohort 1 and the statistical analysi

165 on for cohorts 5, 6, and 7 occurred after an interim analysis of data for cohorts 1 to 4.

166 We conducted an unplanned interim analysis of data from a multicenter, randomized,

167 An interim analysis of data from the HIV Prevention Trials

168 y of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials.

169 We did a 72-week interim analysis of observational data from the ongoing

170 cacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.

171 The interim analysis of OS (64% censored) demonstrated a 13%

172 At the second interim analysis of overall survival (58% maturity), ove

173 We present data from the second interim analysis of overall survival and a retrospective

174 Interim analysis of overall survival favoured the pertuz

175 An interim analysis of overall survival showed no significa

176 as specified in the protocol; a prespecified interim analysis of overall survival was conducted and i

177 In the planned interim analysis of overall survival, 14 deaths occurred

178 We report results from a preplanned second interim analysis of overall survival, which was planned

179 Data presented are from the planned primary interim analysis of part one of the study when all patie

180 y for futility based on results of a planned interim analysis of participants enrolled at least 5 yea

181 , we report safety and efficacy data from an interim analysis of patients with severe Wiskott-Aldrich

182 primary endpoint at the prespecified second interim analysis of progression-free survival in the int

183 nted in this report reflect the prespecified interim analysis of recurrence-free survival after 90 ev

184 The authors performed a preplanned interim analysis of results from 12,631 examinations int

185 These data provide a 10-year interim analysis of safety and effectiveness in TOP.

186 rrent findings are based on the prespecified interim analysis of the first 160 randomly assigned pati

187 On the basis of an interim analysis of the first 188 patients who completed

188 The first interim analysis of the KEYNOTE-426 study showed superio

189 eath ligand 1 (PD-L1) and report here on the interim analysis of the malignant pleural mesothelioma c

190 The interim analysis of the multicentre New EPOC trial in pa

191 We report data from the interim analysis of the ongoing VIVIANE study, the aim o

192 lment, and current findings are based on the interim analysis of the patients who had completed 12-mo

193 Because interim analysis of the primary end point revealed an im

194 not enrolling participants; results for the interim analysis of the primary endpoint are presented.

195 A planned interim analysis of the primary outcome showed improved

196 Here, we present the first interim analysis of the R/M cSCC cohort from the 2-cohor

197 at 1 year after the end of treatment, as an interim analysis of the REP 301-LTF trial (planned durat

198 This trial is ongoing; here, we report an interim analysis of the SCLC cohort.

199 This report is a prespecified, 3-year interim analysis of the trial.

200 We report an interim analysis of this ongoing trial.

201 This report is the third interim analysis of this study.

202 An interim analysis of this trial is reported here.

203 lyses and stopped the trial after the second interim analysis on Aug 3, 2013, as directed by the data

204 At the interim analysis on Oct 11, 2019, the first 25 evaluable

205 eight to crypt depth, and stopped at planned interim analysis on reaching this end point.

206 comparisons, which stopped accrual early at interim analysis on the basis of failure-free survival.

207 The trial was stopped early after a planned interim analysis on the recommendation of the data and s

208 rior to phase 3 for treatment futility after interim analysis on the recommendations of an independen

209 In this interim analysis, patients were assessed for the occurre

210 At the second interim analysis, pembrolizumab alone improved overall s

211 An interim analysis (performed after 15 subjects completed

212 Because of the interim-analysis plan, a P value of less than 0.044 at t

213 The interim analysis presented here was protocol-specified a

214 terminated for efficacy at the prespecified interim analysis, radium-223 improved overall survival.

215 The trial is closed and this is the first interim analysis, reporting the objective response prima

216 This interim analysis reports outcomes of 60 patients with a

217 d during recruitment because results from an interim analysis revealed futility.

218 The results from this planned interim analysis show clinically significant histologica

219 INTERPRETATION: The results of this interim analysis show that venetoclax has durable clinic

220 Recruitment was stopped early when an interim analysis showed an increased rate of death at 36

221 data and safety monitoring board, after the interim analysis showed efficacy of hypothermia.

222 The study was stopped after interim analysis showed higher mortality in the pyridoxa

223 0 participants were recruited when a planned interim analysis showed increased adverse events in the

224 d Kingdom had been enrolled in the trial, an interim analysis showed increased mortality at a correct

225 In December, 2010, an interim analysis showed lack of efficacy and the trial w

226 ollow-up of 33.3 months after a prespecified interim analysis showed that medical management alone wa

227 results from this unplanned, FDA-requested, interim analysis showed that the benefit-risk profile of

228 results from this unplanned, FDA-requested, interim analysis showed that the benefit-risk profile of

229 A prespecified interim analysis showed that the rate of progression-fre

230 men With Mammography-Negative Dense Breasts' interim analysis shows that ultrasound has better increm

231 On the basis of an interim analysis significance level of 0.081 (overall on

232 ted by early termination due to an unplanned interim analysis that appeared to have suggested futilit

233 the trial was prematurely halted based on an interim analysis that indicated a low probability of cli

234 ecommendation was based on the results of an interim analysis that showed superiority of these groups

235 On May 15, 2015, on the basis of an interim analysis, the data and safety monitoring board d

236 At its first interim analysis, the Data Monitoring and Ethics Committ

237 At interim analysis, the FOLFOX-cetuximab arm was stopped (

238 At the third planned interim analysis, the futility boundary was crossed, and

239 At first interim analysis, the hazard ratio (HR) by independent r

240 At the time of the interim analysis, the median follow-up was 29.4 months (

241 of 9 months (IQR 5-23), at a second planned interim analysis, the median progression-free survival w

242 At the time of the interim analysis, the observed mean decrease from baseli

243 At the time of a preplanned interim analysis, the primary efficacy analysis populati

244 At interim analysis, the primary end point was significantl

245 In this planned interim analysis, the primary endpoints of reactogenicit

246 At the 24-month interim analysis, the rate of overall survival was 84% i

247 In this interim analysis, the REGN-COV2 antibody cocktail reduce

248 At the first prespecified interim analysis, the study was stopped early on the rec

249 Following a pre-planned interim analysis, the trial was terminated early due to

250 These results are based on an interim analysis; the study is active but not recruiting

251 tistical criterion was alpha=0.00411 at this interim analysis), then in patients with CPS of 1 or mor

252 At interim analysis, there was insufficient evidence to sup

253 Within the limitations of this interim analysis, there was no significant difference in

254 because of evidence of futility at a planned interim analysis; therefore, all prespecified haematolog

255 In a midseason interim analysis, this estimate was 16.5% (95% CI, 10.3%

256 Consistent with the first interim analysis, this second interim overall survival a

257 analysis after approximately 87 events (25% interim analysis) to assess a noninferiority HR of 2.0 f

258 utility boundary was crossed at a preplanned interim analysis, trial accrual terminated in April, 201

259 This is an interim analysis, up to Nov 1, 2012, when the trial was

260 the primary endpoints were met at the first interim analysis, updated data are reported with nominal

261 Planned interim analysis using the O'Brien-Fleming boundary was

262 The single end point for this interim analysis was all-cause mortality.

263 The otamixaban dose selected at interim analysis was an intravenous bolus of 0.080 mg/kg

264 A planned interim analysis was conducted at 69.8% of expected even

265 An interim analysis was conducted in November, 2013, after

266 A preplanned interim analysis was conducted to identify the regimen t

267 This interim analysis was done when the first six patients tr

268 ample size) an unplanned and funder-mandated interim analysis was done, resulting in premature discon

269 The primary endpoint of this 6 month interim analysis was geometric mean titres (GMTs) of neu

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

271 A preplanned interim analysis was performed at month 24, stratifying

272 Methods: Interim analysis was performed of the first 10 patients

273 A preplanned interim analysis was performed on January 29, 2016, afte

274 Preplanned interim analysis was performed on the first 120 patients

275 A non-pre-specified interim analysis was performed to evaluate ramipril's im

276 Interim analysis was performed when 221 patients died (1

277 ing by the European Medicines Agency, and an interim analysis was performed.

278 One interim analysis was planned to allow the study to stop

279 An interim analysis was pre-planned after 500 patients achi

280 The data cutoff for this interim analysis was Sept 3, 2018.

281 The primary endpoint of this interim analysis was the proportion of patients who lost

282 The primary endpoint of this interim analysis was the proportion of patients with an

283 This prespecified interim analysis was to be conducted on the first 315 pa

284 The aim of this second interim analysis was to compare overall survival between

285 The midseason interim analysis we performed demonstrates that our meth

286 In this 2-year interim analysis, we analysed patients who were selected

287 In this first interim analysis, we investigated the risk of HHF among

288 This study is ongoing; data for this interim analysis were collected per regulatory agencies'

289 The main outcomes of this 2-year interim analysis were cumulative incidence of spontaneou

290 The primary endpoints for the month-18 interim analysis were fibrosis improvement (>=1 stage) w

291 on was prematurely closed after an unplanned interim analysis when 298 patients had been randomly ass

292 At the time of a planned interim analysis, when 23 episodes of cellulitis had occ

293 owed preliminary antitumour activity in this interim analysis, which could represent a new potential

294 At the interim analysis, which involved 809 patients, radium-22

295 Study was terminated prematurely after interim analysis, which showed no difference in overall

296 At the planned second interim analysis with 42 evaluable patients and a median

297 Median PFS at the protocol prespecified interim analysis with 58 PFS events (primary end point)

298 Here, we present an interim analysis with data cutoff on March 29, 2019.

299 with CPS of 1 or more (alpha=0.00111 at this interim analysis, with partial alpha from progression-fr

300 significantly improved with pertuzumab in an interim analysis without the median being reached.