ライフサイエンスコーパス: ITT population

1 w-dose (n=555) low-molecular-weight heparin (ITT population).

2 n=190) or best supportive care group (n=182; ITT population).

3 9, respectively, were enrolled concurrently (ITT population).

4 o either carvedilol (n=89) or placebo (n=93; ITT population).

5 intensity care (n=542) or usual care (n=536; ITT population).

6 ab (n=237) or TACE plus dual placebo (n=243; ITT population).

7 us placebo (n=207), or placebo alone (n=205; ITT population).

8 (n=212) or the no intervention group (n=208; ITT population).

9 to pembrolizumab (n=487) or placebo (n=489; ITT population).

10 eive the bioadaptor (n=1201) or DES (n=1198; ITT population).

11 survival in all randomly assigned patients (ITT population).

12 cabozantinib plus atezolizumab or sorafenib (ITT population).

13 with acute coronary syndrome assessed in the ITT population).

14 ive no ablation and 253 to receive ablation (ITT population).

15 estimated cost were also compared (modified ITT population).

16 hose who received chemotherapy (45.9% of the ITT population).

17 ration (n = 125) treatment (intent-to-treat [ITT] population).

18 all randomised patients (intention-to-treat [ITT] population).

19 , 356; lifitegrast, 355 (intention-to-treat [ITT] population).

20 nsive care unit (ICU) stay (intent-to-treat [ITT] population).

21 Median OS (mOS) was 3.3 months in the ITT population.

22 with PD-L1 TPS of >=50%) and included in the ITT population.

23 after randomisation was not included in the ITT population.

24 asis of the number of active patients in the ITT population.

25 S 20.6 versus 19.3 months) in the non-tBRCAm ITT population.

26 opulation and 13.3 months (10.5-16.0) in the ITT population.

27 hest ORR (52.6%, 95% CI: 28.9%-75.6%) in the ITT population.

28 afety outcomes were assessed in the pregnant ITT population.

29 hile the other patients were assigned to the ITT population.

30 Safety outcomes were analysed in the ITT population.

31 Safety was assessed in the ITT population.

32 of OS was conducted after 251 deaths in the ITT population.

33 S 24.2 versus 19.3 months) in the non-tBRCAm ITT population.

34 1 (SP142) assay] population, and then in the ITT population.

35 The remaining 390 lesions constituted the ITT population.

36 he coprimary end points of PFS and OS in the ITT population.

37 d at least one dose and were included in the ITT population.

38 .35 to 0.95) and 0.58 (0.36 to 0.92) for the ITT population.

39 All randomised patients were included in the ITT population.

40 4371 patients were included in the modified ITT population.

41 P = 0.68; 39.0% maturity) in the non-tBRCAm ITT population.

42 n the non-tBRCAm HRD-positive and non-tBRCAm ITT populations.

43 hed were analyzed as the intention-to-treat (ITT) population.

44 overall survival in the intention-to-treat (ITT) population.

45 ed hierarchically in the intention-to-treat (ITT) population.

46 analysis was done in the intention-to-treat (ITT) population.

47 es were conducted in the intention-to-treat (ITT) population.

48 review committee in the intention-to-treat (ITT) population.

49 months follow-up in the intention-to-treat (ITT) population.

50 ication Committee in the intention-to-treat (ITT) population.

51 hich was assessed in the intention-to-treat (ITT) population.

52 ird interim analysis in the intent-to treat (ITT) population.

53 trial requirements, and intention-to treat (ITT) population.

54 -2.68% to 2.95%]) in the intention-to-treat (ITT) population.

55 ays after first dose in the intent-to-treat (ITT) population.

56 e analyses were based on an intent-to-treat (ITT) population.

57 ndomized and constitute the intent-to-treat (ITT) population.

58 -positive and non-tBRCAm intention-to-treat (ITT) populations.

59 urvival (invPFS) in HRD and intent-to-treat (ITT) populations.

60 fference 0.06 [95% CI -0.11 to 0.23] for the ITT population; 0.04 [-0.14 to 0.21] for the per-protoco

61 djusted HR 0.97 [95% CI 0.83 to 1.12] in the ITT population; 0.94 [0.80 to 1.09] in the per-protocol

62 ), and up to 11 dB SL at week 12 of phase 2 (ITT population: -10.9 [95% CI, -15.2 to -6.5] dB; P = .0

63 tive and control groups (intention-to-treat [ITT] population: +11.4 letters and +13.8 letters [P = 0.

64 zumab group than in the placebo group in the ITT population (12.9 months [95% CI 11.9-14.0] vs 11.5 m

65 ecreases in TFI scores at week 6 of phase 1 (ITT population: -12.0 [95% CI, -16.9 to -7.9] points; P

66 ference 5.96%p [0.16 to 11.76], p=0.044) and ITT populations (-2.57%p [-6.68 to 1.54], p=0.215, vs -8

67 was seen in the active versus control group (ITT population: -212.1 mum and -178.6 mum [P = 0.089]; P

68 was seen in the active versus control group (ITT population: -212.1 um and -178.6 um [P = 0.089]; PP

69 included clinical cure rates in the modified ITT population (231/250 [92.4%] vs 228/249 [91.6%]; diff

70 At randomization, in the ITT population, 27% had normal integrated LV health (64%

71 enrolled, and 41 in each group comprised the ITT population; 33 participants received opicinumab and

72 parib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib v 18

73 the endarterectomy group (119 vs 72 events; ITT population, 5-year cumulative risk 15.2% vs 9.4%, HR

74 reatment control group at week 6 of phase 1 (ITT population: -5.8 [95% CI, -9.5 to -2.2] dB; P = .08;

75 2%, 97.5% CI 0.2-30.3; p=0.024) and modified ITT populations (53 of 103 [51%] vs 36 of 101 [36%]; 15.

76 zumab group than in the placebo group in the ITT population (65.3% [95% CI 60.9-69.5] in the pembroli

77 In the ITT population, 79.3% of solithromycin patients and 79.7

78 In the micro-ITT population, 80.3% of solithromycin patients and 79.1

79 In the ITT population, 84.6% of solithromycin patients and 88.6

80 nce interval [CI], 16-36%; P < .001) and the ITT population (91% [80 of 88] vs 71% [63 of 89]; absolu

81 ally favored the upfront surgery arm B. mOS (ITT population), a secondary endpoint, numerically favor

82 In the ITT population, a non-significant reduction in incidence

83 We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at p

84 placebo), and serious adverse events in the ITT population (all groups).

85 ankin Scale score in the intention-to-treat (ITT) population (all patients randomly assigned to a tre

86 of either study drug in the intent-to-treat (ITT) population (all randomized patients).

87 he microbiological intention-to-treat (micro-ITT) population, all participants randomly allocated to

88 disease (median 3 x 10-6 sensitivity) in the ITT population also increased from induction (28.8%) to

89 he cure rate was comparable at day 42 in the ITT population (AM-PQP, 94.4% vs AL, 93.1%).

90 in the modified intention-to-treat (modified ITT) population (analysed according to their randomly as

91 14.5-17.2) in the progression-free survival ITT population and 13.3 months (10.5-16.0) in the ITT po

92 igible RCTs contributed 3729 patients in the ITT population and 3126 in the PP population.

93 time was 58 months (IQR 46-73 months) in the ITT population and 58 months (46-72) in the per-protocol

94 llow-up was 6.2 months (IQR 3.4-9.2) for the ITT population and 8.9 months (7.1-10.5) for the OITT po

95 (5-10 days after last dose) in the modified ITT population and in the clinically evaluable populatio

96 Safety outcomes were reported in the ITT population and included symptomatic intracranial hae

97 ations] and OS (tested hierarchically in the ITT population and, if significant, in the PD-L1 IC-posi

98 d out on the basis of an intention-to-treat (ITT) population and a full-analysis set (FAS).

99 e IOG (p = 0.053) in the Intention to Treat (ITT) population and dlPFC (p = 0.088) in high-anxious pa

100 nce-free survival in the intention-to-treat (ITT) population and in patients with PD-L1-positive tumo

101 t central review] in the intention-to-treat (ITT) population and in the prespecified FRa high populat

102 overall survival in the intention-to-treat (ITT) population and in the subset of patients without li

103 analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all pati

104 ded OS in the stage IB-IIIA intent-to-treat (ITT) population and safety in randomised treated patient

105 biomarkers, both in the intention-to-treat (ITT) population and the cohort of patients with proficie

106 treatment initiation in the intent-to-treat (ITT) population and the European Medicines Agency-define

107 90 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or

108 rogression-free survival intention-to treat [ITT] population) and overall survival in all randomly as

109 rogression-free survival intention-to-treat [ITT] population), and overall survival in all patients r

110 up and 33 in the placebo group comprised the ITT population, and 30 and 27 comprised the mITT populat

111 urvival, assessed in the intention-to-treat (ITT) population, and the populations with a PD-L1 combin

112 d hierarchically, in the intention-to-treat (ITT) population, and then the populations with high PD-L

113 analysed in the modified intention-to-treat (ITT) population (any randomised patient who received at

114 Median overall survival (mOS) (ITT population) as a secondary endpoint was 25.5 months

115 een the opicinumab and placebo groups in the ITT population at week 24.

116 transplantation need in the intent-to-treat (ITT) population at day 180 (P = 0.087).

117 complete response in the intention-to-treat (ITT) population at the end of treatment.

118 the observation group were excluded from the ITT population because they did not meet post-surgery in

119 death) in all patients (intention-to-treat [ITT] population), both assessed by BIRC.

120 months (95% CI, 1.66 to 5.40 months) in the ITT population, BRCA-mutant cohort, HRD cohort, and BRCA

121 rable ORR (26.1%, 95% CI: 10.2%-48.4% in the ITT population) but with more high grade ( 3) adverse ev

122 Re-review of all patients in the ITT population by the clinical events committee identifi

123 of progression-free survival was met in the ITT population; cabozantinib showed significant improvem

124 nts withdrew immediately and, therefore, the ITT population comprised 1710 patients.

125 The modified ITT population comprised 274 patients assigned to mepoli

126 The ITT population comprised 70 patients randomly assigned t

127 The modified ITT population consisted of 12 patients in the placebo g

128 The ITT population consisted of all patients who received on

129 The ITT populations consisted of 65 patients who received mu

130 y up until day 42 in the intention-to-treat (ITT) population (defined as randomly assigned participan

131 eline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwen

132 Composite evacuation scores of PP and ITT populations did not show statistically significant d

133 and 89.1% with moxifloxacin in the modified ITT population (difference, -1.6% [1-sided 97.5% CI, -6.

134 30 days, analysed in the intention-to-treat (ITT) population excluding those with unknown mortality s

135 The modified ITT population for the efficacy analysis comprised 526 s

136 The ITT population for this analysis comprised concurrently

137 mab did not significantly improve DFS in the ITT population [hazard ratio (HR) 0.81, 95% confidence i

138 ificantly associated with remission (for the ITT population, hazard ratio 1.1, 95%CI 0.6-1.7; for the

139 not significantly associated with remission (ITT population: hazard ratio [HR], 1.1 [95% confidence i

140 37.0-45.8) at this 3.5-year follow-up in the ITT population (HR 0.59 [95% CI 0.49-0.70]) and in those

141 4.6-not reached) months with placebo for the ITT population (HR 0.83, 95% CI 0.58-1.17).

142 ratio [HR] 0.38; 95% CI 0.19-0.75; p=0.0056; ITT population, HR 0.42; 95% CI 0.22-0.80; p=0.0080).

143 In the ITT population, HR for disease-free survival was 0.81 (0

144 Safety was assessed in the ITT population (ie, all randomly assigned participants).

145 cacy was assessed in the intention-to-treat (ITT) population (ie, all participants randomly assigned

146 e-sided p=0.0012) in the intention-to-treat (ITT) population (ie, all participants randomly assigned

147 ssed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned

148 urrence or death) in the intention-to-treat (ITT) population (ie, all patients randomly assigned to t

149 sation), assessed in the intention-to-treat (ITT) population (ie, all patients randomly assigned to t

150 ety were assessed in the intention-to-treat (ITT) population (ie, all patients validly randomly assig

151 A versus group C in the intention-to-treat (ITT) population (ie, all randomised patients), and overa

152 cation committee, in the intention-to-treat (ITT) population (ie, all women randomly assigned to trea

153 otocol efficacy [PPE] or intention-to-treat [ITT] population in clinical trials, or all participants

154 The ITT population included 153 patients ((131)I-apamistamab

155 The ITT population included 188 patients with FMS, 78% of wh

156 The micro-ITT population included 406 participants (202 in the gep

157 llow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants.

158 the log-rank test in the intention-to-treat (ITT) population, including all randomly allocated partic

159 In the ITT population (median follow-up 7.2 months [95% CI 5.8-

160 atients with POMS in the intention-to-treat (ITT) population (median [range] age, 15 [10-17] years; 1

161 In the ITT population, median OS was 33.0 and 27.2 months for e

162 In the ITT population, median overall survival had an HR of 0.9

163 In the ITT population, median PFS was 7.9, 8.3, and 7.3 months

164 noninferiority in ECR in the microbiological ITT population (micro-ITT) and determination of investig

165 Median survival in the ITT population (n=815 in both groups) was 15.8 months (I

166 nferiority was demonstrated for QALYs in the ITT population (n=919) and per-protocol (n=871) populati

167 se of the study drug in the intent-to-treat (ITT) population (noninferiority margin, 12.5%).

168 lation group and nine in the ablation group; ITT population) occurred during follow-up.

169 icant improvement in overall survival in the ITT population of IMvigor130.

170 ) demonstrated differential censoring in the ITT population of the CM743 trial favoring the control g

171 tically significant for the intent-to-treat (ITT) population on the basis of diary cards (primary ana

172 val, non-inferiority was demonstrated in the ITT population only (adjusted HR 0.97 [95% CI 0.83 to 1.

173 In the ITT population, overall survival was improved with atezo

174 showed a trend for improved survival in the ITT population (P =.125).

175 ndpoint, assessed in the intention-to-treat (ITT) population (participants who received at least one

176 In the modified intention-to-treat (ITT) population, PFS-6 was increased from 42.6% with TMZ

177 3 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; p

178 8 months in the modified intention-to-treat (ITT) population [R0/R1-resected patients who started neo

179 Excluding the comparison against ABI+ADT (ITT population; random effects), which was not statistic

180 follow-up of 1.9 years (IQR 0.9-2.5) in the ITT population, recurrence events were reported in 136 (

181 In the intention-to-treat (ITT) population, remission occurred in 37 (84%) of the p

182 In the intention-to-treat (ITT) population, remission occurred in 37 (84%) of the p

183 versus 25.2 months (P = .32) in the mPP and ITT population, respectively.

184 In the ITT population, rhIL-11 significantly decreased the requ

185 in the intention-to-treat (ITT) and modified ITT populations; safety was assessed in the safety popul

186 ly, composite incontinence scores for PP and ITT populations showed no statistically significant diff

187 44-0.67]), and SNA+ADT (0.44 [0.28-0.70]) in ITT population; similar results were observed in high-vo

188 ulation, and finally the intention-to-treat (ITT) population (stage IB-IIIA).

189 l survival benefit versus regorafenib in the ITT population (stratified hazard ratio [HR] 0.80 [95% C

190 tor receptor 2-negative tumors (86.0% of the ITT population), the absolute improvement in 12-year ove

191 In the ITT population, the CS group exhibited normal LV health

192 In the ITT population, the dCR rate was significantly higher wi

193 In the ITT population, the incidence of postoperative atrial fi

194 -1a, and in a sensitivity analysis among the ITT population, the proportions were 10 patients receivi

195 In the intention-to-treat (ITT) population, the 12-year DFS (4.6% absolute improvem

196 Although OS remains immature for the ITT population, these data indicate a positive trend fav

197 ot meet post-surgery inclusion criteria; the ITT population thus consisted of 361 patients in the vit

198 dose of the study drug (intention-to-treat [ITT] population) using a 10% non-inferiority margin.

199 m first dose of study drug to day 42 for the ITT population was 19% with isavuconazole (48 patients)

200 Median OS in the ITT population was 21.0 months [95% confidence interval

201 treatment-related adverse event rates in the ITT population was 30% for posaconazole and 40% for vori

202 nced magnetic resonance imaging scans of the ITT population was 35% (8% complete response [CR], 27% p

203 The ITT population was also evaluated for safety.

204 The median OS in the ITT population was not estimable; the stratified hazard

205 Although the OS benefit in the ITT population was not statistically significant, preclu

206 However, improvement in PFS in the ITT population was primarily attributed to results from

207 ORR in the intention-to-treat (ITT) population was 17% (nine of 54).

208 d fragility index in the intention-to-treat (ITT) populations was as low as 0.22% of the total sample

209 evaluated in the pooled intention-to-treat (ITT) population (Week 24), SINUS-52 ITT (Week 52) and in

210 Specifically, 10-year remission rates in the ITT population were 5.5% for medical therapy (95% CI 1.0

211 Results in the ITT population were consistent with the PD-L1-positive p

212 Most participants in the micro-ITT population were male (372 [92%] vs 34 [8%] female),

213 The intention-to-treat (ITT) and modified ITT populations were included in primary and safety anal

214 ere done in the modified intention-to-treat (ITT) population, which consisted of all patients who rec

215 nts were assessed in the intention-to-treat (ITT) population, which included all randomly assigned pa

216 cacy was analysed in the intention-to-treat (ITT) population, which included all randomly assigned pa

217 3.4% after induction in the intent-to-treat (ITT) population, which was similar in the 92 patients wi

218 d in all patients in the intention-to-treat (ITT) population who had severe acute respiratory syndrom

219 l population, which excluded patients in the ITT population with major protocol violations and who di

220 (WSAS), assessed in the intention-to-treat (ITT) population with multiple imputation.