1 t domain because no reported thresholds were
prespecified.
2 is on the primary and secondary outcomes was
prespecified.
3 Time to ACM was
prespecified.
4 al, 0.87-2.82; 1-sided P = .068) and met the
prespecified 1-sided alpha of 0.10.
5 eet the criterion for non-inferiority at the
prespecified -
10% margin.
6 The results of this
prespecified 24-month analysis suggest that pretreatment
7 Here we report on the
prespecified 24-month analysis.
8 We
prespecified a comparison of the effect of empagliflozin
9 We
prespecified a successful anaesthetic wean as the discon
10 Although the trial did not meet the
prespecified activity criteria, brentuximab vedotin plus
11 for arm B (P = .55); both arms exceeded the
prespecified activity threshold.
12 Seven trials
prespecified adaptive sample size strategies that might
13 interpreted with caution owing to a lack of
prespecified adjustment for multiple comparisons.
14 The incidence of
prespecified adverse events did not differ significantly
15 during dose-dense paclitaxel according to a
prespecified algorithm seems to be safe and feasible and
16 Prespecified analyses by baseline HF status included ris
17 Prespecified analyses examined all coronary revasculariz
18 Secondary
prespecified analyses of the primary outcome, done to as
19 d by the high dropout rate, null findings of
prespecified analyses that accounted for potentially con
20 As
prespecified,
analyses were done by intention to treat a
21 This
prespecified analysis assessed the association between a
22 In this
prespecified analysis of a randomized, placebo-controlle
23 In a
prespecified analysis of secondary and exploratory outco
24 In a
prespecified analysis of the COMPASS trial (Cardiovascul
25 nal power for the primary outcome based on a
prespecified analysis of the first 267 randomized partic
26 This was a
prespecified analysis of the ODYSSEY OUTCOMES randomized
27 We aimed to explore this issue in a
prespecified analysis of the ODYSSEY OUTCOMES trial of t
28 The
prespecified analysis of the randomized controlled EXSCE
29 This
prespecified analysis pooled efficacy data through the f
30 This
prespecified analysis was designed to assess the effect
31 The current
prespecified analysis was performed to assess the NCB of
32 (primary analysis) and 12 months (additional
prespecified analysis) after the permanent implant.
33 In a
prespecified analysis, PAD events (critical limb ischemi
34 In this
prespecified analysis, patients were categorized by the
35 One of 23 participants improved by the
prespecified ARAT subtest level at 3 months, and three p
36 ference of at least 10 percentage points was
prespecified as a substantial difference.
37 ent substudy, including 30 participants, was
prespecified as part of the Mineralocorticoid Receptor A
38 A per-protocol analysis was
prespecified as the primary analysis.
39 ganization obesity class, with normal weight
prespecified as the reference group.
40 This was a
prespecified,
as-treated analysis evaluating outcomes re
41 None of the other six
prespecified aspects of HRQOL differed significantly aft
42 365 days, adjusted for group differences in
prespecified baseline covariates (stability intracerebra
43 When adjusted for
prespecified baseline variables, the odds ratio for 90-d
44 019 registry sought to develop and implement
prespecified best practices combined with grassroots eff
45 and tenofovir disoproxil fumarate in all six
prespecified bone mineral density and renal biomarker sa
46 Prespecified cardiovascular analyses included analyses o
47 e of HHF/CV death, overall and stratified by
prespecified characteristics.
48 xamine the potential moderator effect of ten
prespecified clinical and demographic variables.
49 Association of 8
prespecified clinical predictors with LTVA (SCD, aborted
50 Of the 8
prespecified clinical predictors, only 4 (younger age, m
51 vival results favoured the CDKI group in all
prespecified clinicopathological subgroups analysed, wit
52 Prespecified co-primary QOL end points at 12 months, inc
53 e no significant differences in any of the 6
prespecified comparative secondary outcomes.
54 In addition to the
prespecified composite cortex target ROI, individual cer
55 mpact on kidney events was investigated by a
prespecified composite kidney outcome (defined as a sust
56 tic regression within surveys, adjusting for
prespecified covariables including age, sex, household w
57 ncluding a total of 679 patients meeting the
prespecified criteria for inclusion, was identified.
58 On the basis of
prespecified criteria for interim analyses, the study wa
59 es of 0.3 mg/kg of osocimab did not meet the
prespecified criteria for noninferiority, with risk diff
60 lation (all enrolled patients who adhered to
prespecified criteria for pharmacokinetic assessment).
61 stopped early and no treatment strategy met
prespecified criteria for statistical superiority, precl
62 2, patients received treatment as needed per
prespecified criteria.
63 d externally validate the model according to
prespecified criteria.
64 cept as needed at weeks 4, 8, 16, and 20 per
prespecified criteria.
65 d in the per-protocol population of infants (
prespecified criterion for success, lower bound of the 9
66 val between patient subgroups defined by the
prespecified cutoffs.
67 Achievement of the
prespecified day 2 AUC/MIC thresholds was not associated
68 The
prespecified definition of tTMB-high status was at least
69 Primary bleeding and MACE outcomes were the
prespecified definitions in each trial.
70 to those assigned to observation if they met
prespecified deterioration criteria of distance VA or ne
71 ith assigned treatment (PCI or CABG) and two
prespecified effect-modifiers, which were selected on th
72 mized participants, 459 were included in the
prespecified efficacy analyses.
73 The HRQOL statistical analysis plan
prespecified eight aspects of HRQOL, assessed by four qu
74 patients with ES-SCLC and the study met its
prespecified end point.
75 We compared the adjudication of
prespecified end points made by investigators and by the
76 Investigators identified 7529
prespecified end points, 6793 of which were confirmed by
77 Prespecified end points, reported by investigators (all
78 vival analysis had also occurred before this
prespecified end-of-study analysis, analyses presented h
79 Prespecified endpoints were area under the receiver oper
80 All
prespecified endpoints were met.
81 nt smoker within the last 7 years, and 3) no
prespecified exclusion criteria contraindicating LDCT sc
82 This
prespecified exploratory biomarker analysis aimed to eva
83 Prespecified exploratory cardiac end points included mea
84 Prespecified exploratory end points included the concent
85 This endpoint was also assessed as a
prespecified exploratory endpoint in all patients who ha
86 elated quality of life, reported here, was a
prespecified exploratory endpoint, and was assessed with
87 nd were 42.8 percentage points higher in the
prespecified exploratory MRSA subgroup (74.1% vs. 31.3%,
88 Biomarker assessment was a
prespecified exploratory outcome of the trial.
89 An additional
prespecified exploratory outcome was the primary outcome
90 We aimed to evaluate
prespecified exploratory patient-reported outcomes (PROs
91 Prespecified,
exploratory outcomes of chemotherapy-free
92 regression to evaluate associations between
prespecified factors of interest and 3 levels of pLLV (<
93 At the time of this
prespecified final analysis, which had been planned to b
94 ccess criteria for the primary analysis were
prespecified for each replication.
95 A hierarchy was
prespecified for examination of individual and composite
96 margin of 1.08 in terms of hazard ratio was
prespecified for the upper boundary of 95% confidence in
97 Study data were abstracted into
prespecified forms.
98 ulting in early study closure according to a
prespecified futility boundary after 341 patients had en
99 All the men had a qualifying alteration in
prespecified genes with a direct or indirect role in hom
100 patients) had alterations in any of 12 other
prespecified genes, prospectively and centrally determin
101 least one alteration in any of the other 12
prespecified genes.
102 t a planned interim analysis; therefore, all
prespecified haematological malignancy endpoints were de
103 utide dose could be adjusted on the basis of
prespecified HbA(1c) and tolerability criteria.
104 All
prespecified hierarchical end points were meaningfully a
105 There was no difference in
prespecified ICH rates.
106 A superiority analysis was
prespecified if noninferiority was established.
107 Patients received a unified
prespecified imaging evaluation (CT, CT angiography, and
108 In a
prespecified immune correlates analysis, antibody-depend
109 s could be switched to an oral study drug if
prespecified improvement criteria were met.
110 complications through 90 days; analyses were
prespecified in subgroups defined according to the prese
111 ions to manage the pneumothorax, for reasons
prespecified in the protocol, and 137 (84.6%) did not un
112 included in the primary efficacy analysis as
prespecified in the protocol.
113 The
prespecified inferiority limit was not crossed.
114 lf-report and direct clinician assessment of
prespecified infusion-site symptoms 3 days after infusio
115 A
prespecified integrated safety analysis was conducted fo
116 Enrollment was stopped for futility based on
prespecified interim analysis criteria.
117 ated intervention, based on the results of a
prespecified interim analysis for futility.
118 Results presented are from a
prespecified interim analysis for overall survival.
119 results presented in this report reflect the
prespecified interim analysis of recurrence-free surviva
120 lment, and current findings are based on the
prespecified interim analysis of the first 160 randomly
121 d at a mean follow-up of 33.3 months after a
prespecified interim analysis showed that medical manage
122 t updated efficacy and safety results from a
prespecified,
interim, overall survival analysis of ALCY
123 es of the primary outcome, the patients were
prespecified into two subgroups according to concomitant
124 Here, we report
prespecified,
investigator-assessed, exploratory post-pr
125 In a
prespecified kidney substudy of a randomized noninferior
126 ority of the dolutegravir monotherapy at the
prespecified level.
127 reduced with procalcitonin-guided therapy or
prespecified limited duration, meta-analysis and trial s
128 rameters predicting REE were identified, and
prespecified linear regression models adjusted for nusin
129 Between baseline and 12 months, the
prespecified longitudinal PROs of interest, cough (MMRM-
130 tistically significant, but did not meet the
prespecified lower bound of the confidence interval crit
131 a noninferiority analysis with the use of a
prespecified margin of 1.25 on the relative scale.
132 e interval [CI], -6.3 to 5.3), exceeding the
prespecified margin.
133 imilar and reference product on the basis of
prespecified margins, using a study population and effic
134 We did a
prespecified meta-analysis of the two single large-scale
135 intellectual disability), with an additional
prespecified model that included additional adjustment f
136 sted for stratification factors), and in the
prespecified model with further adjustment, it was -1.17
137 e to conduct moderation analyses for several
prespecified moderators due to an insufficient number of
138 probability of ECMO superiority exceeded the
prespecified monitoring boundary.
139 ng cumulative and nadir/peak measures during
prespecified moving time windows.
140 ents with and without diabetes mellitus, the
prespecified net benefit for rivaroxaban appeared partic
141 ies (dmAbs) for direct in vivo production of
prespecified neutralizing activity.
142 at least one dose of any study drug, with a
prespecified non-inferiority margin of -10%.
143 of the 95% CI of the IRR, was less than the
prespecified non-inferiority margin of 1.62 (IRR 0.47 [9
144 incidence rate ratio (IRR) was less than the
prespecified non-inferiority margin of 1.62.
145 58.8%]), while specificity did not meet the
prespecified noninferiority criterion (76.2% [95% CI: 71
146 The
prespecified noninferiority margin for risk ratio (RR) w
147 f the 95% confidence interval was within the
prespecified noninferiority margin of -9 percentage poin
148 The
prespecified noninferiority margin was 1.75 percentage p
149 The
prespecified noninferiority margin was a relative risk (
150 ints (95% CI, -18.4 to -3.5) was outside the
prespecified noninferiority margin.
151 rcentages were significantly higher than the
prespecified null hypothesis of 40% (P = 0.02 and P = 0.
152 very 24 weeks for at least 120 weeks until a
prespecified number (n=253) of disability events occurre
153 As a
prespecified objective, we evaluated antibacterial envel
154 ween 1 month and 1 year was performed in the
prespecified one-month clear population of patients pool
155 This study is a
prespecified open-label extension analysis of a phase 1
156 Utilizing the
prespecified optical density thresholds, a specificity a
157 Additional
prespecified outcomes included experience and perpetrati
158 In the
prespecified per-protocol analysis (210 patients in the
159 A
prespecified,
per protocol (PP) analysis excluded 17 pat
160 ce limit was 76%, which was greater than the
prespecified performance goal of 35% (p<0.0001).
161 (lower confidence limit, 89.0%), meeting the
prespecified performance goal of 85.8%.
162 The study was powered to meet
prespecified performance goals for sensitivity and speci
163 %), respectively, both of which exceeded the
prespecified performance goals.
164 Here, we present findings from a
prespecified pilot phase of the full trial.
165 We performed a
prespecified post hoc analysis of ischemic stroke patien
166 We used
prespecified predictors-age >=65 years old, diabetes mel
167 The
prespecified primary analysis was a permutation test of
168 In the
prespecified primary analysis, parasitemia was lower in
169 The
prespecified primary endpoint was the change in serum T(
170 utcome was breast cancer incidence (protocol
prespecified primary monitoring outcome for harm) and se
171 The
prespecified primary outcome for this review was a compo
172 The
prespecified primary outcome was units of blood collecte
173 The
prespecified primary study outcome was MMR vaccination i
174 was greater for CT+E than E at 3 months, the
prespecified primary trial end point, and at 6 months, b
175 ed independently by two investigators onto a
prespecified proforma.
176 biopsied before implantation according to a
prespecified protocol in France and Belgium, where preim
177 tween January 2000 and January 2020, using a
prespecified protocol.
178 and ventilation were allowed to vary within
prespecified ranges.
179 This
prespecified REDUCE-IT (Reduction of Cardiovascular Even
180 ys it is typically performed with respect to
prespecified reference genes, but the lack of robust str
181 Herein, we present the results of the
prespecified renal composite outcome (time to first occu
182 death from renal or cardiovascular causes; a
prespecified renal-specific composite outcome was the sa
183 ients who had a clinical response (i.e., met
prespecified response criteria) were randomly assigned i
184 en surgery vs arthroscopic synovectomy), and
prespecified risk factors were tested in a univariate an
185 rences between the two groups for any of the
prespecified safety endpoints.
186 Prespecified safety outcomes included major bleeding (fa
187 The software can be used to compare
prespecified schedules on the basis of the number of res
188 We report the
prespecified second interim overall survival analysis of
189 Prespecified secondary analyses compared ertugliflozin (
190 Prespecified secondary analyses included assessment of t
191 In
prespecified secondary analyses, netarsudil demonstrated
192 This
prespecified secondary analysis compared AKI (serum crea
193 chocardiography are lacking.Objectives: In a
prespecified secondary analysis of the largest multicent
194 Here, we present a
prespecified secondary analysis showing that much of the
195 In this
prespecified secondary analysis, patient-reported outcom
196 In a
prespecified secondary analysis, we compared the primary
197 infection rates between the two groups was a
prespecified secondary analysis.
198 A
prespecified secondary cardiorenal composite outcome was
199 None of the 7 other
prespecified secondary clinical end points were signific
200 Seven of 9
prespecified secondary end points showed no significant
201 All
prespecified secondary end points were consistently impr
202 None of the 3
prespecified secondary end points were statistically sig
203 Of 16 other
prespecified secondary end points, 10 showed no signific
204 Of 30
prespecified secondary end points, 25 showed no signific
205 Of 38
prespecified secondary end points, 34 showed no signific
206 Of 5
prespecified secondary end points, 4 are reported and 3
207 Of 7
prespecified secondary end points, 5 showed no significa
208 Of 9
prespecified secondary end points, no significant betwee
209 Of the 6
prespecified secondary end points, none showed a statist
210 Of the 31
prespecified secondary end points, there were statistica
211 A
prespecified secondary endpoint, reported here, was pati
212 al (time to death due to all causes) was the
prespecified secondary endpoint.
213 A
prespecified secondary objective was to explore the rela
214 Quality of life was a
prespecified secondary outcome of the ICON8 study.
215 tality, as assessed by verbal autopsy, was a
prespecified secondary outcome.
216 Of 19
prespecified secondary outcomes analyzed, 15 showed no s
217 Prespecified secondary outcomes at week 24 were an overa
218 Prespecified secondary outcomes included 90-days all-cau
219 Prespecified secondary outcomes included change from bas
220 Prespecified secondary outcomes included primary outcome
221 Prespecified secondary outcomes included the need for tr
222 There was no significant difference in the
prespecified secondary outcomes of all-cause mortality a
223 Among 12
prespecified secondary outcomes reported, 11 showed no s
224 For the 5
prespecified secondary outcomes reported, there were no
225 Three
prespecified secondary outcomes were change in knee pain
226 Prespecified secondary outcomes were level of disability
227 Prespecified secondary outcomes were percentage of patie
228 Prespecified secondary outcomes were tested hierarchical
229 Of 22
prespecified secondary outcomes, 19 were not significant
230 Among the 9
prespecified secondary outcomes, 3 were intraoperative c
231 Among the 11
prespecified secondary outcomes, 6 showed no significant
232 Among the 9
prespecified secondary outcomes, 6 were not significantl
233 Of the 12
prespecified secondary outcomes, 7 were null and 5 were
234 There were 31
prespecified secondary outcomes, including additional CG
235 -group differences were found for any of the
prespecified secondary outcomes, including changes in kn
236 Of the 4
prespecified secondary outcomes, none showed a significa
237 Of 16
prespecified secondary outcomes, there were no statistic
238 Of 20
prespecified secondary outcomes, there were statisticall
239 cant differences were noted in any of the 24
prespecified secondary outcomes.
240 tal vitamin D supplementation on most of the
prespecified secondary outcomes.
241 nces favoring acetaminophen vs placebo for 3
prespecified secondary outcomes: delirium duration (medi
242 The association remained significant in a
prespecified sensitivity analysis excluding patients wit
243 Candidate gene variants derived from a
prespecified set of 2,016 genes associated with ciliary
244 arning models also generally have additional
prespecified settings called hyperparameters, which must
245 We
prespecified six secondary bone mineral density and rena
246 ne first in patients with CPS of 10 or more (
prespecified statistical criterion was alpha=0.00411 at
247 The
prespecified statistical testing hierarchy meant that ov
248 sult could not be formally tested due to the
prespecified statistical testing hierarchy.
249 t population, and present estimates for four
prespecified strata (age, sex, region, and race and ethn
250 Findings were comparable in
prespecified subanalyses of children born to mothers at
251 Prespecified subgroup analyses and safety analyses were
252 Prespecified subgroup analyses for the primary outcome s
253 We did
prespecified subgroup analyses in patients with progeste
254 Prespecified subgroup analyses resulted in similar resul
255 Effect estimates in
prespecified subgroup analyses revealed a reduced freque
256 Prespecified subgroup analyses were conducted for parity
257 Three
prespecified subgroup analyses were conducted.
258 Prespecified subgroup analyses were performed.
259 For sexual health outcomes,
prespecified subgroup analyses were significant for inte
260 In the
prespecified subgroup analyses, 195 (75% [95% CI 66.9-82
261 illance use were defined from each study and
prespecified subgroup analyses.
262 ndividually randomised controlled trial with
prespecified subgroup analyses.
263 In a
prespecified subgroup analysis from COMPASS, we examined
264 A
prespecified subgroup analysis of elderly patients with
265 In the
prespecified subgroup analysis of the full analysis set
266 In this
prespecified subgroup analysis of the VALIDATE-SWEDEHEAR
267 Prespecified subgroup analysis of venous thromboembolism
268 For this
prespecified subgroup analysis, consultant neuroradiolog
269 In a
prespecified subgroup analysis, treatment within 7 days
270 In this
prespecified subgroup analysis, we included 1653 patient
271 Those with previous MI (n=3584) made up a
prespecified subgroup of interest.
272 without type 2 diabetes mellitus, and other
prespecified subgroups (all P values for interaction=NS)
273 Adjusted analyses restricted to
prespecified subgroups based on infection complexity and
274 assess oseltamivir benefit overall and in 36
prespecified subgroups defined by age, comorbidity, prev
275 fits of sotagliflozin were consistent in the
prespecified subgroups of patients stratified according
276 Consistent results were seen in all
prespecified subgroups of patients.
277 lly, we assessed the effects of treatment in
prespecified subgroups on the combined risk of cardiovas
278 S inhibition at higher or lower eGFR, across
prespecified subgroups, after adjustment and stratificat
279 a reduced frequency of exacerbations in all
prespecified subgroups, including a high level of benefi
280 dapagliflozin versus placebo across various
prespecified subgroups, including those defined by basel
281 s (95% [BCrI] 0.74-1.31) overall, and in the
prespecified subgroups, ranged from 0.70 (95% BCrI 0.30-
282 BCrI] 1.20-1.39) overall and in 30 of the 36
prespecified subgroups, with estimated hazard ratios ran
283 We did a
prespecified substudy of EUropean Comparative Effectiven
284 ccination in pregnant women did not meet the
prespecified success criterion for efficacy against RSV-
285 s 63.6% (97.5% CI 36.4 to 79.1), meeting the
prespecified success criterion.
286 Each of these end points included a
prespecified target threshold ranging from 80 to 90% tha
287 We
prespecified that primary inferences would be drawn from
288 ISCHEMIA
prespecified that the primary and major secondary compos
289 vents reflecting worsening heart failure and
prespecified their analysis in individual and composite
290 Although the
prespecified threshold for activity was not met in the t
291 l loss to follow-up, the comparison with the
prespecified threshold for an acceptable success rate of
292 symptoms at 12 months that did not meet the
prespecified threshold for clinical importance.
293 with checkpoint inhibitors did not meet the
prespecified threshold for progression free survival, bu
294 MRI accuracy with a pragmatic algorithm and
prespecified threshold may be helpful to confirm this po
295 Dose finding ended before the
prespecified thresholds for dose suspension and dose sel
296 When stratified by
prespecified time epochs, the elevated risk for symptoma
297 , when the fully enrolled cohort reached the
prespecified timepoint for the primary analysis.
298 ks on followed by 1 week off if patients had
prespecified toxic effects (grade 2 or worse diarrhoea,
299 bility to public health care services within
prespecified travel times while guaranteeing sufficient
300 int, showing a significant difference at the
prespecified two-sided alpha of 0.2 in median progressio