1 In this
interim 12-month analysis of the ongoing global OLE stud
2 Interim (
18)F-FDG PET is also used for relapse-treatment
3 The value of
interim (
18)F-FDG PET/CT (iPET)-guided treatment decisio
4 Two of 5
interim (
18)F-FDG PET/CT scans and 3 of 9 end-of-treatme
5 At this
interim 3-year time point, comorbidities were significan
6 on the utility of pre-therapeutic and early
interim (
68)Ga-DOTA-Tyr3-octreotide ((68)Ga-DOTATOC) pos
7 Interim (
68)Ga-DOTATOC PET does not provide information
8 s on the utility of pretherapeutic and early
interim (
68)Ga-DOTATOC PET tumor uptake and volumetric p
9 26 patients were evaluable for
interim activity assessment, with at least one post-base
10 atients, respectively, at 12 months (overall
interim-
adjusted odds ratio 1.00, 95% CI 0.85-1.17; p=0.
11 We planned
interim analyses at n = 10 and n = 25.
12 We planned
interim analyses at n=10 and n=25.
13 value were corrected for the three previous
interim analyses by the inverse normal method.
14 Endpoints for the week 96
interim analyses included the proportions of participant
15 PRETATION: Substantiating the results of the
interim analyses of KEYNOTE-006, pembrolizumab continued
16 In the
interim analyses of the LATITUDE study, the addition of
17 In two
interim analyses of this trial, patients with advanced h
18 e planned sample size was 510 patients, with
interim analyses planned after every 102 patients were e
19 d sequential trial conducted in France, with
interim analyses planned every 50 patients.
20 Interim analyses suggest long-term efficacy and safety o
21 y (primary endpoint); here we report planned
interim analyses through week 96.
22 Preplanned
interim analyses were assessed per protocol and were agr
23 Treatment duration was event-driven, and
interim analyses were planned and conducted after approx
24 Three
interim analyses were planned.
25 On the basis of prespecified criteria for
interim analyses, the study was terminated early for fut
26 To adjust for previous
interim analyses, the two-sided statistical significance
27 nt committee using an adaptive approach with
interim analyses.
28 After the results of the first
interim analysis (cutoff date Oct 31, 2016), the study w
29 At the time of the
interim analysis (data cutoff April 29, 2016), median fo
30 At the second
interim analysis (data cutoff Jan 2, 2019), median follo
31 At the second
interim analysis (data cutoff, Dec 11, 2019), median fol
32 Since the TOP 5-year
interim analysis (December 2012), cohort size (6148 vs 4
33 roved overall survival (OS) after the second
interim analysis (in 2012) of 271 deaths in the Gynecolo
34 signed to an arm of the study at the time of
interim analysis (January 20, 2016).
35 At the first preplanned
interim analysis (March, 2016), the independent data mon
36 At the second preplanned
interim analysis (Nov 9, 2016), the primary endpoint was
37 We did a planned
interim analysis after 219 (41%) deaths had occurred to
38 The trial was stopped upon predefined
interim analysis after 30 patients because of significan
39 d when the trial was closed after the second
interim analysis after 46 events occurred in 68 patients
40 stopping criterion for noninferiority at the
interim analysis after 827 of planned 1200 patients were
41 trial was stopped for efficacy at the third
interim analysis after a median of 5.1 years of follow-u
42 The study was terminated at the
interim analysis after randomizing 30 patients.
43 g committee reviewed the data at the planned
interim analysis and declared overall survival superiori
44 [95% CI 0.63-0.93], p=0.0034) at the second
interim analysis and in the CPS of 20 or more population
45 and the study sponsor (except members of the
interim analysis and primary endpoint analysis data moni
46 fety monitoring board requested an unplanned
interim analysis and subsequently recommended the termin
47 The results of a preplanned
interim analysis as of September 5, 2020, are reported h
48 present the findings of an unplanned, ad-hoc
interim analysis at the request of the US Food and Drug
49 A prespecified
interim analysis at week 8 showed a greater than expecte
50 stopped early by the funder after the second
interim analysis because of futility.
51 f improvement did not cross the prespecified
interim analysis boundary of P=0.000019.
52 study was terminated at the first preplanned
interim analysis by the National Heart, Lung, and Blood
53 s stopped for futility based on prespecified
interim analysis criteria.
54 ched, the month 18 visit by the prespecified
interim analysis cutoff date.
55 e group was closed on June 5, 2020, after an
interim analysis determined that there was a lack of eff
56 Here, we present the results of an unplanned
interim analysis done to assess the benefit-risk of the
57 closed to accrual on Oct 14, 2019, after the
interim analysis failed to meet the predefined criteria.
58 that hypothesis; this occurred at the second
interim analysis for 11 hypotheses and at final analysis
59 The trial was stopped at the fourth
interim analysis for futility with a sample size of 479
60 tion, based on the results of a prespecified
interim analysis for futility.
61 The trial was stopped at the second
interim analysis for futility.
62 A prespecified
interim analysis for overall survival was conducted at t
63 Results presented are from a prespecified
interim analysis for overall survival.
64 The first
interim analysis from EMPRISE showed that compared with
65 This 10-year
interim analysis further supports the robust real-world
66 This
interim analysis includes adult WLWH randomized and enro
67 pre-specified stopping rule for futility at
interim analysis led the trial to be stopped.
68 e drug to be superior or inferior, a planned
interim analysis led to the trial being stopped.
69 nded the trial be closed to accrual after an
interim analysis met prespecified criteria for early sto
70 A preplanned
interim analysis met the efficacy criterion for early cl
71 The study was terminated when the second
interim analysis met the prespecified futility stopping
72 We present herein the results of an
interim analysis of 316 patients enrolled at Houston Met
73 We did this
interim analysis of a non-randomised, phase 2 trial at 2
74 In this
interim analysis of a phase 2 trial, one of three doses
75 We recently reported results from
interim analysis of a propensity score-matched study sug
76 ascular devices, the results of an unplanned
interim analysis of all-cause mortality did not show a d
77 G, AND PARTICIPANTS: Preliminary exploratory
interim analysis of an ongoing randomized trial.
78 Here we report results from a planned
interim analysis of an ongoing, phase 3 study of obetich
79 We conducted an unplanned
interim analysis of data from a multicenter, randomized,
80 y of the ChAdOx1 nCoV-19 vaccine in a pooled
interim analysis of four trials.
81 We did a 72-week
interim analysis of observational data from the ongoing
82 cacious against symptomatic COVID-19 in this
interim analysis of ongoing clinical trials.
83 We report results from a preplanned second
interim analysis of overall survival, which was planned
84 , we report safety and efficacy data from an
interim analysis of patients with severe Wiskott-Aldrich
85 nted in this report reflect the prespecified
interim analysis of recurrence-free survival after 90 ev
86 These data provide a 10-year
interim analysis of safety and effectiveness in TOP.
87 rrent findings are based on the prespecified
interim analysis of the first 160 randomly assigned pati
88 The first
interim analysis of the KEYNOTE-426 study showed superio
89 eath ligand 1 (PD-L1) and report here on the
interim analysis of the malignant pleural mesothelioma c
90 The
interim analysis of the multicentre New EPOC trial in pa
91 lment, and current findings are based on the
interim analysis of the patients who had completed 12-mo
92 Here, we present the first
interim analysis of the R/M cSCC cohort from the 2-cohor
93 at 1 year after the end of treatment, as an
interim analysis of the REP 301-LTF trial (planned durat
94 An
interim analysis of this trial is reported here.
95 At the
interim analysis on Oct 11, 2019, the first 25 evaluable
96 eight to crypt depth, and stopped at planned
interim analysis on reaching this end point.
97 comparisons, which stopped accrual early at
interim analysis on the basis of failure-free survival.
98 The trial was stopped early after a planned
interim analysis on the recommendation of the data and s
99 The
interim analysis presented here was protocol-specified a
100 This
interim analysis reports outcomes of 60 patients with a
101 d during recruitment because results from an
interim analysis revealed futility.
102 The results from this planned
interim analysis show clinically significant histologica
103 INTERPRETATION: The results of this
interim analysis show that venetoclax has durable clinic
104 0 participants were recruited when a planned
interim analysis showed increased adverse events in the
105 ollow-up of 33.3 months after a prespecified
interim analysis showed that medical management alone wa
106 results from this unplanned, FDA-requested,
interim analysis showed that the benefit-risk profile of
107 results from this unplanned, FDA-requested,
interim analysis showed that the benefit-risk profile of
108 On the basis of an
interim analysis significance level of 0.081 (overall on
109 ted by early termination due to an unplanned
interim analysis that appeared to have suggested futilit
110 the trial was prematurely halted based on an
interim analysis that indicated a low probability of cli
111 ecommendation was based on the results of an
interim analysis that showed superiority of these groups
112 The single end point for this
interim analysis was all-cause mortality.
113 This
interim analysis was done when the first six patients tr
114 ample size) an unplanned and funder-mandated
interim analysis was done, resulting in premature discon
115 The primary endpoint of this 6 month
interim analysis was geometric mean titres (GMTs) of neu
116 Methods:
Interim analysis was performed of the first 10 patients
117 Preplanned
interim analysis was performed on the first 120 patients
118 A non-pre-specified
interim analysis was performed to evaluate ramipril's im
119 ing by the European Medicines Agency, and an
interim analysis was performed.
120 One
interim analysis was planned to allow the study to stop
121 The data cutoff for this
interim analysis was Sept 3, 2018.
122 The primary endpoint of this
interim analysis was the proportion of patients who lost
123 The primary endpoint of this
interim analysis was the proportion of patients with an
124 The aim of this second
interim analysis was to compare overall survival between
125 The midseason
interim analysis we performed demonstrates that our meth
126 This study is ongoing; data for this
interim analysis were collected per regulatory agencies'
127 The main outcomes of this 2-year
interim analysis were cumulative incidence of spontaneou
128 The primary endpoints for the month-18
interim analysis were fibrosis improvement (>=1 stage) w
129 on was prematurely closed after an unplanned
interim analysis when 298 patients had been randomly ass
130 At the planned second
interim analysis with 42 evaluable patients and a median
131 Here, we present an
interim analysis with data cutoff on March 29, 2019.
132 tistical criterion was alpha=0.00411 at this
interim analysis), then in patients with CPS of 1 or mor
133 n-to-treat population (alpha=0.00111 at this
interim analysis).
134 After an
interim analysis, 10 additional patients received the se
135 Of the 160 patients included in the
interim analysis, 121 (76%) were randomly assigned to th
136 At the time of the
interim analysis, 745 (99%) of the planned 748 patients
137 At the
interim analysis, 80 mg telmisartan was taken forward in
138 In the
interim analysis, a significantly higher percentage of i
139 In this 3-year
interim analysis, ALP concentrations were significantly
140 e unmasking took place at age 2 years for an
interim analysis, but participants and nearly all invest
141 In this
interim analysis, children aged 6 months to 17 years wer
142 At the third
interim analysis, criteria for futility were met and the
143 This is an
interim analysis, initiated after all enrolled patients
144 from available DNA samples from PANTHER-IPF (
interim analysis, n = 79; final analysis, n = 118).
145 In this
interim analysis, patients were assessed for the occurre
146 At the second
interim analysis, pembrolizumab alone improved overall s
147 At
interim analysis, the FOLFOX-cetuximab arm was stopped (
148 At the time of the
interim analysis, the median follow-up was 29.4 months (
149 of 9 months (IQR 5-23), at a second planned
interim analysis, the median progression-free survival w
150 At the time of the
interim analysis, the observed mean decrease from baseli
151 At
interim analysis, the primary end point was significantl
152 In this planned
interim analysis, the primary endpoints of reactogenicit
153 At the 24-month
interim analysis, the rate of overall survival was 84% i
154 In this
interim analysis, the REGN-COV2 antibody cocktail reduce
155 Following a pre-planned
interim analysis, the trial was terminated early due to
156 At
interim analysis, there was insufficient evidence to sup
157 Within the limitations of this
interim analysis, there was no significant difference in
158 In a midseason
interim analysis, this estimate was 16.5% (95% CI, 10.3%
159 Consistent with the first
interim analysis, this second interim overall survival a
160 the primary endpoints were met at the first
interim analysis, updated data are reported with nominal
161 In this 2-year
interim analysis, we analysed patients who were selected
162 In this first
interim analysis, we investigated the risk of HHF among
163 At the time of a planned
interim analysis, when 23 episodes of cellulitis had occ
164 owed preliminary antitumour activity in this
interim analysis, which could represent a new potential
165 with CPS of 1 or more (alpha=0.00111 at this
interim analysis, with partial alpha from progression-fr
166 essment, and this is the report of a planned
interim analysis.
167 We report the results of a planned
interim analysis.
168 d not cross the significance boundary at the
interim analysis.
169 data were not available at the time of this
interim analysis.
170 alysis and 24 months at the overall survival
interim analysis.
171 the platinum-etoposide group from a planned
interim analysis.
172 The lottery arm was dropped at
interim analysis.
173 oved progression-free survival at the second
interim analysis.
174 protocol-defined efficacy threshold for the
interim analysis.
175 s terminated for futility after a preplanned
interim analysis.
176 icacy thresholds were not met at the planned
interim analysis.
177 concluded early for futility after a planned
interim analysis.
178 onsor stopped the trial after a prespecified
interim analysis.
179 ped because of the results of a prespecified
interim analysis.
180 Data reported are from the
interim analysis.
181 imary end point was tested in a prespecified
interim analysis.
182 groups for this prospectively planned second
interim analysis.
183 urrence of 2 deaths in the placebo arm in an
interim analysis.
184 than with bortezomib and dexamethasone in an
interim analysis.
185 related deaths were reported since the first
interim analysis.
186 d early as a result of futility at a planned
interim analysis.
187 trial was stopped for benefit at the second
interim analysis.
188 opped per protocol after the last designated
interim analysis.
189 This is a 1-year-
interim analysis.
190 f an overall survival benefit was seen in an
interim analysis; confirmation will be required in the p
191 nts by study group was observed at the first
interim analysis; enrollment was stopped based on recomm
192 The study was stopped after the second
interim analysis; follow-up for safety is ongoing.
193 f progression-free survival was done at this
interim analysis; follow-up to assess overall survival i
194 These results are based on an
interim analysis; the study is active but not recruiting
195 because of evidence of futility at a planned
interim analysis; therefore, all prespecified haematolog
196 mary analyses were by intention-to-treat and
interim and adverse events analyses per protocol.
197 high proportions of false-positives both at
interim and at end-of-treatment evaluations.
198 Interim and end-of-treatment PET/CT have become central
199 e event information), assessed at the second
interim and final analysis by the masked Data and Safety
200 Using station observations, ERA-
Interim and MERRA2 reanalysis, we find that wet season p
201 y of current United Kingdom (UK) improvised,
interim and specialist mass casualty decontamination pro
202 is common and it is not clear how it affects
interim and treatment outcomes.
203 Post hoc,
interim,
and cost-effective analyses of randomized contr
204 , the standardisation of PET-CT for staging,
interim,
and end-of-treatment response assessment of Hod
205 a about the significance of (18)F-FDG PET at
interim assessment and end of treatment in pediatric Hod
206 NTERPRETATION: The results add weight to the
interim assessment that rVSV-ZEBOV offers substantial pr
207 nt of 0.12 mug/ml for the BMD method and WHO
interim CCs of 1 mug/ml for MGIT and 0.25 mug/ml for the
208 ideline development is necessary, and in the
interim,
clearer guidance on treatment and diagnosis sho
209 Rapid clinical responses and high
interim complete response rates to anti-PD1 based first-
210 IC breakpoints and World Health Organization
interim critical concentrations (CCs) for categorizing c
211 among 2831 participants who remained free of
interim CVD events; of these, 1723 received gadolinium-e
212 Observational analysis based on
interim data from 16 rural Kenyan (n = 6) and Ugandan (n
213 ith primary biliary cholangitis using 3-year
interim data from the 5-year open-label extension of the
214 opped early due to concern for harm based on
interim data from this trial and from another trial that
215 safety monitoring committee on the basis of
interim data suggesting greater activity in the melflufe
216 tors from the time of randomisation until an
interim database lock at week 16, and was open label fro
217 egression analysis explored risk factors for
interim death or cardiac transplantation.
218 We evaluated the
interim effect of the programme and feasibility of achie
219 cterial resistance but also provide at least
interim effective protection against emerging bacterial
220 The second
interim efficacy analysis and an unplanned futility anal
221 ssess the predictive and prognostic value of
interim FDG PET (iPET) in evaluating early response to i
222 ssess the predictive and prognostic value of
interim FDG PET (iPET) in evaluating early response to i
223 Interim findings indicate that selection of active compa
224 The planned
interim futility analysis when 35 deaths (of 103 analyza
225 patients and was terminated after a planned
interim futility analysis.
226 An
interim futility assessment was performed on the basis o
227 Instead, the
interim glycolytic products (pyruvate and NADH) are held
228 ed to reduce hypoxic area to 5,000 km(2) The
interim goal of a 20% load reduction is expected to prod
229 trol and Prevention (CDC) recently published
interim guidance for a public health response to contain
230 However, in the
interim,
HCC surveillance should continue indefinitely i
231 lemented beyond individual herds but, in the
interim,
herd management may be used to reduced FMD impa
232 -FOV) in (18)F-FDG PET/CT staging (sPET) and
interim (
iPET) scans in pediatric lymphoma patients.
233 goal and to determine the effect of the 20%
interim load reduction.
234 full COG-augmented BFM regimen, including 2
interim maintenance and delayed intensification phases.
235 4 or DUX4-target gene expression might be an
interim measure of drug activity; however, only a subset
236 n of the progestogen-only pill as a bridging
interim method of contraception with emergency contracep
237 ity to adjust for baseline factors and allow
interim monitoring for trials.
238 show how this approach can provide rigorous
interim monitoring of the trials and efficient assessmen
239 On the basis of these findings, an
interim national policy decision was made that SDR would
240 gs and regimens are associated with improved
interim outcomes and acceptable safety profiles in adult
241 final progression-free survival analysis and
interim overall survival analysis (May 31, 2019), median
242 ol to trastuzumab emtansine after the second
interim overall survival analysis (median follow-up dura
243 ol to trastuzumab emtansine after the second
interim overall survival analysis crossed the prespecifi
244 with the first interim analysis, this second
interim overall survival analysis of IMpassion130 indica
245 We report the prespecified second
interim overall survival analysis of the phase 3 IMpassi
246 esults were previously reported at the first
interim overall survival analysis.
247 cacy and safety results from a prespecified,
interim,
overall survival analysis of ALCYONE with more
248 Interim performance of the resource is compromised by va
249 One hundred
interim PET (i-PET) and 95 end-of-treatment PET (EoT-PET
250 Forty-three had
interim PET (iPET) performed after 2 cycles (iPET2), 95
251 at baseline, after 2 cycles of chemotherapy (
interim PET [i-PET]), and at end of treatment (EoT) to i
252 Interim PET can assess chemosensitivity in these lymphom
253 We compared 3 competing methods of
interim PET evaluation.
254 Escalation of therapy based on
interim PET in pediatric HL needs further conclusive evi
255 when needed, and no treatment adaptation on
interim PET scanning was allowed.
256 = quantitative) and DeltaSUV(max) scales to
interim PET scans performed after 2 cycles of chemothera
257 On early
interim PET, a decrease in SUV(mean) of more than 17% (7
258 On early
interim PET, a decrease in SUVmean of more than 17% (P75
259 ion: Continuous scales are better suited for
interim PET-based outcome prediction than the ordinal De
260 P therapy and underwent a centrally reviewed
interim PET/computed tomography scan (iPET).
261 Event-free survival based on
interim PET/CT (RIW) response was 93.3 +/- 4.1 versus 89
262 The specificity of
interim PET/CT based on RIW criteria (61.5%) and Deauvil
263 Interim PET/CT has better specificity, and use of Deauvi
264 d brentuximab-AVD for 4 to 6 cycles based on
interim positron emission tomography/computed tomography
265 opsies from 31 patients and results of early
interim positron emission tomography/computed tomography
266 the UK, 4088 in Brazil) were included in the
interim primary efficacy analysis.
267 Three combinations of
interim questionnaire responses were selected for analys
268 se uncertainties are then prioritised via an
interim ranking survey and a final workshop to achieve c
269 r-February) is identified from the daily ERA
interim reanalysis data.
270 trajectory approach applied to the ECMWF-ERA-
interim reanalysis data.
271 Committee on Immunization Practices made an
interim recommendation not to use the live attenuated in
272 hat even if complete recovery is reached, an
interim recovery debt will accumulate.
273 35 sampling plots worldwide, to quantify the
interim reduction of biodiversity and functions occurrin
274 In this
interim report, we demonstrate that a booster dose of Ch
275 Here we report
interim results from all three patients enrolled on dose
276 n-inferior to longer regimens, and promising
interim results of a novel 6 month 3-drug regimen (bedaq
277 We present the 3-year
interim results of the 5-year prospective, randomized tr
278 INTERPRETATION: Our
interim results suggest that evolocumab is an effective
279 Interim results were previously published, and we now re
280 We discontinued randomisation at
interim review when the futility boundary was crossed.
281 o all data, including efficacy data, at each
interim review.
282 Thirty-four individuals were assessed at
interim review.
283 We sought to assess
interim safety and efficacy of an additional 2 years of
284 Interim safety and immunogenicity data about the vaccine
285 n younger and older adults, added to earlier
interim safety and immunogenicity data regarding BNT162b
286 enrolled into increased dosing groups after
interim safety assessments.
287 pies for patients who remain PET-positive on
interim scanning.
288 sed on SUV(max) changes between baseline and
interim scans.
289 In this
interim subset analysis of the TAUSSIG study, which was
290 n Democratic Republic of Congo (DRC) has had
interim successes while facing ongoing difficulties.
291 An
interim summary released in February 2018 by the FDA con
292 from the North American Carbon Program Site
Interim Synthesis in 18 forest sites.
293 onservation targets is to use milestones, or
interim targets linked to specific ecological mechanisms
294 AMD was obtained at study visits and 6-month
interim telephone calls.
295 However,
interim tests interspersed throughout learning showed pr
296 In the
interim,
the National Institutes of Health-sponsored "AP
297 Interim transplant-free survival over 12 years in this F
298 pendent complex traits and diseases from the
interim UK Biobank release (average N = 130K).
299 In the
interim,
we conclude that HBCR may be a reasonable optio
300 isting of two binuclear metal centers and an
interim zinc-binding site.