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1 y and safety concerns identified by the Data Safety Monitoring Board.
2 tility on the recommendation of the data and safety monitoring board.
3 he basis of a recommendation by the data and safety monitoring board.
4 e retina specialist (M.A.Z.) on the Data and Safety Monitoring Board.
5 im and final analysis by the masked Data and Safety Monitoring Board.
6 vessel dilation as assessed by the Data and Safety Monitoring Board.
7 early on the recommendation of the data and safety monitoring board.
8 y 2006 at the recommendation of the data and safety monitoring board.
9 rd interim analysis reviewed by the data and safety monitoring board.
10 2003, on the recommendation of the data and safety monitoring board.
11 uine group was stopped early by the data and safety monitoring board.
12 r lack of efficacy as determined by the Data Safety Monitoring Board.
13 oversight of Steering Committee and Data and Safety Monitoring Board activities), whereas the CRO pro
15 The study was terminated by the data and safety monitoring board after randomization of 1331 pati
16 he recommendation of an independent data and safety monitoring board, after the interim analysis show
17 nt recruitment and participation in the data safety monitoring board and clinical coordinating center
18 on makers, institutional review boards, data safety monitoring boards, and confidentiality measures.
19 s stopped on April 15, 2013, when a data and safety monitoring board appointed by the National Instit
20 by the sponsor and the independent data and safety monitoring board because of both a lack of effica
21 e trial was stopped by the external data and safety monitoring board because the second preplanned in
22 trials and recommendation from the data and safety monitoring board, but were analysed as being in t
23 interim analysis by an independent data and safety monitoring board, crossover from dacarbazine to v
24 s after enrollment, the independent data and safety monitoring board detected an unanticipated imbala
25 domization of the last subject, the Data and Safety Monitoring Board determined that the primary rese
26 e basis of an interim analysis, the data and safety monitoring board determined that the study questi
28 interim analysis at 50% enrollment, the Data Safety Monitoring Board (DSMB) expressed concern that an
29 to this complexity, an Independent Data and Safety Monitoring Board (DSMB) is best suited to deal wi
32 4 weeks, upon recommendation of the data and safety monitoring board due to futility for efficacy at
35 is study was reviewed by an independent data safety monitoring board for safety and efficacy after en
37 r an interim analysis by an independent data safety monitoring board indicated no discernible treatme
39 2003, on the recommendation of the data and safety monitoring board; mortality in these groups did n
40 minated early after the independent data and safety monitoring board noted an increased annualised re
41 ated early on the recommendation of its data safety monitoring board on the basis of slow accrual and
42 h bioanalysts who prepared data for the data safety monitoring board or generated pharmacokinetic or
43 early on the recommendation of the data and safety monitoring board owing to overwhelming efficacy.
44 early, on the recommendation of the data and safety monitoring board, owing to a low likelihood of be
45 a recommendation by an independent data and safety monitoring board, randomisation was stopped and i
46 ility boundary was crossed, and the data and safety monitoring board recommend study closure, having
47 ta from the first 443 patients, the data and safety monitoring board recommended discontinuation of e
49 he basis of these observations, the data and safety monitoring board recommended early discontinuatio
51 he basis of evidence of futility, a data and safety monitoring board recommended early termination af
52 bjects worsening on sildenafil, the data and safety monitoring board recommended early termination of
57 o deaths; P = 0.005) an independent Data and Safety Monitoring Board recommended stopping the study a
59 mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial o
60 periority boundary (P = .0061), the data and safety monitoring board recommended study termination on
61 (planned duration, 8.5 years), the data and safety monitoring board recommended terminating the estr
62 y end point events, the independent data and safety monitoring board recommended termination of the t
64 cted total number), the independent data and safety monitoring board recommended termination of the t
65 ter a planned interim analysis, the data and safety monitoring board recommended that the studies be
68 rual was halted on the basis of the data and safety monitoring board review of a futility analysis.
69 d, the patient enrollment was stopped (after safety monitoring board review) because of excess reject
70 ndertaken during the studies, and a data and safety monitoring board reviewed all the data during and
71 llment of the first 197 patients, a data and safety monitoring board reviewed potential drug-related
72 ed interim review by an independent data and safety monitoring board showed significant differences i
76 itoring conducted by an independent data and safety monitoring board, study enrollment was terminated
77 standard care and the conclusion of the data safety monitoring board that further recruitment would n
79 r treatment; this was judged by the data and safety monitoring board to be possibly related to treatm
80 n therapy, prompted the independent data and safety monitoring board to recommend termination of the
82 terminated early by an independent data and safety monitoring board when statistically significant r
83 t the recommendation of an external Data and Safety Monitoring Board, which noted a negative trend in
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