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For the 12 studies prospectively adjudicated by MHI, the sponsor identified potential cases for adjudication based on AEs and SAEs with PTs that correlated with the following Standardized MedDRA Queries (SMQs) groupings, as defined by the current version of MedDRA: "ischemic heart disease" (adjudicated for possible MI) and "cerebrovascular disorders" (adjudicated for possible stroke).
All suspected CV events were prospectively adjudicated by a blinded independent expert committee.
CV events will be prospectively adjudicated by an independent Clinical Events Committee.
The studies included in this analysis were not designed to assess CV events and events were not prospectively adjudicated.
All suspected CV events and fatalities were prospectively adjudicated by a blinded, independent clinical event committee (CEC).
All CV outcome events and deaths are being prospectively adjudicated by a Clinical Events Committee, as recommended in FDA guidelines.
Similar(49)
The new guidelines require sponsors to establish an independent CV end point committee to prospectively adjudicate, in a blinded fashion, CV events during all phase 2 and 3 clinical trials.
However, the outcomes were prospectively ascertained and adjudicated by a trained research coordinator to reduce the possibility of informational bias.
This was a pre-specified meta-analysis in which suspected CV events were prospectively captured and adjudicated in a blinded fashion by an independent CV expert committee.
Data from concurrent, nonrandomized patient accrual from 17 United States institutions were prospectively gathered and independently adjudicated for safety and efficacy.
Adjudicated outcomes were prospectively ascertained over the ensuing 3 years for all subjects after enrollment.
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