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A medical-device manufacturer used an inaccurate, but favorable, approximation in the primary endpoint analysis of a pivotal medical trial for a billion-dollar coronary stent.
The Per-Protocol dataset was used as the primary analysis set for the primary endpoint analysis.
Fig. 1 Flow diagram of patient enrolment and primary endpoint analysis.
The protocol required a baseline and 3-month MR study for the primary endpoint analysis (reduction in perfused fibroid volume).
On this background, we present a proposed mechanism to explain the findings from the primary endpoint analysis, as shown in Fig. 3.
The primary endpoint analysis (n = 511) and the secondary endpoint analyses (n = 601) were performed on available patients, samples and data.
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Regarding the primary endpoint, survival analysis (Kaplan Meier estimators) will be used for estimating time to a new affective episode.
The primary endpoint for analysis is 6 months.
Regarding the primary endpoint, an analysis of covariance will be performed.
The primary endpoint for analysis will be data collected at week 24.
The primary endpoint for analysis was relapse-free survival during follow-up after the start of treatment.
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