Data on 1,042 patients with potential GI events were reviewed for end-points adjudication; the adjudication committee confirmed 89 patients with CSULGIEs.
For RegARd-C, there is no end point adjudication committee or steering committee.
The end-point adjudication committee, whose members were blind to treatment allocation, examined all medical records related to end-points.
All medical records related to end points were examined by the end point adjudication committee, whose members were blind to treatment allocation.
Primary outcomes and all deaths were reviewed and validated by an independent end point adjudication committee blinded to treatment allocation (4, 8).
All outcomes were determined by the members of a separate central end point adjudication committee who used standard definitions and were unaware of treatment allocation and NAT2 genotypes.
Observational studies reflect clinical practice and without end point adjudication, site monitoring, etc., a margin for error must be taken into account.
Study strengths were the large sample size of high-risk participants analyzed, the balanced sex randomization, diverse ethnic participation, high rate of follow-up, and rigorous CVD end point adjudication procedures.
In the extension, the subject and the investigator, study site personnel, laboratory personnel conducting the clinical assays, and the Pathology Panel used in end point adjudication remained blinded to vaccination group.
End point event adjudication was based on review of medical records by JAD and LAW and included time to initial thromboembolic event or death (cardiovascular and non-cardiovascular).
After criticism that inclusion of heart failure events negated any positive improvement in the CV end points, post hoc adjudication of serious adverse events was performed, and an increase in heart failure was confirmed, albeit on a high background rate (18).
