The outcomes were evaluated independently by an adjudication committee consisting of experienced cardiologists.
A 10-member blinded adjudication board evaluated all reported primary outcomes, any death, and all cardiovascular secondary outcomes according to predefined criteria.
The Gastrointestinal (GI) Randomized Event and Safety Open-Label Nonsteroidal Anti-inflammatory Drug (NSAID) Study (GI-REASONS) was designed to reflect standard clinical practice while including endpoints rigorously evaluated by a blinded adjudication committee.
The endpoint adjudication committee evaluated and classified the primary and secondary outcomes under blinded conditions.The source data included case report forms, hospital records and laboratory data (e.g. biomarkers, electrocardiogram, images of computerised tomography [CT] scans and MRI).
Finally, an independent adjudication committee evaluated all patients with a diagnosis of pulmonary embolism despite a low Wells score and negative D-dimer test result (see supplementary file for a full description of the reference standard strategy).
Potential GI endpoint events were adjudicated by an independent, blinded, expert GI events adjudication committee that evaluated whether the suspected GI event met predefined criteria for a component of the composite GI endpoint.
Additionally, the use of a central adjudication process that evaluated reasons for and management of treatment discontinuation contributes to the strength and clinical impact of our data.
Additionally, an independent clinical event committee (CEC) prospectively reviewed, in a blinded fashion, all reports of treatment-emergent fatal events and suspected cardiovascular (CV) events and evaluated whether prespecified criteria for adjudication end points (CV death, stroke, MI, and hospitalization for unstable angina) were met.
Once a test was selected for the first-tier review or adjudication, all the CRC tests of the particular patient (except FOBTs) were evaluated at the first-tier review, and/or adjudication, as appropriate.
Major adverse cardiovascular events (MACE; a composite of total cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) were evaluated and classified by an independent, blinded adjudication committee.
