Table 1.
Characteristics of investigator reported serious adverse events and certainty of adjudicator’s diagnosis.
Fig 1.
Agreement on serious adverse event diagnosis between central adjudicators and local investigators.
Table 2.
Agreement on likely causality of serious adverse events between central adjudicators and local investigators.
Table 3.
Agreement on likely causality of SAEs between central adjudicators and local investigators–dichotomous analysis.
Table 4.
Number of patients with serious adverse events during follow-up at day 90 classified by local investigators and central adjudicators: GTN vs no GTN and continue vs stop.