Table 3. Agreement on likely causality of SAEs between central adjudicators and local investigators–dichotomous analysis.

	Central Adjudicators
Local Investigators	Definitely not, Unlikely or Possibly	Probably or Definitely	Total
Definitely not, Unlikely or Possibly	1420	5	1425
Probably or Definitely	15	12	27
Total	1435	17	1452
Disagreements (%)	15 (1%)	5 (29%)	20 (1%)

Crude agreement = 1432/1452 = 99%

Unweighted kappa = 0.54 (0.49, 0.24)

21 events did not have relatedness of treatment to SAE recorded by either adjudicators or investigators (Central Adjudicators = 19, Local Investigators = 2) and so were not included in this analysis