A DAG-based comparison of interventional effect underestimation between composite endpoint and multi-state analysis in cardiovascular trials

Table 1 Expected patient numbers in the discrete failure time example for time to first event stratified by subgroup (“Selection bias” section)

Stratum	Group	Event at t ₂	No event at t ₂	At risk at t ₂	OR
Low-risk subgroup	Treatment	144	576	720	0.5
	Placebo	200	400	600
High-risk subgroup	Treatment	225	225	450	0.5
	Placebo	200	100	300
All patients (unstratified)	Treatment	369	801	1170	0.57
	Placebo	400	500	900

Patients are at risk for a first event at t ₂, if they have not experienced an event at t ₁. Odds Ratio (OR) for experiencing an event under treatment as compared to control

ISSN: 1471-2288