Table 1 Overview of the primary estimand
Analysis | Treatment | Population | Variable | Intervention effect (strategy) | Summary measure |
|---|---|---|---|---|---|
Primary | Specified in Intervention description (11a) | Defined by the in- and exclusion criteria | DFS | Death: composite Incomplete observation due to loss to follow-up or early drop-out: hypothetical Others: treatment policy | Hazard ratio (Cox proportional hazards regression model) |