Analysis population derivation
Eligible or assigned population → declared inclusion rules → named analysis populations
Flow diagram
Steps
Study population
Define the starting population.
Apply population-specific rules
Apply each population definition independently; sets may overlap.
Primary analysis population
Define the population required by the primary estimand.
Safety analysis population
Specify exposure and safety observation requirements.
Additional analysis population
Specify per-protocol or another supplementary population as appropriate.
Tables and supporting information
Analysis population definitions
These sets may overlap. Their counts must not be summed as a partition.
Population rationale
Link each population to the relevant estimand and protocol.
Overlapping sets
No additive count rule is installed for these populations.