As far as I interpret Tab. 4 from the FDA guide, ITT, safety, and per-protocol population should be counted only for randomized subjects. (See screenshot below.)
However, make_table_04() displays these counts for all subjects, not only randomized. The screenshot below shows 134 subjects for drug X included in ITT and safety population, although only 59 subjects have been randomized.
What happened?
As far as I interpret Tab. 4 from the FDA guide, ITT, safety, and per-protocol population should be counted only for randomized subjects. (See screenshot below.)
However,
make_table_04()displays these counts for all subjects, not only randomized. The screenshot below shows 134 subjects for drug X included in ITT and safety population, although only 59 subjects have been randomized.sessionInfo()
No response
Relevant log output
No response