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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
The text was updated successfully, but these errors were encountered:
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
The text was updated successfully, but these errors were encountered: