Safety analysis
Safety population → exposure and observation → event definitions → summaries and comparisons
Flow diagram
Steps
Safety population and observation
Define included participants, risk period and treatment-emergent rules.
Exposure and denominators
Specify participant counts, treatment duration and exposure time.
Event definitions and coding
Specify coding dictionary/version, event categories, severity and seriousness.
Participants versus recurrent events
Distinguish participants with any event from total events and recurring episodes.
Summaries and comparisons
Specify counts, proportions, exposure-adjusted rates and justified comparisons.
Review signals and contextual interpretation
Consider exposure, ascertainment, baseline risk and uncertainty.
Tables and supporting information
Safety result table
Counts and rates have different denominators; enter units and observation windows.
Safety coding and observation rules
Do not conflate severity with seriousness.
Rate definition
Event rate uses events divided by exposure time; it is not the proportion of participants with an event.
Safety definitions and evidence
Reference protocol definitions and coding documentation.