Reports event counts separately from participant incidence, and counts SAE
status from the explicit serious field rather than a CTCAE grade cutoff.
Arguments
- events
List of
adverseEvent()rows or a data frame using the same schema.- allocation
Data frame with unique
participant_idandarm.- arms
Optional complete arm order, including zero-event arms.
Examples
allocation <- data.frame(
participant_id = c("p1", "p2"),
arm = c("active", "control")
)
events <- list(adverseEvent(
"p1", "Nausea", as.Date("2026-01-02"),
ctcae_grade = 1
))
aeSummary(events, allocation, arms = c("active", "control"))
#> <ae_summary>
#> arm n_randomized n_ae n_participants_ae n_sae n_participants_sae ae_risk
#> active 1 1 1 0 0 1
#> control 1 0 0 0 0 0
#> sae_risk
#> 0
#> 0