Creates one typed adverse-event row. CTCAE severity and regulatory seriousness are stored independently; a serious event is not inferred from a grade threshold. MedDRA fields preserve externally assigned coding metadata and are not checked against a bundled terminology.
Usage
adverseEvent(
participant_id,
term,
onset_date,
end_date = as.Date(NA),
ctcae_grade,
serious = FALSE,
causality = c("not_assessed", "unrelated", "unlikely", "possible", "probable",
"definite"),
action = NA_character_,
outcome = c("unknown", "not_recovered", "recovering", "recovered",
"recovered_with_sequelae", "fatal"),
meddra_pt = NA_character_,
meddra_code = NA_character_,
meddra_version = NA_character_,
metadata = list()
)Arguments
- participant_id
Non-empty participant identifier.
- term
Verbatim adverse-event term.
- onset_date
Event onset date.
- end_date
Optional event end date.
- ctcae_grade
Integer CTCAE grade from 1 through 5.
- serious
Whether the event meets a seriousness criterion.
- causality
Investigator causality assessment.
- action
Optional action taken.
- outcome
Controlled event outcome.
- meddra_pt
Optional MedDRA preferred term.
- meddra_code
Optional MedDRA code.
- meddra_version
Optional MedDRA version.
- metadata
Free-form list stored as a list-column.
Examples
adverseEvent(
"P001", "Nausea", as.Date("2026-01-02"),
ctcae_grade = 2, causality = "possible"
)
#> participant_id term onset_date end_date ctcae_grade serious causality
#> 1 P001 Nausea 2026-01-02 <NA> 2 FALSE possible
#> action outcome meddra_pt meddra_code meddra_version metadata
#> 1 <NA> unknown <NA> <NA> <NA>