Model 2.0IG 3.4Content 1.0.0Curated educational coverage

AE / events

Adverse Events

Event data describes something that happened, with dates that may have different precision and an account of what was reported.

Follow an occurrence over time

An event may begin in a known month but lack an exact day. Preserve that uncertainty instead of forcing it through a date-picker default. The identity of an event is separate from its position in a sorted table.

Look inside the structure

8 selected variables. Follow an identifier to its lesson.

8 records · all fields included
AE selected variable lessons
IdentifierDomainTeaching explanationExample JSON typeExample value
STUDYIDAEThe study identifier keeps the adverse-event extract within its study context. Preserve it when combining event records from multiple study exports.stringCLD-SYN-001
DOMAINAEThe value AE identifies the adverse-event context in this lesson. An event term and its timing belong together here; they do not describe a measurement or a medication record.stringAE
USUBJIDAEThe fictional subject key connects an adverse event to its participant. Several events can concern the same participant, so the subject key alone does not distinguish individual event rows.stringSYN-001
AESEQAEThis example sequence number separates rows inside the AE teaching extract. It is useful for referring to an observation, but the original collection identifier is retained separately in the mapping manifest.number1
AETERMAEOriginal event text captures what was reported before dictionary coding. The fictional symptom phrase here is independently authored and carries no medical dictionary code.stringBrief discomfort after walking
AESTDTCAEA month-only string expresses a different amount of knowledge from a full calendar date. Keeping the original precision makes that difference inspectable.string2025-02
AEENDTCAEA missing end date is represented as null in our JSON extract. The example does not decide whether an event is ongoing, unknown or simply not collected; those are separate questions.nullnull (missing)
AESERAEThis lesson reserves a place for a seriousness-related value but leaves it null. We do not apply clinical criteria or claim a verified controlled value in this edition.nullnull (missing)

See the relationship in an example

A date can be precise about uncertainty →

Follow the source

Original ClinDevLab explanations. Publisher material is linked, not reproduced. Reviewed 8 October 2026.

  • SDTM 2.0https://www.cdisc.org/standards/foundational/sdtm/sdtm-v2-0 · CDISC · 2.0 · accessed 2026-10-08
  • SDTMIG 3.4https://www.cdisc.org/standards/foundational/sdtmig/sdtmig-v3-4 · CDISC · 3.4 · accessed 2026-10-08