Follow-up and disposition

Entry population → ongoing follow-up → completion, withdrawal, loss or other end states

Flow diagram

Follow-up and dispositionFollow-up and dispositionF1.S1Follow-up populationF1.S2Completed follow-upF1.S3Ongoing at cutoffF1.S4Ended follow-up earlyF1.S5WithdrawalF1.S6Lost to follow-upF1.S7Death or other end reasonF1.N1Disposition reason definitionsReasonDefinitionPriorityCountCutoffWithdrawalLostDeathOtherF1.N2Observation period and evidence

Steps

Follow-up population

Define the population and common cutoff.

Completed follow-up

Define completion for this particular observation period.

Ongoing at cutoff

Count participants who remain under observation.

Ended follow-up early

Use one mutually exclusive disposition per participant at cutoff.

Withdrawal

Distinguish withdrawal from treatment versus withdrawal from follow-up.

Lost to follow-up

Specify attempts and operational definition.

Death or other end reason

Use a declared priority for competing disposition reasons.

Tables and supporting information

Disposition reason definitions

Disposition reason definitionsReasonDefinitionPriorityCountCutoffWithdrawalLostDeathOther

Treatment discontinuation may coexist with continued follow-up and should not be double-counted.

Observation period and evidence

Reference follow-up rules and source of disposition status.

Sources