Table 1.

Description of Early-Termination Categories

Reason for Early Termination: Category	Description
Enrollment	Study terminated because of inability to feasibly recruit target sample size or number of events in a reasonable time.
Funding	Study terminated by the sponsor because the study was not meeting its goals within the approved budget, with no additional funding granted at the end of approval period.
Safety	Study terminated upon recommendation from independent monitoring committee because of excess safety risk to participants, based on interim data analysis or newly published evidence or guidance with direct impact on the study.
Futility	Study terminated because of results of an interim futility analysis indicating that continuing the trial would not yield actionable results.
Benefit	Study terminated on the basis of meeting a priori criteria for successful intervention.
Change in clinical practice	Study terminated because of lack of clinical equipoise of intervention that affected care delivery and successful completion of the trial according to the protocol
Other	Study terminated for unforeseen reasons, including political pressure, data-quality issues, or withdrawal of support from drug product manufacturer.