Definitions of Status Terminology-ACTIV Therapeutic Agents

Status

What it means

Failed interim analysis

Data showed lack of efficacy or safety concerns were detected. Product discontinued from further investigation in this trial.

Passed interim analysis

Data showed preliminary efficacy and no safety concerns were detected. Product to continue with investigation in this trial.

Graduation criteria unmet

Agent failed to meet one or more of the preset requirements to proceed from early to later phase testing; on this basis, the Data Monitoring Committee determined the agent should not proceed with further testing in the trial.

Awaiting topline results

Accrual goal met and primary data are being analyzed for efficacy.

Efficacy shown

Agent demonstrates efficacy by assessment of primary outcome data analysis.

EUA filed

Emergency Use Authorization has been submitted to FDA for review.

EUA granted

Product maybe used/prescribed under FDA’s Emergency Use Authorization

Ended due to company decision

Company or manufacturer of product requested investigation of the product in this trial to be stopped.

Enrollment closed due to operational futility

Participant enrollment stopped due to decision by the Data Monitoring Committee that under the current trial design, and current state of the disease within the population being studied, achieving enough data to determine the agent’s efficacy was not feasible.

Enrollment closed

Participants no longer being enrolled for this trial.

Paused

Enrollment temporarily stopped.

Ended

Enrollment stopped because accrual or endpoint goals were met or for other reasons.

This page last reviewed on March 15, 2022