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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. |
Results published |
Trial results published in peer-reviewed journal. |
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 July 14, 2022