April 19, 2021

The external Data and Safety Monitoring Board (DSMB) conducted a scheduled meeting to review safety data from the EMPIRICAL project. As a result of the review, the DSMB identified no safety signals in their review and recommended that the EMPIRICAL study can continue without modification.

During the meeting, the EMPIRICAL Central Management Team provided all data available by that day. The Interim Analysis will be conducted in January 2022. The results will be shared with the corresponding authorities.

>> DSMB Report (412 downloads )
Data and Safety Monitoring Board Meeting to Review Safety Data