| Question | Response |
|---|---|
| Is the subject a screen failure (signed an informed consent but was not randomized/registered)? If Yes, please provide the reason | NO YES |
| Primary Screen Failure Reason |
DS.EPOCH="SCREENING" DS.DSSCAT="SCREEN FAILURE" DS.DSCAT="DISPOSITION EVENT" DS.DSDECOD DS.DSTERM when response is not 'OTHER' ADVERSE EVENT LOST TO FOLLOW-UP WITHDRAWAL BY SUBJECT OTHER |
| If Primary Screen Failure Reason is 'Other' please specify |
DS.DSTERM when DS.DSDECOD='OTHER' |