Example 2: Observation date after treatment discontinuation (e.g., after treatment discontinuation/withdrawal of consent after which there were no follow-up visits; or after the last follow-up visit). The table below represents selected columns and rows from the SE, LB, SV and DS for a single subject in order to illustrate the following: DS (Subject Disposition) TAETORD AE Row SV Row SE Row Explanation Per Recommendation Number Additional unplanned element study discontinuation” added. 1 4 4 7 “After AE (Adverse Events) Row USUBJID AESEQ AETERM AEDECOD AESTDTC AEENDTC AEENRF EPOCH 1 001-1002 1 Rash Rash 2014-04-01 Ongoing Post Follow Up Row USUBJID DSCAT DSSCAT DSDECOD DSSTDTC SE (Subject Elements) 1 001-1002 PROTOCOL MILESTONE RANDOMIZATION Screening 2013-11-11 1 Row USUBJID ETCD ELEMENT SESTDTC SEENDTC TAETORD EPOCH SEUPDES 001-1002 DISPOSITION EVENT END OF TREATMENT AE Treatment 2014-02-01 2 2 1 001-1002 SCR Screening 2014-01-01 2014-01-10 1 Screening 3 001-1002 DISPOSITION EVENT END OF CONSENT WITHDRAWAL Treatment 2014-03-14 2 001-1002 TRT Treatment 2014-01-10 2014-02-21 2 Treatment 001-1002 UNPLAN 2014-02-21 2014-03-14 Treatment Treatment Delay 3
DS (Subject Disposition) Row USUBJID DSCAT DSSCAT DSDECOD DSSTDTC TAETORD 1 001-1002 PROTOCOL MILESTONE RANDOMIZATION Screening 2013-11-11 1 2 001-1002 DISPOSITION EVENT END OF TREATMENT AE Treatment 2014-02-01 2 3 001-1002 DISPOSITION EVENT END OF CONSENT WITHDRAWAL Treatment 2014-03-14 SE (Subject Elements) Row USUBJID ETCD ELEMENT SESTDTC SEENDTC TAETORD EPOCH SEUPDES 1 001-1002 SCR Screening 2014-01-01 2014-01-10 1 Screening 2 001-1002 TRT Treatment 2014-01-10 2014-02-21 2 Treatment 3 001-1002 UNPLAN 2014-02-21 2014-03-14 Treatment Treatment Delay Example 2: Observation date after treatment discontinuation (e.g., after treatment discontinuation/withdrawal of consent after which there were no follow-up visits; or after the last follow-up visit). The table below represents selected columns and rows from the SE, LB, SV and DS for a single subject in order to illustrate the following: AE Row SV Row SE Row Explanation Per Recommendation Number 1 4 4 Additional unplanned element “After study discontinuation” added. 7 AE (Adverse Events) Row USUBJID AESEQ AETERM AEDECOD AESTDTC AEENDTC AEENRF EPOCH 1 001-1002 1 Rash Rash 2014-04-01 Ongoing Post Follow Up