Use last modification date for ongoing subjects

Check this box to use the date of the last modification made to the AE or ADAE tables as the end date for subjects that are continuing in the clinical trial.

When this check box option is checked, the last modification date/time stamp of the Adverse Events study data set is used as the end date for subjects that are ongoing on a clinical trial and therefore missing values for the Study or Exposure End Date Variable. For example: if RFENDTC is missing in DM for a patient record because that patient is still ongoing on the clinical trial, the date of the last modification to AE or ADAE table in the study data directory is used as the end date value.

Note: If a valid end date variable exists and is populated, the end date value is always used for subjects who have completed the trial and have a valid end date value, regardless of whether this option is checked. The date of the last modification to the AE data table is used only when this option is checked and only for the subjects who do not have a valid end date value. The date of the last modification is used for all subjects only when the end date variable either does not exist or contains no valid end date values.

When this option is NOT checked, subjects ongoing (missing End Date values) will be excluded from the incidence rate analysis.