Table 1 The definition of each analysis set
Analysis set | Definition |
|---|---|
All enrolled subjects | Population of subjects enrolled in the study, excluding those who are doubly or wrongly registered |
Full analysis set (FAS) | Population of all enrolled subjects, excluding the following subjects: |
● Subjects who are found ex post facto to be ineligible (fail to meet all of the eligibility criteria or meet any of the exclusion criteria) based on information obtained in accordance with the protocol | |
● Subjects who are found to be ineligible based on information obtained after enrollment or unscheduled examination results | |
● Subjects who have never received transcatheter arterial embolization (non-implementation) | |
● Subjects from whom no data have been collected after enrollment, except information at enrollment into the study | |
Safety analysis set (SAS) | Population of all enrolled subjects who have been treated with arterial embolization at least once |
Per protocol set (PPS) | Population of subjects in the FAS who are in compliance with the protocol |