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Table 3.3.8.2 BDS Population Indicators
Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
ITTRFL | Intent-To-Treat Record-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific record. Useful when the subject is included in the subject-level population, but there are records for the subject that do not satisfy requirements for the population. The valid values of these record-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
SAFRFL | Safety Analysis Record-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific record. Useful when the subject is included in the subject-level population, but there are records for the subject that do not satisfy requirements for the population. The valid values of these record-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
FASRFL | Full Analysis Set Record-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific record. Useful when the subject is included in the subject-level population, but there are records for the subject that do not satisfy requirements for the population. The valid values of these record-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
PPROTRFL | Per-Protocol Record-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific record. Useful when the subject is included in the subject-level population, but there are records for the subject that do not satisfy requirements for the population. The valid values of these record-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
COMPLRFL | Completers Record-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific record. Useful when the subject is included in the subject-level population, but there are records for the subject that do not satisfy requirements for the population. The valid values of these record-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
ITTPFL | Intent-To-Treat Parameter-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific parameter. Useful when the subject is included in the subject-level population, but there are parameters for which the subject does not satisfy requirements for the population. The valid values of these parameter-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
SAFPFL | Safety Analysis Parameter-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific parameter. Useful when the subject is included in the subject-level population, but there are parameters for which the subject does not satisfy requirements for the population. The valid values of these parameter-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
FASPFL | Full Analysis Set Parameter-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific parameter. Useful when the subject is included in the subject-level population, but there are parameters for which the subject does not satisfy requirements for the population. The valid values of these parameter-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
PPROTPFL | Per-Protocol Parameter-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific parameter. Useful when the subject is included in the subject-level population, but there are parameters for which the subject does not satisfy requirements for the population. The valid values of these parameter-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
COMPLPFL | Completers Parameter-Level Flag | Char | Y | Perm | These indicators identify whether or not the subject was in the specified analysis for the specific parameter. Useful when the subject is included in the subject-level population, but there are parameters for which the subject does not satisfy requirements for the population. The valid values of these parameter-level population indicators are Y or null. If a flag is used, the corresponding numeric version (*FN, where 1=Yes) of the flag can also be included. As described in Item 8 in Section 3.1.1 General Variable Conventions, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, Flag Variable Conventions. |
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