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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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