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Table 3.2.3 ADSL Population Indicator Variables
Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
| FASFL | Full Analysis Set Population Flag | Char | Y, N | Cond | These flags identify whether or not the subject is included in the specified population. A minimum of one subject-level population flag variable is required in ADSL. Not all of the indicators listed here need to be included in ADSL. As stated in Section 3.1.4, Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL. This list of flags is not meant to be all-inclusive. Additional population flags may be added. The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to Section 3.1.4, Flag Variable Conventions. |
SAFFL | Safety Population Flag | Char | Y, N | Cond | These flags identify whether or not the subject is included in the specified population. A minimum of one subject-level population flag variable is required in ADSL. Not all of the indicators listed here need to be included in ADSL. As stated in Section 3.1.4, Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL. This list of flags is not meant to be all-inclusive. Additional population flags may be added. The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to Section 3.1.4, Flag Variable Conventions. |
ITTFL | Intent-To-Treat Population Flag | Char | Y, N | Cond | These flags identify whether or not the subject is included in the specified population. A minimum of one subject-level population flag variable is required in ADSL. Not all of the indicators listed here need to be included in ADSL. As stated in Section 3.1.4, Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL. This list of flags is not meant to be all-inclusive. Additional population flags may be added. The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to Section 3.1.4, Flag Variable Conventions. |
PPROTFL | Per-Protocol Population Flag | Char | Y, N | Cond | These flags identify whether or not the subject is included in the specified population. A minimum of one subject-level population flag variable is required in ADSL. Not all of the indicators listed here need to be included in ADSL. As stated in Section 3.1.4, Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL. This list of flags is not meant to be all-inclusive. Additional population flags may be added. The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to Section 3.1.4, Flag Variable Conventions. |
COMPLFL | Completers Population Flag | Char | Y, N | Cond | These flags identify whether or not the subject is included in the specified population. A minimum of one subject-level population flag variable is required in ADSL. Not all of the indicators listed here need to be included in ADSL. As stated in Section 3.1.4, Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL. This list of flags is not meant to be all-inclusive. Additional population flags may be added. The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to Section 3.1.4, Flag Variable Conventions. |
RANDFL | Randomized Population Flag | Char | Y, N | Cond | These flags identify whether or not the subject is included in the specified population. A minimum of one subject-level population flag variable is required in ADSL. Not all of the indicators listed here need to be included in ADSL. As stated in Section 3.1.4, Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL. This list of flags is not meant to be all-inclusive. Additional population flags may be added. The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to Section 3.1.4, Flag Variable Conventions. |
ENRLFL | Enrolled Population Flag | Char | Y, N | Cond | These flags identify whether or not the subject is included in the specified population. A minimum of one subject-level population flag variable is required in ADSL. Not all of the indicators listed here need to be included in ADSL. As stated in Section 3.1.4, Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL. This list of flags is not meant to be all-inclusive. Additional population flags may be added. The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to Section 3.1.4, Flag Variable Conventions. |
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