Illustrates Domains
ADEFF
Illustrates Variables
ABLFL
Illustrates Data Structures
BDS
Content
This is an example ADCGMTIR dataset. It is based on an SDTM LB dataset containing the observations per CGM value per visit per subject.
The following is an example of the ADCGMTIR metadata for the analysis of the TIR as defined by the study protocol. A BDS structure was used. The BDS dataset contains 1 or more records per subject, per analysis parameter, per analysis timepoint.
ADCGMTIR Dataset Metadata
Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|---|---|---|---|---|---|---|
ADCGMTIR | Analysis of Time-in-range | BASIC DATA STRUCTURE | One record per subject per parameter per visit. | Analysis | STUDYID, USUBJID, PARAMCD, AVISITN | ADCGMTIR.xpt | SAP |
ADCGMTIR Variable Metadata
Variable Name | Variable Label | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|---|---|---|---|
| STUDYID | Study Identifier | text | ADSL.STUDYID | |
| USUBJID | Unique Subject Identifier | text | ADSL.USUBJID | |
| SPDEVID | Device Identifier | text | ADSL.SPDEVID | |
| TRT01P | Planned Treatment for Period 01 | text | ADSL.TRT01P | |
| PARAM | Parameter | text | Time below range (%) 24 Hours Prior to the End of the Analysis Interval, Time in range (%) 24 Hours Prior to the End of the Analysis Interval, Time above range (%) 24 Hours Prior to the End of the Analysis Interval, Time below range (%) 2 Weeks Prior to the End of the Analysis Interval, Time in range (%) 2 Weeks Prior to the End of the Analysis Interval, Time above range (%) 2 Weeks Prior to the End of the Analysis Interval | Assigned |
| PARAMCD | Parameter Code | text | TBRGL24H (= Time below range (%) 24 Hours Prior to the End of the Analysis Interval) TIRGL24H (= Time in range (%) 24 Hours Prior to the End of the Analysis Interval) TARGL24H (= Time above range (%) 24 Hours Prior to the End of the Analysis Interval) TBRGL2W (= Time below range (%) 2 Weeks Prior to the End of the Analysis Interval) TIRGL2W (= Time in range (%) 2 Weeks Prior to the End of the Analysis Interval) TARGL2W (= Time above range (%) 2 Weeks Prior to the End of the Analysis Interval) | Assigned |
| PARAMN | Parameter (N) | integer | 1 (= Time below range (%) 24 Hours Prior to the End of the Analysis Interval) 2 (= Time in range (%) 24 Hours Prior to the End of the Analysis Interval) 3 (= Time above range (%) 24 Hours Prior to the End of the Analysis Interval) 4 (= Time below range (%) 2 Weeks Prior to the End of the Analysis Interval) 5 (= Time in range (%) 2 Weeks Prior to the End of the Analysis Interval) 6 (= Time above range (%) 2 Weeks Prior to the End of the Analysis Interval) | Assigned |
| AVISITN | Analysis Visit (N) | integer | 0 (= Baseline) 52 (= Week 52) | LB.VISITNUM |
| AVISIT | Analysis Visit | text | Baseline Week 52 | Assigned |
| AVAL | Analysis Value | float | Derived: See Parameter-Level Metadata. | |
| BASE | Baseline Value | float | Derived: Equals to AVAL when ABLFL="Y" retained across all observations within a given USUBJID/PARAMCD. | |
| CHG | Change from Baseline | float | Derived: Set to blank if AVAL or BASE are missing; If AVAL and BASE are not missing and ABLFL NE "Y", then set to AVAL-BASE. | |
| ABLFL | Baseline Record Flag | text | Y | Set to "Y" for the last non-missing value prior to dosing |
| ASTDTM | Analysis Start Datetime | datetime | Derived: ASTDTM is the numeric equivalent of LBDTC at the start of the interval as indicated in the PARAM description. | |
| AENDTM | Analysis End Datetime | datetime | Derived: AENDTM is the numeric equivalent of LBDTC at the end of the interval as indicated in the PARAM description. | |
| A1LO | Analysis Range 1 Lower Limit | integer | Assigned: Set to 70 | |
| A1HI | Analysis Range 1 Upper Limit | integer | Assigned: Set to 180 |
Parameter Value List - ADCGMTIR [AVAL]
Variable Name | Where | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|---|---|---|---|
| AVAL | PARAMCD="TBRGL24H" | float | AVAL is the percentage of time that the blood glucose levels (as measured with CGM) is below the defined target range (70-180 mg/dL) during the last 24 hours prior to the assigned LBDTC datetime endpoint. The measurements fall entirely within the 24-hour period ending within 5 minutes of the analysis timepoint. | |
| AVAL | PARAMCD="TIRGL24H" | float | AVAL is the percentage of time that the blood glucose levels (as measured with CGM) is within the defined target range (70-180 mg/dL) during the last 24 hours prior to the assigned LBDTC datetime endpoint. The measurements fall entirely within the 24-hour period ending within 5 minutes of the analysis timepoint. | |
| AVAL | PARAMCD="TARGL24H" | float | AVAL is the percentage of time that the blood glucose levels (as measured with CGM) is above the defined target range (70-180 mg/dL) during the last 24 hours prior to the assigned LBDTC datetime endpoint. The measurements fall entirely within the 24-hour period ending within 5 minutes of the analysis timepoint. | |
| AVAL | PARAMCD="TBRGL2W" | float | AVAL is the percentage of time that the blood glucose levels (as measured with CGM) is below the defined target range (70-180 mg/dL) during the last 2 weeks prior to the assigned LBDTC datetime endpoint. The measurements fall entirely within the 2-week period ending within 5 minutes of the analysis timepoint. | |
| AVAL | PARAMCD="TIRGL2W" | float | AVAL is the percentage of time that the blood glucose levels (as measured with CGM) is within the defined target range (70-180 mg/dL) during the last 2 weeks prior to the assigned LBDTC datetime endpoint. The measurements fall entirely within the 2-week period ending within 5 minutes of the analysis timepoint. | |
| AVAL | PARAMCD="TARGL2W" | float | AVAL is the percentage of time that the blood glucose levels (as measured with CGM) is above the defined target range (70-180 mg/dL) during the last 2 weeks prior to the assigned LBDTC datetime endpoint. The measurements fall entirely within the 2-week period ending within 5 minutes of the analysis timepoint. |