Illustrates Domains
ADSL
Illustrates Variables
BASE
ABLFL
PCHG
CONFRMFL
CONFRMDT
LBTESTCD
LBSTRESN
Content
The ADGFR Dataset is an ADaM Basic Data Set (BDS) dataset to support analysis of laboratory data. Not all of the parameters, lab tests, or variables that would typically be provided are shown; this example focuses on specific variables useful for analysis based on the selected composite endpoint: death through day 90, initiation of RRT through day 90, or >=25% decrease in eGFR at day 90 visit.
The analysis dataset metadata as well as the analysis variable metadata for ADAKIEP are presented in the first 2 tables that follow. The remainder of the tables represent parameter value-level lists for applicable variables.
ADGFR Dataset Metadata
| Dataset Name | Description | Class | Structure | Keys | Location | Documentation |
|---|---|---|---|---|---|---|
| ADGFR | Lab Analysis Dataset | BASIC DATA STRUCTURE | One record per subject per parameter per analysis date | USUBJID, PARAMCD, ADT | ADGFR.xpt | See SAP, Section X.X.X |
ADGFR Variable Metadata
| Variable Name | Variable Label | Type | Length | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|---|---|---|---|---|
| USUBJID | Unique Subject Identifier | text | 8 | Predecessor: ADSL.USUBJID | |
| LBSEQ | Sequence Number | integer | 3 | Predecessor: LB.LBSEQ | |
| ASEQ | Analysis Sequence Number | integer | 3 | Predecessor: Set to LBSEQ | |
| ADT | Analysis Date | integer | 8 | Derived: LB.LBDTC ISO value converted to numeric | |
| BASE | Baseline Value | float | 3 | Derived: AVAL where ABLFL="Y" | |
| ABLFL | Baseline Record Flag | text | 1 | Y | Predecessor: LB.LBLOBXFL |
| PCHG | Percent Change from Baseline | float | 5 | Derived: (AVAL-BASE)/BASE)*100 | |
| PARAM | Parameter | text | 20 | Creatinine Observation;eGFR Observation | Assigned |
| PARAMCD | Parameter Code | text | 8 | CREAT;GFRE | Assigned |
| AVAL | Analysis Value | float | 5 | See parameter value metadata | |
| CONFRMFL | Confirmation Flag | text | 1 | Y | See parameter value metadata |
| CONFRMDT | Confirmation Date | integer | 8 | See parameter value metadata | |
| LBTESTCD | Lab Test or Examination Short Name | text | 8 | Predecessor: LB.LBTESTCD | |
| LBSTRESN | Numeric Result/Finding in Std Format | float | 3 | Predecessor: LB.LBSTRESN |
These tables represent parameter value-level lists for applicable variables.
ADGFR Parameter [CL.PARAM.ADGFR]
| Permitted Value (Code) |
|---|
| Creatinine Observation |
| eGFR Observation |
ADGFR Parameter Code [CL.PARAMCD.ADGFR]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| CREAT | Creatinine Observation |
| GFRE | eGFR Observation |
Parameter Value Level List - ADGFR [AVAL]
| Variable | Where | Type | Length | Controlled Terms or Format | Origin | Derivation/Comment |
|---|---|---|---|---|---|---|
| AVAL | PARAMCD="CREAT" | float | 3 | (3.1) | Derived | Set to value of LB.LBSTRESN where LB.LBTESTCD is "CREAT" |
| AVAL | PARAMCD="GFRE" | integer | 2 | Derived | Set to value of LB.LBSTRESN where LB.LBTESTCD is "GFRE" |
Parameter Value Level List - ADGFR [CONFRMFL]
| Variable | Where | Type | Length | Controlled Terms or Format | Origin | Derivation/Comment |
|---|---|---|---|---|---|---|
| CONFRMFL | PARAMCD="CREAT" | text | 1 | Assigned | Null | |
| CONFRMFL | PARAMCD="GFRE" | text | 1 | Y | Derived | Set to Y if there is a record in LB where LB.LBDTC>=ADT+14 and LB.TESTCD="GRFE" and PCHG <=-25 |
Parameter Value Level List - ADGFR [CONFRMDT]
| Variable | Where | Type | Length | Controlled Terms or Format | Origin | Derivation/Comment |
|---|---|---|---|---|---|---|
| CONFRMDT | PARAM="CREAT" | date | Assigned | Null | ||
| CONFRMDT | PARAMCD="GFRE" | date | Derived | Set to LB.LBDTC for the earliest record where LB.LBDTC>=ADT+14 and LB.TESTCD="GRFE" and PCHG <-.25 |