Illustrates Domains
ADEXSUM
Illustrates Variables
EXSPID
ITTFL
FASFL
Content
In this example, a combination cream was compared to a single agent (drug Y). The subjects applied the cream once daily. Each subject was given an identical 130g single tube of medication to use between study visits. A new tube was dispensed at each visit and the previously dispensed tube was returned. The returned tubes were weighed and these values were recorded. The exposure data was based on the total amount of cream used (in grams). Example source SDTM datasets submitted by the sponsor using the Drug Accountability (DA), Exposure as Collected (EC), and Exposure (EX) domains are included in Section 5.2, Topical Study Treatment, Example 3.
A BDS analysis dataset and analysis-variable metadata for the exposure data are provided below. In this case, the handling of missing data was not included. Sponsor-defined algorithms estimated the exposure based on the collected exposure data; however, other algorithms to estimate exposure may be used.
Traceability between the source SDTM domain or ADaM dataset and the record used for analysis must be present. If having both the SDTM source values and derived exposure variables available within ADaM datasets is desired, an intermediate and summary dataset may be created. This will make it easier and faster for both developers and reviewers to find the calculated variables. No intermediate dataset examples are shown here. The dataset below only includes records for the subject who used 2 tubes of medication.
The ordering of the variables in the analysis dataset should follow a logical ordering that is defined by the sponsor. The order of the variables in the dataset below is only an example.
ADEXSUM Dataset Metadata
Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|---|---|---|---|---|---|---|
ADEXSUM | Exposure Analysis Data | BASE DATA STRUCTURE | 1 record per subject per parameter, per EXSPID | Analysis | STUDYID, USUBJID, PARAMCD, EXSPID | ADEXSUM.xpt | ADEXSUM.SAS/SAP |
ADEXSUM 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 | ||
| EXSPID | Sponsor-Defined Identifier | text | EX.EXSPID. In this example, this is the dispensed tube's identification number. | ||
PARAM | Parameter | text | See parameter-value metadata. | ||
PARAMCD | Parameter Code | text | See parameter-value metadata. | ||
| ASTDT | Analysis Start Date | num | Derived from EXSTDTC for each tube used (EXSPID). For analysis of exposure for the study. ASTDT is derived from first EXSTDTC. | ||
| AENDT | Analysis End Date | num | Derived from EXENDTC for each tube used (EXSPID). For analysis of exposure for the study. AENDT is derived from EXENDTC. | ||
ITTFL | Intent-To-Treat Flag | text | Y; N | ADSL.ITTFL | |
FASFL | Full Analysis Set Population Flag | text | Y; N | ADSL.FASFL | |
AVISIT | Analysis Visit | text | Week 2; Week 4 | Assigned based on the corresponding visit from SDTM. | |
AVAL | Analysis Value | float | Derivations are described per parameter in the parameter-value metadata. | ||
SRCDOM | Source Data | text | This is the source SDTM domain or ADaM dataset to which the record being used for the analysis value can be traced. This will be study-specific and therefore these variables are not included in the example dataset. | ||
| SRCVAR | Source Variable | text | This is the source SDTM domain or ADaM dataset to which the record being used for the analysis value can be traced. This will be study-specific and therefore these variables are not included in the example dataset. | ||
| SRCSEQ | Source Sequence Number | float | This is the source SDTM domain or ADaM dataset to which the record being used for the analysis value can be traced. This will be study-specific and therefore these variables are not included in the example dataset. |
Parameter Code [CL.PARAMCD.ADEXSUM]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| VMDOSE | Number of missed doses |
| VAMT | Amount used (g) |
| VDUSED | Number of days used |
| VDAYS | Number of treatment days |
| TMDOSE | Total number of missed doses |
| TAMT | Total amount used (g) |
| TDUSED | Total number of days used |
| TDAYS | Total number of treatment days |
| ADDOSE | Average daily dose (g/day) |
Parameter Value Level List - ADEXSUM [AVAL]
Variable | Where | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|---|---|---|---|
AVAL | PARAMCD = "VMDOSE" | integer | AVAL=NSEX.EXNMDOSE for the specified tube. The number of missed doses between ASDT and AENDT. EXSPID is used to identify the tube used. | |
AVAL | PARAMCD = "VAMT" | integer | AVAL=DA.DAORRES where (DATESTCD="DISPAMT" and DASPID=EXSPID) -DA.DAORRES where (DATESTCD="RETAMT" and DASPID=EXSPID). Calculation of the grams used from each tube. See the SAP for details on algorithm used. | |
| AVAL | PARAMCD = "VDUSED" | integer | AVAL=Days between AESTDT and AENDT. Derivation of the number of days tube was used. | |
| AVAL | PARAMCD = "VDAYS" | integer | AVAL=Days between AESTDT and (AENDT - NVEX.EXNMDOSE). Derivation of the days treatment applied. | |
AVAL | PARAMCD = "TMDOSE" | integer | AVAL=Sum of VMDOSE over all tubes. The total number of missed doses. | |
| AVAL | PARAMCD = "TAMT" | integer | AVAL=Sum of VAMT over all tubes. The total amount used (g). | |
| AVAL | PARAMCD = "TDUSED" | integer | AVAL=Sum of VDUSED over all tubes. The total number of days used. | |
| AVAL | PARAMCD = "TDAYS" | integer | AVAL=Sum of VDAYS over all tubes. The total number of treatment days. | |
| AVAL | PARAMCD = "ADDOSE" | float | AVAL=TAMT/TDAYS. Average daily dose (g/day). |