...
- Percent change in ejection fraction over time (1 year)
- Decline in ejection fraction over time (1 year) grouped by a decline greater than 5%-5.0%
- Percent change in NT-proBNP over time (1 year)
...
The SDTM examples used as the source data are from Section 2.1, Basic Systolic Function. The records in the CV dataset for which CVTESTCD = "LVEF_C" and "RVEF_C" were selected for analysis. The records in the LB dataset where LBTESTCD = "BNPPRONT" were used to compute the percent change over time and as a potential covariate. Both SDTM domains are used in one analysis dataset to demonstrate the flexibility of ADaM and to show that the various SDTM domains can be combined into one dataset both as rows and also as covariates.
Example Analysis Datasets
The following tables show the analysis dataset metadata| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-3 |
|---|
|
and parameters used for this example.metadata and parameters used for this example.
-
| Definexmltable |
|---|
| Multiple | true |
|---|
| Level | Dataset |
|---|
| Purpose |
|---|
|
| Definexmltable |
|---|
| Multiple | true |
|---|
| Level | Dataset |
|---|
| Purpose | Analysis |
|---|
|
Dataset Name | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|
ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject. | Analysis | USUBJID | adsl.xpt | ADSL.SAS | | ADCVNTPADEFNTP | CV MRI EF and NT-proBNP Analysis | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | Analysis | USUBJID, AVISITN, PARAMN | adcvntpadefntp.xpt | ADEFNTP.SAS/SAP | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-4 |
|---|
|
| | ADEFMRI | CV MRI Ejection Fraction Analysis | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | Analysis | ADCVCMR | CV CMR Ejection Fraction Analysis | BASIC DATA STRUCTURE | One record per subject per analysis visit per parameter. | Analysis | USUBJID, AVISITN, PARAMN | adcvcmradefmri.xpt | |
|
ADSL
The ADSL contains subject characteristics and covariates that are important for analyses. Stratification variables can be created in the ADSL to subset the data. More than one SDTM dataset may be used as input to the ADSL. This is a simplified example ADSL dataset; the ADaMIG should be referenced for additional variables.| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-2 |
|---|
|
For this example:
For this example:
- Analysis age (AAGE) Analysis age (AAGE) was included to provide age with more precision.
- A flag indicating the use of ACE inhibitors (ACEINHFL) is shown with example derivation from the CM dataset.
- Body surface area at screening (BSASC) was derived from the VS dataset using height and weight at the screening visit. There are many possible calculations for BSA; for this example, the Du Bois method was used.[11] Note that the screening visit and visit 1 occurred at the same time in this example.
| Definexmltable |
|---|
| Dataset | ADSL |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | Variable |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|
| STUDYID | Study Identifier | text |
| Predecessor: DM.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Predecessor: DM.USUBJID | | BRTHDT | Date of Birth | integer |
date9| yymmdd10. | Derived: Date portion of DM.BRTHDTC converted to numeric and displayed in a format, such as |
date9.| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-5 |
|---|
|
| | AAGE | Analysis Age | float |
| Derived: Age as screening, computed by DM.RFICDTC - BRTHDTC as continuous variable. Note that some countries do not allow capturing date of birth, so this could be computed by capturing age in years and months on a CRF. | | AGE | Age | integer |
| Predecessor: DM.AGE | | AGEU | Age Units | text | YEARS | Predecessor: DM.AGEU | SEX | Sex | text | (SEX) | Predecessor: DM.SEX | RACE | Race | text | (RACE) | Predecessor: DM.RACE | | TRTSDT | Date of First Exposure to Treatment | integer |
date9| yymmdd10. | Derived: Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as |
date9date9| yymmdd10. | Derived: Date portion of DM.RFICDTC converted to numeric and displayed in a format such as |
date9date9| yymmdd10. | Derived: Date portion of DM. |
DTHDT| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-6 |
|---|
|
converted DTHDT converted to numeric and displayed in a format such as |
date9 | | DTHFL | | text | Y | Predecessor: DM.DTHFL | | TRT01P | Planned Treatment for Period 01 | text | Drug A |
, | ; Drug B | Predecessor: DM.ARM. May be changed to lower case or more descriptive term for use in tables and listings. | | TRT01A | Actual Treatment for Period 01 | text | Drug A |
, | ; Drug B | Predecessor: DM.ACTARM. Note: Actual treatment matches planned treatment unless there is a reason subject does not take planned drug. | ITTFL | Intent-To-Treat Population Flag | text | Y; N | Derived: Derive the intent-to-treat population as per the protocol and SAP. | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Derived: Select a list of ACE inhibitor medications from concomitant medications (CM) domain as per SAP or protocol. Set to "Y" if these medications were taken during the study, and "N" if they are absent. Can be used to subset or to exclude the population who took ACE inhibitors. | HEIGHTSC | Height (cm) at Screening | float |
| Predecessor: Set to VS.VSSTRESN where VS.VSTESTCD = "HEIGHT" and VISITNUM= 1 (or screening visit). | WEIGHTSC | Weight (kg) at Screening | float |
| Predecessor: Set to VS.VSSTRESN where VS.VSTESTCD = "WEIGHT" and VISITNUM = 1 (or screening visit). | BSASC | Body Surface Area at Screening | float |
| Derived: Select where VISITNUM = 1 (or screening visit). Compute from HEIGHT and WEIGHT, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725 There are multiple methods for calculating BSA (e.g., Du Bois, Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, Schlich); the study protocol should describe which to use. |
|
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| | Row | STUDYID | USUBJID | BRTHDT | AAGE | AGE | AGEU | SEX | RACE | TRTSDT | RFICDT | DTHDT | DTHFL | TRT01P | ITTFL | ACEINHFL | HEIGHTSC | WEIGHTSC | BSASC |
|---|
| 1 | DMD-EFLGE | DMD-EF-01-101 |
07FEB2010| 2010-02-07 | 12.3 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN |
16JUN2022 | 16JUN2022| 2022-06-16 | 2022-06-16 |
|
| Drug A | Y | Y | 119 | 20 | 0.82 | | 2 | DMD-EFLGE | DMD-EF-01-101 |
01MAY20082008-05-01 | 14.1 | 14 | YEARS | M | ASIAN |
13JUN2022 | 13JUN20222022-06-13 | 2022-06-13 |
|
| Drug A | Y | Y | 115 | 30 | 0.95 | | 3 | DMD-EFLGE | DMD-EF-01-101 |
10JUL2003| 2003-07-10 | 19.0 | 19 | YEARS | M | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER |
15JUL2022 | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-7 |
|---|
|
| 15JUL2022 | | 2022-07-15 |
|
| Drug B | Y | N | 140 | 45 | 1.30 | | 4 | DMD-EFLGE | DMD-EF-01-101 |
15JAN1999| 1999-01-15 | 23.7 | 23 | YEARS | M | WHITE |
06SEP2022 | 06SEP2022 | 23NOV20232022-09-06 | 2022-09-06 | 2023-11-23 | Y | Drug B | Y | Y | 132 | 42 | 1.21 |
|
|
...
ADEFNTP
The ADCVNTP ADEFNTP includes tests pertinent to analyses. The records from CV (CVTESTCD = "LVEF_C" and "RVEF_C") and the records from LB (LBTESTCD = "BNPPRONT") were selected. Many lab draws may occur throughout the year, but only those linked to a specific visit were included. By subsetting the LB dataset by LBLNKID not missing, laboratory data that aligns with CV data can be filtered out and sorted using USUBJID and VISIT. If LBLNKID is not available or the LB dataset does not contain VISIT, a windowing strategy could be used to select the laboratory draw closest to that visit for merging with CV, computed in AVISITusing date of lab draw (LB.LBDTC.).
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-8 |
|---|
|
.In this example, variables BASE, CHG, PCHG, and CHGCAT1 were used to facilitate analyses of the efficacy endpoints.
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | Variable |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|
| STUDYID | Study Identifier | text |
| Predecessor: CV.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Predecessor: CV.USUBJID | | BRTHDT | Date of Birth | integer | yymmdd10. | Predecessor: ADSL.BRTHDT | | AAGE | Analysis Age | float |
| Predecessor: ADSL.AAGE | | AGEU | Age Unit | text |
|
Predecessor: ADSL.AGEU | SEX | Sex | text | (SEX) | | RACE | Race | text | (RACE) | Predecessor: ADSL.RACE | | TRTSDT | Date of First Exposure to Treatment | integer | yymmdd10. | Predecessor: ADSL.TRTSDT | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADSL.TRT01P | | TRT01A | Actual Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADSL.TRT01A | ITTFL | Intent-To-Treat Population Flag | text | Y; N | | HEIGHT | Height (cm) | float |
| Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit. | WEIGHT | Weight (kg) | float |
| Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit. | | BSA | Body Surface Area (m2) | float |
| Derived: Compute from HEIGHT and WEIGHT at each visit, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725 There are multiple methods for calculating BSA; the study protocol should describe which to use. | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Predecessor: ADSL.ACEINHFL | | PARAM | Parameter | text | Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%); N-Terminal ProB-type Natriuretic Peptide (ng/L) | Predecessor: CV.CVTEST LB.LBTEST | | PARAMCD | Parameter Code | text | LVEF_C; RVEF_C; BNPPRONT | Predecessor: CV.CVTESTCD LB.LBTESTCD | | PARAMN | Parameter (N) | integer | 1; 2; 3 | Assigned: Number PARAMCD as follows: LVEF_C = "1" RVEF_C = "2" BNPPRONT = "3" | | AVAL | Analysis Value | float |
| See Parameter Value Metadata | | AVISIT | Analysis Visit | text | Visit 1 (Baseline); Visit 6 (1 Year) | If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". If CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)". | | AVISITN | Analysis Visit (N) | integer | 1; 6 | Predecessor: CV.VISITNUM LB.VISITNUM | | VISIT | Visit | integer | VISIT 1; VISIT 6 | Predecessor: CV.VISIT LB.VISIT | | ADT | Analysis Date | integer | yymmdd10. | Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as yymmdd10. | | ABLFL | Baseline Record Flag | text | Y | Derived: If CV.VISIT = "VISIT 1" then ABLFL = "Y". | | BASE | Baseline Value | float |
| Derived: Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional visits by merging the value of BASE in the baseline record by USUBJID and PARAMCD. | | CHG | Change from Baseline | float |
| Derived: Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records. | | PCHG | Percent Change from Baseline | float |
| Derived: Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records. | | CHGCAT1 | Change from Baseline Category 1 | text | Decline >=-5.0%; Decline <-5.0%; No Decline | See Parameter Value Metadata | | SRCDOM | Source Data | text | CV; LB | Assigned: Set to the SDTM domain name that relates to the analysis value. | | SRCVAR | Source Variable | text | CVSTRESN; LBSTRESN | Assigned: Set to the SDTM variable that relates to the analysis value. | | SRCSEQ | Source Sequence Number | integer |
| Predecessor: Set to the SDTM domain sequence number that relates to the analysis value, CV.CVSEQ or LB.LBSEQ. |
|
In this example, variables BASE, CHG, PCHG, and CHGCAT1 were added to facilitate analyses of the efficacy endpoints. the variables SRCDOM, SRCVAR, and SRCSEQ provide traceability to the combined source datasets. The tables below represent parameter value level lists for applicable variables.
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Example | true |
|---|
| Level | Codelist |
|---|
| Purpose | Analysis |
|---|
| OID | PARAM.ADEFNTP |
|---|
| Name | Parameter |
|---|
|
| Permitted Value (code) |
|---|
Left Ventricular Ejection Fraction, Cal (%) | | Right Ventricular Ejection Fraction, Cal (%) | | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
|
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Example | true |
|---|
| Level | Codelist |
|---|
| Purpose | Analysis |
|---|
| OID | PARAMCD.ADEFNTP |
|---|
| Name | Parameter Code |
|---|
|
| Permitted Value (code) | Display Value (Decode) |
|---|
LVEF_C | Left Ventricular Ejection Fraction, Cal (%) | | RVEF_C | Right Ventricular Ejection Fraction, Cal (%) | | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
|
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Level | Value |
|---|
| Purpose | Analysis |
|---|
| Name | AVAL |
|---|
|
| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
|---|
| AVAL | CV.CVSTRESN in ("LVEF_C", "RVEF_C") | float |
| Predecessor | CV.CVSTRESN | | AVAL | LB.LBTESTCD = "BNPPRONT" | float |
| Predecessor | LB.LBSTRESN |
|
In this table the ADaM parameters are used rather than the source SDTM data.
| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Level | Value |
|---|
| Purpose | Analysis |
|---|
| Name | CHGCAT1 |
|---|
|
| Definexmltable |
|---|
| Dataset | ADCVNTP |
|---|
| Level | Value |
|---|
| Purpose | Analysis |
|---|
| OID | AVAL |
|---|
|
| Dataset | Variable | Where | Type | Origin | Derivation/Comment |
|---|
| ADCVNTP | AVAL | PARAMCD in ("LVEF_C", "RVEF_C") | float | Predecessor | Predecessor: CV.CVSTRESN |
| ADCVNTP | AVAL | PARAMCD = "BNPPRONT" | float | Predecessor | Predecessor: LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" |
ADCVNTP | CHGCAT1 | PARAMCD in ("LVEF_C", "RVEF_C") | text | Derived: Categorize the value of CHGCAT1 as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=5%". | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-9 |
|---|
|
Else if CHG not missing and CHG < 5.00 THEN CHGCAT1 = "Decline <5%" | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-10 |
|---|
|
| ADCVNTP | CHGCAT1 | PARAMCD = "BNPPRONT" | text | Derived: Categorize the value of CHCAT1 as follows: "Increase >100 ng/L"; "Increase <=100 ng/L"; "No increase" | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-11 |
|---|
|
| | Definexmltable |
|---|
| Dataset | ADCVNTP |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | Variable |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|
STUDYID | Study Identifier | text | Predecessor: CV.STUDYID | USUBJID | Unique Subject Identifier | text | Predecessor: CV.USUBJID | | BRTHDT | Date of Birth | integer | date9. | Predecessor: ADSL.BRTHDT | AAGE | Analysis Age | float | Predecessor: ADSL.AAGE | AGEU | Age Unit | text | Predecessor: ADSL.AGEU SEX | Sex | text | (SEX) | Predecessor: ADSL.SEX | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-16 |
|---|
|
| RACE | Race | text | (RACE) | Predecessor: ADSL.RACE | | TRTSDT | Date of First Exposure to Treatment | integer | date9 | Predecessor: ADSL.TRTSDT | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADSL.TRT01P | | TRT01A | Actual Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADSL.TRT01A | ITTFL | Intent-To-Treat Population Flag | text | Y; N | | HEIGHT | Height (cm) | float | Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit. | WEIGHT | Weight (kg) | float | Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit. | BSA | Body Surface Area (m2) | float | Derived: Compute from HEIGHT and WEIGHT at each visit, using the Du Bois method. BSA = 0.007184 × W0.425 × H0.725 There are multiple methods for calculating BSA; the study protocol should describe which to use. | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Predecessor: ADSL.,ACEINHFL | | PARAM | Parameter | text | Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%); N-Terminal ProB-type Natriuretic Peptide (ng/L) | Predecessor: CV.CVTEST LB.LBTEST | | PARAMCD | Parameter Code | text | LVEF_C; RVEF_C; BNPPRONT | Predecessor: CV.CVTESTCD LB.LBTESTCD | | PARAMN | Parameter (N) | integer | 1; 2; 3; | Assigned: Number PARAMCD as follows: LVEF_C = "1" RVEF_C = "2" BNPPRONT = "3" | AVAL | Analysis Value | float | See Parameter Value Metadata | | AVISIT | Analysis Visit | text | Visit 1 (Baseline); Visit 6 (1 Year) | If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". If CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)". | | AVISITN | Analysis Visit (N) | integer | 1; 6 | Predecessor: CV.VISITNUM LB.VISITNUM | | VISIT | Visit | integer | VISIT 1; VISIT 6 | Predecessor: CV.VISIT LB.VISIT | | ADT | Analysis Date | integer | date9. | Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9. | | ABLFL | Baseline Record Flag | text | Y | Derived: If CV.VISIT = "VISIT 1" then ABLFL = "Y". | BASE | Baseline Value | float | Derived: Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional visits by merging the value of BASE in the baseline record by USUBJID and PARAMCD. | CHG | Change from Baseline | float | Derived: Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records. | PCHG | Percent Change from Baseline | float | Derived: Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records. | | CHGCAT1 | Change from Baseline Category 1 | text | Decline >=5%; Decline <5%; Increase GT 100 ng/L | See Parameter Value Metadata | | SRCDOM | Source Data | text | CV; LB | Assigned: Set to the SDTM domain name that relates to the analysis value. | SRCVAR | Source Variable | text | Assigned: Set to the SDTM variable that relates to the analysis value.| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
|---|
| CHGCAT1 | PARAMCD in ("LVEF_C", "RVEF_C") | text | Decline >=-5.0%; Decline <-5.0%; No Decline | Derived | Categorize the value of CHG as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=-5.0%". | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-9 |
|---|
|
Else if CHG GT 0 and CHG < 5.00 THEN CHGCAT1 = "Decline <-5.0%" Else if CHG <0 then CHGCAT1 = "No Decline" | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-10 |
|---|
|
| | CHGCAT1 | PARAMCD = "BNPPRONT" | text | Increase >100 ng/L; Increase <=100 ng/L; No Increase | Derived | Categorize the value of CHCAT1 as follows: "Increase >100 ng/L"; "Increase <=100 ng/L"; "No Increase" |
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee |
|---|
|
|
-f633aaaf4a45| key | TAUGDMDCIS-12 |
|---|
SRCSEQ | Source Sequence Number | integer | Predecessor: CV.CVSEQ LB.LBSEQ Set to the SDTM domain sequence number that relates to the analysis value.| -f633aaaf4a45 | | key | TAUGDMDCIS-11 |
|---|
|
|
|
| Dataset wrap |
|---|
| Show | true |
|---|
| Name | adcvntpADEFNTP |
|---|
|
| Dataset2 |
|---|
| | Row | STUDYID | USUBJID | AAGE | AGEU | SEX | RACE | TRT01P | TRT01A | ITTFL | HEIGHT | WEIGHT | BSA | ACEINHFL | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 | SRCDOM | SRCVAR | SRCSEQ |
|---|
| 1 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y | Left Ventricular Ejection Fraction, Cal (%) | LVEF_C | 1 | 67 | Visit 1 (Baseline) | 1 | VISIT 1 |
16MAY2022| 2022-05-16 | Y | 67 |
|
|
| CV | CVTESTCD| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-13 |
|---|
|
| 3 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y | Right Ventricular Ejection Fraction, Cal (%) | RVEF_C | 2 | 74 | Visit 1 (Baseline) | 1 | VISIT 1 |
16MAY2022| 2022-05-16 | Y | 74 |
|
|
| CV | CVTESTCD | 7 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 119 | 20 | 0.82 | Y | N-Terminal ProB-type Natriuretic Peptide (ng/L) | BNPPRONT | 3 | 40 | Visit 1 (Baseline) | 1 | VISIT 1 |
16MAY2022| 2022-05-16 | Y | 40 |
|
|
| LB | LBTESTCD | 1 | | 4 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | Left Ventricular Ejection Fraction, Cal (%) | LVEF_C | 1 | 60 | Visit 6 (1 Year) | 6 | VISIT 6 |
06APR2023| 2023-04-23 |
| 67 | -7 | -10.447761 | Decline >=-5.0% | CV | CVTESTCD | 11 | | 5 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | Right Ventricular Ejection Fraction, Cal (%) | RVEF_C | 2 | 61 | Visit 6 (1 Year) | 6 | VISIT 6 |
06APR2023| 2023-04-23 |
| 74 | -13 | -17.567568 | Decline >=-5.0% | CV | CVTESTCD | 15 | | 6 | DMD-EFLGE | DMD-EF-01-101 | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Drug A | Y | 132 | 32 | 1.08 | Y | N-Terminal ProB-type Natriuretic Peptide (ng/L) | BNPPRONT | 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 6 |
06APR2023| 2023-04-23 |
| 40 | 860 | 2,150 | Increase >100 ng/L | LB | LBTESTCD | 2 |
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...
ADEFMRI
The ADCVMR ADEFMRI is an efficacy analysis dataset with only a few records for more complex modeling of changes in ejection fraction, plus the proB-type test results. It is an ADaM Basic Data Structure (BDS) dataset| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-15 |
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, with additional variables added from ADCVNTPADEFNTP dataset.
The dataset can provide multivariate analyses can be used for analyses with multiple covariates
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-14 |
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by taking the lab tests of interest (PARAMCD = "BNPPRONT") or other analysis datasets, and and merging variables of interest with the
ADCVNTP ADEFNTP dataset. This summary dataset is created from other ADaM datasets and only variables used in the analysis are kept.
| Definexmltable |
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| Dataset | ADCVCMRADEFMRI |
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| Level | Variable |
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| Purpose | Analysis |
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| Name | Variable |
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|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
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| STUDYID | Study Identifier | text |
| Predecessor: |
ADCVNTPADEFNTP.STUDYID | | USUBJID | Unique Subject Identifier | text |
| |
ADCVNTP | | BRTHDT | Date of Birth | integer |
date9 ADCVNTPADEFNTP.BRTHDT | | AAGE | Analysis Age | float |
| Predecessor: |
ADCVNTPADEFNTP.AAGE | | AGEU | Age Unit | text | YEARS | Predecessor: |
ADCVNTPADEFNTP.AGEU | SEX | Sex | text | (SEX) | Predecessor: |
ADCVNTPADEFNTP.SEX | RACE | Race | text | (RACE) | Predecessor: |
ADCVNTPADEFNTP.RACE | | TRTSDT | Date of First Exposure to Treatment | Num |
date9 ADCVNTP| ADEFNTP.TRTSDT | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: |
ADCVNTP| ADEFNTP.TRT01P | ITTFL | Intent-To-Treat Population Flag | text | Y; N | Predecessor: |
ADCVNTPADEFNTP.ITTFL | | BSA | Body Surface Area (m2) | float |
| Predecessor: |
ADCVNTPADEFNTP.BSA | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Predecessor: |
ADCVNTPADEFNTP.ACEINHFL | BNPPRONT |
| integer |
| Derived: BNPPRONT = AVAL where PARAMCD = |
ADCVNTPADEFNTP.BNPPRONT, and merge by USUBJID and AVISITN. Note: There are many ways to add this including transposing the data. | | PARAM | Parameter | text | Left Ventricular Ejection Fraction, Cal (%); Right Ventricular Ejection Fraction, Cal (%) | Predecessor: |
ADCVNTPADEFNTP.PARAM | | PARAMCD | Parameter Code | text | LVEF_C; RVEF_C | Predecessor: |
ADCVNTPADEFNTP.PARAMCD | | PARAMN | Parameter (N) | integer |
| Predecessor: |
ADCVNTPADEFNTP.PARAMN | | AVAL | Analysis Value |
f;oat ADCVNTPADEFNTP.AVAL | | AVISIT | Analysis Visit | text | Visit 1 (Baseline); Visit 6 (1 Year) | Predecessor: |
ADCVNTPADEFNTP.AVISIT | | AVISITN | Analysis Visit (N) | integer | 1; 6 | Predecessor: |
ADCVNTPADEFNTP.AVISITN | | ADT | Analysis Date | float |
date9 ADCVNTP| ADEFNTP.ADT | | ABLFL | Baseline Record Flag | text | Y | Predecessor: |
ADCVNTP| ADEFNTP.ABLFL | | BASE | Baseline Value | float |
| Predecessor: |
ADCVNTP| ADEFNTP.BASE | | CHG | Change from Baseline | float |
| Predecessor: |
ADCVNTP| ADEFNTP.CHG | | PCHG | Percent Change from Baseline | float |
| Predecessor: |
ADCVNTP| ADEFNTP.PCHG | | CHGCAT1 | Change from Baseline Category 1 | text | Decline >=5.0%; Decline |
<5<-5.0%; Increase >100 ng/L | Predecessor: |
ADCVNTP |
| Dataset wrap |
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| Show | true |
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| Name | adcvcmradefmri |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | BRTHDT | TRT01P | AAGE | AGU | SEX | RACE | TRT01A | ITTFL | BSA | ACEINHFL | BNPPRONT | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 |
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| 1 | DMD-EFLGE | DMD-EF-01-101 |
07FEB2010| 2010-02-07 | Drug A | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 0.82 | Y | 40 | Left Ventricular Ejection Fraction, Cal (%) | LVEF_C | 1 | 70 | Visit 1 (Baseline) | 1 |
16MAY2022| 2022-05-16 | Y | 70 |
|
|
| | 2 | DMD-EFLGE | DMD-EF-01-101 |
07FEB2010| 2010-02-07 | Drug A | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 0.82 | Y | 40 | Right Ventricular Ejection Fraction, Cal (%) | RVEF_C | 2 | 75 | Visit 1 (Baseline) | 1 |
16MAY2022| 2022-05-16 | Y | 75 |
|
|
| | 3 | DMD-EFLGE | DMD-EF-01-101 |
07FEB2010| 2010-02-07 | Drug A | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 1.08 | Y | 900 | Left Ventricular Ejection Fraction, Cal (%) | LVEF_C | 1 | 65 | Visit 6 (1 Year) | 6 |
06APR2023| 2023-04-23 |
| 70 | -5 | -10.447761 | Decline >==5.0% | | 4 | DMD-EFLGE | DMD-EF-01-101 |
07FEB2010| 2010-02-07 | Drug A | 12.3 | YEARS | M | BLACK OR AFRICAN AMERICAN | Drug A | Y | 1.08 | Y | 900 | Right Ventricular Ejection Fraction, Cal (%) | RVEF_C | 2 | 70 | Visit 6 (1 Year) | 6 |
06APR2023| 2023-04-23 |
| 75 | -5 | -17.567568 | Decline >==5.0% |
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