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| Definexmltable |
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| Dataset | ADSL |
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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: DM.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Predecessor: DM.USUBJID | | BRTHDT | Date of Birth | integer | date9. | Derived: Date portion of DM.BRTHDTC converted to numeric and displayed in a format such as date9. | 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-5 |
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|
| | 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. | Derived: Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as date9. | | RFICDT | | integer | date9. | Derived: Date portion of DM.RFICDTC converted to numeric and displayed in a format such as date9. | | DTHDT | | integer | date9. | Derived: Date portion of DM.DTHDT| 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-6 |
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|
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. |
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| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | BRTHDT | AAGE | AGE | AGEU | SEX | RACE | TRTSDT | RFICDT | DTHDT | DTHFL | TRT01P | ITTFL | ACEINHFL | HEIGHTSC | WEIGHTSC | BSASC |
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| 1 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | 12.3 | 12 | YEARS | M | BLACK OR AFRICAN AMERICAN | 16JUN2022 | 16JUN2022 |
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| Drug A | Y | Y | 119 | 20 | 0.82 | | 2 | DMD-EFLGE | DMD-EF-01-101 | 01MAY2008 | 14.1 | 14 | YEARS | M | ASIAN | 13JUN2022 | 13JUN2022 |
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| Drug A | Y | Y | 115 | 30 | 0.95 | | 3 | DMD-EFLGE | DMD-EF-01-101 | 10JUL2003 | 19.0 | 19 | YEARS | M | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 15JUL2022 | 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-7 |
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| 15JUL2022 |
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| Drug B | Y | N | 140 | 45 | 1.30 | | 4 | DMD-EFLGE | DMD-EF-01-101 | 15JAN1999 | 23.7 | 23 | YEARS | M | WHITE | 06SEP2022 | 06SEP2022 | 23NOV2023 | Y | Drug B | Y | Y | 132 | 42 | 1.21 |
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| Definexmltable |
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| Dataset | ADCVNTP |
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| Level | Value |
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| Purpose | Analysis |
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| Name | AVAL |
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| Variable | Where | Type | Origin | Derivation/Comment |
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| AVAL | PARAMCD in ("LVEF_C", "RVEF_C") | float | Predecessor |
Predecessor: CVSTRESN | CVSTRESN | | AVAL | PARAMCD = "BNPPRONT" | float | Predecessor |
Predecessor: | LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT" |
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| Definexmltable |
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| Dataset | ADCVNTP |
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| Level | Value |
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| Purpose | Analysis |
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| Name | CHGCAT1 |
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| Variable | Where | Type | Origin | Derivation/Comment |
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| 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 |
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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-9 |
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|
Else if CHG not missing and CHG < 5.00 THEN CHGCAT1 = "Decline <5%" | 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-10 |
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|
| | CHGCAT1 | PARAMCD = "BNPPRONT" | text | Derived | Categorize the value of CHCAT1 as follows: "Increase >100 ng/L"; "Increase <=100 ng/L"; "No increase" | 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-11 |
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| Definexmltable |
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| Dataset | ADCVNTP |
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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: 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 |
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Predecessor: ADSL.AGEU | SEX | Sex | text | (SEX) | Predecessor: ADSL.SEX | 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-16 |
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|
| 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.| 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-12 |
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| | SRCSEQ | Source Sequence Number | integer |
| Predecessor: CV.CVSEQ LB.LBSEQ Set to the SDTM domain sequence number that relates to the analysis value. |
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| Dataset wrap |
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| Dataset2 |
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| | 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 |
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| 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 | Y | 67 |
|
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| CV | CVTESTCD| 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-13 |
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| 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 | Y | 74 |
|
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| 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 | Y | 40 |
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| 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 |
| 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 |
| 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 |
| 40 | 860 | 2,150 | Increase >100 ng/L | LB | LBTESTCD | 2 |
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|
ADCVCMR
The ADCVMR 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 ADCVNTP.
The dataset can provide multivariate analyses
| 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 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 | ADCVCMR |
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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 |
|---|
| STUDYID | Study Identifier | text |
| Predecessor: ADCVNTP.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Predecessor: ADCVNTP.USUBJID | | BRTHDT | Date of Birth | integer | date9. | Predecessor: ADCVNTP.BRTHDT | | AAGE | Analysis Age | float |
| Predecessor: ADCVNTP.AAGE | | AGEU | Age Unit | text | YEARS | Predecessor: ADCVNTP.AGEU | SEX | Sex | text | (SEX) | Predecessor: ADCVNTP.SEX | RACE | Race | text | (RACE) | Predecessor: ADCVNTP.RACE | | TRTSDT | Date of First Exposure to Treatment | Num | date9. | Predecessor: ADCVNTP.TRTSDT | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADCVNTP.TRT01P | ITTFL | Intent-To-Treat Population Flag | text | Y; N | Predecessor: ADCVNTP.ITTFL | | BSA | Body Surface Area (m2) | float |
| Predecessor: ADCVNTP.BSA | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Predecessor: ADCVNTP.ACEINHFL | BNPPRONT |
| integer |
| Derived: BNPPRONT = AVAL where PARAMCD = ADCVNTP.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: ADCVNTP.PARAM | | PARAMCD | Parameter Code | text | LVEF_C; RVEF_C | Predecessor: ADCVNTP.PARAMCD | | PARAMN | Parameter (N) | integer |
| Predecessor: ADCVNTP.PARAMN | | AVAL | Analysis Value |
f;oat| float |
| Predecessor: ADCVNTP.AVAL | | AVISIT | Analysis Visit | text | Visit 1 (Baseline); Visit 6 (1 Year) | Predecessor: ADCVNTP.AVISIT | | AVISITN | Analysis Visit (N) | integer | 1; 6 | Predecessor: ADCVNTP.AVISITN | | ADT | Analysis Date | float | date9. | Predecessor: ADCVNTP.ADT | | ABLFL | Baseline Record Flag | text | Y | Predecessor: ADCVNTP.ABLFL | | BASE | Baseline Value | float |
| Predecessor: ADCVNTP.BASE | | CHG | Change from Baseline | float |
| Predecessor: ADCVNTP.CHG | | PCHG | Percent Change from Baseline | float |
| Predecessor: ADCVNTP.PCHG | | CHGCAT1 | Change from Baseline Category 1 | text | Decline >=5.0%; Decline <5.0%; Increase >100 ng/L | Predecessor: ADCVNTP.CHGCAT1 |
|
| Dataset wrap |
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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 |
|---|
| 1 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | 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 | Y | 70 |
|
|
| | 2 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | 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 | Y | 75 |
|
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| | 3 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | 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 |
| 70 | -5 | -10.447761 | Decline >=5.0% | | 4 | DMD-EFLGE | DMD-EF-01-101 | 07FEB2010 | 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 |
| 75 | -5 | -17.567568 | Decline >=5.0% |
|
|