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| Definexmltable |
|---|
| Dataset | ADEFNTP |
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| Example | true |
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| Level | Codelist |
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| Purpose | Analysis |
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| OID | PARAM.ADCVNTPADEFNTP |
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| Name | Parameter |
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|
| Permitted Value (code) |
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Left Ventricular Ejection Fraction, Cal (%) | | Right Ventricular Ejection Fraction, Cal (%) | | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
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| Definexmltable |
|---|
| Dataset | ADEFNTP |
|---|
| Example | true |
|---|
| Level | Codelist |
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| Purpose | Analysis |
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| OID | PARAMCD.ADEFNTP |
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| Name | Parameter Code |
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|
| Permitted Value (code) | Display Value (Decode) |
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LVEF_C | Left Ventricular Ejection Fraction, Cal (%) | | RVEF_C | Right Ventricular Ejection Fraction, Cal (%) | | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (ng/L) |
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| Definexmltable |
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| Dataset | ADCVNTPADEFNTP |
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| Level | Variable |
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| Purpose | Analysis |
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| Name | AVAL |
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|
| Variable | Where | Type | Controlled Terms or Format | Origin | Derivation/Comment |
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| 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 | ADCVNTPADEFNTP |
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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 | Controlled Terms or Format | Origin | Derivation/Comment |
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| CHGCAT1 | PARAMCD in ("LVEF_C", "RVEF_C") | text | Decline >=5% Decline <5% No Decline | Derived | Categorize the value of CHG 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 GT 0 and CHG < 5.00 THEN CHGCAT1 = "Decline <5%" Else if CHG <0 then CHGCAT1 = "No Decline" | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-10 |
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|
| | 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 |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TAUGDMDCIS-11 |
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|
|
|
| Dataset wrap |
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| Show | true |
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| Name | adcvntpADEFNTP |
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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 |
|---|
| 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 |
|---|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
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 |
|---|
| showSummary | false |
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| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TAUGDMDCIS-15 |
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|
, with additional variables added from ADEFNTP dataset.
The dataset can can be used for multivariate analyses
| Jira |
|---|
| showSummary | false |
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| server | Issue Tracker (JIRA) |
|---|
| 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 merging variables of interest with the 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 |
|---|
| STUDYID | Study Identifier | text |
| Predecessor: ADEFNTP.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Predecessor: ADEFNTP.USUBJID | | BRTHDT | Date of Birth | integer | date9. | Predecessor: ADEFNTP.BRTHDT | | AAGE | Analysis Age | float |
| Predecessor: ADEFNTP.AAGE | | AGEU | Age Unit | text | YEARS | Predecessor: ADEFNTP.AGEU | SEX | Sex | text | (SEX) | Predecessor: ADEFNTP.SEX | RACE | Race | text | (RACE) | Predecessor: ADEFNTP.RACE | | TRTSDT | Date of First Exposure to Treatment | Num | date9. | Predecessor: ADEFNTP.TRTSDT | | TRT01P | Planned Treatment for Period 01 | text | Drug A; Drug B | Predecessor: ADEFNTP.TRT01P | ITTFL | Intent-To-Treat Population Flag | text | Y; N | Predecessor: ADEFNTP.ITTFL | | BSA | Body Surface Area (m2) | float |
| Predecessor: ADEFNTP.BSA | ACEINHFL | ACE Inhibitor Medications Flag | text | Y; N | Predecessor: ADEFNTP.ACEINHFL | BNPPRONT |
| integer |
| Derived: BNPPRONT = AVAL where PARAMCD = ADEFNTP.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: ADEFNTP.PARAM | | PARAMCD | Parameter Code | text | LVEF_C; RVEF_C | Predecessor: ADEFNTP.PARAMCD | | PARAMN | Parameter (N) | integer |
| Predecessor: ADEFNTP.PARAMN | | AVAL | Analysis Value | float |
| Predecessor: ADEFNTP.AVAL | | AVISIT | Analysis Visit | text | Visit 1 (Baseline); Visit 6 (1 Year) | Predecessor: ADEFNTP.AVISIT | | AVISITN | Analysis Visit (N) | integer | 1; 6 | Predecessor: ADEFNTP.AVISITN | | ADT | Analysis Date | float | date9. | Predecessor: ADEFNTP.ADT | | ABLFL | Baseline Record Flag | text | Y | Predecessor: ADEFNTP.ABLFL | | BASE | Baseline Value | float |
| Predecessor: ADEFNTP.BASE | | CHG | Change from Baseline | float |
| Predecessor: ADEFNTP.CHG | | PCHG | Percent Change from Baseline | float |
| Predecessor: ADEFNTP.PCHG | | CHGCAT1 | Change from Baseline Category 1 | text | Decline >=5.0%; Decline <5.0%; Increase >100 ng/L | Predecessor: ADEFNTP.CHGCAT1 |
|
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