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The analysis dataset includes treatment and demographic information drawn from the ADSL, defined in the Metadata Table below. In this example, we only show some of the required variables plus important stratification variables from ADSL. One variable mentioned body surface area (BSA), can be computed and added to ADSL. However, since the subjects are children, their body surface area changes over time. Therefore it would probably be better to have a separate dataset to capture this over time.
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The table below presents the sample analysis datasets and unique parameters generated for this example. The Subject Level Analysis Dataset (ADSL) is a necessary component in the creation process of subsequent analysis datasets for human trials. The ADSL incorporates demographics, treatment groups, study dates, and stratification variables. In this example, the ADSL is not displayed directly but serves as a source for standard ADaM variables. Additional information on this can be found in Section 2.3.1 of the ADaM Implementation Guide (ADaMIG) v1.3.
The second and third datasets follow the naming convention for ADaM by starting with the letters 'AD' representing 'Analysis Dataset'. There is flexibility in the use of the other 6 letters allowed in the dataset name, and also the Dataset description which is also the label
. In this example, the ADCVEF dataset selectively captures tests pertinent to this analysis, specifically those with CVTESTCD equal to "LVEF_C" or "RVEF_C". The relationship dataset RELREC illustrates the connections between datasets. There exists a many-to-one relationship between cardiovascular tests (CV) and laboratory data collected during the same visits.
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Analysis Datasets
The subsequent section outlines provides the data structures for the example ADaM datasets. In this example, columns for derived variables BASE, and CHG, PCHG and CHGCAT1 have been added fto facilitate analyses of efficacy endpoints. Specifically, example demographic data for ADSL were created for an 8 year old male child. Also, BSA at baseline (BSABASE), an example of a custom variable, was added from ADSL. The ADaM standard only suggests variable order, so the demographics and treatment variables are shown at the right of the dataset.
| 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/Format | Source | Derivation/Comment |
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| STUDYID | Study Identifier | Char |
| CV.STUDYID |
| | USUBJID | Unique Subject Identifier | Char |
| | Select for records with RE data. | | ASEQ | Analysis Sequence Number | Num |
| CV.CVSEQ | Number records 1 to n after sorting by keys. | | BSABASE | Body Surface Area (m2) at Baseline | Num |
| ADSL.BSABASE | Compute in ADSL where VS.VSTESTCD = "BSA". | | PARAM | Parameter | Char | Left Ventricular Ejection Fraction, Calculated (%) Right Ventricular Ejection Fraction, Calculated (%) N-Terminal ProB-type Natriuretic Peptide (pg/mL) |
| For tests from CV, set to the values of CV.CVTEST plus CV.CVTESTU with spaces and parentheses as shown. For tests from LB, set to the value of LB.LBTEST plus LB.LBTESTU with spaces and parentheses as shown. | | PARAMCD | Parameter Code | Char | LVEFC RVEFC BNPPRONT
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| If CV.CVTESTCD = "LVEF_C" then PARAMCD = "LVEFC" If CV.CVTESTCD = "RVEF_C" then PARAMCD = "RVEFC". If LB.LBTESTDC = "BNPPRONT" then PARAMCD = "BNPPRONT. Note: for this example dataset, select the records where the test values shown above are included. | | PARAMN | Parameter Number | Num |
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| Number PARAMCD as follows: "LVEFC = 1" "LVRFC = 2" BNPPRONT = "3" | | AVAL | Analysis Value | Num |
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| See Parameter Value List | | AVISIT | Analysis Visit | Char |
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| If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". Else if CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)". | | AVISITN | Analysis Visit (N) | Num |
|
| Set to value of CV.VISITNUM or LB.VISITNUM | | VISIT | Visit | Num |
| CV.VISIT LB.VISIT |
| | ADT | Analysis Date | Num | date9. |
| Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9. | | ABLFL | Baseline Record Flag | Char | Y |
| If CV.VISIT = 1 then ABLFL = "Y". | | BASE | Baseline Value | Num |
|
| Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional visits by merging copying the value of BASE in the baseline record by USUBJID and ADT. (Or by AVISIT if ADT varies for labs, and where windowing is applied to select record closest to the visit) | | CHG | Change from Baseline | Num |
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| Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records. | | PCHG | Percent Change from Baseline | Num |
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| Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records. | | CHGCAT1 | Change from Baseline Category 1 | Char | >1.0 (IU/L); <=1.0 (IU/L) |
| Categorise the value of CHG CHG. | | LBSTRNRLO | Reference Range Lower Limit-Std Units | Num |
| LB.LBSTRNRLO |
| | LBSTRNHI | Reference Range Upper Limit-Std Units | Num |
| LB.LBSTRNHI |
| | LBNRIND | Reference Range
Indicator | Char | (NRIND) | LB.LBNRIND |
| | TRT01P | Planned Treatment for Period 01 | Char | "Treatment A" | ADSL.TRT01P | For this example we are using "Treatment A". In a Real World Evidence study this could be non-treatment related, e.g. "Group A". | ITTFL | Intent-to-Treat Population Flag | Char | Y; N | ADSL.ITTFL | Pick other population? POSSIBLE RWE STUDY | | AGE | Age | Num |
| ADSL.AGE |
| | AGEU | Age Units | Char | (AGEU) | ADSL.AGEU |
| | SEX | Sex | Char | (SEX) | ADSL.SEX |
| | SRCDOM | Source Data | Char | CV; LB |
| Set to the SDTM domain name that relates to the analysis value. | | SRCSEQ | Source Sequence Number | Num |
| 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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| Rowcaps |
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| Rows 1-42: | Show the baseline CMR ejection fraction measurements for participant 101 at VISIT 1. | | Row 53: | Shows the baseline NTProbTest for participant 101 at VISIT 1. | | Rows 64-95: | Show the CMR ejection fraction measurements for participant 101 at VISIT 6. | | Row 106: | Shows the NTProbTest for participant 101 at VISIT 6. |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | ASEQ | BSABASE | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | CHGCAT1 | LBSTRNRLO | LBSTRNRHI | LBNRIND | TRT01P | ITTFL | AGE | AGEU | SEX | SRCDOM | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 0.65 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May2022 | Y | 67 |
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| Treatment A | Y | 8 | YEARS | M | CV | 3 | | 2 | DMD-EFLGE | DMD-EFLGE-101 | 2 | 0.65 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 74 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May2022 | Y | 74 |
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| Treatment A | Y | 8 | YEARS | M | CV | 7 | | 3 | DMD-EFLGE | DMD-EFLGE-101 | 3 | 0.65 | N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 40 | Visit 1 (Baseline) | 1 | VISIT 1 | 16May2022 | Y | 40 |
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| 100 | 40 | NORMAL | Treatment A | Y | 8 | YEARS | M | LB | 1 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 0.65 | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun2023 |
| 67 | -7 | -10.447761 |
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| Treatment A | Y | 8 | YEARS | M | CV | 11 | | 5 | DMD-EFLGE | DMD-EFLGE-101 | 5 | 0.65 | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun2023 |
| 74 | -13 | -17.567568 |
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| Treatment A | Y | 8 | YEARS | M | CV | 15 | | 6 | DMD-EFLGE | DMD-EFLGE-101 | 6 | 0.65 | N-Terminal ProB-type Natriuretic Peptide (IU/L) | BNPPRONT | 3 | 900 | Visit 6 (1 Year) | 6 | VISIT 1 | 1Jun2023 |
| 40 | 860 | 2150 | >1.0 (IU/L) | 100 | 900 | HIGH | Treatment A | Y | 8 | YEARS | M | LB | 2 |
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| Dataset | Value | Where | Variable | Variable Label |
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| ADCVNTP | AVAL | PARAMCD ="BNPPRONT" | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide (IU/L) |
| ADCVNTP | CHGCAT1 | PARAMCD ="BNPPRONT" | BNPPRCHG | N-Term ProB-type N Pep Change Category |
| Dataset wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | ASEQ | BSABASE | BNPPRONT | BNPPRCHG | PARAM | PARAMCD | PARAMN | AVAL | AVISIT | AVISITN | VISIT | ADT | ABLFL | BASE | CHG | PCHG | TRT01P | ITTFL | AGE | AGEU | SEX | SRCDOM | SRCSEQ |
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| 1 | DMD-EFLGE | DMD-EFLGE-101 | 1 | 0.65 | 40 |
| Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 67 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May2022 | Y | 67 |
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| Treatment A | Y | 8 | YEARS | M | CV | 3 | | 2 | DMD-EFLGE | DMD-EFLGE-101 | 2 | 0.65 | 40 |
| Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 74 | Visit 1 (Month 1) | 1 | VISIT 1 | 16May2022 | Y | 74 |
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| Treatment A | Y | 8 | YEARS | M | CV | 7 | | 3 | DMD-EFLGE | DMD-EFLGE-101 | 3 | 0.65 | 900 | >1.0 (IU/L) | Left Ventricular Ejection Fraction, Calculated (%) | LVEFC | 1 | 60 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun2023 |
| 67 | -7 | -10.447761 | Treatment A | Y | 8 | YEARS | M | CV | 11 | | 4 | DMD-EFLGE | DMD-EFLGE-101 | 4 | 0.65 | 900 | >1.0 (IU/L) | Right Ventricular Ejection Fraction, Calculated (%) | RVEFC | 2 | 61 | Visit 6 (Month 12) | 6 | VISIT 6 | 01Jun2023 |
| 74 | -13 | -17.567568 | Treatment A | Y | 8 | YEARS | M | CV | 15 |
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