| Info |
|---|
Questions:
|
This example illustrates example analysis datasets for the following endpoints:
- From CV domain
- Percent change in ejection fraction over time
- Decline in ejection fraction over a time period (yearly) grouped by a decline greater than 10.0%.
- From the LB domain
- Percent change in NTproBNP over a period of time (yearly).
Source Data
The SDTM examples used as the source data are from Section 2.1, Basic CMR tests - Systolic Function. The example datasets show visits 1 and 6 for one subject. The subject was enrolled in the study on 20-May-2021 and the study visits were every two months. Visit 1 represents the visit at day 1 of the study, and visit 6 represents the visit at month 12 of the study. The associated laboratory test, N-Terminal ProB-type Natriuretic Peptide, is used in conjunction with ejection fraction as a biomarker and is important for diagnosis and treatment. It is also used separately to identify the percent change over a period of time.
Analysis Datasets
The example analysis dataset includes treatment and demographic information drawn from the ADSL, defined in the Metadata Table below. In this example, only some of the required variables, plus important stratification variables from ADSL, are shown. One variable mentioned body surface area (BSA), can be computed and added to ADSL. However, since the subjects are children, the body surface area changes over time. Therefore, it would probably be better to have a separate dataset to represent this over time.
This example illustrates example analysis datasets for the following endpoints:
- From CV domain
- Percent change in ejection fraction over time
- Decline in ejection fraction over a time period (yearly) grouped by a decline greater than 10.0%.
- From the LB domain
- Percent change in NTproBNP over a period of time (yearly).
The SDTM examples used as the source data are from Section 2.1, Basic CMR tests - Systolic Function. The example datasets show visits 1 and 6 for one subject. The subject was enrolled in the study on 20-May-2021 and the study visits were every two months. Visit 1 represents the visit at day 1 of the study, and visit 6 represents the visit at month 12 of the study. The associated laboratory test, N-Terminal ProB-type Natriuretic Peptide, is used in conjunction with ejection fraction as a biomarker and is important for diagnosis and treatment. It is also used separately to identify the percent change over a period of time.
The example analysis dataset includes treatment and demographic information drawn from the ADSL, defined in the Metadata Table below. In this example, only some of the required variables, plus important stratification variables from ADSL, are shown. One variable mentioned body surface area (BSA), can be computed and added to ADSL. However, since the subjects are children, the body surface area changes over time. Therefore, it would probably be better to have a separate dataset to represent this over time.
| Info |
|---|
Questions:
|
...
The table below shows the example analysis datasets and unique parameters 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 illustrated, but serves as a source for standard ADaM variables. Additional information can be found in Section 2.3.1 of the ADaM Implementation Guide (ADaMIG) v1.3.
...