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| Xfancy |
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| Lines 2-1112: | Show the "Treatment-Emergent Adverse Events" data subset defined as a simple condition that specifies that the value of the TRTEMFL variable in the ADAE dataset is equal to "Y". This condition could be expressed as: The sponsor chose to assign a label of "TEAE" for this data subset (line 4). | | Lines 1213-2122: | Show the "Vital Signs Analysis Records" data subset defined as a simple condition that specifies that the value of the ANL01FL variable in the ADVS dataset is equal to "Y". This condition could be expressed as: The sponsor chose not to assign a label for this data subset. |
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| Code Block |
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| title | YAML Example |
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| linenumbers | true |
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dataSubsets:
- id: Dss01_TEAE
labelname: Treatment-Emergent Adverse Events
label: TEAE
level: 1
order: 1
condition:
dataset: ADAE
variable: TRTEMFL
comparator: EQ
value:
- Y
- id: Dss09_VS_AnRec
labelname: Vital Signs Analysis Records
level: 1
order: 1
condition:
dataset: ADVS
variable: ANL01FL
comparator: EQ
value:
- Y |
These data subsets could be represented in tabular form as shown in the following table where each instance of the DataSubset class is represented on a separate row.
| Dataset2 |
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| Row | id | name | label | level | order | dataset | variable | comparator | value |
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| 1 | Dss01_TEAE | Treatment-Emergent Adverse Events | TEAE | 1 | 1 | ADAE | TRTEMFL | EQ | Y | | 2 | Dss09_VS_AnRec | Vital Signs Analysis Records |
| 1 | 1 | ADVS | ANL01FL | EQ | Y |
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