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David Steward
- logged in as: datasteward@sycamore.com
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- Manage Clinical Concepts
- Manage Therapeutic Areas
- Manage Drugs/Treatments
- Manage Users
- 2
AESTDAT
What is the date the
adverse event started? DateTime (dd MMM yyyy)
|
AESTTIM
At what time did the
adverse event start? DateTime (hh:mm)
|
VS.VSTEST
Vital Signs Test
"Diastolic Blood Pressure"
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VS.VSTESTCD
Short Name
"DIABP"
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VS.VSORRES
Result
text ($300)
|
VS.VSORRESU
Unit
"mmHg"
|
VS.VSPOS
Position
"Sitting"
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VS.VISITNUM
Visit Number
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VS.VSDTC
Date/Time
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ADVS.VSTEST
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ADVS.VSTESTCD
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ADVS.VSORRES
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ADVS.VSORRESU
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ADVS.VSPOS
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ADVS.VISITNUM
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ADVS.VSDTC
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ADVS.PARAM
Vital Signs Parameter
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ADVS.PARAMCD
Code
|
SUPPMH.QNAM
Qualifier Name
"MHOSDTC"
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SUPPMH.QLABEL
Qualifier Label
"Onset of Symptoms Date"
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SUPPMH.QVAL
Value
text ($300)
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SUPPMH.QORIG
Origination
"CRF"
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SUPPMH.QEVAL
Who was evaluated?
"STUDY SUBJECT"
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ADMH.QNAM
|
ADMH.QLABEL
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ADMH.QVAL
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ADMH.QORIG
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ADMH.QEVAL
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ADaM Derivation Rules |
||||||||
Dataset Name | Variable Name | Variable Label | Variable Type | Variable Format | Parameter Identifier | Codelist | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|---|
ADVS | VSTEST | Vital Signs Test Name |
text | $40 | *ALL* | Predecessor | VS.VSTEST |
|
ADVS | VSTESTCD | Vital Signs Test Short Name |
text | $40 | *ALL* | Predecessor | VS.VSTESTCD |
|
ADVS | VSORRES | Results in Original Units |
text | $300 | *ALL* | Predecessor | VS.VSPRRES |
|
ADVS | VSPOS | Position of Subject |
text | $40 | *ALL* | Predecessor | VS.VSPOS |
|
ADVS | VISITNUM | Visit Number |
text | $40 | *ALL* | Predecessor | VS.VISITNUM |
|
ADVS | VSDTC | Date/Time of Measurement |
text | $40 | *ALL* | Predecessor | VS.VSDTC |
|
ADVS | PARAM | Parameter |
text | $40 | *DEFAULT* | Diastolic Blood Pressure (mmHg) Systolic Blood Pressure (mmHg) Heart Rate (BEATS/MIN) Weight (kg) Height (cm) |
Derived | Test (VS.VSTEST) and unit (VS.VSTESTU) as one string |
BMI | BMI (kg/m^2) | Assigned | Additional rows for calculated BMI |
|||||
ADVS | PARAMCD | Parameter Code |
text | $40 | *DEFAULT* | DIABP SYSBP HR WEIGHT HEIGHT | Predecessor | Test code (VS.VSTESTCD) |
BMI | BMI | Assigned | Additional rows for calculated BMI |
|||||
SDTM Derivation Rules |
||||||||
Dataset Name | Variable Name | Variable Label | Variable Type | Variable Format | Parameter Identifier | Codelist | Origin | Derivation / Comment |
VS | VSTEST | Vital Signs Test Name |
text | $40 | *ALL* | Derived | If CRF field is DIABP, set to "Diastolic Blood Pressure" |
|
VS | VSTESTCD | Vital Signs Test Short Name |
text | $8 | *ALL* | Derived | If CRF field is DIABP, set to "DIABP" |
|
VS | VSORRES | Results in Original Units |
text | $200 | *ALL* | Derived | Value of DIABP CRF field |
|
VS | VSORRESU | Units |
text | $40 | *ALL* | Derived | If CRF field is DIABP, set to "mmHg" |
|
VS | VSPOS | Position of Subject |
text | $40 | *ALL* | Derived | If CRF field is DIABP, set to "Sitting" |
|
VS | VISITNUM | Visit Number |
float | 8 | *ALL* | Derived | Study visit number |
|
VS | VSDTC | Date/Time of Measurement |
datetime | $90 | *ALL* | Derived | Study visit date/time (dd MMM yyyy) |
|
CDASH Representation |
||||||||
Dataset Name | Variable Name | Variable Label | Variable Type | Variable Format | Parameter Identifier | Codelist | ||
VS | DIABP | Sitting Diastolic Blood Pressure |
Char | $3 | *ALL* |
ADaM Derivation Rules |
||||||||
Dataset Name | Variable Name | Variable Label | Variable Type | Variable Format | Parameter Identifier | Codelist | Origin | Derivation / Comment |
---|---|---|---|---|---|---|---|---|
ADVS | VSTEST | Vital Signs Test Name |
text | $40 | *ALL* | Predecessor | VS.VSTEST |
|
SDTM Derivation Rules |
||||||||
Dataset Name | Variable Name | Variable Label | Variable Type | Variable Format | Parameter Identifier | Codelist | Origin | Derivation / Comment |
VS | VSTEST | Vital Signs Test Name |
text | $40 | *ALL* | Derived | If CRF field is DIABP, set to "Diastolic Blood Pressure" |
|
CDASH Representation |
||||||||
Dataset Name | Variable Name | Variable Label | Variable Type | Variable Format | Parameter Identifier | Codelist | ||
VS | DIABP | Sitting Diastolic Blood Pressure |
Char | $3 | *ALL* |