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Vital Signs

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Description

date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
subject number
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
visit type
Description

visit type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing date/time
Description

This item should be filled in for all 4 weeks of the two cycles (once per visit). Item is read-only.

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Time relative to dosing
Description

This item should be filled in for all 4 weeks of both cycles. Collect at each 8 time points values for both before and after infusion.

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C0178602
Actual date/time
Description

This item should be filled in for all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements (for the latter not required).

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0518766
Height
Description

This item should be filled out at the Screening Visit.

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

This item should be filled out at the Screening Visit, pre-infusion for all 4 weeks of both cycles and in case of any unscheduled measurements.

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood pressure
Description

This item should be filled in for screening, all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

This item should be filled in for screening, all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

This item should be filled in for screening, all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements.

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Description

This item should be filled in for screening, all 4 weeks of the two cycles for both pre- and post-infusion, as well as in case of unscheduled measurements.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Calculated Subject position
Description

[hidden] This item should be filled in for all 4 weeks of the two cycles (once per visit).

Data type

text

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0444686
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Similar models

Vital Signs

1 forms
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
Screening visit (1)
CL Item
Cycle 1 week 1 (2)
CL Item
Cycle 1 week 2 (3)
CL Item
Cycle 1 week 3 (4)
CL Item
Cycle 1 week 4 (5)
CL Item
Cycle 2 week 1 (6)
CL Item
Cycle 2 week 2 (7)
CL Item
Cycle 2 week 3 (8)
CL Item
Cycle 2 week 4 (9)
CL Item
unscheduled visit (10)
Dosing date/time
Item
Dosing date/time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Time relative to dosing
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Vital signs time relative to dosing
Code List
Time relative to dosing
CL Item
Pre-Infusion (1)
CL Item
Post-Infusion (2)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Calculated Subject position
Item
Calculated Subject position
text
C1262869 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
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