Vital Signs

  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
Site
Description

Study site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Visit
Description

Type of Visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing Date and Time
Description

Dosing Date and Time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C1264639
Dosing date/time
Description

Applicable to Visit 2 through to 8 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
Measurement Type
Description

At Visit 1 / Screening, select "Measurement 1". At Visit 2 to 5, 7 and 8, fill in itemgroup both for "Pre-dose" and "10h". For all other visits, skip this item.

Data type

text

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0332307
Actual date/time
Description

Vital Signs Date/Time

Data type

datetime

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

Applicable to Visit 1 only

Data type

integer

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

Applicable to Visit 1 only

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Description

Applicable to Visit 1 only

Data type

float

Measurement units
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2
Blood pressure systolic
Description

Blood pressure Systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure Diastolic

Data type

integer

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

Heart rate

Data type

integer

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

Respiration rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Oral temperature
Description

Oral temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C

Similar models

Vital Signs

  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])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item
Study Visit
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Study Visit
CL Item
Visit 1 (Screening) (Visit 1 (Screening))
CL Item
Visit 2 (Visit 2)
CL Item
Visit 3 (Visit 3)
CL Item
Visit 4 (Visit 4)
CL Item
Visit 5 (Visit 5)
CL Item
Visit 6 (Visit 6)
CL Item
Visit 7 (Visit 7)
CL Item
Visit 8 (Visit 8)
CL Item
EW (EW)
CL Item
Day 7 FU (Day 7 FU)
CL Item
Day 14 FU (Day 14 FU)
Item Group
Dosing Date and Time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
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
Measurement Type
text
C0242485 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Measurement Type
CL Item
Measurement 1 (Measurement 1)
CL Item
Pre-dose (Pre-dose)
CL Item
10h (10h)
Vital Signs 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])
Body Mass Index
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Blood pressure Systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure Diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Oral temperature
Item
Oral temperature
float
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])