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Vitals Signs

1 Formulaires  
  1. StudyEvent: ODM
    1. Vitals Signs
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Type of Visit
Description

Identical for all Parts/Cohorts/Subcohorts. At Screening, Vital Signs need to be recorded three times. On Day 1, Vital Signs are recorded at the times designated in the "Time relative to dosing" item below.

Type de données

integer

Alias
UMLS CUI [1]
C3641100
Date of Visit
Description

Date of Visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Dosing Date and Time
Description

Dosing Date and Time

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

only applicable to Part A/B Day 1 Visits

Type de données

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Time relative to dosing
Description

Only applicable on Day 1 (identical for all Parts/Cohorts/Subcohorts). Fill in the entire repeating itemgroup once per Vital Sign assessment on this day.

Type de données

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Measurement Number
Description

At Screening, record Vital Signs three times (Measurements 1 to 3). Fill in for repeat Vital Signs if necessary. Fill in the entire repeating itemgroup once per Vital Sign assessment. At Screening, Measurement 1 (of 3), fill in all items. At the two other Screening Measurements, record time, blood pressure, heart rate and respiratory rate.

Type de données

integer

Alias
UMLS CUI [1]
C0449788
Actual date/time
Description

Date/time

Type de données

datetime

Alias
UMLS CUI [1]
C1264639
Height
Description

Height

Type de données

integer

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

calculated from height and weight

Type de données

float

Unités de mesure
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Blood pressure systolic
Description

Blood pressure systolic

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure diastolic

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

Heart Rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body Temperature
Description

Body Temperature

Type de données

float

Unités de mesure
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Respiration rate
Description

Respiration rate

Type de données

integer

Unités de mesure
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
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Similar models

Vitals Signs

1 Formulaires
  1. StudyEvent: ODM
    1. Vitals Signs
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Type of Visit
integer
C3641100 (UMLS CUI [1])
Type of Visit
Code List
Type of Visit
CL Item
Screening (1)
CL Item
Early Withdrawal (2)
CL Item
Part A/B Day 1 (3)
CL Item
Part A/B Day 2 (4)
CL Item
Part A/B Day 3 (5)
CL Item
Part A/B Day 5 (6)
CL Item
Part A/B Day 7 (7)
CL Item
Part A/B Day 14 (8)
CL Item
Part A/B Day 28 (9)
CL Item
Repeat Assessment (10)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Dosing Date and Time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Start Dosing date/time
Item
Start Dosing date/time
datetime
C3897500 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Type of Visit
Code List
Time relative to dosing
CL Item
Predose (1)
CL Item
2 Hours Post Start of Infusion (2)
CL Item
4 Hours Post Start of Infusion (3)
CL Item
8 Hours Post Start of Infusion (4)
CL Item
12 Hours Post Start of Infusion (5)
Measurement Number
Item
Measurement Number
integer
C0449788 (UMLS CUI [1])
Date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
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])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
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