Day 15/ Early Termination - Visit Date; Efficacy Assessments; Investigator Assessment; Subject Assessment; Vital Signs; End of Study

Visit Date
Description

Visit Date

Alias
UMLS CUI-1
C1320303
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Or if visit Not Done, enter reason:
Description

Or if visit Not Done, enter reason:

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C2826287
Number of days from Baseline visit (derived)
Description

Number of days from Baseline visit (derived)

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0237753
Efficacy Assessments
Description

Efficacy Assessments

Alias
UMLS CUI-1
C1280519
UMLS CUI-2
C0220825
Has the subject used hand moisturizer since the last visit?
Description

Has the subject used hand moisturizer since the last visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C3848663
UMLS CUI [1,2]
C0018563
Investigator Assessment
Description

Investigator Assessment

Investigator Static Global Assessment
Description

Investigator Static Global Assessment

Data type

integer

Alias
UMLS CUI [1]
C0450973
ISGA Assessor Name (First Initial, Last Name)
Description

ISGA Assessor Name

Data type

text

Alias
UMLS CUI [1,1]
C0401804
UMLS CUI [1,2]
C0027365
Subject Assessment
Description

Subject Assessment

Alias
UMLS CUI-1
C0681850
UMLS CUI-2
C0220825
Subject Global Assessment
Description

Subject Global Assessment

Data type

integer

Alias
UMLS CUI [1]
C0451514
Pruritus
Description

Pruritus

Data type

integer

Alias
UMLS CUI [1]
C0033774
Stinging
Description

Stinging

Data type

integer

Alias
UMLS CUI [1]
C0677500
Burning
Description

Burning

Data type

integer

Alias
UMLS CUI [1]
C0241057
Pain
Description

Pain

Data type

integer

Alias
UMLS CUI [1]
C0030193
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic BP (mmHg)
Description

Systolic BP (mmHg)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP (mmHg)
Description

Diastolic BP (mmHg)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse (beats/minute)
Description

Pulse (beats/minute)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature C
Description

Temperature C

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature F
Description

Temperature F

Data type

float

Measurement units
  • F
Alias
UMLS CUI [1]
C0005903
F
End of Study
Description

End of Study

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C0444930
Date of Study Completion/ Termination
Description

Date of Study Completion/ Termination

Data type

date

Alias
UMLS CUI [1]
C4554101
Reason for Completion / Termination
Description

Reason for Completion / Termination

Data type

integer

Alias
UMLS CUI [1,1]
C1283212
UMLS CUI [1,2]
C0392360
If 'Other,' specify
Description

If 'Other,' specify

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Fatal Outcome
Description

Fatal Outcome

Alias
UMLS CUI-1
C0206277
Date of Death
Description

Date of Death

Data type

date

Alias
UMLS CUI [1]
C1148348
Cause of Death
Description

Cause of Death

Data type

text

Alias
UMLS CUI [1]
C0007465

Similar models

Day 15/ Early Termination - Visit Date; Efficacy Assessments; Investigator Assessment; Subject Assessment; Vital Signs; End of Study

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Visit Date
C1320303 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Or if visit Not Done, enter reason:
Item
Or if visit Not Done, enter reason:
text
C0545082 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Number of days from Baseline visit (derived)
Item
Number of days from Baseline visit (derived)
integer
C0545082 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Item Group
Efficacy Assessments
C1280519 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Has the subject used hand moisturizer since the last visit?
Item
Has the subject used hand moisturizer since the last visit?
boolean
C3848663 (UMLS CUI [1,1])
C0018563 (UMLS CUI [1,2])
Item Group
Investigator Assessment
Item
Investigator Static Global Assessment
integer
C0450973 (UMLS CUI [1])
Code List
Investigator Static Global Assessment
CL Item
Clear - Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting (0)
CL Item
Almost Clear - May be trace faint pink erythema, w/ almost no induration/papulation and no oozing/crusting (1)
CL Item
Mild - May be faint erythema w/ mild induration/papulation and no oozing/crusting (2)
CL Item
Moderate - May be pink-red erythema w/ moderate induration/papulation and some oozing/crusting (3)
CL Item
Severe - May be deep or bright red erythema w/ severe induration/papulation and w/ oozing/crusting (4)
ISGA Assessor Name
Item
ISGA Assessor Name (First Initial, Last Name)
text
C0401804 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Item Group
Subject Assessment
C0681850 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Item
Subject Global Assessment
integer
C0451514 (UMLS CUI [1])
Code List
Subject Global Assessment
CL Item
My skin is clear (0)
CL Item
My dermatitis is minimal, maybe a few light pink areas (1)
CL Item
My dermatitis is mild, maybe occasional light pink areas (2)
CL Item
My dermatitis is moderate, easily noticeable pink-red areas (3)
CL Item
My dermatitis is severe, deep or bright red areas which may be warm when touched (4)
Item
Pruritus
integer
C0033774 (UMLS CUI [1])
Code List
Pruritus
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Stinging
integer
C0677500 (UMLS CUI [1])
Code List
Stinging
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Burning
integer
C0241057 (UMLS CUI [1])
Code List
Burning
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item
Pain
integer
C0030193 (UMLS CUI [1])
Code List
Pain
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Systolic BP (mmHg)
Item
Systolic BP (mmHg)
integer
C0871470 (UMLS CUI [1])
Diastolic BP (mmHg)
Item
Diastolic BP (mmHg)
integer
C0428883 (UMLS CUI [1])
Pulse (beats/minute)
Item
Pulse (beats/minute)
integer
C0232117 (UMLS CUI [1])
Temperature C
Item
Temperature C
float
C0005903 (UMLS CUI [1])
Temperature F
Item
Temperature F
float
C0005903 (UMLS CUI [1])
Item Group
End of Study
C0008972 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Date of Study Completion/ Termination
Item
Date of Study Completion/ Termination
date
C4554101 (UMLS CUI [1])
Item
Reason for Completion / Termination
integer
C1283212 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason for Completion / Termination
CL Item
Completed (1)
CL Item
Adverse Event (2)
CL Item
Lost to Follow up (3)
CL Item
Non- compliance with Study Treatment (4)
CL Item
Withdrawal of Consent (5)
CL Item
Disease Progression/ Lack of Efficacy (6)
CL Item
Death (7)
CL Item
Other (8)
If 'Other,' specify
Item
If 'Other,' specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Fatal Outcome
C0206277 (UMLS CUI-1)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Cause of Death
Item
Cause of Death
text
C0007465 (UMLS CUI [1])