ID

41988

Description

Study documentation part: Baseline Inspection. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Görge, University Hospital of Münster. EudraCT - Nr. 2012-000108-13.

Mots-clés

  1. 25/11/2015 25/11/2015 -
  2. 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
Téléchargé le

15 mars 2021

DOI

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Licence

Creative Commons BY-NC 3.0

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Baseline Inspection_Riliva_CRF_EudraCT - Nr. 2012-000108-13 DRKS00004652

Baseline Inspection_Riliva_CRF_EudraCT - Nr. 2012-000108-13

Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Visit could be carried out
Description

study continuation

Type de données

text

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0805733
Visit date= date of day 1 of the study medication administration
Description

date

Type de données

date

Alias
UMLS CUI [1]
C0011008
Height
Description

Height

Type de données

integer

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0489786
cm
Body weight
Description

Weight

Type de données

integer

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Pulse
Description

Pulse Rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Dosis of emergency medication, Enoxaparin sodium
Description

dosis Enoxaparin sodium

Type de données

text

Unités de mesure
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0206460
Systolic blood pressure left arm
Description

systolic blood pressure in left arm

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C2039699
mmHg
Diastolic blood pressure in left arm
Description

diastolic blood pressure in left arm

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C2183314
mmHg
Systolic blood pressure right arm
Description

systolic blood pressure in right arm

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C2039704
mmHg
Diastolic blood pressure right arm
Description

diastolic blood pressure in right arm

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C2183317
mmHg
Systolic blood pressure in left ankle
Description

Systolic blood pressure ankle

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0003086
mmHg
Diastolic blood pressure in left ankle
Description

Diastolic blood pressure ankle

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0003086
mmHg
Systolic blood pressure in right ankle
Description

Systolic blood pressure ankle

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0003086
mmHg
Diastolic blood pressure in right ankle
Description

Diastolic blood pressure ankle

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0003086
mmHg
Chronic venous insufficiency according to Widmer
Description

Chronic venous insufficiency

Type de données

text

Alias
UMLS CUI [1]
C1306557
Hemoglobin
Description

Hemoglobin

Type de données

float

Unités de mesure
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Platelet transfusions in the last 30 days?
Description

Platelet transfusions

Type de données

boolean

Alias
UMLS CUI [1]
C0086818
Examination of skin (left lower leg / foot)
Description

Examination of skin (left lower leg / foot)

Alias
UMLS CUI-1
C0436149
Number of active lesion in proximal lower leg backside
Description

Lesion Active Leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C1140621
Number of healing lesion in proximal lower leg backside
Description

Lesion healing Leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C1140621
Number of active lesion in distal lower leg backside
Description

Lesion Active leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C1140621
Number of healing lesion in distal lower leg backside
Description

Lesion healing leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C1140621
Number of active lesion in proximal lower leg front side
Description

Lesion Active leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C1140621
Number of healing lesion in proximal lower leg front side
Description

Lesion healing leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C1140621
Number of active lesion in distal lower leg front side
Description

Lesion Active leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C1140621
Number of healing lesion in distal lower leg front side
Description

Lesion healing leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C1140621
Number of active lesion lateral ankle
Description

Lesion Active ankle

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0003086
Number of healing lesion lateral ankle
Description

Lesion healing ankle

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C0003086
Number of active lesion medial ankle
Description

Lesion Active ankle

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0003086
Number of healing lesion medial ankle
Description

Lesion healing ankle

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C0003086
Number of active lesion arch of foot
Description

Lesion Active Arch of foot

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0230467
Number of healing lesion arch of foot
Description

Lesion healing Arch of foot

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C0230467
Number of atrophie blanche on left lower leg/ foot
Description

atrophie blanche

Type de données

integer

Alias
UMLS CUI [1]
C1306862
Examination of skin (right lower leg / foot)
Description

Examination of skin (right lower leg / foot)

Alias
UMLS CUI-1
C0436149
Number of active lesion in proximal lower leg backside
Description

Lesion Active Leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C1140621
Number of healing lesion in proximal lower leg backside
Description

Lesion healing Leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C1140621
Number of active lesion in distal lower leg backside
Description

Lesion Active leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C1140621
Number of healing lesion in distal lower leg backside
Description

Lesion healing leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C1140621
Number of active lesion in proximal lower leg front side
Description

Lesion Active leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C1140621
Number of healing lesion in proximal lower leg front side
Description

Lesion healing leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C1140621
Number of active lesion in distal lower leg front side
Description

Lesion Active leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C1140621
Number of healing lesion in distal lower leg front side
Description

Lesion healing leg

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C1140621
Number of active lesion lateral ankle
Description

Lesion Active ankle

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0003086
Number of healing lesion lateral ankle
Description

Lesion healing ankle

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C0003086
Number of active lesion medial ankle
Description

Lesion Active ankle

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0003086
Number of healing lesion medial ankle
Description

Lesion healing ankle

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C0003086
Number of active lesion arch of foot
Description

Lesion Active Arch of foot

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0230467
Number of healing lesion arch of foot
Description

Lesion healing Arch of foot

Type de données

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0043240
UMLS CUI [1,3]
C0230467
Number of atrophie blanche on lower leg/ foot
Description

atrophie blanche

Type de données

integer

Alias
UMLS CUI [1]
C1306862
LV - Score
Description

LV - Score

Erythema score
Description

score Erythema

Type de données

text

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C0041834
Pain score
Description

Pain score

Type de données

text

Alias
UMLS CUI [1]
C0582148
Ulceration score
Description

score Ulceration

Type de données

text

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C3887532
Examination of skin- Livedo racemosa
Description

Examination of skin- Livedo racemosa

Alias
UMLS CUI-1
C0436149
UMLS CUI-2
C2674235
Upper arm livedo racemosa
Description

Livedo racemosa upper arm

Type de données

boolean

Alias
UMLS CUI [1,1]
C2674235
UMLS CUI [1,2]
C0446516
Forearm livedo racemosa
Description

Livedo racemosa Forearm

Type de données

boolean

Alias
UMLS CUI [1,1]
C2674235
UMLS CUI [1,2]
C0016536
Hand livedo racemosa
Description

Livedo racemosa hand

Type de données

boolean

Alias
UMLS CUI [1,1]
C2674235
UMLS CUI [1,2]
C0018563
Thigh livedo racemosa
Description

Livedo racemosa thigh

Type de données

boolean

Alias
UMLS CUI [1,1]
C2674235
UMLS CUI [1,2]
C1281586
Lower leg livedo racemosa
Description

Livedo racemosa lower leg

Type de données

boolean

Alias
UMLS CUI [1,1]
C2674235
UMLS CUI [1,2]
C0222279
Foot livedo racemosa
Description

Livedo racemosa foot

Type de données

boolean

Alias
UMLS CUI [1,1]
C2674235
UMLS CUI [1,2]
C0016504
Trunk livedo racemosa
Description

Livedo racemosa trunk

Type de données

boolean

Alias
UMLS CUI [1,1]
C2674235
UMLS CUI [1,2]
C0460005
Pain intensity on the visual analogue scale
Description

Visual analogue scale

Type de données

text

Alias
UMLS CUI [1]
C0042815

Similar models

Baseline Inspection_Riliva_CRF_EudraCT - Nr. 2012-000108-13

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Visit could be carried out
text
C0008972 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
Code List
Visit could be carried out
CL Item
yes (1)
CL Item
no, study discontinuation (Please fill the form Adverse event, if study discontinuation occured due to AE) (2)
CL Item
 (sind, bitte auf AE-Bogen dokumentieren.)
date
Item
Visit date= date of day 1 of the study medication administration
date
C0011008 (UMLS CUI [1])
Height
Item
Height
integer
C0489786 (UMLS CUI [1])
Weight
Item
Body weight
integer
C0005910 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item
Dosis of emergency medication, Enoxaparin sodium
text
C3174092 (UMLS CUI [1,1])
C0206460 (UMLS CUI [1,2])
Code List
Dosis of emergency medication, Enoxaparin sodium
CL Item
20 mg (1)
CL Item
40 mg (2)
CL Item
60 mg (3)
CL Item
80 mg (4)
CL Item
100 mg (5)
systolic blood pressure in left arm
Item
Systolic blood pressure left arm
integer
C2039699 (UMLS CUI [1])
diastolic blood pressure in left arm
Item
Diastolic blood pressure in left arm
integer
C2183314 (UMLS CUI [1])
systolic blood pressure in right arm
Item
Systolic blood pressure right arm
integer
C2039704 (UMLS CUI [1])
diastolic blood pressure in right arm
Item
Diastolic blood pressure right arm
integer
C2183317 (UMLS CUI [1])
Systolic blood pressure ankle
Item
Systolic blood pressure in left ankle
integer
C0871470 (UMLS CUI [1,1])
C0003086 (UMLS CUI [1,2])
Diastolic blood pressure ankle
Item
Diastolic blood pressure in left ankle
integer
C0428883 (UMLS CUI [1,1])
C0003086 (UMLS CUI [1,2])
Systolic blood pressure ankle
Item
Systolic blood pressure in right ankle
integer
C0871470 (UMLS CUI [1,1])
C0003086 (UMLS CUI [1,2])
Diastolic blood pressure ankle
Item
Diastolic blood pressure in right ankle
integer
C0428883 (UMLS CUI [1,1])
C0003086 (UMLS CUI [1,2])
Item
Chronic venous insufficiency according to Widmer
text
C1306557 (UMLS CUI [1])
Code List
Chronic venous insufficiency according to Widmer
CL Item
no (1)
CL Item
yes, grade I (2)
CL Item
yes, grade II (3)
CL Item
yes, grade III (4)
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Platelet transfusions
Item
Platelet transfusions in the last 30 days?
boolean
C0086818 (UMLS CUI [1])
Item Group
Examination of skin (left lower leg / foot)
C0436149 (UMLS CUI-1)
Lesion Active Leg
Item
Number of active lesion in proximal lower leg backside
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion healing Leg
Item
Number of healing lesion in proximal lower leg backside
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion Active leg
Item
Number of active lesion in distal lower leg backside
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion healing leg
Item
Number of healing lesion in distal lower leg backside
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion Active leg
Item
Number of active lesion in proximal lower leg front side
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion healing leg
Item
Number of healing lesion in proximal lower leg front side
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion Active leg
Item
Number of active lesion in distal lower leg front side
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion healing leg
Item
Number of healing lesion in distal lower leg front side
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion Active ankle
Item
Number of active lesion lateral ankle
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0003086 (UMLS CUI [1,3])
Lesion healing ankle
Item
Number of healing lesion lateral ankle
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C0003086 (UMLS CUI [1,3])
Lesion Active ankle
Item
Number of active lesion medial ankle
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0003086 (UMLS CUI [1,3])
Lesion healing ankle
Item
Number of healing lesion medial ankle
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C0003086 (UMLS CUI [1,3])
Lesion Active Arch of foot
Item
Number of active lesion arch of foot
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0230467 (UMLS CUI [1,3])
Lesion healing Arch of foot
Item
Number of healing lesion arch of foot
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C0230467 (UMLS CUI [1,3])
atrophie blanche
Item
Number of atrophie blanche on left lower leg/ foot
integer
C1306862 (UMLS CUI [1])
Item Group
Examination of skin (right lower leg / foot)
C0436149 (UMLS CUI-1)
Lesion Active Leg
Item
Number of active lesion in proximal lower leg backside
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion healing Leg
Item
Number of healing lesion in proximal lower leg backside
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion Active leg
Item
Number of active lesion in distal lower leg backside
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion healing leg
Item
Number of healing lesion in distal lower leg backside
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion Active leg
Item
Number of active lesion in proximal lower leg front side
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion healing leg
Item
Number of healing lesion in proximal lower leg front side
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion Active leg
Item
Number of active lesion in distal lower leg front side
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion healing leg
Item
Number of healing lesion in distal lower leg front side
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
Lesion Active ankle
Item
Number of active lesion lateral ankle
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0003086 (UMLS CUI [1,3])
Lesion healing ankle
Item
Number of healing lesion lateral ankle
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C0003086 (UMLS CUI [1,3])
Lesion Active ankle
Item
Number of active lesion medial ankle
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0003086 (UMLS CUI [1,3])
Lesion healing ankle
Item
Number of healing lesion medial ankle
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C0003086 (UMLS CUI [1,3])
Lesion Active Arch of foot
Item
Number of active lesion arch of foot
integer
C0221198 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0230467 (UMLS CUI [1,3])
Lesion healing Arch of foot
Item
Number of healing lesion arch of foot
integer
C0221198 (UMLS CUI [1,1])
C0043240 (UMLS CUI [1,2])
C0230467 (UMLS CUI [1,3])
atrophie blanche
Item
Number of atrophie blanche on lower leg/ foot
integer
C1306862 (UMLS CUI [1])
Item Group
LV - Score
Item
Erythema score
text
C0449820 (UMLS CUI [1,1])
C0041834 (UMLS CUI [1,2])
Code List
Erythema score
CL Item
no erythema (1)
CL Item
slight (2)
CL Item
moderate (3)
CL Item
severe (4)
Item
Pain score
text
C0582148 (UMLS CUI [1])
Code List
Pain score
CL Item
no pain (1)
CL Item
slight (2)
CL Item
moderate (3)
CL Item
severe (4)
Item
Ulceration score
text
C0449820 (UMLS CUI [1,1])
C3887532 (UMLS CUI [1,2])
Code List
Ulceration score
CL Item
no ulceration (1)
CL Item
scab (2)
CL Item
ulceration without scab (3)
CL Item
deep ulceration (4)
Item Group
Examination of skin- Livedo racemosa
C0436149 (UMLS CUI-1)
C2674235 (UMLS CUI-2)
Livedo racemosa upper arm
Item
Upper arm livedo racemosa
boolean
C2674235 (UMLS CUI [1,1])
C0446516 (UMLS CUI [1,2])
Livedo racemosa Forearm
Item
Forearm livedo racemosa
boolean
C2674235 (UMLS CUI [1,1])
C0016536 (UMLS CUI [1,2])
Livedo racemosa hand
Item
Hand livedo racemosa
boolean
C2674235 (UMLS CUI [1,1])
C0018563 (UMLS CUI [1,2])
Livedo racemosa thigh
Item
Thigh livedo racemosa
boolean
C2674235 (UMLS CUI [1,1])
C1281586 (UMLS CUI [1,2])
Livedo racemosa lower leg
Item
Lower leg livedo racemosa
boolean
C2674235 (UMLS CUI [1,1])
C0222279 (UMLS CUI [1,2])
Livedo racemosa foot
Item
Foot livedo racemosa
boolean
C2674235 (UMLS CUI [1,1])
C0016504 (UMLS CUI [1,2])
Livedo racemosa trunk
Item
Trunk livedo racemosa
boolean
C2674235 (UMLS CUI [1,1])
C0460005 (UMLS CUI [1,2])
Visual analogue scale
Item
Pain intensity on the visual analogue scale
text
C0042815 (UMLS CUI [1])

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