Checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion)

Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Patient initials
Beskrivning

Patient initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Centre Number
Beskrivning

Centre Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit type
Beskrivning

Visit type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Concomitant Medication
Beskrivning

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section
Beskrivning

Concomitant Medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Medical Procedure
Beskrivning

Medical Procedure

Alias
UMLS CUI-1
C0199171
Please record any medical procedures performed since the last visit
Beskrivning

Medical Procedure

Datatyp

text

Alias
UMLS CUI [1]
C0199171
RLS Rating Scales
Beskrivning

RLS Rating Scales

Alias
UMLS CUI-1
C0450973
UMLS CUI-2
C0035258
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
Beskrivning

Scales RLS

Datatyp

integer

Alias
UMLS CUI [1,1]
C0450973
UMLS CUI [1,2]
C0035258
Adverse Experiences
Beskrivning

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section.
Beskrivning

Adverse Events

Datatyp

boolean

Clinical Global Impression
Beskrivning

Clinical Global Impression

Alias
UMLS CUI-1
C3639708
Clinical Global Impression Questionaire completed?
Beskrivning

Clinical Global Impression

Datatyp

text

Alias
UMLS CUI [1]
C3639708
Exclusion Criterion
Beskrivning

Exclusion Criterion

Patient has clinically significant abnormal laboratory findings not resolved prior to baseline examinations.
Beskrivning

Only for Baseline/Screening Visit.

Datatyp

text

Alias
UMLS CUI [1]
C0680251

Similar models

Checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion)

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient initials
Item
Patient initials
text
C2986440 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Baseline (1)
CL Item
Day 2 (2)
CL Item
Week 1 (3)
CL Item
Week 2 (4)
CL Item
Week 3 (5)
CL Item
Week 4 (6)
CL Item
Week 5 (7)
CL Item
Week 6 (8)
CL Item
Week 7 (9)
CL Item
Week 8 (10)
CL Item
Week 12 (11)
CL Item
Week 24 (12)
CL Item
Week 36 (13)
CL Item
Week 48 (14)
CL Item
Week 52 (15)
CL Item
Early withdrawal  (16)
CL Item
Follow-up (17)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section
boolean
C2347852 (UMLS CUI [1])
Item Group
Medical Procedure
C0199171 (UMLS CUI-1)
Medical Procedure
Item
Please record any medical procedures performed since the last visit
text
C0199171 (UMLS CUI [1])
Item Group
RLS Rating Scales
C0450973 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
Scales RLS
Item
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
integer
C0450973 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Adverse Events
Item
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section.
boolean
Item Group
Clinical Global Impression
C3639708 (UMLS CUI-1)
Item
Clinical Global Impression Questionaire completed?
text
C3639708 (UMLS CUI [1])
Code List
Clinical Global Impression Questionaire completed?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Exclusion Criterion
Item
Patient has clinically significant abnormal laboratory findings not resolved prior to baseline examinations.
text
C0680251 (UMLS CUI [1])
Code List
Patient has clinically significant abnormal laboratory findings not resolved prior to baseline examinations.
CL Item
Yes (Y)
CL Item
No (N)