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

Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Patient initials
Beschreibung

Patient initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Centre Number
Beschreibung

Centre Number

Datentyp

integer

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

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit type
Beschreibung

Visit type

Datentyp

integer

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

Concomitant Medication

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

Concomitant Medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Medical Procedure
Beschreibung

Medical Procedure

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

Medical Procedure

Datentyp

text

Alias
UMLS CUI [1]
C0199171
RLS Rating Scales
Beschreibung

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.
Beschreibung

Scales RLS

Datentyp

integer

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

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.
Beschreibung

Adverse Events

Datentyp

boolean

Clinical Global Impression
Beschreibung

Clinical Global Impression

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

Clinical Global Impression

Datentyp

text

Alias
UMLS CUI [1]
C3639708
Exclusion Criterion
Beschreibung

Exclusion Criterion

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

Only for Baseline/Screening Visit.

Datentyp

text

Alias
UMLS CUI [1]
C0680251

Ähnliche Modelle

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

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)