ID

40787

Beschreibung

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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  1. 13.05.20 13.05.20 -
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GlaxoSmithKline

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13. Mai 2020

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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

Englisch

Form D; Missing Data; Clinical Data Review

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Form D
Beschreibung

Form D

Alias
UMLS CUI-1
C0011065
Certified Cause of Death:
Beschreibung

Certified Cause of Death:

Datentyp

text

Alias
UMLS CUI [1]
C0007465
Date of Death
Beschreibung

Date of Death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Was a post-mortem carried out?
Beschreibung

If yes, please summarize findings (include diagnosis):

Datentyp

text

Alias
UMLS CUI [1]
C0004398
Post-mortem findings
Beschreibung

Post-mortem findings

Datentyp

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0243095
Physician’s Signature:
Beschreibung

Physician’s Signature:

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Physician’s Signature Date:
Beschreibung

Physician’s Signature Date:

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Missing Data
Beschreibung

Missing Data

Alias
UMLS CUI-1
C0814891
Form
Beschreibung

Form

Datentyp

text

Alias
UMLS CUI [1]
C3846158
Visit
Beschreibung

Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Missing Data Point
Beschreibung

Missing Data Point

Datentyp

text

Alias
UMLS CUI [1]
C0814891
Missing Data - Reason
Beschreibung

Missing Data - Reason

Datentyp

text

Alias
UMLS CUI [1]
C0814891
UMLS CUI [2]
C0392360
Clinical Data Review - Administrative
Beschreibung

Clinical Data Review - Administrative

Alias
UMLS CUI-1
C1516606
UMLS CUI-2
C1320722
To Data Management
Beschreibung

To Data Management

Datentyp

text

Alias
UMLS CUI [1]
C0596404
Drug ID
Beschreibung

Drug ID

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0600091
Protocol No
Beschreibung

Protocol No

Datentyp

text

Alias
UMLS CUI [1,1]
C0442711
UMLS CUI [1,2]
C0237753
Inv.Name/Centre No
Beschreibung

Inv.Name/Centre No

Datentyp

text

Alias
UMLS CUI [1]
C2826892
UMLS CUI [2,1]
C0600091
UMLS CUI [2,2]
C0019994
Patient No
Beschreibung

Patient No

Datentyp

text

Alias
UMLS CUI [1]
C2348585
From: Medical Dept.
Beschreibung

From: Medical Dept.

Datentyp

text

Alias
UMLS CUI [1]
C1553421
CRF Module(s)
Beschreibung

CRF Module(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1709061
or pages
Beschreibung

or pages

Datentyp

text

Alias
UMLS CUI [1]
C1548329
other data (questionnaires, diary, cards, etc.)
Beschreibung

other data (questionnaires, diary, cards, etc.)

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1511726
Clinical Data Review - Review comments
Beschreibung

Clinical Data Review - Review comments

Alias
UMLS CUI-1
C1516606
UMLS CUI-2
C0947611
1) Serious AE:
Beschreibung

1) Serious AE:

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
AE Text
Beschreibung

AE Text

Datentyp

text

Alias
UMLS CUI [1]
C0877248
2) Missing pages:
Beschreibung

2) Missing pages:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548329
UMLS CUI [1,2]
C1705492
To follow
Beschreibung

To follow

Datentyp

text

Alias
UMLS CUI [1]
C4281991
3) Missing data:
Beschreibung

3) Missing data:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C1511726
Page No
Beschreibung

Page No

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0237753
To follow:
Beschreibung

To follow:

Datentyp

text

Alias
UMLS CUI [1]
C4281991
Unobtainable:
Beschreibung

Unobtainable:

Datentyp

text

Alias
UMLS CUI [1]
C2046401
4) Protocol Violations:
Beschreibung

4) Protocol Violations:

Datentyp

boolean

Alias
UMLS CUI [1]
C1709750
Page No
Beschreibung

Page No

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0237753
5) DRQ replies:
Beschreibung

5) DRQ replies:

Datentyp

text

Alias
UMLS CUI [1]
C3846158
6) Other comments:
Beschreibung

6) Other comments:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0205394
Page No:
Beschreibung

Page No:

Datentyp

text

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0237753
Monitor
Beschreibung

Monitor

Datentyp

text

Alias
UMLS CUI [1]
C1521743
Name:
Beschreibung

Name:

Datentyp

text

Alias
UMLS CUI [1]
C0027365
Date of review:
Beschreibung

Date of review:

Datentyp

text

Alias
UMLS CUI [1,1]
C3166277
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Form D; Missing Data; Clinical Data Review

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Form D
C0011065 (UMLS CUI-1)
Certified Cause of Death:
Item
Certified Cause of Death:
text
C0007465 (UMLS CUI [1])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Was a post-mortem carried out?
Item
Was a post-mortem carried out?
text
C0004398 (UMLS CUI [1])
Post-mortem findings
Item
Post-mortem findings
text
C0004398 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Physician’s Signature:
Item
Physician’s Signature:
text
C2346576 (UMLS CUI [1])
Physician’s Signature Date:
Item
Physician’s Signature Date:
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Missing Data
C0814891 (UMLS CUI-1)
Form
Item
Form
text
C3846158 (UMLS CUI [1])
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Missing Data - Reason
Item
Missing Data - Reason
text
C0814891 (UMLS CUI [1])
C0392360 (UMLS CUI [2])
Item Group
Clinical Data Review - Administrative
C1516606 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
Item
To Data Management
text
C0596404 (UMLS CUI [1])
Review comments
Code List
To Data Management
Drug ID
Item
Drug ID
text
C0013227 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Protocol No
Item
Protocol No
text
C0442711 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Inv.Name/Centre No
Item
Inv.Name/Centre No
text
C2826892 (UMLS CUI [1])
C0600091 (UMLS CUI [2,1])
C0019994 (UMLS CUI [2,2])
Patient No
Item
Patient No
text
C2348585 (UMLS CUI [1])
From: Medical Dept.
Item
From: Medical Dept.
text
C1553421 (UMLS CUI [1])
CRF Module(s)
Item
CRF Module(s)
text
C1516308 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
or pages
Item
or pages
text
C1548329 (UMLS CUI [1])
other data (questionnaires, diary, cards, etc.)
Item
other data (questionnaires, diary, cards, etc.)
text
C0205394 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Item Group
Clinical Data Review - Review comments
C1516606 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
1) Serious AE:
Item
1) Serious AE:
boolean
C1519255 (UMLS CUI [1])
AE Text
Item
AE Text
text
C0877248 (UMLS CUI [1])
2) Missing pages:
Item
2) Missing pages:
boolean
C1548329 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
To follow
Item
To follow
text
C4281991 (UMLS CUI [1])
3) Missing data:
Item
3) Missing data:
boolean
C1705492 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Page No
Item
Page No
integer
C1704732 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
To follow:
Item
To follow:
text
C4281991 (UMLS CUI [1])
Unobtainable:
Item
Unobtainable:
text
C2046401 (UMLS CUI [1])
4) Protocol Violations:
Item
4) Protocol Violations:
boolean
C1709750 (UMLS CUI [1])
Page No
Item
Page No
integer
C1704732 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
5) DRQ replies:
Item
5) DRQ replies:
text
C3846158 (UMLS CUI [1])
6) Other comments:
Item
6) Other comments:
boolean
C0947611 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Page No:
Item
Page No:
text
C1704732 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Monitor
Item
Monitor
text
C1521743 (UMLS CUI [1])
Name:
Item
Name:
text
C0027365 (UMLS CUI [1])
Date of review:
Item
Date of review:
text
C3166277 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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