ID

40883

Description

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Keywords

Versions (1)
  1. 5/31/20 5/31/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 31, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

English

Form D; Missing Data; Clinical Data Review Form

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

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

Form D

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

Certified Cause of Death:

Data type

text

Alias
UMLS CUI [1]
C0007465
Date of Death
Description

Date of Death

Data type

date

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

If yes, please summarize findings (include diagnosis)

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Autopsy findings
Description

Autopsy findings

Data type

text

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

Physician’s Signature:

Data type

text

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

Physician’s Signature Date

Data type

date

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

Missing Data

Alias
UMLS CUI-1
C1705492
UMLS CUI-2
C1511726
Form
Description

Form

Data type

text

Alias
UMLS CUI [1]
C0348078
Visit
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Missing Data Point
Description

Missing Data Point

Data type

text

Alias
UMLS CUI [1]
C0814891
Missing Data Reason
Description

Missing Data Reason

Data type

text

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

Clinical Data Review - Administrative

Alias
UMLS CUI-1
C1516606
UMLS CUI-2
C1320722
To: Data Management
Description

To: Data Management

Data type

text

Alias
UMLS CUI [1]
C0596404
Drug ID
Description

Drug ID

Data type

text

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

Protocol No

Data type

text

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

Inv.Name/Centre No

Data type

text

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

Patient No

Data type

text

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

From: Medical Dept.

Data type

text

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

CRF Module(s)

Data type

text

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

or pages

Data type

text

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

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

Data type

text

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

Clinical Data Review - Review comments

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

1) Serious AE:

Data type

boolean

Alias
UMLS CUI [1]
C1519255
AE Text
Description

AE Text

Data type

text

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

2) Missing pages:

Data type

boolean

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

To follow

Data type

text

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

3) Missing data:

Data type

boolean

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

Page No

Data type

integer

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

To follow:

Data type

text

Alias
UMLS CUI [1]
C4281991
Unobtainable:
Description

Unobtainable:

Data type

text

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

4) Protocol Violations:

Data type

boolean

Alias
UMLS CUI [1]
C1709750
Page No
Description

Page No

Data type

integer

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

5) DRQ replies:

Data type

text

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

6) Other comments:

Data type

boolean

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

Page No:

Data type

integer

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

Monitor

Data type

text

Alias
UMLS CUI [1]
C1521743
Name:
Description

Name:

Data type

text

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

Date of review:

Data type

date

Alias
UMLS CUI [1,1]
C3166277
UMLS CUI [1,2]
C0011008
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Similar models

Form D; Missing Data; Clinical Data Review Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject 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?
boolean
C0004398 (UMLS CUI [1])
Autopsy findings
Item
Autopsy 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
C1705492 (UMLS CUI-1)
C1511726 (UMLS CUI-2)
Form
Item
Form
text
C0348078 (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 [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Clinical Data Review - Administrative
C1516606 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
To: Data Management
Item
To: Data Management
text
C0596404 (UMLS CUI [1])
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:
integer
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:
date
C3166277 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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