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)
- 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)
Form D; Missing Data; Clinical Data Review Form
- StudyEvent: ODM
Description
Form D
Alias
- UMLS CUI-1
- C0011065
Description
Certified Cause of Death:
Data type
text
Alias
- UMLS CUI [1]
- C0007465
Description
Date of Death
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
If yes, please summarize findings (include diagnosis)
Data type
boolean
Alias
- UMLS CUI [1]
- C0004398
Description
Autopsy findings
Data type
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Description
Physician’s Signature:
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Physician’s Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Missing Data
Alias
- UMLS CUI-1
- C1705492
- UMLS CUI-2
- C1511726
Description
Form
Data type
text
Alias
- UMLS CUI [1]
- C0348078
Description
Visit
Data type
text
Alias
- UMLS CUI [1]
- C0545082
Description
Missing Data Point
Data type
text
Alias
- UMLS CUI [1]
- C0814891
Description
Missing Data Reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0814891
- UMLS CUI [1,2]
- C0392360
Description
Clinical Data Review - Administrative
Alias
- UMLS CUI-1
- C1516606
- UMLS CUI-2
- C1320722
Description
To: Data Management
Data type
text
Alias
- UMLS CUI [1]
- C0596404
Description
Drug ID
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0600091
Description
Protocol No
Data type
text
Alias
- UMLS CUI [1,1]
- C0442711
- UMLS CUI [1,2]
- C0237753
Description
Inv.Name/Centre No
Data type
text
Alias
- UMLS CUI [1]
- C2826892
- UMLS CUI [2,1]
- C0600091
- UMLS CUI [2,2]
- C0019994
Description
Patient No
Data type
text
Alias
- UMLS CUI [1]
- C2348585
Description
From: Medical Dept.
Data type
text
Alias
- UMLS CUI [1]
- C1553421
Description
CRF Module(s)
Data type
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1709061
Description
or pages
Data type
text
Alias
- UMLS CUI [1]
- C1548329
Description
other data (questionnaires, diary, cards, etc.)
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1511726
Description
Clinical Data Review - Review comments
Alias
- UMLS CUI-1
- C1516606
- UMLS CUI-2
- C0947611
Description
1) Serious AE:
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
AE Text
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
2) Missing pages:
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1548329
- UMLS CUI [1,2]
- C1705492
Description
To follow
Data type
text
Alias
- UMLS CUI [1]
- C4281991
Description
3) Missing data:
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C1511726
Description
Page No
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Description
To follow:
Data type
text
Alias
- UMLS CUI [1]
- C4281991
Description
Unobtainable:
Data type
text
Alias
- UMLS CUI [1]
- C2046401
Description
4) Protocol Violations:
Data type
boolean
Alias
- UMLS CUI [1]
- C1709750
Description
Page No
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Description
5) DRQ replies:
Data type
text
Alias
- UMLS CUI [1]
- C3846158
Description
6) Other comments:
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0205394
Description
Page No:
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Description
Monitor
Data type
text
Alias
- UMLS CUI [1]
- C1521743
Description
Name:
Data type
text
Alias
- UMLS CUI [1]
- C0027365
Description
Date of review:
Data type
date
Alias
- UMLS CUI [1,1]
- C3166277
- UMLS CUI [1,2]
- C0011008
Similar models
Form D; Missing Data; Clinical Data Review Form
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C1320722 (UMLS CUI-2)
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [2,1])
C0019994 (UMLS CUI [2,2])
C1709061 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C1705492 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])