ID
40883
Beschrijving
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
Trefwoorden
Versies (1)
- 31-05-20 31-05-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
31 mei 2020
DOI
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Licentie
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
Beschrijving
Form D
Alias
- UMLS CUI-1
- C0011065
Beschrijving
Certified Cause of Death:
Datatype
text
Alias
- UMLS CUI [1]
- C0007465
Beschrijving
Date of Death
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
If yes, please summarize findings (include diagnosis)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschrijving
Autopsy findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Beschrijving
Physician’s Signature:
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Physician’s Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Missing Data
Alias
- UMLS CUI-1
- C1705492
- UMLS CUI-2
- C1511726
Beschrijving
Form
Datatype
text
Alias
- UMLS CUI [1]
- C0348078
Beschrijving
Visit
Datatype
text
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Missing Data Point
Datatype
text
Alias
- UMLS CUI [1]
- C0814891
Beschrijving
Missing Data Reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C0814891
- UMLS CUI [1,2]
- C0392360
Beschrijving
Clinical Data Review - Administrative
Alias
- UMLS CUI-1
- C1516606
- UMLS CUI-2
- C1320722
Beschrijving
To: Data Management
Datatype
text
Alias
- UMLS CUI [1]
- C0596404
Beschrijving
Drug ID
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0600091
Beschrijving
Protocol No
Datatype
text
Alias
- UMLS CUI [1,1]
- C0442711
- UMLS CUI [1,2]
- C0237753
Beschrijving
Inv.Name/Centre No
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
- UMLS CUI [2,1]
- C0600091
- UMLS CUI [2,2]
- C0019994
Beschrijving
Patient No
Datatype
text
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
From: Medical Dept.
Datatype
text
Alias
- UMLS CUI [1]
- C1553421
Beschrijving
CRF Module(s)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1709061
Beschrijving
or pages
Datatype
text
Alias
- UMLS CUI [1]
- C1548329
Beschrijving
other data (questionnaires, diary, cards, etc.)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1511726
Beschrijving
Clinical Data Review - Review comments
Alias
- UMLS CUI-1
- C1516606
- UMLS CUI-2
- C0947611
Beschrijving
1) Serious AE:
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
AE Text
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
2) Missing pages:
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1548329
- UMLS CUI [1,2]
- C1705492
Beschrijving
To follow
Datatype
text
Alias
- UMLS CUI [1]
- C4281991
Beschrijving
3) Missing data:
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C1511726
Beschrijving
Page No
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Beschrijving
To follow:
Datatype
text
Alias
- UMLS CUI [1]
- C4281991
Beschrijving
Unobtainable:
Datatype
text
Alias
- UMLS CUI [1]
- C2046401
Beschrijving
4) Protocol Violations:
Datatype
boolean
Alias
- UMLS CUI [1]
- C1709750
Beschrijving
Page No
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Beschrijving
5) DRQ replies:
Datatype
text
Alias
- UMLS CUI [1]
- C3846158
Beschrijving
6) Other comments:
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0205394
Beschrijving
Page No:
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Beschrijving
Monitor
Datatype
text
Alias
- UMLS CUI [1]
- C1521743
Beschrijving
Name:
Datatype
text
Alias
- UMLS CUI [1]
- C0027365
Beschrijving
Date of review:
Datatype
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])