ID
40883
Beschreibung
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
Stichworte
Versionen (1)
- 31.05.20 31.05.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
31. Mai 2020
DOI
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Lizenz
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
Beschreibung
Form D
Alias
- UMLS CUI-1
- C0011065
Beschreibung
Certified Cause of Death:
Datentyp
text
Alias
- UMLS CUI [1]
- C0007465
Beschreibung
Date of Death
Datentyp
date
Alias
- UMLS CUI [1]
- C1148348
Beschreibung
If yes, please summarize findings (include diagnosis)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschreibung
Autopsy findings
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Beschreibung
Physician’s Signature:
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Physician’s Signature Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Missing Data
Alias
- UMLS CUI-1
- C1705492
- UMLS CUI-2
- C1511726
Beschreibung
Form
Datentyp
text
Alias
- UMLS CUI [1]
- C0348078
Beschreibung
Visit
Datentyp
text
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Missing Data Point
Datentyp
text
Alias
- UMLS CUI [1]
- C0814891
Beschreibung
Missing Data Reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0814891
- UMLS CUI [1,2]
- C0392360
Beschreibung
Clinical Data Review - Administrative
Alias
- UMLS CUI-1
- C1516606
- UMLS CUI-2
- C1320722
Beschreibung
To: Data Management
Datentyp
text
Alias
- UMLS CUI [1]
- C0596404
Beschreibung
Drug ID
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0600091
Beschreibung
Protocol No
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0442711
- UMLS CUI [1,2]
- C0237753
Beschreibung
Inv.Name/Centre No
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
- UMLS CUI [2,1]
- C0600091
- UMLS CUI [2,2]
- C0019994
Beschreibung
Patient No
Datentyp
text
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
From: Medical Dept.
Datentyp
text
Alias
- UMLS CUI [1]
- C1553421
Beschreibung
CRF Module(s)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1516308
- UMLS CUI [1,2]
- C1709061
Beschreibung
or pages
Datentyp
text
Alias
- UMLS CUI [1]
- C1548329
Beschreibung
other data (questionnaires, diary, cards, etc.)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1511726
Beschreibung
Clinical Data Review - Review comments
Alias
- UMLS CUI-1
- C1516606
- UMLS CUI-2
- C0947611
Beschreibung
1) Serious AE:
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
AE Text
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
2) Missing pages:
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1548329
- UMLS CUI [1,2]
- C1705492
Beschreibung
To follow
Datentyp
text
Alias
- UMLS CUI [1]
- C4281991
Beschreibung
3) Missing data:
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C1511726
Beschreibung
Page No
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Beschreibung
To follow:
Datentyp
text
Alias
- UMLS CUI [1]
- C4281991
Beschreibung
Unobtainable:
Datentyp
text
Alias
- UMLS CUI [1]
- C2046401
Beschreibung
4) Protocol Violations:
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1709750
Beschreibung
Page No
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Beschreibung
5) DRQ replies:
Datentyp
text
Alias
- UMLS CUI [1]
- C3846158
Beschreibung
6) Other comments:
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0205394
Beschreibung
Page No:
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C0237753
Beschreibung
Monitor
Datentyp
text
Alias
- UMLS CUI [1]
- C1521743
Beschreibung
Name:
Datentyp
text
Alias
- UMLS CUI [1]
- C0027365
Beschreibung
Date of review:
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3166277
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
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])