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