ID
40876
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)
- 29.05.20 29.05.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
29. 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)
Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments
Beschreibung
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschreibung
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschreibung
If ’NO’, mark the one most appropriate category
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348577
Beschreibung
If the subject did not complete the study as planned, mark the most appropriate category
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0683312
Beschreibung
If other reason for not completing the study, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Beschreibung
Comments on reason for withdrawal:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Beschreibung
Date of Withdrawal:
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0011008
Beschreibung
Time of Withdrawal:
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0040223
Beschreibung
Date of Final Dose:
Datentyp
date
Alias
- UMLS CUI [1]
- C1762893
Beschreibung
Time of Final Dose:
Datentyp
time
Alias
- UMLS CUI [1]
- C0946444
Beschreibung
Investigator's Statement
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1710187
Beschreibung
Check all Adverse Event forms are up to date and complete
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0920316
- UMLS CUI [1,3]
- C0205197
Beschreibung
Check that the Concomitant Medication form is up to date
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0920316
- UMLS CUI [1,3]
- C0237400
Beschreibung
Check that all appropriate pages are signed (thus indicating completion) and dated
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0805732
- UMLS CUI [1,2]
- C1283174
Beschreibung
Check that laboratory results are included
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0920316
Beschreibung
I certify that the observtions and findings are recorded correctly and completely in this CRF.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
General Comments
Alias
- UMLS CUI-1
- C0947611
Ähnliche Modelle
Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments
C0683312 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1710187 (UMLS CUI-2)
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
C1283174 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,2])