ID

25556

Descripción

Study part: Study Conclusion. A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. 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. Study ID: 101468/201. Clinical Study ID: 101468/201

Palabras clave

Versiones (3)
  1. 5/9/17 5/9/17 -
  2. 10/5/19 10/5/19 -
  3. 10/5/19 10/5/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Study Conclusion Ropinirole Restless Legs Syndrome 101468/201

Inglés

Study Conclusion

1 formularios  
  1. StudyEvent: ODM
    1. Study Conclusion
STUDY CONCLUSION
Descripción

STUDY CONCLUSION

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Did the subject complete the study as planned?
Descripción

study subject participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
If ‘No’, mark one most appropriate category:
Descripción

reason

Tipo de datos

integer

Alias
UMLS CUI [1]
C0392360
Other, please specify
Descripción

Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
Comments on reason for withdrawal:
Descripción

reason for withdrawal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Date of withdrawal:
Descripción

Date of withdrawal

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2349954
Time of withdrawal:
Descripción

Time of withdrawal

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2349954
Date of final dose:
Descripción

Date of final dose

Tipo de datos

date

Alias
UMLS CUI [1]
C1531784
Time of final dose:
Descripción

Time of final dose

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0013227
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Similar models

Study Conclusion

1 formularios
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
STUDY CONCLUSION
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
study subject participation status
Item
Did the subject complete the study as planned?
boolean
C2348568 (UMLS CUI [1])
Item
If ‘No’, mark one most appropriate category:
integer
C0392360 (UMLS CUI [1])
reason
Code List
If ‘No’, mark one most appropriate category:
CL Item
Adverse event (complete adverse event form)  (1)
CL Item
Insufficient therapeutic effect  (2)
CL Item
Deviation from protocol (including non-compliance)  (3)
CL Item
Lost to Follow-Up  (4)
CL Item
Other (5)
Other
Item
Other, please specify
text
C0205394 (UMLS CUI [1])
reason for withdrawal
Item
Comments on reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Date of withdrawal
Item
Date of withdrawal:
date
C0011008 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Time of withdrawal
Item
Time of withdrawal:
time
C0040223 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Date of final dose
Item
Date of final dose:
date
C1531784 (UMLS CUI [1])
Time of final dose
Item
Time of final dose:
time
C1522314 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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