ID

26889

Beschreibung

Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A 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 Documentation part (Visit Description): Study Conclusion

Stichworte

Versionen (1)
  1. 27.10.17 27.10.17 -
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GlaxoSmithKline

Hochgeladen am

27. Oktober 2017

DOI

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Pharmacokinetics of a new unmarketed formulation of ropinirole Study Conclusion 101468/199

Englisch

Study Conclusion

1 Formulare  
  1. StudyEvent: ODM
    1. Study Conclusion
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
UMLS CUI-3
C0244821
Date of subject completion or withdrawal
Beschreibung

Date of subject completion or withdrawal

Datentyp

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Beschreibung

withdraw

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
If Yes, check the primary reason for withdrawal:
Beschreibung

reason for withdrawal

Datentyp

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
If Other reason for withdrawal, please specify
Beschreibung

reason for withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Time of withdrawal
Beschreibung

Time of withdrawal

Datentyp

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Investigator Comment Log
Beschreibung

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Investigator's Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0008976
Investigator’s signature
Beschreibung

Investigator’s signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

Study Conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C0244821 (UMLS CUI-3)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
withdraw
Item
Was the subject withdrawn from the study?
boolean
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Item
If Yes, check the primary reason for withdrawal:
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for withdrawal
Code List
If Yes, check the primary reason for withdrawal:
CL Item
Adverse event a Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Other, specify (7)
reason for withdrawal
Item
If Other reason for withdrawal, please specify
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Time of withdrawal
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Comment
Item
Investigator's Comment
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
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