ID

40761

Beskrivning

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Nyckelord

Versioner (1)
  1. 2020-05-08 2020-05-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 maj 2020

DOI

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Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

Engelsk

Pregnancy Information; Study Conclusion, Investigator's Statement (Follow-Up)

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

Centre Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Pregnancy Information
Beskrivning

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the patient become pregnant during the study?
Beskrivning

(mark one box below)

Datatyp

text

Alias
UMLS CUI [1]
C3828490
Study Conclusion
Beskrivning

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the subject complete the study as planned?
Beskrivning

Did the subject complete the study as planned?

Datatyp

boolean

Alias
UMLS CUI [1]
C2348577
If the subject did not complete the study as planned, mark the most appropriate category
Beskrivning

If the subject did not complete the study as planned, mark the most appropriate category

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C2826287
Other reason for not completing the study as planned
Beskrivning

Other reason for not completing the study as planned

Datatyp

text

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C2826287
UMLS CUI [1,3]
C0205394
Comments on reason for withdrawal:
Beskrivning

Comments on reason for withdrawal:

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0566251
Date of Withdrawal:
Beskrivning

Date of Withdrawal:

Datatyp

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
Time of Withdrawal:
Beskrivning

Time of Withdrawal:

Datatyp

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Date of Final Dose:
Beskrivning

Date of Final Dose:

Datatyp

date

Alias
UMLS CUI [1]
C1762893
Time of Final Dose:
Beskrivning

Time of Final Dose:

Datatyp

time

Alias
UMLS CUI [1]
C0946444
Investigator's Statement
Beskrivning

Investigator's Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Check all Adverse Event forms are up to date and complete
Beskrivning

Check all Adverse Event forms are up to date and complete

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0205197
Check that the Concomitant Medication form is up to date
Beskrivning

Check that the Concomitant Medication form is up to date

Datatyp

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0237400
Check that all appropriate pages are signed (thus indicating completion) and dated
Beskrivning

Check that all appropriate pages are signed (thus indicating completion) and dated

Datatyp

integer

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C1283174
Check that laboratory results are included
Beskrivning

Check that laboratory results are included

Datatyp

integer

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0920316
Investigator's Signature
Beskrivning

I certify that the observations and findings are recorded correctly and completely in this CRF.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Beskrivning

Investigator's Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Tillbaka till toppen

Similar models

Pregnancy Information; Study Conclusion, Investigator's Statement (Follow-Up)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the patient become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Did the patient become pregnant during the study?
Code List
Did the patient become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (If ’Yes’ record details on Pregnancy Notification Form) (Y)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Did the subject complete the study as planned?
Item
Did the subject complete the study as planned?
boolean
C2348577 (UMLS CUI [1])
Item
If the subject did not complete the study as planned, mark the most appropriate category
integer
C2348577 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
If the subject did not complete the study as planned, mark the most appropriate category
Code List
If the subject did not complete the study as planned, mark the 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, Please specify (5)
Other reason for not completing the study as planned
Item
Other reason for not completing the study as planned
text
C2348577 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Comments on reason for withdrawal:
Item
Comments on reason for withdrawal:
text
C0947611 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Date of Withdrawal:
Item
Date of Withdrawal:
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Withdrawal:
Item
Time of Withdrawal:
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of Final Dose:
Item
Date of Final Dose:
date
C1762893 (UMLS CUI [1])
Time of Final Dose:
Item
Time of Final Dose:
time
C0946444 (UMLS CUI [1])
Item Group
Investigator's Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Item
Check all Adverse Event forms are up to date and complete
integer
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Check all Adverse Event forms are up to date and complete
Code List
Check all Adverse Event forms are up to date and complete
CL Item
All Adverse Event forms are up to date and complete (1)
Item
Check that the Concomitant Medication form is up to date
integer
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
Check that the Concomitant Medication form is up to date
Code List
Check that the Concomitant Medication form is up to date
CL Item
Concomitant Medication form is up to date (1)
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
integer
C0805732 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Check that all appropriate pages are signed (thus indicating completion) and dated
Code List
Check that all appropriate pages are signed (thus indicating completion) and dated
CL Item
All appropriate pages are signed (thus indicating completion) and dated (1)
Item
Check that laboratory results are included
integer
C1254595 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Check that laboratory results are included
Code List
Check that laboratory results are included
CL Item
Laboratory results are included (1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tillbaka till toppen 

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