ID

40876

Descrição

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

Palavras-chave

Versões (1)
  1. 29/05/2020 29/05/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

29 de maio de 2020

DOI

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Licença

Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

Inglês

Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments

1 Formulários  
Administrative
Descrição

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Pregnancy Information
Descrição

Pregnancy Information

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

(mark one box below)

Tipo de dados

text

Alias
UMLS CUI [1]
C3828490
Did the female partner of a male patient become pregnant during the study?
Descrição

(mark one box below)

Tipo de dados

text

Alias
UMLS CUI [1]
C0919624
Study Conclusion
Descrição

Study Conclusion

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

If ’NO’, mark the one most appropriate category

Tipo de dados

boolean

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

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

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0683312
If other reason for not completing the study, specify
Descrição

If other reason for not completing the study, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C2348235
Comments on reason for withdrawal:
Descrição

Comments on reason for withdrawal:

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
Date of Withdrawal:
Descrição

Date of Withdrawal:

Tipo de dados

date

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

Time of Withdrawal:

Tipo de dados

time

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

Date of Final Dose:

Tipo de dados

date

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

Time of Final Dose:

Tipo de dados

time

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

Investigator's Statement

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

Check all Adverse Event forms are up to date and complete

Tipo de dados

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
Descrição

Check that the Concomitant Medication form is up to date

Tipo de dados

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
Descrição

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

Tipo de dados

integer

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

Check that laboratory results are included

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0920316
Investigator
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Date
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008
General Comments
Descrição

General Comments

Alias
UMLS CUI-1
C0947611
General Comments
Descrição

General Comments

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did patient become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Did patient become pregnant during the study?
Code List
Did patient become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes a If ’Yes’ record details on Pregnancy Notification Form. (Y)
Item
Did the female partner of a male patient become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Did the female partner of a male patient become pregnant during the study?
Code List
Did the female partner of a male patient become pregnant during the study?
CL Item
Not applicable (subject is female, female partner not of childbearing potential or female partner) (X)
CL Item
No (N)
CL Item
Yes a 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])
C0683312 (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)
If other reason for not completing the study, specify
Item
If other reason for not completing the study, specify
text
C2348577 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Comments on reason for withdrawal:
Item
Comments on reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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
Item
Investigator
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
General Comments
C0947611 (UMLS CUI-1)
General Comments
Item
General Comments
text
C0947611 (UMLS CUI [1])
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