ID

40874

Description

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

Keywords

Versions (1)
  1. 5/29/20 5/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 29, 2020

DOI

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License

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

English

Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Are there any concomitant medication CHANGES since the start of the study?
Description

If ’YES’, please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0443172
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Drug Name
Description

(Trade Name Preferred)

Data type

text

Alias
UMLS CUI [1]
C2360065
SINGLE Dose/Unit
Description

(eg.500mg)

Data type

text

Alias
UMLS CUI [1,1]
C1960417
UMLS CUI [1,2]
C0869039
Frequency of this Dose
Description

(e.g.BID,PRN)

Data type

text

Alias
UMLS CUI [1]
C3476109
Concomitant Medication Route
Description

Concomitant Medication Route

Data type

text

Alias
UMLS CUI [1]
C2826730
Concomitant Medication Indication
Description

Concomitant Medication Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
Concomitant Medication Start Date/Time
Description

Concomitant Medication Start Date/Time

Data type

datetime

Alias
UMLS CUI [1]
C2826825
Concomitant Medication End Date/Time
Description

Concomitant Medication End Date/Time

Data type

datetime

Alias
UMLS CUI [1]
C2826815
Concomitant Medication continuing at end of Study?
Description

Concomitant Medication continuing at end of Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Are there any concomitant medication CHANGES since the start of the study?
Item
Are there any concomitant medication CHANGES since the start of the study?
boolean
C2347852 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
SINGLE Dose/Unit
Item
SINGLE Dose/Unit
text
C1960417 (UMLS CUI [1,1])
C0869039 (UMLS CUI [1,2])
Frequency of this Dose
Item
Frequency of this Dose
text
C3476109 (UMLS CUI [1])
Concomitant Medication Route
Item
Concomitant Medication Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication Indication
Item
Concomitant Medication Indication
text
C2826696 (UMLS CUI [1])
Concomitant Medication Start Date/Time
Item
Concomitant Medication Start Date/Time
datetime
C2826825 (UMLS CUI [1])
Concomitant Medication End Date/Time
Item
Concomitant Medication End Date/Time
datetime
C2826815 (UMLS CUI [1])
Concomitant Medication continuing at end of Study?
Item
Concomitant Medication continuing at end of Study?
boolean
C2826666 (UMLS CUI [1])
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