ID

41072

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 (2)
  1. 6/19/20 6/19/20 -
  2. 6/19/20 6/19/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 19, 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 Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject prior to dosing and/or during the study?
Description

If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Description

(Trade Name Preferred)

Data type

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Description

(eg.500mg)

Data type

float

Alias
UMLS CUI [1]
C0869039
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

(e.g.BID)

Data type

text

Alias
UMLS CUI [1]
C3476109
Concomitant Medication Route
Description

Concomitant Medication Route

Data type

text

Alias
UMLS CUI [1]
C2826730
Reason for Concomitant Medication
Description

Reason for Concomitant Medication

Data type

text

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

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Concomitant Medication Start Time
Description

Concomitant Medication Start Time

Data type

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Concomitant medication taken prior to study?
Description

Concomitant medication taken prior to study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant Medication Stop Date
Description

Concomitant Medication Stop Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Concomitant Medication Stop Time
Description

Concomitant Medication Stop Time

Data type

time

Alias
UMLS CUI [1]
C2826659
Ongoing medication?
Description

Ongoing medication?

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 Medications
C2347852 (UMLS CUI-1)
Were any concomitant medications taken by the subject prior to dosing and/or during the study?
Item
Were any concomitant medications taken by the subject prior to dosing and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C0869039 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
Tablet  (TAB)
CL Item
Microlitre  (MCL)
CL Item
Millilitre  (ML)
CL Item
Litre  (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Frequency
text
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
Item
Concomitant Medication Route
text
C2826730 (UMLS CUI [1])
Concomitant Medication Route
Code List
Concomitant Medication Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Reason for Concomitant Medication
Item
Reason for Concomitant Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Concomitant Medication Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication Start Time
Item
Concomitant Medication Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Concomitant medication taken prior to study?
Item
Concomitant medication taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication Stop Date
Item
Concomitant Medication Stop Date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Stop Time
Item
Concomitant Medication Stop Time
time
C2826659 (UMLS CUI [1])
Ongoing medication?
Item
Ongoing medication?
boolean
C2826666 (UMLS CUI [1])
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