ID

41072

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2020-06-19 2020-06-19 -
  2. 2020-06-19 2020-06-19 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

19 juni 2020

DOI

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Licens

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

Engelsk

Concomitant Medication

1 Formulär  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medications
Beskrivning

Concomitant Medications

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

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.

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Beskrivning

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beskrivning

(Trade Name Preferred)

Datatyp

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Beskrivning

(eg.500mg)

Datatyp

float

Alias
UMLS CUI [1]
C0869039
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beskrivning

(e.g.BID)

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Concomitant Medication Route
Beskrivning

Concomitant Medication Route

Datatyp

text

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

Reason for Concomitant Medication

Datatyp

text

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

Concomitant Medication Start Date

Datatyp

date

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

Concomitant Medication Start Time

Datatyp

time

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

Concomitant medication taken prior to study?

Datatyp

boolean

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

Concomitant Medication Stop Date

Datatyp

date

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

Concomitant Medication Stop Time

Datatyp

time

Alias
UMLS CUI [1]
C2826659
Ongoing medication?
Beskrivning

Ongoing medication?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Tillbaka till toppen

Similar models

Concomitant Medication

1 Formulär
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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