ID

40834

Beschreibung

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

Stichworte

Versionen (1)
  1. 21.05.20 21.05.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

21. Mai 2020

DOI

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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

Englisch

Dosing Details; ECG Monitoring; Safety ECG Monitoring

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Dosing Details
Beschreibung

Dosing Details

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1522508
Dosing Details - Study Time
Beschreibung

Dosing Details - Study Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0040223
Dosing Details - Date
Beschreibung

Dosing Details - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0011008
Dosing Details - Actual Time
Beschreibung

Dosing Details - Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0040223
Dosing Details
Beschreibung

Dosing Details

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1522508
Dosing Details - Study Time
Beschreibung

Dosing Details - Study Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0040223
Dosing Details - Date
Beschreibung

Dosing Details - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0011008
Dosing Details - Actual Time
Beschreibung

Dosing Details - Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0040223
Dose checked and administered by:
Beschreibung

Dose checked and administered by:

Datentyp

text

Alias
UMLS CUI [1]
C2348343
Dose checked and witnessed by:
Beschreibung

Dose checked and witnessed by:

Datentyp

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C1283174
UMLS CUI [1,3]
C0178602
ECG Monitoring - Supine
Beschreibung

ECG Monitoring - Supine

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C1283169
UMLS CUI-3
C0038846
Is the subject experiencing vasovagal Adverse Events?
Beschreibung

If ’Yes’, please record as an Adverse Event.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710621
UMLS CUI [1,2]
C0877248
ECG Monitoring - Supine
Beschreibung

ECG Monitoring - Supine

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C1283169
UMLS CUI-3
C0038846
ECG Monitoring - Supine - Study Time
Beschreibung

ECG Monitoring - Supine - Study Time

Datentyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0040223
ECG Monitoring - Supine - Date
Beschreibung

ECG Monitoring - Supine - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0011008
ECG Monitoring - Supine - Actual Time
Beschreibung

ECG Monitoring - Supine - Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0040223
ECG Monitoring - Supine - ECG normal?
Beschreibung

ECG Monitoring - Supine - ECG normal?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [1,4]
C0522054
ECG Monitoring - Supine - Comments
Beschreibung

ECG Monitoring - Supine - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0947611
ECG Monitoring - Supine (Follow-Up)
Beschreibung

ECG Monitoring - Supine (Follow-Up)

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C1283169
UMLS CUI-3
C0038846
UMLS CUI-4
C1522577
ECG Monitoring - Supine - Study Time
Beschreibung

ECG Monitoring - Supine - Study Time

Datentyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0040223
ECG Monitoring - Supine - Date
Beschreibung

ECG Monitoring - Supine - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0011008
ECG Monitoring - Supine - Actual Time
Beschreibung

ECG Monitoring - Supine - Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0040223
ECG Monitoring - Supine - ECG normal?
Beschreibung

ECG Monitoring - Supine - ECG normal?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [1,4]
C0522054
ECG Monitoring - Supine - Comments
Beschreibung

ECG Monitoring - Supine - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0947611
Safety ECG Monitoring - Supine
Beschreibung

Safety ECG Monitoring - Supine

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C1283169
UMLS CUI-3
C0038846
ECG Monitoring - Supine - Study Time
Beschreibung

ECG Monitoring - Supine - Study Time

Datentyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0040223
ECG Monitoring - Supine - Date
Beschreibung

ECG Monitoring - Supine - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0011008
ECG Monitoring - Supine - Actual Time
Beschreibung

ECG Monitoring - Supine - Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0040223
ECG Monitoring - Supine - ECG normal?
Beschreibung

ECG Monitoring - Supine - ECG normal?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [1,4]
C0522054
ECG Monitoring - Supine - Comments
Beschreibung

ECG Monitoring - Supine - Comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0038846
UMLS CUI [2]
C0947611
ECG Monitoring - Supine - Research Physician's Signature
Beschreibung

ECG Monitoring - Supine - Research Physician's Signature

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C1283169
UMLS CUI-3
C0038846
UMLS CUI-4
C1519316
UMLS CUI-5
C0031831
Research Physician’s Signature
Beschreibung

Research Physician’s Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
Research Physician’s Signature - Date
Beschreibung

Research Physician’s Signature - Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C0011008
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Ähnliche Modelle

Dosing Details; ECG Monitoring; Safety ECG Monitoring

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Dosing Details
C0678766 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Dosing Details - Study Time
Item
Dosing Details - Study Time
time
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Dosing Details - Date
Item
Dosing Details - Date
date
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Dosing Details - Actual Time
Item
Dosing Details - Actual Time
time
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Dosing Details
C0678766 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Dosing Details - Study Time
Item
Dosing Details - Study Time
time
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Dosing Details - Date
Item
Dosing Details - Date
date
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Dosing Details - Actual Time
Item
Dosing Details - Actual Time
time
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Dose checked and administered by:
Item
Dose checked and administered by:
text
C2348343 (UMLS CUI [1])
Dose checked and witnessed by:
Item
Dose checked and witnessed by:
text
C0682356 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Item Group
ECG Monitoring - Supine
C1623258 (UMLS CUI-1)
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
Is the subject experiencing vasovagal Adverse Events?
Item
Is the subject experiencing vasovagal Adverse Events?
boolean
C1710621 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
ECG Monitoring - Supine
C1623258 (UMLS CUI-1)
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
Item
ECG Monitoring - Supine - Study Time
integer
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
ECG Monitoring - Supine - Study Time
Code List
ECG Monitoring - Supine - Study Time
CL Item
Pre-dose (1)
CL Item
+0.25 hr (2)
CL Item
+0.5 hr (3)
CL Item
+0.75 hr (4)
CL Item
+1 hr (5)
CL Item
+1.25 hrs (6)
CL Item
+ 1.5 hrs (7)
CL Item
+ 2 hrs (8)
CL Item
+ 3 hrs (9)
CL Item
+ 4 hrs (10)
CL Item
+ 6 hrs (11)
CL Item
+ 8 hrs (12)
CL Item
+ 16 - 18 hrs (13)
ECG Monitoring - Supine - Date
Item
ECG Monitoring - Supine - Date
date
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
ECG Monitoring - Supine - Actual Time
Item
ECG Monitoring - Supine - Actual Time
time
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0040223 (UMLS CUI [2])
ECG Monitoring - Supine - ECG normal?
Item
ECG Monitoring - Supine - ECG normal?
boolean
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0522054 (UMLS CUI [1,4])
ECG Monitoring - Supine - Comments
Item
ECG Monitoring - Supine - Comments
text
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item Group
ECG Monitoring - Supine (Follow-Up)
C1623258 (UMLS CUI-1)
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Item
ECG Monitoring - Supine - Study Time
integer
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
ECG Monitoring - Supine - Study Time
Code List
ECG Monitoring - Supine - Study Time
CL Item
Follow-Up (1)
ECG Monitoring - Supine - Date
Item
ECG Monitoring - Supine - Date
date
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
ECG Monitoring - Supine - Actual Time
Item
ECG Monitoring - Supine - Actual Time
time
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0040223 (UMLS CUI [2])
ECG Monitoring - Supine - ECG normal?
Item
ECG Monitoring - Supine - ECG normal?
boolean
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0522054 (UMLS CUI [1,4])
ECG Monitoring - Supine - Comments
Item
ECG Monitoring - Supine - Comments
text
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item Group
Safety ECG Monitoring - Supine
C1623258 (UMLS CUI-1)
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
Item
ECG Monitoring - Supine - Study Time
integer
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C2348563 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
ECG Monitoring - Supine - Study Time
Code List
ECG Monitoring - Supine - Study Time
CL Item
+1 hr  (1)
CL Item
+2 hrs  (2)
CL Item
+ 3 hrs  (3)
CL Item
+ 4 hrs (4)
ECG Monitoring - Supine - Date
Item
ECG Monitoring - Supine - Date
date
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2])
ECG Monitoring - Supine - Actual Time
Item
ECG Monitoring - Supine - Actual Time
time
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0040223 (UMLS CUI [2])
ECG Monitoring - Supine - ECG normal?
Item
ECG Monitoring - Supine - ECG normal?
boolean
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0522054 (UMLS CUI [1,4])
ECG Monitoring - Supine - Comments
Item
ECG Monitoring - Supine - Comments
text
C1623258 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item Group
ECG Monitoring - Supine - Research Physician's Signature
C1623258 (UMLS CUI-1)
C1283169 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
C1519316 (UMLS CUI-4)
C0031831 (UMLS CUI-5)
Research Physician’s Signature
Item
Research Physician’s Signature
text
C1519316 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Research Physician’s Signature - Date
Item
Research Physician’s Signature - Date
date
C1519316 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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