ID

40834

Descripción

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

Palabras clave

Versiones (1)
  1. 21/5/20 21/5/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de mayo de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

Inglés

Dosing Details; ECG Monitoring; Safety ECG Monitoring

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Dosing Details
Descripción

Dosing Details

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

Dosing Details - Study Time

Tipo de datos

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
Descripción

Dosing Details - Date

Tipo de datos

date

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

Dosing Details - Actual Time

Tipo de datos

time

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

Dosing Details

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

Dosing Details - Study Time

Tipo de datos

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
Descripción

Dosing Details - Date

Tipo de datos

date

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

Dosing Details - Actual Time

Tipo de datos

time

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

Dose checked and administered by:

Tipo de datos

text

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

Dose checked and witnessed by:

Tipo de datos

text

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

ECG Monitoring - Supine

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

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

Tipo de datos

boolean

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

ECG Monitoring - Supine

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

ECG Monitoring - Supine - Study Time

Tipo de datos

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
Descripción

ECG Monitoring - Supine - Date

Tipo de datos

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
Descripción

ECG Monitoring - Supine - Actual Time

Tipo de datos

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?
Descripción

ECG Monitoring - Supine - ECG normal?

Tipo de datos

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
Descripción

ECG Monitoring - Supine - Comments

Tipo de datos

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)
Descripción

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
Descripción

ECG Monitoring - Supine - Study Time

Tipo de datos

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
Descripción

ECG Monitoring - Supine - Date

Tipo de datos

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
Descripción

ECG Monitoring - Supine - Actual Time

Tipo de datos

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?
Descripción

ECG Monitoring - Supine - ECG normal?

Tipo de datos

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
Descripción

ECG Monitoring - Supine - Comments

Tipo de datos

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
Descripción

Safety ECG Monitoring - Supine

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

ECG Monitoring - Supine - Study Time

Tipo de datos

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
Descripción

ECG Monitoring - Supine - Date

Tipo de datos

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
Descripción

ECG Monitoring - Supine - Actual Time

Tipo de datos

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?
Descripción

ECG Monitoring - Supine - ECG normal?

Tipo de datos

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
Descripción

ECG Monitoring - Supine - Comments

Tipo de datos

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
Descripción

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
Descripción

Research Physician’s Signature

Tipo de datos

text

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

Research Physician’s Signature - Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C0011008
Volver a la parte superior de la página

Similar models

Dosing Details; ECG Monitoring; Safety ECG Monitoring

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial