Información:
Error:
ID
41252
Descripción
Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)
Palabras clave
Versiones (1)
- 24/7/20 24/7/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
24 de julio de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 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.
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.
Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)
24 Hrs Holter ECG; 12-Lead ECG
- StudyEvent: ODM
Similar models
24 Hrs Holter ECG; 12-Lead ECG
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
24 Hrs Holter ECG (Screening)
C0013801 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
C0220908 (UMLS CUI-2)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start Time of Holter
Item
Start Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
End Time of Holter
Item
End Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Mean HR
Item
Mean HR
integer
C1881634 (UMLS CUI [1])
Item
Result of the Holter
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
24 Hrs Holter ECG (Lead II Monitoring) - 0 hr - 6 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)
C0013801 (UMLS CUI-1)
C2347804 (UMLS CUI-2)
C2347804 (UMLS CUI-2)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start Time of Holter
Item
Start Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
End Time of Holter
Item
End Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Mean HR
Item
Mean HR
integer
C1881634 (UMLS CUI [1])
Item
Result of the Holter
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
24 Hrs Holter ECG - 0 hr - 24 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)
C0013801 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
C0439568 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start Time of Holter
Item
Start Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
End Time of Holter
Item
End Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Mean HR
Item
Mean HR
integer
C1881634 (UMLS CUI [1])
Item
Result of the Holter
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
12-Lead ECG (Screening)
C0430456 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
C0220908 (UMLS CUI-2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
CL Item
Screening (1)
CL Item
Unscheduled (2)
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
integer
C1880451 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
12-Lead ECG (Mean Calculation) (Screening)
C0430456 (UMLS CUI-1)
C0444504 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
C0444504 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
Screening - QTc Interval
Item
Screening - QTc Interval
integer
C0489625 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
Screening - Is the reading within acceptable limits?
Item
Screening - Is the reading within acceptable limits?
boolean
C0220908 (UMLS CUI [1])
C0456984 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0456984 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
Mean screening - QTc Interval
Item
Mean screening - QTc Interval
integer
C0444504 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2])
C0220908 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2])
Mean screening - QTc Interval - 10%
Item
Mean screening - QTc Interval - 10%
integer
C0220908 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0444504 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Mean screening - QTc Interval + 10%
Item
Mean screening - QTc Interval + 10%
integer
C0220908 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0444504 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Item Group
12-Lead ECG (Treatment Period 1, 2, 3, 4, 5)
C0430456 (UMLS CUI-1)
C2347804 (UMLS CUI-2)
C2347804 (UMLS CUI-2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
CL Item
Pre-dose (1)
CL Item
15 mins (2)
CL Item
45 mins (3)
CL Item
1.5 hrs (4)
CL Item
4 hrs (5)
CL Item
8 hrs (6)
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
integer
C1880451 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
12-Lead ECG (Follow-Up)
C0430456 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C1522577 (UMLS CUI-2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
CL Item
Follow-Up (1)
CL Item
Unscheduled (2)
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
integer
C1880451 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)