ID

41252

Description

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)

Keywords

Versions (1)
  1. 7/24/20 7/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 24, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

English

24 Hrs Holter ECG; 12-Lead ECG

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
24 Hrs Holter ECG (Screening)
Description

24 Hrs Holter ECG (Screening)

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0220908
Start Date of Holter
Description

Start Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time of Holter
Description

Start Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
End Date of Holter
Description

End Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
End Time of Holter
Description

End Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Mean HR
Description

Mean HR

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C1881634
beats/min
Result of the Holter
Description

Check one

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1274040
24 Hrs Holter ECG (Lead II Monitoring) - 0 hr - 6 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)
Description

24 Hrs Holter ECG (Lead II Monitoring) - 0 hr - 6 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C2347804
Start Date of Holter
Description

Start Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time of Holter
Description

Start Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
End Date of Holter
Description

End Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
End Time of Holter
Description

End Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Mean HR
Description

Mean HR

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C1881634
beats/min
Result of the Holter
Description

Check one

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1274040
24 Hrs Holter ECG - 0 hr - 24 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)
Description

24 Hrs Holter ECG - 0 hr - 24 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0439568
UMLS CUI-3
C2347804
Start Date of Holter
Description

Start Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time of Holter
Description

Start Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
End Date of Holter
Description

End Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
End Time of Holter
Description

End Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Mean HR
Description

Mean HR

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C1881634
beats/min
Result of the Holter
Description

Check one

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1274040
12-Lead ECG (Screening)
Description

12-Lead ECG (Screening)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0220908
Start Date of ECG
Description

Start Date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
C0439564
Start Time of ECG
Description

Start Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Description

Ventricular Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval
Description

QRS Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1880451
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG (Mean Calculation) (Screening)
Description

12-Lead ECG (Mean Calculation) (Screening)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0444504
UMLS CUI-3
C0220908
Screening - QTc Interval
Description

Screening - QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0220908
ms
Screening - Is the reading within acceptable limits?
Description

Screening - Is the reading within acceptable limits?

Data type

boolean

Alias
UMLS CUI [1]
C0220908
UMLS CUI [2,1]
C0456984
UMLS CUI [2,2]
C1879533
Mean screening - QTc Interval
Description

Mean screening - QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0444504
UMLS CUI [1,2]
C0220908
UMLS CUI [2]
C0489625
ms
Mean screening - QTc Interval - 10%
Description

Mean screening - QTc Interval - 10%

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0489625
UMLS CUI [2,2]
C0439165
ms
Mean screening - QTc Interval + 10%
Description

Mean screening - QTc Interval + 10%

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0489625
UMLS CUI [2,2]
C0439165
ms
12-Lead ECG (Treatment Period 1, 2, 3, 4, 5)
Description

12-Lead ECG (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C2347804
Start Date of ECG
Description

Start Date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
C0439564
Start Time of ECG
Description

Start Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Description

Ventricular Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval
Description

QRS Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1880451
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG (Follow-Up)
Description

12-Lead ECG (Follow-Up)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1522577
Start Date of ECG
Description

Start Date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
C0439564
Start Time of ECG
Description

Start Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Description

Ventricular Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval
Description

QRS Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1880451
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Back to the top of the page

Similar models

24 Hrs Holter ECG; 12-Lead ECG

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
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)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
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])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
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])
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])
Result of the Holter
Code List
Result of the Holter
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)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
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])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
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])
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])
Result of the Holter
Code List
Result of the Holter
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)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
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])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
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])
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])
Result of the Holter
Code List
Result of the Holter
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)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
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])
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])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
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)
Screening - QTc Interval
Item
Screening - QTc Interval
integer
C0489625 (UMLS CUI [1,1])
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])
Mean screening - QTc Interval
Item
Mean screening - QTc Interval
integer
C0444504 (UMLS CUI [1,1])
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])
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])
Item Group
12-Lead ECG (Treatment Period 1, 2, 3, 4, 5)
C0430456 (UMLS CUI-1)
C2347804 (UMLS CUI-2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
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])
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])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
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)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
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])
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])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal  (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal - clinically significant  (3)
CL Item
No result (not available) (4)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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