ID

34111

Description

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (1)
  1. 1/14/19 1/14/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 14, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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 :

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

Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

English

24hrs Holter Monitoring

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Session number
Description

Session number 1 means screening procedure.

Data type

integer

Alias
UMLS CUI [1,1]
C1883017
UMLS CUI [1,2]
C0750480
Day number
Description

Day numbers can only be selected in Session 2.

Data type

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0439228
24hrs Holter Monitoring
Description

24hrs Holter Monitoring

Alias
UMLS CUI-1
C2046759
Start date
Description

Start date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2046759
Planned relative time
Description

Time relative to dosing. Screening should be selected in Session number 1, 0-24hrs in Session number 2.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C2046759
Actual time monitoring commenced
Description

Actual time monitoring commenced

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2046759
Stop date
Description

Stop date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2046759
Actual time monitoring completed
Description

Actual time monitoring completed

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C2046759
Maximum HR
Description

HR means Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C2046759
beats/min
Minimum HR
Description

HR means Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1524031
UMLS CUI [1,3]
C2046759
beats/min
Mean HR
Description

HR means Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C2046759
beats/min
Number of QRS complexes
Description

Number of QRS complexes

Data type

text

Alias
UMLS CUI [1,1]
C1287080
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of supraventricular ectopics
Description

Number of supraventricular ectopics

Data type

integer

Alias
UMLS CUI [1,1]
C0033036
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of ventricular ectopics
Description

Number of ventricular ectopics

Data type

integer

Alias
UMLS CUI [1,1]
C0428994
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of ventricular couplets
Description

Number of ventricular couplets

Data type

integer

Alias
UMLS CUI [1,1]
C0429001
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of ventricular triplets
Description

Number of ventricular triplets

Data type

integer

Alias
UMLS CUI [1,1]
C4087466
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Number of ventricular runs
Description

Number of ventricular runs

Data type

integer

Alias
UMLS CUI [1,1]
C0042514
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2046759
Were any clinically significant abnormalities observed?
Description

Session 1: If YES, record abnormality as an Adverse Event on the ADVERSE EVENT FORM. Session 2: If YES, record abnormality as an Adverse Event on the ADVERSE EVENT FORM.

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C2046759
QTc Results.
Description

QTc Results.

Alias
UMLS CUI-1
C0489625
UMLS CUI-2
C2046759
Row number
Description

Row number

Data type

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0489625
UMLS CUI [1,3]
C2046759
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0489625
UMLS CUI [1,3]
C2046759
Planned relative time. Perform a measurement at each time specified.
Description

Time relative to dosing.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0489625
UMLS CUI [1,3]
C2046759
Mean
Description

Mean

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0444504
UMLS CUI [1,2]
C0489625
UMLS CUI [1,3]
C2046759
msec
Back to the top of the page

Similar models

24hrs Holter Monitoring

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Session number
integer
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session number
Code List
Session number
CL Item
1 (1)
CL Item
2 (2)
Item
Day number
integer
C0750729 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Day number
Code List
Day number
CL Item
2 (2)
CL Item
4 (4)
CL Item
6 (6)
CL Item
9 (9)
CL Item
11 (11)
CL Item
13 (13)
Item Group
24hrs Holter Monitoring
C2046759 (UMLS CUI-1)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Item
Planned relative time
text
C0439564 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
Screening (Screening)
CL Item
0-24hrs (0-24hrs)
Actual time monitoring commenced
Item
Actual time monitoring commenced
time
C1301880 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Actual time monitoring completed
Item
Actual time monitoring completed
time
C1522314 (UMLS CUI [1,1])
C2046759 (UMLS CUI [1,2])
Maximum HR
Item
Maximum HR
integer
C0018810 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Minimum HR
Item
Minimum HR
integer
C0018810 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Mean HR
Item
Mean HR
integer
C0018810 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of QRS complexes
Item
Number of QRS complexes
text
C1287080 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of supraventricular ectopics
Item
Number of supraventricular ectopics
integer
C0033036 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of ventricular ectopics
Item
Number of ventricular ectopics
integer
C0428994 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of ventricular couplets
Item
Number of ventricular couplets
integer
C0429001 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of ventricular triplets
Item
Number of ventricular triplets
integer
C4087466 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Number of ventricular runs
Item
Number of ventricular runs
integer
C0042514 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Clinically significant abnormalities
Item
Were any clinically significant abnormalities observed?
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Item Group
QTc Results.
C0489625 (UMLS CUI-1)
C2046759 (UMLS CUI-2)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Item
Planned relative time. Perform a measurement at each time specified.
text
C0439564 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
Planned relative time
Code List
Planned relative time. Perform a measurement at each time specified.
CL Item
-0.5hr-0.5hr (-0.5hr-0.5hr)
CL Item
0.5hr-1.5hrs (0.5hr-1.5hrs)
CL Item
1.5hrs-2.5hrs (1.5hrs-2.5hrs)
CL Item
2.5hrs-3.5hrs (2.5hrs-3.5hrs)
CL Item
3.5hrs-4.5hrs (3.5hrs-4.5hrs)
CL Item
4.5hrs-5.5hrs (4.5hrs-5.5hrs)
CL Item
5.5hrs-6.5hrs (5.5hrs-6.5hrs)
CL Item
11.5hrs-12.5hrs (11.5hrs-12.5hrs)
CL Item
7.5hrs-8.5hrs (7.5hrs-8.5hrs)
CL Item
8.5hrs-9.5hrs (8.5hrs-9.5hrs)
CL Item
9.5hrs-10.5hrs (9.5hrs-10.5hrs)
CL Item
12.5hrs-13.5hrs (12.5hrs-13.5hrs)
CL Item
13.5hrs-14.5hrs (13.5hrs-14.5hrs)
CL Item
14.5hrs-15.5hrs (14.5hrs-15.5hrs)
CL Item
15.5hrs-16.5hrs (15.5hrs-16.5hrs)
CL Item
18.5hrs-19.5hrs (18.5hrs-19.5hrs)
CL Item
6.5hrs-7.5hrs (6.5hrs-7.5hrs)
CL Item
10.5hrs-11.5hrs (10.5hrs-11.5hrs)
CL Item
16.5hrs-17.5hrs (16.5hrs-17.5hrs)
CL Item
17.5hrs-18.5hrs (17.5hrs-18.5hrs)
CL Item
19.5hrs-20.5hrs (19.5hrs-20.5hrs)
CL Item
20.5hrs-21.5hrs (20.5hrs-21.5hrs)
CL Item
21.5hrs-22.5hrs (21.5hrs-22.5hrs)
CL Item
22.5hrs-23.5hrs (22.5hrs-23.5hrs)
Mean
Item
Mean
integer
C0444504 (UMLS CUI [1,1])
C0489625 (UMLS CUI [1,2])
C2046759 (UMLS CUI [1,3])
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