ID

34118

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. This form contains information about lung function tests during Treatment Period. It has to be filled in in Session 2.

Keywords

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

GlaxoSmithKline

Uploaded on

January 14, 2019

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License

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

English

Lung function tests: Treatment Period

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
Day number
Description

Day number

Data type

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0439228
Lung function tests (FEV1): Treatment period
Description

Lung function tests (FEV1): Treatment period

Alias
UMLS CUI-1
C0024119
UMLS CUI-2
C0748133
UMLS CUI-3
C2347804
Row number
Description

Row number

Data type

integer

Alias
UMLS CUI [1]
C2348184
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0748133
Planned relative time
Description

Time relative to dosing. Measurements at Pre-dose, 1hr and 3hrs should be entered.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0748133
Actual time of first reading
Description

Actual time of first reading

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C0748133
Reading 1
Description

Reading 1

Data type

float

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0748133
Reading 2
Description

Reading 2

Data type

float

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0748133
Reading 3
Description

Reading 3

Data type

float

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0748133
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Similar models

Lung function tests: Treatment Period

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
Day number
integer
C0750729 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Day number
Code List
Day number
CL Item
1 (1)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
5 (5)
(Comment:en)
CL Item
8 (8)
(Comment:en)
CL Item
10 (10)
(Comment:en)
CL Item
12 (12)
(Comment:en)
Item Group
Lung function tests (FEV1): Treatment period
C0024119 (UMLS CUI-1)
C0748133 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Item
Planned relative time
text
C0439564 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
Pre-dose (Pre-dose)
CL Item
1hr (1hr)
CL Item
3hrs (3hrs)
Actual time of first reading
Item
Actual time of first reading
time
C1301880 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
Reading 1
Item
Reading 1
float
C0242485 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Reading 2
Item
Reading 2
float
C0242485 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Reading 3
Item
Reading 3
float
C0242485 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
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