ID

34242

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. 1/15/19 1/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 15, 2019

DOI

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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

Laboratory Data

1 forms  
  1. StudyEvent: ODM
    1. Laboratory Data
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Session number
Description

Session number 1: screening procedure. Session number 1.1: Repeat screening (unscheduled). Session number 2: Treatment period. Session number 3: Follow-up. Repeat: Repeat (unscheduled)

Data type

text

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]
C0439228
UMLS CUI [1,2]
C0237753
Hematology Data
Description

Hematology Data

Alias
UMLS CUI-1
C0474523
Lab code
Description

For GSK use only. This item has to be filled in only once for one session respectively one study day.

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Day hematology sample taken
Description

This item has to be filled in only once for one session respectively one study day.

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0474523
Time of sample
Description

This item has to be filled in only once for one session respectively one study day.

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0474523
Were there any clinically significant hematology abnormalities?
Description

if NO, the following questions should not be answered. This item has to be filled in only once for one session respectively one study day.

Data type

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
If YES, choose abnormal hematology parameter(s)
Description

Abnormal hematology parameters

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0549193
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2985739
Record primary reason for clinically significant hematology abnormality
Description

This item has to be filled in only, if the previous question was answered YES.

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
UMLS CUI [1,4]
C1549995
If answer 'X' was choosen as primary reason, specify abnormality in hematology parameter
Description

Primary reason for hematology abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
UMLS CUI [1,4]
C1549995
Clinical Chemistry Data
Description

Clinical Chemistry Data

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0243095
Lab code
Description

For GSK use only. This item has to be filled in only once for one session respectively one study day.

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Day clinical chemistry sample taken
Description

This item has to be filled in only once for one session respectively one study day.

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
Time of sample
Description

This item has to be filled in only once for one session respectively one study day.

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
Were there any clinically significant clinical chemistry abnormalities?
Description

if NO, the following questions should not be answered. This item has to be filled in only once for one session respectively one study day.

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
If YES, choose abnormal clinical chemistry parameter(s)
Description

Abnormal clinical chemistry parameters

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0549193
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2985739
Record primary reason for clinical chemistry abnormality
Description

This item has to be filled in only, if the previous question was answered YES.

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
UMLS CUI [1,4]
C1549995
If answer 'X' was choosen as primary reason, specify abnormality in clinical chemistry parameter
Description

Primary reason for clinical chemistry abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
UMLS CUI [1,4]
C1549995
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Day urinalysis sample taken
Description

This item has to be filled in only once for one session respectively one study day.

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0042014
Time of sample
Description

This item has to be filled in only once for one session respectively one study day.

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0042014
Were there any clinically significant urinalysis abnormalities?
Description

if NO, the following questions should not be answered. This item has to be filled in only once for one session respectively one study day.

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
If YES, choose abnormal dip-sticks parameter(s)
Description

Abnormal dip-sticks parameters

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1160927
UMLS CUI [1,3]
C0549193
UMLS CUI [1,4]
C1704258
UMLS CUI [1,5]
C2985739
Record primary reason for clinically significant urinalysis abnormality in dip-sticks
Description

This item has to be filled in only, if the previous question was answered YES.

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1160927
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2985739
UMLS CUI [1,5]
C1549995
If answer 'X' was choosen as primary reason, specify abnormality in dip-sticks parameter
Description

Primary reason for urinalysis abnormality in dip-sticks

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1160927
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2985739
UMLS CUI [1,5]
C1549995
Choose abnormal urinalysis sedimentary microscopy parameter(s)
Description

Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.

Data type

text

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
Record primary reason for abnormality in sedimentary microscopy
Description

Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2985739
UMLS CUI [1,5]
C1549995
If answer 'X' was choosen as primary reason, specify abnormality in urinalysis sedimentary microscopy parameter choosen above.
Description

Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2700128
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2985739
UMLS CUI [1,5]
C1549995
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Similar models

Laboratory Data

1 forms
  1. StudyEvent: ODM
    1. Laboratory Data
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Session number
text
C1883017 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Session number
Code List
Session number
CL Item
1 (1)
(Comment:en)
CL Item
1.1 (1.1)
(Comment:en)
CL Item
2 (2)
(Comment:en)
CL Item
3 (3)
(Comment:en)
CL Item
Repeat (Repeat)
Item
Day number
integer
C0439228 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Day number
Code List
Day number
CL Item
1 (1)
(Comment:en)
CL Item
7 (7)
(Comment:en)
CL Item
14 (14)
(Comment:en)
Item Group
Hematology Data
C0474523 (UMLS CUI-1)
Lab code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Day hematology sample taken
Item
Day hematology sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
Clinically significant hematology abnormalities
Item
Were there any clinically significant hematology abnormalities?
boolean
C0474523 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Item
If YES, choose abnormal hematology parameter(s)
text
C0474523 (UMLS CUI [1,1])
C0549193 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
Clinically significant hematology abnormality
Code List
If YES, choose abnormal hematology parameter(s)
CL Item
Hemoglobin  (Hemoglobin)
CL Item
Hematocrit  (Hematocrit)
CL Item
RBC (RBC)
CL Item
MCH (MCH)
CL Item
MCHC (MCHC)
CL Item
Platelets (Platelets)
CL Item
Total WBC (Total WBC)
CL Item
Neutrophils (Neutrophils)
CL Item
Lymphocytes (Lymphocytes)
CL Item
Monocytes (Monocytes)
CL Item
Eosinophils (Eosinophils)
CL Item
Basophils (Basophils)
Item
Record primary reason for clinically significant hematology abnormality
text
C0474523 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
Hematology abnormality present
Code List
Record primary reason for clinically significant hematology abnormality
CL Item
Due to disease under study (D)
(Comment:en)
CL Item
Due to other concurrent disease (C)
(Comment:en)
CL Item
Reasonable possibility due to investigational product (T)
(Comment:en)
CL Item
Reasonable possibility due to other concomitant medication (M)
(Comment:en)
CL Item
Other, specify in the following item (X)
(Comment:en)
Primary reason for hematology abnormality
Item
If answer 'X' was choosen as primary reason, specify abnormality in hematology parameter
text
C0474523 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
Item Group
Clinical Chemistry Data
C0008000 (UMLS CUI-1)
C0243095 (UMLS CUI-2)
Lab code
Item
Lab code
text
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Day clinical chemistry sample taken
Item
Day clinical chemistry sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Clinically significant clinical chemistry abnormalities
Item
Were there any clinically significant clinical chemistry abnormalities?
boolean
C0008000 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Item
If YES, choose abnormal clinical chemistry parameter(s)
text
C0008000 (UMLS CUI [1,1])
C0549193 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
Clinically significant hematology abnormality
Code List
If YES, choose abnormal clinical chemistry parameter(s)
CL Item
Sodium (Sodium)
CL Item
Potassium (Potassium)
CL Item
Chloride (Chloride)
CL Item
Calcium (Calcium)
CL Item
Glucose (Glucose)
CL Item
CPK (CPK)
CL Item
Creatinine (Creatinine)
CL Item
Urea (Urea)
CL Item
Total bilirubin (Total bilirubin)
CL Item
Alkaline Phosphatase (Alkaline Phosphatase)
CL Item
AST (SGOT) (AST (SGOT))
CL Item
ALT (SGPT) (ALT (SGPT))
CL Item
GGT (GGT)
CL Item
LDH (LDH)
CL Item
CK-MB (CK-MB)
CL Item
Troponin I (Troponin I)
Item
Record primary reason for clinical chemistry abnormality
text
C0008000 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
Hematology abnormality present
Code List
Record primary reason for clinical chemistry abnormality
CL Item
Due to disease under study (D)
(Comment:en)
CL Item
Due to other concurrent disease (C)
(Comment:en)
CL Item
Reasonable possibility due to investigational product (T)
(Comment:en)
CL Item
Reasonable possibility due to other concomitant medication (M)
(Comment:en)
CL Item
Other, specify in the following item (X)
(Comment:en)
Primary reason for clinical chemistry abnormality
Item
If answer 'X' was choosen as primary reason, specify abnormality in clinical chemistry parameter
text
C0008000 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,4])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Day urinalysis sample taken
Item
Day urinalysis sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Clinically significant urinalysis abnormalities
Item
Were there any clinically significant urinalysis abnormalities?
boolean
C0042014 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Item
If YES, choose abnormal dip-sticks parameter(s)
text
C0042014 (UMLS CUI [1,1])
C1160927 (UMLS CUI [1,2])
C0549193 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
C2985739 (UMLS CUI [1,5])
Clinically significant hematology abnormality
Code List
If YES, choose abnormal dip-sticks parameter(s)
CL Item
Protein (Protein)
CL Item
Blood (Blood)
CL Item
Ketones (Ketones)
CL Item
Glucose (Glucose)
CL Item
Bilirubin (Bilirubin)
CL Item
Leucocytes (Leucocytes)
Item
Record primary reason for clinically significant urinalysis abnormality in dip-sticks
text
C0042014 (UMLS CUI [1,1])
C1160927 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
Hematology abnormality present
Code List
Record primary reason for clinically significant urinalysis abnormality in dip-sticks
CL Item
Due to disease under study (D)
(Comment:en)
CL Item
Due to other concurrent disease (C)
(Comment:en)
CL Item
Reasonable possibility due to investigational product (T)
(Comment:en)
CL Item
Reasonable possibility due to other concomitant medication (M)
(Comment:en)
CL Item
Other, specify in the following item (X)
(Comment:en)
Primary reason for urinalysis abnormality in dip-sticks
Item
If answer 'X' was choosen as primary reason, specify abnormality in dip-sticks parameter
text
C0042014 (UMLS CUI [1,1])
C1160927 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
Item
Choose abnormal urinalysis sedimentary microscopy parameter(s)
text
C2700128 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Clinically significant urinalysis abnormality in Sedimentary microscopy
Code List
Choose abnormal urinalysis sedimentary microscopy parameter(s)
CL Item
WBC (WBC)
CL Item
RBC (RBC)
CL Item
Hyaline casts (Hyaline casts)
CL Item
Granular casts (Granular casts)
CL Item
Cellular casts (Cellular casts)
Item
Record primary reason for abnormality in sedimentary microscopy
text
C0042014 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
Hematology abnormality present
Code List
Record primary reason for abnormality in sedimentary microscopy
CL Item
Due to disease under study (D)
(Comment:en)
CL Item
Due to other concurrent disease (C)
(Comment:en)
CL Item
Reasonable possibility due to investigational product (T)
(Comment:en)
CL Item
Reasonable possibility due to other concomitant medication (M)
(Comment:en)
CL Item
Other, specify in the following item (X)
(Comment:en)
Primary reason for abnormality in sedimentary microscopy
Item
If answer 'X' was choosen as primary reason, specify abnormality in urinalysis sedimentary microscopy parameter choosen above.
text
C0042014 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C1549995 (UMLS CUI [1,5])
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