ID

34242

Beschrijving

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

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Versies (1)
  1. 15-01-19 15-01-19 -
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GlaxoSmithKline

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15 januari 2019

DOI

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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)

Engels

Laboratory Data

1 Formulieren  
  1. StudyEvent: ODM
    1. Laboratory Data
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Session number
Beschrijving

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)

Datatype

text

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

Day numbers can only be selected in session 2.

Datatype

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0237753
Hematology Data
Beschrijving

Hematology Data

Alias
UMLS CUI-1
C0474523
Lab code
Beschrijving

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

Datatype

text

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

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

Datatype

date

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

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

Datatype

time

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

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.

Datatype

boolean

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

Abnormal hematology parameters

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Primary reason for hematology abnormality

Datatype

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
Beschrijving

Clinical Chemistry Data

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

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

Datatype

text

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

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

Datatype

date

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

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

Datatype

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?
Beschrijving

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.

Datatype

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)
Beschrijving

Abnormal clinical chemistry parameters

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Primary reason for clinical chemistry abnormality

Datatype

text

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

Urinalysis

Alias
UMLS CUI-1
C0042014
Day urinalysis sample taken
Beschrijving

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

Datatype

date

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

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

Datatype

time

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

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.

Datatype

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)
Beschrijving

Abnormal dip-sticks parameters

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Primary reason for urinalysis abnormality in dip-sticks

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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 Formulieren
  1. StudyEvent: ODM
    1. Laboratory Data
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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