ID

22950

Description

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (1)
  1. 6/18/17 6/18/17 -
Uploaded on

June 18, 2017

DOI

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Repeat Screening (Unscheduled) - GSK Milveterol COPD 100527

English

Repeat Screening (Unscheduled) - GSK Milveterol COPD 100527

1 forms  
Hematology Data
Description

Hematology Data

Alias
UMLS CUI-1
C0474523
Lab code
Description

Lab code

Data type

integer

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

Date hematology sample taken

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0474523
dd.mm.yyyy
Time of sample
Description

Time of blood sample

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0040223
hh:mm
Were there any clinically significant hematology abnormalities?
Description

Hematology abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0850715
UMLS CUI [1,2]
C2985739
Hematology test
Description

Hematology test

Data type

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0332307
Hematology test result
Description

Hematology test result

Data type

float

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0587081
lf clinically significant, record primary reason for the clinically significant abnormality:
Description

clinically significant abnormality reason

Data type

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Clinical Chemistry Data
Description

Clinical Chemistry Data

Alias
UMLS CUI-1
C2347783
Lab code
Description

Lab code

Data type

integer

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

Date clinical chemistry sample taken

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
dd.mm.yyyy
Time of sample
Description

Time of sample

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
hh:mm
Were there any clinically significant clinical chemistry abnormalities?
Description

clinically significant clinical chemistry abnormalities

Data type

boolean

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1704258
Clinical chemistry test
Description

Clinical chemistry test

Data type

integer

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C0332307
Clinical chemistry test result
Description

Clinical chemistry test result

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
lf clinically significant, record primary reason for the clinically significant abnormality:
Description

clinically significant abnormality reason

Data type

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Lab code
Description

Lab code

Data type

integer

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

Date sample taken

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0042036
dd.mm.yyyy
Time of sample
Description

Time sample taken

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0042036
hh:mm
Were there any clinically significant urinalysis abnormalities?
Description

clinically significant urinalysis abnormalities

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C1704258
Dipstick test
Description

Urinalysis dipstick

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0332307
Dipstick test result
Description

Dipstick test result

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0587081
lf clinically significant, record primary reason for the clinically significant abnormality:
Description

clinically significant abnormality reason

Data type

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
Description

Sedimentary microscopy test

Data type

integer

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C0332307
Sedimentary microscopy test result
Description

Sedimentary microscopy test result

Data type

float

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C0587081
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Description

clinically significant abnormality reason

Data type

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
FEV1 / Reversibility Testing
Description

FEV1 / Reversibility Testing

Alias
UMLS CUI-1
C0024119
Row number
Description

Sequence number

Data type

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0024119
Date
Description

Date of lung function test

Data type

date

Measurement units
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0024119
dd.mm.yyyy
Test
Description

Lung function test

Data type

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0332307
Actual time of first reading
Description

Time of pulmonary function test

Data type

time

Measurement units
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0024119
hh:mm
Reading 1
Description

Reading 1

Data type

integer

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Reading 2
Description

Reading 2

Data type

integer

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Reading 3
Description

Reading 3

Data type

integer

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Highest reading FEV1 Pre-Salbutamol (A)
Description

Highest reading

Data type

integer

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0802965
UMLS CUI [1,4]
C0024119
Predicted normal FEV1 (B)
Description

Predicted normal

Data type

integer

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0802965
UMLS CUI [1,4]
C0024119
% Predicted value (A/B x 100)
Description

Percent of Predicted value

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C2239179
%
Highest reading FEV1 Post-Salbutamol (C)
Description

Highest reading

Data type

integer

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0802965
UMLS CUI [1,4]
C0024119
% Reversibility (C-A/A x 100)
Description

Percent of Reversibility

Data type

integer

Alias
UMLS CUI [1]
C3830088
Highest reading FEV1/FVC
Description

Highest reading FEV1/FVC

Data type

integer

Alias
UMLS CUI [1,1]
C1522410
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0429745
UMLS CUI [1,4]
C0024119
Is the pre-sambutamol FEV1 >60% of predicted?
Description

FEV1 percent of predicted value

Data type

boolean

Alias
UMLS CUI [1]
C2239179
Is there an increase in FEV 1 of ≥ 12% over baseline and an absolute change of ≥300ml within 30 minutes following 400µg salbutamol administration?
Description

FEV1, volume, reversibility post salbutamol

Data type

boolean

Alias
UMLS CUI [1,1]
C0802965
UMLS CUI [1,2]
C0449468
UMLS CUI [1,3]
C1271924
Is the post-salbutamol FEV1/FVC ratio ≥ 0.7?
Description

post-salbutamol FEV1/FVC ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C1271924
UMLS CUI [1,2]
C0429745
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Similar models

Repeat Screening (Unscheduled) - GSK Milveterol COPD 100527

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Hematology Data
C0474523 (UMLS CUI-1)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date hematology sample taken
Item
Date hematology sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
Time of blood sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Hematology abnormality
Item
Were there any clinically significant hematology abnormalities?
boolean
C0850715 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item
Hematology test
integer
C0018941 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Hematology test
Code List
Hematology test
CL Item
Hemoglobin (1)
CL Item
Hematocrit (PCV) (2)
CL Item
RBC (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
Platelets (7)
CL Item
Total WBC (8)
CL Item
Neutrophils (9)
CL Item
Lymphocytes (10)
CL Item
Monocytes (11)
CL Item
Eosinophils (12)
CL Item
Basophils (13)
Hematology test result
Item
Hematology test result
float
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
clinically significant abnormality reason
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item Group
Clinical Chemistry Data
C2347783 (UMLS CUI-1)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date clinical chemistry sample taken
Item
Date 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
C2985739 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Clinical chemistry test
integer
C0525044 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Clinical chemistry test
Code List
Clinical chemistry test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Calcium (4)
CL Item
Glucose (5)
CL Item
CPK (6)
CL Item
Creatinine (7)
CL Item
Urea (8)
CL Item
Total bilirubin (9)
CL Item
Alkaline Phosphatase (10)
CL Item
AST (SGOT) (11)
CL Item
ALT (SGPT) (12)
CL Item
GGT (13)
CL Item
LOH (14)
CL Item
CK-MB (15)
CL Item
Troponin T (16)
Clinical chemistry test result
Item
Clinical chemistry test result
float
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
clinically significant abnormality reason
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Lab code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
Time sample taken
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
clinically significant urinalysis abnormalities
Item
Were there any clinically significant urinalysis abnormalities?
boolean
C0042014 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Dipstick test
integer
C0430370 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Urinalysis dipstick
Code List
Dipstick test
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Bilirubin (5)
CL Item
Leucocytes (6)
Item
Dipstick test result
integer
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
undefined item
Code List
Dipstick test result
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ (3)
CL Item
++ (4)
CL Item
+++ (5)
CL Item
++++ (6)
Item
lf clinically significant, record primary reason for the clinically significant abnormality:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
clinically significant abnormality reason
Code List
lf clinically significant, record primary reason for the clinically significant abnormality:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
integer
C2700128 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Sedimentary microscopy test
Code List
Sedimentary microscopy test (Sedimentary microscopy should only be performed if any of the dip-stick results are abnormal.)
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Sedimentary microscopy test result
Item
Sedimentary microscopy test result
float
C2700128 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
integer
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
clinically significant abnormality reason
Code List
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
CL Item
D - Due to disease under study (1)
CL Item
C - Due to other concurrent disease (2)
CL Item
T - Reasonable possibility due to investigational product (3)
CL Item
M - Reasonable possibility due to other concomitant medication (4)
CL Item
X - Other (5)
Item Group
FEV1 / Reversibility Testing
C0024119 (UMLS CUI-1)
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Date of lung function test
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Item
Test
integer
C0024119 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Lung function test
Code List
Test
CL Item
FEV1 (L) Pre-Salbutamol (1)
CL Item
FEV1 (L) Post-Salbutamol (2)
CL Item
FVC (L) Post-Salbutamol (3)
CL Item
FEV1/FVC Post-Salbutamol (4)
Time of pulmonary function test
Item
Actual time of first reading
time
C0040223 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Reading 1
Item
Reading 1
integer
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Reading 2
Item
Reading 2
integer
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Reading 3
Item
Reading 3
integer
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Highest reading
Item
Highest reading FEV1 Pre-Salbutamol (A)
integer
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0802965 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
Predicted normal
Item
Predicted normal FEV1 (B)
integer
C0205307 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0802965 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
Percent of Predicted value
Item
% Predicted value (A/B x 100)
integer
C2239179 (UMLS CUI [1])
Highest reading
Item
Highest reading FEV1 Post-Salbutamol (C)
integer
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0802965 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
Percent of Reversibility
Item
% Reversibility (C-A/A x 100)
integer
C3830088 (UMLS CUI [1])
Highest reading FEV1/FVC
Item
Highest reading FEV1/FVC
integer
C1522410 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0429745 (UMLS CUI [1,3])
C0024119 (UMLS CUI [1,4])
FEV1 percent of predicted value
Item
Is the pre-sambutamol FEV1 >60% of predicted?
boolean
C2239179 (UMLS CUI [1])
FEV1, volume, reversibility post salbutamol
Item
Is there an increase in FEV 1 of ≥ 12% over baseline and an absolute change of ≥300ml within 30 minutes following 400µg salbutamol administration?
boolean
C0802965 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C1271924 (UMLS CUI [1,3])
post-salbutamol FEV1/FVC ratio
Item
Is the post-salbutamol FEV1/FVC ratio ≥ 0.7?
boolean
C1271924 (UMLS CUI [1,1])
C0429745 (UMLS CUI [1,2])
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