ID

43762

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2017-06-19 2017-06-19 -
  2. 2017-06-19 2017-06-19 -
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Creative Commons BY-NC 3.0
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Follow-up - GSK Milveterol COPD 100527

Engelsk

Follow-up - GSK Milveterol COPD 100527

1 Formulär  
Vital Signs (Follow-up)
Beskrivning

Vital Signs (Follow-up)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1522577
Row number
Beskrivning

Sequence number

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0518766
Date
Beskrivning

Date of vital signs

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826644
dd.mm.yyyy
Time relative to dosing
Beskrivning

Time relative to dosing

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Actual time
Beskrivning

Time of measurement

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
hh:mm
Systolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
Beskrivning

SBP

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
Beskrivning

DBP

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (Heart rate measurement must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-Lead Electrocardiogram (Follow-up)
Beskrivning

12-Lead Electrocardiogram (Follow-up)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1522577
Row number (ECG measurements to be taken with the subject in a SUPINE position, having rested in this position for at least 10 minutes before each reading.)
Beskrivning

Sequence number

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0430456
Date
Beskrivning

Date of ECG

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826640
dd.mm.yyyy
Time relative to dosing
Beskrivning

Time relative to dosing

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Actual time
Beskrivning

Time of ECG

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
hh:mm
Ventricular rate
Beskrivning

Ventricular rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT Interval
Beskrivning

QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG finding
Beskrivning

ECG finding

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Is the abnormality clinically significant?
Beskrivning

ECG abnormality clinically significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2985739
Hematology Data (Follow-up)
Beskrivning

Hematology Data (Follow-up)

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C1522577
Lab code
Beskrivning

Lab code

Datatyp

integer

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

Date hematology sample taken

Datatyp

date

Måttenheter
  • 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
Beskrivning

Time of blood sample

Datatyp

time

Måttenheter
  • 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?
Beskrivning

Hematology abnormality

Datatyp

boolean

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

Hematology test

Datatyp

integer

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

Hematology test result

Datatyp

float

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

clinically significant abnormality reason

Datatyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Clinical Chemistry Data (Follow-up)
Beskrivning

Clinical Chemistry Data (Follow-up)

Alias
UMLS CUI-1
C2347783
UMLS CUI-2
C1522577
Lab code
Beskrivning

Lab code

Datatyp

integer

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

Date clinical chemistry sample taken

Datatyp

date

Måttenheter
  • 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
Beskrivning

Time of sample

Datatyp

time

Måttenheter
  • 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?
Beskrivning

clinically significant clinical chemistry abnormalities

Datatyp

boolean

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

Clinical chemistry test

Datatyp

integer

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

Clinical chemistry test result

Datatyp

float

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

clinically significant abnormality reason

Datatyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
Urinalysis (Follow-up)
Beskrivning

Urinalysis (Follow-up)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C1522577
Lab code
Beskrivning

Lab code

Datatyp

integer

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

Date sample taken

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0042036
dd.mm.yyyy
Time of sample
Beskrivning

Time sample taken

Datatyp

time

Måttenheter
  • 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?
Beskrivning

clinically significant urinalysis abnormalities

Datatyp

boolean

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

Urinalysis dipstick

Datatyp

integer

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

Dipstick test result

Datatyp

integer

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

clinically significant abnormality reason

Datatyp

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.)
Beskrivning

Sedimentary microscopy test

Datatyp

integer

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

Sedimentary microscopy test result

Datatyp

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:
Beskrivning

clinically significant abnormality reason

Datatyp

integer

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0566251
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Similar models

Follow-up - GSK Milveterol COPD 100527

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Vital Signs (Follow-up)
C0518766 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Date of vital signs
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Time relative to dosing
Code List
Time relative to dosing
CL Item
Follow-up (1)
CL Item
Unscheduled (2)
Time of measurement
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
SBP
Item
Systolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
integer
C0871470 (UMLS CUI [1])
DBP
Item
Diastolic blood pressure (Blood pressure measurements must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (Heart rate measurement must be taken with the subject in a SUPINE position, having rested in this position for 10 minutes.)
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead Electrocardiogram (Follow-up)
C0430456 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Sequence number
Item
Row number (ECG measurements to be taken with the subject in a SUPINE position, having rested in this position for at least 10 minutes before each reading.)
integer
C2348184 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Date of ECG
Item
Date
date
C2826640 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Time relative to dosing
Code List
Time relative to dosing
CL Item
Follow-up (1)
CL Item
Unscheduled (2)
Time of ECG
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Ventricular rate
Item
Ventricular rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
QT Interval
Item
QT Interval
integer
C0577807 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0855331 (UMLS CUI [1])
Item
ECG finding
integer
C0438154 (UMLS CUI [1])
ECG finding
Code List
ECG finding
CL Item
Normal (1)
CL Item
Abnormalities present (2)
ECG abnormality clinically significant
Item
Is the abnormality clinically significant?
boolean
C0522055 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Item Group
Hematology Data (Follow-up)
C0474523 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
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 (Follow-up)
C2347783 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
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 (Follow-up)
C0042014 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
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)
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