ID

43753

Beschreibung

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

Stichworte

Versionen (2)
  1. 19.06.17 19.06.17 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527

Englisch

Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527

1 Formulare  
Vital Signs (Treatment Period 3, Day 3-6)
Beschreibung

Vital Signs (Treatment Period 3, Day 3-6)

Alias
UMLS CUI-1
C0518766
Row number (HR and BP measurements to be taken prior to lung function tests.)
Beschreibung

Sequence number

Datentyp

integer

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

Date of vital signs

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826644
dd.mm.yyyy
Study day
Beschreibung

Study day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Time relative to dosing
Beschreibung

Time relative to dosing

Datentyp

integer

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

Time of measurement

Datentyp

time

Maßeinheiten
  • 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.)
Beschreibung

SBP

Datentyp

integer

Maßeinheiten
  • 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.)
Beschreibung

DBP

Datentyp

integer

Maßeinheiten
  • 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.)
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-Lead Electrocardiogram (Treatment period 3, Day 3-6)
Beschreibung

12-Lead Electrocardiogram (Treatment period 3, Day 3-6)

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

Sequence number

Datentyp

integer

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

Date of ECG

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826640
dd.mm.yyyy
Study day
Beschreibung

Study day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Time relative to dosing
Beschreibung

Time relative to dosing

Datentyp

integer

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

Time of ECG

Datentyp

time

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

Ventricular rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT Interval
Beschreibung

QT Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG finding
Beschreibung

ECG finding

Datentyp

integer

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

ECG abnormality clinically significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2985739
FEV1 (Treatment Period 3, Day 3-6)
Beschreibung

FEV1 (Treatment Period 3, Day 3-6)

Alias
UMLS CUI-1
C0429706
Row number
Beschreibung

Sequence number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0429706
Date
Beschreibung

Date of FEV1

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0429706
dd.mm.yyyy
Study day
Beschreibung

Study day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Time relative to dosing
Beschreibung

Time relative to dosing

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Actual time of first reading
Beschreibung

Time of FEV1 measurement

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0429706
hh:mm
Reading 1
Beschreibung

Reading 1

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Reading 2
Beschreibung

Reading 2

Datentyp

float

Maßeinheiten
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Pharmacokinetic sampling (Treatment Period 3, Day 5-6)
Beschreibung

Pharmacokinetic sampling (Treatment Period 3, Day 5-6)

Alias
UMLS CUI-1
C0201734
Row number
Beschreibung

Sequence number pharmacokinetic study

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0201734
Date
Beschreibung

Date of pharmacokinetic study

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0201734
dd.mm.yyyy
Study day
Beschreibung

Study day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Time relative to dosing
Beschreibung

Time relative to dosing

Datentyp

integer

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

Time of pharmacokinetic study

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0201734
hh:mm
Sample number
Beschreibung

Sample number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0201734
4mL blood sample taken
Beschreibung

Blood sample taken

Datentyp

boolean

Alias
UMLS CUI [1]
C1277698
Potassium (Treatment Period 3, Day 5-6)
Beschreibung

Potassium (Treatment Period 3, Day 5-6)

Alias
UMLS CUI-1
C0202194
Row number
Beschreibung

Sequence number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0202194
Date
Beschreibung

Date of measurement

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0202194
dd.mm.yyyy
Study day
Beschreibung

Study day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Time relative to dosing
Beschreibung

Time relative to dosing

Datentyp

integer

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

Time of measurement

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0202194
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0337438
hh:mm
Result
Beschreibung

Test result

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0202194
mmol/L
Investigational Product (Treatment period 3, Day 3-6)
Beschreibung

Investigational Product (Treatment period 3, Day 3-6)

Alias
UMLS CUI-1
C0304229
Date of dose
Beschreibung

Date of dose

Datentyp

date

Maßeinheiten
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
dd.mm.yyyy
Study day
Beschreibung

Study day

Datentyp

integer

Alias
UMLS CUI [1]
C2826182
Start time of inhalation
Beschreibung

Start time of inhalation

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0001559
hh:mm
End time of inhalation
Beschreibung

End time of inhalation

Datentyp

time

Maßeinheiten
  • hh:mm
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0001559
hh:mm
Were there any significant changes to investigational product (investigational product not administered as per the requirements of the protocol)?
Beschreibung

investigational product change of administration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0443172
If 'Yes', specify investigational product changes, dates, and reasons:
Beschreibung

Specification investigational product change of administration

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C0443172
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Ähnliche Modelle

Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Vital Signs (Treatment Period 3, Day 3-6)
C0518766 (UMLS CUI-1)
Sequence number
Item
Row number (HR and BP measurements to be taken prior to lung function tests.)
integer
C2348184 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Date of vital signs
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study day
Code List
Study day
CL Item
3 (1)
CL Item
4 (2)
CL Item
5 (3)
CL Item
6 (4)
CL Item
Unscheduled (5)
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
Pre-Dose (1)
CL Item
45 min (2)
CL Item
Unscheduled (3)
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 (Treatment period 3, Day 3-6)
C0430456 (UMLS CUI-1)
Sequence number
Item
Row number (ECG measurements to be taken prior to lung function tests 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
Study day
integer
C2826182 (UMLS CUI [1])
Study day
Code List
Study day
CL Item
3 (1)
CL Item
4 (2)
CL Item
5 (3)
CL Item
6 (4)
CL Item
Unscheduled (5)
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
Pre-Dose (1)
CL Item
45 min (2)
CL Item
Unscheduled (3)
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
FEV1 (Treatment Period 3, Day 3-6)
C0429706 (UMLS CUI-1)
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Date of FEV1
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study day
Code List
Study day
CL Item
3 (1)
CL Item
4 (2)
CL Item
5 (3)
CL Item
6 (4)
CL Item
Unscheduled (5)
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
Pre-Dose (1)
CL Item
Unscheduled (2)
Time of FEV1 measurement
Item
Actual time of first reading
time
C0040223 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Reading 1
Item
Reading 1
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Reading 2
Item
Reading 2
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item Group
Pharmacokinetic sampling (Treatment Period 3, Day 5-6)
C0201734 (UMLS CUI-1)
Sequence number pharmacokinetic study
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Date of pharmacokinetic study
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study day
Code List
Study day
CL Item
5 (1)
CL Item
6 (2)
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Time relative to dose
Code List
Time relative to dosing
CL Item
45 min (1)
Time of pharmacokinetic study
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Sample number
Item
Sample number
integer
C1299222 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Blood sample taken
Item
4mL blood sample taken
boolean
C1277698 (UMLS CUI [1])
Item Group
Potassium (Treatment Period 3, Day 5-6)
C0202194 (UMLS CUI-1)
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Date of measurement
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study day
Code List
Study day
CL Item
5 (1)
CL Item
6 (2)
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
45 min (1)
Time of measurement
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
Test result
Item
Result
float
C0587081 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Item Group
Investigational Product (Treatment period 3, Day 3-6)
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Study day
integer
C2826182 (UMLS CUI [1])
Study day
Code List
Study day
CL Item
3 (1)
CL Item
4 (2)
CL Item
5 (3)
CL Item
6 (4)
Start time of inhalation
Item
Start time of inhalation
time
C1301880 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
End time of inhalation
Item
End time of inhalation
time
C1522314 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
investigational product change of administration
Item
Were there any significant changes to investigational product (investigational product not administered as per the requirements of the protocol)?
boolean
C0304229 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
Specification investigational product change of administration
Item
If 'Yes', specify investigational product changes, dates, and reasons:
text
C2348235 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
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