ID

43753

Beschrijving

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

Trefwoorden

Versies (2)
  1. 19-06-17 19-06-17 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

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

1 Formulieren  
Vital Signs (Treatment Period 3, Day 3-6)
Beschrijving

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.)
Beschrijving

Sequence number

Datatype

integer

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

Date of vital signs

Datatype

date

Maateenheden
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826644
dd.mm.yyyy
Study day
Beschrijving

Study day

Datatype

integer

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

Time relative to dosing

Datatype

integer

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

Time of measurement

Datatype

time

Maateenheden
  • 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.)
Beschrijving

SBP

Datatype

integer

Maateenheden
  • 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.)
Beschrijving

DBP

Datatype

integer

Maateenheden
  • 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.)
Beschrijving

Heart rate

Datatype

integer

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

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.)
Beschrijving

Sequence number

Datatype

integer

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

Date of ECG

Datatype

date

Maateenheden
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C2826640
dd.mm.yyyy
Study day
Beschrijving

Study day

Datatype

integer

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

Time relative to dosing

Datatype

integer

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

Time of ECG

Datatype

time

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

Ventricular rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR Interval
Beschrijving

PR Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschrijving

QRS Duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT Interval
Beschrijving

QT Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Beschrijving

QTc Interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG finding
Beschrijving

ECG finding

Datatype

integer

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

ECG abnormality clinically significant

Datatype

boolean

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

FEV1 (Treatment Period 3, Day 3-6)

Alias
UMLS CUI-1
C0429706
Row number
Beschrijving

Sequence number

Datatype

integer

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

Date of FEV1

Datatype

date

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

Study day

Datatype

integer

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

Time relative to dosing

Datatype

integer

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

Time of FEV1 measurement

Datatype

time

Maateenheden
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0429706
hh:mm
Reading 1
Beschrijving

Reading 1

Datatype

float

Maateenheden
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Reading 2
Beschrijving

Reading 2

Datatype

float

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

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

Alias
UMLS CUI-1
C0201734
Row number
Beschrijving

Sequence number pharmacokinetic study

Datatype

integer

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

Date of pharmacokinetic study

Datatype

date

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

Study day

Datatype

integer

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

Time relative to dosing

Datatype

integer

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

Time of pharmacokinetic study

Datatype

time

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

Sample number

Datatype

integer

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

Blood sample taken

Datatype

boolean

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

Potassium (Treatment Period 3, Day 5-6)

Alias
UMLS CUI-1
C0202194
Row number
Beschrijving

Sequence number

Datatype

integer

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

Date of measurement

Datatype

date

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

Study day

Datatype

integer

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

Time relative to dosing

Datatype

integer

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

Time of measurement

Datatype

time

Maateenheden
  • 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
Beschrijving

Test result

Datatype

float

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

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

Alias
UMLS CUI-1
C0304229
Date of dose
Beschrijving

Date of dose

Datatype

date

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

Study day

Datatype

integer

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

Start time of inhalation

Datatype

time

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

End time of inhalation

Datatype

time

Maateenheden
  • 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)?
Beschrijving

investigational product change of administration

Datatype

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:
Beschrijving

Specification investigational product change of administration

Datatype

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C0443172
Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial