ID

43744

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 (4)
  1. 2017-06-18 2017-06-18 -
  2. 2017-06-19 2017-06-19 -
  3. 2017-06-19 2017-06-19 -
  4. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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Main CRF (Treatment Period 1, Day 1-2) - GSK Milveterol COPD 100527

Engelsk

Main CRF (Treatment Period 1, Day 1-2) - GSK Milveterol COPD 100527

1 Formulär  
Investigational Product (Treatment period 1, Day 1)
Beskrivning

Investigational Product (Treatment period 1, Day 1)

Alias
UMLS CUI-1
C0304229
Date of dose
Beskrivning

Date of dose

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
dd.mm.yyyy
Start time of inhalation
Beskrivning

Start time of inhalation

Datatyp

time

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

End time of inhalation

Datatyp

time

Måttenheter
  • 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)?
Beskrivning

investigational product change of administration

Datatyp

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:
Beskrivning

Specification investigational product change of administration

Datatyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C0443172
Investigational Product (Treatment period 1, Day 2)
Beskrivning

Investigational Product (Treatment period 1, Day 2)

Alias
UMLS CUI-1
C0304229
Date of dose
Beskrivning

Date of dose

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
dd.mm.yyyy
Start time of inhalation
Beskrivning

Start time of inhalation

Datatyp

time

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

End time of inhalation

Datatyp

time

Måttenheter
  • 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)?
Beskrivning

investigational product change of administration

Datatyp

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:
Beskrivning

Specification investigational product change of administration

Datatyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3469597
UMLS CUI [1,4]
C0443172
Hematology Data (Treatment Period 1, Day 1, Pre-dose)
Beskrivning

Hematology Data (Treatment Period 1, Day 1, Pre-dose)

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0332152
UMLS CUI-3
C0304229
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 (Treatment Period 1, Day 1, Pre-dose)
Beskrivning

Clinical Chemistry Data (Treatment Period 1, Day 1, Pre-dose)

Alias
UMLS CUI-1
C2347783
UMLS CUI-2
C0332152
UMLS CUI-3
C0304229
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 (Treatment Period 1, Day 1, Pre-dose)
Beskrivning

Urinalysis (Treatment Period 1, Day 1, Pre-dose)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0332152
UMLS CUI-3
C0304229
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
Vital Signs (Treatment Period 1, Day 1)
Beskrivning

Vital Signs (Treatment Period 1, Day 1)

Alias
UMLS CUI-1
C0518766
Row number (Three pre-dose measurements are to be taken at least 5 mins apart.)
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
Vital Signs (Treatment Period 1, Day 2)
Beskrivning

Vital Signs (Treatment Period 1, Day 2)

Alias
UMLS CUI-1
C0518766
Row number (Three measurements to be taken at least 5 minutes apart.)
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

Alias
UMLS CUI [1]
C0428883
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 (Treatment period 1, Day 1)
Beskrivning

12-Lead Electrocardiogram (Treatment period 1, Day 1)

Alias
UMLS CUI-1
C0430456
Row number (All measurements to be taken with the subject in a SUPINE position, having rested in this postion for at least 10 min.)
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
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0429025
dd.mm.yyyy
QT Interval
Beskrivning

QT Interval

Datatyp

integer

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0577807
dd.mm.yyyy
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0855331
dd.mm.yyyy
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
12-Lead Electrocardiogram (Treatment period 1, Day 2)
Beskrivning

12-Lead Electrocardiogram (Treatment period 1, Day 2)

Alias
UMLS CUI-1
C0430456
Row number (All measurements to be taken with the subject in a SUPINE position, having rested in this postion for at least 10 min.)
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
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0429025
dd.mm.yyyy
QT Interval
Beskrivning

QT Interval

Datatyp

integer

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0577807
dd.mm.yyyy
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1]
C0855331
dd.mm.yyyy
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
FEV1 (Treatment Period 1, Day 1)
Beskrivning

FEV1 (Treatment Period 1, Day 1)

Alias
UMLS CUI-1
C0429706
Row number
Beskrivning

Sequence number

Datatyp

integer

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

Date of FEV1

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0429706
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 of first reading
Beskrivning

Time of FEV1 measurement

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0429706
hh:mm
Reading 1
Beskrivning

Reading 1

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Reading 2
Beskrivning

Reading 2

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Reading 3
Beskrivning

Reading 3

Datatyp

float

Måttenheter
  • L
Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0429706
L
Pharmacokinetic sampling (Treatment Period 1, Day 1)
Beskrivning

Pharmacokinetic sampling (Treatment Period 1, Day 1)

Alias
UMLS CUI-1
C0201734
Row number
Beskrivning

Sequence number pharmacokinetic study

Datatyp

integer

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

Date of pharmacokinetic study

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0201734
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 pharmacokinetic study

Datatyp

time

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

Sample number

Datatyp

integer

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

Blood sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C1277698
Potassium and Glucose (Treatment Period 1, Day 1)
Beskrivning

Potassium and Glucose (Treatment Period 1, Day 1)

Alias
UMLS CUI-1
C0202194
UMLS CUI-2
C0337438
Row number
Beskrivning

Sequence number

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0202194
UMLS CUI [2,1]
C2348184
UMLS CUI [2,2]
C0337438
Date
Beskrivning

Date of measurement

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0202194
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0337438
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]
C0040223
UMLS CUI [1,2]
C0202194
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0337438
hh:mm
Test
Beskrivning

Test type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
Result
Beskrivning

Test result

Datatyp

float

Måttenheter
  • mmol/L
Alias
UMLS CUI [1]
C0587081
mmol/L
Pharmacokinetic Urine lnterval Collection Data (Treatment Period 1, Day 1)
Beskrivning

Pharmacokinetic Urine lnterval Collection Data (Treatment Period 1, Day 1)

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C1610733
Row number
Beskrivning

Sequence number Pharmacokinetic Urine lnterval Collection

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0201734
UMLS CUI [1,3]
C1610733
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
Start date
Beskrivning

Start date urine interval collection

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0200354
dd.mm.yyyy
Actual start time
Beskrivning

Start time urine interval collection

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0200354
hh:mm
Stop date
Beskrivning

Stop date urine interval collection

Datatyp

date

Måttenheter
  • dd.mm.yyyy
Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0200354
dd.mm.yyyy
Actual stop time
Beskrivning

End time urine interval collection

Datatyp

time

Måttenheter
  • hh:mm
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0200354
hh:mm
Sample number
Beskrivning

Sample number urine interval collection

Datatyp

integer

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0200354
Total sample volume
Beskrivning

Total sample volume urine interval collection

Datatyp

integer

Måttenheter
  • mL
Alias
UMLS CUI [1,1]
C1278293
UMLS CUI [1,2]
C0200354
mL
10 mL aliquot taken
Beskrivning

aliquot taken

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1510844
UMLS CUI [1,2]
C0200354
Was all urine collected for this interval?
Beskrivning

all urine collected for this interval

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
Hematology Data (Treatment Period 1, Day 1, 24 h Post-Dose)
Beskrivning

Hematology Data (Treatment Period 1, Day 1, 24 h Post-Dose)

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0687676
UMLS CUI-3
C0304229
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 (Treatment Period 1, Day 1, Post-dose)
Beskrivning

Clinical Chemistry Data (Treatment Period 1, Day 1, Post-dose)

Alias
UMLS CUI-1
C2347783
UMLS CUI-2
C0687676
UMLS CUI-3
C0304229
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 (Treatment Period 1, Day 1, Post-dose)
Beskrivning

Urinalysis (Treatment Period 1, Day 1, Post-dose)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0687676
UMLS CUI-3
C0304229
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
Tillbaka till toppen

Similar models

Main CRF (Treatment Period 1, Day 1-2) - GSK Milveterol COPD 100527

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Investigational Product (Treatment period 1, Day 1)
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])
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])
Item Group
Investigational Product (Treatment period 1, Day 2)
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])
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])
Item Group
Hematology Data (Treatment Period 1, Day 1, Pre-dose)
C0474523 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
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 (Treatment Period 1, Day 1, Pre-dose)
C2347783 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
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 (Treatment Period 1, Day 1, Pre-dose)
C0042014 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
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
Vital Signs (Treatment Period 1, Day 1)
C0518766 (UMLS CUI-1)
Sequence number
Item
Row number (Three pre-dose measurements are to be taken at least 5 mins apart.)
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
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
Mean Pre-Dose (Baseline) (4)
CL Item
15 min (5)
CL Item
30 min (6)
CL Item
1 h (7)
CL Item
2 h (8)
CL Item
3 h (9)
CL Item
4 h (10)
CL Item
5 h (11)
CL Item
6 h (12)
CL Item
8 h (13)
CL Item
10 h (14)
CL Item
12 h (15)
CL Item
14 h (16)
CL Item
16 h (17)
CL Item
22,5 h (18)
CL Item
24 h (19)
CL Item
Unscheduled (20)
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
Vital Signs (Treatment Period 1, Day 2)
C0518766 (UMLS CUI-1)
Sequence number
Item
Row number (Three measurements to be taken at least 5 minutes apart.)
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
45 min (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 (Treatment period 1, Day 1)
C0430456 (UMLS CUI-1)
Sequence number
Item
Row number (All measurements to be taken with the subject in a SUPINE position, having rested in this postion for at least 10 min.)
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
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
Mean Pre-Dose (Baseline) (4)
CL Item
15 min (5)
CL Item
30 min (6)
CL Item
1 h (7)
CL Item
2 h (8)
CL Item
3 h (9)
CL Item
4 h (10)
CL Item
5 h (11)
CL Item
6 h (12)
CL Item
8 h (13)
CL Item
10 h (14)
CL Item
12 h (15)
CL Item
24 h (16)
CL Item
Unscheduled (17)
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
12-Lead Electrocardiogram (Treatment period 1, Day 2)
C0430456 (UMLS CUI-1)
Sequence number
Item
Row number (All measurements to be taken with the subject in a SUPINE position, having rested in this postion for at least 10 min.)
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
45 min (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
FEV1 (Treatment Period 1, Day 1)
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
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
5 min (2)
CL Item
15 min (3)
CL Item
30 min (4)
CL Item
1 h (5)
CL Item
2 h (6)
CL Item
3 h (7)
CL Item
4 h (8)
CL Item
5 h (9)
CL Item
6 h (10)
CL Item
8 h (11)
CL Item
10 h (12)
CL Item
12 h  (13)
CL Item
14 h (14)
CL Item
16 h (15)
CL Item
22,5 h (16)
CL Item
24 h (17)
CL Item
Unscheduled (18)
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])
Reading 3
Item
Reading 3
float
C0456984 (UMLS CUI [1,1])
C0429706 (UMLS CUI [1,2])
Item Group
Pharmacokinetic sampling (Treatment Period 1, Day 1)
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
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
Pre-Dose (1)
CL Item
15 min (2)
CL Item
30 min (3)
CL Item
45 min (4)
CL Item
1 h (5)
CL Item
2 h (6)
CL Item
3 h (7)
CL Item
4 h (8)
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 and Glucose (Treatment Period 1, Day 1)
C0202194 (UMLS CUI-1)
C0337438 (UMLS CUI-2)
Sequence number
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
Date of measurement
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
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
Pre-Dose (1)
CL Item
30 min (2)
CL Item
1 h (3)
CL Item
2 h (4)
CL Item
3 h (5)
CL Item
4 h (6)
CL Item
8 h (7)
CL Item
12 h (8)
CL Item
24 h (9)
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])
Item
Test
integer
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Test type
Code List
Test
CL Item
Potassium (1)
CL Item
Glucose (2)
Test result
Item
Result
float
C0587081 (UMLS CUI [1])
Item Group
Pharmacokinetic Urine lnterval Collection Data (Treatment Period 1, Day 1)
C0201734 (UMLS CUI-1)
C1610733 (UMLS CUI-2)
Sequence number Pharmacokinetic Urine lnterval Collection
Item
Row number
integer
C2348184 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
C1610733 (UMLS CUI [1,3])
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
0-2 h (1)
CL Item
2-8 h (2)
CL Item
8-24 h (3)
Start date urine interval collection
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Start time urine interval collection
Item
Actual start time
time
C1301880 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Stop date urine interval collection
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
End time urine interval collection
Item
Actual stop time
time
C1522314 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Sample number urine interval collection
Item
Sample number
integer
C1299222 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Total sample volume urine interval collection
Item
Total sample volume
integer
C1278293 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
aliquot taken
Item
10 mL aliquot taken
boolean
C1510844 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
all urine collected for this interval
Item
Was all urine collected for this interval?
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
Hematology Data (Treatment Period 1, Day 1, 24 h Post-Dose)
C0474523 (UMLS CUI-1)
C0687676 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
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 (Treatment Period 1, Day 1, Post-dose)
C2347783 (UMLS CUI-1)
C0687676 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
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 (Treatment Period 1, Day 1, Post-dose)
C0042014 (UMLS CUI-1)
C0687676 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
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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