ID

41929

Beschreibung

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Stichworte

Versionen (2)
  1. 31.01.21 31.01.21 -
  2. 15.02.21 15.02.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. Februar 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

Englisch

Treatment Period 1 - 5 - Pharmacokinetics; Pharmacodynamics; Local Laboratory; Urinalysis;

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Pharmacokinetics - Blood Sample (Odd Numbered Subjects) (Day 7)
Beschreibung

Pharmacokinetics - Blood Sample (Odd Numbered Subjects) (Day 7)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0178913
Planned Relative Time (Pharmacokinetics - Blood Sampe)
Beschreibung

Planned Relative Time (Pharmacokinetics - Blood Sampe)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0178913
Date Sample Taken (Pharmacokinetics - Blood Sampe)
Beschreibung

Date Sample Taken (Pharmacokinetics - Blood Sampe)

Datentyp

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0178913
Actual Time (Pharmacokinetics - Blood Sampe)
Beschreibung

Actual Time (Pharmacokinetics - Blood Sampe)

Datentyp

time

Alias
UMLS CUI [1]
C0040223
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0178913
Sample Number (Pharmacokinetics - Blood Sampe)
Beschreibung

Sample Number (Pharmacokinetics - Blood Sampe)

Datentyp

integer

Alias
UMLS CUI [1]
C1299222
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0178913
Pharmacokinetics - Blood Sample (Even Numbered Subjects) (Day 7)
Beschreibung

Pharmacokinetics - Blood Sample (Even Numbered Subjects) (Day 7)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0178913
Planned Relative Time (Pharmacokinetics - Blood Sampe)
Beschreibung

Planned Relative Time (Pharmacokinetics - Blood Sampe)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0178913
Date Sample Taken (Pharmacokinetics - Blood Sampe)
Beschreibung

Date Sample Taken (Pharmacokinetics - Blood Sampe)

Datentyp

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0178913
Actual Time (Pharmacokinetics - Blood Sampe)
Beschreibung

Actual Time (Pharmacokinetics - Blood Sampe)

Datentyp

time

Alias
UMLS CUI [1]
C0040223
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0178913
Sample Number (Pharmacokinetics - Blood Sampe)
Beschreibung

Sample Number (Pharmacokinetics - Blood Sampe)

Datentyp

integer

Alias
UMLS CUI [1]
C1299222
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0178913
Pharmacodynamics - Blood Sample (Day 7)
Beschreibung

Pharmacodynamics - Blood Sample (Day 7)

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0178913
Planned Relative Time (Pharmacodynamics - Blood Sample)
Beschreibung

Planned Relative Time (Pharmacodynamics - Blood Sample)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0178913
Date Sample Taken (Pharmacodynamics - Blood Sample)
Beschreibung

Date Sample Taken (Pharmacodynamics - Blood Sample)

Datentyp

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0178913
Actual Time (Pharmacodynamics - Blood Sample)
Beschreibung

Actual Time (Pharmacodynamics - Blood Sample)

Datentyp

time

Alias
UMLS CUI [1]
C0040223
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0178913
Sample Number (Pharmacodynamics - Blood Sample)
Beschreibung

Sample Number (Pharmacodynamics - Blood Sample)

Datentyp

integer

Alias
UMLS CUI [1]
C0040223
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0178913
Pharmacodynamics Urine Cortisol (Day 7 - Post-Dose)
Beschreibung

Pharmacodynamics Urine Cortisol (Day 7 - Post-Dose)

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0201968
UMLS CUI-3
C0042036
UMLS CUI-4
C0439568
Planned Relative Time (Pharmacodynamics Urine Cortisol )
Beschreibung

Planned Relative Time (Pharmacodynamics Urine Cortisol )

Datentyp

time

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0201968
UMLS CUI [2,3]
C0042036
Start Date (Pharmacodynamics Urine Cortisol )
Beschreibung

Start Date (Pharmacodynamics Urine Cortisol )

Datentyp

date

Alias
UMLS CUI [1]
C0808070
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0201968
UMLS CUI [2,3]
C0042036
Actual Start Time (Pharmacodynamics Urine Cortisol )
Beschreibung

Actual Start Time (Pharmacodynamics Urine Cortisol )

Datentyp

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0201968
UMLS CUI [2,3]
C0042036
Stop Date (Pharmacodynamics Urine Cortisol )
Beschreibung

Stop Date (Pharmacodynamics Urine Cortisol )

Datentyp

date

Alias
UMLS CUI [1]
C0806020
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0201968
UMLS CUI [2,3]
C0042036
Actual Stop Time (Pharmacodynamics Urine Cortisol )
Beschreibung

Actual Stop Time (Pharmacodynamics Urine Cortisol )

Datentyp

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0201968
UMLS CUI [2,3]
C0042036
Total Sample (Pharmacodynamics Urine Cortisol )
Beschreibung

Total Sample (Pharmacodynamics Urine Cortisol )

Datentyp

integer

Maßeinheiten
  • g
Alias
UMLS CUI [1]
C0807984
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0201968
UMLS CUI [2,3]
C0042036
g
Was all of the sample collected for this interval? (Pharmacodynamics Urine Cortisol )
Beschreibung

Was all of the sample collected for this interval? (Pharmacodynamics Urine Cortisol )

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0201968
UMLS CUI [2,3]
C0042036
Sample Number (Pharmacodynamics Urine Cortisol )
Beschreibung

Sample Number (Pharmacodynamics Urine Cortisol )

Datentyp

integer

Alias
UMLS CUI [1]
C1299222
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C0201968
UMLS CUI [2,3]
C0042036
Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose)
Beschreibung

Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C0439565
Date and time sample taken (Local Laboratory - Clinical Chemistry, Pre-Dose)
Beschreibung

Date and time sample taken (Local Laboratory - Clinical Chemistry, Pre-Dose)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C0008000
UMLS CUI [2,3]
C0439565
Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose)
Beschreibung

Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C0439565
Clinical Chemistry Test (Pre-Dose)
Beschreibung

Clinical Chemistry Test (Pre-Dose)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C0439565
Clinical Chemistry Test Result (Pre-Dose)
Beschreibung

Clinical Chemistry Test Result (Pre-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0439565
Local Laboratory - Haematology (Day 7 - Pre-Dose)
Beschreibung

Local Laboratory - Haematology (Day 7 - Pre-Dose)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
UMLS CUI-3
C0439565
Date and time sample taken (Local Laboratory - Haematology, Pre-Dose)
Beschreibung

Date and time sample taken (Local Laboratory - Haematology, Pre-Dose)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C0018941
UMLS CUI [2,3]
C0439565
Local Laboratory - Haematology (Day 7 - Pre-Dose)
Beschreibung

Local Laboratory - Haematology (Day 7 - Pre-Dose)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
UMLS CUI-3
C0439565
Haematology Test (Pre-Dose)
Beschreibung

Haematology Test (Pre-Dose)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0439565
Haematologic Test Result (Pre-Dose)
Beschreibung

Haematologic Test Result (Pre-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0439565
Urinalysis - Local (Day 7 - Pre-Dose)
Beschreibung

Urinalysis - Local (Day 7 - Pre-Dose)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0439565
Date and time sample taken (Urinalysis, Pre-Dose))
Beschreibung

Date and time sample taken (Urinalysis, Pre-Dose)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
UMLS CUI [1,4]
C0439565
Result of dipstick (Pre-Dose)
Beschreibung

Result of dipstick (Pre-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0439565
Urinalysis - Local (Day 7 - Pre-Dose)
Beschreibung

Urinalysis - Local (Day 7 - Pre-Dose)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0439565
Urinalysis Test (Pre-Dose)
Beschreibung

Urinalysis Test (Pre-Dose)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0439565
Urinalysis Test Result (Pre-Dose)
Beschreibung

Urinalysis Test Result (Pre-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0439565
Urinalysis - Microscopy (Day 7 - Pre-Dose)
Beschreibung

Urinalysis - Microscopy (Day 7 - Pre-Dose)

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C0439565
Was sedimentary microscopy performed?
Beschreibung

Was sedimentary microscopy performed?

Datentyp

boolean

Alias
UMLS CUI [1]
C0430397
Urinalysis - Microscopy (Day 7 - Pre-Dose)
Beschreibung

Urinalysis - Microscopy (Day 7 - Pre-Dose)

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C0439565
Urinalysis - Microscopy Test (Pre-Dose)
Beschreibung

Urinalysis - Microscopy Test (Pre-Dose)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0439565
Urinalysis - Microscopy Test Result (Pre-Dose)
Beschreibung

Urinalysis - Microscopy Test Result (Pre-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0439565
Clinical Chemistry (Day 7 - Post-Dose)
Beschreibung

Clinical Chemistry (Day 7 - Post-Dose)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C0439568
Date and time sample taken (Local Laboratory - Clinical Chemistry, Post-Dose)
Beschreibung

Date and time sample taken (Local Laboratory - Clinical Chemistry, Post-Dose)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C0008000
UMLS CUI [2,3]
C0439568
Local Laboratory - Clinical Chemistry (Day 7 - Post-Dose)
Beschreibung

Local Laboratory - Clinical Chemistry (Day 7 - Post-Dose)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C0439568
Clinical Chemistry Test (Post-Dose)
Beschreibung

Clinical Chemistry Test (Post-Dose)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C0439568
Clinical Chemistry Test Result (Post-Dose)
Beschreibung

Clinical Chemistry Test Result (Post-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0439568
Local Laboratory - Haematology (Day 7 - Post-Dose)
Beschreibung

Local Laboratory - Haematology (Day 7 - Post-Dose)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
UMLS CUI-3
C0439568
Date and time sample taken (Local Laboratory - Haematology, Post-Dose)
Beschreibung

Date and time sample taken (Local Laboratory - Haematology, Post-Dose)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C1264639
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C0018941
UMLS CUI [2,3]
C0439568
Local Laboratory - Haematology (Day 7 - Post-Dose)
Beschreibung

Local Laboratory - Haematology (Day 7 - Post-Dose)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
UMLS CUI-3
C0439568
Haematology Test (Post-Dose)
Beschreibung

Haematology Test (Post-Dose)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0439568
Haematologic Test Result (Post-Dose)
Beschreibung

Haematologic Test Result (Post-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0439568
Urinalysis - Local (Day 7 - Post-Dose)
Beschreibung

Urinalysis - Local (Day 7 - Post-Dose)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0439568
Date and time sample taken (Urinalysis, Post-Dose)
Beschreibung

Date and time sample taken (Urinalysis, Post-Dose)

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
UMLS CUI [1,4]
C0439568
Result of dipstick (Post-Dose)
Beschreibung

Result of dipstick (Post-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0439568
Urinalysis - Local (Day 7 - Post-Dose)
Beschreibung

Urinalysis - Local (Day 7 - Post-Dose)

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0439568
Urinalysis (Post-Dose)
Beschreibung

Urinalysis (Post-Dose)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0439568
Urinalysis Test Result (Post-Dose)
Beschreibung

Urinalysis Test Result (Post-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0439568
Urinalysis - Microscopy (Day 7 - Post-Dose)
Beschreibung

Urinalysis - Microscopy (Day 7 - Post-Dose)

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C0439568
Was sedimentary microscopy performed?
Beschreibung

Was sedimentary microscopy performed?

Datentyp

boolean

Alias
UMLS CUI [1]
C0430397
Urinalysis - Microscopy (Day 7 - Post-Dose)
Beschreibung

Urinalysis - Microscopy (Day 7 - Post-Dose)

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C0439568
Urinalysis - Microscopy Test (Post-Dose)
Beschreibung

Urinalysis - Microscopy Test (Post-Dose)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0439568
Urinalysis - Microscopy Test Result (Post-Dose)
Beschreibung

Urinalysis - Microscopy Test Result (Post-Dose)

Datentyp

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0439568
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Treatment Period 1 - 5 - Pharmacokinetics; Pharmacodynamics; Local Laboratory; Urinalysis;

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Pharmacokinetics - Blood Sample (Odd Numbered Subjects) (Day 7)
C0031328 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Item
Planned Relative Time (Pharmacokinetics - Blood Sampe)
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Planned Relative Time (Pharmacokinetics - Blood Sampe)
Code List
Planned Relative Time (Pharmacokinetics - Blood Sampe)
CL Item
Pre-dose (1)
CL Item
0.5 - h (2)
CL Item
2 - 4h (3)
CL Item
6 - 8h (4)
CL Item
10 - 12h (5)
CL Item
13 - 16h (6)
Date Sample Taken (Pharmacokinetics - Blood Sampe)
Item
Date Sample Taken (Pharmacokinetics - Blood Sampe)
date
C1302413 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Actual Time (Pharmacokinetics - Blood Sampe)
Item
Actual Time (Pharmacokinetics - Blood Sampe)
time
C0040223 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Item
Sample Number (Pharmacokinetics - Blood Sampe)
integer
C1299222 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Sample Number (Pharmacokinetics - Blood Sampe)
Code List
Sample Number (Pharmacokinetics - Blood Sampe)
CL Item
BLD001 (1)
CL Item
BLD002 (2)
CL Item
BLD003 (3)
CL Item
BLD004 (4)
CL Item
BLD005 (5)
CL Item
BLD006 (6)
Item Group
Pharmacokinetics - Blood Sample (Even Numbered Subjects) (Day 7)
C0031328 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Item
Planned Relative Time (Pharmacokinetics - Blood Sampe)
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Planned Relative Time (Pharmacokinetics - Blood Sampe)
Code List
Planned Relative Time (Pharmacokinetics - Blood Sampe)
CL Item
0.08 - 0.5h (1)
CL Item
1 - 2h (2)
CL Item
4 - 6h (3)
CL Item
8 - 10h (4)
CL Item
12 - 13h (5)
CL Item
16 - 24h (6)
Date Sample Taken (Pharmacokinetics - Blood Sampe)
Item
Date Sample Taken (Pharmacokinetics - Blood Sampe)
date
C1302413 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Actual Time (Pharmacokinetics - Blood Sampe)
Item
Actual Time (Pharmacokinetics - Blood Sampe)
time
C0040223 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Item
Sample Number (Pharmacokinetics - Blood Sampe)
integer
C1299222 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Sample Number (Pharmacokinetics - Blood Sampe)
Code List
Sample Number (Pharmacokinetics - Blood Sampe)
CL Item
BLD001  (1)
CL Item
BLD002  (2)
CL Item
BLD003  (3)
CL Item
BLD004  (4)
CL Item
BLD005  (5)
CL Item
BLD006 (6)
Item Group
Pharmacodynamics - Blood Sample (Day 7)
C0851347 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Item
Planned Relative Time (Pharmacodynamics - Blood Sample)
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0851347 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Planned Relative Time (Pharmacodynamics - Blood Sample)
Code List
Planned Relative Time (Pharmacodynamics - Blood Sample)
CL Item
Pre-dose (1)
CL Item
1h (2)
CL Item
2h (3)
CL Item
3h (4)
CL Item
4h (5)
CL Item
6h (6)
CL Item
8h (7)
CL Item
10h (8)
CL Item
12h (9)
CL Item
16h (10)
CL Item
24h (11)
Date Sample Taken (Pharmacodynamics - Blood Sample)
Item
Date Sample Taken (Pharmacodynamics - Blood Sample)
date
C1302413 (UMLS CUI [1])
C0851347 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Actual Time (Pharmacodynamics - Blood Sample)
Item
Actual Time (Pharmacodynamics - Blood Sample)
time
C0040223 (UMLS CUI [1])
C0851347 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Item
Sample Number (Pharmacodynamics - Blood Sample)
integer
C0040223 (UMLS CUI [1])
C0851347 (UMLS CUI [2,1])
C0178913 (UMLS CUI [2,2])
Sample Number (Pharmacodynamics - Blood Sample)
Code List
Sample Number (Pharmacodynamics - Blood Sample)
CL Item
BLD002 (1)
CL Item
BLD003 (2)
CL Item
BLD004 (3)
CL Item
BLD005 (4)
CL Item
BLD006 (5)
CL Item
BLD007 (6)
CL Item
BLD008 (7)
CL Item
BLD009 (8)
CL Item
BLD010 (9)
CL Item
BLD011 (10)
CL Item
BLD012 (11)
Item Group
Pharmacodynamics Urine Cortisol (Day 7 - Post-Dose)
C0851347 (UMLS CUI-1)
C0201968 (UMLS CUI-2)
C0042036 (UMLS CUI-3)
C0439568 (UMLS CUI-4)
Planned Relative Time (Pharmacodynamics Urine Cortisol )
Item
Planned Relative Time (Pharmacodynamics Urine Cortisol )
time
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0851347 (UMLS CUI [2,1])
C0201968 (UMLS CUI [2,2])
C0042036 (UMLS CUI [2,3])
Start Date (Pharmacodynamics Urine Cortisol )
Item
Start Date (Pharmacodynamics Urine Cortisol )
date
C0808070 (UMLS CUI [1])
C0851347 (UMLS CUI [2,1])
C0201968 (UMLS CUI [2,2])
C0042036 (UMLS CUI [2,3])
Actual Start Time (Pharmacodynamics Urine Cortisol )
Item
Actual Start Time (Pharmacodynamics Urine Cortisol )
time
C1301880 (UMLS CUI [1])
C0851347 (UMLS CUI [2,1])
C0201968 (UMLS CUI [2,2])
C0042036 (UMLS CUI [2,3])
Stop Date (Pharmacodynamics Urine Cortisol )
Item
Stop Date (Pharmacodynamics Urine Cortisol )
date
C0806020 (UMLS CUI [1])
C0851347 (UMLS CUI [2,1])
C0201968 (UMLS CUI [2,2])
C0042036 (UMLS CUI [2,3])
Actual Stop Time (Pharmacodynamics Urine Cortisol )
Item
Actual Stop Time (Pharmacodynamics Urine Cortisol )
time
C1522314 (UMLS CUI [1])
C0851347 (UMLS CUI [2,1])
C0201968 (UMLS CUI [2,2])
C0042036 (UMLS CUI [2,3])
Total Sample (Pharmacodynamics Urine Cortisol )
Item
Total Sample (Pharmacodynamics Urine Cortisol )
integer
C0807984 (UMLS CUI [1])
C0851347 (UMLS CUI [2,1])
C0201968 (UMLS CUI [2,2])
C0042036 (UMLS CUI [2,3])
Was all of the sample collected for this interval? (Pharmacodynamics Urine Cortisol )
Item
Was all of the sample collected for this interval? (Pharmacodynamics Urine Cortisol )
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0851347 (UMLS CUI [2,1])
C0201968 (UMLS CUI [2,2])
C0042036 (UMLS CUI [2,3])
Item
Sample Number (Pharmacodynamics Urine Cortisol )
integer
C1299222 (UMLS CUI [1])
C0851347 (UMLS CUI [2,1])
C0201968 (UMLS CUI [2,2])
C0042036 (UMLS CUI [2,3])
Sample Number (Pharmacodynamics Urine Cortisol )
Code List
Sample Number (Pharmacodynamics Urine Cortisol )
CL Item
URI001 (1)
Item Group
Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Date and time sample taken (Local Laboratory - Clinical Chemistry, Pre-Dose)
Item
Date and time sample taken (Local Laboratory - Clinical Chemistry, Pre-Dose)
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0008000 (UMLS CUI [2,2])
C0439565 (UMLS CUI [2,3])
Item Group
Local Laboratory - Clinical Chemistry (Day 7 - Pre-Dose)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Item
Clinical Chemistry Test (Pre-Dose)
integer
C0525044 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Clinical Chemistry Test
Code List
Clinical Chemistry Test (Pre-Dose)
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Urea (5)
CL Item
Creatinine (6)
CL Item
Glucose (7)
CL Item
Calcium (8)
CL Item
Phosphate (9)
CL Item
Uric Acid (10)
CL Item
Total Bilirubin (11)
CL Item
Alkaline Phosphatase (12)
CL Item
Gamma GT (13)
CL Item
Aspartate Transferase (AST) (14)
CL Item
Alanine Transferase (ALT) (15)
CL Item
Total Protein (16)
CL Item
Albumin (17)
CL Item
Globulin (18)
Clinical Chemistry Test Result (Pre-Dose)
Item
Clinical Chemistry Test Result (Pre-Dose)
text
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Local Laboratory - Haematology (Day 7 - Pre-Dose)
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Date and time sample taken (Local Laboratory - Haematology, Pre-Dose)
Item
Date and time sample taken (Local Laboratory - Haematology, Pre-Dose)
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
C0439565 (UMLS CUI [2,3])
Item Group
Local Laboratory - Haematology (Day 7 - Pre-Dose)
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Item
Haematology Test (Pre-Dose)
integer
C0018941 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Haematology Test
Code List
Haematology Test (Pre-Dose)
CL Item
Haemoglobin (1)
CL Item
Red Blood Cells (2)
CL Item
Hematocrit (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
White Blood Cells (7)
CL Item
Neutrophils (8)
CL Item
Lymphocytes (9)
CL Item
Monocytes (10)
CL Item
eosinophils (11)
CL Item
Basophils (12)
CL Item
Platelets (13)
Haematologic Test Result (Pre-Dose)
Item
Haematologic Test Result (Pre-Dose)
text
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Urinalysis - Local (Day 7 - Pre-Dose)
C0042014 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Date and time sample taken (Urinalysis, Pre-Dose)
Item
Date and time sample taken (Urinalysis, Pre-Dose))
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Item
Result of dipstick (Pre-Dose)
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Result of dipstick
Code List
Result of dipstick (Pre-Dose)
CL Item
Negative (NEG)
CL Item
Positive (If positive, record results of individual tests) (POS)
CL Item
No result (NR)
Item Group
Urinalysis - Local (Day 7 - Pre-Dose)
C0042014 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Item
Urinalysis Test (Pre-Dose)
integer
C0042014 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Urinalysis Test
Code List
Urinalysis Test (Pre-Dose)
CL Item
Leucocyte Esterase (1)
CL Item
Nitrite (2)
CL Item
Urobilinogen (3)
CL Item
Protein (4)
CL Item
Urine pH (5)
CL Item
Blood (6)
CL Item
Specific Gravity (7)
CL Item
Ketones (8)
CL Item
Bilirubin (9)
CL Item
Glucose (10)
Item
Urinalysis Test Result (Pre-Dose)
text
C0042014 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Urinalysis Test Result
Code List
Urinalysis Test Result (Pre-Dose)
CL Item
none or negative (NEG)
CL Item
trace (TRA)
CL Item
+ or 1+ (1+)
CL Item
++ or 2+ (2+)
CL Item
+++ or 3+ (3+)
CL Item
++++ or 4+ (4+)
CL Item
+++++ or 5+ (5+)
Item Group
Urinalysis - Microscopy (Day 7 - Pre-Dose)
C0430397 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1])
Item Group
Urinalysis - Microscopy (Day 7 - Pre-Dose)
C0430397 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Item
Urinalysis - Microscopy Test (Pre-Dose)
integer
C0430397 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Urinalysis - Microscopy Test
Code List
Urinalysis - Microscopy Test (Pre-Dose)
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Urinalysis - Microscopy Test Result (Pre-Dose)
Item
Urinalysis - Microscopy Test Result (Pre-Dose)
text
C0430397 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Clinical Chemistry (Day 7 - Post-Dose)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date and time sample taken (Local Laboratory - Clinical Chemistry, Post-Dose)
Item
Date and time sample taken (Local Laboratory - Clinical Chemistry, Post-Dose)
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0008000 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
Item Group
Local Laboratory - Clinical Chemistry (Day 7 - Post-Dose)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Item
Clinical Chemistry Test (Post-Dose)
integer
C0525044 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Clinical Chemistry Test (Post-Dose)
Code List
Clinical Chemistry Test (Post-Dose)
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Urea (5)
CL Item
Creatinine (6)
CL Item
Glucose (7)
CL Item
Calcium (8)
CL Item
Phosphate (9)
CL Item
Uric Acid (10)
CL Item
Total Bilirubin (11)
CL Item
Alkaline Phosphatase (12)
CL Item
Gamma GT (13)
CL Item
Aspartate Transferase (AST) (14)
CL Item
Alanine Transferase (ALT) (15)
CL Item
Total Protein (16)
CL Item
Albumin (17)
CL Item
Globulin (18)
Clinical Chemistry Test Result (Post-Dose)
Item
Clinical Chemistry Test Result (Post-Dose)
text
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Item Group
Local Laboratory - Haematology (Day 7 - Post-Dose)
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date and time sample taken (Local Laboratory - Haematology, Post-Dose)
Item
Date and time sample taken (Local Laboratory - Haematology, Post-Dose)
datetime
C0200345 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
Item Group
Local Laboratory - Haematology (Day 7 - Post-Dose)
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Item
Haematology Test (Post-Dose)
integer
C0018941 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Haematology Test (Post-Dose)
Code List
Haematology Test (Post-Dose)
CL Item
Haemoglobin (1)
CL Item
Red Blood Cells (2)
CL Item
Hematocrit (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
White Blood Cells (7)
CL Item
Neutrophils (8)
CL Item
Lymphocytes (9)
CL Item
Monocytes (10)
CL Item
eosinophils (11)
CL Item
Basophils (12)
CL Item
Platelets (13)
Haematologic Test Result (Post-Dose)
Item
Haematologic Test Result (Post-Dose)
text
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Item Group
Urinalysis - Local (Day 7 - Post-Dose)
C0042014 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Date and time sample taken (Urinalysis, Post-Dose)
Item
Date and time sample taken (Urinalysis, Post-Dose)
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
Item
Result of dipstick (Post-Dose)
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Result of dipstick (Post-Dose)
Code List
Result of dipstick (Post-Dose)
CL Item
Negative  (NEG)
CL Item
Positive (If positive, record results of individual tests)  (POS)
CL Item
No result (NR)
Item Group
Urinalysis - Local (Day 7 - Post-Dose)
C0042014 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Urinalysis (Post-Dose)
integer
C0042014 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Urinalysis - Microscopy Test (Post-Dose)
Code List
Urinalysis (Post-Dose)
CL Item
Leucocyte Esterase (1)
CL Item
Nitrite (2)
CL Item
Urobilinogen (3)
CL Item
Protein (4)
CL Item
Urine pH (5)
CL Item
Blood (6)
CL Item
Specific Gravity (7)
CL Item
Ketones (8)
CL Item
Bilirubin (9)
CL Item
Glucose (10)
Item
Urinalysis Test Result (Post-Dose)
text
C0042014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Urinalysis Test Result (Post-Dose)
Code List
Urinalysis Test Result (Post-Dose)
CL Item
none or negative  (NEG)
CL Item
trace  (TRA)
CL Item
+ or 1+  (1+)
CL Item
++ or 2+  (2+)
CL Item
+++ or 3+  (3+)
CL Item
++++ or 4+  (4+)
CL Item
+++++ or 5+ (5+)
Item Group
Urinalysis - Microscopy (Day 7 - Post-Dose)
C0430397 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1])
Item Group
Urinalysis - Microscopy (Day 7 - Post-Dose)
C0430397 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Urinalysis - Microscopy Test (Post-Dose)
integer
C0430397 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Urinalysis - Microscopy Test (Post-Dose)
Code List
Urinalysis - Microscopy Test (Post-Dose)
CL Item
WBC  (1)
CL Item
RBC  (2)
CL Item
Hyaline casts  (3)
CL Item
Granular casts  (4)
CL Item
Cellular casts (5)
Urinalysis - Microscopy Test Result (Post-Dose)
Item
Urinalysis - Microscopy Test Result (Post-Dose)
text
C0430397 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
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