ID

41722

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

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Versionen (1)
  1. 07.01.21 07.01.21 -
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GlaxoSmithKline

Hochgeladen am

7. Januar 2021

DOI

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

Englisch

Screening - Alcohol Intake; Alcohol Breath Test; Urine Test for Drugs of Abuse; Urine Cotinine Test; History of Tobacco Use

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Alcohol Intake
Beschreibung

Alcohol Intake

Alias
UMLS CUI-1
C0001948
Record the average number of units of alcohol consumed per day
Beschreibung

Record the average number of units of alcohol consumed per day

Datentyp

integer

Maßeinheiten
  • units per day
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per day
Alcohol Breath Test
Beschreibung

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Date sample taken (Alcohol Breath Test)
Beschreibung

Date sample taken (Alcohol Breath Test)

Datentyp

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2]
C0202306
Alcohol Breath Test Result
Beschreibung

Alcohol Breath Test Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
Urine Test for Drugs of Abuse
Beschreibung

Urine Test for Drugs of Abuse

Alias
UMLS CUI-1
C0202274
Date of sample taken (Urine Test for Drugs of Abuse)
Beschreibung

Date of sample taken (Urine Test for Drugs of Abuse)

Datentyp

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2]
C0202274
Urine Test for Drugs of Abuse
Beschreibung

Urine Test for Drugs of Abuse

Alias
UMLS CUI-1
C0202274
Drug
Beschreibung

Drug

Datentyp

integer

Alias
UMLS CUI [1]
C0086190
Urine Test for Drugs of Abuse - Result
Beschreibung

Urine Test for Drugs of Abuse - Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C1274040
Urine Cotinine Test
Beschreibung

Urine Cotinine Test

Alias
UMLS CUI-1
C1697737
Date of sample taken (Urine Cotinine Test)
Beschreibung

Date of sample taken (Urine Cotinine Test)

Datentyp

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2]
C1697737
Cotinine Test Result
Beschreibung

Cotinine Test Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C1697737
UMLS CUI [1,2]
C1274040
History of Tobacco Use
Beschreibung

History of Tobacco Use

Alias
UMLS CUI-1
C0841002
What is the subject's history of tobacco use (includes all tobacco products)?
Beschreibung

What is the subject's history of tobacco use (includes all tobacco products)?

Datentyp

integer

Alias
UMLS CUI [1]
C0841002
When did the subject last smoke?
Beschreibung

When did the subject last smoke?

Datentyp

date

Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C1517741
Average number of cigarettes smoked per day
Beschreibung

Average number of cigarettes smoked per day

Datentyp

integer

Maßeinheiten
  • cigarettes per day
Alias
UMLS CUI [1]
C1608325
cigarettes per day
Number of years during which the subject has smoked?
Beschreibung

Number of years during which the subject has smoked?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
Number of pack years
Beschreibung

Number of pack years

Datentyp

integer

Maßeinheiten
  • pack years
Alias
UMLS CUI [1]
C1277691
pack years
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Ähnliche Modelle

Screening - Alcohol Intake; Alcohol Breath Test; Urine Test for Drugs of Abuse; Urine Cotinine Test; History of Tobacco Use

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
Alcohol Intake
C0001948 (UMLS CUI-1)
Record the average number of units of alcohol consumed per day
Item
Record the average number of units of alcohol consumed per day
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Date sample taken (Alcohol Breath Test)
Item
Date sample taken (Alcohol Breath Test)
date
C1302413 (UMLS CUI [1])
C0202306 (UMLS CUI [2])
Item
Alcohol Breath Test Result
integer
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Alcohol Breath Test Result
Code List
Alcohol Breath Test Result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Urine Test for Drugs of Abuse
C0202274 (UMLS CUI-1)
Date of sample taken (Urine Test for Drugs of Abuse)
Item
Date of sample taken (Urine Test for Drugs of Abuse)
date
C1302413 (UMLS CUI [1])
C0202274 (UMLS CUI [2])
Item Group
Urine Test for Drugs of Abuse
C0202274 (UMLS CUI-1)
Item
Drug
integer
C0086190 (UMLS CUI [1])
Drug
Code List
Drug
CL Item
Amphetamines (1)
CL Item
Cocaine (2)
CL Item
Methamphetamine (3)
CL Item
Opiates (Morphine) (4)
CL Item
Cannabinoids (Cannabis) (5)
CL Item
Barbiturates (6)
CL Item
Methadone (7)
CL Item
Benzodiazepines (8)
Item
Urine Test for Drugs of Abuse - Result
integer
C0202274 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Urine Test for Drugs of Abuse - Result
Code List
Urine Test for Drugs of Abuse - Result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Urine Cotinine Test
C1697737 (UMLS CUI-1)
Date of sample taken (Urine Cotinine Test)
Item
Date of sample taken (Urine Cotinine Test)
date
C1302413 (UMLS CUI [1])
C1697737 (UMLS CUI [2])
Item
Cotinine Test Result
integer
C1697737 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Cotinine Test Result
Code List
Cotinine Test Result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
History of Tobacco Use
C0841002 (UMLS CUI-1)
Item
What is the subject's history of tobacco use (includes all tobacco products)?
integer
C0841002 (UMLS CUI [1])
What is the subject's history of tobacco use (includes all tobacco products)?
Code List
What is the subject's history of tobacco use (includes all tobacco products)?
CL Item
Never smoked (1)
CL Item
Former smoker (2)
When did the subject last smoke?
Item
When did the subject last smoke?
date
C0037369 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Average number of cigarettes smoked per day
Item
Average number of cigarettes smoked per day
integer
C1608325 (UMLS CUI [1])
Number of years during which the subject has smoked?
Item
Number of years during which the subject has smoked?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of pack years
Item
Number of pack years
integer
C1277691 (UMLS CUI [1])
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