ID

41717

Description

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

Keywords

Versions (1)
  1. 1/6/21 1/6/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 6, 2021

DOI

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License

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

English

Screening - Demography; Child-bearing Potential; Pregnancy Test; Physical Examination; Vital Signs; Medical Conditions

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Volunteer Identifier
Description

Volunteer Identifier

Data type

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0020155
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Check one

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Chek one

Data type

integer

Alias
UMLS CUI [1]
C0034510
Child-Bearing Potential
Description

Child-Bearing Potential

Alias
UMLS CUI-1
C3831118
Child-Bearing Potential
Description

Check one

Data type

integer

Alias
UMLS CUI [1]
C3831118
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Date of test
Description

Date of test

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Results
Description

Results

Data type

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Physical Examination
Description

Physical Examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Physical Examination Not Done
Description

Physical Examination Not Done

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1272696
Physical Examination Result
Description

Physical Examination Result

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
If Abnormal, specify
Description

If Abnormal, specify

Data type

text

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2348235
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date (Vital Signs)
Description

Date (Vital Signs)

Data type

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time (Vital Signs)
Description

Planned Relative Time (Vital Signs)

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Actual Time (Vital Signs)
Description

Actual Time (Vital Signs)

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart Rate (Vital Signs)
Description

Heart Rate (Vital Signs)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0012634
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Data type

text

Alias
UMLS CUI [1]
C0011900
Medical Condition Status
Description

Medical Condition Status

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
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Similar models

Screening - Demography; Child-bearing Potential; Pregnancy Test; Physical Examination; Vital Signs; Medical Conditions

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1,1])
C0020155 (UMLS CUI [1,2])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic (1)
CL Item
Not Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Hertiage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Child-Bearing Potential
C3831118 (UMLS CUI-1)
Item
Child-Bearing Potential
integer
C3831118 (UMLS CUI [1])
Child-Bearing Potential
Code List
Child-Bearing Potential
CL Item
Post-menopausal (1)
CL Item
Sterile (of child-bearing age) (2)
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Date of test
Item
Date of test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Results
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Results
Code List
Results
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Physical Examination
integer
C0031809 (UMLS CUI [1])
Physical Examination
Code List
Physical Examination
CL Item
Hair and Skin (1)
CL Item
Lymph nodes (2)
CL Item
Eyes (3)
CL Item
Ears, Nose and Throat (4)
CL Item
Breast (5)
CL Item
Respiratory (6)
CL Item
Cardiovascular (7)
CL Item
Abdomen (8)
CL Item
Urogenital (9)
CL Item
Pelvic (10)
CL Item
Rectal (11)
CL Item
Musculoskeletal (12)
CL Item
Neurological (13)
CL Item
Mental Status (14)
Item
Physical Examination Not Done
integer
C0031809 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Physical Examination Not Done
Code List
Physical Examination Not Done
CL Item
Not Done (1)
Item
Physical Examination Result
integer
C0031809 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Physical Examination Result
Code List
Physical Examination Result
CL Item
Normal (1)
CL Item
Abnormal (2)
If Abnormal, specify
Item
If Abnormal, specify
text
C0243095 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date (Vital Signs)
Item
Date (Vital Signs)
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time (Vital Signs)
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Planned Relative Time (Vital Signs)
Code List
Planned Relative Time (Vital Signs)
CL Item
Screening (1)
Actual Time (Vital Signs)
Item
Actual Time (Vital Signs)
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart Rate (Vital Signs)
Item
Heart Rate (Vital Signs)
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Medical Condition Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Medical Condition Status
Code List
Medical Condition Status
CL Item
Current (1)
CL Item
Past (2)
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