ID
41752
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)
- 1/12/21 1/12/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 12, 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)
Screening - Serious Adverse Event; Local Laboratory; Urinalysis; Serology - Screen for HIV Antibody and Hepatitis B & C
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Description
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Description
Clinical Chemistry Test
Data type
integer
Alias
- UMLS CUI [1]
- C0525044
Description
If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Seriopus Adverse Events page or Serious Adverse Event page.
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Description
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0018941
Description
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Description
Haematology Test
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
If the laboratory results meet the protocol definition of an adverse event, record the details in the Non-Serious Adverse Events or Serious Adverse Event section(s).
Data type
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Description
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Description
Date and time sample taken (Urinalysis)
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Description
Result of dipstick
Data type
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Description
Urinalysis - Microscopy
Alias
- UMLS CUI-1
- C0430397
Description
Urinalysis - Microscopy
Alias
- UMLS CUI-1
- C0430397
Description
Urinalysis Microscopy Test
Data type
integer
Alias
- UMLS CUI [1]
- C0430397
Description
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) section(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Data type
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0587081
Description
Local Laboratory - Unscheduled Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C3854240
Description
Local Laboratory - Unscheduled Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C3854240
Description
Clinical Chemistry Test
Data type
integer
Alias
- UMLS CUI [1]
- C0525044
Description
If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Description
Local Laboratory - Unscheduled Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0018941
- UMLS CUI-3
- C3854240
Description
Local Laboratory - Unscheduled Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0018941
- UMLS CUI-3
- C3854240
Description
Haematology Test
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
If the laboratory results meet the protocol definition of an adverse event, record the details in the Non-Serious Adverse Events or Serious Adverse Event section(s).
Data type
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Description
Unscheduled Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C3854240
Description
Date and time sample taken (Unscheduled Urinalysis)
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C3854240
- UMLS CUI [2,1]
- C0200345
- UMLS CUI [2,2]
- C1264639
Description
Result of dipstick
Data type
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
Unscheduled Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C3854240
Description
Urinalysis - Microscopy (Unscheduled)
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C3854240
Description
Urinalysis - Microscopy (Unscheduled)
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C3854240
Description
Urinalysis Microscopy Test
Data type
integer
Alias
- UMLS CUI [1]
- C0430397
Description
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) section(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Data type
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0587081
Description
Serology - Screen for HIV Antibody and Hepatitis B&C
Alias
- UMLS CUI-1
- C0036743
- UMLS CUI-2
- C0019682
- UMLS CUI-3
- C0019163
- UMLS CUI-4
- C0019196
Description
Date sample taken (Serology)
Data type
date
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C1302413
Description
HIV 1&2 antibodies
Data type
integer
Alias
- UMLS CUI [1]
- C0019683
Description
Hepatitis B surface antigen
Data type
integer
Alias
- UMLS CUI [1]
- C0019168
Description
Hepatitis C antibody
Data type
integer
Alias
- UMLS CUI [1]
- C0201487
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Screening - Serious Adverse Event; Local Laboratory; Urinalysis; Serology - Screen for HIV Antibody and Hepatitis B & C
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