ID
41752
Beschrijving
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
Trefwoorden
Versies (1)
- 12-01-21 12-01-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
12 januari 2021
DOI
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Licentie
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
Beschrijving
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beschrijving
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beschrijving
Clinical Chemistry Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0525044
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Beschrijving
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0018941
Beschrijving
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschrijving
Haematology Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
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).
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Beschrijving
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Date and time sample taken (Urinalysis)
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1264639
Beschrijving
Result of dipstick
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschrijving
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Urinalysis Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0042014
Beschrijving
Urinalysis Test Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
Beschrijving
Urinalysis - Microscopy
Alias
- UMLS CUI-1
- C0430397
Beschrijving
Urinalysis - Microscopy
Alias
- UMLS CUI-1
- C0430397
Beschrijving
Urinalysis Microscopy Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0587081
Beschrijving
Local Laboratory - Unscheduled Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C3854240
Beschrijving
Local Laboratory - Unscheduled Clinical Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C3854240
Beschrijving
Clinical Chemistry Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0525044
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0587081
Beschrijving
Local Laboratory - Unscheduled Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0018941
- UMLS CUI-3
- C3854240
Beschrijving
Local Laboratory - Unscheduled Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0018941
- UMLS CUI-3
- C3854240
Beschrijving
Haematology Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
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).
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Beschrijving
Unscheduled Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C3854240
Beschrijving
Date and time sample taken (Unscheduled Urinalysis)
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C3854240
- UMLS CUI [2,1]
- C0200345
- UMLS CUI [2,2]
- C1264639
Beschrijving
Result of dipstick
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschrijving
Unscheduled Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C3854240
Beschrijving
Urinalysis Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0042014
Beschrijving
Urinalysis Test Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
Beschrijving
Urinalysis - Microscopy (Unscheduled)
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C3854240
Beschrijving
Urinalysis - Microscopy (Unscheduled)
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C3854240
Beschrijving
Urinalysis Microscopy Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0587081
Beschrijving
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
Beschrijving
Date sample taken (Serology)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C1302413
Beschrijving
HIV 1&2 antibodies
Datatype
integer
Alias
- UMLS CUI [1]
- C0019683
Beschrijving
Hepatitis B surface antigen
Datatype
integer
Alias
- UMLS CUI [1]
- C0019168
Beschrijving
Hepatitis C antibody
Datatype
integer
Alias
- UMLS CUI [1]
- C0201487
Similar models
Screening - Serious Adverse Event; Local Laboratory; Urinalysis; Serology - Screen for HIV Antibody and Hepatitis B & C
C0008000 (UMLS CUI-2)
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0008000 (UMLS CUI-2)
C0587081 (UMLS CUI [1,2])
C0018941 (UMLS CUI-2)
C0870078 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0474523 (UMLS CUI-2)
C1274040 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
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C0008000 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
C3854240 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0008000 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
C0587081 (UMLS CUI [1,2])
C0018941 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
C3854240 (UMLS CUI [1,2])
C0870078 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0018941 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
C1274040 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C3854240 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C3854240 (UMLS CUI-2)
C1274040 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C2700128 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C0587081 (UMLS CUI [1,2])
C0019682 (UMLS CUI-2)
C0019163 (UMLS CUI-3)
C0019196 (UMLS CUI-4)
C1302413 (UMLS CUI [1,2])