ID
41780
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)
- 1/19/21 1/19/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 19, 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)
Running Logs and End of Study - Non-Serious Adverse Events; Serious Adverse Event
Description
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Description
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Description
Diagnosis Only (if known), otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C1518404
Description
Non-Serious Adverse Event Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2697888
Description
Non-Serious Adverse Event Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Description
Non-Serious Adverse Event Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
Non-Serious Adverse Event End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2697886
Description
Non-Serious Adverse Event End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Description
Non-Serious Adverse Event Frequency
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Description
Non-Serious Adverse Event Maximum Intensity
Data type
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C0806909
Description
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Data type
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Description
Did the subject withdraw from study as a result of this AE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Description
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Description
Diagnosis Only (if known), Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697888
Description
Serious Adverse Event Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697889
Description
Serious Adverse Event Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697886
Description
Serious Adverse Event End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826658
Description
Serious Adverse Event Maximum Intensity
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Action Taken with Investigational Product(s) as a Result of the SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Did the subject withdraw from study as a result of this SAE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Description
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event - Section 2 (Seriousness)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Description
Check all that apply
Data type
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
Description
Specify other reason for considering this a SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C2348235
Description
Serious Adverse Event - Section 3 (Demography Data)
Alias
- UMLS CUI-1
- C0011298
- UMLS CUI-2
- C1519255
Description
Serious Adverse Event - Section 4
Alias
- UMLS CUI-1
- C1519255
Description
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0457454
Description
Serious Adverse Event - Section 5
Alias
- UMLS CUI-1
- C1519255
Description
Check all thath apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0205394
Description
Specify other Possible Causes of SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
Description
Serious Adverse Event - Section 6 (Relevant Medical Conditions)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0262926
Description
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Data type
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C0012634
- UMLS CUI [3]
- C0020517
- UMLS CUI [4]
- C0543467
Description
Date of Onset (Medical Condition)
Data type
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Description
Condition Present at Time of the SAE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Description
If No, Date of Last Occurrence
Data type
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Description
Serious Adverse Event - Section 7
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event - Section 8 (Concomitant Medication)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2826666
Description
Trade Name preferred
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Medication Dose
Data type
float
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Medication Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Medication Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication taken Prior to Study?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Medication Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Medication Stop Date
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Ongoing Medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
Serious Adverse Event - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
Treatment Period
Data type
integer
Alias
- UMLS CUI [1]
- C2347804
Description
Investigational Product Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
Investigational Product Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Serious Adverse Event - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
Serious Adverse Event - Section 10
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event - Section 11
Alias
- UMLS CUI-1
- C1519255
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
Confirm that the data on the SAE pages are accurate and complete.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator's signature - Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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