ID
41780
Beskrivning
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
Nyckelord
Versioner (1)
- 2021-01-19 2021-01-19 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
19 januari 2021
DOI
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Licens
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
Beskrivning
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Diagnosis Only (if known), otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Non-Serious Adverse Event Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2697888
Beskrivning
Non-Serious Adverse Event Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Beskrivning
Non-Serious Adverse Event Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beskrivning
Non-Serious Adverse Event End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2697886
Beskrivning
Non-Serious Adverse Event End Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Beskrivning
Non-Serious Adverse Event Frequency
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beskrivning
Non-Serious Adverse Event Maximum Intensity
Datatyp
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C0806909
Beskrivning
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beskrivning
Did the subject withdraw from study as a result of this AE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Diagnosis Only (if known), Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Serious Adverse Event Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697888
Beskrivning
Serious Adverse Event Start Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697889
Beskrivning
Serious Adverse Event Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
Serious Adverse Event End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697886
Beskrivning
Serious Adverse Event End Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826658
Beskrivning
Serious Adverse Event Maximum Intensity
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Action Taken with Investigational Product(s) as a Result of the SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Did the subject withdraw from study as a result of this SAE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beskrivning
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event - Section 2 (Seriousness)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beskrivning
Check all that apply
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
Beskrivning
Specify other reason for considering this a SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C2348235
Beskrivning
Serious Adverse Event - Section 3 (Demography Data)
Alias
- UMLS CUI-1
- C0011298
- UMLS CUI-2
- C1519255
Beskrivning
Serious Adverse Event - Section 4
Alias
- UMLS CUI-1
- C1519255
Beskrivning
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0457454
Beskrivning
Serious Adverse Event - Section 5
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Check all thath apply
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0205394
Beskrivning
Specify other Possible Causes of SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
Beskrivning
Serious Adverse Event - Section 6 (Relevant Medical Conditions)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0262926
Beskrivning
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C0012634
- UMLS CUI [3]
- C0020517
- UMLS CUI [4]
- C0543467
Beskrivning
Date of Onset (Medical Condition)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beskrivning
Condition Present at Time of the SAE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Beskrivning
If No, Date of Last Occurrence
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beskrivning
Serious Adverse Event - Section 7
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event - Section 8 (Concomitant Medication)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2826666
Beskrivning
Trade Name preferred
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Medication Dose
Datatyp
float
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Medication Frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Medication Route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Medication taken Prior to Study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beskrivning
Medication Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Medication Stop Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Ongoing Medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826696
Beskrivning
Serious Adverse Event - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beskrivning
Treatment Period
Datatyp
integer
Alias
- UMLS CUI [1]
- C2347804
Beskrivning
Investigational Product Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beskrivning
Investigational Product Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
Serious Adverse Event - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beskrivning
Serious Adverse Event - Section 10
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event - Section 11
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
Confirm that the data on the SAE pages are accurate and complete.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator's name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Investigator's signature - Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Running Logs and End of Study - Non-Serious Adverse Events; Serious Adverse Event
C0019994 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2697888 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C2697888 (UMLS CUI [1,2])
C2697889 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C2697886 (UMLS CUI [1,2])
C2826658 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1710056 (UMLS CUI-2)
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C1519255 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0457454 (UMLS CUI [2,2])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0012634 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0012634 (UMLS CUI [2])
C0020517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2826666 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C0220825 (UMLS CUI [2,1])
C1522508 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])