ID
41780
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)
- 19-01-21 19-01-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
19 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)
Running Logs and End of Study - Non-Serious Adverse Events; Serious Adverse Event
Beschrijving
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Diagnosis Only (if known), otherwise Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Non-Serious Adverse Event Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2697888
Beschrijving
Non-Serious Adverse Event Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Beschrijving
Non-Serious Adverse Event Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschrijving
Non-Serious Adverse Event End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2697886
Beschrijving
Non-Serious Adverse Event End Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Beschrijving
Non-Serious Adverse Event Frequency
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beschrijving
Non-Serious Adverse Event Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C0806909
Beschrijving
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschrijving
Did the subject withdraw from study as a result of this AE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschrijving
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Diagnosis Only (if known), Otherwise Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious Adverse Event Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697888
Beschrijving
Serious Adverse Event Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697889
Beschrijving
Serious Adverse Event Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious Adverse Event End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697886
Beschrijving
Serious Adverse Event End Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826658
Beschrijving
Serious Adverse Event Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Action Taken with Investigational Product(s) as a Result of the SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
Did the subject withdraw from study as a result of this SAE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschrijving
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event - Section 2 (Seriousness)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
Beschrijving
Specify other reason for considering this a SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Serious Adverse Event - Section 3 (Demography Data)
Alias
- UMLS CUI-1
- C0011298
- UMLS CUI-2
- C1519255
Beschrijving
Serious Adverse Event - Section 4
Alias
- UMLS CUI-1
- C1519255
Beschrijving
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0457454
Beschrijving
Serious Adverse Event - Section 5
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Check all thath apply
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0205394
Beschrijving
Specify other Possible Causes of SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
Beschrijving
Serious Adverse Event - Section 6 (Relevant Medical Conditions)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0262926
Beschrijving
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C0012634
- UMLS CUI [3]
- C0020517
- UMLS CUI [4]
- C0543467
Beschrijving
Date of Onset (Medical Condition)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beschrijving
Condition Present at Time of the SAE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Beschrijving
If No, Date of Last Occurrence
Datatype
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beschrijving
Serious Adverse Event - Section 7
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event - Section 8 (Concomitant Medication)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2826666
Beschrijving
Trade Name preferred
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Medication Dose
Datatype
float
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Medication Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Medication Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medication taken Prior to Study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschrijving
Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Medication Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Ongoing Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
Serious Adverse Event - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschrijving
Treatment Period
Datatype
integer
Alias
- UMLS CUI [1]
- C2347804
Beschrijving
Investigational Product Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
Investigational Product Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Serious Adverse Event - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschrijving
Serious Adverse Event - Section 10
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event - Section 11
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Confirm that the data on the SAE pages are accurate and complete.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator's name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator's signature - Date
Datatype
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])