ID
41780
Beschreibung
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
Stichworte
Versionen (1)
- 19.01.21 19.01.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
19. Januar 2021
DOI
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Lizenz
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
Beschreibung
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Diagnosis Only (if known), otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Non-Serious Adverse Event Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2697888
Beschreibung
Non-Serious Adverse Event Start Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Beschreibung
Non-Serious Adverse Event Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschreibung
Non-Serious Adverse Event End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2697886
Beschreibung
Non-Serious Adverse Event End Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Beschreibung
Non-Serious Adverse Event Frequency
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beschreibung
Non-Serious Adverse Event Maximum Intensity
Datentyp
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C0806909
Beschreibung
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschreibung
Did the subject withdraw from study as a result of this AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschreibung
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Diagnosis Only (if known), Otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Serious Adverse Event Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697888
Beschreibung
Serious Adverse Event Start Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697889
Beschreibung
Serious Adverse Event Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
Serious Adverse Event End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697886
Beschreibung
Serious Adverse Event End Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826658
Beschreibung
Serious Adverse Event Maximum Intensity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschreibung
Action Taken with Investigational Product(s) as a Result of the SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschreibung
Did the subject withdraw from study as a result of this SAE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschreibung
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Serious Adverse Event - Section 1
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event - Section 2 (Seriousness)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beschreibung
Check all that apply
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
Beschreibung
Specify other reason for considering this a SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C2348235
Beschreibung
Serious Adverse Event - Section 3 (Demography Data)
Alias
- UMLS CUI-1
- C0011298
- UMLS CUI-2
- C1519255
Beschreibung
Serious Adverse Event - Section 4
Alias
- UMLS CUI-1
- C1519255
Beschreibung
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0457454
Beschreibung
Serious Adverse Event - Section 5
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Check all thath apply
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0205394
Beschreibung
Specify other Possible Causes of SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
Beschreibung
Serious Adverse Event - Section 6 (Relevant Medical Conditions)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0262926
Beschreibung
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C0012634
- UMLS CUI [3]
- C0020517
- UMLS CUI [4]
- C0543467
Beschreibung
Date of Onset (Medical Condition)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beschreibung
Condition Present at Time of the SAE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Beschreibung
If No, Date of Last Occurrence
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beschreibung
Serious Adverse Event - Section 7
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event - Section 8 (Concomitant Medication)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2826666
Beschreibung
Trade Name preferred
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Medication Dose
Datentyp
float
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Medication Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Medication Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Medication taken Prior to Study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschreibung
Medication Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Medication Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Ongoing Medication
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Serious Adverse Event - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschreibung
Treatment Period
Datentyp
integer
Alias
- UMLS CUI [1]
- C2347804
Beschreibung
Investigational Product Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
Investigational Product Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
Serious Adverse Event - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschreibung
Serious Adverse Event - Section 10
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event - Section 11
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Confirm that the data on the SAE pages are accurate and complete.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator's name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator's signature - Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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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])