ID

29236

Beschreibung

Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: Non-serious Adverse Event

Stichworte

Versionen (2)
  1. 10.03.18 10.03.18 -
  2. 05.04.18 05.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. März 2018

DOI

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Creative Commons BY-NC 3.0
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Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults GSK102932

Englisch

Non-serious Adverse Event

1 Formulare  
Non-Serious Adverse Event
Beschreibung

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Sequence Number
Beschreibung

Sequence Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2348184
Modified term
Beschreibung

Modified term

Datentyp

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1518404
MedDRA synonym
Beschreibung

MedDRA synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C1518404
MedDRA lower level term code
Beschreibung

MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C1518404
Non-serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
Beschreibung

Non-serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event Start Date
Beschreibung

Non-Serious Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697888
Start Time Non-Serious Adverse Event
Beschreibung

Start Time Non-Serious Adverse Event

Datentyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697889
Non-Serious Adverse Event End Date
Beschreibung

Non-Serious Adverse Event End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697886
Non-Serious Adverse Event End Time
Beschreibung

Non-Serious Adverse Event End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826658
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C1518404
Non-Serious Adverse Event Frequency
Beschreibung

Non-Serious Adverse Event Frequency

Datentyp

integer

Intensity (maximum)
Beschreibung

Intensity (maximum)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1518404
Non-Serious Adverse Event Maximum Grade
Beschreibung

Non-Serious Adverse Event Maximum Grade

Datentyp

integer

Alias
UMLS CUI [1,1]
C2985911
UMLS CUI [1,2]
C1518404
Action Taken with Investigational Product(s) as a Result of the AE
Beschreibung

Action Taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C1547656
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
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
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship investigational product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Duration of AE if < 24 hours
Beschreibung

Duration of AE

Datentyp

integer

Maßeinheiten
  • Hr(s)
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449238
Hr(s)
Time to Onset Since Last Dose
Beschreibung

Time to Onset Since Last Dose

Datentyp

integer

Maßeinheiten
  • Min(s)
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0449244
Min(s)
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Ähnliche Modelle

Non-serious Adverse Event

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
text
C1518404 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Non-serious Adverse Event
Item
Non-serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event Start Date
Item
Non-Serious Adverse Event Start Date
date
C1518404 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Start Time Non-Serious Adverse Event
Item
Start Time Non-Serious Adverse Event
time
C1518404 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
Non-Serious Adverse Event End Date
Item
Non-Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Non-Serious Adverse Event End Time
Item
Non-Serious Adverse Event End Time
time
C1518404 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Outcome
integer
C1624730 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving  (2)
CL Item
Not recovered/Not resolved  (3)
CL Item
Recovered/Resolved with sequelae (4)
Item
Non-Serious Adverse Event Frequency
integer
Non-Serious Adverse Event Frequency
Code List
Non-Serious Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Intensity (maximum)
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Intensity (maximum)
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Non-Serious Adverse Event Maximum Grade
integer
C2985911 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Non-Serious Adverse Event Maximum Grade
Code List
Non-Serious Adverse Event Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade4 (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1547656 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
lnvestigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Duration of AE
Item
Duration of AE if < 24 hours
integer
C1518404 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
integer
C1518404 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
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