ID

33310

Beschreibung

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Stichworte

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  1. 05.12.18 05.12.18 -
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GlaxoSmithKline

Hochgeladen am

5. Dezember 2018

DOI

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Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181

Englisch

Non-Serious Adverse Events

1 Formulare  
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Did the subject experience any non-serious adverse events during the study?
Beschreibung

Non-serious Adverse Event, During, Clinical Trials

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Event
Beschreibung

Non-serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Start Date
Beschreibung

Non-serious Adverse Event, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Start Time
Beschreibung

Non-serious Adverse Event, Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Outcome
Beschreibung

Non-Serious Adverse Event, Adverse Event Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date
Beschreibung

Non-Serious Adverse Event, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
End Time
Beschreibung

Non-Serious Adverse Event, End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Frequency
Beschreibung

Non-serious Adverse Event, Frequencies

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Beschreibung

Non-Serious Adverse Event, Seriousness of Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710056
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschreibung

Non-serious Adverse Event; Action Taken with Study Treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Beschreibung

Non-serious Adverse Event, Withdraw

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Non-serious Adverse Event, Experimental Drug, Causations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0085978
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Ähnliche Modelle

Non-Serious Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-Serious Adverse Events
Non-serious Adverse Event, During, Clinical Trials
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Event
text
C1518404 (UMLS CUI [1])
Event number
Code List
Event
Non-serious Adverse Event, Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious Adverse Event, Start Time
Item
Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event, Adverse Event 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)
Non-Serious Adverse Event, End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event, End Time
Item
End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Non-Serious Adverse Event, Seriousness of Adverse Event
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
Code List
Action taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational 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 (X)
Non-serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Non-serious Adverse Event, Experimental Drug, Causations
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
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