ID

22471

Descripción

Study part: Non-Serious Adverse Events.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Palabras clave

Versiones (1)
  1. 5/6/17 5/6/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de junio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Non-Serious Adverse Events Mepolizumab HES NCT00086658

Inglés

Non-Serious Adverse Events

1 formularios  
NON-SERIOUS ADVERSE EVENTS (AE)
Descripción

NON-SERIOUS ADVERSE EVENTS (AE)

Alias
UMLS CUI-1
C1518404
Subject ID
Descripción

Subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Did the subject experience any non-serious adverse events during the study?
Descripción

Non-Serious Adverse Events

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518404
Event
Descripción

Non-Serious Adverse Events

Tipo de datos

text

Alias
UMLS CUI [1]
C1518404
Start Date
Descripción

Start Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0808070
Outcome
Descripción

Outcome

Tipo de datos

integer

Alias
UMLS CUI [1]
C1705586
End Date
Descripción

End Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
Frequency
Descripción

Frequency

Tipo de datos

integer

Alias
UMLS CUI [1]
C1561548
Maximum Intensity
Descripción

Maximum Intensity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Descripción

Adverse Event Action Taken with Study Treatment

Tipo de datos

text

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this AE?
Descripción

Complete Study Conclusion page and Adverse event as reason for withdrawal.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

Causations Adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
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Similar models

Non-Serious Adverse Events

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
NON-SERIOUS ADVERSE EVENTS (AE)
C1518404 (UMLS CUI-1)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-Serious Adverse Events
Item
Event
text
C1518404 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
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)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Item
Frequency
integer
C1561548 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Not applicable (Not applicable)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C2826626 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (Investigational product(s) withdrawn)
CL Item
Dose reduced (Dose reduced)
CL Item
Dose increased (Dose increased)
CL Item
Dose not changed (Dose not changed)
CL Item
Dose interrupted (Dose interrupted)
CL Item
Not applicable (Not applicable)
subject withdraw from study as a result of AE
Item
Did the subject withdraw from study as a result of this AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Causations Adverse event
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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