ID

22765

Descripción

Study part: Run-In Screen Failure.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

  1. 11/6/17 11/6/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de junio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0

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Run-In Screen Failure Mepolizumab HES NCT00086658

Run-In Screen Failure

  1. StudyEvent: ODM
    1. Run-In Screen Failure
SCREEN FAILURE / RUN-IN FAILURE
Descripción

SCREEN FAILURE / RUN-IN FAILURE

Alias
UMLS CUI-1
C1710476
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Was this subject a screen failure / run-in failure?
Descripción

Screen Failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1710476
If Yes, screen failure / run-in failure date
Descripción

date Screen Failure

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710476
Primary reason Adverse event
Descripción

Record details on Non-Serious Adverse Events or Serious Adverse Event page(s) as appropriate.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C0877248
Primary reason Lost to follow-up
Descripción

primary reason Lost to follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C1302313
Primary reason Protocol violation
Descripción

primary reason Protocol violation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C1709750
Primary reason Did not fulfil eligibility criteria
Descripción

primary reason eligibility criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C1516637
Other, specify
Descripción

Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394

Similar models

Run-In Screen Failure

  1. StudyEvent: ODM
    1. Run-In Screen Failure
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
SCREEN FAILURE / RUN-IN FAILURE
C1710476 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Screen Failure
Item
Was this subject a screen failure / run-in failure?
boolean
C1710476 (UMLS CUI [1])
date Screen Failure
Item
If Yes, screen failure / run-in failure date
date
C0011008 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
primary reason Adverse event
Item
Primary reason Adverse event
boolean
C1549995 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
primary reason Lost to follow-up
Item
Primary reason Lost to follow-up
boolean
C1549995 (UMLS CUI [1,1])
C1302313 (UMLS CUI [1,2])
primary reason Protocol violation
Item
Primary reason Protocol violation
boolean
C1549995 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
primary reason eligibility criteria
Item
Primary reason Did not fulfil eligibility criteria
boolean
C1549995 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Other
Item
Other, specify
text
C0205394 (UMLS CUI [1])

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