ID

22765

Description

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.

Keywords

Versions (1)
  1. 6/11/17 6/11/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 11, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Run-In Screen Failure Mepolizumab HES NCT00086658

English

Run-In Screen Failure

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

SCREEN FAILURE / RUN-IN FAILURE

Alias
UMLS CUI-1
C1710476
Subject Identifier
Description

Subject Identifier

Data type

text

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

Screen Failure

Data type

boolean

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

date Screen Failure

Data type

date

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

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

Data type

boolean

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

primary reason Lost to follow-up

Data type

boolean

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

primary reason Protocol violation

Data type

boolean

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

primary reason eligibility criteria

Data type

boolean

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

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
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Similar models

Run-In Screen Failure

1 forms
  1. StudyEvent: ODM
    1. Run-In Screen Failure
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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