ID

22459

Description

Study part: Investigational Product Discontinuation.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. 6/5/17 6/5/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 5, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Investigational Product Discontinuation Mepolizumab HES NCT00086658

English

Investigational Product Discontinuation

1 forms  
INVESTIGATIONAL PRODUCT DISCONTINUATION
Description

INVESTIGATIONAL PRODUCT DISCONTINUATION

Alias
UMLS CUI-1
C0013230
UMLS CUI-2
C0457454
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Was the investigational product stopped permanently before the end of the scheduled treatment period?
Description

Investigational Product Discontinuation

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0457454
The primary reason the investigational product was stopped:
Description

Reason Investigational Product Discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0457454
If other, please specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
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Similar models

Investigational Product Discontinuation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
INVESTIGATIONAL PRODUCT DISCONTINUATION
C0013230 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Investigational Product Discontinuation
Item
Was the investigational product stopped permanently before the end of the scheduled treatment period?
boolean
C0013230 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Item
The primary reason the investigational product was stopped:
text
C0392360 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Reason Investigational Product Discontinuation
Code List
The primary reason the investigational product was stopped:
CL Item
Lost to follow-up (Lost to follow-up)
C1302313 (UMLS CUI-1)
CL Item
Protocol violation (Protocol violation)
C1709750 (UMLS CUI-1)
CL Item
Subject decided to withdraw from the study (Subject decided to withdraw from the study)
C2348571 (UMLS CUI-1)
CL Item
Lack of efficacy (Lack of efficacy)
C0235828 (UMLS CUI-1)
CL Item
Sponsor terminated study (Sponsor terminated study)
C1710224 (UMLS CUI-1)
CL Item
Disease progression (Disease progression)
C0242656 (UMLS CUI-1)
CL Item
Other, specify (Other, specify)
C0205394 (UMLS CUI-1)
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate))
C0877248 (UMLS CUI-1)
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
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