ID

22448

Beschreibung

Study part: HES History or Prior HES Therapies Screening Visit.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.

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  1. 04.06.17 04.06.17 -
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GlaxoSmithKline

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4. Juni 2017

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HES History or Prior HES Therapies Screening Visit Mepolizumab HES NCT00086658

Englisch

HES History or Prior HES Therapies Screening Visit

1 Formulare  
DIAGNOSIS
Beschreibung

DIAGNOSIS

Alias
UMLS CUI-1
C0011900
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Year of diagnosis of HES
Beschreibung

year of diagnosis Hypereosinophilic Syndrome

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C1540912
HISTORY OF HES THERAPY
Beschreibung

HISTORY OF HES THERAPY

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C1540912
Has the subject received any of the below therapies for HES within 5 years prior to the Screening Visit?
Beschreibung

Therapy HES

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1540912
Interferon α
Beschreibung

Interferon alpha

Datentyp

boolean

Alias
UMLS CUI [1]
C0002199
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Hydroxyurea
Beschreibung

Hydroxyurea

Datentyp

boolean

Alias
UMLS CUI [1]
C0020402
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Cyclosporin
Beschreibung

Cyclosporin

Datentyp

boolean

Alias
UMLS CUI [1]
C0010592
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Cyclophosphomide
Beschreibung

Cyclophosphamide

Datentyp

boolean

Alias
UMLS CUI [1]
C0010583
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Imatinib Mesylate
Beschreibung

Imatinib Mesylate

Datentyp

boolean

Alias
UMLS CUI [1]
C0939537
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Methotrexate
Beschreibung

Methotrexate

Datentyp

boolean

Alias
UMLS CUI [1]
C0025677
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Vincristine
Beschreibung

Vincristine

Datentyp

boolean

Alias
UMLS CUI [1]
C0042679
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Busulfan
Beschreibung

Busulfan

Datentyp

boolean

Alias
UMLS CUI [1]
C0006463
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Chlorambucil
Beschreibung

Chlorambucil

Datentyp

boolean

Alias
UMLS CUI [1]
C0008163
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Immunotherapy (other monoclonal antibodies or anti-T cell therapies eg., TNF α inhibitors, alefacept)
Beschreibung

Immunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Systemic Corticosteroid(s)
Beschreibung

Systemic Corticosteroid

Datentyp

boolean

Alias
UMLS CUI [1]
C4039704
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
Other (specify):
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1]
C0205394
Reason for Treatment Discontinuation
Beschreibung

Reason Treatment Discontinuation

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
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Ähnliche Modelle

HES History or Prior HES Therapies Screening Visit

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
DIAGNOSIS
C0011900 (UMLS CUI-1)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
year of diagnosis Hypereosinophilic Syndrome
Item
Year of diagnosis of HES
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1540912 (UMLS CUI [1,3])
Item Group
HISTORY OF HES THERAPY
C0087111 (UMLS CUI-1)
C1540912 (UMLS CUI-2)
Therapy HES
Item
Has the subject received any of the below therapies for HES within 5 years prior to the Screening Visit?
boolean
C0087111 (UMLS CUI [1,1])
C1540912 (UMLS CUI [1,2])
Interferon alpha
Item
Interferon α
boolean
C0002199 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Hydroxyurea
Item
Hydroxyurea
boolean
C0020402 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Cyclosporin
Item
Cyclosporin
boolean
C0010592 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Cyclophosphamide
Item
Cyclophosphomide
boolean
C0010583 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Imatinib Mesylate
Item
Imatinib Mesylate
boolean
C0939537 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Methotrexate
Item
Methotrexate
boolean
C0025677 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Vincristine
Item
Vincristine
boolean
C0042679 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Busulfan
Item
Busulfan
boolean
C0006463 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Chlorambucil
Item
Chlorambucil
boolean
C0008163 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Immunotherapy
Item
Immunotherapy (other monoclonal antibodies or anti-T cell therapies eg., TNF α inhibitors, alefacept)
boolean
C0021083 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Systemic Corticosteroid
Item
Systemic Corticosteroid(s)
boolean
C4039704 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
Other
Item
Other (specify):
text
C0205394 (UMLS CUI [1])
Item
Reason for Treatment Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
Reason Treatment Discontinuation
Code List
Reason for Treatment Discontinuation
CL Item
Lack of Efficacy (Lack of Efficacy)
CL Item
Adverse Event (Adverse Event)
CL Item
Treatment Related Toxicity (Treatment Related Toxicity)
CL Item
Unknown (Unknown)
CL Item
Ongoing (Ongoing)
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