ID

44028

Descripción

Study part: Hypersensitivity/ Anaphylaxis Evaluation.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 (2)
  1. 5/6/17 5/6/17 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Hypersensitivity/ Anaphylaxis Evaluation Mepolizumab HES NCT00086658

Inglés

Hypersensitivity/ Anaphylaxis Evaluation

1 formularios  
HYPERSENSITIVITY/ ANAPHYLAXIS EVALUATION
Descripción

HYPERSENSITIVITY/ ANAPHYLAXIS EVALUATION

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0020517
Subject ID
Descripción

Subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date and time of onset of hypersensitivity/ anaphylaxis reaction
Descripción

Date and time of onset Hypersensitivity

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C0020517
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Face edema?
Descripción

Face edema

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0542571
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Laryngeal edema?
Descripción

Laryngeal edema

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023052
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Hypotension ?
Descripción

Hypotension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020649
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Hypotension symptomatic ?
Descripción

Hypotension symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0863113
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Nausea?
Descripción

Nausea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027497
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Vomiting?
Descripción

Vomiting

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042963
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Diarrhoea?
Descripción

Diarrhoea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011991
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction-Pruritus?
Descripción

Pruritus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0033774
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction-Fever?
Descripción

Fever

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Rash?
Descripción

rash

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015230
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Bronchospasm?
Descripción

Bronchospasm

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006266
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Arthropathy?
Descripción

Arthropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022408
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Proteinuria?
Descripción

Proteinuria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0033687
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Lymphadenopathy?
Descripción

Lymphadenopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497156
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Other, specify:
Descripción

Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
3. Specify treatment provided for this Hypersensitivity/ Anaphylaxis reaction- Systemic corticosteroids?
Descripción

Systemic corticosteroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2825233
3. Specify treatment provided for this Hypersensitivity/ Anaphylaxis reaction- Adrenaline?
Descripción

Adrenaline

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014563
3. Specify treatment provided for this Hypersensitivity/ Anaphylaxis reaction- Antihistamines?
Descripción

Antihistamines

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019590
3. Specify treatment provided for this Hypersensitivity/ Anaphylaxis reaction- Other, specify:
Descripción

other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
4. Can the event be related to any other cause, other than the study drug?-Underlying disease
Descripción

Underlying disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277554
4. Can the event be related to any other cause, other than the study drug?-Microbial/ Biological
Descripción

Microbial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0445623
4. Can the event be related to any other cause, other than the study drug?-Pharmaceutical
Descripción

Pharmaceutical

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013227
4. Can the event be related to any other cause, other than the study drug?-Food
Descripción

Food

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0016452
4. Can the event be related to any other cause, other than the study drug?- Pets
Descripción

Pets

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031268
4. Can the event be related to any other cause, other than the study drug?-Environment
Descripción

Environment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014406
4. Can the event be related to any other cause, other than the study drug?-Chemical contact
Descripción

Hypersensitivity Chemicals

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0220806
4. Can the event be related to any other cause, other than the study drug?-Other, specify:
Descripción

Other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
5. Were any diagnostic tests performed for the Hypersensitivity/ Anaphylaxis reaction?
Descripción

Diagnostic tests Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0086143
UMLS CUI [1,2]
C0020517
5. 1) Laboratory tests including full blood count/ eosinophil?
Descripción

Laboratory tests Eosinophilia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0014457
5. 2) ECG?
Descripción

ECG

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1623258
5. 3)Bone marrow aspiration?
Descripción

Bone marrow aspiration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0398523
5. 4) Skin Biopsy?
Descripción

Skin Biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0150866
5. 5) Photograph
Descripción

Photograph

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0441468
5. Other, specify:
Descripción

other

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
5. If there is a report, can that be provided to appropiate Clinical contact?
Descripción

Report diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0011900
6. Local or disseminated rash
Descripción

rash

Tipo de datos

text

Alias
UMLS CUI [1]
C0015230
7. Distribution of rash- Facial
Descripción

site rash Facial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0015230
UMLS CUI [1,3]
C0015450
7. Distribution of rash-Trunk
Descripción

site rash trunk

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0015230
UMLS CUI [1,3]
C0460005
7. Distribution of rash-Extremities
Descripción

site rash Extremities

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0015230
UMLS CUI [1,3]
C0278454
7. Distribution of rash-Intertriginous (Skin folds)
Descripción

site rash Intertriginous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0015230
UMLS CUI [1,3]
C0205268
7. Distribution of rash- Extensor surfaces
Descripción

site rash Extensor surfaces

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0015230
UMLS CUI [1,3]
C1184148
UMLS CUI [1,4]
C0205148
7. Distribution of rash-Palms/ Soles
Descripción

site rash Palms sole rash

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0015230
UMLS CUI [1,3]
C0230373
UMLS CUI [1,4]
C0241203
8. Nature of cutaneous findings-Urticaria
Descripción

cutaneous findings Urticaria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C0042109
8. Nature of cutaneous findings- Erythema multiforme
Descripción

cutaneous findings Erythema multiforme

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C0014742
8. Nature of cutaneous findings- Toxic epidermal necrolysis
Descripción

cutaneous findings Toxic epidermal necrolysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C0014518
8. Nature of cutaneous findings- Mucous membrane involvement
Descripción

cutaneous findings Mucous membrane

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C0026724
8. Nature of cutaneous findings- Ulceration
Descripción

cutaneous findings Ulceration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C3887532
8. Nature of cutaneous findings- Macular or Maculopapular rash
Descripción

cutaneous findings Maculopapular rash

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C0423791
8. Nature of cutaneous findings- Vesicular
Descripción

cutaneous findings Vesicular

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C0205378
8. Nature of cutaneous findings-Erythema
Descripción

cutaneous findings Erythema

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C0041834
8. Nature of cutaneous findings-Edema with or without induration
Descripción

cutaneous findings Erythema Induratum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C0014741
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Similar models

Hypersensitivity/ Anaphylaxis Evaluation

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
HYPERSENSITIVITY/ ANAPHYLAXIS EVALUATION
C0220825 (UMLS CUI-1)
C0020517 (UMLS CUI-2)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Date and time of onset Hypersensitivity
Item
Date and time of onset of hypersensitivity/ anaphylaxis reaction
datetime
C0332162 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
Face edema
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Face edema?
boolean
C0542571 (UMLS CUI [1])
Laryngeal edema
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Laryngeal edema?
boolean
C0023052 (UMLS CUI [1])
Hypotension
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Hypotension ?
boolean
C0020649 (UMLS CUI [1])
Hypotension symptomatic
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Hypotension symptomatic ?
boolean
C0863113 (UMLS CUI [1])
Nausea
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Nausea?
boolean
C0027497 (UMLS CUI [1])
Vomiting
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Vomiting?
boolean
C0042963 (UMLS CUI [1])
Diarrhoea
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Diarrhoea?
boolean
C0011991 (UMLS CUI [1])
Pruritus
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction-Pruritus?
boolean
C0033774 (UMLS CUI [1])
Fever
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction-Fever?
boolean
C0015967 (UMLS CUI [1])
rash
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Rash?
boolean
C0015230 (UMLS CUI [1])
Bronchospasm
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Bronchospasm?
boolean
C0006266 (UMLS CUI [1])
Arthropathy
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Arthropathy?
boolean
C0022408 (UMLS CUI [1])
Proteinuria
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Proteinuria?
boolean
C0033687 (UMLS CUI [1])
Lymphadenopathy
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Lymphadenopathy?
boolean
C0497156 (UMLS CUI [1])
Other
Item
2. Signs and Symptoms at the time of Hypersensitivity/ Anaphylaxis reaction- Other, specify:
text
C0205394 (UMLS CUI [1])
Systemic corticosteroids
Item
3. Specify treatment provided for this Hypersensitivity/ Anaphylaxis reaction- Systemic corticosteroids?
boolean
C2825233 (UMLS CUI [1])
Adrenaline
Item
3. Specify treatment provided for this Hypersensitivity/ Anaphylaxis reaction- Adrenaline?
boolean
C0014563 (UMLS CUI [1])
Antihistamines
Item
3. Specify treatment provided for this Hypersensitivity/ Anaphylaxis reaction- Antihistamines?
boolean
C0019590 (UMLS CUI [1])
other
Item
3. Specify treatment provided for this Hypersensitivity/ Anaphylaxis reaction- Other, specify:
text
C0205394 (UMLS CUI [1])
Underlying disease
Item
4. Can the event be related to any other cause, other than the study drug?-Underlying disease
boolean
C0277554 (UMLS CUI [1])
Microbial
Item
4. Can the event be related to any other cause, other than the study drug?-Microbial/ Biological
boolean
C0445623 (UMLS CUI [1])
Pharmaceutical
Item
4. Can the event be related to any other cause, other than the study drug?-Pharmaceutical
boolean
C0013227 (UMLS CUI [1])
Food
Item
4. Can the event be related to any other cause, other than the study drug?-Food
boolean
C0016452 (UMLS CUI [1])
Pets
Item
4. Can the event be related to any other cause, other than the study drug?- Pets
boolean
C0031268 (UMLS CUI [1])
Environment
Item
4. Can the event be related to any other cause, other than the study drug?-Environment
boolean
C0014406 (UMLS CUI [1])
Hypersensitivity Chemicals
Item
4. Can the event be related to any other cause, other than the study drug?-Chemical contact
boolean
C0020517 (UMLS CUI [1,1])
C0220806 (UMLS CUI [1,2])
Other
Item
4. Can the event be related to any other cause, other than the study drug?-Other, specify:
text
C0205394 (UMLS CUI [1])
Diagnostic tests Hypersensitivity
Item
5. Were any diagnostic tests performed for the Hypersensitivity/ Anaphylaxis reaction?
boolean
C0086143 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Laboratory tests Eosinophilia
Item
5. 1) Laboratory tests including full blood count/ eosinophil?
boolean
C0022885 (UMLS CUI [1,1])
C0014457 (UMLS CUI [1,2])
ECG
Item
5. 2) ECG?
boolean
C1623258 (UMLS CUI [1])
Bone marrow aspiration
Item
5. 3)Bone marrow aspiration?
boolean
C0398523 (UMLS CUI [1])
Skin Biopsy
Item
5. 4) Skin Biopsy?
boolean
C0150866 (UMLS CUI [1])
Photograph
Item
5. 5) Photograph
boolean
C0441468 (UMLS CUI [1])
other
Item
5. Other, specify:
text
C0205394 (UMLS CUI [1])
Report diagnosis
Item
5. If there is a report, can that be provided to appropiate Clinical contact?
boolean
C0684224 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
6. Local or disseminated rash
text
C0015230 (UMLS CUI [1])
rash
Code List
6. Local or disseminated rash
CL Item
Local (Local)
CL Item
Disseminated (Disseminated)
site rash Facial
Item
7. Distribution of rash- Facial
boolean
C1515974 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0015450 (UMLS CUI [1,3])
site rash trunk
Item
7. Distribution of rash-Trunk
boolean
C1515974 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0460005 (UMLS CUI [1,3])
site rash Extremities
Item
7. Distribution of rash-Extremities
boolean
C1515974 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0278454 (UMLS CUI [1,3])
site rash Intertriginous
Item
7. Distribution of rash-Intertriginous (Skin folds)
boolean
C1515974 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0205268 (UMLS CUI [1,3])
site rash Extensor surfaces
Item
7. Distribution of rash- Extensor surfaces
boolean
C1515974 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C1184148 (UMLS CUI [1,3])
C0205148 (UMLS CUI [1,4])
site rash Palms sole rash
Item
7. Distribution of rash-Palms/ Soles
boolean
C1515974 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0230373 (UMLS CUI [1,3])
C0241203 (UMLS CUI [1,4])
cutaneous findings Urticaria
Item
8. Nature of cutaneous findings-Urticaria
boolean
C0455205 (UMLS CUI [1,1])
C0042109 (UMLS CUI [1,2])
cutaneous findings Erythema multiforme
Item
8. Nature of cutaneous findings- Erythema multiforme
boolean
C0455205 (UMLS CUI [1,1])
C0014742 (UMLS CUI [1,2])
cutaneous findings Toxic epidermal necrolysis
Item
8. Nature of cutaneous findings- Toxic epidermal necrolysis
boolean
C0455205 (UMLS CUI [1,1])
C0014518 (UMLS CUI [1,2])
cutaneous findings Mucous membrane
Item
8. Nature of cutaneous findings- Mucous membrane involvement
boolean
C0455205 (UMLS CUI [1,1])
C0026724 (UMLS CUI [1,2])
cutaneous findings Ulceration
Item
8. Nature of cutaneous findings- Ulceration
boolean
C0455205 (UMLS CUI [1,1])
C3887532 (UMLS CUI [1,2])
cutaneous findings Maculopapular rash
Item
8. Nature of cutaneous findings- Macular or Maculopapular rash
boolean
C0455205 (UMLS CUI [1,1])
C0423791 (UMLS CUI [1,2])
cutaneous findings Vesicular
Item
8. Nature of cutaneous findings- Vesicular
boolean
C0455205 (UMLS CUI [1,1])
C0205378 (UMLS CUI [1,2])
cutaneous findings Erythema
Item
8. Nature of cutaneous findings-Erythema
boolean
C0455205 (UMLS CUI [1,1])
C0041834 (UMLS CUI [1,2])
cutaneous findings Erythema Induratum
Item
8. Nature of cutaneous findings-Edema with or without induration
boolean
C0455205 (UMLS CUI [1,1])
C0014741 (UMLS CUI [1,2])
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