ID

44028

Description

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.

Keywords

Versions (2)
  1. 6/5/17 6/5/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

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

English

Hypersensitivity/ Anaphylaxis Evaluation

1 forms  
HYPERSENSITIVITY/ ANAPHYLAXIS EVALUATION
Description

HYPERSENSITIVITY/ ANAPHYLAXIS EVALUATION

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

Subject ID

Data type

text

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

Date and time of onset Hypersensitivity

Data type

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?
Description

Face edema

Data type

boolean

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

Laryngeal edema

Data type

boolean

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

Hypotension

Data type

boolean

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

Hypotension symptomatic

Data type

boolean

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

Nausea

Data type

boolean

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

Vomiting

Data type

boolean

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

Diarrhoea

Data type

boolean

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

Pruritus

Data type

boolean

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

Fever

Data type

boolean

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

rash

Data type

boolean

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

Bronchospasm

Data type

boolean

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

Arthropathy

Data type

boolean

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

Proteinuria

Data type

boolean

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

Lymphadenopathy

Data type

boolean

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

Other

Data type

text

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

Systemic corticosteroids

Data type

boolean

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

Adrenaline

Data type

boolean

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

Antihistamines

Data type

boolean

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

other

Data type

text

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

Underlying disease

Data type

boolean

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

Microbial

Data type

boolean

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

Pharmaceutical

Data type

boolean

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

Food

Data type

boolean

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

Pets

Data type

boolean

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

Environment

Data type

boolean

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

Hypersensitivity Chemicals

Data type

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:
Description

Other

Data type

text

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

Diagnostic tests Hypersensitivity

Data type

boolean

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

Laboratory tests Eosinophilia

Data type

boolean

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

ECG

Data type

boolean

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

Bone marrow aspiration

Data type

boolean

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

Skin Biopsy

Data type

boolean

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

Photograph

Data type

boolean

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

other

Data type

text

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

Report diagnosis

Data type

boolean

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

rash

Data type

text

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

site rash Facial

Data type

boolean

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

site rash trunk

Data type

boolean

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

site rash Extremities

Data type

boolean

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

site rash Intertriginous

Data type

boolean

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

site rash Extensor surfaces

Data type

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
Description

site rash Palms sole rash

Data type

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
Description

cutaneous findings Urticaria

Data type

boolean

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

cutaneous findings Erythema multiforme

Data type

boolean

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

cutaneous findings Toxic epidermal necrolysis

Data type

boolean

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

cutaneous findings Mucous membrane

Data type

boolean

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

cutaneous findings Ulceration

Data type

boolean

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

cutaneous findings Maculopapular rash

Data type

boolean

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

cutaneous findings Vesicular

Data type

boolean

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

cutaneous findings Erythema

Data type

boolean

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

cutaneous findings Erythema Induratum

Data type

boolean

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

Hypersensitivity/ Anaphylaxis Evaluation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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