ID

44028

Beschreibung

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.

Stichworte

Versionen (2)
  1. 05.06.17 05.06.17 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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Hypersensitivity/ Anaphylaxis Evaluation Mepolizumab HES NCT00086658

Englisch

Hypersensitivity/ Anaphylaxis Evaluation

1 Formulare  
HYPERSENSITIVITY/ ANAPHYLAXIS EVALUATION
Beschreibung

HYPERSENSITIVITY/ ANAPHYLAXIS EVALUATION

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

Subject ID

Datentyp

text

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

Date and time of onset Hypersensitivity

Datentyp

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?
Beschreibung

Face edema

Datentyp

boolean

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

Laryngeal edema

Datentyp

boolean

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

Hypotension

Datentyp

boolean

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

Hypotension symptomatic

Datentyp

boolean

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

Nausea

Datentyp

boolean

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

Vomiting

Datentyp

boolean

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

Diarrhoea

Datentyp

boolean

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

Pruritus

Datentyp

boolean

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

Fever

Datentyp

boolean

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

rash

Datentyp

boolean

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

Bronchospasm

Datentyp

boolean

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

Arthropathy

Datentyp

boolean

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

Proteinuria

Datentyp

boolean

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

Lymphadenopathy

Datentyp

boolean

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

Other

Datentyp

text

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

Systemic corticosteroids

Datentyp

boolean

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

Adrenaline

Datentyp

boolean

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

Antihistamines

Datentyp

boolean

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

other

Datentyp

text

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

Underlying disease

Datentyp

boolean

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

Microbial

Datentyp

boolean

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

Pharmaceutical

Datentyp

boolean

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

Food

Datentyp

boolean

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

Pets

Datentyp

boolean

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

Environment

Datentyp

boolean

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

Hypersensitivity Chemicals

Datentyp

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:
Beschreibung

Other

Datentyp

text

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

Diagnostic tests Hypersensitivity

Datentyp

boolean

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

Laboratory tests Eosinophilia

Datentyp

boolean

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

ECG

Datentyp

boolean

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

Bone marrow aspiration

Datentyp

boolean

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

Skin Biopsy

Datentyp

boolean

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

Photograph

Datentyp

boolean

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

other

Datentyp

text

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

Report diagnosis

Datentyp

boolean

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

rash

Datentyp

text

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

site rash Facial

Datentyp

boolean

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

site rash trunk

Datentyp

boolean

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

site rash Extremities

Datentyp

boolean

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

site rash Intertriginous

Datentyp

boolean

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

site rash Extensor surfaces

Datentyp

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
Beschreibung

site rash Palms sole rash

Datentyp

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
Beschreibung

cutaneous findings Urticaria

Datentyp

boolean

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

cutaneous findings Erythema multiforme

Datentyp

boolean

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

cutaneous findings Toxic epidermal necrolysis

Datentyp

boolean

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

cutaneous findings Mucous membrane

Datentyp

boolean

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

cutaneous findings Ulceration

Datentyp

boolean

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

cutaneous findings Maculopapular rash

Datentyp

boolean

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

cutaneous findings Vesicular

Datentyp

boolean

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

cutaneous findings Erythema

Datentyp

boolean

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

cutaneous findings Erythema Induratum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0455205
UMLS CUI [1,2]
C0014741
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Ähnliche Modelle

Hypersensitivity/ Anaphylaxis Evaluation

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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