ID

22446

Descripción

Study part: HES Related Medical Conditions 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.

Palabras clave

Versiones (1)
  1. 4/6/17 4/6/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de junio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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HES Related Medical Conditions Screening Visit Mepolizumab HES NCT00086658

Inglés

HES Related Medical Conditions Screening Visit

1 formularios  
CARDIAC DISORDERS
Descripción

CARDIAC DISORDERS

Alias
UMLS CUI-1
C0018799
Subject Identifier
Descripción

Subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
1. Clot blood
Descripción

blood clot

Tipo de datos

text

Alias
UMLS CUI [1]
C0302148
2. Fibrosis
Descripción

Fibrosis

Tipo de datos

text

Alias
UMLS CUI [1]
C0016059
3. Cardiac failure
Descripción

Cardiac failure

Tipo de datos

text

Alias
UMLS CUI [1]
C0018801
4. Pulmonary edema
Descripción

Pulmonary edema

Tipo de datos

text

Alias
UMLS CUI [1]
C0034063
NERVOUS SYSTEM DISORDERS
Descripción

NERVOUS SYSTEM DISORDERS

Alias
UMLS CUI-1
C0810273
5. Confusional state
Descripción

Confusional state

Tipo de datos

text

Alias
UMLS CUI [1]
C0009676
6. Mental status changes
Descripción

Mental status changes

Tipo de datos

text

Alias
UMLS CUI [1]
C0856054
7. Gait abnormal
Descripción

Gait abnormal

Tipo de datos

text

Alias
UMLS CUI [1]
C0575081
8. Balance difficulty
Descripción

Balance difficulty

Tipo de datos

text

Alias
UMLS CUI [1]
C1744587
9. Coordination abnormal
Descripción

Coordination abnormal

Tipo de datos

text

Alias
UMLS CUI [1]
C0520966
10. Cranial nerve disorder
Descripción

Cranial nerve disorder

Tipo de datos

text

Alias
UMLS CUI [1]
C0010266
11. Motor dysfunction
Descripción

Motor dysfunction

Tipo de datos

text

Alias
UMLS CUI [1]
C0521654
12. Hyporeflexia
Descripción

Hyporeflexia

Tipo de datos

text

Alias
UMLS CUI [1]
C0151888
13. Sensory disturbance
Descripción

Sensory disturbance

Tipo de datos

text

Alias
UMLS CUI [1]
C0152027
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Descripción

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

Alias
UMLS CUI-1
C0037274
14. Skin swelling
Descripción

Skin swelling

Tipo de datos

text

Alias
UMLS CUI [1]
C0281982
15. Erythema
Descripción

Erythema

Tipo de datos

text

Alias
UMLS CUI [1]
C0041834
16. Itching
Descripción

Itching

Tipo de datos

text

Alias
UMLS CUI [1]
C0033774
17. Rash
Descripción

Rash

Tipo de datos

text

Alias
UMLS CUI [1]
C0015230
18. Sweating
Descripción

Sweating

Tipo de datos

text

Alias
UMLS CUI [1]
C0038990
GASTROINTESTINAL DISORDERS
Descripción

GASTROINTESTINAL DISORDERS

Alias
UMLS CUI-1
C0017178
19. Nausea
Descripción

Nausea

Tipo de datos

text

Alias
UMLS CUI [1]
C0027497
20. Swallowing difficult
Descripción

Swallowing difficult

Tipo de datos

text

Alias
UMLS CUI [1]
C0011168
21. Abdominal pain
Descripción

Abdominal pain

Tipo de datos

text

Alias
UMLS CUI [1]
C0000737
22. Diarrhea
Descripción

Diarrhea

Tipo de datos

text

Alias
UMLS CUI [1]
C0011991
23. Vomiting
Descripción

Vomiting

Tipo de datos

text

Alias
UMLS CUI [1]
C0042963
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Descripción

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

Alias
UMLS CUI-1
C0263660
24. Polyarthritis
Descripción

Polyarthritis

Tipo de datos

text

Alias
UMLS CUI [1]
C0162323
25. Muscle pain
Descripción

Muscle pain

Tipo de datos

text

Alias
UMLS CUI [1]
C0231528
EYE DISORDERS
Descripción

EYE DISORDERS

Alias
UMLS CUI-1
C0015397
26. Retinal disorder
Descripción

Retinal disorder

Tipo de datos

text

Alias
UMLS CUI [1]
C0035309
27. Visual disturbance
Descripción

Visual disturbance

Tipo de datos

text

Alias
UMLS CUI [1]
C0547030
28. Blurred vision
Descripción

Blurred vision

Tipo de datos

text

Alias
UMLS CUI [1]
C0344232
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Descripción

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

Alias
UMLS CUI-1
C0851355
29. Breathlessness
Descripción

Breathlessness

Tipo de datos

text

Alias
UMLS CUI [1]
C0013404
30. Exertional dyspnea
Descripción

Exertional dyspnea

Tipo de datos

text

Alias
UMLS CUI [1]
C0231807
31. Cough
Descripción

Cough

Tipo de datos

text

Alias
UMLS CUI [1]
C0010200
OTHER HES RELATED MEDICAL CONDITIONS
Descripción

OTHER HES RELATED MEDICAL CONDITIONS

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C1540912
Diagnosis
Descripción

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Tipo de datos

text

Alias
UMLS CUI [1]
C0011900
Diagnosis
Descripción

Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1]
C0011900
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Similar models

HES Related Medical Conditions Screening Visit

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
CARDIAC DISORDERS
C0018799 (UMLS CUI-1)
Subject ID
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item
1. Clot blood
text
C0302148 (UMLS CUI [1])
blood clot
Code List
1. Clot blood
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
2. Fibrosis
text
C0016059 (UMLS CUI [1])
blood clot
Code List
2. Fibrosis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
3. Cardiac failure
text
C0018801 (UMLS CUI [1])
blood clot
Code List
3. Cardiac failure
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
4. Pulmonary edema
text
C0034063 (UMLS CUI [1])
blood clot
Code List
4. Pulmonary edema
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item Group
NERVOUS SYSTEM DISORDERS
C0810273 (UMLS CUI-1)
Item
5. Confusional state
text
C0009676 (UMLS CUI [1])
blood clot
Code List
5. Confusional state
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
6. Mental status changes
text
C0856054 (UMLS CUI [1])
blood clot
Code List
6. Mental status changes
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
7. Gait abnormal
text
C0575081 (UMLS CUI [1])
blood clot
Code List
7. Gait abnormal
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
8. Balance difficulty
text
C1744587 (UMLS CUI [1])
blood clot
Code List
8. Balance difficulty
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
9. Coordination abnormal
text
C0520966 (UMLS CUI [1])
blood clot
Code List
9. Coordination abnormal
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
10. Cranial nerve disorder
text
C0010266 (UMLS CUI [1])
blood clot
Code List
10. Cranial nerve disorder
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
11. Motor dysfunction
text
C0521654 (UMLS CUI [1])
blood clot
Code List
11. Motor dysfunction
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
12. Hyporeflexia
text
C0151888 (UMLS CUI [1])
blood clot
Code List
12. Hyporeflexia
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
13. Sensory disturbance
text
C0152027 (UMLS CUI [1])
blood clot
Code List
13. Sensory disturbance
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item Group
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
C0037274 (UMLS CUI-1)
Item
14. Skin swelling
text
C0281982 (UMLS CUI [1])
blood clot
Code List
14. Skin swelling
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
15. Erythema
text
C0041834 (UMLS CUI [1])
blood clot
Code List
15. Erythema
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
16. Itching
text
C0033774 (UMLS CUI [1])
blood clot
Code List
16. Itching
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
17. Rash
text
C0015230 (UMLS CUI [1])
blood clot
Code List
17. Rash
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
18. Sweating
text
C0038990 (UMLS CUI [1])
blood clot
Code List
18. Sweating
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item Group
GASTROINTESTINAL DISORDERS
C0017178 (UMLS CUI-1)
Item
19. Nausea
text
C0027497 (UMLS CUI [1])
blood clot
Code List
19. Nausea
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
20. Swallowing difficult
text
C0011168 (UMLS CUI [1])
blood clot
Code List
20. Swallowing difficult
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
21. Abdominal pain
text
C0000737 (UMLS CUI [1])
blood clot
Code List
21. Abdominal pain
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
22. Diarrhea
text
C0011991 (UMLS CUI [1])
blood clot
Code List
22. Diarrhea
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
23. Vomiting
text
C0042963 (UMLS CUI [1])
blood clot
Code List
23. Vomiting
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item Group
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
C0263660 (UMLS CUI-1)
Item
24. Polyarthritis
text
C0162323 (UMLS CUI [1])
blood clot
Code List
24. Polyarthritis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
25. Muscle pain
text
C0231528 (UMLS CUI [1])
blood clot
Code List
25. Muscle pain
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item Group
EYE DISORDERS
C0015397 (UMLS CUI-1)
Item
26. Retinal disorder
text
C0035309 (UMLS CUI [1])
blood clot
Code List
26. Retinal disorder
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
27. Visual disturbance
text
C0547030 (UMLS CUI [1])
blood clot
Code List
27. Visual disturbance
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
28. Blurred vision
text
C0344232 (UMLS CUI [1])
blood clot
Code List
28. Blurred vision
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item Group
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
C0851355 (UMLS CUI-1)
Item
29. Breathlessness
text
C0013404 (UMLS CUI [1])
blood clot
Code List
29. Breathlessness
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
30. Exertional dyspnea
text
C0231807 (UMLS CUI [1])
blood clot
Code List
30. Exertional dyspnea
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item
31. Cough
text
C0010200 (UMLS CUI [1])
blood clot
Code List
31. Cough
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
Not Assessed (Not Assessed)
CL Item
No Medical Condition (No Medical Condition)
Item Group
OTHER HES RELATED MEDICAL CONDITIONS
C0262926 (UMLS CUI-1)
C1540912 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Diagnosis
Code List
Diagnosis
CL Item
Current (Current)
CL Item
Past (Past)
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