ID

22446

Description

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.

Keywords

Versions (1)
  1. 6/4/17 6/4/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 4, 2017

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License

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

English

HES Related Medical Conditions Screening Visit

1 forms  
CARDIAC DISORDERS
Description

CARDIAC DISORDERS

Alias
UMLS CUI-1
C0018799
Subject Identifier
Description

Subject ID

Data type

text

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

blood clot

Data type

text

Alias
UMLS CUI [1]
C0302148
2. Fibrosis
Description

Fibrosis

Data type

text

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

Cardiac failure

Data type

text

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

Pulmonary edema

Data type

text

Alias
UMLS CUI [1]
C0034063
NERVOUS SYSTEM DISORDERS
Description

NERVOUS SYSTEM DISORDERS

Alias
UMLS CUI-1
C0810273
5. Confusional state
Description

Confusional state

Data type

text

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

Mental status changes

Data type

text

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

Gait abnormal

Data type

text

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

Balance difficulty

Data type

text

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

Coordination abnormal

Data type

text

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

Cranial nerve disorder

Data type

text

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

Motor dysfunction

Data type

text

Alias
UMLS CUI [1]
C0521654
12. Hyporeflexia
Description

Hyporeflexia

Data type

text

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

Sensory disturbance

Data type

text

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

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

Alias
UMLS CUI-1
C0037274
14. Skin swelling
Description

Skin swelling

Data type

text

Alias
UMLS CUI [1]
C0281982
15. Erythema
Description

Erythema

Data type

text

Alias
UMLS CUI [1]
C0041834
16. Itching
Description

Itching

Data type

text

Alias
UMLS CUI [1]
C0033774
17. Rash
Description

Rash

Data type

text

Alias
UMLS CUI [1]
C0015230
18. Sweating
Description

Sweating

Data type

text

Alias
UMLS CUI [1]
C0038990
GASTROINTESTINAL DISORDERS
Description

GASTROINTESTINAL DISORDERS

Alias
UMLS CUI-1
C0017178
19. Nausea
Description

Nausea

Data type

text

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

Swallowing difficult

Data type

text

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

Abdominal pain

Data type

text

Alias
UMLS CUI [1]
C0000737
22. Diarrhea
Description

Diarrhea

Data type

text

Alias
UMLS CUI [1]
C0011991
23. Vomiting
Description

Vomiting

Data type

text

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

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

Alias
UMLS CUI-1
C0263660
24. Polyarthritis
Description

Polyarthritis

Data type

text

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

Muscle pain

Data type

text

Alias
UMLS CUI [1]
C0231528
EYE DISORDERS
Description

EYE DISORDERS

Alias
UMLS CUI-1
C0015397
26. Retinal disorder
Description

Retinal disorder

Data type

text

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

Visual disturbance

Data type

text

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

Blurred vision

Data type

text

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

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

Alias
UMLS CUI-1
C0851355
29. Breathlessness
Description

Breathlessness

Data type

text

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

Exertional dyspnea

Data type

text

Alias
UMLS CUI [1]
C0231807
31. Cough
Description

Cough

Data type

text

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

OTHER HES RELATED MEDICAL CONDITIONS

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

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

Data type

text

Alias
UMLS CUI [1]
C0011900
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
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Similar models

HES Related Medical Conditions Screening Visit

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