ID

22446

Beschreibung

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.

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  1. 04.06.17 04.06.17 -
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GlaxoSmithKline

Hochgeladen am

4. Juni 2017

DOI

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HES Related Medical Conditions Screening Visit Mepolizumab HES NCT00086658

HES Related Medical Conditions Screening Visit

CARDIAC DISORDERS
Beschreibung

CARDIAC DISORDERS

Alias
UMLS CUI-1
C0018799
Subject Identifier
Beschreibung

Subject ID

Datentyp

text

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

blood clot

Datentyp

text

Alias
UMLS CUI [1]
C0302148
2. Fibrosis
Beschreibung

Fibrosis

Datentyp

text

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

Cardiac failure

Datentyp

text

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

Pulmonary edema

Datentyp

text

Alias
UMLS CUI [1]
C0034063
NERVOUS SYSTEM DISORDERS
Beschreibung

NERVOUS SYSTEM DISORDERS

Alias
UMLS CUI-1
C0810273
5. Confusional state
Beschreibung

Confusional state

Datentyp

text

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

Mental status changes

Datentyp

text

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

Gait abnormal

Datentyp

text

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

Balance difficulty

Datentyp

text

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

Coordination abnormal

Datentyp

text

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

Cranial nerve disorder

Datentyp

text

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

Motor dysfunction

Datentyp

text

Alias
UMLS CUI [1]
C0521654
12. Hyporeflexia
Beschreibung

Hyporeflexia

Datentyp

text

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

Sensory disturbance

Datentyp

text

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

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

Alias
UMLS CUI-1
C0037274
14. Skin swelling
Beschreibung

Skin swelling

Datentyp

text

Alias
UMLS CUI [1]
C0281982
15. Erythema
Beschreibung

Erythema

Datentyp

text

Alias
UMLS CUI [1]
C0041834
16. Itching
Beschreibung

Itching

Datentyp

text

Alias
UMLS CUI [1]
C0033774
17. Rash
Beschreibung

Rash

Datentyp

text

Alias
UMLS CUI [1]
C0015230
18. Sweating
Beschreibung

Sweating

Datentyp

text

Alias
UMLS CUI [1]
C0038990
GASTROINTESTINAL DISORDERS
Beschreibung

GASTROINTESTINAL DISORDERS

Alias
UMLS CUI-1
C0017178
19. Nausea
Beschreibung

Nausea

Datentyp

text

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

Swallowing difficult

Datentyp

text

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

Abdominal pain

Datentyp

text

Alias
UMLS CUI [1]
C0000737
22. Diarrhea
Beschreibung

Diarrhea

Datentyp

text

Alias
UMLS CUI [1]
C0011991
23. Vomiting
Beschreibung

Vomiting

Datentyp

text

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

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

Alias
UMLS CUI-1
C0263660
24. Polyarthritis
Beschreibung

Polyarthritis

Datentyp

text

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

Muscle pain

Datentyp

text

Alias
UMLS CUI [1]
C0231528
EYE DISORDERS
Beschreibung

EYE DISORDERS

Alias
UMLS CUI-1
C0015397
26. Retinal disorder
Beschreibung

Retinal disorder

Datentyp

text

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

Visual disturbance

Datentyp

text

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

Blurred vision

Datentyp

text

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

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

Alias
UMLS CUI-1
C0851355
29. Breathlessness
Beschreibung

Breathlessness

Datentyp

text

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

Exertional dyspnea

Datentyp

text

Alias
UMLS CUI [1]
C0231807
31. Cough
Beschreibung

Cough

Datentyp

text

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

OTHER HES RELATED MEDICAL CONDITIONS

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

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

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Diagnosis
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900

Ähnliche Modelle

HES Related Medical Conditions Screening Visit

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
Code List
Diagnosis
CL Item
Current (Current)
CL Item
Past (Past)

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