ID

23887

Description

Study part: General Medical History/ Physical Examination Visit 1. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Keywords

Versions (1)
  1. 7/16/17 7/16/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 16, 2017

DOI

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License

Creative Commons BY-NC 3.0
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General Medical History/ Physical Examination Visit 1 Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

English

General Medical History/ Physical Examination Visit 1

1 forms  
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Description

GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject since the end of the primary study ?
Description

medical history

Data type

boolean

Alias
UMLS CUI [1]
C0262926
Diagnosis of cutaneous symptoms
Description

Diagnosis Cutaneous

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0221912
Diagnosis of cutaneous symptoms
Description

Diagnosis Cutaneous

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0221912
Diagnosis of eye symptoms
Description

Diagnosis Eyes

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0015392
Diagnosis of eye symptoms
Description

Diagnosis Eyes

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0015392
Diagnosis of ears-nose-throat symptoms
Description

Ears-nose-throat diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0395797
UMLS CUI [1,2]
C0011900
Diagnosis of ears-nose-throat symptoms
Description

Ears-nose-throat diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0395797
UMLS CUI [1,2]
C0011900
Diagnosis of cardiovascular symptoms
Description

Diagnosis Cardiovascular

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C3887460
Diagnosis of cardiovascular symptoms
Description

Diagnosis Cardiovascular

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C3887460
Diagnosis of respiratory symptoms
Description

Diagnosis Respiratory

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0035237
Diagnosis of respiratory symptoms
Description

Diagnosis Respiratory

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0035237
Diagnosis of gastrointestinal symptoms
Description

Diagnosis Gastrointestinal

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0521362
Diagnosis of gastrointestinal symptoms
Description

Diagnosis Gastrointestinal

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0521362
Diagnosis of muskuloskeletal symptoms
Description

Diagnosis Muskuloskeletal

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0026860
Diagnosis of muskuloskeletal symptoms
Description

Diagnosis Muskuloskeletal

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0026860
Diagnosis of neurological symptoms
Description

Diagnosis Neurological

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0027765
Diagnosis of neurological symptoms
Description

Diagnosis Neurological

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0027765
Diagnosis of genitourinary symptoms
Description

Diagnosis Genitourinary

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0042066
Diagnosis of genitourinary symptoms
Description

Diagnosis Genitourinary

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0042066
Diagnosis of haematology symptoms
Description

Diagnosis Haematology

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0474523
Diagnosis of haematology symptoms
Description

Diagnosis Haematology

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0474523
Diagnosis of allergies
Description

Diagnosis Allergies

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0020517
Diagnosis of allergies
Description

Diagnosis Allergies

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0020517
Diagnosis of endocrine symptoms
Description

Endocrine diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0011900
Diagnosis of endocrine symptoms
Description

Endocrine diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0011900
Diagnosis of other symptoms (specify)
Description

Diagnosis Other

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0205394
Diagnosis of other
Description

Diagnosis Other

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0205394
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Similar models

General Medical History/ Physical Examination Visit 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
C0031809 (UMLS CUI-1)
medical history
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject since the end of the primary study ?
boolean
C0262926 (UMLS CUI [1])
Diagnosis Cutaneous
Item
Diagnosis of cutaneous symptoms
text
C0011900 (UMLS CUI [1,1])
C0221912 (UMLS CUI [1,2])
Item
Diagnosis of cutaneous symptoms
text
C0011900 (UMLS CUI [1,1])
C0221912 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of cutaneous symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Eyes
Item
Diagnosis of eye symptoms
text
C0011900 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Item
Diagnosis of eye symptoms
text
C0011900 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of eye symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Ears-nose-throat diagnosis
Item
Diagnosis of ears-nose-throat symptoms
text
C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Diagnosis of ears-nose-throat symptoms
text
C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of ears-nose-throat symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Cardiovascular
Item
Diagnosis of cardiovascular symptoms
text
C0011900 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
Item
Diagnosis of cardiovascular symptoms
text
C0011900 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of cardiovascular symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Respiratory
Item
Diagnosis of respiratory symptoms
text
C0011900 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
Item
Diagnosis of respiratory symptoms
text
C0011900 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of respiratory symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Gastrointestinal
Item
Diagnosis of gastrointestinal symptoms
text
C0011900 (UMLS CUI [1,1])
C0521362 (UMLS CUI [1,2])
Item
Diagnosis of gastrointestinal symptoms
text
C0011900 (UMLS CUI [1,1])
C0521362 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of gastrointestinal symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Muskuloskeletal
Item
Diagnosis of muskuloskeletal symptoms
text
C0011900 (UMLS CUI [1,1])
C0026860 (UMLS CUI [1,2])
Item
Diagnosis of muskuloskeletal symptoms
text
C0011900 (UMLS CUI [1,1])
C0026860 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of muskuloskeletal symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Neurological
Item
Diagnosis of neurological symptoms
text
C0011900 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
Item
Diagnosis of neurological symptoms
text
C0011900 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of neurological symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Genitourinary
Item
Diagnosis of genitourinary symptoms
text
C0011900 (UMLS CUI [1,1])
C0042066 (UMLS CUI [1,2])
Item
Diagnosis of genitourinary symptoms
text
C0011900 (UMLS CUI [1,1])
C0042066 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of genitourinary symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Haematology
Item
Diagnosis of haematology symptoms
text
C0011900 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Item
Diagnosis of haematology symptoms
text
C0011900 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of haematology symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Allergies
Item
Diagnosis of allergies
text
C0011900 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Item
Diagnosis of allergies
text
C0011900 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of allergies
CL Item
Past (Past)
CL Item
Current (Current)
Endocrine diagnosis
Item
Diagnosis of endocrine symptoms
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Diagnosis of endocrine symptoms
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of endocrine symptoms
CL Item
Past (Past)
CL Item
Current (Current)
Diagnosis Other
Item
Diagnosis of other symptoms (specify)
text
C0011900 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Diagnosis of other
text
C0011900 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Diagnosis Cutaneous
Code List
Diagnosis of other
CL Item
Past (Past)
CL Item
Current (Current)
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