Phase A - Year 2 - Telephone contact 1 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

Subject's contact
Description

Subject's contact

Alias
UMLS CUI-1
C0332158
UMLS CUI-2
C0681850
Was the subject successfully contacted at scheduled Telephone Contact 1?
Description

telephone contact

Data type

boolean

Alias
UMLS CUI [1]
C0420309
Has the subject been seen or contacted between Visit 3 and the scheduled telephone contact 1?
Description

Only fill in, if you answered previous question with 'no'.

Data type

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
Last date
Description

Date of last contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Household exposure
Description

Household exposure

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0020052
Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between Visit 3 and this contact ?
Description

Exposure in household to varicella/zoster

Data type

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0020052
UMLS CUI [2,1]
C0740380
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0020052
Household exposure number
Description

Household exposure number

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0020052
UMLS CUI-3
C0449788
Household Exposure No
Description

Household Exposure No

Data type

integer

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0020052
UMLS CUI [1,3]
C0449788
Date of onset exposure
Description

Date of onset exposure

Data type

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0332157
Type of exposure
Description

Type of exposure

Data type

integer

Alias
UMLS CUI [1]
C0332157
Varicella or zoster
Description

Varicella or zoster

Alias
UMLS CUI-1
C0008049
UMLS CUI-3
C0740380
Did the subject present any signs of varicella or zoster symptoms between Visit 3 and and this contact?
Description

if 'yes', please complete the Varicella or Zoster Case section.

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0740380
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0008049
How many episodes?
Description

Number of episodes of varicella/zoster signs and symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0740380
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0008049
Serious adverse event
Description

Serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse event between Visit 3 and and this contact?
Description

If 'yes, please complete the Serious Adverse Event form.

Data type

boolean

Alias
UMLS CUI [1]
C1519255

Similar models

Phase A - Year 2 - Telephone contact 1 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject's contact
C0332158 (UMLS CUI-1)
C0681850 (UMLS CUI-2)
telephone contact
Item
Was the subject successfully contacted at scheduled Telephone Contact 1?
boolean
C0420309 (UMLS CUI [1])
contact with subject
Item
Has the subject been seen or contacted between Visit 3 and the scheduled telephone contact 1?
boolean
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Date of last contact
Item
Last date
date
C0805839 (UMLS CUI [1])
Item Group
Household exposure
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
Exposure in household to varicella/zoster
Item
Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between Visit 3 and this contact ?
boolean
C0008049 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0020052 (UMLS CUI [1,3])
C0740380 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0020052 (UMLS CUI [2,3])
Item Group
Household exposure number
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
C0449788 (UMLS CUI-3)
Household Exposure No
Item
Household Exposure No
integer
C0332157 (UMLS CUI [1,1])
C0020052 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Date of onset exposure
Item
Date of onset exposure
date
C0574845 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Item
Type of exposure
integer
C0332157 (UMLS CUI [1])
Code List
Type of exposure
CL Item
Varicella (1)
CL Item
Zoster (2)
Item Group
Varicella or zoster
C0008049 (UMLS CUI-1)
C0740380 (UMLS CUI-3)
signs or symptoms of varicella or zoster
Item
Did the subject present any signs of varicella or zoster symptoms between Visit 3 and and this contact?
boolean
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
Number of episodes of varicella/zoster signs and symptoms
Item
How many episodes?
integer
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
Item Group
Serious adverse event
C1519255 (UMLS CUI-1)
serious adverse event
Item
Did the subject experience any serious adverse event between Visit 3 and and this contact?
boolean
C1519255 (UMLS CUI [1])