ID

25356

Description

Phase A - Year 2 Demographics and Parents contact for rash - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Keywords

Versions (1)
  1. 9/2/17 9/2/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 2, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Phase A - Year 2 Demographics and Parents contact for rash - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

English

Phase A - Year 2 Demographics and Parents contact for rash - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 forms  
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Center number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Parents/Guardians contact for rash
Description

Parents/Guardians contact for rash

Alias
UMLS CUI-1
C0015230
UMLS CUI-2
C0030551
UMLS CUI-3
C0582446
UMLS CUI-5
C0015230
UMLS CUI-6
C0023226
UMLS CUI-7
C0582446
Have the subject's parents/guardians contacted the investigator about the occurrence of any skin rash / eruption which was not reported in the Varicella / Zoster Case section?
Description

If yes, please complete below.

Data type

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C0582446
UMLS CUI [2,1]
C0015230
UMLS CUI [2,2]
C0023226
UMLS CUI [2,3]
C0582446
Parents/Guardians contact for rash
Description

Parents/Guardians contact for rash

Alias
UMLS CUI-1
C0015230
UMLS CUI-2
C0030551
UMLS CUI-3
C0582446
UMLS CUI-5
C0015230
UMLS CUI-6
C0023226
UMLS CUI-7
C0582446
Contact number
Description

1-6

Data type

integer

Alias
UMLS CUI [1,1]
C3812666
UMLS CUI [1,2]
C0449788
Date of contact
Description

Date of contact

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Has a visit to the investigator been arranged?
Description

arranged visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0420317
Why has no visit been arranged?
Description

Only answer, if no visit has been arranged.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0420317
Other, specify:
Description

Only answer, if no visit has been arranged.

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0420317
Why has a visit been arranged?
Description

Only answer, if visit to the investigator has been arranged.

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0420317
Diagnosis, specify
Description

Only answer, if visit to the investigator has been arranged.

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C0420317
Comments
Description

Only answer, if visit to the investigator has been arranged.

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0420317
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Similar models

Phase A - Year 2 Demographics and Parents contact for rash - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item Group
Parents/Guardians contact for rash
C0015230 (UMLS CUI-1)
C0030551 (UMLS CUI-2)
C0582446 (UMLS CUI-3)
C0015230 (UMLS CUI-5)
C0023226 (UMLS CUI-6)
C0582446 (UMLS CUI-7)
Parents/Guardians contact for rash
Item
Have the subject's parents/guardians contacted the investigator about the occurrence of any skin rash / eruption which was not reported in the Varicella / Zoster Case section?
boolean
C0015230 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0582446 (UMLS CUI [1,3])
C0015230 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C0582446 (UMLS CUI [2,3])
Item Group
Parents/Guardians contact for rash
C0015230 (UMLS CUI-1)
C0030551 (UMLS CUI-2)
C0582446 (UMLS CUI-3)
C0015230 (UMLS CUI-5)
C0023226 (UMLS CUI-6)
C0582446 (UMLS CUI-7)
Contact number
Item
Contact number
integer
C3812666 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
arranged visit
Item
Has a visit to the investigator been arranged?
boolean
C0545082 (UMLS CUI [1,1])
C0420317 (UMLS CUI [1,2])
Item
Why has no visit been arranged?
integer
C0545082 (UMLS CUI [1,1])
C0420317 (UMLS CUI [1,2])
no arranged visit
Code List
Why has no visit been arranged?
CL Item
No need; diagnosis obviously not varicella/zoster (1)
CL Item
Other, specify (2)
Specify other reason for non arranged visit to investigator
Item
Other, specify:
text
C3840932 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0420317 (UMLS CUI [1,3])
Item
Why has a visit been arranged?
text
C0545082 (UMLS CUI [1,1])
C0420317 (UMLS CUI [1,2])
arranged visit
Code List
Why has a visit been arranged?
CL Item
Diagnosis, specify (1)
CL Item
Comments (2)
Specify diagnosis for arranged visit
Item
Diagnosis, specify
text
C0011900 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C0420317 (UMLS CUI [1,3])
Comment arranged visit
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0420317 (UMLS CUI [1,3])
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