ID

24857

Description

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 3 - Day 84 and Parents/ Guardians contact for rash 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. 8/20/17 8/20/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

August 20, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 3 and Guardians contact for rash

English

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 3 and Guardians contact for rash

1 forms  
Check for study continuation
Description

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 3?
Description

study continuation

Data type

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0805733
Why didn't the subject return to visit 3?
Description

Please tick the ONE most appropriate reason and skip the following pages of this visit

Data type

text

Alias
UMLS CUI [1]
C2348568
Same reason and decision as previous visit.
Description

Same reason and decision as previous visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C2127115
SAE No
Description

Please specify number of SAE if that is the reason, why subject didn't return to visit 2.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Please specify unsolicited AE No
Description

number of unsolicited adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
solicited AE code
Description

solicited AE code

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Please specify 'other' most appropriate category for not returning to visit 2.
Description

e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2348568
Please tick who took the decision
Description

decision for study withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Description

Blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Description

Please complete only if different from visit date

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
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 1 and Visit 2?
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 1 and Visit 2?
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
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

1-3

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
Back to the top of the page

Similar models

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 3 and Guardians contact for rash

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject return for visit 3?
integer
C0008972 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
study continuation
Code List
Did the subject return for visit 3?
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please complete below. (2)
Item
Why didn't the subject return to visit 3?
text
C2348568 (UMLS CUI [1])
Why didn't the subject return to visit 2?
Code List
Why didn't the subject return to visit 3?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Same reason and decision as previous visit.
Item
Same reason and decision as previous visit.
boolean
C2348568 (UMLS CUI [1,1])
C2127115 (UMLS CUI [1,2])
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
solicited AE code
Item
solicited AE code
text
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for not returning to visit 2.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
decision for study withdrawal
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents / Guardians (P)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date blood sample taken
Item
Date blood sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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 1 and Visit 2?
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])
Type of exposure
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 1 and Visit 2?
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
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial