ID

26277

Description

Visit 6 Booster Dose Diary Card - Local Symptoms Biologicals HepA/HepB vaccine 208127/125 form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Keywords

Versions (1)
  1. 10/15/17 10/15/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 15, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Visit 6 Booster Dose Diary Card - Local Symptoms Biologicals HepA/HepB vaccine 208127/125

English

Visit 6 Booster Dose Diary Card - Local Symptoms Biologicals HepA/HepB vaccine 208127/125

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Protocol
Description

Protocol

Data type

text

Alias
UMLS CUI [1]
C1507394
Activity
Description

Activity

Data type

text

Alias
UMLS CUI [1]
C1512346
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Redness
Description

Redness

Alias
UMLS CUI-1
C0332575
Size Day 0
Description

Size Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C2826301
mm
Size Day 1
Description

Size Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C1442449
mm
Size Day 2
Description

Size Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C3842676
mm
Size Day 3
Description

Size Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C3842675
mm
Swellling
Description

Swellling

Alias
UMLS CUI-1
C0038999
Size Day 0
Description

Size Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C2826301
mm
Size Day 1
Description

Size Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C1442449
mm
Size Day 2
Description

Size Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C3842676
mm
Size Day 3
Description

Size Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C3842675
mm
Soreness
Description

Soreness

Alias
UMLS CUI-1
C0030193
Intensity Day 0
Description

Intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C2826301
Intensity Day 1
Description

Intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442449
Intensity Day 2
Description

Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842676
Intensity Day 3
Description

Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C3842675
Other Local Symptoms
Description

Other Local Symptoms

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
OTHER : Please give details below (description - start date - end date - intensity)
Description

Description, start date, end date, intensity

Data type

text

Alias
UMLS CUI [1]
C0424450
UMLS CUI [2]
C0808070
UMLS CUI [3]
C0806020
UMLS CUI [4]
C0518690
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Similar models

Visit 6 Booster Dose Diary Card - Local Symptoms Biologicals HepA/HepB vaccine 208127/125

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Activity
Item
Activity
text
C1512346 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Redness
C0332575 (UMLS CUI-1)
Size Day 0
Item
Size Day 0
integer
C0456389 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Size Day 1
Item
Size Day 1
integer
C0456389 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Size Day 2
Item
Size Day 2
integer
C0456389 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Size Day 3
Item
Size Day 3
integer
C0456389 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Item Group
Swellling
C0038999 (UMLS CUI-1)
Size Day 0
Item
Size Day 0
integer
C0456389 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Size Day 1
Item
Size Day 1
integer
C0456389 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Size Day 2
Item
Size Day 2
integer
C0456389 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Size Day 3
Item
Size Day 3
integer
C0456389 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Item Group
Soreness
C0030193 (UMLS CUI-1)
Item
Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 0
CL Item
Nihil  (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 1
integer
C0518690 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 1
CL Item
Nihil  (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 2
integer
C0518690 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity Day 0
Code List
Intensity Day 2
CL Item
Nihil  (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Intensity Day 3
integer
C0518690 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity Day 3
Code List
Intensity Day 3
CL Item
Nihil  (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item Group
Other Local Symptoms
C0205394 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Description, start date, end date, intensity
Item
OTHER : Please give details below (description - start date - end date - intensity)
text
C0424450 (UMLS CUI [1])
C0808070 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
C0518690 (UMLS CUI [4])
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