ID

25017

Beschrijving

Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876

Link

https://clinicaltrials.gov/ct2/show/NCT00291876

Trefwoorden

Versies (3)
  1. 24-08-17 24-08-17 -
  2. 24-08-17 24-08-17 -
  3. 24-08-17 24-08-17 -
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24 augustus 2017

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876

Engels

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876

1 Formulieren  
Study administration
Beschrijving

Study administration

Center
Beschrijving

Center

Datatype

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
LOCAL SYMPTOMS
Beschrijving

LOCAL SYMPTOMS

Redness, size
Beschrijving

Redness

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size day 0
Beschrijving

Redness size day 0

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size day 1
Beschrijving

Redness size day 1

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size day 2
Beschrijving

Redness size day 2

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness size day 3
Beschrijving

Redness size day 3

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0549178
Date of last day of symptoms
Beschrijving

Date of last day of symptoms

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Size Swelling
Beschrijving

Size Swelling

Datatype

integer

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
dd/mm/yy
Size Swelling Day 0
Beschrijving

Size Swelling Day 0

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
mm
Size Swelling Day 1
Beschrijving

Size Swelling Day 1

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
mm
Size Swelling Day 2
Beschrijving

Size Swelling Day 2

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
mm
Size Swelling Day 3
Beschrijving

Size Swelling Day 3

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
mm
Ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Beschrijving

Date of last day of symptoms

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Pain intensity
Beschrijving

Pain (at injection site): 0 : Absent 1 : Painful on touch 2 : Painful when limb is moved 3 : Spontaneously painful

Datatype

integer

Alias
UMLS CUI [1,1]
C3840282
UMLS CUI [1,2]
C2700396
Pain intensity day 0
Beschrijving

Pain intensity day 0

Datatype

integer

Alias
UMLS CUI [1]
C3840282
Pain intensity day 1
Beschrijving

Pain intensity day 1

Datatype

integer

Alias
UMLS CUI [1]
C3840282
Pain intensity day 2
Beschrijving

Pain intensity day 2

Datatype

integer

Alias
UMLS CUI [1]
C3840282
Pain intensity day 3
Beschrijving

Pain intensity day 3

Datatype

integer

Alias
UMLS CUI [1]
C3840282
Ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0030193
Date of last day of symptoms
Beschrijving

Date of last day of symptoms

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
Other Local Symptoms
Beschrijving

Other Local Symptoms

Description - please specify side(s) and site(s)
Beschrijving

Description - please specify side(s) and site(s)

Datatype

text

Alias
UMLS CUI [1]
C0441987
UMLS CUI [2]
C1515974
Intensity
Beschrijving

Intensity

Datatype

integer

Alias
UMLS CUI [1]
C0522510
Start date
Beschrijving

Start date

Datatype

date

Maateenheden
  • day month year
Alias
UMLS CUI [1]
C0808070
day month year
End date
Beschrijving

End date

Datatype

date

Maateenheden
  • day month year
Alias
UMLS CUI [1]
C0806020
day month year
check box if continuing
Beschrijving

Ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C0549178
MEDICATION
Beschrijving

MEDICATION

Alias
UMLS CUI-1
C0013227
Trade / Generic Name
Beschrijving

Trade / Generic Name

Datatype

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0013227
Reason
Beschrijving

Medical Indication

Datatype

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total Daily Dose
Beschrijving

Total Daily Dose

Datatype

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Start date
Beschrijving

Start date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Beschrijving

End date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
check box if continuing
Beschrijving

pharmacotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0549178
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Similar models

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Study administration
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
LOCAL SYMPTOMS
Redness
Item
Redness, size
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 0
Item
Redness size day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 1
Item
Redness size day 1
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 2
Item
Redness size day 2
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 3
Item
Redness size day 3
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling
Item
Size Swelling
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 0
Item
Size Swelling Day 0
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 1
Item
Size Swelling Day 1
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 2
Item
Size Swelling Day 2
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 3
Item
Size Swelling Day 3
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity
Item
Pain intensity
integer
C3840282 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain intensity day 0
integer
C3840282 (UMLS CUI [1])
Pain intensity day 0
Code List
Pain intensity day 0
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity day 1
integer
C3840282 (UMLS CUI [1])
Medically attended visit
Code List
Pain intensity day 1
CL Item
HO  (1)
CL Item
ER  (2)
CL Item
MD (3)
Item
Pain intensity day 2
integer
C3840282 (UMLS CUI [1])
Medically attended visit
Code List
Pain intensity day 2
CL Item
HO  (1)
CL Item
ER  (2)
CL Item
MD (3)
Item
Pain intensity day 3
integer
C3840282 (UMLS CUI [1])
Medically attended visit
Code List
Pain intensity day 3
CL Item
HO  (1)
CL Item
ER  (2)
CL Item
MD (3)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Item Group
Other Local Symptoms
Description - please specify side(s) and site(s)
Item
Description - please specify side(s) and site(s)
text
C0441987 (UMLS CUI [1])
C1515974 (UMLS CUI [2])
Item
Intensity
integer
C0522510 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek. medical advice). (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing
Item
check box if continuing
boolean
C0549178 (UMLS CUI [1])
Item Group
MEDICATION
C0013227 (UMLS CUI-1)
Trade / Generic Name
Item
Trade / Generic Name
text
C0027365 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Item
Reason
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
pharmacotherapy
Item
check box if continuing
boolean
C0013216 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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