ID

24017

Beskrivning

Study ID: 101377 Clinical Study ID: 101377 Study Title: A phase III, open, randomized, multicentre study to demonstrate the non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine according to a 0-1-6 month schedule, to the monovalent hepatitis A vaccine Havrix and hepatitis B vaccine Engerix separately administered, in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name:BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B Documentation part: Visit 2, Month 1 (30 ± 7 Days after Visit 1), Vaccination 2 for Twinrix, Engerix

Nyckelord

Versioner (1)
  1. 2017-07-23 2017-07-23 -
Uppladdad den

23 juli 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults Visit 2 101377

Engelsk

Visit 2 Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults 101377

1 Formulär  
Check for Study Continuation
Beskrivning

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject come at visit 2?
Beskrivning

subject return for visit

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beskrivning

If No, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
SAE Number
Beskrivning

If Serious adverse event, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Other reason for Study Discontinuation
Beskrivning

If Other, please specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
reason for study discontinuation
Beskrivning

reason for study discontinuation

Datatyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Laboratory Tests
Beskrivning

Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
UMLS CUI-3
C0430056
UMLS CUI-4
C0042210
Has a blood sample been taken?
Beskrivning

blood sample

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Beskrivning

Please complete only if different from visit date:

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Has a urine sample been taken?
Beskrivning

urine sample

Datatyp

integer

Alias
UMLS CUI [1]
C0200354
If Yes, please complete only if different from visit date:
Beskrivning

date sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
Result Hcg Pregnancy Test
Beskrivning

Result Hcg Pregnancy Test

Datatyp

integer

Alias
UMLS CUI [1,1]
C0546577
UMLS CUI [1,2]
C1274040
Vaccine Administration, Vaccination 2 for Twinrix
Beskrivning

Vaccine Administration, Vaccination 2 for Twinrix

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0042196
UMLS CUI-3
C0593953
Date of Vaccine Administration
Beskrivning

Please complete only if different from visit date

Datatyp

date

Alias
UMLS CUI [1,1]
C0593953
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0011008
Pre-Vaccination temperature:
Beskrivning

Pre-Vaccination temperature

Datatyp

float

Måttenheter
  • C
Alias
UMLS CUI [1]
C0005903
C
Pre-Vaccination temperature Route:
Beskrivning

Pre-Vaccination temperature Route

Datatyp

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Vaccine Administration
Beskrivning

Vaccine Administration

Datatyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0593953
Wrong vial number
Beskrivning

If Wrong vial number, please specify number

Datatyp

integer

Alias
UMLS CUI [1]
C0184301
Administration Side
Beskrivning

Administration Side

Datatyp

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Site
Beskrivning

Administration Site

Datatyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Route
Beskrivning

Administration Route

Datatyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the Protocol ?
Beskrivning

Study vaccine Administration

Datatyp

boolean

Alias
UMLS CUI [1]
C2368628
Study vaccine Administration: Side
Beskrivning

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Datatyp

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Site
Beskrivning

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Datatyp

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Route
Beskrivning

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Datatyp

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2368628
Vaccine Administration, Vaccination 2 for Engerix
Beskrivning

Vaccine Administration, Vaccination 2 for Engerix

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0116078
UMLS CUI-3
C0700881
Date of Vaccine Administration
Beskrivning

Please complete only if different from visit date

Datatyp

date

Alias
UMLS CUI [1,1]
C0116078
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0011008
Pre-Vaccination temperature:
Beskrivning

Pre-Vaccination temperature

Datatyp

float

Måttenheter
  • C
Alias
UMLS CUI [1]
C0005903
C
Pre-Vaccination temperature Route:
Beskrivning

Pre-Vaccination temperature Route

Datatyp

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Vaccine Administration
Beskrivning

Vaccine Administration

Datatyp

integer

Alias
UMLS CUI [1,1]
C0116078
UMLS CUI [1,2]
C2368628
Wrong vial number
Beskrivning

If Wrong vial number, please specify number

Datatyp

integer

Alias
UMLS CUI [1]
C0184301
Administration Side
Beskrivning

Administration Side

Datatyp

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Site
Beskrivning

Administration Site

Datatyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Route
Beskrivning

Administration Route

Datatyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the Protocol ?
Beskrivning

Study vaccine Administration

Datatyp

boolean

Alias
UMLS CUI [1]
C2368628
Study vaccine Administration: Side
Beskrivning

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Datatyp

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Site
Beskrivning

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Datatyp

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Route
Beskrivning

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Datatyp

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2368628
Vaccine Administration, Non administration
Beskrivning

Vaccine Administration, Non administration

Alias
UMLS CUI-1
C1533734
UMLS CUI-2
C0392360
UMLS CUI-3
C1272696
Please tick the major reason for non administration
Beskrivning

Please complete for each vaccine if not administered

Datatyp

text

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Serious adverse event Number
Beskrivning

If reason for non administration = Serious adverse event

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Non-serious adverse event Number
Beskrivning

If reason for non administration = Non-serious adverse event

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
reason for non administration, if other please specify
Beskrivning

reason for non administration

Datatyp

text

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Please tick who took the decision
Beskrivning

non administration

Datatyp

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Unsolicited Adverse Events
Beskrivning

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Beskrivning

Unsolicited Adverse Events

Datatyp

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0042196
Solicited Adverse Events - Local Symptoms - Vaccination 2 for Twinrix
Beskrivning

Solicited Adverse Events - Local Symptoms - Vaccination 2 for Twinrix

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0593953
UMLS CUI-4
C0877248
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Vaccination 2 for Twinrix
Beskrivning

Vaccination 2 for Twinrix

Datatyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0593953
Redness
Beskrivning

Redness

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness, size (mm)
Beskrivning

If Yes, please specify

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 0
Beskrivning

Redness on Day 0

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 1
Beskrivning

Redness on Day 1

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 2
Beskrivning

Redness on Day 2

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 3
Beskrivning

Redness on Day 3

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness ongoing after day 3?
Beskrivning

Redness ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Beskrivning

Redness ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0332575
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0332575
Swelling
Beskrivning

Swelling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling, size (mm)
Beskrivning

If Yes, please specify

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 0
Beskrivning

Swelling on Day 0

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 1
Beskrivning

Swelling on Day 1

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 2
Beskrivning

Swelling on Day 2

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 3
Beskrivning

Swelling on Day 3

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling ongoing after day 3?
Beskrivning

Swelling ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Beskrivning

Swelling ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0038999
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0038999
Pain
Beskrivning

Pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain, intensity
Beskrivning

If Yes, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 0
Beskrivning

Pain on Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 1
Beskrivning

Pain on Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 2
Beskrivning

Pain on Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 3
Beskrivning

Pain on Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain ongoing after day 3?
Beskrivning

Pain ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Beskrivning

Pain ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0030193
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0030193
Solicited Adverse Events - Local Symptoms - Vaccination 2 for Engerix-B
Beskrivning

Solicited Adverse Events - Local Symptoms - Vaccination 2 for Engerix-B

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0116078
UMLS CUI-4
C0877248
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Vaccination 2 for Engerix-B
Beskrivning

Vaccination 2 for Engerix-B

Datatyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0116078
Redness
Beskrivning

Redness

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness, size (mm)
Beskrivning

If Yes, please specify

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 0
Beskrivning

Redness on Day 0

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 1
Beskrivning

Redness on Day 1

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 2
Beskrivning

Redness on Day 2

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 3
Beskrivning

Redness on Day 3

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness ongoing after day 3?
Beskrivning

Redness ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Beskrivning

Redness ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0332575
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0332575
Swelling
Beskrivning

Swelling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Swelling, size (mm)
Beskrivning

If Yes, please specify

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 0
Beskrivning

Swelling on Day 0

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 1
Beskrivning

Swelling on Day 1

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 2
Beskrivning

Swelling on Day 2

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 3
Beskrivning

Swelling on Day 3

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling ongoing after day 3?
Beskrivning

Swelling ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Beskrivning

Swelling ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0038999
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0038999
Pain
Beskrivning

Pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain, intensity
Beskrivning

If Yes, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 0
Beskrivning

Pain on Day 0

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 1
Beskrivning

Pain on Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 2
Beskrivning

Pain on Day 2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain on Day 3
Beskrivning

Pain on Day 3

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Pain ongoing after day 3?
Beskrivning

Pain ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Date of last day of symptoms
Beskrivning

Pain ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0030193
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0030193
Solicited Adverse Events - General Symptoms
Beskrivning

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Fever
Beskrivning

Axillary > 37.5°C Oral > 37.5°C

Datatyp

boolean

Alias
UMLS CUI [1]
C0015967
Fever
Beskrivning

If Yes, please specify

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever, Site of measurement
Beskrivning

Site of measurement

Datatyp

text

Alias
UMLS CUI [1,1]
C0449687
UMLS CUI [1,2]
C0015967
Fever on Day 0
Beskrivning

Fever on Day 0

Datatyp

integer

Alias
UMLS CUI [1]
C0015967
Fever on Day 0
Beskrivning

if taken, please specify

Datatyp

float

Måttenheter
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever on Day 1
Beskrivning

Fever on Day 1

Datatyp

integer

Alias
UMLS CUI [1]
C0015967
Fever on Day 1
Beskrivning

if taken, please specify

Datatyp

float

Måttenheter
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever on Day 2
Beskrivning

Fever on Day 2

Datatyp

integer

Alias
UMLS CUI [1]
C0015967
Fever on Day 2
Beskrivning

if taken, please specify

Datatyp

float

Måttenheter
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever on Day 3
Beskrivning

Fever on Day 3

Datatyp

integer

Alias
UMLS CUI [1]
C0015967
Fever on Day 3
Beskrivning

if taken, please specify

Datatyp

float

Måttenheter
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever ongoing after day 3?
Beskrivning

Fever ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1]
C0015967
Date of last day of symptoms
Beskrivning

Fever ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Causality?
Beskrivning

Causality

Datatyp

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0015967
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0015967
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0015967
Fatigue
Beskrivning

Fatigue

Datatyp

boolean

Alias
UMLS CUI [1]
C0015672
Fatigue, Intensity
Beskrivning

If Yes, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0522510
Fatigue on Day 0
Beskrivning

Fatigue on Day 0

Datatyp

integer

Alias
UMLS CUI [1]
C0015672
Fatigue on Day 1
Beskrivning

Fatigue on Day 1

Datatyp

integer

Alias
UMLS CUI [1]
C0015672
Fatigue on Day 2
Beskrivning

Fatigue on Day 2

Datatyp

integer

Alias
UMLS CUI [1]
C0015672
Fatigue on Day 3
Beskrivning

Fatigue on Day 3

Datatyp

integer

Alias
UMLS CUI [1]
C0015672
Fatigue ongoing after day 3?
Beskrivning

Fatigue ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1]
C0015672
Date of last day of symptoms
Beskrivning

Fatigue ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0011008
Causality?
Beskrivning

Causality

Datatyp

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0015672
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0015672
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0015672
Headache
Beskrivning

Headache

Datatyp

boolean

Alias
UMLS CUI [1]
C0018681
Headache, Intensity
Beskrivning

If Yes, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0522510
Headache on Day 0
Beskrivning

Headache on Day 0

Datatyp

integer

Alias
UMLS CUI [1]
C0018681
Headache on Day 1
Beskrivning

Headache on Day 1

Datatyp

integer

Alias
UMLS CUI [1]
C0018681
Headache on Day 2
Beskrivning

Headache on Day 2

Datatyp

integer

Alias
UMLS CUI [1]
C0018681
Headache on Day 3
Beskrivning

Headache on Day 3

Datatyp

integer

Alias
UMLS CUI [1]
C0018681
Headache ongoing after day 3?
Beskrivning

Headache ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1]
C0018681
Date of last day of symptoms
Beskrivning

Headache ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0011008
Causality
Beskrivning

Causality

Datatyp

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0018681
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0018681
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0018681
Gastrointestinal symptoms
Beskrivning

Gastrointestinal symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms, Intensity
Beskrivning

If Yes, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0522510
Gastrointestinal symptoms on Day 0
Beskrivning

Gastrointestinal symptoms on Day 0

Datatyp

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms on Day 1
Beskrivning

Gastrointestinal symptoms on Day 1

Datatyp

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms on Day 2
Beskrivning

Gastrointestinal symptoms on Day 2

Datatyp

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms on Day 3
Beskrivning

Gastrointestinal symptoms on Day 3

Datatyp

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms ongoing after day 3?
Beskrivning

Gastrointestinal symptoms ongoing after day 3

Datatyp

boolean

Alias
UMLS CUI [1]
C0426576
Date of last day of symptoms
Beskrivning

Gastrointestinal symptoms ongoing after day 3? If Yes, please specify

Datatyp

date

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0011008
Causality?
Beskrivning

Causality

Datatyp

boolean

Alias
UMLS CUI [1]
C0015127
UMLS CUI [2]
C0426576
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C0426576
Medically attended visit Type
Beskrivning

Medically attended visit Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C0426576
Tillbaka till toppen

Similar models

Visit 2 Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults 101377

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject come at visit 2?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject return for visit 2
Code List
Did the subject come at visit 2?
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please specify (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse Event (1)
CL Item
Other (2)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other reason for Study Discontinuation
Item
Other reason for Study Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for study discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject return for visit 2
Code List
reason for study discontinuation
CL Item
Investigator (1)
CL Item
Subject (2)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0430056 (UMLS CUI-3)
C0042210 (UMLS CUI-4)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1])
urine sample
Code List
Has a urine sample been taken?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
date sample taken
Item
If Yes, please complete only if different from visit date:
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result Hcg Pregnancy Test
integer
C0546577 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result Hcg Pregnancy Test
Code List
Result Hcg Pregnancy Test
CL Item
negativ (1)
CL Item
positiv (2)
Item Group
Vaccine Administration, Vaccination 2 for Twinrix
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0593953 (UMLS CUI-3)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0593953 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1])
Item
Pre-Vaccination temperature Route:
text
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Pre-Vaccination temperature Route
Code List
Pre-Vaccination temperature Route:
CL Item
Axillary (A)
CL Item
Oral (O)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Twinrix Vaccine (1)
(Comment:en)
CL Item
Replacement vial  (2)
(Comment:en)
CL Item
Wrong vial number (3)
(Comment:en)
CL Item
Not administered (Please complete below) (4)
(Comment:en)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1])
Administration Side
Item
Administration Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Site
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1])
Item
Study vaccine Administration: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Side
Code List
Study vaccine Administration: Side
CL Item
Left (1)
CL Item
Right (2)
Item
Study vaccine Administration: Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Site
Code List
Study vaccine Administration: Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration Route
Code List
Study vaccine Administration: Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item Group
Vaccine Administration, Vaccination 2 for Engerix
C2368628 (UMLS CUI-1)
C0116078 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0116078 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1])
Item
Pre-Vaccination temperature Route:
text
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Pre-Vaccination temperature Route
Code List
Pre-Vaccination temperature Route:
CL Item
Axillary (A)
CL Item
Oral (O)
Item
Vaccine Administration
integer
C0116078 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Engerix-B Vaccine (1)
CL Item
Replacement vial  (2)
CL Item
Wrong vial number  (3)
CL Item
Not administered (4)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1])
Administration Side
Item
Administration Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Site
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1])
Item
Study vaccine Administration: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Side
Code List
Study vaccine Administration: Side
CL Item
Left (1)
CL Item
Right (2)
Item
Study vaccine Administration: Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Site
Code List
Study vaccine Administration: Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration Route
Code List
Study vaccine Administration: Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item Group
Vaccine Administration, Non administration
C1533734 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
C1272696 (UMLS CUI-3)
Item
Please tick the major reason for non administration
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
reason for non administration
Code List
Please tick the major reason for non administration
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
Serious adverse event Number
Item
Serious adverse event Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serious adverse event Number
Item
Non-serious adverse event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
reason for non administration
Item
reason for non administration, if other please specify
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Please tick who took the decision
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
non administration
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Subject (2)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
C0877248 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
Unsolicited Adverse Events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (U)
CL Item
No vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. (Y)
Item Group
Solicited Adverse Events - Local Symptoms - Vaccination 2 for Twinrix
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0593953 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Vaccination 2 for Twinrix
text
C1457887 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
symptoms
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Vaccination 2 for Twinrix
CL Item
Information not available (U)
CL Item
No vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
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])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (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])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (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])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Solicited Adverse Events - Local Symptoms - Vaccination 2 for Engerix-B
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0116078 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Vaccination 2 for Engerix-B
text
C1457887 (UMLS CUI [1,1])
C0116078 (UMLS CUI [1,2])
symptoms
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Vaccination 2 for Engerix-B
CL Item
Information not available (U)
CL Item
No vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
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])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (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])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (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])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Solicited Adverse Events - General Symptoms
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Fever, Site of measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Site of measurement
Code List
Fever, Site of measurement
CL Item
Axillary (A)
CL Item
Oral (O)
Item
Fever on Day 0
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 0
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 0
Item
Fever on Day 0
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 1
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 1
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 1
Item
Fever on Day 1
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 2
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 2
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 2
Item
Fever on Day 2
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 3
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 3
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 3
Item
Fever on Day 3
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever ongoing after day 3
Item
Fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0015967 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue, Intensity
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Fatigue, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Fatigue on Day 0
integer
C0015672 (UMLS CUI [1])
Pain
Code List
Fatigue on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Fatigue on Day 1
integer
C0015672 (UMLS CUI [1])
Pain
Code List
Fatigue on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Fatigue on Day 2
integer
C0015672 (UMLS CUI [1])
Pain
Code List
Fatigue on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Fatigue on Day 3
integer
C0015672 (UMLS CUI [1])
Pain
Code List
Fatigue on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Fatigue ongoing after day 3
Item
Fatigue ongoing after day 3?
boolean
C0015672 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0015672 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015672 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0015672 (UMLS CUI [2])
reason for non administration
Code List
Medically attended visit Type
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Item
Headache, Intensity
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Headache, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Headache on Day 0
integer
C0018681 (UMLS CUI [1])
Pain
Code List
Headache on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Headache on Day 1
integer
C0018681 (UMLS CUI [1])
Pain
Code List
Headache on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Headache on Day 2
integer
C0018681 (UMLS CUI [1])
Pain
Code List
Headache on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Headache on Day 3
integer
C0018681 (UMLS CUI [1])
Pain
Code List
Headache on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Headache ongoing after day 3
Item
Headache ongoing after day 3?
boolean
C0018681 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1])
C0018681 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0018681 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0018681 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms, Intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Gastrointestinal symptoms, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Gastrointestinal symptoms on Day 0
integer
C0426576 (UMLS CUI [1])
Pain
Code List
Gastrointestinal symptoms on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Gastrointestinal symptoms on Day 1
integer
C0426576 (UMLS CUI [1])
Pain
Code List
Gastrointestinal symptoms on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Gastrointestinal symptoms on Day 2
integer
C0426576 (UMLS CUI [1])
Pain
Code List
Gastrointestinal symptoms on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Gastrointestinal symptoms on Day 3
integer
C0426576 (UMLS CUI [1])
Pain
Code List
Gastrointestinal symptoms on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Gastrointestinal symptoms ongoing after day 3
Item
Gastrointestinal symptoms ongoing after day 3?
boolean
C0426576 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0426576 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0426576 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0426576 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
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