ID

38324

Descripción

Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Palabras clave

  1. 10/10/19 10/10/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

10 de octubre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)

Dose 3 - Solicited Adverse Events - Local Symptoms; Visit 5 - Laboratory Tests

Administration
Descripción

Administration

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Solicited Adverse Events - Local Symptoms
Descripción

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Has the subject experienced any of the following local (at administration site) signs/symptoms during the solicited period?
Descripción

If yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C0013153
Solicited Adverse Events - Local Symptoms (Engerix Vaccine)
Descripción

Solicited Adverse Events - Local Symptoms (Engerix Vaccine)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-5
C0116078
Redness
Descripción

Redness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332575
Redness size Day 0
Descripción

Redness size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 1
Descripción

Redness size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 2
Descripción

Redness size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 3
Descripción

Redness size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness Ongoing after Day 3?
Descripción

Redness Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C3174772
If Redness is ongoing, record date of last Day of Symptoms
Descripción

If Redness is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0332575
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Swelling
Descripción

Swelling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038999
Swelling Size Day 0
Descripción

Swelling Size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 1
Descripción

Swelling Size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 2
Descripción

Swelling Size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 3
Descripción

Swelling Size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Ongoing after Day 3? +
Descripción

Swelling Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3174772
If Swelling is ongoing, record date of last Day of Symptoms
Descripción

If Swelling is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Pain
Descripción

Pain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity Day 0
Descripción

Pain intensity Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 1
Descripción

Pain intensity Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 2
Descripción

Pain intensity Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 3
Descripción

Pain intensity Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain Ongoing after Day 3?
Descripción

Pain Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C3174772
If Pain is ongoing, record date of last Day of Symptoms
Descripción

If Pain is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Solicited Adverse Events - Local Symptoms (Infanrix Vaccine)
Descripción

Solicited Adverse Events - Local Symptoms (Infanrix Vaccine)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C1964896
Redness
Descripción

Redness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332575
Redness size Day 0
Descripción

Redness size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 1
Descripción

Redness size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 2
Descripción

Redness size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 3
Descripción

Redness size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness Ongoing after Day 3?
Descripción

Redness Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C3174772
If Redness is ongoing, record date of last Day of Symptoms
Descripción

If Redness is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0332575
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Swelling
Descripción

Swelling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038999
Swelling Size Day 0
Descripción

Swelling Size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 1
Descripción

Swelling Size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 2
Descripción

Swelling Size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 3
Descripción

Swelling Size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Ongoing after Day 3?
Descripción

Swelling Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3174772
If Swelling is ongoing, record date of last Day of Symptoms
Descripción

If Swelling is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Pain
Descripción

Pain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity Day 0
Descripción

Pain intensity Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 1
Descripción

Pain intensity Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 2
Descripción

Pain intensity Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 3
Descripción

Pain intensity Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain Ongoing after Day 3?
Descripción

Pain Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C3174772
If Pain is ongoing, record date of last Day of Symptoms
Descripción

If Pain is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Solicited Adverse Events - Local Symptoms (Prevnar Vaccine)
Descripción

Solicited Adverse Events - Local Symptoms (Prevnar Vaccine)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C0876134
Redness
Descripción

Redness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332575
Redness size Day 0
Descripción

Redness size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 1
Descripción

Redness size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 2
Descripción

Redness size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 3
Descripción

Redness size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness Ongoing after Day 3?
Descripción

Redness Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C3174772
If Redness is ongoing, record date of last Day of Symptoms
Descripción

If Redness is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0332575
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Swelling
Descripción

Swelling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038999
Swelling Size Day 0
Descripción

Swelling Size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 1
Descripción

Swelling Size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 2
Descripción

Swelling Size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 3
Descripción

Swelling Size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Ongoing after Day 3?
Descripción

Swelling Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3174772
If Swelling is ongoing, record date of last Day of Symptoms
Descripción

If Swelling is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Pain
Descripción

Pain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity Day 0
Descripción

Pain intensity Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 1
Descripción

Pain intensity Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 2
Descripción

Pain intensity Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 3
Descripción

Pain intensity Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain Ongoing after Day 3?
Descripción

Pain Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C3174772
If Pain is ongoing, record date of last Day of Symptoms
Descripción

If Pain is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Solicited Adverse Events - Local Symptoms (HibTITER® Vaccine)
Descripción

Solicited Adverse Events - Local Symptoms (HibTITER® Vaccine)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C1524027
Redness
Descripción

Redness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332575
Redness size Day 0
Descripción

Redness size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 1
Descripción

Redness size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 2
Descripción

Redness size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 3
Descripción

Redness size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness Ongoing after Day 3?
Descripción

Redness Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C3174772
If Redness is ongoing, record date of last Day of Symptoms
Descripción

If Redness is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0332575
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Swelling
Descripción

Swelling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038999
Swelling Size Day 0
Descripción

Swelling Size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 1
Descripción

Swelling Size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 2
Descripción

Swelling Size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 3
Descripción

Swelling Size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Ongoing after Day 3?
Descripción

Swelling Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3174772
If Swelling is ongoing, record date of last Day of Symptoms
Descripción

If Swelling is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Pain
Descripción

Pain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity Day 0
Descripción

Pain intensity Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 1
Descripción

Pain intensity Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 2
Descripción

Pain intensity Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 3
Descripción

Pain intensity Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain Ongoing after Day 3?
Descripción

Pain Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C3174772
If Pain is ongoing, record date of last Day of Symptoms
Descripción

If Pain is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Solicited Adverse Events - Local Symptoms (ActHib Vaccine)
Descripción

Solicited Adverse Events - Local Symptoms (ActHib Vaccine)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C0042196
Redness
Descripción

Redness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332575
Redness size Day 0
Descripción

Redness size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 1
Descripción

Redness size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 2
Descripción

Redness size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 3
Descripción

Redness size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness Ongoing after Day 3?
Descripción

Redness Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C3174772
If Redness is ongoing, record date of last Day of Symptoms
Descripción

If Redness is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0332575
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Swelling
Descripción

Swelling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038999
Swelling Size Day 0
Descripción

Swelling Size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 1
Descripción

Swelling Size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 2
Descripción

Swelling Size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 3
Descripción

Swelling Size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Ongoing after Day 3?
Descripción

Swelling Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3174772
If Swelling is ongoing, record date of last Day of Symptoms
Descripción

If Swelling is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Pain
Descripción

Pain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity Day 0
Descripción

Pain intensity Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 1
Descripción

Pain intensity Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 2
Descripción

Pain intensity Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 3
Descripción

Pain intensity Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain Ongoing after Day 3?
Descripción

Pain Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C3174772
If Pain is ongoing, record date of last Day of Symptoms
Descripción

If Pain is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Solicited Adverse Events - Local Symptoms (Comvax Vaccine)
Descripción

Solicited Adverse Events - Local Symptoms (Comvax Vaccine)

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C0535643
Redness
Descripción

Redness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332575
Redness size Day 0
Descripción

Redness size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 1
Descripción

Redness size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 2
Descripción

Redness size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 3
Descripción

Redness size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness Ongoing after Day 3?
Descripción

Redness Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C3174772
If Redness is ongoing, record date of last Day of Symptoms
Descripción

If Redness is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0332575
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Swelling
Descripción

Swelling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038999
Swelling Size Day 0
Descripción

Swelling Size Day 0

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 1
Descripción

Swelling Size Day 1

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 2
Descripción

Swelling Size Day 2

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 3
Descripción

Swelling Size Day 3

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Ongoing after Day 3?
Descripción

Swelling Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3174772
If Swelling is ongoing, record date of last Day of Symptoms
Descripción

If Swelling is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Pain
Descripción

Pain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity Day 0
Descripción

Pain intensity Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 1
Descripción

Pain intensity Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 2
Descripción

Pain intensity Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 3
Descripción

Pain intensity Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C1320357
Pain Ongoing after Day 3?
Descripción

Pain Ongoing after Day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C3174772
If Pain is ongoing, record date of last Day of Symptoms
Descripción

If Pain is ongoing, record date of last Day of Symptoms

Tipo de datos

date

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Laboratory Tests
Descripción

Laboratory Tests

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

Has a blood sample been taken?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834

Similar models

Dose 3 - Solicited Adverse Events - Local Symptoms; Visit 5 - Laboratory Tests

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Has the subject experienced any of the following local (at administration site) signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
CL Item
Unknown  (U)
CL Item
No  (N)
CL Item
Yes (Y)
Item Group
Solicited Adverse Events - Local Symptoms (Engerix Vaccine)
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0116078 (UMLS CUI-5)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3? +
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
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
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Solicited Adverse Events - Local Symptoms (Infanrix Vaccine)
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1964896 (UMLS CUI-4)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3?
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
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
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 1
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 2
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 3
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Solicited Adverse Events - Local Symptoms (Prevnar Vaccine)
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0876134 (UMLS CUI-4)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3?
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
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
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 1
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 2
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 3
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Solicited Adverse Events - Local Symptoms (HibTITER® Vaccine)
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1524027 (UMLS CUI-4)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3?
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
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
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 1
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 2
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 3
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Solicited Adverse Events - Local Symptoms (ActHib Vaccine)
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0042196 (UMLS CUI-4)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3?
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
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
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 1
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 2
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 3
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Solicited Adverse Events - Local Symptoms (Comvax Vaccine)
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0535643 (UMLS CUI-4)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3?
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
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
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 1
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 2
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 3
CL Item
0  (1)
CL Item
1  (2)
CL Item
2  (3)
CL Item
3 (4)
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])

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