ID

26175

Descripción

Study ID: 101223 Clinical Study ID: 101223 Study Title: Study to assess the lot-to-lot consistency of the production method of GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine and to compare to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine, when administered as a primary vaccination course. 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: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 2, Month 2, 49-70 days after Visit 1

Palabras clave

Versiones (1)
  1. 10/10/17 10/10/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

10 de octubre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine Visit 2 101223

Inglés

Visit 2 GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 formularios  
Check for Study Continuation
Descripción

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C2240392
Did the subject return for visit 2 ?
Descripción

subject return for visit 2

Tipo de datos

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.
Descripción

If No, please specify

Tipo de datos

integer

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

If Serious adverse event, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number or Code
Descripción

If Non-serious adverse event, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Other reason for Study Discontinuation
Descripción

If Other, please specify

Tipo de datos

text

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

reason for study discontinuation

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Vaccine Administration, DTPw-HBV/Hib Kft. groups
Descripción

Vaccine Administration, DTPw-HBV/Hib Kft. groups

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C2240392
Date of Vaccine Administration
Descripción

Please complete only if different from visit date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Pre-Vaccination temperature:
Descripción

Pre-Vaccination temperature

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1]
C0005903
C
Pre-Vaccination temperature Route:
Descripción

Pre-Vaccination temperature Route

Tipo de datos

integer

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

Vaccine Administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C2368628
Wrong vial number
Descripción

If Wrong vial number, please specify number

Tipo de datos

integer

Alias
UMLS CUI [1]
C0184301
Replacement vial
Descripción

If Replacement vial number, please specify number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Please tick the major reason for non administration
Descripción

If not administered

Tipo de datos

integer

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

If reason for non administration = Serious adverse event

Tipo de datos

integer

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

If reason for non administration = Non-serious adverse event

Tipo de datos

integer

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

reason for non administration

Tipo de datos

text

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

non administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Administration Side
Descripción

Administration Side

Tipo de datos

text

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

Administration Site

Tipo de datos

text

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

Administration Route

Tipo de datos

text

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

Study vaccine Administration

Tipo de datos

boolean

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Vaccine administration
Descripción

Vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C2368628
Administration Route
Descripción

Administration Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the Protocol ? (OPV Vaccine)
Descripción

Study vaccine Administration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2368628
Vaccine Administration, Tritanrix-Hep B/Hiberix group
Descripción

Vaccine Administration, Tritanrix-Hep B/Hiberix group

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0042196
UMLS CUI-3
C2240392
Date of Vaccine Administration
Descripción

Please complete only if different from visit date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Pre-Vaccination temperature:
Descripción

Pre-Vaccination temperature

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1]
C0005903
C
Pre-Vaccination temperature Route:
Descripción

Pre-Vaccination temperature Route

Tipo de datos

integer

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

Vaccine Administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C2368628
Wrong vial number
Descripción

If Wrong vial number, please specify number

Tipo de datos

integer

Alias
UMLS CUI [1]
C0184301
Replacement vial
Descripción

If Replacement vial number, please specify number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Please tick the major reason for non administration
Descripción

If not administered

Tipo de datos

integer

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

If reason for non administration = Serious adverse event

Tipo de datos

integer

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

If reason for non administration = Non-serious adverse event

Tipo de datos

integer

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

reason for non administration

Tipo de datos

text

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

non administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Administration Side
Descripción

Administration Side

Tipo de datos

text

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

Administration Site

Tipo de datos

text

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

Administration Route

Tipo de datos

text

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

Study vaccine Administration

Tipo de datos

boolean

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Vaccine administration
Descripción

Vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C2368628
Administration Route
Descripción

Administration Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the Protocol ? (OPV Vaccine)
Descripción

Study vaccine Administration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2368628
Vaccine Administration, Triple Antigen + Hiberix group
Descripción

Vaccine Administration, Triple Antigen + Hiberix group

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0042196
UMLS CUI-3
C2240392
Date of Vaccine Administration
Descripción

Please complete only if different from visit date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Pre-Vaccination temperature:
Descripción

Pre-Vaccination temperature

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1]
C0005903
C
Pre-Vaccination temperature Route:
Descripción

Pre-Vaccination temperature Route

Tipo de datos

integer

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

Vaccine Administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C2368628
Wrong vial number
Descripción

If Wrong vial number, please specify number

Tipo de datos

integer

Alias
UMLS CUI [1]
C0184301
Replacement vial
Descripción

If Replacement vial number, please specify number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Please tick the major reason for non administration
Descripción

If not administered

Tipo de datos

integer

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

If reason for non administration = Serious adverse event

Tipo de datos

integer

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

If reason for non administration = Non-serious adverse event

Tipo de datos

integer

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

reason for non administration

Tipo de datos

text

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

non administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Administration Side
Descripción

Administration Side

Tipo de datos

text

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

Administration Site

Tipo de datos

text

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

Administration Route

Tipo de datos

text

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

Study vaccine Administration

Tipo de datos

boolean

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Vaccine administration
Descripción

Vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C2368628
Administration Route
Descripción

Administration Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the Protocol ? (OPV Vaccine)
Descripción

Study vaccine Administration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2368628
Vaccine Administration, Triple Antigen + Hiberix group
Descripción

Vaccine Administration, Triple Antigen + Hiberix group

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0042196
UMLS CUI-3
C2240392
Vaccine Administration
Descripción

Vaccine Administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C2368628
Wrong vial number
Descripción

If Wrong vial number, please specify number

Tipo de datos

integer

Alias
UMLS CUI [1]
C0184301
Replacement vial
Descripción

If Replacement vial number, please specify number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Please tick the major reason for non administration
Descripción

If not administered

Tipo de datos

integer

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

If reason for non administration = Serious adverse event

Tipo de datos

integer

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

If reason for non administration = Non-serious adverse event

Tipo de datos

integer

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

reason for non administration

Tipo de datos

text

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

non administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Administration Side
Descripción

Administration Side

Tipo de datos

text

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

Administration Site

Tipo de datos

text

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

Administration Route

Tipo de datos

text

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

Study vaccine Administration

Tipo de datos

boolean

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Adverse Events, Post-Vaccination Observation
Descripción

Adverse Events, Post-Vaccination Observation

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0700325
UMLS CUI-3
C0877248
UMLS CUI-4
C2240392
Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?
Descripción

serious or non-serious unsolicited adverse events

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib Kft. groups +Tritanrix-Hep B/Hiberix group
Descripción

Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib Kft. groups +Tritanrix-Hep B/Hiberix group

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C2240392
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Descripción

symptoms

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2240392
Redness
Descripción

Redness

Tipo de datos

boolean

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

If Yes, please specify

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 0
Descripción

Redness on Day 0

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 1
Descripción

Redness on Day 1

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 2
Descripción

Redness on Day 2

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 3
Descripción

Redness on Day 3

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
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]
C2700396
Date of last day of symptoms
Descripción

Redness ongoing after day 3? If Yes, please specify

Tipo de datos

date

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

Medically attended visit

Tipo de datos

boolean

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

Medically attended visit Type

Tipo de datos

text

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

Swelling

Tipo de datos

boolean

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

If Yes, please specify

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 0
Descripción

Swelling on Day 0

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 1
Descripción

Swelling on Day 1

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 2
Descripción

Swelling on Day 2

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 3
Descripción

Swelling on Day 3

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
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]
C2700396
Date of last day of symptoms
Descripción

Swelling ongoing after day 3? If Yes, please specify

Tipo de datos

date

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

Medically attended visit

Tipo de datos

boolean

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

Medically attended visit Type

Tipo de datos

text

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

Pain

Tipo de datos

boolean

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

If Yes, please specify

Tipo de datos

integer

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

Pain on Day 0

Tipo de datos

integer

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

Pain on Day 1

Tipo de datos

integer

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

Pain on Day 2

Tipo de datos

integer

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

Pain on Day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
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]
C2700396
Date of last day of symptoms
Descripción

Pain ongoing after day 3? If Yes, please specify

Tipo de datos

date

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

Medically attended visit

Tipo de datos

boolean

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

Medically attended visit Type

Tipo de datos

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 - Triple Antigen vaccine
Descripción

Solicited Adverse Events - Local Symptoms - Triple Antigen vaccine

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0877248
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Descripción

symptoms

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2240392
Redness
Descripción

Redness

Tipo de datos

boolean

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

If Yes, please specify

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 0
Descripción

Redness on Day 0

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 1
Descripción

Redness on Day 1

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 2
Descripción

Redness on Day 2

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 3
Descripción

Redness on Day 3

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
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]
C2700396
Date of last day of symptoms
Descripción

Redness ongoing after day 3? If Yes, please specify

Tipo de datos

date

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

Medically attended visit

Tipo de datos

boolean

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

Medically attended visit Type

Tipo de datos

text

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

Swelling

Tipo de datos

boolean

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

If Yes, please specify

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 0
Descripción

Swelling on Day 0

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 1
Descripción

Swelling on Day 1

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 2
Descripción

Swelling on Day 2

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 3
Descripción

Swelling on Day 3

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
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]
C2700396
Date of last day of symptoms
Descripción

Swelling ongoing after day 3? If Yes, please specify

Tipo de datos

date

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

Medically attended visit

Tipo de datos

boolean

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

Medically attended visit Type

Tipo de datos

text

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

Pain

Tipo de datos

boolean

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

If Yes, please specify

Tipo de datos

integer

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

Pain on Day 0

Tipo de datos

integer

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

Pain on Day 1

Tipo de datos

integer

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

Pain on Day 2

Tipo de datos

integer

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

Pain on Day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
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]
C2700396
Date of last day of symptoms
Descripción

Pain ongoing after day 3? If Yes, please specify

Tipo de datos

date

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

Medically attended visit

Tipo de datos

boolean

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

Medically attended visit Type

Tipo de datos

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 - Hiberix vaccine
Descripción

Solicited Adverse Events - Local Symptoms - Hiberix vaccine

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C2240392
UMLS CUI-4
C0877248
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Descripción

symptoms

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C2240392
Redness
Descripción

Redness

Tipo de datos

boolean

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

If Yes, please specify

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 0
Descripción

Redness on Day 0

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 1
Descripción

Redness on Day 1

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 2
Descripción

Redness on Day 2

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Redness on Day 3
Descripción

Redness on Day 3

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
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]
C2700396
Date of last day of symptoms
Descripción

Redness ongoing after day 3? If Yes, please specify

Tipo de datos

date

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

Medically attended visit

Tipo de datos

boolean

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

Medically attended visit Type

Tipo de datos

text

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

Swelling

Tipo de datos

boolean

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

If Yes, please specify

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 0
Descripción

Swelling on Day 0

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 1
Descripción

Swelling on Day 1

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 2
Descripción

Swelling on Day 2

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling on Day 3
Descripción

Swelling on Day 3

Tipo de datos

float

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
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]
C2700396
Date of last day of symptoms
Descripción

Swelling ongoing after day 3? If Yes, please specify

Tipo de datos

date

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

Medically attended visit

Tipo de datos

boolean

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

Medically attended visit Type

Tipo de datos

text

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

Pain

Tipo de datos

boolean

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

If Yes, please specify

Tipo de datos

integer

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

Pain on Day 0

Tipo de datos

integer

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

Pain on Day 1

Tipo de datos

integer

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

Pain on Day 2

Tipo de datos

integer

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

Pain on Day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
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]
C2700396
Date of last day of symptoms
Descripción

Pain ongoing after day 3? If Yes, please specify

Tipo de datos

date

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

Medically attended visit

Tipo de datos

boolean

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

Medically attended visit Type

Tipo de datos

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
Descripción

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C2240392
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms during the solicited period?
Descripción

signs/symptoms

Tipo de datos

integer

Alias
UMLS CUI [1]
C1457887
Fever
Descripción

Fever

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
Fever
Descripción

Fever

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015967
Site of measurement
Descripción

Fever Site of measurement

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0015967
Fever day 0
Descripción

Fever day 0

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever day 1
Descripción

Fever day 1

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever day 2
Descripción

Fever day 2

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever day 3
Descripción

Fever day 3

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

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

Causality?

Tipo de datos

boolean

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

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medically attended visit
Descripción

Medically attended visit

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Irritability/ Fussiness
Descripción

Irritability

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022107
Irritability / Fussiness intensity day 0
Descripción

Irritability intensity day 0

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability / Fussiness intensity day 1
Descripción

Irritability / Fussiness intensity day 1

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability / Fussiness intensity day 2
Descripción

Irritability / Fussiness intensity day 2

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Irritability / Fussiness intensity day 3
Descripción

Irritability / Fussiness intensity day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0011008
Causality?
Descripción

Causality?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0022107
Was the crying continuous ( i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps) ?
Descripción

Irritability/Fussiness: In case of intensity 3 :

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438697
Was the crying unaltered > 3 hours ?
Descripción

Irritability/Fussiness: In case of intensity 3 :

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438697
Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medically attended visit
Descripción

Medically attended visit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Drowsiness
Descripción

Drowsiness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013144
Drowsiness intensity day 0
Descripción

Drowsiness intensity day 0

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Drowsiness intensity day 1
Descripción

Drowsiness intensity day 1

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Drowsiness intensity day 2
Descripción

Drowsiness intensity day 2

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Drowsiness intensity day 3
Descripción

Drowsiness intensity day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0011008
Causality?
Descripción

Causality?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015127
Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medically attended visit
Descripción

Medically attended visit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Loss of appetite
Descripción

Loss of appetite

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1971624
Loss of appetite intensity day 0
Descripción

Loss of appetite intensity day 0

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite intensity day 1
Descripción

Loss of appetite intensity day 1

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite intensity day 2
Descripción

Loss of appetite intensity day 2

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite intensity day 3
Descripción

Loss of appetite intensity day 3

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0011008
Causality?
Descripción

Causality?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015127
Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medically attended visit
Descripción

Medically attended visit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
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Similar models

Visit 2 GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
Item
Did the subject return for visit 2 ?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject come at visit 2
Code List
Did the subject return for 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
Non-Serious adverse event (2)
CL Item
Other (3)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (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])
reason for study discontinuation
Code List
reason for study discontinuation
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Vaccine Administration, DTPw-HBV/Hib Kft. groups
C2368628 (UMLS CUI-1)
C2240392 (UMLS CUI-2)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1])
Item
Pre-Vaccination temperature Route:
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Vaccine Administration
Code List
Pre-Vaccination temperature Route:
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
DTPw-HBV/Hib Kft. 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])
Replacement vial
Item
Replacement vial
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Please tick the major reason for non administration
integer
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 made 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 made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
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
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)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
OPV Vaccine (1)
CL Item
Not administered (2)
Item
Administration Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration Route
Code List
Administration Route
CL Item
Oral (1)
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ? (OPV Vaccine)
boolean
C2368628 (UMLS CUI [1])
Item Group
Vaccine Administration, Tritanrix-Hep B/Hiberix group
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1])
Item
Pre-Vaccination temperature Route:
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Vaccine Administration
Code List
Pre-Vaccination temperature Route:
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Tritanrix-Hep B/Hiberix. 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])
Replacement vial
Item
Replacement vial
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Please tick the major reason for non administration
integer
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 made 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 made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
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
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)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
OPV Vaccine (1)
CL Item
Not administered (2)
Item
Administration Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration Route
Code List
Administration Route
CL Item
Oral (1)
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ? (OPV Vaccine)
boolean
C2368628 (UMLS CUI [1])
Item Group
Vaccine Administration, Triple Antigen + Hiberix group
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1])
Item
Pre-Vaccination temperature Route:
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Vaccine Administration
Code List
Pre-Vaccination temperature Route:
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Hiberix 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])
Replacement vial
Item
Replacement vial
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Please tick the major reason for non administration
integer
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 made 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 made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
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
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)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
OPV Vaccine (1)
CL Item
Not administered (2)
Item
Administration Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration Route
Code List
Administration Route
CL Item
Oral (1)
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ? (OPV Vaccine)
boolean
C2368628 (UMLS CUI [1])
Item Group
Vaccine Administration, Triple Antigen + Hiberix group
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Triple Antigen 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])
Replacement vial
Item
Replacement vial
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Please tick the major reason for non administration
integer
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 made 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 made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
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
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)
Item Group
Adverse Events, Post-Vaccination Observation
C0042196 (UMLS CUI-1)
C0700325 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C2240392 (UMLS CUI-4)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?
integer
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
serious or non-serious unsolicited adverse events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?
CL Item
Information not retrievable (1)
CL Item
No (2)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (3)
CL Item
No Vaccine administered (4)
Item Group
Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib Kft. groups +Tritanrix-Hep B/Hiberix group
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
symptoms
Code List
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)
CL Item
No (2)
CL Item
No vaccine administered (3)
CL Item
Information not available (4)
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 - Triple Antigen vaccine
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
symptoms
Code List
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)
CL Item
No (2)
CL Item
No vaccine administered (3)
CL Item
Information not available (4)
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 - Hiberix vaccine
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
symptoms
Code List
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)
CL Item
No (2)
CL Item
No vaccine administered (3)
CL Item
Information not available (4)
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)
C2240392 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
signs/symptoms
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1])
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Fever
integer
C0015967 (UMLS CUI [1])
Fever
Code List
Fever
CL Item
taken (1)
CL Item
not taken (2)
Item
Site of measurement
integer
C1515974 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Site
Code List
Site of measurement
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Fever day 0
Item
Fever day 0
float
C0015967 (UMLS CUI [1])
Fever day 1
Item
Fever day 1
float
C0015967 (UMLS CUI [1])
Fever day 2
Item
Fever day 2
float
C0015967 (UMLS CUI [1])
Fever day 3
Item
Fever day 3
float
C0015967 (UMLS CUI [1])
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medical advice Type
Code List
Medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Irritability
Item
Irritability/ Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability / Fussiness intensity day 0
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Irritability / Fussiness intensity day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability / Fussiness intensity day 1
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Irritability / Fussiness intensity day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability / Fussiness intensity day 2
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Irritability / Fussiness intensity day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability / Fussiness intensity day 3
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Irritability / Fussiness intensity day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0022107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
continuous crying
Item
Was the crying continuous ( i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps) ?
boolean
C0438697 (UMLS CUI [1])
unaltered crying
Item
Was the crying unaltered > 3 hours ?
boolean
C0438697 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medical advice Type
Code List
Medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness intensity day 0
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Drowsiness intensity day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness intensity day 1
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Drowsiness intensity day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness intensity day 2
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Drowsiness intensity day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness intensity day 3
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Drowsiness intensity day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medical advice Type
Code List
Medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite intensity day 0
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Loss of appetite intensity day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite intensity day 1
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Loss of appetite intensity day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite intensity day 2
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Loss of appetite intensity day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite intensity day 3
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Loss of appetite intensity day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C1971624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medical advice Type
Code List
Medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
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