ID

26168

Beschreibung

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 1, Day 0, Dose 1

Stichworte

Versionen (1)
  1. 10.10.17 10.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Oktober 2017

DOI

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Lizenz

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GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine Visit 1 101223

Englisch

Visit 1 GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 Formulare  
Informed Consent
Beschreibung

Informed Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C1955348
Informed Consent Date
Beschreibung

Informed Consent Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
UMLS CUI-2
C1955348
Center number
Beschreibung

Center number

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Other Race, please specify
Beschreibung

If you chose 'Other Race', please specify

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C1516637
UMLS CUI-2
C0042210
Did the subject meet all the entry criteria?
Beschreibung

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschreibung

Tick the boxes corresponding to any of the inclusion criteria the subject failed

Datentyp

integer

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Beschreibung

Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datentyp

integer

Alias
UMLS CUI [1]
C0680251
Record treatment number
Beschreibung

Record treatment number

Datentyp

text

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
General Medical History / Physical Examination
Beschreibung

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
UMLS CUI-3
C0042210
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Beschreibung

If Yes, please tick appropriate box(es) and give diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1457887
Cutaneous: Diagnosis
Beschreibung

Cutaneous disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0011900
Cutaneous disease
Beschreibung

Cutaneous disease

Datentyp

integer

Alias
UMLS CUI [1]
C0037274
Eyes: Diagnosis
Beschreibung

Disorder of eye

Datentyp

text

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0011900
Disorder of eye
Beschreibung

Disorder of eye

Datentyp

integer

Alias
UMLS CUI [1]
C0015397
Ears-nose-throat: Diagnosis
Beschreibung

Ears-nose-throat disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0395797
UMLS CUI [1,2]
C0011900
Ears-nose-throat disorder
Beschreibung

Ears-nose-throat disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0395797
Cardiovascular: Diagnosis
Beschreibung

Cardiovascular disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0011900
Cardiovascular disorder
Beschreibung

Cardiovascular disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0007222
Respiratory: Diagnosis
Beschreibung

Respiratory disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0011900
Respiratory disorder
Beschreibung

Respiratory disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0035204
Gastrointestinal: Diagnosis
Beschreibung

Gastrointestinal disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0011900
Gastrointestinal disorder
Beschreibung

Gastrointestinal disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0017178
Muskuloskeletal: Diagnosis
Beschreibung

Musculoskeletal disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C0011900
Musculoskeletal disorder
Beschreibung

Musculoskeletal disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0026857
Neurological: Diagnosis
Beschreibung

Neurological disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0011900
Neurological disorder
Beschreibung

Neurological disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0027765
Genitourinary: Diagnosis
Beschreibung

Genitourinary disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0080276
UMLS CUI [1,2]
C0011900
Genitourinary disorder
Beschreibung

Genitourinary disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0080276
Haematology: Diagnosis
Beschreibung

Hematology disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0011900
Hematology disorder
Beschreibung

Hematology disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0018939
Allergies: Diagnosis
Beschreibung

Allergies

Datentyp

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0011900
Allergies
Beschreibung

Allergies

Datentyp

integer

Alias
UMLS CUI [1]
C0020517
Endocrine: Diagnosis
Beschreibung

Endocrine disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0011900
Endocrine disorder
Beschreibung

Endocrine disorder

Datentyp

integer

Alias
UMLS CUI [1]
C0014130
Persistent Crying (crying continuous and unaltered for over 3 hours): Diagnosis
Beschreibung

Persistent Crying

Datentyp

text

Alias
UMLS CUI [1,1]
C2721683
UMLS CUI [1,2]
C0011900
Persistent Crying (crying continuous and unaltered for over 3 hours)
Beschreibung

Persistent Crying

Datentyp

integer

Alias
UMLS CUI [1]
C2721683
Other disorder, please specify
Beschreibung

Other disorder

Datentyp

text

Alias
UMLS CUI [1]
C0012634
Other disorder
Beschreibung

Other disorder

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011900
Laboratory tests
Beschreibung

Laboratory tests

Alias
UMLS CUI-1
C0022885
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Has a blood sample been taken?
Beschreibung

Blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample was taken
Beschreibung

Please complete only if different from visit date

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Vaccine Administration, Tritanrix-Hep B/Hiberix group
Beschreibung

Vaccine Administration, Tritanrix-Hep B/Hiberix group

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

Please complete only if different from visit date

Datentyp

date

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

Pre-Vaccination temperature

Datentyp

float

Maßeinheiten
  • C
Alias
UMLS CUI [1]
C0005903
C
Pre-Vaccination temperature Route:
Beschreibung

Pre-Vaccination temperature Route

Datentyp

integer

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

Vaccine Administration

Datentyp

integer

Alias
UMLS CUI [1]
C2368628
Wrong vial number
Beschreibung

If Wrong vial number, please specify number

Datentyp

integer

Alias
UMLS CUI [1]
C0184301
Replacement vial
Beschreibung

If Replacement vial number, please specify number

Datentyp

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
Beschreibung

If not administered

Datentyp

integer

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

If reason for non administration = Serious adverse event

Datentyp

integer

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

If reason for non administration = Non-serious adverse event

Datentyp

integer

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

reason for non administration

Datentyp

text

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

non administration

Datentyp

integer

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

Administration Side

Datentyp

text

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

Administration Site

Datentyp

text

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

Administration Route

Datentyp

text

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

Study vaccine Administration

Datentyp

boolean

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

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

Vaccine administration

Datentyp

integer

Alias
UMLS CUI [1]
C2368628
Administration Route
Beschreibung

Administration Route

Datentyp

integer

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

Study vaccine Administration

Datentyp

boolean

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

Vaccine Administration, Triple Antigen + Hiberix group

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

Please complete only if different from visit date

Datentyp

date

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

Pre-Vaccination temperature

Datentyp

float

Maßeinheiten
  • C
Alias
UMLS CUI [1]
C0005903
C
Pre-Vaccination temperature Route:
Beschreibung

Pre-Vaccination temperature Route

Datentyp

integer

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

Vaccine Administration

Datentyp

integer

Alias
UMLS CUI [1]
C2368628
Wrong vial number
Beschreibung

If Wrong vial number, please specify number

Datentyp

integer

Alias
UMLS CUI [1]
C0184301
Replacement vial
Beschreibung

If Replacement vial number, please specify number

Datentyp

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
Beschreibung

If not administered

Datentyp

integer

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

If reason for non administration = Serious adverse event

Datentyp

integer

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

If reason for non administration = Non-serious adverse event

Datentyp

integer

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

reason for non administration

Datentyp

text

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

non administration

Datentyp

integer

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

Administration Side

Datentyp

text

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

Administration Site

Datentyp

text

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

Administration Route

Datentyp

text

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

Study vaccine Administration

Datentyp

boolean

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

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

Vaccine administration

Datentyp

integer

Alias
UMLS CUI [1]
C2368628
Administration Route
Beschreibung

Administration Route

Datentyp

integer

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

Study vaccine Administration

Datentyp

boolean

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

Vaccine Administration, Triple Antigen + Hiberix group

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

Vaccine Administration

Datentyp

integer

Alias
UMLS CUI [1]
C2368628
Wrong vial number
Beschreibung

If Wrong vial number, please specify number

Datentyp

integer

Alias
UMLS CUI [1]
C0184301
Replacement vial
Beschreibung

If Replacement vial number, please specify number

Datentyp

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
Beschreibung

If not administered

Datentyp

integer

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

If reason for non administration = Serious adverse event

Datentyp

integer

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

If reason for non administration = Non-serious adverse event

Datentyp

integer

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

reason for non administration

Datentyp

text

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

non administration

Datentyp

integer

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

Administration Side

Datentyp

text

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

Administration Site

Datentyp

text

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

Administration Route

Datentyp

text

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

Study vaccine Administration

Datentyp

boolean

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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?
Beschreibung

serious or non-serious unsolicited adverse events

Datentyp

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
Beschreibung

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?
Beschreibung

symptoms

Datentyp

integer

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

Redness

Datentyp

boolean

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

If Yes, please specify

Datentyp

float

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

Redness on Day 0

Datentyp

float

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

Redness on Day 1

Datentyp

float

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

Redness on Day 2

Datentyp

float

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

Redness on Day 3

Datentyp

float

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

Redness ongoing after day 3

Datentyp

boolean

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

Redness ongoing after day 3? If Yes, please specify

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit Type

Datentyp

text

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

Swelling

Datentyp

boolean

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

If Yes, please specify

Datentyp

float

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

Swelling on Day 0

Datentyp

float

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

Swelling on Day 1

Datentyp

float

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

Swelling on Day 2

Datentyp

float

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

Swelling on Day 3

Datentyp

float

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

Swelling ongoing after day 3

Datentyp

boolean

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

Swelling ongoing after day 3? If Yes, please specify

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit Type

Datentyp

text

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

Pain

Datentyp

boolean

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

If Yes, please specify

Datentyp

integer

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

Pain on Day 0

Datentyp

integer

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

Pain on Day 1

Datentyp

integer

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

Pain on Day 2

Datentyp

integer

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

Pain on Day 3

Datentyp

integer

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

Pain ongoing after day 3

Datentyp

boolean

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

Pain ongoing after day 3? If Yes, please specify

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit Type

Datentyp

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
Beschreibung

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?
Beschreibung

symptoms

Datentyp

integer

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

Redness

Datentyp

boolean

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

If Yes, please specify

Datentyp

float

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

Redness on Day 0

Datentyp

float

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

Redness on Day 1

Datentyp

float

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

Redness on Day 2

Datentyp

float

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

Redness on Day 3

Datentyp

float

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

Redness ongoing after day 3

Datentyp

boolean

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

Redness ongoing after day 3? If Yes, please specify

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit Type

Datentyp

text

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

Swelling

Datentyp

boolean

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

If Yes, please specify

Datentyp

float

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

Swelling on Day 0

Datentyp

float

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

Swelling on Day 1

Datentyp

float

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

Swelling on Day 2

Datentyp

float

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

Swelling on Day 3

Datentyp

float

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

Swelling ongoing after day 3

Datentyp

boolean

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

Swelling ongoing after day 3? If Yes, please specify

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit Type

Datentyp

text

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

Pain

Datentyp

boolean

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

If Yes, please specify

Datentyp

integer

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

Pain on Day 0

Datentyp

integer

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

Pain on Day 1

Datentyp

integer

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

Pain on Day 2

Datentyp

integer

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

Pain on Day 3

Datentyp

integer

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

Pain ongoing after day 3

Datentyp

boolean

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

Pain ongoing after day 3? If Yes, please specify

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit Type

Datentyp

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
Beschreibung

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?
Beschreibung

symptoms

Datentyp

integer

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

Redness

Datentyp

boolean

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

If Yes, please specify

Datentyp

float

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

Redness on Day 0

Datentyp

float

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

Redness on Day 1

Datentyp

float

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

Redness on Day 2

Datentyp

float

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

Redness on Day 3

Datentyp

float

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

Redness ongoing after day 3

Datentyp

boolean

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

Redness ongoing after day 3? If Yes, please specify

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit Type

Datentyp

text

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

Swelling

Datentyp

boolean

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

If Yes, please specify

Datentyp

float

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

Swelling on Day 0

Datentyp

float

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

Swelling on Day 1

Datentyp

float

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

Swelling on Day 2

Datentyp

float

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

Swelling on Day 3

Datentyp

float

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

Swelling ongoing after day 3

Datentyp

boolean

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

Swelling ongoing after day 3? If Yes, please specify

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit Type

Datentyp

text

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

Pain

Datentyp

boolean

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

If Yes, please specify

Datentyp

integer

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

Pain on Day 0

Datentyp

integer

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

Pain on Day 1

Datentyp

integer

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

Pain on Day 2

Datentyp

integer

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

Pain on Day 3

Datentyp

integer

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

Pain ongoing after day 3

Datentyp

boolean

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

Pain ongoing after day 3? If Yes, please specify

Datentyp

date

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit Type

Datentyp

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
Beschreibung

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?
Beschreibung

signs/symptoms

Datentyp

integer

Alias
UMLS CUI [1]
C1457887
Fever
Beschreibung

Fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
Fever
Beschreibung

Fever

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Site of measurement
Beschreibung

Fever Site of measurement

Datentyp

integer

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

Fever day 0

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever day 1
Beschreibung

Fever day 1

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever day 2
Beschreibung

Fever day 2

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever day 3
Beschreibung

Fever day 3

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Ongoing after day 3?
Beschreibung

Ongoing after day 3?

Datentyp

boolean

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

Date of last day of symptoms

Datentyp

date

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

Causality?

Datentyp

boolean

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

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

text

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

Irritability

Datentyp

boolean

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

Irritability intensity day 0

Datentyp

integer

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

Irritability / Fussiness intensity day 1

Datentyp

integer

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

Irritability / Fussiness intensity day 2

Datentyp

integer

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

Irritability / Fussiness intensity day 3

Datentyp

integer

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

Ongoing after day 3?

Datentyp

boolean

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

Date of last day of symptoms

Datentyp

date

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

Causality?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0022107
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

integer

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

Drowsiness

Datentyp

boolean

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

Drowsiness intensity day 0

Datentyp

integer

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

Drowsiness intensity day 1

Datentyp

integer

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

Drowsiness intensity day 2

Datentyp

integer

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

Drowsiness intensity day 3

Datentyp

integer

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

Ongoing after day 3?

Datentyp

boolean

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

Date of last day of symptoms

Datentyp

date

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

Causality?

Datentyp

boolean

Alias
UMLS CUI [1]
C0015127
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

integer

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

Loss of appetite

Datentyp

boolean

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

Loss of appetite intensity day 0

Datentyp

integer

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

Loss of appetite intensity day 1

Datentyp

integer

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

Loss of appetite intensity day 2

Datentyp

integer

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

Loss of appetite intensity day 3

Datentyp

integer

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

Ongoing after day 3?

Datentyp

boolean

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

Date of last day of symptoms

Datentyp

date

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

Causality?

Datentyp

boolean

Alias
UMLS CUI [1]
C0015127
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

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

Medically attended visit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
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Ähnliche Modelle

Visit 1 GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
Informed Consent Date
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C1704791 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East & South East Asian (5)
CL Item
South Asian (6)
CL Item
Other (9)
CL Item
American Hispanic (7)
CL Item
Japanese (8)
Race
Item
Other Race, please specify
text
C0034510 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item
Inclusion Criteria
integer
C1512693 (UMLS CUI [1])
Inclusion Criteria
Code List
Inclusion Criteria
CL Item
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. (1)
CL Item
A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination. (2)
CL Item
Written informed consent obtained from the parent or guardian of the subject. (3)
CL Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study. (4)
CL Item
Born after a normal gestation period (between 36 and 42 weeks (5)
CL Item
For Venezuela and Argentina: born to a mother proven seronegative for HBsAg (6)
CL Item
For Venezuela and Argentina: results of maternal blood sample assayed for the presence of (7)
CL Item
HBsAg must be available before the infant can be enrolled in the study. (8)
CL Item
For Venezuela and Argentina: written Informed consent will be obtained from the mothers in (8)
CL Item
case the prenatal screening is done at the study site. (10)
Item
Exclusion Criteria
integer
C0680251 (UMLS CUI [1])
Exclusion Criteria
Code List
Exclusion Criteria
CL Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.  (9)
CL Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth, (10)
CL Item
Any chronic drug therapy to be continued during the study. (11)
CL Item
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period from 30 days before each dose of vaccine and ending 30 days after each dose. (12)
CL Item
Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life. (13)
CL Item
Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, H. influenzae or poliomyelitis. (14)
CL Item
History of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib disease (15)
CL Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (16)
CL Item
A family history of congenital or hereditary immunodeficiency. (17)
CL Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). (18)
CL Item
Major congenital defects or serious chronic illness (19)
CL Item
History of any neurologic disorders or seizures. (20)
CL Item
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. rectal temperature <38°C/ axillary temperature ≥ 37.5°C). (21)
CL Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. (22)
CL Item
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes (23)
Record treatment number
Item
Record treatment number
text
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
pre-existing conditions or signs and/or symptoms
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0262926 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Cutaneous disease
Item
Cutaneous: Diagnosis
text
C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Cutaneous disease
integer
C0037274 (UMLS CUI [1])
Cutaneous disease
Code List
Cutaneous disease
CL Item
Past (1)
CL Item
Current (2)
Disorder of eye
Item
Eyes: Diagnosis
text
C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Disorder of eye
integer
C0015397 (UMLS CUI [1])
Cutaneous disease
Code List
Disorder of eye
CL Item
Past (1)
CL Item
Current (2)
Ears-nose-throat disorder
Item
Ears-nose-throat: Diagnosis
text
C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Ears-nose-throat disorder
integer
C0395797 (UMLS CUI [1])
Cutaneous disease
Code List
Ears-nose-throat disorder
CL Item
Past (1)
CL Item
Current (2)
Cardiovascular disorder
Item
Cardiovascular: Diagnosis
text
C0007222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Cardiovascular disorder
integer
C0007222 (UMLS CUI [1])
Cutaneous disease
Code List
Cardiovascular disorder
CL Item
Past (1)
CL Item
Current (2)
Respiratory disorder
Item
Respiratory: Diagnosis
text
C0035204 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Respiratory disorder
integer
C0035204 (UMLS CUI [1])
Cutaneous disease
Code List
Respiratory disorder
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal disorder
Item
Gastrointestinal: Diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Gastrointestinal disorder
integer
C0017178 (UMLS CUI [1])
Cutaneous disease
Code List
Gastrointestinal disorder
CL Item
Past (1)
CL Item
Current (2)
Musculoskeletal disorder
Item
Muskuloskeletal: Diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Musculoskeletal disorder
integer
C0026857 (UMLS CUI [1])
Cutaneous disease
Code List
Musculoskeletal disorder
CL Item
Past (1)
CL Item
Current (2)
Neurological disorder
Item
Neurological: Diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Neurological disorder
integer
C0027765 (UMLS CUI [1])
Cutaneous disease
Code List
Neurological disorder
CL Item
Past (1)
CL Item
Current (2)
Genitourinary disorder
Item
Genitourinary: Diagnosis
text
C0080276 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Genitourinary disorder
integer
C0080276 (UMLS CUI [1])
Cutaneous disease
Code List
Genitourinary disorder
CL Item
Past (1)
CL Item
Current (2)
Hematology disorder
Item
Haematology: Diagnosis
text
C0018939 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Hematology disorder
integer
C0018939 (UMLS CUI [1])
Cutaneous disease
Code List
Hematology disorder
CL Item
Past (1)
CL Item
Current (2)
Allergies
Item
Allergies: Diagnosis
text
C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Allergies
integer
C0020517 (UMLS CUI [1])
Cutaneous disease
Code List
Allergies
CL Item
Past (1)
CL Item
Current (2)
Endocrine disorder
Item
Endocrine: Diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Endocrine disorder
integer
C0014130 (UMLS CUI [1])
Cutaneous disease
Code List
Endocrine disorder
CL Item
Past (1)
CL Item
Current (2)
Persistent Crying
Item
Persistent Crying (crying continuous and unaltered for over 3 hours): Diagnosis
text
C2721683 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Persistent Crying (crying continuous and unaltered for over 3 hours)
integer
C2721683 (UMLS CUI [1])
Cutaneous disease
Code List
Persistent Crying (crying continuous and unaltered for over 3 hours)
CL Item
Past (1)
CL Item
Current (2)
Other disorder
Item
Other disorder, please specify
text
C0012634 (UMLS CUI [1])
Item
Other disorder
integer
C0012634 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Cutaneous disease
Code List
Other disorder
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Collection Date
Item
Date blood sample was taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Vaccine Administration, Tritanrix-Hep B/Hiberix group
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:
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
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, 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:
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (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
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
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 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])
Vaccine Administration
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])
Vaccine Administration
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])
Vaccine Administration
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])
Vaccine Administration
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])
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])
Vaccine Administration
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])
Vaccine Administration
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])
Vaccine Administration
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])
Vaccine Administration
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])
Vaccine Administration
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])
Vaccine Administration
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])
Vaccine Administration
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])
Vaccine Administration
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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