ID

30036

Descripción

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: Study to assess immunogenicity and non-inferiority of investigational vaccination regimen as compared to Tritanrix-HepB/Hiberix and as compared to Meningitec when administered to healthy infants 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Visit 1, Day 0, Dose 1

Palabras clave

Versiones (2)
  1. 10.07.17 10.07.17 -
  2. 04.05.18 04.05.18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

4. Mai 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Visit 1 100480

Inglés

Visit 1 Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

1 formularios  
Informed Consent
Descripción

Informed Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0042210
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Informed Consent Date
Descripción

I certify that Informed Consent has been obtained prior to any study procedure.

Tipo de datos

time

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

Demographics

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C0042210
Center number
Descripción

Center number

Tipo de datos

text

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

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Race

Tipo de datos

integer

Alias
UMLS CUI [1]
C0034510
Race, if other please specify
Descripción

Race

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
Height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility Question
Descripción

Eligibility Question

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

f No, please complete below.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Descripción

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Descripción

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C0680251
General Medical History / Physical Examination
Descripción

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?
Descripción

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

Tipo de datos

boolean

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

Cutaneous disease

Tipo de datos

text

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

Cutaneous disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0037274
Eyes: Diagnosis
Descripción

Disorder of eye

Tipo de datos

text

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

Disorder of eye

Tipo de datos

integer

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

Ears-nose-throat disorder

Tipo de datos

text

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

Ears-nose-throat disorder

Tipo de datos

integer

Alias
UMLS CUI [1]
C0395797
Cardiovascular: Diagnosis
Descripción

Cardiovascular disorder

Tipo de datos

text

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

Cardiovascular disorder

Tipo de datos

integer

Alias
UMLS CUI [1]
C0007222
Respiratory: Diagnosis
Descripción

Respiratory disorder

Tipo de datos

text

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

Respiratory disorder

Tipo de datos

integer

Alias
UMLS CUI [1]
C0035204
Gastrointestinal: Diagnosis
Descripción

Gastrointestinal disorder

Tipo de datos

text

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

Gastrointestinal disorder

Tipo de datos

integer

Alias
UMLS CUI [1]
C0017178
Muskuloskeletal: Diagnosis
Descripción

Musculoskeletal disorder

Tipo de datos

text

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

Musculoskeletal disorder

Tipo de datos

integer

Alias
UMLS CUI [1]
C0026857
Neurological: Diagnosis
Descripción

Neurological disorder

Tipo de datos

text

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

Neurological disorder

Tipo de datos

integer

Alias
UMLS CUI [1]
C0027765
Genitourinary: Diagnosis
Descripción

Genitourinary disorder

Tipo de datos

text

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

Genitourinary disorder

Tipo de datos

integer

Alias
UMLS CUI [1]
C0080276
Haematology: Diagnosis
Descripción

Hematology disorder

Tipo de datos

text

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

Hematology disorder

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018939
Allergies: Diagnosis
Descripción

Allergies

Tipo de datos

text

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

Allergies

Tipo de datos

integer

Alias
UMLS CUI [1]
C0020517
Endocrine: Diagnosis
Descripción

Endocrine disorder

Tipo de datos

text

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

Endocrine disorder

Tipo de datos

integer

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

Persistent Crying

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2721683
UMLS CUI [1,2]
C0011900
Persistent Crying
Descripción

Persistent Crying

Tipo de datos

integer

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

Other disorder

Tipo de datos

text

Other disorder
Descripción

Other disorder

Tipo de datos

integer

Laboratory Tests
Descripción

Laboratory Tests

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

blood sample

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Descripción

Please complete only if different from visit date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Pre-Vaccination Assessment
Descripción

Pre-Vaccination Assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0005903
UMLS CUI-3
C0042196
Temperature
Descripción

Route: Axillary

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Vaccine Administration, Single Injection
Descripción

Vaccine Administration, Single Injection

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

Please complete only if different from visit date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
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
Administration Side
Descripción

Left

Tipo de datos

text

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

Anterolateral thigh

Tipo de datos

text

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

I.M.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
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
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, Multi Injections
Descripción

Vaccine Administration, Multi Injections

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]
C0011008
UMLS CUI [1,2]
C2368628
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
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, Multi Injections
Descripción

Vaccine Administration, Multi Injections

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0042196
UMLS CUI-3
C0700144
Vaccine Administration
Descripción

Vaccine Administration

Tipo de datos

integer

Alias
UMLS CUI [1]
C2368628
Date of Vaccine Administration
Descripción

Please complete only if different from visit date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Wrong vial number
Descripción

If Wrong vial number, please specify number

Tipo de datos

integer

Alias
UMLS CUI [1]
C0184301
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
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 - Single Injection
Descripción

Solicited Adverse Events - Local Symptoms - Single Injection

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
UMLS CUI-4
C0877248
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Single Injection
Descripción

Single Injection

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0042196
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 - Tritanrix-HepB/Hiberix vaccine
Descripción

Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/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? Tritanrix-HepB/Hiberix vaccine
Descripción

Tritanrix-HepB/Hiberix vaccine

Tipo de datos

boolean

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 - Meningitec vaccine
Descripción

Solicited Adverse Events - Local Symptoms - Meningitec vaccine

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0700144
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? Meningitec™ vaccine
Descripción

Meningitec™ vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0700144
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
C0042196
UMLS CUI-3
C0877248
Fever
Descripción

Axillary ≥ 37.5°C Oral ≥ 37.5°C Tympanic (oral conversion) ≥ 37.5°C Tympanic (rectal conversion) ≥ 38°C Rectal ≥ 38°C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
Fever
Descripción

If Yes, please specify

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1]
C0015967
C
Fever, Site of measurement
Descripción

Site of measurement

Tipo de datos

text

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

Fever on Day 0

Tipo de datos

integer

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

if taken, please specify

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever on Day 1
Descripción

Fever on Day 1

Tipo de datos

integer

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

if taken, please specify

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever on Day 2
Descripción

Fever on Day 2

Tipo de datos

integer

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

if taken, please specify

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever on Day 3
Descripción

Fever on Day 3

Tipo de datos

integer

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

if taken, please specify

Tipo de datos

float

Unidades de medida
  • C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0015967
C
Fever ongoing after day 3?
Descripción

Fever ongoing after day 3

Tipo de datos

boolean

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

Fever ongoing after day 3? If Yes, please specify

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]
C0015127
UMLS CUI [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 [2]
C0015967
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]
C0015967
Irritability/Fussiness
Descripción

Irritability/Fussiness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness, Intensity
Descripción

If Yes, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
In case of intensity 3: was the crying continuous ( i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps) ?
Descripción

Irritability / Fussiness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438697
In case of intensity 3: was the crying unaltered for > 3 hours ?
Descripción

Irritability / Fussiness

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438697
UMLS CUI [1,2]
C0449238
Irritability/Fussiness on Day 0
Descripción

Irritability/Fussiness on Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness on Day 1
Descripción

Irritability/Fussiness on Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness on Day 2
Descripción

Irritability/Fussiness on Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness on Day 3
Descripción

Irritability/Fussiness on Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness ongoing after day 3?
Descripción

Irritability/Fussiness ongoing after day 3

Tipo de datos

boolean

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

Irritability/Fussiness ongoing after day 3? If Yes, please specify

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]
C0015127
UMLS CUI [2]
C0022107
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]
C0022107
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]
C0022107
Drowsiness
Descripción

Drowsiness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013144
Drowsiness, Intensity
Descripción

If Yes, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Drowsiness on Day 0
Descripción

Drowsiness on Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness on Day 1
Descripción

Drowsiness on Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness on Day 2
Descripción

Drowsiness on Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness on Day 3
Descripción

Drowsiness on Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness ongoing after day 3?
Descripción

Drowsiness ongoing after day 3

Tipo de datos

boolean

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

Drowsiness ongoing after day 3? If Yes, please specify

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
UMLS CUI [2]
C0013144
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]
C0013144
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]
C0013144
Loss of appetite
Descripción

Loss of appetite

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1971624
Loss of appetite, Intensity
Descripción

If Yes, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite on Day 0
Descripción

Loss of appetite on Day 0

Tipo de datos

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite on Day 1
Descripción

Loss of appetite on Day 1

Tipo de datos

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite on Day 2
Descripción

Loss of appetite on Day 2

Tipo de datos

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite on Day 3
Descripción

Loss of appetite on Day 3

Tipo de datos

integer

Alias
UMLS CUI [1]
C1971624
Loss of appetite ongoing after day 3?
Descripción

Loss of appetite ongoing after day 3

Tipo de datos

boolean

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

Loss of appetite ongoing after day 3? If Yes, please specify

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
UMLS CUI [2]
C1971624
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]
C1971624
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]
C1971624
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Similar models

Visit 1 Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
time
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
C0042210 (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
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
Other, please specify (6)
Race
Item
Race, if other 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 56-83 days of age (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 gestation period of 36 to 42 weeks (5)
CL Item
Subjects who have received a birth dose of hepatitis B vaccine within the first 72 hours of life (6)
Item
Exclusion Criteria
integer
C0680251 (UMLS CUI [1])
Exclusion Criteria
Code List
Exclusion Criteria
CL Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no lab testing required at study entry) (1)
CL Item
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV). (2)
CL Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. (3)
CL Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed). (4)
CL Item
Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life. (5)
CL Item
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease. (6)
CL Item
History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease. (7)
CL Item
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth. (8)
CL Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (9)
CL Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. (10)
CL Item
A family history of congenital or hereditary immunodeficiency (11)
CL Item
Major congenital defects or serious chronic illness. (12)
CL Item
History of any neurologic disorders or seizures. (13)
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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C ). (14)
CL Item
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes. (15)
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)
Item
Gastrointestinal: Diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Gender
Code List
Gastrointestinal: Diagnosis
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
integer
C2721683 (UMLS CUI [1])
Persistent Crying
Code List
Persistent Crying
CL Item
Past (1)
CL Item
Current (2)
Other disorder
Item
Other disorder, please specify
text
Item
Other disorder
integer
Cutaneous disease
Code List
Other disorder
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Pre-Vaccination Assessment
C0220825 (UMLS CUI-1)
C0005903 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Vaccine Administration, Single Injection
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Tritanrix-HepB/HibMenAC Vaccine (1)
CL Item
Tritanrix-HepB/Hiberix Vaccine (2)
CL Item
Replacement vial  (3)
CL Item
Wrong vial number (4)
CL Item
Not administered (Please complete below) (5)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1])
Administration Side
Item
Administration Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Site
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
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)
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1])
Item
Study vaccine Administration: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Side
Code List
Study vaccine Administration: Side
CL Item
Left (1)
CL Item
Right (2)
Item
Study vaccine Administration: Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Site
Code List
Study vaccine Administration: Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration Route
Code List
Study vaccine Administration: Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item Group
Vaccine Administration, Multi Injections
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Tritanrix-HepB/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])
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
Vaccine Administration, Multi Injections
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Meningitec Vaccine (1)
CL Item
Replacement vial  (2)
CL Item
Wrong vial number  (3)
CL Item
Not administered (4)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1])
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)
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 - Single Injection
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Single Injection
text
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
symptoms
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Single Injection
CL Item
Information not available (U)
CL Item
No vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Solicited Adverse Events - Local Symptoms - Tritanrix-HepB/Hiberix vaccine
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
symptoms
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Tritanrix-HepB/Hiberix vaccine
boolean
C1457887 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
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 - Meningitec vaccine
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
symptoms
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Meningitec™ vaccine
boolean
C1457887 (UMLS CUI [1,1])
C0700144 (UMLS CUI [1,2])
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain, intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Code List
Pain on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Solicited Adverse Events - General Symptoms
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Fever, Site of measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Site of measurement
Code List
Fever, Site of measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item
Fever on Day 0
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 0
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 0
Item
Fever on Day 0
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 1
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 1
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 1
Item
Fever on Day 1
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 2
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 2
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 2
Item
Fever on Day 2
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 3
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Code List
Fever on Day 3
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 3
Item
Fever on Day 3
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever ongoing after day 3
Item
Fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0015967 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Irritability/Fussiness
Item
Irritability/Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/Fussiness, Intensity
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Irritability/Fussiness, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
crying continuous
Item
In case of intensity 3: 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])
crying unaltered
Item
In case of intensity 3: was the crying unaltered for > 3 hours ?
boolean
C0438697 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Irritability/Fussiness on Day 0
integer
C0022107 (UMLS CUI [1])
Pain
Code List
Irritability/Fussiness on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 1
integer
C0022107 (UMLS CUI [1])
Pain
Code List
Irritability/Fussiness on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 2
integer
C0022107 (UMLS CUI [1])
Pain
Code List
Irritability/Fussiness on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 3
integer
C0022107 (UMLS CUI [1])
Pain
Code List
Irritability/Fussiness on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Irritability/Fussiness ongoing after day 3
Item
Irritability/Fussiness ongoing after day 3?
boolean
C0022107 (UMLS CUI [1])
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])
C0022107 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0022107 (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)
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness, Intensity
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Drowsiness, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness on Day 0
integer
C0013144 (UMLS CUI [1])
Pain
Code List
Drowsiness on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness on Day 1
integer
C0013144 (UMLS CUI [1])
Pain
Code List
Drowsiness on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness on Day 2
integer
C0013144 (UMLS CUI [1])
Pain
Code List
Drowsiness on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Drowsiness on Day 3
integer
C0013144 (UMLS CUI [1])
Pain
Code List
Drowsiness on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Drowsiness ongoing after day 3
Item
Drowsiness ongoing after day 3?
boolean
C0013144 (UMLS CUI [1])
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])
C0013144 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0013144 (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)
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite, Intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Loss of appetite, Intensity
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite on Day 0
integer
C1971624 (UMLS CUI [1])
Pain
Code List
Loss of appetite on Day 0
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite on Day 1
integer
C1971624 (UMLS CUI [1])
Pain
Code List
Loss of appetite on Day 1
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite on Day 2
integer
C1971624 (UMLS CUI [1])
Pain
Code List
Loss of appetite on Day 2
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Loss of appetite on Day 3
integer
C1971624 (UMLS CUI [1])
Pain
Code List
Loss of appetite on Day 3
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Loss of appetite ongoing after day 3
Item
Loss of appetite ongoing after day 3?
boolean
C1971624 (UMLS CUI [1])
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])
C1971624 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1971624 (UMLS CUI [2])
Medical advice Type
Code List
Medically attended visit Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
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