ID

36918

Beschrijving

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Trefwoorden

Versies (1)
  1. 21-06-19 21-06-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

21 juni 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

Engels

Dose 2

1 Formulieren  
  1. StudyEvent: ODM
    1. Dose 2
Administrative Data
Beschrijving

Administrative Data

Subject Number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Unsolicited Adverse Events
Beschrijving

Unsolicited Adverse Events

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

Adverse Event, Vaccination, Post

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group - Hib-MenCY-TT vaccine
Beschrijving

Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group - Hib-MenCY-TT vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Hib-MenCY-TT vaccine
Beschrijving

Hib-MenCY-TT vaccine

Datatype

text

Alias
UMLS CUI [1]
C2352428
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group - Infanrix® penta vaccine
Beschrijving

Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group - Infanrix® penta vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Infanrix® penta vaccine
Beschrijving

Infanrix (DTaP)

Datatype

text

Alias
UMLS CUI [1]
C1964896
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group - Prevenar® vaccine
Beschrijving

Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group - Prevenar® vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Prevenar® vaccine
Beschrijving

Prevnar, Vaccination

Datatype

text

Alias
UMLS CUI [1,1]
C0876134
UMLS CUI [1,2]
C0042196
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - Lic MenC group - ActHIB® vaccine
Beschrijving

Solicited Adverse Events - Local Symptoms - Lic MenC group - ActHIB® vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
ActHIB® vaccine
Beschrijving

Administration of vaccine

Datatype

text

Alias
UMLS CUI [1]
C2368628
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - Lic MenC group -Infanrix® penta vaccine
Beschrijving

Solicited Adverse Events - Local Symptoms - Lic MenC group -Infanrix® penta vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Infanrix® penta vaccine
Beschrijving

Infanrix (DTaP)

Datatype

text

Alias
UMLS CUI [1]
C1964896
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - Lic MenC group -Prevenar® vaccine
Beschrijving

Solicited Adverse Events - Local Symptoms - Lic MenC group -Prevenar® vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Prevenar® vaccine
Beschrijving

Prevnar, Vaccination

Datatype

text

Alias
UMLS CUI [1,1]
C0876134
UMLS CUI [1,2]
C0042196
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - Lic MenC group - Meningitec® vaccine
Beschrijving

Solicited Adverse Events - Local Symptoms - Lic MenC group - Meningitec® vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Meningitec® vaccine
Beschrijving

Meningococcal vaccine

Datatype

text

Alias
UMLS CUI [1]
C0700144
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - General SymptomsAdverse Events - Local Symptoms - ActHIB group - ActHIB® vaccine
Beschrijving

Solicited Adverse Events - General SymptomsAdverse Events - Local Symptoms - ActHIB group - ActHIB® vaccine

ActHIB® vaccine
Beschrijving

Administration of vaccine

Datatype

text

Alias
UMLS CUI [1]
C2368628
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - ActHIB group - Infanrix® penta vaccine
Beschrijving

Solicited Adverse Events - Local Symptoms - ActHIB group - Infanrix® penta vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Infanrix® penta vaccine
Beschrijving

Infanrix (DTaP)

Datatype

text

Alias
UMLS CUI [1]
C1964896
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - ActHIB group - Prevenar® vaccine
Beschrijving

Solicited Adverse Events - Local Symptoms - ActHIB group - Prevenar® vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Prevenar® vaccine
Beschrijving

Prevnar, Vaccination

Datatype

text

Alias
UMLS CUI [1,1]
C0876134
UMLS CUI [1,2]
C0042196
Local Symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschrijving

Vaccination, Adverse Event, Symptoms, Local

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschrijving

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - General Symptoms
Beschrijving

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
Has the subject experienced any of the following signs/symptoms during the solicited period ?
Beschrijving

Adverse Event, General symptom

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
General Symptoms
Beschrijving

Adverse Event, General symptom

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 0
Beschrijving

Adverse Event, General symptom

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 1
Beschrijving

Adverse Event, General symptom

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 2
Beschrijving

Adverse Event, General symptom

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 3
Beschrijving

Adverse Event, General symptom

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Ongoing after day 3?
Beschrijving

Adverse Event, General symptom, Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Date of last day of symptoms
Beschrijving

Adverse Event, General symptom, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0806020
Causality
Beschrijving

Adverse Event, General symptom, Etiology aspects

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0015127
Medically attended visit
Beschrijving

Adverse Event, General symptom, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C1386497
Medically attended visit - Type
Beschrijving

Adverse Event, General symptom, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C1386497
UMLS CUI [1,5]
C0332307
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Similar models

Dose 2

1 Formulieren
  1. StudyEvent: ODM
    1. Dose 2
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious/specific adverse events at any time post vaccination ?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Adverse Event, Vaccination, Post
Code List
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious/specific adverse events at any time post vaccination ?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (4)
Item Group
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group - Hib-MenCY-TT vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Hib-MenCY-TT vaccine
text
C2352428 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Hib-MenCY-TT vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group - Infanrix® penta vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Infanrix® penta vaccine
text
C1964896 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Infanrix® penta vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group - Prevenar® vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Prevenar® vaccine
text
C0876134 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Hib-MenCY-TT vaccine
Code List
Prevenar® vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - Lic MenC group - ActHIB® vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
ActHIB® vaccine
text
C2368628 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
ActHIB® vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - Lic MenC group -Infanrix® penta vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Infanrix® penta vaccine
text
C1964896 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Infanrix® penta vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - Lic MenC group -Prevenar® vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Prevenar® vaccine
text
C0876134 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Hib-MenCY-TT vaccine
Code List
Prevenar® vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - Lic MenC group - Meningitec® vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Meningitec® vaccine
text
C0700144 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Meningitec® vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - General SymptomsAdverse Events - Local Symptoms - ActHIB group - ActHIB® vaccine
Item
ActHIB® vaccine
text
C2368628 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
ActHIB® vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - ActHIB group - Infanrix® penta vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Infanrix® penta vaccine
text
C1964896 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Infanrix® penta vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - ActHIB group - Prevenar® vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Prevenar® vaccine
text
C0876134 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Hib-MenCY-TT vaccine
Code List
Prevenar® vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period ?
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period ?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
Item
General Symptoms
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Code List
General Symptoms
CL Item
Fever (give °C) (1)
CL Item
Fever route of measurement (Axillary (preferably), Oral, Tympanic oral, Tympanic rectal, Rectal) (2)
CL Item
Irritability / Fussiness (give intensity) (3)
CL Item
Drowsiness (give intensity) (4)
CL Item
Loss of appetite (give intensity) (5)
Adverse Event, General symptom
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom, Continuous
Item
Ongoing after day 3?
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Adverse Event, General symptom, End Date
Item
Date of last day of symptoms
date
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Adverse Event, General symptom, Etiology aspects
Item
Causality
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
Adverse Event, General symptom, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,4])
Adverse Event, General symptom, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,5])
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