ID

36922

Descripción

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

Palabras clave

Versiones (1)
  1. 21/6/19 21/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de junio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

Inglés

Booster Dose

1 formularios  
  1. StudyEvent: ODM
    1. Booster Dose
Administrative Data
Descripción

Administrative Data

Subject Number
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Unsolicited Adverse Events
Descripción

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 ?
Descripción

Adverse Event, Vaccination, Post

Tipo de datos

text

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

Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC 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
Descripción

Hib-MenCY-TT vaccine

Tipo de datos

text

Alias
UMLS CUI [1]
C2352428
Local Symptoms
Descripción

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

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?
Descripción

Vaccination, Adverse Event, Symptoms, Local, Continuous

Tipo de datos

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
Descripción

Vaccination, Adverse Event, Symptoms, Local, End Date

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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/Lic MenC group - M-M-R® II Vaccine
Descripción

Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - M-M-R® II Vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
M-M-R® II Vaccine
Descripción

Vaccines

Tipo de datos

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Descripción

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

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?
Descripción

Vaccination, Adverse Event, Symptoms, Local, Continuous

Tipo de datos

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
Descripción

Vaccination, Adverse Event, Symptoms, Local, End Date

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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/Lic MenC group - Varivax® vaccine
Descripción

Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - Varivax® vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Varivax® vaccine
Descripción

Vaccines

Tipo de datos

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Descripción

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

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?
Descripción

Vaccination, Adverse Event, Symptoms, Local, Continuous

Tipo de datos

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
Descripción

Vaccination, Adverse Event, Symptoms, Local, End Date

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Adverse Events - Local Symptoms - ActHIB group - PedvaxHIB® vaccine
Descripción

Adverse Events - Local Symptoms - ActHIB group - PedvaxHIB® vaccine

PedvaxHIB® vaccine
Descripción

Vaccines

Tipo de datos

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Descripción

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

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?
Descripción

Vaccination, Adverse Event, Symptoms, Local, Continuous

Tipo de datos

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
Descripción

Vaccination, Adverse Event, Symptoms, Local, End Date

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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 - M-M-R® II Vaccine
Descripción

Solicited Adverse Events - Local Symptoms - ActHIB group - M-M-R® II Vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
M-M-R® II Vaccine
Descripción

Vaccines

Tipo de datos

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Descripción

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

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?
Descripción

Vaccination, Adverse Event, Symptoms, Local, Continuous

Tipo de datos

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
Descripción

Vaccination, Adverse Event, Symptoms, Local, End Date

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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 - Varivax® vaccine
Descripción

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

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Varivax® vaccine
Descripción

Vaccines

Tipo de datos

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Descripción

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

text

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

Vaccination, Adverse Event, Symptoms, Local

Tipo de datos

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?
Descripción

Vaccination, Adverse Event, Symptoms, Local, Continuous

Tipo de datos

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
Descripción

Vaccination, Adverse Event, Symptoms, Local, End Date

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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 ?
Descripción

Adverse Event, General symptom

Tipo de datos

text

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

Adverse Event, General symptom

Tipo de datos

text

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

Adverse Event, General symptom

Tipo de datos

text

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

Adverse Event, General symptom

Tipo de datos

text

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

Adverse Event, General symptom

Tipo de datos

text

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

Adverse Event, General symptom

Tipo de datos

text

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

Adverse Event, General symptom, Continuous

Tipo de datos

boolean

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

Adverse Event, General symptom, End Date

Tipo de datos

date

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

Adverse Event, General symptom, Etiology aspects

Tipo de datos

boolean

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

Adverse Event, General symptom, Visit, Advice, Medical

Tipo de datos

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
Descripción

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

Tipo de datos

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
Fever
Descripción

Adverse Event, General symptom, Fever

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0015967
General rash/ exanthema
Descripción

Adverse Event, General symptom, Exanthema

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0015230
Parotid / salivary gland swelling
Descripción

Adverse Event, General symptom, parotid gland swelling, Swelling of salivary gland

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0240668
UMLS CUI [1,4]
C0240925
Febrile convulsions –suspected signs of meningism
Descripción

Adverse Event, General symptom, Febrile Convulsions

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0009952
Volver a la parte superior de la página

Similar models

Booster Dose

1 formularios
  1. StudyEvent: ODM
    1. Booster Dose
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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/Lic MenC 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/Lic MenC group - M-M-R® II Vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
M-M-R® II Vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
M-M-R® II 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/Lic MenC group - Varivax® vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Varivax® vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Varivax® 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
Adverse Events - Local Symptoms - ActHIB group - PedvaxHIB® vaccine
Item
PedvaxHIB® vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
PedvaxHIB® 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 - M-M-R® II Vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
M-M-R® II Vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
M-M-R® II 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 - Varivax® vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Varivax® vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Varivax® 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
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])
Adverse Event, General symptom, Fever
Item
Fever
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Adverse Event, General symptom, Exanthema
Item
General rash/ exanthema
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015230 (UMLS CUI [1,3])
Adverse Event, General symptom, parotid gland swelling, Swelling of salivary gland
Item
Parotid / salivary gland swelling
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0240668 (UMLS CUI [1,3])
C0240925 (UMLS CUI [1,4])
Adverse Event, General symptom, Febrile Convulsions
Item
Febrile convulsions –suspected signs of meningism
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0009952 (UMLS CUI [1,3])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial