ID

36630

Beskrivning

Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal

Länk

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Nyckelord

Versioner (1)
  1. 2019-05-26 2019-05-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 maj 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422

Engelsk

Visit 1 - Month 0 - Vaccination

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Elimination Criteria During the Study
Beskrivning

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0347984
UMLS CUI-3
C0008976
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the study period.
Beskrivning

Pharmaceutical Preparations, Vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0042196
[B] Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Beskrivning

Immunosuppressive Agents, Chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
Administration of a vaccine not foreseen by the study protocol during the period starting from vaccine administration and ending 30 days after.
Beskrivning

Vaccination, Concomitant Agent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Administration of immunoglobulins and/or any blood products during the study period.
Beskrivning

Immunoglobulins, Blood Product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0456388
Informed Consent
Beskrivning

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Beskrivning

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

Datatyp

date

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

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Beskrivning

Institution name, Identifier

Datatyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Beskrivning

Patient date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beskrivning

Racial group

Datatyp

text

Alias
UMLS CUI [1]
C0034510
Eligibility Check
Beskrivning

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beskrivning

Eligibility Determination

Datatyp

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visit) should be enrolled in the study.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
A male or female between, and including 2 and 30 years of age at the time of vaccination.
Beskrivning

Gender, Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Beskrivning

Healthy

Datatyp

boolean

Alias
UMLS CUI [1]
C3898900
If the subject is female, she must be of non-childbearing potential. If a subject is a female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.
Beskrivning

Childbearing Potential; Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of study vaccine, or planned use during the study period.
Beskrivning

Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Beskrivning

Immunosuppressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0021081
Vaccination with a meningococcal vaccine within the last five years.
Beskrivning

Meningococcal vaccine, Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700144
UMLS CUI [1,2]
C0205156
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 15 days before vaccine administration and ending 30 days after.
Beskrivning

Concomitant Agent, Vaccination, Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C1301732
History of meningococcal serogroup A, C, W135 or Y disease.
Beskrivning

Meningitis, Meningococcal, Serogroup A, Medical History; Meningitis, Meningococcal, Serogroup B, Medical History; Meningitis, Meningococcal, Serogroup C, Medical History; Meningitis, Meningococcal, Serogroup Y, Medical History; Meningitis, Meningococcal, Serogroup W-135, Medical History

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1135745
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1135746
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C1135747
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C1136209
UMLS CUI [4,2]
C0262926
UMLS CUI [5,1]
C1136210
UMLS CUI [5,2]
C0262926
Known exposure to meningococcal serogroup A, C, W135 or Y disease or contacts with subjects who had meningococcal disease.
Beskrivning

Meningitis, Meningococcal, Serogroup A, Exposure to; Meningitis, Meningococcal, Serogroup B, Exposure to; Meningitis, Meningococcal, Serogroup C, Exposure to; Meningitis, Meningococcal, Serogroup Y, Exposure to; Meningitis, Meningococcal, Serogroup W-135, Exposure to

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1135745
UMLS CUI [1,2]
C0332157
UMLS CUI [2,1]
C1135746
UMLS CUI [2,2]
C0332157
UMLS CUI [3,1]
C1135747
UMLS CUI [3,2]
C0332157
UMLS CUI [4,1]
C1136209
UMLS CUI [4,2]
C0332157
UMLS CUI [5,1]
C1136210
UMLS CUI [5,2]
C0332157
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Beskrivning

Immunologic Deficiency Syndromes

Datatyp

boolean

Alias
UMLS CUI [1]
C0021051
A family history of congenital or hereditary immunodeficiency.
Beskrivning

Immunodeficiency congenital, Family history; Immunologic Deficiency Syndromes, Hereditary, Family History

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853602
UMLS CUI [1,2]
C0241889
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0241889
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Beskrivning

Vaccination, Hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0020517
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, Axillary temperature < 37.5°C (99.5 °F).
Beskrivning

Acute Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0001314
Administration of immunoglobulins and/or any blood products within the three months preceding administration of study vaccine or planned use during the study period.
Beskrivning

Immunoglobulins, Blood product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0456388
Pregnant or lactating female.
Beskrivning

Pregnancy; Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
History of chronic alcohol consumption and/or drug abuse.
Beskrivning

Alcohol consumption, chronic, Medical History; Drug abuse, Medical History

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0013146
UMLS CUI [2,2]
C0262926
Female planning to become pregnant in the next two months.
Beskrivning

Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032992
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Beskrivning

Disease, Interferes with, Result

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1274040
Randomisation / Treatment Allocation
Beskrivning

Randomisation / Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Beskrivning

Randomization, Numbers

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
General Medical History / Physical Examination
Beskrivning

General Medical History / Physical Examination

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

Disease; Symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1457887
Organ
Beskrivning

body system or organ function

Datatyp

text

Alias
UMLS CUI [1]
C0678852
Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Past or Current?
Beskrivning

Diagnosis, Past, Current

Datatyp

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
UMLS CUI [1,3]
C0521116
Laboratory Tests - Blood Sample
Beskrivning

Laboratory Tests - Blood Sample

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken?
Beskrivning

Collection of blood specimen for laboratory procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
Date if different from visit date
Beskrivning

Collection of blood specimen for laboratory procedure, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
HCG Urine Pregnancy Test
Beskrivning

HCG Urine Pregnancy Test

Alias
UMLS CUI-1
C0430056
Has a urine sample been taken ?
Beskrivning

Urine Specimen Collection

Datatyp

text

Alias
UMLS CUI [1]
C0200354
Date (Please complete only if different from visit date)
Beskrivning

Urine Specimen Collection, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
Result
Beskrivning

Urine pregnancy test, Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C1274040
Vaccine Administration
Beskrivning

Vaccine Administration

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2368628
Date if different from visit date
Beskrivning

Vaccination, Administration of Vaccine, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0011008
Pre-Vaccination temperature
Beskrivning

Vaccination, Body Temperature, Vaccination, Before

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0005903
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
°C
Route
Beskrivning

Vaccination, Administration of vaccine, Body Temperature, Measurement site

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0005903
UMLS CUI [1,4]
C0449687
Vaccine Administration (only one box must be ticked by vaccine)
Beskrivning

Vaccination, Administration of Vaccine

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
If Replacement vial, give number
Beskrivning

Vaccination, Administration of Vaccine, Vial Device, Replacement, Numbers

Datatyp

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0184301
UMLS CUI [1,4]
C0559956
UMLS CUI [1,5]
C0600091
If Wrong vial, give number
Beskrivning

Vaccination, Administration of Vaccine, Vial Device, Wrong, Numbers

Datatyp

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0184301
UMLS CUI [1,4]
C3827420
UMLS CUI [1,5]
C0600091
Side / Site, Route
Beskrivning

Vaccination, Administration of Vaccine, Anatomic Site, Drug Administration Routes

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C0013153
Has the study vaccine been administered according to the Protocol?
Beskrivning

Vaccination, Administration of Vaccine, Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0525058
If No, Side
Beskrivning

Vaccination, Administration of Vaccine, Side

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0441987
If No, Site
Beskrivning

Vaccination, Administration of Vaccine, Anatomic site

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1515974
If No, Route
Beskrivning

Vaccination, Administration of Vaccine, Drug Administration Routes

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0013153
Why not administered? Please tick the major reason for non administration.
Beskrivning

Vaccination, Administration of Vaccine, Not done

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1272696
Please tick who made the decision
Beskrivning

Vaccination, Administration of Vaccine, Decision

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0679006
Unsolicited Adverse Event
Beskrivning

Unsolicited Adverse Event

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

Adverse Event, Vaccination

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
Solicited Adverse Events - Local Symptoms
Beskrivning

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C0545082
UMLS CUI-5
C0332307
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Local Symptoms
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 0
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 1
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 2
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 3
Beskrivning

Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Ongoing after Day 3
Beskrivning

Adverse Event, Symptoms, Local, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0549178
Date of last Day of Symptoms
Beskrivning

Adverse Event, Symptoms, Local, End Date

Datatyp

date

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

Adverse Event, Symptoms, Local, Visit/Advice

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0545082
Medically attended visit - Type
Beskrivning

Adverse Event, Symptoms, Local, Visit/Advice, Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0545082
UMLS CUI [1,5]
C0332307
Solicited Adverse Events - General Symptoms - "2-5 Years"
Beskrivning

Solicited Adverse Events - General Symptoms - "2-5 Years"

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Ongoing after Day 3
Beskrivning

Adverse Event, General symptom, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Date of last Day of Symptoms
Beskrivning

Adverse Event, General symptom, End Date

Datatyp

date

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

Adverse Event, General symptom, Etiology aspects

Datatyp

boolean

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

Adverse Event, General symptom, Visit/Advice

Datatyp

boolean

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

Adverse Event, General symptom, Visit/Advice, Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0332307
Solicited Adverse Events - General Symptoms - "6-30 Years"
Beskrivning

Solicited Adverse Events - General Symptoms - "6-30 Years"

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

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

Adverse Event, General symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Ongoing after Day 3
Beskrivning

Adverse Event, General symptom, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Date of last Day of Symptoms
Beskrivning

Adverse Event, General symptom, End Date

Datatyp

date

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

Adverse Event, General symptom, Etiology aspects

Datatyp

boolean

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

Adverse Event, General symptom, Visit/Advice

Datatyp

boolean

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

Adverse Event, General symptom, Visit/Advice, Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0332307
Tillbaka till toppen

Similar models

Visit 1 - Month 0 - Vaccination

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Pharmaceutical Preparations, Vaccination
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the study period.
boolean
C0013227 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
Immunosuppressive Agents, Chronic
Item
[B] Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Vaccination, Concomitant Agent
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from vaccine administration and ending 30 days after.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Immunoglobulins, Blood Product
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent, Date in time
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Institution name, Identifier
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
undefined item
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
CL Item
African Heritage / African American  (1)
CL Item
American Indian or Alaskan Native  (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other, specify (10)
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Protocol Compliance
Item
Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visit) should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1])
Gender, Age
Item
A male or female between, and including 2 and 30 years of age at the time of vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Healthy
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C3898900 (UMLS CUI [1])
Childbearing Potential; Contraceptive methods
Item
If the subject is female, she must be of non-childbearing potential. If a subject is a female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Pharmaceutical Preparations
Item
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of study vaccine, or planned use during the study period.
boolean
C0013227 (UMLS CUI [1])
Immunosuppressive Agents
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1])
Meningococcal vaccine, Previous
Item
Vaccination with a meningococcal vaccine within the last five years.
boolean
C0700144 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Concomitant Agent, Vaccination, Planned
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 15 days before vaccine administration and ending 30 days after.
boolean
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Meningitis, Meningococcal, Serogroup A, Medical History; Meningitis, Meningococcal, Serogroup B, Medical History; Meningitis, Meningococcal, Serogroup C, Medical History; Meningitis, Meningococcal, Serogroup Y, Medical History; Meningitis, Meningococcal, Serogroup W-135, Medical History
Item
History of meningococcal serogroup A, C, W135 or Y disease.
boolean
C1135745 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1135746 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1135747 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C1136209 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C1136210 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
Meningitis, Meningococcal, Serogroup A, Exposure to; Meningitis, Meningococcal, Serogroup B, Exposure to; Meningitis, Meningococcal, Serogroup C, Exposure to; Meningitis, Meningococcal, Serogroup Y, Exposure to; Meningitis, Meningococcal, Serogroup W-135, Exposure to
Item
Known exposure to meningococcal serogroup A, C, W135 or Y disease or contacts with subjects who had meningococcal disease.
boolean
C1135745 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C1135746 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C1135747 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C1136209 (UMLS CUI [4,1])
C0332157 (UMLS CUI [4,2])
C1136210 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
Immunologic Deficiency Syndromes
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C0021051 (UMLS CUI [1])
Immunodeficiency congenital, Family history; Immunologic Deficiency Syndromes, Hereditary, Family History
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
Vaccination, Hypersensitivity
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C0042196 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Acute Disease
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, Axillary temperature < 37.5°C (99.5 °F).
boolean
C0001314 (UMLS CUI [1])
Immunoglobulins, Blood product
Item
Administration of immunoglobulins and/or any blood products within the three months preceding administration of study vaccine or planned use during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
Pregnancy; Breast Feeding
Item
Pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Alcohol consumption, chronic, Medical History; Drug abuse, Medical History
Item
History of chronic alcohol consumption and/or drug abuse.
boolean
C0001948 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0013146 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Pregnancy, Planned
Item
Female planning to become pregnant in the next two months.
boolean
C0032992 (UMLS CUI [1])
Disease, Interferes with, Result
Item
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Randomisation / Treatment Allocation
C0034656 (UMLS CUI-1)
Randomization, Numbers
Item
Record treatment number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Disease; 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
C0012634 (UMLS CUI [1])
C1457887 (UMLS CUI [2])
Item
Organ
text
C0678852 (UMLS CUI [1])
MedDRA System Organ Class
Code List
Organ
CL Item
Cutaneous (1)
CL Item
Eyes (2)
CL Item
Ears-Nose-Throat (3)
CL Item
Cardiovascular (4)
CL Item
Respiratory (5)
CL Item
Gastrointestinal (6)
CL Item
Muskuloskeletal (7)
CL Item
Neurological (8)
CL Item
Genitourinary (9)
CL Item
Haematology (10)
CL Item
Allergies (12)
CL Item
Endocrine (13)
CL Item
Other (specify) (14)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Past or Current?
text
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Diagnosis, Past, Current
Code List
Past or Current?
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory Tests - Blood Sample
C0005834 (UMLS CUI-1)
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure, Date in time
Item
Date if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
HCG Urine Pregnancy Test
C0430056 (UMLS CUI-1)
Item
Has a urine sample been taken ?
text
C0200354 (UMLS CUI [1])
Urine Specimen Collection
Code List
Has a urine sample been taken ?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
Urine Specimen Collection, Date in time
Item
Date (Please complete only if different from visit date)
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
text
C0430056 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Urine pregnancy test, Result
Code List
Result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Vaccine Administration
C0042196 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
Vaccination, Administration of Vaccine, Date in time
Item
Date if different from visit date
date
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Vaccination, Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0042196 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Item
Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
Influenza virus vaccine, Administration of vaccine, Drug Administration Routes
Code List
Route
CL Item
Axillary (1)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Influenza virus vaccine, Administration of Vaccine
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
MencevaxTM ACWY Vaccine (1)
CL Item
Not administered (2)
Vaccination, Administration of Vaccine, Vial Device, Replacement, Numbers
Item
If Replacement vial, give number
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
Vaccination, Administration of Vaccine, Vial Device, Wrong, Numbers
Item
If Wrong vial, give number
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C3827420 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
Item
Side / Site, Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
Influenza virus vaccine, Administration of Vaccine, Anatomic Site, Drug Administration Routes
Code List
Side / Site, Route
CL Item
Upper left, Deltoid, S.C. (Upper left, Deltoid, S.C.)
Vaccination, Administration of Vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Item
If No, Side
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
If No, Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
If No, Site
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
If No, Site
CL Item
Deltoid  (1)
CL Item
Thigh  (2)
CL Item
Buttock (3)
Item
If No, Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
If No, Route
CL Item
I.M.  (1)
CL Item
S.C (2)
Item
Why not administered? Please tick the major reason for non administration.
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
Why not administered? Please tick the major reason for non administration.
CL Item
Serious adverse event (Please specify SAE No.) (1)
CL Item
Non-Serious adverse event. (Please specify AE No.) (2)
CL Item
Other, please specify (3)
Item
Please tick who made the decision
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Unsolicited Adverse Event
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Adverse Event, Vaccination
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
CL Item
Information not available  (1)
CL Item
No vaccine administered  (2)
CL Item
No (3)
CL Item
Yes (4)
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0545082 (UMLS CUI-4)
C0332307 (UMLS CUI-5)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Code List
Has the subject experienced any of the following signs/symptoms at the administration site 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
Local Symptoms
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
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)
Adverse Event, Symptoms, Local
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,5])
Adverse Event, Symptoms, Local, Visit/Advice, Type
Code List
Medically attended visit - Type
CL Item
Hospitalization  (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Solicited Adverse Events - General Symptoms - "2-5 Years"
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
Temperature, give °C (Axillary) (1)
CL Item
Irritability/Fussiness, give intensity (2)
CL Item
Drowsiness, give intensity (3)
CL Item
Loss of appetite, give intensity (4)
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
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Adverse Event, General symptom, Visit/Advice, Type
Code List
Medically attended visit - Type
CL Item
Hospitalization (1)
CL Item
Emergency Room  (2)
CL Item
Medical Personnel (3)
Item Group
Solicited Adverse Events - General Symptoms - "6-30 Years"
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 (Axillary) (1)
CL Item
Fatigue, give intensity (2)
CL Item
Headache, give intensity (3)
CL Item
Gastrointestinal symptoms, give intensity (4)
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
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Adverse Event, General symptom, Visit/Advice, Type
Code List
Medically attended visit - Type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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