ID

36620

Beskrivning

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

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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DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

Engelsk

Visit 2 - Dose 2

1 Formulär  
  1. StudyEvent: ODM
    1. Visit 2 - Dose 2
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
Check for Study Continuation
Beskrivning

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for visit 2 ?
Beskrivning

Continuation status, Clinical Trials

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beskrivning

Continuation status, Clinical Trials, Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Specify
Beskrivning

Continuation status, Clinical Trials, Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Please tick who made the decision
Beskrivning

Continuation status, Clinical Trials, Decision

Datatyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
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
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
Beskrivning

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?
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
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
Tillbaka till toppen

Similar models

Visit 2 - Dose 2

1 Formulär
  1. StudyEvent: ODM
    1. Visit 2 - Dose 2
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
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Continuation status, Clinical Trials
Item
Did the subject return for visit 2 ?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (Please specify SAE No.) (1)
CL Item
Non-Serious adverse event (Please specify AE No. or solicited AE code) (2)
CL Item
Other, please specify (3)
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
Specify
Item
Please tick who made the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
Please tick who made the decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (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)
CL Item
Oral (protocol case - using an oral digital thermometer) (2)
CL Item
Rectal (3)
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
DTPa-HBV-IPV/Hib Vaccine  (1)
CL Item
DTPa-HBV-IPV Vaccine (2)
CL Item
Not administered (3)
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
Right, Thigh, I.M. (Right, Thigh, I.M.)
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
Left (1)
CL Item
Right (2)
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
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
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 (1)
CL Item
Temperature: Axillary, Oral or 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
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
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)
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