ID

27326

Description

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 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 GSK’s Clinical Study Register is no longer maintained for this study.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-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal

Link

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

Keywords

Versions (1)
  1. 11/8/17 11/8/17 -
Copyright Holder

Pfizer

Uploaded on

November 8, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976

English

Diary Card Part 2 Vaccination 2 3-5 years of age

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
Description

Date Diary Card return

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C1548100
Fever
Description

Fever

Alias
UMLS CUI-1
C0015967
Fever
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Location of fever measurement
Description

Location of fever measurement

Data type

text

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

Fever

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever Day 1 Evening
Description

Fever

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever Day 2 Evening
Description

Fever

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever Day 3 Evening
Description

Fever

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever Day 4 Evening
Description

Fever

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever Day 5 Evening
Description

Fever

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever Day 6 Evening
Description

Fever

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Fever Day 7 Evening
Description

Fever

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Ongoing after day 7?
Description

Ongoing symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
UMLS CUI [1,3]
C0015967
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0015967
Irritability
Description

Irritability

Alias
UMLS CUI-1
C0022107
Irritability/ Fussiness
Description

Irritability

Data type

boolean

Alias
UMLS CUI [1]
C0022107
Irritability/Fussiness Intensity Day 0
Description

Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Intensity of Irritability/fussiness Day 1 Evening
Description

Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Intensity of Irritability/fussiness Day 2 Evening
Description

Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Intensity of irritability/fussiness day 3 Evening
Description

Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Intensity of irritability/fussiness day 4 Evening
Description

Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Intensity of irritability/fussiness Day 5 Evening
Description

Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Intensity of irritability/fussiness Day 6 Evening
Description

Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Intensity of irritability/fussiness Day 7 Evening
Description

Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0022107
Ongoing after day 7?
Description

Ongoing symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
UMLS CUI [1,3]
C0022107
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022107
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0022107
Drowsiness
Description

Drowsiness

Alias
UMLS CUI-1
C0013144
Drowsiness
Description

Drowsiness

Data type

boolean

Alias
UMLS CUI [1]
C0013144
Drowsiness Intensity Day 0
Description

Intensity of Drowsiness

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Intensity of Drowsiness Day 1 Evening
Description

Intensity of Drowsiness

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Intensity of drowsiness Day 2 Evening
Description

Intensity of drowsiness

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Intensity of Drowsiness Day 3 Evening
Description

Intensity of Drowsiness

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Intensity of Drowsiness Day 4 Evening
Description

Intensity of Drowsiness

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Intensity of Drowsiness Day 5 Evening
Description

Intensity of Drowsiness

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Intensity of Drowsiness Day 6 Evening
Description

Intensity of Drowsiness

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Intensity of Drowsiness Day 7 Evening
Description

Intensity of Drowsiness

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Ongoing after day 7?
Description

Ongoing symptom?

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
UMLS CUI [1,3]
C0013144
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013144
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0013144
IN CASE OF HOSPITALISATION, PLEASE INFORM
Description

Contact information

Data type

text

Alias
UMLS CUI [1,1]
C1880174
UMLS CUI [1,2]
C0019993
Loss of appetite
Description

Loss of appetite

Alias
UMLS CUI-1
C1971624
Loss of appetite
Description

Loss of appetite

Data type

boolean

Alias
UMLS CUI [1]
C1971624
Loss of appetite, Intensity Day 0
Description

Loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite, Intensity Day 1 Evening
Description

Loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite, Intensity day 2 Evening
Description

Loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite, Intensity Day 3 Evening
Description

Loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite, Intensity Day 4 Evening
Description

Loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite, Intensity Day 5 Evening
Description

Loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite, Intensity Day 6 Evening
Description

Loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Loss of appetite, Intensity Day 7 Evening
Description

Loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
Ongoing after day 7?
Description

Ongoing symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
UMLS CUI [1,3]
C1971624
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1971624
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1971624
Other General Symptoms (Day 0 to day 30)
Description

Other General Symptoms (Day 0 to day 30)

Alias
UMLS CUI-1
C0029625
Description - please give details below
Description

Description

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0029625
Intensity
Description

Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C0159028
Start date
Description

Start date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0159028
End date
Description

End date

Data type

text

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0159028
Check box if continuing
Description

Ongoing Symptom

Data type

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C3174772
Medically attended visit
Description

Medically attended visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0159028
Medication - Please fill in below if any medication has been taken since the vaccination
Description

Medication - Please fill in below if any medication has been taken since the vaccination

Alias
UMLS CUI-1
C0013227
Trade/Generic name
Description

Medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Reason
Description

Reason

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Start date
Description

Start date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Description

End date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Check box if continuing
Description

Ongoing medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Diary Card Part 2 Vaccination 2 3-5 years of age

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date Diary Card return
Item
PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
date
C0011008 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
Item Group
Fever
C0015967 (UMLS CUI-1)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Location of fever measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Location of fever measurement
Code List
Location of fever measurement
CL Item
Axillary (A)
CL Item
rectal (R)
Fever
Item
Fever Day 0
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 1 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 2 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 3 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 4 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 5 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 6 Evening
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 7 Evening
float
C0015967 (UMLS CUI [1])
Ongoing symptom
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Item Group
Irritability
C0022107 (UMLS CUI-1)
Irritability
Item
Irritability/ Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/Fussiness Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Intensity
Code List
Irritability/Fussiness Intensity Day 0
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of Irritability/fussiness Day 1 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Intensity
Code List
Intensity of Irritability/fussiness Day 1 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of Irritability/fussiness Day 2 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Intensity
Code List
Intensity of Irritability/fussiness Day 2 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness day 3 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Intensity
Code List
Intensity of irritability/fussiness day 3 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness day 4 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Intensity
Code List
Intensity of irritability/fussiness day 4 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness Day 5 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Intensity
Code List
Intensity of irritability/fussiness Day 5 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness Day 6 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Intensity
Code List
Intensity of irritability/fussiness Day 6 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
Intensity of irritability/fussiness Day 7 Evening
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Intensity
Code List
Intensity of irritability/fussiness Day 7 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Ongoing symptom
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0022107 (UMLS CUI [1,4])
Item Group
Drowsiness
C0013144 (UMLS CUI-1)
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness Intensity Day 0
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of Drowsiness
Code List
Drowsiness Intensity Day 0
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 1 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of Drowsiness
Code List
Intensity of Drowsiness Day 1 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of drowsiness Day 2 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of drowsiness
Code List
Intensity of drowsiness Day 2 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 3 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of Drowsiness
Code List
Intensity of Drowsiness Day 3 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 4 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of Drowsiness
Code List
Intensity of Drowsiness Day 4 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 5 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of Drowsiness
Code List
Intensity of Drowsiness Day 5 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 6 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of Drowsiness
Code List
Intensity of Drowsiness Day 6 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 7 Evening
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of Drowsiness
Code List
Intensity of Drowsiness Day 7 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Ongoing symptom?
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Contact information
Item
IN CASE OF HOSPITALISATION, PLEASE INFORM
text
C1880174 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Item Group
Loss of appetite
C1971624 (UMLS CUI-1)
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite, Intensity Day 0
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite
Code List
Loss of appetite, Intensity Day 0
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 1 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite
Code List
Loss of appetite, Intensity Day 1 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity day 2 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite
Code List
Loss of appetite, Intensity day 2 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 3 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite
Code List
Loss of appetite, Intensity Day 3 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 4 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite
Code List
Loss of appetite, Intensity Day 4 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 5 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite
Code List
Loss of appetite, Intensity Day 5 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 6 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite
Code List
Loss of appetite, Intensity Day 6 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Item
Loss of appetite, Intensity Day 7 Evening
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Loss of appetite
Code List
Loss of appetite, Intensity Day 7 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
Ongoing symptom
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Item Group
Other General Symptoms (Day 0 to day 30)
C0029625 (UMLS CUI-1)
Description
Item
Description - please give details below
text
C0678257 (UMLS CUI [1,1])
C0029625 (UMLS CUI [1,2])
Item
Intensity
text
C1710066 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
End date
Item
End date
text
C0806020 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Ongoing Symptom
Item
Check box if continuing
boolean
C0159028 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Item Group
Medication - Please fill in below if any medication has been taken since the vaccination
C0013227 (UMLS CUI-1)
Medication
Item
Trade/Generic name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Ongoing medication
Item
Check box if continuing
boolean
C2826666 (UMLS CUI [1])
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