Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route of temperature measurement
text
C0005903 (UMLS CUI [1])
Code List
Route of temperature measurement
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
CMI response determination
Item
Has a blood sample been taken for CMI response determination?
boolean
C0020966 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
urine sample
Item
Has a urine sample been taken?
boolean
C0200354 (UMLS CUI [1])
Item
Result Urine Pregnancy test – HCG)
integer
C0427777 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
Code List
Result Urine Pregnancy test – HCG)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Code List
Vaccine Administration
CL Item
HAVRIX Vaccine (1)
CL Item
Not administered (Please complete below) (2)
Administration Side
Item
Administration Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Site
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1])
Item
Study vaccine Administration: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
Study vaccine Administration: Side
CL Item
Non-dominant arm (1)
Item
Study vaccine Administration: Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
Study vaccine Administration: Site
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
Study vaccine Administration: Route
symptoms
Item
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
boolean
C1457887 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Fever, Site of measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Code List
Fever, Site of measurement
Item
Fever on Day 0
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Item
Fever on Day 0
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 1
integer
C0015967 (UMLS CUI [1])
Fever on Day 1
Item
Fever on Day 1
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 2
integer
C0015967 (UMLS CUI [1])
Fever on Day 2
Item
Fever on Day 2
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 3
integer
C0015967 (UMLS CUI [1])
Fever on Day 3
Item
Fever on Day 3
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever ongoing after day 3
Item
Fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue, Intensity
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Fatigue, Intensity
Item
Fatigue on Day 0
integer
C0015672 (UMLS CUI [1])
Code List
Fatigue on Day 0
Item
Fatigue on Day 1
integer
C0015672 (UMLS CUI [1])
Code List
Fatigue on Day 1
Item
Fatigue on Day 2
integer
C0015672 (UMLS CUI [1])
Code List
Fatigue on Day 2
Item
Fatigue on Day 3
integer
C0015672 (UMLS CUI [1])
Code List
Fatigue on Day 3
Fatigue ongoing after day 3
Item
Fatigue ongoing after day 3?
boolean
C0015672 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0015672 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015672 (UMLS CUI [2])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Item
Headache, Intensity
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Headache, Intensity
Item
Headache on Day 0
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 0
Item
Headache on Day 1
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 1
Item
Headache on Day 2
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 2
Item
Headache on Day 3
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 3
Headache ongoing after day 3
Item
Headache ongoing after day 3?
boolean
C0018681 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1])
C0018681 (UMLS CUI [2])
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms, Intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Gastrointestinal symptoms, Intensity
Item
Gastrointestinal symptoms on Day 0
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 0
Item
Gastrointestinal symptoms on Day 1
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 1
Item
Gastrointestinal symptoms on Day 2
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 2
Item
Gastrointestinal symptoms on Day 3
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 3
Gastrointestinal symptoms ongoing after day 3
Item
Gastrointestinal symptoms ongoing after day 3?
boolean
C0426576 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0426576 (UMLS CUI [2])