Did the subject come at visit 9?
Item
Did the subject come at visit 9?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Other please specify (2)
Item
Please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Code List
Please specify SAE Number
Other specify
Item
If other please specify
text
C3845569 (UMLS CUI [1])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Code List
Please tick who took the decision
Vaccination Date
Item
Date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Pre-Vaccination temperature
integer
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Code List
Pre-Vaccination temperature
Item
Route
text
C0489453 (UMLS CUI [1])
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Code List
Vaccine Administration
CL Item
Twinrix Adult (720/20) Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following page) (N)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Code List
Vaccine Administration
CL Item
Engerix (20) Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following page) (N)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Code List
Vaccine Administration
CL Item
Havrix (720 EL.U) Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following page) (N)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Why not administered? Please tick the ONE most appropriate category for non administration
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Why not administered? Please tick the ONE most appropriate category for non administration
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (OTH)
SAE number
Item
Please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
unsolicited AE number
Item
Please specify unsolicited AE number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
solicited AE code
Item
Please specify solicited AE code
integer
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other specify
Item
If other please specify
text
C3845569 (UMLS CUI [1])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Code List
Please tick who took the decision
Item
Solicited Adverse Events - local symptoms
text
C0877248 (UMLS CUI [1,1])
C0853813 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
Solicited Adverse Events - local symptoms
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
Local Symptoms
Item
Local Symptoms - Redness
boolean
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness Day 0
integer
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness Day 1
integer
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness Day 2
integer
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness Day 3
integer
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
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])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling
boolean
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 0
integer
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 1
integer
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 2
integer
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 3
integer
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms
Item
Local Symptoms - Swelling ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
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])
Local Symptoms - Pain
Item
Local Symptoms - Pain
boolean
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Item
Local Symptoms - Pain Intensity Day 0
integer
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Code List
Local Symptoms - Pain Intensity Day 0
Item
Local Symptoms - Pain Intensity Day 1
integer
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Code List
Local Symptoms - Pain Intensity Day 1
Item
Local Symptoms - Pain Intensity Day 2
integer
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Code List
Local Symptoms - Pain Intensity Day 2
Item
Local Symptoms - Pain Intensity Day 3
integer
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Code List
Local Symptoms - Pain Intensity Day 3
Local Symptoms
Item
Local Symptoms - Pain ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
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])
Item
Solicited Adverse Events- Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Code List
Solicited Adverse Events- Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
General Symptoms - Fever
Item
General Symptoms - Fever
boolean
C0015967 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
Item
If Fever is yes, measurement route
text
C0489453 (UMLS CUI [1])
Code List
If Fever is yes, measurement route
Body temperature Day 0
Item
Body temperature Day 0
float
C0005903 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Body temperature Day 0 not taken
Item
Body temperature Day 0 not taken
boolean
C2826301 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature Day 1
Item
Body temperature Day 1
float
C0005903 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Body temperature Day 1 not taken
Item
Body temperature Day 1 not taken
boolean
C1442449 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature Day 2
Item
Body temperature Day 2
float
C0005903 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Body temperature Day 2 not taken
Item
Body temperature Day 2 not taken
boolean
C3842676 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature Day 3
Item
Body temperature Day 3
float
C0005903 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Body temperature Day 3 not taken
Item
Body temperature Day 3 not taken
boolean
C3842675 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Ongoing after Day 3
Item
Fever ongoing after Day 3
boolean
C0015967 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
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 [1,1])
C0015967 (UMLS CUI [1,2])
General Symptoms - Fatigue
Item
General Symptoms - Fatigue
boolean
C0015672 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
Item
Symptom intensity - Fatigue Day 0
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Code List
Symptom intensity - Fatigue Day 0
Item
Symptom intensity - Fatigue Day 1
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Code List
Symptom intensity - Fatigue Day 1
Item
Symptom intensity - Fatigue Day 2
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Code List
Symptom intensity - Fatigue Day 2
Item
Symptom intensity - Fatigue Day 3
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Code List
Symptom intensity - Fatigue Day 3
Fatigue: Ongoing after Day 3
Item
Fatigue Ongoing after Day 3
boolean
C0015672 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
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 [1,1])
C0015967 (UMLS CUI [1,2])
General Symptoms - Headache
Item
General Symptoms - Headache
boolean
C0018681 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
Item
Symptom intensity - Headache Day 0
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Code List
Symptom intensity - Headache Day 0
Item
Symptom intensity - Headache Day 1
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Code List
Symptom intensity - Headache Day 1
Item
Symptom intensity - Headache Day 2
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Code List
Symptom intensity - Headache Day 2
Item
Symptom intensity - Headache Day 3
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Code List
Symptom intensity - Headache Day 3
Headache: Ongoing after Day 3
Item
Headache Ongoing after Day 3
boolean
C0018681 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
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 [1,1])
C0015967 (UMLS CUI [1,2])
General Symptoms - Gastrointestinal
Item
Gastrointestinal Symptoms
boolean
C0426576 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
Item
Symptom intensity - Gastrointestinal symptoms Day 0
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Code List
Symptom intensity - Gastrointestinal symptoms Day 0
Item
Symptom intensity - Gastrointestinal symptoms Day 1
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Code List
Symptom intensity - Gastrointestinal symptoms Day 1
Item
Symptom intensity - Gastrointestinal symptoms Day 2
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Code List
Symptom intensity - Gastrointestinal symptoms Day 2
Item
Symptom intensity - Gastrointestinal symptoms Day 3
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Code List
Symptom intensity - Gastrointestinal symptoms Day 3
Gastrointestinal symptoms: Ongoing after Day 3
Item
Gastrointestinal symptoms Ongoing after Day 3
boolean
C0426576 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
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 [1,1])
C0015967 (UMLS CUI [1,2])