Has the study vaccine been administered?
Item
Has the study vaccine been administered?
boolean
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Reason for study vaccine not been administered
Item
Reason for study vaccine not been administered
text
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Item
If study Vaccine (Twinrix Vaccine) has been administered, record Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C2368628 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C0013153 (UMLS CUI [3])
Code List
If study Vaccine (Twinrix Vaccine) has been administered, record Side/ Site Route
CL Item
Deltoid i.m. left (1)
CL Item
Deltoid i.m. right (2)
Has the study vaccine been administered according to the protocol?
Item
If study Vaccine (Twinrix Vaccine) has been administered, has the study vaccine been administered according to the protocol?
boolean
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0593953 (UMLS CUI [1,4])
Item
If study vaccine has not been administered according to the protocol, record Site of Administration.
integer
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Code List
If study vaccine has not been administered according to the protocol, record Site of Administration.
Item
If study vaccine has not been administered according to the protocol, record Route of Administration.
integer
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Code List
If study vaccine has not been administered according to the protocol, record Route of Administration.
Has the Diary Card been returned?
Item
Has the Diary Card been returned?
boolean
C3890583 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period ?
Item
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period ?
boolean
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Item
Local Symptoms (at the injection site)
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [2])
Code List
Local Symptoms (at the injection site)
Redness/ Swelling - Size in mm (Day 0, 5-9 hours)
Item
Redness/ Swelling - Size in mm (Day 0, 5-9 hours)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Item
Pain intensity (Day 0, 5-9 hours)
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity (Day 0, 5-9 hours)
Redness/ Swelling - Size in mm (Day 1)
Item
Redness/ Swelling - Size in mm (Day 1)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Item
Pain intensity (Day 1)
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity (Day 1)
Redness/ Swelling - Size in mm (Day 2)
Item
Redness/ Swelling - Size in mm (Day 2)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Item
Pain intensity (Day 2)
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity (Day 2)
Redness/ Swelling - Size in mm (Day 3)
Item
Redness/ Swelling - Size in mm (Day 3)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Item
Pain intensity (Day 3)
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity (Day 3)
If ongoing after Day 3 - Date of last day of symptom
Item
If ongoing after Day 3 - Date of last day of symptom
date
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period ?
Item
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period ?
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Item
General symptom
integer
C0159028 (UMLS CUI [1])
Code List
General symptom
CL Item
Irratibility/ Fussiness (2)
CL Item
Loss of appetite (4)
Item
Fever (Day 0, 5-9 hours)
integer
C0015967 (UMLS CUI [1])
Code List
Fever (Day 0, 5-9 hours)
CL Item
Axillary (>= 37,5°C) (1)
CL Item
Oral (>= 37,5°C) (2)
CL Item
Rectal (>= 38°C) (3)
Temperature (Day 0, 5-9 hours)
Item
Temperature (Day 0, 5-9 hours)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 0, 5-9 hours)
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C1971624 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
Code List
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 0, 5-9 hours)
Item
Fever (Day 1)
integer
C0015967 (UMLS CUI [1])
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
CL Item
Rectal (>= 38 °C) (3)
Temperature (Day 1)
Item
Temperature (Day 1)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 1)
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C1971624 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
Code List
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 1)
Item
Fever (Day 2)
integer
C0015967 (UMLS CUI [1])
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
CL Item
Rectal (>= 38 °C) (3)
Temperature (Day 2)
Item
Temperature (Day 2)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 2)
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C1971624 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
Code List
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 2)
Item
Fever (Day 3)
integer
C0015967 (UMLS CUI [1])
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
CL Item
Rectal (>= 38 °C) (3)
Temperature (Day 3)
Item
Temperature (Day 3)
float
C0005903 (UMLS CUI [1])
Item
Relationship
text
C0439849 (UMLS CUI [1])
If ongoing after Day 3 - Date of last day of symptoms
Item
If ongoing after Day 3 - Date of last day of symptoms
date
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item
General symptom
integer
C0159028 (UMLS CUI [1])
Code List
General symptom
CL Item
Gastrointestinal symptoms (4)
Item
Fever (Day 0, 5-9 hours)
integer
C0015967 (UMLS CUI [1])
Code List
Fever (Day 0, 5-9 hours)
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
Temperature (Day 0, 5-9 hours)
Item
Temperature (Day 0, 5-9 hours)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 0, 5-9 hours)
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
Code List
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 0, 5-9 hours)
Item
Fever (Day 1)
integer
C0015967 (UMLS CUI [1])
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
Temperature (Day 1)
Item
Temperature (Day 1)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 1)
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
Code List
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 1)
Item
Fever (Day 2)
integer
C0015967 (UMLS CUI [1])
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
Temperature (Day 2)
Item
Temperature (Day 2)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 2)
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
Code List
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 2)
Item
Fever (Day 3)
integer
C0015967 (UMLS CUI [1])
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
Temperature (Day 3)
Item
Temperature (Day 3)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 3)
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
Code List
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 3)
Item
Relationship
text
C0439849 (UMLS CUI [1])
CL Item
Suspected PB=Probable (SU)