Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Are you aware of any pre-existing conditions or or signs and/or symptoms present in the subject prior to the start of the study?
text
C0521987 (UMLS CUI [1])
Code List
Are you aware of any pre-existing conditions or or signs and/or symptoms present in the subject prior to the start of the study?
CL Item
Yes (Please choose appropriate box(es)and give diagnosis (2)
Item
Cutaneous
text
C0221912 (UMLS CUI [1])
CL Item
not appropriate (1)
Cutaneous: diagnosis
Item
Cutaneous: diagnosis
text
C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Eyes
text
C0015392 (UMLS CUI [1])
CL Item
not appropriate (1)
Eyes: diagnosis
Item
Eyes: diagnosis
text
C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Ears-Nose-Throat
text
C0395797 (UMLS CUI [1])
Code List
Ears-Nose-Throat
CL Item
not appropriate (1)
Ears-Nose-Throat: diagnosis
Item
Ears-Nose-Throat: diagnosis
text
C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Cardiovascular
text
C0007226 (UMLS CUI [1])
CL Item
not appropriate (1)
Cardiovascular: diagnosis
Item
Cardiovascular: diagnosis
text
C0007222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Respiratory
text
C0035237 (UMLS CUI [1])
CL Item
not appropriate (1)
Respiratory: diagnosis
Item
Respiratory: diagnosis
text
C0035204 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Gastrointestinal
text
C0012240 (UMLS CUI [1])
Code List
Gastrointestinal
CL Item
not appropriate (1)
Gastrointestinal: diagnosis
Item
Gastrointestinal: diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Muskuloskeletal
text
C0026860 (UMLS CUI [1])
Code List
Muskuloskeletal
CL Item
not appropriate (1)
Muskuloskeletal: diagnosis
Item
Muskuloskeletal: diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Neurological
text
C0027763 (UMLS CUI [1])
CL Item
not appropriate (1)
Neurological: diagnosis
Item
Neurological: diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Genitourinary
text
C0042066 (UMLS CUI [1])
CL Item
not appropriate (1)
Genitourinary: diagnosis
Item
Genitourinary: diagnosis
text
C0080276 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Haematology
text
C0474523 (UMLS CUI [1])
CL Item
not appropriate (1)
Haematology: diagnosis
Item
Haematology: diagnosis
text
C0018939 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Allergies
text
C0020517 (UMLS CUI [1])
CL Item
not appropriate (1)
Allergies: diagnosis
Item
Allergies: diagnosis
text
C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Endocrine
text
C0014130 (UMLS CUI [1])
CL Item
not appropriate (1)
Endocrine: diagnosis
Item
Endocrine: diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Other (specify)
Item
Other (specify)
text
C3845569 (UMLS CUI [1])
Item
Other
text
C0205394 (UMLS CUI [1])
CL Item
not appropriate (1)
Item
Has a blood sample been taken?
text
C0005834 (UMLS CUI [1])
Code List
Has a blood sample been taken?
CL Item
yes (please answer the following question if different from visit date) (1)
Date of blood sample
Item
Date of blood sample
date
C1317250 (UMLS CUI [1])
Item
Has a urine sample been taken?
text
C0430056 (UMLS CUI [1])
Code List
Has a urine sample been taken?
CL Item
yes (please answer the following question of different from visit date) (1)
CL Item
NA (not of childbearing potential or male) (3)
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result from pregnancy test
text
C0427777 (UMLS CUI [1])
Code List
Result from pregnancy test
Date of vaccine administration
Item
Date of vaccine administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-vaccination temperature
Item
Pre-vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Vaccacine administration
text
Code List
Vaccacine administration
CL Item
Twinrix™ Adult (720/20) Vaccine (1)
CL Item
Twinrix™ Adult (720/20) Vaccine: Not administered -> Please complete following page (2)
CL Item
Engerix™ (20 μg) Vaccine (3)
CL Item
Engerix™ (20 μg) Vaccine: Not administered -> Please complete following page (4)
CL Item
Havrix™ (720 EL.U)Vaccine (5)
CL Item
Havrix™ (720 EL.U)Vaccine: Not administered -> Please complete following page (6)
Item
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
text
C0595042 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
Code List
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
CL Item
No (Please tick all Items that apply) (2)
Item
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
text
C0595042 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Code List
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
CL Item
Site: Deltoid (3)
CL Item
Site: Buttock (5)
Item
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
text
C0116078 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Code List
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
CL Item
Site: Deltoid (3)
CL Item
Site: Buttock (5)
Item
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
text
C0700881 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Code List
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
CL Item
Site: Deltoid (3)
CL Item
Site: Buttock (5)
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
Why not administered?
CL Item
Serious adverse event (complete Serious Adverse Event form) (1)
CL Item
Non-serious adverse event (complete the Non-serious Adverse Event section) (2)
Specification of reason for non administration
Item
Other, please specify (reason for non administration)
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Code List
Please tick who took the decision
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (4)
Item
Has the subject experienced any of the following sings/symptoms at the administration site during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Code List
Has the subject experienced any of the following sings/symptoms at the administration site during the solicited period?
CL Item
Information available (1)
CL Item
No Vaccine administered (2)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item
Local symptoms: Redness
text
C0041834 (UMLS CUI [1])
Code List
Local symptoms: Redness
CL Item
Size (please fill in next item) (2)
Erythema: day 0
Item
Local symptoms day 0
float
C0041834 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Erythema: day 1
Item
Local symptoms day 1
float
C0041834 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Erythema: day 2
Item
Local symptoms day 2
float
C0041834 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Erythema: day 3
Item
Local symptoms day 3
float
C0041834 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Erythema: Ongoing
Item
Ongoing after Day 3
boolean
C0041834 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Erythema: Date of last day of symptoms
Item
Date of last day of symptoms (redness)
date
C0041834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item
Local symptoms: swelling
text
C0038999 (UMLS CUI [1])
Code List
Local symptoms: swelling
CL Item
Yes (please fill in the next item) (2)
Swelling: day 0
Item
Local symptoms day 0
float
C0038999 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Swelling: day 1
Item
Local symptoms day 1
float
C0038999 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Swelling: day 2
Item
Local symptoms day 2
float
C0038999 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Swelling: day 3
Item
Local symptoms day 3
float
C0038999 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Swelling: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Swelling: Date of last day of symptoms
Item
Date of last day of symptoms (swelling)
date
C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item
Local symptoms: pain
text
C1320357 (UMLS CUI [1])
Code List
Local symptoms: pain
CL Item
Yes, intensity: (please fill in next item) (2)
Item
Intensity of pain day 0
text
C1320357 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Code List
Intensity of pain day 0
Item
Intensity of pain day 1
text
C1320357 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Code List
Intensity of pain day 1
Item
Intensity of pain day 2
text
C1320357 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Code List
Intensity of pain day 2
Item
Intensity of pain day 3
text
C1320357 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Code List
Intensity of pain day 3
Intensity of pain: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C1320357 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Intensity of pain: Date of last day of symptoms
Item
Date of last day of symptoms (pain)
date
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
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])
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
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Fever
Item
General symptoms: Fever
boolean
C0015967 (UMLS CUI [1])
Body Temperature
Item
Fever: if yes, please specify amount of fever
float
C0005903 (UMLS CUI [1])
Item
Taking temperature
text
C0886414 (UMLS CUI [1])
Code List
Taking temperature
Fever: day 0
Item
Fever day 0
float
C0015967 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Fever: Day 0 Specification
Item
Fever not taken day 0
boolean
C0015967 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: day 1
Item
Fever day 1
float
C0015967 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Fever: Day 1 Specification
Item
Fever not taken day 1
boolean
C0015967 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: day 2
Item
Fever day 2
float
C0015967 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Fever: Day 2 Specification
Item
Fever not taken day 2
boolean
C0015967 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: day 3
Item
Fever day 3
float
C0015967 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Fever: Day 3 Specification
Item
Fever not taken day 3
boolean
C0015967 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Fever: Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0015967 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Fever: Causality
Item
Causality
boolean
C0015967 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item
Fatigue
text
C0015672 (UMLS CUI [1])
CL Item
Yes, please fill in next question (2)
Item
Intensity fatigue day 0
text
C0015672 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Code List
Intensity fatigue day 0
Item
Intensity fatigue day 1
text
C0015672 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Code List
Intensity fatigue day 1
Item
Intensity fatigue day 2
text
C0015672 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Code List
Intensity fatigue day 2
Item
Intensity fatigue day 3
text
C0015672 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Code List
Intensity fatigue day 3
Fatigue: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0015672 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Fatigue: Date of last Day of symptoms
Item
Date of last Day of symptoms
date
C0015672 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Fatigue: Causality?
Item
Causality?
boolean
C0015672 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item
Headache
text
C0018681 (UMLS CUI [1])
CL Item
Yes, intensity: please fill in the next items (2)
Item
Intensity headache day 0
text
C0018681 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Code List
Intensity headache day 0
Item
Intensity headache day 1
text
C0018681 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Code List
Intensity headache day 1
Item
Intensity headache day 2
text
C0018681 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Code List
Intensity headache day 2
Item
Intensity headache day 3
text
C0018681 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Code List
Intensity headache day 3
Headache: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0018681 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Headache: Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Headache: Causality
Item
Causality
boolean
C0018681 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item
Gastrointestinal symptoms
text
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms
CL Item
Yes, intensity: please fill in the next items (2)
Item
Intensity gastrointestinal symptoms day 0
text
C0426576 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Code List
Intensity gastrointestinal symptoms day 0
Item
Intensity gastrointestinal symptoms day 1
text
C0426576 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Code List
Intensity gastrointestinal symptoms day 1
Item
Intensity gastrointestinal symptoms day 2
text
C0426576 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Code List
Intensity gastrointestinal symptoms day 2
Item
Intensity gastrointestinal symptoms day 3
text
C0426576 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Code List
Intensity gastrointestinal symptoms day 3
Gastrointestinal Symptoms: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0426576 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Gastrointestinal Symptoms: Date of last day of symptoms
Item
Date of last day of symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Gastrointestinal Symptoms: Causality
Item
Causality
boolean
C0426576 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])