ID

44193

Description

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Keywords

Versions (5)
  1. 4/8/19 4/8/19 -
  2. 4/8/19 4/8/19 -
  3. 4/8/19 4/8/19 -
  4. 4/11/19 4/11/19 -
  5. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718

English

Long-Term Follow Up (Year 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

1 forms  
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Informed Consent date:
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Centre number
Description

Centre number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
If other race, please specify
Description

If other race, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
General Medical History / Physical Examination
Description

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Description

Please tick appropriate box and give diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0521987
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C2347804
UMLS CUI [2,3]
C0332152
Medical Condition
Description

Medical Condition

Alias
UMLS CUI-1
C0012634
Medical Condition
Description

Medical Condition

Data type

integer

Alias
UMLS CUI [1]
C0012634
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Status
Description

Status

Data type

integer

Alias
UMLS CUI [1]
C0449438
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Description

Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0201473
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0201478
Date of Blood sample been taken
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Description

Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?

Data type

boolean

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1711239
UMLS CUI [2,1]
C2240392
UMLS CUI [2,2]
C0545082
UMLS CUI [2,3]
C1517741
UMLS CUI [2,4]
C1711239
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
Description

If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C2240392
UMLS CUI [2,2]
C2348235
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Description

Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?

Data type

boolean

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0332152
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
Description

If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.

Data type

integer

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C2348235
Has an additional blood sample been taken prior to additional vaccine dose?
Description

Has an additional blood sample been taken prior to additional vaccine dose?

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1524062
Additional blood sample Date
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0011008
HCG Urine Pregnancy Test
Description

HCG Urine Pregnancy Test

Alias
UMLS CUI-1
C0430056
Has a urine sample been taken ?
Description

Has a urine sample been taken ?

Data type

integer

Alias
UMLS CUI [1]
C0430056
Date of urine sample been taken
Description

Date if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0011008
Result
Description

Result

Data type

integer

Alias
UMLS CUI [1]
C1274040
Blood Sample Conclusion
Description

Blood Sample Conclusion

Alias
UMLS CUI-1
C0178913
UMLS CUI-2
C1254595
Has the patient became seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)
Description

If yes, please give an additional vaccine dose of Twinrix™ Adult (720/20)

Data type

boolean

Alias
UMLS CUI [1,1]
C0521144
UMLS CUI [1,2]
C0062524
UMLS CUI [2]
C0475208
Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)
Description

If yes, please give an additional vaccine dose of either Engerix™ (20 µg) vaccine or Havrix™ (720 EL.U) vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0521144
UMLS CUI [1,2]
C0201478
UMLS CUI [2]
C0475208
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Date
Description

fill in only if different from visit date

Data type

date

Alias
UMLS CUI [1]
C0011008
Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Temperature Route
Description

Temperature Route

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Vaccine Administration
Description

(only one box must be ticked by vaccine)

Data type

integer

Alias
UMLS CUI [1]
C2368628
Replacement vial
Description

Replacement vial

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Wrong vial number
Description

Wrong vial number

Data type

integer

Alias
UMLS CUI [1]
C0184301
Side/ Site Route
Description

Side/ Site Route

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Has the study vaccine been administered according to the Protocol?
Description

Has the study vaccine been administered according to the Protocol?

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If study vaccine has not been administered according to the Protocol, please tick all items that apply
Description

If study vaccine has not been administered according to the Protocol, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Why not administered?
Description

Please tick the ONE most appropriate category for non administration

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
If not administered because of SAE, please specify SAE No.
Description

If not administered because of SAE, please specify SAE No.

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0237753
If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
Description

If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0237753
If other reason for non administration, please specify
Description

(e.g. consent withdrawal, protocol violation, …)

Data type

text

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Please tick who took the decision
Description

Please tick who took the decision

Data type

text

Alias
UMLS CUI [1]
C0679006
Unsolicited Adverse Events
Description

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
Has the subject experienced any serious or non-serious unsolicited adverse events during the 30-day (Day 0 to Day 29) post-vaccination?
Description

Has the subject experienced any serious or non-serious unsolicited adverse events during the 30-day (Day 0 to Day 29)post-vaccination?

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0042196
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0042196
Solicited Adverse Events - Local Symptoms
Description

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1]
C0332575
Redness size Day 0
Description

Redness size Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 1
Description

Redness size Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 2
Description

Redness size Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness size Day 3
Description

Redness size Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
mm
Redness Ongoing after Day 3?
Description

Redness Ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C3174772
If Redness is ongoing, record date of last Day of Symptoms
Description

If Redness is ongoing, record date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1]
C0332575
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Swelling
Description

Swelling

Data type

boolean

Alias
UMLS CUI [1]
C0038999
Swelling Size Day 0
Description

Swelling Size Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 1
Description

Swelling Size Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 2
Description

Swelling Size Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Size Day 3
Description

Swelling Size Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Swelling Ongoing after Day 3? +
Description

Swelling Ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3174772
If Swelling is ongoing, record date of last Day of Symptoms
Description

If Swelling is ongoing, record date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Pain
Description

Pain

Data type

boolean

Alias
UMLS CUI [1]
C0030193
Pain intensity Day 0
Description

Pain intensity Day 0

Data type

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 1
Description

Pain intensity Day 1

Data type

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 2
Description

Pain intensity Day 2

Data type

integer

Alias
UMLS CUI [1]
C1320357
Pain intensity Day 3
Description

Pain intensity Day 3

Data type

integer

Alias
UMLS CUI [1]
C1320357
Pain Ongoing after Day 3?
Description

Pain Ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C3174772
If Pain is ongoing, record date of last Day of Symptoms
Description

If Pain is ongoing, record date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Solicited Adverse Events - General Symptoms
Description

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

Has the subject experienced any of the following signs/symptoms during the solicited period?

Data type

text

Alias
UMLS CUI [1]
C0037088
Fever
Description

Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Temperature Route
Description

Temperature Route

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Temperature Day 0
Description

Temperature Day 0

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature not taken Day 0
Description

Temperature not taken Day 0

Data type

integer

Alias
UMLS CUI [1]
C0437722
Temperature Day 1
Description

Temperature Day 1

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature not taken Day 1
Description

Temperature not taken Day 1

Data type

integer

Alias
UMLS CUI [1]
C0437722
Temperature Day 2
Description

Temperature Day 2

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature not taken Day 2
Description

Temperature not taken Day 2

Data type

integer

Alias
UMLS CUI [1]
C0437722
Temperature Day 3
Description

Temperature Day 3

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature not taken Day 3
Description

Temperature not taken Day 3

Data type

integer

Alias
UMLS CUI [1]
C0437722
Fever ongoing after Day 3?
Description

Fever ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C3174772
If Fever is ongoing, record date of last Day of Symptoms
Description

If Fever is ongoing, record date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Fever - Causality?
Description

Fever - Causality?

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0085978
Fatigue
Description

Fatigue

Data type

boolean

Alias
UMLS CUI [1]
C0015672
Fatigue intensity Day 0
Description

Fatigue intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
Fatigue intensity Day 1
Description

Fatigue intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
Fatigue intensity Day 2
Description

Fatigue intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
Fatigue intensity Day 3
Description

Fatigue intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
Fatigue ongoing after Day 3?
Description

Fatigue ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C3174772
If Fatigue is ongoing, record date of last Day of Symptoms
Description

If Fatigue is ongoing, record date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1]
C0015672
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Fatigue - Causality?
Description

Fatigue - Causality?

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0085978
Headache
Description

Headache

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Headache intensity Day 0
Description

Headache intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
Headache intensity Day 1
Description

Headache intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
Headache intensity Day 2
Description

Headache intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
Headache intensity Day 3
Description

Headache intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
Headache ongoing after Day 3?
Description

Headache ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C3174772
If Headache is ongoing, record date of last Day of Symptoms
Description

If Headache is ongoing, record date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1]
C0018681
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Headache - Causality?
Description

Headache - Causality?

Data type

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0085978
Gastrointestinal symptoms
Description

Gastrointestinal symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms intensity Day 0
Description

Gastrointestinal symptoms intensity Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
Gastrointestinal symptoms intensity Day 1
Description

Gastrointestinal symptoms intensity Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
Gastrointestinal symptoms intensity Day 2
Description

Gastrointestinal symptoms intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
Gastrointestinal symptoms intensity Day 3
Description

Gastrointestinal symptoms intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
Gastrointestinal Symptoms ongoing after Day 3?
Description

Gastrointestinal Symptoms ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C3174772
If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms
Description

If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1]
C0426576
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1457887
Gastrointestinal Symptoms - Causality?
Description

Gastrointestinal Symptoms - Causality?

Data type

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0085978
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Similar models

Long-Term Follow Up (Year 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Informed Consent date
Item
Informed Consent date:
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Centre number
Item
Centre number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East & South East Asian (5)
CL Item
South Asian (6)
CL Item
American Hispanic (7)
CL Item
Japanese (8)
CL Item
Other, please specify (9)
If other race, please specify
Item
If other race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0521987 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Item Group
Medical Condition
C0012634 (UMLS CUI-1)
Item
Medical Condition
integer
C0012634 (UMLS CUI [1])
Diagnosis
Code List
Medical Condition
CL Item
Cutaneous (10)
CL Item
Eyes (5)
CL Item
Ears-Nose-Throat (6)
CL Item
Cardiovascular (2)
CL Item
Respiratory (3)
CL Item
Gastrointestinal (1)
CL Item
Muskuloskeletal (7)
CL Item
Neurological (8)
CL Item
Genitourinary (12)
CL Item
Haematology (11)
CL Item
Allergies (4)
CL Item
Endocrine (9)
CL Item
Other (specify) (99)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Status
integer
C0449438 (UMLS CUI [1])
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1,1])
C0201473 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0201478 (UMLS CUI [2,2])
Date of Blood sample been taken
Item
Date of Blood sample been taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Item
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
boolean
C0170300 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
C2240392 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C1517741 (UMLS CUI [2,3])
C1711239 (UMLS CUI [2,4])
Item
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
integer
C0170300 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
Code List
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
CL Item
Hepatitis A vaccine (1)
CL Item
Hepatitis B vaccine (2)
CL Item
Combined Hepatitis A and B vaccine (3)
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Item
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
boolean
C3652495 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0062525 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Item
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
integer
C3652495 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0062525 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
Code List
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
Has an additional blood sample been taken prior to additional vaccine dose?
Item
Has an additional blood sample been taken prior to additional vaccine dose?
boolean
C0005834 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1524062 (UMLS CUI [2,3])
Additional blood sample Date
Item
Additional blood sample Date
date
C0005834 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
HCG Urine Pregnancy Test
C0430056 (UMLS CUI-1)
Item
Has a urine sample been taken ?
integer
C0430056 (UMLS CUI [1])
Has a urine sample been taken ?
Code List
Has a urine sample been taken ?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
Date of urine sample been taken
Item
Date of urine sample been taken
date
C0430056 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C1274040 (UMLS CUI [1])
Result
Code List
Result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Blood Sample Conclusion
C0178913 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
Has the patient became seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)
Item
Has the patient became seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)
boolean
C0521144 (UMLS CUI [1,1])
C0062524 (UMLS CUI [1,2])
C0475208 (UMLS CUI [2])
Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)
Item
Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)
text
C0521144 (UMLS CUI [1,1])
C0201478 (UMLS CUI [1,2])
C0475208 (UMLS CUI [2])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Temperature Route
text
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Temperature Route
Code List
Temperature Route
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Twinrix™ Adult (720/20) Vaccine  (1)
CL Item
Twinrix™ Adult (720/20) Vaccine - Replacement vial (2)
CL Item
Twinrix™ Adult (720/20) Vaccine - Wrong vial number (3)
CL Item
Twinrix™ Adult (720/20) Vaccine not administered (4)
CL Item
Engerix™ (20 µg) Vaccine  (5)
CL Item
Engerix™ (20 µg) Vaccine - Replacement vial (6)
CL Item
Engerix™ (20 µg) Vaccine - Wrong vial number (7)
CL Item
Engerix™ (20 µg) Vaccine not administered (8)
CL Item
Havrix™ (720 EL.U) Vaccine  (9)
CL Item
Havrix™ (720 EL.U) Vaccine - Replacement vial (10)
CL Item
Havrix™ (720 EL.U) Vaccine - Wrong vial number (11)
CL Item
Havrix™ (720 EL.U)Vaccine not administered (12)
Item
Replacement vial
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Vaccine Administration
Code List
Replacement vial
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1])
Item
Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Side/ Site Route
Code List
Side/ Site Route
CL Item
Non dominant Deltoid i.m. (1)
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
If study vaccine has not been administered according to the Protocol, please tick all items that apply
integer
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
If study vaccine has not been administered according to the Protocol, please tick all items that apply
Code List
If study vaccine has not been administered according to the Protocol, please tick all items that apply
CL Item
Dominant (1)
CL Item
Non dominant (2)
CL Item
Deltoid (3)
CL Item
Thigh (4)
CL Item
Buttock (5)
CL Item
i.m. (6)
CL Item
s.c. (7)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Why not administered?
Code List
Why not administered?
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 (e.g.: consent withdrawal, protocol violation, …) (OTH)
If not administered because of SAE, please specify SAE No.
Item
If not administered because of SAE, please specify SAE No.
integer
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
Item
If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
integer
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
If other reason for non administration, please specify
Item
If other reason for non administration, please specify
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1])
Please tick who took the decision
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents/ Guardians (P)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events during the 30-day (Day 0 to Day 29) post-vaccination?
text
C1519255 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events during the 30-day (Day 0 to Day 29) post-vaccination?
CL Item
Information not available  (U)
CL Item
No Vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (Y)
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available  (U)
CL Item
No Vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3? +
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
Pain intensity Day 0
Code List
Pain intensity Day 0
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Pain intensity Day 1
integer
C1320357 (UMLS CUI [1])
Pain intensity Day 1
Code List
Pain intensity Day 1
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Pain intensity Day 2
Code List
Pain intensity Day 2
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Pain intensity Day 3
Code List
Pain intensity Day 3
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1])
Has the subject experienced any of the following signs/symptoms during the solicited period?
Code List
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
No  (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Temperature Route
text
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Temperature Route
Code List
Temperature Route
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Temperature Day 0
Item
Temperature Day 0
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 0
integer
C0437722 (UMLS CUI [1])
Temperature not taken
Code List
Temperature not taken Day 0
CL Item
Not taken (1)
Temperature Day 1
Item
Temperature Day 1
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 1
integer
C0437722 (UMLS CUI [1])
Temperature not taken Day 1
Code List
Temperature not taken Day 1
CL Item
Not taken (1)
Temperature Day 2
Item
Temperature Day 2
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 2
integer
C0437722 (UMLS CUI [1])
Temperature not taken Day 2
Code List
Temperature not taken Day 2
CL Item
Not taken (1)
Temperature Day 3
Item
Temperature Day 3
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 3
integer
C0437722 (UMLS CUI [1])
Temperature not taken Day 3
Code List
Temperature not taken Day 3
CL Item
Not taken (1)
Fever ongoing after Day 3?
Item
Fever ongoing after Day 3?
boolean
C0015967 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Fever is ongoing, record date of last Day of Symptoms
Item
If Fever is ongoing, record date of last Day of Symptoms
date
C0015967 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Fever - Causality?
Item
Fever - Causality?
boolean
C0015967 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue intensity Day 0
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Fatigue intensity Day 0
Code List
Fatigue intensity Day 0
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Fatigue intensity Day 1
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Fatigue intensity Day 1
Code List
Fatigue intensity Day 1
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Fatigue intensity Day 2
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Fatigue intensity Day 2
Code List
Fatigue intensity Day 2
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Fatigue intensity Day 3
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Fatigue intensity Day 3
Code List
Fatigue intensity Day 3
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Fatigue ongoing after Day 3?
Item
Fatigue ongoing after Day 3?
boolean
C0015672 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Fatigue is ongoing, record date of last Day of Symptoms
Item
If Fatigue is ongoing, record date of last Day of Symptoms
date
C0015672 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Fatigue - Causality?
Item
Fatigue - Causality?
boolean
C0015672 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Item
Headache intensity Day 0
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Headache intensity Day 0
Code List
Headache intensity Day 0
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Headache intensity Day 1
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Headache intensity Day 1
Code List
Headache intensity Day 1
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Headache intensity Day 2
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Headache intensity Day 2
Code List
Headache intensity Day 2
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Headache intensity Day 3
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Headache intensity Day 3
Code List
Headache intensity Day 3
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Headache ongoing after Day 3?
Item
Headache ongoing after Day 3?
boolean
C0018681 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Headache is ongoing, record date of last Day of Symptoms
Item
If Headache is ongoing, record date of last Day of Symptoms
date
C0018681 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Headache - Causality?
Item
Headache - Causality?
boolean
C0018681 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms intensity Day 0
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Gastrointestinal symptoms intensity Day 0
Code List
Gastrointestinal symptoms intensity Day 0
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Gastrointestinal symptoms intensity Day 1
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Gastrointestinal symptoms intensity Day 1
Code List
Gastrointestinal symptoms intensity Day 1
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Gastrointestinal symptoms intensity Day 2
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Gastrointestinal symptoms intensity Day 2
Code List
Gastrointestinal symptoms intensity Day 2
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Gastrointestinal symptoms intensity Day 3
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Gastrointestinal symptoms intensity Day 3
Code List
Gastrointestinal symptoms intensity Day 3
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Gastrointestinal Symptoms ongoing after Day 3?
Item
Gastrointestinal Symptoms ongoing after Day 3?
boolean
C0426576 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms
Item
If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms
date
C0426576 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Gastrointestinal Symptoms - Causality?
Item
Gastrointestinal Symptoms - Causality?
boolean
C0426576 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
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