ID
36048
Beschreibung
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
Stichworte
Versionen (1)
- 11.04.19 11.04.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
11. April 2019
DOI
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Lizenz
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
Long-Term Follow Up (Year 13, Additional Vaccination) - General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms
Beschreibung
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschreibung
Please tick appropriate box and give diagnosis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0521987
- UMLS CUI [2,1]
- C0037088
- UMLS CUI [2,2]
- C2347804
- UMLS CUI [2,3]
- C0332152
Beschreibung
Medical Condition
Alias
- UMLS CUI-1
- C0012634
Beschreibung
Medical Condition
Datentyp
integer
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Diagnosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
Status
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449438
Beschreibung
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschreibung
HCG Urine Pregnancy Test
Alias
- UMLS CUI-1
- C0430056
Beschreibung
Has a urine sample been taken ?
Datentyp
integer
Alias
- UMLS CUI [1]
- C0430056
Beschreibung
Please complete only if different from visit date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0011008
Beschreibung
Result
Datentyp
integer
Alias
- UMLS CUI [1]
- C1274040
Beschreibung
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Beschreibung
fill in only if different from visit date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Pre-Vaccination temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0332152
Beschreibung
Temperature Route
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Beschreibung
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Beschreibung
(only one box must be ticked by vaccine)
Datentyp
integer
Alias
- UMLS CUI [1]
- C2368628
Beschreibung
Side/ Site Route
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Beschreibung
Has the study vaccine been administered according to the Protocol?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschreibung
If study vaccine has not been administered according to the Protocol, please tick all items that apply
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschreibung
Comments
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Please tick the ONE most appropriate category for non administration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1272696
Beschreibung
If not administered because of SAE, please specify SAE No.
Datentyp
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
Beschreibung
If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
Datentyp
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
Beschreibung
(e.g. consent withdrawal, protocol violation, …)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1272696
Beschreibung
Please tick who took the decision
Datentyp
text
Alias
- UMLS CUI [1]
- C0679006
Beschreibung
Unsolicited Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
Datentyp
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
Beschreibung
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beschreibung
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
Beschreibung
Redness
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0332575
Beschreibung
Redness size Day 0
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschreibung
Redness size Day 1
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschreibung
Redness size Day 2
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschreibung
Redness size Day 3
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschreibung
Redness Ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Redness is ongoing after Day 3, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0332575
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Swelling
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038999
Beschreibung
Swelling Size Day 0
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Swelling Size Day 1
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Swelling Size Day 2
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Swelling Size Day 3
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Swelling Ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Swelling is ongoing after Day 3, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0038999
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Pain
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030193
Beschreibung
Pain intensity Day 0
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Pain intensity Day 1
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Pain intensity Day 2
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Pain intensity Day 3
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Pain Ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Pain is ongoing after Day 3, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0030193
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Beschreibung
Has the subject experienced any of the following signs/symptoms during the solicited period?
Datentyp
text
Alias
- UMLS CUI [1]
- C0037088
Beschreibung
Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschreibung
Temperature Route
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Beschreibung
Temperature Day 0
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature not taken Day 0
Datentyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beschreibung
Temperature Day 1
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature not taken Day 1
Datentyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beschreibung
Temperature Day 2
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature not taken Day 2
Datentyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beschreibung
Temperature Day 3
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature not taken Day 3
Datentyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beschreibung
Fever ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Fever is ongoing after Day 3, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0015967
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Fever - Causality?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0085978
Beschreibung
Fatigue
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015672
Beschreibung
Fatigue intensity Day 0
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Beschreibung
Fatigue intensity Day 1
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Beschreibung
Fatigue intensity Day 2
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Beschreibung
Fatigue intensity Day 3
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Beschreibung
Fatigue ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Fatigue is ongoing after Day 3, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0015672
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Fatigue - Causality?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0085978
Beschreibung
Headache
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018681
Beschreibung
Headache intensity Day 0
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Beschreibung
Headache intensity Day 1
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Beschreibung
Headache intensity Day 2
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Beschreibung
Headache intensity Day 3
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Beschreibung
Headache ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Headache is ongoing after Day 3, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0018681
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Headache - Causality?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0085978
Beschreibung
Gastrointestinal symptoms
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0426576
Beschreibung
Gastrointestinal symptoms intensity Day 0
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Beschreibung
Gastrointestinal symptoms intensity Day 1
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Beschreibung
Gastrointestinal symptoms intensity Day 2
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Beschreibung
Gastrointestinal symptoms intensity Day 3
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Beschreibung
Gastrointestinal Symptoms ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Gastrointestinal symptoms are ongoing after Day 3, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0426576
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Gastrointestinal Symptoms - Causality?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0085978
Ähnliche Modelle
Long-Term Follow Up (Year 13, Additional Vaccination) - General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms
C0031809 (UMLS CUI-2)
C0037088 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
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])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0159028 (UMLS CUI-2)
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0085978 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0085978 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0085978 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0085978 (UMLS CUI [1,2])