ID
25019
Beschreibung
Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876
Link
https://clinicaltrials.gov/ct2/show/NCT00291876
Stichworte
Versionen (3)
- 24.08.17 24.08.17 -
- 24.08.17 24.08.17 -
- 24.08.17 24.08.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. August 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
Beschreibung
LOCAL SYMPTOMS
Beschreibung
Redness
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschreibung
Redness size day 0
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschreibung
Redness size day 1
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschreibung
Redness size day 2
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschreibung
Redness size day 3
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschreibung
Ongoing after day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0549178
Beschreibung
Date of last day of symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschreibung
Size Swelling
Datentyp
integer
Maßeinheiten
- dd/mm/yy
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschreibung
Size Swelling Day 0
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschreibung
Size Swelling Day 1
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschreibung
Size Swelling Day 2
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschreibung
Size Swelling Day 3
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschreibung
Ongoing after day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0549178
Beschreibung
Date of last day of symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschreibung
Pain (at injection site): 0 : Absent 1 : Painful on touch 2 : Painful when limb is moved 3 : Spontaneously painful
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3840282
- UMLS CUI [1,2]
- C2700396
Beschreibung
Pain intensity day 0
Datentyp
integer
Alias
- UMLS CUI [1]
- C3840282
Beschreibung
Pain intensity day 1
Datentyp
integer
Alias
- UMLS CUI [1]
- C3840282
Beschreibung
Pain intensity day 2
Datentyp
integer
Alias
- UMLS CUI [1]
- C3840282
Beschreibung
Pain intensity day 3
Datentyp
integer
Alias
- UMLS CUI [1]
- C3840282
Beschreibung
Ongoing after day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C0030193
Beschreibung
Date of last day of symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
Beschreibung
Other Local Symptoms
Beschreibung
Description - please specify side(s) and site(s)
Datentyp
text
Alias
- UMLS CUI [1]
- C0441987
- UMLS CUI [2]
- C1515974
Beschreibung
Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0522510
Beschreibung
Start date
Datentyp
date
Maßeinheiten
- day month year
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End date
Datentyp
date
Maßeinheiten
- day month year
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Ongoing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0549178
Beschreibung
MEDICATION
Alias
- UMLS CUI-1
- C0013227
Beschreibung
Trade / Generic Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0013227
Beschreibung
Medical Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschreibung
Total Daily Dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Beschreibung
Start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
End date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschreibung
pharmacotherapy ongoing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0549178
Beschreibung
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Beschreibung
Adverse Events General Symptoms
Datentyp
text
Alias
- UMLS CUI [1]
- C1556354
Beschreibung
Fever
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschreibung
body temperature site
Datentyp
integer
Alias
- UMLS CUI [1]
- C0489453
Beschreibung
Fever Day 0
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschreibung
Fever Day 1
Datentyp
float
Maßeinheiten
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0015967
Beschreibung
Fever Day 2
Datentyp
float
Maßeinheiten
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0015967
Beschreibung
Fever Day 3
Datentyp
float
Maßeinheiten
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0015967
Beschreibung
symptom ongoing
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschreibung
date last symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschreibung
Fatigue
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015672
Beschreibung
Fatigue Day 0
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beschreibung
Fatigue Day 1
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beschreibung
Fatigue Day 2
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beschreibung
Fatigue Day 3
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beschreibung
Fatigue ongoing after day 3
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C3174772
Beschreibung
Date of last day of symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015672
- UMLS CUI [1,3]
- C2700396
Beschreibung
Headache
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018681
Beschreibung
If Yes, please specify
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
Beschreibung
Headache on Day 0
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018681
Beschreibung
Headache on Day 1
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018681
Beschreibung
Headache on Day 2
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018681
Beschreibung
Headache on Day 3
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018681
Beschreibung
Headache ongoing after day 3
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018681
Beschreibung
Headache ongoing after day 3? If Yes, please specify
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0011008
Beschreibung
Gastrointestinal symptoms
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0426576
Beschreibung
If Yes, please specify
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0522510
Beschreibung
Gastrointestinal symptoms on Day 0
Datentyp
integer
Alias
- UMLS CUI [1]
- C0426576
Beschreibung
Gastrointestinal symptoms on Day 1
Datentyp
integer
Alias
- UMLS CUI [1]
- C0426576
Beschreibung
Gastrointestinal symptoms on Day 2
Datentyp
integer
Alias
- UMLS CUI [1]
- C0426576
Beschreibung
Gastrointestinal symptoms on Day 3
Datentyp
integer
Alias
- UMLS CUI [1]
- C0426576
Beschreibung
Gastrointestinal symptoms ongoing after day 3
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0426576
Beschreibung
Gastrointestinal symptoms ongoing after day 3? If Yes, please specify
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0011008
Beschreibung
visit date
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
telephone number
Datentyp
text
Alias
- UMLS CUI [1]
- C1515258
Beschreibung
Other General Symptoms
Alias
- UMLS CUI-1
- C1457887
Beschreibung
symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C1457887
Beschreibung
Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beschreibung
symptom Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
ongoing
Datentyp
date
Alias
- UMLS CUI [1]
- C0549178
Ähnliche Modelle
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
C0600091 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])