ID
35989
Beschrijving
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
Trefwoorden
Versies (2)
- 08-04-19 08-04-19 -
- 08-04-19 08-04-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 april 2019
DOI
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Licentie
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 12) - Concomitant Vaccination; Medication; Non-serious Adverse Events
Beschrijving
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beschrijving
If Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beschrijving
Trade Name/ (Generic) Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0592502
Beschrijving
Administration Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Administration Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Beschrijving
Medication
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Medication
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Trade/ Generic Name
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Medical Indication
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Total daily dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Beschrijving
Administration Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Medication End Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Tick box if continuing at end of study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2983670
Beschrijving
Non- serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
If yes, please complete the following table.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [1,4]
- C0687676
Beschrijving
Non-Serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
AE No
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Non-Serious Adverse Event Description
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0678257
Beschrijving
Non-Serious Adverse Event location
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0450429
Beschrijving
If Administation sites, specify vaccine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beschrijving
Date Non-Serious Adverse Event Started
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschrijving
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [1,4]
- C0687676
- UMLS CUI [1,5]
- C0205253
Beschrijving
Date Non-Serious Adverse Event Stopped
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschrijving
Non-Serious Adverse Event Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1710066
Beschrijving
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Non-Serious Adverse Event Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Similar models
Long-Term Follow Up (Year 12) - Concomitant Vaccination; Medication; Non-serious Adverse Events
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0592502 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,2])
C2983670 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0237753 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
C0806020 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])