ID
25215
Beschrijving
Adverse Experiences - Continued form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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 (1)
- 28-08-17 28-08-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
28 augustus 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Adverse Experiences - Continued Biologicals HepA/HepB vaccine 208127/125
Adverse Experiences - Continued Biologicals HepA/HepB vaccine 208127/125
Beschrijving
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Experience
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Local reaction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0853813
- UMLS CUI [1,2]
- C2700396
Beschrijving
General reaction
Datatype
boolean
Alias
- UMLS CUI [1]
- C1710276
Beschrijving
day/month/year
Datatype
date
Alias
- UMLS CUI [1]
- C3173309
Beschrijving
hours/minutes if the experience is observed during the immediate post vaccination period specified in the protocol, the exact time of onset has to be specified
Datatype
time
Alias
- UMLS CUI [1]
- C0449244
Beschrijving
day/month/year
Datatype
date
Alias
- UMLS CUI [1]
- C1531784
Beschrijving
hours/minutes
Datatype
time
Alias
- UMLS CUI [1]
- C0449238
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
Relationship to Study Vaccine
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0439849
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
continuing at end of study
Datatype
boolean
Alias
- UMLS CUI [1]
- C1553904
Beschrijving
If yes, record in the Medication Section
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
If yes, report experience to SB by phone within 24hrs and complete the SAEF form.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1547644
Beschrijving
For SB
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
Administrative Data
Alias
- UMLS CUI-1
- C1320722
Similar models
Adverse Experiences - Continued Biologicals HepA/HepB vaccine 208127/125
C0877248 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])