ID
26278
Description
Visit 4 Dose 2 Diary Card - General Symptoms 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
Keywords
Versions (2)
- 8/29/17 8/29/17 -
- 10/15/17 10/15/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 15, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Visit 4 Dose 2 Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125
Visit 4 Dose 2 Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125
Description
Temperature
Alias
- UMLS CUI-1
- C0005903
Description
Axillary temperature
Data type
boolean
Alias
- UMLS CUI [1]
- C1531924
Description
Oral temperature
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0442027
Description
Rectal temperature
Data type
boolean
Alias
- UMLS CUI [1]
- C0489749
Description
Temperature Day 0
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C2826301
Description
Temperature Day 0 not taken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826301
- UMLS CUI [1,2]
- C0437722
Description
Temperature Day 1
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1442449
Description
Temperature Day 1 not taken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1442449
- UMLS CUI [1,2]
- C0437722
Description
Temperature Day 2
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C3842676
Description
Temperature Day 2 not taken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3842676
- UMLS CUI [1,2]
- C0437722
Description
Temperature Day 3
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C3842675
Description
Temperature Day 3 not taken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3842675
- UMLS CUI [1,2]
- C0437722
Description
Headache
Alias
- UMLS CUI-1
- C0018681
Description
Intensity Day 0
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826301
Description
Intensity Day 1
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1442449
Description
Intensity Day 2
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842676
Description
Intensity Day 3
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842675
Description
Malaise
Alias
- UMLS CUI-1
- C0231218
Description
Intensity Day 0
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826301
Description
Intensity Day 1
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1442449
Description
Intensity Day 2
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842676
Description
Intensity Day 3
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842675
Description
Fatigue
Alias
- UMLS CUI-1
- C0015672
Description
Intensity Day 0
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826301
Description
Intensity Day 1
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1442449
Description
Intensity Day 2
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842676
Description
Intensity Day 3
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842675
Description
Nausea
Alias
- UMLS CUI-1
- C0027497
Description
Intensity Day 0
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826301
Description
Intensity Day 1
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1442449
Description
Intensity Day 2
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842676
Description
Intensity Day 3
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842675
Description
Vomiting
Alias
- UMLS CUI-1
- C0042963
Description
Intensity Day 0
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C2826301
Description
Intensity Day 1
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1442449
Description
Intensity Day 2
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842676
Description
Intensity Day 3
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C3842675
Description
Other General Symptoms
Alias
- UMLS CUI-1
- C0029625
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Visit 4 Dose 2 Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125
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