Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Code List
Workbook number
Date of non-serious adverse event
Item
Date of non-serious adverse event
date
C1518404 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Case number
Item
Case number
integer
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Non-serious adverse event leading to non-administration of vaccine, visit/contact not done
Item
Has any non-serious adverse event leading to a non-administration of the vaccine or a visit/contact not done or a withdrawn?
boolean
C1518404 (UMLS CUI [1])
C1298908 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
C0545082 (UMLS CUI [3,1])
C1272696 (UMLS CUI [3,2])
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description of AE
Item
Description of AE
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Site/Location of Adverse event
integer
C0877248 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Code List
Site/Location of Adverse event
CL Item
10Pn-PD-DiT vaccine / HBV Vaccine administration site (1)
CL Item
10Pn-PD-DiT vaccine / HAV Vaccine administration site (2)
CL Item
DTPa-IPV/Hib vaccine / Infanrix Hexa administration site (3)
CL Item
Non-administration site (4)
Date Started
Item
Date Started
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Date started: post-vaccination periode
Item
Date started: during immediate post-vaccination period (30 minutes)
boolean
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0231291 (UMLS CUI [1,3])
Date Stopped
Item
Date Stopped
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Intensity
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Outcome of AE
integer
C1518404 (UMLS CUI [1,1])
C1624730 (UMLS CUI [1,2])
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Code List
Medically attended visit
Item
Type of medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Code List
Type of medically attended visit
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])