Gastroenteritis Episode
Item
Episode Number
integer
C0017160 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type - Medical advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Code List
Type - Medical advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Stool collection time
Item
First stool collection day and time
datetime
C0015733 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Stool collection time
Item
Second stool collection day and time
datetime
C0015733 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Item
Medication for diarrhea
text
C0011991 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Medication for diarrhea
CL Item
Oral rehydration (1)
CL Item
IV rehydration (2)
CL Item
Oral and IV rehydration (3)
CL Item
No medication (4)
CL Item
Other, please specify (5)
date of gastroenteritis episode
Item
Date
date
C0011008 (UMLS CUI [1])
loose stool count
Item
Number of looser than normal stools per day
integer
C2129214 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
vomiting count
Item
Number of episodes of vomiting per day
integer
C0042963 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Temperature not taken
Item
Not taken (Temperature)
boolean
C0039476 (UMLS CUI [1])
Concomitant vaccination
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol ?
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Name
Item
Trade/Generic Name
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
CL Item
Intramuscular (IM)
CL Item
Subcutaneous (SC)
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Have any medications/treatments been administered during study period?
integer
C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Code List
Have any medications/treatments been administered during study period?
CL Item
Yes, please complete the following table. (2)
Medication name
Item
Trade or generic name
text
C2360065 (UMLS CUI [1])
Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
Medical Indication: Prophylactic?
boolean
C0199176 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Subcutaneous (SC)
Medication Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing: tick box if continuing at end of study
boolean
C2826666 (UMLS CUI [1])
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
integer
C1518404 (UMLS CUI [1])
Code List
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
Yes, please complete the following table (2)
Adverse Event Number
Item
Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Non-serious adverse events: Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-serious adverse events: Description
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Non-serious adverse events: Description
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Item
Type of vaccine
integer
C0042210 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
Code List
Type of vaccine
CL Item
Tritanrix-HepB/Hib-MenAC vaccine (1)
CL Item
Tritanrix-HepB/Hiberix vaccine (2)
CL Item
Meningitec vaccine (3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start
Item
Start: during immediate post-vaccination period (30 minutes)
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Intensity
Relationship to investigational product(s)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (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)
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Item
Medically attended visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2])
Code List
Medically attended visit type
CL Item
Hospitalisation (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)