Item
Dose number
integer
C1115464 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Return date for diary card
Item
Please do not forget to bring back the diary card on...
date
C0011008 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,4])
contact person
Item
In case of hospitalisation, please inform
text
C0337611 (UMLS CUI [1])
Telephone number of contact person
Item
In case of hospitalisation, please inform (Telephone)
integer
C1515258 (UMLS CUI [1,1])
C0337611 (UMLS CUI [1,2])
Item
Day of symptoms
text
C0439228 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Code List
Day of symptoms
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Intensity of irritability / fussiness
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of irritability / fussiness
CL Item
crying more than usual / no effect on normal activity (1)
CL Item
crying more than usual / interferes with normal activity (2)
CL Item
crying that cannot be comforted / prevents normal activity (3)
CL Item
behavior as usual (0)
Item
Intensity of Loss of appetite
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of Loss of appetite
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
CL Item
Appetite as usual (0)
Times of Vomiting
Item
Number of times of Vomiting per day
integer
C0042963 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Number of looser than normal stools
Item
Number of looser than normal stools per day
integer
C2129214 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
Item
Temperature Site of Meassurement
text
C0489453 (UMLS CUI [1])
Code List
Temperature Site of Meassurement
Temperature Duration
Item
Temperature ongoing after day 7?
boolean
C0005903 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Date of last day of temperature
Item
If ongoing, Date of last day of temperature
date
C0005903 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Irritability / Fussiness Duration
Item
If Irritability / Fussiness (IR), ongoing after day 7?
boolean
C0022107 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Date of last day of Irritability / Fussiness
Item
If ongoing, Date of last day of Irritability / Fussiness (IR)
date
C0022107 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Loss of Appetite Duration
Item
If Loss of Appetite (LO), ongoing after day 7?
boolean
C1971624 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Date of last day of Loss of Appetite
Item
If ongoing, Date of last day of Loss of Appetite
date
C1971624 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Vomiting Duration
Item
If Vomiting (VO), ongoing after day 7?
boolean
C0042963 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
date of last day of Vomiting
Item
If ongoing, date of last day of Vomiting
date
C0042963 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Diarrhea Duration
Item
If Diarrhea (DA), ongoing after day 7?
boolean
C0011991 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Date of last day of Diarrhea
Item
If ongoing, Date of last day of Diarrhea (DA)
date
C0011991 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stools samples
Item
Stools samples taken
boolean
C1550661 (UMLS CUI [1])
Date of stools samples
Item
If yes, Date
date
C0011008 (UMLS CUI [1,1])
C1550661 (UMLS CUI [1,2])
Diarrhea episode symptoms
Item
Diarrhea episode symptoms: Please give details
text
C0011991 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Item
Diarrhea episode symptom intensity
integer
C0011991 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Diarrhea episode symptom intensity
CL Item
gastroenteritis episode which is easily tolerated by the subject, causing minimal discomfort and not interfering with everday activities. (1)
CL Item
Gastroenteritis episode which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Gastroenteritis episode which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing Diarrhea
Item
check box if continuing.
boolean
C0011991 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Stool sample date
Item
Please fill in below the date of any stool collection.
date
C1550661 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Medication name
Item
Medication name
text
C2360065 (UMLS CUI [1])
Total Daily dose
Item
Total Daily dose
text
C2348070 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing Gastroenteritis
Item
check box if continuing.
boolean
C0017160 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Symptom description
Item
Other general symptoms (excluding gastroenteritis episode), Description - please give details below.
text
C1457887 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Symptom intensity
integer
C0518690 (UMLS CUI [1])
Code List
Symptom intensity
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing symptoms
Item
Check box if continuing.
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Trade/generic name
Item
Trade/generic name
text
C2360065 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Ongoing Medication
Item
Check box, if continuing.
boolean
C2826666 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])