assess the occurrence of general signs or symptoms
Item
Please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed below.
text
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
Temperature
Item
Temperature
float
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
Medically attended Visit?
Item
Was the visit medically attended?
boolean
CL Item
Day 1 evening (2)
CL Item
Day 2 evening (3)
CL Item
Day 3 evening (4)
CL Item
Behaviour as usual (1)
CL Item
Crying more than usual/ no effect on normal activity (2)
CL Item
Crying more than usual/ interferes with normal activity (3)
CL Item
Crying that cannot be comforted/ prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Continuous crying?
Item
Was the crying continuous?
boolean
unaltered crying >= 3 hrs
Item
Was the crying unaltered >=3 hours?
boolean
CL Item
Day 1 evening (2)
CL Item
Day 2 evening (3)
CL Item
Day 3 evening (4)
CL Item
Behavior as usual (1)
CL Item
Drowsiness easily tolerated (2)
CL Item
Drowsiness that interferes with normal activity (3)
CL Item
Drowsiness that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
medically attended visit?
Item
medically attended visit?
boolean
CL Item
Day 1 evening (2)
CL Item
Day 2 evening (3)
CL Item
Day 3 evening (4)
CL Item
Appetite as usual (1)
CL Item
Eating less than usual / no effect on normal activity (2)
CL Item
Eating less than usual / interferes with normal activity (3)
CL Item
Not eating at all (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
medically attended visit?
Item
medically attended visit?
boolean
Description
Item
Description
integer
CL Item
Mild (an AE which is easily tolerated by the subject, causing minimal discomfort and non interfering with everyday activities) (1)
CL Item
Moderate (an AE which is sufficiently discomforting to interfere with normal everyday activities) (2)
CL Item
Severe (an AE which prevents normal, everyday activities: 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
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
medically attended visit?
Item
Was the visit medically attended?
boolean
Please do not forget to bring back the diary card on
Item
Please do not forget to bring back the diary card on
date
