Solicited Adverse Events Record - Local Symptoms
Local Symptom
text
Symptom Occurrence
boolean
Study Day
integer
Intensity: Pain (at injection site): 0:Absent. 1:Painful on touch. 2:Painful when limb is moved. 3:Spontaneously painful / prevents normal activity.
integer
Please measure the greatest diameter (in mm), if redness, swelling or ecchymosis is ticked
integer
Ongoing Symptom
boolean
if ongoing after Day 6
date
Other Local Symptoms (Day 0 to Day 29)
please specify side(s) and site(s
text
Other local symptoms: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy).
integer
Start Date
date
End Date
date
tick box if continuing
boolean
Medication
Trade/Generic Name
text
Reason
text
Total Daily Dose
text
Start Date
date
End Date
date
tick box if continuing
boolean
Solicited Adverse Events Record - General Symptoms
arthralgia = joint pain
text
Symptom Occurrence
boolean
Study Day
integer
Fatigue, Headache, Muscle Ache, Shivering, Arthralgia/Joint Pain 0: Normal 1: Easily tolerated 2: Interferes with normal activity 3: That prevents normal activity
integer
Ongoing Symptom
boolean
Date of Last Day of Symptoms
date
Solicited Adverse Events - Fever
Fever: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C Temperature: Please record the temperature every day in the evening. Should additional temperature measurements be performed at other times of the day, the highest temperature is to be recorded.
boolean
If fever is ticked oral is preferred
text
Study Day
integer
Body Temperature
float
Ongoing Symptom
boolean
Date of Last Day of Symptoms
date
Other General Symptoms (Day 0 to Day 29)
please specify side(s) and site(s
text
Other local symptoms: 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy).
integer
Start Date
date
End Date
date
tick box if continuing
boolean