Solicited Adverse Events Record - Local Symptoms
for each symptom, every item hereafter should be ticked accordingly.
text
Fill out for each 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), for redness, swelling or ecchymosis
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
if symptom ended during the study period
date
tick if symptom has not ended during the study period
boolean
Medication
Trade/Generic Name
text
Reason
text
Total Daily Dose
text
Start Date
date
tick if medication has ended during the study period
date
tick if medication has not ended during the study period
boolean
Solicited Adverse Events Record - General Symptoms
arthralgia = joint pain for each symptom, every item hereafter should be ticked accordingly.
text
Fill out for each 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 - Temperature
oral is preferred
text
Fill out for each 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 general 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
tick if symptom has ended during the study period
date
tick if symptom has not ended during the study period
boolean