Has the Subject experienced any adverse events?
Item
Has the Subject experienced any adverse events?
boolean
If YES, please add Adverse Event details below
Item
If YES, please add Adverse Event details below
text
Adverse Event Number
Item
Adverse Event Number
text
CL Item
Cardiovascular (4)
CL Item
Injection site reaction (6)
CL Item
Diabetic retinopathy (7)
If Other, specify
Item
If Other, specify
text
Start Date
Item
Start Date
date
CL Item
Recovered/resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/resolved with sequelae (4)
End Date
Item
End Date
date
Item
Maximum Intensity
text
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Not applicable (3)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
Is there a reasonable possibility the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility the AE may have been caused by the investigational product?
boolean
Item
Was a concomitant medication/non-drug therapy taken for this AE?
text
Code List
Was a concomitant medication/non-drug therapy taken for this AE?
CL Item
Yes (please record on Concomitant Medications page) (1)
Was event serious?
Item
Was event serious?
boolean
Item
Specify reason(s) for considering this a SAE, check all that apply
text
Code List
Specify reason(s) for considering this a SAE, check all that apply
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
If Other, specify
Item
If Other, specify
text
Item
If Investigational Product(s) was stopped, did the reported event(s) recur after further Investigational Product(s) were administered?
text
Code List
If Investigational Product(s) was stopped, did the reported event(s) recur after further Investigational Product(s) were administered?
CL Item
Not Applicable (1)
Item
Possible causes of SAE other than Investigational Product(s)
text
Code List
Possible causes of SAE other than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) (5)
CL Item
Activity related to study participation (e.g. procedures) (6)
If Other, specify
Item
If Other, specify
text
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
Date of Onset
Item
Date of Onset
date
Condition present at time of the SAE?
Item
Condition present at time of the SAE?
boolean
If No, record date of last occurence
Item
If No, record date of last occurence
date
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
Item
Provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE
text
Details of Investigational Product
Item
Details of Investigational Product
text
Provide details of any other tests/procedures which were carried out to diagnose of confirm the SAE
Item
Provide details of any other tests/procedures which were carried out to diagnose of confirm the SAE
text
Provide a brief narrative description of the SAE and details of treatment given
Item
Provide a brief narrative description of the SAE and details of treatment given
text