Section 1
Adverse Event Number
integer
Diagnosis or Sign/Symptom
text
Type of event
text
Start date
date
End date
date
Outcome
text
Maximum intensity
text
action with investigational products
text
If subject withdrew from active treatment period, check 'Adverse Event'; If subject withdrew from follow-up period, check 'Adverse event' on Study Conclusion Page.
boolean
Relationship to Investigational Prosuct(s)
boolean
If Yes, please record on Concomitant Medications/Non-Drug Therapies page.
boolean
seriousness
boolean
Section 2 - Seriousness
Section 3 - Demography Data
Section 4 - Adverse event after Investigational product withdrawal
Adverse Event Number
integer
If investigational Product(s) was stopped, did the reported event(s) recur after further investigational product(s) were administered?
boolean
Section 5 - Possible Causes of SAE
Adverse Event Number
integer
Check all that apply
text
If Other, specify
text
Section 6 - Relevant Medical Conditions
Relevant Medical Condition
text
Diagnosis
text
Date of Onset
date
Condition Present at Time of the SAE?
boolean
If No, record date of last occurrence
date
Section 7 - Relevant Risk Factors
Adverse Event Number
integer
e.g., smoking, alcohol, diet, drug abuse, occupational hazard
text
Other relevant risk factors
text
Section 8 - Relevant Concomitant Medications
Adverse Event Number
integer
include details of any concomitant medication(s) which may have contributed to the event
text
Dose
text
Unit
text
Frequency
text
Route
text
Taken prior to study
boolean
Start Date
date
Stop Date
date
Ongoing Medication?
boolean
Reason for medication
text
Section 9 - Details of Investigational Product
Section 10 - Relevant Assessment
Adverse Event Number
integer
e.g. laboratory data with units and normal range
text
details of relevant assessment
text
details of relevant assessment
text
Section 11 - Narrative Remarks