Serious Adverse Event Entry
Start Date
date
Outcome
text
if FATAL, Date of Death
date
Maximum Intensity
text
Intensity at onset of event
text
Maximum Grade
text
Grade at onset of event
text
Record maximum grade or intensity throughout duration of event
text
Record grade of intensity at the onset of the event
text
Action taken with Investigational Product(s) as a result of AE?
text
Did the subject withdraw from the study as a result of AE?
boolean
Use best judgement at initial entry. May be amended when additional information becomes available.
boolean
HH:MM
text
Time to Onset since last Dose
time
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
boolean
Was the event serious?
boolean
Related Investigational Product
text
Seriousness
Relevant Concomitant/Treatment Medication
Iclude any details of any medication that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
text
Enter drug name, not description (Generic name preferred. If combination product, enter Trade Name).
text
Modified reported term
text
Dose
float
Unit
text
Frequency
text
Route
text
Start Date
date
Ongoing?
boolean
If NO, specify End Date
date
Enter a medical diagnosis not description
text
Modified reported term
text
Drug Type
text
Relevant Medical Conditions/Risk Factors
MHx Sequence Number
text
Enter a medical diagnosis not description.
text
Modified reported term
text
Date of onset
date
Continuing?
text
If NO, specify date of last occurrence
date
Relevant Diagnosis Results
Provide details of any tests or procedures carried out to diagnose the SAE.
text
Test Name
text
Test Date
date
Test Result
text
Test Units
text
Normal Low Range
integer
Normal High Range
integer
Relevant diagnostic results not noted above
text
Rechallenge
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
Investigational Product
General narrative comments
Non Clinical
Send incomplete SAE data to GSK Safety
text
Receipt by GSK date
date
Was the event serious?
boolean
SAE Sequence number
text
Version Number
text
Case ID
text
Randomisation Number
text
OCEANS Code
text