Non-Serious Adverse Event
Non-Serious Adverse Event - Sequence Number
integer
Diagnosis Only (if known) Otherwise Sign/Symptom
text
Non-Serious Adverse Event - Modified term
text
Non-Serious Adverse Event - MedDRA synonym
text
Non-Serious Adverse Event - MedDRA lower level term code
text
Non-Serious Adverse Event - Failed coding
text
Non-Serious Adverse Event - Start Date and Time
datetime
Non-Serious Adverse Event - Outcome
integer
Non-Serious Adverse Event - End Date and Time
datetime
Non-Serious Adverse Event - Frequency
integer
Non-Serious Adverse Event - Maximum Intensity
integer
Non-Serious Adverse Event - Maximum Grade
text
Non-Serious Adverse Event - Maximum Grade or Intensity
text
Action Taken with Investigational Product(s) as a Result of the AE
text
Did the subject withdraw from study as a result of this AE?
boolean
Use best judgment at initial entry. May be amended when additional information becomes available.
boolean
Duration of AE if < 24 hours
integer
Duration of AE if < 24 hours
integer
Non-Serious Adverse Event - Time to Onset Since Last Dose
integer
Non-Serious Adverse Event - Time to Onset Since Last Dose
integer
Serious Adverse Event - Type of Report
Serious Adverse Event - Initial Report
integer
Serious Adverse Event - Follow-Up Report
integer
Serious Adverse Event - Randomisation
Serious Adverse Event
SAE Sequence Number
integer
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
text
Serious Adverse Event - Modified Term
text
Serious Adverse Event - MedDRA synonym
text
Serious Adverse Event - MedDRA lower level term code
text
Serious Adverse Event - Failed Coding
text
Serious Adverse Event - Start Date and Time
datetime
Serious Adverse Event - Outcome
integer
Serious Adverse Event - End Date and Time
datetime
Serious Adverse Event - Date and Time of Death
datetime
Serious Adverse Event - Maximum Intensity
integer
Serious Adverse Event - Maximum Grade
text
Serious Adverse Event - Maximum Grade or Intensity
text
Action Taken with Investigational Product(s) as a Result of the SAE
text
Did the subject withdraw from study as a result of this SAE?
boolean
Use best judgment at initial entry. May be amended when additional information becomes available.
boolean
Serious Adverse Event - Duration of AE if < 24 hours
integer
Serious Adverse Event - Duration of AE if < 24 hours
text
Serious Adverse Event - Time to Onset Since Last Dose
integer
Serious Adverse Event - Time to Onset Since Last Dose
integer
Was the SAE caused by activities related to study participation other than investigational product?
boolean
Was the event serious?
boolean
Serious Adverse Event - Related Investigational Product
text
Serious Adverse Event - Seriousness
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
CM Sequence Number
integer
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
text
Concomitant Medications - Modified reported term
text
Concomitant Medications - Dose
integer
Concomitant Medications - Unit
text
Concomitant Medications - Frequency
text
Concomitant Medications - Route
text
Concomitant Medications - Start Date
date
If no, specify End Date
boolean
Concomitant Medications - End date
date
Enter a medical diagnosis not description
text
Concomitant Medications - Modified reported term
text
Concomiant Medications - Drug Type
text
Serious Adverse Event - Relevant Medical Conditions/Risk Factors
MHx Sequence Number
integer
Enter a medical diagnosis not description.
text
Medical Condition - Modified reported term
text
If no, specify date of last occurrence
text
Medical Conditions - Date of last occurrence
date
Serious Adverse Event - Relevant Diagnostic Results
Lab Sequence Number
integer
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
Serious Adverse Event - Rechallenge
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
Serious Adverse Event - Investigational Product Double Blind Phase
Double Blind Investigational product
text
Double Blind Investigational product - Start Date
date
Double Blind Investigational product - Stop Date
date
Serious Adverse Event - Investigational Product Open Label Phase
Study Drug
text
Start date of open label period
date
Open Label Course at time of event
integer
Open Label Phase - Start Date
date
Open Label Phase - Stop Date
date
Study Drug
text
Study Drug Start Date
date
Study Drug Stop Date
date
Study Drug Dose
text
Study Drug Cumulative Dose
text
Serious Adverse Event - General Narrative Comments
Serious Adverse Event - Non Clinical
Send incomplete SAE data to GSK Safety
text
Receipt by GSK date
datetime
Was the event serious?
boolean
SAE Sequence Number
integer
Version Number
integer
Case ID
text
Randomisation Number
text
OCEANS Code
text
Email Flag
text