Date of Visit/Assessment
Date of Visit
date
AE status
non-serious adverse events
boolean
Log status
serious adverse events
concomitant medications
Concomitant Medications
Sequence number
integer
Drug name
text
Modified reported term
Unit Dose
float
Units
Frequency
Route
Reason for Medication
Generic Dispensed
Prescription or OTC
Medication start datetime
datetime
Taken Prior to Study?
If No, specify End Date
Concomitant Medication: End Date
Device used to administer medication
Total Daily Dose
drug adminstered for an exacerbation
Rescue Medication
Total Dose
drug use
Total duration
duration
Non-serious adverse event
[hidden]
Diagnosis Only (if known) Otherwise Sign/Symptom
Condition item Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
Outcome
If outcome "Recovered/Resolved" or "Recovered/Resolved with sequelae", provide End Date.
Record maximum intensity throughout duration of event. Optional item: This item may be hidden if either the Maximum Grade or Maximum Grade or Intensity item has been used.
Record intensity at the onset of the event [hidden]. Conditional item: Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Grade/Grade or Intensity at onset of event item has been used.
Record maximum grade throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade or Intensity item has been used. Grade 5 is optional.
Conditional item Conditional on using the Intensity change section. If the section is not used the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional
Record maximum grade or intensity throughout duration of event [hidden]. Optional item: This item may be hidden if either the Maximum Intensity or Maximum Grade item has been used. Grade 5 is optional.
Record grade or intensity at the onset of the event [hidden]. Conditional item Conditional on the use of the Intensity change section. If the section is not used then the item must be hidden. This item may be hidden if either the Intensity or Grade at onset of event item has been used. Grade 5 is optional
Action Taken with Investigational Product
Withdrawal from study
Use best judgment at initial entry. May be amended when additional information becomes available. If the study has multiple IP then remove Yes and keep Yes, select appropriate investigational product(s)' and set selection value to Y. Otherwise remove Yes, select appropriate investigational product(s) and keep Yes.
If AE start and end time are used this item must be hidden.
[hidden] This item is optional
Report
Initial report
Follow-up report
Randomisation
SAE after initiation of study medication
Serious Adverse Event
Sequence Number
Modified term
MedDRA synonym
MedDRA lower level term code
serious adverse event
Did SAE occur after initiation of study medication
Serious Adverse Event Start Date
Start Time Serious Adverse Event
time
Serious Adverse Event End Date
Serious Adverse Event End Time
Date of Death
Intensity (maximum)
Intensity at onset of event
Record grade at the onset of the event [hidden]. Conditional item Conditional on using the Intensity change section. If the section is not used the item must be hidden. This item may be hidden if either the Intensity/Grade or Intensity at onset of event item has been used. Grade 5 is optional
Action Taken
Relationship investigational product
Did the subject withdraw from study as a result of this AE?
Duration of AE if < 24 hours
Time to Onset Since Last Dose
SAE Causation
investigational product
Intensity changes
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
If the decision has been made to record every change in intensity, time must be collected to differentiate between, and to indicate the order of, changes that occur within a single day.
Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section.
Optional item: This item may be hidden if either the Intensity of event segment or Grade or intensity of event segment item has been used and item not included in the section. Grade 5 is optional.
Optional item: This item may be hidden if either the Grade of event segment or Grade or Intensity of event segment item has been used and item not included in the section. Grade 5 is optional.
Seriousness
Seriousness Other
Relevant concomitant / treatment medications
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Dose
units of medication
Route of medication
Start Date
Ongoing medication
End date medication
Enter a medical diagnosis not description
Drug Type
Relevant diagnostic results
Only allow site to choose from List of Values.
Test Date
Test Result
Test Units
Normal Low Range
Normal High Range
Relevant diagnostic results not noted above
Rechallenge
INVESTIGATIONAL PRODUCT
Study drug
start date
stop date
Regimen
General narrative comments
Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
Non clinical
Send incomplete SAE data to GSK Safety [hidden]. This item is optional
[read-only]