SAE to be adjudicated
[hidden] If yes, select all that apply.
boolean
If event is to be adjudicated, select all that apply.
boolean
If event is to be adjudicated, select all that apply.
boolean
If event is to be adjudicated, select all that apply.
boolean
If event is to be adjudicated, select all that apply.
boolean
If event is to be adjudicated, select all that apply.
boolean
If event is to be adjudicated, select all that apply.
boolean
SAE as non-adjudicated endpoint
[hidden] If yes, select all that apply
boolean
If event is a non-adjudicated endpoint, select all that apply.
boolean
If event is a non-adjudicated endpoint, select all that apply.
boolean
If event is a non-adjudicated endpoint, select all that apply.
boolean
Occurence of endpoints
Please provide all SAE/EP details in sections 2-11 below
boolean
Occurence of death
boolean
Occurence of death cardiovascular
integer
Occurence of Myocardial infarction
boolean
Occurence of Hospitalisation for unstable angina
boolean
Occurence of Coronary revascularisation
boolean
Occurence of Stroke/TIA
boolean
Hospitalisation for heart failure
boolean
Hospitalisation for Non-adjudicated ischaemic event
boolean
Hospitalisation for Limb amputation due to vascular cause
boolean
Hospitalisation for Non-coronary revascularisation
boolean
Hospitalisation for non-coronary ischaemic event
boolean
Event adjudicated to be study endpoint
Report
Randomization
Serious Adverse Event
[read-only]
text
Diagnosis Only (if known) Otherwise Sign/Symptom. Include ONE event term only
text
[hidden]
text
[hidden]
text
[hidden]
text
[hidden]
text
Start Time is conditional. If times of intensity/toxicity change are being collected, AE start times must also be collected.
date
Outcome
integer
If "Recovered/Resolved", "Recovered/Resolved with sequelae", or "Fatal, record Date of Death", provide End date. End Time is optional
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.
text
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.
text
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.
integer
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
integer
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.
text
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
text
Action Taken with Investigational Product
text
Withdrawal from study
boolean
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.
boolean
If AE start and end time are used this item must be hidden.
integer
If AE start and end time are used this item must be hidden.
integer
Time to Onset Since Last Dose hours
integer
This item is optional
integer
SAE caused by activities related to study participation
boolean
[hidden]
boolean
[hidden]
text
Intensity changes
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
text
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.
date
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.
time
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.
integer
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.
integer
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.
text
Specify the reason for considering this an SAE. Check all that apply.
SAE results in death
boolean
SAE life-threatening
boolean
SAE requires hospitalisation
boolean
SAE results in disability/incapacity
boolean
SAE congenital anomaly/birth defect
boolean
Other SAE
boolean
Other SAE specification
text
Relevant concomitant/treatment medications
[hidden]
text
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
text
[hidden]
text
Dose
text
units of medication
text
Frequency
text
Route of medication
text
Start Date
date
Ongoing medication
boolean
End date medication
date
Enter a medical diagnosis not description
text
[hidden]
text
Drug Type
text
Relevant medical conditions / Risk factors
[hidden]
text
Enter a medical diagnosis not description.
text
[hidden]
text
Date of onset
date
Continuing medical condition
text
Medical condition last occurence
date
[hidden]
text
Relevant diagnostic results
[hidden]
text
Only allow site to choose from List of Values.
text
Test Date
date
Test Result
text
Test Units
text
Normal Low Range
text
Normal High Range
text
Relevant diagnostic results not noted above
text
Rechallenge
text
Investigational product
Investigational product [hidden]
Investigational product [hidden]
General narrative comments
Non clinical
Send incomplete SAE data to GSK Safety [hidden]. This item is optional
boolean
[hidden]
date
[hidden]
time
[hidden]
boolean
[read-only]
text
[hidden]
text
[hidden]
text
[hidden]
text
[hidden]
text
[hidden]
text