Death
Cause of Death
Cause of death as specified on Death Certificate or other documentation:
text
Was an autopsy performed?
boolean
If Yes, please provide a copy of the report. Every effort to obtain the report should be made.
boolean
Classification of Primary Cause of Death
Non-cardiovascular death
Cardiovascular death
1. Sudden death
boolean
If Yes, record AE/SAE number
integer
Please complete an Acute MI/Hospitalized Angina or Chest pain event form and record the event number from that form
boolean
If Yes, record AE/SAE number
integer
Please complete a Stroke/TIA event form and record the event number from that form
boolean
If Yes, record AE/SAE number
integer
If applicable, please complete a Hospitalization For Heart Failure event form and record the event number from that form.
boolean
If Yes, record AE/SAE number
integer
Specify
text
Date performed
date
6. Death due to pulmonary embolism
boolean
Specify
text
8. Cause of death unknown
boolean
Place of Death
Other data
Please complete any other appropriate event form(s) pertaining to the hospitalization and record the event number(s) from those forms below
text
AE/SAE number
integer
AE/SAE number
integer
AE/SAE number
integer
In the 14 days prior to death, had the subject been discharged from the hospital?
boolean
If Yes, please specify
text
Reason for Hospitalization
text
AE/SAE Number
integer
Reason for Hospitalization 2
text
AE/SAE Number
integer
Reason for Hospitalization 3
text
AE/SAE Number
integer
Reason for Hospitalization 4
text
AE/SAE Number
integer
Circumstances of Death
Considering the subject's condition prior to death, was the death clinically expected?
text
Was the death witnessed?
text
If No, how long since the subject had last been seen alive by anyone?
text
When last seen, was the subject observed to be in his/her usual state of health?
text
In the 14 days prior to death, had the subject undergone any procedure(s)/operation(s)?
boolean
If Yes, specify
text
Date
date
Further comment
text
Date
date
What was the duration of new or worsening symptoms immediately before death?
text
Was a life threatening arrhythmia or conduction disturbance identified?
text
If Yes, check all that apply
text
Was resuscitation attempted prior to death?
text
Date and Time of resuscitation attempt
datetime
If Yes, check all that apply
text
If Other, specify
text
Narrative
Include the subject's clinical condition prior to death, changes in signs and symptoms, changes in therapy, hospitalizations, and any procedures or operations that you feel may be relevant when considering the cause of this subject's death. Please describe the exact circumstances and place of death and any relevant autopsy findings. Please provide sufficient information to allow the Endpoint Committee to accurately classify the cause of death. A copy of the hospital discharge summary should be submitted.
text
Description of Event (Cont.)
text
Description of Event (Cont.)
text