Download For Pfizer Internal use only

Investigator Initiated Research Non-Interventional Study Adverse Event Report Form
For Pfizer internal use only
Local #
Date Reported to Pfizer
AER # (insert when known)
___-______-___
PROTOCOL #
SUBJECT #
Protocol Title: Prospective cross-sectional and long-term longitudinal epidemiological study on pulmonary arterial hypertension
(PAH) in Estonia
Initial Report
Follow Up Report
Country where event occurred: Estonia
Ethnicity: Asian
Other (specify)
Date of Birth
Patient Data
Male
If patient
has died:
Female
Date of Death
Patient History
None
Unknown
Weight
Cause(s) of Death
Onset Date
Study Drug (Trade and Generic), Formulation,
Route, Indication
Test
Version 1.0 June2013
kg
Native American
White
Cannot ask per local regulations
in
Height
cm
Determined by Autopsy: Y
N
Unknown
If yes, what was the autopsy determined cause of Death:
Stop Date
Check box
if Pfizer
Drug
Pertinent Details
Include surgical procedures and dates
Check box
if Ongoing
Dose
Units
Frequency
Start
Date
Stop
Date
Check
box if
Ongoing
List below concomitant drugs taken within two weeks before the event onset. Exclude all drugs only administered
more than two weeks before the event, and any drug used to treat the event or taken after event onset. If additional
space is necessary, use additional copies of this page.
Drug Name (Trade and Generic)
Relevant Tests
lb
Hispanic
Provide relevant medical history below Include other illnesses present at time of event and pre-existing medical
conditions. If additional space is necessary, use addiitonal copies of this page.
Illness (specify)
Concomitant Drugs
None
Unknown
Black
Reason for Use
Route
Start
Date
Stop
Date
Check
box if
Ongoing
List only relevant confirmatory test results for serious adverse event(s), for example, from blood tests, diagnostic
imaging. If additional space is necessary, use additional copies of this page.
Normal Range
Date
Result
Units
Comments
Low
High
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Investigator Initiated Research Non-Interventional Study Adverse Event Report Form
For Pfizer internal use only
Local #
Date Reported to Pfizer
AER # (insert when known)
___-______-___
PROTOCOL #
SUBJECT #
ADVERSE EVENTS (if more than two, use additional copies of this page)
Specify diagnosis if known, rather than symptoms or signs
Adverse Event Term
Adverse Event Term
Onset Date:
Onset Date:
Is the event serious?
Yes
If yes, identify seriousness criteria below:
No
Is the event serious?
If yes, identify seriousness criteria below:
Yes
Seriousness Criteria (Check all that apply):
Resulted in death
Life-threatening
Hospitalization/Prolongation of hospitalization
Persistent/Significant disability/Incapacity
Congenital anomaly/Birth defect
Important medical event
Seriousness Criteria (Check all that apply):
Resulted in death
Life-threatening
Hospitalization/Prolongation of hospitalization
Persistent/Significant disability/Incapacity
Congenital anomaly/Birth defect
Important medical event
Status at date of report or at
death:
Recovered
}
Recovered with sequelae }
Recovering
Not Recovered
Unknown
Status at date of report or at
death:
Recovered
Recovered with sequelae
Recovering
Not Recovered
Unknown
Date of
Recovery:
}
}
No
Date of
Recovery:
Is there a reasonable possibility that the event is related to
Study Drug
Yes
No
Is there a reasonable possibility that the event is related to
Study Drug
Yes
No
If yes, specify Study Drug:
If yes, specify Study Drug:
Is there a reasonable possibility that the event is related to
Concomitant Drug
Yes
No
Is there a reasonable possibility that the event is related to
Concomitant Drug
Yes
No
If yes, specify Concomitant Drug:
If yes, specify Concomitant Drug:
Last Drug Action Taken During Event(s), specify drug name:
Last Drug Action Taken During Event(s), specify drug name:
Withdrawn (temporarily
or permanently, or delayed)
Dose reduced
Dose increased
Dose not changed
Unknown
Not applicable
Withdrawn (temporarily
or permanently, or delayed)
Dose reduced
Dose increased
Dose not changed
Unknown
Not applicable
Withdrawn (temporarily
or permanently or delayed)
Dose reduced
Dose increased
Dose not changed
Unknown
Not applicable
Did an SAE/AE recur with re-administration of drug?
Yes
No
If yes, which SAE(s)/AE(s):
Version 1.0 June2013
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Unknown
Withdrawn (temporarily
or permanently or delayed)
Dose reduced
Dose increased
Dose not changed
Unknown
Not applicable
Not Applicable
Investigator Initiated Research Non-Interventional Study Adverse Event Report Form
For Pfizer internal use only
Local #
Date Reported to Pfizer
AER # (insert when known)
___-______-___
PROTOCOL #
SUBJECT #
Event Narrative
Provide any information regarding the circumstances, sequence, diagnosis and treatment of the event(s) not otherwise reported on this form.
If additional space is necessary, use additional copies of this page.
Reporter Comments:
Reporter:
Last Name (Please PRINT)
First Name
Address:
Date: DD-MMM-YYYY
/
Street
Telephone:
City / State
Fax:
Zip Code
Country
Email:
Investigator’s Name:
Investigator (or Designee) Awareness Date:
Investigator or Designee Signature : _________________________
Version 1.0 June2013
-
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DD-MMM-YYYY