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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 # 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 Page __ of __ 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 Page __ of __ 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 - Page __ of __ DD-MMM-YYYY