Astrazenec&? Serious Adverse Event Report — Clinical Study @ Initat Report 1D Follow up Report GeotNo: SO77ILIO114 | SiteNoz 010 Country: USA Clintrace Nos Iment Ne 0013 Randomization Nox 0013 Patient initials: DRM Weight: 179 Ibs : 25INOv976 Male a Age: 27 Date of bith 25h eee Height: 76 in ‘Serious Adverse Event (SAE): (Main diagnosis): Suicide Brief Description of SAE: (Symptoms, couse, testment of SAE), ‘Subject has been compliant in CAFE study, currently on 4 study tablets twice per day (8 total). Reports from group home, county case manager and outpatient day treatment program have all indicated that DRM was invested in his treatment plan, cooperative all treatments, including the provisions of his court ordered stay of commitment. Last study visit performed on 28 April, 2004, At this time, DRM denied all positive symptoms including depression, paranoia, delusional thinking or hallucinations. None of these ‘symptoms were apparent in PANSS interview or throughout the visit. ‘This presentation has been consistent throughout the majority of his involvement in the CAFE study. Also, consistent throughout the study has been DRM's presentation of guardedness and minimal insight. He acknowledged past symptoms but would continually deny any present concerns. Over the last few months, DRM's ADLs have deteriorated, often with a disheveled appearance and wearing the same clothes as previous visits. These observations were discussed with the subject. Prior to the SAE, client was said to have gone about his normal routine. He retired to bed, got up in the night #="ltook a shower as was his typical behavior. Staff at the group ‘noticed he was in the bathroom an unusual amount of time. he did not respond to thelr inquiries, the bathroom door wi te. .d open, DRM was found dead apparently from suicide. This is said to have occurred at approximately 1 am on May 8 2004. An autopsy may be pending, but we have insufficient data to know the details of is no leryer enroiliy an af in, 2004; This stud subjects 2004-08-11 in accordance with the Drug Safety SOP valid from 31 March 2000 Date AE Started: 08/May/2004 (eomerrs aera Dad of first occurrence of symptoms, add tie i relevant Date AE met Serious Criteria: 08/Mayi2004 poananrery Detection Date: TiiMay/2004 Date when investigator Became aware that event was 2 SAE. ‘The Event is Serious due to: Desth © Utethrestering C1 In-patient hospitalization or prolongation of existing hosptateton (1) Perit origin cssbyinapacty {5 Acongenalsbrermatyien detec 1D Inport media overt Hospitalized: Date of hospitalization: N/A Date of discharge [AE Stopped: resolved): oBmay/2008 Lac day when AS was present ad tel leant Outcome: RecoverediResolved © Recovering Resoiving Dy NotrecoverediNot resolved Ly RecoverediResoWved with sequelae & Fata" "ate of Deatn: 081M AY / 2004 Autopsy performed: C] No] Yes (tach repor) Probable cause of death suicide exer 16) Psu nnni4sAstrazenece? Serious Adverse Event Report — Clinical Study Was the subject withdrawn from the study due to this serious adverse event? Yes O No Oo Investigational Route | Daily | Total oan eration ET RSS Causal ‘Action Take Product(s) eget | Frequency | Daily (evindcsencwtact triad” | Assessment | 9.42.3 Olenzapine /auetiapine | “ws | we eevie | DSH (tes ort “ria 3 lumber of - 2 1 Risperidone Nabe sted stopped [CAFE medication |oal [4610 | 2 | oS-DEC-2x, Oregn [oe _ Cver One ~ Oves No ———— pen earn en proce T Da you conser tat are sa reasonable poss thatthe event 1 Sela meouin peannge oot reed pe poeed may Have been caused by te dua? i Reeiniesacs: 43 frentacra praia sop Na hot Appt © wha pt en on veto pec Treatment code BoKen by mvesigator” BY No] Ves —[) Notappieabie 090188 2004-05-11/in accordance with the Drug Safety SOP valid from 31 March 2000 p 4 2)