SUSPECT ADVERSE REACTION REPORT
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- Darleen Aubrey Gilmore
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1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1. COUNTRY 2. DATE OF BIRTH 2. AGE 3. SEX 4-6 REACTION ONSET privcy ( ): Abdominl discomfort ] ( ): Bck pin ] ( ): Lighthededness ] ( ): Insomni ] ( ): Mylgi ] ( ): Skin rection ] Reporter's comments: DE DA MO YR * Mle DA MO YR Sonstiges: usgeprägtes krdio-vskuläres Risikoprofil, Dibetes gut eingestellt, RR gut eingestellt, Cholesterinwerte ungenügend eingestellt 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevnt tests/lb dt) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic nme) (cont.) torvsttin 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 20 Mg 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 02-MAR-2000 to 12-MAY Dy III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to tret rection) DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? þ YES NO NA 23. OTHER RELEVANT HISTORY (e.g. dignostics, llergics, pregnncy with lst month of period, etc.) [ MedDRA 19.1 ( ): Coronry rtery disese ] Continuing: Unknown [ MedDRA 19.1 ( ): Type 2 dibetes mellitus ] Continuing: Unknown [ MedDRA 19.1 ( ): Aortocoronry bypss ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24. NAME AND ADRESS OF SENDER * 2. AG Adult (>18.Lj. bis einschl. 65.Lj.) Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 04-NOV- DATE OF THIS REPORT 17-NOV- 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continution on ttched sheet(s)
2 17-NOV- Report Pge: 2 of Describe Rection(s) (including relevnt tests/lb dt) (... continution...) Rection text s reported MedDRA coding Outcome* Term highlighted Time intervl 1** Time intervl 2*** [MedDRA 19.1 PT ( ): Abdominl discomfort ] ( ): Abdominl discomfort ] [MedDRA 19.1 PT ( ): Bck pin ] ( ): Bck pin ] [MedDRA 19.1 PT ( ): Dizziness ] ( ): Lighthededness ] [MedDRA 19.1 PT ( ): Insomni ] ( ): Insomni ] [MedDRA 19.1 PT ( ): Mylgi ] ( ): Mylgi ] [MedDRA 19.1 PT ( ): Skin rection ] ( ): Skin rection ] * Outcome of rection/event t the time of lst observtion ** Time intervl between beginning of suspect drug *** nd strt of rection/event Results of tests Dte Test Result Unit rml low rnge rml high rnge More inform. vilble 19-OCT- Cholesterol 253 mg/dl 19-OCT- LDL 152 mg/dl 19-OCT- HbA1C 5.9 % 14. (s) (including generic nme) (... continution...) Administrtion torvsttin 02-MAR- 12-MAY- 72 Dy A: C: 20Mg
3 17-NOV- Report Pge: 3 of 7 Cumultive dose number (to first rection) Number of seprte dosges Number of units in the intervl torvsttin Cuslity ssessment Rection Source Method Result AkdÄ Globl Introspection (WHO GI) 14. (s) (including generic nme) (... continution...) Administrtion fluvsttin 02-AUG- 01-SEP- 31 Dy A: C: 20Mg
4 17-NOV- Report Pge: 4 of 7 Cumultive dose number (to first rection) Number of seprte dosges Number of units in the intervl fluvsttin 14. (s) (including generic nme) (... continution...) Administrtion simvsttin 02-SEP- 02-NOV- 62 Dy A: C: 20Mg Cumultive dose number (to first rection) Number of seprte dosges Number of units in the intervl simvsttin 14. (s) (including generic nme) (... continution...) Administrtion prvsttin 04-JUL- 02-AUG- 30 Dy A: C: 10Mg
5 17-NOV- Report Pge: 5 of 7 Cumultive dose number (to first rection) Number of seprte dosges Number of units in the intervl prvsttin 14. (s) (including generic nme) (... continution...) Administrtion ezetimib 29-FEB- 04-MAR- 5 Dy A: C: 10Mg
6 17-NOV- Report Pge: 6 of 7 Cumultive dose number (to first rection) Number of seprte dosges Number of units in the intervl ezetimibe 23. Other relevnt history (... continution...) Rections, Symptoms nd Events Continuing Comments [ MedDRA 19.1 ( ): Coronry rtery disese ] Unknown [ MedDRA 19.1 ( ): Type 2 dibetes mellitus ] Unknown [ MedDRA 19.1 ( ): Aortocoronry bypss ] Unknown Z.n. ACVB-OP [ MedDRA 19.1 ( ): Percutneous trnsluminl coronry ngioplsty ] Z.n. PTCA RIVA [ MedDRA 19.1 ( ): Middle cerebrl rtery infrct ] Z.n. Cerebri medi Infrkt [ MedDRA 19.1 ( ): Peripherl rteril occlusive disese ] [ MedDRA 19.1 ( ): Prosthetic vessel implnttion ] MAR- Unknown Unknown Z.n. Y-Prothese [ MedDRA 19.1 ( ): Mixed hyperlipidemi ] Unknown Report duplictes Duplicte source Duplicte number DE-DCGMA Ptient pst drug therpy Nme of drug s reported Indiction MedDRA code Rections MedDRA code colestyrmin [ MedDRA 19.1 (0): unbeknnt ] [ MedDRA 19.1 ( ): INR fluctution ] fibrte [ MedDRA 19.1 (0): unbeknnt ] [ MedDRA 19.1 ( ): Renl insufficiency ] fibrte [ MedDRA 19.1 (0): unbeknnt ] [ MedDRA 19.1 ( ): Hyperklemi ] Prent Prent identifiction Dte of birth Age LMP Weight(kg) Height(cm) Sex Text for relevnt medicl history nd concurrent conditions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Sfetyreportversion 1
7 17-NOV- Report Pge: 7 of 7 where the rection/event occur Serious Dte Formt of receipt of the most recent informtion for this report Additionl documents 1104 List of documents held by sender Does this cse fulfill the locl criteri for n expedited report? Regultory uthority's cse report number Other cse identifiers in previous trnsmissions Ws the cse mediclly confirmed, if not initilly from helth professionl? Primry source(s) of informtion Reporter postcode Reporter country Qulifiction Literture reference(s) Study nme Sponsor study number Study type in which the rection(s)/event(s) were observed 49 Physicin SENDER INFORMATION (... continution...) Type Orgnistion Helth professionl Deprtment Street ddress City Berlin Postcode Country Fx +49 / (0) / Telephone +49 / (0) / E-mil ddress phv@kde.de PATIENT INFORMATION (... continution...) Investigtion number Gesttion period Ptient ge group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 93 Height (cm) 173 Lst menstrul periode Text for relevnt medicl history nd concurrent conditions
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