The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASE I F COD FOLL SEQ IMAGE EVENT DT MFR DT FDA DT REPT COD MFR NUM MFR SNDR AGE AGE COD GNDR COD E SUB WT WT COD REPT DT OCCP COD DEATH DT TO MFR CONFID REPORTER COUNTRY
5388052 6530143 F 1 5388052-6 20070626 20070712 EXP DSA_30057_2007 BIOVAIL PHARMACEUTICALS INC. F N 20070711 MD JAPAN

Drug(s) used by person

Event ID DRUG SEQ ROLE COD DRUGNAME VAL VBM ROUTE DOSE VBM DECHAL RECHAL LOT NUM EXP DT NDA NUM
5388052 1008701184 PS DILTIAZEM HCL 1 ORAL 100 MG QD ORAL D D 18602
5388052 1008713012 SS FLUVASTATIN 1 ORAL 20 MG ORAL D D

Indications of drugs used

Event ID DRUG SEQ INDI PT
5388052 1008701184 HYPERTENSION
5388052 1008713012 HYPERCHOLESTEROLAEMIA

Outcome of event

Event ID OUTC COD
5388052 LT

Reactions reported

Event ID PT
5388052 LARGE INTESTINE CARCINOMA

Reporting Sources (this data is often not reported and may therefore be missing here)

Event ID RPSR COD
5388052 FGN
5388052 HP
5388052 OTH

Therapies reported

Event ID DRUG SEQ START DT END DT DUR DUR COD
5388052 1008701184 19980401
5388052 1008713012 20020204 20070128