The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASEID CASEVERSION I F COD EVENT DT MFR DT INIT FDA DT FDA DT REPT COD AUTH NUM MFR NUM MFR SNDR LIT REF AGE AGE COD AGE GRP GNDR COD E SUB WT WT COD REPT DT TO MFR OCCP COD REPORTER COUNTRY OCCR COUNTRY
127099921 12709992 1 I 20160731 20160804 20160902 20160902 EXP DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-51456DE BOEHRINGER INGELHEIM 78.00 YR M Y 84.00000 KG 20160902 MD DE DE

Drug(s) used by person

Event ID CASEID DRUG SEQ ROLE COD DRUGNAME PROD AI VAL VBM ROUTE DOSE VBM CUM DOSE CHR CUM DOSE UNIT DECHAL RECHAL LOT NUM EXP DT NDA NUM DOSE AMT DOSE UNIT DOSE FORM DOSE FREQ
127099921 12709992 1 PS PRADAXA DABIGATRAN ETEXILATE MESYLATE 1 Oral 220 MG 22512 110 MG CAPSULE, HARD BID
127099921 12709992 2 SS ASPIRIN. ASPIRIN 1 Oral 100 MG 0 100 MG QD
127099921 12709992 3 SS ASPIRIN. ASPIRIN 1 0
127099921 12709992 4 SS ASPIRIN. ASPIRIN 1 0
127099921 12709992 5 SS CLOPIDOGREL CLOPIDOGREL BISULFATE 1 Oral 7 MG 0 7 MG QD
127099921 12709992 6 SS CLOPIDOGREL CLOPIDOGREL BISULFATE 1 0
127099921 12709992 7 SS CLOPIDOGREL CLOPIDOGREL BISULFATE 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127099921 12709992 1 Atrial fibrillation
127099921 12709992 2 Percutaneous coronary intervention
127099921 12709992 3 Coronary arterial stent insertion
127099921 12709992 4 Coronary artery disease
127099921 12709992 5 Percutaneous coronary intervention
127099921 12709992 6 Coronary arterial stent insertion
127099921 12709992 7 Coronary artery disease

Outcome of event

Event ID CASEID OUTC COD
127099921 12709992 HO
127099921 12709992 LT
127099921 12709992 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127099921 12709992 Dizziness
127099921 12709992 Fall
127099921 12709992 Haemorrhage intracranial
127099921 12709992 Headache
127099921 12709992 Laceration
127099921 12709992 Subdural haemorrhage
127099921 12709992 Syncope

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

no results found

Therapies reported

Event ID CASEID DSG DRUG SEQ START DT END DT DUR DUR COD
127099921 12709992 1 20160430 20160731 0