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
125422381 12542238 1 I 20160705 20160708 20160708 PER US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-44669BI BOEHRINGER INGELHEIM MAW T,HENRY B,SINGH T. USE OF HEMODIALYSIS FOR THE TREATMENT OF INTRACEREBRAL HEMORRHAGE IN PATIENTS ON DABIGATRAN WITH NORMAL RENAL FUNCTION. CLINICAL NEPHROLOGY. CASE STUDIES 2015;2015:1:. 68.00 YR F Y 0.00000 20160709 OT COUNTRY NOT SPECIFIED US

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
125422381 12542238 1 PS PRADAXA DABIGATRAN ETEXILATE MESYLATE 1 Unknown 300 MG 22512 150 MG BID

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125422381 12542238 1 Atrial fibrillation

Outcome of event

Event ID CASEID OUTC COD
125422381 12542238 HO
125422381 12542238 LT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125422381 12542238 Haemorrhage intracranial

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

no results found

Therapies reported

no results found