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
125527791 12552779 1 I 20160705 20160713 20160713 EXP US-LUNDBECK-DKLU2016106 LUNDBECK 0.00 F Y 0.00000 20160713 MD US 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
125527791 12552779 1 PS ONFI CLOBAZAM 1 Unknown 203993 1 ML ORAL SUSPENSION BID
125527791 12552779 2 SS ONFI CLOBAZAM 1 Unknown 203993 3 ML ORAL SUSPENSION BID
125527791 12552779 3 SS ONFI CLOBAZAM 1 203993
125527791 12552779 4 SS DEPAKOTE DIVALPROEX SODIUM 1 Unknown 0
125527791 12552779 5 C KEPPRA LEVETIRACETAM 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125527791 12552779 1 Idiopathic generalised epilepsy
125527791 12552779 2 Epilepsy
125527791 12552779 3 Status epilepticus
125527791 12552779 4 Product used for unknown indication
125527791 12552779 5 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
125527791 12552779 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125527791 12552779 Aggression
125527791 12552779 Atonic seizures
125527791 12552779 Mood altered
125527791 12552779 Myoclonus
125527791 12552779 Seizure
125527791 12552779 Urinary incontinence

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
125527791 12552779 1 20160523 0